Immix Biopharma(IMMX)
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Immix Biopharma Announces Enrollment Completion of BLA-Enabling Relapsed/Refractory AL Amyloidosis Trial NEXICART-2, and Upcoming Milestones
Globenewswire· 2026-03-30 12:45
Core Insights - Immix Biopharma has completed enrollment for the NEXICART-2 trial, with topline results expected in Q3 2026, followed by a Biologics License Application (BLA) submission and planned commercial launch [1][2] - The company has appointed Richard Graydon, MD, PhD, as Chief Medical Officer, who has extensive experience in clinical development from Merck and Johnson & Johnson [2] - NXC-201, the lead candidate, is a CAR-T cell therapy targeting relapsed/refractory AL Amyloidosis and has received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy designation from the FDA [6][8] Company Overview - Immix Biopharma, Inc. is a leader in the treatment of relapsed/refractory AL Amyloidosis, a disease characterized by the production of toxic light chains that lead to organ failure [7] - The company is focused on developing NXC-201, a CAR-T therapy designed to eliminate the source of toxic light chains [6][7] Clinical Trial Details - NEXICART-2 is a Phase 2 clinical trial involving 40 patients, designed to evaluate the efficacy of NXC-201 in treating relapsed/refractory AL Amyloidosis [3] - The trial has a registrational design, indicating its potential to support a BLA submission upon successful results [3] Market Insights - The AL Amyloidosis patient population in the U.S. is projected to grow at a rate of 12% annually, reaching approximately 38,500 patients by 2026 [4] - The market for AL Amyloidosis treatments was valued at $3.6 billion in 2017 and is expected to grow to $6 billion by 2025 [5]
Immix Biopharma(IMMX) - 2025 Q4 - Annual Report
2026-03-25 21:19
Financial Performance - Immix Biopharma, Inc. reported general and administrative expenses of $13,697,817 for the year ended December 31, 2025, an increase from $11,381,978 in 2024, primarily due to higher employee compensation and professional services costs [358][359]. - Research and development expenses rose to $16,258,598 in 2025 from $11,292,702 in 2024, driven by costs associated with ongoing clinical trials and increased spending funded by share offerings totaling net proceeds of $107,349,347 [360][361]. - Interest income decreased to $555,526 in 2025 from $1,017,354 in 2024, attributed to lower balances in money market funds [362]. - Net cash used in operating activities for the year ended December 31, 2025 was $23,930,304, primarily due to a net loss of $29,438,613 [379]. - Net cash provided by financing activities was $107,386,859 for the year ended December 31, 2025, primarily from the sale of common stock [381]. - Net cash used in investing activities was $7,213,785 for the year ended December 31, 2025, primarily for short-term investments [380]. - The company recorded stock-based compensation expense of $2,441,875 for the year ended December 31, 2025 [379]. Funding and Capital - The company received approximately $6.2 million in grant reimbursements from the California Institute for Regenerative Medicine (CIRM) as part of an $8 million grant awarded to support the clinical development of NXC-201 [367]. - Immix Biopharma conducted an underwritten public offering in December 2025, selling 19,117,646 shares at $5.10 per share, resulting in net proceeds of approximately $93.7 million after underwriting discounts [371]. - The company completed a private placement in September 2025, raising approximately $9.3 million from the sale of 3,915,604 shares and warrants [370]. - The company entered into an At The Market Offering Agreement in June 2025, allowing for the sale of up to $50 million in shares, with net proceeds of $4,409,430 from sales in 2025 [369]. - The company anticipates needing additional capital beyond the next 12 months to continue planned operations [373]. Operational Expenses - Immix Biopharma's primary cash usage is for operating expenses, including clinical research and development, with expectations of increased expenses as clinical programs expand [365]. - The company expects to incur significant commercialization expenses if marketing approval is obtained for any product candidates [372]. - The company has committed to funding NXC-201 clinical trials in Israel with an estimated total cost of approximately $13 million over four years [353]. - The company entered into a long-term operating lease agreement for biopharmaceutical manufacturing space with total lease payments expected to be $1.4 million through December 2033 [377]. - The company has no long-term manufacturing and supply agreements but enters into contracts on an as-needed basis [378]. Strategic Considerations - The company has incurred significant net losses since inception and does not expect to generate revenue until regulatory approval and commercialization of its product candidates [364]. - The company may need to relinquish valuable rights to technologies or revenue streams if additional funds are raised through collaborations or strategic alliances [374]. - As of December 31, 2025, the company had total assets of approximately $104.8 million and working capital of approximately $91.1 million [373].
