VIE Viela Bio Inc.

36.41
+1.65  (+5%)
Previous Close 34.76
Open 35.37
52 Week Low 23.69
52 Week High 70.66
Market Cap $1,996,634,868
Shares 54,837,541
Float 24,271,372
Enterprise Value $1,534,008,184
Volume 226,857
Av. Daily Volume 189,115
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Upcoming Catalysts

Drug Stage Catalyst Date
VIB7734
COVID-19-Related Acute Lung Injury
Phase 1b
Phase 1b
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Drug Pipeline

Drug Stage Notes
Inebilizumab
IgG4-related disease
Phase 2b
Phase 2b
Phase 2b trial initiated 4Q 2020.
Inebilizumab
Myasthenia gravis
Phase 3
Phase 3
Phase 3 trial initiated 4Q 2020.
VIB7734
Cutaneous lupus erythematosus
Phase 2
Phase 2
Phase 2 trial to commence 1H 2021.
VIB4920
Sjögren’s syndrome
Phase 2b
Phase 2b
Phase 2b enrollment resumed following pause due to COVID-19.
Inebilizumab
Kidney transplant desensitization
Phase 2
Phase 2
Phase 2 enrolment paused due to COVID-19.
VIB4920
Kidney transplant rejection
Phase 2
Phase 2
Phase 2a trial has resumed enrollment following pause due to COVID-19.
Inebilizumab
Neuromyelitis Optica Spectrum Disorder
Approved
Approved
FDA Approval announced June 11, 2020.

Latest News

  1. GAITHERSBURG, Md., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Viela Bio (NASDAQ:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases, today reported financial results and provided program highlights for the third quarter ended September 30, 2020.

    "Several months into UPLIZNA's launch, we have gained valuable insights into how to meet our customer's needs, which continue to evolve during the COVID-19 pandemic. We are encouraged by the increasing product uptake and our commercial team remains nimble in how we engage with individual practitioners and centers of excellence across the U.S.," said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. "As…

    GAITHERSBURG, Md., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Viela Bio (NASDAQ:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases, today reported financial results and provided program highlights for the third quarter ended September 30, 2020.

    "Several months into UPLIZNA's launch, we have gained valuable insights into how to meet our customer's needs, which continue to evolve during the COVID-19 pandemic. We are encouraged by the increasing product uptake and our commercial team remains nimble in how we engage with individual practitioners and centers of excellence across the U.S.," said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. "As we and our partners await the potential approval of UPLIZNA in several Asian countries, we continue to expand its development in the U.S. in various diseases, including myasthenia gravis and IgG4-related disease, where we believe it could have a significant clinical benefit over existing therapies."

    Added Dr. Yao: "While we pursue the potential expansion of UPLIZNA to additional patient populations, we continue to make solid progress across our entire pipeline. Recently, we presented data from our Phase 1b study of VIB7734 in an oral presentation at ACR Convergence 2020, confirming its potential to reduce lesions in lupus patients and have selected systemic lupus erythematosus for our planned Phase 2 trial. Additionally, we continue to enroll new patients into our ongoing trials with VIB4920, which include mid-stage studies in Sjögren's syndrome, rheumatoid arthritis and kidney transplant rejection and are planning to submit an IND for a new preclinical candidate by the end of this year."

    PROGRAM HIGHLIGHTS

    UPLIZNA® (inebilizumab-cdon)

    UPLIZNA® is a CD19-directed cytolytic antibody indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

    • As part of its commercialization strategy for UPLIZNA®, Viela continues to focus on both centers of excellence and community neurologists throughout the U.S. To date, UPLIZNA® has been prescribed to a mix of newly diagnosed patients and those experiencing an inadequate response to their current maintenance regimen.

    • Viela recently initiated a Phase 3 trial with inebilizumab in patients with myasthenia gravis, a chronic, rare autoimmune neuromuscular disorder which affects about 56,000 people in the U.S.

    • Viela initiated a Phase 3 trial in patients with IgG4-related disease, a group of disorders marked by tumor-like swelling and fibrosis of affected organs.

