Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [7] - The lead candidate is NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy [4][7] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [4][8] Clinical Trials - The NEXICART-2 trial is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial evaluating NXC-201 in relapsed/refractory AL Amyloidosis, expected to enroll 40 patients with preserved heart function [3] - The primary endpoint of the Phase 1 portion is safety, while the Phase 2 portion focuses on efficacy [3] - Initial data from an ex-U.S. study, NEXICART-1, has shown high complete response rates in relapsed/refractory AL Amyloidosis [4] Market Insights - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients in 2024 [6] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [6] Upcoming Events - Phase 1/2 interim readout data from the NEXICART-2 trial will be presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago on June 3, 2025 [1][2] - The presentation will be led by Dr. Heather Landau, Director of the Amyloidosis Program at Memorial Sloan-Kettering Cancer Center [1]

Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [8] - The lead candidate is NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy [5][8] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [5][9] Clinical Trials - The ongoing NEXICART-2 trial (NCT06097832) is a single-arm multi-site Phase 1/2 clinical trial evaluating NXC-201 in relapsed/refractory AL Amyloidosis [4] - The trial aims to enroll 40 patients with preserved heart function who have not previously received BCMA-targeted therapy [4] - The primary endpoint for Phase 1 is safety, while for Phase 2 it is efficacy [4] Upcoming Presentation - Interim readout data from the NEXICART-2 trial will be presented at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) in Chicago [2] - The presentation is scheduled for June 3, 2025, and will be led by Dr. Heather Landau from Memorial Sloan-Kettering Cancer Center [2][3] Market Insights - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients in 2024 [7] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [7]

Financial Performance - Immix Biopharma reported general and administrative expenses of $11,381,978 for the year ended December 31, 2024, an increase of 53.4% from $7,406,082 in 2023[349]. - Research and development expenses rose to $11,292,702 for the year ended December 31, 2024, compared to $8,735,031 in 2023, reflecting increased spending on clinical trials[351]. - Provision for income taxes for the year ended December 31, 2024 was $41,037, an increase from $26,415 for the year ended December 31, 2023[354]. - Net cash used in operating activities for the year ended December 31, 2024 was $14,595,102, compared to $11,371,438 for the year ended December 31, 2023, primarily due to a net loss of $21,698,363[365]. - Net cash provided by financing activities was $15,948,567 for the year ended December 31, 2024, compared to $15,463,512 for the year ended December 31, 2023[367]. - Net cash used in investing activities was $1,177,680 for the year ended December 31, 2024, compared to $52,089 for the year ended December 31, 2023[366]. - The Company has incurred significant net losses since inception and does not expect to generate revenue from product sales until regulatory approval is obtained[355]. Funding and Grants - The company raised net proceeds of $13,565,760 from an underwritten public offering of 5,535,055 shares at a public offering price of $2.71 per share[346]. - The company was awarded an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to support clinical development of NXC-201, contingent on achieving specific milestones[347]. - The Company was awarded an $8 million grant from the California Institute for Regenerative Medicine to support clinical development of NXC-201, with $3.6 million received in reimbursements as of March 11, 2025[358]. - The Company anticipates needing additional capital to continue operations beyond the next 12 months and plans to seek funds through various financing sources[360]. Operational Developments - Nexcella was merged into the company on May 20, 2024, with the company issuing 989,876 shares of common stock to former Nexcella stockholders[339]. - The company entered into a Research and License Agreement with Hadasit and BIRAD, committing to additional payments totaling approximately $13 million through September 2026[340]. - The company entered into a long-term operating lease agreement for biopharmaceutical manufacturing space, with total lease payments expected to be $1.6 million through December 2033[363]. Regulatory and Clinical Updates - The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to CAR-T NXC-201 for treating relapsed/refractory AL amyloidosis on February 10, 2025[348]. - The company expects to incur significant commercialization expenses if regulatory approval is obtained for its product candidates[336]. - The Company expects to incur significant commercialization expenses if marketing approval is obtained for any product candidates[359]. Assets and Liquidity - As of December 31, 2024, total assets were approximately $22.9 million, with working capital of approximately $11.5 million and liquidity of approximately $17.7 million in cash and cash equivalents[360]. - The Company has incurred recurring losses primarily due to research and development activities and negative cash flows from operations[336]. - Interest income increased to $1,017,354 for the year ended December 31, 2024, up from $572,006 in 2023, due to higher balances in money market funds[353].

