Core Insights - Immix Biopharma is advancing its NEXICART-2 clinical trial for relapsed/refractory AL Amyloidosis, expanding to 18 sites in the U.S. [1][2] - The company is on track for the first Biologics License Application (BLA) for a cell therapy targeting an unaddressed orphan indication [1][2] - Interim results from the NEXICART-2 trial were presented at ASCO 2025, showcasing the progress of the therapy [1][2][3] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [3] - The lead candidate is NXC-201, a BCMA-targeted CAR-T cell therapy, currently evaluated in a multi-center study [3] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) from the FDA and EMA [3] Market Context - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% annually, reaching approximately 33,277 patients by 2024 [5] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [5]

NXC-201 Platform and Clinical Trial - NXC-201 is a sterically-optimized CAR-T construct from the Immix N-GENIUS platform with a "digital filter" to reduce non-specific activation and enhance tolerability[6] - The company plans to submit a BLA for NXC-201[9] - The NEXICART-2 trial is a U S multi-center trial with registrational design for relapsed/refractory AL Amyloidosis with 40 patients enrolled[6,39] - Interim clinical data readout for the NEXICART-2 trial in relapsed/refractory AL Amyloidosis is expected in 2Q 2025[35] - Planned NEXICART-2 enrollment completion is expected in 4Q 2025 / 1Q 2026[35] AL Amyloidosis Market and NXC-201 Potential - The relapsed/refractory AL Amyloidosis target market has a U S patient prevalence of 34,600, representing a multi-billion dollar value[6] - There are currently no FDA-approved drugs for relapsed/refractory AL Amyloidosis[6,27] - Current standards of care induce a complete response in 0-10% of patients with relapsed/refractory AL Amyloidosis[19,21,27] - In the NEXICART-2 U S trial, 70% complete responses (CR) were observed in 7 out of 10 patients, with the remaining three being MRD-negative 10-6, predicting future CR[49] NXC-201 Safety and Tolerability - NXC-201 demonstrated no ICANS neurotoxicity in clinical trials[54] - NXC-201 has a median CRS duration of 1 day, which is 4-8x shorter than other CAR-T therapies[32]

Core Viewpoint - Immix Biopharma, Inc. (IMMX) has received an upgrade to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, indicating potential for stock price increase [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [2][4]. - Rising earnings estimates for Immix Biopharma suggest an improvement in the company's underlying business, likely leading to increased stock prices [5]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [7]. - Immix Biopharma's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating superior earnings estimate revisions and potential for market-beating returns [10]. Earnings Estimate Revisions - For the fiscal year ending December 2025, Immix Biopharma is expected to earn -$0.62 per share, reflecting an 18.4% year-over-year change [8]. - Over the past three months, the Zacks Consensus Estimate for Immix Biopharma has increased by 27.1%, indicating positive sentiment among analysts [8].

Core Points - Immix Biopharma, Inc. was selected to attend an FDA CEO forum led by FDA Commissioner Marty A. Makary on June 5, 2025, focusing on modernizing the regulatory framework for biotechnology and pharmaceutical industries [1][2] - The forum aimed to gather input from industry leaders to enhance patient access to safe and effective therapies, with Immix Biopharma expressing alignment with the FDA's vision for an efficient regulatory environment [2] - Immix Biopharma is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis, with its lead candidate being NXC-201, a BCMA-targeted CAR-T cell therapy currently in a multi-center study [3] Company Overview - Immix Biopharma, Inc. (Nasdaq: IMMX) is focused on developing cell therapies for serious diseases, particularly AL Amyloidosis [3] - The lead candidate, NXC-201, is being evaluated in the NEXICART-2 study (NCT06097832) for relapsed/refractory AL Amyloidosis, with interim results presented at ASCO 2025 [3] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) from the FDA and EMA [3]

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 ...