On May 12, 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 first quarter ended March 31, 2022 (Press release, Arcellx, MAY 12, 2022, View Source [SID1234614352]).
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"This is an exciting time for our company as we successfully completed our initial public offering in February, raising $142 million in gross proceeds and strengthened our balance sheet as we advance our pioneering platform to treat cancer and other incurable diseases," said Rami Elghandour, Arcellx’s chairman and chief executive officer. "In our first quarter as a public company, we continued to lay the foundation for our near-term and long-term success and our dedicated team made meaningful strides towards our 2022 milestones. We are looking forward to presenting additional patient and longer-term follow-up data on approximately 25 patients for our lead CART-ddBCMA program for patients with relapsed or refractory multiple myeloma (r/r MM) during an oral presentation at ASCO (Free ASCO Whitepaper) in June. Recently, we also advanced our development pipeline programs with the dosing of the first patient in our Phase 1 study evaluating ACLX-001 for patients with r/r MM utilizing our ARC-SparX technology. ARC-SparX has the potential to overcome some of the core challenges in cell therapy by reducing toxicities and addressing antigen heterogeneity, opening up significant market opportunities in harder to treat indications. In the second half of this year, we look forward to initiating our Phase 1 ARC-SparX clinical trial in patients with acute myeloid leukemia and high-risk myelodysplastic syndrome, our Phase 2 CART-ddBCMA pivotal trial in patients with r/r MM, and presenting longer-term patient data from our Phase 1 CART-ddBCMA expansion trial in r/r MM. The capstone of our progress is driven by our D-Domain technology which allows us to choose the right approach for the right indication, and we believe this differentiates our programs from traditional CAR-T therapies."
Recent Business Highlights
Clinical results from CART-ddBCMA Phase 1 study published in Blood Advances. On May 9, 2022, Arcellx announced the publication of clinical results from the dose escalation cohorts of its CART-ddBCMA Phase 1 study in patients with r/r MM in Blood Advances, the open-access journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). The data demonstrate 100% ORR and 75% CR/sCR; and evidence of durable clinical benefit in a population with poor prognostic features were observed in the dose escalation cohorts with CART-ddBCMA. The full online publication can be accessed here.
Dosed first patient in Phase 1 clinical trial evaluating ACLX-001 utilizing the ARC-SparX platform for the treatment of patients with r/r MM. On May 10, 2022, Arcellx announced that the first patient was dosed in its open-label, multicenter Phase 1 clinical trial (NCT04155749) to evaluate the company’s novel dosable and controllable ARC-SparX program in patients with r/r MM. ARC-SparX is comprised of SparX (soluble protein antigen receptor X-linkers) proteins engineered to target BCMA on myeloma cells together with ARC-T (Antigen Receptor Complex-T) cells that are dosed separately and engineered to activate only when engaged with a SparX protein bound to a myeloma cell. Both the ARC cells and the SparX proteins utilize the company’s proprietary novel synthetic binding scaffold called the D-Domain.
CART-ddBCMA accepted as an oral abstract presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. On April 27, 2022, Arcellx announced the presentation of new clinical data from its CART-ddBCMA Phase 1 trial in patients with relapsed or refractory multiple myeloma in an oral abstract session at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022, in Chicago, Illinois.
Oral Presentation Details:
Title: Phase 1 Study of CART-ddBCMA in Relapsed or Refractory Multiple Myeloma
Speaker: Matthew J. Frigault, M.D., Assistant Director of the Cellular Therapy Service at Massachusetts General Cancer Center, and Instructor at Harvard Medical School
Session Type/Title: Oral Abstract Session/Hematologic Malignancies—Plasma Cell Dyscrasia
Session Date: Sunday, June 5, 2022
Session Time: 8:00 a.m. – 11:00 a.m. CDT
Location: McCormick Place Convention Center, Chicago, Illinois
Abstract Number: 8003
Live webcast event with management and panel of clinician experts. On Sunday, June 5, 2022, at 7:00 p.m. CDT, Arcellx will host a live webcast event with an expert panel of clinicians to discuss the clinical results from its CART-ddBCMA study being presented during ASCO (Free ASCO Whitepaper). The event will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcast will be archived and available for 30 days following the event.
First Quarter 2022 Financial Highlights
Cash, cash equivalents, and marketable securities:
As of March 31, 2022, Arcellx had cash, cash equivalents, and marketable securities of $210.9 million, which is anticipated to fund its operations into the second half of 2023.
R&D expenses:
Research and development expenses were $24.4 million and $8.5 million for the quarters ended March 31, 2022 and 2021, respectively, an increase of $15.9 million. This increase was driven by higher external costs associated with the advancement of our CART-ddBCMA clinical program, preclinical development of our other pipeline candidates, and increased headcount.
G&A expenses:
General and administrative expenses were $8.0 million and $2.8 million for the quarters ended March 31, 2022 and 2021, respectively, an increase of $5.2 million. This increase was driven by increased headcount, professional fees related to consulting and accounting, audit services, and other expenses.
Net loss:
Net loss was $32.4 million and $11.3 million for the quarters ended March 31, 2022 and 2021, respectively.
About the ARC-SparX Platform Technology
The ARC-SparX platform is designed to allow for controllability and adaptability to potentially reduce toxicities that are often associated with serious dose-limiting adverse events and to overcome tumor heterogeneity. It is a modular therapy which utilizes a universal ARC-T cell combined with an off-the-shelf SparX protein to separate the tumor-recognition and tumor-killing functions. SparX (soluble protein antigen-receptor X-linkers) proteins utilize our D-Domain technology engineered to recognize antigens on the surface of diseased cells and flags those cells for detection by the ARC-T cells. ARC-T cells express a D-Domain-based CAR engineered to specifically recognize a unique TAG in the SparX protein. ARC-T cells are dosed separately and only activated to kill the target cell when they encounter a SparX protein bound to the target antigen and thus are controlled through SparX dose modulation. Arcellx has developed a collection of SparX proteins that bind different antigens on the surface of diseased cells. Multiple SparX proteins with different antigen specificity can be administered to potentially address antigen heterogeneity or antigen escape that contribute to relapsed and refractory disease.