Filed
pursuant to Rule 424(b)(3)
Registration No. 333-
210387
PROSPECTUS SUPPLEMENT NO. 15
4,156,757 Shares of Common Stock
of
Guided Therapeutics, Inc.
This prospectus supplement supplements and amends
the prospectus dated April 7, 2016, as previously supplemented,
which constitutes part of our registration statement on Form S-1
(No. 333-210387) relating to up to 4,156,757 shares of our common
stock. This prospectus supplement includes our amendment to current
report on Form 8-K filed March 24, 2017.
THIS IS NOT A NEW REGISTRATION OF
SECURITIES.
This
prospectus supplement should be read in conjunction with the
prospectus, which is to be delivered with this prospectus
supplement. This prospectus supplement is qualified by
reference to the prospectus, except to the extent that the
information in this prospectus supplement updates and supersedes
the information contained in the prospectus.
This
prospectus supplement is not complete without, and may not be
delivered or utilized except in connection with, the
prospectus.
Investing in our common stock involves a high degree of risk. We
urge you to carefully read the “Risk Factors” section
beginning on page 4 of the prospectus.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus supplement is truthful
or complete. Any representation to the contrary is a criminal
offense.
The date of this prospectus supplement is March 24,
2017.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 8-K/A
Amendment
No. 1
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date of
Report (Date of earliest event reported): January 22,
2017
GUIDED THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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0-22179
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58-2029543
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(State
or other jurisdiction of incorporation)
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(Commission
File Number)
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(IRS
Employer Identification No.)
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5835 Peachtree Corners East, Suite D
Norcross, Georgia
(Address
of principal executive offices)
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30092
(Zip
Code)
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Registrant’s
telephone number, including area code:
(770) 242-8723
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:
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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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EXPLANATORY NOTE
Guided
Therapeutics, Inc. (the “Company”) hereby amends its
current report on Form 8-K filed with the U.S. Securities and
Exchange Commission (the “Commission”) on January 26,
2017 ( the “Current Report”). The Company had
previously submitted a request for confidential treatment to the
Commission concerning Exhibit 10.1 to the Current Report, which has
been withdrawn. An unredacted copy of the agreement is
included as Exhibit 10.1 hereto and the disclosure under Item 1.01
of this amendment reflects the unredacted information.
Other
than as expressly set forth above, this amendment does not, and
does not purport to, amend, restate, or update the information
contained in the Current Report, or reflect any events that have
occurred after the Current Report was filed. As a result, the
Current Report, as amended hereby, continues to speak as of the
initial filing date and time of the Current Report.
Item
1.01.
Entry
into a Material Definitive Agreement.
On
January 22, 2017, the Company entered into a license agreement with
Shandong Yaohua Medical Instrument Corporation, or SMI, pursuant to
which the Company granted SMI an exclusive global license to
manufacture the LuViva device and related disposables (subject to a
carve-out for manufacture in Turkey) and exclusive distribution
rights in the Peoples Republic of China, Macau, Hong Kong and
Taiwan. In exchange for the license, SMI will pay a $1.0 million
licensing fee, payable in five installments through October 2017,
underwrite the cost of securing approval of LuViva with the Chinese
Food and Drug Administration, or CFDA, and, once it obtains CFDA
approval, pay $1.90 royalty on each disposable sold in the
territories by purchasing directly from the Company a Controlled
Programmable Chip (CPC), necessary for the operation of disposable
unit. Pursuant to the SMI agreement, SMI must become capable of
manufacturing LuViva in accordance with ISO 13485 for medical
devices by the second anniversary of the SMI agreement, and achieve
CFDA approval by July 22, 2019, or else forfeit the license. During
2017, SMI must purchase no fewer than ten devices at $13,000 each
(with up to four devices pushed to 2018 if there is a delay in
obtaining approval from the CFDA). In the three full calendar years
following CFDA approval, SMI must sell a minimum of 3,500 devices
(500 in the first year, 1,000 in the second, and 2,000 in the
third), and purchase a minimum of 25,200,000 CPC’s from the
Company, resulting in revenues of $47,880,000 to the Company over
the three-year period, or else forfeit the license. As manufacturer
of the devices and disposables, SMI will be obligated to sell each
to the Company at costs no higher than the Company’s current
costs. As partial consideration for, and as a condition to, the
license, and to further align the strategic interests of the
parties, the Company agreed to issue $1.0 million in shares of its
common stock to SMI, in five installments through October 2017, at
a price per share equal to the lesser of the average closing price
for the five days prior to issuance and $1.25.
