CRNX Crinetics Pharmaceuticals Inc.

18.97
-1.96  -9%
Previous Close 20.93
Open 20.51
52 Week Low 13.83
52 Week High 28.95
Market Cap $901,072,837
Shares 47,499,886
Float 37,103,951
Enterprise Value $711,069,837
Volume 317,248
Av. Daily Volume 287,072
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Upcoming Catalysts

Drug Stage Catalyst Date
CRN04777
Congenital hyperinsulinism (HI)
Phase 1
Phase 1
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CRN04894
Congenital adrenal hyperplasia and Cushing’s disease
Phase 1
Phase 1
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Paltusotine (PATHFNDR-1)
Acromegaly
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Paltusotine
Carcinoid syndrome associated with neuroendocrine tumors (NETs)
Phase 2
Phase 2
Phase 2 trial to be initiated in 2022.
CRN00808 - (ACROBAT EVOLVE)
Acromegaly
Phase 2
Phase 2
Phase 2 data showed that 23 of 41 participants had completed 51 weeks of treatment with only four participants discontinuing from the study. Results also showed that dosing was generally well tolerated, noted November 8, 2021.

Latest News

  1. - Phase 1 multiple ascending dose data for CRN04894 and CRN04777 expected in 1Q 2022 –

    - Initiation of patient dosing in a Phase 2 trial of paltusotine in carcinoid syndrome associated with neuroendocrine tumors expected in 2022 -

    - Initiation of IND-enabling studies for parathyroid receptor type-1 antagonist expected in 2022 -

    SAN DIEGO, Jan. 12, 2022 (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 Scott Struthers, Ph.D., founder & CEO of Crinetics, will provide a company update at the 40th annual J.P. Morgan Healthcare…

    - Phase 1 multiple ascending dose data for CRN04894 and CRN04777 expected in 1Q 2022 –

    - Initiation of patient dosing in a Phase 2 trial of paltusotine in carcinoid syndrome associated with neuroendocrine tumors expected in 2022 -

    - Initiation of IND-enabling studies for parathyroid receptor type-1 antagonist expected in 2022 -

    SAN DIEGO, Jan. 12, 2022 (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 Scott Struthers, Ph.D., founder & CEO of Crinetics, will provide a company update at the 40th annual J.P. Morgan Healthcare Conference today, Wednesday, January 12th at 4:30 PM Eastern Time / 1:30 PM Pacific Time. A live audio webcast of Dr. Struthers' presentation may be accessed on the Events page of the company's website.

    During his presentation, Dr. Struthers will discuss Crinetics' key priorities and anticipated milestones for 2022. These include:

    • Continued progress in the two ongoing Phase 3 PATHFNDR trials of paltusotine in acromegaly. Both trials remain on track and topline data is expected 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.

    "2021 was a transformational year for Crinetics as we achieved a number of important milestones that diversified our clinical pipeline and highlighted the strength of our drug discovery capabilities," stated Dr. Struthers. "We advanced paltusotine into a registrational Phase 3 program and reported Phase 1 clinical proof-of-concept data for both CRN04894 and CRN04777. Each of these data announcements provided additional validation for our drug development roadmap, which aims for early de-risking through animal and healthy volunteer studies leveraging well-established endocrine biomarkers. Looking ahead, we will continue to follow this plan as we work to advance our PTHR1 antagonist program and expand our pipeline. With a talented drug discovery and development team, a steady cadence of catalysts ahead of us, and a strong balance sheet, we believe we are well positioned for sustained success."

    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 (SST2) biased agonist for the treatment of acromegaly, an orphan disease affecting more than 26,000 people in the United States. A Phase 3 clinical program in acromegaly with paltusotine is underway. Crinetics also plans to advance paltusotine into a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors. 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.

    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 SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading "Risk Factors" in Crinetics' periodic reports, including its annual report on Form 10-K for the year ended December 31, 2020, filed with the SEC. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    Contacts:

    Marc Wilson

    Chief Financial Officer



    (858) 450-6464

    Investors / Media:

    Corey Davis

    LifeSci Advisors, LLC



    (212) 915-2577

    Aline Sherwood

    Scienta Communications



    (312) 238-8957

     



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  2. SAN DIEGO, Jan. 05, 2022 (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 appointment of Rogério Vivaldi Coelho, M.D., M.B.A. to the company's board of directors. Dr. Vivaldi comes to Crinetics with over two decades of experience as a physician and industry executive with deep expertise commercializing pharmaceuticals, especially those treating rare and orphan diseases, in the U.S. and globally.

