UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) of the SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported):
June 26, 2019
Vivos
Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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00-53497
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80-0138937
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(State
or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS
Employer
Identification Number)
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719
Jadwin Avenue
Richland,
WA 99352
(Address
of principal executive offices)
(509)
736-4000
(Registrant’s
telephone number, including area code)
Not
Applicable
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2. below):
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[ ]
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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[ ]
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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[ ]
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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[ ]
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities
registered pursuant to Section (12)b of the Act: None
Securities
registered pursuant to Section 12(g) of the Act:
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Title
of each class
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Trading
Symbols(s)
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Name
of each exchange on which registered
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Common
Stock, par value $0.001
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RDGL
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OTC
PINK
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Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR
230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2) [ ]
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act [ ]
Item
3.03 Material Modification to Rights of Security Holders.
See
Item 5.03.
Item
5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year
On
June 26 2019, Vivos Inc. (the “
Company
”) filed a Certificate of Amendment to its Certificate of Incorporation,
as amended (“
Charter
”) (the “
Amendment
”), a copy of which is attached as Exhibit 3.1 to
this Current Report on Form 8-K, with the Secretary of State of the State of Delaware to effect a 1-for-8 reverse stock split
of the Company’s issued and outstanding shares of common stock, par value $0.001 per share (“
Common Stock
”),
with an effective date of June 25, 2019 at 11:59 p.m. Eastern Time (the “
Reverse Split
”). In addition, the
Amendment decreased the number of shares of Common Stock authorized for issuance under the Company’s Charter from 2 billion
shares to 950 million shares (the “
Change in Authorized
”).
As
disclosed in the Company’s Definitive Information Statement, as amended (“
Information Statement
”), filed
with the Securities and Exchange Commission (“
SEC
”) on May 22, 2019 and mailed to the Company’s stockholders
on or about June 3, 2019, the Reverse Split and Change in Authorized were approved by the Company’s Board of Directors and
by written consent of holders of a majority of the Company’s outstanding voting securities on March 28, 2019. More information
about the Reverse Split and Change in Authorized can be found in the Company’s Information Statement.
As
a result of the Reverse Split, every eight shares of the Company’s issued and outstanding Common Stock will be automatically
combined into one issued and outstanding share of the Common Stock, without any change in the par value per share. No fractional
shares will be issued as a result of the Reverse Split. No fractional shares of Common Stock will be issued in connection with
the Reverse Split; instead, any stockholder who would otherwise be entitled to receive a fractional share of Common Stock as a
result of the Reverse Split shall be entitled to receive a cash payment in lieu thereof based on the 5-day volume weighted average
price of the Company’s Common Stock immediately prior to the Reverse Split.
The
Reverse Split was approved by the Financial Industry Regulation Authority (“
FINRA
”) on June 27, 2019, and began
trading on the OTC:PINK marketplace at the opening of trading on June 28, 2019 under the symbol “RDGLD.” The “D”
will appear on the Company’s ticker symbol for the next 20 business days. The Company’s new CUSIP number will be 92858K204.
The
foregoing description of the Amendment does not purport to be complete, and is qualified in its entirety by reference to the full
text of the Certificate of Amendment, a copy of which is filed as Exhibit 3.1 to this Current Report on Form 8-K and incorporated
by reference herein.
Item
8.01 Other Events
On
June 26, 2019, the Company issued a press release announcing the Company’s plans to effect the Reverse Split and Change
in Authorized, and providing certain information to stockholders. A copy of the Company’s press release is attached as Exhibit
99.1 to this Current Report on Form 8-K. On June 27, 2019, the Company issued a corrective press release regarding the timing
of the Reverse Split, a copy of which is attached as Exhibit 99.2 to this Press Release.
Item
9.01 Financial Statements and Exhibits.
See
Exhibit Index.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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Vivos
Inc.
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Date:
July 2, 2019
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By:
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/s/
Michael K. Korenko
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Name:
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Michael
K. Korenko
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Title:
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Chief
Executive Officer
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EXHIBIT
INDEX
CERTIFICATE
OF AMENDMENT
OF
CERTIFICATE
OF INCORPORATION
OF
VIVOS
INC
Pursuant
to Section 242 of the General Corporation Law of the State of Delaware, the undersigned, by and on behalf of Vivos Inc (the “
Corporation
”),
a corporation duly organized and existing under and by virtue of the General Corporation Law of the State of Delaware, DOES HEREBY
CERTIFY:
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FIRST:
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This
Certificate of Amendment amends the provisions of the Corporation’s Certificate of Incorporation, as amended (the “
Certificate
of Incorporation
”).
