- Active dialogue with FDA regarding potential peginterferon lambda COVID-19 EUA submission
- Phase 3 HDV D-LIVR (lonafarnib) topline data from studies scheduled by the end of the year
- Phase 3 Congenital Hyperinsulinism Avant (Abexitide) program start
- Zokinvy Approval EuropeAffiliation with AnGes Japan
- Strong cash position: $141.8 million Cash, Cash Equivalents and Total Investments
Palo Alto, California, August 4, 2022 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR) is a commercial-stage biopharmaceutical focused on developing innovative treatments for hepatitis delta virus (HDV) infection and other serious diseases. company, which today reported financial results for the second quarter of 2022. and business updates.
“We had a quarter of continued execution that strengthened and expanded our business through achievements such as the approval of Zokinvy. Europe,” Said David Corey, President and CEO Iger. “Looking forward, in addition to our strong cash position, we are excited about the upcoming major catalysts across our development program that give us confidence in our ability to deliver long-term shareholder value. .”
business highlights
Pegylated interferon lambda for COVID-19 infection in newly diagnosed outpatients
- single subcutaneous injection
- Stimulates immune responses critical for host protection during viral infection
- Since the release of our topline data at , we have actively engaged with the U.S. Food and Drug Administration (FDA) on a potential Emergency Use Authorization (EUA) application. March 2022 During this time, we responded to all FDA requests for information.
Hepatitis Delta Virus (HDV) Platform
Lonafarnib for HDV
- First-in-class oral prenylation inhibitor
- D-LIVR Potentially Approved Phase 3 Study of Two Lonafarnib-Based Regimens
- Combination with oral lonafarnib/ritonavir and peginterferon alfa
- Topline data expected by the end of 2022
Pegylated interferon lambda for HDV
- First-in-class, well-tolerated interferon
- Potential interferon of choice for HDV combination therapy
- LIMT-2 Phase 3 study of peginterferon lambda monotherapy
- Enroll patients with a goal of N=150
Combination of peginterferon lambda and lonafarnib for HDV
- Combination of two Eiger proprietary HDV therapies in development
- Lift-2 Phase 2 study to start in 2022 in collaboration with the National Institutes of Health
- Single-arm study (N=30), 48 weeks of treatment and 24 weeks of follow-up
Zokinvi® (Lonafarnib) for Progeria (Hutchinson-Gilford Progeria Syndrome and Processing Defective Progeria Laminopathy)
- EU marketing authorization granted by the European Commission
- Formed an exclusive partnership with AnGes, Inc. to seek regulatory approval and commercialization of Zokinvy. Japan
Abexitide for rare metabolic diseases
- Start Phase 3 Avant Congenital Hyperinsulinism (HI) Program
- HI Breakthrough Therapy Designation
- Rare Pediatric Disease Designation for HI – Priority Review Voucher Eligible
Corporate
- appointment Lisa Kelly-CrosswellSenior Human Resources Officer, to the Board
- Entered into a term loan agreement with Innovatus Capital Partners to refinance a previous debt facility and extend the interest-only term by five years, further strengthening our cash position ahead of a major milestone.
financial guidance
- $141.8 million Current cash, cash equivalents and total investments June 30, 2022 Expected to fund planned operations by 2024
Second Quarter 2022 Results
total revenue is $4.1 million Compared to Q2 2022 $2.1 million This increase is mainly due to $1.2 million Increased Zokinvy net product sales and $800,000 from upfront payments received by us in connection with our exclusive partnership with AnGes, Inc. to seek regulatory approval and commercialization of Zokinvy; Japan.
Cost of sales is $200,000 Q2 2022 $300,000 The decrease was primarily due to product manufacturing related costs, including product testing.
R&D expenses are $17 million Q2 2022 $14.3 million The increase was primarily driven by personnel expenses, including stock-based compensation for additional personnel, and external services, including consulting and advisory services.
Selling, general and administrative expenses $7 million Q2 2022 $5.9 million The increase was primarily due to higher external services, including consulting and advisory services, as well as personnel-related and other operating-related expenses.
Total operating expenses include the following non-cash expenses: $4.1 million Q2 2022 $2.7 million Same period in 2021.
The company reported a net loss $21.9 millionAlso $0.51 On a per share basis in Q2 2022.this is a net loss $19.2 millionAlso $0.57 On a per share basis for the same period in 2021.
Current cash, cash equivalents and total investments June 30, 2022 totaled $141.8 million compared to $106.1 million Current December 31, 2021.
Current June 30, 2022the company had issued 44 million ordinary shares.
Conference call
and 4:30 PM ET today, August 4, 2022Eiger will host conference calls to discuss financial results and provide business updates.
A live and replayed webcast of the call is available on the company’s website at www.eigerbio.com. To join the live call by phone, register in advance at https://register.vevent.com/register/BIfd526d893fcb47fc96359096e28232bb to receive a dial-in number and a unique passcode to access the call. The webcast will be archived and available for replay for at least 90 days after the event.
About the Eiger
Eiger is a commercial-stage biopharmaceutical company focused on developing innovative treatments for hepatitis delta virus (HDV) and other serious and rare diseases. The Eiger HDV platform includes two of his first-in-class therapies in phase 3 that target key host processes involved in viral replication. Eiger is also developing peginterferon lambda as a treatment for COVID-19. All five Eiger rare disease programs have received FDA breakthrough therapy designation. Eiger is also developing peginterferon lambda as a treatment for COVID-19.
