UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 9, 2019
EIGER BIOPHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-36183 | 33-0971591 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
Eiger Biopharmaceuticals, Inc.
2155 Park Blvd.
Palo Alto, California 94306
(Address of principal executive offices, including zip code)
(650) 272-6138
(Registrants telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Common Stock (par value $0.001 per share) | EIGR | The Nasdaq Stock Market LLC |
Item 2.02. | Results of Operations and Financial Condition. |
On May 9, 2019, Eiger BioPharmaceuticals, Inc. reported its financial results for the quarter ended March 31, 2019. A copy of the press release titled Eiger BioPharmaceuticals Reports First Quarter 2019 Financial Results and Provides Business Update, is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto and is incorporated herein by reference.
The information in this item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information in this item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Eiger BioPharmaceuticals, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01. | Financial Statements and Exhibits. |
(d) | Exhibits. |
Exhibit No. |
Description | |
99.1 |
Press release, dated May 9, 2019, titled Eiger BioPharmaceuticals Reports First Quarter 2019 Financial Results and Provides Business Update. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Eiger BioPharmaceuticals, Inc. | ||||||
Dated: May 9, 2019 | ||||||
By: | /s/ Sriram Ryali | |||||
Sriram Ryali | ||||||
Chief Financial Officer |
Exhibit 99.1
Eiger BioPharmaceuticals Reports First Quarter 2019 Financial Results and Provides Business Update
| First-Ever Phase 3 HDV International D-LIVR Study Underway |
| NDA and MAA filings for Progeria & Progeroid Laminopathies planned in 2019 |
| Strong Balance Sheet with Recent Financing Completed |
PALO ALTO, Calif., May 9, 2019 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 the three months ended March 31, 2019 and provided a business update.
Eiger is on track to file the first-ever NDA and MAA for Progeria and Progeroid Laminopathies in 2019, said David Cory, Eiger President and Chief Executive Officer. In addition, with our recently completed financing, we plan to aggressively advance pegylated interferon lambda for treatment of Hepatitis Delta Virus infection toward Phase 3, further solidifying our leadership position in HDV.
Recent Highlights
Hepatitis D Virus (HDV) Program
Lonafarnib in HDV
| Lonafarnib+Ritonavir patent portfolio expanded to include US, Europe and Japan |
Peginterferon Lambda (Lambda) in 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
| Positive Phase 2 PREVENT 28-day study results (N=18) reported at ENDO 2019 |
Corporate Activity
| $53.2 million raised in net proceeds from underwritten public offering in April 2019 |
| Amit K. Sachdev, JD, market access, public policy expert and biotech veteran appointed to Board of Directors |
| Stephana Patton, PhD, JD, pharma industry veteran, appointed as Eiger General Counsel, Corporate Secretary and Chief Compliance Officer |
| Christine Murray, MS, RAC, industry veteran and Senior Vice President of Global Regulatory Affairs at Ultragenyx Pharmaceutical, Inc., appointed to Board of Directors |
Anticipated 2019 Milestones
| Phase 3 D-LIVR study in HDV (N=400) site activation and enrollment |
| Phase 2 LIFT (Lambda combination therapy with Lonafarnib+Ritonavir) end-of-treatment study results in HDV at AASLD |
| NDA and MAA submissions in Progeria and Progeroid Laminopathies |
| End of Phase 2 meeting for Avexitide in PBH |
| End of Phase 2 meeting for Lambda in HDV |
First Quarter 2019 Financial Results
Cash, cash equivalents, and short-term investments as of March 31, 2019 totaled $85.8 million compared to $100.4 million at December 31, 2018, a decrease of $14.6 million. In April 2019, Eiger completed an underwritten public offering of common stock that raised approximately $53.2 million in net proceeds.
The Company reported net losses of $17.2 million, or $0.90 per share, for first quarter 2019, as compared to $8.8 million, or $0.84 per share, for the same period in 2018.
Research and development expenses were $12.9 million for first quarter 2019, as compared to $5.5 million for the same period in 2018, an increase of $7.4 million. The increase was primarily due to expenditures associated with clinical development programs, including related clinical material costs.
General and administrative expenses were $4.1 million for first quarter 2019, as compared to $3.0 million for the same period in 2018, an increase of $1.1 million. The increase was primarily due to expenditures for consulting and professional services and employee-related costs, including stock-based compensation, from increased headcount.
Total first quarter 2019 operating expenses include non-cash expenses of $1.4 million, as compared to $1.1 million for the same period in 2018.
In April 2019, Eiger completed an underwritten 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 Eigers effective shelf registration statement and resulted in net proceeds to the company of approximately $53.2 million, after deducting underwriting discounts and commissions and estimated offering expenses.
As of March 31, 2019, Eiger had 19.3 million of common shares outstanding. Following the April public offering, total shares outstanding were 24.4 million.
About Eiger
Eiger is a late-stage biopharmaceutical company focused on the development and commercialization of a pipeline of first-in-class, well-characterized drugs for serious rare and ultra-rare diseases for patients with high unmet medical needs and for which no approved therapies exist.
The companys lead program is in Phase 3, developing lonafarnib, a first-in-class prenylation inhibitor for the treatment of Hepatitis Delta Virus (HDV) infection. The company is also rapidly advancing peginterferon lambda, a first-in-class interferon, toward a Phase 3 study for the treatment of HDV. Eiger is preparing an NDA and MAA for lonafarnib to treat Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies with plans to file in 2019. 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 ongoing and planned clinical development, including plans to complete enrollment of our D-LIVR study by the end of 2019, submit an NDA and MAA for Progeria and progeroid laminopathies in 2019, present end-of-treatment data in our LIFT study and progress our Phase 3 study in HDV, hold an end of Phase 2 meeting for avexitide in PBH and hold an end of Phase 2 meeting for peginterferon lambda in HDV; our ability to transition into a commercial stage biopharmaceutical company; our ability to finance the continued advancement of our development pipeline products; 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 the risks described in the Risk Factors sections in the Quarterly Report on Form 10-Q for the year ended March 31, 2019 and Eigers periodic reports filed with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.
SOURCE Eiger BioPharmaceuticals, Inc.
Investors: Ingrid Choong, PhD
Email: [email protected] / Phone: 1-650-619-6115
Eiger BioPharmaceuticals Inc.
Condensed Consolidated Balance Sheets
(in thousands)
Three Months Ended March 31, |
Year Ended December 31, |
|||||||
2019 | 2018(1) | |||||||
(unaudited) | ||||||||
ASSETS |
||||||||
Cash and cash equivalents |
$ | 63,407 | $ | 61,262 | ||||
Debt securities, available-for-sale |
22,385 | 39,091 | ||||||
Prepaid expenses and other current assets |
2,594 | 1,492 | ||||||
|
|
|
|
|||||
Total current assets |
88,386 | 101,845 | ||||||
Property and equipment, net |
155 | 167 | ||||||
Operating lease right-of-use assets |
1,861 | | ||||||
Other assets |
2,706 | 436 | ||||||
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|
|
|
|||||
Total assets |
$ | 93,108 | $ | 102,448 | ||||
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LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities |
$ | 10,825 | $ | 10,024 | ||||
Other liabilities |
31,475 | 25,832 | ||||||
Stockholders equity |
50,808 | 66,592 | ||||||
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Total liabilities and stockholders equity |
$ | 93,108 | $ | 102,448 | ||||
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(1) | Derived from the audited financial statements, included in the Companys Annual Report on Form 10-K for the year ended December 31, 2018. |
Eiger BioPharmaceuticals Inc.
Condensed Consolidated Statements of Operations Financial Data
(in thousands, except per share and share amounts)
Three Months Ended March 31, (unaudited) |
||||||||
2019 | 2018 | |||||||
Operating expenses: |
||||||||
Research and development(1) |
$ | 12,868 | $ | 5,512 | ||||
General and administrative(1) |
4,057 | 2,994 | ||||||
|
|
|
|
|||||
Total operating expenses |
16,925 | 8,506 | ||||||
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|||||
Loss from operations |
(16,925 | ) | (8,506 | ) | ||||
Interest expense |
(765 | ) | (398 | ) | ||||
Interest income |
511 | 94 | ||||||
Other expense, net |
(10 | ) | (21 | ) | ||||
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|||||
Net loss |
$ | (17,189 | ) | $ | (8,831 | ) | ||
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Net loss per common share: |
||||||||
Basic and diluted |
$ | (0.90 | ) | $ | (0.84 | ) | ||
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Shares used to compute net loss per common share: |
||||||||
Basic and diluted |
19,168,448 | 10,529,350 | ||||||
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(1) Includes stock-based compensation expense of: |
||||||||
Three Months Ended March 31, |
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2019 | 2018 | |||||||
Research and development |
$ | 365 | $ | 323 | ||||
General and administrative |
830 | 680 | ||||||
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Total stock-based compensation expense |
$ | 1,195 | $ | 1,003 | ||||
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