Private company
NKGen Biotech, Inc.
American biological products company based in Wilmington2
In its 2025 annual report the company says: “We are a biotechnology company developing cell therapies for neurodegenerative and oncological diseases based on activated NK cells. Our product candidates are based on a proprietary manufacturing and cryopreservation process which produces SuperNK TM cells that have shown increased activity as compared to the starting population of NK cells, based on the results of in vitro experiments performed by NKMAX, as defined by parameters such as cytotoxicity, cytokine production and activating receptor expression.”4
Last updated Oct 20, 2026.
Overview
- IndustryBiological Products, (No Diagnostic Substances)2
- HeadquartersWilmington, United States2
- Incorporated inDE3
- Business address3001 Daimler St,, Santa Ana, Ca 927053
- Filer category, Emerging growth company3
- Legal formCorporation2
- LEI988400S3R367UBPJDZ552
- StatusActive2
- LEI statusIssued and current2
- Registered address251 Little Falls Drive, Wilmington, 19808 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 49077812
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Our mission is to improve patient outcomes in the areas of neurodegenerative and oncological diseases by developing safe and effective cellular therapies that leverage the power of a patient’s immune system. Our vision is to become the global leader in natural killer (“ NK ”) cell therapies.4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2023
Financial statements
| Fiscal year | 2021 | 2022 | 2023 |
|---|---|---|---|
| Revenue | $77.0K5 | $05 | |
| Cost of revenue | $18.0K5 | $05 | |
| Research and development | $16.7M5 | $15.7M6 | |
| Operating expenses | $24.4M5 | $29.7M6 | |
| Operating income | -$24.3M5 | -$29.7M6 | |
| Interest | $2.3M5 | $745.0K5 | |
| Income before tax | -$26.7M5 | -$82.9M5 | |
| Income tax | $7.0K5 | $7.0K6 | |
| Net income | -$26.8M5 | -$83.0M6 | |
| Earnings per share | -$4.215 | -$5.386 | |
| Earnings per share (diluted) | -$4.215 | -$5.386 | |
| Shares (weighted, basic) | 6.4M shares5 | 15.4M shares6 | |
| Shares (weighted, diluted) | 6.4M shares5 | 15.4M shares6 |
| Fiscal year | 2021 | 2022 | 2023 |
|---|---|---|---|
| Cash | $1.7M10 | $117.0K5 | $26.0K6 |
| Receivables | $29.0K5 | $05 | |
| Current assets | $2.5M10 | $350.0K5 | $1.9M6 |
| Property, plant and equipment | $15.5M5 | $14.5M6 | |
| Total assets | $174.2M10 | $16.3M5 | $16.5M6 |
| Accounts payable | $51.8K10 | $975.0K5 | $11.0M6 |
| Short-term debt | $05 | $5.0M5 | |
| Current liabilities | $1.9M10 | $14.7M5 | $39.5M6 |
| Total liabilities | $13.5M10 | $14.8M5 | $75.2M6 |
| Retained earnings | -$10.9M10 | -$79.2M5 | -$162.1M6 |
| Shareholders’ equity | -$38.1M5 | $1.6M6 | -$58.7M6 |
| Shares outstanding | 4.3M shares11 | 13.3M shares5 | 21.9M shares6 |
Corporate structure
NKGen Biotech, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of NKGen Biotech, Inc.
