UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
otPursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934
Date of
Report (Date of earliest event reported): April 24, 2019
AYTU BIOSCIENCE, INC.
(Exact
name of registrant as specified in its charter)
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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))
Item 1.01 Entry into a Material Definitive Agreement.
As
disclosed previously, on August 11, 2017, Aytu BioScience, Inc.
(the “Company”) entered into a Securities Purchase
Agreement (“SPA”) with certain purchasers (the
“Purchasers”) of the Company’s securities. Among
other terms, the SPA granted the Purchasers the right to
participate in future financing transactions by the Company and
also prohibited the Company from entering into certain
“variable rate transactions,” until August 11, 2022. On
April 24, 2019, the Company entered into an amendment to the SPA
(the “Amendment”) in accordance with the terms of the
SPA. Under the Amendment, the Purchasers continue to have a right
to participate in future financing transactions by the Company
until August 11, 2019, but the Amendment reduces and simplifies
some of the notice requirements of the Company in connection with
this right. In addition, the Amendment removes the prohibition
against the Company engaging in certain other transactions. No
consideration was given by the Company in exchange for Purchasers'
agreement to this Amendment.
The
foregoing summary of the Amendment does not purport to be complete
and is subject to, and qualified in its entirety by, the full text
of the Amendment, the form of which is filed as Exhibit 10.1 to
this report and is incorporated herein by reference.
Item 7.01 Regulation FD Disclosure.
On
April 26, 2019, the Company issued a press release announcing the
submission of ZolpiMistTM for approval by the
Australian Therapeutic Goods Administration. A copy of the press
release is filed as Exhibit 99.1 to this report and is incorporated
herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d)
The following exhibit is being filed herewith:
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Exhibit
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Description
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Form of
Amendment No. 1 to Securities Purchase Agreement, dated April 24,
2019
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Press
Release dated April 26, 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:
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April
26, 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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AMENDMENT NO. 1
TO
SECURITIES
PURCHASE AGREEMENT
This
AMENDMENT NO. 1 TO SECURITIES PURCHASE AGREEMENT (this
“Amendment”) is
made effective as of April 24, 2019. This Amendment amends that
certain Securities Purchase Agreement (the “Agreement”) dated August 11, 2017
by and among Aytu BioScience, Inc., a Delaware corporation (the
“Company”) and
the purchasers set forth identified on the signature pages thereto
(the “Purchasers” and, together, with
the Company, the “Parties”).
WHEREAS, Section 5.5 of the Agreement
provides that the Agreement may be waived, supplemented or amended
with a written instrument signed by the Company and the Purchasers
holding at least 51% in interest of the outstanding securities
issued or issuable pursuant to the Agreement;
WHEREAS, the Parties desire to amend and
restate Section 4.11 of the Agreement as set forth in this
Amendment; and
WHEREAS, as set forth more fully in
Section 1.1 below, the Parties affirm the rights set forth in
Section 4.11(a) of the Agreement granting the Purchasers the right
to participate in up to 35% of a Subsequent Financing on the same
terms, conditions and price provided for in the Subsequent
Financing.
NOW, THEREFORE, in consideration of the
mutual covenants contained herein and other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties hereby agree as follows:
SECTION 1
Amendment of the Agreement
Section
1.1 Amendment of
Section 4.11. Effective immediately as of the date hereof,
Section 4.11 of the Agreement is hereby amended and restated in its
entirety to read as follows:
4.11
Participation in Future
Financing.
(a) From
the date hereof until the date that is the twenty four (24) month
anniversary of the Effective Date, upon any issuance by the Company
or any of its Subsidiaries of Common Stock, Common Stock
Equivalents for cash consideration, Indebtedness or a combination
of units hereof (a “Subsequent Financing”), each
Purchaser shall have the right to participate in up to an amount of
the Subsequent Financing equal to 35% of the Subsequent Financing
(the “Participation Maximum”) on the same terms,
conditions and price provided for in the Subsequent
Financing.
(b) At
least four (4) hours prior to the pricing of the Subsequent
Financing, the Company shall deliver to each Purchaser a written
notice of its intention to effect a Subsequent Financing
(“Notice”), which Notice shall describe in reasonable
detail the proposed terms of such Subsequent Financing, the amount
of proceeds intended to be raised thereunder and the Person or
Persons through or with whom such Subsequent Financing is proposed
to be effected and shall include a term sheet or similar document
relating thereto as an attachment.
