As filed with the Securities and Exchange
Commission on June 8, 2020
Registration
File No.: 333-
UNITED STATES SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM S-4
REGISTRATION STATEMENT UNDER THE SECURITIES
ACT OF 1933
AYTU BIOSCIENCE, INC.
(Exact name of registrant as specified in
charter)
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Delaware
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47-0883144
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(State or other jurisdiction of
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(I.R.S. Employer
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incorporation or organization)
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Identification No.)
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373 Inverness Parkway, Suite 206
Englewood, Colorado 80112
(720) 437-6580
(Address, including zip code and telephone
number, including area code, of registrant’s principal executive offices)
Joshua R. Disbrow
Chief Executive Officer
373 Inverness Parkway, Suite 206
Englewood, Colorado 80112
Telephone: (720) 437-6580
(Name, address, including zip code and telephone
number, including area code, of agent for service of process)
Copy to:
Nolan S. Taylor
Anthony W. Epps
Kymra Archibald
Dorsey & Whitney LLP
111 S. Main Street, Suite 2100
Salt Lake City, Utah 84111
(801) 933-7360
Approximate Date
of Commencement of Proposed Sale to Public: From time to time after the effective date of this Registration Statement.
If the securities being
registered on this form are being offered in connection with the formation of a holding company and there is compliance with General
Instruction G, check the following box: ☐
If this form is filed
to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and
list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this form is a post-effective
amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the Registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions
of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging
growth company” in Rule 12b-2 of the Exchange Act:
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Large accelerated filer ☐
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Smaller reporting company ☒
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Accelerated Filer ☐
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Emerging growth company ☐
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Non-accelerated filer ☒
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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 7(a)(2)(B) of the Securities Act. ☐
If applicable, place
an X in the box to designate the appropriate rule provision relied upon in conducting this transaction:
Exchange Act Rule 13e-4(i)
(Cross-Border Issuer Tender Offer) ☐
Exchange Act Rule 14d-1(d)
(Cross-Border Third-Party Tender Offer) ☐
CALCULATION OF REGISTRATION FEE
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Title of Each Class of Securities to be Registered
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Amount to be
Registered(1)
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Proposed
Maximum
Offering Price
per Unit(1)(2)
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Proposed
Maximum
Aggregate
Offering
Price(1)(2)
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Amount of
Registration Fee
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Common Stock, par value $0.0001 per share
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24,539,877.30
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$
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1.63
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$
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40,000,000
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$
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5,192.00
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(1)
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Pursuant to Rule 416 under the Securities Act of 1933, as amended (the “Securities Act”),
the shares being registered hereunder include such indeterminate number of shares of common stock as may be issuable with respect
to the shares being registered hereunder as a result of stock splits, stock dividends or similar transactions.
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(2)
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Estimated in accordance with Rule 457(c) solely for purposes of calculating the registration fee. The maximum price per Security
and the maximum aggregate offering price are based on the average of the $1.70 (high) and $1.55 (low) sale price of the Registrant's
Common Stock, par value $0.0001 per share as reported on the Nasdaq Capital Market on 06/01/2020, which date is within five
business days prior to filing this Registration Statement.
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The Registrant
hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant
shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in
accordance with Section 8(a) of the Securities Act or until this Registration Statement shall become effective on such date as
the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
The information
in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement
filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities
and it is not soliciting an offer to buy these securities in any state where such offer or sale is not permitted.
SUBJECT TO
COMPLETION, DATED JUNE 8, 2020
PROSPECTUS
$40,000,000
Common Stock
This prospectus relates
to the offering of common stock, par value $0.0001 per share, of Aytu BioScience, Inc., a Delaware corporation, (“Aytu”
or the “Company”), having a maximum aggregate offering price of $40,000,000, which may be issued from time to time
by the Company in connection with acquisitions by the Company of assets, businesses, or securities. We expect that the terms of
acquisitions involving the issuance of any such shares will be determined by direct negotiations with the owners or controlling
persons of the assets, businesses or securities to be acquired, and that the shares of common stock issued will be valued at prices
reasonably related to the market price of the common stock either at the time an agreement is entered into concerning the terms
of the acquisition or at or about the time the shares are delivered.
We do not expect to receive
any cash proceeds when we issue shares of common stock offered by this prospectus.
Our
common stock is listed on The NASDAQ Capital Market under the symbol “AYTU.” On June 1, 2020, the last reported sale
price for our common stock was $1.58 per share
Investing in our
securities involves risks. Please refer to the “Risk Factors” section on page 5 contained in any applicable
prospectus supplement and in the documents we incorporate by reference for a description of the risks you should consider when
evaluating this investment.
THESE SECURITIES
HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS.
ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The date of this prospectus is
2020
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This prospectus is
part of an “acquisition shelf” registration statement on Form S-4 that we filed with the Securities and Exchange Commission,
or the Commission, under the Securities Act of 1933, as amended, or the Securities Act, using an “acquisition shelf”
registration process. This prospectus relates to the offering of common stock, par value $0.0001 per share, of Aytu BioScience,
Inc., a Delaware corporation, having a maximum aggregate offering price of $40,000,000, which may be issued from time to time by
the Company in connection with acquisitions by the Company of assets, businesses, or securities. We expect that the terms of acquisitions
involving the issuance of any such shares will be determined by direct negotiations with the owners or controlling persons of the
assets, businesses or securities to be acquired, and that the shares of common stock issued will be valued at prices reasonably
related to the market price of the common stock either at the time an agreement is entered into concerning the terms of the acquisition
or at or about the time the shares are delivered. A prospectus supplement or post-effective amendment to this registration statement
will contain more specific information about an acquisition target or any of the terms of a definitive acquisition agreement. Any
statement that we make in this prospectus will be modified or superseded by any inconsistent statement made by us in a prospectus
supplement or post-effective amendment. Before deciding to receive any of our securities as part of an acquisition transaction,
you should read both this prospectus and any accompanying post-effective amendment together with the additional information described
under the headings “Where You Can Find More Information” and “Incorporation of Certain Documents by Reference.”
You should rely only
on the information contained in this prospectus, any applicable prospectus supplement or any post-effective amendment and those
documents incorporated by reference in this prospectus or any post-effective amendment. We have not authorized anyone to provide
you with information different from that contained in this prospectus, any applicable prospectus supplement or any post-effective
amendment. If anyone provides you with different or additional information you should not rely on it. This prospectus may only
be used where it is legal to sell these securities. This prospectus is not an offer to sell, or a solicitation of an offer to buy,
in any state where the offer or sale is prohibited. The information in this prospectus, any applicable prospectus supplement any
post-effective amendment or any document incorporated herein or therein by reference is accurate as of the date contained on the
cover of such documents. Neither the delivery of this prospectus, any applicable prospectus supplement or any post-effective amendment,
nor any sale made under this prospectus or any post-effective amendment will, under any circumstances, imply that the information
in this prospectus, any applicable prospectus supplement or any post-effective amendment is correct as of any date after the date
of this prospectus or any such post-effective amendment.
References in this
prospectus to the “Company,” “Aytu,” “we,” “our,” and “us,” refer to
Aytu BioScience, Inc.
SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus, and
the documents incorporated by reference herein, contain certain “forward-looking statements” within the meaning of
Section 27A of the Securities Act, Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995, and
are based on management’s current expectations. These forward-looking statements can be identified by the use of forward-looking
terminology, including, but not limited to, “believes,” “may,” “will,” “would,”
“should,” “expect,” “anticipate,” “seek,” “see,” “confidence,”
“trends,” “intend,” “estimate,” “on track,” “are positioned to,” “on
course,” “opportunity,” “continue,” “project,” “guidance,” “target,”
“forecast,” “anticipated,” “plan,” “potential” and the negative of these terms
or comparable terms.
