Annual Report for Fiscal Year Ending --12-31, 2023 (Form 10-K)

thmo20231231_10k.htm

Cautionary Statement Regarding Forward Looking Statements

This Annual Report contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact included in this Annual Report, are forward-looking statements. Reference is made in particular to the description of our plans and objectives for future operations, assumptions underlying such plans and objectives, and other forward-looking statements included in this Annual Report. Such statements may be identified by the use of forward-looking terminology such as "may," "will," "expect," "believe," "estimate," "anticipate," "intend," "continue," "plan," "predict," "seek," "should," "would," "could," "potential," "ongoing," or similar terms, variations of such terms, or the negative of such terms, and include, but are not limited to, statements regarding projected results of operations, capital expenditures, earnings, management's future strategic plans, development of new technologies and services, litigation, regulatory matters, market acceptance and performance of our services, the success and effectiveness of our technologies and services, our ability to retain and hire key personnel, the competitive nature of and anticipated growth in our markets, market position of our services, marketing efforts and partnerships, liquidity and capital resources, our accounting estimates, and our assumptions and judgments. Such statements are based on management's current expectations, estimates and projections about our industry, management's beliefs, and certain assumptions made by us, all of which are subject to change.

These forward-looking statements are not guarantees of future results and are subject to a number of risks, uncertainties and assumptions that are difficult to predict and that could cause actual results to differ materially and adversely from those described in the forward-looking statements, including:

●

the sufficiency and source of capital required to fund our operations and in furtherance of our business plan;

●

our ability to remain listed on Nasdaq Capital Market and remain in compliance with its listing standards;

●

the global perception of the clinical utility of banked cord blood and the amount of investment in research and development supporting clinical data for additional applications;

●

the success of any collaborative arrangements to commercialize our products;

●

our reliance on significant distributors or end users;

●

the availability and sufficiency of commercial scale manufacturing facilities and reliance on third-party contract manufacturers;

●

risks associated with our new CDMO business; and

●

our ability to protect our patents and trademarks in the U.S. and other countries.

These forward-looking statements speak only as of the date of this Annual Report and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the expectations with regard thereto or any change in events, conditions, or circumstances on which any such statement is based, except as otherwise required by law. Additional factors that could cause such results to differ materially from those described in the forward-looking statements are set forth in connection with the forward-looking statements.

Trademarks

This Annual Report contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this Annual Report, including logos, artwork and other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend our use or display of other companies' trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Reverse Stock Split

On December 22, 2022, we effected a one (1) for forty-five (45) reverse stock split of our issued and outstanding common stock. All historical share amounts disclosed in this Annual Report on Form 10-K have been retroactively restated to reflect the reverse split and subsequent share exchange. No fractional shares were issued as a result of the reverse stock split, as fractional shares of common stock were rounded up to the nearest whole share.

PART I

ITEM 1.

Business

Overview

ThermoGenesis Holdings, Inc. ("ThermoGenesis Holdings," the "Company," "we," "our," "us") develops and commercializes a range of automated technologies for cell-banking, cell-processing, and cell-based therapeutics. Since the 1990's, ThermoGenesis Holdings has been a pioneer in, and a leading provider of, automated systems that isolate, purify and cryogenically store units of hematopoietic stem and progenitor cells for the cord blood banking industry. The Company was founded in 1986 and is incorporated in the State of Delaware and headquartered in Rancho Cordova, CA.

Medical Device Products for Automated Cell Processing

The Company provides the AutoXpress® and BioArchive® platforms for automated clinical bio-banking, PXP® platform for point-of-care cell-based therapies and X-Series® products for cell processing services. All product lines are reporting as a single reporting segment in the financial statements.

Clinical Bio-Banking Applications:

●

AXP®IIAutomated Cell Separation System - an automated, fully closed cell separation system for isolating stem and progenitor cells from umbilical cord blood, registered as a U.S. FDA 510(k) medical device.

●

BioArchive® Automated Cryopreservation System - an automated, robotic, liquid nitrogen controlled-rate-freezing and cryogenic storage system for cord blood samples and cell therapeutic products used in clinical applications, registered as a U.S. FDA 510(k) medical device.

Point-of-Care Applications:

●

PXP®Point-of-Care System - an automated, fully closed, sterile system allows for the rapid, automated processing of autologous peripheral blood or bone marrow aspirate derived stem cells at the point-of-care, such as surgical centers or clinics, registered as a U.S. FDA 510(k) medical device.

●

PXP-1000 System - an automated, fully closed system that provides fast, reproducible separation of multiple cellular components from blood with minimal red blood cell contamination, registered as a U.S. FDA 510(k) medical device.

Cell Processing:

●

X-Series® Products for general laboratory use: X-Lab® for cell isolation, X-Wash® System for cell washing and reformulation, and X-Mini® for high efficiency small scale cell purification.

Contract Development and Manufacturing Services for Cell and Cell-Based Gene Therapies

The Company expanded its business to include contract development and manufacturing services for cell and cell-based gene therapies. In October 2023, the Company announced the completion of its new state-of-the-art facility, housing ISO 7 cGMP cleanroom suites, along with research and development labs giving it the capabilities to become a world-class Contract Development and Manufacturing Organization ("CDMO") for cell and cell-based gene therapies. The ReadyStart cGMP Cleanrooms and IncuStart Wet Labs are an incubator facility which provide the cleanroom environment, equipment, and services needed for R&D and cGMP manufacturing of cell and gene therapies and other life science products. The ReadyStart Cleanrooms consist of twelve leasable cGMP compliant ISO 7 cleanroom suites. Each private cGMP suite comes fully equipped and can be configured to meet the client's specific needs. Within the cGMP facility are the IncuStart Wet Labs. The facility will be maintained and supported by ThermoGenesis' operations, quality, regulatory and scientific staff, with more than 25 years of industry experience.

The Company believes that CDMO cell manufacturing services are becoming increasingly important for cell therapies to make their way through clinical trials. One of the major issues with moving cell therapy products from "bench to bedside" has been manufacturing bottlenecks. The heterogeneous nature of cell therapy products has introduced manufacturing complexity and regulatory concerns, as well as scale-up complexities that are not present within traditional pharmaceutical manufacturing. Additionally, establishing a manufacturing facility for cell therapies requires specific expertise and significant capital which can delay clinical trials. These factors often result in a significant number of cell therapy-based companies seeking CDMOs for their cell manufacturing needs. The Company believes that it can leverage its current proprietary automated and semi-automated cell processing technologies to more effectively develop CDMO capabilities.

Sales and Distribution Channels

We market and sell our medical device products through independent distributors, except in North America and India, where we sell direct to end-user customers.

Research and Development

Research and development expenses related to our medical device products were $1,284,000 and $1,659,000 for the years ended December 31, 2023 and 2022, respectively. Research and development activities include expenses associated with the engineering, regulatory, and scientific affairs functions.

As of December 31, 2023, we have not incurred any material research and development expenses related to our new CDMO business.

Manufacturing and Raw Materials

We source components for our medical device products from multiple suppliers that manufacture to our engineering specifications. Our high-volume AXP disposable products are manufactured using contract manufacturers. We utilize our manufacturing facility and in-house clean room in Rancho Cordova, California for production of our higher complexity devices and X-Series disposable cartridges. Various raw materials are used to manufacture our products. The raw materials are generally available from multiple sources. We have not had significant difficulty obtaining necessary raw materials.

Quality System

Our quality system for our medical device products business is compliant with domestic and international standards and is appropriate for the specific devices we manufacture. Our corporate quality policies govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. Such policies are intended to ensure that the products we market are safe, effective, and otherwise in compliance with the FDA Quality System Regulation ("QSR") (21 C.F.R. Part 820), EN ISO 13485: 2016 standard, the European Union Medical Device Regulations (EU MDR 2017/745), the Canadian Medical Device Regulations (SOR 98-282), the Brazil ANVISA RDC 16/2013, UK MDR and/or other applicable local, state, national and international regulations.

The Company and its contract manufacturers are subject to inspections by the FDA and other regulatory agencies to ensure compliance with the FDA's QSRs. Compliance requirements relate to manufacturing processes, product testing, documentation control and other quality assurance procedures. Our facilities have undergone International Organization of Standards ("ISO") 13485:2016 and EU Medical Device Directive ("MDD") (93/42/EEC) inspections and we have obtained approval to CE-Mark our products. We have received our updated certificate demonstrating compliance to this standard under the Medical Device Single Audit Program ("MDSAP").

Regulatory Scheme and Strategy

The development, manufacture and marketing of our medical device products are subject to regulation by the FDA as well as the equivalent agencies of other countries including the countries of the European Union and India.

We have a quality and regulatory compliance management system that meets the requirements of the ISO 13485: 2003 standard, the FDA's QSRs, the EU MDD, Canadian Medical Device Regulations (SOR 98-282), and all other applicable local, state, national and international regulations.

The FDA regulates medical devices to ensure their safety and efficacy under the Federal Food Drug and Cosmetic Act ("FD&C"). Medical devices are defined by language within the FD&C Act which essentially states that a product is considered a medical device if it is intended to provide a diagnosis or basis for treatment. Once a company determines that its product is a medical device, it is required to comply with a number of federal regulations. These include the following:

●

510(k) clearance or Premarket Approval Application ("PMA") approval from the FDA, prior to commercialization (unless the device is classified as "exempt");

●

Registration of the company and listing of the medical device with the FDA (within 30 days prior to commercialization);

●

Establishment and adherence to the FDA's labeling requirements; and

●

Establishment and adherence to the FDA's Quality Systems and Medical Device Reporting regulations.

The FDA classifies medical devices into three groups: Class I, II or III. These are stratified from lowest to highest safety risk, and regulatory controls increase based on Class.

Class I Devices

Some of our products are considered to pose little or no risk when used as directed and have been deemed by the FDA to be "exempt" from FDA approval or clearance processes prior to commercialization. While pre-marketing FDA review is not mandatory for Exempt Class I medical devices, the manufacturer's compliance with QSR is required.

Class II Devices

Several of our products, including the BioArchive and the AXP II are categorized as U.S. Class II medical devices and require premarket notification, also known as a section 510(k) clearance, prior to commercialization. Data submitted as part of a 510(k) process must demonstrate a device is "substantially equivalent" with a predicate device that is already on the market. Once 510(k) clearance has been secured, the new medical device may be marketed for its intended use and distributed in the U.S.

Class III Devices

If a product is considered a Class III device, the FDA approval process is more stringent and time-consuming, and includes the following:

●

Extensive pre-clinical laboratory and animal testing;

●

Submission and approval of an Investigational Device Exemption ("IDE") application prior to the conduct of a clinical study;

●

Human clinical studies (or trials) to establish the safety and efficacy of the medical device for the intended use; and

●

Submission and approval of a PMA application to the FDA.

Pre-clinical testing typically involves in vitro laboratory analysis and in vivo animal studies to obtain information related to such things as product safety, feasibility, biological activity and reproducibility. The results of pre-clinical studies are submitted to the FDA as part of an IDE application and are reviewed by the Agency before human clinical trials can begin.

Higher risk clinical trials conducted inside the U.S. are subject to FDA IDE regulation (21 C.F.R. Part 812), or an Investigational New Drug ("IND") application (21 C.F.R. Part 312). Clinical trials conducted outside the U.S., and the data collected therefrom are allowed in accordance with applicable FDA requirements. The FDA or the sponsor may suspend a clinical trial at any time if either one believes that study participants may be exposed to an unacceptable health risk.

For certain Class III devices, data generated during product development, pre-clinical studies, and human clinical studies must be submitted to the FDA as a PMA application in order to secure approval for commercialization in the U.S. The FDA may deny the approval of a PMA application if applicable regulatory criteria are not satisfied and, in some cases, may mandate additional clinical testing. Product approvals, once obtained, can be withdrawn if compliance with regulatory standards is not maintained or if safety concerns arise after the product reaches the market. The FDA might also require post-marketing testing and surveillance programs to monitor the safety and efficacy of a medical device and has the power to forbid or limit future marketing of the product based on the results of such programs.

Other U.S. Regulatory Information

Medical device manufacturers must register with the FDA and submit their manufacturing facilities to biennial inspections to ensure compliance with applicable regulations. Failure to comply with FDA requirements can result in withdrawal of marketing clearances, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production or loss of distribution rights. In addition, device manufacturing facilities in the state of California must be registered with the California State Food and Drug Branch of the California Department of Public Health and submit to an annual inspection by the State of California to ensure compliance with applicable state regulations. We are also subject to a variety of environmental laws as well as workplace safety, hazardous material, and controlled substances regulations.

Also, federal transparency requirements, sometimes referred to as the "Sunshine Act" under the Patient Protection and Affordable Care Act, require manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children's Health Insurance Program to report to the Department of Health and Human Services information related to physician payments and other transfers of value and physician ownership and investment interests.

Changes in these laws at all levels of government are frequent and could increase our cost of doing business. If we fail to comply, even inadvertently, with any of these requirements, we could be required to alter our operations, refund payments to the government, lose our licensure or accreditation, enter into corporate integrity, deferred prosecution or similar agreements with state or federal government agencies, and become subject to significant civil and criminal penalties.

International Regulatory Requirements

International regulatory requirements differ somewhat from those of the U.S. In the European Union ("EU"), a single regulatory approval process has been created and approval is represented by CE-Marking. To be able to affix the CE-Mark to our medical devices and distribute them in the EU, we must meet minimum standards for safety and quality (known as the essential requirements) and comply with one or more conformity rules. A notified body assesses our quality management system and compliance with the Medical Device Directive. Marketing authorization can be revoked by the applicable governmental agency or notified body in the event of an unsuccessful quality system annual audit.

Patents and Proprietary Rights

We believe that patent protection is important for our products and current and proposed business. We currently have over 30 issued patents globally relating to our medical devices that will expire at various times between March 2031 and May 2040. The patent positions can be uncertain because they involve interpretation of complex factual information and an evolving legal environment. The coverage sought in a patent application can be denied or significantly reduced either before or after the patent is issued. There can be no assurance that any of our pending patent applications will actually result in an issued patent. Furthermore, there can be no assurance that any existing or future patent will provide significant protection or commercial advantage, or that any existing or future patent will not be circumvented by a more basic patent. Generally, patent applications can be maintained in secrecy for at least 18 months after their earliest priority date. In addition, publication of discoveries in the scientific or patent literature often lags behind actual discoveries. Therefore, we cannot be certain that we were the first to invent or the first to file a patent application for the subject matter covered by each of our pending U.S. and foreign patent applications.

If a third party files a patent application relating to an invention claimed in our patent application, we may be required to participate in an interference or derivation proceeding conducted by the U.S. Patent and Trademark Office to determine who owns the patent. Such proceeding could involve substantial uncertainties and cost, even if the eventual outcome is favorable to us. There can be no assurance that our patents, if issued, would be upheld as valid in court.

Material Agreements

The following are certain material agreements involving our business in effect as of December 31, 2023:

Corning Incorporated

On August 30, 2019, the Company entered into a Supply Agreement with Corning (the "Supply Agreement"). The Supply Agreement has an initial term of five years with automatic two-year renewal terms, unless terminated by either party in accordance with the terms of the Supply Agreement (collectively, the "Term"). Pursuant to the Supply Agreement, the Company has granted to Corning exclusive worldwide distribution rights for substantially all X-Series® products (the "Products") manufactured by its subsidiary, ThermoGenesis Corp., for the duration of the Term, subject to certain geographical and other exceptions. In addition, the Company has granted Corning rights of first refusal for the exclusive worldwide distribution of certain future products developed or introduced by the Company relating to cell isolation or cell selection, including any such products substantially related or similar to the Products (the "ROFR Products"). As consideration for the exclusive worldwide distribution rights for the Products and ROFR Products, Corning paid a $2,000,000 upfront fee, in addition to any amounts payable throughout the Term for the Products and any ROFR Products.

CBR Systems, Inc. ("CBR")

Manufacturing and Supply Agreement

Effective July 13, 2020, the Company entered a Manufacturing and Supply Amending Agreement #2 (the "Amendment") with CBR Systems, Inc. ("CBR"), an amendment to the Manufacturing Supply Amending Agreement #1 effective March 16, 2020 and the Manufacturing and Supply Agreement effective May 15, 2017 (the "CBR Agreement"), in which we agreed to supply CBR with AXP cord blood processing system and disposables. The term of the CBR Agreement is for three years and will automatically renew in one-year increments unless either party provides written notice of its intention not to renew six months prior to the end of the term. The Amendment, among other things, revised the amount of certain products to be purchased, pricing of those products and removal of the safety stock requirement.

Technology License and Escrow Agreement

As part of the Amendment, the Company updated the compliance conditions in the Technology License and Escrow Agreement (the "Escrow Agreement"), which was originally signed by the Company and CBR in June 2010. Under the Escrow Agreement, we granted CBR a perpetual, royalty-free license to certain intellectual property necessary for the manufacture of AXP® devices and disposables. The license is for the sole and limited purpose of ensuring continued supply of AXP devices and disposables for use by CBR. The licensed intellectual property is held in escrow and available to CBR only in the event of a default under the Escrow Agreement. The Escrow Agreement requires that our cash balance and short-term investments, net of non-convertible debt and borrowed funds that are payable within one year, is greater than $1,000,000 at the end of each month or we will be in default of the agreement. Upon a default, CBR may take possession of the escrowed intellectual property and initiate manufacturing of AXP device and disposables for their internal use. The Company was in compliance with the License and Escrow Agreement at December 31, 2023.

Employees

As of December 31, 2023, we and our subsidiaries had 25 employees consisting of 23 full-time U.S. employees and 2 full-time employees in India. We also utilize temporary employees throughout the year to address business needs and significant fluctuations in orders and product manufacturing. None of our employees are covered by a collective bargaining agreement, nor have we experienced any work stoppage.

We endeavor to maintain workplaces that are free from discrimination or harassment on the basis of color, race, sex, national origin, ethnicity, religion, age, disability, sexual orientation, gender identification or expression or any other status protected by applicable law. The basis for recruitment, hiring, development, training, compensation and advancement is a person's qualifications, performance, skills and experience. We believe that our employees are fairly compensated, without regard to gender, race and ethnicity, and routinely recognized for outstanding performance.

Foreign Sales and Operations

See Note 12 of our Notes to Consolidated Financial Statements for information on our sales and operations outside of the U.S.

Where you can Find More Information

We are required to file annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and other information, including our proxy statement, with the Securities and Exchange Commission ("SEC"). The public can obtain copies of these materials by accessing the SEC's website at http://www.sec.gov. In addition, as soon as reasonably practicable after these materials are filed with or furnished to the SEC, we will make copies available to the public free of charge through our website, http://www.thermogenesis.com. The information on our website is not incorporated into, and is not part of, this Annual Report on Form 10-K or our other filings with the SEC.

ITEM 1A.

Risk Factors

An investment in our common stock is subject to risks inherent to our business. The material risks and uncertainties that management believes affect us are described below. Before making an investment decision, you should carefully consider the risks and uncertainties described below together with all of the other information included or incorporated by reference in this Annual Report. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are not aware of or focused on or that we currently deem immaterial may also impair our business operations. This Annual Report is qualified in its entirety by these risk factors.

If any of the following risks actually occur, our financial condition and results of operations could be materially and adversely affected. If this were to happen, the value of our common stock could decline significantly, and you could lose all or part of your investment.

Risks Related to Our Structure and Business

A third party owns 20% of our subsidiary, CARTXpress Bio, Inc. ("CARTXpress Bio"), and holds certain minority investor rights therein. These rights could limit or delay our ability to take certain major actions relating to CARTXpress Bio. In January 2019, ThermoGenesis Corp. contributed its X-Series business into a newly formed subsidiary of ThermoGenesis Corp., CARTXpress Bio. Pursuant to the terms of a reorganization and share exchange agreement, ThermoGenesis Holdings acquired a 20% equity ownership in ThermoGenesis Corp. from Bay City Capital Fund V, L.P. and certain of its affiliates ("Bay City"). In exchange, Bay City acquired a 20% ownership in CARTXpress Bio. As a result of these transactions, ThermoGenesis Corp. became a wholly-owned subsidiary of ThermoGenesis Holdings, and ThermoGenesis Corp. owns 80% of the outstanding equity of CARTXpress Bio, while Bay City owns the remaining 20% of the outstanding equity of CARTXpress Bio. While we continue to indirectly own 80% of the outstanding capital stock of CARTXpress Bio, Bay City was granted certain minority investor rights in CARTXpress Bio. These rights include board representation rights, a right of first refusal over sales of CARTXpress Bio. stock by us, co-sale rights with respect to any sale of CARTXpress Bio stock by us, certain piggyback and Form S-3 registration rights in the event that CARTXpress Bio becomes a publicly traded company at any time in the future and other rights as detailed in the Investors' Rights Agreement. In addition, the board of directors of CARTXpress Bio is comprised of three persons, two of whom are designated by us and one of whom is designated by Bay City. The foregoing minority investor rights in CARTXpress Bio could limit or delay our ability or flexibility to take certain major actions or make major decisions relating to CARTXpress Bio that might be beneficial to our stockholders, unless such actions or decisions have the consent or support of Bay City. Accordingly, the minority investor rights in CARTXpress Bio could have a negative impact on the market price of our common stock.

Our largest stockholder has significant influence over us which could limit your ability to influence the outcome of key transactions, including a change of control, and could negatively impact the market price of our common stock by discouraging third party investors. As of December 31, 2023, approximately 9% of our outstanding common stock is owned by Boyalife Group USA ("Boyalife"). In addition, pursuant to the terms of the Amended Nomination Agreement we entered into with Boyalife in April 2018, Boyalife has the right to designate a number of members of our board of directors that is in proportion to the "Boyalife Ownership Percentage", which is Boyalife and its affiliates' combined percentage ownership of outstanding common stock, treating as outstanding any shares of common stock underlying convertible securities that are immediately exercisable by Boyalife and its affiliates' (including under the debt facility) without any further payment. The Amended Nomination Agreement will terminate according to its terms when and if the Boyalife Ownership Percentage falls below 20%.

