Tue, Mar 25, 10:01 AM (32 days ago)
### Summary of Financial Performance **Revenue**: The company reported no revenue for the fiscal year ended December 31, 2024, as it has not yet commercialized any products. **Net Income**: The company reported a net loss of $21,698,363 for the fiscal year ended December 31, 2024, compared to a net loss of $15,595,522 for the fiscal year ended December 31, 2023. **Operating Expenses**: Total operating expenses were $22,674,680 for the fiscal year ended December 31, 2024, compared to $16,141,113 for the fiscal year ended December 31, 2023. This increase was primarily due to higher research and development expenses. **Research and Development Expenses**: Research and development expenses were $11,292,702 for the fiscal year ended December 31, 2024, compared to $8,735,031 for the fiscal year ended December 31, 2023. This increase was due to ongoing Phase 1b/2a clinical trials and CAR-T clinical trials. **General and Administrative Expenses**: General and administrative expenses were $11,381,978 for the fiscal year ended December 31, 2024, compared to $7,406,082 for the fiscal year ended December 31, 2023. This increase was due to higher investor relations and professional services, increased compensation, and stock-based compensation. ### Strategic Overview **Lead Program**: The company's lead cell therapy candidate is FDA IND cleared CAR-T NXC-201, currently being evaluated in ongoing United States Phase 1b/2 NEXICART-2 (NCT06097832) clinical trial and ex-U.S. phase 1b/2a NEXICART-1 (NCT04720313) clinical trial. **Market Opportunity**: The first indication for NXC-201 is relapsed/refractory AL Amyloidosis, with a growing U.S. observed prevalence estimated to reach 37,270 patients in 2025. The current market size for amyloidosis therapies is estimated at $3.6 billion, expected to reach $6 billion in 2027. **Regulatory Milestones**: NXC-201 has been awarded Orphan Drug Designation (ODD) by both the FDA and European Commission (EMA) in AL Amyloidosis. In December 2024, NXC-201 clinical data in relapsed/refractory AL Amyloidosis was presented at the 66th annual American Society of Hematology (ASH) meeting, covering 16 patients, indicating an overall response rate of 94% and a complete response rate of 75%. ### Future Outlook **Clinical Trials**: The company plans to enroll 40 patients in its open-label, single-arm clinical trial for NXC-201 and then submit a biologics license application (BLA) for FDA approval. **Funding**: The company received an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to support the clinical development of NXC-201. As of March 11, 2025, the company has received $3.6 million in grant reimbursements under the grant agreement. ### Risk Factors **Financial Condition**: The company has incurred substantial losses since its inception and anticipates continuing to incur substantial and increasing losses for the foreseeable future. The company's ability to continue as a going concern is dependent upon its ability to obtain continued financial support from its stockholders and the attainment of profitable operations. **Regulatory Approval**: The company's success depends on obtaining regulatory approval for its product candidates, which involves significant risks and uncertainties. **Market Position Changes**: The company faces competition from other biotechnology and pharmaceutical companies developing therapies for AL amyloidosis and immune-mediated diseases. The market acceptance of the company's products will depend on their efficacy, safety, and cost-effectiveness compared to competing products.