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Presentation Announcement: Immix Biopharma will present interim data from its Phase 1/2 NEXICART-2 trial for relapsed/refractory AL Amyloidosis at the ASCO 2025 Annual Meeting in Chicago, scheduled for June 3, 2025.

About NXC-201: The investigational CAR-T cell therapy NXC-201 has shown promising results in initial studies and is currently undergoing clinical trials to assess its safety and efficacy in treating AL Amyloidosis.

FDA RMAT Designation: Immix Biopharma's CAR-T therapy NXC-201 has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for treating relapsed/refractory AL amyloidosis, potentially expediting its path to market approval through enhanced interactions with the FDA.

Clinical Trial Progress: The NEXICART-2 clinical trial is accelerating enrollment and aims to evaluate the safety and efficacy of NXC-201, with updates expected in the first half of 2025.

FDA RMAT Designation: Immix Biopharma's NXC-201 has received RMAT designation from the U.S. FDA for treating relapsed/refractory AL amyloidosis, highlighting its potential as a new treatment option where no FDA-approved drugs currently exist.

Trial Progress: The company reported accelerated enrollment in the NEXICART-2 trial following successful safety run-in results, with plans to share further updates in the first half of 2025.

Clinical Trial Progress: Immix Biopharma has successfully completed the safety run-in segment of its NEXICART-2 study for NXC-201, a CAR-T therapy targeting relapsed/refractory AL Amyloidosis, allowing for accelerated patient enrollment starting January 2025.

AL Amyloidosis Overview: AL Amyloidosis is a serious condition affecting approximately 33,000 patients in the U.S., with no FDA-approved treatments currently available, highlighting the significance of NXC-201 as a potential new therapy.

Early Trial Results: Immix Biopharma announced promising early results from its Phase 1b/2 NEXICART-2 trial for NXC-201, showing that all four patients normalized disease markers within 30 days, with two classified as complete responders and two showing minimal residual disease negativity.

Future Plans: The company plans to continue patient enrollment in the trial, with interim data expected in mid-2025 and final results anticipated by mid-2026, while also hosting a conference call to discuss topline data.

Clinical Trial Results: Immix Biopharma reported that all four patients treated with their CAR-T cell therapy, NXC-201, for relapsed/refractory AL Amyloidosis normalized disease markers within 30 days, with two classified as complete responders and the other two showing bone marrow MRD negativity.

Next Steps and Future Updates: The company plans to continue patient enrollment in the NEXICART-2 trial and will provide further updates in H1 2025, with interim clinical data expected by Q2/Q3 2025.

NXC-201 CAR-T Therapy Results: NXC-201, a novel CAR-T cell therapy for relapsed/refractory AL Amyloidosis, showed a 75% complete response rate in a clinical trial with frail patients, highlighting its promising efficacy and safety profile.

Ongoing Clinical Trials: Immix Biopharma is advancing the U.S. Phase 1b/2 trial (NEXICART-2) focusing on patients with preserved heart function, building on positive results from the ex-U.S. NEXICART-1 study, as they aim to address an unmet medical need in AL Amyloidosis treatment.

Conference Call Announcement: Immix Biopharma will hold a conference call on December 10, 2024, at 4:30 p.m. ET to discuss positive developments regarding their CAR-T therapy NXC-201 for relapsed/refractory AL Amyloidosis, followed by a Q&A session.

About NXC-201: NXC-201 is a promising CAR-T cell therapy showing robust clinical responses without neurotoxicity in early studies, and it has received Orphan Drug Designation from the FDA and EMA for treating AL Amyloidosis.

Clinical Trial Results: Immix Biopharma announced a 75% complete response rate in relapsed/refractory AL Amyloidosis patients treated with their CAR-T therapy NXC-201, which will be presented at the ASH Annual Meeting on December 9, 2024.

Company Overview: Immix Biopharma is focused on developing cell therapies for AL Amyloidosis and has received Orphan Drug Designation for NXC-201 from both the US FDA and the EU EMA.

NXC-201 CAR-T Therapy Progress: Immix Biopharma is advancing its NEXICART-2 clinical study of the NXC-201 CAR-T therapy for relapsed/refractory AL Amyloidosis, with successful dosing at 450 million CAR+T cells and promising results from previous studies showing complete responses.

AL Amyloidosis Overview: AL Amyloidosis affects approximately 33,000 patients in the U.S., causing severe organ damage, and NXC-201 is currently the only one-time CAR-T treatment option being studied for this condition in clinical trials.

Dr. Comenzo's Contributions: Dr. Raymond Comenzo, a leading expert in AL Amyloidosis, has joined Immix Biopharma's Nexcella Scientific Advisory Board and is recognized for his pivotal role in the Andromeda trial that led to the first FDA-approved therapy for the disease.

Focus on CAR-T Therapy: Dr. Comenzo expressed enthusiasm for advancing CAR-T therapy NXC-201, aimed at treating relapsed/refractory AL Amyloidosis, highlighting the need for new treatment options in this area.

Health Care Stocks Performance: Health care stocks experienced a slight decline, with the NYSE Health Care Index down 0.1% and the Health Care Select Sector SPDR Fund (XLV) dropping 0.3%, while the iShares Biotechnology ETF (IBB) saw a minor increase of 0.1%.

Corporate Developments: Avadel Pharmaceuticals' shares fell 6.2% following a legal victory related to its Lumryz medication, UTime's shares plummeted over 95% after acquiring Bowen Therapeutics' lab, and Immix Biopharma announced new clinical trial sites for its Nexicart-2 trial, resulting in a 0.5% decrease in its shares.

Zacks Upgrade for Immix Biopharma: Immix Biopharma, Inc. (IMMX) has been upgraded to a Zacks Rank #2 (Buy) due to an upward trend in earnings estimates, indicating a positive outlook for the company's stock price.

Impact of Earnings Estimates on Stock Movement: The correlation between rising earnings estimates and stock price movements suggests that institutional investors may drive price increases for Immix Biopharma, reflecting improvements in its underlying business.

Immix Biopharma Q2 2024 Earnings: Immix Biopharma reported a second-quarter earnings per share of -15 cents, surpassing the analyst estimate of -21 cents, but did not generate any revenue for the quarter.

InvestorPlace Earnings Automation: InvestorPlace Earnings utilizes automated data from TradeSmith to quickly provide coverage of quarterly earnings reports, highlighting key metrics such as EPS and revenue without human intervention.

CIRM Grant Award: Immix Biopharma's cell therapy division, Nexcella, received an $8 million grant from the California Institute for Regenerative Medicine to support the clinical development of CAR-T therapy NXC-201 for relapsed/refractory AL Amyloidosis, addressing a significant unmet medical need in this rare disease.

Clinical Trials Overview: The ongoing NEXICART-2 trial aims to evaluate the safety and efficacy of NXC-201 in patients with adequate cardiac function who have not previously undergone BCMA-targeted therapy, building on promising results from earlier studies that indicated a 92% overall response rate.