Core Insights - The article discusses the investment potential of IMMX, highlighting a beneficial long position in its shares [1] Company Analysis - IMMX has shown promising performance, which may attract investor interest [1] - The article emphasizes the importance of individual research and due diligence before making investment decisions [2] Industry Context - The broader market context is not explicitly detailed in the provided content, focusing primarily on IMMX [1][2]

– Financing includes leading U.S. biotechnology institutional investors and mutual funds – LOS ANGELES, CA, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a global leader in relapsed/refractory AL Amyloidosis, today announced the closing of its previously announced underwritten registered offering of 19,117,646 shares of its common stock at a price to the public of $5.10 per share, and to certain investors in lieu of common stock, pre-funded warrants ...

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Cemtrex, Inc. (CETX) has increased by 284% to $11.79 - Treasure Global Inc. (TGL) has risen by 135% to $59.83 - Top Wealth Group Holding Limited (TWG) is up 95% at $11.73 - Fulcrum Therapeutics, Inc. (FULC) has gained 49% to $13.29 - MetaVia Inc. (MTVA) is up 33% at $10.90 - Kymera Therapeutics, Inc. (KYMR) has increased by 31% to $87.58 - Confluent, Inc. (CFLT) is up 27% at $29.40 - Immix Biopharma, Inc. (IMMX) has risen by 23% to $6.85 - Nurix Therapeutics, Inc. (NRIX) is up 18% at $21.46 - SU Group Holdings Limited (SUGP) has increased by 15% to $6.44 [3] Premarket Losers - SMX (Security Matters) Public Limited Company (SMX) has decreased by 27% to $242.01 - Meihua International Medical Technologies Co., Ltd. (MHUA) is down 27% at $10.20 - Polyrizon Ltd. (PLRZ) has declined by 16% to $10.90 - Fly-E Group, Inc. (FLYE) is down 16% at $6.90 - Sensei Biotherapeutics, Inc. (SNSE) has decreased by 14% to $8.29 - Kentucky First Federal Bancorp (KFFB) is down 10% at $4.00 - Arteris, Inc. (AIP) has declined by 7% to $16.27 - Fusion Fuel Green PLC (HTOO) is down 6% at $3.89 - Kamada Ltd. (KMDA) has decreased by 5% to $6.69 - iOThree Limited (IOTR) is down 5% at $3.11 [4]

Core Viewpoint - Immix Biopharma, Inc. has announced a registered offering of 19,117,646 shares of common stock priced at $5.10 per share, aiming to raise approximately $100 million in gross proceeds to support the development of its lead candidate, NXC-201, and for general corporate purposes [1][2]. Group 1: Offering Details - The offering includes pre-funded warrants to purchase 490,196 shares at a price of $5.09 per warrant, with the gross proceeds expected to be $100 million before expenses [1]. - The offering is expected to close on or about December 9, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering, along with existing cash and cash equivalents, will be used to fund the development of NXC-201 and for working capital and general corporate purposes [2]. - The company anticipates that these funds will be sufficient to meet operational needs into mid-2027 [2]. Group 3: Company Overview - Immix Biopharma, Inc. is a leader in the treatment of relapsed/refractory AL Amyloidosis, a serious condition caused by toxic light chains produced by the immune system [6]. - The lead candidate, NXC-201, is a CAR-T cell therapy designed to filter out non-specific activation and target the source of toxic light chains [6]. - NXC-201 is currently being evaluated in a multi-center study in the U.S. and has received Regenerative Medicine Advanced Therapy designation from the FDA [6].

