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Arcellx Provides Second Quarter 2022 Financial Highlights and Report

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Completed additional public offering of common stock and increased capital $128.8 million Gross proceeds including the full exercise of the underwriter’s option to purchase additional shares —

— Continuing Robust Long-Term Responses from CART-ddBCMA Phase 1 Expansion Study Evaluating in Patients With r/r MM Announced at ASCO Annual Meeting 2022 —

— Preclinical results of CART-ddBCMA Molecular Cancer Therapeutics

redwood city, california, August 15, 2022 /PRNewswire/ — Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reshaping cell therapy through the development of innovative immunotherapies for patients with cancer and other intractable diseases, today announced the Wright reported financial results for the second quarter. June 30, 2022.

“We are thrilled with the rapid progress we have made since going public in February this year. Rami Elgandor, Chairman and Chief Executive Officer of Acerx. “In the second quarter, we achieved a significant milestone by announcing new clinical data for our lead product candidate, CART-ddBCMA, in an oral presentation at ASCO. , $128.8 millionfirst patient dosed in ACLX-001, a Phase 1 trial utilizing Arc-SparX technology. We have also expanded our management team and board of directors, adding top professionals to the diversity of our team. In the second half of this year, we will have an encore presentation of the CART-ddBCMA Phase 1 trial at ESMO to discuss the Phase 1 CART-ddBCMA expansion in relapsed or refractory multiple myeloma (r/r MM), r/r MM. Presenting long-term patient data from the trial and initiating the Phase 1 ARC-SparX clinical trial of ACLX-002 in patients with acute myeloid leukemia and high-risk myelodysplastic syndrome. We are committed to establishing Arcellx as a leading cell therapy organization by continuing to grow our business, advancing new platforms to help as many patients as possible, and attracting and retaining exceptional talent. . “

Recent business highlights

Completed an increased public offering of common stock and fully exercised the option to purchase additional shares by the underwriters. upon June 21, 2022, Arcellx announced that it has closed an increased public offering of 8,050,000 shares of its common stock. This included the full exercise of the underwriter’s option to purchase an additional 1,050,000 shares of his common stock at the public price. $16.00 per share. The total revenue raised in the offering will be $128.8 million, before deducting underwriting discounts and fees paid by Arcellx and recruitment costs. All shares in the public offering were provided by Arcellx.

appointment Mariam Abdul Kareem as legal counsel. upon June 21, 2022Acerx appointed Mariam Abdul Kareem as legal counsel. Mr. Abdul-Kareem brings extensive legal and business expertise to the biopharmaceutical industry, including senior positions at Kinnate Biopharma and AstraZeneca. At Arcellx, she oversees a wide range of legal, contractual and compliance matters.

Continuing Strong Long-Term Responses from Lead Product Candidate CART-ddBCMA Being Evaluated in Phase 1 Expansion Study in Patients With Relapsed or Refractory Multiple Myeloma at ASCO Annual Meeting 2022 announced. upon June 3, 2022, Arcellx presents new clinical data from an ongoing Phase 1 expansion trial of a novel autologous CART-ddBCMA therapy for the treatment of patients with r/r MM in an oral presentation at the 2022 American Society of Clinical Oncology Annual Meeting announced. The data showed an ORR of 100%. Deep and durable responses were observed in patients with poor prognostic factors. Overall, 22 of 31 evaluable patients (71%) reached his CR/sCR. Of the 16 patients (including 8 patients with EMD (50%)) who were followed up for 12 months, 13 (81%) achieved CR/sCR and 9 patients ( 56%) maintain an ongoing response. Median follow-up was 17.7 months. At the recommended Phase 2 dose of 100 million CAR+ cells (n=25), there were no cases of grade 3 or greater CRS, and no late neurotoxicity or Parkinson’s disease-like events were observed.

Preclinical results of CART-ddBCMA were Molecular Cancer Therapeutics. of June 2022Arcellx preclinical results for the CART-ddBCMA candidate are: Molecular Cancer Therapeutics In an article entitled “Preclinical efficacy of BCMA-directed CAR T cells incorporating novel D-domain antigen recognition domains”. This report showed that ddBCMA CAR T cells co-cultured with BCMA-positive cell lines exhibited a very strong dose-dependence. in vitro Measurement of cytotoxicity, cytokine production, T cell degranulation, and T cell proliferation in vivo Tumor suppression in three disseminated BCMA-expressing tumor models. The full online publication can be accessed here.

appointment Michelle Gilson as Chief Financial Officer. upon May 23, 2022Arcellx has announced the appointment of Michelle Gilson as Chief Financial Officer. Mr. Gilson joined Arcellx from Canaccord Genuity, most recently as Managing Director and Senior Covering Biotechnology Companies, Equity, and Research, where he was an Analyst. Mr. Gilson oversees the company’s financial functions and plays a key role in overall corporate strategy.