- CFIC-2015 NV Family Investments, LLC Filed SCHEDULE 13D on NKGen Biotech, Inc., latest Jun 2, 2025 (2 filings since Aug 22, 2024)
- METEORA CAPITAL, LLC Filed SCHEDULE 13G/A on NKGen Biotech, Inc., latest May 15, 2025 (4 filings since Feb 14, 2024)
- Paul Y. Song Filed SCHEDULE 13D on NKGen Biotech, Inc., latest May 12, 2025
- PATHSTONE FAMILY OFFICE, LLC Filed SCHEDULE 13G on NKGen Biotech, Inc., latest Feb 28, 2025
- Radcliffe Capital Management, L.P. Filed SC 13G/A on NKGen Biotech, Inc., latest Feb 14, 2024 (2 filings since May 23, 2023)
- ADAGE CAPITAL PARTNERS GP, L.L.C. Filed SC 13G/A on NKGen Biotech, Inc., latest Feb 7, 2024
- NKMAX Co., Ltd. Filed SC 13D/A on NKGen Biotech, Inc., latest Dec 19, 2023 (2 filings since Oct 10, 2023)
- HIGHBRIDGE CAPITAL MANAGEMENT LLC Filed SC 13G/A on NKGen Biotech, Inc., latest Jan 25, 2023 (2 filings since Feb 3, 2022)
- Graf Acquisition Partners IV LLC Filed SC 13G on NKGen Biotech, Inc., latest Feb 11, 2022
- NKGen Biotech, Inc. Wilmington, Delaware, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What NKGen Biotech, 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 | $18.2M6 Dec 31, 2024 | $18.3M6 Dec 31, 2023 | −0.5% |
| Accumulated depreciation | $4.9M6 Dec 31, 2024 | $3.8M6 Dec 31, 2023 | +28.2% |
| Property and equipment, net | $13.3M6 Dec 31, 2024 | $14.5M6 Dec 31, 2023 | −8.0% |
| Operating-lease assets (leased space) | $379.0K6 Dec 31, 2024 | $06 Dec 31, 2023 |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $106.0K6 Dec 31, 2024 | $26.0K6 Dec 31, 2023 | +307.7% |
Properties, in its own words
Our principal office is located in Santa Ana California, where we own approximately 25,000 square feet of office, manufacturing and laboratory space, approximately half of which is fit for GMP production of NK cells. We also lease office facilities in Irvine, California.
We believe our facilities are adequate to meet its current needs, although we may seek to negotiate new leases or evaluate additional or alternate space for its operations.
Item 2 of the 10-K filed Oct 8, 2025.4
Leadership
Who has led NKGen Biotech, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
Chief operating officer
- Chief executive officerPaul Y. Song Oct 10, 2023 to now12
- Chief executive officerJames A. Graf May 20, 2021 to Jul 14, 202113
- PresidentGus Garcia May 20, 2021 to May 26, 202114
- PresidentLewis Silberman May 20, 2021 to May 20, 202115
- Chief financial officerJames A. Graf Oct 4, 2023 to now16
- Chief financial officerSterling Cross May 12, 2022 to May 12, 202217
- Chief financial officerAnantha Ramamurti May 20, 2021 to May 20, 202118
- Chief operating officerPierre Gagnon Oct 10, 2023 to now19
Board members and other officers (14)
- CSO and CIOYong Man Kim Oct 10, 2023 to now20
- EVP, GC and SecretaryAnthony A. Kuznik May 20, 2021 to May 20, 202121
- EVP, StrategySabrina McKee May 20, 2021 to May 20, 202122
- Board memberMarco Gottardis Jul 18, 2024 to now23
- Board memberAlana B. McNulty Oct 10, 2023 to Oct 10, 202324
- Board memberKathleen D. Scott Oct 10, 2023 to now25
- Board memberMichael Klowden Oct 10, 2023 to now26
- Board memberPaul Y. Song Oct 10, 2023 to now12
- Board memberAnatolio B. Cruz Iii. May 20, 2021 to May 20, 202127
- Board memberEdwin Rigaud May 20, 2021 to May 20, 202128
- Board memberGus Garcia May 20, 2021 to May 26, 202114
- Board memberJeanne L. Manischewitz May 20, 2021 to May 20, 202129
- Board memberLewis Silberman May 20, 2021 to May 20, 202115
- Board memberAlexandra Lebenthal Jul 14, 2021 to Jul 14, 202130
