Crinetics Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update
“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
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 $17.00per share. Net proceeds were approximately $106.5 million, after deducting underwriting discounts, commissions, and offering expenses.
- Awarded up to
$3.2 millionin SBIR grants for congenital hyperinsulinism and acromegaly. In June 2018, Crinetics was awarded up to approximately $3.2 millionin Small Business Innovation Research(SBIR) grants from the National Institute of Diabetes and Digestiveand 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 millionfor CHI and $1.3 millionfor acromegaly.
Fourth Quarter and Full Year 2018 Financial Results
- Research and development expenses were
$7.7 millionand $24.5 millionfor the three months and full year ended December 31, 2018, respectively, compared to $2.6 millionand $9.2 millionfor 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 millionand $6.7 millionfor the three months and full year ended December 31, 2018, compared to $0.5 millionand $1.9 millionfor 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.
- Net loss for the three months ended
December 31, 2018was $8.5 million, compared to a net loss of $2.5 millionfor the three months ended December 31, 2017. For the full year ended December 31, 2018, the company’s net loss was $27.1 millioncompared to a net loss of $9.2 millionfor the full year ended December 31, 2017.
- Cash, cash equivalents and short-term investments totaled
$163.9 millionas of December 31, 2018, compared with $14.2 millionas of December 31, 2017.
- As of
February 28, 2018, the company had 24,095,485 common shares outstanding.
Crinetics expects that its cash, cash equivalents and investments will fund its current operating plan at least through the end of 2020.
Crinetics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the anticipated timing to commence clinical trials for CRN00808 and plans to advance other pipeline programs. The inclusion of forward-looking statements should not be regarded as a representation by Crinetics that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Crinetics’ business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; the company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crinetics’ clinical trials and preclinical studies for CRN00808 and its other product candidates; regulatory developments in
Chief Financial Officer
|CRINETICS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA|
|Three months ended December 31,||Twelve months ended December 31,|
|STATEMENTS OF OPERATIONS DATA:||2018||2017||2018||2017|
|Research and development||7,651||2,562||24,479||9,233|
|General and administrative||2,561||467||6,659||1,939|
|Total operating expenses||10,212||3,029||31,138||11,172|
|Loss from operations||(9,431||)||(2,501||)||(28,710||)||(9,127||)|
|Total other income (expense), net||936||(20||)||1,595||(30||)|
|Net loss per share - basic and diluted||$||(0.35||)||$||(1.68||)||$||(2.23||)||$||(6.68||)|
|Weighted-average shares - basic and diluted||24,046||1,503||12,142||1,371|
|BALANCE SHEET DATA:||December 31,
|Cash, cash equivalents and short-term investments||$||163,875||$||14,192|
|Convertible preferred stock||$||-||$||29,700|
|Total stockholders’ equity (deficit)||$||160,225||$||(15,022||)|
Source: Crinetics Pharmaceuticals, Inc.