GUIDED THERAPEUTICS INC

Previous wording

Additional debt or equity financing will be required for us to continue as a going concern. We may seek to obtain additional funds for the financing of our cervical cancer detection business through additional debt or equity financings and/or new collaborative arrangements. Management believes that additional financing, if obtainable, will be sufficient to support planned operations only for a limited period. Management has implemented operating actions to reduce cash requirements. Any required additional funding may not be available on terms attractive to us, on a timely basis, or at all. If we cannot obtain additional funds or achieve profitability, we may not be able to continue as a going concern.

Current wording

Additional debt or equity financing will be required for us to continue as a going concern. We may seek to obtain additional funds for the financing of our cervical cancer detection business through additional debt or equity financings and/or new collaborative arrangements. Management believes that additional financing, if obtainable, will be sufficient to support planned operations only for a limited period. Management has implemented operating actions to reduce cash requirements. Any required additional funding may not be available on terms attractive to us, on a timely basis, or at all. We currently hold $1.13 million of senior unsecured convertible debentures that are in default, which may further hinder our ability to obtain additional debt funding. If we cannot obtain additional funds or achieve profitability, we may not be able to continue as a going concern.

Previous wording

Our independent registered public accountants’ report on our consolidated financial statements as of and for the year ended December 31, 2023, indicates that there is substantial doubt about our ability to continue as a going concern, because we have suffered recurring losses from operations and had an accumulated deficit of $151.1 million at December 31, 2023, summarized as follows:

Current wording

Our independent registered public accountants’ report on our consolidated financial statements as of and for the year ended December 31, 2024, indicates that there is substantial doubt about our ability to continue as a going concern, because we have suffered recurring losses from operations and had an accumulated deficit of $153.7 million at December 31, 2024, summarized as follows:

Previous wording

We have never been profitable and we have had operating losses since our inception. We expect our operating losses to continue as we continue to expend substantial resources to complete commercialization of our products, obtain regulatory clearances or approvals; build our marketing, sales, manufacturing and finance capabilities, and conduct further research and development. The further development and commercialization of our products will require substantial development, regulatory, sales and marketing, manufacturing and other expenditures. We have only generated limited revenues from product sales. As of December 31, 2023 and 2022, our accumulated deficit was approximately $151.1 million and $147.4 million, respectively.

Current wording

We have never been profitable and we have had operating losses since our inception. We expect our operating losses to continue as we continue to expend substantial resources to complete commercialization of our products, obtain regulatory clearances or approvals; build our marketing, sales, manufacturing and finance capabilities, and conduct further research and development. The further development and commercialization of our products will require substantial development, regulatory, sales and marketing, manufacturing and other expenditures. We have only generated limited revenues from product sales. As of December 31, 2024 and 2023, our accumulated deficit was approximately $153.7 million and $151.1 million, respectively.

Previous wording

In order for us to market our products in Europe and some other international jurisdictions, we and our distributors and agents must obtain required regulatory registrations or approvals. We must also comply with extensive regulations regarding safety, efficacy and quality in those jurisdictions. We may not be able to obtain the required regulatory registrations or approvals, or we may be required to incur significant costs in obtaining or maintaining any regulatory registrations or approvals we receive. Delays in obtaining any registrations or approvals required for marketing our products, failure to receive these registrations or approvals, or future loss of previously obtained registrations or approvals would limit our ability to sell our products internationally. For example, international regulatory bodies have adopted various regulations governing product standards, packaging requirements, labeling requirements, import restrictions, tariff regulations, duties and tax requirements. These regulations vary from country to country. In order to sell our products in Europe, in 2018 we had to undergo an inspection and re-file for ISO 13485:2016 and the CE Mark, which is an international symbol of quality and compliance with applicable European medical device directives. Failure to maintain ISO 13485:2016 certification or CE mark certification or other international regulatory approvals would prevent us from selling in some countries in the European Union.

Current wording

For us to market our products in Europe and some other international jurisdictions, we and our distributors and agents must obtain required regulatory registrations or approvals. We must also comply with extensive regulations regarding safety, efficacy and quality in those jurisdictions. We may not be able to obtain the required regulatory registrations or approvals, or we may be required to incur significant costs in obtaining or maintaining any regulatory registrations or approvals we receive. Delays in obtaining any registrations or approvals required for marketing our products, failure to receive these registrations or approvals, or future loss of previously obtained registrations or approvals would limit our ability to sell our products internationally. For example, international regulatory bodies have adopted various regulations governing product standards, packaging requirements, labeling requirements, import restrictions, tariff regulations, duties and tax requirements. These regulations vary from country to country. In order to sell our products in Europe, in 2018 we had to undergo an inspection and re-file for ISO 13485:2016 and the CE Mark, which is an international symbol of quality and compliance with applicable European medical device directives. Failure to maintain ISO 13485:2016 certification or CE mark certification or other international regulatory approvals would prevent us from selling in some countries in the European Union.

Previous wording

For our products to be marketed and sold in the People’s Republic of China, they must gain approval from the NMPA, formerly known as the Chinese Food and Drug Administration. We are working with our partner in China, Shandong Yaohua Medical Instrument Corporation, to achieve NMPA approval. In 2022 compliance testing for device safety was passed and late in 2023 enrollment in the pivotal clinical trial was completed at four hospitals. Our Chinese partner, SMI, expects the clinical trial data to be filed with NMPA in the first quarter of 2024.