    Scott Struthers, Ph.D., founder and chief executive officer of Crinetics, stated, "Dr. Vivaldi's expertise in global commercial operations…

    SAN DIEGO, Jan. 05, 2022 (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 appointment of Rogério Vivaldi Coelho, M.D., M.B.A. to the company's board of directors. Dr. Vivaldi comes to Crinetics with over two decades of experience as a physician and industry executive with deep expertise commercializing pharmaceuticals, especially those treating rare and orphan diseases, in the U.S. and globally.

    Scott Struthers, Ph.D., founder and chief executive officer of Crinetics, stated, "Dr. Vivaldi's expertise in global commercial operations, coupled with his passion for meeting the needs of patients with rare diseases, make him a natural fit for Crinetics. As we advance our expanding portfolio of novel therapeutics for multiple rare endocrine diseases, we are looking forward to leveraging his skills and experience building commercial enterprises to ensure we are prepared to deliver treatments to patients worldwide."

    Dr. Vivaldi is currently the president and chief executive officer of Sigilon Therapeutics, Inc., where he also serves as a member of the company's board of directors. Prior to joining Sigilon, Dr. Vivaldi served as executive vice president and chief global therapeutics officer at Bioverativ Inc., where he was responsible for building and managing their commercial organization, including sales and marketing efforts for the franchise's lead products, until it was acquired by Sanofi S.A. in 2018. He also previously served as chief commercial officer at Spark Therapeutics, Inc., where he spearheaded the launch of global commercial operations, and patient advocacy, market access, and medical affairs efforts for Luxturna. Earlier, he held several positions of increasing responsibility over a 20-year career at Genzyme, most recently serving as the head of the company's rare disease business, president of both the rare disease business and the renal & endocrine group, and as senior vice president and general manager of its Latin America group. During his time at Genzyme, he led the successful approval of more than 15 orphan products in more than 20 countries.

    Dr. Vivaldi earned a medical degree from the Universidade do Rio de Janeiro, after which he completed a residency in endocrinology at the Universidade do Estado do Rio de Janeiro and a fellowship at Mount Sinai Hospital Center in New York in the department of genetics, focusing on Gaucher disease. He later became the first physician in Brazil to treat Gaucher disease using enzyme replacement therapy. In addition, Dr. Vivaldi holds an M.B.A. degree from COPPEAD, Universidade Federal do Rio de Janeiro.​

    "While each rare disease impacts only a small number of people, they collectively affect an estimated 25-30 million Americans. It's an enormous unmet need and one that must be addressed," added Dr. Vivaldi. "Crinetics and I share a unique and strong commitment to developing therapies for the millions of rare disease patients around the world, specifically those with endocrine disorders. I look forward to lending my skills and expertise to the Crinetics board as we work with the company to advance its ongoing clinical programs and bring additional therapeutic candidates into the clinic."

    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, is an investigational, oral, selective nonpeptide somatostatin receptor type 2 biased agonist for the treatment of acromegaly, an orphan disease affecting more than 26,000 people in the United States. A Phase 3 clinical program in acromegaly with paltusotine is underway. Crinetics also plans to advance paltusotine into a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors. 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 congenital adrenal hyperplasia, Cushing's disease 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.

    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 potential to advance Crinetics' ongoing clinical programs and bring additional therapeutic candidates into the clinic. 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 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 SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading "Risk Factors" in Crinetics' periodic reports, including its annual report on Form 10-K for the year ended December 31, 2020, filed with the SEC. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    Contacts:

    Marc Wilson

    Chief Financial Officer



    (858) 450-6464

    Investors / Media:

    Corey Davis

    LifeSci Advisors, LLC



    (212) 915-2577

    Aline Sherwood

    Scienta Communications



    (312) 238-8957



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  3. SAN DIEGO, Nov. 18, 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, announced today that company management will participate in a fireside chat and one-on-one investor meetings at the 4th Annual Evercore ISI HealthCONx Conference, which is taking place virtually November 30, 2021 through December 2, 2021.

