ALLK Allakos Inc.

85.08
+0.09  (+0%)
Previous Close 84.99
Open 85.4
52 Week Low 41.605
52 Week High 139.99
Market Cap $4,149,041,143
Shares 48,766,351
Float 18,184,653
Enterprise Value $3,673,272,171
Volume 193,186
Av. Daily Volume 275,169
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Upcoming Catalysts

Drug Stage Catalyst Date
Antolimab (subcutaneous)
Healthy Volunteers
Phase 1
Phase 1
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Antolimab (AK002)
Eosinophilic esophagitis
Phase 2/3
Phase 2/3
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Antolimab (AK002)
Eosinophilic Gastritis
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
AK002
Severe Allergic Conjunctivitis
Phase 1b
Phase 1b
Phase 1b presentation at ASCRS May 16, 2020.
AK002
Chronic Urticaria
Phase 2
Phase 2
Phase 2 additional data released February 11, 2019. 9% UAS7 complete responder rate.
AK002
Indolent Systemic Mastocytosis
Phase 1
Phase 1
Phase 1 data released February 19, 2019.

Latest News

  1. REDWOOD CITY, Calif., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Allakos Inc. (the "Company") (NASDAQ:ALLK), a biotechnology company developing AK002 for the treatment of eosinophil and mast cell-related diseases, today reported financial results for the second quarter ended June 30, 2020 and provided an update of its ongoing development activities.

    Business Updates

    • 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…

    REDWOOD CITY, Calif., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Allakos Inc. (the "Company") (NASDAQ:ALLK), a biotechnology company developing AK002 for the treatment of eosinophil and mast cell-related diseases, today reported financial results for the second quarter ended June 30, 2020 and provided an update of its ongoing development activities.

    Business Updates

    • 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 March 2020.



    • 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 May 2020.



    • 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 $28.3 million in the second quarter of 2020 as compared to $14.1 million in the same period in 2019, an increase of $14.2 million.

    General and administrative expenses were $12.1 million in the second quarter of 2020 as compared to $5.9 million in the same period in 2019, an increase of $6.2 million.

    Allakos reported a net loss of $39.3 million in the second quarter of 2020 as compared to $19.1 million in the same period in 2019, an increase of $20.2 million. Net loss per basic and diluted share was $0.80 for the second quarter of 2020 compared to $0.44 in the same period in 2019.

    Allakos ended the second quarter of 2020 with $454.9 million in cash, cash equivalents and marketable securities.

    About Allakos

    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, lirentelimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Lirentelimab 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. Lirentelimab has been tested in multiple clinical studies, in which lirentelimab eliminated blood and tissue eosinophils, inhibited mast cells and improved disease symptoms in patients with eosinophilic gastritis and/or eosinophilic duodenitis, eosinophilic esophagitis, mast cell gastrointestinal disease, severe allergic conjunctivitis, chronic urticaria and indolent systemic mastocytosis. For more information, please visit the Company's website at www.allakos.com.

    Forward-Looking Statements

    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 Allakos is targeting; Allakos' ability to advance additional product candidates beyond lirentelimab (AK002); Allakos' ability to obtain additional capital to finance its operations; and other important risk factors set forth in Allakos' most recent Annual Report on Form 10-K filed with the SEC on February 25, 2020, Quarterly Report on Form 10-Q filed with the SEC on August 10, 2020 and future reports to be filed with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos' forward-looking statements. 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. These forward-looking statements should not be relied upon as representing Allakos' views as of any date subsequent to the date of this press release.

    Source: Allakos Inc.



    ALLAKOS INC.

    STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (in thousands, except per share data)

    (unaudited)

      Three Months Ended  Six Months Ended 
      June 30,  June 30, 
      2020  2019  2020  2019 
    Operating expenses                
    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)
    Net loss  (39,292)  (19,072)  (67,116)  (39,025)
    Unrealized gain (loss) on marketable securities, net of tax  (1,219)  84   650   129 
    Comprehensive loss $(40,511) $(18,988) $(66,466) $(38,896)
    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 



    ALLAKOS INC.