Boyalife is 100% owned by Dr. Xiaochun Xu, our Chief Executive Officer and Chairman of our Board of Directors. As a result of their ownership and ability to designate members of our Board of Directors, Boyalife (including Dr. Xu) is able to exercise significant influence over all matters affecting us, including the election of directors, formation and execution of business strategy and approval of mergers, acquisitions and other significant corporate transactions, which may have an adverse effect on our stock price and ability to execute our strategic initiatives. Boyalife and/or Dr. Xu may have conflicts of interest and interests that are not aligned with those of other investors in all respects. As a result of the concentrated ownership of our common stock, Dr. Xu may be able to control matters requiring stockholder approval, including the election of directors, the adoption of amendments to our certificate of incorporation and bylaws, and approval of a sale of our Company, and other significant corporate transactions. This concentration of ownership may delay or prevent a change in control and may have a negative impact on the market price of our common stock by discouraging third party investors from investing or making tender offers for our shares.

Boyalife is also a material creditor of our Company. We are a party to a revolving debt facility with Boyalife which has a maximum borrowing availability of $10,000,000 and an outstanding balance as of December 31, 2023 of $7,278,000 in principal and $634,000 in accrued interest. The debt facility, as amended, matures on December 31, 2024, with accrued interest due annually on the last day of each calendar year. Because this debt facility is secured by all of our shares in our ThermoGenesis Corp. subsidiary, an event of default under the debt facility would have a material adverse impact on our interest in ThermoGenesis Corp. if the lender under the debt facility elected to foreclose on such security interest.

We may seek to enter into collaborative arrangements to develop and commercialize products which may not be successful. We may seek to enter into collaborative arrangements to develop and commercialize some of our potential products and product candidates both in North America and international markets. There can be no assurance that we will be able to negotiate collaborative arrangements on favorable terms or at all or that current or future collaborative arrangements will be successful.

A significant portion of revenue is derived from customers outside the United States. We may lose revenues, market share, and profits due to exchange rate fluctuations and political and economic changes related to its foreign business. For the year ended December 31, 2023, sales to customers outside the U.S. comprised approximately 33% of revenues. This compares to 37% for the year ended December 31, 2022. Our foreign business is subject to economic, political and regulatory uncertainties and risks that are unique to each area of the world. Fluctuations in exchange rates may also affect the prices that foreign customers are willing to pay and may put us at a price disadvantage compared to other competitors. Potentially volatile shifts in exchange rates may negatively affect our financial position and results.

The loss of a significant customer may adversely affect our financial condition and results of operations. The percentage of revenues from our largest customer were 30% and 33% for the years ended December 31, 2023 and 2022, respectively. The loss of a large customer may significantly decrease revenues.

We may be exposed to liabilities under the foreign corrupt practices act and any determination that we violated these laws could have a material adverse effect on our business. We are subject to the Foreign Corrupt Practices Act ("FCPA"), and other laws that prohibit improper payments or offers of payments to foreign governments and their officials and political parties by U.S. persons and issuers as defined by the statute, for the purpose of obtaining or retaining business. It is our policy to implement safeguards to discourage these practices by our employees. However, our existing safeguards and any future improvements may prove to be less than effective, and our employees, consultants, sales agents or distributors may engage in conduct for which we might be held responsible. Violations of the FCPA may result in severe criminal or civil sanctions and we may be subject to other liabilities, which could negatively affect our business, operating results and financial condition.

Adverse results of legal proceedings could have a material adverse effect on us. We are subject to, and may in the future be subject to, a variety of legal proceedings and claims that arise out of the ordinary conduct of our business. Results of legal proceedings cannot be predicted with certainty. Irrespective of their merits, legal proceedings may be both lengthy and disruptive to our operations and may cause significant expenditure and diversion of management attention. We may be faced with significant monetary damages or injunctive relief against us that could have a material adverse effect on a portion of our business operations or a material adverse effect on our financial condition and results of operations.

Risks Related to Our Operations

We do not have commercial-scale manufacturing capability and have minimal commercial manufacturing experience. We operate GMP manufacturing facilities for device production; however, they are not of sufficient size for large commercial production. We do not have experience in large scale manufacturing, and currently rely on third-party contract manufacturers for a significant portion of our device production. We expect to depend on these contract manufacturers for the foreseeable future. Any performance failure on the part of our contract manufacturers could delay production of our current or future products, depriving us of potential product revenues and resulting in additional losses.

We have limited sales, marketing and distribution capabilities which may limit our ability to significantly increase sales quickly. We have limited internal capabilities in the sales, marketing, and distribution areas. There can be no assurance that we will be able to establish sales, marketing, and distribution capabilities internally or make arrangements with current collaborators or others to perform such activities or that such effort will be successful. If we decide to market any of our new products directly, we must either partner, acquire or internally develop a marketing and sales force with technical expertise and with supporting distribution capabilities. The acquisition or development of a sales, marketing and distribution infrastructure would require substantial resources, which may not be available to us or, even if available, divert the attention of our management and key personnel, and have a negative impact on further product development efforts.

Our inability to protect our patents, trademarks, trade secrets and other proprietary rights could adversely impact our competitive position. We believe that our patents, trademarks, trade secrets and other proprietary rights are important to our success and our competitive position. Accordingly, we commit substantial resources to the establishment and protection of our patents, trademarks, trade secrets and proprietary rights. We use various methods, including confidentiality agreements with employees, vendors, and customers, to protect our trade secrets and proprietary know-how for our products. We currently hold patents for products and have patents pending in certain countries for additional products that we market or intend to market. However, our actions to establish and protect our patents, trademarks, and other proprietary rights may be inadequate to prevent imitation of our products by others or to prevent others from claiming violations of their trademarks and proprietary rights by us. If our products are challenged as infringing upon patents of other parties, we may be required to modify the design of the product, obtain a license, or litigate the issues, all of which may have an adverse business effect on us.

We may be subject to claims that our products or processes infringe the intellectual property rights of others, which may cause us to pay unexpected litigation costs or damages, modify our products or processes or prevent us from selling our products. Although it is our intention to avoid infringing or otherwise violating the intellectual property rights of others, third parties may nevertheless claim that our processes and products infringe their intellectual property and other rights. Our strategies of capitalizing on growing international demand as well as developing new innovative products across multiple business lines present similar infringement claim risks both internationally and in the U.S. as we expand the scope of our product offerings and markets. We compete with other companies for contracts in some small or specialized industries, which increases the risk that the other companies will develop overlapping technologies leading to an increased possibility that infringement claims will arise. Whether or not these claims have merit, we may be subject to costly and time-consuming legal proceedings, and this could divert management's attention from operating our business. In order to resolve such proceedings, we may need to obtain licenses from these third parties or substantially re-engineer or rename our products in order to avoid infringement. In addition, we might not be able to obtain the necessary licenses on acceptable terms, or at all, or be able to re-engineer or rename our products successfully.

We may not be able to protect our intellectual property in countries outside the United States. Intellectual property law outside the United States is uncertain and in many countries is currently undergoing review and revisions. The laws of some countries do not protect our patent and other intellectual property rights to the same extent as United States laws. This is particularly relevant to us as a significant amount of our current and projected future sales are outside of the United States. Third parties may attempt to oppose the issuance of patents to us in foreign countries by initiating opposition proceedings. Opposition proceedings against any of our patent filings in a foreign country could have an adverse effect on our corresponding patents that are issued or pending in the United States. It may be necessary or useful for us to participate in proceedings to determine the validity of our patents or our competitors' patents that have been issued in countries other than the U.S. This could result in substantial costs, divert our efforts and attention from other aspects of our business, and could have a material adverse effect on our results of operations and financial condition.

Any failure to achieve and maintain the high design and manufacturing standards that our products require may seriously harm our business. Our products require precise, high-quality manufacturing. Achieving precision and quality control requires skill and diligence by our personnel as well as our vendors. Our failure to achieve and maintain these high manufacturing standards, including the incidence of manufacturing errors, design defects or component failures could result in patient injury or death, product recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could seriously hurt our business. Additionally, the large amount of AXP disposable inventory certain distributors and end-users maintain may delay the identification of a manufacturing error and expand the financial impact. A manufacturing error or defect, or previously undetected design defect, or uncorrected impurity or variation in a raw material component, either unknown or undetected, could affect the product. Despite our high manufacturing standards, we cannot completely eliminate the risk of errors, defects or failures. If we or our vendors are unable to manufacture our products in accordance with necessary quality standards, our business and results of operations may be negatively affected.

Our products may be subject to product recalls which may harm our reputation and divert our managerial and financial resources. The FDA and similar governmental authorities in other countries have the authority to order the mandatory recall of our products or order their removal from the market if the governmental entity finds our products might cause adverse health consequences or death. The FDA may also seize product or prevent further distribution. A government-mandated or voluntary recall by us could occur as a result of component failures, manufacturing errors or design defects (including labeling defects). In the past, we have initiated voluntary recalls of some of our products and we could do so in the future. Any recall of our products may harm our reputation with customers, divert managerial and financial resources and negatively impact our profitability.

We are dependent on our suppliers and manufacturers to meet existing regulations. Certain of our suppliers and manufacturers are subject to heavy government regulations, including FDA QSR compliance, in the operation of their facilities, products and manufacturing processes. Any adverse action by the FDA against our suppliers or manufacturers could delay supply or manufacture of component products required to be integrated or sold with our products. Although we attempt to mitigate this risk through inventory held directly or through distributors, and audit our suppliers, there are no assurances we will be successful in identifying issues early enough to allow for corrective action or transition to an alternative supplier, or in locating an alternative supplier or manufacturer to meet product shipment or launch deadlines. As a result, our sales, contractual commitments and financial forecasts may be significantly affected by any such delays.

Dependence on suppliers for custom components may impact the production schedule. We obtain products and custom components from a limited number of suppliers. If the supplier raises the price or discontinues production, we may have to find another qualified supplier to provide the item or re-engineer the item. In the event that it becomes necessary for us to find another supplier, we would first be required to qualify the quality assurance systems and product quality of that alternative supplier. Any operational issues with re-engineering or the alternative qualified supplier may impact the production schedule, therefore delaying revenues, and this may cause the cost of disposables or key components to increase.

Dependence on contract manufacturers for disposable products. We obtain the majority of our disposable products from contract manufacturers. Production halts or delays by these manufacturers could have a significant impact on our business. Our safety stock levels are generally not sufficient to handle an unexpected shut-down or delay in production by these contract manufacturers. In the event of a significant unplanned delay in production, we may need to find a new contract manufacturer, which could be a lengthy process and require a significant financial commitment, impacting our ability to fulfill customer orders and maintain current sales levels for a period of time until the new contract manufacturer can start production of our disposable products.

Failure to meet the financial covenant in our Technology License and Escrow Agreement could decrease our AXP revenues. Under our Sixth Amended and Restated Technology License and Escrow Agreement with CBR if our cash balance and short-term investments net of non-convertible debt and borrowed funds that are payable within one year are not greater than $1,000,000 at any month end, CBR may take possession of the escrowed intellectual property and initiate manufacturing of the applicable device and disposables. If this were to occur, our revenues would be negatively impacted. In order to remain compliant, we may have to complete additional financings or provide consideration to the counter party to modify the obligations.

Failure to retain or hire key personnel may adversely affect our ability to sustain or grow our business. Our ability to operate successfully and manage our potential future growth depends significantly upon retaining key research, technical, clinical, regulatory, sales, marketing and managerial personnel. Our future success partially depends upon the continued services of key technical and senior management personnel. Our future success also depends on our continuing ability to attract, retain and motivate highly qualified managerial and technical personnel. The inability to retain or attract qualified personnel could have a significant negative effect upon our efforts and thereby materially harm our business and future financial condition.

Most of our operations are conducted at a single location. Any disruption at our facilities could delay revenues or increase our expenses. Our U.S. device operations are conducted at a single location although we contract the manufacturing of certain devices, disposables and components. We take precautions to safeguard our facilities, through insurance, health and safety protocols, and off-site storage of computer data. However, a natural disaster, such as a fire, flood or earthquake, could cause substantial delays in our operations, damage or destroy our manufacturing equipment or inventory, and cause us to incur additional expenses. The insurance we maintain against fires, floods, and other natural disasters may not be adequate to cover our losses in any particular case.

Failure to maintain and/or upgrade our information technology systems may have an adverse effect on our operations. We rely on various information technology systems to manage our operations, and we evaluate these systems against our current and expected requirements. Although we have no current plans to implement modifications or upgrades to our systems, we will eventually be required to make changes to legacy systems and acquire new systems with new functionality. Any information technology system disruptions, if not anticipated and appropriately mitigated, could have an adverse effect on our business and operations.

If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, our ability to operate our business and investors' views of us. We are required to establish and maintain adequate internal control over financial reporting, which are processes designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. We are also required to comply with Section 404 of the Sarbanes-Oxley Act of 2002, which (among other things) requires public companies to conduct an annual review and evaluation of their internal control over financial reporting. However, as a "smaller reporting company," we are not required to obtain an auditor attestation regarding our internal control over financial reporting. If, in the future, we require an attestation report from our independent registered public accounting firm and that firm is unable to provide an unqualified attestation report on the effectiveness of our internal controls over financial reporting, investor confidence and, in turn, our stock price could be materially adversely affected.

Security breaches and other disruptions could compromise our information and expose us to liability, which would cause our business and reputation to suffer. In the ordinary course of the Company's business, the Company collects and stores sensitive data, including intellectual property, our proprietary business information and that of our customers, suppliers and business partners and personally identifiable information of the Company's employees on its networks. The secure processing, maintenance and transmission of this information is critical to the Company's operations and business strategy. Despite the Company's security measures, its information, technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions. Any such breach could compromise the Company's networks and the information stored there could be accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings or regulatory penalties and could disrupt the Company's operations and the services it provides to customers, damage the Company's reputation, and cause a loss of confidence in the Company's products and services, which could adversely affect the Company's business.

The COVID-19 pandemic created a global health crisis and an unprecedented disruption of commercial activity around the world. The future consequences of COVID-19 or other pandemics, wars or other hostilities, geopolitical instability, widespread cyberattacks, climate events or other national or global crises are uncertain and we cannot predict how such events may affect our future financial condition and results of operations. Disruptions in commercial activity and changes in consumer spending resulting from the COVID-19 pandemic significantly affected worldwide commerce and the global economy. Although we operated continuously throughout the pandemic, and while conditions in the U.S. and around the world have significantly improved, we cannot predict how new variants of coronavirus could impact our operations in the future. In addition, we could be affected by other significant events in the United States or abroad that could cause similar disruptions in commerce, like future pandemics, the outbreak of war or other hostilities, geopolitical conflicts, cyberattacks affecting infrastructure we depend on, and climate emergencies. The direct and indirect effects of the COVID-19 pandemic are widespread and may evolve, and the effects of similar future disasters are also uncertain. It is possible that the pandemic and similar events, and economic conditions resulting from those events, could affect our business in the future in ways that we do not or cannot now anticipate.

Risks Related to Our Industry

Our business is heavily regulated, resulting in increased costs of operations and delays in product sales.Many of our products require FDA approval or clearance to sell in the U.S. and will require approvals from comparable agencies to sell in foreign countries. These authorizations may limit the U.S. or foreign markets in which our products may be sold. Further, our products must be manufactured under the requirements of our quality system for continued CE-Marking so they can continue to be marketed and sold in Europe. These requirements are similar to the QSR of both the FDA and California Department of Public Health. Failure to comply with or incorrectly interpret these quality system requirements and regulations may subject us to delays in production while we correct deficiencies found by the FDA, the State of California, or our notifying body as a result of any audit of our quality system. If we are found to be out of compliance, we could receive a Warning Letter or an untitled letter from the FDA or even be temporarily shut down in manufacturing and product sales while the non-conformances are rectified. Also, we may have to recall products and temporarily cease their manufacture and distribution, which would increase our costs and reduce our revenues. The FDA may also invalidate our PMA or 510(k) if appropriate regulations relative to the PMA or 510(k) products are not met. The notified bodies may elect to not renew CE-Mark certification. Any of these events would negatively impact our revenues and costs of operations.

Changes in governmental regulations may reduce demand for our products or increase our expenses. We compete in many markets in which we and our customers must comply with federal, state, local and international regulations, such as environmental, health and safety and food and drug regulations. We develop, configure and market our products to meet customer needs created by those regulations. Any significant change in regulations could reduce demand for our products or increase our expenses. For example, many of our instruments are marketed to the industry for enabling new regenerative therapies. Changes in the FDA's regulation of the devices and products directed at regenerative medicine, and development process for new therapeutic applications could have an adverse effect on the demand for these products.

To sell in international markets we are subject to regulation in foreign countries. In cooperation with our distribution partners, we market our current and future products both domestically and in many foreign markets. A number of risks are inherent in international transactions. In order for us to market our products in certain non-U.S. jurisdictions, we need to obtain and maintain required regulatory approvals or clearances and must comply with extensive regulations regarding safety, manufacturing processes and quality. These regulations, including the requirements for approvals or clearances to market, may differ from the FDA regulatory scheme. International sales also may be limited or disrupted by political instability, price controls, trade restrictions and changes in tariffs. Additionally, fluctuations in currency exchange rates may adversely affect demand for our products by increasing the price of our products in the currency of the countries in which the products are sold.

There can be no assurance that we will obtain regulatory approvals or clearances in all of the countries where we intend to market our products, or that we will not incur significant costs in obtaining or maintaining foreign regulatory approvals or clearances, or that we will be able to successfully commercialize current or future products in various foreign markets. Delays in receipt of approvals or clearances to market our products in foreign countries, failure to receive such approvals or clearances or the future loss of previously received approvals or clearances could have a substantial negative effect on our results of operations and financial condition.

Operating in foreign jurisdictions subjects us to regulation by non-U.S. authorities. We have operations in India, and as such are subject to Indian regulatory agencies. A number of risks are inherent in conducting business and clinical operations overseas. In order for us to operate as a majority owned foreign corporation in India, we are subject to financial regulations imposed by the Reserve Bank of India. This includes the rules specific to the capital funding, pledging of assets, repatriation of funds and payment of dividends from and to the foreign subsidiaries and from and to us in the U.S.

If our competitors develop and market products that are more effective than our product candidates or obtain regulatory and market approval for similar products before we do, our commercial opportunity may be reduced or eliminated. The development and commercialization of new pharmaceutical products is competitive, and we will face competition from numerous sources, including major biotechnology and pharmaceutical companies worldwide. Many of our competitors have substantially greater financial and technical resources and development, production and marketing capabilities than we do. In addition, many of these companies have more experience than we do in pre-clinical testing, clinical trials and manufacturing of compounds, as well as in obtaining FDA and foreign regulatory approvals. As a result, there is a risk that one of the competitors will develop a more effective product for the same indications for which we are developing a product or, alternatively, bring a similar product to market before we can. With regards to the BioArchive and AXP Systems, numerous larger and better-financed medical device manufacturers may choose to enter this market.

Changes in healthcare policy could subject us to additional regulatory requirements that may delay the commercialization of our products and increase our costs.The U.S. government and other governments have shown significant interest in pursuing healthcare reform. Any government-adopted reform measures could adversely impact the pricing of our diagnostic products and tests in the U.S. or internationally and the amount of reimbursement available from governmental agencies or other third-party payors. The continuing efforts of the U.S. and foreign governments, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce healthcare costs may adversely affect our ability to set prices for our products and services that we believe are fair, which may impact our ability to generate revenues and achieve and maintain profitability.

New laws, regulations and judicial decisions, or new interpretations of existing laws, regulations and judicial decisions, that relate to healthcare availability, methods of delivery or payment for products and services, or sales, marketing or pricing, may limit our potential revenue or force us to revise our research and development programs. The pricing and reimbursement environment may change in the future and become more challenging for several reasons, including policies advanced by the current executive administration in the U.S., new healthcare legislation or fiscal challenges faced by government health administration authorities. Specifically, in both the U.S. and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably.

The Food and Drug Administration Amendments Act of 2007 gives the FDA enhanced post-marketing authority, including the authority to require post-marketing studies and clinical studies of products, labeling changes based on new safety information, and compliance with risk evaluations and mitigation strategies approved by the FDA. The FDA's exercise of this authority could result in delays or increased costs during product development, clinical studies and regulatory review, increased costs to assure compliance with post-approval regulatory requirements, and potential restrictions on the sale and/or distribution of approved products, all of which could materially adversely affect our business, prospects and financial condition.

Product liability and uninsured risks may adversely affect the continuing operations. We operate in an industry susceptible to significant product liability claims. We may be liable if any of our products or services cause injury, illness, or death. These claims may be brought by individuals seeking relief or by groups seeking to represent a class. We also may be required to recall certain of our products should they become damaged or if they are defective. We are not aware of any material product liability claims against us. However, product liability claims may be asserted against us in the future based on events we are not aware of at the present time. We maintain a product liability policy and a general liability policy that includes product liability coverage. However, a product liability claim against us could have a material adverse effect on our business or future financial condition.

Risks Related to Operating Results and Financial Markets

We have incurred net losses and we anticipate that our losses will continue. We have not been profitable for a significant period. For the years ended December 31, 2023 and 2022, we had a net loss of $18,819,000 and $11,812,000 respectively and an accumulated deficit at December 31, 2023 of $284,168,000. The report of our independent auditors on our December 31, 2023 financial statements includes an explanatory paragraph indicating there is substantial doubt about our ability to continue as a going concern. We will continue to incur significant costs as we develop and market our current products and related applications. Although we are executing our business plan to develop, market and launch new products, continuing losses may impair our ability to fully meet our objectives for new product sales or threaten our ability to continue as a going concern in future years.

We will need to raise additional capital to fund our operations and the furtherance of our business plan. Due to our recurring losses from operations and the expectation that we will continue to incur losses in the future, we will need to raise additional capital. We have historically relied upon private and public sales of our equity, as well as debt financings to fund our operations. In order to raise additional capital, we may seek to sell additional equity and/or debt securities or obtain a credit facility or other loan, which we may not be able to do on favorable terms, or at all. Our ability to obtain additional financing will be subject to a number of factors, including market conditions, our operating performance and investor sentiment. If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue the development and/or commercialization of one or more of our product candidates, restrict our operations or obtain funds by entering into agreements on unfavorable terms.

Risks Related to Our Common Stock

If our common stock, including the price of our common stock does not meet the requirements of the Nasdaq Capital Market Stock Exchange ("Nasdaq"), our shares may be delisted. Our ability to publicly or privately sell equity securities and the liquidity of our common stock could be adversely affected if we are delisted. The listing standards of Nasdaq provide, among other things, that a company may be delisted if the bid price of its stock drops below $1.00 for a period of 30 consecutive business days.

