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News 2017-03-23T14:18:55+00:00
Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2016 Financial Results
  • Five Phase 2 Programs in Four Orphan Indications
  • Multiple Value-Creating Events Across Programs Expected in Next 12-18 Months

PALO ALTO, Calif., March 23, 2017 — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for rare diseases, announced today a business update and financial results for the three months and full year ended December 31, 2016.

“We believe that 2016, Eiger’s first year as a publicly traded company, was a year of significant accomplishment and advancement,” said David Cory, President and CEO of Eiger BioPharmaceuticals.  “We advanced our pipeline of five Phase 2 programs across four therapeutically diverse orphan diseases spanning international clinical sites.  We believe that these achievements have moved us closer to our goal of building a leading biotechnology company, and delivering value to patients and shareholders.  We look forward to another year of accomplishment in 2017 as our pipeline matures, we anticipate advancement toward important Phase 2 data read-outs, and we will continue to pursue multiple shots on goal for clinical and regulatory success.”

Key 2016 Milestones Achieved

Lonafarnib in HDV

  • Phase 2 data across international sites from LOnafarnib With Ritonavir in HDV (LOWR HDV) program presented at the European Association for the Study of Liver Disease (EASL) and the American Association for the Study of Liver Diseases (AASLD) meetings

Pegylated Interferon Lambda in HDV

  • License agreement for global rights to Lambda from Bristol-Myers Squibb
  • First patient dosed in Phase 2 Lambda Interferon MonoTherapy in HDV (LIMT HDV) international study

Exendin 9-39 in Post-Bariatric Hypoglycemia (PBH)

  • Phase 2 single-ascending dose study data presented at the American Diabetes Association (ADA)
  • Phase 2 multiple-ascending dose (MAD) study data
  • Development of novel liquid formulation for subcutaneous injection
  • US orphan designation for hyperinsulinemic hypoglycemia
  • EMA orphan designation for non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS) which includes PBH

Ubenimex in Pulmonary Arterial Hypertension (PAH)

  • First patient dosed in Phase 2 LIBERTY North American study
  • EMA orphan designation

Ubenimex in Lymphedema

  • First patient dosed in Phase 2 ULTRA international study

Extended company runway through mid-2018

  • $20 million follow on financing in August
    • $15 million tranche from $25 million venture debt line received from Oxford in December
Fourth Quarter and Full Year 2016 Financial Results

Net loss for the fourth quarter of 2016 was $12.8 million, or $1.53 per share basic and diluted, compared to a net loss of $7.1 million, or $25.78 per share basic and diluted for the fourth quarter of 2015.  Net loss for the year ended December 31, 2016 was $47.1 million, or $7.84 per share basic and diluted, compared to a net loss of $13.3 million, or $62.19 per share basic and diluted for the year ended December 31, 2015.

Research and development expenses for the fourth quarter of 2016 were $9.4 million compared to $3.6 million for the fourth quarter of 2015. The increase was primarily due to a $4.4 million increase in clinical expenditures coupled with a $0.9 million increase in compensation and personnel related expenses due to an increase in headcount.

Research and development expenses for the year ended December 31, 2016 were $33.0 million compared to $8.1 million for the year ended December 31, 2015. The increase was primarily due to a $15.0 million increase in clinical expenditures due to increased program activity, a $5.2 million expense related to upfront payments under our license agreement with Bristol-Meyers Squibb and a $2.2 million increase in compensation and personnel related expenses due to an increase in headcount.

General and Administrative expenses for the fourth quarter of 2016 were $3.5 million compared to $3.1 million for the fourth quarter of 2015. The increase was primarily due to a $1.0 million stock compensation charge.

General and administrative expenses for the year ended December 31, 2016 were $13.1 million compared to $4.9 million for the year ended December 31, 2015. The increase was primarily due to a $3.4 million increase in consulting, advisory, legal and accounting services incurred in connection with the merger with Celladon and the costs of being a public company and a $2.3 million increase in stock-based compensation expense.

