Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington,WASHINGTON, D.C. 20549

 


FORM 10-K


 

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE

SECURITIES EXCHANGE ACT OF 1934

For the Fiscal Year Ended:June 30, 2017 December 31, 2022

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from        to

 

Commission File Number: 000-16375

thmo20221231_10kimg001.jpg

 

Cesca TherapeuticsThermoGenesis Holdings, Inc.

(Exact name of registrant as specified in its charter)

   

Delaware

(State of incorporation)

 

94-3018487

(I.R.S. Employer Identification No.)

   

2711 Citrus Road

Rancho Cordova, California 95742

(Address of principal executive offices) (Zip Code)

 

(916) 858-5100

(Registrant’s telephone number, including area code)

 

Securities Registered Pursuant to Section 12(b) of the Act:

Title of each class

Trading symbol(s)

Name of each exchange on which registered

Common Stock, $0.001$.001 par value

THMO

Nasdaq StockCapital Market LLC

 

Securities Registered Pursuant to Section 12(g) of the Act: None

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.      [  ]     

Yes [X] No

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.      [  ]     

Yes [X] No

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.           [X]     

Yes [  ] No


 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files.)     [X]     .

Yes [  ] No

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K, is not contained herein, and will not be contained, to the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment of this Form 10-K. [ ]

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting companyorcompany or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer [  ]         Accelerated filer [  ]

Large accelerated filer ☐           Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒

Emerging growth company ☐

Smaller reporting company [X ]

Non-accelerated filer [  ]       (Do not check if a smaller reporting company)

Emerging growth company [  ]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

 

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

     [  ]     Yes [X] No

 

TheAs of June 30, 2022, the aggregate market value of the common stockequity held by non-affiliates as of December 30, 2016 (the last business day of the most recently completed second quarter)registrant was $10,334,000approximately $4,277,535 based on the closing salesales price as reported on such day.the Nasdaq Stock Market.

 

As of September 15, 2017, 9,946,193 shares of the registrant’s Common Stock were outstanding.

Documents Incorporated By Reference: The registrant intends to file an amendment to this Annual Report on Form 10-K within 120 days after the end of the fiscal year ended June 30, 2017, which will include the information required by Part III of Form 10-K.

Class

Outstanding at March 27, 2023

Common stock, $.001 par value

1,535,869

 

 

 

TABLE OF CONTENTS

Part I

Part I

  

Page Number

ITEM 1.

Business

4

3

ITEM 1A.

Risk Factors

14

10

ITEM 1B.

Unresolved Staff Comments

26

21

ITEM 2.

Properties

26

21

ITEM 3.

Legal Proceedings

26

21

ITEM 4.

Mine Safety Disclosures

27

21

Part II

   

Part II

   

ITEM 5.

Market for the Registrant’s Common Equity, Related Stockholder Mattersand Issuer Purchases of Equity Securities

2722

ITEM 6.

Selected Financial Data[Reserved]

27

22

ITEM 7.

Management’s Discussion and Analysis of Financial Condition andResults of Operations

27

22

ITEM 7A.

Quantitative and Qualitative Disclosures about Market Risk

36

26

ITEM 8.

Financial Statements and Supplementary Data

36

26

ITEM 9.

Changes in and Disagreements with Accountants on Accountingand Financial Disclosure

70

57

ITEM 9A.

Controls and Procedures

70

57

ITEM 9B.

Other Information

58

70ITEM 9C.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

58
  

Part III

  

   

ITEM 10.

Directors, Executive Officers and Corporate Governance

71

59

ITEM 11.

Executive Compensation

71

65

ITEM 12.

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

71

68

ITEM 13.

Certain Relationships and Related Transactions, and Director Independence

71

69

ITEM 14.

Principal Accounting Fees and Services

71

Part IV

   

Part IV

   

ITEM 15.

Exhibits and Financial Statement Schedules

72

ITEM 16.

Form 10-K Summary

72

 

i
2

 

PART I

CAUTIONARY STATEMENT REGARDING FORWARD LOOKING STATEMENTSCautionary Statement Regarding Forward Looking Statements

 

This reportAnnual Report contains forward-lookingforward‑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 report,Annual Report, are forward-lookingforward‑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-lookingforward‑looking statements included in this report.Annual Report. Such statements may be identified by the use of forward-lookingforward‑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 lookingforward-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-lookingforward‑looking statements, including:

 

 

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

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

 

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

the global perception of the clinical utility of banked cord blood and remainthe amount of investment in compliance with its listing standards;research and development supporting clinical data for additional applications;

 

the global perceptionsuccess of the clinical utility of banked cord blood and the amount of investment in research and development supporting clinical data for additional applications;any collaborative arrangements to commercialize our products;

 

delays in commencingour reliance on significant distributors or completing clinical testing of products;end users;

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 partythird-party contract manufacturers; and

risks associated with launching our planned CDMO business;

 

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

uncertainty regarding the impact of the COVID-19 pandemic on our business and operations.

 

These forward-lookingforward‑looking statements speak only as of the date of this reportAnnual Report and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-lookingforward‑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-lookingforward‑looking statements are set forth in connection with the forward-lookingforward‑looking statements.

 

TRADEMARKS

Trademarks

 

This reportAnnual Report contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this report,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.

 

ITEM 1.     BUSINESSReverse Stock Split

 

Cesca TherapeuticsOn 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. (“Cesca Therapeutics,” “Cesca,ThermoGenesis Holdings,” the “Company,” “we,” “our,” “us”), develops and commercializes a Delaware corporation, isrange of automated technologies for cell-banking, cell-processing, and cell-based therapeutics. Since the 1990’s, ThermoGenesis Holdings has been a regenerative medicine companypioneer 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. We develop, commercialize and market a range of automated technologies and products

Medical Device Products for cell-based therapeutics. ThermoGenesis Corp. (“ThermoGenesis”), our device division,Automated Cell Processing

The Company provides the AutoXpress®platformAutoXpress® and BioArchive® platforms for automated clinical biobanking, PXP™bio-banking, PXP® platform forpoint-of-carefor point-of-care cell-based therapies and the CAR-TXpress™ platform under development for bio-manufacturing for immuno-oncology applications. Cesca is also leveraging its proprietary PXP™ technology platform to develop autologous cell-based therapies that address significant unmet needslarge scale cell manufacturing services. All product lines are reporting as a single reporting segment in the vascular and orthopedic markets. Our strategy is to continue to enhance the performance and competitiveness of our flagship product lines in the cord blood banking arena while expanding into significant new growth opportunity areas in point-of-care therapies in hospitals and cellular processing for immune-oncology product development and manufacturing.financial statements.

 

Cesca is an affiliate of the Boyalife Group, a China-based industry research alliance encompassing top research institutions for stem cell and regenerative medicine.

Cesca’s Device Division- ThermoGenesis Corp.

ThermoGenesis owns and operates the Company’s device division, a pioneer and market leader in the development and commercialization ofautomated technologies for cell-based therapeutics and bio-processing. ThermoGenesis’ automated solution offerings include:

AutoXpress (AXP)for Clinical BioBankinga proprietary, automated system for the isolation, collection and storage of hematopoietic stem cell concentrates derived from cord blood and peripheral blood.

Point-of-CareXpress (PXP) forPoint-of-CareApplicationsa proprietary, automated system for the rapid, automated processing of autologous peripheral or bone marrow derived stem cells for cell-based therapiesat point-of-care situations, such as surgical centers or clinics.

CAR-TXpress (CXP), for Immuno-Oncology Applications –a proprietary automated system under development that allows for the automated manufacturing, expansion and storage of cellular therapies for immuno-oncology, including various T-cell and natural killer (NK) cell-based therapies. CAR-TXpress works in bulk volumes of cells, dramatically reducing both processing time and the cost of the required capital equipment.

Cesca’s Clinical Development Division

Cesca is developing autologous (utilizing the patient’s own cells) stem cell-based therapies that address significant unmet medical needs for applications within the vascular, cardiology and orthopedic markets.

Vascular Diseases - Critical Limb Ischemia (“CLI”) –Cesca has a proprietary point-of-care, autologous stem cell-based therapy under development which is intended for the treatment of patients with CLI. The Company’s 362 patient, multi-center pivotal Phase III Critical Limb Ischemia Rapid Stem Cell Treatment (“CLIRST”) trial is designed to evaluate the safety and efficacy of autologous stem cell-based therapy to stimulate the regeneration of blood vessels, promote wound healing and prevent amputation. Previous clinical studies using Cesca’s proprietary, point-of-care-technologies have demonstrated the regeneration of blood vessels and improved blood circulation in the limbs, using a patient’s own bone marrow derived stem cells.

Cardiology - Acute Myocardial Infarction – Cesca has a proprietary, point-of-care autologous stem cell-based therapy under development which is intended as an adjunct treatment for patients who have suffered an acute ST-elevated myocardial infarction (“STEMI”), the most serious type of heart attack.  Such treatments are aimed at minimizing the adverse remodeling of the heart post-STEMI.

