Filed
Pursuant to Rule 424(b)(5)
Registration
No. 333-199392
PROSPECTUS
SUPPLEMENT
(To
Prospectus dated October 28, 2014)
MYOS
RENS TECHNOLOGY INC.
500,000
Shares of Common Stock
We
are offering up to 500,000 shares of our common stock. The shares are being issued and sold pursuant to a Securities Purchase
Agreement, dated February 3, 2017, between us and the institutional investors identified therein.
Our common stock is listed
on the Nasdaq Capital Market under the symbol “MYOS.” On February 3, 2017, the last reported sale price for our common
stock on the Nasdaq Capital Market was $3.65 per share. As of the date hereof, we have not sold any securities pursuant to General
Instruction I.B.6. of Form S-3 during the twelve calendar months prior to the date of this prospectus supplement. The aggregate
market value of our common stock held by non-affiliates was $21,203,270, based on 5,340,604 shares of common stock outstanding,
of which 3,108,984 are held by non-affiliates, and a closing sale price on the Nasdaq Capital Market of $6.82 on January 11, 2017.
As a result, we are currently eligible to offer and sell up to an aggregate of $7,067,756 of our securities pursuant to General
Instruction I.B.6 of Form S-3.
Investing
in our securities involves a high degree of risk. Before deciding whether to invest in our securities, you should review carefully
the risks and uncertainties described under the heading “Risk Factors” on page S-4 of this prospectus supplement
and page 16 of the accompanying prospectus and in the other documents that are incorporated by reference into this prospectus
supplement.
Chardan
Capital Markets, LLC, or Chardan, has agreed to act as our placement agent in this offering. The placement agent is not purchasing
any of the securities offered by us, and is not required to sell any specific number or dollar amount of securities, but will
use its best efforts to sell the securities offered. We have agreed to pay the placement agent a placement fee equal to 7.0% of
the aggregate gross proceeds of this offering. See “Plan of Distribution” beginning on page S-9 of this prospectus
supplement for more information on this offering and the placement agent arrangements.
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Per Share
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Total
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Public offering price
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$
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4.25
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$
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2,125,000
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Placement agent’s fees(1)
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$
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0.2975
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$
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148,750
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Proceeds, before expenses, to us
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$
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3.9525
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$
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1,976,250
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(1)
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See
“Plan of Distribution” for additional disclosure regarding placement agent
fees and estimated offering expenses.
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Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
determined if this prospectus supplement or the accompanying prospectus is truthful or complete. Any representation to the contrary
is a criminal offense.
Chardan
The
date of this prospectus supplement is February 3, 2017
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS SUPPLEMENT
On
October 16, 2014, we filed with the Securities and Exchange Commission, or the SEC, a registration statement on Form S-3 (File
No. 333-199392) utilizing a shelf registration process relating to the securities described in this prospectus supplement, which
registration statement was declared effective on October 28, 2014. Under this shelf registration process, we may, from time to
time, sell up to $75 million in the aggregate of common stock, preferred stock, debt securities, warrants and rights to purchase
securities and units, of which approximately $2.125 million will be sold in this offering.
This
document is in two parts. The first part is this prospectus supplement, which describes the specific terms of this offering and
also adds to, updates or changes information contained in the accompanying prospectus and the documents incorporated by reference
into the prospectus. The second part, the accompanying prospectus, gives more general information, some of which does not apply
to this offering. You should read this entire prospectus supplement as well as the accompanying prospectus and the documents incorporated
by reference that are described under “Where You Can Find More Information” in this prospectus supplement and the
accompanying prospectus.
If
information in this prospectus supplement is inconsistent with the accompanying prospectus, you should rely on this prospectus
supplement. Any statement contained in a document incorporated by reference, or deemed to be incorporated by reference, into this
prospectus supplement or the accompanying prospectus will be deemed to be modified or superseded for purposes of this prospectus
supplement or the accompanying prospectus to the extent that a statement contained herein, therein or in any other subsequently
filed document which also is incorporated by reference in this prospectus supplement or the accompanying prospectus modifies or
supersedes that statement. Any such statement so modified or superseded will not be deemed, except as so modified or superseded,
to constitute a part of this prospectus supplement or the accompanying prospectus.
We
further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any
document that is incorporated by reference in this prospectus supplement and the accompanying prospectus were made solely for
the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties to
such agreements, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations,
warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants
should not be relied on as accurately representing the current state of our affairs.
Unless
otherwise stated, all references to “us,” “our,” “MYOS,” “we,” the “Company”
and similar designations refer to MYOS RENS Technology Inc. Our logo, trademarks and service marks are the property of MYOS RENS
Technology Inc. Other trademarks or service marks appearing in this prospectus are the property of their respective holders.
PROSPECTUS
SUPPLEMENT SUMMARY
The
following summary highlights some of the information contained elsewhere in this prospectus supplement or the accompanying prospectus
or incorporated by reference herein or therein. Because this is only a summary, however, it does not contain all of the information
that may be important to you. You should carefully read this prospectus supplement and the accompanying prospectus, including
the documents incorporated by reference, which are described under “Information Incorporated by Reference” in this
prospectus supplement and under “Information Incorporated by Reference” and “Where You Can Find More Information”
in the accompanying prospectus. You also should carefully consider the matters discussed in the section entitled “Risk Factors”
in the accompanying prospectus and in other periodic reports incorporated herein by reference.
As
used herein, the “Company”, “MYOS”, “our”, or “we” refers to MYOS RENS Technology
Inc. and its wholly-owned subsidiary, unless the context indicates otherwise.
Our
Company
Overview
We
are an emerging bionutrition and biotherapeutics company focused on the discovery, development and commercialization of products
that improve muscle health and function essential to the management of sarcopenia, cachexia and degenerative muscle diseases,
and as an adjunct to the treatment of obesity.
Since
February 2011, we have been focusing on the discovery, development, and commercialization of nutritional supplements, functional
foods, therapeutic products, and other technologies aimed at maintaining or improving the health and performance of muscle tissue.
Our principal business activities have been to: (i) deepen our scientific understanding of the activity of Fortetropin, which
refers to a proprietary proteo-lipid composite derived from fertilized eggs of specific chicken species processed using a patented
methodology which preserves the bioactivity of the constituent proteins and lipids, specifically as a natural, reversible, temporary
reducing agent of myostatin, and to leverage this knowledge to strengthen and build our intellectual property; (ii) conduct research
and development activities to evaluate myostatin modulation in a range of both wellness and disease states; (iii) identify other
products and technologies which may broaden our portfolio and define a business development strategy to protect, enhance and accelerate
the growth of our products; (iv) reduce the cost of manufacturing through process improvement; (v) identify contract manufacturing
resources that can fully meet our future growth requirements; (vi) develop a differentiated and advantaged consumer positioning,
brand name and iconography; and, (vii) create sales and marketing capabilities to maximize near-term and future revenues. We believe
that existing wellness and therapeutic targets, such as myostatin, represent a rational entry point for additional drug discovery
efforts and are evaluating a separate, concurrent objective in this area.
We
are developing nutritional and therapeutic products aimed at maintaining and improving the health and performance of muscle tissue.
One current target of research which we are actively evaluating is the modulation of myostatin. Our research is focused on developing
strategies and therapeutic interventions to address muscle related conditions including sarcopenia, cachexia, and inherited and
acquired muscle diseases.
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Sarcopenia
is a degenerative process characterized by the progressive loss of muscle mass
with advancing age. The loss of muscle affects all individuals regardless of ethnicity
or gender although the rate and degree of muscle loss varies between individuals and
is affected by many factors. Those individuals who have lost significant amounts of muscle
mass and strength often require assistance for accomplishing daily living activities,
which has a significant economic burden on a nation’s healthcare system and impacts
the overall economy. In addition to the many direct costs, sarcopenia adversely affects
the overall quality of life.
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Cachexia
is a syndrome that occurs in many diseases such as cancer, chronic heart failure,
chronic kidney failure and AIDS. It is characterized by a loss of body weight as a consequence
of pathological changes in different metabolic pathways, with the loss of muscle mass
as the core component of the syndrome. Cachexia leads to a poor quality of life and increased
mortality. As skeletal muscle is diminished, individuals experience a reduced ability
to move, a loss of strength, and an increase in conditions associated with immobility
such as thrombosis, pneumonia, respiratory failure and ultimately death. Weight loss
is an important prognosticator in cancer therapy with the greater the weight loss the
shorter the survival time. Weight loss in cancer patients due to cachexia arises from
the loss of both adipose tissue and skeletal muscle.
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Inherited
and acquired muscle diseases
, such as muscular dystrophy and muscle dysfunction
that occur as a consequence of denervation such as seen in amyotrophic lateral sclerosis
(ALS), are conditions marked by the progressive deterioration of muscle tissue that results
in weakness and impairs normal function. These diseases are typified by difficulty with
walking, balance, and coordination with many such diseases affecting speech, swallowing,
and breathing. There are currently no cures for degenerative muscle diseases outside
of palliative care.
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Corporate
Information
Our
executive offices are currently located at 45 Horsehill Road, Suite 106, Cedar Knolls, New Jersey 07927 and our telephone number
is (973) 509-0444. Our website address is http://www.myosrens.com. Our website and the information contained on our website are
not incorporated by reference into this prospectus supplement, the accompanying prospectus or the registration statement of which
it forms a part.
THE
OFFERING
Common
stock offered by us
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500,000
shares
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Offering
price
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$4.25
per share
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Common
stock outstanding immediately prior to this offering
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5,340,604
shares
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Common
stock to be outstanding after this offering
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5,840,604
shares
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Use
of proceeds
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We
intend to use the net proceeds from this offering for general corporate purposes, including working capital, marketing, research
and development and other general corporate purposes. See “Use of Proceeds.”
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Nasdaq
Capital Market symbol
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“MYOS”
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Risk
factors
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This
investment involves a high degree of risk. See the information set forth in “Risk Factors” beginning on page S-4
of this prospectus supplement and page 16 in the accompanying prospectus and the documents incorporated by reference into
this prospectus supplement and the accompanying prospectus.
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The
number of shares of common stock outstanding immediately before and after this offering excludes the following:
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301,090
shares of common stock issuable upon exercise of outstanding stock options with a weighted average exercise price of
$15.09 per share;
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821,202
shares of common stock issuable upon exercise of outstanding warrants with a weighted average exercise price of $15.02 per
share; and
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548,910
additional shares of common stock reserved for future issuance under our equity incentive plan.
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RISK
FACTORS
An
investment in our shares of common stock involves a high degree of risk. Before making an investment decision, you should carefully
consider the risks described below and discussed in the section titled “Risk Factors” in our most recent Annual Report
on Form 10-K, as well as the risks, uncertainties and additional information set forth in the documents incorporated by reference
in this prospectus supplement. The risks described in such documents are not intended to be an all-inclusive list of the potential
risks relating to an investment in our securities. Any of such risk factors could significantly and adversely affect our business,
prospects, financial condition and results of operations. Additional risks and uncertainties not currently known or that are currently
considered to be immaterial may also materially and adversely affect our business. As a result, the trading price or value of
our securities could be materially adversely affected and you may lose all or part of your investment.
Risks
Related to This Offering
Management
will have broad discretion as to the use of the proceeds from this offering and may not use the proceeds effectively.
Because
we have not designated the amount of net proceeds from this offering to be used for any particular purpose, our management will
have broad discretion as to the application of the net proceeds from this offering, as described below in “Use of Proceeds,”
and could use them for purposes other than those contemplated at the time of the offering. Our management may use the net proceeds
for corporate purposes that may not improve our financial condition or market value of our common stock.
If
you purchase our shares in this offering, you will incur immediate and substantial dilution in the net tangible book value of
your shares.
The
public offering price for shares in this offering is substantially higher than the net tangible book value per share of our common
stock. Investors purchasing shares in this offering will pay a price per share that substantially exceeds the book value of our
tangible assets after subtracting our liabilities. As a result, investors purchasing shares in this offering will incur immediate
dilution of $2.83 per share, based on a public offering price of $4.25 per share. See “Dilution.”
This
dilution is due to our history of losses and the fact that some of our investors who purchased shares directly from us prior to
this offering paid substantially less than the price offered to the public in this offering when they purchased their shares.
In addition, as of the date of this prospectus supplement, we had options and warrants outstanding which allow the holders to
purchase up to 1,122,292 shares of our common stock at a weighted average exercise price of $13.98 per share. As a result of the
dilution to investors purchasing shares in this offering, investors may receive significantly less than the purchase price paid
in this offering, if anything, in the event of a liquidation of our company.
You
may experience future dilution as a result of future equity offerings.
In
order to raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible
into or exchangeable for our common stock at prices that may not be the same as the price per share in this offering. We may sell
shares or other securities in any other offering at a price per share that is less than the price per share paid by investors
in this offering, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders.
The price per share at which we sell additional shares of our common stock, or securities convertible or exchangeable into common
stock, in future transactions may be higher or lower than the price per share paid by investors in this offering.
Fluctuations
in the price of our common stock, including as a result of actual or anticipated sales of shares by stockholders, may make our
common stock more difficult to resell.
The
market price and trading volume of our common stock have been and may continue to be subject to significant fluctuations due not
only to general stock market conditions, but also to a change in sentiment in the market regarding the industry in which we operate,
our operations, business prospects or liquidity or this offering. During the period from March 1, 2015 to February 3, 2017, our
common stock has fluctuated from a high of $7.50 per share to a low of $1.02 per share. In addition to the risk factors discussed
in our periodic reports and in this prospectus supplement and in the accompanying prospectus, the price and volume volatility
of our common stock may be affected by actual or anticipated sales of common stock by existing stockholders, including of shares
purchased in this offering, whether in the market or in subsequent public offerings. Stock markets in general may experience extreme
volatility that is unrelated to the operating performance of listed companies. These broad market fluctuations may adversely affect
the trading price of our common stock, regardless of our operating results.
As
a result, these fluctuations in the market price and trading volume of our common stock may make it difficult to predict the market
price of our common stock in the future, cause the value of your investment to decline and make it more difficult to resell our
common stock.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus supplement, the accompanying prospectus and the documents we have filed or will file with the SEC that are or will
be incorporated by reference into this prospectus supplement contain forward-looking statements, within the meaning of Section
27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934,
as amended, or the Exchange Act, that involve risks and uncertainties. Any statements contained, or incorporated by reference,
in this prospectus supplement that are not statements of historical fact may be forward-looking statements. When we use the words
“anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “predict,” “project,” “will” and other similar terms
and phrases, including references to assumptions, we are identifying forward-looking statements. Forward-looking statements involve
risks and uncertainties which may cause our actual results, performance or achievements to be materially different from those
expressed or implied by forward-looking statements.
A
variety of factors, some of which are outside our control, may cause our operating results to fluctuate significantly. They include:
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our
ability to market and generate sales of our products;
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our
ability to adequately protect our intellectual property;
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our
ability to develop and introduce new products, including our planned branded products,
and secure new and or retain existing distributor relationships;
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projected
future sales, profitability and other financial metrics;
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our
ability to attract and retain key members of our management team;
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our
reliance on third-party processors;
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shortages
in the supply of, or increases in the prices of, raw materials or shelf life limits on
ingredients or finished product;
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our
ability to conduct research and development activities and the success of such activities;
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our
ability to obtain governmental approvals and comply with governmental regulations;
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future
financing plans;
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anticipated
needs for working capital;
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anticipated
trends in our industry; and
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competition
existing today or that will likely arise in the future.
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The
foregoing risks do not represent an exhaustive list of risks that may impact upon the forward-looking statements used herein or
in the documents incorporated by reference herein. Please see “Risk Factors” in our reports filed with the SEC, the
accompanying prospectus, or in this prospectus supplement for additional risks which could adversely impact our business and financial
performance.
Moreover,
new risks regularly emerge and it is not possible for our management to predict all risks, nor can we assess the impact of all
risks on our business or the extent to which any risk, or combination of risks, may cause actual results to differ from those
contained in any forward-looking statements. All forward-looking statements included in this prospectus supplement are based on
information available to us on the date hereof or thereof. Except to the extent required by applicable laws or rules, we undertake
no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events
or otherwise. All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf are
expressly qualified in their entirety by the cautionary statements contained throughout (or incorporated by reference in) this
prospectus supplement, any accompanying prospectus and the documents we have filed with the SEC.
USE
OF PROCEEDS
We
estimate the net proceeds to us from the sale of the securities offered under this prospectus, after deducting estimated placement
agent fees and our other estimated offering expenses, will be approximately $1.9 million.
