Biota Pharmaceuticals Reports First Quarter Fiscal Year 2016 Financial Results
"This quarter was about pipeline momentum and expanding our leadership team at Biota. As for our antiviral portfolio, we continued enrolling patients in our ongoing Phase 2 SPIRITUS trial for vapendavir and are now nearing the completion of a single ascending dose trial for BTA585, our RSV F-protein inhibitor. On the corporate front, we are thrilled with the recent addition of a chief financial officer and two new directors to our Board," reflected Dr.
Corporate Updates
Appointed
Appointed
Anticipated Upcoming Pipeline Milestones
BTA585. BTA585 is an orally bioavailable compound being developed to treat respiratory syncytial virus (RSV) infections in children, the elderly and immunocompromised patients. The Company is currently conducting a 50-subject, randomized, placebo-controlled, Phase 1 single ascending dose (SAD) clinical trial to evaluate the safety and pharmacokinetics (PK) of BTA585 in healthy volunteers. The ongoing Phase 1 SAD clinical trial has five dose level cohorts ranging from 50 mg to 500 mg and includes an evaluation of the effect of food on the plasma PK of BTA585. To date, four cohorts have completed the study and top-line PK and safety data is anticipated by year-end. The Company also expects to begin a Phase 1 multiple ascending dose trial this month and anticipates top-line results in the first quarter of calendar year 2016.
BTA074 5% topical gel. BTA074 is a novel, direct-acting antiviral with activity against human papillomavirus types 6 and 11. BTA074 is currently in development for the treatment of genital warts, or condyloma, as well as recurrent respiratory papillomatosis. The Company anticipates that dosing will commence early next year in a double-blind placebo-controlled, randomized, Phase 2 study to assess the safety, tolerability, pharmacokinetics and efficacy of BTA074 5% gel, dosed topically, twice a day for up to 16 weeks in duration, in approximately 210 adult condyloma patients.
Vapendavir. Vapendavir is an oral treatment for human rhinovirus infections in moderate-to-severe asthmatics. The Company is continuing enrollment in the ongoing Phase 2b SPIRITUS trial. The multi-center, randomized, double-blind, placebo-controlled dose-ranging study is designed and powered to equally randomize approximately 190 laboratory-confirmed human rhinovirus infected patients across three treatment arms. The primary endpoint of the trial is the change from baseline to study day 14 in asthma symptoms and lung function as measured by the asthma control questionnaire-6 total score. Key secondary endpoints include safety and tolerability, specific lung function assessments such as forced expiratory volume in one second (FEV1), daily b2-agonist use and the incidence of moderate and severe asthma exacerbations. The Company anticipates top-line data from this trial to be available in the second half of next year.
Financial Results for the Three Month Period Ended
Revenue increased 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 reported a net loss of
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 availability of top-line PK and safety data from the BTA585 Phase 1 single ascending dose trial; the planned initiation of the Phase 1 multiple ascending dose study for BTA585; the planned initiation of a Phase 2 clinical trial for BTA074; and the timing of top-line data from the Phase 2b SPIRITUS trial.
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 Company, 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 U.S. Federal securities laws to do so.
Biota is a registered trademark of
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CONDENSED CONSOLIDATED BALANCE SHEETS | ||||
(in millions, except per share amounts) | ||||
(unaudited) | ||||
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ASSETS | ||||
Current assets | ||||
Cash and cash equivalents |
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Short-term investments | 11.9 | 12.9 | ||
Accounts receivable, net of allowance | 3.2 | 12.6 | ||
Prepaid and other current assets | 0.8 | 0.6 | ||
Total current assets | 61.2 | 70.8 | ||
Non-current assets: | ||||
Long-term investments | 9.1 | 7.9 | ||
Property and equipment, net | 0.2 | 0.2 | ||
Deferred tax asset | 0.5 | 0.5 | ||
Total non-current assets | 9.8 | 8.6 | ||
Total assets |
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LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
Current liabilities: | ||||
Contract payables (BARDA) | $ -- |
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Accounts payable | 2.9 | 1.9 | ||
Accrued expenses | 3.1 | 5.3 | ||
Accrued severance obligations | -- | 0.1 | ||
Deferred tax liability | 0.5 | 0.5 | ||
Short term note payable | 0.2 | 0.2 | ||
Total current liabilities | 6.7 | 9.0 | ||
Non-current liabilities: | ||||
Long term note payable, net of current portion | 0.7 | 0.8 | ||
Other liabilities, net of current portion | 0.1 | 0.1 | ||
Total liabilities | 7.5 | 9.9 | ||
Stockholders' equity: | ||||
Common stock, |
3.9 | 3.9 | ||
Additional paid-in capital | 156.2 | 155.6 | ||
Accumulated other comprehensive income | 18.9 | 18.9 | ||
Accumulated deficit | (115.5) | (108.9) | ||
Total stockholders' equity | 63.5 | 69.5 | ||
Total liabilities and stockholders' equity |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||
(in millions, except per share amounts) | ||
(unaudited) | ||
Three Months Ended |
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2015 | 2014 | |
Revenue: | ||
Royalty revenue and milestones |
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$ -- |
Revenue from services | -- | 0.7 |
Total revenue | 1.7 | 0.7 |
Operating expense: | ||
Cost of revenue | -- | 1.7 |
Research and development | 5.5 | 4.9 |
General and administrative | 2.2 | 2.4 |
Foreign exchange loss (gain) | 0.7 | (1.3) |
Total operating expense | 8.4 | 7.7 |
Loss from operations | (6.7) | (7.0) |
Non-operating income: | ||
Interest income | 0.1 | 0.1 |
Total non-operating income | 0.1 | 0.1 |
Loss before tax | (6.6) | (6.9) |
Income tax benefit (expense) | -- | -- |
Net loss |
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Basic loss per share |
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Diluted loss per share |
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Basic weighted-average shares outstanding | 38,624,227 | 35,029,300 |
Diluted weighted-average shares outstanding | 38,624,227 | 35,029,300 |
CONTACT:Source:Joseph M. Patti , PhD President and Chief Executive Officer (678) 221-3352 j.patti@biotapharma.comSarah McCabe Stern Investor Relations, Inc. (212) 362-1200 sarah@sternir.com
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