ANAB AnaptysBio Inc.

22.53
-0.23  -1%
Previous Close 22.76
Open 23.56
52 Week Low 10
52 Week High 56.72
Market Cap $614,553,401
Shares 27,277,115
Float 17,768,248
Enterprise Value $258,344,137
Volume 209,121
Av. Daily Volume 386,540
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
ANB020 - etokimab
Nasal polyps
Phase 2
Phase 2
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
ANB019 - POPLAR
Palmo-plantar pustular psoriasis
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
ANB019
Generalized pustular psoriasis
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
ANB020 - etokimab
Moderate-to-severe adult atopic dermatitis
Phase 2b
Phase 2b
Phase 2b data failed to meet primary endpoint - November 8, 2019.
ANB020 - etokimab
Severe adult eosinophilic asthma
Phase 2a
Phase 2a
Phase 2b trial initiation postponed.

Latest News

    • Additional Data and Regulatory Strategy Update From Generalized Pustular Psoriasis (GPP) Phase 2 GALLOP Trial Anticipated During H2 2020
    • Palmoplantar pustulosis (PPP) Phase 2 POPLAR Trial Top-Line Data Anticipated in H2 2020
    • Company Plans To Expand Clinical Development of Imsidolimab To Additional Indications During H2 2020  

    SAN DIEGO, July 08, 2020 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (NASDAQ:ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for imsidolimab, the company's proprietary anti-interleukin-36…

    • Additional Data and Regulatory Strategy Update From Generalized Pustular Psoriasis (GPP) Phase 2 GALLOP Trial Anticipated During H2 2020
    • Palmoplantar pustulosis (PPP) Phase 2 POPLAR Trial Top-Line Data Anticipated in H2 2020
    • Company Plans To Expand Clinical Development of Imsidolimab To Additional Indications During H2 2020  

    SAN DIEGO, July 08, 2020 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (NASDAQ:ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for imsidolimab, the company's proprietary anti-interleukin-36 receptor (IL-36R) antibody, for the treatment of patients with GPP. 

    The FDA's Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S.  Orphan drug designation may provide certain benefits to AnaptysBio, including market exclusivity upon regulatory approval, if received, exemption of FDA application fees and tax credits for qualified clinical trials. 

    "Receiving orphan drug designation for the treatment of GPP is an important milestone for our wholly-owned imsidolimab program," said Hamza Suria, president and chief executive officer of AnaptysBio. "We look forward to advancing clinical development of imsidolimab in GPP, PPP and additional clinical indications that may be driven by dysregulated IL-36R signaling."

    GPP is a chronic, life-threatening, rare disease with no currently approved therapies. This systemic inflammatory disease is characterized by the development of widespread pustules marked by exacerbations. In severe cases, GPP patients can die from cardio-pulmonary failure, exhaustion and/or infection subsequent to occurrences of pustular flares. Patients with GPP suffer without robust therapeutic options because currently approved psoriasis management therapies have not demonstrated clear efficacy in the treatment of this condition. In addition, these therapies, including high-dose cyclosporine, methotrexate and retinoids, are often tapered or discontinued due to toxicity. Studies have shown that GPP is associated with uncontrolled signaling through the IL-36R, which in some patients can be mediated by genetic mutations. We estimate GPP affects approximately 3,000 patients in the United States.

    AnaptysBio is currently advancing clinical development of imsidolimab in two indications and plans to expand into additional unmet medical needs.  Treatment of GPP by imsidolimab is being evaluated in the GALLOP Phase 2 trial, where additional clinical data and a regulatory update is anticipated in the second half of 2020.  PPP treatment with imsidolimab is being evaluated in the randomized, placebo-controlled POPLAR Phase 2 trial where top-line data is anticipated in the second half of 2020.  In addition, AnaptysBio intends to initiate Phase 2 clinical trials with imsidolimab in two additional indications, in which human translational data suggests dysregulated IL-36R signaling, during the second half of 2020.

