On August 8, 2019 Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, reported financial results for the three and six months ended June 30, 2019 and provided a business update (Press release, Eiger Biopharmaceuticals, AUG 8, 2019, View Source [SID1234538471]).
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"Eiger is advancing a late stage pipeline with three breakthrough therapy designations towards key milestones in 2019, including submission of the first ever NDA and MAA for Progeria and Progeroid Laminopathies," said David Cory, Eiger President and Chief Executive Officer. "In addition, enrollment of D-LIVR, the first-ever international Phase 3 study in Hepatitis Delta Virus infection, is ongoing, and we expect FDA registration guidance on our Lambda and Avexitide programs by year end. Eiger is poised for future growth."
Recent Highlights
Peginterferon Lambda (Lambda) in Hepatitis D Virus (HDV)
Positive Phase 2 LIMT (Lambda mono therapy) study results (N=33): 36% durable virologic response at 24 weeks post-treatment reported at The International Liver Congress 2019
Avexitide in Post-Bariatric Hypoglycemia (PBH) Program
Breakthrough Therapy Designation granted by FDA
Corporate Activity
Mark Mannebach, PhD, RPh, appointed as Vice President, Global Regulatory Affairs
Jeysen Yogaratnam, MB.BCh, BAO, MRCSEd, PhD, MBA, appointed as Vice President, Global HDV Clinical Development
Anticipated 2019 Milestones
FDA Guidance for Avexitide in PBH
Phase 2 LIFT (Lambda combination therapy with Lonafarnib and Ritonavir) end-of-treatment study results in HDV at AASLD
End of Phase 2 meeting for Lambda in HDV
NDA and MAA submissions in Progeria and Progeroid Laminopathies in Q4 2019
Phase 3 D-LIVR study in HDV (N=400) enrollment update
Second Quarter 2019 Financial Results
Cash, cash equivalents, and short-term investments as of June 30, 2019 totaled $125.3 million compared to $85.8 million at March 31, 2019, an increase of $39.5 million.
The Company reported net losses of $17.5 million, or $0.75 per share for second quarter 2019, as compared to $9.9 million, or $0.82 per share, for the same period in 2018.
Research and Development expenses were $12.9 million for second quarter 2019, as compared to $6.4 million for the same period in 2018, an increase of $6.5 million. The increase was primarily due to expenditures related to our clinical programs and licenses and other fees.
General and Administrative expenses were $4.2 million for second quarter 2019, as compared to $3.2 million for the same period in 2018, an increase of $1.0 million. The increase was primarily due to additional employee-related costs, including stock-based compensation, and external professional services as Eiger continued to build its infrastructure to support the development and potential commercialization of its clinical programs.
Second quarter 2019 operating expenses include total non-cash expenses of $1.8 million, as compared to $1.4 million for the same period in 2018.
In April 2019, Eiger completed a public offering of 5,175,000 shares of its common stock, including 675,000 shares sold upon full exercise of the underwriters’ option to purchase additional shares of common stock, at a price of $11.00 per share. The offering was made under Eiger’s effective shelf registration statement and resulted in net proceeds to the company of approximately $53.2 million, after deducting underwriting discounts and commissions and offering expenses.
As of June 30, 2019, Eiger had 24.4 million of common shares outstanding.