Biota Announces Restructuring Plan
02 June 2014 - 8:00PM
Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) (the "Company") today
announced that following the completion of an operational review of
the Company, its Board of Directors has adopted a plan to
restructure the Company's operations. The adoption of the plan was
the result of a recent decision by the Department of Health and
Human Services Office of Assistant Secretary for Preparedness and
Response (ASPR) Biomedical Advanced Research and Development
Authority (BARDA) to terminate its contract with the Company for
the convenience of the U.S. Government. This contract was
supporting the development of laninamivir octanoate, a long-acting
neuraminidase inhibitor (LANI), for the treatment of uncomplicated
influenza A and B.
Immediate actions resulting from the adoption of this plan will
involve a re-alignment of the Company's operations and resources.
Specifically, the Company plans to reduce its workforce by
approximately two-thirds over the next six to nine months and close
its Melbourne, Australia facility by June 30, 2015. The
Company anticipates recording an estimated total charge of
approximately $5.0 - $5.5 million over this and the next several
quarters in association with this restructuring plan. Upon
expected completion of the plan in the first half of 2015, the
Company estimates its annual, ongoing research and development and
general and administrative overhead costs will be reduced by
approximately $8.0 - $10.0 million from current annualized
levels.
In the near-term the Company intends to focus its efforts on its
late-stage clinical assets, namely LANI and vapendavir, as well as
preclinical compounds being developed for the treatment of
respiratory syncytial infections (RSV). The Company
anticipates data that will inform on the possible next steps in the
development of each of these respective programs will be available
in the third quarter. Further, the Company anticipates
exploring alternative business development and/or financing
arrangements that could facilitate the continued development of
LANI in later-stage clinical trials.
"We believe that these operational changes, while very
unfortunate and difficult to make, will more closely align our
ongoing fixed costs with our expected revenues going forward and
allow us to continue to support our later-stage clinical and
preclinical programs," stated Russell Plumb, President and Chief
Executive Officer of Biota Pharmaceuticals, Inc.
About Biota
Biota Pharmaceuticals, Inc. is a biopharmaceutical company
focused on the discovery and development of products to prevent and
treat serious and potentially life-threatening viral respiratory
infectious diseases. The Company currently has two Phase 2
clinical-stage product candidates: laninamivir octanoate, which the
Company is developing for the treatment of influenza A and B
infections under an IND in the United States; and vapendavir, a
potent, oral broad spectrum capsid inhibitor of enteroviruses,
including human rhinovirus, which is being developed to treat
patients with underlying respiratory illnesses, such as asthma and
chronic obstructive pulmonary disease (COPD). In addition to
these late-stage clinical development programs, the Company has
preclinical programs focused on developing oral antivirals for the
treatment of respiratory syncytial virus infections. For additional
information about the Company, please visit
www.biotapharma.com.
Safe Harbor Statement
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. Any
statements that are not historical facts may be deemed to be
forward-looking statements, including statements related to
Company's intent to focus its near-term efforts on LANI,
vapendavir, and its preclinical RSV compounds, the anticipated time
in which data from these programs that will inform on possible next
steps may be available, the Company's intent to explore alternative
business development and/or financing arrangements for LANI, the
estimated amount of anticipated total charges to be recorded
related to the restructuring plan and the timing thereof, the
estimated reduction in annual ongoing overhead costs as a result of
the restructuring plan, and the Company's belief that the
operational changes will more closely align its ongoing fixed costs
with expected revenues going forward and allow it to continue to
support its later-stage clinical and preclinical programs.
Various important factors could cause actual results,
performance, events or achievements to materially differ from those
expressed or implied by the 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 laninamivir octanoate or vapendavir at any time for
a lack of safety, tolerability, anti-viral activity, commercial
viability, regulatory or manufacturing issues, or any other reason
whatsoever; the Company's ability to obtain the necessary financial
resources or enter into a business development arrangement to
continue the development of laninamivir octanoate; the Company's
ability to secure, manage and retain qualified third-party clinical
research, preclinical research, data management and contract
manufacturing organizations upon which it relies to assist in the
design, development and implementation of the clinical development
of laninamivir octanoate and vapendavir, future changes in the
Company's strategy and the implementation of those changes; the
Company's ability to successfully manage its expenses, operating
results and financial position in line with its plans and
expectations, and other cautionary statements contained elsewhere
in this press release and in the Company's Annual Report on Form
10-K for the year ended June 30, 2013, as filed with the U.S.
Securities and Exchange Commission, or SEC, on September 27, 2013
and its Form 10-Q's as filed with the SEC on November 12, 2013,
February 10, 2014 and May 12, 2014.
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 Biota Pharmaceuticals,
Inc.
CONTACT: Russell H. Plumb
Chief Executive Officer
(678) 221-3351
r.plumb@biotapharma.com
Lee M. Stern
The Trout Group
(646) 378-2922
lstern@troutgroup.com
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