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 4, 2015
ELEVEN BIOTHERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Charter)
Delaware | 001-36296 | 26-2025616 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) | ||
215 First Street, Suite 400 Cambridge, MA |
02142 | |||
(Address of Principal Executive Offices) | (Zip Code) |
Registrants telephone number, including area code: (617) 871-9911
None
(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)) |
Item 2.02 Results of Operations and Financial Condition
On March 4, 2015, Eleven Biotherapeutics, Inc. (the Company) announced its financial results for the year ended December 31, 2014. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information provided under this Form 8-K (including Exhibit 99.1) shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:
99.1 | Press release issued by the Company on March 4, 2015 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ELEVEN BIOTHERAPEUTICS, INC. | ||||||
Date: March 4, 2015 | By: | /s/ Abbie C. Celniker | ||||
Abbie C. Celniker, Ph.D. President & Chief Executive Officer |
EXHIBIT INDEX
Exhibit Number |
Description of Exhibit | |
99.1 | Press release issued by the Company on March 4, 2015 |
Exhibit 99.1
Eleven Biotherapeutics Reports Fourth Quarter and Year-End 2014 Financial Results
Management to host conference call today at 8:30 a.m. EST
Cambridge, MA, March 4, 2015 Eleven Biotherapeutics (NASDAQ: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today reported financial results for the fourth quarter and full year ended December 31, 2014.
We made significant progress advancing our pipeline of novel protein therapeutics for eye disease including our lead product candidate, EBI-005, which is in late-stage clinical development for dry eye disease and allergic conjunctivitis. said Abbie Celniker, Ph.D., President and Chief Executive Officer. We completed patient enrollment in our pivotal Phase 3 clinical study for EBI-005 in patients with moderate to severe dry eye disease and expect to report top-line results from that study in the second quarter of 2015. One of the requirements for regulatory approval and an important milestone for the pivotal clinical program was the initiation of a twelve-month safety study with EBI-005 in dry eye disease. We also reported encouraging Phase 2 top-line safety and efficacy results for EBI-005 in patients with moderate to severe allergic conjunctivitis, further validating EBI-005 as a clinically active anti-inflammatory ocular agent. In addition to the progress made with EBI-005 we are also pleased with the progress that we have made with our second product candidate in development for diabetic macular edema with a planned IND filing by the end of 2015.
Fourth Quarter and Recent Business Highlights:
| Completed patient enrollment in the OASIS study (A Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Control in Subjects with Moderate to Severe Dry Eye Disease), our first pivotal Phase 3 clinical study for EBI-005 in patients with dry eye disease. Top-line results are expected in the second quarter of 2015. |
| Initiated a twelve-month clinical study in patients with moderate to severe dry eye disease to assess the long-term safety and tolerability of EBI-005 as part of its ongoing pivotal Phase 3 program. |
| Reported in October top-line results from our proof of concept Phase 2 clinical trial of EBI-005 in patients with moderate to severe allergic conjunctivitis. In a modified CAPT (conjunctival allergen provocation test) model, patients treated with EBI-005 showed statistically significant improvements in mean change from baseline in patient reported ocular itching, ocular tearing and total nasal symptoms compared to vehicle-control at the second to last and final assessment time points. These data helped us to determine our path forward with EBI-005 as a potential new treatment option for patients with moderate to severe allergic conjunctivitis. We will be making comments on our allergic conjunctivitis development plan on todays call. |
| Granted a U.S. patent for EBI-005 encompassing both composition-of-matter and methods of use claims, which expires in 2031. |
| Advanced our EBI-031 (anti-IL-6) program toward an expected IND filing for the indication of diabetic macular edema (DME) by the end of 2015. EBI-031 is an antibody with the potential for a longer half-life compared with approved intravitreal protein therapeutics. |
| Raised $20 million in a private placement financing of Eleven Biotherapeutics common stock and warrants. Funding from the financing will be used to further advance Elevens pipeline of protein therapeutics to treat diseases of the eye including EBI-005 for the treatment of moderate to severe dry eye disease and moderate to severe allergic conjunctivitis. |
| Appointed industry and academic leaders Wendy L. Dixon, PhD, Jay S. Duker, MD and Barry Gertz, MD, PhD to our Board of Directors. Dr. Dixon is the former Chief Marketing Officer and President of Global Marketing for Bristol Myers Squibb. Dr. Duker is professor and chair of Ophthalmology at Tufts University School of Medicine and director of the New England Eye Center. Dr. Gertz is a venture partner at Clarus Ventures, Chief Medical Advisor for Relay Pharmaceuticals and former Senior Vice President of Global Clinical Development at Merck. |
Fourth Quarter and Year-End 2014 Financial Results
| Revenue: Revenue was $0.4 million for the three months ended December 31, 2014, compared to $0.5 million for the same period in 2013. Revenue was $2.2 million for the twelve months ended December 31, 2014 compared to $1.3 million for the same period in 2013. |