As of December 31, 2016, Eiger had cash, cash equivalents and short term marketable securities of $59.9 million, compared to $4.8 million at December 31, 2015. The increase was primarily attributable to cash received from investors and Celladon in connection with our merger with Celladon which closed March 22, 2016.  Also during 2016 were the $20.0 million in gross proceeds from a common stock offering that was completed in August and in December gross proceeds of $15.0 million from the first tranche of our debt agreement with Oxford.

Key Anticipated Milestones in 2017

  • LOWR HDV program: end-of-study data in Q2, and agency meeting in Q4
  • Lambda in HDV: US IND filing in Q2, interim data from LIMT HDV study in Q4
  • Exendin 9-39 in PBH: completion of MAD study in Q2, completion of PK study with novel liquid formulation in Q3, and initiation of Phase 2 – 28-day study in Q4
  • Ubenimex in PAH: complete LIBERTY enrollment in Q2; data Q1 2018
  • Ubenimex in Lymphedema: complete ULTRA enrollment in Q3; data Q2 2018.

About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed.  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, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward- looking statements may be accompanied by such words as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, our ability to timely and successfully achieve, all or any of the anticipated 2017 and 2018 milestones, whether or not pegylated interferon lambda or lonafarnib or ubenimex or exendin 9-39 may be further developed and approved, statements relating to the availability of cash for Eiger’s future operations and drug development portfolio, Eiger’s ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. 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 Annual Report on Form 10-K for the period ended December 31, 2016 and Eiger’s periodic reports filed with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.

Eiger BioPharmaceuticals

SOURCE Eiger Bio, Inc.

Investors:
Andrew McDonald LifeSci Advisors, LLC, 646-597-6987, andrew@lifesciadvisors.com
Jim Welch, Eiger BioPharmaceuticals, 650-279-9845, jwelch@eigerbio.com

