株探米国株
日本語 英語
エドガーで原本を確認する
false 0001786205 0001786205 2025-05-08 2025-05-08
 
 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 8, 2025

 

 

Arcellx, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-41259   47-2855917

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

800 Bridge Parkway

Redwood City, CA 94065

(Address of principal executive offices, including zip code)

(240) 327-0630

(Registrant’s telephone number, including area code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.001 par value per share   ACLX   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 
 


Item 2.02

Results of Operations and Financial Condition.

On May 8, 2025, Arcellx, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the fiscal quarter ended March 31, 2025. A copy of the Company’s press release is attached hereto as Exhibit 99.1.

The information furnished pursuant to Item 2.02 on this Form 8-K, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

 No. 

  

Description

99.1    Press Release dated May 8, 2025
104    Cover Page Interactive Data File (embedded within the Inline XBRL Document)


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    Arcellx, Inc.
Date: May 8, 2025   By:  

/s/ Rami Elghandour

   

Rami Elghandour

Chief Executive Officer

EX-99.1 2 d916048dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

LOGO

Arcellx Provides First Quarter 2025 Financial Results and Business Highlights

— iMMagine-1 data accepted for Oral Presentation at EHA —

— iMMagine-3 study updated to include MRD negativity as a dual primary endpoint —

— Added two new Board members with commercial and operational expertise —

— Ended the quarter with $565M in cash, which is expected to fund operations into 2028 —

REDWOOD CITY, Calif., May 8, 2025 (BUSINESS WIRE) — Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today reported business highlights and financial results for the first quarter ended March 31, 2025.

“Delivering therapies that can positively impact patients’ lives is our mission,” said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. “We are pleased that minimal residual disease negativity has been added as a dual primary endpoint to the iMMagine-3 protocol in addition to progression-free survival. This addition is in line with the feedback provided by the Oncologic Drug Advisory Committee to the Food and Drug Administration during the March 2024 ODAC meeting, and we believe this is a significant advancement for multiple myeloma patients that will allow impactful therapies to reach patients earlier, saving more lives. Additionally, we are on track to present updated data on all 117 patients dosed in iMMagine-1 at the European Hematology Association meeting on Saturday, June 14, 2025, in Milan. As we accelerate toward becoming a commercial organization with the planned launch of anito-cel in 2026, we added two Board members, Andrew Galligan and Kristin Myers, who bring relevant launch and scale expertise. It’s an inspiring time at Arcellx! We continue to attract outstanding talent who recognize the opportunity to play a part in advancing our category-defining therapy and value our diverse and inclusive culture, which allows them to do what they do best every day. I’m proud to work alongside such a talented team as we build on our unique culture while keeping patients centered at the core of what we do.”

Recent Business Progress

 

   

iMMagine-1 data accepted for oral presentation at the European Hematology Association Congress.

Date: Saturday, June 14, 2025

Time: 17:00-18:15 CEST

Session: Treatment of Relapsed and/or Multiple Myeloma

 

   

Minimal Residual Disease (MRD) negativity was added as a dual primary endpoint in addition to progression-free survival in the global Phase 3, randomized controlled iMMagine-3 clinical study. The iMMagine-3 study was initiated in the second half of 2024 at approximately 130 study sites across North America, Europe, and the rest of the world. Anito-cel is partnered with Kite, a Gilead Company.


   

Appointed Andrew Galligan and Kristin Myers to Board of Directors.

Most recently, Mr. Galligan served as Chief Financial Officer at Nevro Corp., a medical device company in the implantable spinal cord stimulation market. During his 10-year tenure at Nevro, he built the finance and operations group from commercial launch and drove year-over-year revenue growth. Prior to that, he was Vice President, Finance, and Chief Financial Officer at Ooma, Inc., where he currently serves as a board member. Before that, he served in the same executive capacity at Reliant Technologies, Inc. and helped complete the acquisition of the company by Thermage, Inc. Mr. Galligan’s biotechnology industry executive experience also includes senior financial leadership roles at Metrika Inc. (acquired by Bayer), Corcept Therapeutics Incorporated, and Amira Medical (acquired by Roche). He holds a Business Studies degree from Trinity College, Dublin University, Dublin, Ireland and is a Fellow of the Irish Institute of Chartered Accountants.

Ms. Myers brings 20+ years of healthcare experience, including senior leadership roles across the payer, provider and medtech sectors. Currently, she serves as the Chief Operating Officer at Blue Cross Blue Shield Association, leading strategic, operational and technology teams to support the BCBS System. Prior to this, Ms. Myers founded and led Hopscotch Primary Care as the CEO, standing up primary care centers to serve vulnerable patient populations across rural America. Previously, Ms. Myers held several positions of increasing responsibility at Aetna, beginning as Chief of Staff to the CEO and Chairman, and eventually rising to President of the Great Lakes Region. Ms. Myers’ career also included time in venture capital investing in the healthcare and biotech sectors. She holds an MBA from Harvard Business School and a BS in Biomedical Engineering from the University of Wisconsin-Madison.

