8-K
CA false 0001305253 0001305253 2020-11-05 2020-11-05

 

 

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, 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 November 5, 2020, Eiger BioPharmaceuticals, Inc. reported its financial results for the quarter ended September 30, 2020. A copy of the press release titled “Eiger BioPharmaceuticals Reports Third 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 November 5, 2020, titled “Eiger BioPharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Business Update.”
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).


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: November 5, 2020      
    By:  

/s/ Sriram Ryali

      Sriram Ryali
      Chief Financial Officer
EX-99.1

Exhibit 99.1

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

Palo Alto, Calif., November 5, 2020 /PRNewswire/ — 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 third quarter 2020 and provided a business update.

Recent Highlights and Upcoming Milestones

ZokinvyTM (lonafarnib) in Progeria and Progeroid Laminopathies

 

   

New Drug Application (NDA) Prescription Drug User Fee Act (PDUFA) target action date November 20, 2020

Lonafarnib in Hepatitis Delta Virus (HDV)

 

   

Phase 3 D-LIVR study full enrollment expected in 2021

Peginterferon Lambda (Lambda) in HDV

 

   

Phase 2 LIFT (combo with lonafarnib) end-of-study data expected at AASLD 2020

 

   

Agreement with FDA and EMA on single, Phase 3 Lambda monotherapy study design

Peginterferon Lambda (Lambda) in COVID-19

 

   

Toronto General Hospital, University Health Network (N=60)

 

   

Mean baseline viral load: 6.7 log copies/mL

   

79% (Lambda) vs 38% (placebo) (p=0.013) clear virus by Day 7

   

> 6 log copies/mL correlates with the threshold for infectivity

 

   

Stanford University School of Medicine (N=120)

 

   

Mean baseline viral load: < 4 log copies/mL

   

Median time to cessation of viral shedding was 7 days in both groups

 

   

Results of both studies support Lambda activity in high baseline viral load patients

 

   

Lambda was well tolerated in both studies with few adverse events, which included minimal elevations of transaminases which self-resolved

 

   

Plan to meet with FDA to discuss data and next steps

Third Quarter 2020 Financial Results

Cash, cash equivalents, and short-term investments as of September 30, 2020 totaled $125.3 million.

The Company reported net loss of $15.7 million, or $0.52 per share, for third quarter 2020, as compared to $18.6 million, or $0.76 per share, for third quarter 2019.

Research and Development expenses were $9.8 million for third quarter 2020, as compared to $14.1 million for third quarter 2019. The decrease was primarily due to a decrease in clinical trial related expenses, including clinical trial material costs.


General and Administrative expenses were $5.0 million for third quarter 2020, as compared to $4.2 million for third quarter 2019. The increase was primarily due to an increase in outside consulting, advisory and accounting services and an increase in personnel-related expenses.

Total operating expenses include total non-cash expenses of $1.9 million for third quarter 2020, as compared to $1.8 million for the same period in 2019.

As of September 30, 2020, the Company had 31.9 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.

Eiger’s lead clinical programs target Hepatitis Delta Virus (HDV) infection, the most serious form of human viral hepatitis. Eiger is developing two complementary treatments for HDV. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, well-tolerated type III interferon entering Phase 3.

Eiger has filed an NDA and MAA for lonafarnib for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies. FDA PDUFA date is November 20, 2020.

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 and 2021, the timing of our ongoing and planned clinical development, including the potential for approval of our lonafarnib product candidate in the U.S. 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 Lambda in HDV in the U.S. and EU; our plans for continued advancement of avexitide in registration trials; and our plans to initiate and conduct clinical studies of 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 additional applicable risks and uncertainties described in the “Risk Factors” sections in the Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and Eiger’s subsequent filings with the SEC. The forward-looking statements contained in this press release are based on information currently available to Eiger and speak only as of the date on which they are made. Eiger does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.

 

LOGO

SOURCE Eiger BioPharmaceuticals, Inc.

Investors and Media:

Ingrid Choong, PhD

(650) 619-6115

[email protected]

Sri Ryali

(650) 272-6138

[email protected]


Eiger BioPharmaceuticals Inc.

Condensed Consolidated Balance Sheets

(in thousands)

 

     Nine Months Ended      Year Ended  
     September 30,      December 31,  
     2020      2019(1)  
     (unaudited)         

ASSETS

     

Cash and cash equivalents

   $ 51,993      $ 39,373  

Debt securities, available-for-sale

     73,341        55,621  

Prepaid expenses and other current assets

     9,608        5,390  
  

 

 

    

 

 

 

Total current assets

     134,942        100,384  

Property and equipment, net

     670        590  

Operating lease right-of-use assets

     1,300        1,654  

Other assets

     3,781        2,511  
  

 

 

    

 

 

 

Total assets

   $ 140,693      $ 105,139  
  

 

 

    

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

     

Current liabilities

   $ 21,660      $ 16,949  

Other liabilities

     26,083        31,710  

Stockholders’ equity

     92,950        56,480  
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 140,693      $ 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     Nine Months Ended  
     September 30,     September 30,  
     (unaudited)     (unaudited)  
     2020     2019     2020     2019  

Operating expenses:

        

Research and development(1)

   $ 9,810     $ 14,059     $ 29,045     $ 39,863  

General and administrative(1)

     5,027       4,247       15,141       12,529  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     14,837       18,306       44,186       52,392  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (14,837     (18,306     (44,186     (52,392

Interest expense

     (906     (884     (2,681     (2,518

Interest income

     76       585       629       1,598  

Other income (expense), net

     (13     (11     (7     (20
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (15,680   $ (18,616   $ (46,245   $ (53,332
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per common share:

        

Basic and diluted

   $ (0.52   $ (0.76   $ (1.74   $ (2.40
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used to compute net loss per common share:

        

Basic and diluted

     29,879,135       24,437,451       26,639,201       22,261,715  
  

 

 

   

 

 

   

 

 

   

 

 

 

(1) Includes stock-based compensation expense of:

        
     Three Months Ended     Nine Months Ended  
     September 30,     September 30,  
     2020     2019     2020     2019  

Research and development

   $ 367     $ 559     $ 1,154     $ 1,366  

General and administrative

     1,078       1,090       3,382       2,965  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total stock-based compensation expense

   $ 1,445     $ 1,649     $ 4,536     $ 4,331