    • The Phase 2 trial for kidney transplant desensitization remains voluntarily paused due to the COVID-19 pandemic.

    • Regulatory applications have been filed in several Asian countries based on results from the N-MOmentum study. If approved, Mitsubishi Tanabe Pharma Corporation (MTPC) and Hansoh Pharma—Viela's partners in Asia—will be responsible for commercializing inebilizumab in their respective territories, and Viela will be eligible for payments based on certain commercial milestones, as well as royalties on sales revenue.

    VIB4920

    VIB4920 is an investigational fusion protein designed to bind to CD40L on activated T cells, blocking their interaction with CD40-expressing B cells.

    • Viela is currently conducting a Phase 2b trial with VIB4920 in Sjögren's syndrome in addition to Phase 2 trials in patients with kidney transplant rejection and rheumatoid arthritis. Due to the COVID-19 pandemic, new patient enrollment in the Sjögren's syndrome and kidney transplant rejection trials had been voluntarily paused, but has recently resumed in both trials.

    VIB7734

    VIB7734 is designed to target and bind to ILT7, a cell surface molecule specific to pDCs, leading to their depletion. This depletion may also decrease other inflammatory cytokines such as TNF-alpha and IL-6, which are critical to the pathogenesis of a number of autoimmune diseases.

    • Viela recently reported the final data from its Phase 1b trial with VIB7734 in an oral presentation during a late-breaking session at the American College of Rheumatology (ACR) Convergence 2020—a premiere medical conference for inflammatory disease research. The results confirmed previously reported data, demonstrating that VIB7734 effectively reduced blood and skin plasmacytoid dendritic cells, leading to reduced type I Interferon levels in the blood and inflamed skin of patients with cutaneous lupus erythematosus (CLE). More CLE subjects treated with VIB7734 than placebo had a clinically significant improvement in CLASI-A scores—a scale that quantifies skin disease activity. Rates of adverse events were similar between VIB7734 and placebo groups.

    • Based on results from the Phase 1b study, Viela has selected systemic lupus erythematosus (SLE) as the lead indication of a planned Phase 2 trial, anticipated to initiate in H1 2021.

    • Viela is currently enrolling patients into its Phase 1 study with VIB7734 for the treatment of COVID-19-related acute lung injury. Results from this study are anticipated in H1 2021, at which time the Company will decide whether to pursue additional clinical trials in this indication.

    FINANCIAL RESULTS

    • Total net product sales for the third quarter of 2020 were $2.3 million, resulting from sales of UPLIZNA®. The company did not generate product sales in the third quarter of 2019.

    • For the third quarter of 2020, Viela reported a net loss of $37.6 million, compared to a net loss of $48.4 million for the third quarter of 2019. As of September 30, 2020, Viela had $387.5 million in cash, cash equivalents, and investments and no outstanding debt. Research and development expenses were $26.0 million for the third quarter of 2020, which include $1.4 million of non-cash stock-based compensation expenses.
    • Selling, general and administrative expenses were $14.0 million for the third quarter of 2020, which include $2.0 million of non-cash stock-based compensation expenses.
    • Total operating expenses for the third quarter of 2020 totaled $38.2 million, compared to $48.9 million for the third quarter of 2019. Non-cash share-based compensation expenses totaled $3.4 million for the third quarter of 2020, compared to $0.9 million for the third quarter of 2019.

    Conference Call and Webcast

    The Company will host a live webcast and conference call to discuss financial results and program highlights for the third quarter of 2020 today at 5:00 p.m. EST.

    The webcast will be accessible on the Events & Presentations page of Viela Bio's website. Individuals can participate in the conference call by dialing (877) 783-8848 (domestic) or (631) 350-0960 (international) and referring to conference ID #: 1237908.

    The archived webcast will be available for replay on the Viela Bio website approximately two hours after the event.