    About AnaptysBio

    AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications. The Company's proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody etokimab, previously referred to as ANB020, for the treatment of chronic rhinosinusitis with nasal polyps, or CRSwNP, and eosinophilic asthma; its anti-IL-36R antibody imsidolimab, previously referred to as ANB019, for the treatment of rare inflammatory diseases, including generalized pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP; its anti-PD-1 agonist program, ANB030, for treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated, and its BTLA modulator program, ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. AnaptysBio's antibody pipeline has been developed using its proprietary somatic hypermutation, or SHM platform, which uses in vitro SHM for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of competing antibody discovery technologies. AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology partnership with GlaxoSmithKline, including an anti-PD-1 antagonist antibody (dostarlimab, TSR-042), an anti-TIM-3 antagonist antibody (cobolimab, TSR-022) and an anti-LAG-3 antagonist antibody (encelimab, TSR-033), and an inflammation partnership with Bristol-Myers Squibb, including an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in clinical development.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from our clinical trials, including imsidolimab's Phase 2 clinical trials in GPP and PPP, the timing of a regulatory strategy update for GPP and the timing of initiation of clinical trials in additional indications with imsidolimab. Statements including words such as "plan," "continue," "expect," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company's ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company's ability to fund development activities and achieve development goals, the company's ability to protect intellectual property and other risks and uncertainties described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

    Contact:

    Eric Loumeau

    AnaptysBio, Inc.

    858.732.0179

    Primary Logo

    View Full Article Hide Full Article
    • Interim Top-Line Data From Etokimab ECLIPSE Phase 2 Trial in Chronic Rhinosinusitis with Nasal Polyps Anticipated in Third Quarter of 2020, Decided to Over-Enroll Trial Due to COVID-19  
    • Additional Topline Data from GALLOP Phase 2 Clinical Trial of ANB019 Monotherapy in Moderate-to-Severe Generalized Pustular Psoriasis on Track for Second Half of 2020
    • Topline Data from POPLAR Phase 2 Clinical Trial of ANB019 Monotherapy in Palmoplantar Pustulosis on Track for Second Half of 2020
    • IND Cleared For Company's Third Wholly-Owned Program, ANB030, an anti-PD-1 Agonist Antibody, and Phase 1 Trial Initiation Anticipated in First Half of 2020
    • US BLA and EU MAA for Dostarlimab, Our PD-1 Antagonist Antibody Partnered With GlaxoSmithKline (GSK), in Endometrial…
    • Interim Top-Line Data From Etokimab ECLIPSE Phase 2 Trial in Chronic Rhinosinusitis with Nasal Polyps Anticipated in Third Quarter of 2020, Decided to Over-Enroll Trial Due to COVID-19  
    • Additional Topline Data from GALLOP Phase 2 Clinical Trial of ANB019 Monotherapy in Moderate-to-Severe Generalized Pustular Psoriasis on Track for Second Half of 2020
    • Topline Data from POPLAR Phase 2 Clinical Trial of ANB019 Monotherapy in Palmoplantar Pustulosis on Track for Second Half of 2020
    • IND Cleared For Company's Third Wholly-Owned Program, ANB030, an anti-PD-1 Agonist Antibody, and Phase 1 Trial Initiation Anticipated in First Half of 2020
    • US BLA and EU MAA for Dostarlimab, Our PD-1 Antagonist Antibody Partnered With GlaxoSmithKline (GSK), in Endometrial Cancer Accepted by the FDA and the EMA, Respectively

    SAN DIEGO, May 06, 2020 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (NASDAQ:ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today reported operating results for the first quarter ended March 31, 2020 and provided pipeline updates.

    "Our wholly-owned pipeline continues to advance with three Phase 2 clinical trial readouts anticipated in the remainder of 2020," said Hamza Suria, president and chief executive officer of AnaptysBio. "AnaptysBio's capital-efficient business model has resulted in the advancement of 7 internally-generated antibodies to the clinic to date, and we anticipate continued discovery and development of novel antibodies in the upcoming future. We also look forward to significant revenues associated with regulatory filing related milestone payment and future royalties upon FDA approval of dostarlimab under our GSK partnership later this year."

    Etokimab (ANB020 Anti-IL-33) Program

    • AnaptysBio is conducting a randomized, placebo-controlled Phase 2 trial in 100 adult patients with chronic rhinosinusitis with nasal polyps, also referred to as the ECLIPSE trial. Patients are being treated with two multi-dosing frequencies of subcutaneously-administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy. We have over-enrolled this trial beyond the first 100 patients to compensate for lost patient visits due to the COVID-19 pandemic, and hence anticipate interim top-line data from this trial to be available in the third quarter of 2020.
    • As previously announced, the Company has decided to postpone the initiation of its planned Phase 2b etokimab clinical trial in eosinophilic asthma, a multi-dose, randomized, double-blinded, placebo-controlled trial in 300-400 patients, until results are available from the ECLIPSE trial.

