BioCryst Reports Second Quarter 2016 Financial Results
"We continue to make progress, and have initiated subject screening to start the APeX-1 trial evaluating our once daily oral kallikrein inhibitor BCX7353 to prevent HAE attacks," said
Second Quarter Financial Results
For the three months ended
Research and Development (R&D) expenses for the second quarter of 2016 decreased to
General and administrative (G&A) expenses for the second quarter of 2016 decreased to
Interest expense, which is primarily related to Company's non-recourse notes payable, was
The net loss for the second quarter of 2016 was
Cash, cash equivalents and investments decreased to
Year to Date Financial Results
For the six months ended
R&D expenses increased to
G&A expenses decreased to
In the first half of 2016 and 2015, interest expense was
The net loss for the six months ended
Corporate Update & Outlook
- The APeX-1 clinical trial of BCX7353 for prophylaxis of angioedema attacks in patients with HAE has received regulatory approval in
Canada and several European countries, and patient screening has commenced. We expect initial data from APeX-1 to be available by year end 2016.
- A clinical pharmacology study of several dosage formulations of avoralstat is nearing completion. Cohorts of healthy volunteers have received single doses
ranging from 200 mg to 2000 mg of avoralstat in tablet or suspension formulations, with no clinically significant adverse events reported. While these dosing formulations have improved total avoralstat exposure (AUC) up to approximately five-fold compared to a 500 mg dose given as soft gel capsules, the plasma concentration-time profile has not met our objectives of twice-daily dosing with drug levels at or above the target range. For that reason, we have decided to stop further development of avoralstat.
- A phase 1 first-in-human study of the broad-spectrum antiviral drug BCX4430 has been completed. Study drug was administered by i.m. injection to healthy volunteers. Single doses of BCX4430 ranging from 0.3 to 10 mg/kg were administered, and daily doses of 2.5 mg/kg to 10 mg/kg were administered for 7 days. Exposure to BCX4430 was dose-proportional. BCX4430 dosing was
generally safe and well-tolerated, and there were no grade 3 or 4 adverse events.
- On
July 5, 2016 , BioCryst announced that theNational Institute of Allergy and Infectious Diseases (NIAID) has provided additional funding for efficacy studies of BCX4430 in non-human primates to further assess effective dose regimens. This funding represents an increase of$5.5 million for the development of BCX4430 as a treatment for hemorrhagic fever viruses. The NIAID contract value now totals$39.5 million , if all contract options are exercised. To date, approximately$35.4 million of funding has been awarded under the contract.
About APeX-1
APeX-1 is a two part, Phase 2, randomized, double-blind, placebo-controlled proof of concept and dose ranging trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of BCX7353 as a preventative treatment to eliminate or reduce the frequency of angioedema attacks in HAE patients. Up to a total of approximately 50 eligible subjects with HAE will be enrolled in the trial.
In part 1 of APeX-1, up to 36 subjects with HAE will be randomized in a 1:1 ratio to receive an oral dose of either 350 mg of BCX7353 once daily or placebo once daily for four weeks. An interim analysis will be conducted after the first 24 subjects have completed treatment through study day 28. If a robust treatment effect is observed at the interim analysis, Part 2 of the study will be initiated. In the event the treatment effect is not well characterized with 24 subjects, a total of up to approximately 36 subjects will be enrolled in part 1. The sample size in Part 1 was kept flexible to cover a range of response options that would achieve 90% power with an alpha of 0.05, based on reduction of attack rate of at least 70% on BCX7353, placebo response rate of approximately 30%, and standard deviation of approximately 0.45 attacks per week.
To characterize dose-response in part 2 of APeX-1, 14 additional subjects with HAE will be randomized to 250mg of BCX7353 once daily (n=6), 125mg of BCX7353 once daily (n=6) or placebo (n=2).
The primary efficacy endpoint of APeX-1 is the number of angioedema attacks; attack rate per week, counts of attacks, proportion of subjects with no attacks, and number of attack-free days will be analyzed. Efficacy analyses will be conducted for HAE attacks reported over the entire dosing interval (Days 1 through 28) and during the dosing period in which plasma concentrations of BCX7353 should be at steady-state conditions (Days 8 through 28). Secondary efficacy endpoints include severity and duration of angioedema attacks, and measures of health-related quality of life. Safety will be characterized through evaluation of adverse events and laboratory testing. Pharmacokinetics and pharmacodynamic effects will be assessed through measurement of plasma drug levels and kallikrein inhibition.