Core Viewpoint - Immix Biopharma has received RMAT designation from the FDA for its CAR-T therapy NXC-201, aimed at treating relapsed/refractory AL amyloidosis, highlighting the potential of this therapy to address unmet medical needs in a serious condition [1][2][7] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL amyloidosis and select immune-mediated diseases [10] - The lead candidate, NXC-201, is a sterically-optimized BCMA-targeted CAR-T cell therapy currently undergoing clinical trials [10] Product Development - NXC-201 is the only CAR-T therapy in development specifically for AL amyloidosis, with initial data showing high complete response rates and no neurotoxicity [3][4] - The NEXICART-2 trial is a Phase 1b/2 study designed to evaluate the safety and efficacy of NXC-201 in patients with relapsed/refractory AL amyloidosis, aiming to enroll 40 patients [6] Regulatory Designation - The RMAT designation is intended to expedite the development and review process for promising investigational products, allowing for early interactions with the FDA [2][5] - NXC-201 has also received Orphan Drug Designation from both the US FDA and the EU EMA, further supporting its development [5][10] Market Context - The prevalence of relapsed/refractory AL amyloidosis in the U.S. is estimated to grow at 12% annually, reaching approximately 33,277 patients by 2024 [8] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [9]

Core Insights - Immix Biopharma has successfully completed the six-patient Phase 1b safety run-in segment of the NEXICART-2 study for NXC-201, a CAR-T therapy targeting relapsed/refractory AL Amyloidosis, which is expected to accelerate patient enrollment starting January 2025 [1][3][5] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and select immune-mediated diseases [10] - The lead candidate, NXC-201, is a BCMA-targeted CAR-T cell therapy that has shown promising results in initial studies, including high complete response rates and no neurotoxicity [4][10] Clinical Study Details - The NEXICART-2 study is an open-label, single-arm, multi-site Phase 1b/2 clinical trial designed to evaluate the safety and efficacy of NXC-201 in patients with relapsed/refractory AL Amyloidosis [6] - The study consists of a safety run-in segment with six patients, followed by a 34-patient dose expansion segment, with two dosing levels evaluated [2][6] Market Context - AL Amyloidosis affects approximately 33,000 patients in the U.S., with no FDA-approved therapies currently available for relapsed/refractory cases [7][9] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025, indicating significant growth potential [9]

Clinical Trial Results - All four patients treated with NXC-201 normalized their disease markers within 30 days of dosing, with two classified as complete responders (CR) and the remaining two achieving bone marrow MRD negativity [1][5] - Bone marrow MRD negativity predicts future CR, and the company believes the remaining two patients could be confirmed as CRs in the coming weeks and months [1][5] - Median follow-up was 85 days (range 29-141) as of the data cut-off date of November 14, 2024 [2][4] - Patients NX2-001, NX2-002, and NX2-004 had reduction of dFLC to <1 mg/dL, with MRD negativity in bone marrow by flow cytometry [5] - Patient NX2-003 had resolution of M-spike 15 days following NXC-201 treatment [5] - Improvement in NYHA class from class II to class I occurred in one patient 14 days following NXC-201 treatment [5] Patient Characteristics - All patients were relapsed (n=1) or refractory (n=3) to an anti-CD38 antibody and had a median of 4 prior lines of therapy (range: 2-6) [3] - Two patients (50%) had received prior autologous stem cell transplant [3] - At enrollment, median difference in free light chain (dFLC) was 65 mg/L (range: 24-86) among Patients NX2-001, NX2-002, and NX2-004, and Patient NX2-003 had an M-spike of 0.79 g/dL [3] - Patients were cardiac Mayo stage I/II with median NT-proBNP 389 pg/mL (range: 146-1,297) [3] - Three patients had NYHA class I heart failure, while one had class II [3] - One patient had kidney involvement with 3.0gm albuminuria in 24 hours [3] Tolerability and Safety - No patient developed immune effector cell-associated neurotoxicity syndrome [5] - No cytokine-release syndrome (CRS) was observed in two patients, while Grade 1 (n=1) and Grade 2 (n=1) CRS was observed in the other two patients, both lasting less than 24 hours following one dose of tocilizumab [5] - Hematologic adverse events included neutropenia in all four patients (three grade 3, one grade 4) [5] - No febrile neutropenia, treatment-related infections, cardiac toxicity, or deaths were reported [5] Next Steps and Program Updates - The company plans to continue enrolling patients in its potentially pivotal NEXICART-2 U.S. clinical trial for relapsed/refractory AL Amyloidosis [6] - The next program update is expected in H1 2025 [1][6] - Interim clinical data readout is expected in Q2/Q3 2025, with final topline clinical data readout expected in Q2/Q3 2026 [6] About NEXICART-2 and NXC-201 - NEXICART-2 is a Phase 1b/2, multi-site U.S. open-label dose escalation and dose expansion trial enrolling relapsed/refractory AL Amyloidosis patients with preserved heart function [1][7] - NXC-201 is a sterically-optimized BCMA-targeted CAR-T cell therapy, with initial data from Phase 1b/2 ex-U.S. study NEXICART-1 demonstrating high complete response rates and no neurotoxicity [8] - NXC-201 has been awarded Orphan Drug Designation (ODD) in AL Amyloidosis by the US FDA and in the EU by the EMA [8][9] Market and Industry Context - AL Amyloidosis is caused by abnormal plasma cells producing misfolded amyloid proteins, leading to organ damage and high mortality rates [9] - The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year, reaching approximately 33,277 patients in 2024 [9] - The Amyloidosis market was $3.6 billion in 2017 and is expected to reach $6 billion in 2025 [9] Virtual Investor Event - The company will host a virtual investor event on Dec 19 at 11:00 a.m. ET to discuss the results [1][7]