We
expect to use the net proceeds from this offering for general corporate purposes including We intend to use the net proceeds from
this offering for general corporate purposes, including working capital, marketing, research and development and other general
corporate purposes. Our management will have significant flexibility in applying the net proceeds of this offering.
DILUTION
If you purchase shares of our common
stock in this offering, you will experience dilution to the extent of the difference between the price per share you pay in this
offering and the net tangible book value per share of our common stock immediately after this offering. Our net tangible book
value as of September 30, 2016 was approximately $5,321,000, or approximately $1.05 per share. Net tangible book value per share
represents our total tangible assets less total tangible liabilities, divided by the number of shares of common stock outstanding
as of September 30, 2016.
After giving effect to the assumed sale
by us of 500,000 shares of our common stock in this offering at an offering price of $4.25 per share, and after deducting the
estimated fees and commissions and estimated offering expenses payable by us, our as adjusted net tangible book value as of September
30, 2016 would have been approximately $7,297,250 or approximately $1.42 per share of common stock. This represents an immediate
increase in net tangible book value of approximately $0.37 per share to existing shareholders and an immediate dilution of approximately
$2.83 per share to new investors. The following table illustrates this per share dilution:
Assumed public offering price per share
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$
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4.25
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Net tangible book value per share as of September 30, 2016
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$
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1.05
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Increase in net tangible book value per share attributable to new investors
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$
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0.37
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As adjusted net tangible book value per share as of September 30, 2016, after giving effect to this offering
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$
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1.42
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Dilution per share to new investors in the offering
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$
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2.83
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The
above discussion and table are based on 5,086,055 shares of our common stock outstanding as of September 30, 2016 and exclude
the following, as of that date:
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301,090
shares of common stock issuable upon exercise of outstanding stock options with a weighted average exercise price of
$15.09 per share;
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1,136,878
shares of common stock issuable upon exercise of outstanding warrants with a weighted average exercise price of $15.01 per
share;
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225,864
shares of common stock issued upon the conversion of a promissory note in the amount of $575,000 in December 2016;
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26,685
shares of common stock issued to our directors in December 2016 under our equity incentive plan; and
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548,910
additional shares of common stock reserved for future issuance under our equity incentive plan.
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PLAN
OF DISTRIBUTION
We
are offering up to 500,000 shares of our common stock. Pursuant to an engagement letter agreement dated as of February 3, 2017,
we have engaged Chardan as our placement agent for this offering. Chardan is not purchasing or selling any shares, nor are they
required to arrange for the purchase and sale of any specific number or dollar amount of shares, other than to use their “best
efforts” to arrange for the sale of shares by us. Subject to the terms and conditions of the engagement letter agreement,
the placement agent is using its best efforts to introduce us to selected institutional or accredited investors who will purchase
the shares. Therefore, we may not sell the entire amount of shares being offered.
We
have agreed to pay the placement agent a placement fee equal to 7.0% of the aggregate gross proceeds of this offering. The placement
agent shall also be entitled to three and one-half percent (3.5%) of the gross proceeds to us, with respect to any investors introduced
by the placement agent to us that invest in this offering and any subsequent capital-raising transaction for a 12 month period
following the termination of the engagement letter agreement.
The
placement agent may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act and any commissions
received by it and any profit realized on the sale of the securities by it while acting as principal might be deemed to be underwriting
discounts or commissions under the Securities Act. The placement agent will be required to comply with the requirements of the
Securities Act and the Securities Exchange Act of 1934, as amended, or the Exchange Act, including, without limitation, Rule 10b-5
and Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases and sales of shares of
common stock by the placement agent. Under these rules and regulations, the placement agent may not (i) engage in any stabilization
activity in connection with our securities; and (ii) bid for or purchase any of our securities or attempt to induce any person
to purchase any of our securities, other than as permitted under the Exchange Act, until they have completed their participation
in the distribution.
The
engagement letter agreement provides that we will indemnify the placement agent against specified liabilities, including liabilities
under the Securities Act. We have been advised that, in the opinion of the SEC, indemnification for liabilities under the Securities
Act is against public policy as expressed in the Securities Act and is therefore unenforceable.
We
intend to offer and sell the shares offered hereby to institutional investors in certain states. However, we will not make any
offer of shares in any jurisdiction where the offer is not permitted or exempted.
Electronic
Offer, Sale and Distribution of Shares
A
prospectus in electronic format may be made available on the websites maintained by the placement agent or selling group members,
if any, participating in this offering and the placement agent participating in this offering may distribute the prospectus electronically.
The representatives may agree to allocate a number of shares to placement agent and selling group members for sale to their online
brokerage account holders. Internet distributions will be allocated by the placement agent and selling group members that will
make internet distributions on the same basis as other allocations. Other than the prospectus in electronic format, the information
on these websites is not part of this prospectus or the registration statement of which this prospectus forms a part, has not
been approved or endorsed by us or the placement agent in its capacity as placement agent, and should not be relied upon by investors.
Corporate Information
The
transfer agent for our common stock is Island Stock Transfer, 1550 Roosevelt Blvd., Suite 301, Clearwater, Florida 33760.
Our
common stock is traded on The NASDAQ Capital Market under the symbol “MYOS.”
EXPERTS
Our
consolidated balance sheet for the fiscal years ended December 31, 2015 and December 31, 2014, and the related consolidated statements
of operations, changes in stockholders’ equity and cash flows, incorporated by reference herein, have been so incorporated
in reliance on the report of EisnerAmper LLP, an independent registered public accounting firm, given on the authority of such
firm as experts in accounting and auditing.
LEGAL
MATTERS
Ellenoff
Grossman & Schole LLP has passed upon the validity of the securities offered by this prospectus supplement.
INFORMATION
INCORPORATED BY REFERENCE
This
prospectus supplement is part of a registration statement on Form S-3. The SEC allows this filing to "incorporate by reference"
information that we previously have filed with the SEC. This means we can disclose important information to you by referring you
to other documents that we have filed with the SEC. The information that is incorporated by reference is considered part of this
prospectus supplement, and information that we file later will automatically update and may supersede this information. For further
information about our company and the securities being offered, you should refer to the registration statement and the following
documents that are incorporated by reference:
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Our
Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed with the SEC on March 30, 2016;
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Our
Quarterly Reports on Form 10-Q for the quarter ended September 30, 2016, filed with the SEC on November 14, 2016, for the
quarter ended June 30, 2016, filed with the SEC on August 12, 2016, and for the quarter ended March 31, 2016, filed with the
SEC on May 13, 2016, respectively;
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Our
Current Reports on Form 8-K filed with the SEC on February 4, 2016, March 8, 2016, March 22, 2016, May 20, 2016, June 29,
2016, August 8, 2016, August 24, 2016, August 31, 2016, November 25, 2016, December 22, 2016, January 11, 2017, January 23,
2017 and February 7, 2017;
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Our
Definitive Proxy Statement on Schedule 14A filed with the SEC on November 22, 2016;
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All
other reports filed by us pursuant to Section 13(a) or 15(d) of the Exchange Act since the end of the fiscal year covered
by the annual report referred to above; and
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The
description of our common stock contained in our registration statement on Form 8-A filed with the SEC on July 9, 2014, including
any amendments or reports filed for the purpose of updating such description.
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All
documents filed by us subsequent to those listed above with the SEC pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange
Act following the date of filing of the registration statement of which this prospectus supplement is a part and prior to the
termination of the offering, shall be deemed to be incorporated by reference into this prospectus supplement and to be a part
hereof from the date of filing of such documents. The information relating to our company contained in this prospectus supplement
does not purport to be comprehensive and should be read together with the information contained in the incorporated documents.
Any statement contained in a document incorporated by reference herein shall be deemed to be modified or superseded for purposes
of this prospectus supplement to the extent that a statement contained herein or in any other subsequently filed document which
also is or is deemed to be incorporated by reference herein modifies or supersedes such statement. Any statement so modified or
superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus supplement.
You
may request a copy of all documents that are incorporated by reference in this prospectus supplement by writing or telephoning
us at the following address and number: MOYS RENS Technology Inc., 45 Horsehill Road, Suite 106 Cedar Knolls, New Jersey, (973)
509-0444. We will provide copies of all documents requested (not including exhibits to those documents, unless the exhibits are
specifically incorporated by reference into those documents or this prospectus supplement) without charge.
You
should rely only on the information provided in and incorporated by reference into this prospectus supplement or the accompanying
prospectus. We have not authorized anyone else to provide you with different information. You should not assume that the information
in this prospectus supplement or the accompanying prospectus is accurate as of any date other than the date on the front cover
of these documents.
Prospectus
MYOS
CORPORATION
$75,000,000
COMMON
STOCK
PREFERRED
STOCK
DEBT
SECURITIES
WARRANTS
RIGHTS
UNITS
We
may offer and sell from time to time, in one or more series, any one of the following securities of our company, for total gross
proceeds of up to $75,000,000:
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stock;
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preferred
stock;
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debt
securities (which may be senior or subordinated, convertible or non-convertible, secured or unsecured);
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purchase
contracts;
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warrants
to purchase our securities;
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subscription
rights to purchase any of the foregoing securities; and
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units
comprised of the foregoing securities.
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We
may offer and sell these securities separately or together, in one or more series or classes and in amounts, at prices and on
terms described in one or more offerings. When we decide to sell a particular class or series of those securities, we will provide
specific terms of the securities, including the initial offering price and the aggregate amount of the offering, in one or more
supplements to this prospectus.
We
may offer securities through underwriting syndicates managed or co-managed by one or more underwriters or dealers, through agents
or directly to purchasers. The prospectus supplement for each offering of securities will describe in detail the plan of distribution
for that offering. For general information about the distribution of securities offered, please see “Plan of Distribution”
in this prospectus.
Our
common stock is traded on the Nasdaq Capital Market under the symbol “MYOS.” The last reported sale price of our common
stock on the Nasdaq Capital Market on October 13, 2014 was $11.25 per share.
The
aggregate market value of the outstanding shares of our common stock held by non-affiliates was $40,398,595, based on 2,909,435
shares of common stock outstanding, of which 2,571,521 are held by non-affiliates, and a closing sale price on the Nasdaq Capital
Market of $15.71 on September 18, 2014. Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell securities
in a public primary offering with a value exceeding more than one-third of our “public float” (the market value of
our common stock held by our non-affiliates) in any 12-month period so long as our public float remains below $75,000,000. We
have not sold any securities pursuant to General Instruction I.B.6. of Form S-3 during the twelve calendar months prior to and
including the date of this prospectus.
Investing
in our securities involves certain risks. You should carefully read and consider the section entitled “Risk Factors”
on page 16 and the risk factors included in our periodic reports filed with the Securities and Exchange Commission and, if any,
in the relevant prospectus supplement. We urge you to carefully read this prospectus and the applicable prospectus supplement,
together with the documents we incorporate by reference, before making your investment decision.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The
date of this prospectus is October 28, 2014.
Table
of Contents
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission, or SEC,
utilizing a “shelf” registration process. Under this shelf registration process, we may offer and sell, either individually
or in combination, in one or more offerings, any of the securities described in this prospectus, for total gross proceeds of up
to $75,000,000. This prospectus provides you with a general description of the securities we may offer. Each time we offer securities
under this prospectus, we will provide a prospectus supplement to this prospectus that will contain more specific information
about the terms of that offering. We may also authorize one or more free writing prospectuses to be provided to you that may contain
material information relating to these offerings. The prospectus supplement and any related free writing prospectus that we may
authorize to be provided to you may also add, update or change any of the information contained in this prospectus or in the documents
that we have incorporated by reference into this prospectus. In this prospectus, unless the context indicates otherwise, the terms
“Company,” “we,” “us,” and “our” refer to MYOS Corporation, a Nevada corporation,
and its subsidiaries.
We
urge you to read carefully this prospectus, any applicable prospectus supplement and any free writing prospectuses we have authorized
for use in connection with a specific offering, together with the information incorporated herein by reference as described under
the heading “Incorporation of Certain Information by Reference,” before investing in any of the securities being offered.
You should rely only on the information contained in, or incorporated by reference into, this prospectus and any applicable prospectus
supplement, along with the information contained in any free writing prospectuses we have authorized for use in connection with
a specific offering. We have not authorized anyone to provide you with different or additional information. This prospectus is
an offer to sell only the securities offered hereby, and only under circumstances and in jurisdictions where it is lawful to do
so.
The
information appearing in this prospectus, any applicable prospectus supplement or any related free writing prospectus is accurate
only as of the date on the front of the document and any information we have incorporated by reference is accurate only as of
the date of the document incorporated by reference, regardless of the time of delivery of this prospectus, any applicable prospectus
supplement or any related free writing prospectus, or any sale of a security.
This
prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made
to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents.
Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits
to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below
under the section entitled “Where You Can Find More Information.”
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and any accompanying prospectus supplement and the documents incorporated by reference herein or therein include forward-looking
statements within the meaning of Section 27A of the Securities Act and Section 21B of the Securities Exchange Act of 1934, as
amended, or the Exchange Act. All statements other than statements of historical fact contained or incorporated by reference in
this prospectus are forward-looking statements. The words “believe,” “may,” “will,” “estimate,”
“continue,” “anticipate,” “intend,” “expect” and similar expressions, as they
relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements on our current
expectations and projections about future events and financial trends that we believe may affect our financial condition, results
of operations, business strategy, business prospectus, growth strategy and liquidity. These forward-looking statements are subject
to a number of known and unknown risks, uncertainties and assumptions and our actual results could differ materially from those
anticipated in forward-looking statements for many reasons, including the factors described in the sections entitled “Risk
Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in
our most recent Annual Report on Form 10-K and in our subsequent Quarterly Reports on Form 10-Q filed with the SEC.
The
forward-looking statements speak as of the date made and are not guarantees of future performance. Actual results or developments
may differ materially from the expectations expressed or implied in the forward-looking statements, and we undertake no obligation
to update any such statements unless required by law. You should not place undue reliance on these forward-looking statements.
You
should carefully read the factors described in the “Risk Factors” section of any prospectus supplement or other offering
material, as well as any risks described in the documents incorporated by reference into this prospectus for a description of
certain risks that could, among other things, cause our actual results to differ from these forward-looking statements. You should
understand that it is not possible to predict or identify all such factors and that this list should not be considered a complete
statement of all potential risks and uncertainties. You should also realize that if the assumptions we have made prove inaccurate
or if unknown risks or uncertainties materialize, actual results could vary materially from the views and estimates included or
incorporated by reference in this prospectus.
BUSINESS
Overview
We
are an emerging bionutrition and biotherapeutics company focused on the discovery, development and commercialization of products
that improve muscle health and function essential to the management of sarcopenia, cachexia and degenerative muscle diseases,
and as an adjunct to the treatment of obesity. As used in this report, the “Company”, “MYOS”, “our”,
or “we” refer to MYOS Corporation, its predecessor, Atlas Therapeutics Corporation, and its wholly-owned subsidiary,
unless the context indicates otherwise.
We
were incorporated under the laws of the State of Nevada on April 11, 2007. Prior to February 2011, we did not have any operations
and did not generate revenues. On February 25, 2011, we and Peak Wellness, Inc., or Peak, entered into an intellectual property
purchase agreement pursuant to which our subsidiary purchased from Peak the intellectual property pertaining to MYO-T12
TM
,
a dietary supplement that has been shown in clinical studies to temporarily decrease the levels of serum myostatin, including
the formula, certain trademarks, trade secrets, patent applications and certain domain names. In exchange for the assets, we paid
Peak $1,150,000 (of which $450,000 was paid in cash and $700,000 via the issuance of a promissory note) and issued 7,024,000 shares
of common stock to Peak. On February 22, 2012, we paid the promissory note in full from the proceeds of a private placement that
closed in February 2012.
Since
acquiring the assets from Peak, our principal business activities have been to: (i) deepen our scientific understanding of the
activity of Fortetropin™, the active ingredient in MYO-T12, which refers to a proprietary proteo-lipid composite derived
from fertilized eggs of specific chicken species processed using a patented methodology which preserves the bioactivity of the
constituent proteins and lipids, specifically as a natural, reversible, temporary modulator of the regulatory peptide myostatin,
and to leverage this knowledge to strengthen and build our intellectual property; (ii) conduct research and development activities
to evaluate myostatin modulation in a range of both wellness and disease states; (iii) identify other products and technologies
which may broaden our portfolio and define a business development strategy to protect, enhance and accelerate the growth of our
products; (iv) reduce the cost of manufacturing through process improvement; (v) identify contract manufacturing resources that
can fully meet our future growth requirements; (vi) develop a differentiated and advantaged consumer positioning, brand name and
iconography; and, (vii) create a sales and marketing capability through alliances to maximize near-term and future revenues. We
believe that existing wellness and therapeutic targets, such as myostatin, represent a rational entry point for additional drug
discovery efforts and are evaluating a separate, concurrent objective in this area.
