CRNX Crinetics Pharmaceuticals Inc.

16.54
+0.4  (+2%)
Previous Close 16.14
Open 16.41
52 Week Low 10.63
52 Week High 26.67
Market Cap $543,111,387
Shares 32,845,572
Float 32,593,411
Enterprise Value $421,973,532
Volume 52,325
Av. Daily Volume 242,372
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Drug Stage Catalyst Date
CRN00808 - ACROBAT EVOLVE
Acromegaly
Phase 2
Phase 2
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CRN00808 Paltusotine (ACROBAT EDGE)
Acromegaly
Phase 2
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Latest News

  1. Paltusotine received Orphan Drug Designation for the treatment of acromegaly

    Half of the enrolled patients in the ongoing Phase 2 ACROBAT Edge clinical trial for paltusotine had completed the study as of June and topline data is expected in fourth quarter 2020

    Reported positive interim results for the ACROBAT Edge Phase 2 trial of oral paltusotine for the treatment of acromegaly

    Completed successful public offering raising net proceeds of $107.9 million

    SAN DIEGO, Aug. 07, 2020 (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…

    Paltusotine received Orphan Drug Designation for the treatment of acromegaly

    Half of the enrolled patients in the ongoing Phase 2 ACROBAT Edge clinical trial for paltusotine had completed the study as of June and topline data is expected in fourth quarter 2020

    Reported positive interim results for the ACROBAT Edge Phase 2 trial of oral paltusotine for the treatment of acromegaly

    Completed successful public offering raising net proceeds of $107.9 million

    SAN DIEGO, Aug. 07, 2020 (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 second quarter ended June 30, 2020 and provided a corporate update.

    "Crinetics has made significant progress in the second quarter of the year, which began with our positive interim data from the Phase 2 ACROBAT Edge trial, and Orphan Drug Designation for paltusotine for the treatment of acromegaly, both solidifying the confidence we have in our lead product to be an effective, orally available treatment for patients with this rare disease," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "Looking ahead to the rest of the year, we see additional clinical milestones for the company with topline data from our ongoing Phase 2 trials expected to be presented in the fourth quarter of 2020. Additionally, with the capital from our April financing, we are well positioned to execute on our planned Phase 3 trial in acromegaly, a Phase 2 trial of paltusotine in carcinoid syndrome associated with neuroendocrine tumors, as well as the planned Phase 1 trials for our ACTH antagonist and SST5 agonist programs."

    Second Quarter and Subsequent Highlights

    • Received Orphan Drug Designation for paltusotine for the treatment of acromegaly. In July 2020, the U.S. Food and Drug Administration (FDA) granted paltusotine Orphan Drug Designation for the treatment of acromegaly. Orphan Drug Designation qualifies Crinetics for certain development incentives, that may include exemption from FDA prescription drug user fees, financial incentives for qualified clinical development, and seven years of market exclusivity in the U.S. if the treatment is approved.

       
    • Confirmed completion for half of the enrolled patients in the ongoing Phase 2 ACROBAT Edge clinical trial for paltusotine. In June 2020, Crinetics announced that over 50% (28/47) of the patients enrolled in the ACROBAT Edge Phase 2 clinical trial have completed the study, which is investigating the effects of once daily oral paltusotine on IGF-1 levels after switching patients from injectable depot therapy. Recruitment for the Edge and Evolve trials has been completed with 47 and 13 patients, respectively, and topline data is planned for the fourth quarter of 2020.

       
    • Reported positive interim results for the ACROBAT Edge Phase 2 trial of paltusotine in acromegaly patients. In April 2020, Crinetics reported interim results from its ongoing ACROBAT Edge Phase 2 trial. Results as of the February 23, 2020 data cutoff showed that acromegaly patients switching from injectable depot therapy to once daily oral paltusotine maintained IGF-1 levels previously achieved with commercially available depot injections of somatostatin receptor ligands.

       
    • Successful public offering strengthens cash position. In April 2020, Crinetics completed a public offering in which the company sold an aggregate of 8,222,500 shares of common stock at a price to the public of $14.00 per share. Net proceeds from the public offering after deducting underwriting discounts, commissions and offering expenses, were approximately $107.9 million.