About BCX7353
Discovered by BioCryst, BCX7353 is a novel, once-daily, selective inhibitor of plasma kallikrein in development for the prevention of angioedema attacks in patients diagnosed with HAE. By inhibiting plasma kallikrein, BCX7353 suppresses bradykinin production. Bradykinin is the mediator of acute swelling attacks in HAE patients. BCX7353 has been generally safe and well tolerated in clinical pharmacology studies that have enrolled 117 healthy volunteers, 46 receiving single doses of up to 1000 mg, and 71 receiving once-daily doses of up to 500 mg for 7 days and 350 mg for 14 days. In the second week of study, approximately 4-5% of healthy volunteers administered daily doses of '7353 for at least 7 days developed a drug-related skin rash that resolved within a few days.
Financial Outlook for 2016
Based upon development plans and our awarded government contracts, BioCryst expects its 2016 net operating cash use to be in the range of
Conference Call and Webcast
BioCryst's leadership team will host a conference call and webcast on
About
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst's actual results, performance or achievements to be materially different from any future
results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that planned trials of BCX7353 may not have a favorable outcome, including the APeX-1 trial; that developing a commercial formulation of BCX7353 or any other HAE compound may take longer or may be more expensive than planned; ongoing and future preclinical and clinical development of other plasma kallikrein inhibitor candidates may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of
product candidates; that the Company may not advance human clinical trials with product candidates as expected; that the
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| CONSOLIDATED FINANCIAL SUMMARY | ||||||||||||||||||||||
| (in thousands, except per share) | ||||||||||||||||||||||
| Statements of Operations (Unaudited) | ||||||||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||||||||
| Revenues: | ||||||||||||||||||||||
| Product sales, net | $ | - | $ | - | $ | - | $ | 537 | ||||||||||||||
| Royalty revenue | 629 | 132 | 2,519 | 1,650 | ||||||||||||||||||
| Collaborative and other research and development | 4,158 | 25,710 | 7,088 | 30,481 | ||||||||||||||||||
| Total revenues | 4,787 | 25,842 | 9,607 | 32,668 | ||||||||||||||||||
| Expenses: | ||||||||||||||||||||||
| Cost of products sold | - | - | - | 15 | ||||||||||||||||||
| Research and development | 14,166 | 16,524 | 34,745 | 33,644 | ||||||||||||||||||
| General and administrative | 2,724 | 3,534 | 5,936 | 7,595 | ||||||||||||||||||
| Royalty | 27 | 442 | 104 | 502 | ||||||||||||||||||
| Total expenses | 16,917 | 20,500 | 40,785 | 41,756 | ||||||||||||||||||
| (Loss) income from operations | (12,130 | ) | 5,342 | (31,178 | ) | (9,088 | ) | |||||||||||||||
| Interest and other income | 147 | 116 | 586 | 233 | ||||||||||||||||||
| Interest expense | (1,421 | ) | (1,306 | ) | (2,891 | ) | (2,621 | ) | ||||||||||||||
| (Loss) gain on foreign currency derivative | (2,877 | ) | 749 | (5,630 | ) | 1,213 | ||||||||||||||||
| Net (loss) income | $ | (16,281 | ) | $ | 4,901 | $ | (39,113 | ) | $ | (10,263 | ) | |||||||||||
| Net (loss) income per common share, basic | $ | (0.22 | ) | $ | 0.07 | $ | (0.53 | ) | $ | (0.14 | ) | |||||||||||
| Net (loss) income per common share, diluted | $ | (0.22 | ) | $ | 0.06 | $ | (0.53 | ) | $ | (0.14 | ) | |||||||||||
| Weighted average shares outstanding, basic | 73,695 | 72,642 | 73,648 | 72,492 | ||||||||||||||||||
| Weighted average shares outstanding, diluted | 73,695 | 76,760 | 73,648 | 72,492 | ||||||||||||||||||
| Balance Sheet Data (in thousands) | ||||||||||||||||||||||
| (Unaudited) | (Note 1) | |||||||||||||||||||||
| Cash, cash equivalents and investments | $ | 59,894 | $ | 99,246 | ||||||||||||||||||
| Restricted cash | 4,426 | 1,612 | ||||||||||||||||||||
| Receivables from collaborations | 2,234 | 6,243 | ||||||||||||||||||||
| Total assets | 82,217 | 122,359 | ||||||||||||||||||||
| Non-recourse notes payable (Note 2) | 28,023 | 27,804 | ||||||||||||||||||||
| Accumulated deficit | (550,030 | ) | (510,917 | ) | ||||||||||||||||||
| Stockholders' equity | 13,387 | 47,724 | ||||||||||||||||||||
| Note 1: Derived from audited financial statements. | ||||||||||||||||||||||
| Note 2: Reflects retrospective application of ASU 2015-03, Simplifying the Presentation of Debt Issuance Costs | ||||||||||||||||||||||
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