8-K
Arcellx, Inc. (ACLX)
View as plain text
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 9, 2024
Arcellx, Inc.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 001-41259 | 47-2855917 |
|---|---|---|
| (State or Other Jurisdiction<br>of Incorporation) | (Commission<br> <br>File Number) | (IRS Employer<br>Identification No.) |
| 800 Bridge Parkway | ||
| --- | ||
| Redwood City, CA 94065 | ||
| (Address of principal executive offices, including zip code) |
(240) 327-0603
(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<br>Symbol(s) | Name of each exchange<br> <br>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 9, 2024, Arcellx, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the fiscal quarter ended March 31, 2024. 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<br> <br>No. | Description |
|---|---|
| 99.1 | Press Release dated May 9, 2024 |
| 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 9, 2024 | By: | /s/ Rami Elghandour |
| Rami Elghandour <br>Chief Executive Officer |
EX-99.1
Exhibit 99.1
Arcellx Provides First Quarter 2024 Financial Results
REDWOOD CITY, Calif., May 9, 2024 (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, 2024.
First Quarter 2024 Financial Highlights
Cash,cash equivalents, and marketable securities:
As of March 31, 2024, Arcellx had cash, cash equivalents, and marketable securities of $691.0 million. Arcellx anticipates that its cash, cash equivalents, and marketable securities will fund its operations into 2027.
Collaborationrevenue:
Collaboration revenue were $39.3 million and $17.9 million for the quarters ended March 31, 2024 and 2023, respectively, an increase of $21.4 million. This increase was primarily driven by changes in estimated transaction price used in calculating collaboration revenue under the license and collaboration agreement and amendment with Kite Pharma, Inc. (Kite).
R&D expenses:
Research and development expenses were $32.3 million and $32.9 million for the quarters ended March 31, 2024 and 2023, respectively, a decrease of $0.6 million. This decrease was primarily driven by a decrease in costs associated with our anito-cel clinical program, with such costs primarily relating to expenses associated with our Lonza manufacturing services agreement. The decrease was partially offset by increased personnel costs, which includes non-cash stock-based compensation expense.
G&A expenses:
General and administrative expenses were $22.7 million and $15.4 million for the quarters ended March 31, 2024 and 2023, respectively, an increase of $7.3 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 $7.2 million and $27.3 million for the quarters ended March 31, 2024 and 2023, 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, anito-cel, is being developed for the treatment of relapsed or refractory multiple myeloma (rrMM) in a Phase 2 pivotal trial. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the U.S. Food and Drug Administration.
Arcellx is also developing its dosable and controllable CAR T therapy, ARC-SparX, through two Phase 1 programs, ACLX-001 for rrMM and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. For more information on Arcellx, please visit www.arcellx.com. Follow Arcellx on X (Twitter) at @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, without limitation, Arcellx’s plans for the research, pre-clinical and clinical development of its product candidates; Arcellx’s expectations regarding the potential impact of its product candidates and platforms on patients and cell therapy; and the sufficiency of cash, cash equivalents and marketable securities and Arcellx’s ability to fund operations through certain regulatory milestones and timelines. 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, 2024, 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,<br>2024 | December 31,<br>2023 | |||
|---|---|---|---|---|
| Cash, cash equivalents, and marketable securities | $ | 691,021 | $ | 729,185 |
| Total assets | 779,695 | 825,132 | ||
| Total liabilities | 283,122 | 339,752 | ||
| Total stockholders’ equity | 496,573 | 485,380 |
ARCELLX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
| Three Months Ended March 31, | ||||||
|---|---|---|---|---|---|---|
| 2024 | 2023 | |||||
| Revenue | $ | 39,256 | $ | 17,912 | ||
| Operating expenses: | ||||||
| Research and development | 32,318 | 32,932 | ||||
| General and administrative | 22,748 | 15,437 | ||||
| Total operating expenses | 55,066 | 48,369 | ||||
| Loss from operations | (15,810 | ) | (30,457 | ) | ||
| Other income, net | 8,612 | 3,442 | ||||
| Loss before income taxes | (7,198 | ) | (27,015 | ) | ||
| Income tax expense | — | 329 | ||||
| Net loss | (7,198 | ) | (27,344 | ) | ||
| Other comprehensive loss: | ||||||
| Unrealized gain (loss) on marketable securities | (1,059 | ) | 307 | |||
| Comprehensive loss | $ | (8,257 | ) | $ | (27,037 | ) |
| Net loss per share attributable to common stockholders—basic and diluted | $ | (0.14 | ) | (0.58 | ) | |
| Weighted-average common shares outstanding—basic and diluted | 52,757,973 | 46,769,380 |
Contacts:
Investors:
Myesha Lacy
ir@arcellx.com
510-418-2412
Media:
Andrea Cohen
Sam Brown Inc.
andreacohen@sambrown.com
917-209-7163
###