— Completed extended follow-on offering of common shares, increase 128.8 million dollars in gross proceeds, including full exercise of the underwriters’ option to purchase additional shares —
– Presented robust and continued long-term responses from its Phase 1 CART-ddBCMA expansion trial being evaluated in patients with r/r MM at the 2022 ASCO Annual Meeting —
– Preclinical results of CART-ddBCMA published in Cancer Molecular Therapeutics —
REDWOOD CITY, California, August 15, 2022 /PRNewswire/ — Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy by developing innovative immunotherapies for patients with cancer and other incurable diseases, today reported business highlights and financial results for the ended second quarter. June 30, 2022.
“We are excited about the rapid progress we have made since becoming a public company in February of this year,” he said. Rami Elghandour, President and CEO of Arcellx. “In the second quarter, we achieved significant milestones with the presentation of new clinical data for our lead product candidate, CART-ddBCMA, during an oral presentation at ASCO; we strengthened our balance sheet with a successful follow-on offering, raising revenue gross of 128.8 million dollars; we dosed our first patient in ACLX-001, our Phase 1 study using our Arc-SparX technology; and we have expanded our management team and our Board of Directors with exceptional professionals who add to the diversity of our team. In the second half of this year, we expect to submit a presentation of our CART-ddBCMA Phase 1 study at ESMO, initiating our pivotal Phase 2 CART-ddBCMA trial (iMMagine) in patients with relapsed or refractory multiple myeloma ( r/r MM), presenting long-term patient data from our Phase 1 CART-ddBCMA expansion trial ar/r MM and initiating our Phase 1 ARC-SparX clinical trial of ACLX-002 in leukemia patients acute myeloid and high-risk myelodysplastic. syndrome We are committed to establishing Arcellx as a leading cell therapy organization by continuing to scale our business, advancing our new platform to help as many patients as possible, and attracting and retaining exceptional talent.”
Latest business aspects
The expanded public offering of common shares and the full exercise of the option to purchase additional shares by the underwriters has been completed. Turned on June 21, 2022Arcellx announced the closing of its tender offer of 8,050,000 ordinary shares, which included the full exercise by the underwriters of their option to purchase an additional 1,050,000 ordinary shares, at a public price of $16.00 by action The aggregate gross proceeds raised in the offering were 128.8 million dollars, before deducting the discounts and subscription fees and the offer costs, charged to Arcellx. All shares in the offer were tendered by Arcellx.
Appointed Maryam Abdul-Kareem as general counsel. Turned on June 21, 2022Arcellx appointed Maryam Abdul-Kareem as general counsel. Ms. Abdul-Kareem brings extensive legal and business experience in the biopharmaceutical industry, including holding senior positions at Kinnate Biopharma and AstraZeneca. At Arcellx, he will oversee a broad spectrum of legal, contract and compliance matters.
Robust and sustained long-term responses of the lead product candidate, CART-ddBCMA, being evaluated in a phase 1 expansion trial in patients with relapsed or refractory multiple myeloma were presented at the 2022 ASCO Annual Meeting . Turned on June 3, 2022, Arcellx presented new clinical data from its ongoing phase 1 expansion study of its novel autologous CART-ddBCMA therapy for the treatment of patients with r/r MM during an oral presentation at the annual meeting of the American Society of ‘Clinical Oncology 2022. Data demonstrated 100% ORR; Deep and durable responses were observed in patients with poor prognostic factors. Overall, 22 of 31 (71%) evaluable patients achieved CR/sCR. Of the 16 patients who have had their 12-month follow-up visit, including 8 patients (50%) who had EMD, 13 (81%) have achieved CR/sCR and 9 patients (56%) remain in continuous response with an average follow-up of 17.7 months. No cases of grade ≥3 CRS or delayed neurotoxicity or parkinsonian-like events were observed at the recommended Phase 2 dose of 100 million CAR+ cells (n = 25).
Preclinical results of CART-ddBCMA published in Molecular Cancer Therapeutics. In June 2022, Arcellx’s preclinical results for its CART-ddBCMA candidate were published in Molecular Cancer Therapeutics in an article titled “Preclinical efficacy of BCMA-directed CAR T cells incorporating a novel domain antigen recognition domain D”. This report demonstrated that ddBCMA CAR T cells cocultured with BCMA-positive cell lines exhibited highly potent and dependent in vitro measures of cytotoxicity, cytokine production, T cell degranulation, and T cell proliferation of dose as well as tumor suppression in vivo in three tumor models expressing disseminated BCMA. The full publication can be accessed online here.
Appointed Michelle Gilson as financial director. Turned on May 23, 2022Arcellx announced the appointment of Michelle Gilson as financial director. Ms. Gilson joins Arcellx from Canaccord Genuity, where she most recently served as managing director and senior equity research analyst in biotechnology companies. Ms. Gilson will oversee the company’s finance function and play a key role in overall corporate strategy.
Extended Board of Directors with the appointment of Olivia Ware. Turned on May 16, 2022Arcellx expanded its Board of Directors with the appointment of Olivia Ware. Ms. An accomplished executive, Ware brings a wealth of knowledge with more than 20 years of experience in biotech and pharmaceutical drug development, commercialization and healthcare management.
Financial data for the second quarter of 2022
Cash, cash equivalents and marketable securities:
How of June 30, 2022Arcellx had cash, cash equivalents and marketable securities of $307.0 millionwhich is expected to fund its operations for at least the next twelve months.
Research and development expenses were 23.4 million dollars i 12.6 million dollars because the quarters finished June 30, 2022 and 2021, respectively, an increase of 10.8 million dollars. This increase was driven by higher external costs associated with the advancement of our CART-ddBCMA clinical program, the preclinical development of our other pipeline candidates and increased headcount.
General and administrative expenses were 9.2 million dollars i 3.3 million dollars to end the quarters June 30, 2022 and 2021, respectively, an increase of 5.9 million dollars. This increase was driven by increased headcount and costs to operate as a public company in the three months ended June 30, 2022 compared to the same period in 2021, including professional fees related to consulting and accounting, auditing and legal services.
The net loss was 32.1 million dollars i 15.9 million dollars to end the quarters June 30, 2022 and 2021, 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 advanced pillars of medicine and Arcellx’s mission is to advance humanity by developing safer, more effective and more accessible cell therapies. Arcellx’s lead product candidate, CART-ddBCMA, is being developed for the treatment of relapsed or refractory multiple myeloma (r/r MM) in an ongoing Phase 1 study. CART-ddBCMA has received the Advanced Therapy for Orphan Drug and Regenerative Medicine designations from the US Food and Drug Administration.
Arcellx is also advancing its doseable and controllable CAR-T therapy, ARC-SparX, through two programs: a Phase 1 study of ACLX-001 for ar/r MM, starting in the second quarter of 2022; and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome, which is expected to enter the clinic in the second half of 2022.
visit www.arcellx.com for more information.
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 expectations regarding the timing and results of clinical trials of its product candidates and the release of related data, the potential impact of its product candidates and platforms in patients and cell therapy, the timing of their milestones, their ability to fund operations and the sufficiency of cash, cash equivalents and marketable securities. The forward-looking statements contained herein are based on Arcellx’s current expectations and involve assumptions that may never materialize or may turn out 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 can be found in the section entitled Part II, Item 1A (Risk Factors) of the Quarterly Report on Form 10- Q and other documents that Arcellx files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Arcellx undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except when required by law.
Contact with the media:
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SOURCE Arcellx, Inc