    Second Quarter 2020 Financial Results

    • Research and development expenses were $12.6 million for the three months ended June 30, 2020, compared to $10.3 million for the same period in 2019. The increase was primarily attributable to development and manufacturing activities for paltusotine as well as the advancement of the company's preclinical programs and higher personnel costs.
    • General and administrative expenses were $4.3 million for the three months ended June 30, 2020, compared to $3.1 million for the same period in 2019. The increase was primarily due to personnel costs to support the company's growth.
    • Net loss for the three months ended June 30, 2020 was $16.5 million, compared to a net loss of $12.4 million for the three months ended June 30, 2019.
    • Cash, cash equivalents and investments totaled $205.2 million as of June 30, 2020, compared to $118.4 million as of December 31, 2019. The cash balance includes the $107.9 million of net proceeds from the public equity offering completed in April.



    • As of July 31, 2020, the company had 32,883,582 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 oral, selective nonpeptide somatostatin receptor type 2 biased agonist undergoing two Phase 2 clinical trials 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 trial in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors in 2021. The company is also developing an oral nonpeptide somatostatin receptor type 5 agonist for hyperinsulinism, as well as an 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 www.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 of paltusotine to be an effective treatment option for acromegaly patients; the benefits Crinetics may obtain as a result of the Orphan Drug Designation for paltusotine; the potential to initiate a pivotal Phase 3 trial of paltusotine in acromegaly based on interim results obtained to date and the timing thereof; the planned expansion of the paltusotine development program to include the treatment of carcinoid syndrome in patients with neuroendocrine tumors and the expected timing thereof, including initiation of a Phase 2 trial in these patients; the anticipated timing of topline data for Edge and Evolve and the initiation of Phase 1 trials for its other development programs; and expected cash runway and future capital needs. 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: the risk that interim results of a clinical trial do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; advancement of paltusotine into a Phase 3 trial 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; Crinetics may not be able to maintain the Orphan Drug Designation for paltusotine, and may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity; 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 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, or may result in recalls or product liability claims; Crinetics' ability to obtain and maintain intellectual property protection for its product candidates; 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



    (858) 450-6464

    Robert H. Uhl

    Westwicke ICR



    (858) 356-5932

    CRINETICS PHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA

    (UNAUDITED)

      Three months ended June 30,  Six months ended June 30, 
    STATEMENTS OF OPERATIONS DATA: 2020  2019  2020  2019 
    Grant revenues $-  $-  $71  $367 
    Operating expenses:                
    Research and development  12,607   10,285   26,469   17,540 
    General and administrative  4,322   3,060   8,313   6,216 
    Total operating expenses  16,929   13,345   34,782   23,756 
    Loss from operations  (16,929)  (13,345)  (34,711)  (23,389)
    Total other income (expense), net  438   918   860   1,946 
                     
    Net loss $(16,491) $(12,427) $(33,851) $(21,443)
                     
    Net loss per share - basic and diluted $(0.53) $(0.51) $(1.21) $(0.89)
    Weighted-average shares - basic and diluted  31,409   24,161   27,948   24,128 
                     



    BALANCE SHEET DATA:     June 30,

    2020
      December 31,

    2019
     
    Cash, cash equivalents and investments     $205,165  $118,392 
    Working capital     $200,740  $114,999 
    Total assets     $217,122  $130,377 
    Total liabilities     $14,348  $13,238 
    Accumulated deficit     $(127,653) $(93,802)
    Total stockholders' equity     $202,774  $117,139 

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  2. SAN DIEGO, July 08, 2020 (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 the U.S. Food and Drug Administration (FDA) has granted paltusotine Orphan Drug Designation for the treatment of acromegaly.

    The FDA's Orphan Drug Designation program provides orphan status to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies the sponsor of the drug for certain development incentives…

    SAN DIEGO, July 08, 2020 (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 the U.S. Food and Drug Administration (FDA) has granted paltusotine Orphan Drug Designation for the treatment of acromegaly.

    The FDA's Orphan Drug Designation program provides orphan status to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies the sponsor of the drug for certain development incentives, that may include exemption from FDA prescription drug user fees, financial incentives for qualified clinical development, and seven years of market exclusivity in the U.S. if the treatment is approved.

    "The orphan drug designation by the FDA for paltusotine to treat acromegaly validates the encouraging clinical data we have seen so far in the Phase 2 ACROBAT Edge clinical trial, and underscores the need for a once daily oral treatment option for patients suffering from this rare disease," said Michael Monahan, Senior Director of Regulatory Affairs at Crinetics.