Orthopedics – OsteoArthritis (OA) -Cesca is in early stage development of an autologous stem cell based therapy intended to treat patients with cartilage tissue degeneration that may lead to progressive cartilage loss and painful joint diseases. Localized articular cartilage defects can potentially be repaired by transplantation of autologous cell therapy. Therapies in development using Cesca’s proprietary PXP™system are expected to delay further deterioration and repair the damaged joint cartilage. Treatment is typically via a single procedure in the hospital or clinic.

Our Strategy

Our business strategy involves:

Bio-Banking Applications:

 

Sustaining our leadership position inAXP®Automated Cell Separation System – an automated, devicesfully closed cell separation system for the separationisolating stem and concentration of stem cell preparationprogenitor cells from umbilical cord blood, and bone marrow.registered as a U.S. FDA 510(k) medical device.

 

Leveraging our expertiseBioArchive® 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 biobanking and cell-based therapeutics to introduce new automated manufacturing solutions to developers of CAR-T and other immuno-therapies.applications, registered as a U.S. FDA 510(k) medical device.

 

Becoming the partner-of-choice for immune-oncology developers looking to achieve increased output while adhering to Cellular Manufacture Control (CMC) best practices

Point-of-Care Applications:

 

Delivering aPXP®Point-of-Care System – an automated, fully integrated offering: We intend to deliver all the hardware, software and disposable components necessaryclosed, sterile system allows for the aspiration andrapid, automated processing of autologous peripheral blood or bone marrow to prepare a therapeutic dose of stem cells for re-injection into the patient at the point-of-care.

Partnering our clinical development with market leaders inselected medical areas to maximize internal values of our existing pipelines. Our protocols are based on the use of autologous (donor and recipient are the same individual), bone marrowaspirate derived stem cells which are potentially safer than alternative allogeneic approaches.at the point-of-care, such as surgical centers or clinics, registered as a U.S. FDA 510(k) medical device.

 

FollowingPXP-LAVARE System – an automated, fully closed system that is designed to wash, re-suspend and volume reduce cell suspensions. It allows for volume manipulation, supernatant or media exchange, and cell washing to occur without comprising cell viabilities and maximizing recoveries, registered as a simpler regulatory path: Cesca’s protocols are autologous and the stem cell preparations are minimally manipulated, allowing an investigational device exemption pre-market approval approach. This reduces costs and time to market when compared to investigational new drug or new drug application approaches.U.S. FDA 510(k) medical device.

 

Expanding patent protection: In the US, we have 17 patents issued andPXP-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 series of applications pending. In addition, we have a series of corresponding international patents issued and pending.U.S. FDA 510(k) medical device.

3
5

 

Recent Key EventsLarge Scale Cell Processing and AccomplishmentsBiomanufacturing:

Acquired the assets of SynGen Inc. (“SynGen”). On July 7, 2017, our subsidiary, ThermoGenesis, acquired the business and substantially all of the assets of SynGen, a privately held Sacramento, California-based technology company that develops, markets, and sells advanced cell separation tools and accessories. In the transaction (the “SynGen Transaction”), ThermoGenesis acquired substantially all of SynGen’s operating assets, including its proprietary cell processing platform. In exchange, ThermoGenesis issued to SynGen shares of ThermoGenesis common stock that, after giving effect to the issuance, constitute 20% of ThermoGenesis’ outstanding common shares, and ThermoGenesis also made a one-time cash payment of $1.0 million to SynGen. Immediately prior to the SynGen Transaction, the Company contributed the assets, business, and current liabilities of its blood and bone-marrow processing device business to ThermoGenesis and will operate such business (together with the acquired business) through the ThermoGenesis subsidiary.

Established $5 Million Line of Credit. On March 6, 2017, we entered into a credit agreement with Boyalife Investment Fund II, Inc. (the “Lender”). The Lender is a wholly owned subsidiary of Boyalife Group Inc., which is owned and controlled by the Company’s Chief Executive Officer and Chairman of the Board of Directors. The Credit Agreement grants to the Company the right to borrow up to $5 million on an unsecured basis (the “Loan”) at any time prior to March 6, 2022.

Increased Line of Credit by $5 Million. On September 13, 2017, we entered into an amendment to the Credit Agreement with the Lender, Boyalife Investment Fund II, Inc. increasing our maximum borrowing availability thereunder from $5.0 million to $10.0 million.

Converted Debt to Equity. On August 22, 2016, all outstanding principal and interest payable under the debentures, which included the conversion of $12,500,000 of principal and $8,250,000 of interest up to and including the maturity date of the debentures was converted to equity. Upon conversion, 6,102,941 shares of common stock were issued and the debentures and all related security interest and liens were terminated.

Raised $2 Million in Equity Financing. On August 3, 2016, we sold 600,000 shares of common stock at a price of $4.10 per share. The net proceeds from the sale and issuance of the shares, after deducting the offering expenses borne by the Company of $369,000, were $2,092,000. 

The Markets We Serve

Immuno-Oncology

Immuno-Oncology is an innovative area of research that seeks to help the body’s own immune system to fight cancer. With the significant unmet medical need in the long-term survival of patients with advanced cancer, pharmaceutical developers are competing to bring cost-efficient immune-therapies rapidly to market. Cesca is leveraging its expertise in clinical biobanking and cell-based therapeutics to introduce CAR-TXpress, an automated manufacturing solution that can address a material challenge to developers of CAR-T and other immuno-therapies.

CAR-TXpress can also be customized to address each customer’s unique needs. In addition to CAR-T cell processing, Cesca is also developing manufacturing solutions for contract manufacturing and co-development that may help accelerate the manufacture and the clinical development of novel therapies.

Regenerative Medicine

Regenerative cell therapy relies on the delivery of specific types of stem cells that have been shown to enable the repair, restoration or regeneration of diseased or damaged tissue.  A broad range of cell types has been investigated, including cells found in peripheral blood, umbilical cord blood and bone marrow.

The regenerative medicine field continues to contribute to meaningful advances in the practice of medicine, as evidenced by numerous FDA and European Union (“EU”) therapeutic product approvals and the commercialization of a growing number of cell-based therapies. Most of the progress has been achieved through the broader application of adult stem cells, reflecting a greater awareness and appreciation of their therapeutic potential.

The market for regenerative medicine is supported by companies that develop devices or methods for harvesting, processing, purifying, expanding, modifying, cryopreserving, storing or administering cells, or by companies that develop and commercialize the therapeutic agents themselves. Key success factors for such companies include:

 

The ability to achieveX-Series® Products for general laboratory use: X-Lab® for cell isolation, X-Wash® System for cell washing and reformulation, X-Mini® for high recoveryefficiency small scale cell purification, and concentration of targetX-BACS® System under development for large scale cell typespurification using our proprietary Buoyancy-Activated Cell Sorting (“BACS”) technology.

 

Device ease-of use, efficiencyCAR-TXpress™ Platform for Clinical Manufacturing – a modular designed, functionally closed manufacturing platform that addresses the critical unmet need for large scale cellular processing and speed

chemistry, manufacturing and controls (“CMC”) needs for manufacturing cellular therapies, including CAR-T cell therapies.

Cell product purity, viability and potency

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

Cost effectiveness

Regulatory approval / FDA clearance

 

The deliveryCompany plans to expand its business to include contract development and manufacturing services for cell and cell-based gene therapies.  The Company is in the process building out the capabilities to become a world-class Contract Development and Manufacturing Organization (“CDMO”) for cell and cell-based gene therapies by partnering with Boyalife Genomics Tianjin Ltd., a China-based CDMO organization (“Boyalife Genomics”), to in-license certain know-how and other intellectual property from Boyalife Genomics.  The Company is rolling out a new facility in the Sacramento metro area, containing a total of 12, class-7, ReadyStart cGMP Suites available for lease by early-stage life science and cell gene therapy (“CGT”) companies. The ReadyStart Suites are located in a 35,500+ square foot cGMP facility that will meet the highest scientific, quality, and regulatory requirements.  We intend to leverage our existing technology and combine it with the in-licensed technologies to develop a proprietary manufacturing platform for cell manufacturing activities.

The Company plans to develop and operate its planned CDMO business through a division named TG BiosynthesisTM. It is anticipated that TG Biosynthesis will provide high-quality development and manufacturing capabilities, cell and tissue processing development, quality systems, regulatory compliance, and other cell manufacturing solutions for clients with therapeutic candidates in various stages of development.

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 typically involves a process whereby target cells are harvestedproducts from a donor or patient, processed or expanded (grown) either within a hospital laboratory or by an FDA regulated, therapeutic manufacturer, formulated into an effective, safe dose, and delivered“bench to a patient through a specific delivery device. Cell preparations may also be formulated in a point of care setting such as an operating room.Requirements for the preparation and usebedside” has been manufacturing bottlenecks. The heterogeneous nature of cell therapies at the point of care include system portability, sterile field packaging, minimal manipulation, swift cell processingtherapy products has introduced manufacturing complexity and predictable target cell recovery rates.

Our growth strategy includes the development of autologous cell therapies for treatments intended to be carried out at the point of care. We believe that commercial opportunities for such therapies will emerge in cardiology, orthopedics, dermatology/wound healing and selective areas of oncology, followed by more complex pathologies such as those found in diabetes and central nervous system disorders.

We also believe that developments in the field of regenerative medicine will be critical in helping to address the global increase in health care costs. As emerging cell therapies are proven to be safe, effective, and a cost-effective alternative to current standards of care, we believe adoption will accelerate. A fundamental requirement, however, will be the continued development of baseline clinical and cost-effectiveness data through comprehensive clinical studies.

