Arcellx: Partial Clinical Hold Lifted By FDA On IMMagine-1 Phase 2 Trial; Q2 Net Loss Narrows

(RTTNews) - Arcellx, Inc. (ACLX), a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration has lifted the partial clinical hold placed on its CART-ddBCMA investigational new drug for the treatment of patients with relapsed or refractory multiple myeloma or rrMM. The company also reported narrower net loss and significant collaboration revenue for its second quarter.

On Nasdaq, Arcellx shares closed Tuesday's regular trading at $35.91, up 6.62 percent. In the extended trading, the shares lost 2.9 percent to trade at $34.86.

Regarding the FDA's action, the company noted that iMMagine-1 Phase 2 Clinical Program had been placed on partial clinical hold by FDA on June 19 following a recent patient death. The deceased patient was treated with CART-ddBCMA despite becoming ineligible for treatment under the trial protocol prior to CART-ddBCMA infusion.

Subsequently, the patient was managed in a manner that conflicted with the trial protocol. The partial clinical hold is now lifted after aligning with FDA on modifications to the iMMagine-1 trial protocol related to the prevention and management of the risk of adverse events within the trial.

Arcellx retrained clinical sites as a key effort to enhance protocol adherence. In addition, the agency allowed an expansion of treatment options for therapies that patients in the iMMagine-1 trial are permitted to receive between apheresis and CAR-T infusion, also known as bridging therapies, to better align its protocol with current clinical practice.

The company anticipates presenting preliminary data from the iMMagine-1 study in the second half of 2024, and continues to expect commercial launch of CART-ddBCMA to be in 2026.

Arcellx and Kite Pharma, Inc. recently formed a global strategic collaboration to co-develop and co-commercialize Arcellx's CART-ddBCMA candidate. The companies will jointly advance and commercialize the CART-ddBCMA asset in the United States, and Kite will commercialize the product outside the U.S.

Rami Elghandour, Arcellx's Chairman and Chief Executive Officer, said, "During the review process, we updated our trial protocol, and were pleased that FDA allowed for expanded bridging therapies, which better aligns our protocol with current clinical practice. …. Importantly, during the partial clinical hold, FDA approved dosing of all 17 patients who had been enrolled but not yet dosed prior to the hold, minimizing treatment disruption for patients and clinicians."

The company further said it has a strong balance sheet funding operations through BLA filing and into 2026. As of June 30, Arcellx had cash, cash equivalents, and marketable securities of $506.5 million, which fund its operations into 2026.

In its second quarter, net loss $23.9 million, narrower than last year's loss of $30.8 million.

Research and development expenses were $28.3 million, up from $22.1 million a year ago, primarily driven by higher external costs associated with the advancement of CART-ddBCMA clinical program and personnel.

General and administrative expenses were $15.5 million, higher than prior year's $9.2 million.

Collaboration revenue was $14.3 million, compared to and $0 a year ago. The revenue is from the recognition of research and development performed under the arrangement described in the recent license and collaboration agreement with Kite.

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