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- Phase 1a/1b study of AB-506, a second-generation oral capsid inhibitor, initiated
- Phase 1a/1b study of AB-452, a novel and proprietary oral RNA destabilizer, expected to begin in the second half of 2018
- All oral combination Phase 2 study of AB-506 and AB-452 expected to begin by the end of 2019
- Entering second half of year strong financially with
Second Quarter Conference Call and Webcast Scheduled Today at
Recent Accomplishments and Upcoming Clinical Milestones
Phase 1a/1b study initiated for AB-506, Arbutus’ second generation, and potentially best-in-class, oral capsid inhibitor. The healthy volunteer portion of the study will be followed by dosing cohorts of HBV patients, with top-line results expected in the second quarter of 2019.
The regulatory filing for AB-452, Arbutus’ novel and proprietary RNA destabilizer, is on track for submission in the third quarter, with subject dosing to follow in the fourth quarter of 2018.
Pending completion of the monotherapy Phase 1a/1b studies for AB-506 and AB-452, Arbutus expects to begin an all-oral combination study with AB-506 and AB-452 with an approved nucleoside analogue by the end of 2019.
HBsAg data from the six-week treatment point of patients in the ARB-1467 Phase 2b combination study (with nucleoside analogue), qualifying patients for PEG-IFN add on therapy will be available in Q4.
Partnership with Alnylam
Patisiran is an RNAI therapeutic targeting transthyretin that is being developed as a treatment for hereditary ATTR (hATTR) amyloidosis. Patisiran is currently under Priority Review as a Breakthrough Therapy with the U.S. Food and Drug Administration. The PDUFA date for patisiran is August 11, 2018.
Successful approval of patisiran will trigger a royalty entitlement to Arbutus for the proprietary LNP technology licensed by Arbutus to Alnylam for patisiran.
Genevant, a company formed in the second quarter of 2018 and jointly owned by Arbutus and Roivant Sciences, recently announced that it has entered into a strategic partnership with BioNTech AG, an industry leader in mRNA therapy development.
Cash, Cash Equivalents and Investments
For further details with respect to the Preferred Shares, please refer to Arbutus’ Proxy materials filed on Schedule 14A with the
Net Income (Loss)
For Q2 2018, net income attributable to common shares was
In addition, Arbutus has ongoing license agreements with Alnylam and Spectrum, under which Arbutus is eligible to receive royalties on sales.
Research, Development, Collaborations and Contracts Expenses
Research, development, collaborations and contracts expenses increased to
General and Administrative
General and administrative expenses were
General and administrative expenses decreased in Q2 2018 compared to Q2 2017 primarily due to a decrease in non-cash compensation expense related to the expiry of repurchase rights in Q3 2017, offset by professional fees incurred in Q2 2018 related to the launch of Genevant Sciences.
Gain on Investment in Genevant
As previously announced, on
The Company had 55.3 million common shares issued and outstanding at
|UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||10.2||$||54.3|
|Other current assets||1.6||2.6|
|Investment in Genevant||27.4||—|
|Property and equipment, net||10.7||12.2|
|Accounts payable and accrued liabilities||7.4||10.7|
|Total deferred revenue||1.0||2.7|
|Deferred lease inducements, net of current portion||0.7||0.7|
|Site consolidation accrual||1.1||—|
|Deferred tax liability||16.9||16.9|
|Total stockholders’ equity||238.1||182.5|
|Total liabilities and stockholders’ equity||$||277.0||$||237.2|
|UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
|Three Months Ended||Six Months Ended|
|Net income (loss) for the period||$||3.1||$||(18.3||)||$||(14.3||)||$||(36.9||)|
|Net cash used in operating activities||(17.6||)||(5.1||)||(37.6||)||(22.6||)|
|Net cash provided by (used in) investing activities||15.0||(1.4||)||(60.7||)||21.8|
|Net cash provided by financing activities||0.7||0.0||55.1||0.4|
|Effect of foreign exchange rate changes on cash & cash equivalents||(0.4||)||0.8||(0.9||)||1.2|
|Net (decrease) increase in cash and cash equivalents||$||(2.3||)||$||(5.7||)||$||44.1||$||0.8|
|Cash and cash equivalents, beginning of period||12.5||29.9||54.3||23.4|
|Cash and cash equivalents, end of period||$||10.2||$||24.2||$||10.2||$||24.2|
|UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
|Three Months Ended||Six Months Ended|
|Research, development, collaborations and contracts||16.3||15.4||30.3||29.3|
|General and administrative||3.8||4.6||7.5||8.9|
|Depreciation of property and equipment||0.6||0.5||1.2||0.9|
|Loss from operations||(22.1||)||(19.5||)||(40.5||)||(37.8||)|
|Income tax benefit||—||—||—||—|
|Net income (loss)||$||3.1||$||(18.3||)||$||(14.3||)||$||(36.9||)|
|Accrual of coupon on convertible preferred shares||(2.5||)||—||(4.9||)||—|
|Net income (loss)attributable to common shares||$||0.6||$||(18.3||)||$||(19.2||)||$||(36.9||)|
|UNAUDITED GAAP TO NON-GAAP RECONCILIATION: NET LOSS AND NET LOSS PER SHARE
|Three Months Ended||Six Months Ended|
|GAAP net income (loss) attributable to common shares||$||0.6||$||(18.3||)||$||(19.2||)||$||(36.9||)|
|Gain on investment in Genevant||(24.9||)||—||(24.9||)||—|
|Compensation expense of expired repurchase provision rights||—||3.0||—||6.0|
|Non-GAAP net loss attributable to commons shares||$||(24.3||)||$||(15.3||)||$||(44.1||)||$||(30.9||)|
|GAAP net income (loss) attributable to common shares per common share||$||0.01||$||(0.33||)||$||(0.31||)||$||(0.68||)|
|Non-GAAP net loss per common share||$||(0.44||)||$||(0.28||)||$||(0.80||)||$||(0.57||)|
Use of Non-GAAP Financial Measures
The Company’s consolidated financial statements are prepared in accordance with generally accepted accounting principles in
The Company evaluates items on an individual basis, and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company’s ongoing business operations, and (iii) whether or not the Company expects it to occur as part of its normal business on a regular basis. In the three months ended
Conference Call Today
Arbutus will hold a conference call and webcast today,
An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling 1-855-859-2056 or 1-404-537-3406 and reference conference ID 6966479.
Forward-Looking Statements and Information
This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements in this press release include statements about a paradigm shift in HBV; rapidly initiating an all-oral combination clinical trial using AB-506 and AB-452 with an approved nucleoside analogue drug by the end of 2019; dosing of AB-506 in cohorts of HBV patients, with top-line results expected in 2Q19; regulatory filing for AB-452 in 3Q18, with subject dosing to follow in 4Q18; HBsAg data from the ARB-1467 combination study (with nuc) in 4Q18; FDA approval of patisiran on
With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the timely receipt of expected payments; the effectiveness and timeliness of preclinical and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause Arbutus' actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: expected payments, financings, and royalties may not be as large or as timely as expected, if at all; anticipated pre-clinical and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus' products; economic and market conditions may worsen; and market shifts may require a change in strategic focus.
A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus' Annual Report on Form 10-K and Arbutus' continuous disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
President and CEO
Investor Relations Consultant
Source: Arbutus Biopharma Corporation