8-K

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) May 14, 2015; (May 13, 2015)

GUIDED THERAPEUTICS, INC.

 (Exact Name of Registrant as Specified in Its Charter)

Delaware	0-22179	58-2029543
(State or Other Jurisdiction of	(Commission File Number)	(IRS Employer Identification No.)
Incorporation)

5835 Peachtree Corners East, Suite D Norcross, Georgia (Address of Principal Executive Offices) 30092 (Zip Code)

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:

[ ]	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ]	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ]	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ]	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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Section 2.02 Results of Operations and Financial Condition 

On May 13, 2015, the registrant publicly released its financial results for the first quarter March 31, 2015, as more fully described in the press release, a copy of which is furnished as Exhibit 99.1 hereto and which information is incorporated herein by reference.

Section 7.01   (Regulation FD Disclosure) 

On May 14, 2015, the registrant conducted a conference call discussing its financial results for the first quarter ended March 31, 2015, and other matters concerning the operation of the company, as more fully described in the prepared transcript of the call, a copy of which is furnished as Exhibit 99.2 hereto and which information is incorporated herein by reference.

Item 9.01      Financial Statements and Exhibits.

(d) Exhibits.

Number	Exhibit
99.1	Press Release dated May 13, 2015
99.2	Transcript of Conference Call held on May 14, 2015

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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.

		GUIDED THERAPEUTICS, INC.
	By:	/s/ Gene Cartwright
		Gene Cartwright
		Chief Executive Officer
Date: May 14, 2015

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EX-99.1

Exhibit 99.1

 

5835 Peachtree Corners East, Suite D

Norcross, GA 30092

Contacts

Bill Wells, Guided Therapeutics – 770-242-8723

Investors: Alison Ziegler, Cameron Associates – 212-554-5469

Guided Therapeutics Reports First Quarter 2015 Results

Key Highlights:

• FDA response on amended LuViva PMA application expected by end of May

• Primary sales focus is international screening markets with large unmet need

• Several key markets expected to ramp up screening efforts in 2015

• International market opportunity exceeds $2 billion

Norcross, GA (May 13, 2015) -- Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced its operating results for the first quarter ended March 31, 2015.

Revenue and other income for the first quarter ended March 31, 2015 was approximately $142,000, including approximately $127,000 in sales of LuViva® Advanced Cervical Scan devices and disposables. Related costs of sales and net realizable value expenses were approximately $107,000, which resulted in a gross profit on the device and disposables of approximately $20,000. Contract and grant income was $15,000 in the first quarter of 2015. Revenue for the quarter ended March 31, 2014 was comprised of product sales of approximately $122,000 and contract and grant income of approximately $19,000. The Company reported a gross loss of $70,000 in the year ago period.

Research and development expenses decreased to $373,000 in the first quarter from $607,000 in the first quarter of 2014, primarily related to a reduction in staffing and a transition to product manufacturing.

Sales and marketing expenses decreased to $172,000 in the first quarter, from $283,000 in the year ago period, due to the Company-wide expense reduction and cost savings efforts.

General and administrative costs declined in the quarter to $963,000, down from $1.1 million in the same period last year, due to a continued focus on reducing operating expenses.

The net loss attributable to common stockholders for the first quarter of 2015 was approximately $1.2 million, or $0.01 per share, compared to approximately $1.6 million, or $0.02 per share, in the first quarter of 2014.

Cash on hand at March 31, 2015 was approximately $18,000, as compared to approximately $162,000 at December 31, 2014. Net inventory on hand at the end of the quarter was approximately $1.1 million. After the quarter end, we entered into a subscription agreement to sell an aggregate of 4.0 million shares of our common stock and warrants to purchase an additional 2.0 million shares, for an aggregate purchase price of $720,000 in a private placement and, as of May 11, 2015, have closed on the entire $720,000. We continue to focus on keeping a reduced burn rate, which currently stands at approximately $400,000 per month, however, we will likely be required to raise additional funds through public or private financing, new collaborative relationships or grants, if available.

“We continue to work with our distributors in key international screening markets to educate ministries of health and thought leaders on the benefits of LuViva as a front-line tool for the quick and easy detection of the disease that leads to cervical cancer,” said Gene Cartwright, Chief Executive Officer of Guided Therapeutics. “That work is beginning to bear fruit in the Middle East, Latin America and Africa. In Kenya, our distributor was recently awarded a contract with the Nairobi County Health Services Sector to supply the first LuViva® Advanced Cervical Scan for the agency’s cervical cancer screening program. The LuViva was delivered Tuesday of this week and the first patients have undergone scans. We believe this is the first step to what could be a very significant order for the company, as well as a lever to expand throughout Kenya and elsewhere in East Africa.”

