On November 20, 2017 Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported financial results for the quarter ended September 30, 2017 (Press release, Eleven Biotherapeutics, NOV 20, 2017, View Source [SID1234522156]).
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"I am very pleased with our progress this quarter. In addition to strengthening our balance sheet with a successful public offering in November, we also made strong progress during this quarter on our Phase 3 clinical trial examining Vicinium in patients with non-muscle invasive bladder cancer (NMIBC)," said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. "We are driving our Phase 3 enrollment forward and expect to achieve full enrollment in Q1 2018. The Company also remains on track to report top-line three-month data from our registration trial in mid-2018 with sufficient capital to carry us through this critical milestone. Also, we are excited that the combination trial of Vicinium and durvalumab, Astra Zeneca’s checkpoint inhibitor, has opened at the National Cancer Institute and we will be gathering immune biomarker data that we believe will provide insight into the complementary mechanism of action between checkpoint inhibitors and our TPT platform."
Third Quarter Results, Recent Business Highlights and Anticipated Upcoming Milestones:
Vicinium is a single protein anti-epithelial cell adhesion molecule (anti-EpCAM) antibody fragment fused with Pseudomonas Exotoxin A (ETA) that is designed to specifically target and deliver a potent anti-cancer payload directly into tumor cells. Vicinium is currently in a Phase 3 registration clinical trial for the treatment of high-grade NMIBC in subjects who have previously received two courses of Bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. The company also has a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) evaluating Vicinium in combination with AstraZeneca’s checkpoint inhibitor, durvalumab.
In September, the Company announced completion of the manufacturing of Vicinium necessary for the ongoing Phase 3 registration trial in patients with NMIBC, and the CRADA trial with the NCI.
Completion of enrollment for the Phase 3 registration clinical trial of Vicinium is expected in the first quarter of 2018.
Topline three-month data from the Phase 3 registration clinical trial of Vicinium is expected mid-2018 and topline twelve-month data is expected in the second quarter of 2019.
Initiation of a Phase 1 trial of Vicinium and durvalumab through the NCI CRADA will collect immune response biomarker data in patients with NMIBC and is expected to commence in the fourth quarter of 2017, with initial biomarker data expected in the third quarter of 2018.
Corporate:
In October, the Company announced the appointment of Richard F. Fitzgerald as Interim Chief Financial Officer, adding extensive capital raising and transaction execution experience to Eleven’s management team.
In November, the Company completed a public offering of 5,525,000 shares of its common stock, pre-funded warrants to purchase an aggregate of 4,475,000 shares of common stock, and common warrants to purchase up to an aggregate of 10,000,000 shares of common stock, raising approximately $8.0 million in gross proceeds and $7.0 million in net proceeds, after deducting underwriting discounts and commissions and estimated expenses payable by the Company.
TPT Pipeline:
Eleven’s pipeline includes additional locally delivered product candidates, as well as a systemic TPT platform.
Proxinium is a single protein anti-EpCAM antibody fragment fused with ETA for the treatment of late-stage, EpCAM-expressing, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). In Phase 1 and 2 clinical trials, Proxinium demonstrated anti-tumor activity in both injected as well as un-injected tumors. The Company plans to evaluate Proxinium in a Phase 1/2a clinical trial in combination with a checkpoint inhibitor and is actively seeking partners for a combination program.
VB6-845d is a systemically-administered TPT utilizing a proprietary, highly potent, de-immunized plant toxin, deBouganin, for the treatment of solid tumors. The Company plans to file an investigational new drug (IND) application for VB6-845d and initiate a Phase 1 trial, once funding or a partner is secured for this program.
The Company has deferred further development of Proxinium and VB6-84d in order to focus its efforts and resources on the advancement of its Phase 3 registration trial of Vicinium. The Company is also exploring partnering and collaboration strategies to move these additional product candidates forward.
Third Quarter 2017 Financial Results:
Cash Position: Cash and cash equivalents were $11.3 million as of September 30, 2017, compared to $25.3 million as of December 31, 2016. These amounts do not include the approximately $7.0 million of net proceeds from the Company’s November 2017 public offering.
Revenue: Eleven did not record any revenue for the three months ended September 30, 2017, compared to revenue of $28.7 million for the same period in 2016. This decrease was due to revenue recognized in 2016 from the Company’s License Agreement with Roche. The next licensing milestone payment expected from Roche, if any, will be triggered upon commencement of a Phase 2 clinical trial by Roche.
R&D Expenses: Research and development expenses were $3.6 million for the three months ended September 30, 2017, compared to $2.8 million for the same period in 2016. This increase was primarily due to higher costs incurred for the Company’s ongoing Phase 3 clinical trial for NMIBC that were partially offset by the absence of costs associated with the product candidate licensed to Roche in 2016 and lower compensation related costs.
G&A Expenses: General and administrative expenses were $1.6 million for the three months ended September 30, 2017, compared to $6.4 million for the same period in 2016. This decrease was driven primarily by a reduction in severance, retention and stock-based compensation and professional fees related to the Company’s 2016 review of strategic alternatives and the acquisition of Viventia Bio, Inc.
Net Loss: Net loss was $9.1 million, or $0.37 per basic and diluted share, for the three months ended September 30, 2017, compared to net income of $19.5 million, or $0.95 per basic share and $0.91 per diluted share, for the same period in 2016. The change was primarily the result of revenue recognized in 2016 from the Company’s License Agreement with Roche.
Financial Guidance: Based on current operating plans, the Company anticipates that cash at September 30, 2017, plus the net $7.0 million raised in November 2017, will fund research and development programs and operations into mid-2018.