Core Insights - NXC-201, a CAR-T cell therapy, shows significant clinical activity in treating relapsed/refractory AL Amyloidosis, achieving a 75% complete response rate in a small patient cohort [1][2][5] - The therapy has a favorable safety profile, particularly in frail patients, and is currently being evaluated in ongoing clinical trials in the U.S. [1][6] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and select immune-mediated diseases [10] - The company’s lead candidate, NXC-201, has received Orphan Drug Designation from the FDA and EMA for AL Amyloidosis [6][10] Clinical Trials - NEXICART-1 is an open-label, ex-U.S. Phase 1b/2 clinical trial that has reported promising results for NXC-201 in patients with relapsed/refractory AL Amyloidosis [3][5] - NEXICART-2 is a U.S. Phase 1b/2 trial designed to evaluate NXC-201 in patients with preserved heart function, aiming to enroll 40 patients [4][6] Market Potential - The prevalence of relapsed/refractory AL Amyloidosis in the U.S. is projected to grow at 12% annually, reaching approximately 33,277 patients by 2024 [8] - The amyloidosis market was valued at $3.6 billion in 2017 and is expected to grow to $6 billion by 2025 [9]

Clinical Trials and Product Development - Immix Biopharma's lead candidate NXC-201 is currently in Phase 1b/2 clinical trials for relapsed/refractory AL Amyloidosis, with 3 patients treated in the U.S. and 13 patients treated in ex-U.S. trials as of September 30, 2024[146]. - The overall response rate for NXC-201 in clinical trials is reported at 100% (10/10), with a complete response rate of 70% (7/10) among treated patients[148]. - The observed prevalence of relapsed/refractory AL Amyloidosis is increasing at a rate of 12% per year, expected to reach 33,277 patients in 2024[145]. - Immix Biopharma has incurred recurring losses primarily due to research and development activities, with significant expenses expected to continue as product candidates advance through clinical trials[152]. - The company expects to incur significant commercialization expenses related to product manufacturing, marketing, and distribution if regulatory approval is obtained for any product candidates[152]. Financial Performance - The company sold 328,136 common shares through the July ATM Facility for net proceeds of $1,091,887 from July 14, 2023, to February 5, 2024[158]. - The company completed a public offering of 5,535,055 shares at a public offering price of $2.71 per share, resulting in net proceeds of $13,565,760 after expenses[159]. - General and administrative expenses increased to $2,949,403 for the three months ended September 30, 2024, up from $2,417,776 for the same period in 2023, reflecting a 22% increase[160]. - Research and development expenses rose to $4,445,528 for the three months ended September 30, 2024, compared to $2,106,020 for the same period in 2023, marking a 111% increase[162]. - The net loss for the three months ended September 30, 2024, was $7,149,395, compared to $4,343,912 for the same period in 2023, representing a 64% increase in net loss[165]. - For the nine months ended September 30, 2024, general and administrative expenses totaled $7,769,224, up from $5,130,977 in the same period in 2023, indicating a 51% increase[166]. - Research and development expenses for the nine months ended September 30, 2024, were $9,918,336, compared to $5,634,284 for the same period in 2023, reflecting a 76% increase[168]. - Net cash used in operating activities was $13,118,904 for the nine months ended September 30, 2024, compared to $8,694,001 for the same period in 2023[180]. - The company had $16.2 million in working capital as of September 30, 2024[175]. Market Potential and Agreements - The U.S. market for amyloidosis therapies is estimated at $3.6 billion, projected to grow to $6 billion by 2027[145]. - The current market size for select immune-mediated diseases is estimated at $25 billion, indicating significant potential for Immix Biopharma's other programs[150]. - Immix Biopharma has entered into a Research