Clinical Trials and Product Development - Immix Biopharma's lead candidate NXC-201 is currently in Phase 1b/2 clinical trials for relapsed/refractory AL Amyloidosis, with 3 patients treated in the U.S. and 13 patients treated in ex-U.S. trials as of September 30, 2024[146]. - The overall response rate for NXC-201 in clinical trials is reported at 100% (10/10), with a complete response rate of 70% (7/10) among treated patients[148]. - The observed prevalence of relapsed/refractory AL Amyloidosis is increasing at a rate of 12% per year, expected to reach 33,277 patients in 2024[145]. - Immix Biopharma has incurred recurring losses primarily due to research and development activities, with significant expenses expected to continue as product candidates advance through clinical trials[152]. - The company expects to incur significant commercialization expenses related to product manufacturing, marketing, and distribution if regulatory approval is obtained for any product candidates[152]. Financial Performance - The company sold 328,136 common shares through the July ATM Facility for net proceeds of $1,091,887 from July 14, 2023, to February 5, 2024[158]. - The company completed a public offering of 5,535,055 shares at a public offering price of $2.71 per share, resulting in net proceeds of $13,565,760 after expenses[159]. - General and administrative expenses increased to $2,949,403 for the three months ended September 30, 2024, up from $2,417,776 for the same period in 2023, reflecting a 22% increase[160]. - Research and development expenses rose to $4,445,528 for the three months ended September 30, 2024, compared to $2,106,020 for the same period in 2023, marking a 111% increase[162]. - The net loss for the three months ended September 30, 2024, was $7,149,395, compared to $4,343,912 for the same period in 2023, representing a 64% increase in net loss[165]. - For the nine months ended September 30, 2024, general and administrative expenses totaled $7,769,224, up from $5,130,977 in the same period in 2023, indicating a 51% increase[166]. - Research and development expenses for the nine months ended September 30, 2024, were $9,918,336, compared to $5,634,284 for the same period in 2023, reflecting a 76% increase[168]. - Net cash used in operating activities was $13,118,904 for the nine months ended September 30, 2024, compared to $8,694,001 for the same period in 2023[180]. - The company had $16.2 million in working capital as of September 30, 2024[175]. Market Potential and Agreements - The U.S. market for amyloidosis therapies is estimated at $3.6 billion, projected to grow to $6 billion by 2027[145]. - The current market size for select immune-mediated diseases is estimated at $25 billion, indicating significant potential for Immix Biopharma's other programs[150]. - Immix Biopharma has entered into a Research and License Agreement with Hadasit and BIRAD, committing to pay approximately $13 million in quarterly payments through September 2026[156]. - Nexcella is required to pay sales milestone payments of up to $20 million for net sales exceeding $700 million, along with a 5% royalty on net sales during the royalty period[156]. Corporate Structure and Compliance - The company merged with Nexcella on May 20, 2024, with Nexcella ceasing to exist and its assets and operations being succeeded by Immix Biopharma[154]. - The company is taking advantage of the extended transition periods under the JOBS Act for complying with new accounting standards, which may affect comparability with other public companies[186]. - As an "emerging growth company," the company will remain under this designation until it reaches total annual gross revenues of $1.235 billion or more[187]. - The company’s financial statements are prepared in accordance with U.S. GAAP, requiring management to make estimates and judgments that may materially affect reported amounts[188]. - There have been no material changes to the company's critical accounting policies and estimates since the 2023 Form 10-K[188]. - The company is classified as a "smaller reporting company" and is not required to provide certain market risk disclosures[189]. Grants and Funding - The company was awarded an $8 million grant from CIRM to support clinical development, contingent on achieving specific milestones[176].
Immix Biopharma(IMMX) - 2024 Q3 - Quarterly Report