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 5, 2019

 

Viking Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

001-37355

 

46-1073877

(State or Other Jurisdiction of

Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

12340 El Camino Real, Suite 250, San Diego, California 92130

(Address of Principal Executive Offices) (Zip Code)

 

Registrant’s telephone number, including area code: (858) 704-4660

 

N/A

(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:

 

    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

Name of Each Exchange on Which Registered

Common Stock, par value $0.00001 per share

 

VKTX

The Nasdaq Stock Market LLC

 

Warrants to purchase Common Stock, par value $0.00001 per share

 

VKTXW

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. 

 

 


 

 

In this report, “Viking Therapeutics,” “Viking,” “Company,” “we,” “us” and “our” refer to Viking Therapeutics, Inc.

 

Item 2.02 Results of Operations and Financial Condition.

On November 5, 2019, we issued a press release reporting our financial results for the third quarter and nine months ended September 30, 2019 and providing a corporate update.  The full text of the press release is furnished as exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

In accordance with General Instructions B.2 of Form 8-K, the information in Item 2.02 of this Current Report on Form 8-K 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 liability of that section, and shall not be incorporated by reference into any registration statement or other document filed 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 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No

 

Description

99.1

 

Press release issued November 5, 2019, reporting financial results for the third quarter and nine months ended September 30, 2019 and providing a corporate update. 

 

 

 

 


 


 

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.

 

 

Viking Therapeutics, Inc.

 

 

 

Date: November 5, 2019

By:

/s/ Brian Lian, Ph.D.

 

 

Brian Lian, Ph.D.

 

 

President and Chief Executive Officer

 

 

(Principal Executive Officer)

 

 

 

vktx-ex991_6.htm

 

Exhibit 99.1

 

 

Viking Therapeutics Reports Third Quarter 2019 Financial Results and Provides Corporate Update

 

Conference call scheduled for 8:30 a.m. ET today

 

 

IND Application Filed for Phase 2b Study of VK2809 in Biopsy-Confirmed NASH

 

Clinical Development of VK0214 for X-ALD Expected to Begin 1H20

 

Balance Sheet Remains Strong with Approximately $290 Million in Cash

 

 

SAN DIEGO, November 5, 2019 -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced its financial results for the third quarter ended September 30, 2019, and provided an update on its clinical pipeline and other corporate developments.

 

Highlights from the Quarter, and Subsequent to September 30, 2019:

 

“The last few months have been an exciting and productive period at Viking as we prepare for important near-term milestones,” stated Brian Lian, Ph.D., chief executive officer of Viking Therapeutics.  “With respect to our thyroid receptor beta agonist VK2809, in the third quarter we completed key chronic toxicity studies to support long-term dosing in humans.  This work, along with data from completed clinical and other non-clinical studies, formed the basis of an IND application that was submitted to the FDA to initiate a Phase 2b study of VK2809 in patients with biopsy-confirmed NASH.  With respect to VK0214, our second thyroid receptor beta agonist, we continued the IND-enabling work that will allow us to initiate clinical development, including a proof-of-concept study in patients with X-ALD, in the first half of next year.  In addition to advancing our clinical programs, we’ve also maintained a tight focus on operating expenses, and ended the quarter with approximately $290 million in cash and equivalents.  We believe our current balance sheet is sufficient to see us through multiple value inflection points.”

 

Pipeline and Corporate Highlights

 

Investigational New Drug (IND) application filed for Phase 2b study of VK2809 in biopsy-confirmed non-alcoholic steatohepatitis (NASH).  VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that possesses


 

selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of lipid disorders, including NASH.  In September 2018, we announced positive results from a Phase 2 trial of VK2809 in patients with hypercholesterolemia and non-alcoholic fatty liver disease.  This Phase 2 trial evaluated VK2809 doses of 5 mg daily, 10 mg daily, 10 mg every other day, or placebo, for 12 weeks.  The trial achieved its key primary and secondary endpoints, demonstrating potent reductions in liver fat content and plasma lipids.

 

The company recently completed chronic toxicity studies to support long-term dosing of VK2809 in humans.  The results from certain of these studies, along with additional clinical and non-clinical data, formed the basis of an IND application that was recently filed with the FDA’s Division of Gastrointestinal and Inborn Errors Products (DGIEP).  A new IND is required as the existing IND is filed with the FDA’s Division of Metabolic and Endocrinology Products, while most NASH drugs are reviewed in DGIEP.  Pending clearance of the IND, the company plans to initiate a Phase 2b study of VK2809 in patients with biopsy-confirmed NASH.  

 

IND-enabling work for VK0214 ongoing; Clinical studies expected to begin 1H20.  VK0214 is being evaluated as a potential treatment for X-linked adrenoleukodystrophy, or X-ALD - a devastating disease for which there is no therapeutic treatment.  X-ALD is caused by a defect in the ABCD1 peroxisomal transporter.  This defect can result in an accumulation of very long chain fatty acids in plasma and tissue, which is believed to contribute to the severe cerebral and motor neuron toxicities that are characteristic of the disease. To date, results from in vitro and in vivo studies have demonstrated that administration of VK0214 results in a significant reduction of very long chain fatty acids in both plasma and tissue, potentially leading to a therapeutic benefit.  These promising results for VK0214 were achieved through the company’s ongoing collaboration with the Kennedy Krieger Institute – one of the world’s leading X-ALD research centers. IND-enabling work for VK0214 continues to advance and the company plans to initiate a Phase 1 clinical trial in 1H20.

