Hdv yahoo finance

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– HDV Platform Strategy Rapidly Advancing

– Phase 3 HDV D-LIVR (Lonafarnib) >ninety% Enrolled; On-Track for Full Enrollment in 2021

– Phase three HDV LIMT-2 (Lambda) On-Track for First Patient to Enroll in 2021

– All Five Rare Disease Programs Now Have Breakthrough Therapy Designation

– Company to Host Conference Call Today at 4:30 PM ET

PALO ALTO, Calif., Aug. 5, 2021 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), a industrial-stage biopharmaceutical corporation targeted on the choices improvement and commercialization of targeted cures for serious uncommon and extremely-uncommon diseases, nowadays stated its 2d quarter 2021 economic effects and provided a business update.

“Our unexpectedly advancing HDV platform method, which includes Lonafarnib and Peginterferon Lambda, gives more than one opportunities to deliver a win for HDV patients and positions us to be a pacesetter on this space,” said David Cory, President and CEO of Eiger. “We are on the right track to finish enrollment in our Phase 3 HDV D-LIVR observe this 12 months, putting in pivotal topline information launch in late-2022. Additionally, LIMT-2, our Phase three examine of Peginterferon Lambda for HDV, is on the right track to enroll its first affected person with the aid of quit of 2021.”

Program Updates and Upcoming Milestones

Only oral remedy in development for HDV

Phase three D-LIVR (N=400) is the biggest global have a look at in HDV

Peginterferon Lambda for HDV

Well-tolerated interferon administered as a weekly subcutaneous injection

Phase three LIMT-2 (N=a hundred and fifty) is a pivotal study of Peginterferon Lambda as a single agent for HDV

Avexitide for Rare Metabolic Disorders

FDA Breakthrough Therapy Designation granted for congenital hyperinsulinism

Phase three-allowing production, device improvement, and regulatory sports are ongoing in 2021

Phase three research for put up-bariatric hypoglycemia and congenital hyperinsulinism may want to start as early as 2022

Zokinvy® for Progeria and Processing-Deficient Progeroid Laminopathies

EMA approval expected by stop of 2021

Recipient of 2021 NORD Industry Innovation Award

Nominee for 2021 Prix Galien USA Best Pharmaceutical Product Award

Phase three TOGETHER have a look at enrolling patients throughout medical web sites in Brazil

Interim futility statistics evaluation potentially by way of give up of 2021

Positive facts should help submission for emergency use authorization

Cash and investments of $139.eight million at the end of 2nd area 2021 is expected to fund deliberate operations into fourth area 2023

Second Quarter Financial Results

Net revenues from Zokinvy product income were $2.1 million for second region 2021. The employer commercially launched Zokinvy within the U.S. in January 2021 and stated $3.6 million in first sector 2021, which protected preliminary inventory stocking at the distinctiveness pharmacy.

Research and Development costs had been $14.three million for 2d zone 2021, compared to $9.8 million for the equal period in 2020. The growth became mostly because of scientific trial associated fees, along with settlement manufacturing, headcount associated expenses, together with stock-based repayment price, and regulatory consulting services.

Cost of Sales were $zero.three million for the second one region of 2021 and is associated with positive costs related to Zokinvy that had been incurred after FDA approval.

Selling, General and Administrative expenses were $five.9 million for the second quarter of 2021, compared to $4.9 million for the identical duration in 2020. The growth was on the whole due to outdoor consulting and advisory offerings and headcount related prices, consisting of stock-based totally repayment expense

Total operating charges consist of non-coins expenses of $2.7 million for the second region of 2021, in comparison to $1.8 million for the same period in 2020.

Eiger said a second quarter 2021 internet lack of $19.2 million, or $0.fifty seven on a consistent with share foundation. This compares to a internet lack of $15.three million, or $0.60 on a in line with proportion basis, for the second quarter of 2020.

Cash, cash equivalents, and investments as of June 30, 2021, totaled $139.8 million in comparison to $160.five million on March 31, 2021.

As of June 30, 2021, the company had 33,951,314 not unusual stocks first-rate.

At four:30 PM Eastern Time today, August 5, 2021, Eiger will host a conference name to discuss its financial effects and provide a commercial enterprise replace. The stay and replayed webcast of the call may be to be had through the corporation's website at www.eigerbio.com. To take part inside the live call by smartphone, dial (844) 743-2495 (U.S.) or (661) 378-9529 (International) and input conference ID 9482721. The webcast could be archived and available for replay for at the least ninety days after the occasion.

Eiger is a commercial-degree biopharmaceutical corporation targeted on the improvement and commercialization of targeted remedies for severe rare and ultra-uncommon sicknesses.

Eiger's lead scientific packages are focused on the development of foundational remedies for Hepatitis Delta Virus (HDV) infection, the choices maximum severe shape of viral hepatitis. Eiger's HDV platform strategy includes two complementary HDV remedies. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a primary-in-magnificence, kind III, properly-tolerated interferon entering Phase 3.

Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient progeroid laminopathies is the Company's first FDA accepted product. A Marketing Authorization Application (MAA) is beneath review with the aid of the European Medicines Agency (EMA).

For additional data approximately Eiger and its medical programs, please visit www.eigerbio.com.

Note Regarding Forward-Looking Statements

Investors and Media: Charles ButlerVP, Investor Relations and Corporate CommunicationsEmail: [email protected]: 1-650-272-6138

Condensed Consolidated Balance Sheets

Cash and cash equivalents

Prepaid expenses and different cutting-edge property

Property and device, net

Operating rent right-of-use belongings

LIABILITIES AND STOCKHOLDERS' EQUITY

Total liabilities and stockholders' fairness

(1) Derived from the audited monetary statements, included inside the Company's Annual Report on Form 10-K for the choices year ended December 31, 2020.

Condensed Consolidated Statements of Operations Financial Data

(in hundreds, besides in step with percentage and percentage quantities)

Costs and running expenses:

Selling, trendy and administrative(1)

Other income (price), internet

Income(loss) before provision for taxes

Provision for earnings taxes

Net profits (loss) in keeping with common proportion:

Weighted-average common shares exceptional:

Includes stock-based totally reimbursement rate of:

Total inventory-based compensation fee

View authentic content material to download multimedia:https://www.prnewswire.com/information-releases/eiger-biopharmaceuticals-reports-second-zone-2021-economic-consequences-and-gives-business-replace-301349759.html

SOURCE Eiger BioPharmaceuticals, Inc.

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