Crinetics Pharmaceuticals, Inc. (CRNX)
Chart Events
Performance Outlook
| Previous Close | 16.54 |
| Open | 16.31 |
| Bid | 16.25 x 800 |
| Ask | 16.43 x 1000 |
| Day's Range | 16.22 - 17.08 |
| 52 Week Range | 11.61 - 23.70 |
| Volume | 69,773 |
| Avg. Volume | 126,710 |
| Market Cap | 609.765M |
| Beta (5Y Monthly) | 1.22 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -2.42 |
| Earnings Date | Aug 05, 2021 - Aug 09, 2021 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 34.00 |
- GlobeNewswire
Crinetics Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Corporate Update
Paltusotine Phase 3 PATHFNDR program in acromegaly initiated in 2Q 2021 Phase 1 data for CRN04894 and CRN04777 expected in mid-2021 SAN DIEGO, May 06, 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 first quarter ended March 31, 2021 and provided a corporate update. “In the first quarter we achieved key clinical and regulatory milestones across our pipeline,” said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. “Based on our interactions with the FDA and other regulators, we developed a robust Phase 3 program for paltusotine that is designed to support its approval for all acromegaly patients who require pharmacotherapy, including both untreated patients and those switching from injected standard of care. This progress was complemented by the advancement of CRN04894 and CRN04777 into Phase 1 trials in healthy volunteers, which are designed to generate safety, pharmacokinetic, and biomarker data that could establish clinical proof of concept and provide important dose guidance information for subsequent trials in patients. Looking ahead, we are on track for a steady cadence of catalysts through the remainder of the year, including data from both of our Phase 1 trials and the initiation of a clinical study in patients with neuroendocrine tumors complicated by carcinoid syndrome.” First Quarter and Subsequent Highlights Announced the design of the Phase 3 program for paltusotine in acromegaly. In March 2021, Crinetics announced plans to initiate two Phase 3 studies based on interactions with the U.S. Food and Drug Administration (FDA) and other regulators. The first of these studies, PATHFNDR-1, is a double-blind, placebo-controlled, nine-month clinical trial evaluating the safety and efficacy of paltusotine in acromegaly patients who are biochemically controlled (IGF-1 ≤ 1.0 × upper limit of normal [ULN]) and who are on stable doses of somatostatin receptor ligand monotherapy (octreotide LAR or lanreotide depot). The second study, PATHFNDR-2, is a double-blind, placebo-controlled, twelve-week trial in acromegaly patients with elevated IGF-1 levels who are medication naïve or who are not being treated with pharmacotherapy (untreated patients). If successful, Crinetics believes these trials could support registration of paltusotine in the United States and Europe for all acromegaly patients who require pharmacotherapy, including untreated patients and those switching from standard of care. The company initiated PATHFNDR-1 in April and expects to initiate PATHFNDR-2 in 2H 2021. Showcased broad clinical-stage pipeline at ENDO 2021. In March 2021, Crinetics gave presentations on its three clinical programs at the Endocrine Society’s annual ENDO 2021 congress. Posters on the company’s acromegaly program included a summary of the previously announced ACROBAT Edge Phase 2 results, as well as details of the new tablet formulation of paltusotine. Presentations related to the company’s earlier stage clinical programs included a poster with preclinical data supporting the development of CRN04777 as a treatment for congenital hyperinsulinism (HI) and a live oral presentation with preclinical evidence supporting the further evaluation of CRN04894 in Cushing’s disease and congenital adrenal hyperplasia (CAH).Advanced ACTH antagonist CRN04894 into a Phase 1 study designed to provide clinical proof of concept. In February 2021, Crinetics initiated a Phase 1 study of CRN04894, an investigational, oral, nonpeptide adrenocorticotropic hormone (ACTH) antagonist being developed for the treatment of diseases associated with excess ACTH such as Cushing’s disease and congenital adrenal hyperplasia (CAH). This study is designed to evaluate the safety and tolerability of CRN04894 in healthy volunteers, and to provide clinical proof-of-concept data by measuring the effect of CRN04894 on the suppression of endocrine biomarkers that are used as key endpoints in patient studies and reflect the ability of CRN04894 to block ACTH-stimulated adrenal function. This healthy volunteer trial is also expected to provide important information for dose selection and be predictive of