    "Receiving orphan drug designation is another important milestone for the paltusotine program. We look forward to announcing topline results for our ACROBAT clinical program in the fourth quarter of this year and to the initiation of our planned Phase 3 trial for paltusotine in the first half of 2021," said Ajay Madan, Ph.D., Chief Development Officer of Crinetics.

    About Paltusotine

    Paltusotine (formerly CRN00808) is an orally available nonpeptide biased agonist that is designed to be highly selective for the somatostatin type 2 receptor. It was designed by the Crinetics discovery team to provide a once daily oral option for patients with acromegaly and neuroendocrine tumors that are currently treated by injected therapies that sell approximately $3.1 billion annually. Non-clinical chronic toxicology studies are complete and no dose limiting toxicity was identified at the maximum feasible doses in rats and dogs. Crinetics previously completed a Phase 1 trial that showed potent suppression of the growth hormone (GH) axis in healthy volunteers, which provided clinical proof-of-concept. In addition, the molecule's observed plasma half-life of approximately 2 days suggested the potential for paltusotine for once daily oral administration. A subsequent Phase 1 trial showed that paltusotine was 70% orally bioavailable. Paltusotine is an investigational drug currently undergoing two Phase 2 clinical trials for the treatment of acromegaly, the ACROBAT Edge and Evolve trials. Paltusotine has been discovered, characterized, and developed by Crinetics and U.S. patents have been issued covering paltusotine to 2037.

    About Acromegaly

    Acromegaly is a serious disease generally caused by a benign growth hormone secreting tumor in the pituitary. Excess GH secretion causes excess secretion of insulin-like growth factor-1 (IGF-1) from the liver, which causes bone and cartilage overgrowth, organ enlargement, and changes in glucose and lipid metabolism. The symptoms of acromegaly include abnormal growth of hands and feet and changes in shape of the bone and cartilage that result in alteration of facial features. Overgrowth of bone and cartilage and thickening of tissue leads to arthritis, carpal tunnel syndrome, joint aches, deepening of voice due to enlarged vocal cords, sleep apnea due to obstruction of airways, and enlargement of lips, nose, tongue, heart, liver, and other organs.

    Surgical removal of pituitary adenomas, if possible, is the preferred initial treatment for most acromegaly patients. Pharmacological treatments are used for patients that 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 usually the initial pharmacologic treatment, however these drugs require monthly injections and are commonly associated with pain, injection site reactions, and increased burden in the lives of patients. Although over 90% of patients have demonstrable responses to SRLs (Annals of Internal Medicine. 1992; 117:711-718) only 20-40% of patients achieve normalization of IGF-1 (J Clin Endocrinol Metab 99: 791–799, 2014). Additional pharmacological treatment options include dopamine agonists or GH receptor antagonists that may be used in combination with SRLs.

    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 oral, selective nonpeptide somatostatin receptor type 2 biased agonist undergoing two Phase 2 clinical trials 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 trial in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors in 2021. The company is also developing an oral nonpeptide somatostatin type 5 agonist for hyperinsulinism, as well as an 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 www.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 for any of our ongoing clinical trials to show safety or efficacy; the potential benefits of paltusotine for acromegaly patients; the potential to initiate a pivotal Phase 3 trial of paltusotine in acromegaly based on interim results obtained to date and the timing thereof; the planned expansion of the paltusotine development program to include the treatment of carcinoid syndrome in patients with neuroendocrine tumors and the expected timing thereof, including initiation of a Phase 2 trial in these patients; and the anticipated timing of topline data for Edge and Evolve. 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: potential delays in the commencement, enrollment and completion of clinical trials; advancement of paltusotine into a Phase 3 trial 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 and its other development 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, or may result in recalls or product liability claims; Crinetics may use its available capital resources sooner than it expects; Crinetics' ability to obtain and maintain intellectual property protection for its product candidates; 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

    Robert H. Uhl

    Westwicke ICR



    (858) 356-5932

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  3. 28 patients have completed the open-label Edge trial measuring IGF-1 levels after 13 weeks of treatment when patients with acromegaly were switched to once daily oral paltusotine from commercially available depot injections of the peptide somatostatin receptor ligands (SRLs)

    Recruitment for the Edge and Evolve trials has been completed with 47 and 13 patients, respectively, and topline data is planned for the fourth quarter of 2020

    Management expects to use the results for the two trials to support the initiation of Phase 3 clinical development for paltusotine in the first half of 2021