Nasdaq's listing standards provide that a company may be delisted if the bid price of its stock drops below $1.00 for a period of 30 consecutive business days. On January 8, 2024, we received written notice from the Nasdaq Listing Qualifications Department notifying the Company that it was not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market, due to the bid price of the Company's common stock closing below the minimum $1.00 per share for the thirty (30) consecutive business days prior to the date of the Notification Letter. In accordance with listing rules, the Company was afforded 180 days, or until July 8, 2024, to regain compliance. If during this 180-day compliance period the closing bid price of the Company's common stock is at least $1.00 per share for a minimum of ten consecutive business days, then Nasdaq will provide the Company with written confirmation of compliance and the matter will be closed. If compliance cannot be demonstrated by July 8, 2024, the Company may be eligible for additional time. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards on Nasdaq (except the bid price requirement). In addition, the Company would be required to provide written notice of its intention to cure the minimum bid price deficiency during this second 180-day compliance period by effecting a reverse stock split, if necessary. The Notice states that, if the Company meets these standards, then the Company may be eligible to have an additional 180-calendar day compliance period. If the Company is not granted an additional 180-day compliance period, then Nasdaq will provide written notification that the Company's securities will be subject to delisting. At that time, the Company may appeal the determination to delist its securities to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement or otherwise maintain compliance with the other listing requirements.

Delisting from Nasdaq could adversely affect our ability to raise additional financing through the public or private sale of equity securities, would significantly affect the ability of investors to trade our securities and would negatively affect the value and liquidity of our common stock. Delisting could also have other negative results, including the potential loss of confidence by employees, the loss of institutional investor interest and fewer business development opportunities.

Liquidity of our common stock. Although there is a public market for our common stock, trading volume has been historically low, which could impact the stock price and the ability to sell shares of our common stock. We can give no assurance that an active and liquid public market for shares of common stock will continue in the future. In addition, future sales of large amounts of common stock could adversely affect the market price of our common stock and our ability to raise capital. The price of our common stock could also drop as a result of the exercise of options for common stock or the perception that such sales or exercise of options could occur. These factors could also have a negative impact on the liquidity of our common stock and our ability to raise funds through future stock offerings.

We do not pay cash dividends. We have never paid any cash dividends on our common stock and do not intend to pay cash dividends in the foreseeable future. Instead, we intend to apply earnings, if any, to the expansion and development of our business. Thus, the liquidity of your investment is dependent upon your ability to sell stock at an acceptable price. The price can go down as well as up and may limit your ability to realize any value from your investment, including the initial purchase price.

Our Amended and Restated Bylaws provide that the Court of Chancery of the State of Delaware will be the sole and exclusive venue for certain litigation that may be initiated by our stockholders, which may limit a stockholder's ability to obtain a favorable judicial forum for such disputes with us or our directors, officers or employees.

Our Amended and Restated Bylaws provide that, unless we consent in writing to the selection of an alternative venue, the Court of Chancery of the State of Delaware will be the sole and exclusive venue for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim for breach of a fiduciary duty owed by any of our directors, officers, employees or agents to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law, our certificate of incorporation or bylaws or (iv) any action asserting a claim governed by the internal affairs doctrine, in each case subject to the Court of Chancery of the State of Delaware having personal jurisdiction over the indispensable parties named as defendants therein. This choice of venue provision will not apply to actions or proceedings brought to enforce a duty or liability created by the Securities Act or the Exchange Act.

This choice of venue provision may limit a stockholder's ability to bring certain claims in a judicial forum that it finds favorable for disputes with us or our directors, officers, employees or agents, which may discourage the filing of lawsuits with respect to such claims. If a court were to find this choice of venue provision to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in another jurisdiction, which could adversely affect our business and financial condition.

Sales of substantial amounts of our Common Stock by the selling stockholders named in the Registration Statements on Form S-3 filed by us in April 2023, or the perception that these sales could occur, could adversely affect the price of our Common Stock. In April 2023, we filed two resale registration statements on Form S-3 for the selling stockholders named therein, and such registration statements were declared effective in April and May 2023, respectively. The sale by the selling stockholders of a significant number of shares of Common Stock could have a material adverse effect on the market price of our Common Stock. In addition, the perception in the public markets that the selling stockholders may sell all or a portion of their shares as a result of the registration of such shares for resale pursuant to this prospectus could also in and of itself have a material adverse effect on the market price of our Common Stock. We cannot predict the effect, if any, that market sales of those shares of Common Stock or the availability of those shares of Common Stock for sale will have on the market price of our Common Stock.

Risks Related to Our New Contract Development and Manufacturing Organization (CDMO) Service

Our CDMO business is a new business line for us, and we have not yet recognized any material revenues from this business, and we are subject to the general risks associated with entering into a new business. We have not yet received material revenues from our new CDMO business, and there is no assurance that we will be able to generate sufficient business to generate material revenues. In addition, initiating new business activities or strategies like our new CDMO business may expose us to new or increased financial, regulatory, reputational and other risks. We cannot be certain that we will be able to manage the associated risks and compliance requirements effectively. Such risks include a lack of experienced management-level personnel, increased administrative burden, increased logistical problems common to large, expansive operations, increased credit and liquidity risk and increased regulatory scrutiny.

Our success may depend on our ability to attract and retain key scientific or professional talents in the CDMO field. The Company currently lacks certain unique personnel for CDMO services. We will need to actively search and recruit the talents that are necessary for our business growth. Our success in transforming into CDMO services depends substantially on the efforts and abilities to recruit and retain key personnel. The competition for qualified CDMO services key personnel, is intense. The inability to hire, train, and retain key personnel could delay the launching of our CDMO services, disrupt our business, and interfere with our ability to execute our CDMO business plan.

We will need to increase the size and capabilities of our organization to support our CDMO services, and we may experience difficulties in managing this growth.As our development and commercialization plans develop, we will need to add a significant number of additional managerial, operational, sales, marketing, financial, and other personnel. Future growth may create significant added responsibilities for Company management. Our future financial performance and our ability to successfully run our CDMO services division will depend, in part, on our ability to effectively manage future growth.

We are dependent on our ability to predict the CDMO cell manufacturing market and to identify customers. While there is an increasing number of clinical trials for cell therapies, the number of cell and gene therapy products that have reached commercial production is still limited. Cell therapy is an emerging industry and a significant global market for manufacturing services may never emerge. The number of customers who may use cell-based therapies, and the demand for cell manufacturing services, is difficult to estimate. If cell therapies under development are not proven safe and effective, demonstrate unacceptable risks or side effects or fail to receive regulatory approval if required; our manufacturing business may be significantly impaired. While the therapeutic application of cells to treat serious diseases is currently being explored by a number of companies, to date there are only a handful of approved cell therapy products in the U.S. Ultimately, our success in deriving revenue from manufacturing depends on the development and growth of a broad and profitable global market for cell therapies and services and our ability to capture a share of this market through identifying the proper customers.

We may fail to effectively utilize licensed technologies. We have entered into a licensing agreement and in the future, we may seek additional collaborations or strategic alliances or enter into additional licensing arrangements with organizations that we believe will complement or augment our own technologies and services. Licensing and collaborations arrangements are subject to numerous risks, and we may not realize the benefits of such alliances or licensing arrangements as we anticipated.

External competition from other CDMO cell manufacturing service providers may be harmful to our CDMO business. We face competition from other companies that are large, well-established manufacturers with financial, technical, research and development and sales and marketing resources that are significantly greater than ours. We also face competition from academic and research institutions that may choose to self-manufacture rather than utilize a contract manufacturer. To be successful, we will need to convince potential customers that our technology and capabilities are more innovative, of higher-efficiency and more cost-effective than could be achieved through internal manufacturing; and demonstrate that our technology and expertise in automated cell processing is unique to the industry. Our ability to achieve this and to successfully compete against other manufacturers will depend, in large part, on our success in developing innovative cell processing technologies that improve the efficiency and reduce the drug cost associated with cell therapy manufacturing. If we are unable to successfully demonstrate our competitive advantages, we may not be able to compete against other manufacturers.

While there is an increasing number of product candidates in clinical trials with a smaller number that have reached commercial production, cell therapy is a developing industry and a significant global market for manufacturing services may never emerge. Cell therapy is in its early stages and is still a developing area of research, with few cell therapy products approved for clinical use. Many of the existing cellular therapy candidates are based on novel cell technologies that are inherently risky and may not be understood or accepted by the marketplace, making it difficult for their own funding to enable them to continue their business. The number of people who may use cell or tissue-based therapies, and the demand for cell processing services, is difficult to forecast. If cell therapies under development by third parties are not proven safe and effective, demonstrate unacceptable risks or side effects or, where required, fail to receive regulatory approval, our manufacturing business will be significantly impaired. While the therapeutic application of cells to treat serious diseases is currently being explored by a number of companies, to date there are only a handful of approved cell therapy products in the U.S. Ultimately, our success in deriving revenue from manufacturing depends on the development and growth of a broad and profitable global market for cell, gene and tissue-based therapies and services and our ability to capture a share of this market.

ITEM 1B.

Unresolved Staff Comments

None.

ITEM 1C.

Cybersecurity

Cybersecurity risk management is part of the Company's overall enterprise risk management program. Our cybersecurity risk management program is designed to provide a framework for handling cybersecurity threats and incidents, including threats and incidents associated with the use of services provided by third-party service providers, and facilitate coordination across different departments of our company. This framework includes steps for assessing the severity of a cybersecurity threat, identifying the source of a cybersecurity threat including whether the cybersecurity threat is associated with a third-party service provider, implementing cybersecurity countermeasures and mitigation strategies and informing management and our board of directors of material cybersecurity threats and incidents. We engage with third party service providers to perform penetration tests and to inform us of possible vulnerabilities. In addition, cybersecurity training is provided to all employees on a regular basis but at least annually.

Our board of directors has overall oversight responsibility for our risk management, including the cybersecurity risk management program. Management is responsible for identifying, considering and assessing material cybersecurity risks on an ongoing basis, establishing processes to ensure that such potential cybersecurity risk exposures are monitored, putting in place appropriate mitigation measures and maintaining cybersecurity programs. Our cybersecurity programs are under the direction of our Vice President of Operations who monitors the prevention, detection, mitigation, and remediation of cybersecurity incidents. Any significant Cyber incidents are reported to the audit committee and ultimately to the board of directors.

ITEM 2.

Properties

We lease a facility with approximately 28,000 square feet of space located in Rancho Cordova, California. The facility is comprised of warehouse space, manufacturing operations, office space, a biologics lab, a clean room, and a research and development lab. The lease expires May 31, 2024.

We lease a facility with approximately 35,000 square feet of space in Rancho Cordova, California for space that will house our CDMO cell manufacturing operations. The lease expires September 30, 2027, with the option to renew the lease for two five-year periods.

In Gurugram India, we lease an office facility with approximately 1,500 square feet, which is used for general office space. The lease expires September 14, 2023; however, either party can terminate the lease with three months' notice.

We believe our facilities are adequate for our present needs and expect them to remain adequate for the foreseeable future.

ITEM 3.

Legal Proceedings

In the normal course of operations, we may have disagreements or disputes with distributors, vendors or employees. Such potential disputes are seen by management as a normal part of business and while the outcome of such disagreements and disputes cannot be predicted with certainty, except as described in Note 10, "Commitments and Contingencies," in "Item 8. Financial Statements - Notes to Consolidated Financial Statements", we do not believe that any pending legal proceedings are material. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

The material set forth in Note 10, "Commitments and Contingencies," in "Item 8. Financial Statements - Notes to Consolidated Financial Statements" is incorporated herein by reference.

ITEM 4.

Mine Safety Disclosures

Not applicable.

PART II

ITEM 5.

Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Our common stock, $0.001 par value, is listed on the Nasdaq Capital Market under the symbol THMO.

We have not paid cash dividends on our common stock and do not intend to pay a cash dividend in the foreseeable future. There were approximately 141 stockholders of record on March 1, 2024, not including beneficial owners who own their stock in street name through Cede & Co. and others.

The Company did not repurchase any of its shares during the year ended December 31, 2023.

ITEM 6.

[Reserved]

ITEM 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Certain statements contained in this section and other parts of this Annual Report on Form 10-K which are not historical facts are forward looking statements and are subject to certain risks and uncertainties. Our actual results may differ significantly from the projected results discussed in the forward-looking statements. Factors that might affect actual results include, but are not limited to, those discussed in ITEM 1A "RISK FACTORS" and other factors identified from time to time in our reports filed with the SEC. The following discussion should be read in conjunction with our consolidated financial statements contained in this Annual Report.

General Overview

The Company develops and commercializes a range of automated technologies for cell-banking, cell-processing, and cell-based therapeutics. Since the 1990's ThermoGenesis Holdings has been a pioneer in, and a leading provider of, automated systems that isolate, purify and cryogenically store units of hematopoietic stem and progenitor cells for the cord blood banking industry. The Company was founded in 1986 and is incorporated in the State of Delaware and headquartered in Rancho Cordova, CA.

The Company provides the AutoXpress® and BioArchive® platforms for automated clinical bio-banking, PXP® platform for point-of-care cell-based therapies and X-Series® products for cell processing services. All product lines are reporting as a single reporting segment in the financial statements.

See the "Business" section in Part I, Item 1 of this Form 10-K for additional information.

Reverse Stock Split

On December 22, 2022, the Company effected a one (1) for forty-five (45) reverse stock split of its issued and outstanding common stock. The total number of shares of common stock authorized for issuance by the Company of 350,000,000 shares did not change in connection with the reverse stock split.

All historical share amounts disclosed herein have been retroactively restated to reflect the reverse split and subsequent share exchange. No fractional shares were issued as a result of the reverse stock split, as fractional shares of common stock were rounded up to the nearest whole share.

Results of Operations

Year Ended December 31, 2023 Compared to the Year Ended December 31, 2022

Net Revenues

Net revenues for the year ended December 31, 2023, were $9,445,000 compared to $10,483,000 for the year ended December 31, 2022, a decrease of $1,038,000 or 10%. The decrease in revenue was driven by approximately $1,800,000 less in AXP disposables as a result of the Company's change in its contract manufacturer for AXP bagsets. As the new manufacturer spent a significant portion of the second half of 2023 completing implementation and quality testing, fewer AXP bagsets were available to sell. By December 2023, our new manufacturer was fully operational. We expect our production capacity in 2024 will be sufficient to meet our demand. The decrease in AXP disposable sales was offset by approximately $600,000 more in AXP device sales, as the Company added several new customers for AXP, resulting in additional purchases of the device hardware required to utilize the technology. Additionally, BioArchive revenue increased in 2023, primarily due to higher service revenue; and other sales decreased, primarily due to the Company discontinuing sales of manual disposables in 2023.

Revenues were comprised of the following:

		Years Ended December 31,
		2023			2022
AXP		$	5,202,000			$	6,391,000
BioArchive			2,845,000				2,215,000
CAR-TXpress			1,052,000				1,129,000
Other			346,000				748,000
		$	9,445,000			$	10,483,000

Gross Profit

The Company's gross profit was $1,931,000 or 20% of net revenues for the year ended December 31, 2023, compared to $2,710,000 or 26% for the year ended December 31, 2022, a decrease of $779,000 or 29%. The primary driver of the decrease in 2023 was additional inventory reserves of approximately $900,000, offset by sales at higher margins.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $7,221,000 for the year ended December 31, 2023, as compared to $7,244,000 for the year ended December 31, 2022, a decrease of $23,000. The difference was primarily driven by approximately $400,000 less in accrued employee short term incentives, offset by increased expenses for the Company's CDMO facility of approximately $160,000, consulting costs of approximately $140,000 and advertising expenses of approximately $90,000 in 2023.

Research and Development Expenses

Research and development expenses were $1,284,000 for the year ended December 31, 2023, compared to $1,659,000 for the year ended December 31, 2022, a decrease of $375,000 or 23%. The decrease was driven by lower personnel expenses of approximately $100,000 and lower project expenses of approximately $275,000.

Impairment Charges

The Company incurred impairment charges of $2,036,000 during the year ended December 31, 2023. The Company experienced a significant and sustained decline in its stock price during the year ended December 31, 2023. The decline resulted in the Company's market capitalization falling significantly below the recorded value of its consolidated net assets. Additionally, in February 2024, the Company's distribution agreement with Corning was not extended for up to four years as was available in the agreement. As a result, the Company determined it was unlikely it would be able to successfully commercialize its in-process technology, halted its development, and removed all related revenues from its long-term forecasts. Driven by these factors, the Company determined that it is more likely than not the fair value of the Company's indefinite-lived and developed technology intangible assets and related goodwill is less than the carrying value. The Company recorded an impairment charge of $1,255,000 to intangible assets and $781,000 to goodwill during the year ended December 31, 2023.

Interest Expense

Interest expense increased to $10,032,000 for the year ended December 31, 2023, as compared to $5,616,000 for the year ended December 31, 2022, a difference of $4,416,000. The increase was driven by approximately $5,000,000 in additional amortization expense related to triggering events from a decrease in the conversion price of the Note and January 2019 Note in 2023, offset by lower interest expense related to the notes of approximately $400,000.

Liquidity and Capital Resources

At December 31, 2023, we had cash and cash equivalents of $2,000,000. We have used cash generated from operations and private and public placement of equity securities as our primary sources of liquidity.

The Company has a Revolving Credit Agreement with Boyalife Group, Inc. As of December 31, 2023, the Company had drawn down $7,278,000 of the $10,000,000 that is available under the Revolving Credit Agreement, which matures in December 2024. Boyalife Group Inc. is owned and controlled by the Company's Chief Executive Officer and Chairman of our Board of Directors. The Company does not expect to be able to draw additional funds from the Revolving Credit Agreement in 2024.

The Company also had an unsecured convertible promissory note with an accredited investor pursuant to which the Company issued and sold to such investor with an original principal amount of $1,000,000. As of December 31, 2023, the outstanding balance of the note was $397,000. The note matured on January 31, 2024, at which time the Company paid the outstanding balance of the note.

The Company has incurred historical losses from operations and expects to continue to incur operating losses in the near future. The Company will need to raise additional capital to grow its business, fund operating expenses and make interest payments. The Company's ability to fund its liquidity needs is subject to various risks, many of which are beyond its control. The Company may seek additional funding through debt borrowings, sales of debt or equity securities or strategic partnerships. The Company cannot guarantee that such funding will be available on a timely basis, in needed quantities or on terms favorable to the Company, if at all. These factors and other indicators raise substantial doubt about the Company's ability to continue as a going concern within one year from the filing date of this report.

We manage the concentration of credit risk with our customers and distributors through a variety of methods including, pre-shipment deposits, credit reference checks and credit limits. Although management believes that our customers and distributors are sound and creditworthy, a severe adverse impact on their business operations could have a corresponding material effect on their ability to pay timely and therefore on our net revenues, cash flows and financial condition.

Critical Accounting Estimates

The preparation of our consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our estimates, including those related to stock-based compensation, assumptions made in valuing financial instruments issued in various compensation and financing arrangements, depreciation and amortization, fair values of intangibles and goodwill, allowance for credit losses, carrying amounts of inventories, warranties, deferred income taxes and contingencies. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. See Note 3 "Summary of Significant Accounting Policies" to the Notes to the Consolidated Financial Statements contained in Item 8. We believe the following policies are critical and require significant judgement by the Company:

Revenue Recognition

The Company's revenues primarily consist of device sales and service revenue.

Device Sales

Device sales include devices and consumables for BioArchive, AXP,CAR-TXpress and manual disposables. Revenue is recognized when control of the devices passes to the customer, and the Company's performance obligation has been satisfied.

Service Revenue

Service revenue principally consists of maintenance contracts for BioArchive, AXP and CAR-TXpress products. Devices sold have warranty periods of one to two years. After the warranty expires, the Company offers separately priced annual maintenance contracts. Under these contracts, customers pay in advance. These prepayments are recorded as deferred revenue and recognized over time as the contract performance obligations are satisfied.

Revenue is recognized based on the following five-step process as outlined in the Accounting Standards Codification ("ASC") Topic 606, "Revenue from Contracts with Customers": (i) Identify the Contract with the Customer; (ii) Identify Performance Obligations in the Contract; (iii) Determine the Transaction Price; (iv) Allocate the Transaction Price; and (v) Satisfaction of the Performance Obligations (and Recognize Revenue).

Revenues are recorded net of discounts. Shipping and handling fees billed to customers are included in net revenues, while the related costs are included in cost of revenues. Most sales are made with FOB origin shipping terms, with title and control of the goods passing to the customer at the time of shipment. Payments from domestic customers are normally due in two months or less after the title transfers, the service contract is executed, or the services have been rendered. For international customers, payment terms may extend up to 120 days. All sales have fixed pricing and there are currently no variable components included in the Company's revenue.

Generally, all sales are contract sales (with either an underlying contract or purchase order). The Company does not have any material contract assets. When invoicing occurs prior to revenue recognition, a contract liability is recorded (as deferred revenue on the consolidated balance sheet).

Except for limited exceptions, there is no right of return provided for distributors or customers. For distributors, the Company has no control over the movement of goods to the end customer. The Company's distributors control the timing, terms and conditions of the transfer of goods to the end customer. Additionally, for sales of products made to distributors, the Company considers a number of factors in determining when revenue is recognized. These factors include, but are not limited to, whether the payment terms offered to the distributor are considered to be non-standard, the distributor's history of adhering to the terms of its contractual arrangements with the Company, whether the Company has a pattern of granting concessions for the benefit of the distributor, and whether there are other conditions that may indicate that the sale to the distributor is not substantive.

Inventories

We value inventory at the lower of cost or net realizable value. Cost is determined on a first in first out basis. This policy requires us to make estimates regarding the net realizable value of our inventory, including an assessment of excess or obsolete inventory. Our determination of excess and obsolete inventory requires judgement, which is based on several factors, including demand forecasts, prior sales history, and industry trends. For disposable items with an expiration date, we consider the remaining shelf life in our analysis. Based on our evaluation, an allowance is recorded for inventory which we believe may ultimately not be sold to customers. We update our evaluation every quarter, increasing or decreasing the allowance based on the most current information available at the time. If our actual demand is less than anticipated, we may be required to take additional obsolete inventory charges, decreasing our gross margin and adversely impacting net operating results.

In addition, we sometimes purchase inventory in large quantities to obtain purchase discounts from our suppliers. This leads the Company to split inventory between short term and long term. The Company uses judgement and the forecasted demand information available to determine whether inventory should be recorded as long term.

