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): May 7, 2020

 

 

EIGER BIOPHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36183   33-0971591

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

Eiger BioPharmaceuticals, Inc.

2155 Park Blvd.

Palo Alto, California 94306

(Address of principal executive offices, including zip code)

(650) 272-6138

(Registrant’s telephone number, including area code)

Not Applicable

(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(s)

 

Name of each exchange

on which registered

Common Stock, par value $0.001   EIGR   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 May 7, 2020, Eiger BioPharmaceuticals, Inc. reported its financial results for the quarter ended March 31, 2020. A copy of the press release titled “Eiger BioPharmaceuticals Reports First Quarter 2020 Financial Results and Provides Business Update,” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto and is incorporated herein by reference.

The information in this item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information in this item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Eiger BioPharmaceuticals, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

    No.    

  

Description

99.1    Press release, dated May 7, 2020, titled “Eiger BioPharmaceuticals Reports First Quarter 2020 Financial Results and Provides Business 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.

 

    Eiger BioPharmaceuticals, Inc.
Dated: May 7, 2020      
    By:  

/s/ Sriram Ryali

      Sriram Ryali
      Chief Financial Officer
EX-99.1

Exhibit 99.1

Eiger BioPharmaceuticals Reports First Quarter 2020 Financial Results and Provides Business Update

PALO ALTO, Calif., May 7, 2020 — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today reported financial results for first quarter 2020 and provided a business update.

“We achieved key milestones this quarter across programs, including Eiger’s first NDA and MAA submissions. Lonafarnib would be the first approved treatment for patients with Progeria and Progeroid Laminopathies,” said David Cory, President and CEO of Eiger. “As previously announced, due to the impact of COVID-19, we anticipate full enrollment of our global Phase 3 HDV D-LIVR study in 2021, and we continue to enroll and dose patients. Peginterferon lambda in HDV is now Phase 3-ready, after harmonizing a single pivotal study with FDA and EMA. In addition, we look forward to future results from ongoing investigator sponsored studies of peginterferon lambda in COVID-19 patients.”

Recent Highlights and Upcoming Milestones

Lonafarnib in Progeria and Progeroid Laminopathies

 

   

Marketing Authorization Application (MAA) validated by EMA

 

   

Accelerated Assessment for MAA granted by EMA

 

   

New Drug Application (NDA) submitted to FDA in March 2020

Lonafarnib in Hepatitis Delta Virus (HDV)

 

   

Phase 3 D-LIVR study (N=400) continues to enroll and dose patients

 

   

Full enrollment expected in 2021 due to previously announced impact of COVID-19

 

   

Prioritizing the safety of D-LIVR patients, study continuity, and study integrity

Peginterferon Lambda in HDV

 

   

Single pivotal Phase 3 study harmonized with FDA and EMA

 

   

Phase 2 LIFT (combo with lonafarnib) end-of-treatment data planned for EASL 2020

Peginterferon Lambda in COVID-19

 

   

First patients dosed at Stanford University

 

   

Six International Investigator Sponsored Studies initiating and enrolling

First Quarter 2020 Financial Results

Cash, cash equivalents, and short-term investments as of March 31, 2020 totaled $77.6 million compared to $95.0 million at December 31, 2019, a decrease of $17.4 million.

The Company reported net loss of $15.2 million, or $0.62 per share, for first quarter 2020, as compared to $17.2 million, or $0.90 per share, for first quarter 2019.


Research and Development expenses were $9.5 million for first quarter 2020, as compared to $12.9 million for first quarter 2019. The decrease was primarily due to lower clinical trial related expenses, including clinical material costs.

General and Administrative expenses were $5.2 million for first quarter 2020, as compared to $4.1 million for first quarter 2019. The increase was primarily due to increases in employee-related costs, including stock-based compensation, from increased headcount.

Total operating expenses include total non-cash expenses of $2.0 million for first quarter 2020, as compared to $1.4 million for the same period in 2019. As of March 31, 2020, the Company had 24.6 million of common shares outstanding.

About Eiger

Eiger is a late-stage biopharmaceutical company focused on the development and commercialization of first-in-class, well-characterized drugs for serious rare and ultra-rare diseases for patients with high unmet medical needs, for which no approved therapies exist.

Eiger has completed NDA and MAA submissions for lonafarnib for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies. Eiger has also established a global Managed Access Program, expected to span more than 40 countries, to ensure all children and young adults with Progeria and Progeroid Laminopathies have access to treatment.

