S&P Futures
3,845.00+35.75(+0.94%)Dow Futures
31,151.00+239.00(+0.77%)Nasdaq Futures
13,070.25+159.25(+1.23%)
Crinetics Pharmaceuticals, Inc. (CRNX)
Chart Events
Performance Outlook
| Previous Close | 15.05 |
| Open | 15.28 |
| Bid | 14.50 x 800 |
| Ask | 20.00 x 800 |
| Day's Range | 14.60 - 15.80 |
| 52 Week Range | 10.63 - 23.70 |
| Volume | 102,396 |
| Avg. Volume | 144,368 |
| Market Cap | 503.382M |
| Beta (5Y Monthly) | 1.22 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -2.36 |
| Earnings Date | Nov 06, 2020 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 33.60 |
Fair Value
Related Research
- GlobeNewswire
Crinetics Pharmaceuticals Lead ACTH Antagonist for Congenital Adrenal Hyperplasia and Cushing’s Disease (CRN04894) Advances into Phase 1 Study
SAN DIEGO, Feb. 04, 2021 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced that CRN04894, the company’s lead adrenocorticotropic hormone (ACTH) antagonist for the treatment of diseases associated with excess ACTH such as Cushing’s disease and congenital adrenal hyperplasia (CAH), has advanced into the clinic. Based on encouraging preclinical results, Crinetics has initiated a double-blind, randomized, placebo-controlled Phase 1 study of this orally administered, nonpeptide small molecule drug candidate in healthy volunteers. This study will assess the safety and tolerability of single and multiple doses of CRN04894 and will measure the effect of CRN04894 on suppression of cortisol, cortisol precursors, and adrenal androgens following exogenous ACTH stimulation. Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics, stated, “ACTH is the central hormone mediating the endocrine stress response in humans. While disease due to ACTH excess was first described more than a century ago, until now no agents that can block the action of ACTH have been developed and made available for human clinical studies. This is a major step forward towards a new class of therapeutic for patients suffering from devastating diseases of the stress endocrine axis, such as Cushing’s disease or congenital adrenal hyperplasia. I am extremely proud of our discovery scientists for crafting a molecule that has the potential to solve this long-standing problem in endocrinology.” “CRN04894 is a nonpeptide, small molecule that is designed to be taken orally to block the interaction of ACTH with its target receptor. It has the potential to offer a life-saving treatment option to patients with Cushing’s disease, CAH and related diseases,” said Alan Krasner, M.D., Chief Medical Officer of Crinetics. “Like the first-in-human study for our lead endocrine drug candidate, paltusotine, this first-in-human study for CRN04894 is designed to evaluate not just safety and pharmacokinetic data, but also to assess the pharmacologic activity to lower cortisol levels. Serum cortisol is the biomarker used to evaluate treatments of Cushing’s disease. It has served as the basis for FDA approval of recent therapies and is a meaningful pharmacodynamic readout to assess the ability of CRN04894 to block ACTH signaling in other conditions of ACTH excess, such as CAH. Like our other programs, we believe that if successful, this healthy volunteer study can provide important clinical proof-of-concept data for the program.” About the CRN04894-01 Phase 1 Study Crinetics anticipates enrolling approximately 100 healthy volunteers divided into multiple cohorts in the single ascending dose (SAD) and multiple ascending dose (MAD) phases of the study. In the SAD phase, study participants will receive synthetic ACTH during the study to replicate conditions of excess ACTH and create a baseline of elevated serum cortisol. On day 1, volunteers will undergo ACTH stimulation after which they will be administered placebo or ascending doses of study drug. In the MAD phase, participants will undergo ACTH stimulation test at baseline after which they will be administered placebo or ascending doses of study drug daily for 10 days and an ACTH stimulation test will be performed after repeat dosing. The primary objective is to evaluate the percentage of subjects with treatment-emergent adverse events. In addition to safety, a key endpoint is inhibition of ACTH stimulated serum cortisol levels compared to baseline before treatment with CRN04894. A reduction in serum cortisol could indicate successful blockade of MCR2, the receptor target of ACTH. Pharmacokinetics of CRN04894 will also be assessed. About CRN04894 Adrenocorticotropic hormone (ACTH) is synthesized and secreted by the pituitary gland and binds to melanocortin type 2 receptor (MC2R), which is selectively expressed in the adrenal gland. This interaction of ACTH with MCR2 stimulates the adrenal production of cortisol, a