Former names
- Graf Acquisition Corp. IVFeb 23, 2021 to Sep 29, 20233
Timeline
- Sep 2, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares31
- Jul 17, 20268-K Entered a material agreement32
- Jun 2, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares33
- May 21, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares34
- May 4, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares35
- Apr 21, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares36
- Feb 26, 20268-K Entered a material agreement; New debt or obligation37
- Feb 5, 20268-K Entered a material agreement; New debt or obligation38
- Jan 26, 20268-K Entered a material agreement; New debt or obligation39
- Jan 16, 20268-K Entered a material agreement; New debt or obligation40
- Jan 9, 20268-K Entered a material agreement; New debt or obligation41
- Sep 29, 20258-K Entered a material agreement42
- Oct 10, 2023New chief executive Paul Y. Song becomes CEO12
- May 20, 2021New chief executive James A. Graf becomes CEO13
- Jan 28, 2021Founded NKGen Biotech, Inc. is founded2
Calendar
When it reported results
- Nov 14, 2023Reported quarterly or annual results43
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
243 filings to the SEC since October 2021: 5 annual reports, 12 quarterly reports, 98 major events, 32 insider forms, 16 large holders, 80 other. The latest 20:
- Sep 2, 20268-K CURRENT REPORT EDGAR
- Jul 17, 20268-K CURRENT REPORT EDGAR
- Jun 2, 20268-K CURRENT REPORT EDGAR
- May 21, 20268-K CURRENT REPORT EDGAR
- May 4, 20268-K CURRENT REPORT EDGAR
- Apr 21, 20268-K CURRENT REPORT EDGAR
- Feb 26, 20268-K CURRENT REPORT EDGAR
- Feb 5, 20268-K CURRENT REPORT EDGAR
- Jan 26, 20268-K CURRENT REPORT EDGAR
- Jan 20, 202610-Q EDGAR
- Jan 16, 20268-K CURRENT REPORT EDGAR
- Jan 9, 20268-K CURRENT REPORT EDGAR
- Oct 8, 202510-K EDGAR
- Sep 29, 20258-K CURRENT REPORT EDGAR
- Sep 24, 20258-K CURRENT REPORT EDGAR
- Sep 9, 20258-K CURRENT REPORT EDGAR
- Jul 17, 20258-K CURRENT REPORT EDGAR
- Jul 16, 20258-K CURRENT REPORT EDGAR
- Jun 20, 20258-K CURRENT REPORT EDGAR
- Jun 2, 2025SCHEDULE 13D EDGAR
The 243 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
13 open-market trades by officers, directors and large owners since October 2021: 13 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| May 27, 2025 | Cherng Andrew Jin-Chan10% owner | Buy | 19,669,552 | $0.13 | $2.6M | Form 4 |
| May 5, 2025 | Song Paul Y.Chief Executive Officer | Buy | 20,849,725 | $0.13 | $2.7M | Form 4 |
| Dec 7, 2023 | Song Paul Y.Chief Executive Officer | Buy | 76 | $3.29 | $250 | Form 4 |
| Dec 6, 2023 | Song Paul Y.Chief Executive Officer | Buy | 75 | $3.32 | $250 | Form 4 |
| Dec 5, 2023 | Song Paul Y.Chief Executive Officer | Buy | 105 | $3.33 | $350 | Form 4 |
| Dec 4, 2023 | Song Paul Y.Chief Executive Officer | Buy | 163 | $3.07 | $500 | Form 4 |
| Dec 4, 2023 | Graf James AInterim CFO | Buy | 450 | $3.19 | $1.4K | Form 4 |
| Dec 1, 2023 | Graf James AInterim CFO | Buy | 220 | $3.35 | $737 | Form 4 |
| Nov 27, 2023 | Song Paul Y.Chief Executive Officer | Buy | 244 | $2.88 | $701 | Form 4 |
| Nov 22, 2023 | Song Paul Y.Chief Executive Officer | Buy | 53 | $2.85 | $150 | Form 4 |
| Nov 21, 2023 | Graf Acquisition Partners IV LLC10% owner | Buy | 13 | $2.92 | $38 | Form 4 |
| Nov 21, 2023 | Song Paul Y.Chief Executive Officer | Buy | 100 | $2.80 | $280 | Form 4 |
| Nov 20, 2023 | Graf Acquisition Partners IV LLC10% owner | Buy | 10 | $2.94 | $29 | 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.
