vir-8k_20191119.htm

 

 

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)

November 19, 2019

Vir Biotechnology, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-39083

 

81-2730369

(State or other jurisdiction of incorporation)

 

(Commission File Number)

 

(IRS Employer

Identification No.)

 

499 Illinois Street, Suite 500

San Francisco, California 94158

(Address of principal executive offices, including zip code)

 

(415) 906-4324

(Registrant’s telephone number, including area code)

 

(Former name or former address, if changed since last report)

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 (see General Instruction A.2. below):

 

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, $0.0001 par value per share

VIR

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 2.02    Results of Operations and Financial Condition.

On November 19, 2019, Vir Biotechnology, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2019. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information in this Item 2.02, including the attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01    Financial Statements and Exhibits.

 

(d) Exhibits

 

 

 

Exhibit No.

 

Description

99.1

 

Press Release of the Company, dated November 19, 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 hereunto duly authorized.

 

 

 

VIR BIOTECHNOLOGY, INC.

 

 

 

 

Date: November 19, 2019

 

By:

/s/ Howard Horn

 

 

 

Howard Horn

 

 

 

Chief Financial Officer

 

 

vir-ex991_6.htm

 

Exhibit 99.1

 

 

Vir Biotechnology Provides Corporate Update and
Reports Third Quarter 2019  Financial Results

 

SAN FRANCISCO, Calif. – November 19, 2019 - Vir Biotechnology, Inc. (Nasdaq: VIR), a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases, today provided a corporate update and reported financial results for the third quarter ended September 30, 2019.

 

“Vir Biotechnology was founded to leverage advances in immunology, creating new ways of combatting serious infectious diseases on a global scale,” said George Scangos, Ph.D., Chief Executive Officer of Vir. “In three years, we have assembled four technology platforms and built a broad pipeline targeting some of the world’s largest infectious diseases, including hepatitis B virus, influenza A, human immunodeficiency virus, and tuberculosis. Execution by our team has enabled us to rapidly bring two product candidates into the clinic in the past 12 months and we are on track to initiate two more clinical programs next year. The recent successful completion of our initial public offering provides additional funding to drive our development programs forward and, over the next 12-24 months, we anticipate generating new data across our portfolio to validate our immunologic approach to infectious disease drug development.”

Corporate Updates

In October, Vir raised $142.9 million in gross proceeds from an initial public offering.

VIR-2218, a hepatitis B virus (HBV)-targeting small interfering ribonucleic acid (siRNA) being developed for the functional cure of HBV, has completed Phase 1/2 dosing of all patient cohorts receiving 50 – 200 mg. Data continue to be consistent with those previously shown and the company continues to anticipate additional data for this trial to be available in the first half of 2020.

VIR-2482, a monoclonal antibody being developed as universal prophylaxis for influenza A, is in an ongoing Phase 1/2 clinical trial. Based on a positive review by the trial’s safety review committee of the available safety data for the 300 mg and 1200 mg cohorts, dosing in the 1800 mg cohort was initiated. The company continues to anticipate data from the first flu season of the Phase 1/2 clinical trial to be available in the second half of 2020 and from the second flu season of this trial to be available in the first half of 2021.

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VIR-1111, a human immunodeficiency virus (HIV) T cell vaccine based on human cytomegalovirus (HCMV), and VIR-3434, an HBV-neutralizing monoclonal antibody, both continue to be on track for investigational new drug (IND) and clinical trial application (CTA) submissions respectively in the first half of 2020.

Saira Ramasastry joined the Vir Board of Directors in September. Ms. Ramasastry is a recognized expert on life science alliances and deals and brings more than 20 years of transaction and advisory experience to her role on the Board of Directors.

Steven Rice joined the Vir senior leadership team in September as Chief Human Resources Officer. Over the course of the past 30 years, Mr. Rice has held several HR leadership positions at leading technology and healthcare organizations, most recently as the Chief Human Resources Officer at the Bill and Melinda Gates Foundation.

 

Third Quarter 2019 Financial Results

Revenues: Total revenues for the quarter ended September 30, 2019 were $1.4 million, compared to $2.9 million for same period in 2018. This decrease was primarily due to a decline in grant revenue.  