    CONDENSED BALANCE SHEETS

    (in thousands)

      June 30,  December 31, 
      2020  2019 
      (unaudited)     
    Assets        
    Current assets:        
    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 
    Total assets $474,457  $516,894 
    Liabilities and stockholders' equity        
    Current liabilities:        
    Accounts payable $9,617  $5,963 
    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 
    Total liabilities  27,454   21,173 
    Stockholders' equity:        
    Common stock  49   48 
    Additional paid-in capital  702,767   685,020 
    Accumulated other comprehensive gain  787   137 
    Accumulated deficit  (256,600)  (189,484)
    Total stockholders' equity  447,003   495,721 
    Total liabilities and stockholders' equity $474,457  $516,894 
    Investor Contact:
    Adam Tomasi, President and COO
    
    
    Media Contact:
    Denise Powell
    

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  2. -- Phase 3 study in eosinophilic gastritis and/or eosinophilic duodenitis and Phase 2/3 study in eosinophilic esophagitis --

     -- Top-line safety and efficacy results from both studies expected in the second half of 2021 --

    REDWOOD CITY, Calif., June 03, 2020 (GLOBE NEWSWIRE) -- Allakos Inc. (NASDAQ:ALLK), a biotechnology company developing antolimab (AK002) for the treatment of eosinophil and mast cell related diseases, today announced that it is recruiting patients for two previously announced registrational clinical studies of AK002; a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Top-line safety and efficacy results from both studies are expected…

    -- Phase 3 study in eosinophilic gastritis and/or eosinophilic duodenitis and Phase 2/3 study in eosinophilic esophagitis --

     -- Top-line safety and efficacy results from both studies expected in the second half of 2021 --

    REDWOOD CITY, Calif., June 03, 2020 (GLOBE NEWSWIRE) -- Allakos Inc. (NASDAQ:ALLK), a biotechnology company developing antolimab (AK002) for the treatment of eosinophil and mast cell related diseases, today announced that it is recruiting patients for two previously announced registrational clinical studies of AK002; a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Top-line safety and efficacy results from both studies are expected in the second half of 2021. The Phase 3 EG and/or EoD study and the Phase 2/3 EoE study follow positive results from ENIGMA, the Company's multicenter, randomized, double-blind, placebo-controlled Phase 2 study in patients with EG and/or EoD.

    Phase 3 Eosinophilic Gastritis (EG) and/or Eosinophilic Duodenitis (EoD) Study Design
    The multicenter, randomized, double-blind, placebo-controlled Phase 3 study will enroll approximately 160 patients with active, biopsy-confirmed EG (eosinophil count of ≥30 eosinophils in 5 high powered fields [hpfs] in the stomach) and/or EoD (eosinophil count of ≥30 eosinophils in 3 hpfs in duodenum). Patients will be randomized 1:1 to receive: (a) 1.0 mg/kg of antolimab for the first month followed by five doses of 3.0 mg/kg given monthly, or (b) monthly placebo. The co-primary endpoints of the study are: 1) the proportion of patients achieving ≤ 4 eosinophils in 5 hpfs in the stomach and/or ≤15 eosinophils in 3 hpfs in the duodenum and 2) absolute change in Total Symptom Score (TSS-6: abdominal pain, nausea, bloating, early satiety, abdominal cramping, loss of appetite) measured using the daily patient reported symptom questionnaire used in ENIGMA. The TSS-6 comprises the six most frequent and severe symptoms reported in ENIGMA.

    Phase 2/3 Eosinophilic Esophagitis (EoE) Study Design
    The multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study will enroll approximately 300 patients with active, biopsy-confirmed EoE (eosinophil count of ≥15 eosinophils in a single hpf). Patients will be randomized 1:1:1 to receive: (a) six antolimab doses of 1.0 mg/kg given monthly, (b) 1.0 mg/kg of antolimab for the first month followed by five doses of 3.0 mg/kg given monthly, or (c) monthly placebo. The co-primary endpoints of the study are: (1) the proportion of patients achieving ≤6 eosinophils in a single hpf and (2) absolute change in dysphagia symptoms measured using a daily patient reported symptom questionnaire known as the Dysphagia Symptom Questionnaire (DSQ).