Various factors could
adversely affect our operations, business or financial results in the future and cause our actual results to differ materially
from those contained in the forward looking statements, including those factors discussed under “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and Results of Operations,” or otherwise discussed
in our Annual Report on Form 10-K for the fiscal year ended June 30, 2019, our Quarterly Reports on Form 10-Q for the quarterly
periods ended September 30, 2019, December 31, 2019 and March 31, 2020, and in our other filings made from time to time with the
SEC after the date of this prospectus.
For additional information
about factors that could cause actual results to differ materially from those described in the forward-looking statements, please
see the documents that we have filed with the SEC, including our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current
Reports on Form 8-K and other documents and reports filed from time to time with the SEC.
All subsequent forward-looking
statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements
contained or referred to in this section. We are not under any obligation to, and expressly disclaim any obligation to, update
or alter any forward-looking statements whether as a result of such changes, new information, subsequent events or otherwise.
PROSPECTUS SUMMARY
This document serves
as a prospectus of Aytu BioScience to register shares of our common stock, par value $0.0001 per share, having a maximum aggregate
offering price of $40,000,000, which we plan to use in acquisition transactions from time to time in connection with the acquisition
of assets, stock or businesses, whether by purchase, merger or any other form of business combination. It is expected that the
terms of these acquisitions will be determined by direct negotiations with the owners or controlling persons of the assets, businesses
or securities to be acquired, and that the shares of common stock issued will be valued at prices reasonably related to the market
price of our common stock either at the time an agreement is entered into concerning the terms of the acquisition or at or about
the time the shares are delivered. In addition to shares of our common stock, consideration for these acquisitions may consist
of any consideration permitted by applicable law, including, without limitation, the payment of cash, the issuance of a note or
other form of indebtedness, the assumption of liabilities or any combination of these items.
The common stock we
issue pursuant to this prospectus and applicable prospectus supplement or post-effective amendment in these transactions may be
reoffered pursuant to this prospectus by the stockholders thereof from time to time in transactions on the Nasdaq Capital Market
(or any other exchange on which our common stock may be listed or traded from time to time), in negotiated transactions, in block
trades, through the writing of options on securities, or any combination of these methods of sale, at fixed prices that may be
changed, at market prices prevailing at the time of sale, at prices relating to the prevailing prices or at negotiated prices.
These selling stockholders may sell their shares of common stock to or through broker-dealers, and the broker-dealers may receive
compensation in the form of discounts, concessions or commissions from the selling stockholders or the purchasers of shares for
whom the broker-dealer may act as agent or to whom they may sell as principal or both.
In addition, we may
issue our common stock pursuant to this prospectus and applicable prospectus supplement amendment or post-effective amendment to
acquire the assets, stock or business of debtors in cases under the United States Bankruptcy Code, which may constitute all or
a portion of the debtor’s assets, stock or business. The common stock we issue in these transactions may be sold by the debtor
or its stockholders for cash from time to time in market transactions or it may be transferred by the debtor in satisfaction of
claims by creditors under a plan of reorganization approved by the applicable U.S. Bankruptcy Court or otherwise transferred in
accordance with the Bankruptcy Code.
We will bear all expenses
in connection with the registration of the common stock being resold by selling stockholders, other than selling discounts and
commissions and fees and expenses of the selling stockholders. The terms for the issuance of common stock may include provisions
for the indemnification of the selling stockholders for specified civil liabilities, including liabilities under the Securities
Act of 1933, as amended, or the Securities Act. The selling stockholders and any brokers, dealers or agents that participate in
the distribution of the common stock may be deemed to be underwriters, and any profit on the sale of stock by them and any discounts,
concessions or commissions received by any of these underwriters, brokers, dealers or agents may constitute underwriting discounts
and commissions under the Securities Act.
THE COMPANY
We are a commercial-stage
specialty pharmaceutical company focused on commercializing novel products that address significant healthcare needs in both prescription
and consumer health categories. Through the Company’s heritage prescription business, we currently market a portfolio of
prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto®,
the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or “Low T”), (ii)
ZolpiMist™, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra® XR, the only FDA-approved 12-hour
codeine-based antitussive syrup.
The Company’s
recently acquired prescription pediatric portfolio includes (i) AcipHex® Sprinkle™, a granule formulation of rabeprazole
sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii)
Karbinal® ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions;
and (iv) Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary prescription fluoride-based supplement product lines containing
combinations of fluoride and vitamins in various formulations for infants and children with fluoride deficiency. We use our pediatric
portfolio in our commercialization efforts in order to leverage our internal commercial infrastructure and national sales force.
In February 2020, we
acquired Innovus Pharmaceuticals (“Innovus”), a specialty pharmaceutical company commercializing, licensing and developing
safe and effective consumer healthcare products designed to improve men’s and women’s health and vitality. Innovus commercializes
over thirty-five consumer health products competing in large healthcare categories including diabetes, men’s health, sexual wellness
and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing
the Company’s proprietary Beyond Human® marketing and sales platform.
On March 10, 2020,
we announced the licensing of a COVID-19 IgG/IgM Rapid Test from L.B. Resources, Ltd. The test is intended for professional use
and delivers clinical results between 2 and 10 minutes at the point-of-care. This exclusive agreement grants Aytu the exclusive
right to distribute the product in the United States for a period of three years, with additional three-year autorenewals thereafter.
The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection
of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. We have made an additional investment
to further our interest in fighting the COVID-19 pandemic by signing an exclusive licensing agreement with Cedars-Sinai Medical
Center for a medical device platform technology called Healight™. This technology, which has been studied in the laboratory
setting, is being investigated as a potential treatment for COVID-19 in hospitalized patients. In collaboration with researchers
from the Medically Associated Science and Technology Program (MAST), we expect to advance the development of Healight in the near
term.
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. Key Product Highlights
Key
Product Highlights
Primary Care Rx Portfolio
Prior to November 1,
2019, we were focused on the commercial development of the following three primary care focused products:
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Natesto® – In 2016, we acquired exclusive U.S. rights to Natesto® (testosterone)
nasal gel, a novel formulation of testosterone delivered via a discreet, easy-to-use nasal gel, including a license to four Orange
Book-listed patents. The recorded chain of title from the inventor to the assignee of these four patents is incomplete, but the
licensor Acerus is obligated to complete it. Natesto is approved by the U.S. Food and Drug Administration, or FDA, for the treatment
of hypogonadism (low testosterone) in men and is the only testosterone replacement therapy, or TRT, delivered via a nasal gel.
Natesto offers multiple advantages over currently available TRTs and competes in a $1.7 billion market accounting for nearly 7
million prescriptions annually. Importantly, as Natesto is delivered via the nasal mucosa and not the skin, there is no risk of
testosterone transference to others, a known potential side effect and black box warning associated with all other topically applied
TRTs, including the market leader AndroGel®.
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ZolpiMist® – In June 2018, we acquired an exclusive U.S. license to ZolpiMist®.
ZolpiMist is an FDA-approved prescription product that is indicated for the short-term treatment of insomnia, and is the only oral
spray formulation of zolpidem tartrate - the most widely prescribed prescription sleep aid in the U.S. ZolpiMist®
is not covered by any U.S. patents. ZolpiMist® is commercially available and competes in the non-benzodiazepine
prescription sleep aid category, a $1.8 billion prescription drug category with over 43 million prescriptions written annually.
Thirty million prescriptions of zolpidem tartrate (Ambien®, Ambien® CR, Intermezzo®, Edluar®, ZolpiMist®,
and generic forms of immediate-release, controlled release, and orally dissolving tablet formulations) are written each year in
the U.S., representing almost 70% of the non-benzodiazepine sleep aid category. Approximately 2.5 million prescriptions are written
for novel formulations of zolpidem tartrate products (controlled release and sublingual tablets). We intend to integrate ZolpiMist®
into our sales force’s promotional efforts as an adjunct product to Natesto as there is substantial overlap of physician
prescribers of both testosterone and prescription sleep aids.