Core Insights - Immix Biopharma's NXC-201 demonstrated a complete response (CR) rate of 75% in a Phase 2 trial for relapsed/refractory AL Amyloidosis, with potential to increase to 95% based on MRD negativity predictions [1][3][4] - The company plans to submit a Biologics License Application (BLA) for NXC-201 in 2026 following the final readout of the NEXICART-2 trial [1][2] Clinical Results - In the Phase 2 trial, 15 out of 20 patients achieved a complete response, indicating significant efficacy [1][3] - Prior to treatment, patients had a median of 4 prior lines of therapy, and all had organ involvement due to AL Amyloidosis [3] - Clinical improvements were observed in 70% of evaluable patients, with no neurotoxicity reported [3] Market Context - Current treatments for relapsed/refractory AL Amyloidosis yield a CR rate of 10% or lower, highlighting a significant unmet medical need [4] - The U.S. patient population for relapsed/refractory AL Amyloidosis is projected to grow by 12% annually, reaching approximately 38,500 patients by 2026 [9] - The AL Amyloidosis market is expected to grow from $3.6 billion in 2017 to $6 billion by 2025 [9] Company Overview - Immix Biopharma is focused on developing NXC-201, a BCMA-targeted CAR-T cell therapy, which has received RMAT and Orphan Drug Designation from the FDA [7][10] - The ongoing NEXICART-2 trial is designed to enroll 40 patients and is pivotal for the company's future regulatory submissions [6][10]

Core Insights - Immix Biopharma has appointed Michael Grabow as Chief Commercial Officer to lead the U.S. launch and commercialization of NXC-201 for relapsed/refractory AL Amyloidosis, a rare blood disease with no current FDA-approved therapies [1][2] Company Overview - Immix Biopharma, Inc. is recognized as the global leader in relapsed/refractory AL Amyloidosis [6] - The company is focused on developing NXC-201, a CAR-T cell therapy designed to target and eliminate toxic light chains produced in AL Amyloidosis [5][7] Product Details - NXC-201 is a sterically-optimized BCMA-targeted CAR-T cell therapy that has received both Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation (ODD) from the FDA [5][7] - The therapy aims to address a significant unmet medical need in relapsed/refractory AL Amyloidosis, which is characterized by organ failure and high mortality rates [2][3] Market Insights - The AL Amyloidosis patient population in the U.S. is projected to grow at a rate of 12% annually, reaching approximately 37,270 patients by 2025 [3] - The amyloidosis market was valued at $3.6 billion in 2017 and is expected to grow to $6 billion by 2025 [4]

Clinical Development - Immix Biopharma's lead candidate NXC-201 is currently in clinical trials for relapsed/refractory AL Amyloidosis, with an overall response rate of 100% (10/10) and a complete response rate of 70% (7/10) reported in December 2023 [119]. - Immix Biopharma has treated 10 patients in the U.S. and 16 patients in ex-U.S. clinical trials for NXC-201 as of October 2025 [117]. - The FDA granted Orphan Drug Designation (ODD) to NXC-201 for AL Amyloidosis in September 2023, providing 7 years of exclusivity upon first approval for the disease [118]. - The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to NXC-201 in February 2025, potentially streamlining the path to FDA approval [123]. - The Company expanded the number of clinical trial sites for NEXICART-2 to 18 in July 2025, enhancing its registrational design [125]. Financial Performance - The Company has incurred recurring losses primarily due to research and development activities, with significant expenses expected to continue as product candidates advance through clinical trials [128]. - General and administrative expenses increased to $3,078,378 for the three months ended September 30, 2025, up from $2,949,403 in the same period of 2024 [136]. - Research and development expenses rose to $4,584,131 for the three months ended September 30, 2025, compared to $4,445,528 in the prior year, driven by ongoing clinical trials [138][146]. - Net loss for the three months ended September 30, 2025, was $7,585,692, an increase from $7,149,395 in the same period of 2024 [141]. - The Company expects to require additional capital to fund operations beyond the next twelve months due to increasing expenses related to clinical programs and commercialization efforts [150][156]. Market Opportunity - The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is growing at a rate of 12% per year, estimated to reach 37,270 patients by 2025, with a current market size for amyloidosis therapies estimated at $3.6 billion, expected to reach $6 billion by 2027 [115]. - Immix Biopharma's other programs target a combined annual market size of $25 billion for serious immune-mediated diseases [127]. Funding and Grants - The Company received an $8 million grant from the California Institute for Regenerative Medicine (CIRM) in July 2024 to support the clinical development of NXC-201 [121]. - The Company was awarded an $8 million grant from CIRM for the clinical development of NXC-201, with $4.6 million received in reimbursements as of November 2025 [132][153]. - The Company entered into a June 2025 ATM Agreement to sell up to $50 million in common stock, generating net proceeds of $2,573,375 from the sale of 1,087,381 shares during the nine months ended September 30, 2025 [133][154]. - In September 2025, the Company completed a private placement, selling 3,915,604 shares and warrants for gross proceeds of approximately $9.3 million [134][155]. Cash Flow and Assets - As of September 30, 2025, the Company had total assets of approximately $20.1 million and cash and cash equivalents of approximately $15.9 million [156]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $12,900,697, compared to $13,118,904 for the same period in 2024, reflecting a net loss of $18,750,783 in 2025 versus $16,886,309 in 2024 [162]. - Net cash used in investing activities was $567,799 for the nine months ended September 30, 2025, down from $670,529 in 2024, with both periods consisting solely of purchases of property and equipment [163]. - Net cash provided by financing activities was $11,718,263 for the nine months ended September 30, 2025, compared to $15,948,567 in 2024, primarily from proceeds of $11,878,678 from the sale of common shares in 2025 [164]. Interest Income - Interest income decreased to $84,539 for the three months ended September 30, 2025, down from $256,680 in the same period of 2024, due to lower cash balances [139][147]. - The Company anticipates significant commercialization expenses if marketing approval is obtained for its product candidates [150].

