LOS ANGELES - Immix Biopharma, Inc. (NASDAQ:IMMX), a clinical-stage biotech company with a market capitalization of approximately $58 million, has announced promising initial clinical results from the first four participants in its NEXICART-2 trial, a U.S. study investigating the efficacy of its CAR-T cell therapy, NXC-201, in patients with relapsed/refractory AL Amyloidosis. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 3.47x, indicating sufficient resources to support its clinical programs. As of the data cutoff on November 14, 2024, all patients had normalized disease markers within 30 days of receiving the treatment, with two achieving complete response status and the other two exhibiting bone marrow MRD negativity, a predictor of future complete responses.
The trial, which began enrollment in June 2024, is designed to evaluate the safety and efficacy of NXC-201 in patients who have progressed on Dara-CyBorD and have preserved heart function. The study has completed its first dosing cohort and is currently administering doses to patients in the expansion cohort.
Clinical results from the study showed that, following treatment, patients experienced a reduction in disease markers such as free light chains and M-spike to normal levels. Improvements in heart function were also observed, with one patient’s New York Heart Association (NYHA) class improving from class II to class I. The treatment was well-tolerated, with no cases of immune effector cell-associated neurotoxicity syndrome, and manageable cytokine release syndrome in two patients.
The company is set to continue patient enrollment in the NEXICART-2 trial and plans to provide the next program update in the first half of 2025. Interim and final clinical data readouts are expected in the second and third quarters of 2025 and 2026, respectively. While the company’s stock has experienced a significant decline of nearly 70% year-to-date, InvestingPro analysis reveals that analysts maintain a bullish outlook with a $7.00 price target, suggesting substantial upside potential. Get access to 8 additional exclusive InvestingPro Tips and comprehensive financial analysis to make more informed investment decisions.
Immix Biopharma’s NXC-201 has been granted Orphan Drug Designation for AL Amyloidosis by both the FDA and EMA. AL Amyloidosis is a rare disorder caused by the buildup of misfolded amyloid proteins, leading to organ damage and high mortality rates. The company’s approach with NXC-201 aims to address the unmet medical needs of patients with this condition.
The company will hold a virtual investor event today to discuss these results further. The information in this article is based on a press release statement from Immix Biopharma, Inc. InvestingPro’s Financial Health Score indicates a "FAIR" rating for Immix Biopharma, with notably strong cash position relative to debt, though the company continues to burn through cash as it advances its clinical programs.
In other recent news, Immix Biopharma, a clinical-stage biopharmaceutical company, has reported promising results from its clinical trials for CAR-T therapy NXC-201, showing a 75% complete response rate in patients with relapsed/refractory AL Amyloidosis. The therapy has received Orphan Drug Designation in AL Amyloidosis by both the US FDA and the EU EMA. In addition to these developments, the company has expanded its U.S. Phase 1b/2 study of CAR-T therapy NXC-201 to include three new clinical trial sites.
H.C. Wainwright has maintained a Buy rating for Immix, highlighting the trials’ progress and the potential of NXC-201. Furthermore, Immix Biopharma has appointed Crowe LLP as its new auditor and received an orphan drug designation from the European Commission for NXC-201. These recent developments underline Immix Biopharma’s ongoing efforts in the biopharmaceutical industry, with a focus on clinical trials and expanding its presence in the oncology sector.
Lastly, the company has welcomed Dr. Raymond (NS:RYMD) Comenzo, a renowned AL Amyloidosis expert, to the Scientific Advisory Board of its subsidiary Nexcella. This addition is anticipated to further Immix Biopharma’s development of advanced treatments for AL Amyloidosis.
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