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): November 5, 2019
AYTU
BIOSCIENCE, INC.
(Exact
name of registrant as specified in its charter)
Delaware
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001-38247
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47-0883144
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(State
or other jurisdiction of incorporation)
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(Commission File
Number)
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(IRS
Employer Identification No.)
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373
Inverness Parkway, Suite 206
Englewood,
CO 80112
(Address of
principal executive offices, including Zip Code)
Registrant’s
telephone number, including area code: (720) 437-6580
N/A
(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:
☐
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)) Securities registered pursuant to Section 12(b)
of the Act:
Title of each class
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Trading
Symbol(s)
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Name of each exchange on which registered
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Common
Stock, par value $0.0001 per share
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AYTU
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The
NASDAQ Stock Market LLC
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Indicate by check
mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (§230.405 of
this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934
(§240.12b-2 of this chapter).
Emerging
growth company ☐
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Item 3.01 Notice of Delisting or Failure to Satisfy a Continued
Listing Rule or Standard; Transfer of Listing
The
Company’s common stock is listed on The Nasdaq Capital
Market. In order to maintain compliance with Nasdaq listing
standards, the Company must, amongst other requirements, maintain a
stockholders’ equity balance of at least $2.5 million
pursuant to Nasdaq Listing Rule 5550(b). In that regard, the
Company has been in the process of closing its financial records in
advance of the filing of the Form 10-Q for three months ended
September 30, 2019. On November 1, 2019, the Company became aware
that as of September 30, 2019, the Company’s
stockholders’ equity fell below the $2.5 million threshold.
However, as of October 13, 2019, the deficiency was remediated as a
result of the Company completing an offering, raising approximately
$9.3 million in equity financing. The Company’s
stockholders’ equity balance was further increased on
November 1, 2019 as the Company issued equity securities in closing
the acquisition of a portfolio of commercial pediatric
pharmaceutical assets and related workforce from Cerecor, Inc., in
which the Company issued approximately 9.8 million shares of Series
G Convertible Preferred Stock worth an initial estimate of
approximately $5.6 million. Accordingly, the Company’s
stockholders’ equity balance exceeds the minimum $2.5 million
threshold and therefore the Company is currently in compliance with
all applicable Nasdaq Listing Requirements.
The
Company proactively contacted the Nasdaq Capital Markets on
November 5, 2019 to disclose and discuss non-compliance with Rule
5550(b) as of September 30, 2019 and the subsequent remediation. In
addition, the Company proposed disclosures to be included in our
Form 10-Q for the three months ended September 30, 2019 to mitigate
any need to address the matter subsequent to the filing of the
Company’s Form 10-Q.
Item 8.01 Other Events
On
November 11, 2019, the Company issued a press release announcing
that Mr. Matthew Phillips has joined the Company as its Executive
Vice President of Commercial Operations, effective November 8,
2019. Mr. Phillips will lead the Company’s commercial
operations, inclusive of sales, national accounts, trade
management, specialty distribution, supply chain and commercial
logistics. Mr. Phillips has extensive experience at numerous
healthcare companies including serving as Chief Commercial Officer
at Cerecor, Inc. and prior to that, as President and Chief
Operating Officer at Zylera Pharmaceuticals, Inc. He will report to
Josh Disbrow, the Company’s Chairman and Chief Executive
Officer.
In
accordance with General Instruction B.2 of Form 8-K, the
information in the press release attached as Exhibit 99.1 hereto
shall not be deemed to be “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), nor shall such information be deemed
incorporated by reference in any filing under the Securities Act of
1933, as amended, or the Exchange Act, except as shall be expressly
set forth by specific reference in such filing.
Item
9.01 Financial Statements and Exhibits.
(d) The
following exhibit is being filed herewith:
Exhibit
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Description
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Press Release dated
November 11, 2019
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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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AYTU BIOSCIENCE,
INC.
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Date:
November 12, 2019
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By:
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/s/ Joshua R.
Disbrow
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Joshua R.
Disbrow
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Chief Executive
Officer
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Exhibit
99.1
Aytu BioScience Announces Hiring of Matthew Phillips as Executive
Vice President of Commercial Operations
ENGLEWOOD,
CO / ACCESSWIRE / November 11, 2019 / Aytu BioScience, Inc.
(NASDAQ: AYTU), a specialty pharmaceutical company focused on
global commercialization of novel products addressing significant
medical needs, today announced the hiring of Matthew Phillips as
the company’s Executive Vice President of Commercial
Operations. Mr. Phillips’ hiring became effective November 8,
2019 following the recently announced acquisition of a portfolio of
six prescription products from Cerecor, Inc. (the “Commercial
Portfolio”) and the accompanying commercial team supporting
the products’ growth. Mr. Phillips was responsible for
leading the growth of the Commercial Portfolio as the Chief
Commercial Officer at Cerecor, Inc. and its predecessor company
Zylera Pharmaceuticals.
In his
role as Executive Vice President, Mr. Phillips will lead Aytu
BioScience’s commercial operations, inclusive of sales,
national accounts, trade management, specialty distribution, supply
chain and commercial logistics. He will report to Josh Disbrow,
Aytu’s Chairman and Chief Executive Officer.
Josh
Disbrow commented, “I’m very pleased to welcome Matt to
the leadership team at Aytu BioScience. As we expand the product
portfolio and operationalize the newly expanded commercial team,
Matt’s continuing leadership in this important role will
enable us to build on the sales momentum he and his team have
generated at Cerecor while also building on the growth the Aytu
products. Matt is a highly-respected, seasoned pharmaceutical
executive with great breadth of experience across all aspects of
commercial operations, and he is the ideal commercial leader for
Aytu during this time of rapid growth.”