    ANB019 (Anti-IL-36 Receptor) Program

    • In September, AnaptysBio announced positive topline data from an interim analysis of its Phase 2 clinical trial of ANB019 monotherapy in moderate-to-severe generalized pustular psoriasis, or GPP, also known as the GALLOP trial. In this interim analysis, both patients achieved the primary endpoint of disease score improvement at Day 29 and Day 113 without requiring rescue therapy, demonstrated rapid and sustained mJDA score improvement, with reduction of 58% at Day 8 and 63% at Day 113, and showed complete clearance of skin pustules by Day 8 and through Day 113, with CRP levels decreasing to nearly normal.  The Company anticipates additional clinical data and a regulatory strategy update for the development of ANB019 in GPP during the second half of 2020.
    • The Company is also conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with topline data anticipated in the second half of 2020.
    • Enrollment of the GALLOP and POPLAR trials has been enhanced by expanding clinical sites and geographies involved.  While the Company does not believe that the aforementioned timelines are materially impacted by the COVID-19 pandemic at this point, some of the sites involved in the GALLOP and POPLAR trials have been affected by the COVID-19 pandemic, and the Company will continue to monitor the situation over the upcoming months.

    ANB030 (Anti-PD-1 Agonist) Program

    • ANB030 is a wholly-owned antibody that binds PD-1 in an agonistic manner, leading to reduced T cell activity and anti-inflammatory effects in vivo. Genetic mutations in the PD-1 pathway are associated with increased susceptibility to various inflammatory conditions and we believe ANB030 has the potential to suppress inflammatory diseases by restoring insufficient PD-1-mediated negative signaling on activated T cells. The Company plans to focus future clinical development of ANB030 on certain autoimmune diseases where PD-1 checkpoint receptor function may be under-represented. Our Investigational New Drug Application (IND) for ANB030 has been cleared by the FDA and we plan to initiate a Phase 1 clinical trial in the first half of 2020. Preclinical data from the ANB030 was presented in June at the 2019 FOCIS Annual Meeting.

    ANB032 (Anti-BTLA Modulator) Program

    • Our fourth wholly-owned program is an anti-BTLA modulator antibody, known as ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. Mutations in the BTLA signaling pathway are associated with human inflammatory disease and we believe ANB032 silences pro-inflammatory signaling by modulating BTLA binding to HVEM. We anticipate filing an IND for ANB032 in the second half of 2020.

    Dostarlimab (Anti-PD-1 Antagonist) Program Partnered with GSK

    • In the first quarter of 2020, the FDA accepted the first Biologics License Application (BLA) filing for dostarlimab, an AnaptysBio-generated PD-1 antagonist antibody under partnership with GSK, for the treatment of endometrial cancer. AnaptysBio received a $10.0 million cash milestone payment upon this acceptance, and anticipates an additional $20.0 million cash milestone upon first FDA approval of dostarlimab during 2020. Also in the first quarter of 2020, the EMA accepted GSK's Marketing Authorization Application (MAA) for approval of dostarlimab in the EU for endometrial cancer, for which AnaptysBio has earned a $5.0 million milestone payment. Including additional cash milestones due upon future development and commercialization of dostarlimab, TSR-022, an AnaptysBio-generated TIM-3 antibody, and TSR-033, an AnaptysBio-generated LAG-3 antibody, AnaptysBio can potentially receive a total of $1.1 billion in aggregate milestone payments under this GSK partnership. In addition, AnaptysBio is due a 4% to 8% royalty from GSK, tiered upon global sales, for each of the aforementioned programs.

    First Quarter Financial Results

    • Cash, cash equivalents and investments totaled $412.7 million as of March 31, 2020 compared to $428.5 million as of December 31, 2019, for a decrease of $15.8 million. The decrease relates primarily to cash used for operating activities.
    • Collaboration revenue was $15.0 million for the three months ended March 31, 2020, which related to milestone payments for successful BLA and MAA filings for dostarlimab, compared to zero for the three months ended March 31, 2019.
    • Research and development expenses were $21.0 for the three months ended March 31, 2020, compared to $20.6 million for the three months ended March 31, 2019. The increase was due primarily to continued advancement of the Company's preclinical programs.
    • General and administrative expenses were $4.3 million for the three months ended March 31, 2020, compared to $4.1 million for the three months ended March 31, 2019. The increase was due primarily to personnel-related expenses, including share-based compensation.
    • Net loss was $8.3 million for the three months ended March 31, 2020, or a net loss per share of $0.30, compared to a net loss of $22.1 million for the three months ended March 31, 2019, or a net loss per share of $0.82.

