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]

Core Viewpoint - Immix Biopharma, Inc. (IMMX) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Revisions - The company is projected to earn -$0.72 per share for the fiscal year ending December 2024, reflecting a year-over-year change of 19.1% [8]. - Over the past three months, the Zacks Consensus Estimate for Immix Biopharma has increased by 20.9%, indicating a positive trend in earnings estimates [8]. Zacks Rating System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - The upgrade to Zacks Rank 2 positions Immix Biopharma in the top 20% of Zacks-covered stocks, suggesting a strong potential for near-term price movement [10]. Impact of Institutional Investors - Changes in earnings estimates are closely correlated with stock price movements, largely due to institutional investors who adjust their valuations based on these estimates [4]. - An increase in earnings estimates typically leads to higher fair value for a stock, prompting institutional buying or selling, which influences stock prices [4]. Business Outlook - The rising earnings estimates and the subsequent rating upgrade for Immix Biopharma suggest an improvement in the company's underlying business, which could lead to higher stock prices as investors respond positively to this trend [5].

Clinical Development - Immix Biopharma's lead candidate, CAR-T NXC-201, is currently in Phase 1b/2a clinical trials for relapsed/refractory AL Amyloidosis, with 76 patients treated as of June 2024[114]. - NXC-201 has shown a 100% overall response rate and a 70% complete response rate in a presentation covering 10 patients at the ASH meeting in December 2023[115]. - The FDA granted Orphan Drug Designation to NXC-201 for AL Amyloidosis in September 2023, providing 7 years of exclusivity upon first approval[115]. - The European Commission granted orphan drug designation to NXC-201 in February 2024, offering 10 years of market exclusivity once authorized in the EU[117]. - Nexcella has committed to funding NXC-201 clinical trials in Israel for an estimated total cost of approximately $13 million over four years[123]. - Immix Biopharma's other programs include NXC-201 for autoimmune diseases, targeting a combined annual market size of $25 billion[118]. - The company was awarded an $8 million grant from the California Institute for Regenerative Medicine for clinical development of NXC-201, with funds expected to begin in September 2024[139]. Financial Performance - Immix Biopharma has incurred recurring losses primarily due to research and development activities, with significant expenses expected to continue as product candidates advance[119]. - General and administrative expenses increased to $4,819,821 for the six months ended June 30, 2024, compared to $2,713,201 for the same period in 2023, reflecting a 77.5% increase[133]. - Research and development expenses rose to $5,472,808 for the six months ended June 30, 2024, compared to $3,528,264 for the same period in 2023, marking a 55.0% increase[134]. - Net loss for the six months ended June 30, 2024, was $9,736,914, compared to $6,096,244 for the same period in 2023, representing a 59.0% increase[135]. - Net cash used in operating activities was $9,082,817 for the six months ended June 30, 2024, compared to $5,607,342 for the same period in 2023[142]. - Net cash provided by financing activities was $15,948,567 for the six months ended June 30, 2024, compared to $4,810,576 for the same period in 2023[144]. - As of June 30, 2024, the company had total working capital of $23.4 million[138]. Corporate Actions - The company merged with its subsidiary Nexcella on May 20, 2024, with Nexcella's assets and operations now part of Immix Biopharma[120]. - The company has entered into a Research and License Agreement with Hadasit and BIRAD, involving an upfront fee of $1.5 million and additional payments totaling approximately $13 million through September 2026[122]. - The company entered into an ATM Sales Agreement on July 14, 2023, allowing for the sale of up to $4,200,000 worth of common stock until the public float reaches $75 million[125]. - From July 14, 2023, to February 5, 2024, the company sold 328,136 common shares for net proceeds of $1,091,887 after offering expenses[126]. - On February 5, 2024, the company completed a public offering of 5,535,055 shares at a price of $2.71 per share, resulting in net proceeds of $13,565,760[128]. Regulatory and Compliance - The company intends to rely on exemptions as an "emerging growth company" until it reaches total annual gross revenues of $1.235 billion or more[147]. - Financial statements are prepared in accordance with U.S. GAAP, requiring management to make estimates and judgments that may materially affect reported amounts[148]. - There have been no material changes to the company's critical accounting policies and estimates since the 2023 Form 10-K[148].