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Tuzistra® XR – In November 2018 we acquired U.S. rights to be supplied and to market
Tuzistra XR from Tris Pharma, Inc., the only FDA-approved 12-hour codeine-based antitussive. Tuzistra XR is a prescription antitussive
consisting of codeine polistirex and chlorpheniramine polistirex in an extended-release oral suspension. Tuzistra XR is a patented
combination of codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine-1 receptor antagonist, indicated for relief
of cough and symptoms associated with upper respiratory allergies or a common cold in adults aged 18 years and older. Tuzistra
XR is protected by two Orange Book-listed patents extending to 2027 and 2029 owned by Tris Pharma, subject to a security interest
to Deerfield Management, and multiple pending patents. Aytu benefits from the patent portfolio through its supply and marketing
relationship with Tris Pharma and not by license or ownership of the patents. According to MediMedia, the US cough cold prescription
market is worth in excess of $3 billion at current brand pricing, with 30-35 million annual prescriptions. This market is dominated
by short-acting treatments, which require dosing 4-6 times a day. Tuzistra XR was developed using Tris Pharma’s liquid sustained
release technology, LiquiXR®, which allows for extended drug delivery throughout a 12-hour dosing period.
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The
Pediatric Rx Portfolio
In November 2019 we
acquired a portfolio of pediatric primary care products (the “Commercial Portfolio”) from Cerecor, Inc. in order to
expand our portfolio of commercial-stage products and further leverage our commercial infrastructure and sales force. Through this
acquisition the Company now commercializes nine prescription products and sells directly to pediatric and primary care physicians
throughout the U.S.
The Commercial Portfolio
contains established prescription products competing in markets exceeding $8 billion in annual U.S. sales. Each product has distinct
clinical features and patient-friendly benefits and are indicated to treat common pediatric and primary care conditions.
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AcipHex® Sprinkle™ (rabeprazole sodium) – AcipHex Sprinkle is a granule formulation
of rabeprazole sodium, a commonly prescribed proton pump inhibitor. AcipHex Sprinkle is indicated for the treatment of gastroesophageal
reflux disease (GERD) in pediatric patients 1 to 11 years of age for up to 12 weeks. Aytu does not own or license any patents covering
this product.
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Cefaclor (cefaclor oral suspension) – Cefaclor for oral suspension is a second-generation
cephalosporin antibiotic suspension and is indicated for the treatment of numerous common infections caused by Streptococcus
pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes, and others. Aytu does not own
or license any patents covering this product.
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Flexichamber® – Flexichamber is an anti-static, valved collapsible holding chamber
intended to be used by patients to administer aerosolized medication from most pressurized metered dose inhalers (MDIs) such as
commonly used asthma medications. Aytu does not own or license any patents covering this product.
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Karbinal® ER (carbinoxamine maleate extended-release oral suspension) – Karbinal
ER is an H1 receptor antagonist (antihistamine) indicated to treat various allergic conditions including seasonal and perennial
allergic rhinitis, vasomotor rhinitis, and other common allergic conditions. Aytu does not own or license any patents covering
this product.
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Poly-Vi-Flor® and Tri-Vi-Flor® – Poly-Vi-Flor and
Tri-Vi-Flor are two complementary prescription fluoride-based supplement product lines containing combinations of vitamins and
fluoride in various oral formulations. These prescription supplements are prescribed for infants and children to treat or prevent
fluoride deficiency due to poor diet or low levels of fluoride in drinking water and other sources. While Aytu does not own or
license any patents covering these products, we have an exclusive supply relationship for the use of Metafolin®
in pediatric products and which is a patented ingredient in Poly-Vi-Flor and Tri-Vi-Flor.
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Aytu
Consumer Health Portfolio
Our consumer health
subsidiary markets over 35 products in the U.S. and more than 10 in multiple countries around the world through 5 international
commercial partners. The following represents the core products:
In addition, we currently
expect to launch in the U.S. the following products in 2020, subject to the applicable regulatory approvals, if required:
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Musclin® is a proprietary supplement made of two FDA Generally Recognized As Safe (GRAS) approved
ingredients designed to increase muscle mass, endurance and activity (first half of 2020). The main ingredient in Musclin®
is a natural activator of the transient receptor potential cation channel, subfamily V, member 3 (TRPV3) channels on muscle fibers
responsible to increase fibers width resulting in larger muscles;
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Regenerum™* is a proprietary product containing two natural molecules: the first is an activator
of the TRPV3 channels resulting in the increase of muscle fiber width, and the second targets a different unknown receptor to build
the muscle’s capacity for energy production and increases physical endurance, allowing longer and more intense exercise.
Regenerum™ is being developed for patients suffering from muscle wasting. We currently expect to launch this product in 2020
pending successful clinical trials in patients with muscle wasting or cachexia;
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Octiq™* is an expected FDA ophthalmic OTC monograph compliant product for the treatment of eye
redness and eye lubrication (early 2020); and
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Regoxidine™* is an ANDA approved 5% Minoxidil foam for men and women for hair growth on the
top of the scalp (first half 2020).
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Aytu does not own or license any patents covering these
products.
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The COVID-19 IgG/IgM
Rapid Tests
The Company has signed
distribution agreements to distribute two similar COVID-19 IgG/IgM rapid tests. Both tests are serology-based rapid tests detecting
IgG and IgM antibodies specific to the COVID-19 virus. We initially licensed a rapid test from L.B. Resources, Limited (a Hong
Kong Corporation). We added a second rapid test by signing a distribution agreement with Singapore-based Biolidics, Limited. Aytu
does not own or license any patents covering the COVID-19 IgG/IgM rapid tests.
These tests are intended
for professional use and deliver clinical results between 2 and 10 minutes at the point-of-care.
The COVID-19 IgG/IgM
rapid test are solid phase immunochromatographic assays used in the rapid, qualitative and differential detection of IgG and IgM
antibodies to the COVID-19 in human whole blood, serum or plasma. Both tests have been clinically validated and can be distributed
in the United States following the Company’s notification of our intent to distribute the tests.
Features of the COVID-19
IgG/IgM Rapid Tests:
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Results reported rapidly
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Facilitates patient treatment decisions quickly
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Simple, time-saving procedure
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Small specimens, only 5 µL of serum/plasma or 10 µL of whole blood specimens required
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All necessary reagents provided & no equipment needed
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High sensitivity and specificity
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We have extensive experience
across a wide range of business development activities and have in-licensed or acquired products from large, mid-sized, and small
enterprises in the United States and abroad. Through an assertive product and business development approach, we expect that we
will continue to build a substantial portfolio of complementary products.
Our
Strategy
In the near-term, we
expect to create value for shareholders by implementing a focused strategy of increasing sales of our prescription therapeutics
while leveraging our commercial infrastructure. Further, we expect to increase sales of our newly acquired consumer healthcare
product portfolio following the closing of our acquisition of Innovus Pharmaceuticals. Additionally, we expect to expand both our
Rx and consumer health product portfolios through continuous business and product development. Finally, we expect to identify operational
efficiencies identified through our recent transactions and implement expense reductions accordingly.
Corporate
Information
Our principal executive
offices are located at 373 Inverness Parkway, Suite 206, Englewood, Colorado 80112, and our phone number is (720) 437-6580. Our
corporate website address is http://www.aytubio.com. The information contained on, connected to or that can be accessed via our
website is not part of this prospectus. We have included our website address in this prospectus as an inactive textual reference
only and not as an active hyperlink.