- CFIC-2015 NV Family Investments, LLCSCHEDULE 13D, 2 filings Aug 22, 2024 to Jun 2, 202544
- METEORA CAPITAL, LLCSCHEDULE 13G/A, 4 filings Feb 14, 2024 to May 15, 202545
- Paul Y. SongSCHEDULE 13D, 1 filing May 12, 202546
- PATHSTONE FAMILY OFFICE, LLCSCHEDULE 13G, 1 filing Feb 28, 202547
- Radcliffe Capital Management, L.P.SC 13G/A, 2 filings May 23, 2023 to Feb 14, 202448
- ADAGE CAPITAL PARTNERS GP, L.L.C.SC 13G/A, 1 filing Feb 7, 202449
- NKMAX Co., Ltd.SC 13D/A, 2 filings Oct 10, 2023 to Dec 19, 202350
- HIGHBRIDGE CAPITAL MANAGEMENT LLCSC 13G/A, 2 filings Feb 3, 2022 to Jan 25, 202351
- Graf Acquisition Partners IV LLCSC 13G, 1 filing Feb 11, 202252
SEC filer profile
How NKGen Biotech, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARNKGen Biotech, Inc.1
- CIK0001845459
- Employer ID (EIN)86-21919184
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- 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 address3001 Daimler St,, Santa Ana, CA 927051
- Phone(949) 396-68301
- Shares outstanding130,602,230 as of Jan 16, 20269
- Public float$13.7M as of Jun 30, 20254
- AuditorWithumSmith+Brown, PC, San Francisco, California PCAOB ID 100; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceFeb 23, 20211
- Filings276 in all: 8-K (102), 4 (28), 425 (21), 3 (20), 10-Q (13), CORRESP (11), UPLOAD (10), 424B3 (6)1
All 36 form types
S-1/A (6), SC 13G (6), SC 13G/A (5), 10-K (4), DEF 14A (4), NT 10-Q (4), PRE 14A (4), S-4/A (4), EFFECT (3), 8-A12B (2), CERT (2), NT 10-K (2), S-1 (2), SCHEDULE 13D (2), SCHEDULE 13G/A (2), 10-K/A (1), 10-Q/A (1), 25 (1), 25-NSE (1), 424B4 (1), 8-K/A (1), ARS (1), DEFA14A (1), PRER14A (1), S-4 (1), SC 13D (1), SC 13D/A (1), SCHEDULE 13G (1)
- Latest filingsAnnual report (10-K) Oct 8, 2025
Quarterly report (10-Q) Jan 20, 2026
Proxy statement (DEF 14A) Feb 3, 2025
Latest 8-K (8-K) Sep 2, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.0001 par value per share | NKGN | |
| Warrants, each whole warrant exercisable for one share of Common Stock at an exercise price of $11.50 per share | NKGNW |
From the cover page of the 10-K filed Oct 8, 2025 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks NKGen Biotech, Inc. names in Item 1A of its 10-K filed Oct 8, 2025: 72 risks under these headings, as written.4
- Risks Related to Our Business and Industry
- Risks Related to Our Financial Position
- Risks Related to Government Regulations
- Risks Related to Manufacturing
- Risks Related to Our Intellectual Property
- Risks Related to Ownership of Our Securities
- We currently do not have sufficient funds to service our operations and accrued expenses and payables and require additional capital. Our independent registered public accountants and management have expressed substantial doubt as to our ability to continue as a going concern without additional capital.
- Our business depends upon the success of our NK cell therapy platform.
- Utilizing NK cells represents a novel approach to the treatment of oncological and neurodegenerative diseases, and we must overcome significant challenges in order to develop, commercialize and manufacture our product candidates.
- Certain aspects of the function and production of NK cells are currently unknown or poorly understood, and may only become known through further preclinical testing and clinical trials. Any potential changes to our process may result in delays and additional expenses.
- Results of any patient who receives our product candidates through the compassionate use access program should not be viewed as representative of how the product candidate will perform in a well-controlled clinical trial, and cannot be used to establish safety or efficacy for regulatory approval.
- Clinical development involves a lengthy and expensive process with an uncertain outcome, and we may encounter substantial delays due to a variety of reasons outside our control.
The other 66 risks
- Our business is highly dependent on the clinical success of our product candidates, and on the clinical success of SNK01 and SNK02 in particular, and we may fail to develop SNK01, SNK02 and/or our other product candidates successfully or may be unable to obtain regulatory approval for them.
- Even if we obtain regulatory approval for a product candidate, our products will remain subject to continuous subsequent regulatory obligations and scrutiny.
- We have never commercialized a product candidate before, and we may lack the necessary expertise, personnel and resources to successfully commercialize any products, if approved. We may be unable to establish effective marketing and sales capabilities or enter into agreements with third parties or related parties to market and sell our product candidates, if they are approved, and as a result, we may be unable to generate product revenues.
- Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by multiple factors outside our control.
- Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all.
- The results of preclinical studies and early-stage clinical trials may not be predictive of future results. Interim, “topline” and preliminary data from our clinical trials may differ materially from the final data.
- If any of our product candidates, or any competing product candidates, demonstrate relevant, serious adverse events, we may be required to halt or delay further clinical development.
- If we are not able to maintain or secure agreements with the third parties that conduct the activities related to our clinical trials on acceptable terms, or at all, or if these third parties do not perform their services as contractually required, or if these third parties fail to timely transfer any regulatory information held by them to us, we may not be able to obtain regulatory approval for our product candidates or commercialize any product candidates that may result from our development efforts, or may miss expected deadlines.
- Our business also may be implicated if any of our CROs and/or clinical trial sites violates fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.
