On November 14, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported business highlights and financial results for the third quarter ended September 30, 2022 (Press release, Arcellx, NOV 14, 2022, View Source [SID1234624084]).
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"Helping patients is at the core of everything we do at Arcellx," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "To that end, we made significant progress advancing our lead program, CART-ddBCMA for the treatment of relapsed or refractory multiple myeloma with the initiation of our iMMagine-1 pivotal study. Following the submission of IND amendments for the technical transfer of our cell and vector manufacturing, we have begun to operationally scale by initiating clinical sites, enrolling patients and dosing our first patients from Lonza, our pivotal cell manufacturer. We are currently manufacturing cells with Oxford vector at Lonza and plan to dose patients with our pivotal drug product by the end of the year. Additionally, we look forward to presenting longer-term patient data from our Phase 1 CART-ddBCMA expansion trial at the 64th ASH (Free ASH Whitepaper) Annual Meeting. We continue to plan to initiate our Phase 1 ARC-SparX clinical trial of ACLX-002 in patients with acute myeloid leukemia and high-risk myelodysplastic syndrome by year end. We’re continuing to build our organization, attracting exceptional talent and fostering a diverse and collaborative culture, allowing us to deliver on the incredible promise of our technology and company. I’m incredibly proud of our team who’ve driven these remarkable results and who make Arcellx a special place to be. Each and every one of us at Arcellx recognizes the potential for our therapy to save lives and to be a game-changer in how hematologic and solid tumors are treated. Collectively, our team is committed to maximizing the potential of our cell therapies for patients and the physicians who treat them."
Third Quarter 2022 Financial Highlights
Cash, cash equivalents, and marketable securities:
As of September 30, 2022, Arcellx had cash, cash equivalents, and marketable securities of $280.8 million, which is anticipated to fund its operations for at least the next 12 months.
R&D expenses:
Research and development expenses were $83.5 million and $12.3 million for the quarters
ended September 30, 2022 and 2021, respectively, an increase of $71.2 million. This increase was primarily driven by the accounting for a one-time, non-cash expense of $63.1 million related to Lonza manufacturing services agreements. In accordance with ASC 842, the Company was required to expense the related right of use asset associated with the embedded lease which was determined to have no alternative future use. Other increases were related to higher external costs associated with the advancement of the Company’s CART-ddBCMA clinical program, other pipeline candidates, and increased headcount.
G&A expenses:
General and administrative expenses were $10.4 million and $4.8 million for the quarters ended September 30, 2022 and 2021, respectively, an increase of $5.6 million. This increase was driven by increased headcount, and costs to operate as a public company during the three months ended September 30, 2022, as compared to the same period in 2021, including professional fees related to consulting and accounting, audit and legal services.
Net loss:
Net loss was $92.9 million and $17.1 million for the quarters ended September 30, 2022 and 2021, respectively.