    Financial Guidance

    AnaptysBio expects its net cash burn in 2020 will be approximately $60.0 million, and that its cash, cash equivalents and investments will fund its current operating plan at least into 2023.

    About AnaptysBio

    AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation. The Company's proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody etokimab, previously referred to as ANB020, for the treatment of chronic rhinosinusitis with nasal polyps, or CRSwNP, and eosinophilic asthma; its anti-IL-36R antibody ANB019 for the treatment of rare inflammatory diseases, including generalized pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP; its anti-PD-1 agonist program, ANB030, for treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated, and its BTLA modulator program, ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. AnaptysBio's antibody pipeline has been developed using its proprietary somatic hypermutation, or SHM platform, which uses in vitro SHM for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of competing antibody discovery technologies. AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology partnership with GSK, including an anti-PD-1 antagonist antibody (dostarlimab (TSR-042)), an anti-TIM-3 antagonist antibody (TSR-022) and an anti-LAG-3 antagonist antibody (TSR-033), and an inflammation partnership with Celgene, including an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in clinical development.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from our clinical trials, including etokimab's Phase 2 clinical trial in adult patients with CRSwNP and ANB019's Phase 2 clinical trials in GPP and PPP, the timing of and our ability to launch a Phase 2b clinical trial of etokimab in eosinophilic asthma patients, the timing of a regulatory strategy update for GPP, the timing of initiation of a Phase 1 clinical trial for ANB030, the timing of an IND filing for ANB032, the milestones and royalty payments to be received under the GSK partnership, and our projected 2020 cash burn and cash runway. Statements including words such as "plan," "continue," "expect," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company's ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company's ability to fund development activities and achieve development goals, the company's ability to protect intellectual property and other risks and uncertainties described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

    Contact:
    Eric Loumeau
    AnaptysBio, Inc.
    858.732.0179

    ANAPTYSBIO, INC.
    CONSOLIDATED BALANCE SHEETS
    (in thousands, except par value)

      March 31, 2020   December 31, 2019
      (unaudited)    
    ASSETS      
    Current assets:      
    Cash and cash equivalents $ 165,317     $ 171,017  
    Receivable from collaborative partners 5,000      
    Short-term investments 197,166     203,210  
    Prepaid expenses and other current assets 3,572     3,506  
    Total current assets 371,055     377,733  
    Property and equipment, net 1,610     1,618  
    Long-term investments 50,215     54,305  
    Other long-term assets 1,293     1,481  
    Restricted cash 60     60  
    Total assets $ 424,233     $ 435,197  
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Current liabilities:      
    Accounts payable $ 8,571     $ 16,237  
    Accrued expenses 13,781     11,052  
    Notes payable, current portion     1,375  
    Other current liabilities 898     871  
    Total current liabilities 23,250     29,535  
    Other long-term liabilities 419     654  
    Stockholders' equity:      
    Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at March 31, 2020 and December 31, 2019, respectively      
    Common stock, $0.001 par value, 500,000 shares authorized, 27,277 shares and 27,255 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively 27     27  
    Additional paid in capital 651,680     648,669  
    Accumulated other comprehensive income 1,145     338  
    Accumulated deficit (252,288 )   (244,026 )
    Total stockholders' equity 400,564     405,008  
    Total liabilities and stockholders' equity $ 424,233     $ 435,197  

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

      Three Months Ended
    March 31,
      2020   2019
    Collaboration revenue $ 15,000     $  
    Operating expenses:      
    Research and development 20,968     20,631  
    General and administrative 4,285     4,141  
    Total operating expenses 25,253     24,772  
    Loss from operations (10,253 )   (24,772 )
    Other income (expense), net:      
    Interest expense     (320 )
    Interest income 1,897     2,988  
    Other income, net 94     7  
    Total other income (expense), net 1,991     2,675  
    Loss before income taxes (8,262 )   (22,097 )
    Provision for income taxes     19  
    Net loss (8,262 )   (22,078 )
    Other comprehensive income:      
    Unrealized income on available for sale securities, net of tax of $0 and $115, respectively 807     427  
    Comprehensive loss $ (7,455 )   $ (21,651 )
    Net loss per common share:      
      Basic and diluted $ (0.30 )   $ (0.82 )
    Weighted-average number of shares outstanding:      
      Basic and diluted 27,264     26,981  

