CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.

Previous wording

We have incurred an operating loss of approximately $5.6 million for the year ended December 31, 2023, and a loss of approximately $10.0 million (which included a $5.0 million investment for the research tools referenced in Note 3) for the year ended December 31, 2022, respectively. We expect our operating losses to continue until such time, if ever, that product sales, licensing fees, royalties and other sources generate sufficient revenue to fund our operations. We cannot predict when, if ever, we might achieve profitability and cannot be certain that we will be able to sustain profitability, if achieved.

Current wording

We have incurred an operating loss of approximately $5.7 million for the year ended December 31, 2024, and a loss of approximately $5.6 million for the year ended December 31, 2023, respectively. We expect our operating losses to continue until such time, if ever, that product sales, licensing fees, royalties and other sources generate sufficient revenue to fund our operations. We cannot predict when, if ever, we might achieve profitability and cannot be certain that we will be able to sustain profitability, if achieved.

Previous wording

For the year ended December 31, 2023, our operations used approximately $8.0 million in cash. Cash used in operations consisted primarily of cash on hand and cash raised in our December 2021 public offering and our May 2022 private offering. At December 31, 2023, we had a combined cash, certificates of deposit and short-term U.S. Treasuries balance of approximately $10.0 million. Although we generated gross proceeds in excess of $30 million from our 2021 and 2022 securities offerings, we will need additional capital to maintain our operations, continue our research and development programs, conduct clinical trials, seek regulatory approvals and manufacture and market our products. We will seek such additional funds through public or private equity or debt financings and other sources. We cannot be certain that adequate additional funding will be available to us on acceptable terms, if at all. If we cannot raise the additional funds required for our anticipated operations, we may be required to reduce the scope of or eliminate our research and development programs, delay our clinical trials and the ability to seek regulatory approvals, downsize our general and administrative infrastructure, or seek alternative measures to avoid insolvency. If we raise additional funds through future offerings of shares of our common stock or other securities, such offerings would cause dilution of current stockholders’ percentage ownership in the Company, which could be substantial. Future offerings could also have a material and adverse effect on the price of our common stock.

Current wording

For the year ended December 31, 2024, our operations used approximately $5.3 million in cash. Cash used in operations consisted primarily of cash on hand and cash raised in our December 2021 public offering, our May 2022 private offering and our December 2024 private offering. At December 31, 2024, we had a combined cash, and short-term U.S. treasuries balance of approximately $5.9 million. Although we generated gross proceeds in excess of $32 million from our 2021, 2022 and 2024 securities offerings, we will need additional capital to maintain our operations, continue our research and development programs, conduct clinical trials, seek regulatory approvals and manufacture and market our products. We will seek such additional funds through public or private equity or debt financings and other sources. We cannot be certain that adequate additional funding will be available to us on acceptable terms, if at all. If we cannot raise the additional funds required for our anticipated operations, we may be required to reduce the scope of or eliminate our research and development programs, delay our clinical trials and the ability to seek regulatory approvals, downsize our general and administrative infrastructure, or seek alternative measures to avoid insolvency. If we raise additional funds through future offerings of shares of our common stock or other securities, such offerings would cause dilution of current stockholders’ percentage ownership in the Company, which could be substantial. Future offerings could also have a material and adverse effect on the price of our common stock.

Previous wording

We have generated minimal revenues from our products. We will not achieve profitability unless we generate increased revenues from our current or proposed products or therapies.

Current wording

We have generated minimal revenues from our products and do not expect to generate revenues for the foreseeable future. We will not achieve profitability unless we generate increased revenues from our current or proposed products or therapies.

Previous wording

Revenues generated from sales of our CaverStem® and FemCelz®kits were only $9,000 and $88,600 for the years ended December 31, 2023, and December 31, 2022, respectively. To sustain our operating costs and generate profits, we will need to significantly increase revenues from our CaverStem® and FemCelz®products or from our other products or therapies that have not yet been commercialized.

Current wording

Revenues generated from sales of our CaverStem® kits were only $11,000 and $9,000 for the years ended December 31, 2024, and December 31, 2023, respectively. To sustain our operating costs and generate profits, we will need to generate revenues from our products or therapies that have not yet been commercialized.

Previous wording

We have received the necessary regulatory approval for our Type I Diabetes (CELZ-201 CREATE-1) clinical trial and our AlloStemSpine® Chronic Lower Back Pain (CELZ-202 ADAPT) clinical trial. In addition, we are further developing our cell platforms, and file INDs for additional indications that utilize our cell platforms. We anticipate that our expenses will increase substantially as we:

Current wording

We have received the necessary regulatory approval for our Type I Diabetes (CELZ-201 CREATE-1) clinical trial and our AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT) clinical trial. In addition, we are further developing our cell platforms, and file INDs for additional indications that utilize our cell platforms. We anticipate that our expenses will increase substantially as we:

Previous wording

In the near term, failure to successfully advance the development of our proposed products may have a material adverse effect on us. To date, other than limited sales generated from our CaverStem® and FemCelz®products, we have not successfully developed or commercially marketed, distributed, or sold any product candidate. The success of our business may depend upon our ability to successfully advance the development of our current and future product candidates through preclinical studies and clinical trials, where applicable, have the product candidates approved for sale by the FDA or regulatory authorities in other countries, and ultimately have the product candidates successfully commercialized by us or a commercial partner. We cannot assure you that the results of our ongoing preclinical studies or clinical trials will support or justify the continued development of our product candidates, or that we will receive the necessary approvals from the FDA, or similar regulatory authorities in other countries, to advance the development of our product candidates.