    SAN DIEGO, June 11, 2020 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX), a clinical stage pharmaceutical company focused on the discovery…

    28 patients have completed the open-label Edge trial measuring IGF-1 levels after 13 weeks of treatment when patients with acromegaly were switched to once daily oral paltusotine from commercially available depot injections of the peptide somatostatin receptor ligands (SRLs)

    Recruitment for the Edge and Evolve trials has been completed with 47 and 13 patients, respectively, and topline data is planned for the fourth quarter of 2020

    Management expects to use the results for the two trials to support the initiation of Phase 3 clinical development for paltusotine in the first half of 2021

    SAN DIEGO, June 11, 2020 (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 over 50% of the patients enrolled in the ACROBAT Edge Phase 2 clinical trial have completed the study. So far, 28 of the 47 patients enrolled have completed the study, which is investigating the effects of once daily oral paltusotine on IGF-1 levels after switching patients from injectable depot therapy.   

    "The completion of the trial by these 28 patients is a major milestone for our clinical program at Crinetics. We are extremely grateful for the dedication of our patients and staff at clinical trial sites for keeping us on track in the face of the COVID-19 pandemic," said Alan Krasner, M.D., Chief Medical Officer of Crinetics.

    "As we previously stated, we expect to announce topline results in the fourth quarter of this year. These data together with interactions with the regulatory agencies will guide finalization of our Phase 3 clinical plan which is anticipated to begin in the first half of 2021," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics.

    Based on the results of the previously announced interim analysis, Crinetics believes that the data from Edge is supportive of moving forward into Phase 3. Enrollment in the ACROBAT Evolve study was discontinued at the same time that enrollment in Edge was completed. Patients already enrolled in Evolve have continued in the study. Topline data from the 47 patients in Edge, 25 of which entered the trial on octreotide LAR or lanreotide depot monotherapy (group 1), and the 13 patients in Evolve is expected in the fourth quarter of 2020. To date, the company has not experienced significant disruptions in completing the Edge and Evolve studies due to the COVID-19 global pandemic.

    Trial Design for ACROBAT Edge

    ACROBAT Edge (NCT03789656) is an ongoing open label, single-arm exploratory study designed to evaluate the safety and efficacy of paltusotine in patients with acromegaly who have not achieved normal IGF-1 levels despite stable octreotide LAR or lanreotide depot therapy alone (group 1) or combined with a dopamine agonist (group 2). Additional exploratory subgroups were also eligible for enrollment in this trial, all of whom have normal IGF-1 at baseline: patients treated with octreotide or lanreotide in combination with a dopamine agonist (group 3), pasireotide LAR monotherapy (group 4), or octreotide or lanreotide in combination with pegvisomant (group 5). Eligible patients receive their last injection of their previous SRL 4 weeks prior to switching to once daily oral paltusotine monotherapy for a 13-week dose titration period, followed by a 4-week drug washout period. The primary endpoint is change in IGF-1 from baseline to the completion of the 13-week dose titration period.  

    About Paltusotine

    Paltusotine (formerly CRN00808) is an orally available nonpeptide biased agonist that is designed to be highly selective for the somatostatin sst2 receptor. It was designed by the Crinetics discovery team to provide a once daily option for patients with acromegaly and neuroendocrine tumors that are currently treated by injected therapies that sell approximately $3.1 billion annually. Non-clinical chronic toxicology studies are complete and no dose limiting toxicity was identified at the maximum feasible doses in rats and dogs. Crinetics previously completed a Phase 1 trial that showed potent suppression of the GH axis in healthy volunteers, which provided clinical proof-of-concept. In addition, the molecule's observed plasma half-life of approximately 2 days suggested the potential for paltusotine for once daily oral administration. A subsequent Phase 1 trial showed that paltusotine was 70% orally bioavailable.

    About Acromegaly

    Acromegaly is a serious disease generally caused by a benign growth hormone (GH) secreting tumor in the pituitary. Excess GH secretion causes excess secretion of insulin-like growth factor-1 (IGF-1) from the liver, which causes bone and cartilage overgrowth, organ enlargement, and changes in glucose and lipid metabolism. The symptoms of acromegaly include abnormal growth of hands and feet and changes in shape of the bone and cartilage that result in alteration of facial features. Overgrowth of bone and cartilage and thickening of tissue leads to arthritis, carpal tunnel syndrome, joint aches, deepening of voice due to enlarged vocal cords, sleep apnea due to obstruction of airways, and enlargement of lips, nose, tongue, heart, liver, and other organs.