General
Following
the acquisition of MYO-T12 on February 25, 2011, we have been focusing on the discovery, development, and commercialization of
nutritional supplements, functional foods, therapeutic products, and other technologies aimed at improving the health and performance
of muscle tissue. We currently have two marketed products: MYO-T12, a clinically proven myostatin inhibitor, which is distributed
by Maximum Human Performance, or MHP, principally in the United States under the brand name MYO-X
®
to specialty
retail and other outlets; and, Cenegenics Muscle Formula, a private-label product distributed by Cenegenics Product and Lab Services,
LLC, or Cenegenics, within their age management network. Our directors and members of our Scientific Advisory Board, including
Dr. Robert Hariri, Dr. Craig Venter, Dr. Louis Aronne, Dr. Sol Barer, Dr. Caroline Apovian and Dr. Robert Ashton have significant
research and development experience. While Fortetropin is our first proprietary ingredient technology, we plan to discover, develop,
formulate and/or acquire additional products in the future.
We are developing
nutritional and therapeutic products aimed at maintaining and improving the health and performance of muscle tissue. One current
target of research which we are actively evaluating is the inhibition of myostatin. Our research is focused on developing strategies
and therapeutic interventions to address muscle related conditions including sarcopenia, cachexia, and inherited and acquired
muscle diseases as described in more detail below.
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Sarcopenia
is a degenerative process characterized by the progressive loss of muscle mass
with advancing age. The loss of muscle affects all individuals regardless of ethnicity
or gender although the rate and degree of muscle loss varies between individuals and
is affected by many factors. Those individuals who have lost significant amounts of muscle
mass and strength often require assistance for accomplishing daily living activities,
which has a significant economic burden on a nation’s healthcare system and impacts
the overall economy. In addition to the many direct costs, sarcopenia adversely affects
the overall quality of life.
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Cachexia
is a syndrome that occurs in many diseases such as cancer, chronic heart failure,
chronic kidney failure and AIDS. It is characterized by a loss of body weight as a consequence
of pathological changes in different metabolic pathways, with the loss of muscle mass
as the core component of the syndrome. Cachexia leads to a poor quality of life and increased
mortality. As skeletal muscle is diminished, individuals experience a reduced ability
to move, a loss of strength, and an increase in conditions associated with immobility
such as thrombosis, pneumonia, respiratory failure and ultimately death. Weight loss
is an important prognosticator in cancer therapy with the greater the weight loss
the shorter the survival time. Weight loss in cancer patients due to cachexia arises
from the loss of both adipose tissue and skeletal muscle.
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Inherited
and acquired muscle diseases
, such as muscular dystrophy and muscle dysfunction
that occur as a consequence of denervation such as seen in amyotrophic lateral sclerosis
(ALS), are conditions marked by the progressive deterioration of muscle tissue that results
in weakness and impairs normal function. These diseases are typified by difficulty with
walking, balance, and coordination with many such diseases affecting speech, swallowing,
and breathing. There are currently no cures for degenerative muscle diseases outside
of palliative care.
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Myostatin
Myostatin,
which is a natural regulatory protein, plays a central role in skeletal muscle health. Interest in myostatin continues to grow
within the medical community. Research on animals and humans with genetic deficiency for producing myostatin have shown an increased
muscle mass, suggesting that myostatin is responsible for down-regulating muscle growth and development. In addition, myostatin
increases with age, inhibiting muscle growth and contributing to muscle atrophy in the elderly.
A 1997 article
in the journal Nature first described the discovery of a novel member of the transforming growth factor-β (TGF-β) superfamily
of growth and differentiation factors. This factor was expressed specifically in adult skeletal muscle and referred to as growth/differentiation
factor-8 (GDF-8) (McPherron
et al
., 1997). The researchers created
“knockout” mice, whereby they disrupted the expression of GDF-8 throughout the organism, with the resulting mice showing
a large and widespread increase in skeletal muscle mass. Individual muscles of mutant animals weighted 2-3 times more than those
of wild-type animals, with the increase a result of both muscle cell hypertrophy and hyperplasia. The newly created mice were
subsequently named “mighty mice”. Based on the phenotype, the researchers dubbed the newly discovered protein myostatin.
This work
suggests myostatin exerts an effect on both muscle hypertrophy and hyperplasia, as myostatin knock-out “mighty mice”
were shown to have an increase in both the number of muscle fibers and in fiber sizes. Hypertrophy refers to the enlargement of
a tissue or organ due to the enlargement of its component cells. In contrast, hyperplasia refers to an increase in the number
of cells or a proliferation of cells. Both of these processes can lead to enlargement of an organ.
Skeletal
muscle is the primary producer of myostatin, where it is secreted into the blood stream and acts as a negative regulator of muscle
differentiation and growth. The protein begins as a 375 amino acid dimer that is cleaved by proteases to a 109 amino acid active
domain. The active form of the protein binds to activin type II receptors, ActRIIA and ActRIIB (
Lee
et al
., 2001
). Binding to the receptors initiates a signaling
cascade that results in an increase in protein breakdown and subsequent inhibition of protein synthesis.
In
2005, Dr. Carlon M. Colker, M.D., FACN, the inventor of MYO-T12, discovered that follistatin, a natural substance known to inhibit
myostatin, is found in significant levels in standard fertilized chicken eggs. The follistatin is mostly contained in the vitelline
(yolk) membrane, and is released into the yolk to promote early embryo development and growth, with its expression terminated
after a few days. This discovery was presented by Dr. Colker at the 2006 Annual Meeting of the American College of Nutrition.
Clinical
Research to Evaluate Effects of Fortetropin
In
March 2013, we completed a human clinical trial which confirmed the beneficial effects of Fortetropin in suppressing free serum
myostatin levels. In this double blind, randomized placebo controlled, parallel, single dose study involving 12 healthy adult male
subjects per arm, test subjects in the active arm were administered a 6.6 gram dose of Fortetropin mixed with vanilla fat free/sugar
free pudding. An equal amount of vanilla fat free/sugar free pudding alone was given to the placebo arm. Blood samples were collected
at baseline (before dosing) and at 6, 12, 18, and 24 hours post dose intervals for measurement of myostatin blood concentration.
Results demonstrated greater than 30% decrease in serum myostatin levels compared to baseline during the 24 hour period. No study
related adverse events were reported during this study.
In another
study at the University of Tampa, a double-blind, placebo controlled trial examined the effects of Fortetropin on skeletal muscle
growth, lean body mass, strength, and power in recreationally trained individuals who rely heavily on satellite cell activation.
Forty-five subjects were then divided into placebo, 6.6 gram and 19.8 gram dosing arms of Fortetropin daily for a period of 12
weeks. All exercise sessions were conducted and monitored by trained personnel. Standardized diets consisted of roughly 54% carbohydrates,
22% fat and 24% protein. There were no differences in total calories and macronutrients between groups. Dual emission X-ray absorptiometry
was utilized to measure lean body mass and fat mass. Direct ultrasound measurements determined muscle thickness of the quadriceps.
Results
demonstrated a statistically significant increase in both muscle thickness and lean body mass in subjects taking Fortetropin compared
to a placebo. Strength and power endpoints, as measured by bench press, leg press and Wingate power, significantly increased from
baseline in all study groups. Another important finding was a statistically significant decrease in fat mass in subjects in the
19.8 gram arm. This finding, which has potentially broad implications for metabolism and weight management, bears further investigation
and studies are currently being planned. No study related adverse events were reported during the study.
#
p<0.05 post measurement compared to pre
* p < 0.05 delta compared
to placebo
We believe
improving lean body mass should be a therapeutic objective in the management of aging and chronic illness and all individuals
seeking optimal wellness. Fortetropin, the only proven natural myostatin inhibitor clinically available to increase muscle mass
and lean body mass, provides us with a compelling product in the competitive marketplace. Further studies are planned to examine
its role in the treatment of many disease states in various dosing regimens and delivery mechanisms.
Research
and Development
As
an early development-stage bionutritional and biotherapeutics company, we are dedicated to basic and clinical research that supports
our existing and future product portfolio. We are focused on the following areas of research:
Basic
Research
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Biochemical
characterization of Fortetropin
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Cutting
edge proteomic and lipidomic approaches
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Identifying
proteins, peptides, and lipids responsible for pro-myogenic activity
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Novel
biotherapeutics products
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Computational
design of novel peptide inhibitors of myostatin
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Developing
effective in-vitro assay(s) for rapid screening
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Pro-myogenic
activity of novel bioactive molecules and formulations
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Developing
in-vivo models
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PK/PD
studies to support dosing and formulation
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Pre-Clinical
Research
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Synergistic
effects of Fortetropin and testosterone on skeletal muscle and fat mass
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Potential
alternative to testosterone replacement therapy
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Synergistic
effects of Fortetropin and metformin
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Adjunctive
approach for management for obesity and type II diabetes
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PK/PD
studies of novel bioactive molecules with pro-myogenic activity
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Clinical
Research
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Effect
of Fortetropin on lean muscle mass, strength, and power
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Effect
of Fortetropin on blood chemistry and body mass index in healthy adults
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Effect
of Fortetropin on muscle function and recovery after orthopedic procedures
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Effect
of Fortetropin on blood chemistry and body mass index in aging adults
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We
expect our investment in research and development to continue to grow in the future.
We
have launched our internal research and development efforts through construction of a dedicated laboratory led by Dr. Neerav Padliya.
Our research program is actively evaluating the many active proteins, lipids and peptides in Fortetropin. In addition, we believe
the research performed in this laboratory will establish a basis for the continued submission of patent applications to help protect
our intellectual property. We are dedicated to protecting our innovative technology.
Clinical
and Basic Research Programs
We
invest in research and development activities externally through academic and industry collaborations aimed at enhancing our products,
optimizing manufacturing and broadening the product portfolio. We have developed the following collaborations with various academic
centers:
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In
September 2013, we entered into a clinical study agreement with Hackensack University
Medical Center to conduct a clinical study to determine the effects of Fortetropin on
blood chemistries and body mass index in healthy adult women. The study is expected to
be completed in 2015.
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In
May 2014, we entered into a three-year master service agreement with Rutgers University.
Our first project under the agreement is to develop cell-based assays for high-throughput
screening studies of next generation myostatin inhibitors. We believe the assays that
will be developed will enable us to elucidate the specific molecules in Fortetropinthat
impart activity as it relates to the development of muscle tissue. The project is expected
to be completed in the middle of 2015.
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In
May 2014, we entered into an agreement with the University of Tampa to study the effects
of Fortetropin supplementation on blood myostatin, follistatin and cytokines levels in
trained males. The clinical study is designed to analyze myostatin and follistatin levels
via high-sensitivity ELISA-based spectrophotometric. Serum will be analyzed for a plethora
of relative cytokine levels via high-sensitivity enhanced chemiluminescent-based methods.
The study is expected to be completed by the end of 2014.
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In
August 2014, we entered into a research agreement with Human
Metabolome Technologies America, Inc., which will apply their proprietary, state-of-the-art
capillary electrophoresis-mass spectrometry (CE-MS) technologies to characterize the
metabolomic profiles of plasma samples obtained from healthy male subjects who used either
Fortetropin
™
or placebo with the goal of identifying metabolites
with pro-myogenic activity in the plasma samples of subjects who took Fortetropin as
well as examining the effect on glucose and fat metabolism. We anticipate that the results
from this study will enhance our understanding of the mechanism of action of Fortetropin
and provide guidance for the development of biotherapeutics based on Fortetropin. Additionally,
the early indications of plasma biomarkers may guide future study design for Fortetropin
clinical trials by identifying clinically-relevant endpoints and potential stratification
of patient populations. HMT will use a metabolite database of over 290 lipids and over
900 metabolites which may be potential plasma biomarkers of muscle growth. The study
is expected to be completed by the end of 2014.
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We
are also building a small molecule and biologics discovery program aimed at regulators of myostatin synthesis and activation and
the different pathways that act upon muscle development. In July 2014, we entered into a research and development agreement with
Cloud Pharmaceuticals, Inc., or Cloud, to discover product candidates related to the inhibition of targets in the myostatin regulatory
pathway as well as inflammatory mediators associated with sarcopenia and cachexia. Cloud utilizes cloud computing technology to
initiate and design small molecule drug candidates based on their Inverse Design proprietary cheminformatics tool. The research
will focus on the development of product candidates related to Furin, a convertase that plays a central role in the processing
of myostatin to its biologically active form, and Janus Kinase 3 (JAK3), a tyrosine kinase thought to be a factor in pathways
central to inflammation.
Market
Overview
The
total U.S. retail market for nutritional supplements is approximately $11 billion and is highly fragmented. We believe our proprietary
ingredient, Fortetropin, which is the only clinically proven natural supplement available in the market that temporarily reduces
free serum myostatin level, is well-positioned to market to a wide base of consumers looking for nutritional and performance maximization
as well as for wellness and maintenance products as they age. We hope to capture the first mover advantage in this supplement
category. Additionally, the medical community has increased its focus on muscle health, specifically focusing on the aging U.S.
population that can benefit most from myostatin modulation. We believe persons suffering from sarcopenia, a muscle loss condition
due to aging, and cachexia, a syndrome characterized by loss of body weight in many diseases such as cancer, may also benefit
from Fortetropin as muscle loss can be slowed by a reduction of myostatin in the body.
We
believe the combination of the foregoing marketplace characteristics, combined with the experience of our directors and our management
team and our current and future products, will enable our business model to succeed.
Strategy
Our
strategy is to understand the complex genetic and molecular pathways regulating muscle mass and function as well as other disease
mechanisms. Understanding the impact of complex regulatory pathways which act to build and maintain healthy lean muscle is central
to our biotherapeutic research. This research is the foundation of our bionutritional product development. We are developing nutritional
products that target specific mechanisms to promote health in ways that cannot be met by other treatments, diets or lifestyle
changes.
We
will seek to gain market share for our core branded products in sports nutrition, age and wellness and bariatric/medical markets
by (i) formulating and developing new and complementary product lines, (ii) expanding U.S. distribution by increasing the channels
of sale, (iii) expanding distribution geography beyond the U.S. and expanding our markets and (iv) seeking strategic relationships
with other distributors. Our strategy is to utilize the revenue and awareness generated by the sales and marketing of Fortetropin
to further advance our research and development of nutritional and therapeutic treatments for muscular-related conditions, including
sarcopenia.
Marketing,
Sales and Distribution
Our
commercial focus is to leverage our clinical data to develop proprietary products including direct-to-consumer branded products
using multiple product delivery formats to target the large, but currently underserved, markets focused on muscle health. Our
first commercial product, MYO-T12, is currently sold in the sports nutrition market through a distribution agreement with MHP,
a company engaged in the development, marketing and distribution of nutritional and other supplemental products for consumer use.
MHP distributes MYO-T12 principally in the U.S. under the brand name MYO-X
®
. MYO-X, which is currently available
on popular retailer websites and in specialty retailers, has been well received in the sports nutrition market. The distribution
agreement with MHP expires in March 2015. In February 2014, we expanded our commercial operations into the age management market
through a distribution agreement with Cenegenics. Under the distribution agreement, Cenegenics agreed to exclusively distribute
and promote a proprietary formulation of Fortetropin through its age management centers in the U.S. and its community of physicians
focused on treating a growing population of patients focused on proactively addressing age-related health and wellness concerns.
See “Risk Factors -
Two distributors account for substantially all of our recent sales, and if we are unable collect
our accounts receivable from these distributors, or if these distributors are unable or unwilling to sell our products, our operating
results and financial condition will be adversely affected”
for additional information regarding our relationship with
our distributors.
While
we may continue to sell our products through distributors, we expect to continue developing our own core branded products, which
we anticipate launching in 2015, and to pursue additional markets such as medical foods and international opportunities. As a
result, we may decide not to renew or to revise the agreements with MHP and/or Cenegenics and thereby enable us to continue to
pursue our own marketing, sales and distribution strategies. The growing awareness of the potential therapeutic uses of myostatin
inhibition supports continued development of our own core products. We remain committed to continuing our focus on various clinical
trials in support of our marketing claims as well as to enhance our intellectual property, to develop product improvements and
new products, and to reduce the cost of our products by finding more efficient manufacturing processes and contract manufacturers.