Research and Development Expenses: Research and development expenses were $39.9 million for the quarter ended September 30, 2019, which includes $0.9 million of non-cash stock-based compensation expense, compared to $29.8 million for the same period in 2018, which includes $0.3 million of non-cash stock-based compensation expense. This increase was primarily due to an increase in personnel and ongoing clinical expenses and licenses and collaboration expenses.

General and Administrative Expenses: General and administrative expenses were $9.2 million for the quarter ended September 30, 2019, which includes $1.3 million of non-cash stock-based compensation expense, compared to $7.4 million for the same period in 2018, which includes $1.2 million of non-cash stock-based compensation expense. The increase was primarily due to an increase in personnel-related expenses related to additional headcount, as well as an increase in professional fees.

Net Loss: Net loss for the quarter ended September 30, 2019 was $48.3 million, or $4.60 per share, compared to a net loss of $33.5 million, or $4.16 per share, for the same period in 2018.

Cash and Cash Equivalents: As of September 30, 2019, Vir had approximately $320.2 million in cash, cash equivalents and short-term investments.

 

2


 

About VIR-2218
VIR-2218 is a subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV. Currently in a Phase
1/2 clinical trial, VIR-2218 is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance

stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Initial data suggest that VIR-2218 is generally well-tolerated in healthy volunteers given as a single dose up to 900 mg and in patients with chronic HBV given as two doses of 20 mg, 50 mg, 100 mg or 200 mg each dose. Initial data also demonstrate substantial reductions in HBsAg in patients at doses ranging from 20 mg to 200 mg. VIR-2218 is the first asset in the company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials. Additional clinical data for this trial is anticipated in the first half of 2020.

 

About VIR-2482
VIR-2482 is an intramuscularly administered influenza A-neutralizing monoclonal antibody currently in a Phase 1/2 clinical trial. In vitro, VIR-2482 has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. VIR-2482 is designed as a universal prophylaxis for influenza A. It has the potential to overcome the limitations of current flu vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their own protective antibody response. VIR-2482 has been half-life engineered so that a single dose has the potential to last the entire flu season, which is typically five to six months long. Vir anticipates clinical data from the first flu season of the Phase 1/2 clinical trial to be available in the second half of 2020 and from the second flu season of this trial to be available in the first half of 2021.

 

About VIR-1111

VIR-1111 is a subcutaneously administered HIV T cell vaccine based on human cytomegalovirus (HCMV) that has been designed to elicit T cells that recognize HIV epitopes that are different from those recognized by prior HIV vaccines and to stimulate a different and specific type of T cell immune response to HIV, known as an HLA-E restricted immune response. VIR-1111 is designed to establish proof of concept in a Phase I clinical trial to determine whether the unique immune response observed in preclinical studies can be replicated in humans. Vir plans to file an IND for VIR-1111 in the first half of 2020.

 

About VIR-3434

VIR-3434 is a subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. VIR-3434 has been engineered to have an extended half-life as well as to potentially function as a T cell vaccine against HBV in infected patients. Vir plans to submit a CTA for VIR-3434 in the first half of 2020 and anticipates clinical data from a Phase 1 clinical trial to be available in the first half of 2021.

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About Vir Biotechnology
Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of five product candidates targeting hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.   

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the timing of program updates and data disclosures for Vir’s clinical trials and the anticipated timing of IND and CTA submissions for its product candidates, among others. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical site activation rates or clinical trial enrollment rates that are lower than expected, changes in expected or existing competition, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

 

 

Contact:

Vir Biotechnology, Inc.

IR@VIR.BIO

 

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Vir Biotechnology, Inc.

 

Condensed Consolidate Statements of Operations

(unaudited; in thousands, except share and per share data)

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant revenue

 

$

1,166

 

 

$

2,771

 

 

$

6,771

 

 

$

6,680

 

Contract revenue

 

 

237

 

 

 

114

 

 

 

340

 

 

 

862

 

Total revenue

 

 

1,403

 

 

 

2,885

 

 

 

7,111

 

 

 

7,542

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

39,863

 

 

 

29,837

 

 

 

95,541

 

 

 

78,256

 

General and administrative

 

 

9,220

 

 

 

7,394

 

 

 

25,790

 

 

 

21,182

 

Total operating expenses

 

 

49,083

 

 

 

37,231

 

 

 

121,331

 

 

 

99,438

 

Loss from operations

 

 

(47,680

)

 

 

(34,346

)

 

 

(114,220

)

 

 

(91,896

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

2,012

 

