Private company
Arcellx, Inc.
In its 2026 annual report the company says: “We are a clinical-stage biotechnology company focused on delivering a new class of innovative immunotherapies for patients with cancer and other incurable diseases. Our novel synthetic binding scaffold, the D-Domain, is designed to overcome the limitations of traditional CAR-Ts.”3 It is headquartered in Redwood City, California.1
Last updated Oct 21, 2026.
Overview
- IndustryBiological Products, (No Diagnostic Substances)1
- HeadquartersRedwood City, California1
- Incorporated inDE2
- Business address800 Bridge Parkway, Redwood City, Ca 940652
- Filer categoryLarge accelerated filer2
- Legal formCorporation
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We are a clinical-stage biotechnology company focused on delivering a new class of innovative immunotherapies for patients with cancer and other incurable diseases. We believe immunotherapies are one of the forward pillars of medicine, and our mission is to advance humanity by engineering immunotherapies that are safer, more effective and more broadly accessible. Although Chimeric Antigen Receptor T-cells (CAR-Ts) have shown benefits to date, they have primarily been constrained to existing biologic structures, which has limited their impact and opportunity. Our novel synthetic binding scaffold, the D-Domain, is designed to overcome the limitations of traditional CAR-Ts. Existing CAR-T therapy solutions, most of which use a biologic-based, single chain variable fragment (scFv) binding domain, tend to be difficult to manufacture, beneficial to a limited segment of patients, often result i…3 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 2025
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Research and development100¢$157.6M
- Income tax0¢$69.0K
Out of $22.3M in revenue.4 The company lost money this year.
Financial statements
| Fiscal year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| Revenue | $110.3M4 | $107.9M4 | $22.3M4 | |||
| Research and development | $46.9M5 | $149.6M6 | $133.8M4 | $157.1M4 | $157.6M4 | |
| Operating expenses | $65.0M5 | $191.3M6 | $200.2M4 | $245.5M4 | $275.4M4 | |
| Operating income | -$65.0M5 | -$191.3M6 | -$89.9M4 | -$137.6M4 | -$253.1M4 | |
| Income before tax | -$188.7M6 | -$70.0M4 | -$105.3M4 | -$228.9M4 | ||
| Income tax | $05 | $05 | $663.0K4 | $2.1M4 | $69.0K4 | |
| Net income | -$65.0M5 | -$188.7M6 | -$70.7M4 | -$107.3M4 | -$228.9M4 | |
| Earnings per share | -$145.555 | -$5.196 | -$1.474 | -$2.004 | -$4.074 | |
| Earnings per share (diluted) | -$145.555 | -$5.196 | -$1.474 | -$2.004 | -$4.074 | |
| Shares (weighted, basic) | 446.4K shares5 | 36.4M shares6 | 48.1M shares4 | 53.6M shares4 | 56.3M shares4 | |
| Shares (weighted, diluted) | 446.4K shares5 | 36.4M shares6 | 48.1M shares4 | 53.6M shares4 | 56.3M shares4 |
| Fiscal year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| Cash | $46.8M5 | $30.8M5 | $64.2M9 | $394.6M6 | $105.7M4 | $80.3M4 |
| Current assets | $112.8M5 | $266.9M9 | $716.4M6 | $599.3M4 | $462.2M4 | |
| Property, plant and equipment | $10.3M5 | $11.2M9 | $42.7M6 | $46.5M4 | $42.6M4 | |
| Total assets | $128.8M5 | $313.8M9 | $825.1M6 | $711.3M4 | $604.0M4 | |
| Accounts payable | $1.3M5 | $9.1M9 | $2.6M6 | $2.1M4 | $5.6M4 | |
| Current liabilities | $14.8M5 | $56.7M9 | $118.2M6 | $125.4M4 | $104.2M4 | |
| Total liabilities | $16.9M5 | $108.9M9 | $339.8M6 | $256.5M4 | $201.6M4 | |
| Retained earnings | -$130.1M5 | -$318.8M9 | -$389.5M6 | -$496.8M4 | -$725.8M4 | |
