Key Highlights

  • Third quarter loss per share was USD 0.24 against an estimated loss of USD 1.27, aided by non-cash Warrant gains.
  • Cash, equivalents and short-term investments totaled USD 13.8 million, and the filing discloses substantial doubt about going concern.
  • After July FDA feedback, the company is preparing a Phase 2b acute pancreatitis trial of Auxora, subject to financing.
  • Nine-month net loss was USD 4.4 million, including a USD 10.5 million non-cash gain on warrant and note fair value.

CalciMedica (NASDAQ:CALC), a clinical-stage biotechnology company, reported a third quarter 2026 loss of USD 0.24 per share, against an estimated loss of USD 1.27. The company reported no revenue. For the nine months ended September 30, net loss was USD 4.4 million, compared with USD 18.8 million in the same period of 2025.

The smaller loss reflects accounting items rather than lower spending. The nine-month result includes total operating expenses of USD 14.4 million and interest expense of USD 1.0 million, offset by a non-cash gain of USD 10.5 million from the Fair Value adjustment of its warrant Liability and a promissory note, plus USD 0.3 million of interest income and USD 0.2 million of other income. The accumulated Deficit was USD 193.7 million.

Liquidity and Going Concern Disclosure

At September 30 the company held USD 13.8 million in cash, cash equivalents and short-term investments. The quarterly filing states that its current Liquidity position, recurring losses and negative operating cash flows raise substantial doubt about its ability to continue as a going concern. The filing also lists the need for additional Capital among its risk factors.

Funding sources described include an at-the-market stock sale facility, under which 416,188 shares have been sold in total for net proceeds of about USD 5.8 million, with 9,822 shares sold during the nine months for roughly USD 0.03 million. Remaining capacity under the Facility was USD 25.0 million at quarter end. Earlier financings included a private Placement with gross proceeds of USD 20.4 million and a November 2024 public offering of 544,000 shares for USD 10.2 million gross.

Operating cash use in the 2025 comparison period was USD 16.3 million, and financing inflows that year included USD 9.7 million of debt financing.

Clinical Plans for Auxora

Auxora has been tested in several Phase 2 trials in acute and critical-care settings, including acute pancreatitis, severe COVID-19 pneumonia, pediatric asparaginase-induced pancreatic toxicity and acute kidney injury. Following FDA feedback in July 2026, the company is preparing for a potential Phase 2b trial in acute pancreatitis intended to inform a possible Phase 3 program. The FDA aligned on new-onset severe respiratory failure as the primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints.

Preparations include engagement with a contract research organization and discussions with potential clinical sites, but the filing states that starting the trial depends on obtaining additional financing. The company also plans a Phase 1b proof-of-concept study in pulmonary hypertension, with details expected by year-end 2026 and data anticipated in mid-2027, and it expects to submit an investigational new drug application for CM5480 in mid-2027.

In January 2026 the company paused enrollment in the KOURAGE Phase 2 trial in acute kidney injury and acute hypoxemic respiratory failure after an independent data monitoring committee recommendation, citing a safety concern involving a mortality imbalance. A comprehensive safety assessment covered the 107 patients dosed before the pause. The company has no current plans to resume dosing as it prioritizes other programs.

Financing and Trial Factors to Watch

The main markers are whether the company raises capital to fund the Phase 2b trial, how the going concern language evolves in later filings, and the FDA's response on the development path after the KOURAGE pause. Disclosure of the pulmonary hypertension study design by year end is another near-term item.

Non-cash fair value changes can swing reported losses from quarter to quarter, so operating expenses and cash balance are the figures to compare.