Biota Pharmaceuticals Reports Second Quarter Fiscal Year 2016 Financial Results
"I am very pleased today to report that significant progress is being made with our antiviral pipeline for respiratory indications and we remain on track to have Phase 2 data readouts in the second half of the year from both the HRV and RSV programs. Our oral RSV fusion inhibitor, BTA585, successfully completed a robust Phase 1 single ascending dose study showing a favorable safety and pharmacokinetic profile. We are nearing completion of the Phase 1 multiple ascending dose study and plan to initiate the Phase 2 RSV challenge study next quarter. Additionally we are progressing with enrollment in the Phase 2b SPIRITUS trial of vapendavir and anticipate top-line data in the second half of this year. Not only is this our lead program but it is the most advanced direct-acting antiviral in the field targeting HRV and has the potential to treat problematic upper respiratory infections in
the almost 11 million moderate-to-severe asthmatics in the U.S.," stated
"I am glad to report that we have begun screening patients for the Phase 2 study of BTA074, our first-in-class direct-acting antiviral for the treatment of condyloma caused by HPV types 6 & 11, which is the most common manifestation of HPV infection and also the most common sexually-transmitted viral disease worldwide. Current topical treatments do not act on the virus directly so there is a need for a therapy with improved efficacy and reduced local skin reactions to address this contagious infection."
Recent Highlights
Announced positive Phase 1 data for BTA585. The top-line results were from a blinded, placebo-controlled single ascending dose study, which tested doses of up to 800 mg of BTA585, an oral fusion inhibitor in development for the treatment and prevention of respiratory syncytial virus (RSV) infections. Findings included:
- No serious or severe adverse events
- Low incidence of adverse events
- Pharmacokinetic (PK) data demonstrated that all doses of 100 mg or greater achieved BTA585 plasma levels that exceeded the mean EC50 of RSV clinical isolates for 24 hours.
The EC 50 represents the concentration of drug that is required for 50% inhibition of viral replication in vitro - BTA585 plasma Cmax was rapidly achieved at approximately one hour following oral dosing and the half-life (T1/2) was approximately five to six hours across the dose range
- Dosing of BTA585 with a high fat meal did not adversely affect the PK
Commenced dosing in Phase 1 multiple ascending dose (MAD) study of BTA585. This study will evaluate the safety and PK of BTA585 in healthy volunteers following seven days of oral dosing. Top-line data is anticipated to be available in the first quarter of 2016.
Enrollment on track for Phase 2b SPIRITUS trial for vapendavir. Top-line data are expected in the second half of 2016 from the multi-center, randomized, double-blind, placebo-controlled dose-ranging study in moderate-to-severe adult asthmatics with symptomatic human rhinovirus (HRV) and a history of asthma exacerbation from colds.
Corporate Updates
Appointed
Financial Results for the Three Month Period Ended
The Company reported a net loss of
Revenue decreased to
Cost of revenue decreased to zero for the three month
period ended
Research and development expense increased to
General and administrative expense decreased to
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 Biota's 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 data readouts on our Phase 2 HRV and RSV programs, the availability of top-line PK and safety data from the BTA585 Phase 1 multiple ascending dose trial; and the planned initiation of the Phase 2a challenge study for BTA585.