| Shareholders’ equity | -$63.7M5 | -$121.5M6 | -$205.0M4 | $485.4M4 | $454.8M4 | $402.4M4 |
| Shares outstanding | 544.2K shares5 | 44.1M shares9 | 52.3M shares6 | 54.3M shares4 | 57.9M shares4 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| Cash from operations | -$54.2M5 | -$99.3M6 | $207.6M4 | -$83.5M4 | -$210.3M4 | |
| Depreciation and amortization | $1.0M5 | $1.3M6 | $2.0M4 | $5.2M4 | $6.7M4 | |
| Stock-based compensation | $6.8M5 | $21.5M6 | $41.8M4 | $61.1M4 | $77.9M4 | |
| Capital spending | $5.8M5 | $2.3M6 | $21.4M4 | $13.4M4 | $2.3M4 | |
| Free cash flow | -$60.0M | -$101.6M | $186.1M | -$96.9M | -$212.6M | |
| Cash from investing | -$80.0M5 | -$117.7M6 | -$154.5M4 | -$183.0M4 | $86.3M4 | |
| Cash from financing | $118.5M5 | $252.6M6 | $279.2M4 | -$24.1M4 | $98.5M4 |
Corporate structure
Arcellx, 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 Arcellx, Inc.
- Paradigm Biocapital Advisors LP Filed SCHEDULE 13G/A on Arcellx, Inc., latest Aug 14, 2026 (5 filings since Jul 21, 2023)
- Vestal Point Capital, LP Filed SCHEDULE 13G/A on Arcellx, Inc., latest May 15, 2026 (2 filings since Feb 17, 2026)
- New Enterprise Associates 15, L.P. Filed SCHEDULE 13D/A on Arcellx, Inc., latest Apr 30, 2026 (7 filings since Feb 17, 2022)
- Gilead Sciences Filed SCHEDULE 13D/A on Arcellx, Inc., latest Apr 28, 2026 (4 filings since Feb 6, 2023)
- Rami Elghandour Filed SCHEDULE 13D/A on Arcellx, Inc., latest Apr 28, 2026 (4 filings since Nov 8, 2024)
- VANGUARD GROUP INC Filed SCHEDULE 13G/A on Arcellx, Inc., latest Mar 26, 2026 (3 filings since Jan 30, 2025)
- FMR LLC Filed SCHEDULE 13G/A on Arcellx, Inc., latest Mar 6, 2026 (8 filings since Feb 9, 2024)
- T. Rowe Price Investment Management, Inc. Filed SCHEDULE 13G/A on Arcellx, Inc., latest Mar 6, 2026 (4 filings since Sep 8, 2025)
- RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on Arcellx, Inc., latest Feb 17, 2026 (2 filings since Nov 22, 2024)
- PERCEPTIVE ADVISORS LLC Filed SCHEDULE 13G/A on Arcellx, Inc., latest Aug 14, 2025 (5 filings since Feb 14, 2023)
- BlackRock Filed SCHEDULE 13G/A on Arcellx, Inc., latest Apr 17, 2025 (6 filings since Feb 8, 2023)
- SR ONE CAPITAL MANAGEMENT, LLC Filed SC 13D/A on Arcellx, Inc., latest Mar 25, 2024 (6 filings since Feb 17, 2022)
- Arcellx, Inc. Redwood City, California
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Arcellx, 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 | $58.4M4 Dec 31, 2025 | $55.9M4 Dec 31, 2024 | +4.4% |
| Accumulated depreciation | $15.7M4 Dec 31, 2025 | $9.4M4 Dec 31, 2024 | +66.7% |
| Property and equipment, net | $42.6M4 Dec 31, 2025 | $46.5M4 Dec 31, 2024 | −8.2% |
| Operating-lease assets (leased space) | $23.8M4 Dec 31, 2025 | $23.8M4 Dec 31, 2024 | +0.2% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $80.3M4 Dec 31, 2025 | $105.7M4 Dec 31, 2024 | −24.1% |
| Marketable securities, current | $370.1M4 Dec 31, 2025 | $481.7M4 Dec 31, 2024 | −23.2% |
| Marketable securities, non-current | $69.7M4 Dec 31, 2025 | $38.3M4 Dec 31, 2024 | +82.1% |
| Debt securities available for sale | $439.8M4 Dec 31, 2025 | $520.0M4 Dec 31, 2024 | −15.4% |
Properties, in its own words
Our corporate headquarters are located in Redwood City, California, where we lease 51,822 square feet of office and laboratory space pursuant to a lease agreement that expires on January 31, 2034. In July 2022, we entered into an operating lease agreement for 57,902 square feet of office and laboratory space in Rockville, Maryland pursuant to a lease agreement that expires on May 31, 2035.