Bio-Banking

Cord blood, the blood that remains in the umbilical cord after a baby is born, is rich in stem cells. Since the first cord blood transplant was carried out in 1988, stem cells derived from umbilical cord blood have become widely accepted for medical use and have been used regularly in medical procedures worldwide for the treatment of a wide range of blood diseases, genetic and metabolic disorders, immune-deficiencies and cancers. Cord blood use in clinical applications is now widely accepted and cord blood banks exist in nearly every developed countryregulatory concerns, as well as scale-up complexities that are not present within traditional pharmaceutical manufacturing. Additionally, establishing a growingmanufacturing facility for cell therapies requires specific expertise and significant capital which can delay clinical trials. These factors often result in a significant number of developing nations.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.

In furtherance of our planned CDMO business, on March 24, 2022, we entered into a License and Technology Access Agreement with Boyalife Genomics (the “Boyalife License Agreement”). Boyalife Genomics is an affiliate of our Chairman and CEO, Dr. Chris Xu, and is a Tianjin, China-based cell manufacturing organization that has developed substantial manufacturing technology relating to cell manufacturing services. Under the terms of the Boyalife License Agreement, Boyalife Genomics granted the Company and its subsidiaries and affiliates a perpetual exclusive license in the United States to use Boyalife Genomics’ existing and future know-how and U.S. patents rights (if any) relating to cell manufacturing and related processes, including the right to sublicense such know-how and patent rights to affiliates of the Company. Notwithstanding the foregoing exclusivity, Boyalife Genomics retains the right to use (but not license) the licensed intellectual property in the U.S. for its internal use in connection with the provision of products and services to third parties. In consideration of this license, the Company will, among other things, pay to Boyalife Genomics a running royalty of 7.5% of the Company’s annual net sales of products and services that are covered by one of more Boyalife Genomics’ granted U.S. patents and 5.0% of other products and services covered by the licensed intellectual property. The royalty will be payable on each licensed product or service for a period of 10 years from the first commercial sale of the product or service (or if patented, until the expiration of the applicable licensed patents), and the license will be royalty-free thereafter on such licensed product or service. The agreement also grants the Company a right of first refusal to purchase any cell manufacturing business or operation of Boyalife Genomics upon the same terms as any third-party offer to buy such business or operation.

 

4
7

 

Cesca’s ThermoGenesis divisionThe successful development and launch of TG Biosynthesis will require us to raise additional capital, acquire various equipment for the planned operations, hire certain personnel needed to launch the operation, and timely complete the build-out of our leased Sacramento facility. There is an established leaderno assurance that we will be able to successfully obtain such additional capital resources, as such capital may not be available on reasonable terms, or available at all. We will need to hire, train, and retain additional employees who have experience in the development and manufacture of automated systems that enablecell manufacturing field in order for our CDMO business to be successful. We expect the separation, processing and cryopreservation of stem cell preparations from cord blood. In recent years, however, the overall number of cord blood samples being collected has decreased.CDMO facility to be completed in 2023.

 

Our Products

We design, manufacture and sell advanced devices created specifically for the separation, concentration and cryopreservation of cell types used in the practice of regenerative medicine. Such automated devices are essential to the successful development of cell therapies because they ensure a high degree of quality control over both the preparation and storage of stem cell concentrate. Our current and future product offerings include:

The AutoXpress System (AXP) – a proprietary automated device and companion sterile disposable for concentrating hematopoietic stem cells from cord blood.

The Point-of-CareXpress System (PXP) – a proprietary automated device and companion sterile disposable for the isolation and concentration of hematopoietic stem cells from bone marrow.

The CAR-TXpress System(CXP)– a full suite of multi-componentautomated system that allows for the automated manufacturing, expansion and storage of cellular therapies for immuno-oncology, including various T-cell and natural killer (NK) cell-based therapies.

The BioArchive® System - an automated cryogenic device approved for single-cassette based cryo-storage of biological license applications (BLA) products, including the storage of cord blood units forstem cell applications and CAR-T cellular products forimmune-oncology.

Manual bag sets for use in the processing and cryogenic storage of cord blood.

Cell Manufacturing and Banking Services

Through our TotipotentRX subsidiary in Gurgaon, India, we operate an advanced clinical cell manufacturing, processing, testing, and storage facility, compliant with current Good Manufacturing Practices (“GMP”), Good Tissue Practices (“GTP”), and Good Laboratory Practices (“GLP”). We can support the production of a small, personalized medicine cell prescription. Patient samples and therapeutic aliquots are all labeled in accordance with ISBT 128 and stored in our own cryogenics facility. In addition, our clinical research organization (CRO), also located in Gurgaon, is, to our knowledge, the only specialized, in-hospital, cell therapy CRO in the world. We have unique expertise in the design and management of cell based clinical trials, including the ability to support the device prototyping and validation typically required for a combination product. These services ensure patient safety under Good Clinical Practices (“GCP”), quality laboratory documentation under GLP, and quality cell processing and handling under both GMP and GTP.  In partnership with Fortis Healthcare and through our advanced clinical infrastructure we also operate commercial service programs supporting bone marrow transplantation (hematopoietic stem cell transplantation) for hematological and oncological disorders as well as a licensed umbilical cord blood and tissue bank (“NovaCord”).

Our Clinical Programs

Our therapeutic development initiatives, focused in the fields of cardiovascular diseases and orthopedic cartilageregeneration, are based on our proprietaryPXP™platform for the point-of-careharvesting, processing, and delivery of cells fromthe patient’s own peripheral blood or bone marrow. A key advantage of our point-of-care system is that it is capable of deliveringhigh cell viability and potency through a short intra-operative procedure, including bone marrow collection, target cell selection, characterization of the final cell concentrate, and re-injection into the patient. Basedon our point-of-care platform, our critical limb ischemia clinical program has received FDA clearance to initiate a phase III clinical trial to demonstrate efficacy in“no-option” or“poor-option” CLI patients. In additional to vascular diseases, we are also conducting early phase studies in orthopedic and wound healing areas.We are actively looking for strategic partners to co-develop our clinical programs.

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.

 

CompetitionResearch and Development

 

The regenerative medicine market is characterized by rapidly evolving technology and intense competition from medical device companies, pharmaceutical companies and stem cell companies operating in the fields of cardiovascular, orthopedic and neural medicine. The primary competitors for our current device offerings include BioSafe and MacoPharma (for automated cell processing systems), and BioE, Terumo Harvest, Zimmer BioMet and Pall Corporation (for manual cell processing systems). Our competitors in the field of cell therapeutics development include MesoBlast, Osiris Therapeutics, Baxter International, Athersys, Caladrius, Capricor, Celyad, Juventas Therapeutics, Vericel, Cytori Therapeutics, Pluristem Therapeutics, Zimmer BioMet, and Bioheart.  

Research and Development

Our research and development activities in fiscal 2017 were geared towards expandingthe automated platform for point-of-care applications andimmune-oncology applications. Each of these development initiatives leveraged our existing AXP™ and PXP™ platforms, with a focus on both performance improvements and ease of use in intraoperative applications. Emphasis was also placed on enhancing the capabilities of our contract manufacturing partners and building on our product quality leadership position.

Collectively, research and development expenses related to our medical device products were $2,497,000$1,659,000 and $3,230,000$2,209,000 for the years ended June 30, 2017December 31, 2022 and June 30, 2016,2021, respectively. Research and development activities include expenses associated with the engineering, regulatory, scientific and clinicalscientific affairs functions.

 

We have not to date incurred any material research and development expenses related to our planned CDMO business.

Manufacturing and Raw Materials

 

We expectsource components for our medical device products from multiple suppliers that manufacture to continue to use contract manufacturers for high volume,our engineering specifications. Our high-volume AXP disposable products are manufactured using contract manufacturers. We utilize our manufacturing facility and in-house manufacturingclean room in Rancho Cordova, California for low volume, high complexity devices. In addition, we are exploring the potential for the development of in-house capabilities relating specifically to pilot scale disposable manufacturing in supportproduction of our clinical programs.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 the applicable rules of other governmental agencies.international regulations.

 

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WeThe Company and ourits contract manufacturers are subject to inspections by the FDA and other regulatory agencies to ensure compliance with applicable regulations, codified in the FDA’s Quality System Regulations (“QSRs”).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”) 13485:20122016 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 cell therapymedical device products as well as the design and implementation of our clinical trials, 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.

The trials we conduct in India are compliant with the applicable rules of the Indian Council for Medical Research, Ministry of Health Order No. V.25011/375/2010-HR and requisite institutional ethics committee (IEC) and institutional committee for stem cell research and therapy (IC-SCRT) approvals. Both the U.S. and E.U. regulatory agencies are experienced in dealing with and accepting Indian clinical trial data. GCP necessitates review and approval by an Institutional Review Board (“IRB”) before initiation of a study, continuing review of an ongoing study by an IRB, and the documented receipt of a freely given informed consent prior to participation in the study from each subject participant.

 

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”)(SOR 98-282), and all other applicable local, state, national and international regulations.

