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Mar 31, 2020
Crinetics Q1 2020 Earnings Report
Crinetics reported first quarter 2020 financial results and provided a corporate update.
Key Takeaways
Crinetics Pharmaceuticals reported positive interim results for its ACROBAT Edge Phase 2 trial of oral paltusotine in acromegaly treatment and completed a public offering, raising $107.9 million in net proceeds. The company's pipeline advancements and focus on paltusotine for acromegaly and NETs were also highlighted.
Reported positive interim results from ACROBAT Edge Phase 2 trial of paltusotine in acromegaly patients, showing maintenance of IGF-1 levels.
Discontinued new enrollment in the ACROBAT Evolve trial to focus on paltusotine development.
Completed a public offering in April, raising approximately $107.9 million to strengthen the balance sheet.
Advanced pipeline programs, including oral nonpeptide ACTH antagonist and SST5 agonist, with Phase 1 trials planned for late 2020 or early 2021.
Crinetics
Crinetics
Forward Guidance
Crinetics is focused on advancing its pipeline, particularly paltusotine, through key milestones, including Phase 3 trials and Phase 2 trials. The company anticipates PK/PD data from human proof-of-concept studies in the first half of 2021.
Positive Outlook
- Potential for interim data results to be consistent with final results.
- Potential benefits of paltusotine for acromegaly patients.
- Potential to initiate a pivotal Phase 3 trial of paltusotine in acromegaly.
- Planned expansion of the paltusotine development program to include the treatment of patients with NETs.
- Anticipated timing of topline data for Edge and Evolve and the initiation of proof-of-concept Phase 1 trials and timing of PK/PD data for its other development programs.
Challenges Ahead
- Interim results of a clinical trial do not necessarily predict final results.
- Potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom.
- Advancement of paltusotine into a Phase 3 trial is dependent on and subject to the receipt of further feedback from the FDA.
- The COVID-19 pandemic may disrupt Crinetics’ business and that of the third parties on which it depends.
- Unexpected adverse side effects or inadequate efficacy of the company’s product candidates may limit their development, regulatory approval and/or commercialization.