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SECOND:
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The
Board of Directors of the Corporation, acting in accordance with the provisions of 242 of the General Corporation Law of the
State of Delaware, adopted resolutions setting forth an amendment to the Certificate of Incorporation of the Corporation and
declaring said amendment to be advisable, as follows:
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RESOLVED:
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That
Article IV of the Certificate of Incorporation of the Corporation, as amended to date, be and hereby is further amended
by deleting the first paragraph thereof in its entirety and replacing it with the following new paragraphs:
1.
Authorized Shares.
The Corporation is authorized to issue a total of 970,000,000 shares in two classes designated,
respectively, “Common Stock” and “Preferred Stock.” The total number of shares of Common Stock
authorized to be issued is 950,000,000 shares, $0.001 par value per share. The total number of shares of Preferred Stock
authorized to be issued is 20,000,000 shares, $0.001 par value per share.
Upon
effectiveness of this Certificate of Amendment to the Certificate of Incorporation of the Corporation (the “
Effective
Time
”), every eight (8) shares of the Corporation’s Common Stock issued and outstanding immediately prior
to the Effective Time (the “
Old Common Stock
”), will automatically and without any action on the part
of the respective holders thereof be combined, reclassified and changed into one (1) share of Common Stock of the Corporation
(the “
New Common Stock
”). Notwithstanding the immediately preceding sentence, in lieu of any fractional
interests in shares of New Common Stock to which any stockholder would otherwise be entitled pursuant hereto (taking into
account all shares of capital stock owned by such stockholder), any fractional share will be rounded down to the nearest
whole number and the holder shall be entitled to receive a cash payment in the amount equal to the value of such fractional
share. The combination and conversion of the Old Common Stock shall be referred to as the “
Reverse Stock Split
.”
The
Corporation shall not be obligated to issue certificates evidencing the shares of New Common Stock outstanding as a result
of the Reverse Stock Split unless and until the certificates evidencing the shares held by a holder prior to the Reverse
Stock Split are either delivered to the Corporation or its transfer agent, or the holder notifies the Corporation or its
transfer agent that such certificates have been lost, stolen or destroyed and executes an agreement satisfactory to the
Corporation to indemnify the Corporation from any loss incurred by it in connection with such certificates. Each stock
certificate that, immediately prior to the Effective Time, represented shares of Old Common Stock shall, from and after
the Effective Time, automatically and without the necessity of presenting the same for exchange, represent that number
of whole shares of New Common Stock into which the shares of Old Common Stock represented by such certificate shall have
been reclassified;
provided, however
, that each holder of record of a certificate that represented shares of Old
Common Stock shall receive, upon surrender of such certificate, a new certificate representing the number of whole shares
of New Common Stock into which the shares of Old Common Stock represented by such certificate shall have been reclassified.”
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THIRD:
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The
foregoing amendment was approved by holders of a majority of the Corporation’s outstanding voting securities via written
consent on March 28, 2019, and was duly adopted in accordance with Sections 228 and 242 of the General Corporation Law of
the State of Delaware.
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FOURTH:
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The
foregoing amendment shall be effective as of 11:59 PM Eastern time on June 25, 2019.
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IN
WITNESS WHEREOF, this Certificate of Amendment has been executed by a duly authorized officer of this Corporation on this 25th
day of June, 2019.
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VIVOS INC
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By:
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/s/
Michael Korenko
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Name:
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Michael Korenko
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Title:
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Chief Executive Officer
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Vivos
Inc.
Vivos
Inc. Announces 1-for-8 Reverse Stock Split
Richland,
WA, June 26, 2019
(GLOBAL NEWSWIRE) –
Vivos Inc. (OTC PINK: RDGL)
Vivos
Inc. (the “
Company
”) (OTC PINK: RDGL), a company engaged in the development and commercialization of minimally
invasive brachytherapy treatments to combat cancer in animals and humans, today announced that it will effect a 1-for-8 reverse
stock split of its issued and outstanding shares of common stock (the “
Reverse Split
”), which Reverse Split
was previously approved by the Company’s Board of Directors and stockholders via written consent. The Reverse Split will
be effective as of 11:59 p.m. Eastern Time on June 25, 2019, and the Company’s common stock will begin trading on a post-split
basis on June 26, 2019.
The
Reverse Split will reduce the number of shares of the Company’s common stock currently issued and outstanding from approximately
1.42 billion shares to 177.7 million shares and reduce the shares issuable upon conversion of the Company’s convertible
preferred stock from approximately 240 million to 30 million shares. Proportional adjustments will be made to the exercise prices
of the Company’s outstanding options and warrants, as well as the number of shares issued and issuable under the Company’s
incentive plan. Concurrently with the Reverse Split, the Company will also amend its Certificate of Incorporation, as amended
(the “
Charter
”), to decrease the number of shares of common stock authorized for issuance thereunder from 2.0
billion to 950.0 million shares.