Item 2 of the 10-K filed Feb 26, 2026.3
Leadership
Who has led Arcellx, Inc., and when. Pick a name to see everywhere that person has worked.
Chief financial officer
- Chief financial officerMichelle Gilson May 24, 2022 to now10
Board members and other officers (13)
- Chief Medical OfficerChristopher Heery Feb 3, 2022 to now11
- OfficerLance E. Thibault Feb 3, 2022 to Feb 3, 202212
- OfficerRami Elghandour Feb 3, 2022 to now13
- Board memberAndrew H. Galligan Mar 20, 2025 to now14
- Board memberKristin Myers Mar 20, 2025 to now15
- Board memberAli Behbahani Feb 3, 2022 to now16
- Board memberDavid Charles Lubner Feb 3, 2022 to now17
- Board memberDerek Yoon Feb 3, 2022 to Jun 6, 202418
- Board memberJill Carroll Feb 3, 2022 to now19
- Board memberKavita Patel Feb 3, 2022 to now20
- Board memberLewis T. Williams Feb 3, 2022 to Feb 9, 202221
- Board memberRami Elghandour Feb 3, 2022 to now13
- Board memberOlivia C. Ware May 17, 2022 to now22
Timeline
- Apr 28, 20268-K Completed an acquisition or sale; Listing notice or transfer; Change to shareholders' rights23
- Feb 23, 20268-K Entered a material agreement; Regulation FD disclosure24
- Dec 8, 20258-K Other events25
- Nov 5, 20258-K Results of operations26
- Aug 7, 20258-K Results of operations27
- May 28, 20258-K Shareholder vote28
- May 14, 20258-K Other events29
- May 8, 20258-K Results of operations30
- Mar 20, 20258-K Executive or director change; Regulation FD disclosure31
- Feb 27, 20258-K Results of operations32
- Dec 12, 20248-K Other events33
- Dec 9, 20248-K Other events34
Calendar
When it reported results
- Nov 5, 2025Reported quarterly or annual results26
- Aug 7, 2025Reported quarterly or annual results27
- May 8, 2025Reported quarterly or annual results30
- Feb 27, 2025Reported quarterly or annual results32
- Nov 7, 2024Reported quarterly or annual results35
- Aug 8, 2024Reported quarterly or annual results36
- May 9, 2024Reported quarterly or annual results37
- Feb 28, 2024Reported quarterly or annual results38
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
444 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 46 major events, 187 insider forms, 64 large holders, 2 private raises, 124 other. The latest 20:
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- May 15, 2026SCHEDULE 13G/A EDGAR
- May 8, 202615-12G EDGAR
- Apr 30, 2026SCHEDULE 13D/A EDGAR
- Apr 28, 20264 EDGAR
- Apr 28, 20264 EDGAR
- Apr 28, 20264 EDGAR
- Apr 28, 20264 EDGAR
- Apr 28, 20264 EDGAR
- Apr 28, 20264 EDGAR
