1. Phase 2 KOURAGE trial enrollment is ongoing; data due late 2025. 2. 62.7% mortality reduction seen in CARDEA trial for AKI patients. 3. Cash reserves expected to sustain operations until mid-2026. 4. Auxora shows promise in treating AKI and AP in clinical trials.
Positive clinical trial results and promising cash runway enhance investor confidence. Historical examples, like Moderna's vaccine trials, show stock spikes on promising results.
The article highlights significant developments that could affect CALC’s stock performance as trial data releases approach. Market perception may improve with positive trial outcomes.
Potential effects of clinical trial outcomes will manifest in the long run. Investors await data from ongoing trials that could elevate CALC's market position.
Enrollment ongoing in Phase 2 KOURAGE trial of Auxora™ in acute kidney injury (AKI) and respiratory failure; data expected around the end of 2025.
Post-hoc analysis of a subset of patients with AKI in the Phase 2 CARDEA trial of Auxora in severe COVID-19 pneumonia showed a 62.7% relative reduction in mortality at day 30, which persisted through day 60, for patients treated with Auxora versus placebo.
Cash position expected to fund operations into mid-2026.
LA JOLLA, Calif., March 27, 2025 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today reported financial results for the year ended December 31, 2024, and provided clinical and corporate updates.
"Enrollment in our Phase 2 KOURAGE trial is on track to deliver data around the end of 2025," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "Looking ahead to the KOURAGE readout, we are further encouraged by the promising readthrough from the data recently presented at the 30th International AKI & CRRT Conference, which shows a 62.7% relative reduction in mortality in CARDEA patients with both kidney failure and respiratory failure, mirroring KOURAGE's patient population."
2024 Financial Results:
CalciMedica is a clinical-stage biopharmaceutical company focused on developing novel CRAC channel inhibition therapies for inflammatory and immunologic diseases. CalciMedica's proprietary technology targets the inhibition of CRAC channels to modulate the immune response and protect against tissue cell injury, with the potential to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases for which there are currently no approved therapies.
CalciMedica's lead product candidate Auxora™ has demonstrated positive and consistent clinical results in multiple completed efficacy clinical trials. CalciMedica has announced data for a Phase 2b trial (called CARPO – NCT04681066) in patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS). The Company has also completed a Phase 2 trial (called CARDEA – NCT04345614) in patients with COVID pneumonia. The Company is currently conducting a Phase 2 trial (called KOURAGE – NCT06374797) in patients with acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF) with data expected around the end of 2025 and continuing to support the ongoing investigator-initiated Phase 1/2 trial (called CRSPA – NCT04195347) in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT) with an update expected in the second half of 2025. CalciMedica was founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, and is headquartered in La Jolla, CA. For more information, please visit www.calcimedica.com.
This communication contains forward-looking statements which include, but are not limited to, CalciMedica's expected cash runway; CalciMedica's planned and ongoing clinical trials and the timing, design, expected patient enrollment thereof and the expected timing for the release of data from those trials, including its Phase 2 KOURAGE trial of Auxora in AKI with associated AHRF; its ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with AIPT; plans for an end-of-Phase 2 meeting with the FDA for CARPO and to be in a position to initiate a pivotal trial in AP around the end of 2025; the potential benefits of Auxora for the treatment of AP, AKI and AIPT; the potential of CalciMedica's proprietary technology to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases; and the potential of additional proceeds from the credit facility with Avenue Capital Group if certain milestones are achieved. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. CalciMedica's expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks, and changes in circumstances...
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(in thousands, except par value and share amounts) (Unaudited)
| December 31, 2024 | December 31, 2023 |
|---|---|
| Assets | |
| Current assets | |
| Cash and cash equivalents | $ 7,935 |
| Short-term investments | 10,734 |
| Total current assets | 19,665 |
| Total assets | $ 19,794 |
| Total liabilities and stockholders' equity | $ 19,794 |
(in thousands, except share and per share amounts)(Unaudited)
| Year Ended December 31 | 2024 | 2023 |
|---|---|---|
| Operating expenses: | ||
| Research and development | $ 14,478 | $ 15,859 |
| General and administrative | 9,726 | 22,216 |
| Total operating expenses | 24,204 | 38,075 |
| Net loss | $(13,700) | $(34,357) |
| Net loss per share - basic and diluted | $(1.22) | $(7.66) |