- Our approach to the development of product candidates based on our NK cell therapy platform is unproven, and we do not know whether we will be able to develop any products of commercial value, or if competing technological approaches will limit the commercial value of our product candidates or render our platform obsolete.
- We may seek special designations by the regulatory authorities to expedite regulatory approvals, but may not be successful in receiving such designations, and even if received, they may not benefit the development and regulatory approval process.
- Public opinion and scrutiny of cell-based immuno-oncology therapies for treating neurodegenerative diseases may impact public perception of our company and product candidates, or impair our ability to conduct our business.
- We may not identify or discover other product candidates and may fail to capitalize on programs or product candidates that may present a greater commercial opportunity or for which there is a greater likelihood of success.
- If third parties that we rely on to conduct clinical trials do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize our product candidates.
- If we are not able to establish pharmaceutical or biotechnology collaborations on commercially reasonable terms, or at all, we may have to alter our development and commercialization plans.
- If any of our product candidates are approved for marketing and commercialization and we have not developed or secured marketing, sales and distribution capabilities, either internally or from third parties, we will be unable to successfully commercialize such products and may not be able to generate product revenue.
- The market opportunities for our product candidates, if and when approved, may be limited, and if such market opportunities are smaller than we expect, our revenues could be materially adversely affected and our business could suffer.
- The commercial success of any of our product candidates will depend upon such product candidate’s degree of market acceptance by physicians, patients, third-party payors and others in the medical community.
- We have entered into a collaboration agreement with HekaBio regarding certain product candidates, and we may enter into additional collaborations with third parties to develop or commercialize other product candidates. Our prospects with respect to those product candidates will depend in significant part on the success of those collaborations, and we may not realize the benefits of such collaborations.
- If we fail to compete effectively with academic institutions and other biotechnology companies that develop similar or alternatives to cellular immunotherapy product candidates, our business will be materially adversely affected.
- Risks related to the assets to be acquired in the Acquisition, if consummated, may adversely affect our business, financial condition and results of operation.
- We will need to increase the size of our organization, and we may experience difficulties in managing growth.
- If we fail to attract and retain senior management, clinical, and key scientific personnel, we may be unable to successfully develop our product candidates, conduct our clinical trials and commercialize our product candidates.
- Our employees, independent contractors, consultants, commercial partners, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- If any of the third parties that we rely on for various operational and administrative aspects of our business fail to provide timely, accurate and ongoing service or if the technology systems and infrastructure suffer outages that we are unable to mitigate, our business may be adversely affected.
- Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop.
- Our insurance policies may be inadequate, may not cover all of our potential liabilities and may potentially expose us to unrecoverable risks.
- Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
- We have a limited operating history, have incurred significant losses since our inception, and we expect to continue to incur significant losses for the foreseeable future.
- We have never generated revenue from product sales and may never achieve or maintain profitability.
- The East West Bank Loan Agreement and Equity and Business Loan Agreement (as defined below) provide each lender with a security interest in all of our assets, and contain financial covenants and other restrictions on our actions that may limit our operational flexibility or otherwise adversely affect our results of operations.
- The terms of our 2023 NKMAX Loan Agreements, the East West Bank Loan Agreement, the Equity and Business Loan Agreement, our Unsecured Notes and PIPE Warrants, require us to meet certain payment obligations, and may subject us to default.
- The regulatory approval process of the FDA and comparable foreign regulatory authorities are lengthy, time- consuming and inherently unpredictable, and even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval for any of our product candidates, and any such regulatory approval may be for a more narrow indication than we seek.
- We are and will be subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti- corruption laws and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We could face criminal and/or civil liability and other serious consequences for violations, which would harm our business.
- Healthcare reform initiatives and other administrative and legislative proposals may harm our business.
- If third-party payors fail to provide adequate coverage and reimbursement for our product candidates it could have a material adverse effect on our operating results and overall financial condition.
- Obtaining and maintaining marketing approval or commercialization of our product candidates in one jurisdiction does not mean that we will be successful in obtaining marketing approval of our product candidates in other jurisdictions.
- Our business operations and relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable fraud and abuse and other healthcare laws and regulations, which could expose us to penalties.
- We are subject to stringent and evolving laws, regulations, rules, contractual obligations, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions, litigation, fines and penalties, disruptions of our business operations, reputational harm, loss of revenue or profits, and other adverse business consequences.