 

●      Medical Devices.The FDA regulates medical devices to ensure their safety and efficacy under the Federal Food Drug and Cosmetic Act (“FD&C”) Act.. 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 PMAPremarket 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,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 nevertheless a requirement.required.

 

Class II Devices

Several of our products, including the BioArchive and the AXP II are categorized as USU.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.

 

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Class III Devices

If a product is considered a Class III device, as is the case with the Point-of-care CLI System, the FDA approval process is more stringent and time-consuming, and includes the following:

 

Extensive pre-clinical laboratory and animal testingtesting;

 

Submission and approval of an IDEInvestigational Device Exemption (“IDE”) application prior to the conduct of a clinical studystudy;

 

Human clinical studies (or trials) to establish the safety and efficacy of the medical device for the intended use,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. We use external third parties, as well as our own facility in Gurgaon, India (GLP Compliant) to conduct pre-clinical studies.

 

Higher risk clinical trials conducted inside the U.S. are subject to FDA IDE regulation (21 C.F.R. Part 812), or an INDInvestigational 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 Sponsorsponsor 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.

If we are successful in securing Medicare reimbursement, we will be subject to federal and state laws, such as the Federal False Claims Act, state false claims acts, the illegal remuneration provisions of the Social Security Act, the federal anti-kickback laws, state anti-kickback laws, and the federal “Stark” laws, that govern financial and other arrangements among healthcare providers, their owners, vendors and referral sources, and that are intended to prevent healthcare fraud and abuse. Among other things, these laws prohibit kickbacks, bribes and rebates, as well as other direct and indirect payments or fee splitting arrangements that are designed to induce the referral of patients to a particular provider for medical products or services payable by any federal healthcare program, and prohibit presenting a false or misleading claim for payment under a federal or state program. They also prohibit some physician self-referrals. These laws are liberally interpreted and aggressively enforced by multiple state and federal agencies and law enforcement (including individual “qui tam” plaintiffs) and such enforcement is increasing. For example, the Affordable Care Act increased funding for federal enforcement actions and many states have established their own Medicare/Medicaid Fraud Units and require providers to conspicuously post the applicable Unit’s hotline number. Possible sanctions for violation of any of these restrictions or prohibitions include loss of eligibility to participate in federal and state reimbursement programs and civil and criminal penalties.

 

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 EU,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.

 

In India, the regulatory body having oversight of medical devices, therapies, and cell banking is the Central Drugs Standard Control Organization (“CDSCO”), and specifically the Drugs Controller General India office. Our marketing and facilities licenses are subject to revocation by the applicable state Drug Controller in Haryana or DCGI.

 

Patents and Proprietary Rights

 

We believe that patent protection is important for our products and current and proposed business. We currently have over thirty28 issued patents globally.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.

 

LicensesIntellectual property for our planned CDMO business, primarily in the form of know-how and proprietary trade information, will generally be licensed to us under the Boyalife License Agreement.

Material Agreements

 

The following are certain material agreements involving our business.business in effect as of December 31, 2022:

 

Fortis Healthcare Limited (“Fortis”)Corning Incorporated

On August 1, 2014 we30, 2019, the Company entered into a Supply Agreement with Corning (the “Supply Agreement”). The Supply Agreement has an agreementinitial term of five years with Fortis which renewsautomatic 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 under the CAR-TXpress™ platform (the “Products”) manufactured by its subsidiary, ThermoGenesis Corp., for the duration of the Term, subject to certain geographical and expands our existing services agreement with themother 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 areas including, but not limitedaddition to cord blood banking, pointany amounts payable throughout the Term for the Products and any ROFR Products.

CBR Systems,, Inc. (“CBR”(CBR)

Manufacturing and Supply Agreement

Effective May 15, 2017 weJuly 13, 2020, the Company entered into a Manufacturing and Supply Amending Agreement #2 (the “Amendment”) with CBR which replacedSystems, Inc. (“CBR”), an amendment to the prior December 31, 2013 SaleManufacturing Supply Amending Agreement #1 effective March 16, 2020 and Purchasethe Manufacturing and Supply Agreement effective May 15, 2017 (the “CBR Agreement”), in which we agreed to supply CBR with the AXP cord blood processing system and disposables. The term of the current agreementCBR Agreement is for 3three 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.

 

In June 2010, we entered into aTechnology License and Escrow Agreement in order to alleviate CBR’s concerns about potential long term supply risk. We are

As part of the sole supplier of critical devices and disposables usedAmendment, the Company updated the compliance conditions in the processing of cord blood samplesTechnology License and Escrow Agreement (the “Escrow Agreement”), which was originally signed by the Company and CBR in CBR’s operations.June 2010. Under the License and Escrow Agreement, we granted CBR a perpetual, non-exclusive, royalty-free license to certain intellectual property necessary for the manufacture of AXPAXP® devices and disposables. The license is for the sole and limited purpose of ensuring continued supply of the AXP devices and related 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 agreement. Effective May 15, 2017 we entered into a Sixth Amended and Restated Technology License andEscrow Agreement. The Escrow Agreement with CBR. This amendment, among other things, changes the circumstancesrequires that constitute a “Default” thereunder and conditions the circumstances under which CBR may, upon a default by Cesca, purchase licensed products from other manufacturers and suppliers. The events or conditions of default include: aour cash balance coupled withand short-term investments, net of non-convertible debt orand borrowed funds that are payable within one year, is greater than $1,000,000 at the end of less than two million dollars at anyeach month end or we fail to provide products pursuant towill be in default of the Manufacturingagreement. Upon a default, CBR may take possession of the escrowed intellectual property and Supply Agreement. We wereinitiate manufacturing of AXP device and disposables for their internal use. The Company was in compliance with the License and Escrow Agreement at June 30, 2017 and through AugustDecember 31, 2017.

Boyalife W.S.N.

On August 21, 2017, ThermoGenesis entered into an International Distributor Agreement with Boyalife W.S.N., a Chinese corporation and affiliate. Under the terms of the agreement, Boyalife W.S.N. was granted the exclusive right, subject to existing distributors and customers (if any), to develop, sell to, and service a customer base for ThermoGenesis’ AXP® (AutoXpress®) System and BioArchive System in the People’s Republic of China (excluding Hong Kong and Taiwan), Singapore, Indonesia, and the Philippines (the “Territories”).  The agreement replaced our prior distribution agreement with Golden Meditech, which expired in August 2017 and had granted similar exclusive distribution rights in the Territories. Boyalife W.S.N. is an affiliate of Dr. Xiaochun Xu, our Chief Executive Officer and Chairman of our Board of Directors, and Boyalife (Hong Kong) Limited, our largest stockholder. Boyalife W.S.N,’s rights under the agreement include the exclusive right to distribute AXP® Disposable Blood Processing Sets and use rights to the AXP®(AutoXpress®) System, BioArchive System and other accessories used for the processing of stem cells from cord blood in the Territories. Boyalife W.S.N. is also appointed as the exclusive service provider to provide repairs and preventative maintenance to ThermoGenesis products in the Territories. The term of the agreement is for three years with ThermoGenesis having the right to renew the agreement for successive two-year periods at its option. However, ThermoGenesis has the right to terminate the agreement early if Boyalife W.S.N. fails to meet specified minimum purchase requirements.

2022.

 

Employees

 

As of June 30, 2017,December 31, 2022, we and our subsidiaries had 7041 employees 36consisting of whom were employed in the37 full-time U.S. employees, 1 part-time U.S. employee and 34 of whom were employed in India. On July 7, 2017 in conjunction with the SynGen transaction, we added approximately 143 full-time employees in the U.S.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 footnote 10Note 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 visiting the SEC’s Public Reference Room at 100 F Street, NE, Room 1580, Washington, DC 20549, by calling the SEC at 1-800-732-0330, or 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 itsour website, www.cescatherapeutics.com.http://www.thermogenesis.com. The information on itsour website is not incorporated into, and is not part of, this annual report.Annual Report on Form 10-K or our other filings with the SEC.