Intellectual
Property
We
have adopted a comprehensive intellectual property strategy, the implementation of which is ongoing. We are focusing our efforts
on ensuring our current commercial products and processes, and those currently under development, are being protected to the maximum
extent possible. We are in the process of filing multiple patent applications in the United States and abroad, and we are currently
prosecuting pending patent applications in the United States, all of which are directed towards our compositions and methods of
manufacturing the same. In addition to a proactive protection strategy, we are conducting defensive diligence to ensure our products
and processes do not encroach upon the rights of third parties. Moreover, we are also engaged in a survey of the intellectual
property owned by potential competitors, and are devising a proactive path to stay ahead of such potential competitors.
In
August 2014, the U.S. Patent and Trademark Office, or USPTO, issued U.S. Patent No. 8,815,320 B2 covering our proprietary methods
of manufacturing Fortetropin. The patent entitled “Process for Producing a Composition Containing Active Follistatin,”
provides intellectual property protection for making Fortetropin, the key ingredient in our core commercial muscle health products,
and carries a patent term through early 2033. Additionally, we are currently prosecuting a core patent application covering the
basic science on which our business was built, which application is currently undergoing examination at the USPTO, and has a priority
date of May 18, 2006. The scope of this application covers the various applications of avian follistatin products and the benefits
thereof. In particular, this application is focused on the composition currently in our commercially sold Fortetropin-powered
products, including MYO-X and MYO-T12, and the known benefits thereof. We intend to file as many applications as possible as continuation/
divisional/continuation-in-part applications. Several additional pending patent applications that we are pursuing include:
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Genetically
modified microorganisms - covering the utilization of yeast, algae or other microorganisms
to grow desired proteins/molecules to create our core line of products.
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Method
of obtaining effective amounts of avian follistatin - covering a method of controlling
the amount of avian follistatin and the concentrations thereof within a product by extracting
the proteins from various parts of fertilized and unfertilized avian eggs.
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Methods
of treating degenerative muscle disease – covering methods of treating various
degenerative muscle diseases, such as sarcopenia, with avian egg-based products and the
compositions thereof.
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Methods
and products for increasing muscle mass – covering various combinations of proteins,
lipids and other molecules, which are active in the natural form of our core commercial
products, which may be combined in advantageous amounts to yield improved products and
methods for increasing muscle mass.
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Egg-based
product having hydroxymethylbutyrate, or HMB, for the treatment of degenerative muscle
disease – covering a line of products combining avian egg-based products with HMB
for improved treatment of degenerative muscle diseases and the methods of treating the
same.
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Egg-based
product having leucine for treatment of degenerative muscle disease - covering a line
of products combining avian egg-based products with leucine for improved treatment of
degenerative muscle diseases and the methods of treating the same.
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Methods
of treatment of degenerative muscle disease using egg-based products and testosterone
replacement therapy – covering methods of treating degenerative muscle disease
in combination with testosterone replacement therapy for improved results.
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Methods
of combating cellulite – covering methods of treating cellulite using avian egg-based
products and the compositions thereof.
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Liquid
avian egg-based products – covering avian egg-based products in liquid phase for
ease of consumption and portability.
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In
addition to patent protection, we are also engaged in protecting our brands, including corporate brands and product brands, and
have sought trademark registrations in the United States for the same. We are in the process of implementing a clearance strategy
for new brands we intend to launch, to ensure any risk of encroaching on the rights of third parties is minimized.
We
regard our trademarks and other proprietary rights as valuable assets and believe that protecting our key trademarks is crucial
to our business strategy of building strong brand name recognition. These trademarks are crucial elements of our business, and
have significant value in the marketing of our products. Federally registered trademarks have a perpetual life, provided that
they are maintained and renewed on a timely basis and used correctly as trademarks, subject to the rights of third parties to
attempt to cancel a trademark if priority is claimed or there is confusion of usage. We rely on common law trademark rights to
protect our unregistered trademarks. Common law trademark rights generally are limited to the geographic area in which the trademark
is actually used, while a United States federal registration of a trademark enables the registrant to stop the unauthorized use
of the trademark by third parties in the United States. Much of our ongoing work, including our research and development, is kept
highly confidential. As such, we are in the process of adopting corporate confidentiality policies that comply with the Uniform
Trade Secrets Act to protect some of our most valuable intellectual property assets.
Regulatory
Environment
The
importing, manufacturing, processing, formulating, packaging, labeling, distributing, selling and advertising of our current and
future products may be subject to regulation by one or more federal or state agencies. The Food and Drug Administration, or the
FDA, has primary jurisdiction over our products pursuant to the Federal Food, Drug and Cosmetic Act, as amended by the Dietary
Supplement and Health Education Act, or the FDCA, and the regulations promulgated thereunder. The FDCA provides the regulatory
framework for the safety and labeling of dietary supplements, foods and medical foods. In particular, the FDA regulates the safety,
manufacturing, labeling and distribution of dietary supplements. In addition, the Animal Plant Health and Inspection Service,
or APHIS, regulates the importation of our primary product from Germany. The Federal Trade Commission, or the FTC, and the FDA
share jurisdiction over the promotion and advertising of dietary supplements. Pursuant to a memorandum of understanding between
the two agencies, the FDA has primary jurisdiction over claims that appear on product labels and labeling and the FTC has primary
jurisdiction of product advertising.
Compliance
with applicable federal, state, and local laws and regulations is a critical part of our business. We endeavor to comply with
all applicable laws and regulations. However, as with any regulated industry, the laws and regulations are subject to interpretation
and there can be no assurances that a government agency would necessarily agree with our interpretation of the governing laws
and regulations. Moreover, we are unable to predict the nature of such future laws, regulations, interpretations or applications,
nor can we predict what effect additional governmental regulations or administrative orders, when and if promulgated, would have
on our business in the future. These regulations could, however, require the reformulation of our products to meet new standards,
market withdrawal or discontinuation of certain products not able to be reformulated. The risk of a product recall exists within
the industry although we endeavor to minimize the risk of recalls by distributing products that are not adulterated or misbranded.
However, the decision to initiate a recall is often made for business reasons in order to avoid confrontation with FDA.
Our
products are required to be prepared in compliance with the FDA’s Good Manufacturing Practices, or GMPs, for dietary supplements.
Fortetropin, the active ingredient in our products, must be imported into the United States in conformance with APHIS’s
requirements for egg products. Other statutory obligations include reporting all serious adverse events on a Medwatch Form 3500A.
To date, we have not filed a Medwatch Form 3500A with the FDA nor have we been placed on notice regarding any serious adverse
events related to any of our products. Since eggs are considered a major food allergen under the Food Allergen Labeling and Consumer
Protection Act of 2004, we are required to label all our products containing Fortetropin to note that they contain egg yolk.
Advertising
of dietary supplement products is subject to regulation by the FTC under the Federal Trade Commission Act, or FTCA, which prohibits
unfair methods of competition and unfair or deceptive trade acts or practices in or affecting commerce. The FTCA provides that
the dissemination of any false advertising pertaining to foods, including dietary supplements, is an unfair or deceptive act or
practice. Under the FTC's substantiation doctrine, an advertiser is required to have a reasonable basis for all objective product
claims before the claims are made. All advertising is required to be truthful and not misleading. All testimonials are required
to be typical of the results the consumer may expect when using the product as directed. Accordingly, we are required to have
adequate substantiation of all material advertising claims made for our products. Failure to adequately substantiate claims may
be considered either deceptive or unfair practices.
In
March 2009, the General Accounting Office, or GAO, issued a report that made four recommendations to enhance the FDA’s oversight
of dietary supplements. The GAO recommended that the Secretary of the Department of Health and Human Services direct the Commissioner
of the FDA to: (1) request authority to require dietary supplement companies to identify themselves as a dietary supplement company
and update this information annually, provide a list of all dietary supplement products they sell and a copy of the labels and
update this information annually, and report all adverse events related to dietary supplements, not just serious adverse events;
(2) issue guidance to clarify when an ingredient is considered a new dietary ingredient, the evidence needed to document the safety
of new dietary ingredients, and appropriate methods for establishing ingredient identity; (3) provide guidance to industry to
clarify when products should be marketed as either dietary supplements or conventional foods formulated with added dietary ingredients;
and (4) coordinate with stakeholder groups involved in consumer outreach to identify additional mechanisms for educating consumers
about the safety, efficacy, and labeling of dietary supplements, implement these mechanisms, and assess their effectiveness. These
recommendations could lead to increased regulation by the FDA or future legislation concerning dietary supplements.
We
cannot predict what effect additional domestic or international governmental legislation, regulations, or administrative orders,
when and if promulgated, would have on our business in the future. New legislation or regulations may require the reformulation
of certain products to meet new standards, require the recall or discontinuance of certain products not capable of reformulation,
impose additional record keeping or require expanded documentation of the properties of certain products, expanded or different
labeling or scientific substantiation.
Manufacturing;
Raw Materials and Suppliers
We
are committed to producing and selling highly efficacious products that are trusted for their quality and safety. To date, our
products have been outsourced to third party manufacturers where the products are manufactured in full compliance with the current
good manufacturing practice, or cGMP, standards set by the U.S. Food and Drug Administration, or FDA. We believe these arrangements
provide us with an advantage in our margins, improves our return on assets, and allows us to invest in building consumer awareness
and conducting clinical trials. All of the raw materials for our current products are currently sourced from third-party suppliers.
Any shortages in our raw materials could result in materially higher raw material prices and adversely affect our ability to source
our product. Since the beginning of 2012, we have been focusing on the efficiency and economics of manufacturing Fortetropin.
Our management has examined the production cost and is working to achieve cost savings in production.
We
currently have one third-party manufacturer of Fortetropin. We have an agreement in place with our
Fortetropin manufacturer, which is designed to support our growth and ensure consistence in production and quality. Our
Fortetropin manufacturer purchases all needed raw materials from suppliers and coordinates any additional production steps
with third-parties. In 2014, we qualified a second source Fortetropin manufacturer. Fortetropin manufactured by this
second manufacturer has met our quality criteria for finished product. We are working on a plan with the second source
manufacturer to manufacture commercial quantities of Fortetropin. We have multiple vendors for blending, packaging and
labeling our products.
Competition
Given the
large patient populations that could potentially benefit from treatments targeted at myostatin, a number of pharmaceutical companies
are currently developing various types of myostatin inhibitors. Eli Lilly and Co., Novartis AG, Pfizer Inc., Regeneron Pharmaceuticals
Inc. and Milo Biotechnology are among the companies that we are aware of that are testing new compounds in the field of myostatin
inhibition. In bionutrition, the market for dietary supplements is highly competitive. Competition is based primarily on price,
quality, customer service, marketing and product effectiveness. Our competition includes numerous nutritional supplement companies
that are highly fragmented in terms of geographic market coverage, distribution channels and product categories. In addition,
large pharmaceutical companies and packaged food and beverage companies compete with us in the nutritional supplement market.
These companies and certain nutritional supplement companies have broader product lines and/or larger sales volumes than us and
have greater financial and other resources available to them and possess extensive manufacturing, distribution and marketing capabilities.
Other companies are able to compete more effectively due to a greater extent of vertical integration. Private label products of
our competitors, which in recent years have significantly increased in certain nutrition categories, compete directly with our
products. In several product categories, private label items are the market share leaders. Increased competition from such companies,
including private label pressures, could have a material adverse effect on our results of operations and financial condition.
Many companies within our industry are privately-held and therefore, we are unable to assess the size of all of our competitors
or where we rank in comparison to such privately-held competitors with respect to sales.
Insurance
We
maintain commercial liability, including product liability coverage, and property insurance. Our policy provides for a general
liability of $5.0 million per occurrence, and $10.0 million annual aggregate coverage. We carry property coverage on our main
office facility to cover our legal liability, tenant’s improvements, business property, and inventory. We maintain product
liability insurance with an aggregate cap on retained loss of $10.0 million.
Employees
We
currently have ten full-time employees (including three executive officers) and one part-time employee. We also employ five consultants.
None of our employees are represented by a labor union and we consider our employee relations to be good.
Corporate
Information
Our
executive offices are currently located at 45 Horsehill Road, Suite 106, Cedar Knolls, New Jersey 07927 and our telephone number
is (973) 509-0444. Our website address is http://www.myoscorp.com. The information on our website is not, and shall not be deemed
to be, a part of this prospectus or incorporated in filings we make with the Securities and Exchange Commission.
RISK
FACTORS
Investing
in our securities involves a high degree of risk. Before deciding whether to invest in our securities, you should carefully consider
the risk factors set forth below, as well as those incorporated by reference into any prospectus supplement and in any related
free-writing prospectus for a specific offering of securities. You should also carefully consider other information contained
and incorporated by reference in this prospectus and any applicable prospectus supplement, including our financial statements
and the related notes thereto. The risks and uncertainties set forth below or described in the applicable prospectus supplement
and our other filings with the SEC incorporated by reference herein are not the only ones we face. Additional risks and uncertainties
not presently known to us or that we currently consider immaterial may also adversely affect us. If any of the described risks
occur, our business, financial condition or results of operations could be materially harmed. In such case, the value of our securities
could decline and you may lose all or part of your investment.
RISKS
RELATING TO OUR BUSINESS
Our
limited operating history makes it difficult to evaluate our future prospects and results of operations
.
We
are an emerging company and have a limited operating history. Our future prospects should be considered in light of the risks
and uncertainties experienced by early stage companies in evolving markets such as the market for our current and future products,
if any, in the United States. We will continue to encounter risks and difficulties that companies at a similar stage of development
frequently experience, including the potential failure to:
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Build
a strong and compelling consumer brand;
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Adequately
protect and build our intellectual property;
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Develop
new products;
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Conduct
successful research and development activities;
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Increase
awareness of our products and develop customer loyalty;
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Respond
to competitive market conditions;
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Respond
to requirements and changes in our regulatory environment;
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Maintain
effective control of our costs and expenses; and
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Attract,
retain and motivate qualified personnel.
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If
we are unable to address any or all of the foregoing risks, our business may be materially and adversely affected.
If
we are unable to successfully launch our own core branded products, our business and results of operations would be adversely
affected.
We
currently have two commercial products: MYO-T12, which is branded under the MYO-X name, and distributed by
Maximum
Human Performance, or
MHP, and Cenegenics Muscle Formula, which is a private-label product distributed by Cenegenics Product
and Lab Services, LLC, or Cenegenics. We are in the process of developing our own core branded products, which we anticipate launching
in 2015. We may fail to successfully develop, launch, market and/or promote our own core branded products. Successfully developing,
launching, marketing and promoting products is a complex and uncertain process, dependent on the efforts of management, outside
consultants and general economic conditions, among other things. Any factors that adversely impact the development, launch, marketing
or promotion of our products including, but not limited to, competition, acceptance in the marketplace, or delays related to production
and distribution or regulatory issues, will likely have a negative impact on our cash flow and operating results. The commercial
success of our products also depends upon:
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the
quality and acceptance of other competing brands and products;
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creating effective
distribution channels and brand awareness;
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critical reviews;
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the availability
of alternatives;
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general economic
conditions; and
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other tangible
and intangible factors.
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Each
of these factors is subject to change and cannot be predicted with certainty. We cannot assure you that we will be successful
in developing, launching, marketing or promoting any of our own core branded products. Our inability to successfully develop,
launch, market and promote our own core branded products or any enhancements to our products which we may develop, would have
a material adverse effect on our business and results of operations.
Two
distributors account for substantially all of our recent sales, and if we are unable to collect our accounts receivable from
these distributors, or if these distributors are unable or unwilling to purchase our products, our operating results and
financial condition will be adversely affected.
We
currently sell our products primarily through two distributors, MHP and Cenegenics, and credit risk is concentrated among
these distributors. The accounts receivable balances for MHP and Cenegenics at June 30, 2014, which had not been reduced by
an allowance for doubtful accounts as of such date, were $525,000 and $1,807,858, respectively. For the six months ended June
30, 2014, net sales for our products was only $3.2 million (of which 35% was attributable to MHP and 65% was attributable to
Cenegenics) and for the year ended December 31, 2013, net sales for our products was only $3.3 million, which only included
sales to MHP.
We expect minimal, if any, sales to Cenegenics or MHP during the third and fourth quarters of 2014 as we
seek to restructure our commercial
strategy and position our own core branded products, to be
launched in 2015.
During
the latter half of the third quarter of 2014, Cenegenics advised us that, notwithstanding the terms of its distribution
agreement with us, it does not intend to pay us for private-labeled products that we had manufactured for Cenegenics until it
sells such products to its customers. We are taking action against Cenegenics to enforce the terms of the agreement.