Core Insights - Immix Biopharma, Inc. focuses on NK cell-based immunotherapy, aiming to innovate within the biotech sector [1] Company Overview - The company has been under analysis for nearly two years, with a specific emphasis on its immunotherapy approach [1] - The analyst has a PhD in biochemistry and extensive experience in evaluating clinical trials and biotech firms, indicating a strong foundation for assessing the company's potential [1] Industry Context - The article highlights the importance of understanding the science behind biotech investments, suggesting that due diligence is crucial for investors in this sector [1]

Core Insights - Immix Biopharma, Inc. announced that interim results from its Phase 1/2 NXC-201 NEXICART-2 trial in relapsed/refractory AL Amyloidosis will be presented at ASH 2025 [1][2] Industry Overview - AL Amyloidosis is a severe disease characterized by the immune system producing toxic light chains, leading to organ failure and death [3][7] - The U.S. patient population with relapsed/refractory AL Amyloidosis is projected to grow at a rate of 12% annually, reaching approximately 37,270 patients by 2025 [3] - The amyloidosis market was valued at $3.6 billion in 2017 and is expected to grow to $6 billion by 2025 [4] Company Overview - Immix Biopharma is recognized as the global leader in relapsed/refractory AL Amyloidosis, focusing on the development of NXC-201, a CAR-T cell therapy designed to target and eliminate toxic light chains [5][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 [5][7] - The NEXICART-2 trial is a multi-site Phase 1/2 clinical study aimed at evaluating NXC-201, with an expected enrollment of 40 patients [6][7]

Core Insights - Immix Biopharma, Inc. announced that interim results from its Phase 1/2 NXC-201 NEXICART-2 trial in relapsed/refractory AL Amyloidosis will be presented at ASH 2025 [2][3] Company Overview - Immix Biopharma is recognized as the global leader in relapsed/refractory AL Amyloidosis, a severe disease characterized by the immune system producing toxic light chains that lead to organ failure [4][8] - The company’s lead candidate, NXC-201, is a CAR-T cell therapy designed to target BCMA and has received both Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation from the FDA [6][8] Clinical Trial Information - The NEXICART-2 trial is an ongoing multi-site Phase 1/2 clinical study of NXC-201, which aims to enroll 40 patients and has a registrational design [7] - Interim results from this trial were previously presented at ASCO 2025, indicating ongoing progress in the clinical evaluation of NXC-201 [7] Market Insights - The number of patients in the U.S. with relapsed/refractory AL Amyloidosis is projected to grow at a rate of 12% annually, reaching approximately 37,270 patients by 2025 [4] - The amyloidosis market was valued at $3.6 billion in 2017 and is expected to grow to $6 billion by 2025, reflecting significant market potential for treatments [5]