Off Balance Sheet Arrangements

We have no off-balance sheet arrangements.

ITEM 7A.

Quantitative and Qualitative Disclosures About Market Risk

We are a "smaller reporting company" as defined by Rule 12b-2 of the Exchange Act, and as such, we are not required to provide the disclosure required under this item.

ThermoGenesis Holdings, Inc.

Consolidated Balance Sheets

See accompanying notes to consolidated financial statements.

ThermoGenesis Holdings, Inc.

Consolidated Statements of Operations and Comprehensive Loss

See accompanying notes to consolidated financial statements.

ThermoGenesis Holdings, Inc.

Consolidated Statements of Equity / (Deficit)

For the years ended December 31, 2023 and 2022

*Accumulated other comprehensive loss.

See accompanying notes to consolidated financial statements.

ThermoGenesis Holdings, Inc.

Consolidated Statements of Cash Flows

See accompanying notes to consolidated financial statements.

ThermoGenesis Holdings, Inc.

Notes to Consolidated Financial Statements

1.	Description of Business

The Company develops and commercializes a range of automated technologies for cell-banking, cell-processing, and cell-based therapeutics. Since the 1990's, ThermoGenesis Holdings has been a pioneer in, and a leading provider of, automated systems that isolate, purify and cryogenically store units of hematopoietic stem and progenitor cells for the cord blood banking industry. The Company was founded in 1986 and is incorporated in the State of Delaware and headquartered in Rancho Cordova, CA.

Medical Device Products for Automated Cell Processing

The Company provides the AutoXpress® and BioArchive® platforms for automated clinical bio-banking, PXP® platform for point-of-care cell-based therapies and X-Series® products for cell processing services. All product lines are reporting as a single reporting segment in the financial statements.

CDMO Business

The Company is expanding its business to include contract development and manufacturing services for cell and cell-based gene therapies. The Company is in the process of building out its capabilities to become a world-class Contract Development and Manufacturing Organization ("CDMO") for cell and cell-based gene therapies. The Company opened a new facility in the Sacramento metro area, containing a total of twelve, class-7, ReadyStart cGMP Suites available for lease by early-stage life science and cell gene therapy companies. The ReadyStart Suites are located in a 35,500+ square foot cGMP facility that will meet the highest scientific, quality, and regulatory requirements. The CDMO facility was completed in October of 2023.

Our common stock is traded on the Nasdaq Capital Market exchange under the ticker symbol "THMO".

2.	Going Concern

At December 31, 2023, the Company had cash and cash equivalents of $2,000,000 and a working capital deficit of $6,582,000. The Company has incurred historical losses from operations and expects to continue to incur operating losses in the near future. The Company will need to raise additional capital to grow its business, fund operating expenses and make interest payments. The Company's ability to fund its liquidity needs is subject to various risks, many of which are beyond its control. The Company will seek additional funding through debt borrowings, sales of debt or equity securities or strategic partnerships. The Company cannot guarantee that such funding will be available on a timely basis, in needed quantities or on terms favorable to the Company, if at all. These factors and other indicators raise substantial doubt about the Company's ability to continue as a going concern within one year from the filing date of this report.

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern.

3.	Summary of Significant Accounting Policies

Basis of Presentation

The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) and applicable rules and regulations of the SEC.

Reverse Stock Split

On December 22, 2022, the Company effected a one (1) for forty-five(45) reverse stock split of its issued and outstanding common stock. The total number of shares of common stock authorized for issuance by the Company of 350,000,000 shares did not change in connection with the reverse stock split.

All historical share amounts disclosed herein have been retroactively restated to reflect the reverse split and subsequent share exchange. No fractional shares were issued as a result of the reverse stock split, as fractional shares of common stock were rounded up to the nearest whole share.

Principles of Consolidation

The consolidated financial statements include the accounts of ThermoGenesis Holdings, Inc. and its wholly-owned subsidiaries, ThermoGenesis Corp. and TotipotentRX Cell Therapy, Pvt. Ltd and ThermoGenesis Corp's majority-owned subsidiary, CARTXpress Bio. All significant intercompany accounts and transactions have been eliminated upon consolidation.

Non-controlling Interests

The 20% ownership interest of CARTXpress Bio that is not owned by ThermoGenesis Holdings is accounted for as a non-controlling interest as the Company has an 80% ownership interest in CARTXpress Bio. Earnings or losses attributable to other stockholders of a consolidated affiliated company are classified separately as "non-controlling interest" in the Company's consolidated statements of operations. Net loss attributable to non-controlling interests reflects only its share of the after-tax earnings or losses of an affiliated company. The Company's consolidated balance sheets reflect non-controlling interests within the equity section.

Use of Estimates

Preparation of financial statements in conformity with accounting principles generally accepted in the United States of America ("GAAP") and requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates are used for, but not limited to, the allowance for credit losses, carrying amounts of inventories, depreciation and amortization, warranty obligations, assumptions made in valuing financial instruments issued in various compensation and financing arrangements, deferred income taxes and related valuation allowance and the fair values of intangibles and goodwill. Actual results could materially differ from the estimates and assumptions used in the preparation of the Company's consolidated financial statements.

Revenue Recognition

Revenue is recognized based on the following five-step process as outlined in the Accounting Standards Codification ("ASC") Topic 606, "Revenue from Contracts with Customers": (i) Identify the Contract with the Customer; (ii) Identify Performance Obligations in the Contract; (iii) Determine the Transaction Price; (iv) Allocate the Transaction Price; and (v) Satisfaction of the Performance Obligations (and Recognize Revenue). Revenues are recorded net of discounts. Shipping and handling fees billed to customers are included in net revenues, while the related costs are included in cost of revenues. For more information on revenues, see Note 12.

Cash and Cash Equivalents

The Company considers all highly liquid investments with a maturity of three months or less at the time of purchase to be cash equivalents. Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. The Company's cash and cash equivalents is maintained in checking accounts with reputable financial institutions that may at times exceed amounts covered by insurance provided by the U.S. Federal Deposit Insurance Corporation ("FDIC"). The Company has cash and cash equivalents of $14,000 and $47,000 at December 31, 2023 and 2022, respectively, in India. The Company has not experienced any realized losses on the Company's deposits of cash and cash equivalents.

Foreign Currency Translation

The Company's reporting currency is the US dollar. The functional currency of the Company's subsidiary in India is the Indian rupee ("INR"). Assets and liabilities are translated into US dollars at period end exchange rates. Revenue and expenses are translated at average rates of exchange prevailing during the periods presented. Cash flows are also translated at average exchange rates for the period, therefore, amounts reported on the consolidated statement of cash flows do not necessarily agree with changes in the corresponding balances on the consolidated balance sheet. Equity accounts other than retained earnings are translated at the historic exchange rate on the date of investment.

Goodwill, Intangible Assets and Impairment Assessments

Goodwill represents the excess of the purchase price in a business combination over the fair value of net tangible and intangible assets acquired. Intangible assets that are not considered to have an indefinite useful life are amortized over their useful lives, which generally range from threeto tenyears. Each period the Company evaluates the estimated remaining useful lives of purchased intangible assets and whether events or changes in circumstances warrant a revision to the remaining periods of amortization.

For goodwill and indefinite-lived intangible assets, the carrying amounts are periodically reviewed for impairment (at least annually) and whenever events or changes in circumstances indicate that the carrying value of these assets may not be recoverable. According to ASC350, "Intangibles-Goodwill and Other", the Company can opt to perform a qualitative assessment or a quantitative assessment; however, if the qualitative assessment determines that it is more likely than not (i.e., a likelihood of more than 50 percent) the fair value is less than the carrying amount; the Company would recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit's fair value.

Fair Value of Financial Instruments

In accordance with ASC 820, Fair Value Measurements and Disclosures, fair value is defined as the exit price, or the amount that would be received for the sale of an asset or paid to transfer a liability in an orderly transaction between market participants as of the measurement date.

The guidance also establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that market participants would use in valuing the asset or liability and are developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company's assumptions about the factors that market participants would use in valuing the asset or liability. The guidance establishes three levels of inputs that may be used to measure fair value:

Level 1: Quoted market prices in active markets for identical assets or liabilities.

Level 2: Other observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.

Level 3: Unobservable inputs reflecting the reporting entity's own assumptions.

The carrying values of cash and cash equivalents, accounts receivable and accounts payable approximate fair value due to their short duration.

Accounts Receivable and Allowance for Credit Losses

The Company's receivables are recorded when billed and represent claims against third parties that will be settled in cash. The carrying value of the Company's receivables, net of the allowance for credit losses, represents their estimated net realizable value. The Company estimates the allowance for credit losses based on historical collection trends, age of outstanding receivables, customer creditworthiness and existing economic conditions. A customer's receivable balance is considered past-due based on its contractual terms. Past-due receivable balances are written-off when the Company's internal collection efforts have been unsuccessful in collecting the amount due and there is no possibility of recovery.

Inventories

Inventories are stated at the lower of cost or net realizable value and include the cost of material, labor and manufacturing overhead. Cost is determined on a first-in, first-out basis. The Company writes-down inventory to its estimated net realizable value when conditions indicate that the selling price could be less than cost due to physical deterioration, obsolescence, changes in price levels, or other causes, which it includes as a component of cost of revenues. Additionally, the Company provides valuation allowances for excess and slow-moving inventory on hand that are not expected to be sold to reduce the carrying amount of slow-moving inventory to its estimated net realizable value. The valuation allowances are based upon estimates about future demand from its customers, distributors and market conditions.

At times, the Company will purchase inventories in larger quantities to obtain volume purchase discounts. In some cases, purchases may exceed expected sales for certain products in the following year. If the Company purchases inventory which is likely to not be sold in the next year, that inventory is classified as non-current. As of December 31, 2023 and December 31, 2022, the Company had $0 and $1,003,000, respectively, of non-current inventory.

Equipment and Leasehold Improvements, Net

Equipment consisting of machinery and equipment, computers and software, office equipment and leasehold improvements is recorded at cost less accumulated depreciation. Repair and maintenance costs are expensed as incurred. Depreciation for machinery and equipment, computers and software and office furniture are computed under the straight-line method over the estimated useful lives. Leasehold improvements are amortized under the straight-line method over their estimated useful lives or the remaining lease period, whichever is shorter. When equipment and leasehold improvements are sold or otherwise disposed of, the asset account and related accumulated depreciation account are relieved, and the impact of any resulting gain or loss is recognized within general and administrative expenses in the consolidated statement of operations for the period.

Warranty

We provide for the estimated cost of product warranties at the time revenue is recognized. While we engage in extensive product quality programs and processes, including actively monitoring and evaluating the quality of our component suppliers, our warranty obligation is affected by product failure rates, material usage and service delivery costs incurred in correcting a product failure. Should actual product failure rates, material usage or service delivery costs differ from our estimates, revisions to the estimated warranty liability could have a material impact on our financial position, cash flows or results of operations.

Debt Discount and Issue Costs

The Company amortizes debt discount and debt issue costs over the life of the associated debt instrument, using the straight-line method which approximates the interest rate method.

Stock-Based Compensation

We use the Black-Scholes-Merton option-pricing formula in determining the fair value of our options at the grant date and apply judgment in estimating the key assumptions that are critical to the model such as the expected term, volatility and forfeiture rate of an option. Our estimate of these key assumptions is based on historical information and judgment regarding market factors and trends. If any of the key assumptions change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period. The compensation expense is then amortized over the vesting period.

Valuation and Amortization Method - The Company estimates the fair value of stock options granted using the Black-Scholes-Merton option-pricing formula. This fair value is then amortized on a straight-line basis over the requisite service periods of the awards, which is generally the vesting period. The formula does not include a discount for post-vesting restrictions, as we have not issued awards with such restrictions.

Expected Term - For options which the Company has limited available data, the expected term of the option is based on the simplified method. This simplified method averages an award's vesting term and its contractual term. For all other options, the Company's expected term represents the period that the Company's stock-based awards are expected to be outstanding and was determined based on historical experience of similar awards, giving consideration to the contractual terms of the stock-based awards, vesting schedules and expectations of future employee behavior.

Expected Volatility - Expected volatility is based on historical volatility. Historical volatility is computed using daily pricing observations for recent periods that correspond to the expected term of the options.

Expected Dividend - The Company has not declared dividends and does not anticipate declaring any dividends in the foreseeable future. Therefore, the Company uses a zerovalue for the expected dividend value factor to determine the fair value of options granted.

Risk-Free Interest Rate - The Company bases the risk-free interest rate used in the valuation method on the implied yield currently available on U.S. Treasury zero-coupon issues with the same expected term.

Estimated Forfeitures - When estimating forfeitures, the Company considers voluntary and involuntary termination behavior as well as analysis of actual option forfeitures.

Research and Development

Research and development costs, consisting of salaries and benefits, costs of disposables, facility costs, contracted services and stock-based compensation from the engineering, regulatory and scientific affairs departments, that are useful in developing and clinically testing new products, services, processes or techniques, as well as expenses for activities that may significantly improve existing products or processes are expensed as incurred. Costs to acquire technologies that are utilized in research and development and that have no future benefit are expensed when incurred.

Acquired In-Process Research and Development

Acquired in-process research and development that the Company acquires through business combinations represents the fair value assigned to incomplete research projects which, at the time of acquisition, have not reached technological feasibility. The amounts are capitalized and are accounted for as indefinite-lived intangible assets, subject to impairment testing until completion or abandonment of the projects. Upon successful completion of each project, the Company will make a determination as to the then useful life of the intangible asset, generally determined by the period in which the substantial majority of the cash flows are expected to be generated and begin amortization. The Company tests intangible assets for impairment at least annually, or more frequently if impairment indicators exist, by first assessing qualitative factors to determine whether it is more likely than not that the fair value of the intangible asset is less than its carrying amount. If the Company concludes it is more likely than not that the fair value is less than the carrying amount, a quantitative test that compares the fair value of the intangible asset with its carrying value is performed. If the fair value is less than the carrying amount, an impairment loss is recognized in operating results.

Patent Costs

The costs incurred in connection with patent applications, in defending and maintaining intellectual property rights and litigation proceedings are expensed as incurred.

Credit Risk

Currently, the Company primarily manufactures and sells cellular processing systems and thermodynamic devices principally to the blood and cellular component processing industry and performs ongoing evaluations of the credit-worthiness of the Company's customers. The Company believes that adequate provisions for uncollectible accounts have been made in the accompanying consolidated financial statements. To date, the Company has not experienced significant credit related losses.

Income Taxes

The tax years 2004-2022 remain open to examination by the major taxing jurisdictions to which the Company is subject; however, there is no current examination. The Company's policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense. To date, there have been no interest or penalties charged to the Company in relation to the underpayment of income taxes. There were nounrecognized tax benefits during the periods presented.

The Company's estimates of income taxes and the significant items resulting in the recognition of deferred tax assets and liabilities reflect the Company's assessment of future tax consequences of transactions that have been reflected in the financial statements or tax returns for each taxing jurisdiction in which the Company operates. The Company bases the provision for income taxes on the Company's current period results of operations, changes in deferred income tax assets and liabilities, income tax rates, and changes in estimates of uncertain tax positions in the jurisdictions in which the Company operates. The Company recognizes deferred tax assets and liabilities when there are temporary differences between the financial reporting basis and tax basis of assets and liabilities and for the expected benefits of using net operating loss and tax credit loss carryforwards. The Company establishes valuation allowances when necessary to reduce the carrying amount of deferred income tax assets to the amounts that the Company believes are more likely than not to be realized. The Company evaluates the need to retain all or a portion of the valuation allowance on recorded deferred tax assets. When a change in the tax rate or tax law has an impact on deferred taxes, the differences are expected to reverse. As the Company operates in more than one state, changes in the state apportionment factors, based on operational results, may affect future effective tax rates and the value of recorded deferred tax assets and liabilities. The Company records a change in tax rates in the consolidated financial statements in the period of enactment.

Income tax consequences that arise in connection with a business combination include identifying the tax basis of assets and liabilities acquired and any contingencies associated with uncertain tax positions assumed or resulting from the business combination. Deferred tax assets and liabilities related to temporary differences of an acquired entity are recorded as of the date of the business combination and are based on the Company's estimate of the appropriate tax basis that will be accepted by the various taxing authorities and its determination as to whether any of the acquired deferred tax liabilities could be a source of taxable income to realize the Company's pre-existing deferred tax assets.

Reclassifications

Certain prior period amounts have been reclassified to conform to the current period presentation. The reclassifications did not have an impact on net loss as previously reported. As a result of the reverse stock split effected by the Company on December 22, 2022, common stock and additional paid in capital amounts from prior periods were adjusted as to reflect if the reverse split had occurred in the prior periods. For revenue by product line, manual disposables where consolidated into the other line item as the Company discontinued sales of that product in 2023.

Recently Adopted Accounting Standards

On January 1, 2022, we adopted Accounting Standards Update ("ASU") 2020-06 "Debt-Debt with Conversion and Other Options ("Subtopic 470-20") and Derivatives and Hedging-Contracts in Entity's Own Equity ("Subtopic 815-40"): Accounting for Convertible Instruments and Contracts in an Entity's Own Equity," using the modified retrospective method. ASU 2020-06 provides guidance on how to account for contracts on an entity's own equity. This ASU simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity's own equity. Specifically, the ASU eliminated the need for the Company to assess whether a contract on the entity's own equity (1) permits settlement in unregistered shares, (2) whether counterparty rights rank higher than shareholder's rights, and (3) whether collateral is required. The Company recognized a cumulative effect of $9,739,000 of initially applying the ASU as an adjustment to the January 1, 2022 opening balance of accumulated deficit. Due to the recombination of the equity conversion component of our convertible debt outstanding, the 2022 opening balance of additional paid in capital was reduced by $10,681,000 and the debt discounts of the convertible promissory notes were reduced $942,000.

In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses ("Topic 326"). The ASU introduced a new accounting model, the Current Expected Credit Losses model ("CECL"), which requires earlier recognition of credit losses and additional disclosures related to credit risk. The CECL model utilizes a lifetime expected credit loss measurement objective for the recognition of credit losses at the time the financial asset is originated or acquired. ASU 2016-13 is effective for annual reporting periods beginning after December 15, 2022, including interim reporting periods within those annual reporting periods. The Company adopted the standard effective January 1, 2023. Based on the composition of the Company's trade receivables and unbilled revenue, and expected future losses, the adoption of ASU 2016-13 did not have a material impact on its consolidated financial statements.

Recently Issued Accounting Standards

In December 2023, the FASB issued ASU 2023-09, "Income Taxes (Topic 740): Improvements to Income Tax Disclosures," which is intended to enhance the transparency and decision usefulness of income tax disclosures. Notably, the ASU requires entities to disclose specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold, as well as disclosures of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for annual periods beginning after December 15, 2024 on a prospective basis. Retrospective application to each period presented in the financial statements is permitted. We are currently evaluating the impact of this standard on our consolidated financial statements.

In November 2023, the FASB issued ASU 2023-07, "Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures," which requires all public entities, including those that have a single reportable segment, to provide enhanced disclosures primarily about significant segment expenses. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The new guidance is required to be applied on a retrospective basis, with all required disclosures to be made for all prior periods presented in the financial statements. The segment expense categories and amounts disclosed in prior periods should be based on the significant segment expense categories identified and disclosed in the period of adoption. We are currently evaluating the impact of this standard on our consolidated financial statements.

In October 2023, the FASB issued ASU 2023-06, "Disclosure Improvements-Codification Amendments in Response to the SEC's Disclosure Update and Simplification Initiative." This ASU modifies the disclosure or presentation requirements of a variety of Topics in the Codification by aligning them with the SEC's regulations. The amendments to the various Topics should be applied prospectively, and the effective date for the Company for each amendment will be determined based on the effective date of the SEC's removal of the related disclosure from Regulation S-X or Regulation S-K. If the SEC has not removed the applicable requirement by June 30, 2027, then the related amendment in ASU 2023-06 will be removed from the Codification and will not become effective. Early adoption of this ASU is prohibited. We are currently evaluating the new ASU to determine if it will have an impact on the disclosures or presentation in our consolidated financial statements.

4.	Equipment and Leasehold Improvements

Equipment and leasehold improvements consisted of the following:

		Years Ended December 31,
		2023			2022			Estimated Useful Life (in years)
Machinery and equipment(1)		$	7,705,000			$	6,610,000				2.5	-	10
Computer and software			631,000				631,000				2	-	5
Office equipment			270,000				256,000				5	-	10
Leasehold improvements			1,555,000				932,000				5 years or remaining lease term
Total equipment			10,159,000				8,429,000
Less accumulated depreciation			(7,575,000	)			(7,175,000	)
Total equipment and leasehold improvements, net		$	2,586,000			$	1,254,000

_________

(1)

Includes $131,000 and $391,000 for cost related to construction in progress for the years ended December 31, 2023 and 2022, respectively.

Depreciation expense for the years ended December 31, 2023 and 2022 was $400,000 and $387,000, respectively.

5.	Intangible Assets and Goodwill

For the year ended December 31, 2023, in accordance with ASC 350, the Company performed a qualitative analysis to determine if it is more likely than not the fair value of its intangible assets and goodwill is less than the carrying amount. In performing the assessment, the Company used current market capitalization, internal forecasts, and other factors as the best evidence of fair value. These assumptions represent Level 3 inputs. Reviewing the market capitalization, it was determined that during the year ended December 31, 2023, the Company experienced a significant and sustained decline in its stock price. The decline resulted in the Company's market capitalization falling significantly below the recorded value of its consolidated net assets. Additionally, in February 2024, the Company's distribution agreement with Corning was not extended for up to four years as was available in the agreement. As a result, the Company determined it was unlikely it would be able to successfully commercialize its in-process technology, halted its development, and removed all related revenues from its long-term forecasts. Driven by these factors, the qualitative assessment determined that it is more likely than not the fair value of the Company's indefinite-lived and developed technology intangible assets and related goodwill is less than the carrying value. The Company recorded an impairment charge of $1,255,000 to intangible assets and $781,000 to goodwill during the year ended December 31, 2023, as shown in the following table:

		Intangible Assets			Goodwill
Balance at January 1, 2022, net		$	1,318,000			$	781,000
Amortization			(32,000	)			-
Balance at December 31, 2022, net		$	1,286,000			$	781,000
Amortization			(31,000	)			-
Impairment charge			(1,255,000	)			(781,000	)
Balance at December 31, 2023, net		$	-			$	-

6.	Related Party Transactions

Convertible Promissory Note and Revolving Credit Agreement

In March 2017, ThermoGenesis Holdings entered into a Credit Agreement with Boyalife Group (USA), Inc. (the "Lender"), which is owned and controlled by the Company's Chief Executive Officer and Chairman of our Board of Directors. The Credit Agreement, as amended, grants the Company the right to borrow up to $10,000,000 (the "Loan") at any time prior to the maturity date. On March 6, 2023, the Company entered into an Amendment No. 2 (the "Amendment to the Note") to its Second Amended and Restated Convertible Promissory Note with Boyalife Group Inc. (the "Note"), and an Amendment No. 3 to its First Amended and Restated Revolving Credit Agreement with Boyalife Group Inc. The Amendment to the Note amended and extended the maturity date of the Note from March 6, 2023 to December 31, 2023 (the "Maturity Date") and added to the principal balance of the Note all accrued and unpaid interest at the time of the extension. As of December 31, 2023, the outstanding principal balance of the Note was $7,278,000. Subsequent to December 31, 2023, the Maturity Date of the Note was extended to December 31, 2024.