    Primary Logo

    View Full Article Hide Full Article
    • Interim Top-Line Data From Etokimab ECLIPSE Phase 2 Trial in Chronic Rhinosinusitis with Nasal Polyps Anticipated in First Half of 2020   
    • Reported Positive Topline Data from Interim Analysis of GALLOP Phase 2 Clinical Trial of ANB019 Monotherapy in Moderate-to-Severe Generalized Pustular Psoriasis and Anticipate Additional Clinical Data and Regulatory Update During 2020
    • Phase 1 Trial of Company's Third Wholly-Owned Program, ANB030, an anti-PD-1 Agonist Antibody, Anticipated in First Half of 2020 Following IND Submission in Q4 2019
    • GlaxoSmithKline (GSK) Announced BLA Submission of Dostarlimab, a PD-1 Antagonist Antibody Partnered With AnaptysBio, in Endometrial Cancer

    SAN DIEGO, March 02, 2020 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (NASDAQ…

    • Interim Top-Line Data From Etokimab ECLIPSE Phase 2 Trial in Chronic Rhinosinusitis with Nasal Polyps Anticipated in First Half of 2020   
    • Reported Positive Topline Data from Interim Analysis of GALLOP Phase 2 Clinical Trial of ANB019 Monotherapy in Moderate-to-Severe Generalized Pustular Psoriasis and Anticipate Additional Clinical Data and Regulatory Update During 2020
    • Phase 1 Trial of Company's Third Wholly-Owned Program, ANB030, an anti-PD-1 Agonist Antibody, Anticipated in First Half of 2020 Following IND Submission in Q4 2019
    • GlaxoSmithKline (GSK) Announced BLA Submission of Dostarlimab, a PD-1 Antagonist Antibody Partnered With AnaptysBio, in Endometrial Cancer

    SAN DIEGO, March 02, 2020 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (NASDAQ:ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today reported operating results for the fourth quarter and year ended December 31, 2019 and provided pipeline updates.

    "We look forward to three Phase 2 clinical trial readouts from our wholly-owned etokimab and ANB019 programs and the expansion of our pipeline with ANB030 and ANB032 during 2020," said Hamza Suria, president and chief executive officer of AnaptysBio. "AnaptysBio is a capital-efficient antibody discovery and development engine that has been validated by the advancement of 7 internally-generated therapeutics to the clinic over the last 4 years, and we look forward to anticipated FDA approval of dostarlimab under our GSK partnership."

    Etokimab (ANB020 Anti-IL-33) Program

    • AnaptysBio is conducting a randomized, placebo-controlled Phase 2 trial in approximately 100 adult patients with chronic rhinosinusitis with nasal polyps, also referred to as the ECLIPSE trial. Patients are being treated with two multi-dosing frequencies of subcutaneously-administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy. The Company anticipates topline data from an interim analysis of the ECLIPSE trial in the first half of 2020.

    • The Company previously announced data from its ATLAS trial, a Phase 2b randomized, double-blinded, placebo-controlled, multi-dose study in approximately 300 adult patients treated with etokimab in moderate-to-severe atopic dermatitis. Each of the etokimab dosing arms failed to meet the primary endpoint of the trial, which was demonstration of statistically greater improvement in the Eczema Area and Severity Index (EASI) relative placebo at week 16. AnaptysBio has discontinued development of etokimab in moderate-to-severe atopic dermatitis.

    • The Company has decided to postpone the initiation of its planned Phase 2b etokimab clinical trial in eosinophilic asthma, a multi-dose, randomized, double-blinded, placebo-controlled trial in 300-400 patients, until results are available from the ECLIPSE trial.

    ANB019 (Anti-IL-36 Receptor) Program

    • In September, AnaptysBio announced positive topline data from an interim analysis of its Phase 2 clinical trial of ANB019 monotherapy in moderate-to-severe generalized pustular psoriasis, or GPP, also known as the GALLOP trial.  In this interim analysis, both patients achieved the primary endpoint of disease score improvement at Day 29 and Day 113 without requiring rescue therapy, demonstrated rapid and sustained mJDA score improvement, with reduction of 58% at Day 8 and 63% at Day 113, and showed complete clearance of skin pustules by Day 8 and through Day 113, with CRP levels decreasing to nearly normal.  Enrollment is ongoing in the GALLOP study, and the Company anticipates additional clinical data and a regulatory strategy update for the development of ANB019 in GPP during 2020.

    • The Company is also conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with topline data anticipated in the second half of 2020.

