Business Overview and History
Immix Biopharma, Inc. (NASDAQ: IMMX) is a clinical-stage biopharmaceutical company leading the charge in developing innovative cell therapies for AL Amyloidosis and select autoimmune disorders. With a sharp focus on unmet medical needs, Immix has built a robust pipeline centered around its lead candidate, NXC-201, a sterically-optimized CAR-T therapy targeting AL Amyloidosis, a rare and life-threatening condition.
Immix Biopharma was founded on January 7, 2014, with the goal of harnessing the power of the immune system to deliver widely accessible cures. The company's early years were dedicated to research and development, with a particular emphasis on exploring the potential of chimeric antigen receptor (CAR) T-cell therapies. In August 2016, Immix established a wholly-owned Australian subsidiary, Immix Biopharma Australia Pty Ltd., to conduct various preclinical and clinical activities for its development candidates.
In November 2022, Immix made a strategic move by establishing a majority-owned subsidiary, Nexcella, to house its cell therapy division. This allowed the company to sharpen its focus on advancing NXC-201, its lead CAR-T candidate, through clinical trials for the treatment of relapsed/refractory AL Amyloidosis. In May 2024, Nexcella was fully absorbed back into Immix, further consolidating the company's efforts. To ensure continuity of operations, Immix re-established Nexcella in 2024 as a wholly-owned subsidiary.
Since its inception, Immix has devoted substantially all of its resources to developing product and technology rights, conducting research and development, organizing and staffing the company, business planning, and raising capital. The company has funded its operations primarily through the sale of equity securities, with its primary use of cash being to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures.
In December 2022, Nexcella entered into a Research and License Agreement with Hadasit Medical Research Services Development, Ltd. and BIRAD Research and Development Company Ltd. to acquire intellectual property rights pertaining to CAR-T. Pursuant to the agreement, Nexcella paid the licensors an upfront license fee of $1.5 million in December 2022. Additional quarterly payments totaling approximately $13 million are due through September 2026, along with an annual license fee of $50,000.
Financials
Immix's financial performance has been marked by consistent investment in research and development (R&D), which accounted for 55% and 59% of total expenses in 2023 and 2022, respectively. The company has funded its operations primarily through the sale of equity securities, raising $15.7 million in 2023 and $3.4 million in 2022 through various financing activities.
For the fiscal year 2023, Immix reported a net loss of $15.4 million. The company's operating cash flow was negative $11.4 million, and free cash flow stood at negative $11.4 million. In the most recent quarter (Q3 2024), Immix reported no revenue and a net loss of $7.1 million. As a pre-revenue company, year-over-year growth metrics are not applicable.
Research and development expenses for the nine months ended September 30, 2024, were $9.92 million, while general and administrative expenses amounted to $7.77 million. These figures reflect the company's continued investment in advancing its clinical programs and supporting overall operations.
Liquidity
As of September 30, 2024, Immix reported $19.69 million in cash and cash equivalents, providing a runway to advance its pipeline. The company's net loss for the nine months ended September 30, 2024, was $16.89 million, compared to $10.44 million for the same period in 2023, reflecting increased R&D and general and administrative expenses to support its clinical programs.
Immix's financial position is further characterized by a debt-to-equity ratio of 0.062, indicating a relatively low level of debt compared to equity. The company's current ratio and quick ratio both stand at 3.47, suggesting a strong ability to meet short-term obligations. No credit facilities have been disclosed.
The company believes its current cash position will enable it to fund operations for at least the next 12 months. This runway is supported by the recent $8 million grant from the California Institute for Regenerative Medicine (CIRM) awarded in July 2024 to support the clinical development of NXC-201 in AL Amyloidosis.
Innovative CAR-T Therapy for AL Amyloidosis
Immix's lead candidate, NXC-201, is a sterically-optimized CAR-T therapy targeting AL Amyloidosis, a rare and life-threatening disorder characterized by the abnormal buildup of amyloid proteins in various organs, particularly the heart, kidneys, and liver. The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is growing 12% per year, estimated to reach 33,277 patients in 2024.
In September 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to NXC-201 for the treatment of AL Amyloidosis, a significant milestone that could potentially provide market exclusivity, reduced regulatory fees, and expedited review upon approval. The European Commission has also granted ODD to NXC-201 for AL Amyloidosis treatment.