    Details on the fireside chat can be found below.

    Date:December 2, 2021
    Time:12:35 PM ET
    Webcast Link:https://wsw.com/webcast/evercore21/crnx/2381354

    A webcast of the fireside chat will also be accessible on the Events & Presentations page in the…

    SAN DIEGO, Nov. 18, 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, announced today that company management will participate in a fireside chat and one-on-one investor meetings at the 4th Annual Evercore ISI HealthCONx Conference, which is taking place virtually November 30, 2021 through December 2, 2021.

    Details on the fireside chat can be found below.

    Date:December 2, 2021
    Time:12:35 PM ET
    Webcast Link:https://wsw.com/webcast/evercore21/crnx/2381354

    A webcast of the fireside chat will also be accessible on the Events & Presentations page in the Investors section of the Crinetics website. A replay of the fireside chat will be available at the same location following its conclusion and will be archived for 90 days.

    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, is an investigational, oral, selective nonpeptide somatostatin receptor type 2 (SST2) biased agonist for the treatment of acromegaly, an orphan disease affecting more than 26,000 people in the United States. A Phase 3 clinical program in acromegaly with paltusotine is underway. Crinetics also plans to advance paltusotine into a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors. 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.

    Contacts:

    Marc Wilson

    Chief Financial Officer

      

    (858) 450-6464

    Investors / Media:

    Corey Davis

    LifeSci Advisors, LLC



    (212) 915-2577

    Aline Sherwood

    Scienta Communications



    (312) 238-8957



    Primary Logo

    View Full Article Hide Full Article
  4. SAN DIEGO, Nov. 08, 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, announced today that new data from ACROBAT Advance, the ongoing open label extension (OLE) trial of paltusotine in patients with acromegaly, will be featured in a poster presentation at the annual Society for Endocrinology BES congress in Edinburgh, Scotland. Patients who completed either of the Phase 2 ACROBAT Edge or Evolve studies including a 4-week washout period were eligible to enroll in Advance.

    ACROBAT Edge and Evolve were two separate Phase 2 studies that enrolled…

    SAN DIEGO, Nov. 08, 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, announced today that new data from ACROBAT Advance, the ongoing open label extension (OLE) trial of paltusotine in patients with acromegaly, will be featured in a poster presentation at the annual Society for Endocrinology BES congress in Edinburgh, Scotland. Patients who completed either of the Phase 2 ACROBAT Edge or Evolve studies including a 4-week washout period were eligible to enroll in Advance.

    ACROBAT Edge and Evolve were two separate Phase 2 studies that enrolled a broad cross section of acromegaly patients, including those who were biochemically controlled (defined by IGF-1 ≤1.0x upper limit of normal [ULN]) on an injected somatostatin receptor ligand (SRL), as well as those who were uncontrolled (defined by IGF-1 >1.0x ULN) on treatment regimens that included an SRL. Through August 31, 2021, 84% (41/49) of eligible ACROBAT participants had opted to continue into the Advance OLE.

    As of August 31, 2021, 23 of the 41 Advance participants had completed 51 weeks of treatment with only four participants discontinuing from the study. Treatment with paltusotine resulted in median serum insulin-like growth factor-1 (IGF-1) levels that were lower than those observed in the washout (untreated) period in the parent studies and were then stably maintained at levels achieved on prior SRL therapy for up to 51 weeks. This was true for patients with controlled or uncontrolled IGF-1 at baseline while treated with injected SRLs. Results also showed that paltusotine was generally well tolerated.

    "It is very encouraging that IGF-1 levels, a clinically recognized biomarker of disease severity and registrational endpoint for acromegaly, have been maintained in Advance participants at levels comparable to those achieved with injected SRLs after almost a year on paltusotine," said Alan Krasner, M.D., chief medical officer of Crinetics. "This is an important observation that we look forward to monitoring as the OLE continues. We deeply appreciate the enthusiasm and engagement of our study subjects and investigative teams around the world that allow us to continue to gather this important long-term safety and efficacy data."

    "These promising long-term data further support our thesis that once daily oral paltusotine has the potential to replace injected peptide depots as the standard-of-care for acromegaly," added Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "They also give us added confidence as we advance through our Phase 3 PATHFNDR program, which aims to support the registration of paltusotine for all acromegaly patients who require pharmacotherapy."