 

ITEM 1A.     RISK FACTORS

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 report.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 reportAnnual 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

The Equity in our ThermoGenesis Subsidiary isA third party owns 20% Owned by a Third Party that Holds Certain Minority Investor Rights in that Subsidiary, and Those Rights Could Limit or Delay Our Ability to Take Certain Major Actions Relating to ThermoGenesis.Immediately prior to our acquisition of the assets and business of SynGen Inc. in July 2017, we contributed the assets and business of our bloodsubsidiary, CARTXpress Bio, Inc. (CARTXpress Bio), and bone-marrow processing device businessholds certain minority investor rights therein. These rights could limit or delay our ability to ourtake certain major actions relating to CARTXpress Bio. In January 2019, ThermoGenesis Corp. subsidiary. Substantially all of our historical revenues are attributable to our devicecontributed its X-Series business and asinto a result of such contribution, the device business is now owned and operated by ThermoGenesis. In connection with the SynGen asset acquisition, we issued sharesnewly formed subsidiary of ThermoGenesis common stockCorp., CARTXpress Bio. Pursuant to SynGen resultingthe terms of a reorganization and share exchange agreement, ThermoGenesis Holdings acquired a 20% equity ownership in SynGen owning 20% of the outstanding stock of ThermoGenesis on a post-transaction basis, and such common stock was thereafter transferred toCorp. from Bay City Capital Fund V, L.P. and an affiliated fundcertain of its affiliates (“Bay City”). UnderIn 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 agreements relating tooutstanding equity of CARTXpress Bio, while Bay City owns the SynGen asset acquisition, althoughremaining 20% of the outstanding equity of CARTXpress Bio. While we continue to indirectly own 80% of the outstanding capital stock of ThermoGenesis,CARTXpress Bio, Bay City was granted certain minority investor rights in ThermoGenesis.CARTXpress Bio. These rights include board representation rights, a right of first refusal over sales of ThermoGenesisCARTXpress Bio. stock by us, co-sale rights with respect to any sale of ThermoGenesisCARTXpress Bio stock by us, certain piggyback and supermajority protective votingForm S-3 registration rights over certain major decisions, suchin the event that CARTXpress Bio becomes a publicly traded company at any time in the future and other rights as a sale of ThermoGenesis, raising capitaldetailed in ThermoGenesis with preferred stock, transfers of ThermoGenesis assets, or redemptions of ThermoGenesis stock.the Investors’ Rights Agreement. In addition, the board of directors of ThermoGenesisCARTXpress Bio is comprised of 5three persons, two of whom are designated by us one of whom is designed by Bay City, one of whom is designated by us but must be independent, and one of whom is designated by Bay City but must be independent.City. The foregoing minority investor rights in ThermoGenesisCARTXpress Bio could limit or delay our ability or flexibility to take certain major actions or make major decisions relating to ThermoGenesisCARTXpress 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 ThermoGenesisCARTXpress Bio could have a negative impact on the market price of our common stock.

 

We May Not be Able to Successfully Recognize the Anticipated Benefits from the SynGen Asset Acquisition or Retain Key Acquisition Employees.On July 7, 2017, our ThermoGenesis subsidiary acquired the business and substantially all of the assets of SynGen, a privately held Sacramento, California-based technology company that develops, markets, and sells advanced cell separation tools and accessories. The success of the SynGen asset acquisition depends on ourOur largest stockholder has significant influence over us which could limit your ability to leverageinfluence the intellectual property, other assets,outcome of key transactions, including a change of control, and acquired personnel of SynGen in order to increase our sales and profitability.In order to successfully achieve this, we will need to integratecould negatively impact the businesses and employees of SynGen and ThermoGenesis and motivate such employees. This will place significant demands on our management, our operational and financial systems, our infrastructure, and our other resources. If we do not effectively manage this process, our ability to grow the consolidated business in the manner anticipated by the acquisition will suffer, and we may lose key employees that we acquired from SynGen.

Lack of Demonstrated Clinical Utility of Cord Blood Derived Stem Cells Beyond Hematopoietic Transplantation May Result in a Decline in Demand for Cord Blood Banking Services, Adversely Affecting Sales of Our Products.Transplants using stem cells derived from cord blood and cord tissue have become a standard procedure for treating blood cell lineage disorders including leukemia, lymphoma and anemia. However, clinical research demonstrating the utility of cord blood stem cells for use in treating other diseases or injuries has been minimal, leaving claims of broad clinical utility of cord blood stem cells by cord blood banks largely unsubstantiated. The low utilization rate of banked cord blood samples coupled with the lack of demonstrated clinical results for multiple treatment indications has led to consumer skepticism regarding the benefits of cord blood banking and in turn, a significant reduction in collection rates in a number of geographies in Europe and the U.S. A continued lack of investment in the research and development of supporting clinical data for additional applications may lead to greater skepticism globally, further adversely affecting demand for cord blood banking services and our revenues.

We have Limited Operating History In the Emerging Regenerative Medicine Industry.We are in the business of research, development and commercialization of autologous cell-based therapeutics for use in the emerging regenerative medicine industry, and therefore, we have a limited operating history in such industry on which to base an evaluationmarket price of our business and prospects.  We will be subject to the risks inherent in the operationcommon stock by discouraging third party investors. As of a company in an emerging industry such as regulatory setbacks and delays, fluctuations in expenses, competition, and governmental regulation.

Our Controlling 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 ofJune 30, 2017,December 31, 2022, approximately 70%26% of our outstanding common stock is owned by Boyalife (Hong Kong) Limited.Group USA (“Boyalife”). In addition, pursuant to the terms of athe Amended Nomination and Voting Agreement we entered into with Boyalife (Hong Kong) Limited andin April 2018, Boyalife Investment Inc. in February 2016, Boyalife (Hong Kong) Limited and Boyalife Investment Inc. havehas the right to designate up to threea number of the seven members toof our board of directors until such timethat is in proportion to the “Boyalife Ownership Percentage”, which is Boyalife and its affiliates’ combined percentage ownership of outstanding common stock, treating as they collectively no longer hold at least 50%outstanding any shares of our common stock.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 (Hong Kong) Limited is 100% owned by Yishu Li, the spouse of Dr. XiachunXiaochun Xu, our CEOChief Executive Officer and chairmanChairman of our boardBoard of directors. Boyalife Investment, Inc. is also controlled by Dr. Xu.Directors. As a result of their ownership and ability to designate up to three members of our boardBoard of directors,Directors, Boyalife (Hong Kong) Limited and Boyalife Investment Inc. (including Dr. Xu and his spouse Ms. Li) areXu) 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. TheyBoyalife 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 and Ms. Li, acting together, aremay be able to control all 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,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.

 

Our PotentialCell TherapyProducts and Technologies Are In Early Stages Of Development.The development of new cell therapy productsBoyalife is also a highly risky undertaking, and there can be no assurance that any future research and development efforts we may undertake will be successful. Our potential products in vascular, orthopedic, hematological/oncological and wound care indications will require extensive additional research and development and regulatory approval before any commercial introduction.  There can be no assurance that any future research, development and clinical trial efforts will result in viable products or meet efficacy standards.

We Intend To Rely On Third Parties For Certain Functions In Conducting Clinical Trials Of Our Product Candidates.We intend to rely on third parties for certain clinical trial activitiesmaterial creditor of our products.  InCompany. 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, 2022 of $7,000,000 in principal and $1,492,000 in accrued interest. The debt facility, as amended, matures on December 31, 2023, with accrued interest due annually on the last day of each calendar year. Because this regard, we have an agreement with Fortis Healthcare Limited, a hospital chain networked throughout India and Asia, for contract clinical trial services programs among other services. The agreement expired in August 2017 and we are currently in discussions to renew the agreement. Termination, or non-renewal, of this agreement could jeopardize or delay developmentdebt facility is secured by all of our products.

We May Be Unableshares 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 Obtain Marketing Approval from the FDA For OurPoint-of-Care System for Critical Limb Ischemia (CLI) Indication.At the end of 2016, the Company received approval from the U.S. Food and Drug Administration (FDA) for the Company’s amended pivotal study protocol for treatment of CLI. The amended CLI clinical trial is designed to demonstrate the safety and efficacy of the Company’s point-of-care system for the treatment of CLI patients with limited or no treatment options. The changes approved by the FDA are intended to increase patient enrollment by expanding the patient pool from Rutherford Category 5 patients only, to also include Rutherford Category 4 patients, or patients with a less severe form of the disease. The study population has been expanded to include patients who are poor candidates for either surgery or endovascular therapies. The sample size of the CLI trial was increased from 224 to 362 patients. With the FDA approval of our amended phase III clinical trial protocol of CLI, the company is actively looking for an external strategic partner to move forward with the CLI clinical trial program. The marketing approval of point-of-care device for the treatment of CLI indication is subject to a successful strategic partnership, successful completion of our phase III study with statistical significant results and acceptance of the results by the FDA for the disease indication. Our inability to successfully complete any of the above mentioned steps can affect our ability to obtain marketing approval in the United States.

Delays In The Commencement Or Completion Of Clinical Testing Of Our Products Could Result In Increased Costs To Us And Delay Our Ability To Generate Revenues.Delays in the commencement or completion of clinical testing could significantly impact our product development costs.  We do not know whether current or planned clinical trials will beginforeclose on time or be completed on schedule, if at all.  The commencement of clinical trials can be delayed for a variety of reasons, including delays in:such security interest.

Obtaining regulatory approval to commence a clinical trial;

Having the necessary funding in place to conduct the clinical trial;

Reaching agreement on acceptable terms with prospective contract research organizations and clinical trial sites for Phase II and III trials;

Obtaining proper devices for any or all of the product candidates;

Obtaining institutional review board approval to conduct a clinical trial at a prospective site; and

Recruiting participants for a clinical trial.

 

In addition, oncewe are also a clinical trial has begun, it may be suspended or terminated by us or the FDA or other regulatory authorities dueparty to a numberLicense and Technology Access Agreement and facility lease with affiliates of factors, including:Dr. Xu and Boyalife upon which our planned CDMO business will be dependent.

 

Failure to conduct the clinical trial in accordance with regulatory requirements;

Inspection of the clinical trial operations or clinical trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;

Failure to achieve certain efficacy and/or safety standards;

Reports of serious adverse events including but not limited to death of trial subjects; or

Lack of adequate funding to continue the clinical trial.

Our clinical therapy candidatesWe may produce negative or inconclusive results,seek to enter into collaborative arrangements to develop and wecommercialize products which may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs that we expect to pursue.