    About Viela Bio

    Viela Bio, headquartered in Gaithersburg, Maryland, is a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases. For more information, please visit www.vielabio.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans, objectives of management; our expectations regarding the commercialization of UPLIZNA®; our belief that UPLIZNA® provides prescribing physicians an important new treatment option for patients living with NMOSD; our belief that UPLIZNA® could reduce attacks which can lead to devastating and irreversible disability in patients living with NMOSD; our estimate of the number of people in the U.S. suffering from NMOSD; our estimate of the percentage of patients with NMOSD that test positive for anti-AQP4 antibodies; statements regarding the timing and progress of our ongoing clinical trials with inebilizumab in additional indications, as well as the initiation, timing, progress and results of our completed, ongoing and planned clinical trials for our other product candidates; statements regarding the timing and potential approval of UPLIZNA® in countries outside the United States; potential benefits of UPLIZNA®; our expectations regarding the availability of UPLIZNA®; and the commercialization and market acceptance of UPLIZNA®; our expectations about sufficiency of our existing cash balance and the anticipated impact of the COVID-19 pandemic on our commercialization efforts, business, operations and clinical trials; and our plans and the expected timing for the availability and reporting of data from our ongoing clinical trials are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue" or the negative of these terms or other comparable terminology, which are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various factors may cause differences between our expectations and actual results as discussed in greater detail in our filings with the Securities and Exchange Commission (SEC), including without limitation, the risks and uncertainties described in the section entitled "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2019 that was filed with the SEC on March 25, 2020 and our subsequent periodic and current reports filed with the SEC. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

    Consolidated Statements of Operations and Comprehensive Loss 
    (Unaudited)
    (In thousands, except share and per share amounts)
     
     Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
     2020 2019 2020 2019
    Revenue:               
    Product revenue, net$2,316  $  $2,316  $ 
    License revenue          20,000 
    Total revenue 2,316      2,316   20,000 
    Operating expenses:               
    Cost of products sold 650      650    
    Research and development 25,890   38,700   78,131   72,113 
    Selling, general and administrative 13,995   10,230   43,685   24,575 
    Total operating expenses 40,535   48,930   122,466   96,688 
    Loss from operations (38,219)  (48,930)  (120,150)  (76,688)
    Other income:               
    Interest income 574   520   2,871   1,829 
    Total other income 574   520   2,871   1,829 
    Net loss$(37,645) $(48,410) $(117,279) $(74,859)
    Net loss per share attributable to common stockholders—basic and diluted$(0.69) $(64.59) $(2.23) $(150.34)
    Weighted average common shares outstanding—basic and diluted 54,760,381   749,539   52,583,103   497,924 
    Other comprehensive income (loss)               
    Unrealized gains (loss) on marketable securities, net$(302) $(30) $348  $(30)
    Total other comprehensive income (loss) (302)  (30)  348   (30)
    Total comprehensive loss$(37,947) $(48,440) $(116,931) $(74,889)
                    

































     
    Consolidated Balance Sheets

    (Unaudited)

    (In thousands, except share and per share amounts)

        
     September 30,

    2020
     December 31,

    2019
    Assets       
    Current assets:       
    Cash and cash equivalents$111,649  $200,851 
    Marketable securities 273,534   113,945 
    Accounts receivable, net 2,507   30,000 
    Inventory 438    
    Prepaid and other current assets 14,944   6,242 
    Total current assets 403,072   351,038 
    Marketable securities, non-current 2,354   31,415 
    Property and equipment, net 1,933   1,499 
    Capital lease assets 965    
    Intangible assets, net 19,151    
    Other assets 122   102 
    Total assets$427,597  $384,054 
    Liabilities and stockholders' equity       
    Current liabilities:       
    Accounts payable$5,083  $7,459 
    Accrued expenses and other current liabilities 10,752   9,192 
    Related party liability 4,638   12,892 
    Capital lease liability - current 186    
    Total current liabilities 20,659   29,543 
    Capital lease liability - non-current 788    
    Total liabilities 21,447   29,543 
    Commitments and contingencies (Note 11)       
    Stockholders' equity:       
    Preferred stock, $0.001 par value; 5,000,000 shares authorized as of

