0000950170-23-018779.txt : 20230508 0000950170-23-018779.hdr.sgml : 20230508 20230508160248 ACCESSION NUMBER: 0000950170-23-018779 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20230508 ITEM INFORMATION: Results of Operations and Financial Condition FILED AS OF DATE: 20230508 DATE AS OF CHANGE: 20230508 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Arcellx, Inc. CENTRAL INDEX KEY: 0001786205 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 472855917 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-41259 FILM NUMBER: 23897647 BUSINESS ADDRESS: STREET 1: 25 WEST WATKINS MILL ROAD STREET 2: SUITE A CITY: GAITHERSBURG STATE: MD ZIP: 20878 BUSINESS PHONE: 240-723-6641 MAIL ADDRESS: STREET 1: 25 WEST WATKINS MILL ROAD STREET 2: SUITE A CITY: GAITHERSBURG STATE: MD ZIP: 20878 8-K 1 aclx-20230508.htm 8-K 8-K
0001786205false00017862052023-05-082023-05-08

 

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 08, 2023

 

 

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.)

 

 

 

 

 

25 West Watkins Mill Road

Suite A

 

Gaithersburg, Maryland

 

20878

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 240 327-0603

 

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, 2023, Arcellx, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the fiscal quarter ended March 31, 2023. 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, 2023

 

 

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, 2023

By:

/s/ Rami Elghandour

 

 

 

Rami Elghandour
Chief Executive Officer

 


EX-99 2 aclx-ex99_1.htm EX-99.1 EX-99

 

img167846775_0.jpg 

 

Arcellx Provides First Quarter Financial Results

 

REDWOOD CITY, Calif., May 8, 2023 /PRNewswire/ -- 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 financial results for the first quarter ended March 31, 2023.

 

“Delivering our novel CAR-T therapy to multiple myeloma patients is at the heart of our mission,” said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. “With the closing of our Kite partnership in the first quarter, we believe we are well capitalized to fund our operations through the first half of 2025. We remain laser-focused on key drivers of our business which include completing enrollment of iMMagine-1, initiating iMMagine-2 in earlier multiple myeloma lines, and presenting longer-term data from our Phase 1 expansion study of CART-ddBCMA. This is a pivotal and exciting time for our organization, and we are excited about our progress made to date and look forward to continuing our momentum.”

First Quarter 2023 Financial Highlights
Cash, cash equivalents, and marketable securities:
As of March 31, 2023, Arcellx had cash, cash equivalents, and marketable securities of $533.6 million. Arcellx expects that the cash, cash equivalents, and marketable securities on hand, will fund its operations through BLA filing of CART-ddBCMA planned for the first half of 2025

Collaboration revenue:
Collaboration revenue was $17.9 million and zero for the quarters ended March 31, 2023 and 2022, respectively. The revenue results for the three months ended March 31, 2023 is from the recognition of research and development performed under the arrangement described in the recent license and collaboration agreement with Kite Pharma, Inc. (Kite). Revenue is being recognized on a percentage of completion basis over the term of the contract with Kite.

R&D expenses:
Research and development expenses were $32.9 million and $18.1 million for the quarters ended March 31, 2023 and 2022, respectively, an increase of $14.8 million. This increase was primarily driven by higher external costs associated with the advancement of the company’s CART-ddBCMA clinical program and increased headcount.

G&A expenses:
General and administrative expenses were $15.4 million and $8.0 million for the quarters ended March 31, 2023 and 2022, respectively, an increase of $7.4 million. This increase was driven by increased headcount and professional fees.

Net loss:
Net loss was $27.3 million and $26.0 million for the quarters ended March 31, 2023 and 2022, 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. Arcellx's lead product candidate, CART-ddBCMA, is being developed for the treatment of relapsed or refractory multiple myeloma (rrMM) in a Phase 2 pivotal trial. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the U.S. Food and Drug Administration.

Arcellx is also advancing its dosable and controllable CAR-T therapy, ARC-SparX, through two clinical-stage programs: a Phase 1 study of ACLX-001 for rrMM, initiated in the second quarter of 2022; and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome, initiated in the fourth quarter of 2022. For more information on Arcellx, please visit
www.arcellx.com. Follow Arcellx on Twitter (@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, including Arcellx’s plans for the clinical development of its product candidates, including anticipated announcements of additional data; and the sufficiency of cash, cash equivalents and marketable securities and its ability to fund operations. 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 quarter ended March 31, 2023, 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.

 

 


img167846775_1.jpg 

 

img167846775_2.jpg 

 

 

 

 

Investor Contact:

Myesha Lacy

Arcellx, Inc.

ir@arcellx.com

510-418-2412

 

Media Contact

Andrea Cohen
Sam Brown Inc.
andreacohen@sambrown.com
917-209-7163

 

###


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Document And Entity Information
May 08, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date May 08, 2023
Entity Registrant Name Arcellx, Inc.
Entity Central Index Key 0001786205
Entity Emerging Growth Company true
Securities Act File Number 001-41259
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 47-2855917
Entity Address, Address Line One 25 West Watkins Mill Road
Entity Address, Address Line Two Suite A
Entity Address, City or Town Gaithersburg
Entity Address, State or Province MD
Entity Address, Postal Zip Code 20878
City Area Code 240
Local Phone Number 327-0603
Entity Information, Former Legal or Registered Name Not Applicable
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Ex Transition Period false
Title of 12(b) Security Common Stock, $0.001 par value per share
Trading Symbol ACLX
Security Exchange Name NASDAQ