“We also have high expectations in the coming weeks and months for Turkey, which remains our largest market to date. We expect to begin receiving reimbursement for LuViva as soon as this quarter, which has the potential to open up the entire Turkish market for us. Key opinion leaders throughout the country have lined up behind LuViva, and in addition to the Ministry of Health, where screening is now set to begin, we are also anticipating additional demand from private hospitals later this year.”

“In addition to Kenya and Turkey, we have begun to see activity in Latin America, including Mexico, where our distributor has applied for a government reimbursement code and Costa Rica, where we recently added a new distributor with ties throughout the region. We just completed a two-week trip to Indonesia, which we believe is another significant screening opportunity for LuViva. Pilot studies are expected to take place over the next few months at three sites.”

“Other evaluations are ongoing in Canada, the Netherlands and Indonesia, with additional studies planned throughout Europe. We have also recently signed a letter of intent to negotiate the exclusive distribution rights for LuViva® in China, including an initial sale of five devices and associated single-use-disposables, which have already been booked in the second quarter. As the second largest medical device market in the world, China is a top market opportunity for LuViva.”

“As we have stated previously, we expect revenue for 2015 to be heavily weighted to the latter half of the year, consistent with the quarterly forecasts from our distributors. We continue to project sales of $3 million for 2015 and we expect large ongoing orders from the developing world, particularly Kenya and Turkey, to drive those sales. We are also on the verge of hearing from FDA on our amended PMA application for LuViva.”

“Our global screening market opportunity in countries where we already have distributors exceeds $2 billion. We expect to see growing demand for LuViva around the world as the year progresses and will continue to work hard to deliver results.”

Conference Call

Guided Therapeutics will hold a conference call at 11:00 a.m. EDT Thursday, May 14, 2015, to discuss its financial results and corporate developments. Interested parties are invited to listen to the call live over the Internet at http://www.guidedinc.com/investors.htm. The live call is also available by dialing (888) 438-5524 or for international callers (719) 325-2484 and referencing Conference ID 3010082.

A replay of the teleconference will be available on http://www.guidedinc.com/investors/. A replay will also be available until May 21, 2015, by dialing (877) 870-5176 or for international callers (858) 384-5517 and using pin number 3010082.

About Guided Therapeutics

Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) is the maker of a rapid and painless testing platform based on its patented biophotonic technology that utilizes light for the early detection of disease at the cellular level. The Company’s first product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial, with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. For more information, visit: www.guidedinc.com.

The Guided Therapeutics LuViva^® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use. LuViva, the wave logo and "Early detection, better outcomes" are registered trademarks owned by Guided Therapeutics, Inc.

Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the early stage of products in development, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the sufficiency of capital raised in our prior financings and our ability to realize their expected benefits, the uncertainty of future capital to develop products or continue as a going concern, the uncertainty of regulatory approval of products, and the dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading “Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and subsequent filings.

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GUIDED THERAPEUTICS, INC. AND SUBSIDIARY

Unaudited Condensed Consolidated Statements of Operations

	Three Months Ended March 31,
In thousands, except per share data	2015			2014
Revenue
Sales – devices and disposables		127			122
Cost of goods sold		107			192
Gross Profit (loss)		20			(70	)
Contract and grant revenue	$	15		$	19
Operating Expenses
Research and development	$	373		$	607
Sales and marketing		172			283
General and administration		963			1,138
Total	$	1,508		$	2,028
Operating Loss	$	(1,473	)	$	(2,079	)
Other income		6			2
Interest expense		(492	)		(27	)
Change in fair value of warrants		714			542
Total other income		228			517
Net loss		(1,245	)		(1,562	)
Preferred Stock Dividends		(31	)		(48	)
Net Loss Attributable to Common Stockholders	$	(1,276	)	$	(1,610	)
Basic and Diluted Net Loss per Share	$	(0.01	)	$	(0.02	)
Basic and Diluted Weighted Average Shares Outstanding		97,324			71,451

Selected Balance Sheet Data (Unaudited)

(In thousands)	December 31, 2015	December 31, 2014
Cash & Cash Equivalents	$18	$162
Inventory Working Capital	1,149 (3,588)	1,180 (2,824)
Total Assets	2,560	3,031
Accumulated Deficit	(114,336)	(113,060)
Stockholders’ Equity(Deficit)	(5,018)	(4,465)

###END###

EX-99.2

Exhibit 99.2

Guided Therapeutics, Inc.

