CALC — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-11

• Our pipeline includes Auxora, a potent and selective small-molecule CRAC channel inhibitor formulated for intravenous administration whose active compound is zegocractin (formerly CM4620), and CM5480, a proprietary, selective oral small-molecule CRAC channel inhibitor. Auxora has been evaluated in m…

• CM5480 is being developed as a potential chronic oral therapy for pulmonary hypertension, including pulmonary arterial hypertension and combined pre- and post-capillary pulmonary hypertension associated with heart failure with preserved ejection fraction. We expect to submit an investigational new d…

• In July 2026, following a Type C focused meeting with the U.S. Food and Drug Administration (“FDA”), we announced that we and FDA had aligned on certain design features of the next clinical trial in our planned development program for Auxora in AP. FDA aligned on new-onset severe respiratory failure…

• We may also continue selective research activities to evaluate CRAC channel inhibition in other inflammatory, immunologic and cardiopulmonary indications.

• In January 2026, following a recommendation from the Independent Data Monitoring Committee (“IDMC”), we paused enrollment in the KOURAGE Phase 2 clinical trial evaluating Auxora in patients with AKI and AHRF due to a safety concern relating to a mortality imbalance that warranted reevaluation of the…

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• Our lead product candidate is Auxora, a potent and selective, intravenously formulated small-molecule CRAC channel inhibitor containing the active compound zegocractin (formerly CM4620). Auxora has been evaluated in multiple Phase 2 clinical trials across acute critical care settings, including acut…

• We are continuing development activities in AP and have engaged with the U.S. Food and Drug Administration (“FDA”) regarding the design of a potential pivotal program in AP, with FDA feedback on program design expected in the second quarter of 2026.

• In January 2026, following a recommendation from the Independent Data Monitoring Committee (“IDMC”), we paused enrollment in the KOURAGE Phase 2 clinical trial evaluating Auxora in patients with AKI and AHRF due to a safety concern relating to a mortality imbalance that warranted reevaluation of the…

• In parallel, we have generated preclinical data supporting the potential application of CRAC channel inhibition in both chronic and acute inflammatory and immunologic diseases. These efforts include animal model data suggesting potential relevance in pulmonary arterial hypertension (“PAH”), chronic …

• Our ability to generate revenue from product sales sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Through March 31, 2026, our operations have been funded primarily by aggregate net proceed…

Text added vs the prior filing · source: 10-Q · 2026-08-11

• We are supporting an investigator-initiated Phase 1/2 clinical trial in pediatric patients with AIPT. We completed a Phase 2b trial of Auxora in AP with accompanying SIRS and are planning the next trial in this indication, for which we have aligned with the FDA on a Phase 2b trial intended to inform…

• Our other pipeline programs, which include new product candidates, are in preclinical development, including CM5480, our preclinical asset and proprietary oral small-molecule CRAC channel inhibitor being developed for pulmonary hypertension. CM5480 has not been dosed in humans and will require compl…

• As of June 30, 2026, we had an accumulated deficit of $192.0 million and net loss of $2.7 million for the six months ended June 30, 2026. Other than the three months ended March 31, 2026 and 2024, we have incurred net losses since our inception. We have never generated revenue from product sales and…

• To become and remain profitable, we must develop and eventually commercialize product candidates with significant market potential. This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of our product candidates, obta…

• will continue to incur substantial research and development and other expenditures to develop and market additional product candidates. Our failure to become and remain profitable would decrease the value of the company and could impair our ability to raise capital, maintain our research and develop…

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• We are conducting KOURAGE, a Phase 2 randomized, double-blind, placebo-controlled clinical trial in patients with Stage 2 or Stage 3 AKI and associated AHRF. Enrollment was paused in January 2026 following a recommendation from the Independent Data Monitoring Committee due to a safety concern relati…

• Our other pipeline programs, which include new product candidates, are in preclinical development. As of March 31, 2026, we had an accumulated deficit of $184.4 million and net income of $5.0 million for the three months ended March 31, 2026. Other than the three months ended March 31, 2026 and 2024…

• To become and remain profitable, we must develop and eventually commercialize product candidates with significant market potential. This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of our product candidates, obta…

• Our need for additional capital raises substantial doubt about our ability to continue as a going concern. We will need to obtain substantial additional funding to complete the development and any commercialization of our product candidates. If we are unable

• to raise this capital when needed, on acceptable terms, or at all, we may be forced to delay, reduce or eliminate the development of our product candidates or other operations.*