By writer to www.globenewswire.com
GAITHERSBURG, Md., Nov. 10, 2020 (GLOBE NEWSWIRE) — Viela Bio (Nasdaq:VIE), a biotechnology firm devoted to the invention, improvement and commercialization of novel remedies for autoimmune and extreme inflammatory illnesses, as we speak reported monetary outcomes and offered program highlights for the third quarter ended September 30, 2020.
“A number of months into UPLIZNA’s launch, now we have gained priceless insights into how you can meet our buyer’s wants, which proceed to evolve throughout the COVID-19 pandemic. We’re inspired by the rising product uptake and our business staff stays nimble in how we interact with particular person practitioners and facilities of excellence throughout the U.S.,” stated Bing Yao, Ph.D., Chief Govt Officer at Viela Bio. “As we and our companions await the potential approval of UPLIZNA in a number of Asian international locations, we proceed to increase its improvement within the U.S. in varied illnesses, together with myasthenia gravis and IgG4-related illness, the place we consider it might have a big scientific profit over present therapies.”
Added Dr. Yao: “Whereas we pursue the potential growth of UPLIZNA to extra affected person populations, we proceed to make stable progress throughout our whole pipeline. Not too long ago, we introduced information from our Part 1b research of VIB7734 in an oral presentation at ACR Convergence 2020, confirming its potential to cut back lesions in lupus sufferers and have chosen systemic lupus erythematosus for our deliberate Part 2 trial. Moreover, we proceed to enroll new sufferers into our ongoing trials with VIB4920, which embody mid-stage research in Sjögren’s syndrome, rheumatoid arthritis and kidney transplant rejection and are planning to submit an IND for a brand new preclinical candidate by the tip of this yr.”
UPLIZNA® is a CD19-directed cytolytic antibody indicated for the therapy of neuromyelitis optica spectrum dysfunction (NMOSD) in grownup sufferers who’re anti-aquaporin-4 (AQP4) antibody optimistic.
- As a part of its commercialization technique for UPLIZNA®, Viela continues to concentrate on each facilities of excellence and group neurologists all through the U.S. To this point, UPLIZNA® has been prescribed to a mixture of newly identified sufferers and people experiencing an insufficient response to their present upkeep routine.
- Viela lately initiated a Part Three trial with inebilizumab in sufferers with myasthenia gravis, a power, uncommon autoimmune neuromuscular dysfunction which impacts about 56,000 individuals within the U.S.
- Viela initiated a Part Three trial in sufferers with IgG4-related illness, a bunch of problems marked by tumor-like swelling and fibrosis of affected organs.
- The Part 2 trial for kidney transplant desensitization stays voluntarily paused because of the COVID-19 pandemic.
- Regulatory functions have been filed in a number of Asian international locations primarily based on outcomes from the N-MOmentum research. If accredited, Mitsubishi Tanabe Pharma Company (MTPC) and Hansoh Pharma—Viela’s companions in Asia—will probably be liable for commercializing inebilizumab of their respective territories, and Viela will probably be eligible for funds primarily based on sure business milestones, in addition to royalties on gross sales income.
VIB4920 is an investigational fusion protein designed to bind to CD40L on activated T cells, blocking their interplay with CD40-expressing B cells.
- Viela is at the moment conducting a Part 2b trial with VIB4920 in Sjögren’s syndrome along with Part 2 trials in sufferers with kidney transplant rejection and rheumatoid arthritis. As a result of COVID-19 pandemic, new affected person enrollment within the Sjögren’s syndrome and kidney transplant rejection trials had been voluntarily paused, however has lately resumed in each trials.
VIB7734 is designed to focus on and bind to ILT7, a cell floor molecule particular to pDCs, resulting in their depletion. This depletion can also lower different inflammatory cytokines comparable to TNF-alpha and IL-6, that are essential to the pathogenesis of various autoimmune illnesses.