The Company performed a debt extinguishment vs. modification analysis on the Amendment to the Note and determined that the amendment would be considered an extinguishment, due to an increase of more than 10% to the value of the embedded conversion option. However, no gain or loss was recorded in the consolidated statements of operations and comprehensive loss at the time of the Amendment as it was determined that the fair value of the Amendment to the Note and accrued interest was the same before and after the extension.

On September 28, 2023, the Company received a conversion notice from the Lender to convert a total of $700,000 of the outstanding accrued interest. The conversion resulted in an issuance of 654,206 shares of the Company's common stock at a conversion price of $1.07 per share. Immediately following the conversion, the outstanding principal balance of the Note was $7,278,000 and accrued but unpaid interest of $216,000.

The Credit Agreement and the Note, as amended provide that the principal and all accrued and unpaid interest under the Loan will be due and payable on the Maturity Date, with payments of interest-only due on the last day of each calendar year. The Loan bears interest at 22% per annum, simple interest. The Company has five business days after the Lender demands payment to pay the interest due before the Loan is considered in default. The Loan can be prepaid in whole or in part by the Company at any time without penalty.

The following summarizes the Note:

	Maturity Date		Stated Interest Rate			Conversion Price			Face Value			Debt Discount			Carrying Value
December 31, 2023	12/31/24			22	%		$	0.79			$	7,278,000			$	-			$	7,278,000
December 31, 2022	12/31/23			22	%		$	6.30			$	7,000,000			$	(1,223,000	)		$	5,777,000

The Note includes a down-round anti-dilution provision that lowers its conversion price if the Company sells shares of common stock or issues convertible debt at a lower price per share. Through December 31, 2023, the down-round provision was triggered as noted below:

In January 2023, when the conversion price of the Note was at $6.30 per share, the Company amended a previously outstanding convertible note, resulting in a triggering event lowering the conversion price of the Note to $2.87. The Company determined that it created an incremental value of $2,350,000 which was treated as a discount to the carrying amount of the Note and amortized over its remaining term.

In March 2023, the Company sold shares of common stock and warrants at $2.65 per share, resulting in a down round triggering event lowering the conversion price of the Note to that value. The triggering event created an incremental value of $810,000 which was treated as a discount to the carrying amount of the Note and will be amortized over its remaining term.

In July 2023, when the conversion price of the Note was at $2.65 per share, the Company amended a previously outstanding convertible note, resulting in a triggering event lowering the conversion price of the Note to $1.07. The Company determined that it created an incremental value of $3,660,000 which was treated as a discount to the carrying amount of the Note and amortized over its remaining term.

In December 2023, when the conversion price of the Note was $1.07 per share, the Company entered into an At The Market Offering Agreement with H.C. Wainwright & Co., LLC ("Wainwright"), under which the Company can offer and sell, from time to time, shares of its common stock, $0.001 par value. During the year ended December 31, 2023, through multiple transactions the Company sold shares of its common stock with an average selling price of $0.79, resulting in a triggering event lowering the conversion price of the Note to $0.79. The triggering event created an incremental value of approximately $471,000 which was treated as a discount to the carrying amount of the Note and will be amortized over its remaining term.

A Black-Scholes pricing model was utilized to determine the change in the before and after incremental value of the conversion option at each triggering event, with the following inputs:

		January 2023			March 2023			July 2023			December 2023
Conversion price before		$	6.30			$	2.87			$	2.65			$	1.07
Conversion price after		$	2.87			$	2.65			$	1.07			$	0.79
Term (years)			0.09				0.78				0.42				0.05
Volatility			167	%			168.9	%			156.8	%			71.6	%
Dividend rate			0	%			0	%			0	%			0	%
Risk free rate			4.46	%			4.20	%			4.22	%			4.30

The Company amortized a debt discount of $8,518,000 and $3,413,000 for the years ended December 31, 2023 and 2022, respectively. The debt discounts are related to down round triggering events that occurred during each year. In addition to the amortization, the Company also recorded interest expense of $1,612,000 and $1,890,000 for the years ended December 31, 2023 and 2022, respectively. The interest payable balance as of December 31, 2023 and December 31, 2022 was $634,000 and $1,492,000, respectively.

7.	Convertible Promissory Note

July 2019 Note

On July 23, 2019, the Company entered into a private placement with Orbrex (USA) Co. Limited ("Orbrex"), pursuant to which the Company issued and sold to Orbrex an unsecured convertible promissory note, as amended, in the original principal amount of $1,000,000 (the "July 2019 Note"). The July 2019 Note bears interest at a rate of twenty-four percent (24%) per annum and is payable in arrears on January 31 of each year. In the year ended December 31, 2023, the Company has amended the July 2019 Note two times:

●

On January 31, 2023, the Company entered into Amendment No. 3 to the July 2019 Note, which extended the maturity date from January 31, 2023 to July 31, 2023 and changed the fixed conversion price to $2.87 per share. The Company performed a debt extinguishment vs. modification analysis on this amendment to the July 2019 Note and determined that the extension would be considered an extinguishment, due to an increase of more than 10% to the value of the embedded conversion option. The Company determined that the fair value of the July 2019 Note after the amendment was $1,239,000 representing a $239,000 increase in its fair value. The increase will be recorded as a premium to the July 2019 Note and was amortized over the remaining term.

●

On July 31, 2023, the Company entered into an Amendment No. 4 to the July 2019 Note, which extended the maturity date of the July 2019 Note from July 31, 2023 to January 31, 2024 and changed the fixed conversion price to $1.07 per share. The Company performed a debt extinguishment vs. modification analysis on this amendment to the July 2019 Note and determined that the extension would be considered an extinguishment, due to an increase of more than 10% to the value of the embedded conversion option. The Company determined that the fair value of the July 2019 Note after the amendment was $538,000 representing a $87,000 increase in its fair value. The increase will be recorded as a premium to the July 2019 Note and amortized over the remaining term.

●

Between January 1, 2023 and March 31, 2023, the holder of the July 2019 Note converted $603,000 of the Note for 215,000 shares.

The following summarizes the July 2019 Note:

	Maturity Date		Stated Interest Rate			Conversion Price			Face Value			Debt Discount/ Premium			Carrying Value
December 31, 2023	1/31/2024			24	%		$	0.79			$	397,000			$	19,000			$	416,000
December 31, 2022	7/31/2023			24	%		$	6.30			$	1,000,000			$	(38,000	)		$	962,000

The July 2019 Note includes a down-round anti-dilution provision that lowers its conversion price if the Company sells shares of common stock or issues convertible debt at a lower price per share. In 2023, the anti-dilution provision was triggered, as noted below:

In March 2023, the Company sold shares of common stock at $2.65 per share, resulting in a down round triggering event lowering the conversion price of the Note to that value. The triggering event created an incremental value of $43,000 which was treated as a discount to the carrying amount of the July 2019 Note and was be amortized over its remaining term.

In December 2023, when the conversion price of the Note was $1.07 per share, the Company entered into an At The Market Offering Agreement with Wainwright, under which the Company can offer and sell, from time to time, shares of its common stock, $0.001 par value. During the year ended December 31, 2023, through multiple transactions the Company sold shares of its common stock with an average selling price of $0.79, resulting in a triggering event lowering the conversion price of the Note to $0.79. The triggering event created an incremental value of approximately $56,000 which was treated as a discount to the carrying amount of the Note and will be amortized over its remaining term.

A Black-Scholes pricing model was utilized to determine the change in the before and after incremental value of the conversion option at each triggering event, with the following inputs:

		March 2023			December 2023
Conversion price before		$	2.87			$	1.07
Conversion price after		$	2.65			$	0.79
Term (years)			0.36				0.14
Volatility			182	%			96.3
Dividend rate			0	%			0	%
Risk free rate			4.20	%			4.30	%

The Company amortized a debt discount on the July 2019 Note of $101,000 and $74,000 for the years ended December 31, 2023 and 2022, respectively. The debt discounts are related to the down round triggering events that occurred during each year. Interest expense related to the July 2019 Note was $114,000 and $240,000 for the years ended December 31, 2023 and 2022. The interest payable balance as of December 31, 2023 and 2022 was $94,000 and $120,000, respectively. The July 2019 Note matured on January 31, 2024, at which time the Company paid the outstanding balance of $397,000.

8.	Related Party Lease

Z3 Investment

On March 24, 2022, the Company entered into a fiveyear Lease Agreement with Z3 Investment LLC, an affiliate of the Company's Chairman and CEO, and COO, beginning April 1, 2022, for approximately 35,000 square feet of laboratory and office space in Rancho Cordova, California. Under the terms of the agreement, monthly rent is $108,000 per month (with a 4% annual increase). Additionally, the Company will pay all operating expenses as they become due estimated to be approximately $20,000 per month and will be expensed in the period incurred. The Company has the option to renew the lease for up to ten years after the commencement of the initial five-yearterm.

Operating Lease

Operating lease assets and liabilities are recognized at the lease commencement date. Operating lease liabilities represent the present value of lease payments not yet paid. Operating lease assets represent our right to use an underlying asset and are based upon the operating lease liabilities adjusted for prepayments or accrued lease payments, initial direct costs, lease incentives, and impairment of operating lease assets. To determine the present value of lease payments not yet paid, we use the Company's cost of capital based on existing debt instruments. We recognize the expense for this lease on a straight-line basis over the lease term.

The following summarizes the Company's operating lease at December 31:

		2023			2022
Right-of-use operating lease assets - related party, net		$	3,088,000			$	3,550,000
Current lease liability (included in other current liabilities)			595,000				433,000
Non-current lease liability - related party			2,900,000				3,495,000
Weighted average remaining lease term			3.8				4.8
Discount rate			22	%			22	%

Maturities of lease liabilities by year for our operating lease are as follows:

2024		$	1,307,000
2025			1,359,000
2026			1,428,000
2027			1,133,000
Total lease payments		$	5,227,000
Less: imputed interest			(1,732,000	)
Present value of operating lease liabilities		$	3,495,000

Statement of Cash Flows

Cash paid for amounts included in the measurement of operating lease liabilities was $1,256,000 and $587,000 for the years ended December 31, 2023 and 2022, respectively.

9.

Leases

The Company leases an approximately 28,000 square foot facility located in Rancho Cordova, California for its corporate offices and in-house manufacturing. The lease was renewed in the first quarter of 2019 and is accounted for as an operating lease. The lease expires in May 2024.

Operating Leases

Operating lease assets and liabilities are recognized at the lease commencement date. Operating lease liabilities represent the present value of lease payments not yet paid. Operating lease assets represent our right to use an underlying asset and are based upon the operating lease liabilities adjusted for prepayments or accrued lease payments, initial direct costs, lease incentives, and impairment of operating lease assets. To determine the present value of lease payments not yet paid, we use the Company's cost of capital based on existing debt instruments. Our material leases typically contain rent escalations over the lease term. We recognize expense for these leases on a straight-line basis over the lease term.

The following summarizes the Company's operating leases as of December 31:

		2023			2022
Right-of-use operating lease assets, net		$	122,000			$	372,000
Current lease liability (included in other current liabilities)			131,000				267,000
Non-current lease liability			-				131,000
Weighted average remaining lease term			0.4				1.4
Discount rate			22	%			22	%

Maturities of lease liabilities by year for our operating leases are as follows:

Total lease payments for 2024		$	139,000
Less: imputed interest			(8,000	)
Present value of operating lease liabilities		$	131,000

Statement of Cash Flows

In January 2019, the Company signed an amendment to its Rancho Cordova, California lease. The amendment was accounted for as a modification and resulted in a right-of-use asset of $966,000 being recognized as a non-cash addition on the date of the amendment. Cash paid for amounts included in the measurement of operating lease liabilities in cash flows from operating activities were $329,000 and $319,000 for the years ended December 31, 2023 and 2022, respectively.

Finance Leases

Finance leases are included in equipment and other current and non-current liabilities on the consolidated balance sheet. The amortization and interest expense are included in general and administrative expense and interest expense, respectively on the statement of operations. These leases were not material for the years ended December 31, 2023 and 2022.

10.	Commitments and Contingences

Financial Covenants

On July 13, 2020, the Company, entered into a Manufacturing and Supply Amending Agreement #2 with CBR Systems, Inc. ("CBR") with an effective date of July 13, 2020 (the "Amendment"). The Amendment amends the Manufacturing and Supply Agreement entered into on May 15, 2017 and Amendment #1 dated March 16, 2020 by the Company and CBR. The Amendment, among other things, revised the amounts of certain products to be purchased, pricing of those products and removal of the safety stock requirement. In addition, the Amendment updated the financial requirement to exclude convertible debt from the definition of short-term debt under events or conditions that constitute a default. The Amendment states that the Company's cash balance and short-term investments net of non-convertible debt and borrowed funds that are payable within one year must be greater than $1,000,000 at any month end. The Company was in compliance with this agreement as of December 31, 2023.

Potential Severance Payments

We have entered into an employment agreement with the Company Chief Executive Officer under which payment and benefits would become payable in the event of termination by us for any reason other than cause, or upon a change in control of our Company, or by the employee for good reason.

Contingencies

In the normal course of operations, the Company may have disagreements or disputes with customers, employees or vendors. Such potential disputes are seen by management as a normal part of business. As of December 31, 2023, management believes any liability that may ultimately result from the resolution of these matters will not have a material adverse effect on the Company's consolidated financial position, operating results or cash flows.

11.	Stockholders' Equity

Common Stock

On November 22, 2023, the Company entered into an At The Market Offering Agreement (the "Offering Agreement") with Wainwright with respect to an at-the-market offering program under which the Company may offer and sell, from time to time, shares of its common stock, $0.001 par value having an aggregate offering price of up to $1,288,000 through Wainwright as its sales agent. The shares of Common Stock to be offered and sold under the Offering Agreement, if any, will be offered and sold pursuant to the Company's shelf registration statement. The Company sold a total of 481,382 shares of common stock under the Offering Agreement for aggregate gross proceeds of $429,000 at an average selling price of $0.89 per share, resulting in net proceeds of approximately $216,000 after deducting commissions and other transaction costs of approximately $213,000.

On March 15, 2023, the Company entered into a Securities Purchase Agreement (the "Purchase Agreement") with an accredited investor (the "Investor") pursuant to which the Company agreed to issue and sell to the Investor in a private placement (the "Offering") (i) 125,000 shares of its common stock, $0.001 par value (the "Common Shares"), (ii) 946,429 pre-funded warrants to purchase Common Shares at a purchase price of $2.80, and (iii) common stock warrants to purchase up to an aggregate 1,071,429 Common Shares were issued (the "Underlying Shares"). The common stock warrants have an exercise price of $2.65 per share and are exercisable immediately upon issuance and expire fiveand one-half years following the issuance. The Offering resulted in net proceeds of approximately $2,640,000, excluding legal and other transaction fees of $360,000. The Offering closed on March 20, 2023. All 946,429 pre-funded warrants have been exercised.

In connection with the Offering, the Company entered into a Warrant Amendment Agreement (the "Warrant Amendment Agreement"), dated March 15, 2023, with the Investor, whereby the Company agreed to amend existing warrants, held by the Investor, to purchase up to an aggregate of 158,731 shares of common stock that were previously issued in October 2022. These warrants had an exercise price of $6.30 per share and pursuant to the Warrant Amendment Agreement have been amended to reduce the exercise price to $2.65 per share effective upon the closing of the Offering. During the year ended December 31, 2023, 158,731 common warrants were exercised. The Company received approximately $421,000 from the exercises of the warrants.

The warrant repricing resulted in an immediate and incremental increase of approximately $50,000 in the estimated fair value of the common warrants issued in the Company's October 2022 public offering. The common warrants were valued on the date of the warrant repricing using the Black-Scholes option pricing model based on the following assumptions:

		March 2023
Conversion price before		$	6.30
Conversion price after		$	2.65
Term (years)			4.9
Volatility			123	%
Dividend rate			0	%
Risk free rate			4.20	%

On October 28, 2022, the Company completed a public offering (the "Offering") of an aggregate of 326,171 units (the "Units") and 64,286 pre-funded units (the "Pre-Funded Units") for a purchase price of $6.30 per unit, resulting in aggregate gross proceeds of approximately $2,055,000 resulting in net proceeds of approximately $1,549,000 after deducting commissions and other transaction costs of approximately $506,000. The Offering closed on October 28, 2022. Each Unit sold in the Offering consisted of oneshare of the Company's common stock and onecommon warrant to purchase oneshare of common stock, and each Pre-Funded Unit consisted of onepre-funded warrant to purchase oneshare of common stock and onecommon warrant to purchase oneshare of common stock. The common warrants will be exercisable at an exercise price of $6.30 per share beginning on the effective date of Company stockholder approval of the issuance of the shares upon exercise of the warrants (the "Warrant Stockholder Approval") and will expire on the fifthanniversary of the effective date of the Warrant Stockholder Approval. The Company evaluated the common warrants issued and determined that they should be classified as equity. As of December 31, 2022, all 64,286 pre-funded warrants sold in the Offering have been exercised and none are currently outstanding.

On February 3, 2022, the Company entered into Amendment No. 2 to the At the Market Offering Agreement (the "Offering Agreement") with H.C. Wainwright & Co., LLC to further increase the maximum aggregate offering price of shares of Common Stock that may be offered and sold from time to time under the Offering Agreement from $15,280,000 to $19,555,000, which enables the Company to sell an additional $4,275,000 of shares after taking into account prior sales under the Offering Agreement (the "Additional Shares"). In March 2022, the total offering price was updated to $18,573,000 based on the shares that were currently available on Company's existing Form S-3. The terms and conditions of the Offering Agreement otherwise remain unchanged. For the year ended of December 31, 2022, the Company sold a total of 196,843 shares of common stock under the Offering Agreement for aggregate gross proceeds of $3,293,000 at an average selling price of $16.73 per share, resulting in net proceeds of approximately $3,037,000 after deducting commissions and other transaction costs of approximately $256,000.

Nasdaq's listing standards provide that a company may be delisted if the bid price of its stock drops below $1.00 for a period of 30 consecutive business days. On January 8, 2024, we received written notice from the Nasdaq Listing Qualifications Department notifying the Company that it was not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market, due to the bid price of the Company's common stock closing below the minimum $1.00 per share for the thirty (30) consecutive business days prior to the date of the Notification Letter. In accordance with listing rules, the Company was afforded 180 days, or until July 8, 2024, to regain compliance. See our risk factors for full details.

Warrants

A summary of warrant activity is as follows:

		Number of Shares			Weighted- Average Exercise Price Per Share			Weighted- Average Remaining Contract Term
Balance at January 1, 2022			14,518			$	313.71				1.44
Warrants granted			326,171			$	6.30
Pre-funded warrants granted			64,286			$	0.045
Pre-funded warrants exercised			(64,286	)		$	0.045
Warrants expired/canceled			-			$	-
Outstanding at December 31, 2022			340,689			$	19.40				0.31
Exercisable at December 31, 2022			14,518			$	313.71				0.44
Balance at January 1, 2023			340,689			$	19.40
Warrants granted			1,071,429
Warrants exercised			(158,731	)
Warrants expired/canceled			(14,518	)
Pre-funded warrants granted			946,429
Pre-funded warrants exercised			(946,429	)
Outstanding and Exercisable at December 31, 2023			1,238,869			$	3.14				4.57

Equity Plans and Agreements

The Amended 2016 Equity Incentive Plan (the "Amended 2016 Plan") was approved by the stockholders in May 2017, under which up to 1,334 shares may be issued pursuant to grants of shares, options, or other forms of incentive compensation. On June 22, 2018, the stockholders approved an amendment to the Amended 2016 Plan to increase the number of shares that may be issued to 2,945 shares. On May 30, 2019, the stockholders approved an amendment to the Amended 2016 Plan to increase the number of shares that may be issued from 2,945 shares to 8,723 shares. On January 13, 2022, the stockholders approved an amendment to the Amended 2016 Plan to increase the number of shares that may be issued from 8,723 to 26,667 shares. On December 15, 2022, the stockholders approved an amendment to the Amended 2016 Plan to increase the number of shares that may be issued under the plan from 26,667 the 66,667. As of December 31, 2023, 60,479 awards were available for issuance under the Amended 2016 Plan.

On December 29, 2017, the Board of Directors of ThermoGenesis Corp. adopted the ThermoGenesis Corp. 2017 Equity Incentive Plan (the "ThermoGenesis Plan") and on the same day granted options to purchase an aggregate of 280,000 shares of ThermoGenesis Corp. common stock to employees, directors, consultants, and advisors of ThermoGenesis Corp. The ThermoGenesis Plan was unanimously approved by the ThermoGenesis Corp. stockholders (including the Company) on December 29, 2017. The ThermoGenesis Plan authorizes the issuance of up to 1,000,000 shares of ThermoGenesis Corp. common stock. There are 40,000 shares available for issuance as of December 31, 2023. As the ThermoGenesis Plan is for the Company's subsidiary it was not affected by the reverse split effected on December 22, 2022.