In
order to facilitate the SMI agreement, immediately prior to its
execution the Company entered into an agreement with Shenghuo
Medical, LLC, regarding the Company’s previous license to
Shenghuo. Under the terms of the new agreement, Shenghuo agreed to
relinquish its manufacturing license and its distribution rights in
SMI’s territories, and to waive its rights under the original
Shenghuo agreement, all for as long as SMI performs under the SMI
agreement. As consideration, the Company has agreed to split with
Shenghuo the licensing fees and net royalties from SMI that we the
Company receive under the SMI agreement. Should the SMI agreement
be terminated, the Company has agreed to re-issue the original
license to Shenghuo under the original terms. The Company’s
COO and director, Mark Faupel, is a shareholder of Shenghuo, and
another director, Richard Blumberg, is a managing member of
Shenghuo.
The
above descriptions are qualified in their entirety by reference to
the SMI agreement and the Shenghuo agreement, attached as Exhibits
10.1 and 10.2, respectively, to this current report and
incorporated herein by reference. A press release further
describing the agreements is attached at Exhibit 99.1 and is
incorporated herein by reference.
This
current report on Form 8-K is neither an offer to sell nor the
solicitation of an offer to buy any securities. The securities
described above have not been registered under the Securities Act
and may not be offered or sold in the United States absent
registration or an exemption from registration under the Securities
Act.
Item
3.02
Unregistered
Sales of Equity Securities
The
information set forth under Item 1.01 is incorporated by reference
into this Item 3.02. The issuance of the securities described under
Item 1.01 pursuant to the SMI agreement has been conducted as a
private placement to “accredited investors” (as that
term is defined under Rule 501 of Regulation D), and is exempt from
registration under the Securities Act of 1933 in reliance upon
Section 4(a)(2) of the Securities Act, as a transaction by an
issuer not involving a public offering.
Item
5.05
Amendments
to the Registrant’s Code of Ethics, or Waiver of a Provision
of the Code of Ethics.
The
information set forth under Item 1.01 is incorporated by reference
into this Item 5.05. On January 15, 2017, each of the disinterested
directors on the Company’s Board of Directors, having
considered the interests of Dr. Faupel and Mr. Blumberg and having
approved the agreement, effectively waived the conflict-of-interest
provisions of the Company’s code of ethics.
Item
9.01
Financial
Statements and Exhibits
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Number
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Exhibit
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10.1
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Agreement,
dated January 22, 2017, between the Company and Shandong Yaohua
Medical Instrument Corporation
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10.2*
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Agreement,
dated January 22, 2017, between the Company and Shenghuo Medical,
LLC
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99.1*
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Press
Release, dated January 25, 2017
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*Previously
filed as part of the current report on Form 8-K, filed January 26,
2017.
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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GUIDED
THERAPEUTICS, INC.
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/s/
Gene S. Cartwright, Ph.D.
