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CinCor Pharma has successfully concluded an End-of-Phase 2 meeting with the FDA regarding the Phase 3 program for baxdrostat, a selective aldosterone synthase inhibitor aimed at treating hypertension. The FDA approved the dosing cohorts, patient population size, and endpoints for the upcoming clinical trials, indicating no additional Phase 1 or 2 trials are necessary before starting Phase 3. The pivotal trial is projected to begin in the first half of 2023. The company emphasizes the significant unmet medical needs in hypertension treatment, with nearly 116 million hypertensive patients in the U.S. alone.
CinCor Pharma announced an agreement with AstraZeneca for a cash acquisition at $26.00 per share, plus a contingent value right of $10.00 upon regulatory submission of baxdrostat, totaling approximately $1.8 billion. This represents a 121% premium over CinCor’s closing price prior to the announcement. The acquisition aims to expedite the development of baxdrostat, targeted for cardiorenal diseases. CinCor’s board unanimously approved the agreement, and major shareholders representing 44.8% have committed to the tender offer. The deal is expected to close in Q1 2023, subject to regulatory conditions.
CinCor Pharma reported the topline results from its Phase 2 HALO trial assessing baxdrostat for uncontrolled hypertension. The primary endpoint was not met in the intention-to-treat (ITT) population, but a significant 12.6 mmHg placebo-adjusted reduction in systolic blood pressure (SBP) was observed in a pre-specified non-Hispanic subgroup (81-89% of U.S. hypertensive patients) at the 2 mg dose (p = 0.001). The safety profile matched previous studies, with no discontinuations due to adverse events. The company anticipates entering Phase 3 trials in the first half of 2023, pending FDA confirmation.
CinCor Pharma announced participation in two investor conferences in late November 2022. The first is the Piper Sandler 34th Annual Healthcare Conference, held from November 29 to December 1, with a presentation on November 29 at 1:30 PM EST in New York. The second is the Evercore ISI 5th Annual HealthCONx Conference, taking place virtually from November 30 to December 1, featuring a presentation on December 1 at 3:30 PM EST. Archived replays will be available on their website.
CinCor Pharma announced its participation at the Jefferies London Healthcare Conference from November 15-17, 2022. The presentation is scheduled for November 16, 2022, at 5 PM GMT, at the Waldorf Hilton. CinCor will also engage in one-on-one investor meetings during the event. Founded in 2018, CinCor focuses on developing treatments for cardio-renal diseases, with its lead asset, baxdrostat, targeting hypertension and primary aldosteronism.
CinCor Pharma announced positive results from its Phase 2 BrigHtn trial, showcasing the efficacy of baxdrostat in addressing resistant hypertension. The trial demonstrated a significant 20.3 mmHg reduction in systolic blood pressure at the 2 mg dose, with a statistically significant placebo-adjusted decline of 11 mmHg (p < 0.0001). Results indicate a well-tolerated profile with no serious adverse events. The company aims to provide further insights in a conference call on November 8, 2022, regarding the trial outcomes and implications for hypertension treatment.
CinCor Pharma announces the publication of Phase 2 BrigHtn trial results for baxdrostat, a new treatment for treatment-resistant hypertension, in the New England Journal of Medicine. This trial, involving 275 patients, demonstrated significant and dose-dependent reductions in systolic blood pressure without impacting cortisol levels. The drug aims to address the needs of 10-12 million patients in the US who struggle with uncontrolled hypertension. These findings underscore baxdrostat's potential as a first-in-class treatment.
CinCor Pharma announced the appointment of Michael W. Kalb as Executive Vice President and CFO, effective November 4. Kalb brings over 25 years of experience, particularly in cardiovascular therapeutics, replacing retiring CFO Terry Coelho. CEO Marc de Garidel praised Kalb's expertise as crucial for the upcoming commercialization of baxdrostat, with topline Phase 2 HALO data expected before year-end. Kalb emphasized the potential of baxdrostat to transform hypertension treatment. CinCor continues to face significant operational losses and relies heavily on the success of this single drug.
CinCor Pharma re-issued its earnings press release for Q3 2022, updating CEO quotes. The release highlighted positive Phase 2 BrigHtn data showing a 20.3 mmHg reduction in systolic blood pressure with baxdrostat for treatment-resistant hypertension. They expect topline results from the Phase 2 HALO trial before year-end 2022 and reported strong financials, with $522.5 million in cash post a $242.9 million public offering. However, net losses increased to $21 million in Q3 2022 compared to $9 million in Q3 2021.
CinCor Pharma reported positive topline results from the Phase 2 BrigHtn trial, showing a significant 20.3 mmHg reduction in systolic blood pressure for patients with treatment-resistant hypertension. The company raised $242.9 million in August 2022 from a public offering, enhancing its cash position to $522.5 million. Financially, R&D expenses surged to $17.7 million in Q3 2022, up from $4.6 million a year prior, reflecting ongoing clinical trial progress. However, the company posted a net loss of $21.0 million for Q3 2022, worsening from $9.0 million in Q3 2021.