Matthew
V. Phillips is business leader and commercial executive who has
held progressive leadership positions at numerous healthcare
companies over his twenty-five-plus year career. Most recently,
Matt served as the Chief Commercial Officer of Cerecor, Inc.
(NASDAQ: CERC), where he led all aspects of commercial operations
and built a profitable pediatric commercial business unit. In
Matt’s leadership role at Cerecor, he reported to the Chief
Executive Officer and Board of Directors and had responsibilities
beyond leading the commercial team. These responsibilities included
business development, collaboration with research and development,
leading product and company acquisition processes, and leading
market development in preparation for the commercialization of
multiple orphan drug candidates.
Prior
to Cerecor, Matt was the President and Chief Operating Officer of
Zylera Pharmaceuticals, which was acquired by Cerecor in 2017. Matt
ran all aspects of commercial operations at Zylera and built a
high-performing, entrepreneurial commercial organization that
experienced rapid growth during his tenure. Previous to joining
Zylera, Matt served as Executive Director of Managed Markets and
Corporate Accounts at Victory Pharmaceuticals, where he developed
and oversaw all aspects of reimbursement, distribution, and
government accounts.
Earlier
in his pharmaceutical career, Matt was an integral member of the
management teams at Dura Pharmaceuticals and Eisai, Inc. Matt began
his career in the home health care industry where he held
progressive positions in sales and sales management.
Matt
earned his bachelor’s degree in Business from Central
Michigan University, completed the University of Michigan Executive
Education Leadership Development Program and currently maintains an
appointed position on the North Carolina Board of Science,
Technology and Innovation.
About Aytu BioScience, Inc.
Aytu
BioScience is a commercial-stage specialty pharmaceutical company
focused on commercializing novel products that address significant
patient needs. The company currently markets Natesto®, the
only FDA-approved nasal formulation of testosterone for men with
hypogonadism (low testosterone, or "Low T"). Aytu also has
exclusive U.S. and Canadian rights to ZolpiMist™, an
FDA-approved, commercial-stage prescription sleep aid indicated for
the short-term treatment of insomnia characterized by difficulties
with sleep initiation. Aytu is the exclusive U.S. licensee with
commercial rights to Tuzistra® XR, the only FDA-approved
12-hour codeine-based antitussive syrup. Tuzistra XR is a
prescription antitussive consisting of codeine polistirex and
chlorpheniramine polistirex in an extended-release oral suspension.
Additionally, Aytu is developing MiOXSYS®, a novel, rapid
semen analysis system with the potential to become a standard of
care for the diagnosis and management of male infertility caused by
oxidative stress. MiOXSYS is commercialized outside of the U.S.
where it is a CE Marked, Health Canada cleared, Australian TGA
approved, Mexican COFEPRAS approved product, and Aytu is planning
U.S.-based clinical trials in pursuit of 510k de novo medical
device clearance by the FDA. Aytu's strategy is to continue
building its portfolio of revenue-generating products, leveraging
its focused commercial team and expertise to build leading brands
within large therapeutic markets. For more information visit
aytubio.com.
Forward-Looking Statements
This
press release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, or the
Exchange Act. All statements other than statements of historical
facts contained in this presentation, are forward-looking
statements. Forward-looking statements are generally written in the
future tense and/or are preceded by words such as ''may,''
''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,''
''suggest,'' ''believe,'' ''estimate,'' ''continue,''
''anticipate,'' ''intend,'' ''plan,'' or similar words, or the
negatives of such terms or other variations on such terms or
comparable terminology. These statements are just predictions and
are subject to risks and uncertainties that could cause the actual
events or results to differ materially. These risks and
uncertainties include, among others: the effects of the business
combination of Aytu and the Commercial Portfolio and the previously
announced, but not yet consummated, merger ("Merger") with Innovus
Pharmaceuticals, including the combined company's future financial
condition, results of operations, strategy and plans, the ability
of the combined company to realize anticipated synergies in the
timeframe expected or at all, changes in capital markets and the
ability of the combined company to finance operations in the manner
expected, the diversion of management time on Merger-related issues
and integration of the Commercial Portfolio, the ultimate timing,
outcome and results of integrating the operations the Commercial
Portfolio and Innovus with Aytu's existing operations, the failure
to obtain the required votes of Innovus' shareholders or Aytu's
shareholders to approve the Merger and related matters, the risk
that a condition to closing of the Merger may not be satisfied,
that either party may terminate the merger agreement or that the
closing of the Merger might be delayed or not occur at all, the
price per share utilized in the formula for the initial $8 million
merger consideration in the Merger may not be reflective of the
current market price of Aytu's common stock on the closing date,
potential adverse reactions or changes to business or employee
relationships, including those resulting from the announcement or
completion of the Merger, risks relating to gaining market
acceptance of our products, obtaining or maintaining reimbursement
by third-party payors, the potential future commercialization of
our product candidates, the anticipated start dates, durations and
completion dates, as well as the potential future results, of our
ongoing and future clinical trials, the anticipated designs of our
future clinical trials, anticipated future regulatory submissions
and events, our anticipated future cash position and future events
under our current and potential future collaboration. We also refer
you to the risks described in ''Risk Factors'' in Part I, Item 1A
of the company's Annual Report on Form 10-K and in the other
reports and documents we file with the Securities and Exchange
Commission from time to time.
Contact for Investors:
James
Carbonara
Hayden
IR
(646)
755-7412
james@haydenir.com
SOURCE:
Aytu BioScience, Inc.