stress hormone that is involved in the regulation of many systems. Cortisol is involved for example, in the regulation of blood sugar levels, metabolism, inflammation, blood pressure, and memory formulation. Diseases associated with excess of ACTH, therefore, can have significant impact on physical and mental health. Crinetics’ ACTH antagonist, CRN04894, has exhibited strong binding affinity for MC2R in preclinical models and demonstrated suppression of adrenally derived glucocorticoids and androgens that are under the control of ACTH, while maintaining mineralocorticoid production. About Cushing’s Disease and Congenital Adrenal HyperplasiaCushing’s disease is a rare disease with a prevalence of approximately 10,000 patients in the United States. It is more common in women, between 30 and 50 years of age. Cushing’s disease often takes many years to diagnose and may well be under-diagnosed in the general population as many of its symptoms such as lethargy, depression, obesity, hypertension, hirsutism, and menstrual irregularity can be incorrectly attributed to other more common disorders. Congenital adrenal hyperplasia (CAH) encompasses a set of disorders that are caused by genetic mutations that result in impaired cortisol synthesis with a prevalence of approximately 27,000 patients in the United States. This lack of cortisol leads to a loss of feedback mechanisms and results in persistently high levels of ACTH, which in turn causes overstimulation of the adrenal cortex. The resulting adrenal hyperplasia and over-secretion of other steroids (particularly androgens) and steroid precursors can lead to a variety of effects from improper gonadal development to life-threatening dysregulation of mineralocorticoids. About Crinetics PharmaceuticalsCrinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. The company’s lead product candidate, paltusotine (formerly CRN00808), is an investigational, oral, selective nonpeptide somatostatin receptor type 2 biased agonist for the treatment of acromegaly, an orphan disease affecting more than 25,000 people in the United States. Crinetics plans to advance paltusotine into a Phase 3 program in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with NETs in 2021. The company is also developing CRN04777, an investigational, oral, nonpeptide somatostatin receptor type 5 (SST5) agonist for congenital hyperinsulinism, as well as CRN04894, an investigational, oral, nonpeptide ACTH antagonist for the treatment of Cushing’s disease, congenital adrenal hyperplasia, and other diseases of excess ACTH. All of the company’s drug candidates are new chemical entities resulting from in-house drug discovery efforts and are wholly owned by the company. For more information, please visit crinetics.com. Forward-Looking StatementsCrinetics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential to initiate a Phase 3 program of paltusotine in acromegaly and the expected timing thereof; the potential to initiate a Phase 2 program of paltusotine in patients with carcinoid syndrome due to NETs and the expected timing thereof; the initiation and enrollment of a Phase 1 clinical study in CRN04894 and the expected timing thereof; the potential that CRN04894 could represent a new class of therapeutic for patients suffering from devastating diseases; the potential to generate safety, pharmacodynamic, pharmacokinetic and pharmacologic activity data from such Phase 1 study in healthy volunteers with CRN04894 and the expected timing thereof; and the potential that such data will provide important clinical proof-of-concept for Crinetics’ CRN04894 program. The inclusion of forward-looking statements should not be regarded as a representation by Crinetics that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Crinetics’ business, including, without limitation: advancement of paltusotine into a Phase 3 program for acromegaly or a program for carcinoid syndrome 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, including delaying or otherwise disrupting its clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity; 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 for paltusotine, CRN04894 and its other product candidates; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of the company’s product candidates that may limit their development, regulatory approval and/or commercialization; Crinetics may use its capital resources sooner than it expects; and other risks described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Crinetics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts:Marc WilsonChief Financial OfficerIR@crinetics.com (858) 450-6464 Investors / Media:Corey DavisLifeSci Advisors, LLCcdavis@lifesciadvisors.com(212) 915-2577 Aline SherwoodScienta Communicationsasherwood@scientapr.com(312) 238-8957
