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].
Immix Biopharma(IMMX) - 2024 Q2 - Quarterly Report