RISK FACTORS
Investing in our securities
involves a risk of loss. Before investing in our securities, you should carefully consider the risk factors described under “Risk
Factors” in our Annual Report on Form 10-K filed with the SEC for the most recent year, in any applicable prospectus supplement
and in our filings with the SEC, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, together with all
of the other information included in this prospectus and any prospectus supplement and the other information incorporated by reference
herein and therein. These risks are not the only ones facing us. Additional risks not currently known to us or that we currently
deem immaterial also may impair or harm our business and financial results. Statements in or portions of a future document incorporated
by reference in this prospectus, including, without limitation, those relating to risk factors, may update and supersede statements
in and portions of this prospectus or such incorporated documents. Please also refer to the section entitled “Special Note
Regarding Forward-Looking Statements.”
Risks Related to COVID-19
We are relying
on FDA policies and guidance provisions that have changed very recently, and may continue to change, and relate directly to the
COVID-19 health crisis. If we misinterpret this guidance or the guidance changes unexpectedly and/or materially, potential sales
of the COVID-19 tests would be impacted.
The U.S. Food and Drug
Administration (FDA) issued non-binding guidance for manufacturers relating to the pathway to enable FDA approval for devices related
to testing for COVID-19 under an Emergency Use Authorization (EUA). Following the issuance of the initial published guidance, on
March 16, 2020, revised guidance specific to COVID-19 “antibody tests” was issued. Newer guidance was published on
May 4, 2020 further describing the requirements for serology tests to continue to be marketed under an Emergency Use Authorization.
If our interpretation of the newly revised guidance is incorrect or specifics around the guidance change, the sales of the COVID-19
test could be materially impacted.
If our recently
licensed COVID-19 IgG/IgM rapid tests do not perform as expected or the reliability of the technology is questioned, we could experience
delayed or reduced market acceptance of the tests, increased costs and damage to our reputation.
Our success depends
on the market’s confidence that we can provide reliable, high-quality COVID-19 diagnostic tests. We believe that customers
in our target markets are likely to be particularly sensitive to product defects and errors. Our reputation and the public image
of our licensed COVID-19 diagnostic tests may be impaired if they fail to perform as expected or are perceived as difficult to
use. Despite quality control testing, defects or errors could occur with the tests.
In the future, if our
licensed COVID-19 diagnostic tests experience a material defect or error, this could result in loss or delay of revenues, delayed
market acceptance, damaged reputation, diversion of development resources, legal claims, increased insurance costs or increased
service and warranty costs, any of which could harm our business. Such defects or errors could also prompt us to amend certain
warning labels or narrow the scope of the use of our diagnostic tests, either of which could hinder our success in the market.
Even after any underlying concerns or problems are resolved, any widespread concerns regarding our technology or any manufacturing
defects or performance errors in the test could result in lost revenue, delayed market acceptance, damaged reputation, increased
service and warranty costs and claims against us.
If we become
subject to claims relating to improper handling, storage or disposal of hazardous materials, we could incur significant cost and
time to comply.
Our research and development
processes involve the controlled storage, use and disposal of hazardous materials, including biological hazardous materials. We
are subject to foreign, federal, state and local regulations governing the use, manufacture, storage, handling and disposal of
materials and waste products. We may incur significant costs complying with both existing and future environmental laws and regulations.
In particular, we are subject to regulation by the Occupational Safety and Health Administration, (OSHA), and the Environmental
Protection Agency (EPA), and to regulation under the Toxic Substances Control Act and the Resource Conservation and Recovery Act
in the United States. OSHA or the EPA may adopt additional regulations in the future that may affect our research and development
programs. The risk of accidental contamination or injury from hazardous materials cannot be eliminated completely. In the event
of an accident, we could be held liable for any damages that result, and any liability could exceed the limits or fall outside
the coverage of our workers’ compensation insurance. We may not be able to maintain insurance on acceptable terms, if at
all.
Our licensed
COVID-19 tests have not been manufactured on a high-volume scale and could be subject to unforeseen scale-up risks.
While the manufacturers
of the COVID-19 IgG/IgM rapid rests have experience manufacturing diagnostic tests, there can be no assurance that they can manufacture
the COVID-19 diagnostic tests at a scale that is adequate for our current and future commercial needs. We may face significant
or unforeseen difficulties in securing adequate supply of the COVID-19 diagnostic tests, relating to the manufacturing of the tests.
These risks include but are not limited to:
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Technical issues relating to manufacturing components of the COVID-19 diagnostic tests on a high-volume
commercial scale at reasonable cost, and in a reasonable time frame;
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difficulty meeting demand or timing requirements for orders due to excessive costs or lack of capacity
for part or all of an operation or process;
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changes in government regulations or in quality or other requirements that lead to additional manufacturing
costs or an inability to supply product in a timely manner, if at all; and
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increases in raw material or component supply cost or an inability to obtain supplies of certain critical
supplies needed to complete our manufacturing processes.
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These and other difficulties
may only become apparent when scaling up to the manufacturing process of the COVID-19 diagnostic tests to a more substantive commercial
scale. In the event the tests cannot be manufactured in sufficient commercial quantities or manufacturing is delayed, our future
prospects could be significantly impacted and our financial prospects could be materially harmed.
Our suppliers
may experience development or manufacturing problems or delays that could limit the growth of our revenue or increase our losses.
We may encounter unforeseen
situations in the manufacturing of the COVID-19 diagnostic tests that could result in delays or shortfalls in our production. Suppliers
may also face similar delays or shortfalls. In addition, suppliers’ production processes may have to change to accommodate
any significant future expansion of manufacturing capacity, which may increase suppliers’ manufacturing costs, delay production
of diagnostic tests, reduce our product gross margin and adversely impact our business. If we are unable to keep up with demand
for the COVID-19 diagnostic test by successfully securing supply and shipping our diagnostic tests in a timely manner, our revenue
could be impaired, market acceptance for the test could be adversely affected and our customers might instead purchase our competitors’
diagnostic tests.
We have relied
and expect to continue to rely on third parties to conduct studies of the COVID-19 diagnostic tests that will be required by the
FDA or other regulatory authorities and those third parties may not perform satisfactorily.
Although we intend
to sell the COVID-19 IgG/IgM rapid tests by virtue of recent FDA guidance allowing for reduced product clinical and analytical
studies, we have relied on third parties, such as independent testing laboratories and hospitals, to conduct such studies. Our
reliance on these third parties will reduce our control over these activities. These third-party contractors may not complete activities
on schedule or conduct studies in accordance with regulatory requirements or our study design. We cannot control whether they devote
sufficient time, skill and resources to our studies. Our reliance on third parties that we do not control will not relieve us of
any applicable requirement to prepare, and ensure compliance with, various procedures required under good clinical practices. If
these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines,
if the third parties need to be replaced or if the quality or accuracy of the data they obtain is compromised due to their failure
to adhere to our clinical protocols or regulatory requirements or for other reasons, our studies may be extended, delayed, suspended
or terminated, and we may not be able to obtain regulatory approval for additional diagnostic tests.
If the manufacturers’
delivery of the COVID-19 tests and the required clinical data is delayed, then our ability to obtain necessary regulatory approvals
and/or authorizations to distribute the COVID-19 tests will be impaired, which will adversely affect our business plans.
While the FDA has provided
a path forward to begin selling the COVID-19 tests on an expedited basis, we are still required to provide the FDA with data concerning
the validation of the tests and to satisfy certain labeling conditions. If the manufacturers are delayed in delivering to us the
COVID-19 tests and related validation data, we will, in turn, be delayed in obtaining FDA authorization or approval required before
we can begin selling the COVID-19 tests. Any such delays will adversely affect our business plans.
We rely on
third parties to manufacture the COVID-19 tests for us and if such third party refuses or is unable to supply us with the COVID-19
test, our business will be materially harmed.
