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 7, 2018

 

Viking Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

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))

 

 

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. ☒

 

 

 

 

 

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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 7, 2018, we issued a press release reporting our financial results for the third quarter and nine months ended September 30, 2018 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

 

 

 

 

 

 

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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.

 

 

 

 

 

Exhibit 99.1

 

 

Conference call scheduled for 4:30 p.m. ET today

 

 

 

 

 

 

SAN DIEGO, November 7, 2018 -- 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, 2018, and provided an update on its clinical pipeline and other corporate developments.

 

Highlights from, and Subsequent to, the Quarter Ended September 30, 2018

 

“The third quarter was an exciting period for Viking as we made several important announcements regarding our pipeline programs,” stated Brian Lian, Ph.D., chief executive officer of Viking Therapeutics.  “With our VK2809 program for NASH, we announced topline data from a Phase 2 trial in patients with NAFLD and elevated LDL-C.  These results showed excellent safety and tolerability, as well as unprecedented reductions in liver fat from an oral agent, demonstrating best-in-class efficacy on this key endpoint.  We look forward to presenting the results of this study at the upcoming AASLD meeting.  Also in September, we presented the results of a Phase 2 trial of VK5211, our novel selective androgen receptor modulator (SARM), in patients recovering from hip fracture, at the 2018 meeting of the American Society for Bone and Mineral Research (ASBMR).  These data, which showed the impressive effects of VK5211 on muscle growth and body composition, were highlighted during the oral plenary session of the meeting, and we were honored to receive the Most Outstanding Clinical Abstract award by the conference organizers.  In addition, in early October the

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results of an in vivo study of VK2809 in glycogen storage disease were presented at the oral plenary session at the 88^th Annual Meeting of the American Thyroid Association (ATA).  These data highlighted VK2809’s effect on reducing inflammatory signaling and improving autophagy, characteristics that are relevant to broader settings, such as NASH.  In corporate matters, we raised $176 million during the quarter, strengthening our balance sheet and giving us runway beyond 2020.”

 

 

Pipeline and Corporate Highlights

 

 

 

 

 

The results from this trial will be presented as part of the Oral Late-Breaker session of The Liver Meeting^® 2018, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), on Monday, November 12^th, in San Francisco.

 

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The company is currently in the process of planning for further studies of VK2809 in biopsy-confirmed NASH, which are anticipated to begin in 2019.

 

 

 

During the third quarter, Viking received written correspondence from the FDA, in response to the company’s Type C meeting questions related to potential registration endpoints that might be utilized to evaluate VK5211 in the hip fracture setting.  The company is currently exploring partnering opportunities that will allow us to optimize the value of VK5211 and move the program forward in the most efficient manner possible.  

 

 

Q3 2018 Financial Highlights

Three Months Ended September 30, 2018 and 2017

Research and development expenses for the three months ended September 30, 2018 were $5.7 million compared to $3.5 million for the same period in 2017.  The increase was primarily due to increased manufacturing expenses related to our drug candidates, pre-clinical study efforts, use of third party consultants and stock-based compensation, partially offset by a decrease in clinical study expenses.  

General and administrative expenses for the three months ended September 30, 2018 were $1.7 million compared to $1.2 million for the same period in 2017.  The increase was primarily due to increased expenses related to stock-based compensation, salaries and benefits, professional services, insurance expense, legal and patent expenses, and franchise taxes.

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For the three months ended September 30, 2018, Viking reported a net loss of $6.6 million, or $0.11 per share, compared to a net loss of $6.1 million, or $0.22 per share, in the corresponding period in 2017.  The increase in net loss for the three months ended September 30, 2018 was primarily due to the increase in research and development expenses noted previously, partially offset by decreased expenses related to the change in fair value of the debt conversion feature liability and an increase in interest income.

 

Nine Months Ended September 30, 2018 and 2017

Research and development expenses for the nine months ended September 30, 2018 were $14.0 million compared to $10.7 million for the same period in 2017.  The increase was primarily due to increased expenses related to pre-clinical study efforts, manufacturing related to our drug candidates, use of third party consultants, and stock-based compensation, partially offset by a decrease in clinical study expenses.  

General and administrative expenses for the nine months ended September 30, 2018 were $5.2 million compared to $3.9 million for the same period in 2017.  The increase was primarily due to increased expenses related to stock-based compensation, salaries and benefits, professional services, insurance, legal and patent expenses, and franchise taxes.

For the nine months ended September 30, 2018, Viking reported a net loss of $16.8 million, or $0.32 per share, compared to a net loss of $16.5 million, or $0.67 per share, in the corresponding period in 2017.  The net loss for the nine months ended September 30, 2018 was consistent with the net loss in the corresponding period in 2017 primarily due to the increase in research and development expenses noted previously offset by an increase in other income related to the decrease in the fair value of the debt conversion feature liability, as well as an increase in interest income.

 

Balance Sheet as of September 30, 2018

 

At September 30, 2018, Viking held cash, cash equivalents and short-term investments totaling $304.2 million.   As of October 31, 2018, Viking had 71,459,857 shares of common stock outstanding.  

 

Conference Call

 

Management will host a conference call to discuss the company’s third quarter financial results today at 4:30 pm 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 14, 2018 by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering conference ID #10125870.  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, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and

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endocrine disorders.  The company'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 small molecule thyroid beta agonist.  In a Phase 2 trial for the treatment of non-alcoholic fatty liver disease and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content. VK2809 was shown to be safe and well-tolerated in the study.  The company is also developing 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 to patients who received placebo.  The company is also developing VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes.  Additional programs include a novel and selective agonist of the thyroid beta receptor for X-linked adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia.  Viking holds exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, 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, VK5211 and 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 VK5211; 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, 2017, 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.

 

 

 

 

 

 

 

 

 

 

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Viking Therapeutics, Inc.

Statements of Operations and Comprehensive Loss

 

(In thousands, except per share amounts)

(Unaudited)

 

 

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Viking Therapeutics, Inc.

Balance Sheets

 

(In thousands, except share and per share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

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Contacts:

 

Viking Therapeutics

Michael Morneau

858-704-4660

[email protected]

 

Vida Strategic Partners

Stephanie Diaz (Investors)

415-675-7401

[email protected]

 

Tim Brons (Media)

415-675-7402

[email protected]

 

 

 

 

SEC Filings

Viking Therapeutics (VKTX) Briefly Falls to LowNovember 8, 2018 10:41 AM