Stock Based Compensation

The Company recorded stock-based compensation of $39,000 for the year ended December 31, 2023 and $267,000 for the year ended December 31, 2022, as comprised of the following:

		Year Ended December 31,
		2023			2022
Cost of revenues		$	17,000			$	18,000
Selling, general and administrative			-				229,000
Research and development			22,000				20,000
		$	39,000			$	267,000

Net Loss Per Share

Net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding. The calculation of the basic and diluted earnings per share is the same for all periods presented, as the effect of the potential common stock equivalents noted below is anti-dilutive due to the Company's net loss position for all periods presented. Anti-dilutive securities consisted of the following at December 31:

		2023			2022
Common stock equivalents of convertible promissory notes and accrued interest			10,636,581				1,525,751
Warrants			1,238,869				340,689
Stock options			6,103				6,403
Total			11,881,553				1,872,843

12.

Revenues

The Company's revenues primarily consist of device sales and service revenue.

Device Sales

Device sales include devices and consumables for BioArchive, AXP,CAR-TXpress and manual disposables. Revenue is recognized when control of the devices passes to the customer, and the Company's performance obligation has been satisfied.

Service Revenue

Service revenue principally consists of maintenance contracts for BioArchive, AXP and CAR-TXpress products. Devices sold have warranty periods of oneto twoyears. After the warranty expires, the Company offers separately priced annual maintenance contracts. Under these contracts, customers pay in advance. These prepayments are recorded as deferred revenue and recognized over time as the contract performance obligations are satisfied.

Revenue is recognized based on the following five-step process as outlined in the Accounting Standards Codification ("ASC") Topic 606, "Revenue from Contracts with Customers": (i) Identify the Contract with the Customer; (ii) Identify Performance Obligations in the Contract; (iii) Determine the Transaction Price; (iv) Allocate the Transaction Price; and (v) Satisfaction of the Performance Obligations (and Recognize Revenue).

Revenues are recorded net of discounts. Shipping and handling fees billed to customers are included in net revenues, while the related costs are included in cost of revenues. Most sales are made with FOB origin shipping terms, with title and control of the goods passing to the customer at the time of shipment. Payments from domestic customers are normally due in two months or less after the title transfers, the service contract is executed, or the services have been rendered. For international customers, payment terms may extend up to 120 days. All sales have fixed pricing and there are currently no variable components included in the Company's revenue.

Generally, all sales are contract sales (with either an underlying contract or purchase order). The Company does not have any material contract assets. When invoicing occurs prior to revenue recognition, a contract liability is recorded (as deferred revenue on the consolidated balance sheet).

Except for limited exceptions, there is no right of return provided for distributors or customers. For distributors, the Company has no control over the movement of goods to the end customer. The Company's distributors control the timing, terms and conditions of the transfer of goods to the end customer. Additionally, for sales of products made to distributors, the Company considers a number of factors in determining when revenue is recognized. These factors include, but are not limited to, whether the payment terms offered to the distributor are considered to be non-standard, the distributor's history of adhering to the terms of its contractual arrangements with the Company, whether the Company has a pattern of granting concessions for the benefit of the distributor, and whether there are other conditions that may indicate that the sale to the distributor is not substantive.

The following table presents net sales by geographic areas:

		Years Ended December 31,
		2023			2022
United States		$	6,029,000			$	6,641,000
China			98,000				1,984,000
United Arab Emirates			570,000				-
Vietnam			225,000				515,000
Other			2,523,000				1,343,000
Total		$	9,445,000			$	10,483,000

The following table summarizes the revenues by product line and type:

		Year Ended December 31, 2023
		Device Revenue			Service Revenue			Other Revenue			Total Revenue
AXP		$	4,970,000			$	232,000			$	-			$	5,202,000
BioArchive			1,484,000				1,361,000				-				2,845,000
X-Series			121,000				152,000				779,000				1,052,000
Other			288,000				-				58,000				346,000
Total		$	6,863,000			$	1,745,000			$	837,000			$	9,445,000

		Year Ended December 31, 2022
		Device Revenue			Service Revenue			Other Revenue			Total Revenue
AXP		$	5,911,000			$	480,000			$	-			$	6,391,000
BioArchive			1,247,000				968,000				-				2,215,000
X-Series			654,000				190,000				285,000				1,129,000
Other			719,000				-				29,000				748,000
Total		$	8,531,000			$	1,638,000			$	314,000			$	10,483,000

Contract Balances

Generally, all sales are contract sales (with either an underlying contract or purchase order). The Company does not have any material contract assets. When invoicing occurs prior to revenue recognition, a contract liability is recorded (as deferred revenue on the consolidated balance sheet). Revenues recognized during the year ended December 31, 2023 and 2022 that were included in the beginning balance of deferred revenue were $782,000 and $719,000, respectively. Short-term deferred revenues were $670,000 and $782,000 at December 31, 2023 and 2022, respectively. Long-term deferred revenue was $127,000 and $911,000 at December 31, 2023 and 2022, respectively.

Exclusivity Fee

In 2019, the Company entered into a Supply Agreement with Corning Incorporated (the "Supply Agreement"). The Supply Agreement has an initial term of fiveyears with Corning having twooptions to renew for an additional two years(up to fouryears total), unless terminated by either party in accordance with the terms of the Supply Agreement (collectively, the "Term"). Pursuant to the Supply Agreement, the Company has granted Corning exclusive worldwide distribution rights for substantially all X-Series® products for the duration of the Term, subject to certain geographical and other exceptions. In addition to any amounts payable throughout the Term for the Products, as consideration for the exclusive worldwide distribution rights Corning paid a $2,000,000 exclusivity fee. In February 2024, the Company's distribution agreement with Corning was not extended as was available in the agreement. As a result, the Company revised its estimate of the term for the recognition of the revenue related to the exclusivity fee resulting in an additional $495,000 recognized in 2023. The Company recorded $781,000 and $286,000 in revenue for the years ended December 31, 2023 and 2022.

Distribution Agreement

The Company signed an agreement with its AXP distributor in China through May 2024. The agreement contains annual purchase minimums. In return for the minimum purchase commitment, the Company provided the distributor with AXP processing devices to use during the term of the agreement. The Company maintains ownership of these devices and they must be returned to the Company at the end of the agreement. The Company analyzed the relevant accounting guidance and determined that the equipment and AXP bagsets represented distinct performance obligations. The equipment was concluded to be an embedded lease, accounted for as a sales-type operating lease. For the years December 31, 2023 and 2022, the Company recorded $82,000 in revenue relating to the lease.

Backlog of Remaining Customer Performance Obligations

The following table represents revenue expected to be recognized in the future from the backlog of performance obligations that are unsatisfied (or partially unsatisfied) at the end of the reporting period:

		Remainder of 2024			2025			2026			2027			2028and beyond			Total
Service revenue		$	1,186,000			$	514,000			$	125,000				-			$	-			$	1,825,000
Device revenue (1)			41,000				-				-				-				-				41,000
Exclusivity fee			267,000				-				-				-				-				267,000
Clinical revenue			13,000				13,000				13,000				13,000				83,000				135,000
Total		$	1,507,000			$	527,000			$	138,000			$	13,000			$	83,000			$	2,268,000

(1)

Represents the minimum purchase requirements under the distribution agreement the Company signed with its AXP distributor in China and other revenue deferred at December 31, 2023.

13.	Concentrations

The Company had accounts receivable balances or revenues in excess of 10% for the years ended December 31, 2023 and 2022 as shown in the table below:

Accounts Receivable		2023			2022
Customer 1			-				27	%
Customer 2			-				29	%
Customer 3			25	%			3	%
Customer 4			-				15	%

Revenues		2023			2022
Customer 1			30	%			33	%
Customer 2			1	%			14	%

One supplier accounted for 20% and 70% of total inventory purchases during the years ended December 31, 2023 and 2022, respectively.

14.	Income Taxes

Loss before income tax benefits were comprised of $18,982,000 from U.S. and income of $63,000 from foreign jurisdictions for the year ended December 31, 2023 and $11,752,000 from U.S. and $60,000 from foreign jurisdictions for the year ended December 31, 2022.

The reconciliation of federal income tax attributable to operations computed at the federal statutory tax rate to income tax benefit is as follows for the:

		Year Ended December 31,
		2023			2022
Statutory federal income tax benefit		$	(3,973,000	)		$	(2,481,000	)
Intangible assets			-				-
PPP loan forgiveness			-				-
Incentive stock options			-				-
Change in valuation allowance			3,779,000				(284,000	)
Expiration of net operating losses			1,469,000				1,356,000
Disallowed financing costs			2,210,000				1,179,000
State and local taxes			(3,508,000	)			200,000
Foreign rate differential			-				11,000
Other			23,000				19,000
Total income tax expense		$	-			$	-

As of December 31, 2023, we had federal net operating loss carryforwards of approximately $121,101,000 to offset future federal taxable income, with $89,104,000 available through 2037 and $31,997,000 available indefinitely. We also had state net operating loss carryforwards of approximately $54,441,000 that may offset future state taxable income through 2043.

As of December 31, 2023, the Company has research and experimentation credit carryforwards of $1,478,000 for federal tax purposes that expire in various years between 2024 and 2043, and $1,516,000 for state income tax purposes that do not have an expiration date, and some of which expire in 2031 and 2032.

Significant components of the Company's deferred tax assets and liabilities for federal and state income taxes are as follows:

		Year Ended December 31,
		2023			2022
Deferred tax assets:
Net operating loss carryforwards		$	29,233,000			$	26,465,000
Income tax credit carryforwards			2,676,000				2,738,000
Stock compensation			620,000				421,000
Lease obligation			1,015,000				908,000
Deferred revenue			75,000				251,000
Inventory Reserve			1,003,000				517,000
Sec. 174 Capitalized R&D			488,000				317,000
Other			267,000				159,000
Total deferred tax assets			35,377,000				31,776,000
Deferred tax liabilities
Depreciation and amortization			-				(252,000	)
Lease asset			(898,000	)			(824,000	)
Total deferred tax liabilities			(898,000	)			(1,076,000	)
Valuation allowance			(34,479,000	)			(30,700,000	)
Net deferred taxes		$	-			$	-

ASC 740 requires that the tax benefit of net operating losses, temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses that realization is "more likely than not." Realization of the future tax benefits is dependent on the Company's ability to generate sufficient taxable income within the carryforward period. Because of the Company's recent history of operating losses, management believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not likely to be realized and, accordingly, has provided a valuation allowance.

The valuation allowance increased by $3,779,000,000 and decreased by $284,000 during the years ended December 31, 2023 and 2022, respectively.

In August 2016, the conversion of the Boyalife debentures effected an "ownership change" as defined under the provisions of the Tax Reform Act of 1986. As a result, any net operating loss and credit carryovers existing at that date will be subject to an annual limitation regarding their utilization against taxable income in future periods. Additionally, before the conversion of the debentures, it is possible that "ownership changes" occurred, which could create additional limitations on the use of our net operating losses and credit carryovers. Additionally, ownership changes may have occurred in the periods after 2016 which could limit our utilization of losses and credits generated in the years 2016 - 2023.

On December 22, 2017, the U.S. enacted comprehensive tax legislation (the "Tax Act"). The Tax Act made broad and complex changes to the U.S. tax code, including the amendment of Code Section 174 requiring capitalization of research and experimentation expenditures for tax years beginning after December 31, 2021. The capitalized expenses are amortized over a period of 5 or 15 years depending on whether they are U.S. or foreign based.

On August 16, 2022, the President signed into law H.R. 5376 (commonly called the "Inflation Reduction Act of 2022"). The primary tax provisions in the new law include an alternative minimum tax ("AMT") on certain large corporations, a tax on stock buybacks and certain energy-related tax credits, each of which become effective after December 31, 2022. The provisions of the Inflation Reduction Act are not expected to have a material effect on the Company's financial statements and related disclosures.

The Company does not have any uncertain tax positions at December 31, 2023 or December 31, 2022. For the most part, tax years after 2002 are all open to examination by federal and state tax authorities and after 2015 by foreign tax authorities.

15.	Employee Retirement Plan

401(k) Plan

The Company provides a retirement plan, in accordance with Section 401(k) of the Internal Revenue Code, to all eligible employees. Employees may elect to contribute up to the Internal Revenue Service maximum annual contribution limit. The Company matches employee contributions up to a maximum of 4% per year. The Company recognized an expense of $119,000 and $132,000 for the years ended December 31, 2023 and 2022, respectively, related to matching contributions.

16.	Subsequent Events

On March 15, 2024, the Company received a conversion notice from Boyalife Group, Inc. ("Boyalife") to convert $1,278,000 of the outstanding principal and $285,000 of the outstanding accrued interest for a total of $1,563,000 of the Second Amended and Restated Convertible Promissory Note issued by the Company to Boyalife on April 16, 2018, as amended by Amendment No 1 dated March 4, 2022, Amendment No 2 dated March 6, 2023 and Amendment No 3 dated January 5, 2024 (as amended, the "Note"). The conversion resulted in the issuance of 4,113,158 shares of the Company's common stock at a conversion price of $0.38 per share. Immediately following the conversion, the outstanding principal and accrued interest of the Note was approximately $6,366,000.

Effective January 5, 2024, the Company entered into an Amendment No. 3 (the "Amendment to Note") to its Second Amended and Restated Convertible Promissory Note with Boyalife Group Inc. (the "Note"), and an Amendment No. 4 (the "Amendment to Credit Agreement") to its First Amended and Restated Revolving Credit Agreement with Boyalife Group Inc. (the "Credit Agreement"). The Amendment to Note amends and extends the maturity date of the Note from December 31, 2023 to December 31, 2024, and provides that beginning January 1, 2024, accrued and unpaid interest of approximately $634,293 shall be due and payable on or before July 1 and December 31 of each year. Accrued and unpaid interest as of December 31, 2023, (the "December 2023 Capitalized Amount") shall be paid in six (6) equal installments of approximately $106,000 each on or before the first day of each of January, February, March, April, May, and June of 2024. Any unpaid portion of the December 2023 Capitalized Amount shall bear interest at an annual rate of twenty-two percent (22%), and accrued and unpaid interest on the December 2023 Capitalized Amount shall be due and payable on July 1, 2024. The Amendment to Credit Agreement amends the Credit Agreement to change the defined term "Termination Date" to December 31, 2024.

ITEM 9.

Changes In and Disagreements with Accountants on Accounting and Financial Disclosure

None.

ITEM 9A.

Controls and Procedures

Disclosure Controls and Procedures

Our management, including our Chief Executive Officer and our Chief Financial Officer, conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as amended, as of the end of the period covered by this Annual Report on Form 10-K. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms.

Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure. Based on this evaluation, and in light of the weakness in our internal control over financial reporting described below, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective as of December 31, 2023.

Management's Report on Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act). Our Chief Executive Officer and Chief Financial Officer assessed the effectiveness of our internal control over financial reporting as of December 31, 2023. In making this assessment, our Chief Executive Officer and Chief Financial Officer used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in Internal Control-Integrated Framework. Based on that assessment and using the COSO criteria, our Chief Executive Officer and Chief Financial Officer have concluded that, as of December 31, 2023, our internal controls over financial reporting were not effective because of the material weaknesses described below.

A material weakness is defined as "a deficiency, or a combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company's annual or interim financial statements will not be prevented or detected on a timely basis."

As of December 31, 2023, the following material weaknesses have been identified:

Segregation of Duties: We did not design and maintain effective segregation of duties due to limited staffing in our accounting function. Specifically, we do not have sufficient resources in our accounting department, which restricts our ability to segregate roles and access to ensure effective segregation of duties. This also results in an ineffective review process of the information used to prepare the financial statements.

Privileged access and user access review controls over financial applications were not effectively designed or implemented to ensure appropriate access, authorization and segregation of duties. In addition, service providers for financial reporting were not properly monitored.

Planned Remediation

During 2024, we intend to work to remediate the material weaknesses identified above, which are expected to be the addition of accounting and financial personnel allowing the Company to have sufficient segregation of duties. In addition, the Company will work with available application and service providers to upgrade our information technology resources. However, our current financial position could make it difficult for us to add the necessary resources.

We are currently working to improve and simplify our internal processes and implement enhanced controls, as discussed above, to address the material weakness in our internal controls over financial reporting and to remedy the ineffectiveness of our disclosure controls and procedures. These material weaknesses will not be considered to be remediated until the applicable remediated controls are operating for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively.

Despite the existence of these material weakness, we believe that the financial statements included in the period covered by this Annual Report on Form 10-K fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented in conformity with U.S. generally accepted accounting principles.

Attestation Report of Independent Registered Public Accounting Firm

We are a "non-accelerated filer" as defined by Rule 12b-2 of the Exchange Act, and as such, we are not required to provide an attestation report on the Company's internal control over financial reporting.

Changes in Internal Control over Financial Reporting

Other than as described above, there have been no changes in our internal controls over financial reporting identified in management's evaluation pursuant to Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the year ended December 31, 2023 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

ITEM 9B.

Other Information

During the year ended December 31, 2023, noneof our directors or officers adopted, modified or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement," as each term is defined in Item 408(a) of Regulation S-K.

ITEM 9C.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Not applicable.

PART III

ITEM 10.

Directors, Executive Officers and Corporate Governance

Directors

Set forth below is the name, age, and certain biographical information for each of our current directors.

		Age*
Xiaochun (Chris) Xu, Ph.D., MBA			52
Russell Medford, MD, Ph.D.			69
Jeff Thomis, Ph.D.			78
Biao Xi, Ph.D.			58
James Xu, Esq., DBA, PsyD., CPA			53
Haihong Zhu(1)			58

* Age as of March 22, 2024.

⁽¹⁾ Haihong Zhu resigned from the Board of Directors effective March 8, 2024.

Biographies

Xiaochun (Chris) Xu, Ph.D., MBA

Director since March 2016

Dr. Xu has served on the Board of Directors since March 2016. In November 2016, the Board of Directors elected Dr. Xu as President and Chief Executive Officer. He brings over 15 years of leadership experience in the biopharmaceutical industry and has contributed to numerous successful product launches. In 2009, Dr. Xu founded Boyalife Group, a global diversified life sciences holding company and is currently the principal shareholder of ThermoGenesis Holdings, Inc. Prior to founding Boyalife, Dr. Xu served as a Project Leader at Pfizer, as a Director of Research at two publicly traded companies and as a Vice President at Founder Group. Dr. Xu's expertise spans several diverse therapeutic areas, including arthritis & inflammation, cardiovascular disease, autoimmunity, oncology, and diabetes. He has authored over forty publications and has been recognized by numerous professional societies for his contributions to biomedical research. Dr. Xu received his Ph.D. in immunology from Washington University School of Medicine (St. Louis, USA) and an executive MBA from Emory University (Atlanta, USA). We believe that Dr. Xu is well qualified to serve as a Director, due to his extensive and varied experience and knowledge as an executive and investor in the biotechnology, medical device, and pharmaceuticals industry, and we believe that Dr. Xu will continue to be a valuable asset to the Company and its Board.

Russell Medford, MD, Ph.D.

Director since February 2017

Dr. Medford was appointed to the Board in February 2017. Since 2017, Dr. Medford has served as the Chairman and CEO of Covanos, Inc, an Atlanta-based development stage medical device company, developing advanced computational technologies for the non-invasive diagnosis of cardiovascular disease. He is a senior executive with over 25 years of private and public company experience as Chief Executive Officer and Board member of multiple public and private biotechnology, medical technology, digital health and other health related companies, organizations and research institutes. Dr. Medford serves as Chairman of Board of Directors of the Center for Global Health Innovation (CGHI, 501c3) and its operating division, the Global Health Crisis Coordination Center. Previously, he was Chairman of Global Health ATL, Founding Vice-Chairman of the Georgia Global Health Alliance and a past Chairman of Georgia BIO. He is a board-certified physician, serves on the Executive Committee/Board of Directors of the Global Center for Medical Innovation (GCMI, 501c3) at the Georgia Institute of Technology (GIT), External Advisory Board for GIT's Petit Institute of Bioscience and Bioengineering, Chairman of Oncospherix, Inc, a development stage oncology therapeutics company, Inaugural Fellow of the Council on Basic Cardiovascular Sciences of the American Heart Association, and a past member of Biotechnology Innovation Organization's (BIO) Board of Directors (2002-2014), Co-Chairman of BIO's Bioethics Committee, Chairman of the BIO's 2009 International Convention Steering Committee (held for the first time in Atlanta, Georgia) and a member of the Advisory Council of the National Heart, Lung and Blood Institute. From 1995 to 2009, Dr. Medford served as co-founder, President, CEO and Director of publicly-held AtheroGenics, Inc (Nasdaq: AGIX) and was a founding Board Director of publicly-held Inhibitex, Inc. (Nasdaq: INHX). Dr. Medford is one of our independent directors pursuant to applicable NASDAQ rules. We believe that Dr. Medford is well-qualified to serve as a director due to his experience as a founder and executive of several pharmaceutical development companies, and we believe that Dr. Medford will continue to be a valuable asset to the Company and its Board in connection with the Company's clinical development activities.

Joseph (Jeff) Thomis, Ph.D.

Director since January 2017

Dr. Thomis was appointed to the Board of Directors in January 2017. He brings more than 40 years of experience in drug discovery, clinical development and commercialization. After a short period in academia, Dr. Thomis played a major role in the development and registration of eight commercially successful cardiovascular and infectious disease products while at Bristol-Myers Squibb. He has also held senior clinical development roles at Quintiles, a global provider of pharmaceutical services, where he was instrumental in the growth of clinical research in Europe. He also specialized in designing and implementing effective regional and global clinical strategies as well as repositioning and restructuring organizations. Dr. Thomis is currently Chairman of the Board of Glasgow Memory Clinic Holdings, a private company, offering patient services in the neurosciences area. He is also Chairman of WP Clinical, a private company, offering access services in unlicensed medicines. He previously served on the EMEA and American management boards of Quintiles as well as on the board of PDP Courier Services, Idis Group Holdings, Quotient Sciences and NovaQuest LLC. Dr. Thomis is one of our independent directors pursuant to applicable Nasdaq rules and is qualified as an Audit Committee Financial Expert as defined in Regulation S-K Item 407(d)(5)(ii). We believe that Dr. Thomis is well-qualified to serve as a director due to his extensive experience with clinical trials and contract research organizations, and we believe that Dr. Thomis will continue to be a valuable asset to the Company and its Board by providing valuable insight and knowledge with respect to the Company's clinical development activities.

Biao Xi, Ph.D.

