UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 8, 2023, Crinetics Pharmaceuticals, Inc. (the “Company” or “Crinetics”) issued a press release reporting its financial results for the period ended June 30, 2023. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
In accordance with General Instruction B.2 of Form 8-K, the information contained or incorporated herein, including the press release filed as Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
|
Description |
|
|
|
99.1 |
|
|
|
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
Crinetics Pharmaceuticals, Inc. |
|
|
|
|
Date: |
August 8, 2023 |
By: |
/s/ R. Scott Struthers, Ph.D. |
|
|
|
R. Scott Struthers, Ph.D. |
EXHIBIT 99.1
Crinetics Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Corporate Update
Phase 3 PATHFNDR-1 Study Topline Data expected in September 2023
Enrollment Completed in Phase 3 PATHFNDR-2 Study with Topline Data Expected in 1Q 2024
Development of CRN04777 Suspended
Company Hosting KOL Webinar on Acromegaly Treatment Landscape Today at 12:00 pm ET
SAN DIEGO – August 8, 2023 – Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the second quarter ended June 30, 2023.
“The PATHFNDR program for acromegaly continues to progress as expected. Topline results from our Phase 3 PATHFNDR-1 study are expected in September and should provide insight into paltusotine’s potential as an alternative to standard-of-care somatostatin receptor ligand depot injections. Enrollment in our Phase 3 PATHFNDR-2 study is also now complete and we anticipate topline results in the first quarter of 2024,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. “Unfortunately, we also suffered a setback with our CRN04777 program and made the difficult decision to wind down its development. We know that infants and children living with congenital hyperinsulinism are in desperate need of better treatment options and our hearts go out to them and their families. However, our recently evolved understanding of the nonclinical profile of CRN04777 suggests that it no longer meets the high standards to which we hold all drug candidates in our pipeline.”
Second Quarter 2023 and Recent Highlights:
EXHIBIT 99.1
Second Quarter 2023 Financial Results
Key Opinion Leader (KOL) Webinar on Acromegaly Current Treatment Landscape and Unmet Need
Crinetics is hosting a KOL webinar today, August 8, 2023 at 12:00 pm ET. The webinar will feature key opinion leaders Beverly MK Biller, M.D. and Karen JP Liebert, R.N., B.S.N, both of Massachusetts General Hospital, who will discuss the current landscape and unmet medical need in acromegaly, as well as the treatment burden associated with standard-of-care injectable somatostatin receptor ligands (SRLs). In addition, the Crinetics management team will discuss its pipeline of internally discovered oral small molecule drug candidates, with a focus on the Phase 3 PATHFNDR-1 study of paltusotine.
EXHIBIT 99.1
A live question and answer session will follow the formal presentations. To register for the event, please click here. If you would like to ask a question during the live Q&A, please submit your request to questions@lifesciadvisors.com. A replay of the event will be available by clicking here.
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. Paltusotine, an investigational, oral somatostatin receptor type 2 (SST2) agonist, is in Phase 3 clinical development for acromegaly and Phase 2 clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics has demonstrated pharmacologic proof-of-concept in a Phase 1 clinical study for CRN04894, an investigational, oral ACTH antagonist in development for the treatment of Cushing’s disease and congenital adrenal hyperplasia. All of the company’s drug candidates are orally delivered, small molecule new chemical entities resulting from in-house drug discovery efforts.
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 plans and timelines for the clinical development of paltusotine and CRN04894, including the therapeutic potential and clinical benefits or safety profile thereof; the expected timing of topline data from the ongoing Phase 3 clinical studies of paltusotine in acromegaly and Phase 2 study of paltusotine in carcinoid syndrome; plans to submit data from the ongoing Phase 3 clinical studies of paltusotine in acromegaly to regulators in support of applications seeking approval for the use of paltusotine in acromegaly patients and the expected timing of an NDA submission for paltusotine for the treatment or maintenance of treatment of acromegaly in the United States; the expected timing of data from studies of CRN04894 in Cushing’s disease and congenital adrenal hyperplasia. 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, without limitation, topline data that we report may change following a more comprehensive review of the data related to the clinical studies and such data may not accurately reflect the complete results of a clinical study, and the FDA and other regulatory authorities may not agree with our interpretation of such results; 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 and other geopolitical events may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical studies and preclinical studies, manufacturing and supply chain, or impairing employee productivity; 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 studies and nonclinical studies; regulatory developments in the United States and foreign countries; clinical studies 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’ drug candidates may not advance in development or be approved for marketing; Crinetics may use its capital resources sooner than expected; any future impacts to our business resulting from geopolitical developments outside our control; 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, 2022. You are cautioned not to
EXHIBIT 99.1
place undue reliance on these forward-looking statements, which speak only as of the date hereof. 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.
EXHIBIT 99.1
CRINETICS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA
(In thousands, except per share data)
(Unaudited)
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
||||||||||
STATEMENTS OF OPERATIONS DATA: |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Revenues |
|
$ |
988 |
|
|
$ |
439 |
|
|
$ |
3,667 |
|
|
$ |
3,570 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
40,640 |
|
|
|
32,995 |
|
|
|
79,108 |
|
|
|
61,247 |
|
General and administrative |
|
|
13,343 |
|
|
|
10,489 |
|
|
|
25,532 |
|
|
|
19,195 |
|
Total operating expenses |
|
|
53,983 |
|
|
|
43,484 |
|
|
|
104,640 |
|
|
|
80,442 |
|
Loss from operations |
|
|
(52,995 |
) |
|
|
(43,045 |
) |
|
|
(100,973 |
) |
|
|
(76,872 |
) |
Total other income, net |
|
|
2,016 |
|
|
|
670 |
|
|
|
3,999 |
|
|
|
880 |
|
Loss before equity method investment |
|
|
(50,979 |
) |
|
|
(42,375 |
) |
|
|
(96,974 |
) |
|
|
(75,992 |
) |
Loss on equity method investment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,010 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
(50,979 |
) |
|
$ |
(42,375 |
) |
|
$ |
(96,974 |
) |
|
$ |
(77,002 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share - basic and diluted |
|
$ |
(0.94 |
) |
|
$ |
(0.81 |
) |
|
$ |
(1.79 |
) |
|
$ |
(1.54 |
) |
Weighted-average shares - basic and diluted |
|
|
54,275 |
|
|
|
52,522 |
|
|
|
54,092 |
|
|
|
50,130 |
|
BALANCE SHEET DATA: |
|
June 30, |
|
|
December 31, |
|
||
|
|
|
|
|
|
|
||
Cash, cash equivalents and investments |
|
$ |
264,529 |
|
|
$ |
334,425 |
|
Working capital |
|
$ |
252,200 |
|
|
$ |
317,461 |
|
Total assets |
|
$ |
293,254 |
|
|
$ |
352,176 |
|
Total liabilities |
|
$ |
39,138 |
|
|
$ |
35,848 |
|
Accumulated deficit |
|
$ |
(536,147 |
) |
|
$ |
(439,173 |
) |
Total stockholders’ equity |
|
$ |
254,116 |
|
|
$ |
316,328 |
|
Contact:
Investor Relations
VP, IR & Corporate Communications
cschultz@crinetics.com
(858) 450-6464
Investors / Media:
Corey Davis
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
(212) 915-2577
Aline Sherwood
Scienta Communications
asherwood@scientapr.com
(312) 238-8957