Nexcella, Inc. Announces Additional Positive NXC-201 Clinical Data Demonstrating 100% Complete Responses in Relapsed/Refractory AL Amyloidosis Patients, Duration of Response Not Yet Reached

• NXC-201 treatment continues to demonstrate 100% complete response rate in 6 relapsed/refractory AL amyloidosis patients to-date
• Clinical data published December 2022 in Clinical Cancer Research demonstrated 100% complete response rate; 100% organ response rate; Duration of Response Not Yet Reached at a median follow-up of 5.2 months, resulting in a mean 65% reduction (2,656pg/mL) in NT-proBNP from baseline; no grade 4 Cytokine Release Syndrome (CRS); no ICANS neurotoxicity was observed; a 2-stage improvement in NYHA stage was observed
• Low-grade CRS duration of median 2 days (range: 1-4 days) with median onset on day 2 (range: 1-3 days) points to NXC-201 potentially becoming the first and only out-patient CAR-T for AL Amyloidosis and other BCMA-positive malignancies

LOS ANGELES, CA, Jan. 06, 2023 (GLOBE NEWSWIRE) — Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), a biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that NXC-201 treatment continues to demonstrate 100% complete responses in a total of 6 relapsed/refractory AL amyloidosis patients. Clinical data published December 2022 in Clinical Cancer Research (https://doi.org/10.1158/1078-0432.CCR-22-0637) demonstrated 100% complete response rate; 100% organ response rate; NXC-201 Duration of Response Not Yet Reached at a median follow-up of 5.2 months (range: 2.5-9.5 months), resulting in a mean 65% reduction (2,656pg/mL) in NT-proBNP from baseline; no grade 4 Cytokine Release Syndrome (CRS); no ICANS neurotoxicity was observed; a 2-stage improvement in NYHA stage was observed. Low-grade CRS duration of median 2 days (range: 1-4 days) with median onset on day 2 (range: 1-3 days) points to NXC-201 potentially becoming the first and only out-patient CAR-T to treat AL Amyloidosis and other BCMA-positive malignancies.

“As we enroll additional patients, we continue to be encouraged by the consistent 100% complete response rate for AL amyloidosis patients treated with NXC-201 to-date,” said Gabriel Morris, President, Nexcella, Inc. “We are heartened to provide hope for patients with this devastating disease in our ongoing efforts to bring NXC-201 to market.”

Nexcella, Inc. Announces Additional Positive NXC-201 Clinical Data Demonstrating 100% Complete Responses in Relapsed/Refractory AL Amyloidosis Patients, Duration of Response Not Yet Reached

4 patients with relapsed or refractory AL amyloidosis treated with NXC-201 were included in the December 2022 Clinical Cancer Research publication. 4 of 4 patients (100%) experienced a complete response and 4 of 4 patients (100%) experienced an organ response after treatment with NXC-201. 4 of 4 patients (100%) had cardiac involvement at the time of their baseline echocardiogram reading as defined by NT-proBNP levels (>100 pg/ml) (range: 119 – 7,500. Mean 3,100. Median 2,391). Treatment with NXC-201 resulted in a mean 65% (mean 2,656 pg/mL) reduction in mean NT-proBNP from baseline. Additionally, a 2-stage improvement in NYHA stage was observed after treatment with NXC-201.

About NEXICART-1

NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed or refractory plasma cell dyscrasias, including multiple myeloma and AL amyloidosis.

The primary objective of the Phase 1b portion of the study, is to characterize the safety and confirm the Maximally Tolerated Dose (MTD) and Phase 2 dose of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 with endpoints of overall survival, progression-free survival and response rates.

About NXC-201

NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and amyloidosis. The design consists of a structurally differentiated CAR-T, with our proprietary BCMA-targeting CAR, which has demonstrated reduced toxicity in NEXICART-1, supporting investigating NXC-201 as an outpatient therapy.

About AL Amyloidosis
AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded amyloid proteins produced by plasma cells cause buildup in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage, and high mortality rates.

AL amyloidosis affects roughly 30,000 – 40,000 patients in total throughout the U.S. and Europe, and it is estimated that there are approximately 3,000 – 4,000 new cases of AL amyloidosis annually in the U.S. The annual global incidence of AL Amyloidosis is ~15,000 patients.

About Nexcella, Inc.

Nexcella, Inc., a subsidiary of Immix Biopharma, Inc (NASDAQ:IMMX), is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our N-GENIUS platform allows us to discover, develop, and manufacture cutting-edge cell therapies for patients in need. To learn more about Nexcella, Inc. visit us at www.nexcella.com.

Forward Looking Statements

This press release contains “forward-looking statements” Forward-looking statements reflect our current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements, include, but are not limited to, statements contained in this press release relating to our business strategy, our future operating results and liquidity and capital resources outlook. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward–looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, our ability to raise capital to fund continuing operations; our ability to protect our intellectual property rights; the impact of any infringement actions or other litigation brought against us; competition from other providers and products; our ability to develop and commercialize products and services; changes in government regulation; our ability to complete capital raising transactions; and other factors relating to our industry, our operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Immix Biopharma’s Annual Report on Form 10-K for the year ended December 31, 2021, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Immix Biopharma, Inc. specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements.

Contacts
Nexcella, Inc.
Gabriel Morris
President
ir@nexcella.com