Director since July 2023

Dr. Biao Xi joined ThermoGenesis in July 2023. He has served as Chief Scientific Officer, Co-founder, and member of the Board of Miracure Biotechnology since March 2022. Miracure is an early-stage drug discovery company based in San Diego developing new drug candidates for oncology and immunology applications. Previously, Dr. Xi has served as CEO at ImmunePoint Inc (2018-2021), VP of Translational Study at Theragene Pharmaceuticals, Chief Scientist for China at ACEA Biosciences, an Agilent company (2006-2018), and Research Asst. Professor at Albert Einstein College of Medicine (1999-2006). Dr. Xi received a master's degree from the Chinese Academy of Science and a Ph.D. from Zhejiang University in China. Dr. Xi is one of our independent directors pursuant to applicable Nasdaq rules. We believe that Dr. Xi is well-qualified to serve as a director due to his experience with early-stage drug discovery companies and will be a valuable asset to the Company and the Board.

James Xu, Esq., DBA, PsyD, J.D., CPA

Director since July 2023

Dr. James Xu rejoined ThermoGenesis as a director in July 2023. He previously served as a member of the Board of Directors of ThermoGenesis between November 2016 to December 2019. Dr. Xu is a practicing attorney and licensed CPA in the State of Illinois and is also a Patent Lawyer licensed by U.S. Patent and Trademark Office. Dr. Xu has been practicing patent laws, corporate laws and tax laws for over 25 years. Dr. Xu received his Master of Science in Electrical Engineering and MBA from the University of Mississippi, J.D. and LLM degrees in Taxation from DePaul Law School, an LLM in Intellectual Properties and LLM in Information Technologies from John Marshall Law School, PsyD from California Southern University, and DBA from University of Missouri-St. Louis. Dr. Xu is one of our independent directors pursuant to applicable Nasdaq rules. We believe that Dr. Xu is well-qualified to serve as a director due to his experience as an attorney, certified public accountant, and with patent, corporate, and tax law, and will be a valuable asset to the Company and the Board.

Haihong Zhu

Director since January 2022

Ms. Zhu joined ThermoGenesis in 2004 and was appointed Chief Operating Officer in 2018 and joined our Board in January 2022. Subsequent to December 31, 2023, Ms. Zhu resigned from the Board as of March 8, 2024. During her time with the Company, she has served in various roles with increasing managerial responsibilities in research and development, customer service, global sales and operations. Additionally, Ms. Zhu has helped the Company's clients and partners build over a dozen premier stem cell banks in different regions around the world. Ms. Zhu brings over 20 years of technical and marketing experience in the stem cell field and has contributed significantly to the establishment of ThermoGenesis' commercial global presence. Prior to joining ThermoGenesis, Ms. Zhu worked as a technical professional at BioTransplant Inc., a biopharmaceutical company that develops proprietary pharmaceuticals and organ transplantation systems and conducted biomedical research in the stem cell laboratory at Harvard Medical School, focusing on HIV vaccine research. Ms. Zhu received a bachelor's degree in biology from Shanghai University of Science & Technology and completed an advanced biostatistics program at Boston University.

To our management's knowledge, there are neither any family relationships between any of our directors or executive officers nor have any of our directors been involved in a legal proceeding that would be required to be disclosed pursuant to Item 401(f) of Regulation S-K of the Exchange Act other than as may be disclosed above.

Executive Officers

Set forth below is the name, age, and certain biographical information for each of our current executive officers:

Name	Position		Age
Chris Xu, Ph.D., MBA	Chief Executive Officer & Chairman			52
Haihong Zhu	Chief Operating Officer			58
Jeff Cauble, CPA	Chief Financial Officer			51

Biographies

The biographies for Dr. Xu and Ms. Zhu can be found above under Item 10. Directors, Executive Officers and Corporate Governance - Directors.

Jeffery Cauble joined the Company in 2010 and was appointed Chief Financial Officer in December 2019. During his time with the Company, Mr. Cauble has served in various accounting roles with the Company, including Vice President of Finance, Controller and Director of Financial Planning & Analysis. He brings over 25 years of accounting experience in various financial and managerial roles in the biotechnology, medical device and agricultural industries. Mr. Cauble is a Certified Public Accountant and graduate of the University of Idaho, where he obtained a bachelor's degree with a dual major in accounting and finance.

Executive officers serve at the pleasure of our Board of Directors. To our management's knowledge, there are neither any family relationships between any of our executive officers, directors, or key employees nor have any of our executive officers or key employees been involved in a legal proceeding that would be required to be disclosed pursuant to Item 401(f) of Regulation S-K of the Exchange Act.

CORPORATE GOVERNANCE

General

Our Board believes that good corporate governance is important to ensure that ThermoGenesis is managed for the long-term benefit of our stockholders. This section describes key corporate governance guidelines and practices that we have adopted. Complete copies of our corporate governance guidelines, committee charters and code of ethical conduct described below are available under the "Investors" section of our website at www.thermogenesis.com.

Board Operating and Governance Guidelines

Our Board has adopted a number of operating and governance guidelines, including the following:

-

Formalization of the ability of each committee to retain independent advisors;

-

Directors have open access to the Company's management; and

-

Independent directors may meet in executive session prior to or after each regularly scheduled Board meeting without management present.

Our Board has concluded that Drs. Russell Medford, Joseph Thomis, Biao Xi and James Xu are "independent" as defined by Nasdaq and under Rule 10A-3(b)(1) under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), as that term relates to membership on our Board, and the Board is comprised of a majority of independent directors.

Board Leadership Structure

Dr. Chris Xu serves as both our Chairman of the Board and CEO. The Board and its independent directors believe the most effective Board leadership structure at the present time is for the CEO to serve as Chairman of the Board because the CEO is ultimately responsible for executing our strategy and because our performance is an integral part of the deliberations undertaken by the Board. The Company does not currently designate a "lead independent director" but reserves the authority to do so at any time. The Board reserves the authority to modify this structure to best address and advance the interests of all stockholders, as and when appropriate.

Risk Oversight

The Board has an active role, as a whole and also at the committee level, in overseeing risk management. The Board regularly reviews information regarding the Company's liquidity and operations, as well as the risks associated with each. The Company's Compensation Committee is responsible for overseeing the management of risks relating to the Company's executive compensation plans and arrangements. The Audit Committee oversees management of risks relating to financial reporting, internal controls and compliance with legal and regulatory requirements. The Governance and Nominating Committee oversees the management of risks associated with corporate governance, the independence of the Board and potential conflicts of interest. The Board is also responsible for evaluating and managing cybersecurity risks. While each committee is responsible for evaluating certain risks and overseeing the management of such risks, the entire Board is regularly informed through committee reports about such risks.

Governance and Nominating Committee

The Governance and Nominating Committee was formed to address general governance and policy oversight and succession planning, to identify qualified individuals to become prospective directors and make recommendations regarding nominations for the Board, to advise the Board with respect to appropriate composition of Board committees, to advise the Board about and develop and recommend to the Board appropriate corporate governance documents, to assist the Board in implementing guidelines, to oversee the annual evaluation of the Board and the Company's CEO and to perform such other functions as the Board may assign to the committee from time to time. The Governance and Nominating Committee has a Charter which is available on the Company's website at www.thermogenesis.com. The Governance and Nominating Committee currently consists of three directors: Dr. Russell Medford (Governance and Nominating Committee Chairman), Dr. James Xu and Dr. Joseph Thomis, each of whom has been determined to be independent under applicable Nasdaq rules by the Board.

Audit Committee

The Audit Committee of the Board makes recommendations regarding the appointment, compensation, retention and oversight of the independent registered public accounting firm, reviews the scope of the annual audit undertaken by our independent registered public accounting firm and the progress and results of their work, reviews our financial statements, and oversees the internal controls over financial reporting and corporate programs to ensure compliance with applicable laws. The Audit Committee reviews the services performed by the independent registered public accounting firm and determines whether they are compatible with maintaining the registered public accounting firm's independence. The Audit Committee has a Charter, which is reviewed annually and as may be updated as required due to changes in industry accounting practices or the promulgation of new rules or guidance documents. The Audit Committee Charter is available on the Company's website at www.thermogenesis.com. The Audit Committee currently consists of the following three directors: Dr. Russell Medford (Audit Committee Chairman) Dr. Joseph Thomis, Dr. Biao Xi, each of whom has been determined to be independent under applicable Nasdaq and SEC rules by the Board. The Board has further determined that Dr. Joseph Thomis is qualified as an Audit Committee Financial Expert as defined in Regulation S-K Item 407(d)(5)(ii) and applicable Nasdaq rules.

Compensation Committee

The Compensation Committee of the Board reviews and approves executive compensation policies and practices, reviews salaries and bonuses for our CEO, administers the Company's stock option plans and other benefit plans, and considers other matters as may, from time to time, be referred to them by the Board. The Board, along with the Compensation Committee, believes that the compensation of employees should be fair to both employees and stockholders, externally competitive, and designed to align the interests of employees with those of the stockholders. The Compensation Committee has the authority to form, and to delegate its authority to, one or more subcommittees, as it deems appropriate. The Compensation Committee may consult with the CEO and other executive officers of the Company in determining applicable policies, but the CEO may not be present during any voting or deliberations on his or her compensation. The Compensation Committee has the authority to retain and terminate any independent compensation consultants or other advisors, in accordance with applicable Nasdaq rules, to assist it in any aspect of the evaluation of a director, CEO or senior compensation or on any other subject relevant to the Committee's responsibilities, including the authority to approve such consultant's or advisor's fees and other retention terms. The Compensation Committee elected not to engage an independent compensation consultant in undertaking its duties for fiscal year 2022. The Compensation Committee has a charter which is available on the Company's website at www.thermogenesis.com. The Compensation Committee consists of three directors: Dr. Joseph Thomis (Compensation Committee Chairman) Dr. Russell Medford and Dr. Biao Xi, each of whom has been determined to be independent under applicable Nasdaq rules by the Board.

Compensation Committee Interlocks and Insider Participation

No member of the Compensation Committee has served as one of our officers or employees at any time. None of our executive officers serves as a member of the compensation committee of any other company that has an executive officer serving as a member of our board of directors. None of our executive officers serves as a member of the board of directors of any other company that has an executive officer serving as a member of the Compensation Committee.

Board and Committee Meetings and Attendance

During the calendar year ended December 31, 2023, the Board met four (4) times, the Audit Committee met four (4) times, the Compensation Committee met seven (7) times, and the Governance and Nominating Committee met four (4) times. During the calendar year ended December 31, 2023, each director attended at least 75% of the aggregate of the total number of meetings of the Board held while serving as a director and the aggregate of the total number of meetings of each Board committee of which that director is a member held while serving as a member of such committee. Generally, our directors attend our annual meetings. All of the directors elected to our Board at our most recent annual stockholders' meeting, held December 14, 2023, attended the meeting in person or via conference call; other than Mr. Xi whom was ill and unable to attend.

Director Nominating Procedures

Subject to the Restated Nomination Agreement (as described below), the Governance and Nominating Committee assists our Board in identifying director nominees consistent with criteria established by our Board. Although the Governance and Nominating Committee does not currently have a specific policy with regard to consideration of director candidates recommended by stockholders, the Board and the Governance and Nominating Committee believe that the Governance and Nominating Committee would provide such recommendations the same consideration as other candidates. Any recommendation submitted by a stockholder to the Governance and Nominating Committee should include information relating to each of the qualifications outlined below concerning the potential candidate along with the other information required by the rules of the SEC and our Bylaws for stockholder nominations.

Generally, nominees for director are identified and suggested to the Governance and Nominating Committee by the Company's current directors or management using their business networks and evaluation criteria they deem important, which may or may not include diversity. While the Company does not have a specific policy regarding diversity and has not established minimum experience or diversity qualifications for director candidates, when considering the nomination of directors, the Governance and Nominating Committee does generally consider the diversity of its directors and nominees in terms of knowledge, experience, background, skills, expertise and other demographic factors. The Company does not impose formal term limits on its directors.

Board Diversity

Diversity is one of the important factors the Nominating and Corporate Governance Committee considers when nominating Board candidates. The Committee conducts annual evaluations of our Board effectiveness, providing it with an opportunity to examine whether our Board members have the right composition of skills and experiences. When identifying and recommending new candidates, the Committee continues to consider opportunities to increase our Board diversity in a way that supports the current and anticipated needs of the Company.

Board Diversity Matrix for ThermoGenesis Holdings, Inc. (As of March 8, 2024)
Total Number of Directors			5
Gender		Female			Male
Directors			-			5
Number of Directors Who Identified in Any of the Categories Below:
Asian			-			3
White			-			2

Delinquent Section 16(a) Reports

Section 16(a) of the Securities Exchange Act requires our executive officers and directors, and persons who own more than 10% of our Common Stock, to file reports regarding ownership of, and transactions in, our securities with the SEC and to provide us with copies of those filings. Based solely on our review of the copies of such forms received by us we believe that during the twelve months ended December 31, 2023, all filing requirements applicable to our officers, directors and greater than 10% beneficial owners were filed timely.

Code of Ethics

We have adopted a code of ethics that applies to all employees, including our CEO and CFO, Controller or any person performing similar functions. A copy of our code of ethical conduct can be found in the "Investors" section of our website at www.thermogenesis.com. The code of ethical conduct will be provided without charge upon request submitted to [email protected]. The Company will report any amendment or waiver to the code of ethics on our website within four business days.

ITEM 11.

Executive Compensation

Named Executive Officers Summary Compensation Table

The following table sets forth certain information regarding the compensation paid to our named executive officers ("NEOs") for the fiscal years ended December 31, 2023 and 2022:

Name and Principal Position	Year		Salary ($)			Bonus ($)			Stock Awards ($)			Option Awards ($)			All Other ($)			Total ($)
Chris Xu, Ph.D., MBA	2023			520,000				-				-				-				-				520,000
Chief Executive Officer	2022			519,000				180,000				-				-				-				699,000
Haihong Zhu	2023			460,000				-				-				-				-				460,000
Chief Operating Officer	2022			458,000				96,000				-				-				-				554,000
Jeffery Cauble, CPA	2023			264,000				-				-				-				-				264,000
Chief Financial Officer	2022			264,000				61,000				-				-				-				325,000

Employment Agreements

Dr. Xiaochun (Chris) Xu. Dr. Xu has an employment agreement with the Company (the "Employment Agreement") that provides that Dr. Xu is entitled to a base salary of $520,000 per annum and that Dr. Xu will devote at least a majority of his full working time and efforts to the affairs of the Company. Dr. Xu is eligible to receive a performance bonus equal to a percentage of his base salary based on performance against annual objectives at the discretion of the Board (an "STI Award"). The target percentage is 60%, but the actual percentage as determined by the Board may range from 0% to higher than 100% of his base salary. Either Dr. Xu or the Company may terminate the employment agreement at any time and for any reason. In the event that Dr. Xu's employment is terminated by the Company without "Cause" or he resigns for "Good Reason" (each as defined in the Employment Agreement), he will be entitled to receive a sum equal to eighteen months of base salary in effect as of the termination date, a lump sum cash payment equal to one and a half times the most recently established and earned annual STI Award, all options granted to Dr. Xu to acquire Company Common Stock shall become vested as of the termination date, and the Company shall pay up to eighteen months of COBRA premiums. If Dr. Xu's employment is terminated by the Company without Cause or he resigns for Good Reason, in each case, within three months prior to or eighteen months following certain changes in control of the Company, he will be entitled to receive a lump sum cash payment equal to thirty-six months of the base salary in effect as of the termination date, a lump sum cash payment equal to three times the most recently established and earned annual STI Award, all options granted to Dr. Xu to acquire Company Common Stock shall become vested as of the termination date, and the Company shall pay up to twenty four months of COBRA premiums.

Mr. Jeffery Cauble. The Company does not have an employment agreement with Mr. Cauble. Mr. Cauble's current base salary is $264,000 per year.

Haihong Zhu. The Company does not have an employment agreement with Ms. Zhu. Ms. Zhu's current base salary is $460,000 per year.

Both Mr. Cauble and Ms. Zhu are eligible to receive a paid bonus under the Company's short-term incentive program.

Outstanding Equity Awards at Fiscal Year-End

The following table provides information about outstanding options held by the NEOs as of December 31, 2023.

Option Awards
		No. of Securities Underlying Unexercised Options (#) Exercisable			Equity Incentive Plan Awards: Securities Underlying Unexercised Unearned Options (#)			Option Exercise Price ($)		Option Expiration Date
Chris Xu, Ph.D.			667				-				1,350.00		29-Dec-2027
			356				-				134.06		14-Dec-2028
			1,423				-				134.06		14-Dec-2028
			30,000	(1)			-				1.50		29-Dec-2027
Haihong Zhu			112				-				1,350.00		29-Dec-2027
			178				-				134.06		14-Dec-2028
			712				-				134.06		14-Dec-2028
			50,000	(1)			-				1.50		29-Dec-2027
			-				250,000	(1)			0.65		07-Apr-2029
			-				250,000	(1)			0.65		07-Apr-2029
			250,000	(1)			-				0.65		07-Apr-2029
Jeffery Cauble, CPA			89				-				134.06		14-Dec-2028
			356				-				134.06		14-Dec-2028

(1)	Represents ThermoGenesis Corp. options.

Potential Payments upon Termination or Change in Control

Dr. Xu has certain change of control rights under the Employment Agreement, as described above. The Compensation Committee considers these rights, on a case by case basis, to provide NEOs with the ability to make appropriate, informed decisions on strategy and direction of the Company that may adversely impact their particular positions, but nevertheless are appropriate for the Company and its stockholders. Our Compensation Committee believes that the Company should provide reasonable severance benefits to certain of its executive officers, recognizing that it may be difficult for such officers to find comparable employment within a short period of time and that severance arrangements may be necessary to attract highly qualified officers in a competitive hiring environment.

The following table describes the potential payments upon a hypothetical termination without cause, resignation for good reason or due to a change in control of the Company on December 31, 2023, for Dr. Xu. The actual amounts that may be paid upon an executive's termination of employment can only be determined at the actual time of such termination.

Name		Salary ($)(1)			Incentive Compensation ($)(1)			Health Benefits ($)			Total ($)
Chris Xu, Ph.D.
Termination without cause or resignation for good reason			780,000				154,000				102,000				1,036,000
Termination following a change of control			1,560,000				936,000				136,000				2,632,000

(1)

Payable in a lump-sum payment.

Ms. Zhu and Mr. Cauble do not have change of control rights under an employment agreement.

COMPENSATION OF DIRECTORS

Director Compensation Table

The following table sets forth the compensation received by each of the Company's non-employee directors for the year ended December 31, 2023.

Name		Fees Earned or Paid in Cash ($)			Option Awards ($)			Total ($)
Vivian Liu(1)		$	73,125				-			$	73,125
Russell Medford, Ph.D.		$	54,500				-			$	54,500
Biao Xi, Ph.D.(2)		$	10,000				-			$	10,000
Jeff Thomis, Ph.D.		$	56,000				-			$	56,000
James Xu, Esq., DBA, PsyD., CPA(2)		$	13,375				-			$	13,375

(1)

Ms. Liu resigned from the Board in August 2023. Represents $43,875 for directors fees and $29,250 in fees under consulting agreement between Ms. Liu and the Company.

(2)

Dr. Biao Xi, Ph.D. and Dr. James Xu, Esq., DBA, PsyD., CPA were nominated and appointed to the Board in July 2023 by Boyalife Asset Holding II, Inc., pursuant to the First Amended and Restated Nomination and Voting Agreement, dated April 16, 2018 between the Company and Boyalife Asset Holding II, Inc.

The following table sets forth the aggregate number of option awards held by each non-employee director as of December 31, 2023:

Name		Aggregate Number of Option Awards
Vivian Liu(1)			-
Russell Medford, Ph.D.			375
Biao Xi, Ph.D.(2)			-
Jeff Thomis, Ph.D.			375
James Xu, Esq., DBA, PsyD., CPA(2)			-

(1)

Ms. Liu resigned from the Board in August 2023.

(2)

Dr. Biao Xi, Ph.D. and Dr. James Xu, Esq., DBA, PsyD., CPA were nominated and appointed to the Board in July 2023 by Boyalife Asset Holding II, Inc., pursuant to the First Amended and Restated Nomination and Voting Agreement, dated April 16, 2018 between the Company and Boyalife Asset Holding II, Inc.

Each non-employee director receives an annual fee of $35,000. The chairperson of each standing committee receives an additional annual fee of $15,000 for the Audit Committee, $10,000 for the Compensation Committee and $7,000 for the Governance Committee. Each non-chair committee member receives an annual fee of $7,500 for the Audit Committee, $5,000 for the Compensation Committee, and $3,500 for the Governance Committee.

All fees are paid quarterly. In addition, we reimburse our directors for their reasonable expenses incurred in attending meetings of the Board and its committees.

ITEM 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

Equity Compensation Plans

The following table provides information for all of the Company's equity compensation plans in effect as of December 31, 2023.

Plan Category		Number of securities to be issued upon exercise of outstanding options (a)			Weighted- average exercise price of outstanding options (b)			Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c)
Equity compensation plans approved by security holders			6,103			$	387.05				60,479
Equity compensation plans not approved by security holders			-				-				-
Total			6,103								60,479

On December 29, 2017, the Board of Directors of ThermoGenesis Corp., a wholly-owned subsidiary of the Company ("ThermoGenesis Sub"), adopted the ThermoGenesis Corp. 2017 Equity Incentive Plan (the "ThermoGenesis Sub Plan"). The ThermoGenesis Sub Plan was unanimously approved by the ThermoGenesis Corp. stockholders (including the Company) on December 29, 2017. The ThermoGenesis Sub Plan authorizes the issuance of up to 1,000,000 shares of ThermoGenesis Corp. common stock, all of which may be issued as incentive stock options under Section 422 of the Code. The ThermoGenesis Sub Plan is administered by the Compensation Committee of the ThermoGenesis Corp. Board of Directors, except that if such a committee is not appointed, the plan will be administered by the ThermoGenesis Holdings, Inc. Board of Directors. As of March 15, 2023, Dr. Xu holds 30,000 stock options of ThermoGenesis Corp. out of the ThermoGenesis Sub Plan, of which 30,000 are exercisable. Ms. Zhu holds 300,000 stock options of ThermoGenesis Corp Sub Plan, of which 300,000 are exercisable. As the ThermoGenesis Sub Plan is for the Company's subsidiary it was not affected by the reverse split effected on December 22, 2022.

STOCK OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT OF THERMOGENESIS HOLDINGS, INC.

