On November 14, 2019 Viela Bio (Nasdaq:VIE), a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory diseases, reported financial results and provided program highlights for the third quarter ended September 30, 2019 (Press release, Viela Bio, NOV 14, 2019, View Source [SID1234551291]).
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"Our Company has achieved significant financial, regulatory and business development milestones underscored by our successful recent initial public offering and listing on the Nasdaq Global Select Market," said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. "In August 2019, the U.S. FDA accepted for review our Biologics License Application for inebilizumab, and we now look forward to supporting global development and commercialization activities for this candidate, if approved. In preparation for the potential approval of inebilizumab, our commercial team is hard at work on product launch preparation, while our clinical team prepares to initiate a number of studies across our pipeline of novel autoimmune and severe inflammatory disease therapies."
Continued Dr. Yao, "Based on the positive results from our pivotal study of inebilizumab in neuromyelitis optica spectrum disorder, or NMOSD, we believe it may represent a transformative therapy for patients suffering from this rare and devastating disease. While we look forward to the continued planned expansion of our pipeline, our near-term priority remains delivering inebilizumab to the many patients who currently lack a viable treatment option."
PROGRAM HIGHLIGHTS
Inebilizumab
U.S. FDA Reviewing Inebilizumab BLA for NMOSD
In August 2019, the U.S. Food and Drug Administration (FDA) accepted for review the Company’s Biologics License Application (BLA) for inebilizumab, clinically studied as a first-line monotherapy for neuromyelitis optica spectrum disorder (NMOSD). The FDA set a Prescription Drug User Fee Act, or PDUFA, date of June 11, 2020.
Inebilizumab Commercial Planning Activities Underway
In preparation for inebilizumab’s potential commercialization, if approved, in the United States, Viela is focused on developing a dedicated commercial team to target medical centers of excellence.
Pivotal Trial Data Published in The Lancet
Peer-reviewed journal, The Lancet, published safety and efficacy results from the pivotal N-MOmentum trial, the largest global, placebo-controlled study in NMOSD. The data were also presented earlier this year during a plenary session at the 2019 American Academy of Neurology (AAN) Annual Meeting.
Company Preparing to Initiate Additional Inebilizumab Clinical Trial
Viela is planning to submit an investigational new drug (IND) application and initiate a pivotal trial in myasthenia gravis in first half of 2020. In addition, Viela is planning to submit an IND and initiate a Phase 2b trial in IgG4-Related Disease in the first half of 2020. Furthermore, Viela is planning to initiate a Phase 2 proof-of-concept study to explore the potential of inebilizumab, used alone or in combination with VIB4920, to reduce levels of alloantibodies in kidney transplant candidates thereby improving transplant outcomes before the end of 2019.
VIB4920
Company Prepares to Initiate Phase 2b Trial with VIB4920
Before the end of 2019, Viela expects to initiate a Phase 2b trial in Sjögren’s syndrome. Viela is also expected to initiate a Phase 2 proof-of-concept study with VIB4920 in kidney transplant.
VIB7734
VIB7734 Phase 1b Ongoing
The VIB7734 Phase 1b multiple ascending dose trial is ongoing. The trial includes a cohort of patients with multiple autoimmune diseases as well as separate cohorts of patients with cutaneous lupus erythematosus, in the presence or absence of SLE.
CORPORATE UPDATES
Viela Closed Initial Public Offering (IPO)
In October 2019, the Company closed its IPO of 9,085,000 shares of common stock, which included 1,185,000 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $19.00 per share. Including the option exercise, the gross proceeds to Viela Bio from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses, were approximately $172.6 million.
Viela Entered into Collaborations to Expand Global Commercial Efforts for Inebilizumab
In October 2019, Viela announced a partnership with Mitsubishi Tanabe Pharma Corporation to develop and commercialize inebilizumab in nine Asia regions –including Japan– for NMOSD and other potential future indications. The Company will receive an upfront licensing fee of $30 million as well as development and commercialization milestones and payments based, in part, on sales revenue.
Viela is also currently 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 collaboration fee and is eligible to receive milestone payments of more than $203 million plus royalties on product sales.
FINANCIAL RESULTS
Cash Position: Viela reported cash, cash equivalents and current marketable securities of $198.2 million as of September 30, 2019. This does not include net proceeds from the IPO of approximately $157.2 million, which was subsequent to September 30, 2019. Also, upfront payments from the Company’s strategic partnerships of $35.0 million is expected before end of 2019, which was subsequent to September 30, 2019.
Research and Development Expenses: Research and development expenses were $38.7 million and $72.1 million for the three and nine months ended September 30, 2019, respectively.
General and Administrative Expenses: General and administrative expenses were $10.2 million and $24.6 million for the three and nine months ended September 30, 2019, respectively.
Net Loss: Net loss was $48.4 million and $74.9 million, or $65 and $150 per share, for the three and nine months ended September 30, 2019, respectively.