    Surgical removal of pituitary adenomas, if possible, is the preferred initial treatment for most acromegaly patients. Pharmacological treatments are used for patients that 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 SRLs are usually the initial pharmacologic treatment, however these drugs require monthly injections and are commonly associated with pain, injection site reactions, and increased burden in the lives of patients. Although over 90% of patients have demonstrable responses to SRLs (Annals of Internal Medicine. 1992; 117:711-718) only 20-40% of patients achieve normalization of IGF-1 (J Clin Endocrinol Metab 99: 791–799, 2014). Additional pharmacological treatment options include dopamine agonists or GH receptor antagonists that may be used in combination with SRLs.

    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 oral, selective nonpeptide somatostatin receptor type 2 biased agonist undergoing two Phase 2 clinical trials 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 trial in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors in 2021. The company is also developing an oral nonpeptide somatostatin type 5 agonist for hyperinsulinism, as well as an 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 www.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 for any of our ongoing clinical trials to show safety or efficacy; the potential benefits of paltusotine for acromegaly patients; the potential to initiate a pivotal Phase 3 trial of paltusotine in acromegaly based on interim results obtained to date and the timing thereof; the planned expansion of the paltusotine development program to include the treatment of carcinoid syndrome in patients with neuroendocrine tumors and the expected timing thereof, including initiation of a Phase 2 trial in these patients; and the anticipated timing of topline data for Edge and Evolve. 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: potential delays in the commencement, enrollment and completion of clinical trials; advancement of paltusotine into a Phase 3 trial 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 and its other development 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, or may result in recalls or product liability claims; Crinetics may use its available capital resources sooner than it expects; Crinetics' ability to obtain and maintain intellectual property protection for its product candidates; 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

    Robert H. Uhl

    Westwicke ICR



    (858) 356-5932

    Primary Logo

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  4. Reported positive interim results for the ACROBAT Edge Phase 2 trial of oral paltusotine in the treatment of acromegaly

    Completed successful public offering raising net proceeds of $107.9 million

    SAN DIEGO, May 08, 2020 (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 first quarter ended March 31, 2020 and provided a corporate update.

    "So far, 2020 has proven to be a transformational time for Crinetics, highlighted by the positive interim Phase 2 results for paltusotine, our lead product candidate for the…

    Reported positive interim results for the ACROBAT Edge Phase 2 trial of oral paltusotine in the treatment of acromegaly

    Completed successful public offering raising net proceeds of $107.9 million

    SAN DIEGO, May 08, 2020 (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 first quarter ended March 31, 2020 and provided a corporate update.

    "So far, 2020 has proven to be a transformational time for Crinetics, highlighted by the positive interim Phase 2 results for paltusotine, our lead product candidate for the treatment of acromegaly," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "The interim data we reported showed that acromegaly patients switching from injectable depot therapy to once daily oral paltusotine maintained IGF-1 levels previously achieved with commercially available depot injections of somatostatin receptor ligands. We plan to report topline data from our ongoing Phase 2 trials in the fourth quarter of 2020 and advance paltusotine into Phase 3 development for patients with acromegaly in the first half of 2021 following conversations with regulatory agencies. Additionally, our successful follow-on offering in April strengthened our balance sheet and provided us with sufficient resources to advance our pipeline through key milestones, including our planned Phase 3 trial in acromegaly, a Phase 2 trial of paltusotine in carcinoid syndrome associated with neuroendocrine tumors (NETs), as well as Phase 1 trials to demonstrate proof-of-concept and PK/PD with our ACTH antagonist and SST5 agonist programs."

    "We are both grateful and inspired by the dedication of staff and patients at our clinical trial sites around the world who have worked through the global COVID-19 pandemic to continue their participation in these important studies," said Alan Krasner, M.D., Chief Medical Officer or Crinetics. "Their commitment suggests a strong desire by the global acromegaly patient community and their healthcare providers to seek new therapies to manage their disease."

