Eiger Biopharma Reports Third Quarter 2016 Financial Results
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Yurdaydin, C. et al. | Exploring Optimal | Abstract #1845, Poster Presentation, Session Hepatitis B: Treatment | November 14, 8:00 a.m. 5:30 p.m., Hall C |
Yurdaydin, C. et al. | The Prenylation Inhibitor Lonafarnib Can Induce Post-Treatment ALT Flares with Viral Clearance in Patients with Chronic Delta Hepatitis | Abstract #1875, Poster Presentation, Session Hepatitis B: Treatment | November 14, 8:00 a.m. 5:30 p.m., Hall C |
Wedemeyer, H. et al | A Phase 2 Study of Titrating-Dose Lonafarnib Plus Ritonavir in Patients With Chronic Hepatitis D: Interim Results From The Lonafarnib With Ritonavir In HDV 4 (LOWR HDV 4) Study | Abstract #230, Oral Presentation, Parallel 35: Hepatitis B: Novel Therapies | November 14, 5:00 p.m. 5:15 p.m.,
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About the Lonafarnib LOWR HDV Program
LOWR HDV is a multi-center, international Phase 2 program designed to identify optimal dosing of lonafarnib with ritonavir and/or pegylated interferon alpha for development in the treatment of hepatitis delta infection.
- LOWR HDV 2 is a dose-finding study to identify optimal combination regimens of lonafarnib and ritonavir ± PEG-IFN-, with efficacy and tolerability for longer term dosing to enable HDV RNA clearance. In this open-label study, approximately 40 HDV infected patients have been enrolled to date into 9 groups of different doses of lonafarnib in combination with ritonavir for dosing durations of 12 or 24 weeks. Lonafarnib doses range from 100 mg bid to 25 mg bid. LOWR HDV 2 is being conducted at Ankara University in Ankara, Turkey.
- LOWR HDV 3 is a double-blinded, randomized, placebo-controlled study designed to evaluate the efficacy and tolerability of once-daily doses of lonafarnib 50 mg, 75 mg and 100 mg each combined with ritonavir 100 mg once daily for 12 or 24 weeks. Twenty-one patients with chronic hepatitis delta were randomized into one of six treatment groups. LOWR HDV 3 is being conducted at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland and dosing has been completed.
- LOWR HDV 4 is an open-label study to evaluate the efficacy and tolerability of dose escalation of lonafarnib combined with ritonavir administered twice daily for dosing durations of 24 weeks. Fifteen patients were initiated at lonafarnib 50 mg and ritonavir 100 mg twice daily, and dose-escalated up to lonafarnib 100 mg twice daily at the discretion of the investigator. LOWR HDV 4 is being conducted at Hannover Medical School in Hannover, Germany and dosing has been completed.
Anticipated Q4 2016 Milestones
- Lonafarnib: Eiger expected to present LOWR HDV - 2, - 3, - 4 Phase 2 program data at AASLD 2016
- Exendin 9-39: Data expected by year-end from the Multiple Ascending Dose (MAD) Phase 2 study in patients with Post-Bariatric Hypoglycemia (PBH)
- Eiger hosted PBH / Exendin 9-39 Key Opinion Leader Meeting on December 9th
- Exendin 9-39: Eiger U.S. IND filing
- Exendin 9-39: Orphan designation in the U.S. for hyperinsulinemic hypoglycemia
Anticipated 2017 Milestones
- Ubenimex: Data from the LIBERTY Phase 2 study in PAH
- Ubenimex: Data from the ULTRA Phase 2 study in Lymphedema
- Pegylated Interferon Lambda: Data from the LIMT Phase 2 study in HDV
- Lonafarnib: End of follow up data from the LOWR HDV -2, -3, -4 Phase 2 studies
- Lonafarnib: Regulatory meeting to discuss HDV program and next steps
- Exendin 9-39: Initiation of follow-up Phase 2 study
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 Q4 2016 and 2017 milestones, whether or not PEGylated interferon lambda-1a 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, 2015 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.
Andrew McDonald, LifeSci Advisors, LLC, 646-597-6987, andrew@lifesciadvisors.com
Jim Welch, Eiger BioPharmaceuticals, 650-279-9845, jwelch@eigerbio.com
Eiger BioPharmaceuticals Inc. | |||||||||
Selected Statements of Operations Financial Data | |||||||||
(in thousands, except per share amounts) | |||||||||
(unaudited) | |||||||||
Three Months Ended | Nine Months Ended | ||||||||
September 30, | September 30, | ||||||||
2016 | 2015 | 2016 | 2015 | ||||||
Operating expenses: | |||||||||
Research and development | $ 8,072 | $ 2,110 | $ 23,637 | $ 4,493 | |||||
General and administrative | 3,264 | 762 | 9,574 | 1,768 | |||||
Total operating expenses | 11,336 | 2,872 | 33,211 | 6,261 | |||||
Loss from operations | (11,336) | (2,872) | (33,211) | (6,261) | |||||
Interest expense, net | - | - | (685) | - | |||||
Other expense, net | (34) | - | (423) | - | |||||
Net loss | $ (11,370) | $ (2,872) | $ (34,319) | $ (6,261) | |||||
Net loss per common share: | |||||||||
Basic and diluted | $ (1.49) | $ (14.70) | $ (6.58) | $ (32.22) | |||||
Shares used to compute net loss per common share: | |||||||||
Basic and diluted | 7,623 | 195 | 5,218 | 194 | |||||
Eiger BioPharmaceuticals Inc. | |||||||||
Selected Balance Sheets Financial Data | |||||||||
(in thousands) | |||||||||
(unaudited) | |||||||||
September 30, | December 31, | ||||||||
2016 | 2015 | ||||||||
Balance Sheet Data: | |||||||||
Cash, cash equivalents and investments | $ 56,294 | $ 4,778 | |||||||
Working capital | 51,859 | (2,895) | |||||||
Total assets | 57,427 | 5,582 | |||||||
Total stockholders' equity | 52,065 | (5,152) |
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SOURCE Eiger BioPharmaceuticals, Inc.