The company’s lead program is in Phase 3, developing lonafarnib, a first-in-class oral prenylation inhibitor for the treatment of Hepatitis Delta Virus (HDV) infection. The company is also advancing peginterferon lambda, a first-in-class interferon, toward registration for the treatment of HDV. For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.

Note Regarding Forward-Looking Statements

This press release contains “forward-looking” statements that involve substantial risks and uncertainties. All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, business strategy and plans and objectives for future operations, are forward-looking statements. These forward-looking statements include terminology such as “believe,” “will,” “may,” “estimate,” “continue,” “anticipate,” “contemplate,” “intend,” “target,” “project,” “should,” “plan,” “expect,” “predict,” “could,” “potentially” or the negative of these terms. Forward-looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our anticipating significant milestones in 2020, the timing of our ongoing and planned clinical development, including the potential for approval of our lonafarnib product candidate in the US and EU for Progeria and Progeroid Laminopathies; our progression and enrollment of our Phase 3 D-LIVR study in HDV; our ability to maintain supply of our clinical trial materials; our announcement of data from the trial of lambda and lonafarnib boosted with ritonavir for HDV (LIFT); our plans to advance Peginterferon Lambda in HDV in the US and EU; our plans for continued advancement of avexitide in registration trials;


and our plans to initiate and conduct clinical studies of peginterferon lambda in coronavirus; our ability to transition into a commercial stage biopharmaceutical company; our ability to finance the continued advancement of our development pipeline products; that the company’s expectations regarding the effects of COVID-19 on the Company’s trials and development may be incorrect; and the potential for success of any of our product candidates. These statements concern product candidates that have not yet been approved for marketing by the U.S. Food and Drug Administration (FDA). No representation is made as to their safety or effectiveness for the purposes for which they are being investigated.

Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the “Risk Factors” sections in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 and Eiger’s subsequent filings with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.

 

SOURCE Eiger BioPharmaceuticals, Inc.

Investors and Media:

Ingrid Choong, PhD

(650) 619-6115

ichoong@eigerbio.com

Sri Ryali

(650) 272-6138

sryali@eigerbio.com


Eiger BioPharmaceuticals Inc.

Condensed Consolidated Balance Sheets

(in thousands)

 

     Three Months Ended
March 31,
     Year Ended
December 31,
 
     2020      2019(1)  
     (unaudited)         

ASSETS

     

Cash and cash equivalents

   $ 22,629      $ 39,373  

Debt securities, available-for-sale

     54,978        55,621  

Prepaid expenses and other current assets

     4,858        5,390  
  

 

 

    

 

 

 

Total current assets

     82,465        100,384  

Property and equipment, net

     638        590  

Operating lease right-of-use assets

     1,539        1,654  

Other assets

     3,781        2,511  
  

 

 

    

 

 

 

Total assets

   $ 88,423      $ 105,139  
  

 

 

    

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

     

Current liabilities

   $ 13,433      $ 16,949  

Other liabilities

     31,769        31,710  

Stockholders’ equity

     43,221        56,480  
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 88,423      $ 105,139  
  

 

 

    

 

 

 

 

(1) 

Derived from the audited financial statements, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019.


Eiger BioPharmaceuticals Inc.

Condensed Consolidated Statements of Operations Financial Data

(in thousands, except per share and share amounts)

 

     Three Months Ended  
     March 31,  
     (unaudited)  
     2020     2019  

Operating expenses:

    

Research and development(1)

   $ 9,481     $ 12,868  

General and administrative(1)

     5,241       4,057  
  

 

 

   

 

 

 

Total operating expenses

     14,722       16,925  
  

 

 

   

 

 

 

Loss from operations

     (14,722     (16,925

Interest expense

     (884     (765

Interest income

     367       511  

Other income (expense), net

     —         (10
  

 

 

   

 

 

 

Net loss

   $ (15,239   $ (17,189
  

 

 

   

 

 

 

Net loss per common share:

    

Basic and diluted

   $ (0.62   $ (0.90
  

 

 

   

 

 

 

Shares used to compute net loss per common share:

    

Basic and diluted

     24,501,350       19,168,448  
  

 

 

   

 

 

 

 

(1) 

Includes stock-based compensation expense of:

 

     Three Months Ended  
     March 31,  
     2020      2019  

Research and development

   $ 389      $ 365  

General and administrative

     1,240        830  
  

 

 

    

 

 

 

Total stock-based compensation expense

   $          1,629      $          1,195