 

Balance sheet remains strong with approximately $290 million in cash.  Viking completed the third quarter of 2019 with $288.1 million in cash, cash equivalents, and short-term investments.  

 

Upcoming investor events.  Viking management will participate in the following upcoming investor events:

 

William Blair Boston Innovation Day (at AASLD)

Date: November 12, 2019

Location: Boston, MA

 

Stifel 2019 Healthcare Conference

Dates: November 19 - 20, 2019

Location: Lotte New York Palace Hotel, New York, NY

 

Jefferies London Healthcare Conference

Dates: November 20 - 21, 2019

Location: Waldorf Hilton London, London UK

 


 

Biotech Showcase 2020

Dates: January 13 – 15, 2020

Location:  Hilton San Francisco Union Square, San Francisco, CA

 

Q3 and Nine-Month 2019 Financial Highlights

Third Quarter Ended September 30, 2019 and 2018

Research and development expenses for the three months ended September 30, 2019 were $5.3 million compared to $5.7 million for the same period in 2018.  The decrease in expenses was primarily due to decreased stock-based compensation, manufacturing for our drug candidates and clinical and pre-clinical studies, partially offset by increased expenses related to services provided by third-party consultants.

 

General and administrative expenses for the three months ended September 30, 2019 were $2.2 million compared to $1.7 million for the same period in 2018.  The increase in expenses was primarily due to increased stock-based compensation, services provided by third-party consultants and professional fees, partially offset by decreased expenses related to salaries and benefits.

 

For the three months ended September 30, 2019, Viking reported a net loss of $5.7 million, or $0.08 per share, compared to a net loss of $6.6 million, or $0.11 per share, in the corresponding period in 2018.  The decrease in net loss and net loss per share for the three months ended September 30, 2019 was primarily due to increased interest income recorded in the third quarter of 2019 versus that recorded in the same period of 2018.

 

Nine Months Ended September 30, 2019 and 2018

 

Research and development expenses for the nine months ended September 30, 2019 were $17.1 million compared to $14.0 million for the same period in 2018.  The increase in expenses was primarily due to increased manufacturing for our drug candidates, pre-clinical studies, salaries and benefits and services provided by third-party consultants, partially offset by decreased expenses related to clinical studies.

 

General and administrative expenses for the nine months ended September 30, 2019 were $6.7 million compared to $5.2 million for the same period in 2018.  The increase in expenses was primarily due to increased stock-based compensation, services provided by third-party consultants and professional fees.

 

For the nine months ended September 30, 2019, Viking reported a net loss of $18.3 million, or $0.25 per share, compared to a net loss of $16.8 million, or $0.32 per share, in the corresponding period in 2018.  The increase in net loss for the nine months ended September 30, 2019 was primarily due to the increased research and development and general and administrative expenses noted previously, partially offset by increased interest income as well as the elimination of expenses related to the change in fair value of the debt conversion feature liability due to the repayment of the Ligand Note in May 2018.  The decrease in net loss per share for the nine months ended September 30, 2019 was primarily driven by the additional weighted average shares outstanding at September 30, 2019 versus those weighted average shares outstanding at September 30, 2018, given the public equity financings that occurred during 2018.  

 


 

Balance Sheet as of September 30, 2019

 

At September 30, 2019, Viking held cash, cash equivalents and short-term investments totaling $288.1 million and had 72,255,876 shares of common stock outstanding.  

 

Conference Call

 

Management will host a conference call to discuss the company’s third quarter 2019 financial results today at 8:30 a.m. Eastern.  To participate on the conference call, please dial (844) 850-0543 from the U.S. or (412) 317-5199 from outside the U.S.  In addition, following the completion of the call, a telephone replay will be accessible until November 12, 2019 by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering conference ID # 10136700.  Those interested in listening to the conference call live via the internet may do so by visiting the Investor Relations section of Viking’s website at www.vikingtherapeutics.com.  An archive of the webcast will be available for 30 days on the company's website at www.vikingtherapeutics.com.

 

About Viking Therapeutics, Inc. 

Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel, orally available, first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders.  Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives.  The company's clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, including non-alcoholic steatohepatitis (NASH).  In a Phase 2 trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo.  The company is also developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of X-linked adrenoleukodystrophy (X-ALD). 

 

Viking's other programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator.  In a Phase 2 trial in patients recovering from hip fracture, patients who received VK5211 experienced significant improvements in measures of lean body mass compared with patients who received placebo.  Other programs also include VK0612, a first-in-class, orally available drug candidate in Phase 2 development for the treatment of type 2 diabetes as well as two earlier-stage programs targeting metabolic diseases and anemia.  The company holds exclusive worldwide rights to a portfolio of five therapeutic programs, including those noted above, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.