- Our manufacturing process is novel and complex, and we may encounter difficulties in production, or difficulties with internal manufacturing, which would delay or prevent our ability to provide a sufficient supply of our product candidates for clinical trials or our products for patients, if approved.
- Delays in commissioning and receiving regulatory approvals for our manufacturing facilities could delay our development plans and thereby limit our ability to develop our product candidates and generate revenues.
- Any contamination or interruption in our manufacturing process, shortages of raw materials or failure of our suppliers to deliver necessary components could result in delays in our clinical development or marketing schedules.
- The optimal donor and manufacturing parameters for our product candidates have not been definitively established, which may hinder our ability to optimize our product candidates or to address any safety or efficacy issues that may arise.
- Dependency on third parties to store our NK cells, viral vector, master and working cell banks, and any damage or loss would cause delays in replacement, and our business could suffer.
- We have not yet established a shelf life beyond one to two years for our product candidates, which may have an impact on commercial supply and expenses.
- We may need to license additional intellectual property from third parties, and any such licenses may not be available or may not be available on commercially reasonable terms.
- Our development and commercialization rights to our current and future product candidates and technology are subject, in part, to the terms and conditions of licenses granted to us by others.
- Duration of patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time, and the expiration of our patents may subject us to increased competition.
- If any patent protection we or our licensors obtain is not sufficiently robust, our competitors could develop and commercialize products and technology similar or identical to ours.
- Even after issuance, our in-licensed patents or patents we obtain the future may be subject to challenge, which if successful could require us to obtain licenses from third parties, which may not be available on commercially reasonable terms or at all, or to cease the use of the underlying technology, which could materially and adversely affect our business.
- We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which could materially and adversely affect our ability to develop, manufacture and market our product candidates.
- Claims brought against us for infringing, misappropriating or otherwise violating intellectual property rights of third parties or engaging in unfair competition, would be costly and time-consuming and could prevent or delay us from successfully developing or commercializing our product candidates.
- We may not be able to effectively monitor unauthorized use of our intellectual property and enforce our or our in- licensed intellectual property rights against infringement, and may incur substantial costs as a result of bringing litigation or other proceedings relating to our or our in-licensed intellectual property rights.
- We and our licensors will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
- Changes in U.S. patent law or the patent law of other jurisdictions could decrease the certainty of our or our licensors’ ability to obtain patents and diminish the value of patents in general, thereby impairing our ability to protect our current and any future product candidates.
- We may fail to obtain or enforce assignments of intellectual property rights from our employees and contractors.
- If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and product candidates could be materially diminished.
- General Risk Factors
- Our business is affected by macroeconomic conditions, including rising inflation, interest rates and supply chain constraints.
- Any acquisitions or strategic collaborations may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities or subject us to other risks.
- Changes to, or interpretations of, financial accounting standards may affect our results of operations and could cause us to change our business practices.
- If our information technology systems or data, or those of third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions, litigation, fines and penalties, disruptions of our business operations, reputational harm, loss of revenue or profits, and other adverse consequences.
- We are an “emerging growth company” and “smaller reporting company” within the meaning of the Securities Act and if it takes advantage of certain exemptions from disclosure requirements available to emerging growth companies, it could make our securities less attractive to investors and may make it more difficult to compare our performance to the performance of other public companies.
- Our stock price may be volatile and may decline regardless of its operating performance.
- Our securities have been delisted from Nasdaq.
- Risk of Further Delisting and Additional Adverse Consequences
- We have not been able, and may continue to be unable, to timely file periodic reports with the SEC.
- Future sales of shares by existing stockholders could cause our stock price to decline.
Legal proceedings
From time to time, we may be subject to legal proceedings. We are not currently a party to or aware of any active legal proceedings that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 14SEC EDGARGus Garcia, President
- 15SEC EDGARLewis Silberman, President
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- 20SEC EDGARYong Man Kim, CSO and CIO
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- 22SEC EDGARSabrina McKee, EVP, Strategy
- 23SEC EDGARMarco Gottardis, Board member
- 24SEC EDGARAlana B. McNulty, Board member
- 25SEC EDGARKathleen D. Scott, Board member
- 26SEC EDGARMichael Klowden, Board member
- 27SEC EDGARAnatolio B. Cruz Iii., Board member
- 28SEC EDGAREdwin Rigaud, Board member
- 29SEC EDGARJeanne L. Manischewitz, Board member
- 30SEC EDGARAlexandra Lebenthal, Board member
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- 32SEC EDGAREntered a material agreement
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- 42SEC EDGAREntered a material agreement
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