- GlobeNewswire
Crinetics Pharmaceuticals Advances CRN04777 for Congenital Hyperinsulinism into Phase 1 Study
Phase 1 study is designed to provide clinical proof-of-concept by taking advantage of established methods in endocrinologySAN DIEGO, Feb. 03, 2021 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced the initiation of a Phase 1 study of CRN04777, an oral, nonpeptide somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital hyperinsulinism (HI). Congenital HI is a rare genetic disease associated with dysregulated insulin production in which excess insulin produces life-threatening hypoglycemia (low blood glucose) beginning at birth. The purpose of this study is to evaluate the safety and tolerability of CRN04777 in healthy adult volunteers. In addition, the study is designed to test the mechanism of action of CRN04777 by measuring its ability to suppress insulin secretion in healthy volunteers following stimulation with either glucose or a sulfonylurea, an agent that increases the secretion of insulin. “Congenital HI is a truly devastating disease. Early recognition, diagnosis and treatment is imperative to prevent life-threatening hypoglycemia, severe neurological sequelae and developmental delay,” said Sr. Medical Director Chris Ferrara-Cook, M.D., Ph.D., a pediatric endocrinologist who has specialized in the treatment of children with congenital HI throughout her medical career and who is leading this clinical program at Crinetics. “Families with a child diagnosed with congenital HI are burdened with years of constant glucose monitoring and maintenance in an attempt to minimize the degree and frequency of hypoglycemic events. Treatment options are limited, and we believe the current standard of care is inadequate. CRN04777 is a novel therapy under development that focuses on reducing insulin secretion, with a mechanism of action that we believe could treat all genetic forms of congenital HI. Oral administration has a significant advantage for treating the infants and young children who have the greatest need for novel therapies.” “CRN04777 is another nonpeptide, small molecule drug candidate for a rare, endocrine disease that has emerged from our internal discovery efforts. Like our other clinical programs, including that for paltusotine which has recently completed Phase 2 in acromegaly, this Phase 1 study with CRN04777 is designed to provide important safety and tolerability information as well as evidence of clinical proof-of-concept using established methods in endocrinology,” said Scott Struthers, Ph.D., founder and CEO of Crinetics. “Through patient advocacy groups like Congenital Hyperinsulinism International, we have come to learn the devastating toll this disease has on children with congenital HI and their families. We are ecstatic to bring this drug candidate to the clinic with the hope that it will provide an important new oral therapeutic tool to help these families and their treating physicians.” About the CRN04777-01 Phase 1 StudyCrinetics anticipates enrolling up to 117 healthy volunteers, who will be randomized into cohorts to receive single-ascending doses (SAD) or multiple-ascending doses (MAD) of CRN04777. In the first part of the SAD phase, participants will receive IV glucose to stimulate insulin production and baseline plasma biomarker levels will be recorded. The following day, participants will receive CRN04777 or placebo followed by the IV glucose challenge, and a comparison will be made of plasma biomarker levels to baseline. In the second part of the SAD phase, participants will receive a sulfonylurea to stimulate insulin secretion in the setting of a euglycemic clamp, in which blood glucose levels are maintained (“clamped”) via glucose infusion. Baseline plasma biomarker levels as well as the amount of IV glucose required to maintain euglycemia will be recorded. On the next day, participants will be administered CRN04777 or placebo, after which they will receive the sulfonylurea challenge, and a comparison will be made of plasma biomarker levels and IV glucose support to baseline levels. In the MAD phase, volunteers will undergo the sulfonylurea challenge in the setting of a euglycemic clamp at baseline after which they will be administered placebo or ascending doses of study drug daily for 10 days. Levels of IV glucose support, glucose, insulin and C-peptide will be measured after CRN04777 administration and compared to baselines to determine the degree to which CRN04777 can reduce insulin levels. Food effect, safety and tolerability will also be assessed. In September 2020, it was announced that the U.S. Food and Drug Administration granted rare pediatric