- Viela lately reported the ultimate information from its Part 1b trial with VIB7734 in an oral presentation throughout a late-breaking session on the American Faculty of Rheumatology (ACR) Convergence 2020—a premiere medical convention for inflammatory illness analysis. The outcomes confirmed beforehand reported information, demonstrating that VIB7734 successfully lowered blood and pores and skin plasmacytoid dendritic cells, resulting in lowered kind I Interferon ranges within the blood and infected pores and skin of sufferers with cutaneous lupus erythematosus (CLE). Extra CLE topics handled with VIB7734 than placebo had a clinically vital enchancment in CLASI-A scores—a scale that quantifies pores and skin illness exercise. Charges of hostile occasions had been related between VIB7734 and placebo teams.
- Based mostly on outcomes from the Part 1b research, Viela has chosen systemic lupus erythematosus (SLE) because the lead indication of a deliberate Part 2 trial, anticipated to provoke in H1 2021.
- Viela is at the moment enrolling sufferers into its Part 1 research with VIB7734 for the therapy of COVID-19-related acute lung damage. Outcomes from this research are anticipated in H1 2021, at which era the Firm will resolve whether or not to pursue extra scientific trials on this indication.
- Complete web product gross sales for the third quarter of 2020 had been $2.Three million, ensuing from gross sales of UPLIZNA®. The corporate didn’t generate product gross sales within the third quarter of 2019.
- For the third quarter of 2020, Viela reported a web lack of $37.6 million, in comparison with a web lack of $48.Four million for the third quarter of 2019. As of September 30, 2020, Viela had $387.5 million in money, money equivalents, and investments and no excellent debt. Analysis and improvement bills had been $26.Zero million for the third quarter of 2020, which embody $1.Four million of non-cash stock-based compensation bills.
- Promoting, basic and administrative bills had been $14.Zero million for the third quarter of 2020, which embody $2.Zero million of non-cash stock-based compensation bills.
- Complete working bills for the third quarter of 2020 totaled $38.2 million, in comparison with $48.9 million for the third quarter of 2019. Non-cash share-based compensation bills totaled $3.Four million for the third quarter of 2020, in comparison with $0.9 million for the third quarter of 2019.
Convention Name and Webcast
The Firm will host a dwell webcast and convention name to debate monetary outcomes and program highlights for the third quarter of 2020 as we speak at 5:00 p.m. EST.
The webcast will probably be accessible on the Events & Presentations web page of Viela Bio’s web site. People can take part within the convention name by dialing (877) 783-8848 (home) or (631) 350-0960 (worldwide) and referring to convention ID #: 1237908.
The archived webcast will probably be obtainable for replay on the Viela Bio web site roughly two hours after the occasion.
About Viela Bio
Viela Bio, headquartered in Gaithersburg, Maryland, is a biotechnology firm devoted to the invention, improvement and commercialization of novel remedies for autoimmune and extreme inflammatory illnesses. For extra info, please go to www.vielabio.com.
This press launch accommodates forward-looking statements throughout the which means of the Non-public Securities Litigation Reform Act of 1995. All statements, apart from statements of historic information, contained on this press launch, together with statements concerning our technique, future operations, prospects, plans, aims of administration; our expectations concerning the commercialization of UPLIZNA®; our perception that UPLIZNA® gives prescribing physicians an vital new therapy choice for sufferers residing with NMOSD; our perception that UPLIZNA® might cut back assaults which might result in devastating and irreversible incapacity in sufferers residing with NMOSD; our estimate of the variety of individuals within the U.S. affected by NMOSD; our estimate of the proportion of sufferers with NMOSD that take a look at optimistic for anti-AQP4 antibodies; statements concerning the timing and progress of our ongoing scientific trials with inebilizumab in extra indications, in addition to the initiation, timing, progress and outcomes of our accomplished, ongoing and deliberate scientific trials for our different product candidates; statements concerning the timing and potential approval of UPLIZNA® in international locations