ADDED
As of February 28, 2026, the registrant had 26,509,024 shares of common stock, par value $0.0001 per share, outstanding.
Management's Discussion and Analysis of Financial Condition and Results of Operations 59 Item 7A.
Food and Drug Administration, or FDA, regulation of our product candidates; our ability to obtain and retain key executives and retain qualified personnel: developments relating to our competitors and our industry: any future payouts under the contingent value right, or CVR, issued to our holders of record as of the close of business on December 4, 2023; and our ability to monetize any of our legacy assets.
We leverage our proprietary technology and manufacturing platform to introduce mRNA into cells to provide a therapeutic effect to patients suffering from a variety of autoimmune conditions.
Our cell therapies are designed to be dosed repeatedly like conventional drugs, administered in an outpatient setting and given without pre-treatment chemotherapy required with many conventional cell therapies.
These diseases are typically treated with immunosuppressant medications, such as steroids, biologics and non-steroidal agents such as methotrexate, CD19 directed therapies and intravenous immunoglobulin.
These treatments must be administered chronically and carry risks, including infection, osteoporosis and metabolic disease.
The treatment landscape within generalized myasthenia gravis, or MG, offers agents that block the complement pathway or inhibit the neonatal Fc receptor, or FcRn, that typically must be administered chronically.
Even with recent treatment advancements in the field of MG, we believe there remains a significant unmet need for outpatient treatments, administered over a short period of time, and can provide deep and durable clinical benefit.
Limitations of Current Biologic Treatments in Autoimmune Disease Currently approved biologic therapies for MG, such as complement inhibitors and FcRn inhibitors have improved treatment options.
REMOVED
As of February 28, 2025, the registrant had 25,907,101 shares of common stock, par value $0.0001 per share, outstanding.
Management's Discussion and Analysis of Financial Condition and Results of Operations 56 Item 7A.
Food and Drug Administration, or FDA, regulation of our product candidates; our ability to obtain and retain key executives and retain qualified personnel; and developments relating to our competitors and our industry, including the impact of government regulation.
We leverage our proprietary technology and manufacturing platform to introduce one or more mRNA molecules into cells to enhance their function.
Therefore, our mRNA cell therapies are distinguished by their capacity to be dosed repeatedly like conventional drugs, administered in an outpatient setting, and given without pre-treatment chemotherapy required with many conventional cell therapies.
In a placebo-controlled Phase 2b clinical trial in patients with myasthenia gravis, or MG, a chronic autoimmune disease that causes disabling muscle weakness and fatigue, we observed that our lead product candidate, Descartes-08, generated a deep and durable clinical benefit where we observed an average MG-ADL (Activities of Daily Living) reduction of 5.5 points at Month 4 with a third of patients achieving minimal symptom expression at Month 6 and 80% of participants reaching Month 12 maintained a clinically meaningful response.
Durability of response in MG is commonly measured over a period of 26 to 52 weeks, and maintenance of response over that period is considered durable.
Autoimmune diseases are typically treated with immunosuppressant medications, such as steroids.
These treatments must be administered continually and carry risks, including infection, osteoporosis, and metabolic disease.
Newer agents that block the complement pathway or inhibit the neonatal Fc receptor, or FcRn, must also typically be administered continually.