    September 30, 2020 and December 31, 2019; no shares issued or outstanding

    as of September 30, 2020 and December 31, 2019
         
    Common stock, $0.001 par value; 200,000,000 shares authorized as of

    September 30, 2020 and December 31, 2019; 54,835,873 and 50,617,868

    shares issued and outstanding as of September 30, 2020 and

    December 31, 2019, respectively
     55   51 
    Additional paid-in capital 799,720   631,154 
    Accumulated other comprehensive income 353   5 
    Accumulated deficit (393,978)  (276,699)
    Total stockholders' equity 406,150   354,511 
    Total liabilities and stockholders' equity$427,597  $384,054 
            

    Source: Viela Bio

    Contacts:
    
    Investors:
    Solebury Trout
    Chad Rubin
    646-378-2947
     
    
    Media:
    Solebury Trout
    Amy Bonanno
    914-450-0349
    

    Primary Logo

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  2. -- VIB7734 potently depleted blood and tissue resident plasmacytoid dendritic cells, an important source of inflammatory mediators in autoimmune diseases --

    -- Treatment with VIB7734 resulted in clinically significant reduction in CLASI-A, a clinical measure of cutaneous lupus lesions --

    -- Results selected for oral presentation in "Late-Breaking Abstracts" session during the virtual American College of Rheumatology (ACR) Convergence 2020 --

    GAITHERSBURG, Md., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Viela Bio (NASDAQ:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases, today announced the final data from its Phase 1b trial of VIB7734…

    -- VIB7734 potently depleted blood and tissue resident plasmacytoid dendritic cells, an important source of inflammatory mediators in autoimmune diseases --

    -- Treatment with VIB7734 resulted in clinically significant reduction in CLASI-A, a clinical measure of cutaneous lupus lesions --

    -- Results selected for oral presentation in "Late-Breaking Abstracts" session during the virtual American College of Rheumatology (ACR) Convergence 2020 --

    GAITHERSBURG, Md., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Viela Bio (NASDAQ:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases, today announced the final data from its Phase 1b trial of VIB7734 in patients with cutaneous lupus erythematosus (CLE). VIB7734 is a monoclonal antibody that targets plasmacytoid dendritic cells (pDC), a cell type thought to play a critical role in the pathogenesis of lupus and other autoimmune diseases. In this trial, treatment with VIB7734 was shown to potently deplete pDC, both in blood and in CLE skin lesions. Most patients experienced a clinically significant reduction in the extent and severity of skin lesions following treatment with VIB7734. Rates of adverse events were similar between VIB7734 and placebo groups. This trial was selected for an oral presentation during the "Late-Breaking Abstracts" session hosted by the American College of Rheumatology (ACR20) Convergence 2020 from November 5-9.

    "These results build upon our previously reported data and suggest the potential of VIB7734 to treat autoimmune diseases in which pDCs play a key role. The study demonstrated that VIB7734 potently depleted pDCs and also reduced downstream inflammatory mediators such as type I interferons (IFN) in patients' blood and inflamed skin," said Jorn Drappa, M.D., Ph.D., Viela's Chief Medical Officer. "Patients with CLE treated with VIB7734 showed clinically significant improvements in their skin lesions as measured by the CLASI-A compared to patients treated with placebo. Additionally, VIB7734 exhibited an acceptable safety profile in this Phase 1b study."

    Continued Dr. Drappa: "Based on these results, we recently selected systemic lupus erythematosus (SLE) as the lead indication for subsequent development. We are planning to initiate a Phase 2 trial in SLE early next year. We also look forward to studying VIB7734 in additional autoimmune inflammatory diseases where pDCs play an important role."

    Study Details

    This Phase 1b clinical study enrolled three cohorts and was designed to evaluate the safety and tolerability of VIB7734 when given by three monthly subcutaneous doses at escalating dose levels. Cohort 1 enrolled patients with several autoimmune diseases thought to be driven by pDCs. Cohorts 2 and 3 enrolled active CLE patients with a CLASI-A ≥ 8. In cohorts 2 and 3, skin biopsies were taken before treatment and at Month 3 to enumerate pDCs and measure interferon mediated gene expression. A clinical disease activity score (CLASI-A) was also periodically measured in cohorts 2 and 3. The study enrolled a total of 31 patients.