| R&D Expenses: Research and development expenses were $5.3 million for the three months ended December 31, 2014 compared to $3.2 million for the same period in 2013. This increase was primarily due to EBI-005 related development expenses. Research and development expenses were $26.7 million for the twelve months ended December 31, 2014 compared to $13.8 million for the same period in 2013. |
| G&A Expenses: General and administrative expenses were $2.2 million for the three months ended December 31, 2014, compared to $1.4 million for the same period in 2013. This increase was primarily due to increased operating costs related to operating as a public company since February 2014 and increased stock-based compensation expense. General and administrative expenses were $8.5 million for the twelve months ended December 31, 2014 compared to $4.0 million for the same period in 2013. |
| Net Loss: Net loss applicable to common stockholders was $8.1 million, or $0.49 per share, for the three months ended December 31, 2014, compared to net loss applicable to common stockholders of $6.2 million, or $4.29 per share, for the same period in 2013. Net loss applicable to common stockholders was $34.7 million, or $2.37 per share, for the twelve months ended December 31, 2014 compared to $21.9 million, or $16.18 per share, for the same period in 2013. |
| Cash and Cash Equivalents: Cash and cash equivalents were $54.1 million as of December 31, 2014. We believe that our cash and cash equivalents as of December 31, 2014 will enable us to fund our operating expenses, debt service obligations and capital expenditure requirements into 2016. |
Upcoming Events and Presentations:
| 2015 American Society of Cataract and Refractive Surgery (ASCRS) annual symposium, in San Diego, April 17-21, 2015. |
| Association for Research in Vision and Ophthalmology (ARVO) annual meeting, in Denver, May 3-7, 2015. |
Conference Call Information:
Eleven Biotherapeutics management team will host a conference call and audio webcast today at 8:30 a.m. EST to discuss the fourth quarter and year-end 2014 results and provide a corporate update. To access the conference call, please dial 844-831-3025 (domestic) or 315-625-6887 (international) at least five minutes prior to the start time and refer to conference ID 87544666.
An audio webcast of the call will also be available on the Investors & Media section of the Companys website www.elevenbio.com. An archived webcast will be available on the Companys website approximately two hours after the event and will be available for 30 days.
About EBI-005
Eleven Biotherapeutics most advanced product candidate is EBI-005, a novel, topically-administered interleukin-1 (IL-1) receptor blocker in development as a protein therapeutic for dry eye disease and allergic conjunctivitis. The EBI-005 program is based on the role that elevated levels of the inflammatory cytokine IL-1 play in the initiation and maintenance of the inflammation and pain associated with dry eye disease and the itching and other symptoms associated with allergic conjunctivitis. EBI-005 has been evaluated in a Phase 2 study in patients with moderate to severe allergic conjunctivitis and is currently being evaluated in a pivotal Phase 3 study in dry eye disease.
About EBI-031
Eleven Biotherapeutics most advanced preclinical product candidate is EBI-031 for treatment of diabetic macular edema, or DME, We designed and engineered EBI-031 for intravitreal delivery using our AMP-Rx platform. EBI-005 is a potent blocker of both free IL-6 and IL-6 complexed to the soluble IL-6 receptor (IL-6R) and has a longer vitreal retention time than antibodies and antibody like molecules approved for intra-vitreal injection. We are undertaking the necessary CMC development work and nonclinical safety studies to support the submission of an investigational new drug application, or IND, to the FDA by the end of 2015 for the purpose of conducting clinical trials of EBI-031
About Eleven Biotherapeutics
Eleven Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company with a proprietary protein engineering platform, called AMP-Rx, that it applies to the discovery and development of protein therapeutics to treat diseases of the eye. Elevens therapeutic approach is based on the role of cytokines in diseases of the eye, the companys understanding of the structural biology of cytokines and the companys ability to rationally design and engineer proteins to modulate the effects of cytokines. Cytokines are cell signaling molecules found in the body that can have important inflammatory effects.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Companys strategy, future operations, advancement or maturation of its product candidates and product pipeline, clinical development of the Companys therapeutic candidates, including expectations regarding timing of initiation of clinical trials, patient enrollment and availability of results, regulatory requirements for initiation of clinical trials and registration of product candidates, sufficiency of cash resources and other statements containing the words anticipate, believe, estimate, expect, intend, may, plan, predict, project, target, potential, will,
would, could, should, continue, and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from ongoing clinical trials, whether results of early clinical trials will be indicative of the results of future trials, the adequacy of any clinical models, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals and other factors discussed in the Risk Factors section of the Companys quarterly report on Form 10-Q filed with the Securities and Exchange Commission on November 13, 2014 and other reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Companys views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Companys views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Companys views as of any date subsequent to the date hereof.