    • AnaptysBio has taken steps to enhance enrollment in the GALLOP and POPLAR trials, including expansion of clinical trial sites and countries.

    ANB030 (Anti-PD-1 Agonist) Program

    • ANB030 is a wholly-owned antibody that binds PD-1 in an agonistic manner, leading to reduced T cell activity and anti-inflammatory effects in vivo. Genetic mutations in the PD-1 pathway are associated with increased susceptibility to various inflammatory conditions and we believe ANB030 has the potential to suppress inflammatory diseases by restoring insufficient PD-1-mediated negative signaling on activated T cells. The Company plans to focus future clinical development of ANB030 on certain autoimmune diseases where PD-1 checkpoint receptor function may be under-represented, submitted an Investigational New Drug Application (IND) in the fourth quarter of 2019 and plans to initiate a Phase 1 clinical trial in the first half of 2020. Preclinical data from the ANB030 was presented in June at the 2019 FOCIS Annual Meeting.

    ANB032 (Anti-BTLA Modulator) Program

    • Our fourth wholly-owned program is an anti-BTLA modulator antibody, known as ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. Mutations in the BTLA signaling pathway are associated with human inflammatory disease and we believe ANB032 silences pro-inflammatory signaling by modulating BTLA binding to HVEM.  We anticipate filing an IND for ANB032 in the second half of 2020.

    Dostarlimab (Anti-PD-1 Antagonist) Program Partnered with GSK

    • GSK has recently announced that a first BLA filing for dostarlimab, an AnaptysBio-generated PD-1 antagonist antibody under partnership with TESARO, a GSK company, occurred in the fourth quarter of 2019 for the treatment of endometrial cancer. AnaptysBio anticipates receiving a $10.0 million cash milestone payment upon acceptance of this BLA filing and a $20.0 million cash milestone upon first FDA approval of dostarlimab. Including additional cash milestones due upon future development and commercialization of dostarlimab, TSR-022, an AnaptysBio-generated TIM-3 antibody, and TSR-033, an AnaptysBio-generated LAG-3 antibody, AnaptysBio can potentially receive a total of $1.1 billion in aggregate milestone payments under this GSK partnership. In addition, AnaptysBio is due a 4% to 8% royalty from GSK, tiered upon global sales, for each of the aforementioned programs.

    Board of Directors

    • In September, the Company appointed Laura J. Hamill to its board of directors. Most recently, Ms. Hamill served as Executive Vice President, Worldwide Commercial Operations, for Gilead Sciences, where she was involved in the strategic direction and long-term planning of the organization. Previously, Ms. Hamill held a number of US and international executive roles at Amgen, culminating with Senior Vice President and General Manager where she led ~$20B in U.S. commercial operations.

    Fourth Quarter and Full Year Financial Results

    • Cash, cash equivalents and investments totaled $428.5 million as of December 31, 2019 compared to $500.2 million as of December 31, 2018, for a decrease of $71.7 million. The decrease relates primarily to cash used for operating activities.

    • Collaboration revenue was $3.0 million and $8.0 million for the three months and year ended December 31, 2019, which related to a milestone for initiation of a Phase 2 trial for TSR-033, the anti-LAG-3 antibody partnered with TESARO, a GlaxoSmithKline (GSK) company, compared to zero and $5.0 million for the three and year ended December 31, 2018.

    • Research and development expenses were $21.4 million and $99.3 million for the three months and year ended December 31, 2019, compared to $15.9 million and $56.2 million for the three months and year ended December 31, 2018. The increase was due primarily to continued advancement of the Company's etokimab and ANB019 clinical programs and additional personnel-related expenses, including share-based compensation.

    • General and administrative expenses were $3.8 million and $16.1 million for the three months and year ended December 31, 2019, compared to $3.7 million and $15.5 million for the three months and year ended December 31, 2018. The increase was due primarily to personnel-related expenses, including share-based compensation.

    • Net loss was $20.3 million and $97.3 million for the three months and year ended December 31, 2019, or a net loss per share of $0.75 and $3.60, compared to a net loss of $17.0 million and $61.7 million for the three months and year ended December 31, 2018, or a net loss per share of $0.64 and $2.50.

    Financial Guidance

    AnaptysBio expects its net cash burn in 2020 will be approximately $60.0 million, and that its cash, cash equivalents and investments will fund its current operating plan at least into 2023.