disease designation for CRN04777. A rare pediatric disease is defined as a serious or life-threatening disease, which primarily affects individuals aged from birth to 18 years and affects fewer than 200,000 people in the United States. About Congenital HyperinsulinismHyperinsulinism (HI) is a heterogeneous condition in which dangerously low blood sugar levels are caused by increased insulin secretion from pancreatic β-cells. Congenital HI is a severe form of hyperinsulinism driven by one of more than ten known genetic mutations in certain genes involved in regulating insulin secretion. The incidence of congenital HI is approximately 1 in 30,000 to 50,000 new births in the United States and it is estimated that there are between 2,000 and 4,000 congenital HI patients in the U.S. While this is a rare disease, congenital HI is a leading cause of persistent hypoglycemia in infants and children. Early diagnosis is vital to prevent neurological complications due to recurrent low blood sugar, which can result in apnea, seizures, developmental delays, learning disabilities and even death. About Crinetics Pharmaceuticals Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. The company’s lead product candidate, paltusotine (formerly CRN00808), is an investigational, oral, selective nonpeptide somatostatin receptor type 2 biased agonist for the treatment of acromegaly, an orphan disease affecting more than 25,000 people in the United States. Crinetics plans to advance paltusotine into a Phase 3 program in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with NETs in 2021. The company is also developing CRN04777, an investigational, oral, nonpeptide somatostatin receptor type 5 (SST5) agonist for congenital hyperinsulinism, as well as CRN04894, an investigational, oral, nonpeptide ACTH antagonist for the treatment of Cushing’s disease, congenital adrenal hyperplasia, and other diseases of excess ACTH. All of the company’s drug candidates are new chemical entities resulting from in-house drug discovery efforts and are wholly owned by the company. For more information, please visit crinetics.com. Forward-Looking Statements Crinetics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential to initiate a Phase 3 program of paltusotine in acromegaly and the expected timing thereof; the potential to initiate a Phase 2 program of paltusotine in patients with carcinoid syndrome due to NETs and the expected timing thereof; the initiation and enrollment of a Phase 1 clinical study in CRN04777 and the expected timing thereof; the potential to generate data regarding the safety, tolerability, food effects and mechanism of action of CRN04777 from such Phase 1 study in healthy volunteers and the expected timing thereof; the potential that such data will provide evidence of clinical proof-of-concept of CRN04777; and the potential of CRN04777 to treat all genetic forms of congenital HI. The inclusion of forward-looking statements should not be regarded as a representation by Crinetics that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Crinetics’ business, including, without limitation: advancement of paltusotine into a Phase 3 program for acromegaly or a program for carcinoid syndrome 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, including delaying or otherwise disrupting its clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity; 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 for paltusotine, CRN04777 and its other product candidates; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of the company’s product candidates that may limit their development, regulatory approval and/or commercialization; Crinetics may use its capital resources sooner than it expects; and other risks described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Crinetics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts:Marc WilsonChief Financial OfficerIR@crinetics.com (858) 450-6464 Investors / Media:Corey DavisLifeSci Advisors, LLCcdavis@lifesciadvisors.com(212) 915-2577 Aline SherwoodScienta Communicationsasherwood@scientapr.com(312) 238-8957
- GlobeNewswire
Crinetics Pharmaceuticals to Review 2020 Accomplishments and Provide 2021 Plans at 39th Annual J.P. Morgan Healthcare Conference