The Company has only one class of stock outstanding, our Common Stock. The following table sets forth certain information as of March 31, 2024, with respect to the beneficial ownership of the Company's Common Stock for (i) each director and director nominee, (ii) each named executive officer herein, (iii) all of Company's directors and executive officers as a group, and (iv) each person known to us to own beneficially five percent (5%) or more of the outstanding shares of Company's Common Stock. As of March 31, 2024, there were 7,952,780 shares of Common Stock outstanding. Each share of the Company's Common Stock is entitled to one vote.

To the Company's knowledge, except as indicated in the footnotes to this table or pursuant to applicable community property laws, the persons named in the table have sole voting and investment power with respect to the shares of Common Stock indicated.

Name of Director, Director Nominee or Named Executive Officer		Amount and Nature of Beneficial Ownership(1)			Percent of Class
Xiaochun (Chris) Xu, Ph.D., MBA			21,360,189	(2)			86	%
Jeffery Cauble, CPA			465	(4)			*
Russell Medford, Ph.D.			372	(3)			*
Jeff Thomis, Ph.D.			372	(3)			*
Biao Xi, Ph.D.			-				*
James Xu, Esq., DBA, PsyD, J.D., CPA			-				*
Haihong Zhu			1,002	(3)			*
Officers & Directors as a Group (7 persons)			8,026,795				86	%
Name and Address of 5% Beneficial Owners
Boyalife Group Inc.			8,022,132	(5)			86	%

*	Less than 1%.

(1)

"Beneficial Ownership" is defined pursuant to Rule 13d-3 of the Exchange Act, and generally means any person who directly or indirectly has or shares voting or investment power with respect to a security. A person shall be deemed to be the beneficial owner of a security if that person has the right to acquire beneficial ownership of the security within 60 days, including, but not limited to, any right to acquire the security through the exercise of any option or warrant or through the conversion of a security. Any securities not outstanding that are subject to options or warrants shall be deemed to be outstanding for the purpose of computing the percentage of outstanding securities of the class owned by that person, but shall not be deemed to be outstanding for the purpose of computing the percentage of the class owned by any other person. Some of the information with respect to beneficial ownership has been furnished to us by each director or officer, as the case may be.

(2)

Dr. Xu's beneficial ownership represents (i) 2,446 shares issuable upon the exercise of options; (ii) 16,917,464 shares issuable as of March 31, 2024 upon the conversion of the Second Amended and Restated Convertible Promissory Note payable by the Company to Boyalife Group Inc.; and (iii) 4,440,279 shares owned by Boyalife Group, Inc. Dr. Xu has sole voting and dispositive power over the shares held by Boyalife Group Inc.

(3)	Represents shares issuable upon the exercise of options that are vested as of March 31, 2024 or within 60 days thereafter.

(4)	Includes 20 common shares and 445 shares issuable upon the exercise of options that are vested as of March 31, 2024 or within 60 days thereafter.

(5)

Consists of 4,440,279 common shares owned by Boyalife Group Inc. and 16,917,464 common shares issuable upon the conversion of the Second Amended and Restated Convertible Promissory Note payable by the Company to Boyalife Group Inc. Dr. Xu has sole voting and dispositive power over Boyalife Group Inc. The principal business address of Boyalife Group Inc. is 2453 S. Archer Ave., Suite B, Chicago, IL 60616.

ITEM 13.

Certain Relationships and Related Transactions, and Director Independence

Certain Relationships and Related Party Transactions

For the fiscal year ended December 31, 2023 and 2022, there were the following related party transactions reportable under Item 404 of Regulation S-K.

Convertible Promissory Note and Revolving Credit Agreement

In March 2017, ThermoGenesis Holdings entered into a Credit Agreement with Boyalife Group (USA), Inc. (the "Lender"), which is owned and controlled by the Company's Chief Executive Officer and Chairman of our Board of Directors. The Credit Agreement, as amended, grants the Company the right to borrow up to $10,000,000 (the "Loan") at any time prior to the maturity date. On March 6, 2023, the Company entered into an Amendment No. 2 (the "Amendment to the Note") to its Second Amended and Restated Convertible Promissory Note with Boyalife Group Inc. (the "Note"), and an Amendment No. 3 to its First Amended and Restated Revolving Credit Agreement with Boyalife Group Inc. The Amendment to the Note amended and extended the maturity date of the Note from March 6, 2023 to December 31, 2023 (the "Maturity Date") and added to the principal balance of the Note all accrued and unpaid interest at the time of the extension. As of December 31, 2023, the outstanding principal balance of the Note was $7,278,000. Subsequent to December 31, 2023, the Maturity Date of the Note was extended to December 31, 2024.

The Company performed a debt extinguishment vs. modification analysis on the Amendment to the Note and determined that the amendment would be considered an extinguishment, due to an increase of more than 10% to the value of the embedded conversion option. However, no gain or loss was recorded in the consolidated statements of operations and comprehensive loss at the time of the Amendment as it was determined that the fair value of the Amendment to the Note and accrued interest was the same before and after the extension.

On September 28, 2023, the Company received a conversion notice from the Lender to convert a total of $700,000 of the outstanding accrued interest. The conversion resulted in an issuance of 654,206 shares of the Company's common stock at a conversion price of $1.07 per share. Immediately following the conversion, the outstanding principal balance of the Note was $7,278,000 and accrued but unpaid interest of $216,000.

The Credit Agreement and the Note, as amended provide that the principal and all accrued and unpaid interest under the Loan will be due and payable on the Maturity Date, with payments of interest-only due on the last day of each calendar year. The Loan bears interest at 22% per annum, simple interest. The Company has five business days after the Lender demands payment to pay the interest due before the Loan is considered in default. The Loan can be prepaid in whole or in part by the Company at any time without penalty.

Lease Agreement

On March 24, 2022, the Company entered into a five year Lease Agreement with Z3 Investment LLC, an affiliate of the Company's Chairman and CEO, and COO, beginning April 1, 2022, for approximately 35,000 square feet of laboratory and office space in Rancho Cordova, California. Under the terms of the agreement, monthly rent is $108,000 per month (with a 4% annual increase). Additionally, the Company will pay all operating expenses as they become due, estimated to be approximately $20,000 per month and will be expensed in the period incurred. The Company has the option to renew the lease for up to ten years after the commencement of the initial five-year term.

Nomination and Voting Agreement

We are a party to a First Amended and Restated Nomination and Voting Agreement, dated April 16, 2018 (the "Restated Nomination Agreement"), with Boyalife Asset Holding II, Inc., our largest stockholder ("Boyalife"). The Restated Nomination Agreement provides that Boyalife has the right to designate a number of directors of the Company that is in proportion to the "Boyalife Ownership Percentage", which is Boyalife's and its affiliates' combined percentage ownership of outstanding Common Stock, treating as outstanding any shares of Common Stock underlying convertible securities that are immediately exercisable by Boyalife and its affiliates' (including under the Boyalife Note (as defined below)) without any further payment (the "Boyalife Ownership Percentage"). The Restated Nomination Agreement will terminate according to its terms when and if the Boyalife Ownership Percentage falls below 20%.

Director Independence

Our Board of Directors has concluded that Dr. Medford, Dr. Thomis, Dr. Xi and Dr. James Xu are deemed independent under the Nasdaq rules.

ITEM 14.

Principal Accounting Fees and Services

The following table summarizes the fees billed to us by Marcum LLP for the periods indicated below:

Fee Category		Fiscal 2023			Fiscal 2022
Audit Fees(1)		$	378,000			$	443,000
Audit-Related Fees			-				-
Tax Fees			-				-
All Other Fees			-				-
Total Fees		$	378,000			$	443,000

(1)

The audit fees consisted of fees for the audit of our financial statements, the review of the interim financial statements included in our quarterly reports on Form 10-Q, and other professional services provided in connection with statutory and regulatory filings or engagements and capital market financings.

The Audit Committee pre-approves all audit and non-audit services, and has approved all of the foregoing audit and non-audit services, performed by the independent registered public accounting firm in accordance with the Audit Committee Charter.

PART IV

ITEM 15.

Exhibits and Financial Statement Schedules

The following documents are filed as a part of this Annual Report on Form 10-K.

(a) (1) Financial Statements	Page Number
	Report of Independent Registered Public Accounting Firm (PCAOB ID #688)	27
	Consolidated Balance Sheets at December 31, 2023 and 2022	29
	Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2023 and 2022	30
	Consolidated Statements of Equity / (Deficit) for the Years Ended December 31, 2023 and 2022	31
	Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022	32
	Notes to Consolidated Financial Statements	33
Management's Report on Internal Control over Financial Reporting is contained as part of this Annual Report under Item 9A "Controls and Procedures."
(a) (2) Financial Statement Schedules
	Financial statement schedules have been omitted because they are not required.
(b)	Exhibits
	Exhibits required by Item 601 of Regulation S-K are listed in the Exhibit Index on the next page, which are incorporated herein by this reference.

ITEM 16.

Form 10-K Summary

None.

EXHIBIT INDEX

Exhibit No.	Description
1.1	At the Market Offering Agreement, dated December 13, 2019, by and between ThermoGenesis Holdings, Inc. and H.C. Wainwright & Co., LLC, incorporated by reference to Exhibit 1.2 to the Registration Statement on Form S-3 (Registration No. 333-235509) filed on December 13, 2019.
1.2	Amendment No.1 to At the Market Offering Agreement dated May 19, 2020, by and between ThermoGenesis Holdings, Inc. and H.C. Wainwright & Co., LLC, incorporated by reference to Exhibit 1.1 to Form 8-K filed May 20, 2020.
1.3	Amendment No. 2 to At the Market Offering Agreement dated May 19, 2020, by and between ThermoGenesis Holdings, Inc. and H.C. Wainwright & Co., LLC, incorporated by reference to Exhibit 1.3 to Form 8-K filed February 3, 2022.
1.4	At the Market Offering Agreement, dated November 22, 2023, by and between ThermoGenesis Holdings, Inc. and H.C. Wainwright & Co., LLC, incorporated by reference to Exhibit 1.2 to the Registration Statement on Form S-3 (Registration No. 333-275735) filed on November 22, 2023.
3.1	Amended and Restated Certificate of Incorporation of ThermoGenesis Holdings, Inc. dated as of June 5, 2020, as amended December 21, 2022., incorporated by reference to Exhibit 3.1 to Form 10-K filed March 30, 2023.
3.2	Amended and Restated Bylaws of ThermoGenesis Holdings, Inc., incorporated by reference to Exhibit 3.2 to Form 8-K filed with the SEC on March 10, 2023.
4.1	Form of Common Stock Purchase Warrant, incorporated by reference to Exhibit 4.1 to Form 8-K filed with the SEC on March 28, 2018.
4.2	Form of Common Warrant, incorporated by reference to Exhibit 10.37 of amended Registration Statement on Form S-1 filed with the SEC on May 14, 2018.
4.3	Investors' Rights Agreement, dated January 1, 2019, among CARTXpress Bio, Inc., Bay City Capital Fund V, L.P., and Bay City Capital Fund V Co-Investment Fund, L.P., incorporated by referenced to Exhibit 10.3 to Form 8-K filed with the SEC on January 4, 2019.
4.4	Form of Common Warrant (Incorporated by reference to Exhibit 10.40 to Amendment No. 3 to Form S-1 filed with the SEC on October 17, 2022).
4.5	Form of Common Warrant, incorporated by reference to Exhibit 4.1 to Form 8-K filed with the SEC on March 21, 2023.
4.6	Form of Pre-Funded Warrant, incorporated by reference to 4.2 to Form 8-K filed with the SEC on March 21, 2023.
4.7	Form of Warrant Amendment Agreement, incorporated by reference to 4.3 to Form 8K filed with the SEC on March 21, 2023.
4.8	Description of Securities Registered Under Section 12 of the Securities Exchange Act of 1934, as amended, incorporated by reference to Exhibit 4.4 to Annual Report on Form 10-K filed on March 30, 2023.
10.1	Form of Stock Option Award Agreement, incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on January 3, 2020.
10.2	Manufacturing and Supply Amending Agreement #1, effective as of March 16, 2020, between ThermoGenesis Corp. and CBR Systems, Inc., incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on March 20, 2020.
10.3	Form of Stock Option Agreement dated as of June 4, 2020, incorporated by reference to Exhibit 10.2 to Form 8-K filed June 9, 2020.
10.4†	Manufacturing and Supply Amending Agreement #2, between ThermoGenesis Holdings, Inc. and CBR Systems dated as of July 13, 2020, incorporated by reference to Exhibit 10.1 to Form 8-K filed July 17, 2020.

10.5	Reorganization and Share Exchange Agreement, dated January 1, 2019, among ThermoGenesis Corp., ThermoGenesis Holdings, Inc., CARTXpress Bio, Inc., Bay City Capital Fund V. L.P. and Bay City Capital Fund V. Co-Investment Fund, L.P., incorporated by referenced to Exhibit 10.1 to Form 8-K filed with the SEC on January 4, 2019.
10.6	Voting Agreement, dated January 1, 2019, among CARTXpress Bio, Inc., ThermoGenesis Corp., Bay City Capital Fund V, L.P., and Bay City Capital Fund V Co-Investment Fund, L.P., incorporated by referenced to Exhibit 10.2 to Form 8-K filed with the SEC on January 4, 2019.
10.7	Right of First Refusal and Co-Sale Agreement, dated January 1, 2019, among CARTXpress Bio, Inc., ThermoGenesis Corp., Bay City Capital Fund V, L.P., and Bay City Capital Fund V Co-Investment Fund, L.P., incorporated by referenced to Exhibit 10.4 to Form 8-K filed with the SEC on January 4, 2019.
10.8	Investors' Rights Agreement, dated January 1, 2019, between CARTXpress Bio, Inc., Bay City Capital Fund V, L.P. and Bay City Capital Fund V Co-Investment Fund, L.P., incorporated by reference to Exhibit 10.3 to Form 8-K filed with the SEC on January 4, 2019.
10.9	Amended and Restated Certificate of Incorporation of CARTXpress Bio, Inc., incorporated by reference to Exhibit 10.5 to Form 8-K filed with the SEC on January 4, 2019.
10.10	Supply Agreement, dated as of August 30, 2019, between Corning Incorporated and ThermoGenesis Holdings, Inc., incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on September 6, 2019.
10.11	Joint Venture Agreement, dated October 21, 2019, between ThermoGenesis Holdings, Inc. and Healthbanks Biotech (USA) Inc., and ImmuneCyte Life Sciences, Inc., incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on October 22, 2019.
10.12	Form of Convertible Promissory Note, dated as of July 23, 2019, between ThermoGenesis Holdings, Inc. and Orbrex USA Co., incorporated by reference to Exhibit 4.1 to Form 8-K filed with the SEC on July 29, 2019.
10.13	Amendment No.1, dated August 12, 2019 but effective as of July 23, 2019, to the Convertible Promissory Note, dated July 23, 2019 between ThermoGenesis Holdings, Inc. and Orbrex (USA) Co. Limited, incorporated by reference to Exhibit 10.4 to Form 10-Q filed with the SEC on August 13, 2019.
10.14#	ThermoGenesis Holdings, Inc. Amended 2016 Equity Incentive Plan, incorporated by reference to Exhibit 10.5 to Form 10-Q filed with the SEC on August 13, 2019.
10.15*	Sixth Amended and Restated Technology License and Escrow Agreement between the Company, ThermoGenesis Corp. and CBR Systems, effective May 15, 2017, incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on May 31, 2017.
10.16#	Amended and Restated 2006 Equity Incentive Plan, incorporated by reference to Exhibit 10.6.1 to Form 8-K filed with the SEC on May 1, 2014.
10.17	Form of Indemnification Agreement, incorporated by reference to Exhibit 10.1 to Form 8-K/A filed with the SEC on November 17, 2016.
10.18#	Form of Notice of Grant of Stock Options and Option Agreement, incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on May 11, 2017.
10.19#	Executive Employment Agreement, dated November 13, 2017, between the Company and Xiaochun Xu, incorporated by reference to Exhibit 10.2 to Form 8-K filed with the SEC on November 15, 2017.
10.20#	Form of Stock Option Agreement, incorporated by reference to Exhibit 10.4 to Form 8-K filed with the SEC on November 15, 2017.
10.21	First Amended and Restated Revolving Credit Agreement, dated April 16, 2018, between Cesca Therapeutics Inc. and Boyalife Asset Holding II, Inc., incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on April 18, 2018.

10.22	Second Amended and Restated Convertible Promissory Note, dated April 16, 2018, issued by Cesca Therapeutics Inc. to Boyalife Asset Holding II, Inc., incorporated by reference to Exhibit 10.2 to Form 8-K filed with the SEC on April 18, 2018.
10.23	Amendment No. 1 to Second Amended and Restated Convertible Promissory Note, dated March 4, 2022 incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on March 8, 2022.
10.24	Amendment No. 2 to Second Amended and Restated Convertible Promissory Note, dated March 6, 2023, between ThermoGenesis Holdings, Inc. and Boyalife Group Inc., incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on March 10, 2023.
10.25	First Amended and Restated Nomination and Voting Agreement, dated April 16, 2018, between Cesca Therapeutics Inc. and Boyalife (Hong Kong) Limited, incorporated by reference to Exhibit 10.3 to Form 8-K filed with the SEC on April 18, 2018.
10.26	Amendment No. 1 to First Amended and Restated Revolving Credit Agreement, dated May 7, 2018, between Cesca Therapeutics Inc. and Boyalife Asset Holding II, Inc., incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on May 7, 2018.
10.27	Amendment No. 2 to First Amended and Restated Revolving Credit Agreement, dated March 4, 2022, between ThermoGenesis Holdings, Inc. and Boyalife Group, Inc., incorporated by reference to Exhibit 10.2 to Form 8-K filed with the SEC on March 8, 2022.
10.28	Amendment No. 3 to First Amended and Restated Revolving Credit Agreement, dated March 6, 2023, between ThermoGenesis Holdings, Inc. and Boyalife Group, Inc., incorporated by reference to Exhibit 10.2 to Form 8-K filed with the SEC on March 10, 2023.
10.29#	Form of Stock Option Agreement, incorporated by reference to Exhibit 10.2 to Form 8-K filed with the SEC on December 19, 2018.
10.30	License and Technology Access Agreement, dated March 24, 2022, between ThermoGenesis Holdings, Inc. and Boyalife Genomics Tianjin Ltd., incorporated by reference to Exhibit 10.1 to Form 8-K filed on March 28, 2022.
10.31	Lease Agreement, dated March 24, 2022, between ThermoGenesis Holdings, Inc. and Z3 Investment LLC, incorporated by reference to Exhibit 10.2 to Form 8-K filed on March 28, 2022.
10.32	Fourth Amendment to the Company's Amended 2016 Equity Incentive Plan, effective June 4, 2020, incorporated by reference to exhibit 10.1 to Form 8-K filed January 14, 2022.
10.33	Amendment No. 2 to Convertible Promissory Note, dated July 25, 2022, between ThermoGenesis Holdings, Inc. and Orbrex (USA) Co. Limited, incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on July 28, 2022.
10.34	Amendment No. 3 to Convertible Promissory Note, dated January 31, 2023, between ThermoGenesis Holdings, Inc. and Orbrex (USA) Co Limited, incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on February 6, 2023.
10.35	Form of Securities Purchase Agreement (Incorporated by reference to Exhibit 10.39 to Amendment No. 3 to Form S-1 filed with the SEC on October 17, 2022).
10.36	Amendment No. 4 to Convertible Promissory Note, dated July 31, 2023, between ThermoGenesis Holdings, Inc. and Orbrex (USA) Co Limited, incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on August 3, 2023.
10.37	Amendment No. 3 to Second Amended and Restated Convertible Promissory Note, date January 5, 2024, between ThermoGenesis Holdings, Inc. and Boyalife Group, Inc., incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on January 10, 2024.
10.38	Amendment No. 4 to First Amended and Restated Revolving Credit Agreement, dated January 5, 2024, between ThermoGenesis Holdings, Inc. and Boyalife Group, Inc., incorporated by reference to Exhibit 10.2 to Form 8-K filed with the SEC on January 10, 2024.

21.1	Subsidiaries of ThermoGenesis Holdings, Inc., incorporated by reference to Exhibit 21.1 to Form 10-K filed on March 28, 2022.
23.1	Consent of Marcum LLP, Independent Registered Public Accounting Firm
31.1	Certification by the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2	Certification by the Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32	Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002
97.1	ThermoGenesis Holdings, Inc. Compensation Recovery Policy, filed herewith
101.INS	Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
101.SCH	Inline XBRL Taxonomy Extension Schema Document
101.CAL	Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF	Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB	Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE	Inline XBRL Taxonomy Extension Presentation Linkbase Document
104	Cover Page Interactive Data File (Formatted as Inline XBRL and contained in Exhibit 101)

Footnotes to Exhibit Index

#	Represents a management contract or compensatory plan, contract or arrangement.

*	Confidential treatment has been requested for certain confidential portions of this exhibit pursuant to Rule 24b-2 under the Exchange Act. In accordance with Rule 24b-2, these confidential portions have been omitted from this exhibit and filed separately with the SEC.

†	Portions of this exhibit have been redacted because the Company has determined that such information (i) is not material and (ii) would likely cause competitive harm to the Company if it were to be publicly disclosed.

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Annual Report to be signed on its behalf by the undersigned thereunto duly authorized.

		ThermoGenesis Holdings, Inc.
Dated: April 15, 2024	By:/s/	Xiaochun "Chris" Xu
		Xiaochun "Chris" Xu, Chief Executive Officer (Principal Executive Officer)

KNOW ALL THESE PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Xiaochun "Chris" Xu and Jeffery Cauble and each of them, jointly and severally, his attorneys-in-fact, each with full power of substitution, for him in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each said attorneys-in-fact or his substitute or substitutes, may do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this Annual Report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

By:/s/	Chris Xu		Dated: April 15, 2024
	Chris Xu, Chief Executive Officer and Chairman of the Board (Principal Executive Officer)
By:/s/	Jeffery Cauble		Dated: April 15, 2024
	Jeffery Cauble, Chief Financial Officer (Principal Financial and Principal Accounting Officer)
By: /s/	Russell Medford		Dated: April 15, 2024
	Russell Medford, Director
By: /s/	Joseph Thomis		Dated: April 15, 2024
	Joseph Thomis, Director
By: /s/	Biao Xi		Dated: April 15, 2024
	Biao Xi, Director
By: /s/	James Xu		Dated: April 15, 2024
	James Xu, Director