    About AnaptysBio

    AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation. The Company's proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody etokimab, previously referred to as ANB020, for the treatment of chronic rhinosinusitis with nasal polyps, or CRSwNP, and eosinophilic asthma; its anti-IL-36R antibody ANB019 for the treatment of rare inflammatory diseases, including generalized pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP; its anti-PD-1 agonist program, ANB030, for treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated, and its BTLA modulator program, ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. AnaptysBio's antibody pipeline has been developed using its proprietary somatic hypermutation, or SHM platform, which uses in vitro SHM for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of competing antibody discovery technologies. AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology partnership with TESARO, a GSK company, including an anti-PD-1 antagonist antibody (dostarlimab (TSR-042)), an anti-TIM-3 antagonist antibody (TSR-022) and an anti-LAG-3 antagonist antibody (TSR-033), and an inflammation partnership with Celgene, including an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in clinical development.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from our clinical trials, including etokimab's Phase 2 clinical trial in adult patients with CRSwNP and ANB019's Phase 2 clinical trials in GPP and PPP, the timing of and our ability to launch a Phase 2b clinical trial of etokimab in eosinophilic asthma patients, the timing of a regulatory strategy update for GPP, the timing of initiation of a Phase 1 clinical trial for ANB030, the timing of an IND filing for ANB032, the milestones and royalty payments to be received under the GSK partnership, and our projected 2020 cash burn and cash runway. Statements including words such as "plan," "continue," "expect," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company's ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company's ability to fund development activities and achieve development goals, the company's ability to protect intellectual property and other risks and uncertainties described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

    Contact:
    Eric Loumeau
    AnaptysBio, Inc.
    858.732.0179


    ANAPTYSBIO, INC.
    CONSOLIDATED BALANCE SHEETS
    (in thousands, except par value)
     
      December 31, 2019   December 31, 2018
           
    ASSETS
    Current assets:      
    Cash and cash equivalents $ 171,017     $ 113,596  
    Australian tax incentive receivable     174  
    Short-term investments 203,210     313,486  
    Prepaid expenses and other current assets 3,506     6,960  
    Total current assets 377,733     434,216  
    Property and equipment, net 1,618     1,445  
    Long-term investments 54,305     73,128  
    Other long-term assets 1,481     148  
    Restricted cash 60     60  
    Total assets $ 435,197     $ 508,997  
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:      
    Accounts payable $ 16,237     $ 5,443  
    Accrued expenses 11,052     8,761  
    Notes payable, current portion 1,375     7,574  
    Other current liabilities 871     58  
    Total current liabilities 29,535     21,836  
    Other long-term liabilities 654     796  
    Stockholders' equity:      
    Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at
    December 31, 2019 and December 31, 2018, respectively
         
    Common stock, $0.001 par value, 500,000 shares authorized, 27,255 shares and 26,922 shares
    issued and outstanding at December 31, 2019 and December 31, 2018, respectively
    27     27  
    Additional paid in capital 648,669     633,251  
    Accumulated other comprehensive income (loss) 338     (223 )
    Accumulated deficit (244,026 )   (146,690 )
    Total stockholders' equity 405,008     486,365  
    Total liabilities, preferred stock and stockholders' equity $ 435,197     $ 508,997  




    ANAPTYSBIO, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
    (in thousands, except per share data)
     
      Three Months Ended
    December 31,
      Year Ended
    December 31,
      2019   2018   2019   2018
    Collaboration revenue $ 3,000     $     $ 8,000     $ 5,000  
    Operating expenses:              
    Research and development 21,426     15,920     99,338     56,196  
    General and administrative 3,832     3,743     16,094     15,526  
    Total operating expenses 25,258     19,663     115,432     71,722  
    Loss from operations (22,258 )   (19,663 )   (107,432 )   (66,722 )
    Other income (expense), net:              
    Interest expense (200 )   (365 )   (1,041 )   (1,652 )
    Interest income 2,282     2,834     10,984     6,685  
    Other (expense) income, net (109 )   8     1     (159 )
    Total other income (expense), net 1,973     2,477     9,944     4,874  
    Loss before income taxes (20,285 )   (17,186 )   (97,488 )   (61,848 )
    Provision for income taxes 22     192     152     192  
    Net loss (20,263 )   (16,994 )   (97,336 )   (61,656 )
    Other comprehensive income (loss):              
    Unrealized income (loss) on available for sale securities,
    net of tax of ($36), $55, $153, and $55, respectively
    (142 )   318     561     203  
    Comprehensive loss $ (20,405 )   $ (16,676 )   $ (96,775 )   $ (61,453 )
    Net loss per common share:              
      Basic and diluted $ (0.75 )   $ (0.64 )   $ (3.60 )   $ (2.50 )
    Weighted-average number of shares outstanding:              
      Basic and diluted 27,154     26,788     27,059     24,673  


    Primary Logo

    View Full Article Hide Full Article
  1. SAN DIEGO, Feb. 25, 2020 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (NASDAQ:ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, today announced that Hamza Suria, chief executive officer of AnaptysBio, will present at the Cowen and Company 40th Annual Health Care Conference on Tuesday, March 3, 2020 at 11:20 a.m. ET at the Boston Marriott Copley Place.