efficacy in Cushing’s disease and CAH patients. Crinetics expects preliminary safety, pharmacokinetic, and endocrine biomarker data in mid-2021.Advanced SST5 agonist CRN04777 into a Phase 1 study designed to provide clinical proof of concept. In February 2021, Crinetics initiated a Phase 1 study of CRN04777, an investigational, oral, nonpeptide somatostatin receptor type 5 (SST5) agonist. CRN04777 is being developed as a treatment for congenital HI, a rare genetic disease in which excess insulin secretion causes life-threatening hypoglycemia (low blood glucose). This study is designed to evaluate the safety and tolerability of CRN04777 in healthy volunteers and provide clinical proof-of-concept data by measuring both the ability of CRN04777 to inhibit glucose- and sulfonylurea-induced insulin secretion and the corresponding effects on blood glucose levels. These endocrine biomarkers are indicative of the ability of CRN04777 to prevent hypoglycemia and are expected to provide information for dose selection and be predictive of efficacy in patients with hyperinsulinism. Crinetics expects preliminary safety and pharmacological effect data in mid-2021.Strengthened balance sheet with successful common stock offering. In April 2021, Crinetics completed an underwritten follow-on offering and raised net proceeds of approximately $72.5 million. First Quarter 2021 Financial Results Research and development expenses were $17.6 million for the three months ended March 31, 2021, compared to $13.9 million for the same period in 2020. The increase was primarily attributable to additional personnel costs and clinical development and manufacturing activities for paltusotine, CRN04894, and CRN04777 as well as the company’s other preclinical programs.General and administrative expenses were $5.3 million for the three months ended March 31, 2021, compared to $4.0 million for the same period in 2020. The increase was primarily due to additional personnel costs to support the company’s growth.Net loss for the three months ended March 31, 2021 was $22.9 million, compared to a net loss of $17.4 million for the three months ended March 31, 2020.Unrestricted cash, cash equivalents and investments totaled $150.7 million as of March 31, 2021, compared to $170.9 million as of December 31, 2020. The cash balance at the end of March does not include the $72.5 million of net proceeds from the follow-on offering completed in April.As of April 30, 2021, the company had 37,593,371 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 initiation of the PATHFNDR-2 clinical trial of paltusotine in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors and the expected timing thereof; the potential for such Phase 3 program to support broad approval of paltusotine for all acromegaly patients who require pharmacotherapy; and the potential to generate safety, pharmacokinetic, and biomarker data from the Phase 1 studies in healthy volunteers with CRN04894 and CRN04777 that could establish clinical proof of concept and provide important dose guidance information for subsequent trials, and the expected timing thereof. 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 FDA or other regulatory agencies may require one or more additional clinical trials of paltusotine or suggest changes to our planned Phase 3 clinical trials prior to and in support of the approval of a New Drug Application or applicable foreign regulatory approval; advancement of paltusotine into a Phase 2 trial for carcinoid syndrome is dependent on and subject to the receipt of further feedback from the FDA; the COVID-19 pandemic may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity; the company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crinetics’ clinical trials and nonclinical studies for paltusotine, CRN04894, CRN04777, and its other product candidates; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of the company’s product candidates that may limit their development, regulatory approval and/or commercialization; Crinetics may use its capital resources sooner than it expects; and other risks described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Crinetics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts:Marc WilsonChief Financial OfficerIR@crinetics.com (858) 450-6464 Investors / Media:Corey DavisLifeSci Advisors, LLCcdavis@lifesciadvisors.com(212) 915-2577 Aline SherwoodScienta Communicationsasherwood@scientapr.com(312) 238-8957 CRINETICS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA(In thousands, except per share data)(Unaudited) Three months ended March 31, STATEMENTS OF OPERATIONS DATA: 2021 2020 Grant revenues $- $71 Operating expenses: Research and development 17,584 13,862 General and administrative 5,334 3,991 Total operating expenses 22,918 17,853 Loss from operations (22,918) (17,782)Total other income (expense), net 17 422 Net loss $(22,901) $(17,360) Net loss per share - basic and diluted $(0.69) $(0.71)Weighted-average shares - basic and diluted 33,012 24,488 BALANCE SHEET DATA: March 31,2021 December 31,2020 Cash, cash equivalents and investments $150,665 $170,880 Working capital $147,540 $167,003 Total assets $163,550 $183,445 Total liabilities $14,070 $14,526 Accumulated deficit $(190,515) $(167,614)Total stockholders’ equity $149,480 $168,919
