First Patient Dosed in Phase 2 Trial
CALC has reached a significant milestone in its journey to address severe acute kidney injury (AKI), dosing the first patient in its Phase 2 trial. This advancement has led to a substantial increase in the projected target price (PT) for CALC’s stock, rising from $14 to $20. The company’s innovative approach to tackling AKI, a challenging and severe condition, is bolstered by recent positive Phase 2b results in acute pancreatitis (AP). These results not only showed improvements in severe renal failure but also broadened the supportive clinical evidence for CALC’s flagship drug, Auxora, in treating AKI.
Broadening Clinical Evidence and Potential Market Impact
AKI is a frequent inpatient complication that significantly increases the risks of mortality and respiratory failure, with current treatments limited to supportive care. The promising results from CALC’s AP study, which showed notable improvements in renal failure, have sparked interest in Auxora as a treatment for AKI. This interest could lead to ex-US regional partnerships in the second half of the year, providing potential financial support for the upcoming Phase 3 trial.
The KOURAGE trial, a double-blind study, will randomize 150 patients with Stage 2 or 3 AKI who also have acute hypoxemic respiratory failure (AHRF) and are receiving supplemental oxygen. Participants will receive either Auxora or a placebo. The primary endpoint of this trial is to measure the number of days patients are alive without requiring a ventilator or dialysis through day 30, with a secondary focus on the MAKE-90 diagnostic marker for chronic kidney disease (CKD). Top-line data from this trial is expected next year.
Financial Projections and Market Opportunity
The potential market for Auxora in treating AKI is estimated to be over $1 billion. Each year, approximately 500,000 patients in the United States are hospitalized with Stage 3 AKI, representing the segment with the greatest therapeutic need. If Auxora is priced at a net of $25,000 per course and used in just 10% of these cases, it would generate an estimated $1.3 billion in sales for CALC.
Increased Target Price and Future Catalysts
Reflecting the significant potential of Auxora in both AP and AKI, CALC’s PT has been raised to $20. This valuation is based on a risk-adjusted revenue multiples analysis, with estimated per-share values of approximately $8 for AP and $12 for AKI.
Looking ahead, several key catalysts are anticipated:
- In the second half of 2024, additional data and details from the CARPO study are expected.
- In 2025, an Investigational New Drug (IND) submission for an oral CRAC inhibitor (CRACi) targeting chronic pancreatitis and rheumatoid arthritis is planned.
- Phase 2 topline results for AKI are also expected in 2025.
With these developments, CALC’s prospects in the challenging field of AKI treatment appear increasingly promising, positioning the company for significant market impact and financial success.
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