Eiger BioPharmaceuticals, Inc., focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, reported financial results for third quarter 2020 and provided a business update.
PALO ALTO, Calif., Nov. 5, 2020 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today reported financial results for third quarter 2020 and provided a business update.
Recent Highlights and Upcoming Milestones
ZokinvyTM (lonafarnib) in Progeria and Progeroid Laminopathies
- New Drug Application (NDA) Prescription Drug User Fee Act (PDUFA) target action date November 20, 2020
Lonafarnib in Hepatitis Delta Virus (HDV)
- Phase 3 D-LIVR study full enrollment expected in 2021
Peginterferon Lambda (Lambda) in HDV
- Phase 2 LIFT (combo with lonafarnib) end-of-study data expected at AASLD 2020
- Agreement with FDA and EMA on single, Phase 3 Lambda monotherapy study design
Peginterferon Lambda (Lambda) in COVID-19
- Toronto General Hospital, University Health Network (N=60)
- Mean baseline viral load: 6.7 log copies/mL
- 79% (Lambda) vs 38% (placebo) (p=0.013) clear virus by Day 7
- > 6 log copies/mL correlates with the threshold for infectivity
- Stanford University School of Medicine (N=120)
- Mean baseline viral load: < 4 log copies/mL
- Median time to cessation of viral shedding was 7 days in both groups
- Results of both studies support Lambda activity in high baseline viral load patients
- Lambda was well tolerated in both studies with few adverse events, which included minimal elevations of transaminases which self-resolved
- Plan to meet with FDA to discuss data and next steps
Third Quarter 2020 Financial Results
Cash, cash equivalents, and short-term investments as of September 30, 2020 totaled $125.3 million.
The Company reported net loss of $15.7 million, or $0.52 per share, for third quarter 2020, as compared to $18.6 million, or $0.76 per share, for third quarter 2019.
Research and Development expenses were $9.8 million for third quarter 2020, as compared to $14.1 million for third quarter 2019. The decrease was primarily due to a decrease in clinical trial related expenses, including clinical trial material costs.
General and Administrative expenses were $5.0 million for third quarter 2020, as compared to $4.2 million for third quarter 2019. The increase was primarily due to an increase in outside consulting, advisory and accounting services and an increase in personnel-related expenses.
Total operating expenses include total non-cash expenses of $1.9 million for third quarter 2020, as compared to $1.8 million for the same period in 2019.
As of September 30, 2020, the Company had 31.9 million of common shares outstanding.
About Eiger
Eiger is a late-stage biopharmaceutical company focused on the development and commercialization of first-in-class, well-characterized drugs for serious rare and ultra-rare diseases for patients with high unmet medical needs.
Eiger’s lead clinical programs target Hepatitis Delta Virus (HDV) infection, the most serious form of human viral hepatitis. Eiger is developing two complementary treatments for HDV. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, well-tolerated type III interferon entering Phase 3.
Eiger has filed an NDA and MAA for lonafarnib for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies. FDA PDUFA date is November 20, 2020.
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, including statements regarding our future financial condition, timing for and outcomes of clinical results, business strategy and plans and objectives for future operations, are forward-looking statements. These forward-looking statements include terminology such as “believe,” “will,” “may,” “estimate,” “continue,” “anticipate,” “contemplate,” “intend,” “target,” “project,” “should,” “plan,” “expect,” “predict,” “could,” “potentially” or the negative of these terms. Forward-looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our anticipating significant milestones in 2020 and 2021, the timing of our ongoing and planned clinical development, including the potential for approval of our lonafarnib product candidate in the U.S. and EU for Progeria and Progeroid Laminopathies; our progression and enrollment of our Phase 3 D-LIVR study in HDV; our ability to maintain supply of our clinical trial materials; our announcement of data from the trial of Lambda and lonafarnib boosted with ritonavir for HDV (LIFT); our plans to advance Lambda in HDV in the U.S. and EU; our plans for continued advancement of avexitide in registration trials; and our plans to initiate and conduct clinical studies of Lambda in coronavirus; our ability to transition into a commercial stage biopharmaceutical company; our ability to finance the continued advancement of our development pipeline products; that the company’s expectations regarding the effects of COVID-19 on the Company’s trials and development may be incorrect; and the potential for success of any of our product candidates. These statements concern product candidates that have not yet been approved for marketing by the U.S. Food and Drug Administration (FDA). No representation is made as to their safety or effectiveness for the purposes for which they are being investigated.
Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including additional applicable risks and uncertainties described in the “Risk Factors” sections in the Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and Eiger’s subsequent filings with the SEC. The forward-looking statements contained in this press release are based on information currently available to Eiger and speak only as of the date on which they are made. Eiger does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.
Investors and Media:
Ingrid Choong, PhD
(650) 619-6115
ichoong@eigerbio.com
Sri Ryali
(650) 272-6138
sryali@eigerbio.com
| Eiger BioPharmaceuticals Inc. | |||||||||
| Condensed Consolidated Balance Sheets | |||||||||
| (in thousands) | |||||||||
| Nine Months Ended | Year Ended | ||||||||
| September 30, | December 31, | ||||||||
| 2020 | 2019(1) | ||||||||
| (unaudited) | |||||||||
| ASSETS | |||||||||
| Cash and cash equivalents | $ 51,993 | $ 39,373 | |||||||
| Debt securities, available-for-sale | 73,341 | 55,621 | |||||||
| Prepaid expenses and other current assets | 9,608 | 5,390 | |||||||
| Total current assets | 134,942 | 100,384 | |||||||
| Property and equipment, net | 670 | 590 | |||||||
| Operating lease right-of-use assets | 1,300 | 1,654 | |||||||
| Other assets | 3,781 | 2,511 | |||||||
| Total assets | $ 140,693 | $ 105,139 | |||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||
| Current liabilities | $ 21,660 | $ 16,949 | |||||||
| Other liabilities | 26,083 | 31,710 | |||||||
| Stockholders’ equity | 92,950 | 56,480 | |||||||
| Total liabilities and stockholders’ equity | $ 140,693 | $ 105,139 | |||||||
| (1) | Derived from the audited financial statements, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019. | ||||||||
| Eiger BioPharmaceuticals Inc. | ||||||||||
| Condensed Consolidated Statements of Operations Financial Data | ||||||||||
| (in thousands, except per share and share amounts) | ||||||||||
| Three Months Ended | Nine Months Ended | |||||||||
| September 30, | September 30, | |||||||||
| (unaudited) | (unaudited) | |||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||
| Operating expenses: | ||||||||||
| Research and development(1) | $ 9,810 | $ 14,059 | $ 29,045 | $ 39,863 | ||||||
| General and administrative(1) | 5,027 | 4,247 | 15,141 | 12,529 | ||||||
| Total operating expenses | 14,837 | 18,306 | 44,186 | 52,392 | ||||||
| Loss from operations | (14,837) | (18,306) | (44,186) | (52,392) | ||||||
| Interest expense | (906) | (884) | (2,681) | (2,518) | ||||||
| Interest income | 76 | 585 | 629 | 1,598 | ||||||
| Other income (expense), net | (13) | (11) | (7) | (20) | ||||||
| Net loss | $ (15,680) | $ (18,616) | $ (46,245) | $ (53,332) | ||||||
| Net loss per common share: | ||||||||||
| Basic and diluted | $ (0.52) | $ (0.76) | $ (1.74) | $ (2.40) | ||||||
| Shares used to compute net loss per common share: | ||||||||||
| Basic and diluted | 29,879,135 | 24,437,451 | 26,639,201 | 22,261,715 | ||||||
| (1) | Includes stock-based compensation expense of: | |||||||||
| Three Months Ended | Nine Months Ended | |||||||||
| September 30, | September 30, | |||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||
| Research and development | $ 367 | $ 559 | $ 1,154 | $ 1,366 | ||||||
| General and administrative | 1,078 | 1,090 | 3,382 | 2,965 | ||||||
| Total stock-based compensation expense | $ 1,445 | $ 1,649 | $ 4,536 | $ 4,331 | ||||||
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Company Codes: NASDAQ-NMS:EIGR