    About Eosinophilic Gastritis, Eosinophilic Duodenitis, and Eosinophilic Esophagitis
    Eosinophilic gastritis, eosinophilic duodenitis (previously referred to as eosinophilic gastroenteritis), and eosinophilic esophagitis are severe inflammatory orphan diseases characterized by the presence of high levels of eosinophils in the stomach, duodenum, or esophagus, respectively. Common symptoms of the diseases include severe abdominal pain, nausea, diarrhea, bloating, cramping, early satiety, loss of appetite, vomiting, dysphagia, and weight loss. The current estimated prevalence of eosinophilic gastritis and eosinophilic duodenitis in the United States is approximately 50,000 people. The estimated prevalence of eosinophilic esophagitis in the United States is approximately 150,000 people. The Company believes that these diseases may be significantly under-diagnosed, or misdiagnosed, as other gastrointestinal diseases. There are no treatments approved specifically for these diseases. Treatment with systemic steroids can provide symptomatic improvement, but long-term treatment with steroids is generally not possible due to the numerous side effects. Allakos has received orphan drug designation for antolimab in eosinophilic gastritis, eosinophilic gastroenteritis, and eosinophilic esophagitis.

    About Allakos
    Allakos is a late-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, antolimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Antolimab 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. Antolimab has been tested in multiple clinical studies, in which antolimab eliminated blood and tissue eosinophils, inhibited mast cells and improved disease symptoms in patients with eosinophilic gastritis and/or eosinophilic duodenitis, eosinophilic esophagitis, mast cell gastrointestinal disease, severe allergic conjunctivitis, chronic urticaria and indolent systemic mastocytosis. For more information, please visit the Company's website at www.allakos.com.

    Forward-Looking Statements
    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' 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 Allakos is targeting; Allakos' ability to advance additional product candidates beyond antolimab (AK002); Allakos' ability to obtain additional capital to finance its operations; and other important risk factors set forth in Allakos' most recent Annual Report on Form 10-K filed with the SEC on February 25, 2020, Quarterly Report on Form 10-Q filed with the SEC on May 11, 2020 and future reports to be filed with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos' forward-looking statements. 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. These forward-looking statements should not be relied upon as representing Allakos' views as of any date subsequent to the date of this press release.

    Source: Allakos Inc.

    Investor Contact:
    Adam Tomasi, President and COO
    
    
    Media Contact:
    Denise Powell
    

    Primary Logo

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  3. REDWOOD CITY, Calif., May 21, 2020 (GLOBE NEWSWIRE) -- Allakos Inc. (the "Company") (NASDAQ:ALLK), a biotechnology company developing antolimab (AK002) for the treatment of eosinophil and mast cell related diseases, today announced the acceptance of two oral abstract presentations at the upcoming European Academy of Allergy & Clinical Immunology (EAACI) Annual Congress being held virtually from June 6 to 8, 2020.

    The following virtual oral abstract presentations will be available starting on June 6, 2020.

    Title (Presenter):
    A Siglec-8 Antibody Reduces Substance P-induced Inflammation by Inhibiting MRGPR-mediated Mast Cell Activation (Simon Gebremeskel, PhD)
    Session: Biologicals and DARPins: New Mechanistic Insights and Novel Applications,

    REDWOOD CITY, Calif., May 21, 2020 (GLOBE NEWSWIRE) -- Allakos Inc. (the "Company") (NASDAQ:ALLK), a biotechnology company developing antolimab (AK002) for the treatment of eosinophil and mast cell related diseases, today announced the acceptance of two oral abstract presentations at the upcoming European Academy of Allergy & Clinical Immunology (EAACI) Annual Congress being held virtually from June 6 to 8, 2020.

    The following virtual oral abstract presentations will be available starting on June 6, 2020.

    Title (Presenter):
    A Siglec-8 Antibody Reduces Substance P-induced Inflammation by Inhibiting MRGPR-mediated Mast Cell Activation (Simon Gebremeskel, PhD)
    Session: Biologicals and DARPins: New Mechanistic Insights and Novel Applications, OAS 23
       
    Title (Presenter):
    Treatment of Severe Allergic Conjunctivitis with Antolimab Indicated Improvement of Ocular Signs and Symptoms and Reduction of Severity of Comorbid Atopic Diseases in a Phase 1b Open-Label Study (Andrea Leonardi, MD)
    Session: Diagnosis and Management of Ocular Allergy and Allergic Rhinitis, OAS 18

    Following the presentations, the slides will be available on the Allakos website.

