Immix Biopharma(US:IMMX)2025-11-07 22:25Clinical 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].