Specifically, on October 10, 2014, pursuant to the terms of the distribution agreement, we filed a request for arbitration
before the International Chamber of Commerce against Cenegenics asserting various causes of action, including breach of
contract. The request seeks payment from Cenegenics of approximately $2.72 million, consisting of unpaid invoices for
product shipped and received and for unpaid inventory that was produced for Cenegenics pursuant to the distribution agreement
but not yet shipped, as well as related costs and expenses. We expect to record charges to write down unsold inventories that
were specially formulated for Cenegenics. Furthermore, we expect to record an allowance for doubtful accounts against the
existing accounts receivable balance of Cenegenics, which will be reported in our Quarterly Report on Form 10-Q for the three
months ended September 30, 2014. If we are unable to collect our outstanding accounts receivable from either of these
distributors, or if these distributors are unable or unwilling to purchase our products, our operating results and financial
condition will be adversely affected.
We
have a history of losses and cash flow deficits, and we expect to continue to operate at a loss and to have negative cash flow
for the foreseeable future, which could cause the price of our stock to decline.
We
have incurred net losses since our inception. At June 30, 2014, we had cumulative net losses of approximately $15.3 million. We
also had negative cash flow from start-up activities. Historically, we have funded our operations from the proceeds from the sale
of equity securities, and to a lesser extent, internally generated funds. Our growth strategy is to implement our strategic business
plan, which is likely to result in additional losses and negative cash flow for the foreseeable future. We cannot give assurances
that we will ever become profitable.
We
will need to raise additional funds in the future to grow our business, which funds may not be available on acceptable terms or
at all. If we are unable to raise funds as needed, we may not be able to maintain or expand our business.
We
expect that our current funds, as of June 30, 2014, and cash generated from operations, will be sufficient to fund our projected
operations through December 31, 2014. We require substantial funds for operating expenses, for research and development activities,
to establish manufacturing capability, to develop consumer marketing and retail selling capability, and to cover public company
costs. We expect that we will need to seek additional funding through public or private financing or through collaborative arrangements
with strategic partners in the fourth quarter of 2014.
The
extent of our capital needs will depend on numerous factors, including (i) our profitability, (ii) the release of competitive
products, (iii) the level of investment in research and development, (iv) the amount of our capital expenditures, (v) the amount
of our working capital including collections on accounts receivable, (vi) the sales, marketing and distribution investment needed
to develop and launch our own core branded products and (vii) cash generated by sales of those products. We cannot assure you
that we will be able to obtain capital in the future to meet our needs. If we cannot obtain additional funding, we may be required
to limit our marketing efforts, decrease or eliminate capital expenditures or cease all or a portion of our operations, including
any research and development activities.
We
cannot be certain that additional capital will be available on favorable terms, if at all. In addition, any available additional
financing may not be adequate to meet our goals. Any equity financing would result in dilution to stockholders.
Even
if we are able to locate a source of additional capital, we may not be able to negotiate terms and conditions for receiving the
additional capital that are acceptable to us.
Any
future capital investments could dilute or otherwise materially adversely affect the holdings or rights of our existing stockholders.
In addition, new equity or convertible debt securities issued by us to obtain financing could have rights, preferences and privileges
senior to our common stock. There is no assurance that any additional financing will be available, or if available, will be on
terms favorable to us.
Since
our revenues are generated in U.S. dollars but a significant portion of our expenses may be incurred in euros, our earnings may
be reduced due to currency exchange rate fluctuations.
Our
revenues are generated in U.S. dollars, while a significant portion of our expenses, principally the payments to our primary manufacturer,
are paid in euros. The exchange rate between the euro and the U.S. dollar fluctuates and is affected by, among other things, changes
in political and economic conditions. Any significant fluctuation in the exchange rate for these currencies may materially and
adversely affect our earnings, cash flows and financial condition.
If
we are unable to manage our infrastructure growth, our business results may be materially and adversely affected.
We
need to manage our infrastructure growth to support and maximize our potential revenue growth and achieve our expected business
results. Engaging the full capacity of our limited staff may place a significant strain on our management, operations, and accounting
and information systems. We expect that we will need to continue to improve our financial controls, operating procedures and management
information systems. The failure to manage our infrastructure growth could adversely affect our business results.
If
we are not able to implement our business objectives, our operations and financial performance may be adversely affected.
Our
principal objectives are to: (i) deepen the scientific understanding of the activity of Fortetropin
TM
, specifically
as a natural, reversible, temporary modulator of the regulatory peptide myostatin, and to leverage this knowledge to strengthen
and build our intellectual property, (ii) conduct research and development activities to evaluate myostatin modulation in a range
of both wellness and disease states, (iii) identify other products and technologies which may broaden our portfolio and define
a business development strategy to protect, enhance and accelerate the growth of our products, (iv) reduce the cost of manufacturing
through process improvement, (v) identify contract manufacturing resources that can fully meet our future growth requirements,
(vi) develop a differentiated and advantaged consumer positioning, brand name and iconography, and (vii) create a sales and marketing
capability through alliances to maximize near-term and future revenues. Our business plan is based on circumstances currently
prevailing and assumptions that certain circumstances will or will not occur as well as the inherent risk and uncertainties involved
in various stages of development. However, there is no assurance that we will be successful in achieving our objectives. If we
are not able to achieve our objectives, our business operations and financial performance may be adversely affected.
If
we lose the services of our key personnel, we may be unable to replace them, and our business, financial condition and results
of operations could be adversely affected.
Our
success largely depends on the continued skills, experience, efforts and policies of our management, directors and other key personnel
and our ability to continue to attract, motivate and retain highly qualified employees. In particular, certain of our directors,
including Dr. Robert Hariri, Dr. J. Craig Venter and Dr. Louis Aronne, have significant research and development experience and
are integral to the creation of our future products and the execution of our business strategy. In addition, our prospects depend
substantially on the services of our executive management team.
If
one or more of our key employees or directors leaves us, we will need to find a replacement with the combination of skills and
attributes necessary to execute our strategy. Because competition for skilled employees is intense, and the process of finding
qualified individuals can be lengthy and expensive, we believe that the loss of the services of key personnel could adversely
affect our business, financial condition and results of operations. We cannot assure you that we will continue to retain such
personnel.
Our
success depends on our ability to anticipate and respond in a timely manner to changing consumer demands.
Our
success depends on the appeal of our current and future products to a broad range of consumers whose preferences cannot be predicted
with certainty and are subject to change. If our current and future products do not meet consumer demands, our sales may decline.
In addition, our growth depends upon our ability to develop new products through product line extensions and product modifications,
which involve numerous risks. We may not be able to accurately identify consumer preferences, translate our knowledge into customer
accepted products, establish the appropriate pricing for our products or successfully integrate these products with our existing
product platform or operations. We may also experience increased expenses incurred in connection with product development, marketing
and advertising that are not subsequently supported by a sufficient level of sales, which would negatively affect our margins.
Furthermore, product development may divert management’s attention from other business concerns, which could cause sales
of our existing products to suffer. We cannot assure you that newly developed products will contribute favorably to our operating
results.
Products
often have to be promoted heavily in stores or in the media to obtain visibility and consumer acceptance. Acquiring distribution
for products is difficult and often expensive due to slotting and other promotional charges mandated by retailers. Products can
take substantial periods of time to develop consumer awareness, consumer acceptance and sales volume. Accordingly, some products
may fail to gain or maintain sufficient sales volume and as a result may have to be discontinued.
If
our current or future products fail to properly perform, our business could suffer due to increased costs and reduced income.
Failure of our current or future products to meet consumer expectations could result in decreased sales, delayed market acceptance
of our products, increased accounts receivable, unsaleable inventory and customer returns, and divert our resources to reformulation
or alternative products.
Intense
competition from existing and new entities may adversely affect our revenues and profitability
.
We
face competitors that will attempt to create, or are already creating, products that are similar to our current and future products.
Many of our current and potential competitors have significantly longer operating histories and significantly greater managerial,
financial, marketing, technical and other competitive resources, as well as greater name recognition, than we do. These competitors
may be able to respond more quickly to new or changing opportunities and customer requirements and may be able to undertake more
extensive promotional activities, offer more attractive terms to customers or adopt more aggressive pricing policies. We cannot
assure you that we will be able to compete effectively with current or future competitors or that the competitive pressures we
face will not harm our business.
Our
business is dependent on continually developing or acquiring new and advanced products and processes and our failure to do so
may cause us to lose our competitiveness and may adversely affect our operating results.
To
remain competitive in our industry, we believe it is important to continually develop new and advanced products and processes.
There is no assurance that competitive new products and processes will not render our existing or new products obsolete or non-competitive.
Our competitiveness in the marketplace relies upon our ability to continuously enhance our current products, introduce new products,
and develop and implement new technologies and processes. Our failure to evolve and/or develop new or enhanced products may cause
us to lose our competitiveness in the marketplace and adversely affect our operating results.
Adverse
publicity or consumer perception of our products and any similar products distributed by others could harm our reputation and
adversely affect our sales and revenues.
We
are highly dependent upon positive consumer perceptions of the safety, efficacy and quality of our products as well as similar
products distributed by our competitors. Consumer perception of dietary supplements and our products in particular can be substantially
influenced by scientific research or findings, national media attention and other publicity about product use. Adverse publicity
from such sources regarding the safety, efficacy or quality of dietary supplements, in general, and our products in particular,
could harm our reputation and results of operations. The mere publication of reports asserting that such products may be harmful
or questioning their efficacy could have a material adverse effect on our business, financial condition and results of operations,
regardless of whether such reports are scientifically supported or whether the claimed harmful effects would be present at the
dosages recommended for such products.
The
scientific support for Fortetropin is subject to uncertainty.
Our
research, scientific knowledge and clinical testing supporting the benefits of our products are an essential element of our ability
to legally market our products. There is, however, the risk that new or undiscovered information may become available that may
undermine or refute our scientific support. In addition, our clinical testing of Fortetropin has been limited in scope and additional
testing may reveal deficiencies and side effects that we are currently unaware of. A reduction in the credibility of our scientific
support for the effectiveness of Fortetropin could have a material adverse effect on our operations and financial conditions.
If
we are required to withdraw our products from the market, change the labeling of our products and/or are subject to product liability
claims, our operations and financial performance may be adversely affected.
There
is a potential for any ingested product to result in side effects in certain consumers. Although we are not aware of any adverse
effects of our products on the health of consumers, if any such side effects are identified after marketing and sale of the product,
we may be required to withdraw our products from the market or change its labeling. We may also be required to withdraw our products
from the market as a result of regulatory issues. If we are required to withdraw our products from the market, our business operations
and financial performance may be adversely affected. Furthermore, if a product liability claim is brought against us, it may,
regardless of merit or eventual outcome, result in damage to our reputation, decreased demand for our products, costly litigation
and loss of revenue.
An
increase in product returns could negatively impact our operating results and profitability.
We
permit the return of damaged or defective products and accept limited amounts of product returns in certain instances. While such
returns have historically been nominal and within management’s expectations and the provisions established, future return
rates may differ from those experienced in the past. Any significant increase in damaged or defective products or expected returns
could have a material adverse effect on our operating results for the period or periods in which such returns materialize. With
respect to future sales, we may need to offer distributor and retail customers’ sales incentives, including the right to
return product. If those customers are not able to sell our products to end-consumers, significant product returns may materialize,
which could have a material adverse effect on our operating results.
We
are dependent on third-party manufacturers, suppliers and processors.
We
currently rely on third-party manufacturers, suppliers and processors to produce our products. If our manufacturers, suppliers
or processors are unable to provide us with the required finished products or raw materials or are unable or unwilling to produce
sufficient quantities of our products, our business and revenues will be adversely affected.
A
shortage in the supply of, or a price increase in, raw materials could increase our costs or adversely affect our sales and revenues.
All
of the raw materials for our products are sourced from third-party suppliers. Currently, we have one primary third-party manufacturer
to produce Fortetropin under a fixed price agreement that runs through December 2016. We have qualified a second source manufacturer
and are working on a commercial plan to source product from this manufacturer. Any shortages in our raw materials could adversely
affect operations. Price increases from a supplier will affect our profitability if we are not able to pass price increases on
to customers. The inability to obtain adequate supplies of raw materials in a timely manner or a material increase in the price
of our raw materials could have a material adverse effect on our business, financial condition and results of operations.
Our
products have a limited shelf life which could result in costs associated with inventory which exceeds the appropriate age limits.
Our
products are comprised of dried powder derived from egg-yolk and thus have a limited shelf life. Accordingly, product which exceeds
the appropriate age limits may not be sold and must be destroyed. This would have an adverse financial impact associated with
the cost of writing off obsolete inventory.
We
have no manufacturing capacity and anticipate continued reliance on third-party manufacturers for the development and commercialization
of our products.
We
do not currently operate manufacturing facilities for production of our product. We lack the resources and the capabilities to
manufacture our products on a commercial scale. We do not intend to develop facilities for the manufacture of our products in
the foreseeable future. We rely on third-party manufacturers to produce bulk products required to meet our sales needs. We plan
to continue to rely upon contract manufacturers to manufacture commercial quantities of our products.
Our
contract manufacturers’ failure to achieve and maintain high manufacturing standards, in accordance with applicable regulatory
requirements, or the incidence of manufacturing errors, could result in consumer injury or death, product shortages, product recalls
or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could seriously harm our
business. Contract manufacturers often encounter difficulties involving production yields, quality control and quality assurance,
as well as shortages of qualified personnel. Our existing manufacturers and any future contract manufacturers may not perform
as agreed or may not remain in the contract manufacturing business. In the event of a natural disaster, business failure, strike
or other difficulty, we may be unable to replace a third-party manufacturer in a timely manner and the production of our products
would be interrupted, resulting in delays, additional costs and reduced revenues.
Our
research and development activities may be costly and/or untimely, and there are no assurances that our research and development
activities will either be successful or completed within the anticipated timeframe, if ever at all.
Research
and development activities may be costly and/or untimely, and there are no assurances that our research and development activities
will either be successful or completed within the anticipated timeframe, if at all. The continued research and development of
Foretropin and our future products is important to our success. In addition, the development of new products requires significant
research, development and testing all of which require significant investment and resources. At this time, our resources are limited
and our research and development activities are dependent upon our ability to fund our activities and to raise capital which may
not be possible. We may enter into agreements with third party vendors to engage in research and development for us. However,
the failure of the third-party research to perform under agreements entered into with us, or our failure to renew important research
agreements with a third party, may delay or curtail our research and development efforts. The research and development of new
products is costly and time consuming, and there are no assurances that our research and development activities will be successful.
Even if a new product is developed, there is no assurance that it will be commercialized or result in sales.
We
may not be able to protect our intellectual property rights upon which our business relies, which could cause our assets to lose
value.
Our
business depends on and will continue to depend on our intellectual property, including our valuable brands and internally-developed
products. We believe our intellectual property rights are important to our continued success and our competitive position. However,
we may be unable or unwilling to strictly enforce our intellectual property rights, including our patents and trademarks, from
infringement due to the substantial costs of such enforcement. In addition, while there are patents pending for our core product,
there is no assurance that such application will be approved. Our failure to enforce our intellectual property rights could diminish
the value of our brands and product offerings and harm our business and future growth prospects.
In
addition, unauthorized parties may attempt to copy or otherwise obtain and use our services, technology and other intellectual
property, and we cannot be certain that the steps we have taken to protect our proprietary rights will prevent any misappropriation
or confusion among consumers and merchants, or unauthorized use of these rights. Advancements in technology have exacerbated the
risk by making it easier to duplicate and disseminate intellectual property. In addition, as our business becomes more global
in scope, we may not be able to protect our proprietary rights in a cost-effective manner in a multitude of jurisdictions with
varying laws. If we are unable to procure, protect and enforce our intellectual property rights, we may not realize the full value
of these assets, and our business may suffer. If we need to commence litigation to enforce our intellectual property rights or
determine the validity and scope of the proprietary rights of others, such litigation may be costly and divert the attention of
our management.
We
may be subject to intellectual property rights claims, which are costly to defend, could require us to pay damages and could limit
our ability to sell some of our products.
We
may become subject to intellectual property litigation or infringement claims, which could cause us to incur significant expenses
to defend such claims, divert management’s attention or prevent us from manufacturing, selling or using some aspect of our
current or future products. If we choose or are forced to settle such claims, we may be required to pay for a license to certain
rights, pay royalties on both a retrospective and prospective basis, and/or cease manufacturing and selling certain infringing
products. Future infringement claims against us by third parties may adversely impact our business, financial condition and results
of operations.
Our
insurance coverage may be insufficient to cover our legal claims or other losses that we may incur in the future.
We
maintain insurance, including property, general and product liability and other forms of insurance to protect ourselves against
potential loss exposures. In the future, insurance coverage may not be available at adequate levels or on adequate terms to cover
potential losses. If insurance coverage is inadequate or unavailable, we may face claims that exceed coverage limits or that are
not covered, which could increase our costs and adversely affect our operating results.
We
may be subject to uncertain and costly compliance with government regulations.
The
importing, manufacturing, processing, formulating, packaging, labeling, distributing, selling and advertising of our current and
future products may be subject to regulation by one or more federal or state agencies. The Food and Drug Administration, or the
FDA, has primary jurisdiction over our products pursuant to the Federal Food, Drug and Cosmetic Act, as amended by the Dietary
Supplement and Health Education Act, or the FDCA, and regulations promulgated thereunder. The FDCA provides the regulatory framework
for the safety and labeling of dietary supplements, foods and medical foods. In particular, the FDA regulates the safety, manufacturing,
labeling and distribution of dietary supplements. In addition, the Animal Plant Health and Inspection Service, or APHIS, regulates
the importation of our primary product from Germany. The Federal Trade Commission, or the FTC, and the FDA share jurisdiction
over the promotion and advertising of dietary supplements. Pursuant to a memorandum of understanding between the two agencies,
the FDA has primary jurisdiction over claims that appear on product labels and labeling and the FTC has primary jurisdiction over
product advertising.
Compliance
with applicable federal, state, and local laws and regulations is a critical part of our business. We endeavor to comply with
all applicable laws and regulations. However, as with any regulated industry, the laws and regulations are subject to interpretation
and there can be no assurances that a government agency would necessarily agree with our interpretation of the governing laws
and regulations. Moreover, we are unable to predict the nature of such future laws, regulations, interpretations or applications,
nor can we predict what effect additional governmental regulations or administrative orders, when and if promulgated, would have
on our business in the future. These regulations could, however, require the reformulation of our products to meet new standards,
market withdrawal or discontinuation of certain products not able to be reformulated. The risk of a product recall exists within
the industry although we endeavor to minimize the risk of recalls by distributing products that are not adulterated or misbranded.
However, the decision to initiate a recall is often made for business reasons in order to avoid confrontation with FDA.
Our
products are required to be prepared in compliance with the FDA’s Good Manufacturing Practices, or GMPs, for dietary supplements.
Fortetropin, the main ingredient in our products, is also required to be imported into the United States in conformance with APHIS’s
requirements for egg products. In the event it is determined that we have not complied with the foregoing requirements, we may
be required to initiate a product recall and/or be subject to financial or other penalties. We are continuously monitoring and
reviewing our processes to ensure compliance with APHIS and limit the likelihood of potential recalls.
Other
statutory obligations include reporting all serious adverse events on a Medwatch Form 3500A. To date, we have not filed a Medwatch
Form 3500A with the FDA nor have we been placed on notice regarding any serious adverse events related to any of our products.
Since eggs are considered a major food allergen under the Food Allergen Labeling and Consumer Protection Act of 2004, the labeling
of all our products must note that they contain egg yolk.
Advertising
of dietary supplement products is subject to regulation by the FTC under the Federal Trade Commission Act, or FTCA, which prohibits
unfair methods of competition and unfair or deceptive trade acts or practices in or affecting commerce. The FTCA provides that
the dissemination of any false advertising pertaining to foods, including dietary supplements, is an unfair or deceptive act or
practice. Under the FTC's substantiation doctrine, an advertiser is required to have a reasonable basis for all objective product
claims before the claims are made. All advertising is required to be truthful and not misleading. All testimonials are required
to be typical of the results the consumer may expect when using the product as directed. Accordingly, we are required to have
adequate substantiation of all material advertising claims made for our products. Failure to adequately substantiate claims may
be considered either deceptive or unfair practices.
RISKS
RELATED TO OUR COMMON STOCK
Trading
in our common stock over the last 12 months has been limited, so investors may not be able to sell as many of their shares as
they want at prevailing prices.
Shares
of our common stock began trading on the Nasdaq Capital Market on July 10, 2014 under the symbol “MYOS,” and were
previously traded on the OTC Bulletin Board (and the OTCQB) under the symbol “MYOS.” There has been limited trading
in our shares over the last 12 months. If limited trading in the common stock continues, it may be difficult for investors to
sell such shares in the public market at any given time at prevailing prices. Also, the sale of a large block of common stock
could depress the market price of the common stock to a greater degree than a company that typically has a higher volume of trading
of its securities.
Our
common stock may be delisted from the Nasdaq Capital Market if we cannot satisfy its continued listing requirements.
Among
the conditions required for continued listing on the Nasdaq Capital Market is that we maintain at least $2.5 million in stockholders’
equity. There can be no assurance that our stockholders’ equity will remain above Nasdaq’s $2.5 million minimum. If
we fail to timely comply with the stockholders’ equity requirement, our stock may be delisted. In addition, even if we demonstrate
compliance with the stockholders’ equity requirement, we will need to continue to meet other objective and subjective listing
requirements to continue to be listed on the Nasdaq Capital Market. Delisting from the Nasdaq Capital Market could make trading
our common stock more difficult for investors, potentially leading to declines in our share price and liquidity. Without a Nasdaq
Capital Market listing, stockholders may have a difficult time getting a quote for the sale or purchase of our stock, the sale
or purchase of our stock would likely be made more difficult and the trading volume and liquidity of our stock could decline.
Delisting from the Nasdaq Capital Market could also result in negative publicity and could also make it more difficult for us
to raise additional capital. The absence of such a listing may adversely affect the acceptance of our common stock as currency
or the value accorded by other parties. Further, if we are delisted, we would also incur additional costs under state blue sky
laws in connection with any sales of our securities. These requirements could severely limit the market liquidity of our common
stock and the ability of our stockholders to sell our common stock in the secondary market. If our common stock is delisted by
Nasdaq, our common stock may be eligible to trade on an over-the-counter quotation system, such as the OTCQB market, where an
investor may find it more difficult to sell our stock or obtain accurate quotations as to the market value of our common stock.
We cannot assure you that our common stock, if delisted from the Nasdaq Capital Market, will be listed on another national securities
exchange or quoted on an over-the counter quotation system.
If
the Nasdaq Capital Market delists our shares of common stock from trading on its exchange and we are not able to list our securities
on another national securities exchange, we expect our securities could be quoted on an over-the-counter market. If this were
to occur, we could face significant material adverse consequences, including:
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a
limited availability of market quotations for our securities;
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reduced
liquidity for our shares;
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a
determination that our common stock is a “penny stock” which will require
brokers trading in our common stock to adhere to more stringent rules and possibly result
in a reduced level of trading activity in the secondary trading market for our shares;
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a
limited amount of news and analyst coverage; and
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a
decreased ability to issue additional securities or obtain additional financing in the
future.
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An
active and visible trading market for our common stock may not develop.
We
cannot predict whether an active market for our common stock will develop in the future. In the absence of an active trading market:
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Investors
may have difficulty buying and selling or obtaining market quotations;
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Market
visibility for our common stock may be limited; and
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A
lack of visibility for our common stock may have a depressive effect on the market price for our common stock.
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The
trading price of our common stock is expected to be subject to significant fluctuations in response to variations in quarterly
operating results, changes in analysts’ earnings estimates, announcements of innovations by us or our competitors, general
conditions in the industry in which we operate and other factors. These fluctuations, as well as general economic and market conditions,
may have a material or adverse effect on the market price of our common stock.
The
market price for our stock may be volatile.
The
market price for our stock may be volatile and subject to wide fluctuations in response to factors including the following:
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actual
or anticipated fluctuations in our quarterly operating results;
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changes
in financial estimates by securities research analysts;
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conditions
in nutraceutical and pharmaceutical markets;
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changes
in the economic performance or market valuations of other nutraceutical companies;
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announcements
by us or our competitors of new products, acquisitions, strategic partnerships, joint ventures or capital commitments;
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addition
or departure of key personnel;
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intellectual
property or other litigation; and
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general
economic or political conditions.
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In
addition, the securities market has from time to time experienced significant price and volume fluctuations that are not related
to the operating performance of particular companies. These market fluctuations may also materially and adversely affect the market
price of our stock.
Our
stockholders may experience significant dilution if future equity offerings are used to fund operations or acquire complementary
businesses.
If
our future operations or acquisitions are financed through the issuance of equity securities, our stockholders could experience
significant dilution. In addition, securities issued in connection with future financing activities or potential acquisitions
may have rights and preferences senior to the rights and preferences of our common stock. We have also adopted an equity incentive
plan for our directors, officers, employees, consultants and advisors and granted options to purchase shares of our common stock
under the plan. We have reserved 400,000 shares of our common stock under the plan. The issuance of shares of our common stock
upon the exercise of these options may result in dilution to our stockholders.
Our
current management can exert significant influence over us and make decisions that are not in the best interests of all stockholders.
Our
executive officers and directors as a group own approximately 11.6% of our outstanding shares of common stock. As a result, they
will be able to assert significant influence over all matters requiring stockholder approval, including the election and removal
of directors and any change in control. In particular, this concentration of ownership of our outstanding shares of common stock
could have the effect of delaying or preventing a change in control, or otherwise discouraging or preventing a potential acquirer
from attempting to obtain control. This, in turn, could have a negative effect on the market price of our common stock. It could
also prevent our stockholders from realizing a premium over the market prices for their shares of common stock. Moreover, the
interests of the owners of this concentration of ownership may not always coincide with our interests or the interests of other
stockholders and, accordingly, could cause us to enter into transactions or agreements that we would not otherwise consider.
Compliance
with changing corporate governance regulations and public disclosure, and our management’s inexperience with such regulations,
will result in additional expenses and creates a risk of non-compliance.
Our
reporting obligations as a public company will place a significant strain on our management, operational and financial resources
and systems for the foreseeable future. Changing laws, regulations and standards relating to corporate governance and public disclosure,
including the Sarbanes-Oxley Act of 2002 and related SEC regulations, have created uncertainty for public companies and significantly
increased the costs and risks associated with accessing the public markets and public reporting. Our management team will need
to invest significant time and financial resources to comply with both existing and evolving standards for public companies, which
will lead to increased general and administrative expenses and a diversion of management time and attention from revenue generating
activities to compliance activities. In addition, our management has limited experience with compliance with U.S. securities laws.
This inexperience may cause us to fall out of compliance with applicable regulatory requirements, which could lead to enforcement
action against us and a negative impact on our stock price.
We
do not foresee paying cash dividends in the foreseeable future and, as a result, our investors’ sole source of gain, if
any, will depend on capital appreciation, if any.
We
do not plan to declare or pay any cash dividends on our shares of common stock in the foreseeable future and currently intend
to retain any future earnings for funding growth. As a result, investors should not rely on an investment in our securities if
they require the investment to produce dividend income. Capital appreciation, if any, of our shares may be investors’ sole
source of gain for the foreseeable future. Moreover, investors may not be able to resell their common stock at or above the price
they paid for them.
We
could issue blank check preferred stock without stockholder approval with the effect of diluting then current stockholder interests
and impairing their voting rights, and provisions in our charter documents and under Nevada law could discourage a takeover that
stockholders may consider favorable.
Our
certificate of incorporation provides for the authorization to issue up to 500,000 shares of blank check preferred stock with
designations, rights and preferences as may be determined from time to time by our board of directors. Our board of directors
is empowered, without stockholder approval, to issue a series of preferred stock with dividend, liquidation, conversion, voting
or other rights which could dilute the interest of, or impair the voting power of, our common stockholders. The issuance of a
series of preferred stock could be used as a method of discouraging, delaying or preventing a change in control. For example,
it would be possible for our board of directors to issue preferred stock with voting or other rights or preferences that could
impede the success of any attempt to change control of our company. In addition, advanced notice is required prior to stockholder
proposals.
Nevada
corporate laws limit the personal liability of corporate directors and officers and require indemnification under certain circumstances.
Section
78.138(7) of the Nevada Revised Statutes provides that, subject to certain very limited statutory exceptions or unless the articles
of incorporation provide for greater individual liability, a director or officer of a Nevada corporation is not individually liable
to the corporation or its stockholders for any damages as a result of any act or failure to act in his or her capacity as a director
or officer, unless it is proven that the act or failure to act constituted a breach of his or her fiduciary duties as a director
or officer and such breach involved intentional misconduct, fraud or a knowing violation of law. We have not included in our articles
of incorporation any provision intended to provide for greater liability as contemplated by this statutory provision.
In
addition, Section 78.7502(3) of the Nevada Revised Statutes provides that to the extent a director or officer of a Nevada corporation
has been successful on the merits or otherwise in the defense of certain actions, suits or proceedings (which may include certain
stockholder derivative actions), the corporation shall indemnify such director or officer against expenses (including attorneys’
fees) actually and reasonably incurred by such director or officer in connection therewith.
If
securities or industry analysts do not publish research or reports about our business, or if they change their recommendations
regarding our stock adversely, our stock price and trading volume could decline.
The
trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish
about us or our business. We do not currently have and may never obtain significant research coverage by industry or financial
analysts. If few analysts commence coverage of us, the trading price of our stock would likely decrease. Even if we do obtain
significant analyst coverage, if one or more of the analysts who cover us downgrade our stock, our stock price would likely decline.
If one or more of these analysts cease coverage of us or fail to regularly publish reports on us, we could lose visibility in
the financial markets, which in turn could cause our stock price or trading volume to decline.
A
failure of our internal control over financial reporting could materially impact our business or share price.
Our management
is responsible for establishing and maintaining adequate internal control over financial reporting. An internal control system,
no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control
system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits
of controls must be considered relative to their costs. Because of the inherent limitations in all internal control systems, internal
control over financial reporting may not prevent or detect misstatements. Any failure to maintain an effective system of internal
control over financial reporting could limit our ability to report our financial results accurately and timely or to detect and
prevent fraud, and could expose us to litigation or adversely affect the market price of our common stock.
RISKS
RELATED TO OUR FUTURE PRODUCTS
The
research and development of pharmaceutical products, which is separate from nutritional supplements, entails special considerations
and risks. If we are successful in developing pharmaceutical products for muscular-related conditions, we will be subject to,
and possibly adversely affected by, the following risks:
Our
failure to obtain costly government approvals, including required FDA approvals, or to comply with ongoing governmental regulations
relating to our technologies and proposed products and formulations could delay or limit introduction of our proposed formulations
and products and result in failure to achieve revenues or maintain our ongoing business.
Our
research and development activities for our products and product candidates are currently at an early development stage and are
subject to extensive regulation for safety, efficacy and quality by numerous government authorities in the United States and abroad.
Before receiving FDA regulatory clearance to market our future proposed formulations and products, we will have to demonstrate
that our formulations and products are safe and effective in the patient population and for the indicated diseases that are to
be treated. Clinical trials, manufacturing and marketing of drugs are subject to the rigorous testing and approval process of
the FDA and equivalent foreign regulatory authorities. The Federal Food, Drug and Cosmetic Act and other federal, state and foreign
statutes and regulations govern and influence the testing, manufacture, labeling, advertising, distribution and promotion of drugs
and medical devices. As a result, regulatory approvals can take a number of years or longer to accomplish and require the expenditure
of substantial financial, managerial and other resources.
Conducting
and completing the clinical trials necessary for FDA approval is costly and subject to intense regulatory scrutiny as well as
the risk of failing to meet the primary endpoint of such trials. We will not be able to commercialize and sell our future products
and formulations without successfully completing such trials.
In
order to conduct clinical trials that are necessary to obtain approval by the FDA to market a formulation or product, it is necessary
to receive clearance from the FDA to conduct such clinical trials. The FDA can halt clinical trials at any time for safety reasons
or because we or our clinical investigators did not follow the FDA’s requirements for conducting clinical trials. If we
are unable to receive clearance to conduct clinical trials or the trials are permanently halted by the FDA, we would not be able
to achieve any revenue from such product as it is illegal to sell any drug or medical device for human consumption or use without
FDA approval.
Data
obtained from clinical trials are susceptible to varying interpretations, which could delay, limit or prevent regulatory clearances.
Data
we may obtain in the future, from non-clinical studies and clinical trials do not necessarily predict the results that will be
obtained from later non-clinical studies and clinical trials. Moreover, non-clinical and clinical data are susceptible to multiple
and varying interpretations, which could delay, limit or prevent regulatory approval. A number of companies in the pharmaceutical
industry have suffered significant setbacks in advanced clinical trials, even after promising results in earlier trials. The failure
to adequately demonstrate the safety and effectiveness of a proposed formulation or product under development could delay or prevent
regulatory clearance of the product candidate, resulting in delays to commercialization, and could materially harm our business.
In addition, our clinical trials may not demonstrate sufficient levels of safety and efficacy necessary to obtain the requisite
regulatory approvals for our drugs, and thus our proposed drugs may not be approved for marketing. Finally, if any of our clinical
trials do not meet their primary endpoints, we would need to redo such clinical trials in order to progress development of the
subject product. These additional trials would be costly and divert resources from other projects.