    About Allakos

    Allakos is a late-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, antolimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Antolimab 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. Antolimab has been tested in multiple clinical studies, in which antolimab eliminated blood and tissue eosinophils, inhibited mast cells and improved disease symptoms in patients with eosinophilic gastritis and/or eosinophilic duodenitis, eosinophilic esophagitis, mast cell gastrointestinal disease, severe allergic conjunctivitis, chronic urticaria and indolent systemic mastocytosis. For more information, please visit the Company's website at www.allakos.com.

    Source: Allakos Inc.

    Investor Contact:
    Adam Tomasi, President & COO
    
    
    Media Contact:
    Denise Powell
    

    Primary Logo

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  4. REDWOOD CITY, Calif., May 11, 2020 (GLOBE NEWSWIRE) -- Allakos Inc. (the "Company") (NASDAQ:ALLK), a biotechnology company developing antolimab (AK002) for the treatment of eosinophil and mast cell related diseases, today announced the acceptance of an oral presentation at the upcoming American Society of Cataract and Refractive Surgery (ASCRS) Virtual Annual Meeting.

    The virtual presentation will take place on May 16, 2020 at 6:00pm ET. The abstract is currently available on the ASCRS website where the virtual presentation will be available as well.

    Title (Presenter):
    Phase 1b Study of an Anti-Siglec-8 Monoclonal Antibody, Antolimab (AK002), in
    Severe Allergic Conjunctivitis (Dr. Stephen Anesi, MD)
    Session (Location): Corneal Disease (VM

    REDWOOD CITY, Calif., May 11, 2020 (GLOBE NEWSWIRE) -- Allakos Inc. (the "Company") (NASDAQ:ALLK), a biotechnology company developing antolimab (AK002) for the treatment of eosinophil and mast cell related diseases, today announced the acceptance of an oral presentation at the upcoming American Society of Cataract and Refractive Surgery (ASCRS) Virtual Annual Meeting.

    The virtual presentation will take place on May 16, 2020 at 6:00pm ET. The abstract is currently available on the ASCRS website where the virtual presentation will be available as well.

    Title (Presenter):
    Phase 1b Study of an Anti-Siglec-8 Monoclonal Antibody, Antolimab (AK002), in
    Severe Allergic Conjunctivitis (Dr. Stephen Anesi, MD)
    Session (Location): Corneal Disease (VM - 1, Virtual Room 4) 

    The Phase 1b clinical trial evaluated antolimab in patients with three forms of severe allergic conjunctivitis refractory to topical treatments; atopic keratoconjunctivitis, vernal keratoconjunctivitis and perennial allergic conjunctivitis. Following the presentation, the slides will be available on the Allakos website.

    About Allakos

    Allakos is a late-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, antolimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Antolimab 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. Antolimab has been tested in multiple clinical studies, in which antolimab eliminated blood and tissue eosinophils, inhibited mast cells and improved disease symptoms in patients with eosinophilic gastritis and/or eosinophilic duodenitis, eosinophilic esophagitis, mast cell gastrointestinal disease, severe allergic conjunctivitis, chronic urticaria and indolent systemic mastocytosis. For more information, please visit the Company's website at www.allakos.com.

    Source: Allakos Inc.

    Investor Contact:
    Adam Tomasi, President & COO
    
    
    Media Contact:
    Denise Powell
    

    Primary Logo

    View Full Article Hide Full Article
  5. REDWOOD CITY, Calif., May 11, 2020 (GLOBE NEWSWIRE) -- Allakos Inc. (the "Company") (NASDAQ:ALLK), a biotechnology company developing antolimab (AK002) for the treatment of eosinophil and mast cell-related diseases, today reported financial results for the first quarter ended March 31, 2020.

    First Quarter 2020 Financial Results

    Research and development expenses were $18.3 million in the first quarter of 2020 as compared to $15.1 million in the same period in 2019, an increase of $3.2 million.

    General and administrative expenses were $11.6 million in the first quarter of 2020 as compared to $5.8 million in the same period in 2019, an increase of $5.8 million.

    Allakos reported a net loss of $27.8 million in the first quarter of 2020 as compared…

    REDWOOD CITY, Calif., May 11, 2020 (GLOBE NEWSWIRE) -- Allakos Inc. (the "Company") (NASDAQ:ALLK), a biotechnology company developing antolimab (AK002) for the treatment of eosinophil and mast cell-related diseases, today reported financial results for the first quarter ended March 31, 2020.