We rely on third parties
to manufacture the COVID-19 diagnostic tests, which manufacturers licenses their rights from the owners of the intellectual property
underlying the COVID-19 tests. If any issues arise with respect to the manufacturers’ ability to manufacture and deliver
to us the COVID-19 tests, our business could be materially harmed.
While we have obtained
an exclusive distribution agreement for the right to commercialize one of the COVID-19 test in the United States, Canada and Mexico,
the manufacturer has no obligation to supply us with a minimum amount of, or any, COVID-19 tests. The manufacturer may choose not
to supply us with a sufficient quantity of such tests in order to supply such tests to other distributors, or for any reason. In
addition, the manufacturer may be unable to provide us with an adequate supply of COVID-19 tests for various reasons, including,
among others, if it becomes insolvent, if a United States regulatory authority or other governments block the import or sale of
the COVID-19 tests, if it fails to maintain its rights to manufacture the COVID-19 test, or if the owner of the underlying intellectual
property fails to adequately maintain such intellectual property.
If there is
little or no demand for the COVID-19 tests our business could be materially harmed.
While we have received
a number of inquiries regarding the COVID-19 tests and expect to receive orders upon our receipt of a supply of COVID-19 tests,
there is no guarantee that such inquiries will result in customer orders. If no orders for COVID-19 tests are made, our business
will be materially harmed.
Our business
may be adversely affected by the effects of the COVID-19 pandemic.
In December 2019, a
novel strain of coronavirus, SARS-CoV-2, causing a disease referred to as COVID-19, was reported to have surfaced in Wuhan, China.
It has since spread to multiple other countries; and, in March 2020, the World Health Organization declared the COVID-19 outbreak
a pandemic. This pandemic has adversely affected or has the potential to adversely affect, among other things, the economic and
financial markets and labor resources of the countries in which we operate, our manufacturing and supply chain operations, research
and development efforts, commercial operations and sales force, administrative personnel, third-party service providers, business
partners and customers, and the demand for some of our marketed products.
The COVID-19 pandemic
has resulted in travel and other restrictions to reduce the spread of the disease, including governmental orders across the globe,
which, among other things, direct individuals to shelter at their places of residence, direct businesses and governmental agencies
to cease non-essential operations at physical locations, prohibit certain non-essential gatherings, maintain social distancing,
and order cessation of non-essential travel. As a result of these recent developments, we have implemented work-from-home policies
for a significant part of our employees. The effects of shelter-in-place and social distancing orders, government-imposed quarantines,
and work-from-home policies may negatively impact productivity, disrupt our business, and delay our business timelines, the magnitude
of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our
business in the ordinary course. Such restrictions and limitations may also negatively impact our access to regulatory authorities
(which may be affected, among other things, by travel restrictions and may be delayed in responding to inquiries, reviewing filings,
and conducting inspections). The COVID-19 pandemic may also result in the loss of some of our key personnel, either temporarily
or permanently. In addition, our sales and marketing efforts may be impacted by postponement of face-to-face meetings and restrictions
on access by non-essential personnel to hospitals or clinics, all of which could slow adoption and implementation of our marketed
products, resulting in lower net product sales. For example, while the impact of shelter-in-place and social distancing orders,
physicians’ office closures, and delays in the treatment of patients following the COVID-19 pandemic on our net product sales of
our products for the three months ended March 31, 2020 was limited, overall demand was lower in April 2020 compared to the same
period of 2019. In addition to other potential impacts of the COVID-19 pandemic on net product sales, we expect to see continued
adverse impact on new patient starts for all products while these measures remain in place. See Part I, Item 2. “Management’s
Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations” for a discussion of our
net product sales. Demand for some or all of our marketed products may continue to be reduced while the shelter-in-place or social
distancing orders are in effect and, as a result, some of our inventory may become obsolete and may need to be written off, impacting
our operating results. These and similar, and perhaps more severe, disruptions in our operations may materially adversely impact
our business, operating results, and financial condition.
Quarantines, shelter-in-place,
social distancing, and similar government orders (or the perception that such orders, shutdowns, or other restrictions on the conduct
of business operations could occur) related to COVID-19 or other infectious diseases are impacting personnel at our research and
manufacturing facilities, our suppliers, and other third parties on which we rely, and may impact the availability or cost of materials
produced by or purchased from such parties, which could result in a disruption in our supply chain.
In addition, infections
and deaths related to COVID-19 may disrupt the United States’ healthcare and healthcare regulatory systems. Such disruptions could
divert healthcare resources away from, or materially delay, FDA review and potential approval of our marketed products. It is unknown
how long these disruptions could continue. Further, while we are focused on therapies to address the COVID-19 pandemic, our other
product candidates may need to be de-prioritized. Any elongation or de-prioritization of our other products could materially affect
our business.
While
the potential economic impact brought by, and the duration of, the COVID-19 pandemic may be difficult to assess or predict, it
is currently resulting in significant disruption of global financial markets. This disruption, if sustained or recurrent, could
make it more difficult for us to access capital if needed. In addition, a recession or market correction resulting from the spread
of COVID-19 could materially affect our business and the value of our common stock. The global COVID-19 pandemic continues to rapidly
evolve. The ultimate impact of this pandemic is highly uncertain and subject to change. We do not yet know the full extent of potential
delays or impacts on our business, healthcare systems, or the global economy as a whole. These effects could have a material impact
on our operations. To the extent the COVID-19 pandemic adversely affects our business, prospects, operating results, or financial
condition, it may also materially affect our business.
Risks Related to the Healight Technology
We must rely on a
third party to develop and commercialize the Healight Technology.
We must rely on Cedars-Sinai
Medical Center to conduct testing and clinical trials of the Healight Technology (“Healight”). As a result,
we are expected to remain dependent on a third party to conduct ongoing trials and the timing and completion of these trials will
be partially controlled by such third party and may result in delays to the Healight development program. Nevertheless, we are
responsible for ensuring that each of the trials is conducted in accordance with the applicable protocol and legal, regulatory,
and scientific standards and our reliance on a third party does not relieve us of our regulatory responsibilities. If we or Cedars-Sinai
Medical Center fail to comply with applicable requirements, the FDA may require to perform additional clinical tests.
There is no guarantee
that Cedars-Sinai Medical Center will devote adequate time and resources to the Healight development activities or perform as contractually
required. Furthermore, Cedars-Sinai Medical Center may also have relationships with other entities, some of which may be our competitors.
If Cedars-Sinai Medical Center fails to meet expected deadlines, adhere to our clinical protocols, meet regulatory requirements,
or otherwise performs in a substandard manner, or terminates its engagement with us, the timelines for the Healight technology
development may be extend, delayed, suspended, or terminated.
The development of
Healight faces uncertainties related to testing.
The development of Healight
is based on scientific hypotheses and experimental approaches that may not lead to desired results. It is possible that the timeframe
for obtaining proof of principle and other results may be considerably longer than originally anticipated, or may not be possible
given time, resource, financial, strategic, and collaborator constraints. Success in one stage of testing is not necessarily an
indication that the Healight program will succeed in later stages of testing and development. The discovery of unexpected side
effects, inability to increase scale of manufacture, market attractiveness, regulatory hurdles, competition, as well as other factors
may make the Healight technology unattractive of unsuitable for human use.
