On August 8, 2023 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), (Nasdaq: CRNX) reported financial results for the second quarter ended June 30, 2023 (Press release, Crinetics Pharmaceuticals, AUG 8, 2023, View Source [SID1234633963]).
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"The PATHFNDR program for acromegaly continues to progress as expected. Topline results from our Phase 3 PATHFNDR-1 study are expected in September and should provide insight into paltusotine’s potential as an alternative to standard-of-care somatostatin receptor ligand depot injections. Enrollment in our Phase 3 PATHFNDR-2 study is also now complete and we anticipate topline results in the first quarter of 2024," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "Unfortunately, we also suffered a setback with our CRN04777 program and made the difficult decision to wind down its development. We know that infants and children living with congenital hyperinsulinism are in desperate need of better treatment options and our hearts go out to them and their families. However, our recently evolved understanding of the nonclinical profile of CRN04777 suggests that it no longer meets the high standards to which we hold all drug candidates in our pipeline."
SECOND QUARTER 2023 AND RECENT HIGHLIGHTS:
Topline data from paltusotine’s Phase 3 PATHFNDR-1 study expected in September 2023. PATHFNDR-1 is a placebo-controlled Phase 3 clinical study of oral paltusotine in participants with acromegaly switching from standard-of-care peptide depots. The study enrolled 58 participants with acromegaly whose average IGF-1 levels during screening were within the normal range (IGF-1 ≤ 1.0x upper limit of normal) on octreotide or lanreotide depot monotherapy. The primary endpoint of the study is the proportion of participants whose average IGF-1 levels at weeks 34 and 36 are within the normal range after switching to paltusotine compared to placebo.
Completed enrollment in paltusotine’s Phase 3 PATHFNDR-2 study. PATHFNDR-2 is a placebo-controlled Phase 3 clinical study of oral paltusotine in participants with acromegaly who are treatment-naïve or not currently receiving medical therapy. The study completed enrollment of 112 participants with acromegaly who were either treatment-naïve or untreated for at least four months (Stratum 1: n=82), or who washed out of prior octreotide or lanreotide monotherapy (Stratum 2: n=30). Topline data from the study is expected in the first quarter of 2024.
Paltusotine NDA submission anticipated in 2024. Pending successful data from the PATHFNDR program, Crinetics plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking regulatory approval for the use of paltusotine in acromegaly with both treatment and maintenance of treatment indications.
Clinical and preclinical data presented at the ENDO 2023 Annual Conference. A podium presentation featured results from the ACROBAT Advance open-label extension study of paltusotine in acromegaly. In addition, pre-clinical studies of the company’s thyroid-stimulating hormone (TSH) receptor antagonist for the treatment of thyroid eye disease (orbitopathy) associated with Graves’ disease and of the parathyroid hormone receptor type 1 (PTH1R) antagonist being developed for the treatment of primary hyperparathyroidism (PHPT) were presented as poster presentations. In addition, Scott Struthers, Ph.D., Crinetics’ founder and CEO was awarded the John D. Baxter Prize to recognize extraordinary achievement in endocrinology entrepreneurship at ENDO 2023 and gave an award lecture on the history of discovering nonpeptide oral drugs acting at peptide hormone receptors.
Phase 2 open-label study of paltusotine in carcinoid syndrome ongoing. The Phase 2 open-label study of paltusotine in carcinoid syndrome associated with neuroendocrine tumors is continuing to enroll participants, and preliminary data is anticipated in the fourth quarter of 2023.
CRN04894 studies in Cushing’s disease and congenital adrenal hyperplasia are ongoing. Based on successful Phase 1 studies demonstrating pharmacologic proof-of-concept, Crinetics is conducting clinical studies of CRN04894 in Cushing’s disease and congenital adrenal hyperplasia. Data from both studies are expected in 2024.
CRN04777 update. While developing our response to the clinical hold issued by the FDA, results from additional nonclinical studies became available. These studies uncovered findings at exposure levels that eroded anticipated therapeutic margins for CRN04777. These other findings are not related to those originally cited by the FDA for the clinical hold and, importantly, are not present in nonclinical studies that have been conducted with other Crinetics product candidates under development. We believe them to be specific to CRN04777 and not associated with its somatostatin receptor type 5 (SST5) mechanism of action. In light of these findings, the company has decided to suspend further significant investment into the molecule at this time.
SECOND QUARTER 2023 FINANCIAL RESULTS
Research and development expenses were $40.6 million for the three months ended June 30, 2023, compared to $33.0 million for the same period in 2022. The increase was primarily attributable to an increase in personnel costs of $6.9 million, increased consulting and outside services of $1.6 million, increased other expenditures of $0.7 million, partially offset by decreased net spending on manufacturing and development activities of $1.6 million associated with our clinical and nonclinical programs.
General and administrative expenses were $13.3 million for the three months ended June 30, 2023, compared to $10.5 million for the same period in 2022. The increase was primarily attributable to an increase in personnel costs of $2.7 million.
Net loss for the three months ended June 30, 2023, was $51.0 million, compared to a net loss of $42.4 million for the same period in 2022.
Revenues were $1.0 million for the three months ended June 30, 2023, compared to $0.4 million for the same period in 2022. Revenues in both periods were primarily derived from the paltusotine licensing arrangement with Sanwa Kagaku Kenkyusho Co., Ltd.
Unrestricted cash, cash equivalents, and investments totaled $264.5 million as of June 30, 2023, compared to $334.4 million as of December 31, 2022.
The company had 54,686,550 common shares outstanding as of August 4, 2023.
KEY OPINION LEADER (KOL) WEBINAR ON ACROMEGALY CURRENT TREATMENT LANDSCAPE AND UNMET NEED
Crinetics is hosting a KOL webinar today, August 8, 2023 at 12:00 pm ET. The webinar will feature key opinion leaders Beverly MK Biller, M.D. and Karen JP Liebert, R.N., B.S.N, both of Massachusetts General Hospital, who will discuss the current landscape and unmet medical need in acromegaly, as well as the treatment burden associated with standard-of-care injectable somatostatin receptor ligands (SRLs). In addition, the Crinetics management team will discuss its pipeline of internally discovered oral small molecule drug candidates, with a focus on the Phase 3 PATHFNDR-1 study of paltusotine.
A live question and answer session will follow the formal presentations. To register for the event, please click here. If you would like to ask a question during the live Q&A, please submit your request to [email protected]. A replay of the event will be available by clicking here.