    A webcast of the presentation will be available through the investor section of the AnaptysBio website. A replay of the webcast will be available for 90 days following the event.

    About AnaptysBio

    AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused…

    SAN DIEGO, Feb. 25, 2020 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (NASDAQ:ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, today announced that Hamza Suria, chief executive officer of AnaptysBio, will present at the Cowen and Company 40th Annual Health Care Conference on Tuesday, March 3, 2020 at 11:20 a.m. ET at the Boston Marriott Copley Place.

    A webcast of the presentation will be available through the investor section of the AnaptysBio website. A replay of the webcast will be available for 90 days following the event.

    About AnaptysBio

    AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation. The Company's proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody etokimab, previously referred to as ANB020, for the treatment of chronic rhinosinusitis with nasal polyps, or CRSwNP, and eosinophilic asthma; its anti-IL-36R antibody ANB019 for the treatment of rare inflammatory diseases, including generalized pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP; its anti-PD-1 agonist program, ANB030, for treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated, and its BTLA modulator program, ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. AnaptysBio's antibody pipeline has been developed using its proprietary somatic hypermutation, or SHM platform, which uses in vitro SHM for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of competing antibody discovery technologies. AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology partnership with TESARO, a GSK company, including an anti-PD-1 antagonist antibody (dostarlimab (TSR-042)), an anti-TIM-3 antagonist antibody (TSR-022) and an anti-LAG-3 antagonist antibody (TSR-033), and an inflammation partnership with Celgene, including an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in clinical development.

    Contact:
    Eric Loumeau 
    AnapytsBio, Inc.
    858.362.6348

    Primary Logo

    View Full Article Hide Full Article
  2. SAN DIEGO, Jan. 08, 2020 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (NASDAQ:ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, today announced that Hamza Suria, chief executive officer of AnaptysBio, will present at the J.P. Morgan 38th Annual Healthcare Conference on Wednesday, Jan. 15, 2020 at 2:30 p.m. PT at the Westin St. Francis in San Francisco.

    A webcast of the presentation will be available through the investor section of the AnaptysBio website. A replay of the webcast will be available for 90 days following the event.

    About AnaptysBio

    AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused…

    SAN DIEGO, Jan. 08, 2020 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (NASDAQ:ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, today announced that Hamza Suria, chief executive officer of AnaptysBio, will present at the J.P. Morgan 38th Annual Healthcare Conference on Wednesday, Jan. 15, 2020 at 2:30 p.m. PT at the Westin St. Francis in San Francisco.

    A webcast of the presentation will be available through the investor section of the AnaptysBio website. A replay of the webcast will be available for 90 days following the event.

    About AnaptysBio

    AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation. The Company's proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody etokimab, previously referred to as ANB020, for the treatment of moderate-to-severe atopic dermatitis, eosinophilic asthma, and adult chronic rhinosinusitis with nasal polyps, or CRSwNP; its anti-IL-36R antibody ANB019 for the treatment of rare inflammatory diseases, including generalized pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP; and its anti-PD-1 agonist program, ANB030, and other novel anti-inflammatory checkpoint receptor modulator antibodies for treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated. AnaptysBio's antibody pipeline has been developed using its proprietary somatic hypermutation, or SHM platform, which uses in vitro SHM for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of competing antibody discovery technologies. AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology partnership with TESARO, a GSK company, including an anti-PD-1 antagonist antibody (dostarlimab (TSR-042)), an anti-TIM-3 antagonist antibody (TSR-022) and an anti-LAG-3 antagonist antibody (TSR-033), and an inflammation partnership with Celgene, including an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in clinical development.

    Contact:
    Eric Loumeau 
    AnapytsBio, Inc.
    858.362.6348

    Primary Logo

    View Full Article Hide Full Article
View All AnaptysBio Inc. News