PDF Icon

DateTitle (click to view the full PR)PDF
December 12, 2016Eiger Announces Multiple Advances in Exendin 9-39 Program for the Treatment of Post-Bariatric Hypoglycemia (PBH) – Positive Interim Data from Phase 2 Multiple-Ascending Dose Study – Novel Liquid Formulation of Exendin 9-39 – US Orphan Designation for Hyperinsulinemic HypoglycemiaPDF Icon
November 29, 2016Eiger Updates Progress in Clinical Development Program for Exendin 9-39 to Treat Post-Bariatric Hypoglycemia (PBH) – Exendin 9-39 investigational new drug (IND) application filed – PBH Analyst / Key Opinion Leader Event planned December 9th – Multiple-ascending dose (MAD) study interim data to be presentedPDF Icon
November 14, 2016Eiger Announces Additional LOWR HDV Program Data, Clinical and Regulatory Plans at the American Association for the Study of Liver Diseases (AASLD) Meeting – Update on Data Presented and Analyst Meeting through Monday EveningPDF Icon
November 14, 2016Eiger Announces Positive Phase 2 Data at the American Association for the Study of Liver Diseases (AASLD) Meeting: Multiple Paths Forward Identified with Lonafarnib Therapy in LOWR HDV Program – Data Presented through Monday MorningPDF Icon
November 8, 2016Eiger BioPharmaceuticals Reports Third Quarter 2016 Financial ResultsPDF Icon
October 24, 2016Eiger BioPharmaceuticals Launches Nationwide Hepatitis Delta Virus (HDV) Campaign to Expand Awareness and Testing for HDV Infection – Collaboration with ARUP Laboratories and Hepatitis B Foundation – HDV viral load assay now available in U.S.PDF Icon
October 19, 2016Eiger Announces First Patient Dosed in Phase 2 Study of Pegylated Interferon Lambda in Hepatitis D Virus (HDV) Infection – LIMT HDV: Lambda Interferon MonoTherapy in HDV StudyPDF Icon
October 17, 2016Eiger Announces Orphan Designation of Exendin 9-39 for Treatment of Non-Insulinoma Pancreatogenous Hypoglycemia Syndrome (NIPHS) from European Medicines Agency (EMA)PDF Icon
October 13, 2016Eiger Announces Abstracts and Presentations of LOWR HDV Program at the American Association for the Study of Liver Diseases (AASLD) MeetingPDF Icon
September 7, 2016Eiger Announces Completion of Dosing in Phase 2 LOWR HDV – 4 Study at Hannover Medical SchoolPDF Icon
September 6, 2016Eiger BioPharmaceuticals to Present at the BioCentury NewsMakers in the Biotech Industry Conference on September 9thPDF Icon
September 1, 2016Eiger BioPharmaceuticals to Present at the 5th Annual Liolios Gateway Conference on September 7, 2016PDF Icon
August 18, 2016Eiger BioPharmaceuticals Announces Pricing of Public Offering of Common StockPDF Icon
August 17, 2016Eiger BioPharmaceuticals Announces Proposed Public Offering of Common StockPDF Icon
August 10, 2016Eiger BioPharmaceuticals Reports Second Quarter 2016 Financial ResultsPDF Icon
July 28, 2016Eiger BioPharmaceuticals Announces Partnership with the Hepatitis B Foundation – Raising Awareness of Hepatitis Delta Virus Co-InfectionPDF Icon
July 25, 2016Eiger BioPharmaceuticals Announces First Patient Dosed in Phase 2 ULTRA Study of Ubenimex in Secondary LymphedemaPDF Icon
July 20, 2016Eiger BioPharmaceuticals Announces Completion of Dosing in Phase 2 LOWR HDV – 3 Study at National Institutes of Health (NIH)PDF Icon
July 18, 2016Eiger BioPharmaceuticals Announces First Patient Dosed in Phase 2 LIBERTY Study of Ubenimex in Pulmonary Arterial HypertensionPDF Icon
July 6, 2016Eiger BioPharmaceuticals to Present at the Cantor Fitzgerald 2nd Annual Healthcare Conference on July 12thPDF Icon
June 13, 2016Eiger Announces Positive Clinical Results of Single Ascending Dose Study of Subcutaneous Exendin (9-39) in Patients with Post-Bariatric HypoglycemiaPDF Icon
June 6, 2016Eiger to Participate in Jefferies 2016 Healthcare ConferencePDF Icon
May 10, 2016Eiger Announces First Patient Dosed in Phase 2 Multiple Ascending Dose Study of Subcutaneous Exendin (9-39) in Patients with Hypoglycemia Post-Gastric Bypass SurgeryPDF Icon
May 3, 2016Eiger Bio Strengthens Senior Management Team with Announcement of Debra Odink, PhD as Senior Vice President of Technical OperationsPDF Icon
April 20, 2016Eiger BioPharmaceuticals Announces License of Worldwide Rights to Pegylated Interferon Lambda-1a from Bristol-Myers SquibbPDF Icon
April 4, 2016Eiger BioPharmaceuticals Strengthens Board of Directors with Addition of Industry Veteran Charles J. “Chuck” BramlagePDF Icon