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By: Gene
S. Cartwright, Ph.D.
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President and Chief
Executive Officer
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Date: March
24, 2017
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EXHIBIT
INDEX
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Number
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Exhibit
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10.1
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Agreement,
dated January 22, 2017, between the Company and Shandong Yaohua
Medical Instrument Corporation
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10.2*
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Agreement,
dated January 22, 2017, between the Company and Shenghuo Medical,
LLC
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99.1*
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Press
Release, dated January 25, 2017
|
|
|
|
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*Previously
filed as part of the current report on Form 8-K, filed January 26,
2017.
|
Exhibit
10.1
AGREEMENT
BETWEEN SHANDONG YAOHUA MEDICAL INSTRUMENT
CORPORATION
AND GUIDED THERAPEUTICS, INC.
CONFIDENTIAL,
FINAL 22 JANUARY 2017
This agreement is
dated 22 January, 2017 and is between Guided Therapeutics, Inc., a
Georgia, United States of America corporation (“GTI”),
located at 5835 Peachtree Corners East, Suite D, Norcross, GA
30092, USA and Shandong Yaohua Medical Instrument Corporation,
located at No. 5 Zhuijian Street, High-Tech Development Zone, Laiwu
Shandong, People’s Republic of China
(“SMI”).
WHEREAS GTI has
developed a platform technology for the early detection of disease
that leads to cancer;
WHEREAS GTI’s
first non-invasive cancer detection product is the LuViva®
Advanced Cervical Scan device (the “Device”) and the
related disposable cervical guides (the “Disposables”
and, with the Device, “LuViva). LuViva is in use in Canada,
Latin America, Europe, Turkey, Asia and Africa. GTI owns the
worldwide manufacturing, distribution and intellectual property
(“IP”) rights to LuViva. LuViva is designed
to:
A.
Determine the true
likelihood of treatable cervical disease that may lead to cancer in
women aged 16 years and over who have been screened for cervical
cancer and have an abnormal result.
B.
Be used as a
screening tool both in the developed and developing world where the
Papanicolaou test and/or the Human Papillomavirus Virus tests are
not widely available.
WHEREAS GTI asserts
that they have the rights to license the global manufacturing
rights, excepting the Disposable Cervical guides for the Republic
of Turkey, for LuViva, and the distribution rights and sales rights
for LuViva in the Peoples Republic of China, Macau, Hong Kong and
Taiwan (hereinafter collectively referred to as the
“Jurisdictions”);
WHEREAS SMI is a
medical device company in China with an established distribution
and sales capability and has indicated a capability and willingness
to manufacture for the global market, and distribute and sell
LuViva in the Jurisdictions,
WHEREAS under this
agreement between the Parties, SMI is granted exclusive rights by
GTI for global manufacture as the optimum way to achieve economies
in global manufacturing and exclusive commercialization, both
distribution and sales, of LuViva within the Jurisdictions
(“Global Manufacturing License”)
IT IS HEREBY AGREED
AS FOLLOWS between SMI and GTI that SMI is granted exclusive
manufacturing rights, excepting the Disposable Cervical Guides for
the Republic of Turkey, and exclusive distribution rights and sales
rights for LuViva in the Jurisdictions, subject to the following
terms and conditions.
1.
Payments by SMI and Transfer of Stock
to SMI
:
1. GTI shall
provide payment instructions to SMI for SMI payments to GTI within
5 business days of signing this Agreement.
2. SMI shall
provide disbursement instructions to GTI for distribution of GTI
stock within 15 business days of signing of this
Agreement.
3. Both Parties
will undertake to ensure that the payment or disbursement
instructions are mutually satisfactory and compliant with all
applicable regulations.
B.
SMI shall make
payments to GTI based on the following schedule
●
$50,000 due within
15 business days of signing this Agreement
●
$200,000 due on or
before 20 February 2017*
●
$250,000 due on or
before 30 April 2017
●
$250,000 due on or
before 30 July 2017
●
$250,000 due on or
before 30 October 2017
*To be paid to GTI
providing that GTI provides all documents and data, including
manufacturing transfer plan, product production, guidance
documents, product quality standards, relevant patent certificates,
fixed costs of products, personnel data, etc. as reasonably
required by SMI within 10 business days after GTI receives the
initial payment of USD $50,000. During the first quarter of 2017,
GTI and SMI will agree on the plan and schedule for transfer of
manufacturing.