    About Acromegaly

    Acromegaly is a serious disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone (GH). Excess GH secretion causes excess secretion of IGF-1 from the liver. Together, excess of these hormones leads to the symptoms of acromegaly, including abnormal growth of hands and feet, alteration of facial features, arthritis, carpal tunnel syndrome, joint aches, deepening of voice due to enlarged vocal cords, fatigue, sleep apnea, enlargement of heart, liver and other organs, and changes in glucose and lipid metabolism.

    Surgical removal of pituitary adenomas, if possible, is the preferred initial treatment for most acromegaly patients. Pharmacological treatments are used for patients who are not candidates for surgery, or when surgery is unsuccessful in achieving treatment goals. Approximately 50% of patients with acromegaly prove to be candidates for pharmacological treatment. Long-acting somatostatin-receptor ligands (SRLs) are the most common initial pharmacologic treatment; however, these drugs require monthly depot injections with large gauge needles that are commonly associated with pain, injection site reactions, and increased burden of therapy on the lives of patients.

    About Paltusotine

    Paltusotine is an investigational, orally available nonpeptide agonist that is highly selective for the somatostatin receptor type 2 (SST2). It was designed by the Crinetics discovery team to provide a once-daily option for patients with acromegaly and neuroendocrine tumors. A previously completed Phase 1 trial of paltusotine showed clinical proof of concept by providing evidence of potent suppression of the growth hormone axis in healthy volunteers. In Phase 2 trials, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily oral paltusotine. IGF-1 is the primary biomarker endocrinologists use to manage their acromegaly patients.

    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 26,000 people in the United States. A Phase 3 clinical program in acromegaly with paltusotine is underway. Crinetics also plans to advance paltusotine into a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors. 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.

    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 therapeutic potential and clinical benefits of paltusotine, CRN04777 and CRN04894. 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 the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the public offering, the risks and uncertainties inherent in Crinetics' business, including the risks and uncertainties described in the company's periodic filings with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading "Risk Factors" in Crinetics' periodic reports, including its annual report on Form 10-K for the year ended December 31, 2020, and in the preliminary prospectus supplement related to the offering filed with the SEC. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    Contacts:

    Marc Wilson

    Chief Financial Officer

      

    (858) 450-6464

    Investors / Media:

    Corey Davis

    LifeSci Advisors, LLC

     

    (212) 915-2577

    Aline Sherwood

    Scienta Communications



    (312) 238-8957

     



    Primary Logo

    View Full Article Hide Full Article
  5. – Pipeline Includes Three New Chemical Entities with Clinical Proof-of-concept Following CRN04894 and CRN04777 Phase 1 Readouts –

    – Advancing a Parathyroid Hormone Receptor Antagonist Program Using the Drug Development Blueprint Followed by Paltusotine, CRN04894, and CRN04777 –

    – Co-founded Radionetics Oncology with $30 million in Initial Financing from 5AM Ventures and Frazier Healthcare Partners –

    SAN DIEGO, Nov. 05, 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 financial results for the third quarter ended September…

    – Pipeline Includes Three New Chemical Entities with Clinical Proof-of-concept Following CRN04894 and CRN04777 Phase 1 Readouts –

    – Advancing a Parathyroid Hormone Receptor Antagonist Program Using the Drug Development Blueprint Followed by Paltusotine, CRN04894, and CRN04777 –

    – Co-founded Radionetics Oncology with $30 million in Initial Financing from 5AM Ventures and Frazier Healthcare Partners –

    SAN DIEGO, Nov. 05, 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 financial results for the third quarter ended September 30, 2021 and provided a corporate update.

    "Positive Phase 1 readouts from our CRN04894 and CRN04777 programs during the third quarter have us advancing a diverse pipeline that includes three wholly-owned new chemical entities (NCEs) with clinical proof-of-concept," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "The drug development blueprint followed by these NCEs, which aims for early de-risking through animal and healthy volunteer studies leveraging well-established endocrine biomarkers, is now being applied to our recently unveiled parathyroid hormone receptor antagonist program and other discovery efforts. We also continue to make strong progress in our efforts to develop paltusotine as an oral treatment for acromegaly and neuroendocrine tumors complicated by carcinoid syndrome. With a strong financial foundation that was recently bolstered by our successful common stock offering, we believe we are well positioned to advance our pipeline programs and achieve a regular cadence of milestones."

