GAITHERSBURG, Md., March 25, 2020 (GLOBE NEWSWIRE) — Viela Bio (Nasdaq:VIE), a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory diseases, today reported financial results and provided program highlights for the fourth quarter and full year ended December 31, 2019.
“2019 was a pivotal year for Viela as we achieved many important financial, clinical and regulatory milestones. Supported by our recently completed initial public offering, we ended the year with a strong cash position, enabling continued pipeline growth and expansion,” said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. “With a Biologics License Application (BLA) under review by the U.S. Food and Drug Administration (FDA) for our lead product candidate inebilizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD), we have hired and trained a talented and experienced commercial team in anticipation of its potential approval. Based on strong efficacy and safety results, we believe that inebilizumab has the potential to be an important new treatment option for patients who suffer from NMOSD, a devastating, rare neuroinflammatory disease.“While our top priority remains preparing to launch inebilizumab, we continue to make strong progress throughout our entire pipeline. We recently dosed the first patient in our Phase 2b trial of VIB4920 for the treatment of Sjögren’s syndrome and expect to report interim results from a cohort of patients with cutaneous lupus erythematosus in our ongoing Phase 1b trial of VIB7734 in the second quarter of 2020.” PROGRAM HIGHLIGHTSInebilizumabBLA for the Treatment of NMOSD Under FDA Review
In August 2019, the FDA accepted for review Viela’s BLA for inebilizumab and set a Prescription Drug User Fee Act, or PDUFA, action date of June 11, 2020. Inebilizumab, which was studied as a potential first-line monotherapy in patients with NMOSD, previously received Orphan Drug and Breakthrough Therapy designations from the FDA. The safety and efficacy data from the pivotal N-MOmentum trial—which formed the basis of the BLA filing—were recently published in the peer-reviewed journal, The Lancet.
Commercial Planning Activities On Track
In anticipation of the potential FDA approval of inebilizumab for the treatment of NMOSD under the Company’s first BLA, Viela has hired and trained a seasoned sales force with extensive experience leading neurology or rare disease product launches. Commercial efforts will focus on community and top centers of excellence. There are an estimated 10,000 NMOSD patients in the U.S.Viela Planning to Initiate Additional Clinical Trials, Including a Pivotal Trial
Viela Bio recently submitted two Investigational New Drug (IND) applications to the FDA to begin human studies of inebilizumab in myasthenia gravis and IgG4-related disease, and plans to initiate phase 3 pivotal and Phase 2b trials, respectively, in mid-year 2020.VIB4920Phase 2b Trial in Patients with Sjögren’s Syndrome
In 2019, Viela initiated a Phase 2b trial for VIB4920 in patients with Sjögren’s syndrome— a common rheumatic disease for which there are currently no approved disease-modifying therapies. Patients with Sjögren’s syndrome suffer from debilitating fatigue and mouth and eye dryness, and in some cases, lung and kidney disease as well as an increased risk of lymphoma. Based on earlier clinical data, Viela believes that treatment with VIB4920—a fusion protein designed to bind to CD40L—could address immune overactivation in T and B cell-driven diseases such as Sjögren’s syndrome.Additional Ongoing and Potential VIB4920 Clinical Trials
In 2019, Viela initiated a Phase 2 trial in patients with kidney transplant rejection. The Company is also exploring other potential indications associated with the CD40/CD40L co-stimulatory pathway in which to pursue additional clinical studies with VIB4920.VIB7734Interim Results Anticipated from Phase 1b Trial
Viela plans to report interim results from a cohort of patients with cutaneous lupus erythematosus from the ongoing Phase 1b trial of VIB7734 in the second quarter of 2020. The drug candidate is designed to target and bind to ILT7, a cell surface molecule specific to plasmacytoid dendritic cells (pDCs), leading to their depletion. Assuming the trial is able to establish proof of concept, Viela plans to progress VIB7734 to Phase 2 clinical trials in other autoimmune diseases that are also driven by the overproduction of type I interferons, cytokines and other chemokines secreted by pDCs.CORPORATE UPDATESViela Raised Over $172 Million in Successful Initial Public Offering (IPO)
In October 2019, Viela closed its IPO of 9,085,000 shares of common stock, which included 1,185,000 shares sold pursuant to the full exercise by the underwriters of their option to purchase additional shares, at a price to the public of $19.00 per share, for gross proceeds of approximately $172.6 million, before deducting the underwriting discounts and commissions and estimated offering expenses.
Expanded Partnerships for Global Development and Commercialization of Inebilizumab
In October 2019, Viela announced a partnership with Mitsubishi Tanabe Pharma Corporation to develop and commercialize inebilizumab in Japan and eight additional Asian countries for NMOSD and other potential indications. Viela received an upfront licensing fee of $30 million and will receive development and commercialization milestones and payments based, in part, on sales revenue.
Viela is also partnered with Hansoh Pharmaceuticals Group Company Limited for the development and commercialization of inebilizumab for autoimmune diseases and hematologic cancers in China, Hong Kong and Macau. Viela received a $20 million upfront payment and is eligible to receive milestone payments of up to an aggregate of $203 million, plus royalties on sales revenue.
FINANCIAL RESULTSFor the fourth quarter of 2019, Viela reported a net loss of $11.6 million, compared to a net loss of $15.1 million for the fourth quarter of 2018. For the full year 2019, Viela Bio reported a net loss of $86.4 million, compared to a net loss of $190.3 million for the full year 2018. As of December 31, 2019, Viela had $346.2 million in cash, cash equivalents, and investments and no outstanding debt. Viela received $30.0 million in cash for the upfront licensing fee from Mitsubishi Tanabe Pharma Corporation in 1Q 2020.
Research and development expenses were $32.5 million for the fourth quarter of 2019, which include $0.7 million of non-cash stock-based compensation expenses. For the full year of 2019, research and development expenses were $104.6 million. Research and development expenses for the year include $1.8 million of non-cash stock-based compensation expenses.
General and administrative expenses were $10.5 million for the fourth quarter of 2019, which include $0.7 million of non-cash stock-based compensation expenses. For the full year of 2019, general and administrative expenses were $35.1 million, which include $1.8 million of non-cash stock-based compensation expenses.
Total operating expenses for the fourth quarter of 2019 totaled $43.0 million, compared to $15.7 million for the fourth quarter of 2018. Non-cash share-based compensation expenses totaled $1.4 million for the fourth quarter of 2019, compared to $0.6 million for the fourth quarter of 2018.
Total operating expenses for the full-year 2019 totaled $139.7 million, compared to $192.3 million for the full-year 2018. Non-cash share-based compensation expense totaled $3.6 million for the full-year 2019, compared to $1.9 million for the full-year 2018.2020 Financial GuidanceViela Bio expects that its cash, cash equivalents and investments will fund its operating plans into the first half of 2022.Conference Call and WebcastThe Company will host a live webcast and conference call to discuss its fourth quarter and full year financial results for 2019 and provide an update on recent corporate activities today at 5:00 p.m. ET.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 #: 5057166.The archived webcast will be available for replay on the Viela Bio website approximately two hours after the event.About Viela BioViela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage 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 StatementsThis 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, potential benefits of inebilizumab, the timing and progress of clinical development and potential commercialization of our product candidates, if approved, our expectations about sufficiency of our existing cash balance, and the expected timing and the potential for payments under the agreements with Hansoh and MTPC 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 around the duration and severity of the novel coronavirus outbreak and impact of it and COVID-19 on our product candidates clinical trials, development and, if approved, commercialization plans and business operations and 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. 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.
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