    First Quarter and Subsequent Highlights

    • Reported positive interim results for the ACROBAT Edge Phase 2 trial of paltusotine in acromegaly patients. In April 2020, Crinetics reported interim results from its ongoing ACROBAT Edge Phase 2 trial. Results as of the February 23, 2020 data cutoff showed that acromegaly patients switching from injectable depot therapy to once daily oral paltusotine maintained IGF-1 levels previously achieved with commercially available depot injections of somatostatin receptor ligands. Interim results from an exploratory analysis of the first 13 patients who entered the Edge trial on octreotide or lanreotide depot monotherapy (group 1) showed that patient IGF-1 levels were maintained after switching to once daily oral paltusotine when compared to IGF-1 levels achieved with prior depot therapy [mean change from baseline = -0.015 x ULN (95% CI = -0.123, +0.092)]. Ten of the 11 (91%) patients in group 1 who completed paltusotine treatment maintained IGF-1 levels within 15% of their respective baseline levels at week 13. No patient required "rescue therapy" with prior injected peptide acromegaly therapy after switching to paltusotine. As a result of these data, new enrollment in the ACROBAT Evolve trial has been discontinued. The patients already enrolled in both the Edge and Evolve Phase 2 trials will continue in the studies and topline data is expected to be reported in the fourth quarter.
       
    • Provided a corporate update on the pipeline. In April 2020, Crinetics also provided an update on its other development programs, including an announcement that Phase 1 data for CRN01941 in healthy volunteers showed that the compound did not represent an improvement over paltusotine. Therefore, the company has discontinued development of CRN01941 in order to focus resources on paltusotine for both acromegaly and NETs. Crinetics believes that the acceleration and increased efficiency offered by focusing on paltusotine provides the best path forward for its SST2 franchise. Additionally, first-in-human enabling activities are ongoing for both the oral nonpeptide ACTH antagonist for the treatment of Cushing's disease and congenital adrenal hyperplasia, and the oral nonpeptide SST5 agonist for the treatment of hyperinsulinism. The start of Phase 1 clinical trials for these programs is planned for late 2020 or early 2021 and, if successful, the company anticipates PK/PD data from these human proof-of-concept studies in the first half of 2021.
       
    • Successful public offering strengthens cash position. In April 2020, Crinetics completed a public offering in which the company sold an aggregate of 8,222,500 shares of common stock at a price to the public of $14.00 per share. Net proceeds from the public offering after deducting underwriting discounts, commissions and offering expenses, were approximately $107.9 million.

    COVID-19 Impact

    During these challenging times, Crinetics remains committed to the health and safety of our employees, as well as the clinical sites and patients involved in its clinical trials. The company is closely monitoring public health guidance as it aims to continue to treat patients in its ongoing and planned clinical trials, which, so far, have remained on track. The overall impact of the COVID-19 pandemic on Crinetics' business, its ability to obtain clinical material, and to conduct preclinical research and clinical trials in a timely manner is currently unknown. So far, the pandemic has not had a significant negative impact on the company's ability to conduct business activities, but that could change, and the company is continuously monitoring the impact of the outbreak of the virus.

    First Quarter 2020 Financial Results

    • Research and development expenses were $13.9 million for the three months ended March 31, 2020, compared to $7.3 million for the same period in 2019. The increases were primarily attributable to development and manufacturing activities for paltusotine as well as the advancement of the company's preclinical programs and higher personnel costs.
       
    • General and administrative expenses were $4.0 million for the three months ended March 31, 2020, compared to $3.2 million for the same period in 2019. The increases were primarily due to personnel costs to support the company's growth.
       
    • Net loss for the three months ended March 31, 2020 was $17.4 million, compared to a net loss of $9.0 million for the three months ended March 31, 2019.

    • Cash, cash equivalents and investments totaled $112.8 million as of March 31, 2020, compared with $118.4 million as of December 31, 2019.  The cash balance at the end of March does not include the $107.9 million net proceeds from the public equity offering completed in April.