Expansion of the Board of Directors through the appointment of Olivia Ware. upon May 16, 2022Arcellx has expanded its Board of Directors with the following appointments: Olivia WareA accomplished executive, Mr. Ware brings a wealth of knowledge with over 20 years of experience in biotechnology and pharmaceutical development, commercialization and healthcare management.

number two
2022 quarter financial highlights

Cash, cash equivalents and securities:
Current June 30, 2022Arcellx had cash, cash equivalents, and marketable securities $307 millionexpected to fund operations for at least the next 12 months.

R&D expenses:
R&D expenses are $23.4 million When $12.6 million quarter ended June 30, 2022 and in 2021, respectively $10.8 millionThis increase was due to increased external costs associated with advancing the CART-ddBCMA clinical program, preclinical development of other pipeline candidates, and increased headcount.

General and administrative expenses:
General and administrative expenses $9.2 million When $3.3 million quarter ended June 30, 2022 and in 2021, respectively $5.9 millionThe increase was due to an increase in headcount and the costs of operating as a public company during the three months ended. June 30, 2022 Includes professional fees related to consulting and accounting, auditing and legal services compared to the same period in 2021.

Net loss:
net loss is $32.1 million When $15.9 million quarter ended June 30, 2022 2021 and 2021 respectively.

About Aserx

Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by designing innovative immunotherapies for patients with cancer and other intractable diseases. Arcelux believes cell therapy is one of the pillars of medicine and its mission is to advance humanity by developing safer, more effective and more widely available cell therapies. . Arcellx’s lead product candidate, CART-ddBCMA, is being developed in an ongoing Phase 1 trial for the treatment of relapsed or refractory multiple myeloma (r/r MM). CART-ddBCMA has received Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapeutic Designation from the U.S. Food and Drug Administration.

Arcellx also promotes ARC-SparX, an injectable and controllable CAR-T therapy, through two programs. ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome is expected to enter the clinic in the second half of 2022.

For more information, please visit www.arcellx.com.

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 that are not purely historical in nature in this press release are forward-looking statements, including the timing and results of clinical trials of product candidates and the release of related data. Arcellx’s expectations, the potential impact on patients of its product candidates and platform, and the adequacy of cell therapies, timing of milestone achievement, operating capital capacity, cash, cash equivalents and securities; The forward-looking statements contained herein are based on Arcellx’s current expectations and involve assumptions that may never materialize or prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are based on quarterly reports on Form 10-Q and other documents Arcellx files with the Securities and Exchange Commission from time to time. These forward-looking statements are made as of the date of this press release and Arcellx does not make any statements as a result of new information, future events or otherwise, except as required by law. We undertake no obligation to update or revise any forward-looking statements.

Acerx Co., Ltd.

Selected consolidated balance sheet data

(unaudited)

(Thousands)


June 30th

December 31


2022

2021

Cash, cash equivalents and securities

$306,986

$104,617

Total assets

375,326

128,782

total liabilities

59,370

16,918

Redeemable convertible preferred stock

233,379

Total shareholders’ equity (deficit)

315,956

(121,515)

Acerx Co., Ltd.

Consolidated Income Statement and Comprehensive Loss

(unaudited)

(Thousands of shares, excluding the amount per share)


3 months ended
June 30th

6 months ended
June 30th


2022

2021

2022

2021

Earnings

$ —

$ —

$ —

$ —

Operating expenses:





Research and Development

23,402

12,643

47,802

21,164

General and administration

9,207

3,285

17,241

6,046

Total project cost

32,609

15,928

65,043

27,210

operating loss

(32,609)

(15,928)

(65,043)

(27,210)

Other income, net

518

1

567

2

net loss

(32,091)

(15,927)

(64,476)

(27,208)

Other Comprehensive Loss:





Loss on valuation of securities

218

242

Comprehensive loss

$ (32,309)

$ (15,927)

$ (64,718)

$ (27,208)

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

$ (0.88)

$ (36.42)

$ (2.24)

$ (70.20)

Weighted Average Common Shares Outstanding — Basic and Diluted

36,609,772

437,258

28,729,029

387,556

Investor Contact:
Misha Lacey
Acerlux Co., Ltd.
[email protected]
510-418-2412

Media contact:
Andrea Cohen
Sam Brown & Co.
[email protected]
917-209-7163

SOURCE Acerx Co., Ltd.

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