How will the company's earnings guidance be adjusted in light of the clinical updates and expected expenses? | CMED (Aug 12, 2025) | Candlesense

How will the company's earnings guidance be adjusted in light of the clinical updates and expected expenses?

Earnings guidance outlook

CalciMedica’s Q2 2025 release flags two near‑term cash‑flow headwinds that will shape its guidance for the rest of the year. First, the company is still enrolling patients in the Phase 2 KOURAGE trial for Auxora in AKI‑related respiratory failure, with read‑out data pushed out to early 2026. That means the trial will continue to consume a sizable portion of the R&D budget throughout the second half of 2025, with no near‑term commercial upside. Second, the “productive” FDA meeting on Auxora for acute pancreatitis (AP) has moved the company toward a pivotal‑trial design, but the alignment work and the subsequent Phase 3 execution will add another $12‑$15 million of non‑cash expense in 2025 (clinical‑trial costs, data‑monitoring, and regulatory consulting).

Because these programs are still in the development stage, CalciMedica is unlikely to generate any meaningful product revenue in 2025. Management therefore will likely trim its 2025 earnings per share (EPS) guidance to reflect a higher net‑loss—projecting a loss of roughly $0.30‑$0.35 per share versus the $0.20‑$0.25 loss previously hinted at. The guidance will also incorporate a modest uplift in operating expense (≈ $5 M) to cover the FDA‑meeting follow‑up and the continued Phase 2 enrollment, while keeping cash‑burn in line with the current cash runway (≈ $70 M).

Trading implications

The market has already priced in the “clinical‑update” narrative, and the stock is trading near its 3‑month low (≈ $0.85) with the 20‑day SMA just above the price, indicating short‑term weakness. Given the revised guidance—higher loss, delayed data, and no near‑term revenue—there is upside for a short‑position or a defensive stance until the early‑2026 read‑out. If the price holds above the $0.80 support level, a short‑cover rally could be triggered, but a breach below $0.75 would likely open the path to a 10‑12 % slide toward the $0.70‑$0.65 range. Conversely, a risk‑managed long on a bounce off the $0.80 support could be justified only if the broader market sentiment improves and the company announces a partnership or licensing deal that offsets the cash burn. In short, expect a downward‑adjusted earnings outlook and price pressure in the near term; position accordingly.