UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 13, 2019
Crinetics Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
|
|
|
|
|
|
|||
|
Delaware |
|
001-38583 |
|
26-3744114 |
|||
|
(State or Other Jurisdiction of Incorporation or Organization) |
|
(Commission File Number) |
|
(I.R.S. Employer Identification Number) |
|||
10222 Barnes Canyon Road, Bldg #2
San Diego, California 92121
(858) 450-6464
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
|
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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. ☒
In this report, “Crinetics Pharmaceuticals,” “Crinetics,” “Company,” “we,” “us” and “our” refer to Crinetics Pharmaceuticals, Inc.
Item 2.02 Results of Operations and Financial Condition.
On March 13, 2019, Crinetics Pharmaceuticals, Inc. issued a press release reporting its financial results for the fiscal year ended December 31, 2018. 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 |
|
|
|
2
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 hereunto duly authorized.
|
|
|
|
|
|
|
|
|
|
|
|
|
Crinetics Pharmaceuticals, Inc. |
||
|
|
|
|
|
|||
|
Date: March 13, 2019 |
|
|
|
|
|
/s/ R. Scott Struthers, Ph.D. |
|
|
|
|
|
|
|
R. Scott Struthers, Ph.D. |
|
|
|
|
|
|
|
President and Chief Executive Officer (Principal Executive Officer) |
3
Exhibit 99.1
FOR IMMEDIATE RELEASE
Crinetics Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update
SAN DIEGO – March 13, 2019 – 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 reported financial results for the quarter and full year ended December 31, 2018 and provided an update on its corporate activities and product pipeline.
“2018 was a transformative year for Crinetics, highlighted by our successful initial public offering in July and the progress of our pipeline programs for rare endocrine diseases,” said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. “We have initiated our Phase 2 EVOLVE and EDGE clinical trials for our lead product candidate, CRN00808, in acromegaly, and will initiate our Phase 1 proof-of-concept trial for CRN01941 aimed at neuroendocrine tumors during the first half of the year.”
Anticipated 2019 Activities
|
• |
Continued enrollment of ACROBAT EVOLVE and ACROBAT EDGE Phase 2 clinical trials for CRN00808 in acromegaly. The EVOLVE trial is a double-blind, placebo-controlled, randomized withdrawal study designed to evaluate CRN00808 in patients with acromegaly that respond to somatostatin analog monotherapy. The EDGE trial is an open label exploratory study designed to evaluate CRN00808 in patients with acromegaly that do not respond completely to somatostatin analog monotherapy. |
|
• |
Initiation of Phase 1 clinical trial for CRN01941 for neuroendocrine tumors with topline data expected in late 2019 or early 2020. |
|
• |
Continued advancement of our pipeline programs for congenital hyperinsulinism and Cushing’s Disease. |
Full Year 2018 Highlights
|
• |
Filed IND with the FDA. In August 2018, Crinetics filed its Investigational New Drug (IND) application for CRN00808 in acromegaly. |
|
• |
Completed initial public offering. In July 2018, Crinetics closed its initial public offering of 6,900,000 shares of common stock at a public offering price of $17.00 per share. Net proceeds were approximately $106.5 million, after deducting underwriting discounts, commissions, and offering expenses. |
|
• |
Awarded up to $3.2 million in SBIR grants for congenital hyperinsulinism and acromegaly. In June 2018, Crinetics was awarded up to approximately $3.2 million in Small Business Innovation Research (SBIR) grants from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (NIH) to fund the continued research and development of its nonpeptide, oral somatostatin agonists for congenital hyperinsulinemias (CHI) and acromegaly. Crinetics will be eligible to receive funding for up to approximately $1.9 million for CHI and $1.3 million for acromegaly. |
Fourth Quarter and Full Year 2018 Financial Results
|
• |
Research and development expenses were $7.7 million and $24.5 million for the three months and full year ended December 31, 2018, respectively, compared to $2.6 million and $9.2 million for the same periods in 2017. The increases were primarily attributable to development and manufacturing activities for CRN00808 as well as the company’s clinical and preclinical programs and personnel costs. |
|
• |
General and administrative expenses were $2.6 million and $6.7 million for the three months and full year ended December 31, 2018, compared to $0.5 million and $1.9 million for the same periods in 2017. The increases were primarily due to costs to operate as a public company, as well as personnel costs to support the company’s growth. |
|
• |
Cash, cash equivalents and short-term investments totaled $163.9 million as of December 31, 2018, compared with $14.2 million as of December 31, 2017. |
|
• |
As of February 28, 2018, the company had 24,095,485 common shares outstanding. |
Financial Guidance
Crinetics expects that its cash, cash equivalents and investments will fund its current operating plan at least through the end of 2020.