    Select highlights include:

    • Reductions in circulating pDCs were evident at week 1 and persisted throughout the 3-month treatment period;
    • The median percent change in the peripheral blood IFN signature score at month 3 was -54% in the VIB7734 50 mg group, -83% in the VIB7734 150 mg group, and +8% in the placebo group;
    • In post-treatment skin punch biopsies obtained after 3 months, the median percent change in pDC density was -87% for the 50 mg group, -99% for the 150 mg group, and -14% for the placebo group;
    • At month 3, a ≥50% improvement in CLASI-A was observed in 75% of patients in the 150 mg group compared to 29% in the placebo group. 75% of subjects treated with the 150 mg dose of VIB7734 also achieved a 7-point or greater reduction in CLASI-A score at Month 3, compared to 14.3% of subjects in the placebo group;
    • No serious adverse events occurred in VIB7734-treated subjects;
    • The proportion of subjects with adverse event was similar in the combined VIB7734 and placebo groups (73% vs. 67%).

    ACR20 Presentation Details

    Abstract Title: Targeting Plasmacytoid Dendritic Cells Improves Cutaneous Lupus Erythematosus Skin Lesions and Reduces Type I Interferon Levels: Results of a Phase 1 Study of VIB7734

    Presentation Type: Oral Presentation

    Session: Late-Breaking Abstracts

    Presentation Date/Time: Monday, November 9 at 12:30 PM - 12:45 PM EST

    Abstract ID: 948289

    About VIB7734

    VIB7734 is a novel candidate in development for the treatment of autoimmune diseases caused by the overproduction of type I interferons and other cytokines secreted by specialized innate immune cells called plasmacytoid dendritic cells (pDCs). VIB7734, a monoclonal antibody, is designed to target and bind to ILT7, a cell surface molecule specific to pDCs, leading to their depletion. In turn, this may also decrease other inflammatory cytokines such as TNF-α and IL-6, which are critical to the pathogenesis of a number of autoimmune diseases.

    About Viela Bio

    Viela Bio, headquartered in Gaithersburg, Maryland, is a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases. For more information, please visit www.vielabio.com.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the potential benefits of VIB7734 and the initiation, timing, progress and results of our completed, ongoing and planned clinical trials for VIB7734 are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue" or the negative of these terms or other comparable terminology, which are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various factors may cause differences between our expectations and actual results as discussed in greater detail in our filings with the Securities and Exchange Commission (SEC), including without limitation, the risks and uncertainties described in the section entitled "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2019 that was filed with the SEC on March 25, 2020 and our subsequent periodic and current reports filed with the SEC. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

    Source: Viela Bio

    Contacts:
    
    Investors:
    Solebury Trout
    Chad Rubin
    646-378-2947
    
    
    Media:
    Solebury Trout
    Amy Bonanno
    914-450-0349
    

    Primary Logo

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  3. GAITHERSBURG, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Viela Bio (NASDAQ:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases, today announced it will host a webcast and conference call on Tuesday, November 10, 2020 at 5:00 p.m. EST to discuss its third quarter 2020 financial results and program highlights.

    The webcast will be accessible on the Events & Presentations page of the Company's website. Individuals can participate in the conference call by dialing (877) 783-8848 (domestic) or (631) 350-0960 (international) and referring to conference ID #: 1237908. The archived webcast will be available for replay on the Viela Bio website approximately…

    GAITHERSBURG, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Viela Bio (NASDAQ:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases, today announced it will host a webcast and conference call on Tuesday, November 10, 2020 at 5:00 p.m. EST to discuss its third quarter 2020 financial results and program highlights.

    The webcast will be accessible on the Events & Presentations page of the Company's website. Individuals can participate in the conference call by dialing (877) 783-8848 (domestic) or (631) 350-0960 (international) and referring to conference ID #: 1237908. The archived webcast will be available for replay on the Viela Bio website approximately two hours after the event.

    About Viela Bio

    Viela Bio, headquartered in Gaithersburg, Maryland, is a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases. For more information, please visit www.vielabio.com.