- Apr 28, 20264 EDGAR
- Apr 28, 20264 EDGAR
- Apr 28, 20264 EDGAR
- Apr 28, 20264 EDGAR
- Apr 28, 2026SCHEDULE 13D/A EDGAR
- Apr 28, 2026S-8 POS EDGAR
- Apr 28, 2026S-8 POS EDGAR
- Apr 28, 2026S-8 POS EDGAR
- Apr 28, 2026S-8 POS EDGAR
- Apr 28, 2026S-8 POS EDGAR
The 444 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
127 open-market trades by officers, directors and large owners since October 2021: 5 buys and 122 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Feb 27, 2026 | Elghandour RamiSEE REMARKS | Sale | 89,916 | $113.92 | $10.2M | Form 4 |
| Feb 25, 2026 | Gilson MichelleCHIEF FINANCIAL OFFICER | Sale | 11,219 | $113.82 | $1.3M | Form 4 |
| Feb 19, 2026 | Gilson MichelleCHIEF FINANCIAL OFFICER | Sale | 8,384 | $68.29 | $572.6K | Form 4 |
| Feb 17, 2026 | Gilson MichelleCHIEF FINANCIAL OFFICER | Sale | 11,291 | $69.50 | $784.8K | Form 4 |
| Jan 20, 2026 | Lubner David CharlesDirector | Sale | 6,000 | $75.00 | $450.0K | Form 4 |
| Jan 14, 2026 | Heery ChristopherCHIEF MEDICAL OFFICER | Sale | 5,882 | $68.51 | $403.0K | Form 4 |
| Jan 13, 2026 | Heery ChristopherCHIEF MEDICAL OFFICER | Sale | 7,437 | $65.51 | $487.2K | Form 4 |
| Jan 12, 2026 | Heery ChristopherCHIEF MEDICAL OFFICER | Sale | 6,131 | $64.15 | $393.3K | Form 4 |
| Nov 17, 2025 | Heery ChristopherCHIEF MEDICAL OFFICER | Sale | 340 | $90.00 | $30.6K | Form 4 |
| Oct 15, 2025 | Gilson MichelleCHIEF FINANCIAL OFFICER | Sale | 5,364 | $91.04 | $488.3K | Form 4 |
| Oct 6, 2025 | Gilson MichelleCHIEF FINANCIAL OFFICER | Sale | 1,064 | $86.22 | $91.7K | Form 4 |
| Oct 3, 2025 | Gilson MichelleCHIEF FINANCIAL OFFICER | Sale | 4,882 | $86.00 | $419.9K | Form 4 |
| Sep 30, 2025 | Heery ChristopherCHIEF MEDICAL OFFICER | Sale | 21,034 | $81.28 | $1.7M | Form 4 |
| Sep 29, 2025 | Heery ChristopherCHIEF MEDICAL OFFICER | Sale | 73 | $80.16 | $5.9K | Form 4 |
| Sep 26, 2025 | Heery ChristopherCHIEF MEDICAL OFFICER | Sale | 12,396 | $80.12 | $993.2K | Form 4 |
| Sep 19, 2025 | Heery ChristopherCHIEF MEDICAL OFFICER | Sale | 300 | $80.00 | $24.0K | Form 4 |
| Sep 18, 2025 | Heery ChristopherCHIEF MEDICAL OFFICER | Sale | 3,343 | $80.01 | $267.5K | Form 4 |
| Jun 10, 2025 | Patel KavitaDirector | Sale | 1,500 | $67.36 | $101.0K | Form 4 |
| May 27, 2025 | Gilson MichelleCHIEF FINANCIAL OFFICER | Sale | 12,235 | $64.14 | $784.8K | Form 4 |
| May 20, 2025 | Patel KavitaDirector | Sale | 1,500 | $58.43 | $87.6K | Form 4 |
All 127 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.