exterior the US; potential advantages of UPLIZNA®; our expectations concerning the supply of UPLIZNA®; and the commercialization and market acceptance of UPLIZNA®; our expectations about sufficiency of our present money stability and the anticipated affect of the COVID-19 pandemic on our commercialization efforts, enterprise, operations and scientific trials; and our plans and the anticipated timing for the supply and reporting of information from our ongoing scientific trials are forward-looking statements. In some instances, you possibly can determine forward-looking statements by terminology comparable to “anticipate,” “consider,” “estimate,” “anticipate,” “intend,” “might,” “plan,” “predict,” “undertaking,” “goal,” “potential,” “will,” “would,” “might,” “ought to,” “proceed” or the destructive of those phrases or different comparable terminology, that are meant to determine forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. We might not truly obtain the plans, intentions or expectations disclosed in our forward-looking statements, and you shouldn’t place undue reliance on our forward-looking statements. Precise outcomes or occasions might differ materially from the plans, intentions and expectations disclosed within the forward-looking statements we make. Numerous elements might trigger variations between our expectations and precise outcomes as mentioned in better element in our filings with the Securities and Trade Fee (SEC), together with with out limitation, the dangers and uncertainties described within the part entitled “Danger Components” in our annual report on Type 10-Okay for the yr ended December 31, 2019 that was filed with the SEC on March 25, 2020 and our subsequent periodic and present experiences filed with the SEC. We don’t assume any obligation to replace any forward-looking statements, whether or not on account of new info, future occasions or in any other case, besides as required by regulation.
|Consolidated Statements of Operations and Complete Loss|
|(In 1000’s, besides share and per share quantities)|
|Three Months Ended
|9 Months Ended
|Product income, web||$||2,316||$||—||$||2,316||$||—|
|Price of merchandise bought||650||—||650||—|
|Analysis and improvement||25,890||38,700||78,131||72,113|
|Promoting, basic and administrative||13,995||10,230||43,685||24,575|
|Complete working bills||40,535||48,930||122,466||96,688|
|Loss from operations||(38,219||)||(48,930||)||(120,150||)||(76,688||)|
|Complete different revenue||574||520||2,871||1,829|
|Web loss per share attributable to frequent stockholders—primary and diluted||$||(0.69||)||$||(64.59||)||$||(2.23||)||$||(150.34||)|
|Weighted common frequent shares excellent—primary and diluted||54,760,381||749,539||52,583,103||497,924|
|Different complete revenue (loss)|
|Unrealized good points (loss) on marketable securities, web||$||(302||)||$||(30||)||$||348||$||(30||)|
|Complete different complete revenue (loss)||(302||)||(30||)||348||(30||)|
|Complete complete loss||$||(37,947||)||$||(48,440||)||$||(116,931||)||$||(74,889||)|
|Consolidated Stability Sheets|
|(In 1000’s, besides share and per share quantities)|
|Money and money equivalents||$||111,649||$||200,851|
|Accounts receivable, web||2,507||30,000|
|Pay as you go and different present property||14,944||6,242|
|Complete present property||403,072||351,038|
|Marketable securities, non-current||2,354||31,415|
|Property and tools, web||1,933||1,499|
|Capital lease property||965||—|
|Intangible property, web||19,151||—|
|Liabilities and stockholders’ fairness|
|Accrued bills and different present liabilities||10,752||9,192|
|Associated occasion legal responsibility||4,638||12,892|
|Capital lease legal responsibility – present||186||—|
|Complete present liabilities||20,659||29,543|
|Capital lease legal responsibility – non-current||788||—|
|Commitments and contingencies (Notice 11)|
|Most well-liked inventory, $0.001 par worth; 5,000,000 shares licensed as of
September 30, 2020 and December 31, 2019; no shares issued or excellent
as of September 30, 2020 and December 31, 2019
|Widespread inventory, $0.001 par worth; 200,000,000 shares licensed as of
September 30, 2020 and December 31, 2019; 54,835,873 and 50,617,868
shares issued and excellent as of September 30, 2020 and
December 31, 2019, respectively
|Further paid-in capital||799,720||631,154|
|Gathered different complete revenue||353||5|
|Complete stockholders’ fairness||406,150||354,511|
|Complete liabilities and stockholders’ fairness||$||427,597||$||384,054|
Supply: Viela Bio