\- Paltusotine planned to advance to a pivotal Phase 3 trial in acromegaly in H1 2021 - \- Initiation of Phase 1 proof-of-concept study evaluating CRN04894 for the treatment of congenital adrenal hyperplasia and Cushing’s disease expected in January 2021 -\- Initiation of Phase 1 proof-of-concept study evaluating CRN04777 for the treatment of congenital hyperinsulinism expected in February 2021 -SAN DIEGO, Jan. 06, 2021 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced that company management will participate in the 39th annual J.P. Morgan Healthcare Conference, which is taking place in a virtual format. Scott Struthers, Ph.D., Founder & CEO of Crinetics, will present a company update on Wednesday, January 13th at 1:30 pm Pacific Time. A live audio webcast of Dr. Struthers’ presentation may be accessed on the Events section of the company’s website or directly on the J.P. Morgan virtual meeting platform.During his presentation, Dr. Struthers will discuss Crinetics’ key priorities and anticipated milestones for 2021, including initiating the Phase 3 program for paltusotine (formerly CRN00808) for the treatment of acromegaly, initiating clinical trials for paltusotine in patients with carcinoid syndrome as well as for two new drug candidates for congenital hyperinsulinism (CHI) and diseases of excess adrenocorticotropic hormone (ACTH). To support the company’s growing pipeline, Crinetics has expanded its development and medical teams with the appointments of several additional clinical endocrinology experts, increasing the company’s total headcount to 90 with plans for continued hiring in 2021.Dr. Struthers explained, “Crinetics is a leader in designing and developing small-molecule drugs for the treatment of endocrine diseases. Our current focus is on rare endocrine disorders that have serious health consequences that are not being satisfied by current therapeutic options. Looking forward to 2021 and beyond, we plan to advance these programs into late-stage clinical trials and to apply our drug discovery and development expertise to create new drug candidates for additional diseases that we believe can be treated by regulating endocrine systems. As we continue to grow our already exceptional team, we remain committed to creating new life-changing therapeutics that are designed to solve real problems faced by patients and their health care providers.”2020 Accomplishments * Paltusotine for Acromegaly: In the fourth quarter of 2020, Crinetics reported positive top-line data from its Phase 2 program evaluating paltusotine for the treatment of acromegaly. These results demonstrated that individuals with acromegaly who switched from standard-of-care injected somatostatin receptor ligand (SRL) depots to once-daily oral paltusotine were able to maintain the level of insulin-like growth factor-1 (IGF-1) that was previously achieved on standard-of-care. * Pipeline Programs Advanced Toward the Clinic: Crinetics selected CRN04894 as the company’s lead ACTH antagonist and completed first-in-human-enabling manufacturing and toxicology studies. Such studies were also completed for its somatostatin receptor type 5 (SST5) agonist (CRN04777) drug candidate. After review of preclinical and manufacturing data, as well as Phase 1 study designs, the U.S. Investigational New Drug (IND) application for CRN04894 is now open and Germany’s Federal Institute for Drugs and Medical Devices (BfArM) has approved the start of the Phase 1 trial for CRN04777. * In-house Expertise: Throughout 2020, Crinetics bolstered its clinical and medical teams with the addition of experts in the development of therapeutics and management of clinical trials for endocrine diseases. These new hires include Drs. Alessandra Casagrande, Peter Trainer and Hjalmar Lagast, who join Drs. Alan Krasner and Christine Ferrara-Cook. 2021 Goals * Paltusotine for Acromegaly: Crinetics expects to hold an end-of-Phase-2 meeting with the FDA in the first quarter of 2021 and start its Phase 3 program in the first half of 2021. Crinetics intends to use a new, improved tablet formulation of paltusotine in the Phase 3 program for acromegaly. This formulation is designed to provide convenient once-daily administration but enable a reduced fasting requirement (0.5 to 1 hour before eating) and improved dose-proportional exposure compared to the prior formulation. In addition, the new tablet formulation is designed to enable the administration of paltusotine with commonly used proton pump inhibitors. * Paltusotine for Carcinoid Syndrome: Crinetics expects to advance paltusotine into a clinical study in patients with carcinoid syndrome due to neuroendocrine tumors (NETs). Injected SRLs are the standard of care for patients with carcinoid syndrome, but many patients become increasingly resistant to treatment over time, requiring increased dosage of depot preparations or the addition of short-acting analogs. Crinetics believes that an oral therapy with a long half-life and dose-proportional exposure would be a useful option for these patients, if approved. * CRN04894: A Phase 1 study evaluating the ability of CRN04894 to suppress ACTH-stimulated cortisol secretion in healthy volunteers is planned to commence in January 2021. Results