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Arbutus Biopharma Announces Third Quarter 2015 Financial Results
 November 05, 2015: 05:00 PM ET
VANCOUVER, British Columbia and DOYLESTOWN, Pa., Nov. 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 third quarter 2015 unaudited financial results and provided a corporate update.
"We are excited to advance the development of our lead HBV candidate, TKM-HBV, to a Phase II, multi-dosing, clinical trial that will measure hepatitis B surface antigen (HBsAg) reduction in HBV infected patients," said Dr. Mark J. Murray, Arbutus' President and CEO. "We are also accelerating the development of our other promising HBV candidates, in particular, those that target cccDNA formation and core protein/capsid assembly."
Recent Company Highlights
- Arbutus announced progression of TKM-HBV to Phase II studies in HBV infected patients based on results from a Phase I single ascending dose study. The TKM-HBV product candidate that will be studied in Phase II will be referred to as ARB-1467.
- Arbutus presented preclinical HBV data at the 2015 International Meeting on Molecular Biology of Hepatitis B Viruses, held on October 4-8, 2015. The presentations were titled: 1) "Profiling the Effects of TKM-HBV on cccDNA in Humanized Chimeric Mouse Model of HBV"; 2) "TKM-HBV, a Novel RNA Interference Treatment for Chronic Hepatitis B, Mediates Global Viral Antigen Reductions through a Well-Defined Mechanism of Action"; and 3) "Novel Inhibitors of HBV cccDNA Formation Exhibit Synergistic Effects with Nucleoside and Nucleotide Analog."
- Arbutus announced plans to present at the 2015 American Association for the Study of Liver Diseases (AASLD) Liver Meeting held on November 13-17, 2015. The titles of Arbutus' accepted abstracts are: 1) "TKM-HBV, a Novel RNA Interference Treatment for Chronic Hepatitis B, Rapidly Reduces Surface Antigen and other Viral Proteins in Both Intrahepatic and Peripheral Compartments"; 2) "TKM-HBV, a Novel RNA Interference Treatment for Chronic Hepatitis B, has a Complementary Mode of Action to Current Standard of Care Nucleos(t)ide Analogs"; and 3) "Development of a Direct RNA Interference Therapy for Hepatitis Delta Virus Infection."
Upcoming Pipeline Milestones
- 4Q15: Initiate phase II, multi-dose efficacy study of TKM-HBV in chronically infected patients
- 2016: HBsAg reduction data from TKM-HBV Phase II trial (final data in 2H16)
- 2016: Initiate clinical immune biomarker study for CYT-003 in HBV chronically infected patients
- 2H16: File IND (or equivalent) for cccDNA formation inhibitor
- 2H16: File IND (or equivalent) for core protein/capsid assembly inhibitor
- 2017: Initiate combination studies including two or more Arbutus HBV product candidates
Financial Results
Cash, Cash Equivalents and Investments
As at September 30, 2015, Arbutus had an aggregate balance in cash and investments of $206.1 million, as compared to $112.2 million 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.
Cash used in operating activities
Arbutus is revising its guidance for 2015 cash used in operating activities to $50 million. Results to-date reflect $38.2 million of cash used in operating activities.
Non-GAAP Net Loss
The non-GAAP net loss for the three months and nine months ended September 30, 2015 was $15.7 million ($0.31 loss per common share) and $37.3 million ($0.86 loss per common share), respectively. The non-GAAP net loss has been adjusted to exclude:
- non-cash compensation expense of $5.7 million for the three month period and $11.0 million for the nine 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.
- in both the three and nine month periods ended September 30, 2015, a non-cash estimated impairment charge of $38.0 million on intangible assets related to the discontinuance of the cyclophilins program OCB-030, net of deferred income taxes of $15.2 million.
Net loss
The net loss for Q3 2015 was $29.0 million ($0.57 per common share) as compared to a net loss of $8.6 million ($0.39 per common share) for Q3 2014. The net loss for the nine-months ended September 30, 2015 was $55.9 million ($1.28 per common share) as compared to a net loss of $32.7 million ($1.53 per common share) for the nine-months ended September 30, 2014.
Revenue
Revenue was $4.1 million for Q3 2015 as compared to $4.4 million for Q3 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. In October, the Company received formal notification from the DoD that, due to an unclear development path for TKM-Ebola and TKM-Ebola-Guinea, the Ebola Manufacturing and Ebola-Guinea IND submission statements of work had been terminated, subject to the completion of certain post-termination obligations. For this contract, Arbutus recorded $2.0 million in revenue in Q3 2015 as compared to $1.5 million in Q3 2014. The increase is largely related to the release of deferred revenue as the Company is near completion of the TKM-Ebola portion of the contract, which is expected to complete by the end of 2015, at which point the contract close out procedures will commence.
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 2015, Monsanto made a total of $1.8 million in payments for research services under the arrangement. Arbutus recorded $1.0 million in aggregate Monsanto revenue in Q3 2015.
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 $1.0 million in revenue in respect of the Dicerna collaboration in Q3 2015.
Research, Development, Collaborations and Contracts Expenses
Research, development, collaborations and contracts expenses were $16.4 million in Q3 2015 as compared to $9.3 million in Q3 2014.
Arbutus increased research activities related to HBV assets in Q3 2015, following the merger with Arbutus Inc. (formerly OnCore BioPharma, Inc.).
General and Administrative
General and administrative expenses were $7.7 million in Q3 2015 as compared to $1.8 million in Q3 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 Q3 2015, the Company recorded $5.7 million of incremental non-cash compensation expense. Of this amount, $4.3 million has been included in general and administration expense, and $1.4 million has been included in research and development, collaborations and contracts expenses.
Acquisition Costs
During 2015, Arbutus incurred $9.7 million in costs related to the merger with Arbutus Inc., which was completed on March 4, 2015.
Impairment of intangible assets
In Q3 2015, Arbutus recorded an estimated impairment charge of $38.0 million based on the Company's decision to discontinue the cyclophilin program, OCB-030, after extensive preclinical evaluations which concluded that cyclophilins do not play a meaningful role in HBV biology.
Other Income (Losses)
In Q3 2015, Arbutus recorded a foreign exchange gain of $11.8 million with the appreciation in value of U.S. dollar funds from the prior period, as compared to a foreign exchange gain of $3.1 million in Q3 2014.
The aggregate decrease in fair value of the Company's common share purchase warrants was $2.0 million in Q3 2015 as compared to an increase in the fair value of common share purchase warrants outstanding of $5.1 million in Q3 2014. The decrease is a result of a decrease in the Company's share price from the previous reporting date, and vice versa for Q3 2014.
About Arbutus
Arbutus Biopharma Corporation is a biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic HBV infection. Our strategy is to target the three pillars necessary to develop a curative regimen for HBV: 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, 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 a broad pipeline of 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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发表于 2015-11-6 10:33