We May Seek To Enter Into Collaborative Arrangements To Develop and Commercialize Products Which May Not Be Successful.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 Portionsignificant portion ofRevenue revenue is Derivedderived from Customers Outsidecustomers outside the United States.We may Lose Revenues, Market Share,lose revenues, market share, and Profitsprofits due to Exchange Rate Fluctuationsexchange rate fluctuations andPolitical political and Economic Changes Related economic changes related to its foreign business. Foreign Business.InFor the year ended June 30, 2017,December 31, 2022, sales to customers outside the U.S. comprised approximately 54%37% of revenues. This compares to 57% in fiscal 2016.43% for the year ended December 31, 2021. 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 Lossloss of a Significant Distributor or End User Customer may Adversely AffectFinancial Condition and Results of Operations.Revenues from a significant distributor and a significant customer comprised 42%may adversely affect our financial condition and results of operations. The percentage of revenues from our largest customer were 33% and 23% for the yearyears ended June 30, 2017. In August 2017, we did not renew the contract with this significant distributorDecember 31, 2022 and signed a contract with a new distributor which is an affiliate of the Company.2021, respectively. The loss of a large end user customer or distributor may significantly decrease revenues.

 

We may be Exposedexposed to Liabilitiesliabilities under the Foreign Corrupt Practices Actforeign corrupt practices act and any Determinationdetermination that we Violatedviolated these Lawslaws could have a Material Adverse Effectmaterial adverse effect on our Business.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 Resultsresults of Legal Proceedingslegal proceedings could have a Material Adverse Effectmaterial adverse effect on Us.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

Our Ability to Conduct aCLIRST III Clinical TrialIs Substantially Dependenton Our Ability toEnter into a Strategic Partnership and There Are No Assurances That Such Funding Source will Materialize.We will need additional funding to commence the CLIRST III clinical trial and we are actively looking for a strategic partner to co-sponsor the trial with us. We cannot assure that such funding will be available on a timely basis, in needed quantities, or on terms favorable to us, if at all.

We Do Not Have Commercial-Scale Manufacturing Capability And Lack Commercial Manufacturing Experience.do not have commercial-scale manufacturing capability and have minimal commercial manufacturing experience. We operate GMP manufacturing facilities for both devices and cellulardevice production; however, they are not of sufficient size for medium to large commercial production of product candidates.production. We willdo not have experience in large scale experience in cell-drug formulation or manufacturing, and will lack the resources and the capability to manufacture anycurrently rely on third-party contract manufacturers for a significant portion of our product candidates on a clinical or commercial scale.  Accordingly, wedevice production. We expect to depend on third-partythese contract manufacturers for the foreseeable future. Any performance failure on the part of our contract manufacturers could delay clinical development, regulatory approval or commercializationproduction of our current or future products, depriving us of potential product revenues and resulting in additional losses.

 

We Have Limited Sales, Marketinghave limited sales, marketing and Distribution Experience in Pharmaceutical Products.distribution capabilities which may limit our ability to significantly increase sales quickly. We have limited experienceinternal capabilities in the sales, marketing, and distribution of pharmaceutical products.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 Inabilityinability to Protectprotect our Patents, Trademarks, Trade Secretspatents, trademarks, trade secrets and other Proprietary Rightsproprietary rights could Adversely Impactadversely impact our Competitive Position.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 Subjectsubject to Claimsclaims that our Productsproducts or Processes Infringeprocesses infringe the Intellectual Property Rightsintellectual property rights of Others,others, which may Causecause us to Pay Unexpected Litigation Costspay unexpected litigation costs or Damages, Modifydamages, modify our Productsproducts or Processesprocesses or Preventprevent us from Sellingselling our Products.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 increaseincreases 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 Commercially, in Co-Branding with Fortis Healthcare, Bank and Store Private Cord Blood Stem Cells in our TotipotentRX GMP Facility. We could be Subject to Unexpected Litigation Costs or Damages for Loss ofOne or MoreFamily Owned Units of Cord Blood or if one of the Cord Blood Units We Store Causes Bodily Injury.We face an inherent business risk of exposure to product liability claims if our products or product candidates are alleged or found to have caused injury, or cannot be used for some reason within our control and are found to result in injury or death. While we believe that our current liability insurance coverage is adequate for our present clinical and commercial activities we may not be able to maintain insurance on acceptable terms or at all. If we are unable to obtain insurance or any claims against us substantially exceed our coverage, then our business could be adversely impacted.

If our Cord Blood Processing and Storage Facility in Gurgaon, India is Damaged or Destroyed, our Business, Programs and Prospects could be Negatively Affected.We process and store our customers’ umbilical cord blood at our facility within Fortis Memorial Research Institute (a hospital) in Gurgaon, India. If this facility or the equipment in the facility were to be significantly damaged or destroyed, we could suffer a loss of some or all of the stored cord blood units. Depending on the extent of loss, such an event could reduce our ability to provide cord blood stem cells when requested, could expose us to significant liability from our cord blood banking customers and could affect our ability to continue to provide umbilical cord blood preservation services.

 

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We may not be able to Protectprotect our Intellectual Propertyintellectual property in Countries Outsidecountries 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 Failurefailure to Achieveachieve and Maintainmaintain the High Designhigh design and Manufacturing Standardsmanufacturing standards that our Products Requireproducts require may Seriously Harmseriously harm our Business.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 very 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 Revenues and Operating Results may be Adversely Affected as a Result of our Required Compliance with the Adopted EU Directive on the Restriction of the Use of Hazardous Substances in Electrical and Electronic Equipment, as well as other Standards Around the World.A number of domestic and foreign jurisdictions seek to restrict the use of various substances, a number of which have been or are currently used in our products or processes. For example, the EU Restriction of Hazardous Substances in Electrical and Electronic Equipment (“RoHS”) Directive now requires that certain substances, which may be found in certain products we have manufactured in the past, be removed from all electronics components. Other countries, such as China, have enacted or may enact laws or regulations similar to RoHS. Eliminating such substances from our manufacturing processes requires the expenditure of additional research and development funds to seek alternative substances for our products, as well as increased testing by third parties to ensure the quality of our products and compliance with the RoHS Directive. While we have implemented a compliance program to ensure our product offerings meet these regulations, there may be instances where alternative substances will not be available or commercially feasible, or may only be available from a single source, or may be significantly more expensive than their restricted counterparts. Therefore, we have focused our compliance efforts on those products and geographical areas in which we have the highest revenue potential. Our failure to comply with past, present and future similar laws could result in reduced sales of our products, substantial product inventory write-offs, reputation damage, penalties and other sanctions, any of which could harm our business and operating results.

Compliance with Government Regulations Regarding the Use of “Conflict Minerals” may Result in Additional Expense and Affect our Operations.The SEC has adopted a final rule to implement Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, which imposes new disclosure requirements regarding the use of “conflict minerals” mined from the Democratic Republic of Congo and adjoining countries. These minerals include tantalum, tin, gold and tungsten. We may incur significant costs associated with complying with the new disclosure requirements, including but not limited to costs related to determining which of our products may be subject to the rules and identifying the source of any “conflict minerals” used in those products. Additionally, implementing the new requirements could adversely affect the sourcing, supply and pricing of materials used in the manufacture of our products. We may also face reputational challenges if we are unable to verify through our compliance procedures the origins for all metals used in our products.

Our Products may be Subject to Product Recallsproduct recalls which may Harmharm our Reputationreputation and Divertdivert our Managerialmanagerial and Financial Resourcesfinancial 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 Dependentdependent on our Supplierssuppliers and Manufacturersmanufacturers to Meet Existing Regulations.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 Supplierssuppliers for Disposable Products and Custom ComponentsMay Impactcustom components may impact the Production Schedule.production schedule. We obtain certain disposable 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 Meetmeet the Financial Covenantfinancial covenant in our Technology License and Escrow Agreement could Decreasedecrease our AXP Revenues.revenues. Under our licenseSixth Amended and escrow agreementRestated Technology License and Escrow Agreement with Cbr Systems, Inc.CBR if we fail to meet the financial covenant ofour cash balance and short-term investments net of non-convertible debt orand borrowed funds that are payable within one year ofare not lessgreater than $2,000,000, they$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 Retainretain or Hire Key Personnelhire key personnel may Adversely Affectadversely affect our Abilityability to Sustainsustain or Growgrow our Business.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.our operations are conducted at a single location. Any Disruption At Our Facilities Could Delay Revenues Or Increase Our Expensesdisruption 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 Maintainmaintain and/or Upgrade Our Information Technology Systems May Haveupgrade our information technology systems may have an Adverse Effectadverse effect on Our Operations.our operations. We rely on various information technology systems to manage our operations, and we evaluate these systems against our current and expected requirements. We are currently evaluating alternativesrequirements. Although we have no current plans to implement modifications or upgrades to our systems, we will eventually be required to make changes to legacy ERP system. Until asystems and acquire new system is purchased and implemented, anysystems 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 Failfail to Maintain Propermaintain proper and Effective Internal Controls,effective internal controls, our Abilityability to Produce Accurateproduce accurate and Timely Financial Statements Couldtimely financial statements could be Impaired,impaired, which Could Harmcould harm our Operating Results,operating results, our Abilityability to Operateoperate our Businessbusiness and Investors’ Viewsinvestors views of Us.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.