are expected in the first half of 2021 and, if positive, may provide proof-of-concept data supporting further evaluation of CRN04894 in the treatment of diseases associated with excess ACTH such as Cushing’s disease and congenital adrenal hyperplasia (CAH). CRN04894 is an investigational, oral, selective ACTH antagonist designed to block the action of excess ACTH on the adrenal gland resulting in excess cortisol in Cushing’s disease and excess adrenal androgens in CAH. * CRN04777: A Phase 1 study evaluating the ability of CRN04777 to reduce stimulated insulin secretion in healthy volunteers is planned to commence in February 2021. Data is expected in mid-2021 and, if positive, the results of this trial may provide proof-of-concept data to support further evaluation of CRN04777 in the treatment of children with CHI. CRN04777 is an investigational, oral, selective non-peptide SST5 receptor agonist designed to reduce insulin secretion and thereby correct the life-threatening hypoglycemia (low blood glucose) that affects these children. * In 2021, Crinetics expects to continue its drug discovery efforts with programs to identify drug candidates for hyperparathyroidism, nonfunctional pituitary adenomas and polycystic kidney disease, among other indications. This pipeline expansion is intended to drive continued growth and value for stakeholders. About Crinetics Pharmaceuticals Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. The company’s lead product candidate, paltusotine (formerly CRN00808), is an investigational, oral selective nonpeptide somatostatin receptor type 2 biased agonist for the treatment of acromegaly, an orphan disease affecting more than 25,000 people in the United States. Crinetics plans to advance paltusotine into a Phase 3 program in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with NETs in 2021. The company is also developing CRN04777, an investigational, oral nonpeptide somatostatin receptor type 5 (SST5) agonist for congenital hyperinsulinism, as well as CRN04894, an investigational, oral nonpeptide ACTH antagonist for the treatment of Cushing’s disease, congenital adrenal hyperplasia, and other diseases of excess ACTH. All of the company’s drug candidates are new chemical entities resulting from in-house drug discovery efforts and are wholly owned by the company. For more information, please visit crinetics.com.Forward-looking Statements Crinetics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential benefits of paltusotine for acromegaly patients and for patients with carcinoid syndrome; the potential to initiate a Phase 3 program of paltusotine in acromegaly and the expected timing thereof; Crinetics’ plans to meet with the FDA in the first quarter of 2021; the benefits of Crinetics’ improved tablet formulation of paltusotine; the potential to initiate a of paltusotine in patients with carcinoid syndrome due to NETs and the expected timing thereof; the potential to begin Phase 1 clinical development with CRN04894 and CRN04777 and the expected timing for the commencement thereof and the related generation of proof-of-concept data in healthy volunteers; Crinetics’ plan to advance its programs into late-stage clinical trials and to create new drug candidates for additional diseases; and Crinetics’ plans to identify and create new drug candidates for additional diseases, including hyperparathyroidism, nonfunctional pituitary adenomas and polycystic kidney disease, among other indications. The inclusion of forward-looking statements should not be regarded as a representation by Crinetics that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Crinetics’ business, including, without limitation: advancement of paltusotine into a Phase 3 program for acromegaly or a trial for carcinoid syndrome and CRN04894 and CRN04777 into Phase 1 trials are 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, including delaying or otherwise disrupting its clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity; 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 for paltusotine, CRN04894, CRN04777 and its other product candidates; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of the company’s product candidates that may limit their development, regulatory approval and/or commercialization; Crinetics may use its capital resources sooner than it expects; and other risks described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Crinetics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.Contacts: Marc Wilson Chief Financial Officer IR@crinetics.com (858) 450-6464Investors / Media: Corey Davis LifeSci Advisors, LLC cdavis@lifesciadvisors.com (212) 915-2577Aline Sherwood Scienta Communications asherwood@scientapr.com (312) 238-8957
