With its lead CAR-T flashing some PhI data, Arcellx readies a jump to Nasdaq
Max Gelman of ENDPOINTS NEWS, January 18, 2022

Nearly a year after unveiling a megaround Series C, Arcellx is headed toward Nasdaq.

The Gaithersburg, MD-based biotech penciled in a $100 million IPO raise last Friday, aiming to take its classic CAR-T therapy and experimental, controllable CAR-T to the public market. The lead program, a classical CAR-T which garnered the excitement for last April’s hefty $115 million raise, will likely head to a Phase II study with the IPO funds, Arcellx noted in its S-1.

Biotech IPOs proved a hot market for the first year or so of the Covid-19 pandemic, smashing industry records in total fundraise and number of debuts both last year and in 2020. But the pace slowed down toward the end of last year and the slow movement appears to have trickled into the new year, with only a handful of biotechs filing their SEC paperwork the last few weeks.

On top of that, many of the biopharmas that did file in the latter half of 2021 ended up downsizing their expected deals and pricing toward the lower ends of their ranges. As 2022 began, analysts have taken note of the slowdown and written that most investor interest has shifted to earlier stage investments.

Arcellx is one of a small group of biotechs aiming to develop a CAR-T therapy that can be manipulated after being infused into the patient. Though CAR-Ts have shown dramatic efficacy across a range of blood cancers, most patients eventually relapse as the cancer mutates, and researchers are hoping this approach can help counteract such mutations down the road.

Those programs are still in the preclinical phase, but Arcellx, unlike much of the 2021 biotech IPO crowd, is heading to Nasdaq with some clinical data already in hand. At ASH last month, the biotech revealed some Phase I data from its classic CAR-T candidate for relapsed or refractory multiple myeloma, observing all 19 evaluable patients as of a November cutoff date responded to the therapy.

Additionally, 13 of the 19 patients saw a complete response or a “stringent” complete response, Arcellx reported, with another three notching a “very good” partial response (Arcellx said it is using the CR and PR definitions laid out by the 2016 International Myeloma Working Group response criteria).

Only one patient experienced grade 3 cytokine release syndrome, while two others reported immune effector cell-associated neurotoxicity syndrome (ICANS). All incidents resolved after normal intervention, Arcellx said.

The biotech didn’t dish any details on exactly how much of the IPO raise will go toward this program, but it’s likely to be at least a plurality. Two of its controllable CAR-T programs, an anti-BCMA candidate for r/r MM and an anti-CD123 program for r/r acute myeloid leukemia and myelodysplastic syndrome, will also get some of the cash.

Once Arcellx goes public, it plans to trade under the ticker $ACLX.

- Originally published at January 18, 2022.