 

Our business has been adversely affected by the Coronavirus (COVID-19) pandemic and may continue to be adversely affected by the pandemic. We believe that the COVID-19 pandemic has had a material negative impact on our business and results of operations. The pandemic had a significant impact on the cord blood industry, with fewer cord blood units being stored globally after the start of the pandemic. Internationally, customs delays have led some customers to temporarily switch to manual processing due to the long wait to clear products through customs departments with reduced staffing. As a result, the pandemic resulted in disruption to our supply chain and in customer demand during fiscal 2021. The continued impact of the pandemic on our business and results of operations will depend on future developments relating to the pandemic in general and the cord blood industry in particular, and such future developments are highly uncertain and cannot be predicted. Such developments may include the continued geographic spread of the virus, the severity of the disease, the duration of the outbreak, the actions that may be taken by various governmental authorities in response to the outbreak, and the possible continued impact on the U.S. or global economy. As a result, at the time of this filing, it is impossible to predict the continued impact of the pandemic on our business, liquidity, capital resources and financial results.

Risks Related to Our Industry

Our Businessbusiness is Heavily Regulated, Resultingheavily regulated, resulting in Increased Costsincreased costs of Operationsoperations and Delaysdelays in Product Salesproduct sales.Many.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) productproducts 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 Regulationsgovernmental regulations may Reduce Demandreduce demand for our Productsproducts or Increaseincrease our Expenses.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 Sellsell in International Markets,We will be Subjectinternational markets we are subject to Regulationregulation in Foreign Countries.foreign countries. In cooperation with our distribution partners, we intend to 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.

 

To Operate In Foreign Jurisdictions, We Are SubjectOperating in foreign jurisdictions subjects us to Regulationregulation by Non-U.S. Authorities.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.

 

In orderIf our competitors develop and market products that are more effective than our product candidates or obtain regulatory and market approval for us to manufacture and/or marketsimilar products before we do, our services and products in India, 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, and/or export may differ from the FDA regulatory scheme. Additionally, in order for us to complete clinical trials, clinical trial services and cell banking in India, and other foreign jurisdictions, we need to obtain and maintain approvals and licenses which comply with extensive regulations of the appropriate regulatory body.

International operations alsocommercial opportunity may be limitedreduced or disrupted by political, economic or social instability, price controls, trade restrictions and changes in tariffs as ordered by various governmental agencies. Additionally, fluctuations in currency exchange rates may adversely affect the cost of production for our products by increasing the price of materials and other inputs for our products in the currency of the countries in which the products are sold.

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 Eliminatedeliminated. .The development and commercialization of new pharmaceutical products which target cardiovascular, orthopedic, chronic dermal wounds and other conditions addressed by our current and future 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.

Influence byChanges in healthcare policy could subject us to additional regulatory requirements that may delay the Government and Insurance Companies may Adversely Impact Salescommercialization of our Products.products and increase our costs. Our business may be materially affected by continuing efforts byThe U.S. government third party payers such as Medicare, Medicaid, and private health insurance plans, to reduce the costs of healthcare. For example,other governments have shown significant interest in certain foreign marketspursuing healthcare reform. Any government-adopted reform measures could adversely impact the pricing of our diagnostic products and profit margins of certain healthcare products are subject to government controls. In addition, increasing emphasis on managed caretests in the U.S. will continue to place pressure onor internationally and the pricingamount 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 products. As a result, continuing effortsservices to contain or reduce healthcare costs may result in reduced sales or price reductionsadversely affect our ability to set prices for our products. To date,products and services that we believe are not aware of any directfair, which may impact on our pricing or product sales dueability to such efforts by governments to contain healthcare costs,generate revenues and we do not anticipate any impact in the near future.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 Liabilityliability and Uninsured Risks May Adversely Affectuninsured risks may adversely affect the Continuing Operationscontinuing 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.

We Commercially Process Stem Cells under a Physician’s Order for use in Clinical Applications in India. Our GMP laboratory within Fortis Memorial Research Institute in Gurgaon, India, processes stem cells for certain uses under a physician’s order, and we charge for these services. This service is primarily focused on our growing initiative in bone marrow transplant. We could face product or service liability claim(s) for a bodily injury asserted by a claimant as a result from our GMP services. We mitigate our risks by adhering to international standards, maintain international certification by BSI to GMP, are U.S FDA registered for such activities and are inspected by the Drugs Controller General of India. We believe our global liability insurance is sufficient to cover claims, but in the event it is not it could materially impact our financial health.

 

Risks Related to Operating Results and Financial Markets

We Have Incurred Net Losseshave incurred net losses andWe Anticipate we anticipate that ourLosses losses will Continue.continue. We have not been profitable for a significant period. For the fiscal years ended June 30, 2017December 31, 2022 and 2016,2021, we had a net loss of $29,095,000$11,812,000 and $18,588,000$11,880,000 respectively and an accumulated deficit at June 30, 2017,December 31, 2022, of $185,357,000.$266,193,000. The report of our independent auditors on our December 31, 2022 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 in Furtherance of Our Business Plan.We will need to raise additional capital in the near future to fund our future operations and inthe furtherance of our business plan, including progression of the clinical trials and development of other new products. The proposed financing may include shares of common stock, shares of preferred stock, warrants to purchase shares of common stock or preferred stock, debt securities, units consisting of the forgoing securities, equity investments from strategic development partners or some combination of each. Any additional equity financings may be financially dilutive to, and will be dilutive from an ownership perspectiveplan. Due to our stockholders,recurring losses from operations and such dilution may be significant based upon the size of such financing. Additionally,expectation that we cannot assure that such funding will be available on a timely basis, in needed quantities, or on terms favorablecontinue to us, if at all.

Our Future Financial Results Could be Adversely Impacted by Asset Impairment Charges.We are required to test both goodwilland intangible assets for impairment on an annual basis. We have chosen to perform our annual impairment reviews of goodwill and other intangible assets during the fourth quarter of each fiscal year. We also are required to test for impairment between annual tests if events occur or circumstances change that would more likely than not reduces our fair value below book value. These events or circumstances could include results of our on-going clinical trials, activities and results of our competitor’s clinical trials, a significant change in the regulatory climate, legal factors, operating performance indicators, or other factors. If the fair market value is less than the book value, we could be required to record an impairment charge. The valuation requires judgment in estimating future cash flows, discount rates and estimated product life cycles. In making these judgments, we evaluate the financial health of the business, including such factors as industry performance, changes in technology and operating cash flows.

As of June 30, 2017 we have a goodwill balance of $13,195,000 and a net intangible assets balance of $20,165,000, out of total assets of $46,932,000. As a result, the amount of any annual or interim impairment could be significant and could have a material adverse effect on our reported financial results for the period in which the charge is taken.

We may Incur Significant Non-operating, Non-cash Charges Resulting from Changes in the Fair Value of Warrants.Our Series A warrants are a derivative instrument; as such they have been recorded at their respective relative fair values at the issuance date and will be recorded at their respective fair values at each subsequent balance sheet date. Any change in value between reporting periods will be recorded as a non-operating, non-cash charge at each reporting date. The impact of these non-operating, non-cash charges could have an adverse effect on the Company’s financial results. The fair value of the warrants is tied in large part to our stock price. If the stock price increases between reporting periods, the warrants become more valuable. As such, there is no way to forecast what the non-operating, non-cash charges will beincur 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 what the future impactdebt 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 financial statements.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 Priceprice of our Common Stockcommon stock does not Meetmeet the Requirementsrequirements of the NASDAQNasdaq Capital Market (“NASDAQ”Stock Exchange (Nasdaq), Our Sharesour shares may be Delisted.delisted. Our Abilityability to Publiclypublicly or Privately Sell Equity Securitiesprivately sell equity securities and the Liquidityliquidity of Our Common Stock Couldour common stock could be Adversely Affectedadversely affected if We Are Delisted.we are delisted. The listing standards of NASDAQNasdaq 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. Delisting from NASDAQNasdaq 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.

 

17
25

 

Liquidity of our Common Stock.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 the shares of the 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.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 stockholders ability to obtain a favorable judicial forum for such disputes with us or our directors, officers or employeesITEM 1B.     .

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.

UNRESOLRisks Related to Our Planned Contract Development and Manufacturing Organization (CDMO) Service

Initiating new business activities or strategies or significantly expanding existing business activities or strategies may expose us to new risks and may increase our costs associated with doing business. Initiating new business activities or strategies or significantly expanding existing business activities or strategies may expose us to new or increased financial, regulatory, reputational and other risks. Such innovations are important and necessary ways to grow our business and respond to changing circumstances in our industry; however, 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.

18

Will need to raise additional capital in order to execute our planned CDMO business, the failure of which could adversely impact our business transformation. Without adequate funding, we may not be able to establish CDMO facilities in the United States. We expect to continue to finance start-up costs related to our CDMO division, primarily by issuing equity or convertible debt securities, which could significantly dilute the ownership of existing stockholders. Furthermore, any newly issued securities could have rights, preferences and privileges senior to those of our existing common stock; and any issuances of equity securities may be at or below the prevailing market price of our common stock, which could cause the market price of our common stock to decline. We may have difficulty obtaining additional funds, and we may have to accept terms that would adversely affect our stockholders. In addition, any adverse conditions in the credit and equity markets may adversely affect our ability to raise funds when needed. The failure to achieve adequate funding may delay our planned CDMO business program and service launches.