    Dr. Struthers continued, "Beyond our internal pipeline, our drug discovery platform has also generated exciting radiopharmaceutical candidates with the potential to treat a broad range of cancers. This led us to co-found Radionetics Oncology, which has positioned Crinetics to participate in the value of these assets while maintaining focus on our core mission of delivering much-needed therapies to patients with endocrine diseases."       

    Third Quarter and Subsequent Highlights

    • Reported positive data from single-ascending dose (SAD) cohorts of first-in-human study of CRN04777. In September 2021, Crinetics announced preliminary data from the SAD cohorts of an ongoing Phase 1 study of CRN04777, its somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital hyperinsulinism. The data provided evidence of clinically meaningful suppression of insulin secretion by showing dose-dependent reductions in glucose-stimulated insulin secretion and a dose-dependent reversal of sulfonylurea-induced insulin secretion in a pharmacologic model of congenital hyperinsulinism. In addition, the data suggest CRN04777 was orally bioavailable and demonstrated dose-proportional pharmacokinetics. Single doses of CRN04777 were well tolerated, as all adverse events were considered mild/moderate. Data from multiple-ascending dose (MAD) cohorts of the Phase 1 study are expected in the first quarter of 2022.
    • Reported positive data from SAD cohorts of first-in-human study of CRN04894. In August 2021, Crinetics announced preliminary data from the SAD cohorts of an ongoing Phase 1 study of CRN04894, its adrenocorticotropic hormone (ACTH) antagonist being developed as a treatment for diseases of ACTH excess. The data provided evidence of clinically relevant cortisol suppression and showed dose-dependent reductions in basal cortisol levels as well as suppression of cortisol following ACTH challenge. In addition, the data suggest that CRN04894 was orally bioavailable and demonstrated dose-proportional pharmacokinetics. Single doses of CRN04894 were well-tolerated, as all adverse events were considered mild. Data from the MAD cohorts of the Phase 1 study are expected in the first quarter of 2022.
    • Unveiled its parathyroid hormone receptor antagonist program. In September 2021, Crinetics announced its intent to develop a nonpeptide oral parathyroid hormone (PTH) receptor antagonist for the treatment of hypercalcemia associated with hyperparathyroidism (HPT) and other diseases of PTH receptor type 1 (PTHR1) over-activation. Details of the preclinical efforts supporting the program were presented in a late-breaking poster at the annual meeting of the American Society for Bone and Mineral Research (ASBMR). More information on the program and a copy of the poster can be found here.
    • Co-founded Radionetics Oncology. In October 2021, Crinetics, together with 5AM Ventures and Frazier Healthcare Partners, founded Radionetics Oncology, an independently operated company that aims to develop a deep pipeline of novel, targeted, nonpeptide radiopharmaceuticals for the treatment of a broad range of oncology indications. In conjunction with formation of the company, Radionetics received an exclusive world-wide license to a radiotherapeutics technology platform and intellectual property from Crinetics in exchange for equity, milestones in excess of $1 billion and single-digit royalties on net sales. Radionetics launched with a $30 million private financing with 5AM Ventures and Frazier Healthcare Partners as the sole investors.
    • Strengthened balance sheet with successful common stock offerings. In July 2021, Crinetics entered into a securities purchase agreement with Frazier Healthcare Partners for the private placement of 851,306 shares at $17.62 per share, raising gross proceeds of $15.0 million. In October 2021, Crinetics completed an underwritten public offering of 8,712,400 shares of its common stock at a price to the public of $19.80 per share, raising gross proceeds of $172.5 million.