    Source: Viela Bio

    Contacts:
    
    Investors:
    Solebury Trout
    Chad Rubin
    646-378-2947
    
    
    Media:
    Solebury Trout
    Amy Bonanno
    914-450-0349
    

    Primary Logo

    View Full Article Hide Full Article
  4. GAITHERSBURG, Md., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Viela Bio (NASDAQ:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases, today announced that four abstracts have been accepted for presentation, including a late-breaker, at the upcoming 8th Joint Congress of the American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The congress will be held virtually on September 11-13, 2020 with an Encore event featuring late-breaker and COVID-19 presentations on September 26, 2020.

    Poster Presentations:
    Title: AQP4-IgG seronegative patients…

    GAITHERSBURG, Md., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Viela Bio (NASDAQ:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases, today announced that four abstracts have been accepted for presentation, including a late-breaker, at the upcoming 8th Joint Congress of the American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The congress will be held virtually on September 11-13, 2020 with an Encore event featuring late-breaker and COVID-19 presentations on September 26, 2020.

    Poster Presentations:

    Title: AQP4-IgG seronegative patients in the N-MOmentum trial of inebilizumab in neuromyelitis optica spectrum disorder (P0189)

    Date: Friday, September 11, 2020

    Time: 8:00 AM EDT

    Title: Serum neurofilament light chain levels (sNfL) correlate with attack-related disability in neuromyelitis optica (P0155)

    Date: Friday, September 11, 2020

    Time: 8:00 AM EDT

    Title: Quiescent MRI activity in NMOSD: results from the N-MOmentum randomized placebo-

    controlled trial (P0229)

    Date: Friday, September 11, 2020

    Time: 8:00 AM EDT

    Late-Breaker Presentation:

    Title: Pharmacodynamic modeling and exposure-response assessment of inebilizumab in subjects with neuromyelitis optica spectrum disorders (LB1239)

    Date: Saturday, September 26, 2020

    Time: 8:00 AM EDT

    About Viela Bio

    Viela Bio, headquartered in Gaithersburg, Maryland, is a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases. For more information, please visit www.vielabio.com.

    Source: Viela Bio

    Contacts:

    Investors:

    Solebury Trout

    Chad Rubin

    646-378-2947

     

    Media:

    Solebury Trout

    Amy Bonanno

    914-450-0349

    Primary Logo

    View Full Article Hide Full Article
  5. GAITHERSBURG, Md., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Viela Bio (NASDAQ:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases, today reported financial results and provided program highlights for the second quarter ended June 30, 2020.

    "Viela had another productive quarter marked by the U.S. FDA approval of UPLIZNA™—also known as inebilizumab—in the U.S.," said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. "In parallel, we continue to advance the development of inebilizumab in the U.S. in additional indications such as myasthenia gravis and IgG4-related disease."

    Added Dr. Yao: "Beyond UPLIZNA™, we continue to make progress throughout…

    GAITHERSBURG, Md., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Viela Bio (NASDAQ:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases, today reported financial results and provided program highlights for the second quarter ended June 30, 2020.

    "Viela had another productive quarter marked by the U.S. FDA approval of UPLIZNA™—also known as inebilizumab—in the U.S.," said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. "In parallel, we continue to advance the development of inebilizumab in the U.S. in additional indications such as myasthenia gravis and IgG4-related disease."

    Added Dr. Yao: "Beyond UPLIZNA™, we continue to make progress throughout our entire pipeline. We recently reported positive interim Phase 1b data from our ongoing trial with VIB7734 and selected systemic lupus erythematosus as our area of focus for a Phase 2 trial. Separately, we are planning to initiate a Phase 1 trial with this product candidate in patients with COVID-19-related acute lung injury. Looking toward our objectives for the rest of the year and beyond, we are well-positioned having recently raised gross proceeds of approximately $169 million in an underwritten public offering, which will support our clinical and commercial execution and extends our cash runway into 2023."

    PROGRAM HIGHLIGHTS

    UPLIZNA™ (inebilizumab-cdon)

    • UPLIZNA™ Commercial Launch Underway

      On June 11, the U.S. Food and Drug Administration (FDA) approved UPLIZNA™ for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive as a twice-a-year maintenance regimen following initial doses. UPLIZNA™ is the first and only treatment designed to deplete B cells that is approved by the FDA for this patient population. Commercial launch activities are currently underway, with focus on both centers of excellence and community neurologists throughout the U.S.  

