Two Novel HBV Candidates Planned to
GalNAc Conjugated RNAi Agent Nominated to Enter IND-Enabling Studies
Company to Host a Corporate Update Conference Call Today at
“Our core mission of delivering a cure for chronic HBV is reflected in the advancement of two new, therapeutic candidates into clinical development and a third into IND-enabling studies this year,” said Dr. Mark J Murray, CEO of Arbutus. “This set of agents puts us firmly on the path to delivering a proprietary combination treatment regimen. In addition, this quarter, we launched a new company – Genevant Sciences – jointly-owned with Roivant Sciences. Genevant will employ Arbutus’ LNP and conjugate delivery technologies to develop RNA therapeutics. This development will lead to value creation for Arbutus as it grows and by allowing us to focus entirely on our goal of curing HBV and advancing our robust pipeline of novel HBV agents.”
Recent Highlights and Developments
Cash, Cash Equivalents and Investments
As at March 31, 2018, Arbutus had cash, cash equivalents and short-term investments totaling
For Q1 2018, the net loss was
In addition, Arbutus has ongoing license agreements with Alnylam and Spectrum, under which Arbutus is eligible to receive commercial royalties.
Research, Development, Collaborations and Contracts Expenses
Research, development, collaborations and contracts expenses remained consistent at
The Company's R&D expenses predominantly relate to its HBV programs during both periods. Arbutus initiated a Phase I clinical trial for AB-423 in Q1 2017. In Q1 2018, Arbutus continued to focus on rapidly advancing AB-506 into clinical testing as it has shown striking potency and improved PK over AB-423 in preclinical studies. Arbutus is waiting for AB-506 results before deciding whether or not to proceed with additional clinical evaluation of AB-423. The Company continues to incur costs related to advancing our clinical and pre-clinical programs.
General and Administrative
General and administrative expenses were
General and administrative expenses decreased in Q1 2018 compared to Q1 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 Q1 2018 related to the launch of Genevant Sciences - see Recent Highlights and Developments above.
In Q1 2018, we began executing our previously announced site consolidation plan and recorded expenses of
The Company had 55.1 million common shares issued and outstanding at
|UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
|March 31,||December 31,|
|Cash and cash equivalents||$||12.5||$||54.3|
|Other current assets||1.9||2.6|
|Property and equipment, net||11.8||12.2|
|Accounts payable and accrued liabilities||6.5||10.7|
|Total deferred revenue||1.7||2.7|
|Deferred lease inducements, net of current portion||0.7||0.7|
|Site consolidation accrual||1.0||0.0|
|Deferred tax liability||16.9||16.9|
|Total stockholders’ equity||232.4||182.5|
|Total liabilities and stockholders’ equity||$||270.0||$||237.2|
|UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
|Three Months Ended|
|Net loss for the period||$||(17.4||)||$||(18.6||)|
|Net cash used in operating activities||(20.0||)||(17.5||)|
|Net cash provided by (used in) investing activities||(75.7||)||23.2|
|Net cash provided by financing activities||54.4||0.4|
|Effect of foreign exchange rate changes on cash & cash equivalents||(0.5||)||0.4|
|Net increase (decrease) in cash and cash equivalents||$||(41.8||)||$||6.5|
|Cash and cash equivalents, beginning of period||54.3||23.4|
|Cash and cash equivalents, end of period||$||12.5||$||29.9|
|UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
|Three Months Ended|
|Research, development, collaborations and contracts||13.9||13.9|
|General and administrative||3.7||4.3|
|Depreciation of property and equipment||0.6||0.3|
|Loss from operations||(18.4||)||(18.3||)|
|Other income (losses)||1.0||(0.3||)|
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 1-404-537-3406 or 1-855-859-2056 and referencing conference ID 4169558.
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 developing our GalNAc and LNP platform through a joint partnership with Roivant through a new company called Genevant; more rapid and strategic development of our technologies outside of HBV; offering potential non-dilutive capital on Genevant’s commercialized products; Arbutus retaining its patisiran royalty entitlement and rights to the Delivery Technologies for HBV applications; an IND/CTA filing for AB-729 in late-2018/early-2019; enrolling eligible HBV patients in an ARB-1467 Phase II triple combination study in the first half of 2018, with interim on-treatment results in the second half of 2018, followed by final clinical results in 2019; an IND/CTA filing for AB-506 in mid-2018; an IND/CTA filing for AB-452 in mid-2018; initial regulatory approval for patisiran in 2H18;
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.
Manager, Investor Relations
Source: Arbutus Biopharma Corporation