C.
GTI shall issue
shares of its common stock to SMI or as directed by SMI with each
of the five payments equal in value to the amount of the payment
(e.g $50,000, $200,000 or $250,000) within 30 days after receipt of
payments. The number of shares issued will be calculated at the
lesser of the end of day per share price for the average of five
consecutive days preceding the payment or $1.25 per share. The
shares of stock shall be transferred to SMI or as directed by SMI
within 30 days of SMI’s payment.
a.
Subject to purchase
orders from SMI to GTI, the schedule of minimum orders for 2017
shown in the table below will be maintained in order to maintain
Jurisdiction sales and distribution rights.
|
2017
|
Number of LuViva
Devices
|
Price Per
Device
(by air, CIF
BEIJING; by sea CIF QINGDAO
|
Anticipated
Use
|
|
By 31
March
|
5
|
$13,000
|
- Chinese FDA
Sample (1)
- Clinical Samples
(2)
- Transfer
Manufacturing Sample (1)
- Seed outside PRC
Market (1)
|
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By 31
December
|
5
|
$13,000
|
- Seed PRC
Commercial Market (4)*
- Sales outside of
PRC (1)
|
*If Chinese Food
and Drug Administration (CFDA) approval is delayed, then these four
device orders can be moved to Q1 2018. If SMI needs to order single
use Cervical Guides or other supplies directly from GTI instead of
manufacturing them in China, the prices shall be pursuant to the
published price list for international distributors adjusted by a
10% discount. For clinical trials, GTI agrees to supply 200
Cervical Guides at no cost.
b.
If additional
orders are placed by SMI to GTI prior to SMI having established its
own manufacturing facility, the devices will be priced as
follows:
|
Quantity
|
Price (by air,
CIF BEIJING; by sea CIF QINGDAO)
|
|
11 –
20
|
$12,500
|
|
21 –
40
|
$12,000
|
|
41 and
greater
|
International
distributor list price
|
3.
Minimum Sales
: People’s
Republic of China (Beginning first full calendar year following
CFDA approval). It is expected that full or partial manufacturing
will occur in China, so that minimum orders will not necessarily
occur, unless agreed by both parties. Notwithstanding the
foregoing, SMI will be responsible for minimum royalty payments
based on the minimum sales of LuViva products as shown in the Table
below.
|
Full year
following CFDA Approval
|
Number of
machines placed or sold
|
Number of tests
per day
|
Days per
week
|
Weeks per
year
|
|
1
|
500
|
30
|
5
|
48
|
|
2
|
1000
|
30
|
5
|
48
|
|
3
|
2000
|
30
|
5
|
48
|
4.
Cost of CFDA Approval
: SMI
shall underwrite the entire cost of securing approval of LuViva
with Chinese FDA.
5.
Manufacturing
:
a.
SMI, shall arrange,
at its sole cost, for a manufacturer in China to build tooling to
support manufacture.
b.
The price payable by GTI for each Device and each packet of
Disposables supplied by the manufacturer for resale by GTI outside
of the Territories will be no higher than the then current internal
costs to GTI for manufacturing the Device and the then current
price paid by GTI to its current supplier of
Disposables.
c.
In the event that this is not possible, the Parties agree to
discuss the following options:
a.
SMI retains the
right to manufacture for China, Hong Kong, Macau and Taiwan, where
SMI has distribution and sales rights.
b.
SMI elects to
manufacture just the Cervical Guides which is anticipated to be
able to be at a lower price in China
c.
SMI buys the
devices and Cervical Guides, or just the devices from
GTI
d.
Other options that may be identified and available to find a
mutually satisfactory solution.
If SMI fails to
achieve manufacturing capabilities for either the Devices and
Disposables in accordance with ISO 13485 for medical devices by 24
months after the date hereof, SMI shall no longer have any rights
to manufacture, distribute or sell LuViva.