    Third Quarter 2021 Financial Results

    • Research and development expenses were $21.6 million for the three months ended September 30, 2021, compared to $13.7 million for the same period in 2020. The increase was primarily attributable to increased spending on manufacturing and development activities of $4.3 million associated with our clinical and nonclinical activities for paltusotine and our other clinical and preclinical programs, and an increase in personnel costs of $3.2 million, of which stock-based compensation was $1.2 million.
    • General and administrative expenses were $6.2 million for the three months ended September 30, 2021, compared to $4.8 million for the same period in 2020. The increase was primarily due to additional personnel costs of $1.0 million, of which stock-based compensation was $0.6 million.
    • Net loss for the three months ended September 30, 2021, was $27.9 million, compared to a net loss of $18.3 million for the three months ended September 30, 2020.
    • Unrestricted cash, cash equivalents and investments totaled $193.3 million as of September 30, 2021, compared to $170.9 million as of December 31, 2020. The $193.3 million in unrestricted cash, cash equivalents and investments does not include the $172.5 million in gross proceeds from the Company's October 2021 common stock offering.
    • As of October 31, 2021, the company had 47,499,886 common shares outstanding.

    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 26,000 people in the United States. A Phase 3 program in acromegaly with paltusotine is underway. Crinetics also plans to advance paltusotine into a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors. 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.  

    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 patients with acromegaly or neuroendocrine tumors complicated by carcinoid syndrome; the potential benefits of CRN04984 for patients with conditions of ACTH excess, including Cushing's disease and congenital adrenal hyperplasia; the potential benefits of CRN04777 for patients with congenital hyperinsulinism; the timing of data from the Phase 1 clinical trials of CRN04984 and CRN04777; plans to advance other pipeline product candidates and to invest in the small molecule discovery approach; Radionetics' ability to develop and advance its oncology pipeline; the potential benefits of nonpeptide radiopharmaceutical agents for the treatment of a broad range of oncology indications; the potential for Crinetics and its stockholders to obtain value from Crinetics' equity interest in Radionetics; and Crinetics' potential to receive future milestone and royalty payments from Radionetics. 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 current report due to the risks and uncertainties inherent in Crinetics' business, including, without limitation: 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; advancement of CRN04894 and CRN04777 into later stage trials is dependent on and subject to the receipt of further feedback from the FDA and other regulatory agencies; 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; 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; Radionetics will need additional funds to advance its pipeline and Crinetics' ownership interest may be diminished in connection with future capital raising; Crinetics' ability to receive milestone or royalty payments from Radionetics will depend on Radionetics ability to advance the pipeline through clinical development, regulatory approval and ultimately commercial sales, all of which will take significant time, will be subject to inherent risks in drug development and may be impacted by changes in regulatory requirements, healthcare reform measures and competitive dynamics; the technology platform is novel and unproven and may never lead to approved products of commercial value; clinical trials and preclinical studies may not proceed at the time or in the manner expected, or at all; the timing and outcome of research, development and regulatory review is uncertain, and Crinetics' or Radionetics' drug candidates may not advance in development or be approved for marketing; Crinetics and Radionetics may use their capital resources sooner than expected; 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



    (858) 450-6464

    Investors / Media:

    Corey Davis

    LifeSci Advisors, LLC



    (212) 915-2577

    Aline Sherwood

    Scienta Communications



    (312) 238-8957

    CRINETICS PHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA

    (In thousands, except per share data)

    (Unaudited)

      Three months ended September 30,  Nine Months Ended September 30, 
      2021  2020  2021  2020 
    STATEMENTS OF OPERATIONS DATA:                
    Grant revenues $-  $-  $-  $71 
    Operating expenses:                
    Research and development  21,580   13,699   59,651   40,168 
    General and administrative  6,227   4,752   17,163   13,065 
    Total operating expenses  27,807   18,451   76,814   53,233 
    Loss from operations  (27,807)  (18,451)  (76,814)  (53,162)
    Total other income (expense), net  (44)  131   (33)  991 
                     
    Net loss $(27,851) $(18,320) $(76,847) $(52,171)
                     
    Net loss per share - basic and diluted $(0.73) $(0.56) $(2.13) $(1.76)
    Weighted-average shares - basic and diluted  38,309   32,890   36,147   29,608 
                     



      September 30,

    2021
      December 31,

    2020
     
    BALANCE SHEET DATA:        
    Cash, cash equivalents and investments $193,325  $170,880 
    Working capital $191,533  $167,003 
    Total assets $209,359  $183,445 
    Total liabilities $15,769  $14,526 
    Accumulated deficit $(244,461) $(167,614)
    Total stockholders' equity $193,590  $168,919 


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