For more information about Eiger and its clinical programs, please visit www.eigerbio.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact include statements regarding our future financial condition and the timing and outcome of clinical results. , future products, preclinical and clinical pipelines, regulatory objectives, business strategy and future business plans and objectives are forward-looking statements. Forward-looking statements are current statements of our intentions, beliefs, projections, prospects, analyses, or current expectations, particularly regarding the timing of ongoing and planned clinical development. Sufficient cash, cash equivalents and investments to fund our business; Potential FDA Emergency Use Authorization for peginterferon lambda for COVID-19. Expectations regarding the timing and availability of topline data from the Phase 3 D-LIVR trial in HDV. Ability to fully enroll the Phase 3 LIMT-2 and Phase 3 AVANT trials. our ability to provide any of our product candidates, including peginterferon lambda, in sufficient quantities to meet the anticipated full-scale commercial demand; Our ability to fund the continued advancement of our development pipeline. the likelihood of success of our products or product candidates; A variety of important factors could cause actual results or events to differ materially from Eiger’s forward-looking statements. It includes additional applicable risks and uncertainties described in the “Risk Factors” section of the Quarterly Report on Form 10-Q for the closed quarter. June 30, 2022 Iger’s Subsequent SEC Filings. The forward-looking statements contained in this press release are based on information currently available to Eiger and speak only as of the date they are made. Eiger undertakes no obligation, and expressly disclaims, to update any forward-looking statements, whether as a result of new information, future events, changes in circumstances or otherwise.
Investor:
Sylvia Wheeler
Wheelhouse Life Science Advisor
[email protected]
media:
Sarah Matheson
Senior Vice President, Corporate Affairs
[email protected]
|
Eiger BioPharmaceuticals Inc. |
|||||
|
Condensed Consolidated Balance Sheet |
|||||
|
(Thousands) |
|||||
|
June 30th |
December 31 |
||||
|
2022 |
2021(1) |
||||
|
(unaudited) |
|||||
|
asset |
|||||
|
cash and cash equivalents |
$36,572 |
$22,221 |
|||
|
short-term bonds |
105,220 |
66,594 |
|||
|
accounts receivable |
1,038 people |
2,576 |
|||
|
stock |
2,876 |
2,612 |
|||
|
Prepaid expenses and other current assets |
11,997 |
9,361 |
|||
|
Total current assets |
157,703 |
103,364 |
|||
|
long-term bonds |
– |
17,262 |
|||
|
Property, plant and equipment (net) |
525 |
613 |
|||
|
Operating lease right-of-use assets |
385 |
653 |
|||
|
Other assets |
5,078 |
4,510 |
|||
|
Total assets |
$163,691 |
$126,402 |
|||
|
Liabilities and shareholders’ equity |
|||||
|
Current Liabilities |
$21,847 |
$29,901 |
|||
|
Other liabilities |
38,919 |
24,102 |
|||
|
Shareholders’ equity |
102,925 |
72,399 |
|||
|
total liabilities and shareholders’ equity |
$163,691 |
$126,402 |
|||
|
(1)It is derived from the audited financial statements included in our annual report. |
|||||
|
Eiger BioPharmaceuticals Inc. |
||||||||||
|
Condensed Consolidated Income Statement Financial Data |
||||||||||
|
(Thousands, excluding per share and per share amounts) |
||||||||||
|
3 months ended |
6 months ended |
|||||||||
|
June 30th |
June 30th |
|||||||||
|
(unaudited) |
(unaudited) |
|||||||||
|
2022 |
2021 |
2022 |
2021 |
|||||||
|
Product revenue, net |
$3,341 |
$2,097 |
$6,014 |
$5,743 |
||||||
|
Other income |
750 |
– |
750 |
– |
||||||
|
gross income |
$4,091 |
$2,097 |
$6,764 |
$5,743 |
||||||
|
Costs and Operating Expenses: |
||||||||||
|
Cost of sales |
151 |
270 |
261 |
323 |
||||||
|
Research and Development(1) |
16,993 |
14,302 |
34,563 |
28,144 |
||||||
|
sales, general and administration(1) |
7,027 |
5,886 |
13,840 |
11,450 |
||||||
|
Total cost and operating expenses |
24,171 |
20,458 |
48,664 |
39,917 |
||||||
|
operating loss |
(20,080) |
(18,361) |
(41,900) |
(34,174) |
||||||
|
Interest expense |
(934) |
(880) |
(1,820) |
(1,765) |
||||||
|
interest income |
221 |
33 |
266 |
84 |
||||||
|
Other income (expense), net |
(1,074) |
45 |
(1,047) |
45,959 |
||||||
|
Pre-tax profit (loss) |
(21,867) |
(19,163) |
(44,501) |
10,104 |
||||||
|
Income tax provision |
17 |
11 |
26 |
30 |
||||||
|
net loss |
$ (21,884) |
$ (19,174) |
$ (44,527) |
$10,074 |
||||||
|
Net income (loss) per share of common stock: |
||||||||||
|
Basic |
$ (0.51) |
$ (0.57) |
$ (1.14) |
$0.30 |
||||||
|
diluted |
$ (0.51) |
$ (0.57) |
$ (1.14) |
$0.29 |
||||||
|
Weighted Average Common Shares Outstanding: |
||||||||||
|
Basic |
43,059,809 |
33,932,127 |
39,178,043 |
33,909,637 |
||||||
|
diluted |
43,059,809 |
33,932,127 |
39,178,043 |
34,156,877 |
||||||
|
(1) |
Includes the following stock-based compensation expense: |
|||||||||
|
3 months ended |
6 months ended |
|||||||||
|
June 30th |
June 30th |
|||||||||
|
2022 |
2021 |
2022 |
2021 |
|||||||
|
Research and Development |
$820 |
$551 |
$1,445 |
$942 |
||||||
|
General and administration |
1,388 |
1,507 |
2,810 |
2,665 |
||||||
|
Total stock-based compensation expenses |
$2,208 |
$2,058 |
$4,255 |
$3,607 |
||||||
Source Eiger BioPharmaceuticals, Inc.
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