Follow Viking on Twitter @Viking_VKTX.

 

Forward-Looking Statements

This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines and milestones, as well as the company's goals and plans regarding VK2809, VK0214 and their respective prospects. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance.


 

These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials, including those for VK2809 and VK0214; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission, including Viking's Annual Report on Form 10-K for the year ended December 31, 2018, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings. These forward-looking statements speak only as of the date hereof.  Viking disclaims any obligation to update these forward-looking statements except as required by law.



 

Viking Therapeutics, Inc.

Statements of Operations and Comprehensive Loss

 

(In thousands, except per share amounts)

(Unaudited)

 

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Revenues

 

$

 

 

$

 

 

$

 

 

$

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

5,279

 

 

 

5,687

 

 

 

17,108

 

 

 

13,951

 

General and administrative

 

 

2,160

 

 

 

1,707

 

 

 

6,706

 

 

 

5,173

 

Total operating expenses

 

 

7,439

 

 

 

7,394

 

 

 

23,814

 

 

 

19,124

 

Loss from operations

 

 

(7,439

)

 

 

(7,394

)

 

 

(23,814

)

 

 

(19,124

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of debt conversion feature liability

 

 

 

 

 

 

 

 

 

 

 

1,398

 

Amortization of debt discount

 

 

 

 

 

 

 

 

 

 

 

(404

)

Amortization of financing costs

 

 

(40

)

 

 

(30

)

 

 

(100

)

 

 

(90

)

Interest income, net

 

 

1,742

 

 

 

824

 

 

 

5,581

 

 

 

1,397

 

Realized gain on investments, net

 

 

6

 

 

 

 

 

 

4

 

 

 

 

Total other income, net

 

 

1,708

 

 

 

794

 

 

 

5,485

 

 

 

2,301

 

Net loss

 

 

(5,731

)

 

 

(6,600

)

 

 

(18,329

)

 

 

(16,823

)

Other comprehensive loss, net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on securities

 

 

(82

)

 

 

30

 

 

 

580

 

 

 

(97

)

Comprehensive loss

 

$

(5,813

)

 

$

(6,570

)

 

$

(17,749

)

 

$

(16,920

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(0.08

)

 

$

(0.11

)

 

$

(0.25

)

 

$

(0.32

)

Weighted-average shares used to compute basic and diluted net loss per share

 

 

72,040

 

 

 

61,232

 

 

 

71,907

 

 

 

52,943

 

 

 



 

Viking Therapeutics, Inc.

Balance Sheets

 

(In thousands, except share and per share amounts)

 

 

 

 

 

 

 

September 30,

2019

 

 

December 31,

2018

 

 

 

(Unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

30,952

 

 

$

24,779

 

Short-term investments – available for sale

 

 

257,120

 

 

 

276,741

 

Prepaid clinical trial and preclinical study costs

 

 

612

 

 

 

335

 

Prepaid expenses and other current assets

 

 

572

 

 

 

278

 

Total current assets

 

 

289,256

 

 

 

302,133

 

Right-of-use assets

 

 

664

 

 

 

 

Deferred public offering and other financing costs

 

 

173

 

 

 

150

 

Deposits

 

 

29

 

 

 

29

 

Total assets

 

$

290,122

 

 

$

302,312

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,095

 

 

$

959

 

Other accrued liabilities

 

 

3,802

 

 

 

3,591

 

Lease liability, current

 

 

295

 

 

 

 

Total current liabilities

 

 

6,192

 

 

 

4,550

 

Deferred rent

 

 

 

 

 

12

 

Lease liability, net of current portion

 

 

438

 

 

 

 

Total long-term liabilities

 

 

438

 

 

 

12

 

Total liabilities

 

 

6,630

 

 

 

4,562

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.00001 par value: 10,000,000 shares authorized at September 30, 2019 and December 31, 2018; no shares issued and outstanding at September 30, 2019 and December 31, 2018

 

 

 

 

 

 

Common stock, $0.00001 par value: 300,000,000 shares authorized at September 30, 2019 and December 31, 2018; 72,255,876, and 71,742,043 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively

 

 

1

 

 

 

1

 

Additional paid-in capital

 

 

404,581

 

 

 

401,090

 

Accumulated deficit

 

 

(121,247

)

 

 

(102,918

)

Accumulated other comprehensive income (loss)

 

 

157

 

 

 

(423

)

Total stockholders’ equity

 

 

283,492

 

 

 

297,750

 

Total liabilities and stockholders’ equity

 

$

290,122

 

 

$

302,312

 

 

 

 

 



 

 

Contacts:

 

Viking Therapeutics

Michael Morneau

858-704-4660

mmorneau@vikingtherapeutics.com

 

Vida Strategic Partners

Stephanie Diaz (Investors)

415-675-7401

sdiaz@vidasp.com

 

Tim Brons (Media)

415-675-7402

tbrons@vidasp.com