Immix Biopharma to Participate in Upcoming Investor Conferences
Globenewswire· 2026-03-03 13:45
Company Overview - Immix Biopharma, Inc. is recognized as the global leader in relapsed/refractory AL Amyloidosis, a severe disease caused by the immune system producing toxic light chains that lead to organ failure and death [2] - The company's lead candidate is NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy designed to filter out non-specific activation and teach the immune system to eliminate toxic light chains [2] - NXC-201 is currently being evaluated in a U.S. multi-center study (NEXICART-2) with a registrational design and has received Breakthrough Therapy Designation, Regenerative Medicine Advanced Therapy designation, and Orphan Drug Designation from the FDA and EMA [2] Upcoming Events - Immix Biopharma will present and host investor meetings at institutional investor conferences, including the Leerink Partners 2026 Global Healthcare Conference from March 8-11, 2026, and the Citizens Life Sciences Conference from March 10-11, 2026, both held in Miami Beach, FL [1][3] - Company management will conduct one-on-one meetings during these conferences, and interested investors are encouraged to contact their Leerink or Citizens representative for meeting requests [1]
Immix Biopharma Receives U.S. FDA Breakthrough Therapy Designation for NXC-201
Globenewswire· 2026-01-28 13:45
Core Insights - The FDA has granted Breakthrough Therapy Designation to NXC-201 for the treatment of relapsed/refractory AL Amyloidosis based on positive interim clinical results from the NEXICART-2 Phase 2 trial [1][3][4] Company Overview - Immix Biopharma, Inc. is recognized as the global leader in relapsed/refractory AL Amyloidosis, focusing on developing innovative therapies for this condition [9] - The company’s lead candidate, NXC-201, is a sterically-optimized BCMA-targeted CAR-T cell therapy designed to filter out non-specific activation and teach the immune system to eliminate toxic light chains [8][9] Clinical Development - NEXICART-2 is an ongoing multi-site U.S. Phase 2 clinical trial aimed at enrolling 40 patients to evaluate the efficacy of NXC-201 in relapsed/refractory AL Amyloidosis [5] - Final data from the NEXICART-2 trial is expected to be released this year, followed by a planned Biologics License Application (BLA) submission [1][4] Market Context - The number of patients in the U.S. with relapsed/refractory AL Amyloidosis is projected to grow at a rate of 12% per year, reaching approximately 38,500 patients by 2026 [6] - The AL Amyloidosis market was valued at $3.6 billion in 2017 and is anticipated to reach $6 billion by 2025 [7]
Tuesday After-Hours Session Sees Broad Gains Across Healthcare And Biotech
RTTNews· 2026-01-28 03:58
Group 1: Stock Performance - Several healthcare and biotech stocks experienced significant gains in after-hours trading, with movements largely occurring without specific company news [1][2][3][4] - Acumen Pharmaceuticals, Inc. (ABOS) rose by 8.09% to close at $2.94, adding $0.22 to its share price [1] - Fulgent Genetics, Inc. (FLGT) increased by 5.98% to $28.90, gaining $1.63 in extended trading [1] - Fractyl Health, Inc. (GUTS) climbed 5.19% to $2.23, up $0.11 after hours [1] - Coeptis Therapeutics Holdings, Inc. (COEP) finished up 4.14% at $13.85, a gain of $0.55 [2] - Jin Medical International Ltd. (ZJYL) saw an increase of 4.04% to $0.16, up $0.0061 [2] - Alignment Healthcare, Inc. (ALHC) gained 5.92% to $22.20, adding $1.24 in after-hours trading [2] - Orthofix Medical Inc. (OFIX) rose 4.58% to $13.94, up $0.61 [3] - Alto Neuroscience, Inc. (ANRO) advanced 4.52% to $17.57, gaining $0.76 [3] - Immix Biopharma, Inc. (IMMX) increased by 3.87% to $6.17, adding $0.23 [3] - Amneal Pharmaceuticals, Inc. (AMRX) rose 3.76% to $14.35, up $0.52, and is set to replace TTM Technologies in the S&P SmallCap 600 index [3] - Tyra Biosciences, Inc. (TYRA) gained 3.76% to $32.58, adding $1.18 in extended trading [4]
Immix Biopharma: Thesis Playing Out; Thoughts On Valuation And Competition
Seeking Alpha· 2025-12-11 05:10
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]
Immix Biopharma Announces Closing of Upsized $100 Million Underwritten Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2025-12-09 22:45
Core Viewpoint - Immix Biopharma, Inc. has successfully closed an underwritten registered offering, raising approximately $93.7 million through the sale of common stock and pre-funded warrants, with significant participation from leading U.S. biotechnology institutional investors and mutual funds [1][2]. Financing Details - The offering consisted of 19,117,646 shares of common stock priced at $5.10 per share and pre-funded warrants to purchase 490,196 shares at $5.09 each, resulting in net proceeds of about $93.7 million after expenses [1]. - Morgan Stanley served as the sole book-running manager, with Citizens Capital Markets and Mizuho acting as co-managers for the offering [2]. Regulatory Information - The securities were offered under a "shelf" registration statement on Form S-3, which was filed with the SEC and became effective in January 2023 [3]. Company Overview - Immix Biopharma, Inc. is recognized as a global leader in treating relapsed/refractory AL Amyloidosis, a severe disease characterized by the immune system producing toxic light chains that can lead to organ failure [5]. - The company's lead candidate, NXC-201, is a CAR-T cell therapy designed to target and eliminate the source of toxic light chains, currently being evaluated in a U.S. multi-center study [5].
Morning Market Movers: CETX, TGL, TWG, FULC See Big Swings
RTTNews· 2025-12-08 13:20
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]
Immix Biopharma Announces Pricing of Upsized $100 Million Underwritten Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2025-12-07 23:20
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].
At ASH 2025 Oral Presentation, Immix Biopharma Reports Positive Phase 2 NXC-201 Results, Advancing Toward BLA Submission as a Potentially First- and Best-in-Class Therapy for relapsed/refractory AL Amyloidosis
Globenewswire· 2025-12-07 23:15
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]