On November 4, 2021 Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious rare diseases, reported its third quarter 2021 financial results and provided a business update (Press release, Eiger Biopharmaceuticals, NOV 4, 2021, View Source [SID1234594620]).

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"The recent completion of enrollment in our Phase 3 HDV D-LIVR study of Lonafarnib-based regimens sets up pivotal topline data by the end of 2022," said David Cory, President and CEO. "Additionally, our Phase 3 HDV LIMT-2 study of Peginterferon Lambda is now activating sites and screening patients. Eiger is focused on the development of treatments and a cure for HDV. We are positioned to be a leader in this space with two first-in-class therapies for HDV, offering hope for the over 12 million patients around the globe with this devastating disease."

Program Updates and Upcoming Milestones

HDV Platform

Lonafarnib for HDV

First-in-class prenylation inhibitor and only oral agent in development
D-LIVR, largest Phase 3 global study conducted in HDV
Fully enrolled with over 400 patients
Opportunity for approval of two Lonafarnib-based regimens:
All-oral and combination with peginterferon alfa
Pivotal topline data planned by end of 2022
Peginterferon Lambda for HDV

Well-tolerated interferon administered as a weekly subcutaneous injection
LIMT-2 (N=150), pivotal study of Peginterferon Lambda monotherapy
Now activating sites and screening patients
Avexitide for Rare Metabolic Disorders

Phase 3 studies for post-bariatric hypoglycemia and congenital hyperinsulinism could begin as early as 2022
Zokinvy for Progeria and Processing-Deficient Progeroid Laminopathies

MAA is under EMA review, with an opinion from the Committee for Medicinal Products for Human Use (CHMP) expected around end of 2021
Cohort ATU program (Temporary Use Authorization) approved in France
First ATU shipment completed
Peginterferon Lambda for COVID-19

Phase 3 TOGETHER study enrolling patients across clinical sites in Brazil
DSMB interim futility analysis (n=453) recommended study continuation
Next interim futility data analysis by end of 2021
Positive data could support emergency use authorization package
Corporate

Appointed Erik Atkisson General Counsel and Chief Compliance Officer
Cash and investments of $120.4 million at the end of third quarter 2021 expected to fund planned operations into fourth quarter 2023
Third Quarter Financial Results

Net revenues from Zokinvy product sales were $3.0 million for third quarter 2021, as compared to $2.1 million for second quarter 2021. The increase was primarily driven by modestly higher inventory on-hand at the specialty pharmacy. The company commercially launched Zokinvy in the U.S. in January 2021 and has reported September year-to-date net sales of $8.8 million.

Cost of Sales were $0.3 million for third quarter 2021 and is related to certain costs associated with Zokinvy that were incurred after FDA approval.

Research and Development expenses were $18.1 million for third quarter 2021, as compared to $9.8 million for the same period in 2020. The increase was primarily due to clinical trial related expenses, including contract manufacturing and headcount related expenses, including stock-based compensation expense.

Selling, General and Administrative expenses were $6.5 million for the third quarter of 2021, as compared to $5.0 million for the same period in 2020. The increase was primarily due to outside consulting and advisory services and headcount related expenses, including stock-based compensation expense.

Total operating expenses include non-cash expenses of $3.0 million for the third quarter of 2021, as compared to $1.9 million for the same period in 2020.

Eiger reported a third quarter 2021 net loss of $22.2 million, or $0.65 on a per share basis. This compares to a net loss of $15.7 million, or $0.52 on a per share basis, for the third quarter of 2020.

Cash, cash equivalents, and investments as of September 30, 2021, totaled $120.4 million compared to $139.8 million as of June 30, 2021.

As of September 30, 2021, the company had 33,975,800 common shares outstanding.

Conference Call
At 4:30 PM Eastern Time today, November 4, 2021, Eiger will host a conference call to discuss its financial results and provide a business update. The live and replayed webcast of the call will be available through the company’s website at www.eigerbio.com. To participate in the live call by phone, dial (844) 743-2495 (U.S.) or (661) 378-9529 (International) and enter conference ID 9874006. The webcast will be archived and available for replay for at least 90 days after the event.