- Paradigm Biocapital Advisors LPSCHEDULE 13G/A, 5 filings Jul 21, 2023 to Aug 14, 202639
- Vestal Point Capital, LPSCHEDULE 13G/A, 2 filings Feb 17, 2026 to May 15, 202640
- New Enterprise Associates 15, L.P.SCHEDULE 13D/A, 7 filings Feb 17, 2022 to Apr 30, 202641
- Gilead SciencesSCHEDULE 13D/A, 4 filings Feb 6, 2023 to Apr 28, 202642
- Rami ElghandourSCHEDULE 13D/A, 4 filings Nov 8, 2024 to Apr 28, 202643
- VANGUARD GROUP INCSCHEDULE 13G/A, 3 filings Jan 30, 2025 to Mar 26, 202644
- FMR LLCSCHEDULE 13G/A, 8 filings Feb 9, 2024 to Mar 6, 202645
- T. Rowe Price Investment Management, Inc.SCHEDULE 13G/A, 4 filings Sep 8, 2025 to Mar 6, 202646
- RA CAPITAL MANAGEMENT, L.P.SCHEDULE 13G/A, 2 filings Nov 22, 2024 to Feb 17, 202647
- PERCEPTIVE ADVISORS LLCSCHEDULE 13G/A, 5 filings Feb 14, 2023 to Aug 14, 202548
- BlackRockSCHEDULE 13G/A, 6 filings Feb 8, 2023 to Apr 17, 202549
- SR ONE CAPITAL MANAGEMENT, LLCSC 13D/A, 6 filings Feb 17, 2022 to Mar 25, 202450
- MONTANOVA CAPITAL, LLCSC 13G/A, 3 filings Jun 27, 2022 to Feb 13, 202451
- Cormorant Asset Management, LPSC 13G/A, 2 filings Aug 29, 2022 to Feb 14, 202352
- Novo Holdings A/SSC 13G/A, 3 filings Feb 9, 2022 to Dec 12, 202253
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 |
|---|---|---|---|---|
| 2024 | Rami Elghandour | 46 | $653.3K | $21.4M54 |
| 2024 | Michelle Gilson | 33 | $476.0K | $8.2M54 |
| 2024 | Christopher Heery | 45 | $481.0K | $5.5M54 |
| 2023 | Chief Executive Officer | $601.0K | $25.0M54 | |
| 2023 | Chief Medical Officer | $481.0K | $3.9M54 | |
| 2023 | Chief Financial Officer | $416.5K | $3.6M54 | |
| 2022 | Chief Executive Officer | $565.0K | $14.1M54 | |
| 2022 | Chief Medical Officer | $430.0K | $4.9M54 | |
| 2022 | Chief Financial Officer | $256.3K | $2.1M54 |
Funding
Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.
- Private raises (Form D) $110.0M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2023 | $100.0M | $100.0M |
| 2022 | $10.0M | $10.0M |
Private raises
Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.
