Allakos Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update
- Reported positive results from ENIGMA, a randomized, double-blind, placebo-controlled Phase 2 study using antolimab (AK002) in patients with Eosinophilic Gastritis (EG) and/or Eosinophilic Gastroenteritis (EGE). The study met all prespecified primary and secondary endpoints.
- Podium presentations of the ENIGMA study results were made at the 2019 United European Gastroenterology Week (
Barcelona, Spain; October 2019) by Dr. Joseph Murray, MD and at the 2019 American Collegeof Gastroenterology Annual Scientific Meeting( San Antonio, Texas; October 2019) by Dr. Evan Dellon, MD, MPH.
- Reported positive topline results with antolimab (AK002) in three open-label studies in patients with Chronic Urticaria (CU), Severe Allergic Conjunctivitis (SAC) and Indolent Systemic Mastocytosis (ISM). In these studies, antolimab (AK002) depleted blood eosinophils and improved patient and physician reported symptoms.
- Closed an underwritten public offering in
August 2019, issuing 5,227,272 shares of common stock at an offering price of $77.00per share. Aggregated net proceeds received from the offering were approximately $377.5 million, net of underwriting discounts and commissions and offering expenses.
- Granted orphan drug designation in
October 2019from the United States Food and Drug Administrationfor the treatment of Eosinophilic Esophagitis (EoE) with antolimab (AK002).
Upcoming 2020 Milestones
- Initiation of a randomized, double-blind, placebo-controlled Phase 3 study using antolimab (AK002) in patients with EG and/or EGE in the first quarter 2020.
- Initiation of a randomized, double-blind, placebo-controlled Phase 2/3 study using antolimab (AK002) in patients with EoE in the first quarter 2020.
- Clinical safety and efficacy results from a six-month, open-label Phase 1 study using antolimab (AK002) in patients with Mast Cell Gastrointestinal Disease (MGID) in the first quarter of 2020.
- Clinical safety and efficacy results from the open-label, long-term extension component of the ENIGMA study in patients with EG and/or EGE in the first half of 2020.
- Completion of a Phase 1 study in healthy volunteers evaluating the safety, tolerability and pharmacokinetics of a subcutaneous formulation of antolimab (AK002) in the second half of 2020.
Fourth Quarter and Full Year 2019 Financial Results
Research and development expenses were
General and administrative expenses were
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, Allakos’ progress and business plans. 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 antolimab (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
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
|Three Months Ended||Twelve Months Ended|
|Research and development||$||16,582||$||11,031||$||61,858||$||33,287|
|General and administrative||10,268||4,482||29,560||12,434|
|Total operating expenses||26,850||15,513||91,418||45,721|
|Loss from operations||(26,850||)||(15,513||)||(91,418||)||(45,721||)|
|Interest income, net||2,313||1,023||6,201||2,375|
|Other expense, net||(78||)||(38||)||(155||)||(192||)|
|Unrealized gain (loss) on marketable securities, net of tax||35||18||152||(15||)|
|Net loss per common share:|
|Basic and diluted||$||(0.51||)||$||(0.35||)||$||(1.89||)||$||(2.20||)|
|Weighted-average number of common shares outstanding:|
|Basic and diluted||48,665||42,068||45,191||19,833|
CONDENSED BALANCE SHEETS
|Cash and cash equivalents||$||38,367||$||33,660|
|Investments in marketable securities||457,534||145,246|
|Prepaid expenses and other current assets||3,969||2,703|
|Total current assets||499,870||181,609|
|Property and equipment, net||8,410||8,848|
|Operating lease right-of-use assets||5,775||—|
|Other long-term assets||2,839||802|
|Liabilities and stockholders' equity|
|Accrued expenses and other current liabilities||7,098||3,164|
|Total current liabilities||13,061||5,256|
|Other long-term liabilities||8,112||2,009|
|Additional paid-in capital||685,020||288,079|
|Accumulated other comprehensive income (loss)||137||(15||)|
|Total stockholders’ equity||495,721||183,994|
|Total liabilities and stockholders’ equity||$||516,894||$||191,259|
Adam Tomasi, President and COO firstname.lastname@example.org Media Contact: Denise Powelldenise@redhousecomms.com
Source: Allakos Inc.