Item 8.01 Other Events.
On
During his presentation,
• Continued progress in the two ongoing Phase 3 PATHFNDR trials of paltusotine in acromegaly. Both trials remain on track for topline data in 2023. • The initiation of patient dosing in a Phase 2 trial of paltusotine in patients with carcinoid syndrome associated with neuroendocrine tumors (NETs), which is expected in 2022. • Reporting Phase 1 multiple ascending dose (MAD) data for CRN04894, an investigational, oral, nonpeptide adrenocorticotropic hormone (ACTH) antagonist being developed for the treatment of Cushing's disease and congenital adrenal hyperplasia, which is expected in 1Q 2022. • The initiation of a Phase 2 trial of CRN04894, which is expected in 2H 2022. • Reporting Phase 1 MAD data for CRN04777, an investigational, oral, nonpeptide somatostatin receptor type 5 (SST5) agonist being developed for the treatment of congenital hyperinsulinism, which is expected in 1Q 2022. • The initiation of a Phase 2 trial of CRN04777, which is expected in 2H 2022. • The initiation of IND-enabling studies for a parathyroid receptor type-1 (PTHR1) antagonist, which is expected in 2022. Target indications for this program potentially include hyperparathyroidism and humoral hypercalcemia of malignancy.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. All statements other than
statements of historical facts contained in this press release are
forward-looking statements, including statements regarding the ongoing Phase 3
trials of paltusotine in acromegaly and the related generation of topline data
and the expected timing thereof; the potential to initiate patient dosing in a
Phase 2 trial of paltusotine in patients with carcinoid syndrome due to NETs and
the expected timing thereof; Crinetics' plan to report Phase 1 MAD data for
CRN04894 and CRN04777; the potential to initiate Phase 2 trials of CRN04894 and
CRN04777 and the expected timing thereof; the potential to initiate IND-enabling
studies for a PTHR1 antagonist, the expected timing thereof and the potential
target indications of such program; and the potential to advance Crinetics'
ongoing clinical programs, bring additional therapeutic candidates into the
clinic and expand Crinetics' pipeline. In some cases, you can identify
forward-looking statements by terms such as "may," "will," "should," "expect,"
"plan," "anticipate," "could," "intend," "target," "project," "contemplates,"
"believes," "estimates," "predicts," "potential" or "continue" or the negative
of these terms or other similar expressions. These forward-looking statements
speak only as of the date of this press release and are subject to a number of
risks, uncertainties and assumptions, including risks and uncertainties inherent
in Crinetics' business, including, without limitation, unexpected adverse side
effects or inadequate efficacy of the Company's product candidates that may
limit their development, regulatory approval and/or commercialization, the
Company's dependence on third parties in connection with product manufacturing,
research and preclinical and clinical testing; the success of Crinetics'
clinical trials and nonclinical studies and the other risks and uncertainties
described in the Company's periodic filings with the
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