Competitors
may develop competing technologies or products which outperform or supplant our technologies or products.
Drug
companies and/or other technology companies may in the future seek to develop and market pharmaceutical products which may compete
with our future technologies and products. Competitors may in the future develop similar or different technologies or products
which may become more accepted by the marketplace or which may supplant our technology entirely. In addition, many of our future
competitors may be significantly larger and better financed than we are, thus giving them a significant advantage over us.
We
may be unable to respond to competitive forces presently in the marketplace (including competition from larger companies), which
would severely impact our business. Moreover, should competing or dominating technologies or products come into existence and
the owners thereof patent the applicable technological advances, we could also be required to license such technologies in order
to continue to manufacture, market and sell our products. We may be unable to secure such licenses on commercially acceptable
terms, or at all, and our resulting inability to manufacture, market and sell the affected products could have a material adverse
effect on us.
The
market for our product candidates is rapidly changing and competitive, and new drug delivery mechanisms, drug delivery technologies,
new drugs and new treatments which may be developed by others could impair our ability to maintain and grow our business and remain
competitive.
Even
if successfully developed, our product candidates may not gain market acceptance among physicians, patients and healthcare payers,
which may not utilize our products. If our product candidates do not achieve market acceptance, our business and financial condition
will be materially adversely affected. The pharmaceutical industry is subject to rapid and substantial technological change. Developments
by others may render our technologies and our product candidates noncompetitive or obsolete, or we may be unable to keep pace
with technological developments or other market factors. Technological competition from pharmaceutical and biotechnology companies,
universities, governmental entities and others now existing or diversifying into the field is intense and is expected to increase.
Many of these entities have significantly greater research and development capabilities, human resources and budgets than we do,
as well as substantially more marketing, manufacturing, financial and managerial resources. These entities represent significant
competition for us. Acquisitions of, or investments in, competing pharmaceutical or biotechnology companies by large corporations
could increase such competitors’ financial, marketing, manufacturing and other resources.
USE
OF PROCEEDS
Except
as otherwise disclosed in the applicable prospectus supplement, we intend to use the net proceeds from the sales of securities
hereunder for research and development, including conducting clinical and basic research, expanding our commercial operations,
including sales, marketing and distribution capabilities, to meet our on-going working capital needs and general corporation purposes.
As of the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to us from
the sale of the securities offered by us hereunder and the applicable prospectus supplement. Accordingly, our management will
have broad discretion in the timing and application of these proceeds. Pending application of the net proceeds, we intend to temporarily
invest the proceeds in short-term, interest-bearing instruments.
PLAN
OF DISTRIBUTION
We
may sell the securities from time to time to or through underwriters or dealers, through agents, or directly to one or more purchasers.
A distribution of the securities offered by this prospectus may also be effected through the issuance of derivative securities,
including without limitation, preferred stock, warrants, and rights. In addition, the manner in which we may sell some or all
of the securities covered by this prospectus includes, without limitation, through:
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a
block trade in which a broker-dealer will attempt to sell as agent, but may position or resell a portion of the block, as
principal, in order to facilitate the transaction;
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purchases
by a broker-dealer, as principal, and resale by the broker-dealer for its account; or
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ordinary
brokerage transactions and transactions in which a broker solicits purchasers.
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prospectus supplement or supplements with respect to each series of securities will describe the terms of the offering, including,
to the extent applicable:
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the
terms of the offering;
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the
name or names of the underwriters or agents and the amounts of securities underwritten or purchased by each of them, if any;
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the
public offering price or purchase price of the securities or other consideration thereof, and the proceeds to be received
by us from the sale;
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any
delayed delivery requirements;
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any
over-allotment options under which underwriters may purchase additional securities from us;
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any
underwriting discounts or agency fees and other items constituting underwriters’ or agents’ compensation;
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any
discounts or concessions allowed or re-allowed or paid to dealers; and
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any
securities exchange or market on which the securities may be listed.
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The
offer and sale of the securities described in this prospectus by us, the underwriters or the third parties described above may
be effected from time to time in one or more transactions, including privately negotiated transactions, either:
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at
a fixed price or prices, which may be changed;
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in
an “at the market” offering within the meaning of Rule 415(a)(4) of the Securities Act;
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at
prices related to such prevailing market prices; or
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at
negotiated prices.
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Only underwriters
named in a prospectus supplement will be underwriters of the securities offered pursuant to such prospectus supplement.
Underwriters
and Agents; Direct Sales
If
underwriters are used in a sale, they will acquire the offered securities for their own account and may resell the offered securities
from time to time in one or more transactions, including negotiated transactions, at a fixed public offering price or at varying
prices determined at the time of sale. We may offer the securities to the public through underwriting syndicates represented by
managing underwriters or by underwriters without a syndicate.
Unless
the prospectus supplement states otherwise, the obligations of the underwriters to purchase the securities will be subject to
the conditions set forth in the applicable underwriting agreement. Subject to certain conditions, the underwriters will be obligated
to purchase all of the securities offered by the prospectus supplement, other than securities covered by any over-allotment option.
Any public offering price and any discounts or concessions allowed or re-allowed or paid to dealers may change from time to time.
We may use underwriters with whom we have a material relationship. We will describe in the prospectus supplement, naming the underwriter,
the nature of any such relationship.
We
may sell securities directly or through agents we designate from time to time. We will name any agent involved in the offering
and sale of securities, and we will describe any commissions we will pay the agent in the prospectus supplement. Unless the prospectus
supplement states otherwise, our agent will act on a best-efforts basis for the period of its appointment.
Dealers
We
may sell the offered securities to dealers as principals. The dealer may then resell such securities to the public either at varying
prices to be determined by the dealer or at a fixed offering price agreed to with us at the time of resale.
Institutional
Purchasers
We
may authorize agents, dealers or underwriters to solicit certain institutional investors to purchase offered securities on a delayed
delivery basis pursuant to delayed delivery contracts providing for payment and delivery on a specified future date. The applicable
prospectus supplement or other offering materials, as the case may be, will provide the details of any such arrangement, including
the offering price and commissions payable on the solicitations.
We
will enter into such delayed contracts only with institutional purchasers that we approve. These institutions may include commercial
and savings banks, insurance companies, pension funds, investment companies and educational and charitable institutions.
Indemnification;
Other Relationships
We
may provide agents, underwriters, dealers and remarketing firms with indemnification against certain civil liabilities, including
liabilities under the Securities Act, or contribution with respect to payments that the agents or underwriters may make with respect
to these liabilities. Agents, underwriters, dealers and remarketing firms, and their affiliates, may engage in transactions with,
or perform services for, us in the ordinary course of business. This includes commercial banking and investment banking transactions.
Market-Making;
Stabilization and Other Transactions
There
is currently no market for any of the offered securities, other than our common stock, which is listed on the Nasdaq Capital Market.
If the offered securities are traded after their initial issuance, they may trade at a discount from their initial offering price,
depending upon prevailing interest rates, the market for similar securities and other factors. While it is possible that an underwriter
could inform us that it intends to make a market in the offered securities, such underwriter would not be obligated to do so,
and any such market-making could be discontinued at any time without notice. Therefore, no assurance can be given as to whether
an active trading market will develop for the offered securities. We have no current plans for listing of the preferred stock,
warrants, rights, debt securities or units on any securities exchange or quotation system; any such listing with respect to any
particular securities will be described in the applicable prospectus supplement or other offering materials, as the case may be.
Any
underwriter may engage in over-allotment, stabilizing transactions, short-covering transactions and penalty bids in accordance
with Regulation M under the Exchange Act. Over-allotment involves sales in excess of the offering size, which create a short position.
Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specified
maximum price.
Syndicate-covering or other short-covering transactions involve purchases of the securities, either through exercise
of the over-allotment option or in the open market after the distribution is completed, to cover short positions. Penalty bids
permit the underwriters to reclaim a selling concession from a dealer when the securities originally sold by the dealer are purchased
in a stabilizing or covering transaction to cover short positions. Those activities may cause the price of the securities to be
higher than it would otherwise be. If commenced, the underwriters may discontinue any of the activities at any time.
Any
underwriters or agents that are qualified market makers on the Nasdaq Capital Market may engage in passive market making transactions
in our common stock on the Nasdaq Capital Market in accordance with Regulation M under the Exchange Act, during the business day
prior to the pricing of the offering, before the commencement of offers or sales of our common stock. Passive market makers must
comply with applicable volume and price limitations and must be identified as passive market makers. In general, a passive market
maker must display its bid at a price not in excess of the highest independent bid for such security; if all independent bids
are lowered below the passive market maker’s bid, however, the passive market maker’s bid must then be lowered when
certain purchase limits are exceeded. Passive market making may stabilize the market price of the securities at a level above
that which might otherwise prevail in the open market and, if commenced, may be discontinued at any time.
Fees
and Commissions
If
5% or more of the net proceeds of any offering of securities made under this prospectus will be received by a member of the Financial
Industry Regulatory Authority, or “FINRA,” participating in the offering or affiliates or associated persons of such
FINRA member, the offering will be conducted in accordance with FINRA Rule 5121.
DESCRIPTION
OF SECURITIES WE MAY OFFER
General
This
prospectus describes the general terms of our capital stock. The following description is not complete and may not contain all
the information you should consider before investing in our capital stock. For a more detailed description of these securities,
you should read the applicable provisions of Nevada law and our articles of incorporation, as amended, and our bylaws. When we
offer to sell a particular series of these securities, we will describe the specific terms of the series in a supplement to this
prospectus.
Accordingly, for a description of the terms of any series of securities, you must refer to both the prospectus supplement
relating to that series and the description of the securities described in this prospectus. To the extent the information contained
in the prospectus supplement differs from this summary description, you should rely on the information in the prospectus supplement.
Our
authorized capital stock consists of 6,000,000 shares of common stock, par value $0.001 per share, and 500,000 authorized undesignated
shares of preferred stock, par value $0.001 per share.
We,
directly or through agents, dealers or underwriters designated from time to time, may offer, issue and sell, together or separately,
up to $75,000,000 in the aggregate of:
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common
stock;
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preferred
stock;
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secured
or unsecured debt securities consisting of notes, debentures or other evidences of indebtedness which may be senior debt securities,
senior subordinated debt securities or subordinated debt securities, each of which may be convertible into equity securities;
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warrants
to purchase our securities;
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rights
to purchase our securities; or
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units
comprised of, or other combinations of, the foregoing securities.
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We
may issue the debt securities as exchangeable for or convertible into shares of common stock, preferred stock or other securities.
The preferred stock may also be exchangeable for and/or convertible into shares of common stock, another series of preferred stock
or other securities. When a particular series of securities is offered, a supplement to this prospectus will be delivered with
this prospectus, which will set forth the terms of the offering and sale of the offered securities.
Common
Stock
As
of October 13, 2014, there were 2,909,435 shares of common stock issued and outstanding and 140 holders of record of our common
stock. Further, there were outstanding Series A warrants to purchase 315,676 shares of common stock and Series B warrants to purchase
157,846 shares of common stock.
Voting.
Holders of common stock are entitled to one vote for each share held on all matters submitted to a vote of the stockholders,
and do not have cumulative voting rights.
Dividends.
Subject to preferences that may be applicable to any then outstanding preferred stock, and further subject to any contractual
limitations on the declaration, setting aside or payment of dividends, holders of common stock are entitled to receive ratably
such dividends, if any, as may be declared from time to time by our board of directors out of funds legally available for dividend
payments.
Liquidation
.
In the event of any liquidation, dissolution or winding up of our affairs, holders of common stock will be entitled to share ratably
in our assets that are remaining after payment or provision for payment of all of our debts and other liabilities and the satisfaction
of any liquidation preferences that may be granted to the holders of any then outstanding shares of preferred stock.
Rights
and Preferences
. The common stock has no preemptive, conversion or other subscription rights, and there are no redemption
or sinking fund provisions applicable to the common stock. The rights, preferences and privileges of the holders of common stock
are subject to, and may be adversely affected by, the rights of the holders of shares of any series of preferred stock, which
we may designate and issue in the future.
Our
common stock is admitted for trading on the Nasdaq Capital Market under the symbol “MYOS”.
The
transfer agent and registrar for our common stock is Island Stock Transfer.
Preferred
Stock
Our
board of directors has the authority to issue up to an aggregate of 500,000 shares of preferred stock in one or more series and
to fix the voting powers, designations, preferences and rights, and qualifications, limitations or restrictions thereof, of each
such series without any further vote or action by the stockholders. As of October 13, 2014, there were no shares of preferred
stock outstanding.
We
will fix the rights, preferences, privileges and restrictions of the preferred stock of each series in the certificate of designation
relating to that series. We will file as an exhibit to the registration statement of which this prospectus is a part, or will
incorporate by reference from a Current Report on Form 8-K that we file with the SEC, the form of any certificate of designation
that describes the terms of the series of preferred stock we are offering before the issuance of the related series of preferred
stock. This description will include any or all of the following, as required:
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the
title and stated value;
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the
number of shares we are offering;
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the
liquidation preference per share;
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the
purchase price;
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the
dividend rate, period and payment date and method of calculation for dividends;
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whether
dividends will be cumulative or non-cumulative and, if cumulative, the date from which dividends will accumulate;
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any
contractual limitations on our ability to declare, set aside or pay any dividends;
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the
procedures for any auction and remarketing, if any;
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the
provisions for a sinking fund, if any;
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the
provisions for redemption or repurchase, if applicable, and any restrictions on our ability to exercise those redemption and
repurchase rights;
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any
listing of the preferred stock on any securities exchange or market;
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whether
the preferred stock will be convertible into our common stock, and, if applicable, the conversion price, or how it will be
calculated, and the conversion period;
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whether
the preferred stock will be exchangeable into debt securities, and, if applicable, the exchange price, or how it will be calculated,
and the exchange period;
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voting
rights, if any, of the preferred stock;
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preemptive
rights, if any;
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restrictions
on transfer, sale or other assignment, if any;
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whether
interests in the preferred stock will be represented by depositary shares;
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a
discussion of any material or special United States federal income tax considerations applicable to the preferred stock;
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the
relative ranking and preferences of the preferred stock as to dividend rights and rights if we liquidate, dissolve or wind
up our affairs;
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any
limitations on issuance of any class or series of preferred stock ranking senior to or on a parity with the series of preferred
stock as to dividend rights and rights if we liquidate, dissolve or wind up our affairs; and
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any
other specific terms, preferences, rights or limitations of, or restrictions on, the preferred stock.
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If
we issue shares of preferred stock under this prospectus, after receipt of payment therefor, the shares will be fully paid and
non-assessable.
Our
board of directors may authorize the issuance of preferred stock with voting or conversion rights that could adversely affect
the voting power or other rights of the holders of our common stock. Preferred stock could be issued quickly with terms designed
to delay or prevent a change in control of our company or make removal of management more difficult. Additionally, the issuance
of preferred stock could have the effect of decreasing the market price of our common stock.
Debt
Securities
As
used in this prospectus, the term “debt securities” means the debentures, notes, bonds and other evidences of indebtedness
that we may issue from time to time. The debt securities will either be senior debt securities, senior subordinated debt or subordinated
debt securities. We may also issue convertible debt securities. Debt securities may be issued under an indenture (which we refer
to herein as an Indenture), which are contracts entered into between us and a trustee to be named therein. A form of the Indenture
has been filed as an exhibit to the registration statement of which this prospectus forms a part. We may issue debt securities
and incur additional indebtedness other than through the offering of debt securities pursuant to this prospectus. It is likely
that convertible debt securities will not be issued under an Indenture.
In
the event that any series of debt securities will be subordinated to other indebtedness that we have outstanding or may incur,
the terms of the subordination will be set forth in the prospectus supplement relating to the subordinated debt securities.
We
may issue debt securities from time to time in one or more series, in each case with the same or various maturities, at par or
at a discount. Unless indicated in a prospectus supplement, we may issue additional debt securities of a particular series without
the consent of the holders of the debt securities of such series outstanding at the time of the issuance. Any such additional
debt securities, together with all other outstanding debt securities of that series, will constitute a single series of debt securities
under the applicable Indenture and will be equal in ranking.
Should
an Indenture relate to unsecured indebtedness, in the event of a bankruptcy or other liquidation event involving a distribution
of assets to satisfy our outstanding indebtedness or an event of default under a loan agreement relating to secured indebtedness
of our company or its subsidiaries, the holders of such secured indebtedness, if any, would be entitled to receive payment of
principal and interest prior to payments on the unsecured indebtedness issued under an Indenture.
