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GAITHERSBURG, Md., Nov. 14, 2019 (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 third quarter ended September 30, 2019.
“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
VIB4920
VIB7734
CORPORATE UPDATES
FINANCIAL RESULTS
About Viela Bio
Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory diseases. For more information, please visit www.vielabio.com.
Forward-Looking Statement
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, the timing and progress of clinical development and potential commercialization of our product candidates, if approved; our expectations with respect to the potential regulatory approval, global development and commercialization of inebilizumab; our planned and ongoing clinical trials for our product candidates and the potential advantages of those product candidates, including inebilizumab, VIB4920 and VIB7734; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical trials; our goals with respect to the development and potential use, if approved, of each of its product candidates; the utility of prior non-clinical and clinical data in determining future clinical results; and
the expected timing and the potential for payments under our collaboration agreements 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 final prospectus dated October 2, 2019 and filed with the SEC on October 4, 2019. 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.
Viela Bio Inc.
Selected Financial Data (Unaudited)
Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
|||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Revenue: | ||||||||||||||||
License revenue | $ | — | $ | — | $ | 20,000 | $ | — | ||||||||
Total revenue | — | — | 20,000 | — | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 38,700 | 13,928 | 72,113 | 28,892 | ||||||||||||
General and administrative | 10,230 | 2,401 | 24,575 | 4,399 | ||||||||||||
Acquisition of in-process research and development | — | — | — | 143,333 | ||||||||||||
Total operating expenses | 48,930 | 16,329 | 96,688 | 176,624 | ||||||||||||
Loss from operations | (48,930 | ) | (16,329 | ) | (76,688 | ) | (176,624 | ) | ||||||||
Other income: | ||||||||||||||||
Interest income | 520 | 647 | 1,829 | 1,408 | ||||||||||||
Total other income | 520 | 647 | 1,829 | 1,408 | ||||||||||||
Net loss | $ | (48,410 | ) | $ | (15,682 | ) | $ | (74,859 | ) | $ | (175,216 | ) | ||||
Net loss per share attributable to common stockholders—basic and diluted | $ | (65 | ) | $ | (1,568,200 | ) | $ | (150 | ) | $ | (17,521,600 | ) | ||||
Weighted average common shares outstanding—basic and diluted | 749,539 | 10 | 497,924 | 10 | ||||||||||||
Other comprehensive loss | ||||||||||||||||
Change in unrealized gains losses on marketable securities, net | $ | (30 | ) | $ | — | $ | (30 | ) | $ | — | ||||||
Total other comprehensive loss | (30 | ) | — | (30 | ) | — | ||||||||||
Total comprehensive loss | $ | (48,440 | ) | $ | (15,682 | ) | $ | (74,889 | ) | $ | (175,216 | ) |
Balance Sheets
(Unaudited)
(In thousands)
September 30,
2019 |
December 31,
2018 |
|||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 155,747 | $ | 126,898 | ||||
Marketable securities | 42,495 | — | ||||||
Receivable from stockholders | — | 12,000 | ||||||
Accounts receivable | 5,128 | — | ||||||
Prepaid and other current assets | 4,577 | 456 | ||||||
Total current assets | 207,947 | 139,354 | ||||||
Marketable securities, non-current | 24,915 | — | ||||||
Property and equipment, net | 905 | 473 | ||||||
Other assets | 73 | — | ||||||
Total assets | $ | 233,840 | $ | 139,827 | ||||
Liabilities, redeemable convertible preferred stock and stockholders’ deficit | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 5,660 | $ | 1,142 | ||||
Accrued expenses | 7,487 | 2,769 | ||||||
Related party liability | 13,100 | 12,054 | ||||||
Total current liabilities | $ | 26,247 | 15,965 | |||||
Commitments and contingencies | ||||||||
Series A-1 preferred stock, $.001 par value; 14,225,324 shares authorized, issued and outstanding as of September 30, 2019 and December 31, 2018 | 142,253 | 142,253 | ||||||
Series A-2 preferred stock, $.001 par value; 17,000,000 shares authorized, issued and outstanding as of September 30, 2019 and December 31, 2018 | 170,000 | 170,000 | ||||||
Series A-3 preferred stock, $.001 par value; 4,705,882 shares authorized, issued and outstanding as of September 30, 2019; 6,470,588 shares authorized and no shares issued or outstanding as of December 31, 2018 | 80,000 | — | ||||||
Series B preferred stock, $.001 par value; 4,687,500 shares authorized, issued and outstanding as of September 30, 2019; no shares authorized, issued or outstanding as of December 31, 2018 | 75,000 | — | ||||||
Total redeemable convertible preferred stock | 467,253 | 312,253 | ||||||
Stockholders’ deficit: | ||||||||
Common stock, $.001 par value; 46,159,941 and 41,254,509 shares authorized as of September 30, 2019 and December 31, 2018; 872,324 and 10 shares issued and outstanding as of September 30, 2019 and December 31, 2018 | 1 | — | ||||||
Additional paid-in capital | 5,498 | 1,879 | ||||||
Accumulated other comprehensive loss | (30 | ) | — | |||||
Accumulated deficit | (265,129 | ) | (190,270 | ) | ||||
Total stockholders’ deficit | (259,660 | ) | (188,391 | ) | ||||
Total liabilities, redeemable convertible preferred stock and stockholders’ deficit | $ | 233,840 | $ | 139,827 |
Contacts
Investors:
Solebury Trout
Chad Rubin
646-378-2947
crubin@soleburytrout.com
Media:
Solebury Trout
Amy Bonanno
914-450-0349
abonanno@soleburytrout.com
Source: Viela Bio Inc.