8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): December 11, 2019

 

 

VIELA BIO, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-39067   82-4187338

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

One Medimmune Way, First Floor, Area Two  
Gaithersburg, Maryland   20878
(Address of principal executive offices)   (zip code)

Registrant’s telephone number, including area code: (240) 558-0038

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class    Trading Symbol(s)    Name of each exchange on which registered

 

  

 

  

 

Common Stock, $0.001 par value per share    VIE    The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging Growth Company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 


Item 7.01

Regulation FD Disclosure.

On December 11, 2019, Viela Bio, Inc. (the “Company”) issued a press release entitled “Viela Bio Announces Initiation of Phase 2b Trial of VIB4920 in Sjögren’s Syndrome”, which is attached here as Exhibit 99.1.

The information contained in this Item 7.01 and Exhibit 99.1 attached hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that Section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 8.01

Other Events.

On December 11, 2019, the Company announced that the first patient has been dosed in a Phase 2b trial of VIB4920 for the treatment of Sjögren’s syndrome, which is a chronic, systemic autoimmune disease involving inflammation and destruction of the salivary and lacrimal glands which leads to severe dryness and chronic pain.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.

  

Description

99.1    Press release dated December 11, 2019


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

VIELA BIO, INC.
By:   /s/ Mitchell Chan
 

Mitchell Chan

Chief Financial Officer

Date: December 11, 2019

EX-99.1

Exhibit 99.1

 

LOGO

Viela Bio Announces Initiation of Phase 2b Trial of VIB4920 in Sjögren’s Syndrome

Gaithersburg, MD—December 11, 2019— Viela Bio (Nasdaq:VIE), a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory diseases, today announced that the first patient has been dosed in a Phase 2b trial of VIB4920 for the treatment of Sjögren’s syndrome—a chronic, systemic autoimmune disease involving inflammation and destruction of the salivary and lacrimal glands which leads to severe dryness and chronic pain.

“Sjögren’s is a common rheumatic disease for which there are currently no approved disease-modifying therapies. Patients with this disease suffer from debilitating fatigue and extensive mouth and eye dryness, and in some cases, lung and kidney disease as well as an increased risk of lymphoma,” said Jorn Drappa, M.D., Ph.D., Chief Medical Officer, Head of Research and Development at Viela Bio. “The initiation of this trial is an important milestone in our research and development efforts involving the CD40/CD40L co-stimulatory pathway. We believe that treatment with our product candidate 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.”

The Phase 2b trial is a randomized, double-blind and placebo-controlled trial designed to evaluate the efficacy and safety of VIB4920 in participants with Sjögren’s syndrome. For additional information about this clinical trial, please visit clinicaltrials.gov, identifier NCT04129164.

About VIB4920

VIB4920 is an investigational fusion protein designed to bind to CD40L, blocking the T cells’ interaction with CD40-expressing cells.

About Sjögren’s Syndrome

Sjögren’s syndrome is a chronic, systemic autoimmune disease characterized by lymphocytic infiltration of the exocrine glands such as the lacrimal and salivary glands. The disease frequently leads to keratoconjunctivitis sicca (dry eye) and xerostomia (dry mouth). Sjögren’s syndrome may occur with other autoimmune diseases, such as systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). No treatments have been shown to alter the course of this disease. Supportive treatment is aimed at relieving dry mouth/dry eye symptoms.

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

 

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facts, contained in this press release, including statements regarding our strategy, future operations, prospects and plans; our expectations with respect to the potential regulatory approval of VIB4920 for the treatment of patients with Sjögren’s syndrome; our planned and ongoing clinical trials for our product candidates and the potential advantages of those product candidates, including inebilizumab, VIB4920 for the treatment of patients with Sjögren’s syndrome and VIB7734; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical trials; and our goals with respect to the development and potential use, if approved, of each of its product candidates 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 Quarterly Report on Form 10-Q for the three months ended September 30, 2019, which was filed with the SEC on November 14, 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.

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.

 

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