Arcelex presents the business highlights and reports of the 2022 financial results

— Completed improved monitoring provision common stock, raising 128.8 million dollars Including the full exercise of the underwriters to buy additional shares with gross proceeds —

— Continued strong long-term responses from a phase 1 expansion trial of cART-ddBCMA being evaluated in patients with r/r MM at the 2022 ASCO Annual Meeting —

— Preclinical results published from CART-ddBCMA Molecular cancer therapy —

Redwood City, California, August 15, 2022 /PRNewswire/ — Arcelex, Inc June 30, 2022.

“We are very pleased with our rapid growth since becoming a public company in February of this year,” he said. Rami Elgandre, Arcelex Chairman and CEO. “During the second quarter, we achieved meaningful milestones by presenting new clinical data for our lead product candidate, CART-ddBCMA, during an oral presentation at ASCO; we successfully strengthened our balance sheet while increasing overall revenue.” 128.8 million dollars; We dosed the first patient with ACLX-001, our Phase 1 study of our Arc-SparX technology; And we’ve expanded our management team and board of directors with the diversity of our team. In the second half of this year, we expect to present our CART-ddBCMA Phase 1 study at ESMO, initiating a Phase 2 pivotal CART-ddBCMA (iMMagine) trial in patients with relapsed or refractory multiple myeloma (r/). r MM), from our Phase 1 CART-ddBCMA expansion trial in R/r MM providing long-term patient data and the Phase 1 ARC-SparX clinical trial of ACLX-002 in acute myeloid leukemia and high-risk myelodysplastic syndrome patients. “We are committed to establishing Arcelux as a cell therapy company by expanding our business, advancing our novel platform to help as many patients as possible, and attracting and retaining exceptional talent.”

The latest business headlines

Completed Amended Public Offering Common Stock and Full Exercise of the Underwriters’ Option to Purchase Additional Shares. It’s on June 21, 2022Arcelex announced the closing of its senior public offering of 8,050,000 shares of common stock, which includes the full exercise of the option of the underwriters to purchase an additional 1,050,000 shares of common stock at the price paid to the public. $16.00 per share. It was the total proceeds collected at the offering. 128.8 million dollars, before deducting the discounts and commissions paid by Arcellx and the expenses. All shares in the offer are provided by Arcellx.

He was appointed Maryam Abdul Karim As a general counsel. It’s on June 21, 2022Arcellx was appointed Maryam Abdul Karim As a general counsel. Ms. Abdul-Karim brings extensive legal and commercial expertise in the biopharmaceutical industry, including senior positions at Kinate Biopharma and AstraZeneca. She oversees a wide range of legal, contractual and compliance matters at Arcelx.

Continued strong long-term responses from the lead product candidate, CART-ddBCMA, are being evaluated in a Phase 1 expansion trial in patients with relapsed or refractory multiple myeloma at the 2022 ASCO Annual Meeting. It’s on June 3, 2022During an oral presentation at the 2022 American Society of Clinical Oncology Annual Meeting, Arcelx presented new clinical data from an ongoing phase 1 expansion study of its new, autologous, CART-ddBCMA therapy for patients with R/r MM. The data showed 100% ORR; Profound and durable responses were observed in patients with poor prognosis. Overall, 22 of 31 (71%) patients achieved CR/sCR. Of the 16 patients with 12-month follow-up, 8 patients (50%) had EMD, 13 (81%) achieved CR/sCR, and 9 patients (56%) had a sustained response at a median follow-up of 17.7 months. At the recommended phase 2 dose of 100 million CAR+ cells (n=25), no grade 3 CRS and no delayed neurotoxicity or parkinsonian-like events were observed.

