Globe Newswire 8-Nov-2018 4:01 PM
-- Clinical data expected in early first quarter 2019 --
SAN CARLOS, Calif., Nov. 08, 2018 (GLOBE NEWSWIRE) -- Allakos Inc. (NASDAQ:ALLK), a clinical stage biotechnology company focused on the development of antibodies for the treatment of eosinophil and mast cell related diseases, today announced an update to its clinical studies and the financial results for the third quarter ended September 30, 2018.
AK002 Clinical Study Update:
Third Quarter 2018 Financial Results:
Research and development expenses were $8.7 million in the third quarter of 2018 as compared to $5.3 million in the same period in 2017. The increase in research and development expenses was primarily related to an increase in consulting and personnel-related costs, as well as contract research and development activities related to the continued advancement of AK002, the Company's lead antibody.
General and administrative expenses were $3.3 million in the third quarter of 2018 as compared to $0.9 million in the same period in 2017. The increase in general and administrative expenses was primarily attributable to an increase in personnel-related costs as a result of the Company's increase in employee headcount, as well as incremental expense incurred from outside professional service providers for legal, information technology, and investor relations activities in support of the Company's completed IPO and concurrent private placement.
Allakos reported a net loss of $11.1 million in the third quarter of 2018 as compared to $5.9 million in the same period in 2017, an increase of $5.2 million. Net loss per basic and diluted share was $0.34 for the third quarter of 2018 compared to $3.60 in the same period in 2017.
Allakos ended the third quarter of 2018 with $193.5 million in cash, cash equivalents and marketable securities.
Allakos is a clinical stage biotechnology company developing antibodies that target immunomodulatory receptors present on immune effector cells involved in allergic, inflammatory, and proliferative diseases. The Company's lead antibody, AK002, targets Siglec-8, an inhibitory receptor selectively expressed on human mast cells and eosinophils. Inappropriately activated eosinophils and mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. AK002 has completed two Phase 1 trials, one in healthy volunteers and a single ascending dose trial in patients with indolent systemic mastocytosis. AK002 demonstrated pharmacodynamic activity in both trials and in the trial involving patients with indolent systemic mastocytosis, patients reported improvements in their symptoms. AK002 is being tested in a double-blind, placebo-controlled Phase 2 trial for the treatment of eosinophilic gastritis and eosinophilic gastroenteritis. In addition, Allakos is conducting multiple-dose trials with AK002 in chronic urticaria, indolent systemic mastocytosis, and severe allergic conjunctivitis. For more information, please visit the Company's website at www.allakos.com.
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, the timing of top-line results from Allakos' ongoing clinical trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: Allakos' early stages of clinical drug development; Allakos' ability to timely complete clinical trials for, and if approved, commercialize AK002, its lead compound; Allakos' ability to obtain required regulatory approvals for its product candidates; uncertainties related to the enrollment of patients in its clinical trials; Allakos' ability to demonstrate sufficient safety and efficacy of its product candidates in its clinical trials; uncertainties related to the success of later-stage clinical trials, regardless of the outcomes of preclinical testing and early-stage trials; market acceptance of Allakos' product candidates; uncertainties related to the projections of the size of patient populations suffering from the diseases Allakos is targeting; Allakos' ability to advance additional product candidates beyond AK002; Allakos' ability to obtain additional capital to finance its operations; and other important risk factors set forth in Allakos' Registration Statement on Form S-1 that is on file with the Securities and Exchange Commission ("SEC") and the prospectus dated July 18, 2018 relating to its initial public offering of common stock, Allakos' Form 10-Q filed with the SEC on November 8, 2018, and Allakos' future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Allakos specifically disclaims any obligation to update any forward-looking statement, except as required by law.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||$||8,706||$||5,333||$||22,256||$||13,455|
|General and administrative||3,269||900||7,952||2,353|
|Total operating expenses||11,975||6,233||30,208||15,808|
|Loss from operations||(11,975||)||(6,233||)||(30,208||)||(15,808||)|
|Interest income (expense), net||836||(579||)||1,352||(716||)|
|Other expense, net||(9||)||(74||)||(154||)||(110||)|
|Loss before benefit from income taxes||(11,148||)||(6,886||)||(29,010||)||(16,634||)|
|Provision for (benefit from) income taxes||—||(966||)||—||(966||)|
|Unrealized loss on marketable securities, net of tax||(36||)||—||(33||)||—|
|Net loss per common share:|
|Basic and diluted||$||(0.34||)||$||(3.60||)||$||(2.34||)||$||(10.35||)|
|Weighted-average number of common shares outstanding:|
|Basic and diluted||32,609||1,643||12,406||1,514|
CONDENSED BALANCE SHEETS
|September 30,||December 31,|
|Cash and cash equivalents||$||51,635||$||85,207|
|Investments in marketable securities||141,903||—|
|Prepaid expenses and other current assets||3,647||1,037|
|Total current assets||197,185||86,244|
|Property and equipment, net||7,624||445|
|Other long-term assets||952||340|
|Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)|
|Accrued expenses and other current liabilities||3,742||1,089|
|Total current liabilities||8,075||2,792|
|Other long-term liabilities||1,731||36|
|Convertible preferred stock||—||142,969|
|Stockholders' equity (deficit):|
|Additional paid-in capital||285,530||1,803|
|Accumulated other comprehensive income||(33||)||—|
|Total stockholders' equity (deficit)||195,955||(58,768||)|
|Total liabilities, convertible preferred stock and stockholders' equity (deficit)||$||205,761||$||87,029|
Investor Contact: Adam Tomasi, COO, CFO email@example.com Media Contact: Denise Powell firstname.lastname@example.org
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