Current wording

For our products to be marketed and sold in the People’s Republic of China, they must gain approval from the NMPA. We are working with our partner in China, Shandong Yaohua Medical Instrument Corporation, to achieve NMPA approval. In 2022 compliance testing for device safety was passed and late in 2023 enrollment in the pivotal clinical trial was completed at four hospitals. Our Chinese partner, SMI, filed the application for NMPA approval on October 16, 2024. On January 6, 2025, SMI informed us that NMPA found the application complete and was commencing their review. In the same communication, SMI believed that NMPA approval could occur in the second quarter of 2025, although there is no certainty that NMPA approval will occur within this timeframe.

Previous wording

Currently, we have not obtained clearance or approval from the U.S. FDA, however we have agreed with the U.S. FDA on the clinical trial protocol and have initiated a clinical trial protocol involving approximately 400 study participants.

Current wording

Currently, we have not obtained clearance or approval from the U.S. FDA, however we have agreed with the U.S. FDA on the clinical trial protocol and have initiated a clinical trial protocol involving approximately 400 study participants. As of March 1, 2025, approximately 320 patients have been enrolled and tested, which represents approximately eighty percent of the 400 anticipated patients needed to complete the study. Based on current and expected enrollment rates, we expect the study to be completed in 2025, depending in part by how many women are diagnosed with cervical disease. However, there can be no assurance that the study will progress and be completed within the expected timeframe, or ever.

Previous wording

As of December 31, 2023, we have been issued, or have rights to, 27 U.S. patents (including those under license). In addition, we have filed for, or have rights to, one U.S. patents (including those under license) that is still pending. There are additional international patents and pending applications. One or more of the patents we hold directly or license from third parties, including those for our cervical cancer detection products, may be successfully challenged, invalidated or circumvented, or we may otherwise be unable to rely on these patents. These risks are also present for the process we use or will use for manufacturing our products. In addition, our competitors, many of whom have substantial resources and have made substantial investments in competing technologies, may apply for and obtain patents that prevent, limit or interfere with our ability to make, use and sell our products, either in the United States or in international markets.

Current wording

As of December 31, 2024, we hold six active U.S. patents. In addition, we have filed for, or have rights to, one U.S. patent (including those under license) that is still pending. There are additional international patents and pending applications. One or more of the patents we hold directly or license from third parties, including those for our cervical cancer detection products, may be successfully challenged, invalidated or circumvented, or we may otherwise be unable to rely on these patents. These risks are also present for the process we use or will use for manufacturing our products. In addition, our competitors, many of whom have substantial resources and have made substantial investments in competing technologies, may apply for and obtain patents that prevent, limit or interfere with our ability to make, use and sell our products, either in the United States or in international markets.

Previous wording

Our outstanding indebtedness, which includes all of our liabilities, was $5.5 million at December 31, 2023. The terms of our indebtedness could have negative consequences to us, such as:

Current wording

Our outstanding indebtedness, which includes all of our liabilities, was $6.3 million at December 31, 2024. The terms of our indebtedness could have negative consequences to us, such as:

Previous wording

Our certificate of incorporation authorizes our board of directors to issue up to 5.0 million shares of preferred stock of which 6,882 were outstanding as of December 31, 2023. Our undesignated shares of preferred stock may be issued in one or more series, the terms of which may be determined by the board without further stockholder action. These terms may include, among other terms, voting rights, including the right to vote as a series on particular matters, preferences as to liquidation and dividends, repurchase rights, conversion rights, redemption rights and sinking fund provisions. The issuance of any preferred stock could diminish the rights of holders of our common stock, and therefore could reduce the value of our common stock. In addition, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge with or sell assets to a third party. The ability of our board to issue preferred stock could make it more difficult, delay, discourage, prevent or make it more costly to acquire or effect a change in control, which in turn could prevent our stockholders from recognizing a gain in the event that a favorable offer is extended and could materially and negatively affect the market price of our common stock.

Current wording

Our certificate of incorporation authorizes our board of directors to issue up to 5.0 million shares of preferred stock of which 6,857 were outstanding as of December 31, 2024. Our undesignated shares of preferred stock may be issued in one or more series, the terms of which may be determined by the board without further stockholder action. These terms may include, among other terms, voting rights, including the right to vote as a series on particular matters, preferences as to liquidation and dividends, repurchase rights, conversion rights, redemption rights and sinking fund provisions. The issuance of any preferred stock could diminish the rights of holders of our common stock, and therefore could reduce the value of our common stock. In addition, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge with or sell assets to a third party. The ability of our board to issue preferred stock could make it more difficult, delay, discourage, prevent or make it more costly to acquire or effect a change in control, which in turn could prevent our stockholders from recognizing a gain in the event that a favorable offer is extended and could materially and negatively affect the market price of our common stock.

Previous wording

As of December 31, 2023, our outstanding convertible debt was convertible into an aggregate of 2,809,278 shares of our common stock, and the outstanding shares of our Series C, Series C1, Series C2, Series D, Series E, Series F and Series F-2 preferred stock were convertible into an aggregate of 19,020,513 shares of common stock. Also, as of that date we had warrants outstanding that were exercisable for an aggregate of 28,584,580 shares, and outstanding options to purchase 2,338,636 shares. The shares of common stock issuable upon conversion or exercise of these securities would have constituted approximately 97.5% of the total number of shares of common stock then issued and outstanding.

Current wording

As of December 31, 2024, our outstanding convertible debt was convertible into an aggregate of 4,528,305 shares of our common stock, and the outstanding shares of our preferred stock were convertible into an aggregate of 42,718,453 shares of common stock. Also, as of that date we had warrants outstanding that were exercisable for an aggregate of 37,174,468 shares of common stock, and outstanding vested options to purchase 2,266,023 shares of common stock. The shares of common stock issuable upon conversion or exercise of these securities would have constituted approximately 133.1% of the total number of shares of common stock then issued and outstanding.