Information
for Stockholders
Upon
the effectiveness of the Reverse Split, each eight shares of the Company’s issued and outstanding common stock will be automatically
combined and converted into one issued and outstanding share of common stock, par value $0.001 per share. The Company will not
issue any fractional shares in connection with the Reverse Split. Instead, shareholders entitled to fractional shares immediately
after the Reverse Split will be issued cash in lieu of such fractional shares. The Reverse Split will not modify the rights or
preferences of the Company’s common stock or preferred stock or change the amount of authorized preferred stock.
The
Company’s transfer agent, Pacific Stock Transfer, will act as its exchange agent for the Reverse Split. Pacific Stock Transfer
will provide stockholders of record holding certificates representing pre-split shares of the Company’s common stock as
of the effective date a letter of transmittal providing instructions for the exchange of shares. Registered stockholders holding
pre-split shares of the Company’s common stock electronically in book-entry form are not required to take any action to
receive post-split shares. Stockholders owning shares via a broker or other nominee will have their positions automatically adjusted
to reflect the Reverse Split, subject to brokers’ particular processes, and will not be required to take action in connection
with the Reverse Split.
Additional
information about the Reverse Split can be found in the Company’s definitive information statement filed with the Securities
and Exchange Commission on May 22, 2019, a copy of which is also available at
www.sec.gov
.
About
Vivos Inc. (OTC: RDGL)
Vivos,
Inc. is a development stage pharmaceutical company engaged in the research and development of minimally invasive treatments to
combat cancer in humans and animals. It has developed an Yttrium-90 based brachytherapy injectable device for the treatment of
tumors in animals (IsoPet®) and in humans (Radiogel™). Brachytherapy uses highly localized radiation to destroy cancerous
tumors by placing a radioactive isotope directly inside the treatment area using the Company’s proprietary hydrogel formulation.
The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects
of treatment that characterize external-beam radiation therapy. This feature allows safe delivery of higher doses needed for treating
both non-resectable and radiation-resistant cancers.
IsoPet®
for treating animals uses the same technology as RadioGel™ for treating humans. The Food and Drug Administration advised
using different product names in order to avoid confusion and cross-use.
IsoPet®
is a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor. This hydrogel
is an yttrium-90 carrier at room temperature that gels within the tumor interstitial space after injection to keep the radiation
source safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal
organs and tissues are not adversely affected.
IsoPet®
also has a short half-life – delivering more than 90% of its therapeutic radiation within ten days. This compares favorably
to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy
can be safely administered as an out-patient procedure and the patient may return home without subsequent concern for radiation
dose to the family.
The
IsoPet® Solutions division is using university veterinary hospitals to demonstrate the safety and therapeutic effectiveness
for different animal cancers. The testing on feline sarcoma at the Washington State University is completed and the testing on
canine soft tissue sarcomas at the University of Missouri is currently underway.
The
Company recently obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a device
according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling
which included canine and feline sarcomas as the initial indications for use. FDA does not require pre-market approval for veterinary
devices so no additional approval is required for treating skin cancer, which is the largest market sector. Following this demonstration
phase, Vivos can begin to generate revenues through the sale of IsoPet® to University animal hospitals and private veterinary
clinic consortiums.
The
Company is also engaging the FDA for premarket clearance to market RadioGel™ for the treatment of advanced basal and squamous
cell skin cancers in humans.
Safe
Harbor Statement
This
release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can
identify these statements by the use of the words “may,” “will,” “should,” “plans,”
“expects,” “anticipates,” “continue,” “estimates,” “projects,” “intends,”
and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially
from those projected or anticipated. These risks and uncertainties include, but are not limited to,
the
Company’s ability to secure substantial additional capital to support our operations, including our ongoing clinical development
activities;
the Company’s ability to successfully execute its expanded business strategy including by entering into
definitive agreements with suppliers, commercial partners and customers; general economic and business conditions; the effects
of continued geopolitical unrest and regional conflicts; competition; changes in technology and methods of marketing; delays in
completing various engineering and manufacturing programs; changes in customer order patterns and product mix; continued success
in technical advances and delivering technological innovations; shortages in components; production delays due to performance
quality issues with outsourced components; regulatory requirements and the ability to meet them; government agency rules and changes;
and various other factors beyond the Company’s control.
Certain other risks are more
fully discussed in the section entitled “Risk Factors” in our most recent annual report on Form 10-K, quarterly reports
on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with
the Securities and Exchange Commission (SEC). Our SEC filings are available on the SEC’s website at
www.sec.gov
.
