Crinetics Q2 2020 Earnings Report
Key Takeaways
Crinetics Pharmaceuticals reported a net loss of $16.5 million for the second quarter of 2020. The company's cash, cash equivalents, and investments totaled $205.2 million as of June 30, 2020, which includes $107.9 million from a public offering.
Received Orphan Drug Designation for paltusotine for the treatment of acromegaly.
Confirmed completion for half of the enrolled patients in the ongoing Phase 2 ACROBAT Edge clinical trial for paltusotine.
Reported positive interim results for the ACROBAT Edge Phase 2 trial of paltusotine in acromegaly patients.
Completed a public offering raising net proceeds of $107.9 million.
Crinetics
Crinetics
Forward Guidance
Crinetics anticipates additional clinical milestones with topline data from ongoing Phase 2 trials expected in the fourth quarter of 2020 and is well-positioned to execute planned trials.
Positive Outlook
- Paltusotine has the potential to be an effective treatment option for acromegaly patients.
- Crinetics may obtain benefits as a result of the Orphan Drug Designation for paltusotine.
- Potential to initiate a pivotal Phase 3 trial of paltusotine in acromegaly based on interim results obtained to date.
- Planned expansion of the paltusotine development program to include the treatment of carcinoid syndrome in patients with neuroendocrine tumors.
- Anticipated timing of topline data for Edge and Evolve and the initiation of Phase 1 trials for its other development programs.
Challenges Ahead
- Interim results of a clinical trial do not necessarily predict final results and that one or more of the clinical outcomes may materially change.
- 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.
- COVID-19 pandemic may disrupt Crinetics’ business and that of the third parties on which it depends.
- Crinetics may not be able to maintain the Orphan Drug Designation for paltusotine, and may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity.