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): March 23, 2017
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.) | ||
350 Cambridge Avenue, Suite 350 Palo Alto, California |
94306 | |||
(Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (650) 272-6138
(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 obligations 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)) |
Item 2.02 | Result of Operations and Financial Condition. |
On March 23, 2017, Eiger BioPharmaceuticals, Inc. (Eiger) announced certain financial results for the three months and year ended December 31, 2016. A copy of Eigers press release, titled Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2016 Financial Results, is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit No. |
Description | |
99.1 | Press Release, dated March 23, 2017, titled Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2016 Financial Results. |
The information in this report, including the exhibit hereto, 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 contained herein and in the accompanying exhibit 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.
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: March 23, 2017 | ||||||
By: | /s/ James Welch | |||||
James Welch | ||||||
Chief Financial Officer |
EXHIBIT INDEX
Exhibit No. |
Description | |
99.1 | Press Release, dated March 23, 2017, titled Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2016 Financial Results. |
Exhibit 99.1
Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2016 Financial Results
| Five Phase 2 Programs in Four Orphan Indications |
| Multiple Value-Creating Events Across Programs Expected in Next 12-18 Months |
PALO ALTO, Calif., March 23, 2017 Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for rare diseases, announced today a business update and financial results for the three months and full year ended December 31, 2016.
We believe that 2016, Eigers first year as a publicly traded company, was a year of significant accomplishment and advancement, said David Cory, President and CEO of Eiger BioPharmaceuticals. We advanced our pipeline of five Phase 2 programs across four therapeutically diverse orphan diseases spanning international clinical sites. We believe that these achievements have moved us closer to our goal of building a leading biotechnology company, and delivering value to patients and shareholders. We look forward to another year of accomplishment in 2017 as our pipeline matures, we anticipate advancement toward important Phase 2 data read-outs, and we will continue to pursue multiple shots on goal for clinical and regulatory success.
Key 2016 Milestones Achieved
Lonafarnib in HDV
| Phase 2 data across international sites from LOnafarnib With Ritonavir in HDV (LOWR HDV) program presented at the European Association for the Study of Liver Disease (EASL) and the American Association for the Study of Liver Diseases (AASLD) meetings |
Pegylated Interferon Lambda in HDV
| License agreement for global rights to Lambda from Bristol-Myers Squibb |
| First patient dosed in Phase 2 Lambda Interferon MonoTherapy in HDV (LIMT HDV) international study |
Exendin 9-39 in Post-Bariatric Hypoglycemia (PBH)
| Phase 2 single-ascending dose study data presented at the American Diabetes Association (ADA) |
| Phase 2 multiple-ascending dose (MAD) study data |
| Development of novel liquid formulation for subcutaneous injection |
| US orphan designation for hyperinsulinemic hypoglycemia |
| EMA orphan designation for non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS) which includes PBH |
Ubenimex in Pulmonary Arterial Hypertension (PAH)
| First patient dosed in Phase 2 LIBERTY North American study |
| EMA orphan designation |
Ubenimex in Lymphedema
| First patient dosed in Phase 2 ULTRA international study |
Extended company runway through mid-2018
| $20 million follow on financing in August |
| $15 million tranche from $25 million venture debt line received from Oxford in December |
Fourth Quarter and Full Year 2016 Financial Results
Net loss for the fourth quarter of 2016 was $12.8 million, or $1.53 per share basic and diluted, compared to a net loss of $7.1 million, or $25.78 per share basic and diluted for the fourth quarter of 2015. Net loss for the year ended December 31, 2016 was $47.1 million, or $7.84 per share basic and diluted, compared to a net loss of $13.3 million, or $62.19 per share basic and diluted for the year ended December 31, 2015.
Research and development expenses for the fourth quarter of 2016 were $9.4 million compared to $3.6 million for the fourth quarter of 2015. The increase was primarily due to a $4.4 million increase in clinical expenditures coupled with a $0.9 million increase in compensation and personnel related expenses due to an increase in headcount.
Research and development expenses for the year ended December 31, 2016 were $33.0 million compared to $8.1 million for the year ended December 31, 2015. The increase was primarily due to a $15.0 million increase in clinical expenditures due to increased program activity, a $5.2 million expense related to upfront payments under our license agreement with Bristol-Meyers Squibb and a $2.2 million increase in compensation and personnel related expenses due to an increase in headcount.
General and Administrative expenses for the fourth quarter of 2016 were $3.5 million compared to $3.1 million for the fourth quarter of 2015. The increase was primarily due to a $1.0 million stock compensation charge.
General and administrative expenses for the year ended December 31, 2016 were $13.1 million compared to $4.9 million for the year ended December 31, 2015. The increase was primarily due to a $3.4 million increase in consulting, advisory, legal and accounting services incurred in connection with the merger with Celladon and the costs of being a public company and a $2.3 million increase in stock-based compensation expense.
As of December 31, 2016, Eiger had cash, cash equivalents and short term marketable securities of $59.9 million, compared to $4.8 million at December 31, 2015. The increase was primarily attributable to cash received from investors and Celladon in connection with our merger with Celladon which closed March 22, 2016. Also during
2016 were the $20.0 million in gross proceeds from a common stock offering that was completed in August and in December gross proceeds of $15.0 million from the first tranche of our debt agreement with Oxford.
Key Anticipated Milestones in 2017
| LOWR HDV program: end-of-study data in Q2, and agency meeting in Q4 |
| Lambda in HDV: US IND filing in Q2, interim data from LIMT HDV study in Q4 |
| Exendin 9-39 in PBH: completion of MAD study in Q2, completion of PK study with novel liquid formulation in Q3, and initiation of Phase 2 - 28-day study in Q4 |
| Ubenimex in PAH: complete LIBERTY enrollment in Q2; data Q1 2018 |
| Ubenimex in Lymphedema: complete ULTRA enrollment in Q3; data Q2 2018. |
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed. 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, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward- looking statements may be accompanied by such words as anticipate, believe, could, estimate, expect, forecast, intend, may, plan, potential, project, target, will and other words and terms of similar meaning. Examples of such statements include, but are not limited to, our ability to timely and successfully achieve, all or any of the anticipated 2017 and 2018 milestones, whether or not pegylated interferon lambda or lonafarnib or ubenimex or exendin 9-39 may be further developed and approved, statements relating to the availability of cash for Eigers future operations and drug development portfolio, Eigers ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. 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 Annual Report on Form 10-K for the period ended December 31, 2016 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 Bio, Inc.
Investors:
Andrew McDonald LifeSci Advisors, LLC, 646-597-6987, [email protected]
Jim Welch, Eiger BioPharmaceuticals, 650-279-9845, [email protected]
Eiger BioPharmaceuticals Inc.
Selected Statements of Operations Financial Data
(in thousands, except per share amounts)
(unaudited)
Three Months Ended | Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
Operating expenses: |
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Research and development |
$ | 9,377 | $ | 3,624 | $ | 33,014 | $ | 8,117 | ||||||||
General and administrative |
3,532 | 3,087 | 13,106 | 4,855 | ||||||||||||
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Total operating expenses |
12,909 | 6,711 | 46,120 | 12,972 | ||||||||||||
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Loss from operations |
(12,909 | ) | (6,711 | ) | (46,120 | ) | (12,972 | ) | ||||||||
Interest expense, net |
(5 | ) | (350 | ) | (690 | ) | (350 | ) | ||||||||
Other expense, net |
146 | | (277 | ) | | |||||||||||
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Net loss |
$ | (12,768 | ) | $ | (7,061 | ) | $ | (47,087 | ) | $ | (13,322 | ) | ||||
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Net loss per common share: |
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Basic and diluted |
$ | (1.53 | ) | $ | (25.78 | ) | $ | (7.84 | ) | $ | (62.19 | ) | ||||
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Shares used to compute net loss per common share: |
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Basic and diluted |
8,356,659 | 273,860 | 6,007,027 | 214,228 | ||||||||||||
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Eiger BioPharmaceuticals Inc.
Selected Balance Sheets Financial Data
(in thousands)
(unaudited)
December 31, | December 31, | |||||||
2016 | 2015 | |||||||
Balance Sheet Data: |
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Cash, cash equivalents and investments |
$ | 59,936 | $ | 4,778 | ||||
Working capital |
55,229 | (2,895 | ) | |||||
Total assets |
60,736 | 5,582 | ||||||
Total stockholders equity |
40,721 | (5,152 | ) |