- SmarterAnalyst
Crinetics Pharmaceuticals Stock Is Showing Strong Insider Interest
Clinical-stage pharmaceutical company Crinetics Pharmaceuticals Inc. (CRNX) has seen a key corporate insider snap up shares recently. Regulations require corporate insiders to make their trading activity public, and their actions could signal to investors that now is the time to get in on the action. In the last 12 days, corporate insider Perceptive Advisors LLC, which owns a more than 10% stake in the company, has bought $5 million worth of Crinetics shares. (See Crinetics stock analysis on TipRanks) On March 31, H. C. Wainwright analyst Douglas Tsao reiterated a Buy rating on the stock with a $30 price target (81.3% upside potential). For Crinetics’ three programs under development, paltusotine, CRN04777, and CRN04894, Tsao estimates probabilities of success of 65%, 20%, and 35%, respectively, while valuing the stock. Tsao views the PATHFINDER development program favorably as it “sets up paltusotine for a broad label to treat most acromegaly patients as a first-line therapy.” Crinetics intends to use the results from this program to seek registration in the US as well as in Europe. Additionally, Crinetics is also expecting Phase 1 data for CRN04777 and CRN04894 this year. Tsao remains bullish on these two programs based on data from the earlier animal studies. The other analyst covering the stock, Leerink Partners’ Joseph Schwartz, also has a Buy rating on the stock with a $33 price target. The two ratings add up to a Moderate Buy consensus rating alongside an average analyst price target of $31.50, implying 90.3% upside potential. Related News: Nvidia’s $40B Proposed Takeover of Arm Faces Scrutiny By UK Govt How Taiwan Semiconductor Plans To Address Chip Shortage? Coca-Cola’s 1Q Results Beat Estimates Amid Uneven Global Economic Recovery More recent articles from Smarter Analyst: Middleby Snaps Up Welbilt; Shares Fall 7.5% Pre-Market Snap Earnings Preview: Here’s What To Look For Wednesday’s Pre-Market: Here’s What You Need To Know Before The Market Opens Apple Introduces New Products At Virtual Event
- GlobeNewswire
Crinetics Pharmaceuticals Announces Closing of Common Stock Offering
SAN DIEGO, April 12, 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 it has closed its previously announced underwritten follow-on offering of 4,562,044 shares of its common stock at a price to the public of $16.44 per share. The gross proceeds to Crinetics from the offering, before deducting the underwriting discounts and commissions and other offering expenses, were approximately $75.0 million. Investors in the offering included Deep Track Capital, Bain Capital Life Sciences, and Driehaus Capital Management, with participation from other new and existing stockholders. 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 acted as sole bookrunning manager 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, MA 02110, by telephone at 800-808-7525, ext. 6105 or by email at syndicate@svbleerink.com. Electronic copies of the final prospectus supplement and accompanying prospectus are also available on the website of the SEC at 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 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. Crinetics plans to advance paltusotine into a Phase 3 program in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with 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 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 offering; and the potential to initiate a Phase 3 program of paltusotine in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated 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 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 final prospectus supplement related to the offering filed with the SEC on April 8, 2021, 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 WilsonChief Financial OfficerIR@crinetics.com (858) 450-6464 Investors / Media:Corey DavisLifeSci Advisors, LLCcdavis@lifesciadvisors.com (212) 915-2577 Aline SherwoodScienta Communicationsasherwood@scientapr.com (312) 238-8957
