CRINETICS PHARMACEUTICALS, INC. Item 7.01 Regulation FD Disclosure.
During the week of
The presentation will feature an overview of Crinetics' key priorities and anticipated milestones for 2023. These include:
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The continued advancement of the Phase 3 PATHFNDR-1 and PATHFNDR-2 trials of once-daily oral paltusotine in acromegaly. The trials remain on track for topline data readouts in the third and fourth quarters of 2023, respectively. If successful, Crinetics plans to submit data from the two studies to regulatory authorities in support of applications seeking approval for the use of paltusotine for all acromegaly patients who require pharmacotherapy, including untreated patients and those switching from other therapies.
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Efforts to further increase commercial readiness so that the Company can rapidly provide patients with acromegaly with broad access to once-daily oral paltusotine, if approved.
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The continued advancement of the Phase 2 trial of paltusotine in carcinoid syndrome, which remains on track for topline data in the second half of 2023.
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Building off proof-of-concept Phase 1 results for CRN04894, an investigational adrenocorticotropic hormone (ACTH) antagonist, with the initiation of clinical trials in ACTH-dependent Cushing's syndrome and congenital adrenal hyperplasia. Both studies are expected to begin in the first half of 2023.
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Building off proof-of-concept Phase 1 results for CRN04777, an investigational, oral somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital hyperinsulinism.
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The continued preclinical evaluation of investigational, oral small molecule parathyroid hormone receptor antagonists to identify a candidate for advancement into clinical trials. Initial target indications for this program may include primary hyperparathyroidism and hypercalcemia of malignancy, with potential opportunities in chronic kidney disease also being evaluated.
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Leveraging the company's leading G-protein-coupled receptor (GPCR) drug discovery platform to generate and develop additional small molecule new chemical entities (NCEs) with the potential to address unmet needs in indications such as nonfunctional pituitary adenomas, polycystic kidney disease, metabolic diseases and Graves' Disease (including thyroid eye disease).
The Company's updated corporate presentation has been posted to the Company's website, www.crinetics.com . The Company plans to use its website to disseminate future updates to its corporate presentation and does not intend to file or furnish a Form 8-K alerting investors each time the presentation is updated.
The information contained in this Item 7.01, including in Exhibit 99.1 hereto, is being "furnished" and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, is not subject to the liabilities of that section and is not deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.
By filing this Current Report on Form 8-K and furnishing the information in this
Item 7.01, the Company makes no admission as to the materiality of Item 7.01 in
this report or the presentation available on the Company's website. The
information contained in the presentation is summary information that is
intended to be considered in the context of the Company's filings with the
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Forward-Looking Statements
This report 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 report are forward-looking statements,
including statements regarding the plans and timelines for the clinical
development of paltusotine, CRN04777 and CRN04894, including the therapeutic
potential and clinical benefits thereof; the expected timing of topline data
from the ongoing Phase 3 clinical trials of paltusotine in acromegaly and Phase
2 trial of paltusotine in carcinoid syndrome; plans to submit data from the
ongoing Phase 3 clinical trials of paltusotine in acromegaly to regulators in
support of applications seeking approval for the use of paltusotine in
acromegaly patients; the expected timing of the initiation of studies of
CRN04894 in ACTH-dependent Cushing's syndrome and congenital adrenal
hyperplasia; plans to continue evaluation of investigational, oral small
molecule parathyroid hormone receptor antagonists to identify a candidate for
advancement into clinical trials; and plans to generate and develop additional
small molecule new chemical entities with the potential to address nonfunctional
pituitary adenomas, polycystic kidney disease, metabolic diseases and Graves'
Disease. 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 report and are subject to a number of risks, uncertainties and
assumptions, including, without limitation, topline data that we report may
change following a more comprehensive review of the data related to the clinical
trials and such data may not accurately reflect the complete results of a
clinical trial, and the FDA and other regulatory authorities may not agree with
our interpretation of such results; we may not be able to obtain, maintain and
enforce our patents and other intellectual property rights, and it may be
prohibitively difficult or costly to protect such rights; the COVID-19 pandemic
may disrupt Crinetics' business and that of the third parties on which it
depends, including delaying or otherwise disrupting its clinical trials and
preclinical studies, manufacturing and supply chain, or impairing employee
productivity; 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;
regulatory developments in
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1 Corporate Slide Presentation 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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