SEC filer profile
How Arcellx, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARArcellx, Inc.1
- CIK0001786205
- Employer ID (EIN)47-28559173
- Filer statusLarge accelerated filer not an emerging growth company; not 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 address800 Bridge Parkway, Redwood City, CA 940651
- Phone240-327-06031
- Shares outstanding58,479,812 shares as of Feb 20, 20263
- Public float$3.2B as of Jun 30, 20253
- AuditorPricewaterhouseCoopers LLP, San Jose, California PCAOB ID 238; it also attests to the company’s internal control over financial reporting3
- On EDGAR sinceAug 22, 20191
- Filings460 in all: 4 (167), 144 (61), 8-K (46), 3 (17), SCHEDULE 13G/A (17), SC 13G/A (15), 10-Q (12), SC 13G (10)1
All 49 form types
CORRESP (9), SCHEDULE 13D/A (8), SC 13D/A (7), UPLOAD (7), 10-K (5), S-8 (5), S-8 POS (5), D (4), SC 14D9/A (4), 10-Q/A (3), 4/A (3), ARS (3), DEF 14A (3), DEFA14A (3), DRS/A (3), S-1/A (3), SC 13D (3), SC TO-T/A (3), SCHEDULE 13G (3), 424B4 (2), D/A (2), DRS (2), DRSLTR (2), EFFECT (2), S-1 (2), SC TO-C (2), SC14D9C (2), SEC STAFF LETTER (2), 10-K/A (1), 15-12G (1), 25-NSE (1), 8-A12B (1), CERT (1), NT 10-Q (1), POSASR (1), PRE 14A (1), S-1MEF (1), S-3ASR (1), SC 14D9 (1), SC TO-T (1), SCHEDULE 13D (1)
- Latest filingsAnnual report (10-K) Feb 26, 2026
Quarterly report (10-Q) Nov 5, 2025
Proxy statement (DEF 14A) Apr 17, 2025
Latest 8-K (8-K) Apr 28, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.001 par value per share | ACLX | The Nasdaq Global Select Market |
From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Arcellx, Inc. names in Item 1A of its 10-K filed Feb 26, 2026: 72 risks under these headings, as written.3
- Risks Related to the Proposed Transaction with Gilead
- Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements
- Risks Related to Development of Our Product Candidates
- Risks Related to Commercialization of Our Product Candidates
- Risks Related to Government Regulation
- Risks Related to Our Business
- Risks Related to Reliance on Third Parties
- Risks Related to Our Intellectual Property
- Risks Related to Ownership of our Common Stock
- There are uncertainties as to the timing of the Offer and the Merger, including the risk that the Offer or the Merger may not be completed in a timely manner or at all.
- Our ability to complete the Merger is subject to certain closing conditions that could adversely affect us or cause the Merger to be abandoned.
- The Merger Agreement contains provisions that could discourage a potential competing acquirer of the Company or could result in a competing acquisition proposal being at a lower price than it might otherwise be.
The other 68 risks
- The announcement or pendency of the Transactions may result in disruptions to our business, divert management’s attention and/or disrupt our relationships with third parties and employees, any of which could negatively impact our operating results and ongoing business.
- Stockholder litigation in connection with the Transactions may result in significant costs of defense, indemnification and liability.
- Risks Related to Our Limited Operating History, Financial Condition, and Capital Requirements
- We have a limited operating history and have incurred significant losses since our inception, and we anticipate that we will continue to incur losses for the foreseeable future, which makes it difficult to assess our future viability.
- We will need to obtain substantial additional funding as we continue to advance anito-cel through clinical development, the regulatory approval process and, if approved, commercial launch activities; initiate or continue to advance our ARC-SparX product candidates; and continue to discover and develop additional product candidates.
- We have no products approved for commercial sale and have only one product candidate in late-stage clinical development, which may make it difficult for you to evaluate our current business and predict our future success and viability.
- Our ddCAR and ARC-SparX platforms represent novel and unproven approaches to treatment, which makes it difficult to predict the timing, results and costs of product candidate development and the likelihood of obtaining regulatory approval. In addition, we may experience difficulty in identifying appropriate target binding domains.
- Our ARC-SparX platform is highly dependent on the success of ACLX-001, ACLX-002 and ACLX-004.
- Clinical development is a lengthy, expensive and uncertain process. Our clinical trials may fail to demonstrate adequate safety and/or efficacy of any of our product candidates, which would prevent or delay regulatory approval and commercialization and potentially impact the development of our other product candidates.
- We may encounter substantial delays in our clinical trials.
- If we encounter delays or difficulties enrolling patients in our clinical trials and/or retention of patients in clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
- Interim, preliminary or topline data from our clinical trials 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.
- Our product candidates and the method of treatment may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, require expansion of the trial size, limit their commercial potential, or result in significant negative consequences.
- Development of product candidates in combination with other therapies could expose us to additional risks.