6.
Technical Assistance for Manufacturing
and Sales
:
a.
Both GTI and SMI
recognize the need for technical assistance to set up manufacturing
and to establish sales protocols and marketing materials. To that
end, both parties pledge cooperation in helping to establish the
manufacturing and sales in China.
b.
GTI shall provide
the Curricula Vitae or Resume (personal data) of the inventor of
the LuViva technology to SMI
c.
SMI shall send over
its manufacturing expert to GTI at SMI’s expense to learn the
manufacturing process. GTI will be responsible for all in-country
(US) expenses.
d.
GTI shall send over
its technical expert within 10 days of a request or as soon as
reasonably possible from SMI to SMI at GTI’s expense to
assist with the establishment of the manufacturing and sales
protocols in China. SMI will be responsible for all in-country
(China) expenses.
e.
GTI shall provide
technical support and training for product upgrades consistent with
the technical support provided to other international distributors
of LuViva.
7.
Royalties
:
a.
For each single-use
Cervical Guide chip sold by SMI in the Jurisdictions, SMI shall
transfer funds to the Escrow Agent at a rate of $1.90 per chip.in
the amount equaling the number of chips sold. Funds shall be
transferred monthly.
b.
The Parties agree
to reassess these royalty amounts at the end of the second year of
commercial sales in China to determine if an adjustment to the
royalty amounts, up or down, is warranted. Any adjustments to the
royalty amounts must be mutually agreeable.
8.
Commercialization
: If within 18
months of this License’s Effective Date, SMI fails to achieve
commercialization of LuViva (as defined below) in China. SMI shall
no longer have any rights to manufacture, distribute or sell
LuViva.
Commercialization
of LuViva is defined as SMI achieving all of the
following:
a.
Filing an
application with the CFDA for approval of LuViva
b.
Any assembly or
manufacture of the Device or Disposables that begins in
China
c.
Purchase of at
least 10 Devices and associated Disposables for clinical
evaluations and regulatory use and or sales in the Jurisdictions,
according to the schedule described in Section 2.
above.
9.
Best Efforts
: The Rights
described herein must be maintained by diligent development and
commercial efforts. SMI agrees to use its best efforts to maximize
the royalty payments contemplated herein. Both parties agree to
conduct quarterly reviews to mark progress and agree on forecasts
for orders.
10.
Breach or Failure to Perform
:
Under the following circumstances, SMI shall forfeit this License
and shall no longer have any rights to manufacture, distribute or
sell LuViva in the Jurisdictions if SMI is unable to cure in a
timely manner:
a.
A material breach
of any of SMI’s obligations set forth in this
section.
b.
Failure to achieve
CFDA approval within 30 months from the date of this
agreement.
In the event of
Breach or Failure to Perform,
c.
GTI shall provide
written notification of the breach or failure to
perform.
d.
SMI shall be given
a 45 day period in which to cure the breach or failure to
perform.
e.
If the breach or
failure to perform is not cured, SMI shall return to GTI, at
SMI’s cost, all samples, data, hardware, software, regulatory
documents, bench and clinical test results and all other
information pertaining to LuViva in the Jurisdictions
11.
Notices and Communications
: All
notices and other communications required by this Agreement will be
effective upon deposit in the mail, postage prepaid and addressed
to the parties at their respective addresses set forth below until
such notice that a different person or address shall have been
designated:
If to
SMI:
No. 5 Zhuijian
Street, High-Tech Development Zone, Laiwu Shandong,
People’s
Republic of China
If to
GTI:
5835 Peachtree
Corners East, Suite D,
Norcross, GA 30092,
USA
12.
Relationship of Parties
: The
Parties to this Agreement are and shall remain independent
contractors and nothing herein shall be construed to create a
partnership, agency or joint venture between the parties. Each
party shall be responsible for wages, hours and conditions of
employment of its personnel during the term of, and under this
Agreement.