Preliminary clinical results from CART-ddBCMA have been published Molecular cancer therapy. in June 2022the preclinical results of Arcelex for the CART-ddBCMA candidate have been published Molecular cancer therapy In an article entitled “Preclinical efficacy of BCMA-directed CAR T cells involving novel D Domain antigen recognition.” This report shows that ddBCMA CAR T cells developed with BCMA-positive cell lines are highly potent and dose-dependent. In vitro Cytotoxicity, cytokine production, T-cell degranulation and T-cell proliferation as well as In vivo Tumor suppression in three diffuse BCMA-expressing tumor models. The full online publication can be found here.

He was appointed Michelle Gilson As chief financial officer. It’s on May 23, 2022announced the appointment of Arcelex Michelle Gilson As chief financial officer. Ms. Gilson joins Arcelex from Canaccord Genuity, where she most recently served as a managing director covering biotechnology companies and a senior equity research analyst. Ms. Gilson oversees the company’s finance function and plays a key role in overall corporate strategy.

With the appointment of the expanded board of directors Olivia Weir. It’s on May 16, 2022Arcelex expands by appointing the board of directors Olivia Weir. A successful executive, Ms. Weir brings a wealth of expertise with over 20 years of experience in biotech and pharmaceutical drug development, business operations and healthcare management.

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Quarter 2022 financial highlights

Cash, cash equivalents and marketable securities:
such as June 30, 2022Arcellx had cash, cash equivalents and marketable securities. 307.0 million dollarsIt is expected to fund the project for at least the next twelve months.

R&D Expenditures:
There were research and development costs 23.4 million dollars And 12.6 million dollars for the end of the quarter June 30, 2022 and 2021, respectively, increase 10.8 million dollars. This increase was due to higher external costs related to the development of our CART-ddBCMA clinical program, preclinical development of our other pipeline candidates, and head count.

G&A Expenses:
There were general and administrative expenses 9.2 million dollars And 3.3 million dollars for the end of the quarter June 30, 2022 and 2021, respectively, increase 5.9 million dollars. This increase was driven by increased headcount and costs of operating as a public company during the three months. June 30, 2022 Compared to the same period in 2021, including professional fees related to consulting and accounting, auditing and legal services.

net loss;
It was a net loss 32.1 million dollars And 15.9 million dollars for the end of the quarter June 30, 2022 and 2021 respectively.

About Arcellx, Inc.

Arcelx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immune systems for patients with cancer and other incurable diseases. Arcelex believes that cell therapies are one of the pillars of medicine and Arcelex’s mission is to advance humanity by developing safer, more effective and more accessible cell therapies. Arcelex’s lead product candidate, CART-ddBCMA, is being developed in an ongoing Phase 1 study for the treatment of relapsed or progressive multiple myeloma (r/r MM). CART-ddBCMA has been granted Fast Track, Orphan Drug, and Advanced Therapy designation by the US Food and Drug Administration.

Arcelx is also advancing its injectable and controllable CAR-T therapy ARC-SparX in two programs: A phase 1 study of ACLX-001 for r/r MM starting in the second quarter of 2022; and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome, expected to enter the clinic in the second half of 2022.

For more information, visit www.arcellx.com.

Forward-looking statements
This press release Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, contain forward-looking statements. All statements in this press release that are not historical are forward-looking statements, including Arcelex’s expectations regarding the timing and results of clinical trials for its product candidates and the publication of related information, the potential impact of its product candidates and platforms on patients. Cell Therapy, the success period of the issues, ability to finance operations, and financial capacity, cash equivalents and marketable securities. The forward-looking statements contained herein are based on Arcelex’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are not promises or guarantees and are subject to various risks and uncertainties, which are described in Part II, Item 1A (Risk Factors) of the Quarterly Report on Form 10-Q and other filings by Arcelex with the Securities and Exchange Commission from time to time. These forward-looking statements speak as of the date of this press release, and Arcelx undertakes no obligation to update or revise any forward-looking statements as a result of new information, future events or otherwise, except as required by law.

Investor Relations:
Myesha Lacy
Arcelux, Inc.
[email protected]
510-418-2412

Media Contact:
Andrea Cohen
Sam Brown Inc.
[email protected]
917-209-7163

Source Arcellx, Inc