First Quarter 2015 Conference Call

May 14, 2015

Alison Ziegler: Thank you. Good morning and welcome to the Guided Therapeutics conference call and webcast to discuss first quarter 2015 results. For today’s call, we have Guided Therapeutics’ CEO, Gene Cartwright; and Company Controller, Charles Rufai, Certified Public Accountant.

During this call, the Company will be making forward-looking statements. These statements can obviously differ from actual results, so to rely on them is subject to risk. Factors that could cause forward-looking statements in this call to differ materially from actual results are discussed in the Company’s Form 10-K for the year ended December 31st, 2014, and other filings with the Securities and Exchange Commission.

At this time, I’d like to turn the call over to Gene. Go ahead, Gene.

Gene Cartwright: Thanks Alison.

Good morning and welcome.

Before I update everyone on our progress internationally, let me provide a brief update on our PMA amendment for LuViva. As you know, we are waiting to hear back from FDA and while they are not currently held to any specific timeline or performance standards with regards to our amended PMA, in our most recent correspondence they have confirmed to us that they expect to get back to us this month. I will remind everyone that they have missed several dates they provided to us verbally and in writing due to other priorities that have arisen, but we are optimistic we will hear something over the next week or two. We remain hopeful that they will provide us with a path for approval.

Since we reported Q4 back in March, we have continued to focus on, and gain traction in, the large international market for LuViva as a front line screener for cervical cancer. This strategic shift in direction to focus on screening began in earnest shortly after I came to Guided Therapeutics. The screening market opportunity is much larger than the product’s original intended use as a triage device. The idea is to have LuViva serve as the initial screening test, the way the Pap test is used in developed markets. This is beneficial in countries or regions that lack the infrastructure or trained people to administer and interpret the Pap test. In addition to not needing the expensive infrastructure, LuViva provides immediate results and is painless to the patient.

It has taken some time, but the groundwork we have laid, educating ministries of health and thought leaders throughout the world on the benefits of LuViva, is beginning to pay dividends.

We currently have 78 units in place in 19 countriesincluding multiple units in Turkey, Guatemala, Mexico, Nigeria, Canada and Kuwait. We shipped a total of nine LuViva units in the first quarter along with about four hundred high-margin disposable Cervical Guides, compared to seven units in the first quarter of 2014. Markets that received shipments of LuViva devices in the quarter include Indonesia and Turkey, with disposables also going to Italy, Nigeria and Canada.

The two markets that are the farthest along and that we expect will help drive our results this year are Turkey and Kenya. Together with our distributors, we have dedicated significant time in these markets and are highly confident that we will be able to see results from our efforts in the weeks and months to come.

In our largest market to date, Turkey, we are very close to receiving reimbursement for LuViva. This has the potential to open up the entire market there for us. We anticipate hearing about reimbursement either later this quarter or in early Q3. Key opinion leaders throughout the country have lined up behind LuViva, and in addition to the Ministry of Health, where screening is now set to start and we could see demand for as many as 10 devices and over 10,000 disposables per month, we are also anticipating a number of units going to private hospitals later this year. Our distributor is also looking at three additional Southwest Asian countries to begin to sell into later this year.

Turning to Kenya, as we announced recently, our distributor has been awarded a contract with the Nairobi County Health Services Sector, a true innovator for healthcare in East Africa, to supply the first LuViva for the agency’s cervical cancer screening program. The LuViva was delivered Tuesday and the first patients have already undergone scans. We believe this is the first step to what could be a very significant order for the company, based on money that has been budgeted by Nairobi County. There is the potential later this quarter or in Q3 to begin to expand to six additional facilities in the county which would require 10-12 units with up to 10,000 patients per month being screened. Nairobi County is the largest population center in East Africa with approximately 1.5 million screening-aged women. Our partner, Stem World Enterprises, is optimistic that the screening program will be expanded in 2015 and in turn should support inroads in other parts of the developing world. Nairobi County is just one of 47 counties in Kenya and what Kenya’s capital does is often followed elsewhere in the country and in East Africa.

As you can see, these two markets, Turkey and Kenya, should go a significant way to helping us achieve our objectives for 2015. Particularly when you consider the number of potential disposables.

Turning to Latin America, we continue to make good progress and see significant opportunities for LuViva. In Mexico, our distributor remains active while we await the Cuadro Basico, which is similar to the CPT code in US. Once listed in the catalog, which we continue to expect over the summer, state and local healthcare agencies will be free to purchase LuViva unencumbered.

