Crinetics Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update
“Crinetics made significant progress in 2019 advancing our development programs, as highlighted by the initiation of the ACROBAT Phase 2 clinical trials for acromegaly with our lead product candidate paltusotine,” said
Full Year 2019 Highlights
- Dosed first patients in Phase 2 clinical trials of paltusotine (formerly CRN00808) for acromegaly. In
March 2019, Crinetics dosed the first patients in the ACROBAT EDGE and EVOLVE trials for paltusotine in patients with acromegaly. EDGE is an open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine, an oral selective nonpeptide somatostatin receptor type 2 (sst2) biased agonist, in patients with acromegaly whose disease is not biochemically controlled by octreotide LAR or lanreotide depot alone. EVOLVE is a double-blind, placebo-controlled, randomized withdrawal study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine in patients with acromegaly whose disease is biochemically controlled by octreotide LAR or lanreotide depot monotherapy.
- Initiated Phase 1 trial of CRN01941. In
May 2019, Crinetics initiated a Phase 1, double blind, randomized, placebo-controlled, single- and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CRN01941 in healthy volunteers. Like paltusotine, CRN01941 is an oral nonpeptide sst2 biased agonist. CRN01941 is initially in development as a potential treatment for neuroendocrine tumors (NETs) that originate from neuroendocrine cells commonly found in the gut, lung, or pancreas. Upon analysis of the cumulative data from the paltusotine and CRN01941 preclinical, nonclinical and clinical programs, Crinetics intends to decide whether to advance CRN01941 or paltusotine into a later stage trial in NETs.
- Expanded management team and board of directors. In
March 2019, Crinetics appointed Gina Ford, R.Ph., MBA, as Vice President, Corporate Strategy and Commercial Planning. Ms. Fordjoined Crinetics from One Joule, LLCa commercial and corporate strategy consulting company she founded, where she provided biopharmaceutical clients with strategic advice on corporate, commercial, marketing and global market access strategy. Among her prior roles, Ms. Fordserved as Head of Endocrinology with Ipsen Pharmaceuticals, where she led the endocrine franchise, which included the commercial leadership of a drug to treat acromegaly and neuroendocrine tumors. In July 2019, Crinetics appointed Stephanie S. Okey, M.S. to its board of directors as an independent board member. Ms. Okeybrings extensive leadership and management experience in senior commercial roles including, most recently, Head of North Americaand U.S.General Manager of Rare Diseases at Genzyme.
Fourth Quarter and Full Year 2019 Financial Results
- Research and development expenses were
$12.1 millionand $41.5 millionfor the three months and full year ended December 31, 2019, respectively, compared to $7.7 millionand $24.5 millionfor the same periods in 2018. The increases were primarily attributable to clinical development and manufacturing activities for paltusotine and CRN01941 as well as the company’s preclinical programs.
- General and administrative expenses were
$3.4 millionand $13.5 millionfor the three months and full year ended December 31, 2019, compared to $2.6 millionand $6.7 millionfor the same periods in 2018. The increases were primarily due to costs to operate as a public company, as well as personnel costs to support the company’s growth.
- Net loss for the three months ended
December 31, 2019was $14.5 million, compared to a net loss of $8.5 millionfor the same period in 2018. For the year ended December 31, 2019, the company’s net loss was $50.4 millioncompared to a net loss of $27.1 millionfor the year ended December 31, 2018.
- Unrestricted cash, cash equivalents and investments totaled
$118.4 millionas of December 31, 2019, compared to $131.7 millionas of September 30, 2019and $163.9 millionas of December 31, 2018. Crinetics expects that its cash, cash equivalents and investments will fund its current operating plan into the second half of 2021.
- As of
February 28, 2020, the company had 24,566,896 common shares outstanding.
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 of clinical trials for paltusotine and CRN01941 and the reporting of results from such clinical trials; plans to advance other development programs into the clinic; and anticipated cash runway. 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 nonclinical studies for paltusotine, CRN01941 and its other development candidates; regulatory developments in
Chief Financial Officer
CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA
(In thousands, except per share data)
|Three months ended
||Twelve months ended
|STATEMENTS OF OPERATIONS DATA:||2019||2018||2019||2018|
|Research and development||12,143||7,651||41,506||24,479|
|General and administrative||3,392||2,561||13,519||6,659|
|Total operating expenses||15,535||10,212||55,025||31,138|
|Loss from operations||(15,214||)||(9,431||)||(53,832||)||(28,710||)|
|Total other income (expense), net||665||936||3,410||1,595|
|Net loss per share - basic and diluted||$||(0.60||)||$||(0.35||)||$||(2.09||)||$||(2.23||)|
|Weighted-average shares - basic and diluted||24,235||24,046||24,175||12,142|
|BALANCE SHEET DATA:||
|Cash, cash equivalents and investments||$||118,392||$||163,875|
|Total stockholders’ equity||$||117,139||$||160,225|
Source: Crinetics Pharmaceuticals, Inc.