       
    • Viela Preparing for Additional Clinical Trials with Inebilizumab

      Phase 3 trials of inebilizumab in myasthenia gravis and IgG4-related disease are projected to initiate in Q4 2020. The Company is also conducting a Phase 2 trial for kidney transplant desensitization, which due to the COVID-19 pandemic, remains voluntarily paused.

    VIB4920

    • Viela Resumes New Patient Enrollment in Ongoing Trial with VIB4920

      Viela is currently conducting a Phase 2b trial with VIB4920 in Sjögren's syndrome as well as a Phase 2 trial in patients with kidney transplant rejection. Due to the COVID-19 pandemic, new patient enrollment in both trials had been voluntarily paused, but has recently resumed in the kidney transplant rejection trial, with enrollment in the Sjögren's trial anticipated to resume in Q4 2020. The Company continues to explore other potential indications associated with the CD40/CD40L co-stimulatory pathway for potential additional clinical studies.

    VIB7734

    • Company Reports Interim Results from Phase 1b trial with VIB7734 and Selects SLE for Phase 2 Trial

      In May, the Company reported positive interim data from a Phase 1b study with VIB7734, its novel anti-ILT7 therapy. Interim findings indicated safety and tolerability comparable to placebo control across all cohorts with the final data analysis expected to be completed in Q3 2020. Based on the positive interim results, as well as additional efficacy and biomarker data from cohort 3, the Company has selected systemic lupus erythematosus (SLE) as the lead indication of a planned Phase 2 trial.
    • Viela Prepares for New Study in COVID-19-Related Acute Lung Injury

      Viela is planning to initiate a Phase 1 study in Q3 2020 with VIB7734 in patients with COVID-19-related acute lung injury. Results from this study are anticipated in Q1 2021, at which time the Company will decide whether to pursue additional clinical trials in this indication.

    FINANCIAL RESULTS

    • For the second quarter of 2020, Viela reported a net loss of $38.9 million, compared to a net loss of $5.5 million for the second quarter of 2019. As of June 30, 2020, Viela had $448.4 million in cash, cash equivalents, and investments and no outstanding debt. In June 2020, Viela completed an underwritten public offering of its common stock and issued and sold 3,600,000 shares of common stock, at a public offering price of $47.00 per share, for aggregate gross proceeds of $169.2 million.



    • Research and development expenses were $25.4 million for the second quarter of 2020, which include $1.4 million of non-cash stock-based compensation expenses.

       
    • General and administrative expenses were $14.4 million for the second quarter of 2020, which include $1.7 million of non-cash stock-based compensation expenses.

       
    • Total operating expenses for the second quarter of 2020 totaled $39.8 million, compared to $6.1 million for the second quarter of 2019. Non-cash share-based compensation expenses totaled $3.1 million for the second quarter of 2020, compared to $0.6 million for the second quarter of 2019.

    Conference Call and Webcast

    The Company will host a live webcast and conference call to discuss financial results and program highlights for the second quarter of 2020 today at 5:00 p.m. EDT.

    The webcast will be accessible on the Events & Presentations page of Viela Bio's website. Individuals can participate in the conference call by dialing (877) 783-8848 (domestic) or (631) 350-0960 (international) and referring to conference ID #: 4945969

    The archived webcast will be available for replay on the Viela Bio website approximately two hours after the event.

