Allakos Reports Second Quarter 2020 Financial Results and Provides Business Update
- Patient enrollment was initiated in a randomized, double-blind, placebo-controlled Phase 3 study of AK002 in patients with eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD). Topline data are expected in the second half of 2021.
- Patient enrollment was initiated in a randomized, double-blind, placebo-controlled Phase 2/3 study of AK002 in patients with eosinophilic esophagitis (EoE). Topline data are expected in the second half of 2021.
- The Phase 1 safety, tolerability and pharmacokinetics study of the subcutaneous formulation of AK002 is fully enrolled. Results are expected in the second half of 2020.
- The non-interventional study examining the prevalence of EG, EoD, and mast cell gastrointestinal disease (MGID) in patients with chronic functional gastrointestinal disease is fully enrolled. Results are expected in the second half of 2020.
- Announced positive clinical safety and efficacy results from a six-month, open-label Phase 1 study of AK002 in patients with MGID in
- Announced positive interim safety and efficacy results from the open-label, long-term extension component of the ENIGMA study with AK002 in patients with EG and/or EoD. The results were accepted for oral presentation and presented virtually at the Digestive Disease Week (DDW) Annual Meeting in
- The nonproprietary (generic) name of AK002 was changed from antolimab to lirentelimab as a result of trademark issues identified outside of
the United States. Lirentelimab has been adopted by the United States Adopted Names (USAN) Council and World Health Organization( WHO) International Nonproprietary Names (INN) Program.
Second Quarter 2020 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 lirentelimab (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||Six Months Ended|
|Research and development||$||28,346||$||14,111||$||46,631||$||29,209|
|General and administrative||12,058||5,946||23,646||11,775|
|Total operating expenses||40,404||20,057||70,277||40,984|
|Loss from operations||(40,404||)||(20,057||)||(70,277||)||(40,984||)|
|Interest income, net||1,284||971||3,273||2,001|
|Other income (expense), net||(172||)||14||(112||)||(42||)|
|Unrealized gain (loss) on marketable securities, net of tax||(1,219||)||84||650||129|
|Net loss per common share:|
|Basic and diluted||$||(0.80||)||$||(0.44||)||$||(1.38||)||$||(0.91||)|
|Weighted-average number of common shares outstanding:|
|Basic and diluted||48,816||43,115||48,753||42,868|
CONDENSED BALANCE SHEETS
|Cash and cash equivalents||$||153,898||$||38,367|
|Investments in marketable securities||301,048||457,534|
|Prepaid expenses and other current assets||3,336||3,969|
|Total current assets||458,282||499,870|
|Property and equipment, net||7,703||8,410|
|Operating lease right-of-use assets||5,633||5,775|
|Other long-term assets||2,839||2,839|
|Liabilities and stockholders' equity|
|Accrued expenses and other current liabilities||9,962||7,098|
|Total current liabilities||19,579||13,061|
|Other long-term liabilities||7,875||8,112|
|Additional paid-in capital||702,767||685,020|
|Accumulated other comprehensive gain||787||137|
|Total stockholders’ equity||447,003||495,721|
|Total liabilities and stockholders’ equity||$||474,457||$||516,894|
Adam Tomasi, President and COO firstname.lastname@example.org Media Contact: Denise Powelldenise@redhousecomms.com
Source: Allakos Inc.