13.
Dispute Resolution
: In the
event a dispute arises out of or in connection with this Agreement,
the parties will attempt to resolve the dispute through friendly
consultation. If the dispute is not resolved within a reasonable
period then any or all outstanding issues may be submitted to
mediation in accordance within any statutory rules of mediation. If
mediation is not successful in resolving he entire dispute or is
unavailable, any outstanding issues will be submitted to final and
binding arbitration in accordance with the laws of the State of
Georgia, United States of America. The arbitrator’s award
will be final, and judgment may be entered upon it by any Court
having jurisdiction within the State of Georgia, United States of
America. Each party shall choose one (1) arbitrator and the
two (2) chosen arbitrators shall select a third arbitrator, who
shall be the Chairman of the Arbitration Panel. As soon as
the mediation process has been unsuccessful, either party may
select an arbitrator by sending the name of the arbitrator, in
writing, to the other party. The party receiving the name of
the said arbitrator shall, within fifteen (15) days of receipt,
select their arbitrator and shall send their selection, in writing,
to the other party. Should that party fail to select their
arbitrator within fifteen (15) days of receipt of the name of the
first party’s arbitrator, the initial party may seek Court
appointment of the receiving party’s arbitrator and the
latter shall be responsible for the initial party’s
reasonable attorney’s fees and costs in connection with the
Court appointment. If the two (2) appointed arbitrators fail
to select the third arbitrator within thirty (30) days from
the appointment of the second arbitrator, either party, or the
parties jointly, may seek Court appointment of the third
arbitrator.
14.
Applicable Law
: All questions
concerning the validity, operation, interpretation and construction
of this Agreement will be governed by and determined in accordance
with the laws of the State of Georgia, United States of
America.
15.
Waivers of Breach
: No waiver by
either Party of any breach of any provision shall constitute a
waiver of any other breach of that provision or any other provision
hereof.
16.
Warrants and Representations
:
Each Party represents and warrants that the terms of this Agreement
are not inconsistent with any other contractual or legal
obligations it may have or with the policies of any institution or
company with which such Party is associated.
17.
Interpretation
: The Parties
have participated jointly in the negotiation and drafting of this
Agreement. In the event of an ambiguity or question of intent or
interpretation arises, this Agreement shall be construed as if
drafted jointly by the parties and no presumption or burden of
proof shall arise favoring or disfavoring any Party by virtue of
the authorship of any the provisions of this
agreement.
18.
Assignment
: SMI may not assign
this Agreement in whole or in part, other than manufacturing,
without GTI’s consent, that shall not be unreasonably be
withheld. SMI may outsource all or parts of the manufacturing at
their discretion, provided that SMI is able to maintain and verify
that the quality of the manufacturing maintains CFDA, ISO 14485 and
other regulatory standards that GTI may rely upon in sourcing
LuViva.
19.
Effective Agreement
: This
Agreement may be signed by the parties via facsimile or electronic
signatures. This Agreement will constitute an effective Agreement
when signed by both Parties.
20.
Entire Agreement
: This
Agreement, sets forth the entire agreement and understanding
between the parties as to the subject matter hereof and merges all
prior discussions between them; and neither party shall be bound by
any conditions, definitions, warranties, understandings or
representations with respect to such subject matter other than as
expressly provided herein. This Agreement may not be modified or
altered except in writing by an instrument duly executed by
authorized officers of both parties.
IN WITNESS WHEREOF
, the parties hereto
have caused this Agreement to be duly executed by their duly
authorized officers as of the
22
day of January,
2017.
GTI
/s/ Gene
Cartwright
Gene
Cartwright
Chief
Executive Officer, Guided Therapeutics Inc.
SMI
/s/ Yaohua
Li
Yaohua
Li
Chairman,
Shandong Yaohua Medical Instrument Corporation
7
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