    First Quarter 2020 Financial Results

    Research and development expenses were $18.3 million in the first quarter of 2020 as compared to $15.1 million in the same period in 2019, an increase of $3.2 million.

    General and administrative expenses were $11.6 million in the first quarter of 2020 as compared to $5.8 million in the same period in 2019, an increase of $5.8 million.

    Allakos reported a net loss of $27.8 million in the first quarter of 2020 as compared to $20.0 million in the same period in 2019, an increase of $7.8 million. Net loss per basic and diluted share was $0.57 for the first quarter of 2020 compared to $0.47 in the same period in 2019.

    Allakos ended the first quarter of 2020 with $479.8 million in cash, cash equivalents and marketable securities.

    About Allakos

    Allakos is a late-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, antolimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Antolimab 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. Antolimab has been tested in multiple clinical studies, in which antolimab eliminated blood and tissue eosinophils, inhibited mast cells and improved disease symptoms in patients with eosinophilic gastritis and/or eosinophilic duodenitis, eosinophilic esophagitis, mast cell gastrointestinal disease, severe allergic conjunctivitis, chronic urticaria and indolent systemic mastocytosis. For more information, please visit the Company's website at www.allakos.com.

    Forward-Looking Statements

    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 Allakos is targeting; Allakos' ability to advance additional product candidates beyond antolimab (AK002); Allakos' ability to obtain additional capital to finance its operations; and other important risk factors set forth in Allakos' most recent Annual Report on Form 10-K filed with the SEC on February 25, 2020, Quarterly Report on Form 10-Q filed with the SEC on May 11, 2020 and future reports to be filed with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos' forward-looking statements. 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. These forward-looking statements should not be relied upon as representing Allakos' views as of any date subsequent to the date of this press release.

    Source: Allakos Inc.


    ALLAKOS INC.
    STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
    (in thousands, except per share data)
    (unaudited)

        Three Months Ended  
        March 31,  
        2020     2019  
    Operating expenses                
    Research and development   $ 18,285     $ 15,098  
    General and administrative     11,588       5,829  
    Total operating expenses     29,873       20,927  
    Loss from operations     (29,873 )     (20,927 )
    Interest income, net     1,989       1,030  
    Other income (expense), net     60       (56 )
    Net loss     (27,824 )     (19,953 )
    Unrealized gain on marketable
      securities, net of tax
        1,869       45  
    Comprehensive loss   $ (25,955 )   $ (19,908 )
    Net loss per common share:                
    Basic and diluted   $ (0.57 )   $ (0.47 )
    Weighted-average number of common
      shares outstanding:
                   
    Basic and diluted     48,691       42,620  
     


    ALLAKOS INC.
    CONDENSED BALANCE SHEETS
    (in thousands)

        March 31,     December 31,  
        2020     2019  
        (unaudited)          
    Assets                
    Current assets:                
    Cash and cash equivalents   $ 135,942     $ 38,367  
    Investments in marketable securities     343,863       457,534  
    Prepaid expenses and other current assets     3,953       3,969  
    Total current assets     483,758       499,870  
    Property and equipment, net     8,072       8,410  
    Operating lease right-of-use assets     5,705       5,775  
    Other long-term assets     2,839       2,839  
    Total assets   $ 500,374     $ 516,894  
    Liabilities and stockholders' equity                
    Current liabilities:                
    Accounts payable   $ 9,062     $ 5,963  
    Accrued expenses and other current liabilities     5,273       7,098  
    Total current liabilities     14,335       13,061  
    Other long-term liabilities     7,995       8,112  
       Total liabilities     22,330       21,173  
    Stockholders' equity:                
    Common stock     48       48  
    Additional paid-in capital     693,298       685,020  
    Accumulated other comprehensive gain     2,006       137  
    Accumulated deficit     (217,308 )     (189,484 )
    Total stockholders' equity     478,044       495,721  
    Total liabilities and stockholders' equity   $ 500,374     $ 516,894  

    Investor Contact:
    Adam Tomasi, President and COO
    
    
    Media Contact:
    Denise Powell
    

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