Risks Related to our Bylaws
Our Amended
and Restated Bylaws provides that the Court of Chancery of the State of Delaware is the exclusive forum for certain litigation
that may be initiated by our stockholders, including claims under the Securities Act, which could limit our stockholders’
ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Our Amended and Restated
Bylaws provides that the Court of Chancery of the State of Delaware shall, to the fullest extent permitted by law, be the sole
and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim for breach
of a fiduciary duty owed by any of our directors, officers, employees or agents to us or our stockholders, (iii) any action asserting
a claim arising pursuant to any provision of the Delaware General Corporation Law, our certificate of incorporation or our bylaws
or (iv) any action asserting a claim governed by the internal affairs doctrine. The choice of forum provision may limit a stockholder’s
ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, employees
or agents, which may discourage such lawsuits against us and our directors, officers, employees and agents. Stockholders who do
bring a claim in the Court of Chancery could face additional litigation costs in pursuing any such claim, particularly if they
do not reside in or near the State of Delaware. The Court of Chancery may also reach different judgments or results than would
other courts, including courts where a stockholder considering an action may be located or would otherwise choose to bring the
action, and such judgments or results may be more favorable to us than to our stockholders. Alternatively, if a court were to find
the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we
may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect our business
and financial condition. Notwithstanding the foregoing, the exclusive provision shall not preclude or contract the scope of exclusive
federal or concurrent jurisdiction for actions brought under the Exchange Act, or the Securities Act of 1933, as amended, or the
Securities Act, or the respective rules and regulations promulgated thereunder.
USE OF PROCEEDS
We will receive no
proceeds from the offering of the shares other than the value of the assets, businesses, or securities acquired by us in acquisitions
for which shares are offered under this prospectus.
DESCRIPTION OF COMMON STOCK
General
This prospectus describes
the general terms of our capital stock. For a more detailed description of our capital stock, you should read the applicable provisions
of the Delaware General Corporation Law, or DGCL, and our charter and bylaws.
Our certificate of
incorporation provides that we may issue up to 200,000,000 shares of common stock, par value $0.0001 per share, and up to 50,000,000
shares of preferred stock, par value $0.0001 per share, and permits our board of directors, without stockholder approval, to amend
the charter to increase or decrease the aggregate number of shares of stock or the number of shares of stock of any class or series
that we have authority to issue. As of June 1, 2020, there were 120,614,876 shares of our common stock outstanding and no shares
of our preferred stock outstanding. Under Delaware law, stockholders generally are not personally liable for our debts or obligations
solely as a result of their status as stockholders.
Common Stock
Holders of our common
stock generally have no preference, conversion, exchange, sinking fund, redemption or appraisal rights and have no preemptive rights
to subscribe for any of our securities. Holders of our common stock are entitled to receive dividends when authorized by our board
of directors out of assets legally available for the payment of dividends. They are also entitled to share ratably in our assets
legally available for distribution to our stockholders in the event of our liquidation, dissolution or winding up, after payment
of or adequate provision for all of our known debts and liabilities. These rights are subject to the preferential rights of any
other class or series of our stock. The outstanding shares of common stock are, and any shares offered by this prospectus will
be when issued and paid for, fully paid and nonassessable.
Each outstanding share
of common stock entitles the holder to one vote on all matters submitted to a vote of stockholders, including the election of directors.
Except as provided with respect to any other class or series of stock, the holders of our common stock will possess the exclusive
voting power. In uncontested elections, directors are elected by a majority of all of the votes cast in the election of directors,
and in contested elections, directors are elected by a plurality of all of the votes cast in the election of directors.
Transfer Agent and Registrar
The transfer agent
of our common stock is Issuer Direct Corporation. Their address is 500 Perimeter Park Drive, Suite D, Morrisville, NC 27560.
ANTI-TAKEOVER EFFECTS OF CERTAIN PROVISIONS
OF DELAWARE LAW AND OUR CERTIFICATE OF INCORPORATION AND BYLAWS
Certain provisions
of the Certificate of Incorporation and Bylaws could have an anti-takeover effect. These provisions are intended to enhance the
likelihood of continuity and stability in the composition of the Board and in the policies formulated by the Board and to discourage
an unsolicited takeover of us if the Board determines that such takeover is not in the best interests of us and our stockholders.
However, these provisions could have the effect of discouraging certain attempts to acquire us or remove incumbent management even
if some or a majority of stockholders deemed such an attempt to be in their best interests.
The provisions in the
Certificate of Incorporation and the Bylaws include: (a) a procedure which requires stockholders to nominate directors in advance
of a meeting to elect such directors; (b) the authority to issue additional shares of preferred stock without stockholder approval;
(c) the number of directors on our Board will be fixed exclusively by the Board; (d) any newly created directorship or any vacancy
in our Board resulting from any increase in the authorized number of directors or the death, disability, resignation, retirement,
disqualification, removal from office or other cause will be filled solely by the affirmative vote of a majority of the directors
then in office, even if less than a quorum; and (e) our Bylaws may be amended by our Board.
The Delaware General
Corporation Law (the “DGCL”) contains statutory “anti-takeover” provisions, including Section 203 of the
DGCL which applies automatically to a Delaware corporation unless that corporation elects to opt-out as provided in Section 203.
We, as a Delaware corporation, have not elected to opt-out of Section 203 of the DGCL. Under Section 203 of the DGCL, a stockholder
acquiring more than 15% of the outstanding voting shares of a corporation (an “Interested Stockholder”) but less than
85% of such shares may not engage in certain business combinations with the corporation for a period of three years subsequent
to the date on which the stockholder became an Interested Stockholder unless prior to such date, the board of directors of the
corporation approves either the business combination or the transaction which resulted in the stockholder becoming an Interested
Stockholder, or the business combination is approved by the board of directors and by the affirmative vote of at least 662/3% of
the outstanding voting stock that is not owned by the Interested Stockholder.
Limitation of Liability and Indemnification
of Officers and Directors
Pursuant to provisions
of the DGCL, we have adopted provisions in our Certificate of Incorporation that provide that our directors shall not be personally
liable for monetary damages to us or our stockholders for a breach of fiduciary duty as a director to the full extent that the
DGCL permits the limitation or elimination of the liability of directors.
We have in effect a
directors and officers liability insurance policy indemnifying our directors and officers and the directors and officers of our
subsidiaries within a specific limit for certain liabilities incurred by them, including liabilities under the Securities Act.
We pay the entire premium of this policy. Our Certificate of Incorporation also contains a provision for the indemnification by
us of all of our directors and officers, to the fullest extent permitted by the DGCL.
Exclusive Forum
Our Bylaws provide
that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall,
to the fullest extent permitted by law, be the sole and exclusive forum for (a) any derivative action or proceeding brought on
behalf of the Company, (b) any action asserting a claim of breach of a fiduciary duty owed by any director, officer, other employee
or stockholder of the Company to the Company or the Company’s stockholders, (c) any action asserting a claim arising pursuant
to any provision of the DGCL or as to which the DGCL confers jurisdiction on the Court of Chancery of the State of Delaware, or
(d) any action asserting a claim governed by the internal affairs doctrine. Any person or entity purchasing or otherwise acquiring
any interest in shares of our stock shall be deemed to have notice of and consented to the foregoing forum selection provisions.
PLAN OF DISTRIBUTION
This prospectus is
a part of an “acquisition shelf” registration statement on Form S-4 that we have filed with the SEC. Under the shelf
registration process, we may from time to time offer and sell shares of our common stock, par value $0.0001 per share, having a
maximum aggregate offering price of $40,000,000, in connection with the acquisition of assets, stock or businesses, whether by
purchase, merger or any other form of business combination. We are actively looking for high-quality, durable, cash flow-producing
assets potentially unrelated to our current portfolio of products in order to diversify our business and potentially monetize our
substantial net operating losses as part of our asset redeployment and diversification strategy. We intend to focus our search
primarily in the United States, although we will also evaluate international investment opportunities should we find such opportunities
attractive.
