Aviragen Therapeutics Reports Second Quarter Fiscal Year 2017 Financial Results
"In looking to the 2017 calendar year, we have both near-term events and a broad vision driving the development of our antiviral pipeline. In the coming weeks, we have a key data readout from our lead program, vapendavir, that we feel could be a significant value-creating event for the Company. We are very committed to the advancement of our pipeline and are confident of its potential to address considerable unmet clinical needs for patients with limited therapeutic options," commented
Upcoming Corporate Milestones
Data Readout from Phase 2b SPIRITUS Trial. This month the Company expects to report results from the Phase 2b SPIRITUS trial of vapendavir for the treatment of rhinovirus (RV). The primary endpoint of this multi-center, randomized, double-blind, placebo-controlled dose-ranging study is the change from baseline to study day 14 measured by an asthma control questionnaire (ACQ)-6 total score. The secondary endpoints are focused on safety and tolerability, lung function assessments such as forced expiratory volume in one second (FEV1), incidence of asthma exacerbations, assessments of the severity and duration of cold symptoms measured by the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) and virological assessments.
Initiation of Phase 2 Trial of Vapendavir for Treatment of RV Infections in Hematopoietic Stem Cell Transplant (HSCT) Patients. In the first quarter of 2017, the Company expects to initiate a Phase 2 trial of vapendavir for the treatment of RV infections in HSCT patients. The primary endpoint of the trial will be time-weighted average change from baseline to end of treatment visit in RV viral load. Secondary endpoints will include mortality, rate of progression of RV in upper respiratory tract infection to lower respiratory tract infection, duration of RV shedding in HSCT subjects, and proportion with hospitalization and hospitalization time.
Corporate Update
Reported Data from the Phase 2a RSV Challenge Study of BTA585. Yesterday, the Company announced top-line data
from its double-blind, placebo-controlled Phase 2a study of BTA585 in adults challenged intranasally with respiratory syncytial virus (RSV). The data indicated there was not a significant reduction in the primary endpoint, which was viral load. The data suggested biological activity on several of the endpoints, however, the considerable variability in viral load among the cohorts and the small number of subjects that became infected with RSV likely impacted the ability to detect a significant difference between the groups. The safety profile of BTA585 was favorable and consistent across treatment groups. These safety results, together with the other clinical data and the recently completed non-clinical studies, will form the basis for the Company's interaction with the
Financial Results for the Three Month Period Ended
The Company reported a net loss of
Revenue increased to
Research and development expense increased to
General and administrative expense was
Non-cash implied interest expense was
The Company held
Conference Call and Webcast Information
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve known and unknown risks and uncertainties concerning Aviragen Therapeutics' business, operations and financial performance. Any statements that are not of historical facts may be deemed to be forward-looking statements, including the timing of top-line data readout from the Phase 2 SPIRITUS trial and the timing of the initiation of a Phase 2 trial in hematopoietic stem cell
transplant patients, the timing of the
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
(in millions, except per share amounts) | |||||||
2016 | 2016 | ||||||
(unaudited) | (audited) | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 38.1 | $ | 49.7 | |||
Short-term investments | 11.1 | 19.3 | |||||
Accounts receivable, net of allowance | 4.2 | 0.7 | |||||
Prepaid and other current assets | 2.8 | 2.7 | |||||
Total current assets | 56.2 | 72.4 | |||||
Non-current assets: | |||||||
Property and equipment, net | 0.3 | 0.3 | |||||
Total non-current assets | 0.3 | 0.3 | |||||
Total assets | $ | 56.5 | $ | 72.7 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3.4 | $ | 3.9 | |||
Accrued expenses | 5.6 | 3.6 | |||||
Short-term note payable | 0.3 | 0.4 | |||||
Liabilities related to sale of future royalties, net of deferred financing costs | 1.2 | 1.3 | |||||
Total current liabilities | 10.5 | 9.2 | |||||
Non-current liabilities: | |||||||
Long-term note payable, net of current portion | 0.2 | 0.3 | |||||
Liabilities related to sale of future royalties, net of deferred financing costs and current portion | 17.6 | 16.8 | |||||
Other long-term liabilities, net of current portion | 0.2 | 0.2 | |||||
Total liabilities | 28.5 | 26.5 | |||||
Stockholders' equity: | |||||||
Preferred stock, | - | - | |||||
Common stock, | 3.9 | 3.9 | |||||
Additional paid-in capital | 158.5 | 157.6 | |||||
Accumulated other comprehensive income | 19.0 | 19.0 | |||||
Accumulated deficit | (153.4 | ) | (134.3 | ) | |||
Total stockholders' equity | 28.0 | 46.2 | |||||
Total liabilities and stockholders' equity | $ | 56.5 | $ | 72.7 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||
(in millions, except per share amounts) | ||||||||||||||
(unaudited) | ||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||
Revenue: | ||||||||||||||
Royalty revenue | $ | 1.5 | $ | 1.7 | $ | 1.6 | $ | 3.4 | ||||||
Non-cash royalty revenue related to the sale of future royalties | 2.3 | - | 2.3 | - | ||||||||||
Total revenue | 3.8 | 1.7 | 3.9 | 3.4 | ||||||||||
Operating expense: | ||||||||||||||
Research and development | 10.2 | 6.3 | 17.8 | 11.8 | ||||||||||
General and administrative | 2.1 | 2.1 | 4.3 | 4.4 | ||||||||||
Foreign exchange loss (gain), net | 0.1 | (0.2 | ) | - | 0.5 | |||||||||
Total operating expense | 12.4 | 8.2 | 22.1 | 16.7 | ||||||||||
Loss from operations | (8.6 | ) | (6.5 | ) | (18.2 | ) | (13.3 | ) | ||||||
Non-operating income (expense): | ||||||||||||||
Non-cash interest expense on liability related to sale of future royalties | (0.5 | ) | - | (0.9 | ) | - | ||||||||
Interest income, net | 0.1 | - | 0.1 | 0.1 | ||||||||||
Total non-operating income (expense) | (0.4 | ) | - | (0.8 | ) | 0.1 | ||||||||
Loss before tax | (9.0 | ) | (6.5 | ) | (19.0 | ) | (13.2 | ) | ||||||
Income tax expense | 0.1 | - | 0.1 | - | ||||||||||
Net loss | $ | (9.1 | ) | $ | (6.5 | ) | $ | (19.1 | ) | $ | (13.2 | ) | ||
Basic loss per share | $ | (0.24 | ) | $ | (0.17 | ) | $ | (0.49 | ) | $ | (0.34 | ) | ||
Diluted loss per share | $ | (0.24 | ) | $ | (0.17 | ) | $ | (0.49 | ) | $ | (0.34 | ) | ||
Basic weighted-average shares outstanding | 38,640,487 | 38,636,946 | 38,640,487 | 38,630,587 | ||||||||||
Diluted weighted-average shares outstanding | 38,640,487 | 38,636,946 | 38,640,487 | 38,630,587 | ||||||||||
Contacts:Source:Mark Colonnese Executive Vice President and Chief Financial OfficerAviragen Therapeutics, Inc. (678) 221-3381 mcolonnese@aviragentherapeutics.comBeth DelGiacco Stern Investor Relations, Inc. (212) 362-1200 beth@sternir.com
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