(c) Any
Purchaser desiring to participate in such Subsequent Financing must
provide written notice to the Company within four hours of the time
the Company provided the Notice that such Purchaser is willing to
participate in the Subsequent Financing, the amount of such
Purchaser’s participation, and representing and warranting
that such Purchaser has such funds ready, willing, and available
for investment on the terms set forth in the Notice. If the Company
receives no such notice from a Purchaser by that time, such
Purchaser shall be deemed to have notified the Company that it does
not elect to participate.
(d) If
after four hours from the time the Company provided the Notice,
notifications by the Purchasers of their willingness to participate
in the Subsequent Financing (or to cause their designees to
participate) are, in the aggregate, less than the total amount of
the Subsequent Financing, then the Company may effect the remaining
portion of such Subsequent Financing on the terms and with the
Persons set forth in the Notice.
(e) If
after four hours from the time the Company provided the Notice, the
Company receives responses to the Notice from Purchasers seeking to
purchase more than the aggregate amount of the Participation
Maximum, each such Purchaser shall have the right to purchase its
Pro Rata Portion (as defined below) of the Participation Maximum.
“Pro Rata Portion” means the ratio of (x) the
Subscription Amount of Securities purchased on the Closing Date by
a Purchaser participating under this Section 4.11 and (y) the sum
of the aggregate Subscription Amounts of Securities purchased on
the Closing Date by all Purchasers participating under this Section
4.11.
(f) [RESERVED]
(g) The
Company and each Purchaser agree that if any Purchaser elects to
participate in the Subsequent Financing, the transaction documents
related to the Subsequent Financing shall not include any term or
provision whereby such Purchaser shall be required to agree to any
restrictions on trading as to any of the Securities purchased
hereunder or be required to consent to any amendment to or
termination of, or grant any waiver, release or the like under or
in connection with, this Agreement, without the prior written
consent of such Purchaser.
(h) Notwithstanding
anything to the contrary in this Section 4.11 and unless otherwise
agreed to by such Purchaser, the Company shall either confirm in
writing to such Purchaser that the transaction with respect to the
Subsequent Financing has been abandoned or shall publicly disclose
its intention to issue the securities in the Subsequent Financing,
in either case in such a manner such that such Purchaser will not
be in possession of any material, non-public information, by the
tenth (10th) Business Day following delivery of the Notice. If by
such tenth (10th) Business Day, no public disclosure regarding a
transaction with respect to the Subsequent Financing has been made,
and no notice regarding the abandonment of such transaction has
been received by such Purchaser, such transaction shall be deemed
to have been abandoned and such Purchaser shall not be deemed to be
in possession of any material, non-public information with respect
to the Company or any of its Subsidiaries.
(i) Notwithstanding
the foregoing, this Section 4.11 shall not apply in respect of an
Exempt Issuance.
Section
1.2 Amendment of
Section 4.12. Effective immediately as of the date hereof,
Section 4.12 of the Agreement is hereby amended and restated in its
entirety to read as follows:
4.12
Participation in Future
Financing.
(a) From
the date hereof until the later of (i) two hundred and seventy
(270) days after the Effective Date and (ii) three hundred and
sixty-five (365) days from the Closing Date, without the consent of
the Purchasers that purchased at least fifty-one (51%) percent of
the Shares purchased hereunder, neither the Company nor any
Subsidiary shall issue, enter into any agreement to issue or
announce the issuance or proposed issuance of any shares of Common
Stock or Common Stock Equivalents, or file any registration
statement covering the issuance or resale of any shares of Common
Stock or Common Stock Equivalents.
(b) [RESERVED]
(c) Notwithstanding
the foregoing, clause (a) of this Section 4.12 shall not apply in
respect of an Exempt Issuance.
(d) If
the VWAP of the Common Stock exceeds $1.00 (as adjusted for reverse
and forward stock splits, stock dividends, stock combinations and
other similar transaction of the Common Stock that occurs after the
date of this Agreement, including, without limitation, any reverse
stock splits previously approved by the Company's stockholders) for
five (5) or more consecutive Trading Days, clause (a) of this
Section 4.12 shall terminate and be of no further force and
effect.
SECTION 2
Miscellaneous Provisions
Section
2.1 Effect of
Amendment. This Amendment is not to be construed as a waiver
of any term, condition or provision of the Agreement, and that
except as expressly provided for by this Amendment, all terms and
conditions of the Agreement, as amended by this Amendment shall
remain in full force and effect, without any modification
whatsoever.
Section
2.2 Counterparts.
This Amendment may be executed simultaneously in two or more
counterparts, any one of which need not contain the signatures of
more than one Party, but all such counterparts taken together shall
constitute one and the same agreement.
