Viela Bio Reports Second Quarter 2020 Financial Results and Program Highlights

Rhea-AI Summary

Viela Bio (Nasdaq:VIE) reported its Q2 2020 financial results, highlighting the FDA approval of UPLIZNA™ for neuromyelitis optica spectrum disorder. The company raised approximately $169 million through a public offering, extending its cash runway into 2023. Despite a net loss of $38.9 million, Viela shows potential with ongoing trials for inebilizumab in myasthenia gravis and IgG4-related disease. Positive interim data from the Phase 1b trial of VIB7734 supports its advancement into a Phase 2 trial focused on systemic lupus erythematosus.

Positive

• FDA approval of UPLIZNA™ for NMOSD, the first B cell-depleting treatment.
• Raised approximately $169 million in a public offering, enhancing cash runway.
• Positive interim Phase 1b results for VIB7734, leading to a Phase 2 trial in SLE.

Negative

• Net loss increased to $38.9 million in Q2 2020 from $5.5 million in Q2 2019.
• Operating expenses rose significantly to $39.8 million from $6.1 million year-over-year.

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

FAQ

What were Viela Bio's financial results for Q2 2020?

Viela Bio reported a net loss of $38.9 million for Q2 2020, significantly higher than the $5.5 million loss in Q2 2019.

What is UPLIZNA™ and its significance?

UPLIZNA™ (inebilizumab) is the first FDA-approved treatment for neuromyelitis optica spectrum disorder, designed to deplete B cells.

What is the current cash position of Viela Bio?

As of June 30, 2020, Viela Bio had $448.4 million in cash, cash equivalents, and investments, with no outstanding debt.

What trials is Viela Bio conducting with inebilizumab?

Viela is preparing Phase 3 trials for inebilizumab in myasthenia gravis and IgG4-related disease projected to start in Q4 2020.

What are the interim results for VIB7734?

Viela reported positive interim results from the Phase 1b trial for VIB7734, leading to a planned Phase 2 trial in systemic lupus erythematosus.