March 30, 2016Eiger BioPharmaceuticals Announces Abstracts and Presentations of Lonafarnib Data in Hepatitis Delta at the European Association for the Study of the Liver (EASL) MeetingPDF Icon
March 28, 2016Eiger BioPharmaceuticals Granted Orphan Medicinal Product Designation for Ubenimex in Pulmonary Arterial Hypertension by European Medicines AgencyPDF Icon
March 22, 2016Eiger BioPharmaceuticals Closes Merger With Celladon Renamed Eiger and New Trading Symbol (NASD: EIGR, as of March 23) Developing a Clinical Stage Pipeline of Orphan Disease ProgramsPDF Icon
March 22, 2016Celladon Announces Results of Special MeetingPDF Icon
March 14, 2016Eiger Announces Completion of Enrollment of Phase 2 LOWR HDV – 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus – 4) Study at Hannover Medical SchoolPDF Icon
March 9, 2016ISS and Glass Lewis Recommend Celladon Corporation Shareholders Vote “FOR” Proposed MergerPDF Icon
February 29, 2016Eiger to Participate in Cowen & Company 2016 Health Care ConferencePDF Icon
February 11, 2016Celladon Sets Date for Special Meeting of StockholdersPDF Icon
January 19, 2016Eiger BioPharmaceuticals Announces Completion of Enrollment of Phase 2 LOWR HDV – 3 (LOnafarnib With Ritonavir in Hepatitis Delta Virus – 3) Study at National Institutes of Health (NIH)PDF Icon
January 6, 2016Eiger BioPharmaceuticals Announces First Patient Dosed in Phase 2 LOWR HDV – 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus – 4) Study at Hannover Medical School in Hannover, GermanyPDF Icon
DateTitle (click to view the full PR)PDF
December 15, 2015Eiger BioPharmaceuticals Announces Notice of Allowance for U.S. Patent Covering Bestatin™ (Ubenimex) for the Treatment of Pulmonary Arterial HypertensionPDF Icon
November 30, 2015Eiger BioPharmaceuticals Granted Orphan Drug Status for Ubenimex in Pulmonary Arterial HypertensionPDF Icon
November 18, 2015Eiger BioPharmaceuticals and Celladon Corporation Sign Merger Agreement PDF Icon
November 12, 2015Eiger BioPharmaceuticals Announces Acquisition of Exclusive License to Program for Treatment of Post-Bariatric Hypoglycemia from Stanford University – Clinical Proof of Concept Data Already Generated in PatientsPDF Icon
November 11, 2015Eiger BioPharmaceuticals Announces Acquisition of Exclusive License to Lymphedema Program from Stanford University – Novel Target Identified as Potential Therapeutic Approach for LymphedemaPDF Icon
November 10, 2015Eiger BioPharmaceuticals Announces Acquisition of Exclusive License to Pulmonary Arterial Hypertension (PAH) Program from Stanford UniversityPDF Icon
November 9, 2015Eiger BioPharmaceuticals Announces License Agreement with Nippon Kayaku to Develop Bestatin™ (ubenimex) for Inflammatory Diseases Involving LTB4 – First Clinical Target – Pulmonary Arterial Hypertension (PAH)PDF Icon
October 23, 2015Eiger BioPharmaceuticals Appoints Thomas J. Dietz, Ph.D. to the Eiger Board of DirectorsPDF Icon
October 20, 2015Eiger BioPharmaceuticals Appoints Eduardo Martins, M.D., D.Phil., as Senior Vice President, Liver and Infectious Diseases Drug DevelopmentPDF Icon
August 17, 2015Eiger BioPharmaceuticals Announces Key Operational Hires to Senior Management Team: Jim Welch, Chief Financial Officer & Jim Shaffer, Chief Business OfficerPDF Icon
July 20, 2015The Lancet Infectious Diseases Journal Publishes Results of Phase 2 Study of Lonafarnib in Hepatitis Delta Virus (HDV) Infected PatientsPDF Icon
April 28, 2015Eiger BioPharmaceuticals Announces Interim Results of Lonafarnib in Combination with Ritonavir or Pegylated Interferon in Patients Infected with Hepatitis Delta Virus (HDV)PDF Icon
April 20, 2015FDA Grants Fast Track Designation to Eiger Bio’s Lonafarnib for Hepatitis Delta Virus (HDV) InfectionPDF Icon
April 14, 2015Eiger BioPharmaceuticals Announces Senior Staff Appointments in Clinical Development and Regulatory Affairs: Dr. Joanne Quan, M.D., as Chief Medical Officer & Dr. Shelly Xiong, Ph.D., as Vice President of Regulatory AffairsPDF Icon
April 13, 2015Eiger BioPharmaceuticals Announces Abstracts and Presentations of Lonafarnib Data in Hepatitis Delta (HDV) at the European Association for the Study of the Liver Conference – April 22 to 26, 2015PDF Icon
February 23, 2015Eiger BioPharmaceuticals Announces Presentation of Positive Data in Patients Infected with Hepatitis Delta Virus (HDV) Treated with Lonafarnib – NIH Principal Investigator to Present Abstract and Poster at Conference on Retroviruses and Opportunistic Infections (CROI)PDF Icon