In Guatemala, the pilot program with the Ministry of Public Health and Social Welfare is due to be started in the next few weeks. They are evaluating LuViva as a means to screen for cervical cancer due to the lack of wide spread availability of the Pap test. As we have discussed in the past, cervical cancer is the leading cause of death among Guatemalan women and it is estimated approximately 4.5 million women would be candidates for cervical cancer screening. If successful, the pilot program could lead to the placement of LuViva in the 43 public hospitals in Guatemala.

During the quarter we added a new distributor in Costa Rica, which is ordering a unit. They also have strong relationships throughout South America and look to evaluate opportunities for LuViva in both Nicaragua and El Salvador as well.

And in Chile, we are about to initiate training after shipping units to Santiago in the fourth quarter.

Another market that we are very excited about is Indonesia – where our marketing executive has just spent the last two weeks. Screening evaluations are underway in this 4^th most populous country in the world, with the potential for more than 63 million women candidates for screening. We have been meeting with policy makers and are optimistic that LuViva could make a real difference in this country where today very few women are screened.

Now, let me update you on Canada. As a result of the growing support of healthcare experts across Canada, a new pilot program is now underway in one of the provinces, involving up to 80 women. The trial is going well and patient accrual has been fairly quick. Upon successful completion, expected early third quarter, recommendations could be made to include LuViva as the standard of care in select provinces. As a reminder, this is an opportunity to use LuViva for triage – for which each year in Canada, as many as 400,000 women receive an abnormal Pap result and can wait months for follow-up exams, which typically include colposcopy and biopsy.

In the Netherlands, a multi-center study is progressing well, with approximately 10 patients seen per week. We are also looking at opportunities in Estonia for screening. In Scandinavia we are seeing interest from private clinics and in France and the UK, additional studies are planned in order to gain traction in those markets with leading doctors and government payers.

We are also working on new distributorships in India, China and Russia that should be completed this year.

In China, we signed a letter of intent to negotiate the exclusive distribution rights for LuViva. The letter of intent calls for the sale of five LuViva devices and associated single use disposables to Hong Kong and China, for clinical testing and regulatory evaluation. We received a payment of $55,000 at the end of April, which triggered the shipment of the first two of these devices.

China is the second largest medical device market in the world, according to the U.S. Department of Commerce. Approximately 390 million Chinese women are between 25 and 64 years old, the prime age for cervical cancer screening. As such, China is a top market opportunity for LuViva as both a triage product to reduce unnecessary biopsies after a positive Pap result and also as a point-of-care, primary screening tool for cervical cancer. Our distributor has strong ties to the largest private hospital in China, as well as one of the country’s largest medical technology companies, which should be very helpful as we navigate this market.

As we mentioned, LuViva would need approval from the Chinese Food and Drug Administration, which could take a year. We currently anticipate interim device and disposable sales for clinical study and demonstration purposes. In Hong Kong, which has a different regulatory environment that involves device registration, the time to commercial sales could be much quicker.

After reporting the first quarter – given all the activity around the world, we are even more positive than when we last spoke in March. We continue to project sales of $3.0 million, which is based on the low end of our current distributor forecasts. As we said previously, sales will be more heavily weighted to the second half of the year. There are several large orders that are within reach with opportunities to generate high margin disposable sales.

After the close of the quarter, we did complete the sale of 4.0 million shares of our common stock and warrants to purchase an additional 2.0 million shares, for an aggregate purchase price of $720,000 in a private placement to accredited investors. We also brought in $130,000 from the recent exercise of some warrants that were priced at 10.5 cents. We continue to maintain a low burn rate, which stands at just over $400,000 per month by reducing our employment levels and using stock as a portion of management’s pay.

It is also important to note that approximately 90% of the principal from the Magna financing has been eliminated. We also have funds coming in from sales of units and disposable, to the tune of over $250,000 over the next month or so and have signed a letter of engagement with Ladenburg Thalman to help us with our capital needs.

With that, I will turn the call over to Charles.

Charles Rufai: Thank you Gene. Total revenue for the three months ended March 31, 2015 was about $127,000. Related costs of sales and net realizable value expenses were approximately $107,000, which resulted in a gross profit on the devices and disposables of approximately $20,000.

Revenue for the same period in 2014 was approximately $122,000. Related costs of sales were approximately $192,000, which resulted in a gross loss on the devices and disposables of approximately $70,000.