In addition, any forward-looking statements represent our views only as of the issuance of this release and should not be relied
upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking
statements.
CONTACT:
Vivos
Inc.
Michael
K. Korenko, President & CEO
MKorenko@RadioGel.com
Vivos
Inc. Issues Corrective Press Release Regarding Reverse Stock Split
Richland,
WA, June 27, 2019
. Vivos Inc. (the “
Company
”) (OTC PINK: RDGL), a company engaged in the development and
commercialization of minimally invasive brachytherapy treatments to combat cancer in animals and humans, is issuing this press
release to correct its press release dated June 26, 2019, which announced that it would trade on the OTC PINK beginning June 26,
2019, after effecting a 1-for-8 reverse stock split of its issued and outstanding shares of common stock (the “
Reverse
Split
”). The Company’s common stock will begin trading on a post-split basis when the markets open on June 28,
2019 under the Company’s temporary symbol on the OTC PINK, RDGLD,
which will continue
for a period of 20 business days, after which time the “D” will be removed and the symbol will revert back to “RDGL.”
The Company’s common stock will also be identified under a new CUSIP number (
92858K 204
).
About
Vivos Inc.
Vivos,
Inc. is a development stage pharmaceutical company engaged in the research and development of minimally invasive treatments to
combat cancer in humans and animals. It has developed an Yttrium-90 based brachytherapy injectable device for the treatment of
tumors in animals (IsoPet®) and in humans (Radiogel™). Brachytherapy uses highly localized radiation to destroy cancerous
tumors by placing a radioactive isotope directly inside the treatment area using the Company’s proprietary hydrogel formulation.
The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects
of treatment that characterize external-beam radiation therapy. This feature allows safe delivery of higher doses needed for treating
both non-resectable and radiation-resistant cancers.
IsoPet®
for treating animals uses the same technology as RadioGel™ for treating humans. The Food and Drug Administration advised
using different product names in order to avoid confusion and cross-use.
IsoPet®
is a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor. This hydrogel
is an yttrium-90 carrier at room temperature that gels within the tumor interstitial space after injection to keep the radiation
source safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal
organs and tissues are not adversely affected.
IsoPet®
also has a short half-life – delivering more than 90% of its therapeutic radiation within ten days. This compares favorably
to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy
can be safely administered as an out-patient procedure and the patient may return home without subsequent concern for radiation
dose to the family.
The
IsoPet
®
Solutions division is using university veterinary hospitals to demonstrate the safety and therapeutic effectiveness
for different animal cancers. The testing on feline sarcoma at the Washington State University is completed and the testing on
canine soft tissue sarcomas at the University of Missouri is currently underway.
The
Company recently obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a device
according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling
which included canine and feline sarcomas as the initial indications for use. FDA does not require pre-market approval for veterinary
devices so no additional approval is required for treating skin cancer, which is the largest market sector. Following this demonstration
phase, Vivos can begin to generate revenues through the sale of IsoPet® to University animal hospitals and private veterinary
clinic consortiums.
The
Company is also engaging the FDA for premarket clearance to market RadioGel™ for the treatment of advanced basal and squamous
cell skin cancers in humans.
Safe
Harbor Statement
This
release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can
identify these statements by the use of the words “may,” “will,” “should,” “plans,”
“expects,” “anticipates,” “continue,” “estimates,” “projects,” “intends,”
and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially
from those projected or anticipated. These risks and uncertainties include, but are not limited to,
the
Company’s ability to secure substantial additional capital to support our operations, including our ongoing clinical development
activities;
the Company’s ability to successfully execute its expanded business strategy including by entering into
definitive agreements with suppliers, commercial partners and customers; general economic and business conditions; the effects
of continued geopolitical unrest and regional conflicts; competition; changes in technology and methods of marketing; delays in
completing various engineering and manufacturing programs; changes in customer order patterns and product mix; continued success
in technical advances and delivering technological innovations; shortages in components; production delays due to performance
quality issues with outsourced components; regulatory requirements and the ability to meet them; government agency rules and changes;
and various other factors beyond the Company’s control.
Certain other risks are more
fully discussed in the section entitled “Risk Factors” in our most recent annual report on Form 10-K, quarterly reports
on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with
the Securities and Exchange Commission (SEC). Our SEC filings are available on the SEC’s website at
www.sec.gov
.
In addition, any forward-looking statements represent our views only as of the issuance of this release and should not be relied
upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking
statements.
CONTACT:
Vivos
Inc.
Michael
K. Korenko, President & CEO
mkorenko@radiogel.com