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, CRN00808, is an oral nonpeptide somatostatin agonist for the treatment of acromegaly, an orphan disease affecting more than 25,000 people in the United States. The company is also developing other oral nonpeptide somatostatin agonists for neuroendocrine tumors and hyperinsulinism, as well as an oral nonpeptide ACTH antagonist for the treatment of Cushing's disease. Crinetics was founded by a team of scientists with a track record of endocrine drug discovery and development. 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 anticipated timing to commence clinical trials for CRN00808 and plans to advance other pipeline programs. 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; 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 preclinical studies for CRN00808 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; and other risks described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Crinetics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts:
Marc Wilson
Chief Financial Officer
IR@crinetics.com
(858) 450-6464
Robert H. Uhl
Westwicke Partners
robert.uhl@westwicke.com
(858) 356-5932
CRINETICS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA
(UNAUDITED)
|
|
|
Three months ended December 31, |
|
|
Twelve months ended December 31, |
|
||||||||||
|
STATEMENTS OF OPERATIONS DATA: |
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
||||
|
Grant revenues |
|
$ |
781 |
|
|
$ |
528 |
|
|
$ |
2,428 |
|
|
$ |
2,045 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
7,651 |
|
|
|
2,562 |
|
|
|
24,479 |
|
|
|
9,233 |
|
|
General and administrative |
|
|
2,561 |
|
|
|
467 |
|
|
|
6,659 |
|
|
|
1,939 |
|
|
Total operating expenses |
|
|
10,212 |
|
|
|
3,029 |
|
|
|
31,138 |
|
|
|
11,172 |
|
|
Loss from operations |
|
|
(9,431 |
) |
|
|
(2,501 |
) |
|
|
(28,710 |
) |
|
|
(9,127 |
) |
|
Total other income (expense), net |
|
|
936 |
|
|
|
(20 |
) |
|
|
1,595 |
|
|
|
(30 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(8,495 |
) |
|
$ |
(2,521 |
) |
|
$ |
(27,115 |
) |
|
$ |
(9,157 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted |
|
$ |
(0.35 |
) |
|
$ |
(1.68 |
) |
|
$ |
(2.23 |
) |
|
$ |
(6.68 |
) |
|
Weighted-average shares - basic and diluted |
|
|
24,046 |
|
|
|
1,503 |
|
|
|
12,142 |
|
|
|
1,371 |
|
|
BALANCE SHEET DATA: |
|
|
|
|
|
December 31, 2018 |
|
|
December 31, 2017 |
|
||
|
Cash, cash equivalents and short-term investments |
|
|
|
|
|
$ |
163,875 |
|
|
$ |
14,192 |
|
|
Working capital |
|
|
|
|
|
$ |
158,758 |
|
|
$ |
14,268 |
|
|
Total assets |
|
|
|
|
|
$ |
171,415 |
|
|
$ |
15,598 |
|
|
Total liabilities |
|
|
|
|
|
$ |
11,190 |
|
|
$ |
920 |
|
|
Convertible preferred stock |
|
|
|
|
|
$ |
- |
|
|
$ |
29,700 |
|
|
Accumulated deficit |
|
|
|
|
|
$ |
(43,380 |
) |
|
$ |
(16,265 |
) |
|
Total stockholders’ equity (deficit) |
|
|
|
|
|
$ |
160,225 |
|
|
$ |
(15,022 |
) |