LA JOLLA, Calif. - CalciMedica Inc. (NASDAQ: CALC), a biopharmaceutical company, announced positive outcomes from its Phase 2b CARPO trial of Auxora™ in patients with acute pancreatitis (AP) and systemic inflammatory response syndrome (SIRS). The study met its primary goal, showing a significant reduction in time to solid food tolerance and severe organ failure versus placebo.
The international, double-blind, placebo-controlled CARPO trial enrolled 216 patients, testing the efficacy of Auxora in varying doses. The results demonstrated a dose response, with the highest dose group achieving up to a 43.6% relative reduction in median time to solid food tolerance and up to 61.7% reduction in severe organ failure compared to the placebo.
Furthermore, hospital stays exceeding 21 days were eliminated in the high dose group, signifying a substantial reduction in prolonged hospitalizations. The safety profile of Auxora was reaffirmed, with the treatment being well-tolerated among participants.
CalciMedica's CEO, Rachel Leheny, Ph.D., emphasized the significance of these findings, stating the company's intent to swiftly advance to a Phase 3 trial and engage with the FDA. Joseph Miller, M.D., a principal investigator in the trial, noted the potential benefits of Auxora for patients with AP, a condition with no current drug treatments and costly hospital stays.
The company plans to discuss additional data from the trial at a medical meeting later this year. A conference call to discuss the topline results is scheduled for today at 8:30 a.m. ET.
Auxora is being developed as a treatment for various acute inflammatory and immunologic illnesses. It targets CRAC channels, which are implicated in the pathology of inflammatory syndromes. CalciMedica is also conducting a Phase 2 trial in acute kidney injury (AKI) and supports an ongoing pediatric trial for asparaginase-induced pancreatic toxicity (AIPT).
In other recent news, CalciMedica is making significant strides in its clinical studies. The biopharmaceutical company has received approval from the FDA for clinical studies of Auxora, its leading drug candidate, in treating acute kidney injury (AKI). The Phase 2 KOURAGE trial is set to begin enrollment soon. Additionally, CalciMedica is preparing for the release of top-line results from the Phase 2b CARPO trial in acute pancreatitis (AP) with systemic inflammatory response syndrome (SIRS).
Oppenheimer has maintained its Outperform rating on CalciMedica, underlining the commercial potential of Auxora in treating AP. The firm has set a price target of $14.00 for the company's stock, based on the upcoming developments. Meanwhile, Jones Trading has reiterated its Buy rating and $22.00 stock price target for CalciMedica, following meetings with investors and the company's management team.
The company's upcoming Phase 2b data for acute pancreatitis is expected in late second quarter of 2024 and Phase 2 data for acute kidney injury is anticipated in the first half of 2025. Jones Trading considers CalciMedica as one of its high-conviction stocks for the year 2024 and is hosting a key opinion leader (KOL) call featuring Dr. Bechien Wu, a respected gastroenterologist specializing in pancreatology. The call will provide expert insights into the treatment landscape for acute pancreatitis and the potential role of CalciMedica's treatments within this therapeutic area.
InvestingPro Insights
As CalciMedica Inc. (NASDAQ: CALC) announces promising trial results for its leading drug candidate, Auxora™, the financial health and market performance of the company come into focus. With a market capitalization of just $55.68 million, the company's size indicates it is still in the growth phase of its lifecycle, which aligns with its current clinical development stage.
An examination of CalciMedica's financials through InvestingPro reveals some challenges and potential areas of concern. The company is not profitable over the last twelve months as of Q1 2024, with an adjusted P/E ratio of -3.0 and an EBITDA of -$21.44 million, reflecting significant operating losses. This aligns with one of the InvestingPro Tips indicating that the company is quickly burning through cash, which is a critical consideration for investors given the capital-intensive nature of drug development.
However, it's not all bleak for CalciMedica. The company's stock has experienced a large price uptick over the last six months, with a 60.69% total return, suggesting growing investor confidence, potentially buoyed by the positive clinical trial outcomes. Additionally, another InvestingPro Tip highlights that the company holds more cash than debt on its balance sheet, providing some financial stability and the ability to fund ongoing trials without immediate concern for solvency.
For investors looking for more comprehensive analysis, there are additional InvestingPro Tips available at https://www.investing.com/pro/CALC. These tips could provide deeper insights into the investment potential of CalciMedica. Interested investors can also take advantage of an exclusive offer using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, granting access to a suite of advanced financial tools and data.
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