UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 26, 2016
Aviragen Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
001-35285 |
59-1212264 |
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(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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2500 Northwinds Parkway, Suite 100 Alpharetta, GA |
30009 | |
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(Address of principal executive offices) |
(Zip Code) | |
Registrant’s telephone number, including area code: (678) 221-3350
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events
On May 26, 2016, Aviragen Therapeutics, Inc. (the “Company”) issued a press release announcing an update on Phase 2a Trial of BTA585 for the treatment of respiratory syncytial virus (“RSV”) infections. A copy of the press release is attached as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
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99.1 |
Press release dated May 26, 2016. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Aviragen Therapeutics, Inc. | ||
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Date: May 26, 2016 |
/s/ Joseph M. Patti | |
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Name: |
Joseph M. Patti | |
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Title: |
Chief Executive Officer and President | |
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(Duly Authorized Officer) | ||
EXHIBIT INDEX
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Exhibit Number |
Description | |
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99.1 |
Press release dated May 26, 2016. |
Exhibit 99.1
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PRESS RELEASE | |
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FOR IMMEDIATE RELEASE
Aviragen Therapeutics Provides Update on Phase 2a Trial of BTA585 for the Treatment of RSV Infections
ATLANTA, GA – May 26, 2016 – Aviragen Therapeutics, Inc. (NASDAQ: AVIR; formerly Biota Pharmaceuticals, Inc.), a pharmaceutical company that is developing the next generation of antivirals, today announced that it has voluntarily decided to delay further enrollment in the Phase 2a trial of BTA585 for the treatment of RSV infections being conducted in the U.K. This decision emanated from a lab report from one subject showing an increase of a cardiac enzyme level coupled with transient ECG changes, which led to a hospitalization of less than 24 hours. The subject’s ECGs were normal prior to hospitalization and the cardiac enzyme levels returned to baseline shortly thereafter.
The Company also reported that subsequent to the submission of the requisite safety report to the regulatory authorities, it received verbal communication from the U.S. Food and Drug Administration (FDA) that the investigational new drug application (IND) for BTA585 has been placed on clinical hold for studies being conducted in the U.S. under the IND. There are currently no trials of BTA585 being conducted under the IND. More specific written information from the FDA concerning the clinical hold is expected within 30 days.
“Patient safety is paramount to us, which led to our decision to voluntarily delay enrollment. We have proactively reached out to the Medicines and Healthcare Products Regulatory Agency (MHRA), the regulatory authority in the U.K., to discuss this event and any implications it may have on the continued clinical development of BTA585,” said Joseph M. Patti, PhD, President and Chief Executive Officer of Aviragen Therapeutics.
About Aviragen Therapeutics, Inc.
Aviragen Therapeutics is focused on the discovery and development of the next generation of direct-acting antivirals to treat infections that have limited therapeutic options and affect a significant number of patients globally. The Company has three product candidates in active clinical development: These include vapendavir, an oral treatment for human rhinovirus upper (HRV) respiratory infections in moderate-to-severe asthmatics currently being evaluated in the Phase 2b SPIRITUS trial; BTA585, an oral fusion protein inhibitor that has received Fast Track designation by the U.S. FDA, in Phase 2 development for the treatment and prevention of respiratory syncytial virus (RSV) infections; and BTA074, a topical antiviral treatment in Phase 2 development for condyloma caused by human papillomavirus types 6 & 11. For additional information about the Company, please visit www.aviragentherapeutics.com.
Aviragen Therapeutics, Inc. 2500 ● Northwinds Parkway, Suite 100 ● Alpharetta, GA 30009 ● Tel: (678) 221-3343
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 receiving written information from the U.S. Food and Drug Administration (FDA). 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 FDA or a similar regulatory body in another country, a data safety monitoring board, or an institutional review board delaying, limiting, suspending or terminating the clinical development of any of the Company's product candidates at any time for a lack of safety, tolerability, regulatory or manufacturing issues, or any other reason whatsoever; the Company's ability to secure, manage and retain qualified third-party clinical research data management and contract manufacturing organizations upon which it relies to assist in the design, development, implementation and execution of the clinical development of all its product candidates and those organizations' ability to successfully execute their contracted responsibilities; the Company's ability to comply with applicable government regulations in various countries and regions in which we are conducting, or expect to conduct, clinical trials; and other cautionary statements contained elsewhere in this press release and in our Annual Report on Form 10-K, Quarterly Report on Form 10-Q and our other reports filed with the Securities and Exchange Commission. 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.
Contacts:
Mark Colonnese
Executive Vice President and Chief Financial Officer
Aviragen Therapeutics, Inc.
(678) 221-3381
mcolonnese@aviragentherapeutics.com
Beth DelGiacco
Stern Investor Relations, Inc.
(212) 362-1200
beth@sternir.com
Aviragen Therapeutics, Inc. 2500 ● Northwinds Parkway, Suite 100 ● Alpharetta, GA 30009 ● Tel: (678) 221-3343