Summary of Key Points from the Conference Call Company and Industry - **Company**: IMX - **Industry**: AL amyloidosis treatment, specifically focusing on CAR T cell therapy Core Points and Arguments 1. **Unmet Medical Need**: There are approximately 23,000 patients in the U.S. with relapsed refractory AL amyloidosis, and currently, there are no FDA-approved drugs for this subgroup [5][21][23] 2. **Current Treatment Landscape**: Existing therapies provide modest responses, with about 60% of patients responding to first-line treatments. However, options are limited for those who fail these therapies [13][21][25] 3. **NXC201 (Nexicar-2) Trial**: This is the first CAR T cell trial specifically for AL amyloidosis, targeting BCMA. Initial results show it can be administered safely and leads to rapid and deep hematologic responses [23][25][36] 4. **Safety Profile**: The trial reported manageable cytokine release syndrome (CRS) and no neurotoxicity, which is a significant concern in CAR T therapies [30][39][56] 5. **Efficacy Results**: 70% of evaluable patients achieved a complete hematologic response, with rapid normalization of disease markers [34][36] 6. **Potential for Outpatient Treatment**: Given the safety profile, there is potential for NXC201 to be administered as an outpatient therapy, reducing hospitalization time significantly [85][90] 7. **Market Opportunity**: The potential market for NXC201 is significant, with estimates suggesting that at least 20,000 patients could benefit from this treatment in the U.S. [65][66] Other Important but Possibly Overlooked Content 1. **Patient Demographics**: The median age of patients in the trial was 67, with 70% having received prior stem cell transplants [29] 2. **Durability of Response**: There is optimism regarding the durability of responses, similar to what is seen in multiple myeloma treatments, but this remains to be fully evaluated [49][60] 3. **Comparison with Other Therapies**: The CAR T cell therapy is viewed as a more effective and less toxic option compared to traditional therapies like stem cell transplants and bispecific antibodies [50][76] 4. **Future Considerations**: Ongoing monitoring for infection risks and the long-term durability of responses will be crucial as the therapy is rolled out [55][60][82] This summary encapsulates the key discussions and findings from the conference call regarding the NXC201 trial and its implications for the treatment of relapsed refractory AL amyloidosis.

Core Insights - Immix Biopharma's NXC-201 achieved a complete response (CR) rate of 70% in the NEXICART-2 Phase 1/2 clinical trial for relapsed/refractory AL Amyloidosis, meeting its primary endpoint [1][4][3] - The trial reported no relapses or safety signals to date, indicating a favorable safety profile for NXC-201 [1][4] - Immix plans to submit a Biologics License Application (BLA) to the FDA for NXC-201 following these promising results [1][3] Clinical Trial Details - The NEXICART-2 trial is a U.S. multi-site, single-arm study evaluating NXC-201 in patients with relapsed/refractory AL Amyloidosis, with a data cutoff of April 11, 2025 [1][3][7] - Prior to treatment, patients had a median of 4 lines of therapy, and all had organ involvement from the disease [4] - After treatment, all patients normalized pathological disease markers, with 70% achieving complete responses [4] Safety and Efficacy - No neurotoxicity was observed, and only low-grade cytokine release syndrome was reported [4][9] - The remaining 3 patients who did not achieve CR are minimum residual disease (MRD) negative, suggesting potential future CRs [4] Market Context - Current treatments for relapsed/refractory AL Amyloidosis have a CR rate of less than 10%, highlighting a significant unmet medical need [5] - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients by 2024 [11] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [11] Company Overview - Immix Biopharma is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [12] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation from both the FDA and EMA [9][12]

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, currently being evaluated in the NEXICART-2 study [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][7] Clinical Trial Updates - The NEXICART-2 clinical trial is actively enrolling patients, with 14 U.S. sites currently participating, an increase of 10 sites since the last update [1][2] - The company anticipates completing the NEXICART-2 clinical trial ahead of schedule due to robust enrollment and demand [2] - The trial aims to enroll 40 patients with preserved heart function who have not previously received BCMA-targeted therapy, focusing on safety and efficacy as primary endpoints [3] Market Insights - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% annually, reaching approximately 33,277 patients by 2024 [6] - The AL Amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [6] Upcoming Presentations - 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 from May 30 to June 3, 2025 [2]

Core Insights - Immix Biopharma reported strong efficacy and favorable safety results for its NXC-201 therapy in the NEXICART-2 Phase 1/2 clinical trial for relapsed/refractory AL Amyloidosis, with a complete response (CR) rate of 71% [1][4][3] - The company has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for NXC-201, indicating significant progress towards regulatory approval [3][9] - The upcoming ASCO presentation on June 3, 2025, will provide updated results and further analysis of the trial data [5][2] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [12] - The lead candidate, NXC-201, is a BCMA-targeted CAR-T cell therapy that has shown promising results in initial studies [9][12] - The company aims to enroll 40 patients in the ongoing NEXICART-2 trial, which is designed to evaluate the safety and efficacy of NXC-201 [8] Clinical Trial Details - The NEXICART-2 trial is a U.S. multi-site, single-arm study assessing NXC-201 in patients with relapsed/refractory AL Amyloidosis [8] - Prior to treatment, patients had a median of 4 lines of therapy, and all had organ involvement due to the disease [4] - No relapses or significant safety signals have been reported to date, with only low-grade cytokine release syndrome observed [4][3] Market Context - The prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients in 2024 [11] - The AL Amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [11]

Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [12] - The lead candidate is NXC-201, a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy [12] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [9][12] Clinical Trials - The ongoing NEXICART-2 trial (NCT06097832) is a single-arm multi-site Phase 1/2 clinical trial evaluating NXC-201 in patients with relapsed/refractory AL Amyloidosis [8] - The trial aims to enroll 40 patients with preserved heart function and has safety as the primary endpoint for Phase 1 and efficacy for Phase 2 [8] - Initial data from the ex-U.S. study NEXICART-1 has shown high complete response rates in relapsed/refractory AL Amyloidosis [9] Market Insights - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients by 2024 [11] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [11] Key Opinion Leaders - A virtual KOL event is scheduled for June 3, 2025, featuring experts discussing interim clinical data from the NEXICART-2 trial [1][2] - Notable speakers include Dr. Heather Landau, Dr. Shahzad Raza, and Dr. Jeffrey Zonder, who will share their clinical experiences with NXC-201 [2][4][6][7]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Exact Name of Registrant as Specified in its Charter) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________to ___________ Commission File Number: 001-41159 IMMIX BIOPHARMA, INC. Delaware 45-4869378 (Stat ...

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]