and License Agreement with Hadasit and BIRAD, committing to pay approximately $13 million in quarterly payments through September 2026[156]. - Nexcella is required to pay sales milestone payments of up to $20 million for net sales exceeding $700 million, along with a 5% royalty on net sales during the royalty period[156]. Corporate Structure and Compliance - The company merged with Nexcella on May 20, 2024, with Nexcella ceasing to exist and its assets and operations being succeeded by Immix Biopharma[154]. - The company is taking advantage of the extended transition periods under the JOBS Act for complying with new accounting standards, which may affect comparability with other public companies[186]. - As an "emerging growth company," the company will remain under this designation until it reaches total annual gross revenues of $1.235 billion or more[187]. - The company’s financial statements are prepared in accordance with U.S. GAAP, requiring management to make estimates and judgments that may materially affect reported amounts[188]. - There have been no material changes to the company's critical accounting policies and estimates since the 2023 Form 10-K[188]. - The company is classified as a "smaller reporting company" and is not required to provide certain market risk disclosures[189]. Grants and Funding - The company was awarded an $8 million grant from CIRM to support clinical development, contingent on achieving specific milestones[176].

Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and immune-mediated diseases [4] - The lead candidate is NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy, currently undergoing Phase 1b/2 trials in the U.S. and ex-U.S. [4] - NXC-201 has received Orphan Drug Designation from the US FDA and the EU EMA for AL Amyloidosis [4] Key Personnel - Dr. Raymond Comenzo has joined the scientific advisory board of ImmixBio's subsidiary, Nexcella, bringing extensive expertise in AL Amyloidosis [1][3] - Dr. Comenzo is recognized for his contributions to clinical trial guidelines and was the senior author of the Andromeda trial, which led to the first FDA-approved therapy for AL Amyloidosis [1][3] - He holds multiple prestigious positions, including Director of the Myeloma and Amyloid Program at Tufts Medical Center [3] Research and Development Focus - The company is advancing CAR-T therapy specifically for relapsed/refractory AL Amyloidosis, a condition currently lacking approved treatment options [2] - NXC-201 has shown no neurotoxicity and a short duration of cytokine release syndrome, indicating potential for expansion into other immune-mediated diseases [4]

Core Insights - Immix Biopharma has expanded its clinical trial sites for the NEXICART-2 study, which focuses on CAR-T NXC-201 for relapsed/refractory AL Amyloidosis, enhancing patient access across the U.S. [1][3] - The NEXICART-2 study aims to evaluate the safety and efficacy of CAR-T NXC-201, building on positive results from the previous NEXICART-1 study, which reported a 92% overall response rate [2][4] - NXC-201 is the only CAR-T therapy currently in development for AL Amyloidosis, with no reported neurotoxicity, and has received Orphan Drug Designation from the FDA and EMA [3][7] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and immune-mediated diseases [10] - The company’s lead candidate, NXC-201, is undergoing evaluation in both U.S. and ex-U.S. clinical trials, with promising initial data supporting its safety profile [6][10] Clinical Trial Details - The NEXICART-2 trial is a Phase 1b/2 study designed to enroll 40 patients with adequate cardiac function who have not received prior BCMA-targeted therapy [4] - The trial will evaluate two doses of CAR-T NXC-201, with potential escalation to higher doses based on safety and efficacy outcomes [4] Market Insights - The prevalence of relapsed/refractory AL Amyloidosis in the U.S. is estimated to grow at 12% annually, reaching approximately 33,277 patients in 2024 [9] - The AL Amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [9]