    • As of April 30, 2020, the company had 32,845,572 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 oral, selective nonpeptide somatostatin receptor type 2 biased agonist undergoing two Phase 2 clinical trials 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 trial in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors in 2021. The company is also developing an oral nonpeptide somatostatin receptor type 5 agonist for hyperinsulinism, as well as an 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 www.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 for interim data results to be consistent with final results, once available; the potential benefits of paltusotine for acromegaly patients; the potential to initiate a pivotal Phase 3 trial of paltusotine in acromegaly based on interim results obtained to date and the timing thereof; the planned expansion of the paltusotine development program to include the treatment of patients with NETs and the expected timing thereof, including initiation of a Phase 2 trial in these patients; the anticipated timing of topline data for Edge and Evolve and the initiation of proof-of-concept Phase 1 trials and timing of PK/PD data for its other development programs; the anticipated impact of the COVID-19 pandemic on the company's operations, studies and trials, including any effects on the timing thereof; and expected cash runway and future capital needs. 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: the risk that interim results of a clinical trial do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; advancement of paltusotine into a Phase 3 trial is dependent on and subject to the receipt of further feedback from the U.S. Food and Drug Administration (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 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

    (858) 450-6464

    Robert H. Uhl
    Westwicke ICR

    (858) 356-5932


    CRINETICS PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA
    (UNAUDITED)

      Three months ended March 31,  
    STATEMENTS OF OPERATIONS DATA: 2020     2019  
    Grant revenues $ 71     $ 367  
    Operating expenses:              
    Research and development   13,862       7,255  
    General and administrative   3,991       3,156  
    Total operating expenses   17,853       10,411  
    Loss from operations   (17,782 )     (10,044 )
    Total other income (expense), net   422       1,028  
                   
    Net loss $ (17,360 )   $ (9,016 )
                   
    Net loss per share - basic and diluted $ (0.71 )   $ (0.37 )
    Weighted-average shares - basic and diluted   24,488       24,095  


    BALANCE SHEET DATA: March 31,
    2020
        December 31,
    2019
     
    Cash, cash equivalents and investments $ 112,802     $ 118,392  
    Working capital $ 106,408     $ 114,999  
    Total assets $ 123,884     $ 130,377  
    Total liabilities $ 15,447     $ 13,238  
    Accumulated deficit $ (111,162 )   $ (93,802 )
    Total stockholders' equity $ 108,437     $ 117,139  

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  5. SAN DIEGO, April 17, 2020 (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 it has closed its previously announced underwritten public offering of 8,222,500 shares of its common stock, including 1,072,500 shares sold pursuant to the underwriters' full exercise of their option to purchase additional shares, at a price to the public of $14.00 per share. The gross proceeds to Crinetics from the offering, before deducting the underwriting discounts and commissions and other offering expenses, were approximately $115.1 million. 

    Crinetics…

    SAN DIEGO, April 17, 2020 (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 it has closed its previously announced underwritten public offering of 8,222,500 shares of its common stock, including 1,072,500 shares sold pursuant to the underwriters' full exercise of their option to purchase additional shares, at a price to the public of $14.00 per share. The gross proceeds to Crinetics from the offering, before deducting the underwriting discounts and commissions and other offering expenses, were approximately $115.1 million. 

    Crinetics intends to use the net proceeds from the offering to fund the development of paltusotine and its other research and development programs, and for working capital and general corporate purposes. 

    SVB Leerink, Piper Sandler and Cantor acted as joint bookrunning managers for the offering. H.C. Wainwright & Co. and Roth Capital Partners acted as co-managers for the offering.

    The securities described above were offered by Crinetics pursuant to a shelf registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement relating to this offering has been filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, by telephone at 800-808-7525, ext. 6218 or by email at ; Piper Sandler & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at 800-747-3924 or by email at ; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, by telephone at 212-829-7122 or by email at . Electronic copies of the final prospectus supplement and accompanying prospectus are also available on the website of the SEC at http://www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    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 oral, selective nonpeptide somatostatin receptor type 2 biased agonist undergoing two Phase 2 clinical trials 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 trial in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors in 2021. The company is also developing an oral nonpeptide somatostatin sst5 agonist for hyperinsulinism, as well as an 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 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 Crinetics' anticipated use of proceeds from the public offering; the potential to initiate a Phase 3 trial of paltusotine in acromegaly and the expected timing thereof; and the planned expansion of the paltusotine development program to include the treatment of carcinoid syndrome of patients with neuroendocrine tumors and the expected timing thereof. 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 inherent in Crinetics' business, including uncertainties related to the COVID-19 pandemic, which may disrupt the company's business and that of the third parties on which it depends, delay or otherwise disrupt the company's clinical trials and preclinical studies, manufacturing and supply chain, or impair employee productivity, 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, 2019, and in the final prospectus supplement related to the offering filed with the SEC on April 15, 2020, each available on the SEC's web site at www.sec.gov. 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

    Robert H. Uhl
    Westwicke ICR

    (858) 356-5932

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