    About Viela Bio

    Viela Bio, headquartered in Gaithersburg, Maryland, is a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases. For more information, please visit www.vielabio.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans, objectives of management; our expectations regarding the commercialization of UPLIZNA™; our belief that UPLIZNA™ provides prescribing physicians an important new treatment option for patients living with NMOSD; our belief that UPLIZNA™ could reduce attacks which can lead to devastating and irreversible disability in patients living with NMOSD; our estimate of the number of people in the U.S. suffering from NMOSD; our estimate of the percentage of patients with NMOSD that test positive for anti-AQP4 antibodies; statements regarding the timing and progress of our ongoing clinical trials with inebilizumab in additional indications, as well as with our other product candidates; potential benefits of UPLIZNA™; our expectations regarding the availability of UPLIZNA™; and the commercialization and market acceptance of UPLIZNA™; our expectations about sufficiency of our existing cash balance and the anticipated impact of the COVID-19 pandemic on our commercialization efforts, business, operations and clinical trials; and our plans and the expected timing for the availability and reporting of data from our ongoing clinical trials are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue" or the negative of these terms or other comparable terminology, which are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various factors may cause differences between our expectations and actual results as discussed in greater detail in our filings with the Securities and Exchange Commission (SEC), including without limitation, the risks and uncertainties described in the section entitled "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2019 that was filed with the SEC on March 25, 2020 and our subsequent periodic and current reports filed with the SEC. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

    Statements of Operations and Comprehensive Loss

    (Unaudited)

    (In thousands, except share and per share amounts)

     Three Months Ended

    June 30,
      Six Months Ended

    June 30,
     
     2020

     2019

     2020

     2019 
    Revenue:               
    License revenue$  $20,000  $  $20,000 
    Total revenue    20,000      20,000 
    Operating expenses:               
    Research and development 25,412   16,811   52,241   33,426 
    General and administrative 14,408   9,296   29,690   14,333 
    Total operating expenses 39,820   26,107   81,931   47,759 
    Loss from operations (39,820)  (6,107)  (81,931)  (27,759)
    Other income:               
    Interest income 963   634   2,297   1,310 
    Total other income 963   634   2,297   1,310 
    Net loss$(38,857) $(5,473) $(79,634) $(26,449)
    Net loss per share attributable to common stockholders—basic and diluted$(0.74) $(8.94) $(1.55) $(72.06)
    Weighted average common shares outstanding—basic and diluted 52,212,006   612,059   51,482,502   367,041 
    Other comprehensive income               
    Unrealized gains on marketable securities, net$776  $  $650  $ 
    Total other comprehensive income 776      650    
    Total comprehensive loss$(38,081) $(5,473) $(78,984) $(26,449)
                    

    Balance Sheets

    (Unaudited)

    (In thousands, except share and per share amounts)

     June 30,

    2020
      December 31,

    2019
     
    Assets       
    Current assets:       
    Cash and cash equivalents$131,551  $200,851 
    Marketable securities 293,995   113,945 
    Accounts receivable    30,000 
    Prepaid and other current assets 11,261   6,242 
    Total current assets 436,807   351,038 
    Marketable securities, non-current 22,832   31,415 
    Property and equipment, net 1,517   1,499 
    Capital lease assets 1,017    
    Intangible assets 19,700    
    Other assets 122   102 
    Total assets$481,995  $384,054 
    Liabilities and stockholders' equity       
    Current liabilities:       
    Accounts payable$6,337  $7,459 
    Accrued expenses and other current liabilities 29,930   9,192 
    Related party liability 4,490   12,892 
    Capital lease liability - current 184    
    Total current liabilities 40,941   29,543 
    Capital lease liability - non-current 836    
    Total liabilities 41,777   29,543 
    Commitments and contingencies       
    Stockholders' equity:       
    Preferred stock, $0.001 par value; 5,000,000 shares authorized as of June 30, 2020 and December 31, 2019; no shares issued or outstanding as of June 30, 2020 and December 31, 2019     
    Common stock, $0.001 par value; 200,000,000 shares authorized as of June 30, 2020 and December 31, 2019; 54,722,948 and 50,617,868 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively 54   51 
    Additional paid-in capital 795,842   631,154 
    Accumulated other comprehensive income 655   5 
    Accumulated deficit (356,333)  (276,699)
    Total stockholders' equity 440,218   354,511 
    Total liabilities and stockholders' equity$481,995  $384,054 

    Source: Viela Bio

    Contacts:
    
    Investors:
    Solebury Trout
    Chad Rubin
    646-378-2947
     
    
    Media:
    Solebury Trout
    Amy Bonanno
    914-450-0349
    

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