It is expected that
the terms of these acquisitions will be determined by direct negotiations with the owners or controlling persons of the assets,
businesses or securities to be acquired, and that the shares of common stock issued will be valued at prices reasonably related
to the market price of our common stock at the time an agreement is entered into concerning the terms of the acquisition, at or
about the time the shares are delivered or during some other negotiated period. Factors taken into account in acquisitions may
include, among other factors, the quality and reputation of the business to be acquired and its management, the strategic market
position of the business to be acquired and its proprietary assets, earning power, cash flow and growth potential. In addition
to shares of our common stock, consideration for these acquisitions may consist of any consideration permitted by applicable law,
including, without limitation, the payment of cash, the issuance of preferred stock, the issuance of a note or other form of indebtedness,
the assumption of liabilities or any combination of these items. All expenses of this registration, other than the expenses of
the selling stockholders, if any, will be paid by us. We do not expect to pay underwriting discounts or commissions, although we
may pay finders’ fees from time to time in connection with certain acquisitions. Any person receiving finders’ fees
may be deemed to be an “underwriter” within the meaning of the Securities Act, and any profit on the resale of securities
purchased by them may be considered underwriting commissions or discounts under the Securities Act.
In addition, we may
issue our common stock pursuant to this prospectus and applicable prospectus supplement, or post-effective amendment, to acquire
the assets, stock or business of debtors in cases under the United States Bankruptcy Code, which may constitute all or a portion
of the debtor’s assets, stock or business. The common stock we issue in these transactions may be sold by the debtor or its
stockholders for cash from time to time in market transactions or it may be transferred by the debtor in satisfaction of claims
by creditors under a plan of reorganization approved by the applicable United States Bankruptcy Court or otherwise transferred
in accordance with the Bankruptcy Code.
In an effort to maintain
an orderly market in our securities or for other reasons, we may negotiate agreements with persons receiving common stock covered
by this prospectus that will limit the number of shares that they may sell at specified intervals. These agreements may be more
or less restrictive than restrictions on sales made under exemptions from the registration requirements of the Securities Act,
including the requirements under Rule 144 or Rule 145(d), and the persons party to these agreements may not otherwise be subject
to the Securities Act requirements. We anticipate that, in general, negotiated agreements will be of limited duration and will
permit the recipients of securities issued in connection with acquisitions to sell up to a specified number of shares during a
specified period of time. We may also determine to waive any such agreements without public notice.
This prospectus may
be supplemented to furnish the information necessary for a particular negotiated transaction, and the registration statement of
which this prospectus is a part will be amended or supplemented, as required, to supply information concerning an acquisition.
We may permit individuals
or entities who will receive shares of our common stock in connection with the acquisitions described above, or their transferees
or successors-in-interest, to use this prospectus to cover the resale of such shares. See “Selling Stockholders,” as
it may be amended or supplemented from time to time, for a list of those individuals or entities that are authorized to use this
prospectus to sell their shares of our common stock.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly
and current reports, proxy statements and other information with the SEC. You may obtain such SEC filings from the SEC’s
website at http://www.sec.gov. Copies of our periodic and current reports and proxy statements, may be obtained, free of charge,
on our website at https://irdirect.net/AYTU/sec_filings. This reference to our Internet address is for informational purposes only
and the information contained on or accessible through such Internet address is not and shall not be deemed to be incorporated
by reference into this prospectus.
As permitted by SEC
rules, this prospectus does not contain all of the information we have included in the registration statement and the accompanying
exhibits and schedules we file with the SEC. You may refer to the registration statement, exhibits and schedules for more information
about us and the securities. The registration statement, exhibits and schedules are available through the SEC’s website or
at its public reference room.
INCORPORATION OF CERTAIN DOCUMENTS
BY REFERENCE
In this prospectus,
we “incorporate by reference” certain information that we file with the SEC, which means that we can disclose important
information to you by referring you to that information. The information we incorporate by reference is an important part of this
prospectus, and later information that we file with the SEC will automatically update and supersede this information. The following
documents or information have been filed by us with the SEC and are incorporated by reference into this prospectus (other than,
in each case, documents or information that are or are deemed to have been furnished rather than filed in accordance with SEC rules,
including disclosure furnished under Items 2.02 or 7.01 of Form 8-K):
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our Definitive Proxy Statement on Schedule
14A filed with the SEC on March 4, 2020;
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our Annual Report on Form
10-K for the fiscal year ended June 30, 2019 filed with the SEC on September 26, 2019;
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our Current Reports on Form 8-K filed with the SEC on August
2, 2019, September 18, 2019, October
15, 2019, October 15, 2019 (as
amended on January 10,
2020), November 4, 2019 (as amended
on November 4, 2019, as further amended
on November 7, 2019), November
12, 2019, November 26, 2019, December
2, 2019, December 11, 2019, January
15, 2020, January 24, 2020, February
13, 2020, February
14, 2020 (as amended on February
26, 2020), February
21, 2020, March, 12, 2020, March
13, 2020, March 13, 2020,
March 19, 2020, March
20, 2020, March 23, 2020, March
25, 2020, April 1, 2020, April
3, 2020, April 15, 2020, April
16, 2020, April 24, 2020 and June 1 2020; and
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the description of our Common Stock contained in our Registration Statement on Form 8-A, as filed
with the SEC on October 17, 2017,
including any amendment or report filed for the purpose of updating such description.
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All documents and reports
that we file with the SEC (other than, in each case, documents or information that are or are deemed to have been furnished rather
than filed in accordance with SEC rules) under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended,
which we refer to in this prospectus as the “Exchange Act,” from the date of this prospectus until the completion of
the offering under this prospectus shall be deemed to be incorporated by reference into this prospectus. Unless specifically stated
to the contrary, none of the information we disclose under Items 2.02 or 7.01 of any Current Report on Form 8-K that we may from
time to time furnish to the SEC will be incorporated by reference into, or otherwise included in, this prospectus. The information
contained on or accessible through any websites, including https://irdirect.net/AYTU/sec_filings, is not and shall not be deemed
to be incorporated by reference into this prospectus.
You may request a copy
of these filings, other than an exhibit to these filings unless we have specifically included or incorporated that exhibit by reference
into the filing, at no cost, by writing or telephoning us at the following address:
Aytu BioScience, Inc.
373 Inverness Parkway, Suite 206
Englewood, Colorado 80112
(720) 437-6580
Any statement contained
in a document incorporated or deemed to be incorporated by reference into this prospectus will be deemed to be modified or superseded
for purposes of this prospectus to the extent that a statement contained in this prospectus, any prospectus supplement, or any
other subsequently filed document that is deemed to be incorporated by reference into this prospectus modifies or supersedes the
statement. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to constitute a part
of this prospectus.
EXPERTS
The consolidated financial
statements of Aytu BioScience, Inc. at June 30, 2019 and 2018, and for each of the two years in the period ended June 30, 2019
have been audited by Plante & Moran, PLLC (successor to EKS&H LLLP), independent registered public accounting firm. Such
financial statements have been incorporated herein by reference in reliance on the report of such firm given upon their authority
as experts in accounting and auditing.
The abbreviated financial
statements of the Pediatrics Product Portfolio of Cerecor Inc. at September 30, 2019 and December 31, 2018, and for the nine-month
period ended September 30, 2019 and for the year ended December 31, 2018, incorporated by reference in Aytu BioScience, Inc.’s
Current Report on Form 8-K/A dated January 10, 2020 have been audited by Ernst & Young LLP, independent auditors, as set forth
in their report thereon incorporated by reference therein, and incorporated herein by reference. Such abbreviated financial statements
are incorporated herein by reference in reliance upon such report given on the authority of such firm as experts in accounting
and auditing.
The
consolidated financial statements as of December 31, 2018 and 2017 and each of the two years in the period ended December 31,
2018 of Innovus Pharmaceuticals, Inc. incorporated by reference, have been audited by Hall & Company, an independent registered
public accounting firm, as stated in their reports. Such financial statements have been included in reliance upon the reports
of such firm given upon their authority as experts in accounting and auditing.