- Manufacturing genetically engineered products is complex and subject to both human and systemic risks. We or our third- party manufacturers may encounter difficulties in production and sourcing and may be subject to variations and supply constraints of key components. If we or any of our third-party manufacturers encounter such difficulties, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented.
- Material modifications in the methods of product candidate manufacturing may result in additional costs or delay.
- If we or our third-party manufacturers or collaborators use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.
- The process for treating patients using T cell therapy is subject to human and systemic risks.
- Prior treatments can alter the cancer and negatively impact chances for achieving clinical activity with our product candidates.
- We may not be able to file additional INDs to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.
- The market opportunities for certain of our product candidates may be limited due to a number of factors including, but not limited to, patient availability, competition, reimbursement coverage and access, system capacity or execution challenges. Consequently, markets may be small, and our projections regarding the size of the addressable market may be incorrect.
- We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
- Even if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community.
- We may face difficulties from changes to current regulations and future legislation. Current and future legislation may increase the difficulty and cost for us to commercialize our drugs, if approved, and affect the prices we may obtain, including changes in coverage and reimbursement policies in certain market segments for our product candidates, which could make it difficult for us to sell our product candidates, if approved, profitably.
- We currently have a limited sales and marketing organization and limited experience in marketing cell therapy products. If we are unable to establish adequate marketing and sales capabilities or establish or maintain relationships with third parties to market and sell our product candidates, if approved, we may not be able to generate product revenue.
- Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation and/or adverse publicity and could negatively affect our operating results and business.
- A variety of risks associated with seeking regulatory approval for and marketing our product candidates internationally could materially adversely affect our business.
- Inadequate funding and other disruptions for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- Our business activities may be subject to the Foreign Corrupt Practices Act and similar anti-bribery and anti-corruption laws, as well as U.S. and certain foreign export controls, trade sanctions, and import laws and regulations, all of which can subject us to criminal liability and other serious consequences for violations.
- We may be unable to obtain regulatory approval for our product candidates. The denial or delay of any such approval would delay commercialization and have a material adverse effect on our potential to generate revenue, our business and our results of operations.
- The FDA regulatory approval process is lengthy, time-consuming and inherently unpredictable, and we may experience significant delays in the clinical development and regulatory approval of our product candidates or be unable to generate product revenue.
- We have or may pursue Fast Track, orphan drug, and/or RMAT designations from the FDA for one or more of our product candidates. Even if one or more of our product candidates receive Fast Track, orphan drug, and/or RMAT designations, we may be unable to obtain and maintain the benefits associated with such designations. These designations may not lead to a faster development or regulatory review or approval process, and will not increase the likelihood that such product candidates will receive marketing approval.
- We may pursue Breakthrough Therapy designation for one or more of our product candidates in the future. Even if granted by the FDA, such designation may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that the product candidate will receive marketing approval.
- If approved, our investigational products regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.
- Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
- Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions. Failure to obtain regulatory approval in foreign jurisdictions would prevent our product candidates from being marketed abroad.
- Even if we obtain FDA approval of any of our product candidates, we may never obtain approval or commercialize such products outside of the United States, which would limit our ability to realize their full market potential.
- The impact of recent healthcare reform legislation and other changes in the healthcare industry and in healthcare spending on us is currently unknown, and may adversely affect our business model.
- Global economic, political and market conditions, including downgrades of the U.S. credit rating and inflation, may adversely affect our business, results of operations and financial condition, including our revenue growth and profitability.
- Changes in United States trade policy, including recently announced tariffs, could have an adverse impact on our business, financial condition, and/or results of operations.
- Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, may have serious adverse financial consequences on our business, financial condition and stock price.
- We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
- We expect to grow the size of our organization, and we may experience difficulties in managing this growth.
- Our internal computer systems and networks, or those used by our third-party CROs, other contractors, consultants or collaborators, may fail or suffer security breaches or incidents, which could result in a material disruption of the development programs of our product candidates.
- Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- We will face increasing regulation as we advance our product candidates through clinical trials and pursue commercialization, if approved.
- We may not realize the benefits of any acquisitions, in-licenses or strategic alliances that we enter into.
- We may become exposed to costly and damaging product liability claims, either when testing our product candidates in the clinic or at the commercial stage, and our product liability insurance may not cover all damages from such claims.
- Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition.
- Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
- Our business may be significantly adversely affected if events out of our control disrupt our business or that of our third-party providers.
- If we fail to establish and maintain proper and effective internal controls over financial reporting, our operating results and our ability to operate our business could be harmed.
- If we are unable to maintain effective disclosure controls and procedures, our business, financial position and results of operations could be adversely affected.
- Artificial intelligence presents risks and challenges that can impact our business, including by posing security risks to our confidential information, proprietary information and personal data.
- We rely, and will continue to rely on third parties to conduct our clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.
- We rely and expect to continue to rely on third parties to manufacture our clinical product supplies and clinical candidates, and we may rely on third parties for at least a portion of the manufacturing process of our product candidates, if approved. Our business could be harmed if those third parties fail to provide us with sufficient quantities of product supplies or product candidates or fail to do so at acceptable quality levels or prices.
- Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
- We have entered into a Collaboration Agreement with Kite, and pursuant to the terms of that agreement, are dependent on Kite for certain development, manufacturing and commercialization activities with respect to certain of our product candidates.
- In addition to our collaboration with Kite, we may seek to establish future collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
- If we are unable to obtain and maintain sufficient intellectual property protection for our platforms and our product candidates, or if the scope of the intellectual property protection is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be adversely affected.
- The patent application process is subject to numerous risks and there can be no assurance that we will be successful in obtaining patents for which we have applied.
- We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.
- If our efforts to protect the proprietary nature of the intellectual property related to our technologies are not adequate, we may not be able to compete effectively in our market.
- Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.
- Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts.
- We may become involved in lawsuits to protect or enforce our patents, which could be expensive, time- consuming and unsuccessful.
- Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
Legal proceedings
From time to time, we may become involved in litigation or other legal proceedings. As of December 31, 2025, we were not a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. 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.3
Sources
The numbers on this page point here. Each one links to the record it came from.
- 1SEC EDGARArcellx, Inc. filings on SEC EDGAR
- 2SEC EDGARArcellx, Inc. filings on SEC EDGAR
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- 4SEC EDGARArcellx, Inc. 10-K for fiscal 2025
- 5SEC EDGARArcellx, Inc. 10-K for fiscal 2021
- 6SEC EDGARArcellx, Inc. 10-K for fiscal 2022
- 7SEC EDGARArcellx, Inc. 10-Q for fiscal 2025
- 8SEC EDGARArcellx, Inc. 10-Q for fiscal 2025
- 9SEC EDGARArcellx, Inc. 10-K for fiscal 2022
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- 12SEC EDGARLance E. Thibault, Officer
- 13SEC EDGARRami Elghandour, Officer
- 14SEC EDGARAndrew H. Galligan, Board member
- 15SEC EDGARKristin Myers, Board member
- 16SEC EDGARAli Behbahani, Board member
- 17SEC EDGARDavid Charles Lubner, Board member
- 18SEC EDGARDerek Yoon, Board member
- 19SEC EDGARJill Carroll, Board member
- 20SEC EDGARKavita Patel, Board member
- 21SEC EDGARLewis T. Williams, Board member
- 22SEC EDGAROlivia C. Ware, Board member
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- 25SEC EDGAROther events
- 26SEC EDGARResults of operations
- 27SEC EDGARResults of operations
- 28SEC EDGARShareholder vote
- 29SEC EDGAROther events
- 30SEC EDGARResults of operations
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- 32SEC EDGARResults of operations
- 33SEC EDGAROther events
- 34SEC EDGAROther events
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