First Quarter 2025 Financial Highlights

Cash, cash equivalents, and marketable securities:

As of March 31, 2025, Arcellx had cash, cash equivalents, and marketable securities of $565.2 million. Arcellx anticipates that its cash, cash equivalents, and marketable securities will fund its operations into 2028.

Collaboration revenue:

Collaboration revenue was $8.1 million and $39.3 million for the quarters ended March 31, 2025 and 2024, respectively, a decrease of $31.2 million. This decrease was primarily driven by completion of dosing and manufacturing of anito-cel in the iMMagine-1 trial in the fourth quarter of 2024.

R&D expenses:

Research and development expenses were $50.8 million and $32.3 million for the quarters ended March 31, 2025 and 2024, respectively, an increase of $18.5 million. This increase was primarily driven by increased costs relating to other clinical and preclinical pipeline programs and increased personnel costs, which includes non-cash stock-based compensation expense.

G&A expenses:

General and administrative expenses were $26.2 million and $22.7 million for the quarters ended March 31, 2025 and 2024, respectively, an increase of $3.5 million. This increase was primarily driven by increased personnel costs, which includes non-cash stock-based compensation expense.

Net income or loss:

Net loss was $62.3 million and $7.2 million for the quarters ended March 31, 2025 and 2024, respectively.


About Arcellx, Inc.

Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and Arcellx’s mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. For more information on Arcellx, please visit www.arcellx.com. Follow Arcellx on X @arcellx and LinkedIn.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not purely historical are forward-looking statements which may include, without limitation, statements regarding: the potential of anito-cel for providing meaningful benefit in patients suffering from multiple myeloma and to change the treatment paradigm in multiple myeloma; the potential impact of anito-cel on rrMM patients and expected clinical profile; anito-cel tolerability and toxicity trends; the potential commercial launch of anito-cel in 2026, subject to FDA approval, in partnership with Kite; Arcellx’s ability to deliver cell therapies that will meet the key expectations of patients and clinicians and serve the multiple myeloma community; the potential benefits of an additional primary endpoint in the iMMagine-3 study; the potential benefits of the additional Board members; the expectation that Arcellx’s cash, cash equivalents, and marketable securities will fund its operations into 2028; and trends relating to Arcellx’s development pipeline and organizational growth. The forward-looking statements contained herein are based upon Arcellx’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including risks that may be found in the section entitled Part II, Item 1A (Risk Factors) in the Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2025, filed with the Securities and Exchange Commission (SEC) on or about the date hereof, and the other documents that Arcellx may file from time to time with the SEC. These forward-looking statements are made as of the date of this press release, and Arcellx assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

ARCELLX, INC.

SELECTED CONSOLIDATED BALANCE SHEET DATA

(in thousands)

 

     March 31,
2025
     December 31,
2024
 

Cash, cash equivalents, and marketable securities

     $565,207      $ 625,652  

Total assets

     648,082        711,327  

Total liabilities

     231,176        256,535  

Total stockholders’ equity

     416,906        454,792  


ARCELLX, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share amounts)

 

     Three Months Ended March 31,  
     2025      2024  

Revenue

   $ 8,129      $ 39,256  

Operating expenses:

     

Research and development

     50,801        32,318  

General and administrative

     26,226        22,748  
  

 

 

    

 

 

 

Total operating expenses

     77,027        55,066  
  

 

 

    

 

 

 

Loss from operations

     (68,898      (15,810

Other income, net

     6,628        8,612  
  

 

 

    

 

 

 

Loss before income taxes

     (62,270      (7,198

Income tax expense

     —         —   
  

 

 

    

 

 

 

Net loss

     (62,270      (7,198

Other comprehensive loss:

     

Unrealized loss on marketable securities

     (199      (1,059
  

 

 

    

 

 

 

Comprehensive loss

   $ (62,469    $ (8,257
  

 

 

    

 

 

 

Net loss per share attributable to common stockholders—basic and diluted

   $ (1.13    $ (0.14
  

 

 

    

 

 

 

Weighted-average common shares outstanding—basic and diluted

     55,256,464        52,757,973  
  

 

 

    

 

 

 

Contacts:

Investors:

Myesha Lacy

ir@arcellx.com

510-418-2412

Media:

Andrea Cohen

Sam Brown LLC

andreacohen@sambrown.com

917-209-7163

###