Current wording

In the near term, failure to successfully advance the development of our proposed products may have a material adverse effect on us. To date, other than limited sales generated from our CaverStem® products, we have not successfully developed or commercially marketed, distributed, or sold any product candidate. The success of our business may depend upon our ability to successfully advance the development of our current and future product candidates through preclinical studies and clinical trials, where applicable, have the product candidates approved for sale by the FDA or regulatory authorities in other countries, and ultimately have the product candidates successfully commercialized by us or a commercial partner. We cannot assure you that the results of our ongoing preclinical studies or clinical trials will support or justify the continued development of our product candidates, or that we will receive the necessary approvals from the FDA, or similar regulatory authorities in other countries, to advance the development of our product candidates.

Previous wording

Currently, our CaverStem® and FemCelz®products and related medical procedures are paid for by patients and are not eligible for reimbursement from public or private insurers. As a general rule, reimbursement is available only for products and therapies that have been approved by the FDA. Our CaverStem® and FemCelz®products were exempt from the FDA premarket review and approval process as these autologous therapies involve treating the patient with his or her own cells. While we believe that the requirement that patients directly pay the cost for our CaverStem® and FemCelz®products and procedures make these procedures more attractive to doctors, these treatments are only available to patients that can afford to pay for them. Our success and the extent of our growth will depend in part on the extent to which reimbursement for the costs of our products and related treatments will be available from third party payers, such as public and private insurers and health systems.

Current wording

Currently, our CaverStem® and FemCelz®products and related medical procedures are paid for by patients and are not eligible for reimbursement from public or private insurers. As a general rule, reimbursement is available only for products and therapies that have been approved by the FDA. Our CaverStem® and FemCelz®products were exempt from the FDA premarket review and approval process as these autologous therapies involve treating the patient with his or her own cells. While we believe that the requirement that patients directly pay the cost for our autologous products and procedures make these procedures more attractive to doctors, these treatments are only available to patients that can afford to pay for them. Our success and the extent of our growth will depend in part on the extent to which reimbursement for the costs of our products and related treatments will be available from third party payers, such as public and private insurers and health systems.

Previous wording

Our current sales, marketing and distribution capabilities consist of independent contractors who promote the sale of our CaverStem® and FemCelz®products to medical doctors. To generate sufficient revenues to support our operations, we will have to seek collaborators, especially for marketing and sales outside of the United States or invest significant amounts of financial and management resources to develop internal sales, distribution, and marketing capabilities. We may not be able to enter into collaborations or hire consultants or external service providers to assist us in sales, marketing, and distribution functions on acceptable financial terms, or at all. In addition, our product revenues, and our profitability, if any, may be lower if we rely on third parties for these functions than if we were to market, sell and distribute products that we develop ourselves. We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively. Even if we determine to perform sales, marketing, and distribution functions ourselves, we could face a number of additional related risks, including:

Current wording

To generate sufficient revenues to support our operations, we will have to seek collaborators, especially for marketing and sales in and outside of the United States or invest significant amounts of financial and management resources to develop internal sales, distribution, and marketing capabilities. We may not be able to enter into collaborations or hire consultants or external service providers to assist us in sales, marketing, and distribution functions on acceptable financial terms, or at all. In addition, our product revenues, and our profitability, if any, may be lower if we rely on third parties for these functions than if we were to market, sell and distribute products that we develop ourselves. We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively. Even if we determine to perform sales, marketing, and distribution functions ourselves, we could face a number of additional related risks, including:

Previous wording

During 2023 we effected a 1-for-10 reverse stock split in order to increase the trading price of our common stock and comply with NASDAQA’s $1.00 minimum bid price requirement. Although we are currently in compliance with Nasdaq’s minimum bid price requirement, if we again fail to satisfy this or any other continued listing requirement, Nasdaq may take steps to delist our securities. Such a delisting would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a delisting, we would take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our securities, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.

Current wording

During 2023 we effected a 1-for-10 reverse stock split in order to increase the trading price of our common stock and comply with Nasdaq’s $1.00 minimum bid price requirement. Although we are currently in compliance with Nasdaq’s minimum bid price requirement, if we again fail to satisfy this or any other continued listing requirement, Nasdaq may take steps to delist our securities. Such a delisting would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a delisting, we would take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our securities, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.