Contract and grant revenue was approximately $15,000 for the quarter ended March 31, 2015, compared to approximately $19,000 for the same period in 2014.

The net loss attributable to stockholders for the three months ended March 31, 2015 was about $1.3 million, or $0.01 per share, compared to a loss of about $1.6 million, or $0.02 per share, for the same period last year.

Research and development expenses decreased to approximately $373,000 in the first quarter from about $607,000 in the same period last year. The decrease was primarily related to reduction in staffing and transition to product manufacturing.

Sales and marketing expenses decreased to approximately $172,000 from about $283,000, in the same period last year; primarily due to the Company wide expense reduction and cost savings.

General and administrative expenses decreased to approximately $963,000 in the first quarter, compared to about $1.1 million in the same period last year. The decrease was primarily related to the on-going Companywide expense reduction program.

Interest expense increased to approximately $492,000 for the three months ended March 31, 2015, as compared to approximately $27,000 for the same period in 2014, primarily due to interest on our notes payables and amortization of our debt issuance costs.

Cash on hand at the end of the first quarter was about $18,000 compared to approximately $162,000 at the end of our fiscal year ended December 31, 2014. This excludes $270,000 raised in April. Our projected monthly burn rate remains just over $400,000.

At March 31, 2015, net account receivable based on current invoices totaled about $358,000, up slightly from about $338,000 at the end of our fiscal year ended December 31, 2014. The Company had about $1.1 million of net inventory on hand at the end of the quarter. Our negative working capital was about $3.5 million.

At March 31, 2015, the Company had outstanding warrants exercisable for about 28.5 million shares of common stock, with exercise price averaging $0.27 per share. If exercised, these warrants could bring in about $7.8 million in cash over the next five years, assuming full exercise. So far in the second quarter, 1.25 million warrants were converted, bringing in just over $130,000.At the end of the quarter, the Company had about 100.1 million shares outstanding.

The Company will likely be required to raise additional funds through public or private financing, new collaborative relationships, or grants, if available. As Gene mentioned, we are putting plans in place to support our continued launch of LuViva.

Additional details can be seen in our Form 10-Q, as well as our other subsequent filings.

I will now turn the call back over to Gene. Gene?

Gene Cartwright: Thanks Charles. Before we open the call to your questions, I’d like to review with everyone our key focus areas and goals for the remainder of 2015.

First, we remain focused on getting an answer on our PMA amendment. The FDA has stated that we are at the top of their to-do list and, based on their most recent communication, they have confirmed we will hear their decision before the end of May. We continue to remain hopeful that there will be a path for approval for LuViva.

More important to our success long term, however, is our international screening opportunity. We estimate the international market to be 5 times bigger than the US market. We remain focused on: increasing Cervical Guide orders from customers with the largest Cervical Guide opportunities; pursuing evaluations with key opinion leaders around the world to generate abstracts and publications to showcase LuViva’s performance; and selectively expanding distribution to new countries.

Just recently we were informed that our abstract has been accepted as an oral presentation at the October 2015 FIGO World Congress in Vancouver. FIGO is held every three years and is a leading conference for obstetrics, gynaecology and women’s health with the best scientists, clinicians, teachers and other allied health specialties assembling to present the latest science and best clinical practice.

We continue to target $3 million in sales for 2015 based on our distributor forecast. While our sales results were low for the quarter, we are pleased with the progress we have made and believe it will be reflected in future results. Again, based on guidance from distributors, sales are more heavily weighted towards the second half of the year. We continue to be hopeful we will start to see additional orders from Kenya now that the initial order is in hand and Turkey should see some positive developments over the next weeks and months as well.

Finally, ensuring we have the necessary capital to fund ongoing operations remains a priority, as well as a challenge with regard to limiting dilution. With our new banking agreement, we believe we now have the necessary relationship in place to support the additional capital requirements to fund ongoing operations. We also will continue to pursue funding and partnership opportunities with various foundations and women’s health companies.

There are some very large orders we hope to receive in the very near term, LuViva is performing well in the field, we continue to collect clinical data that supports our initial data and will be useful for future claims, and the screening opportunity is only growing. We currently estimate the international market potential for our “point of care” LuViva product, just in the markets where we have distributors, to now be over $2 billion, based on both the triage market and the screening opportunity in the developing world where access to the Pap smear and HPV is limited.

Thank you for your time and for your patience. We will work hard to continue to keep our shareholders updated in the weeks and months to come. I’ll now turn the call over to the Operator for your questions.