Each
prospectus supplement will describe the terms relating to the specific series of debt securities. These terms will include some
or all of the following:
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the
title of debt securities and whether the debt securities are senior or subordinated;
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any
limit on the aggregate principal amount of debt securities of such series;
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the
percentage of the principal amount at which the debt securities of any series will be issued;
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the
ability to issue additional debt securities of the same series;
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the
purchase price for the debt securities and the denominations of the debt securities;
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the
specific designation of the series of debt securities being offered;
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the
maturity date or dates of the debt securities and the date or dates upon which the debt securities are payable and the rate
or rates at which the debt securities of the series shall bear interest, if any, which may be fixed or variable, or the method
by which such rate shall be determined;
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the
basis for calculating interest;
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the
date or dates from which any interest will accrue or the method by which such date or dates will be determined;
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the
duration of any deferral period, including the period during which interest payment periods may be extended;
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whether
the amount of payments of principal of (and premium, if any) or interest on the debt securities may be determined with reference
to any index, formula or other method, such as one or more currencies, commodities, equity indices or other indices, and the
manner of determining the amount of such payments;
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the
dates on which we will pay interest on the debt securities and the regular record date for determining who is entitled to
the interest payable on any interest payment date;
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the
place or places where the principal of (and premium, if any) and interest on the debt securities will be payable, where any
securities may be surrendered for registration of transfer, exchange or conversion, as applicable, and notices and demands
may be delivered to or upon us pursuant to the applicable Indenture;
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the
rate or rates of amortization of the debt securities;
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any
terms for the attachment to the debt securities of warrants, options or other rights to purchase or sell our securities;
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if
the debt securities will be secured by any collateral and, if so, a general description of the collateral and the terms and
provisions of such collateral security, pledge or other agreements;
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if
we possess the option to do so, the periods within which and the prices at which we may redeem the debt securities, in whole
or in part, pursuant to optional redemption provisions, and the other terms and conditions of any such provisions;
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our
obligation or discretion, if any, to redeem, repay or purchase debt securities by making periodic payments to a sinking fund
or through an analogous provision or at the option of holders of the debt securities, and the period or periods within which
and the price or prices at which we will redeem, repay or purchase the debt securities, in whole or in part, pursuant to such
obligation, and the other terms and conditions of such obligation;
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the
terms and conditions, if any, regarding the option or mandatory conversion or exchange of debt securities;
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the
period or periods within which, the price or prices at which and the terms and conditions upon which any debt securities of
the series may be redeemed, in whole or in part at our option and, if other than by a board resolution, the manner in which
any election by us to redeem the debt securities shall be evidenced;
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any
restriction or condition on the transferability of the debt securities of a particular series;
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the
portion, or methods of determining the portion, of the principal amount of the debt securities which we must pay upon the
acceleration of the maturity of the debt securities in connection with any event of default;
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the
currency or currencies in which the debt securities will be denominated and in which principal, any premium and any interest
will or may be payable or a description of any units based on or relating to a currency or currencies in which the debt securities
will be denominated;
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provisions,
if any, granting special rights to holders of the debt securities upon the occurrence of specified events;
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any
deletions from, modifications of or additions to the events of default or our covenants with respect to the applicable series
of debt securities, and whether or not such events of default or covenants are consistent with those contained in the applicable
Indenture;
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any
limitation on our ability to incur debt, redeem stock, sell our assets or other restrictions;
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the
application, if any, of the terms of the applicable Indenture relating to defeasance and covenant defeasance (which terms
are described below) to the debt securities;
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what
subordination provisions will apply to the debt securities;
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the
terms, if any, upon which the holders may convert or exchange the debt securities into or for our securities or property;
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whether
we are issuing the debt securities in whole or in part in global form;
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any
change in the right of the trustee or the requisite holders of debt securities to declare the principal amount thereof due
and payable because of an event of default;
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the
depositary for global or certificated debt securities, if any;
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any
material federal income tax consequences applicable to the debt securities, including any debt securities denominated and
made payable, as described in the prospectus supplements, in foreign currencies, or units based on or related to foreign currencies;
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any
right we may have to satisfy, discharge and defease our obligations under the debt securities, or terminate or eliminate restrictive
covenants or events of default in the Indentures, by depositing money or U.S. government obligations with the trustee of the
Indentures;
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the
names of any trustees, depositories, authenticating or paying agents, transfer agents or registrars or other agents with respect
to the debt securities;
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to
whom any interest on any debt security shall be payable, if other than the person in whose name the security is registered,
on the record date for such interest, the extent to which, or the manner in which, any interest payable on a temporary global
debt security will be paid;
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if
the principal of or any premium or interest on any debt securities is to be payable in one or more currencies or currency
units other than as stated, the currency, currencies or currency units in which it shall be paid and the periods within and
terms and conditions upon which such election is to be made and the amounts payable (or the manner in which such amount shall
be determined);
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the
portion of the principal amount of any debt securities which shall be payable upon declaration of acceleration of the maturity
of the debt securities pursuant to the applicable Indenture;
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if
the principal amount payable at the stated maturity of any debt security of the series will not be determinable as of any
one or more dates prior to the stated maturity, the amount which shall be deemed to be the principal amount of such debt securities
as of any such date for any purpose, including the principal amount thereof which shall be due and payable upon any maturity
other than the stated maturity or which shall be deemed to be outstanding as of any date prior to the stated maturity (or,
in any such case, the manner in which such amount deemed to be the principal amount shall be determined); and
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any
other specific terms of the debt securities, including any modifications to the events of default under the debt securities
and any other terms which may be required by or advisable under applicable laws or regulations.
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Unless
otherwise specified in the applicable prospectus supplement, we do not anticipate the debt securities will be listed on any securities
exchange. Holders of the debt securities may present registered debt securities for exchange or transfer in the manner described
in the applicable prospectus supplement. Except as limited by the applicable Indenture, we will provide these services without
charge, other than any tax or other governmental charge payable in connection with the exchange or transfer.
Debt
securities may bear interest at a fixed rate or a variable rate as specified in the prospectus supplement. In addition, if specified
in the prospectus supplement, we may sell debt securities bearing no interest or interest at a rate that at the time of issuance
is below the prevailing market rate, or at a discount below their stated principal amount. We will describe in the applicable
prospectus supplement any special federal income tax considerations applicable to these discounted debt securities.
We
may issue debt securities with the principal amount payable on any principal payment date, or the amount of interest payable on
any interest payment date, to be determined by referring to one or more currency exchange rates, commodity prices, equity indices
or other factors. Holders of such debt securities may receive a principal amount on any principal payment date, or interest payments
on any interest payment date, that are greater or less than the amount of principal or interest otherwise payable on such dates,
depending upon the value on such dates of applicable currency, commodity, equity index or other factors. The applicable prospectus
supplement will contain information as to how we will determine the amount of principal or interest payable on any date, as well
as the currencies, commodities, equity indices or other factors to which the amount payable on that date relates and certain additional
tax considerations.
Warrants
We
may issue warrants to purchase our securities or other rights, including rights to receive payment in cash or securities based
on the value, rate or price of one or more specified commodities, currencies, securities or indices, or any combination of the
foregoing. Warrants may be issued independently or together with any other securities and may be attached to, or separate from,
such securities. To the extent warrants that we issue are to be publicly-traded, each series of such warrants will be issued under
a separate warrant agreement to be entered into between us and a warrant agent.
We
will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from
a Current Report on Form 8-K that we file with the SEC, forms of the warrant and warrant agreement, if any. The prospectus supplement
relating to any warrants that we may offer will contain the specific terms of the warrants and a description of the material provisions
of the applicable warrant agreement, if any. These terms may include the following:
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the
title of the warrants;
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the
price or prices at which the warrants will be issued;
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the
designation, amount and terms of the securities or other rights for which the warrants are exercisable;
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the
designation and terms of the other securities, if any, with which the warrants are to be issued and the number of warrants
issued with each other security;
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the
aggregate number of warrants;
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any
provisions for adjustment of the number or amount of securities receivable upon exercise of the warrants or the exercise price
of the warrants;
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the
price or prices at which the securities or other rights purchasable upon exercise of the warrants may be purchased;
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if
applicable, the date on and after which the warrants and the securities or other rights purchasable upon exercise of the warrants
will be separately transferable;
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a
discussion of any material U.S. federal income tax considerations applicable to the exercise of the warrants;
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the
date on which the right to exercise the warrants will commence, and the date on which the right will expire;
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the
maximum or minimum number of warrants that may be exercised at any time;
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information
with respect to book-entry procedures, if any; and
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any
other terms of the warrants, including terms, procedures and limitations relating to the exchange and exercise of the warrants.
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Exercise
of Warrants.
Each warrant will entitle the holder of warrants to purchase the amount of securities or other rights, at the
exercise price stated or determinable in the prospectus supplement for the warrants. Warrants may be exercised at any time up
to the close of business on the expiration date shown in the applicable prospectus supplement, unless otherwise specified in such
prospectus supplement. After the close of business on the expiration date, if applicable, unexercised warrants will become void.
Warrants may be exercised in the manner described in the applicable prospectus supplement. When the warrant holder makes the payment
and properly completes and signs the warrant certificate at the corporate trust office of the warrant agent, if any, or any other
office indicated in the prospectus supplement, we will, as soon as possible, forward the securities or other rights that the warrant
holder has purchased. If the warrant holder exercises less than all of the warrants represented by the warrant certificate, we
will issue a new warrant certificate for the remaining warrants.
Rights
We
may issue rights to purchase our securities. The rights may or may not be transferable by the persons purchasing or receiving
the rights. In connection with any rights offering, we may enter into a standby underwriting or other arrangement with one or
more underwriters or other persons pursuant to which such underwriters or other persons would purchase any offered securities
remaining unsubscribed for after such rights offering. In connection with a rights offering to holders of our capital stock a
prospectus supplement will be distributed to such holders on the record date for receiving rights in the rights offering set by
us.
We
will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from
a Current Report on Form 8-K that we file with the SEC, forms of the subscription rights, standby underwriting agreement or other
agreements, if any. The prospectus supplement relating to any rights that we offer will include specific terms relating to the
offering, including, among other matters:
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the
date of determining the security holders entitled to the rights distribution;
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the
aggregate number of rights issued and the aggregate amount of securities purchasable upon exercise of the rights;
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the
exercise price;
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the
conditions to completion of the rights offering;
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the
date on which the right to exercise the rights will commence and the date on which the rights will expire; and
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any
applicable federal income tax considerations.
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Each
right would entitle the holder of the rights to purchase the principal amount of securities at the exercise price set forth in
the applicable prospectus supplement. Rights may be exercised at any time up to the close of business on the expiration date for
the rights provided in the applicable prospectus supplement. After the close of business on the expiration date, all unexercised
rights will become void.
Holders
may exercise rights as described in the applicable prospectus supplement. Upon receipt of payment and the rights certificate properly
completed and duly executed at the corporate trust office of the rights agent, if any, or any other office indicated in the prospectus
supplement, we will, as soon as practicable, forward the securities purchasable upon exercise of the rights. If less than all
of the rights issued in any rights offering are exercised, we may offer any unsubscribed securities directly to persons other
than stockholders, to or through agents, underwriters or dealers or through a combination of such methods, including pursuant
to standby underwriting arrangements, as described in the applicable prospectus supplement.
Units
We
may issue units consisting of any combination of the other types of securities offered under this prospectus in one or more series.
We may evidence each series of units by unit certificates that we may issue under a separate agreement. We may enter into unit
agreements with a unit agent. Each unit agent, if any, may be a bank or trust company that we select. We will indicate the name
and address of the unit agent, if any, in the applicable prospectus supplement relating to a particular series of units. Specific
unit agreements, if any, will contain additional important terms and provisions. We will file as an exhibit to the registration
statement of which this prospectus is a part, or will incorporate by reference from a Current Report on Form 8-K that we file
with the SEC, the form of unit and the form of each unit agreement, if any, relating to units offered under this prospectus.
If
we offer any units, certain terms of that series of units will be described in the applicable prospectus supplement, including,
without limitation, the following, as applicable
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title of the series of units;
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identification
and description of the separate constituent securities comprising the units;
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the
price or prices at which the units will be issued;
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the
date, if any, on and after which the constituent securities comprising the units will be separately transferable;
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a
discussion of certain United States federal income tax considerations applicable to the units; and
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any
other material terms of the units and their constituent securities.
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LEGAL
MATTERS
Unless
otherwise indicated in the applicable prospectus supplement, the validity of the securities offered by this prospectus will be
passed upon for us by Ellenoff Grossman & Schole LLP, New York, New York. If legal matters in connection with offerings made
by this prospectus are passed on by counsel for the underwriters, dealers or agents, if any, that counsel will be named in the
applicable prospectus supplement.
EXPERTS
Our
consolidated balance sheet for the fiscal years ended December 31, 2013 and December 31, 2012, and the related consolidated statements
of operations, changes in stockholders’ equity and cash flows, incorporated by reference herein, have been so incorporated
in reliance on the report of Seligson & Giannattasio, LLP, an independent registered public accounting firm, given on the
authority of such firm as experts in accounting and auditing.
WHERE
YOU CAN FIND MORE INFORMATION
We
file annual, quarterly and special reports, proxy statements and other information with the SEC. Information filed with the SEC
by us can be inspected and copied at the Public Reference Room maintained by the SEC at 100 F Street, N.E., Washington, D.C. 20549.
You may also obtain copies of this information by mail from the Public Reference Section of the SEC at prescribed rates. Further
information on the operation of the SEC’s Public Reference Room in Washington, D.C. can be obtained by calling the SEC at
1-800-SEC-0330. The SEC also maintains a web site that contains reports, proxy and information statements and other information
about issuers, such as us, who file electronically with the SEC. The address of that website is www.sec.gov.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
We
are “incorporating by reference” in this prospectus certain documents we file with the SEC, which means that we can
disclose important information to you by referring you to those documents. The information in the documents incorporated by reference
is considered to be part of this prospectus. Statements contained in documents that we file with the SEC and that are incorporated
by reference in this prospectus will automatically update and supersede information contained in this prospectus, including information
in previously filed documents or reports that have been incorporated by reference in this prospectus, to the extent the new information
differs from or is inconsistent with the old information. We have filed or may file the following documents with the SEC and they
are incorporated herein by reference as of their respective dates of filing.
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Our
Annual Report on Form 10-K for the fiscal year ended December 31, 2013 filed with the SEC on March 31, 2014;
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Our
Quarterly Reports on Form 10-Q for the quarter ended March 31, 2014 filed with the SEC on May 15, 2014 and for the quarter
ended June 30, 2014 filed with the SEC on August 14, 2014;
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Our
Current Reports on Form 8-K filed with the SEC on January 28, 2014, February 10, 2014, February 14, 2014, February 24, 2014, May
19, 2014, June 6, 2014, June 23, 2014, July 15, 2014 and July 24, 2014;
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The
description of our common stock contained in our Form 8-A filed on July 9, 2014 and as it may be further amended from time
to time.
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All
documents filed by us pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus and
before the termination or completion of this offering of our securities shall be deemed to be incorporated by reference in this
prospectus and to be a part of it from the filing dates of such documents, except in each case for information contained in any
such filing where we indicate that such information is being furnished and is not to be considered “filed” under the
Securities Exchange Act of 1934, as amended.
Any
statement contained in a document incorporated or deemed to be incorporated by reference in this prospectus shall be deemed modified,
superseded or replaced for purposes of this prospectus to the extent that a statement contained in this prospectus, or in any
subsequently filed document that also is deemed to be incorporated by reference in this prospectus, modifies, supersedes or replaces
such statement. Any statement so modified, superseded or replaced shall not be deemed, except as so modified, superseded or replaced,
to constitute a part of this prospectus. None of the information that we disclose under Items 2.02 or 7.01 of any Current Report
on Form 8-K or any corresponding information, either furnished under Item 9.01 or included as an exhibit therein, that we may
from time to time furnish to the SEC will be incorporated by reference into, or otherwise included in, this prospectus, except
as otherwise expressly set forth in the relevant document. Subject to the foregoing, all information appearing in this prospectus
is qualified in its entirety by the information appearing in the documents incorporated by reference.
Documents
incorporated by reference are available from us without charge, excluding all exhibits unless we have specifically incorporated
by reference the exhibit in this prospectus. You may obtain documents incorporated by reference in this prospectus by requesting
them in writing or by telephone from:
MYOS
Corporation
45
Horsehill Road, Suite 106
Cedar
Knolls, New Jersey 07927
Attention:
Secretary
(973) 509-0444
MYOS
RENS TECHNOLOGY INC.
500,000
Shares of Common Stock
PROSPECTUS
SUPPLEMENT
Chardan
February
3, 2017
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