[Signature
Pages Follow]
IN
WITNESS WHEREOF, the undersigned have executed this Amendment No. 1
to Agreement effective as of the date first written
above.
AYTU
BIOSCIENCE, INC.
Name:
Joshua R. Disbrow
Title:
Chief Executive Officer
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[Signature
Page to Amendment No. 1 to Securities Purchase
Agreement]
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4
IN
WITNESS WHEREOF, the undersigned have executed this Amendment No. 1
to Agreement effective as of the date first written
above.
NAME
Name:
Title:
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[Signature
Page to Amendment No. 1 to Securities Purchase
Agreement]
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5
Aytu BioScience Announces Submission of ZolpiMist™ for
Approval to Australian Therapeutic Goods Administration
(TGA)
Australian TGA Approval Decision Expected in Early
2020
ENGLEWOOD, CO / ACCESSWIRE / April 24, 2019 / Aytu
BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company
focused on global commercialization of novel products addressing
significant medical needs, today announced the submission of
ZolpiMist™ (zolpidem tartrate oral spray) for regulatory
approval to the Australian Therapeutic Goods Administration (TGA).
SUDA Pharmaceuticals Ltd (“SUDA”), which holds the
global ZolpiMist sublicense outside the U.S. and Canada, has made
this submission and further disclosed that the TGA has accepted the
ZolpiMist Marketing Authorisation Application (MAA) for review and
the review is underway.
Aytu
BioScience previously announced its partnership with SUDA
Pharmaceuticals as the licensee of ZolpiMist outside the U.S. and
Canada, and SUDA already has multiple sublicensing agreements in
place around the world. This submission to the Australian TGA
represents SUDA’s first direct regulatory submission, and the
expected review period is 255 days. Accordingly, a decision by TGA
is expected in early calendar 2020.
Josh
Disbrow, Chief Executive Officer of Aytu BioScience commented,
“We congratulate SUDA Pharmaceuticals on their successful
submission of the ZolpiMist regulatory file to the Australian TGA.
As the TGA is one of the world’s most rigorous regulatory
bodies, we are encouraged by the agency’s prompt preliminary
assessment and acknowledgement of the file’s completeness and
readiness for full review. We look forward to the potential
approval of ZolpiMist early next year following the completion of
TGA’s review.”
Aytu
recently announced the global licensing agreement for ZolpiMist
with SUDA. The Aytu-SUDA licensing agreement calls for SUDA to lead
commercial development and sublicensing efforts for ZolpiMist in
major territories outside the United States and Canada, including
Europe, Asia, Australia, and Latin America. As specified in the
companies' global licensing agreement, SUDA will pay Aytu a portion
of each upfront and milestone payment received from sublicensees,
and Aytu will receive ongoing royalty payments on sales generated
by SUDA and SUDA’s sublicensees as ZolpiMist is launched in
their territories.
SUDA
has already signed sublicensing agreements in key markets with
large, multi-national pharmaceutical companies and has agreements
in place in Brazil, China, Chile, and throughout Southeast
Asia.
SUDA is
in negotiations with pharmaceutical companies to sublicense
ZolpiMist in additional countries in South America, as well as in
Europe (specifically in Spain, Italy, France, and Germany), Korea,
the Middle East, North Africa, UAE, and Kuwait.
The
global sleep aid market is currently estimated at almost $50
billion in annual revenue, and annual revenue is estimated to reach
nearly $80 billion in 2022.
About Aytu BioScience, Inc.
Aytu
BioScience is a commercial-stage specialty pharmaceutical company
focused on global commercialization of novel products addressing
significant medical 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 recently
acquired exclusive U.S. 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.
About SUDA Pharmaceuticals
SUDA
Pharmaceuticals Ltd (ASX: SUD) is a drug delivery company focused
on oro-mucosal administration, headquartered in Perth, Western
Australia. The company is developing low-risk oral sprays using its
OroMist® technology to reformulate existing pharmaceuticals.
The many potential benefits of administering drugs through the oral
mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use,
lower dosage, reduced side effects and faster response time. SUDA's
product pipeline includes ZolpiMist™, a first-in-class oral
spray of zolpidem for insomnia. ZolpiMist is marketed in the USA
and SUDA has rights to the product outside of the U.S. and Canada.
Other products SUDA has in development include oral sprays for the
treatment of: migraine headache; chemotherapy-induced nausea and
vomiting; erectile dysfunction; PAH; epileptic seizures and
pre-procedural anxiety; and cancer.
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: risks relating to gaining
market acceptance of our products, obtaining 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.