Immix is currently evaluating NXC-201 in two clinical trials: the NEXICART-2 study in the United States and the NEXICART-1 study in ex-U.S. markets. The NEXICART-2 trial dosed its first patient in July 2024 at the lead site, Memorial Sloan Kettering Cancer Center (MSKCC), with plans to expand to additional U.S. sites, including Cleveland Clinic, UC Davis, and Sutter Health.
As of September 2024, Immix has treated 3 patients in the NEXICART-2 trial in the U.S. and 13 patients in the NEXICART-1 trial ex-U.S. Preliminary data from these trials presented in December 2023 showed impressive results, with an overall response rate of 100% and a complete response rate of 70% in 10 relapsed/refractory AL Amyloidosis patients.
In May 2024, Immix presented positive data from the NEXICART-1 study at the American Society of Gene and Cell Therapy (ASGCT) annual meeting. The results showed a 92% overall response rate (ORR) in 13 relapsed/refractory AL Amyloidosis patients, with 12 out of 12 patients not exposed to prior BCMA-targeted bispecific treatments responding to NXC-201, including 9 complete responders (75% CR rate).
Furthermore, in July 2024, Immix announced that the California Institute for Regenerative Medicine (CIRM) awarded the company an $8 million grant to support the clinical development of NXC-201 in the U.S. NEXICART-2 trial, underscoring the potential of this novel therapy.
Expanding into Autoimmune Diseases
While Immix's primary focus remains on AL Amyloidosis, the company has also expanded its pipeline to explore the application of its cell therapy platform in select autoimmune diseases. These conditions, which collectively represent a $25 billion annual market opportunity, present another area of significant unmet need.
Immix's early-stage programs in this therapeutic area are still in the research and development phase, leveraging the company's expertise in immunology and cell therapy to identify new targets and potential treatment approaches.
In addition to its lead AL Amyloidosis program, Immix continues to collect and analyze data on its other preclinical programs, including IMX-110 for soft tissue sarcoma and in combination with anti-PD-1 therapy for colorectal cancer. These programs represent potential future growth opportunities for the company.
Navigating Challenges and Positioning for Growth
Immix Biopharma has navigated several challenges in its journey as a clinical-stage biopharmaceutical company. The company's focus on rare and complex diseases, such as AL Amyloidosis, has required significant investment in research and development to advance its pipeline. Additionally, the inherent risks associated with clinical-stage biotechnology companies, including the potential for trial setbacks or regulatory hurdles, have been a constant consideration.
However, Immix has demonstrated its ability to adapt and capitalize on opportunities. The company's strategic decision to establish Nexcella and the subsequent absorption of the subsidiary have enabled a sharper focus on its lead candidate, NXC-201. Furthermore, the recent CIRM grant for the NEXICART-2 trial underscores the potential of Immix's approach and the recognition of its efforts by key stakeholders.
Looking ahead, Immix Biopharma is well-positioned to continue its trajectory as a pioneer in the field of cell therapies for AL Amyloidosis and autoimmune diseases. With a strong cash position, a promising lead candidate, and a dedicated team, the company is poised to make significant strides in addressing these unmet medical needs and creating value for its shareholders.
The overall market for amyloidosis therapies is estimated to be $3.6 billion currently, with expectations to reach $6 billion by 2027, growing at a compound annual growth rate (CAGR) of 12% according to Grand View Research. This projected market growth aligns well with Immix's focus on developing innovative treatments for AL Amyloidosis.
Conclusion
Immix Biopharma's unwavering commitment to developing innovative cell therapies for AL Amyloidosis and autoimmune diseases has positioned the company as a trailblazer in the field. With its lead candidate, NXC-201, demonstrating promising results in clinical trials and the support of key stakeholders, Immix is well-equipped to navigate the challenges inherent in the biotechnology industry and drive meaningful progress in addressing these critical therapeutic areas.
As Immix Biopharma continues to execute on its strategic priorities, investors should closely monitor the company's advancements, clinical milestones, and efforts to expand its pipeline and geographic reach. The company's ability to successfully develop and commercialize its cell therapy solutions could unlock significant value and make a profound impact on the lives of patients in need.
Currently operating primarily in the United States, Immix represents a small-cap company with significant potential in the growing field of cell therapies. As the company progresses through its clinical trials and potentially expands its geographic footprint, it may present an interesting opportunity for investors interested in the biotechnology sector, particularly in the areas of rare diseases and innovative cell therapies.