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Arbutus Biopharma Announces Second Quarter 2015 Financial Results
August 05, 2015 16:30 ET | Source: Arbutus Biopharma Corporation
VANCOUVER, British Columbia and DOYLESTOWN, Pa., Aug. 5, 2015 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV), today announced its second quarter 2015 unaudited financial results and provided a corporate update.
"We are very pleased with the considerable progress we have made in our business this quarter as we work to advance the development of our pipeline of HBV drug candidates, the largest portfolio in the industry" said Dr. Mark J. Murray, Arbutus' President and CEO. "We look forward to sharing new data on these programs as we proceed towards our goal of developing combination treatment regimens to improve the cure rate in HBV."
Recent Company Highlights
Arbutus Biopharma Corporation recently changed its corporate name from Tekmira Pharmaceuticals Corporation. This name change marks the successful integration of Tekmira and OnCore and reflects the new company's commitment to delivering a cure for chronic HBV.
The TKM-PLK1 Phase IIa clinical trial has been modified to study the effect of PLK1 on viral parameters in chronic HBV patients enrolled in the HCC trial. This is influenced by recent research that suggests PLK1 could have utility in treating HBV (Diab A. et al. Journal of Hepatology, April 2015).
Arbutus announced the formation of a discrete, independently financed business unit to manage, develop and maximize the value of Arbutus' non-HBV assets.
Arbutus announced the commitment to having at least four HBV product candidates advancing in clinical development in 1H16 and to filing three additional INDs for a cccDNA formation inhibitor, a core protein inhibitor (also known as capsid assembly inhibitor), and a surface antigen secretion inhibitor also in 2016.
Upcoming 2015 Pipeline Milestones
HBV Pipeline
2H15: Results from SAD trial of TKM-HBV, formulation selection
2H15: Initiate phase IIa, multi-dose efficacy study for TKM-HBV in chronic infected patients
4Q15: File IND for OCB-030
Non-HBV Pipeline
2H15: Results from TKM-PLK1 Phase IIa trial in GI-NET/ACC
2H15: Results from TKM-PLK1 Phase IIa dose-escalation trial in HCC
2H15: Update from phase II clinical efficacy trial of TKM-Ebola-Guinea
Financial Results
Cash, Cash Equivalents and Investments
As at June 30, 2015, Arbutus had an aggregate balance in cash and cash equivalents and long-term investments of $217.2 million, as compared to an aggregate of $112.2 million in cash and cash equivalents and short-term investments as at December 31, 2014. On March 25, 2015, Arbutus completed an underwritten public offering of 7,500,000 common shares, at a price of $20.25 per share, resulting in net proceeds of $142.2 million. The Company plans to use these proceeds to develop and advance its product candidates through clinical trials, as well as for working capital and general corporate purposes.
Non-GAAP Net Loss
The non-GAAP net loss for the three months and six months ended June 30, 2015 was $10.8 million ($0.20 loss per common share) and $21.6 million ($0.51 loss per common share), respectively. The non-GAAP net loss excludes non-cash compensation expense of $4.1 million for the three month period and $5.3 million for the six month period included in research, development, collaborations and contracts expenses and general and administrative expenses in connection to certain share repurchase provisions related to the merger with Arbutus Inc., described below.
Net loss
The net loss for Q2 2015 was $14.9 million ($0.27 per common share) as compared to a net loss of $6.1 million ($0.28 per common share) for Q2 2014. The net loss for the first half of 2015 was $26.9 million ($0.64 per common share) as compared to a net loss of $24.1 million ($1.15 per common share) for the first half of 2014.
Revenue
Revenue was $3.4 million for Q2 2015 as compared to $1.8 million for Q2 2014.
Under the DoD contract to develop TKM-Ebola, Arbutus is being reimbursed for costs incurred, including an allocation of overheads, and is being paid an incentive fee. For this contract, Arbutus recorded $1.8 million in revenue in Q2 2015 as compared to $0.9 million in Q2 2014. In Q2 2014, Arbutus incurred lower costs than usual as the Company was waiting for the FDA to provide a review of TKM-Ebola Phase I healthy volunteer clinical trial data. In July 2015, the Company announced that DoD Ebola contract activities have been suspended while a joint re-evaluation of the contract is conducted.
Under the Monsanto contract, Arbutus earns revenue from research and collaboration activities, as well as license fees related to Monsanto's use of the Company's delivery technology and related intellectual property in agriculture. In May 2015, Monsanto made a $1.05 million payment for research services under the arrangement. Arbutus recorded $1.1 million in aggregate Monsanto revenue in Q2 2015 as compared to $0.9 million in Q2 2014.
In November 2014, Arbutus entered into a collaboration with Dicerna for the use of its technology to develop, manufacture, and commercialize products related to the treatment of PH1. Arbutus recorded $0.4 million in revenue in respect of the Dicerna collaboration in Q2 2015.
Research, Development, Collaborations and Contracts Expenses
Research, development, collaborations and contracts expenses were $9.7 million in Q2 2015 as compared to $9.3 million in Q2 2014.
Arbutus increased research activities related to HBV assets in Q2 2015, following the merger with Arbutus Inc. (formerly OnCore BioPharma, Inc.). In addition, partner program activities increased as discussed in "Revenue" above.
General and Administrative
General and administrative expenses were $7.7 million in Q2 2015 as compared to $1.8 million in Q2 2014. The increase in general and administrative expenses was largely due to an increase in compensation expense with the growth in employee base to support the expanded portfolio of product candidates, and, in particular, a non-cash compensation expense related to share repurchase rights. As a result of the expiry of share repurchase rights included in the consideration paid for Arbutus Inc. (formerly OnCore), in Q2 2015, the Company recorded $4.1 million of incremental non-cash compensation expense. Of this amount, $3.0 million has been included as part of general and administration expense, and $1.1 million has been included as part of research and development, collaborations and contracts expenses.
Also, in Q2 2015, the Company incurred significant legal costs in relation to the May 2015 arbitration hearing against Alnylam.
Acquisition Costs
In the first half of 2015, Arbutus incurred $9.7 million in costs related to the merger with Arbutus Inc., which was completed on March 4, 2015.
Other Income (Losses)
In Q2 2015, Arbutus recorded a foreign exchange loss of $2.6 million with the depreciation in value of U.S. dollar funds from the prior period, as compared to a foreign exchange loss of $2.7 million in Q2 2014.
The aggregate decrease in fair value of the Company's common share purchase warrants was $2.0 million in Q2 2015 as compared to a decrease in the fair value of common share purchase warrants outstanding of $5.8 million in Q2 2014. The decreases are a result of decreases in the Company's share price from the previous reporting dates.
About Arbutus
Arbutus Biopharma Corporation is a biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic hepatitis B infection (HBV). Our strategy is to target the three pillars necessary to develop a curative regimen for HBV, including suppressing HBV replication within liver cells, stimulating and reactivating the body's immune system so that it can mount an effective defense against the virus and, most importantly, eliminating the reservoir of viral genomic material known as covalently closed circular DNA, or cccDNA, that is the source of HBV persistence. Our portfolio of assets includes nine drug candidates for use in combination to develop a cure for HBV. To support continuous discovery of potential novel drug candidates and technologies, Arbutus has a research collaboration agreement with the Baruch S. Blumberg Institute that provides exclusive rights to in-license any intellectual property generated through the relationship. The Baruch S. Blumberg Institute was established in 2003 by the Hepatitis B Foundation.
Arbutus is headquartered in Vancouver, BC, Canada with offices in Doylestown, PA, USA. For more information, visit www.arbutusbio.com.
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楼主: newchinabok
发表于 2015-8-4 15:25