 

 

712

 

 

 

6,564

 

 

 

1,919

 

Other income (expense), net

 

 

(2,659

)

 

 

178

 

 

 

(3,251

)

 

 

(14

)

Total other income (expense), net

 

 

(647

)

 

 

890

 

 

 

3,313

 

 

 

1,905

 

Loss before benefit from (provision for) income

   taxes

 

 

(48,327

)

 

 

(33,456

)

 

 

(110,907

)

 

 

(89,991

)

Benefit from (provision for) income taxes

 

 

13

 

 

 

 

 

 

(5

)

 

 

500

 

Net loss

 

$

(48,314

)

 

$

(33,456

)

 

$

(110,912

)

 

$

(89,491

)

Net loss per share, basic and diluted

 

$

(4.60

)

 

$

(4.16

)

 

$

(11.53

)

 

$

(12.20

)

Weighted-average shares outstanding, basic and

   diluted

 

 

10,500,848

 

 

 

8,043,283

 

 

 

9,615,379

 

 

 

7,333,986

 

 

 


5


 

Vir Biotechnology, Inc.

 

Balance Sheet Data

(unaudited; in thousands, except share and per share data)

 

 

 

September 30,

2019

 

 

December 31,

2018

 

ASSETS

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

93,698

 

 

$

47,598

 

Short-term investments

 

 

226,512

 

 

 

50,845

 

Restricted cash and cash equivalents, current

 

 

8,822

 

 

 

10,761

 

Prepaid expenses and other current assets

 

 

8,688

 

 

 

8,579

 

Total current assets

 

 

337,720

 

 

 

117,783

 

Intangible assets, net

 

 

35,999

 

 

 

36,917

 

Goodwill

 

 

16,937

 

 

 

16,937

 

Property and equipment, net

 

 

15,448

 

 

 

12,290

 

Restricted cash and cash equivalents, noncurrent

 

 

2,850

 

 

 

1,003

 

Other assets

 

 

13,688

 

 

 

6,666

 

TOTAL ASSETS

 

$

422,642

 

 

$

191,596

 

LIABILITIES, CONVERTIBLE PREFERRED STOCK AND

   STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

 

 

Accounts payable

 

$

5,815

 

 

$

6,473

 

Accrued liabilities

 

 

22,953

 

 

 

14,534

 

Deferred revenue, current portion

 

 

8,822

 

 

 

8,761

 

Advanced proceeds from preferred stock financing

 

 

 

 

 

10,140

 

Contingent consideration, current portion

 

 

6,726

 

 

 

 

Total current liabilities

 

 

44,316

 

 

 

39,908

 

Deferred revenue, noncurrent

 

 

8,408

 

 

 

6,561

 

Convertible preferred stock warrant liability

 

 

4,425

 

 

 

1,024

 

Contingent consideration, noncurrent

 

 

3,343

 

 

 

9,250

 

Deferred tax liability

 

 

3,305

 

 

 

3,305

 

Other long-term liabilities

 

 

3,030

 

 

 

1,588

 

TOTAL LIABILITIES

 

 

66,827

 

 

 

61,636

 

Convertible preferred stock, $0.0001 par value; 421,450,000 shares

   authorized; 88,112,733 and 69,910,520 shares issued and outstanding as

   of September 30, 2019 and December 31, 2018, respectively; aggregate

   liquidation preference of $675,567 and $333,058 as of September 30, 2019

   and December 31, 2018, respectively

 

 

636,612

 

 

 

309,137

 

STOCKHOLDERS’ DEFICIT:

 

 

 

 

 

 

 

 

Common stock, $0.0001 par value; 558,350,000 shares authorized as of

   September 30, 2019 and December 31, 2018; 11,728,232 and 8,858,799

   shares issued and outstanding as of September 30, 2019 and

   December 31, 2018, respectively

 

 

1

 

 

 

1

 

Additional paid-in capital

 

 

23,869

 

 

 

14,672

 

Accumulated other comprehensive income (loss)

 

 

81

 

 

 

(14

)

Accumulated deficit

 

 

(304,748

)

 

 

(193,836

)

TOTAL STOCKHOLDERS’ DEFICIT

 

 

(280,797

)

 

 

(179,177

)

TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND

   STOCKHOLDERS’ DEFICIT

 

$

422,642

 

 

$

191,596

 

 

6