LEGAL MATTERS
Certain legal matters
in connection with the offered securities will be passed upon for us by Dorsey & Whitney LLP, Salt Lake City, Utah. Any underwriters
or agents will be represented by their own legal counsel
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 20. Indemnification of Directors
and Officers
We are incorporated
under the laws of the State of Delaware. Section 145 of the Delaware General Corporation Law provides that a Delaware corporation
may indemnify any persons who are, or are threatened to be made, parties to any threatened, pending or completed action, suit or
proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of such corporation),
by reason of the fact that such person was an officer, director, employee or agent of such corporation, or is or was serving at
the request of such person as an officer, director, employee or agent of another corporation or enterprise. The indemnity may include
expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by
such person in connection with such action, suit or proceeding, provided that such person acted in good faith and in a manner he
reasonably believed to be in or not opposed to the corporation’s best interests and, with respect to any criminal action
or proceeding, had no reasonable cause to believe that his conduct was illegal. A Delaware corporation may indemnify any persons
who are, or are threatened to be made, a party to any threatened, pending or completed action or suit by or in the right of the
corporation by reason of the fact that such person was a director, officer, employee or agent of such corporation, or is or was
serving at the request of such corporation as a director, officer, employee or agent of another corporation or enterprise. The
indemnity may include expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection
with the defense or settlement of such action or suit provided such person acted in good faith and in a manner he or she reasonably
believed to be in or not opposed to the corporation’s best interests except that no indemnification is permitted without
judicial approval if the officer or director is adjudged to be liable to the corporation. Where an officer or director is successful
on the merits or otherwise in the defense of any action referred to above, the corporation must indemnify him against the expenses
which such officer or director has actually and reasonably incurred. Our certificate of incorporation and bylaws provide for the
indemnification of our directors and officers to the fullest extent permitted under the Delaware General Corporation Law.
Section 102(b)(7) of
the Delaware General Corporation Law permits a corporation to provide in its certificate of incorporation that a director of the
corporation shall not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary
duties as a director, except for liability for any:
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transaction from which the director derives an improper personal benefit;
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act or omission not in good faith or that involves intentional misconduct or a knowing violation of
law;
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unlawful payment of dividends or redemption of shares; or
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breach of a director’s duty of loyalty to the corporation or its stockholders.
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Our certificate of
incorporation includes such a provision. Expenses incurred by any officer or director in defending any such action, suit or proceeding
in advance of its final disposition shall be paid by us upon delivery to us of an undertaking, by or on behalf of such director
or officer, to repay all amounts so advanced if it shall ultimately be determined that such director or officer is not entitled
to be indemnified by us.
As permitted by the
Delaware General Corporation Law, we have entered into indemnity agreements with each of our directors and executive officers.
These agreements, among other things, require us to indemnify each director and officer to the fullest extent permitted by law
and advance expenses to each indemnitee in connection with any proceeding in which indemnification is available.
We have an insurance
policy covering our officers and directors with respect to certain liabilities, including liabilities arising under the Securities
Act of 1933, as amended, or the Securities Act, or otherwise.
Item 21. Exhibits and Financial Statement
Schedules
The following exhibits are included herein
or incorporated by reference:
Item 22. Undertakings
The undersigned registrant hereby undertakes:
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(a)
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to file, during any period in which offers or sales are being made, a post-effective amendment
to this registration statement:
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(1)
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to include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
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(2)
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to reflect in the prospectus any facts or events arising after the effective date of the registration
statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental
change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume
of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation
from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission
pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum
aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement;
and
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(3)
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to include any material information with respect to the plan of distribution not previously disclosed
in the registration statement or any material change to such information in the registration statement.
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(b)
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for the purpose of determining any liability under the Securities Act of 1933, each such post-effective
amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof.
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(c)
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to remove from registration by means of a post-effective amendment any of the securities being
registered which remain unsold at the termination of the offering.
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(d)
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that, for purposes of determining any liability under the Securities Act of 1933, each filing of
Aytu BioScience’s annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (and, where applicable,
each filing of any employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934)
that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to
the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering
thereof.
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(e)
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that prior to any public reoffering of the securities registered hereunder through use of a prospectus
which is a part of this registration statement, by any person or party who is deemed to be an underwriter within the meaning of
Rule 145(c), the issuer undertakes that such reoffering prospectus will contain the information called for by the applicable registration
form with respect to reofferings by persons who may be deemed underwriters, in addition to the information called for by the other
items of the applicable form.
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(f)
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that every prospectus: (i) that is filed pursuant to paragraph (1) immediately preceding, or (ii)
that purports to meet the requirements of Section 10(a)(3) of the Act and is used in connection with an offering of securities
subject to Rule 415, will be filed as part of an amendment to the registration statement and will not be used until such amendment
is effective, and that, for purposes of determining any liability under the Securities Act of 1933, each such post-effective amendment
shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
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(g)
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to respond to requests for information that is incorporated by reference into this prospectus pursuant
to Item 4, 10(b), 11 or 13 of this Form, within one business day of receipt of such request, and to send the incorporated documents
by first class mail or other equally prompt means. This includes information contained in documents filed subsequent to the effective
date of the registration statement through the date of responding to the request.
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(h)
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that each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating
to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A,
shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided,
however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in
a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration
statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that
was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately
prior to such date of first use.
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(i)
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to supply by means of a post-effective amendment all information concerning a transaction, and
the company being acquired involved therein, that was not the subject of and included in the registration statement when it became
effective.
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Insofar as indemnification for liabilities
arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant
to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission
such indemnification is against public policy as expressed in the Securities Act of 1933 and is, therefore, unenforceable. In the
event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred
or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding)
is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant
will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act of 1933
and will be governed by the final adjudication of such issue.
SIGNATURES
Pursuant to the requirements of the Securities
Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing
on Form S-4 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized,
in the city of Englewood, Colorado on June 8, 2020.
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AYTU BIOSCIENCE, INC.
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/s/ Joshua R. Disbrow
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Name: Joshua R. Disbrow
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Title: Chairman and Chief Executive Officer
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KNOW ALL BY THESE PRESENTS, that each person
whose signature appears below constitutes and appoints Joshua R. Disbrow and David A. Green as his true and lawful attorneys-in-fact
and agents, each with the full power of substitution, for him and in his name, place or stead, in any and all capacities, to sign
any and all amendments to this registration statement (including post-effective amendments), and to file the same, with exhibits
thereto and other documents in connection therewith, with the SEC, granting unto said attorneys-in-fact and agents, and each of
them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the
premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said
attorneys-in-fact and agents, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities
Act of 1933, this registration statement has been signed by the following persons in the capacities indicated and on the dates
indicated.
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Signature
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Capacity in Which Signed
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Date
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/s/ Joshua R. Disbrow
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Chairman and Chief Executive Officer
(Principal Executive Officer)
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June 8, 2020
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Joshua R. Disbrow
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/s/ David A. Green
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Chief Financial Officer
(Principal Financial and Accounting
Officer)
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June 8, 2020
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David A. Green
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/s/ Steven J. Boyd
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Director
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June 8, 2020
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Steven J. Boyd
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/s/ Gary V. Cantrell
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Director
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June 8, 2020
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Gary V. Cantrell
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/s/ Carl C. Dockery
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Director
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June 8, 2020
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Carl C. Dockery
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/s/ John A. Donofrio, Jr.
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Director
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June 8, 2020
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John A. Donofrio, Jr.
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/s/ Michael E. Macaluso
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Director
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June 8, 2020
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Michael E. Macaluso
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/s/ Ketan B. Mehta
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Director
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June 8, 2020
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Ketan B. Mehta
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II-4
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