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|Item 2.02.|| |
Results of Operations and Financial Condition.
In connection with the press release described in Item 8.01 below, on January 7, 2021, Eiger BioPharmaceuticals, Inc. (the “Company”) provided, on a preliminary and unaudited basis, certain estimates regarding its cash, cash equivalents and investments as of December 31, 2020 on a pro forma basis. The estimate is a preliminary estimate based on currently available information and does not present all necessary information for a complete understanding of the Company’s financial condition as of December 31, 2020 or the Company’s results of operations for the year ended December 31, 2020.
|Item 8.01.|| |
On January 7, 2021, the Company issued a press release titled “Eiger Updates on 2020 Progress and 2021 Plans.” A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Statements in this report that are not strictly historical in nature constitute “forward-looking statements.” Such statements include, but are not limited to the pro forma cash, cash equivalents and investments as of December 31, 2020. Such forward-looking statements involve known and unknown risks, uncertainties and other factors. More information about the risks the Company faces is included under the headings “Risk Factors” in the Company’s most recently filed documents with the U.S. Securities and Exchange Commission. The Company is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this report as a result of new information, future events or otherwise.
|Item 9.01.|| |
Financial Statements and Exhibits.
|99.1||Press release, dated January 7, 2021, titled “Eiger Updates on 2020 Progress and 2021 Plans.”|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document).|
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: January 7, 2021|
|Chief Financial Officer|
Eiger BioPharmaceuticals Updates on 2020 Progress and 2021 Plans
Phase 3 HDV D-LIVR (Lonafarnib) Planned to Complete Enrollment in 2021
Phase 3 HDV LIMT-2 (Lambda) Planned to Initiate in 2H21
Zokinvy EMA Approval Expected in 2H21
Strong Cash Position with ~$176M Pro Forma Cash to Begin 2021
Palo Alto, Calif., January 7, 2021 /PRNewswire/ Eiger BioPharmaceuticals, Inc (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, today updated on progress across its product pipeline, including planned 2021 milestones.
Lonafarnib in HDV
First and only oral agent in development for HDV
Phase 3 D-LIVR study (N=400) enrollment completion planned in 2021
End of treatment data planned in 2022
Peginterferon Lambda (Lambda) monotherapy in HDV
Well-tolerated interferon for weekly subcutaneous injection
Phase 3 LIMT-2 study (N=150) planned start in 2H21
Lambda-Lonafarnib Combination in HDV
Positive end of study Phase 2 LIFT data presented at AASLD 2020
Publication expected in 2021
Zokinvy for Progeria and Processing-Deficient Progeroid Laminopathies
U.S. FDA approval in November 2020
U.S. commercial launch planned in January 2021
EMA approval expected 2H21
Lambda in COVID-19
Positive Phase 2 proof of concept data presented at RespiDART 2020
Data support impact of baseline viral loads on viral clearance with Lambda
Pre-IND package submitted to FDA with guidance expected in Q1 2021
PRV sale for $95M expected to close in January 2021; Eiger will retain 50%
Pro forma cash, cash equivalents and investments of approximately $176M, reflecting $128.8M as of December 31, 2020 plus $47.5M from PRV sale proceeds anticipated in January 2021, expected to fund planned operations through at least Q4 2023
Our priority in 2021 are our HDV programs, where we plan to complete D-LIVR enrollment and initiate the Lambda Phase 3 LIMT-2 study, said David Cory, President and CEO of Eiger. Lonafarnib is the only oral therapy in development and Lambda is a well-tolerated interferon in development for HDV, both with the potential to become foundational chronic treatments with convenience and optionality for patients affected by this most serious form of viral hepatitis.
Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of foundational therapies for 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.
Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Companys first FDA approval. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA). Outside the U.S., Eigers established global Managed Access Program, expected to span greater than 40 countries, ensures all children and young adults with Progeria and Progeroid Laminopathies have access to treatment.
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 2021, the timing of our ongoing and planned clinical development, including our ability to support
the launch of a new product and ship to specialty pharmacies; the sufficiency of our cash, cash equivalents and investments to fund our operations through at least Q4 2023; the expected closing of the sale of our PRV; our development programs for Zokinvy generally; and the potential approval of Zokinvy in jurisdictions outside of the U.S., including the EU; the risks related to the commercialization of Zokinvy, our ability to manufacture sufficient quantities of Zokinvy, and the commercial launch of Zokinvy in the U.S., the market potential for Zokinvy as a treatment for Progeria and processing-deficient Progeroid Laminopathies; our progression and enrollment of our Phase 3 D-LIVR study in HDV; our ability to maintain supply of our commercial and clinical trial materials; our plans to advance Lambda in HDV in the U.S. and EU; our ability to transition into a commercial stage biopharmaceutical company; our ability to finance the continued advancement of our development pipeline products; 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 Eigers 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.
SOURCE Eiger BioPharmaceuticals, Inc.
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