Various important factors could cause actual results, performance, events or achievements to materially differ from those expressed or implied by forward-looking
statements, including the
There may be events in the future that the Company is unable to predict, or over which it has no control, and the Company's business, financial condition, results of operations and prospects may change in the future. The Company may not update these forward-looking statements more frequently than quarterly unless it has an obligation under
Biota is a registered trademark of
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
(in millions, except per share amounts) | |||||||
(unaudited) | (audited) | ||||||
ASSETS | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 39.0 | $ | 44.7 | |||
Short-term investments | 13.0 | 12.9 | |||||
Accounts receivable, net of allowance | 5.1 | 12.6 | |||||
Prepaid and other current assets | 1.5 | 0.6 | |||||
Total current assets | 58.6 | 70.8 | |||||
Non-current assets: | |||||||
Long-term investments | 5.2 | 7.9 | |||||
Property and equipment, net | 0.4 | 0.2 | |||||
Deferred tax asset | - | 0.5 | |||||
Total non-current assets | 5.6 | 8.6 | |||||
Total assets | $ | 64.2 | $ | 79.4 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1.3 | $ | 1.9 | |||
Accrued expenses | 4.3 | 5.4 | |||||
Short term note payable | 0.4 | 0.2 | |||||
Contract payables (BARDA) | - | 1.0 | |||||
Deferred tax liability | - | 0.5 | |||||
Total current liabilities | 6.0 | 9.0 | |||||
Non-current liabilities: | |||||||
Long term note payable, net of current portion | 0.5 | 0.8 | |||||
Other liabilities, net of current portion | 0.2 | 0.1 | |||||
Total liabilities | 6.7 | 9.9 | |||||
Stockholders' equity: | |||||||
Common stock, | 3.9 | 3.9 | |||||
Additional paid-in capital | 156.8 | 155.6 | |||||
Accumulated other comprehensive income | 18.9 | 18.9 | |||||
Accumulated deficit | (122.1 | ) | (108.9 | ) | |||
Total stockholders' equity | 57.5 | 69.5 | |||||
Total liabilities and stockholders' equity | $ | 64.2 | $ | 79.4 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||
(in millions, except per share amounts) | ||||||||||||||
(unaudited) | ||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||
Revenue: | ||||||||||||||
Royalty revenue and milestones | $ | 1.7 | $ | 6.5 | $ | 3.4 | $ | 6.5 | ||||||
Revenue from services | - | 7.4 | - | 8.1 | ||||||||||
Total revenue | 1.7 | 13.9 | 3.4 | 14.6 | ||||||||||
Operating expense: | ||||||||||||||
Cost of revenue | - | 1.6 | - | 3.3 | ||||||||||
Research and development | 6.3 | 4.8 | 11.8 | 9.7 | ||||||||||
General and administrative | 2.1 | 2.6 | 4.4 | 5.0 | ||||||||||
Foreign exchange loss (gain) | (0.2 | ) | (1.5 | ) | 0.5 | (2.8 | ) | |||||||
Total operating expense | 8.2 | 7.5 | 16.7 | 15.2 | ||||||||||
Income (loss) from operations | (6.5 | ) | 6.4 | (13.3 | ) | (0.6 | ) | |||||||
Non-operating income: | ||||||||||||||
Interest income | - | 0.1 | 0.1 | 0.2 | ||||||||||
Total non-operating income | - | 0.1 | 0.1 | 0.2 | ||||||||||
Income (loss) before tax | (6.5 | ) | 6.5 | (13.2 | ) | (0.4 | ) | |||||||
Income tax benefit | - | - | - | - | ||||||||||
Net income (loss) | $ | (6.5 | ) | $ | 6.5 | $ | (13.2 | ) | $ | (0.4 | ) | |||
Basic income (loss) per share | $ | (0.17 | ) | $ | 0.19 | $ | (0.34 | ) | $ | (0.01 | ) | |||
Diluted income (loss) per share | $ | (0.17 | ) | $ | 0.19 | $ | (0.34 | ) | $ | (0.01 | ) | |||
Basic weighted-average shares outstanding | 38,636,946 | 35,100,961 | 38,630,587 | 35,100,961 | ||||||||||
Diluted weighted-average shares outstanding | 38,636,946 | 35,103,086 | 38,630,587 | 35,100,961 | ||||||||||
Contacts:Source:Mark P. Colonnese Executive Vice President and Chief Financial OfficerBiota Pharmaceuticals, Inc. (678) 221-3381 m.colonnese@biotapharma.comBeth DelGiacco Stern Investor Relations, Inc. (212) 362-1200 beth@sternir.com
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