Contact:
Leah Monteiro
Eleven Biotherapeutics
Leah.Monteiro@elevenbio.com
617-714-0619
ELEVEN BIOTHERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share data)
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Collaboration revenue |
$ | 375 | $ | 510 | $ | 2,243 | $ | 1,334 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Operating expenses: |
||||||||||||||||
Research and development |
5,258 | 3,212 | 26,703 | 13,788 | ||||||||||||
General and administrative |
2,212 | 1,418 | 8,471 | 4,024 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses |
7,470 | 4,630 | 35,174 | 17,812 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Loss from operations |
(7,095 | ) | (4,120 | ) | (32,931 | ) | (16,478 | ) | ||||||||
Other income (expense): |
||||||||||||||||
Other expense, net |
(905 | ) | (51 | ) | (849 | ) | (147 | ) | ||||||||
Interest expense, net |
(139 | ) | (895 | ) | (376 | ) | (1,400 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total other expense |
(1,044 | ) | (946 | ) | (1,225 | ) | (1,547 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss |
$ | (8,139 | ) | $ | (5,066 | ) | $ | (34,156 | ) | $ | (18,025 | ) | ||||
|
|
|
|
|
|
|
|
|||||||||
Cumulative preferred stock dividends |
| (1,142 | ) | (519 | ) | (3,857 | ) | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss applicable to common stockholders |
$ | (8,139 | ) | $ | (6,208 | ) | $ | (34,675 | ) | $ | (21,882 | ) | ||||
|
|
|
|
|
|
|
|
|||||||||
Net loss per share applicable to common stockholdersbasic and diluted |
$ | (0.49 | ) | $ | (4.29 | ) | $ | (2.37 | ) | $ | (16.18 | ) | ||||
|
|
|
|
|
|
|
|
|||||||||
Weighted-average number of common shares used in net loss per share applicable to common stockholdersbasic and diluted |
16,692 | 1,447 | 14,644 | 1,352 | ||||||||||||
|
|
|
|
|
|
|
|
ELEVEN BIOTHRAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(unaudited)
(in thousands)
December 31, | ||||||||
2014 | 2013 | |||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 54,059 | $ | 7,942 | ||||
Prepaid expenses and other current assets |
342 | 88 | ||||||
|
|
|
|
|||||
Total current assets |
54,401 | 8,030 | ||||||
Property and equipment, net |
486 | 759 | ||||||
Restricted cash |
94 | 94 | ||||||
Other assets |
19 | 2,354 | ||||||
|
|
|
|
|||||
Total assets |
$ | 55,000 | $ | 11,237 | ||||
|
|
|
|
|||||
Liabilities, convertible preferred stock, and stockholders equity (deficit) |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 2,458 | $ | 1,746 | ||||
Accrued expenses |
1,987 | 850 | ||||||
Notes payable, current portion |
251 | 1,642 | ||||||
Deferred revenue, current portion |
506 | 1,115 | ||||||
|
|
|
|
|||||
Total current liabilities |
5,202 | 5,353 | ||||||
Deferred revenue, net of current portion |
| 355 | ||||||
Restricted stock liability |
4 | 10 | ||||||
Notes payable, net of current portion |
9,749 | 2,876 | ||||||
Warrant liability |
3,219 | 297 | ||||||
Series A convertible preferred stock |
| 45,035 | ||||||
Series B convertible preferred stock |
| 11,643 | ||||||
Stockholders equity (deficit): |
||||||||
Preferred stock |
| | ||||||
Common stock |
18 | 2 | ||||||
Additional paid-in capital |
128,558 | 3,260 | ||||||
Accumulated deficit |
(91,750 | ) | (57,594 | ) | ||||
|
|
|
|
|||||
Total stockholders equity (deficit) |
36,826 | (54,332 | ) | |||||
|
|
|
|
|||||
Total liabilities, convertible preferred stock and stockholders equity (deficit) |
$ | 55,000 | $ | 11,237 | ||||
|
|
|
|
00RH1[H*\7,LIS#)ZZPN9866$K6NHR<7IW3A*47]YZF"S#!YA2]M@JZKTU
MI=*4?PDHR7W':5YYV!0`=/PHV\K!^AP?CSXG>`_AAI\&J>//$EGX;L+J<6]O
M/=Q7DWG3$9$:165M-(3COLQ[UZ>5Y-F>FD%^;/I.$<'=U\9)6Y
M5R1_5_D>5Y'ITX_`?Y%?CU[7U_X;_.]C[BWR`<>@QVZ8Q_G%-.WDUI;]?OT^
M8-6T[;'L'P]T[R;.>_=<-`;:YBCGMY=?LDE@E0/'(I<`JZ,"&'L:_HCB.4J>29G.$G&4:$VF
MM&K+34_(