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.

Our competitive advantages such as our CAR-TXpress technology being able to compete favorably and profitably in the CDMO cell manufacturing business, are critical to the success of our planned CDMO business. While we believe our proprietary CAR-TXpress™ technology platform is superior to other existing cell processing technologies, our data is based on very limited sources. CAR-TXpress™ technology has not been used to manufacture any cell therapy product candidate previously. The ability to accurately calculate total cost for the manufacturing expenses, expected future revenue, and profitability can vary among different product candidates and is difficult to estimate. There is no guarantee that our technology would reduce the manufacturing cost and deliver the competitive advantage that we have anticipated.

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 planned 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 2.PROPERTIES

Properties

 

We lease a facility with approximately 28,000 square feet of space located in Rancho Cordova, California. The facility is used by both our clinical development and device segments and is devoted tocomprised of warehouse space, manufacturing of products,operations, office space, a biologics lab, a clean room, and a research and development lab. The lease expires May 31, 2019.2024.

We lease a facility with approximately 35,000 square feet of space in Rancho Cordova, California for space that will house our planned CDMO cell manufacturing operations. The lease expires September 30, 2027, with the option to renew the lease for two 5-year periods.

 

In GurgaonGurugram India, we lease approximately 5,800 square feet for an office facility for our clinical development segment. The lease expires March 1, 2018. In August 2017, we gave a 30 days notice of our intention to terminate this lease and entered into a lease for a different facility forwith approximately 1,500 square feet.feet, which is used for general office space. The new lease expires September 14, 2023,2023; however, either party can terminate the lease after September 2019 with three monthsmonths’ notice.

Additionally in Gurgaon India, as part of our agreement with Fortis Healthcare, we occupy and manage a 2,800 square foot cord blood banking and cellular therapy processing facility in the Fortis Memorial Research Institute.

 

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

 

ITEM 3.     LEGAL PROCEEDINGS
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 below,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.

 

On May 4, 2017, Mavericks Capital LLCThe material set forth in Note 10, “Commitments and Mavericks Capital Securities LLC filed suit against the CompanyContingencies,” in the Superior Court of the State of California for the County of Santa Clara (Case No. 17 CV 309652). The complaint relates“Item 8. Financial Statements – Notes to a July 20, 2015 agreement between the parties in which plaintiffs agreed to assist the Company in finding strategic partners. The complaint alleges that the Company breached the agreementConsolidated Financial Statements” is incorporated herein by failing to pay plaintiffs a $1 million "Transaction Fee" in connection with what plaintiffs allege was a "Sale of the Company." The complaint seeks compensatory and special damages, interest, costs, and attorneys' fees. On June 22, 2017, the Company answered the complaint, denying all material allegations. The parties are currently engaged in discovery, and no trial date has been set.reference.

 

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Table of Contents

On September 9, 2014, we filed a complaint against SynGen Inc., PHC Medical Inc., Philip Coelho and others (the Defendants) in the case captioned asCesca Therapeutics, Inc. v. SynGen, Inc., et al,United States District Court, Eastern District of California, Case No. 2:14-cv-02085-GEB-KJN alleging misappropriation of trade secrets and breach of contract among other claims. On July 7, 2017, as part of the SynGen acquisition transaction and in consideration of the parties’ agreement pursuant thereto, we settled this dispute and the parties granted each other customary mutual releases.

ITEM 4.MINE SAFETY DISCLOSURES

Mine Safety Disclosures

 

Not applicable.

 

PART II

 

ITEM 5.

MARKET FOR THE REGISTRANT’S COMMONEQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.Market for the Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

 

Our common stock, $0.001 par value, is listed on the NASDAQNasdaq Capital Market under the symbol KOOL. The following table sets forth the range of high and low closing bid prices for our common stock for the past two fiscal years as reported on the NASDAQ Capital Market.THMO.

Fiscal 2017

High

Low

 

Fiscal 2016

High

Low

       

First Quarter (Sep. 30)

$5.42

$2.75

 

First Quarter (Sep. 30)

$16.44

$10.60

Second Quarter (Dec. 31)

$3.90

$2.52

 

Second Quarter (Dec. 31)

$12.40

$3.64

Third Quarter (Mar. 31)

$3.67

$2.75

 

Third Quarter (Mar. 31)

$6.20

$2.12

Fourth Quarter (June 30)

$3.28

$2.94

 

Fourth Quarter (June 30)

$4.01

$1.91

 

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 206140 stockholders of record on June 30, 2017 (notMarch 1, 2023, not including beneficial owners who own their stock in street name holders).through Cede & Co. and others.

 

DuringThe Company did not repurchase any of its shares during the fiscal yearquarter ended June 30, 2017, we engaged in deemed repurchases of 47,024 shares of our common stock as a result of permitting holders of restricted stock unit awards under our equity plans to surrender shares issuable pursuant to such awards in order to satisfy tax withholding obligations.December 31, 2022.

 

ITEM 6.SELECTED FINANCIAL DATA

[Reserved]

 

Not applicable for Smaller Reporting Companies.

ITEM 7.MANAGEMENT’S DISCUSSIONAND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Managements Discussion and Analysis of Financial Condition and Results of Operations

 

Certain statements contained in this section and other parts of this annual reportAnnual 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 lookingforward-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 report.

OverviewAnnual Report.

 

Cesca is aregenerative medicinecompany thatdevelops,General Overview

The Company develops and commercializes and markets a range ofautomatedof automated technologies forcell-basedtherapeutics.Cesca’s device division providesa fullsuitefor cell-banking, cell-processing, and cell-based therapeutics. Since the 1990’s ThermoGenesis Holdings has been a pioneer in, and a leading provider of solutionsautomated 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 biobanking,bio-banking, PXP® platform for point-of-care applications,cell-based therapies and automation forimmuno-oncology. Cesca is also leveraging its proprietary AutoXpress® technologyCAR-TXpress™ platform to develop autologous stem cell-basedtherapies that address significant unmet needs for large scale cell manufacturing services. All product lines are reporting as a single reporting segment in thevascular, cardiology and orthopedicmarkets.the financial statements.

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

Reverse Stock Split

 

On July 7, 2017, our wholly-owned subsidiary, ThermoGenesis Corp. (“ThermoGenesis”), acquiredDecember 22, 2022, the businessCompany effected a one (1) for forty-five (45) reverse stock split of its issued and substantially alloutstanding common stock. The total number of the assets of SynGen, a privately held Sacramento, California-based technology company that develops, markets, and sells advanced cell separation tools and accessories. In the transaction (the “SynGen Transaction”),ThermoGenesis acquired substantially all of SynGen’s operating assets, including its proprietary cell processing platform. In exchange, ThermoGenesis issued to SynGen shares of ThermoGenesis common stock that, after giving effect to theauthorized for issuance constitute 20% of ThermoGenesis’ outstanding common shares, and ThermoGenesis also made a one-time cash payment of $1.0 million to SynGen. Immediately prior to the SynGen Transaction,by the Company contributed the assets, business, and current liabilities of its blood and bone-marrow processing device business to ThermoGenesis and will operate such business (together350,000,000 shares did not change in connection with the acquired business) through the ThermoGenesis subsidiary.reverse stock split.

 

PriorAll historical share amounts disclosed herein have been retroactively restated to reflect the SynGen Transaction, Cesca’s device business was ownedreverse split and operated directly by Cesca, and from and after the SynGen Transaction, Cesca’s device business (together with the business acquired from SynGen) is and will be owned and operated by ThermoGenesis.

In August 2017, our Board of Directors approved changing our fiscal year from June 30 to a calendar year ending December 31. As a result, we will file a transition report on Form 10-K for the six month period ending December 31, 2017. Prior to filing the transition report, we will file a quarterly report on Form 10-Q for the quarter ending September 30, 2017.

Cesca’s Device Division- ThermoGenesis Corp.

ThermoGenesis Corp. (“ThermoGenesis”), a wholly owned subsidiary of the Company that owns and operates the Company’s device division, is a pioneer and market leader in the development and commercialization ofautomated technologies for cell-based therapeutics and bio-processing. The Device segment’s automated solution offerings include:

Clinical BioBanking

AXP® + BioArchive® provide automated isolation, collection and storage of cord blood stem cell concentrates.

Point-of-Care Solutions for Cell-Based Therapeutics

PXP allows for the rapid, automated processing of autologous peripheral or bone marrow derived stem cells at the point-of-care, such as surgical centers or clinics.

Cellular Processing for Immuno-Oncology Applications

CXP + BioArchive® allow for the automated manufacturing, expansion and storage of cellular therapies for immuno-oncology, including various T-cell and nature killer (NK) cell based therapies.

The Device Segment’s product pipeline includes:

AutoXpress® System (AXP®) - a proprietary, automated system for the isolation and collection of hematopoietic stem cells from cord blood and peripheral blood.

PXP forPoint-of-CareApplicationsa proprietary, automated system for the rapid, automated processing of autologous peripheral or bone marrow derived stem cells for cell-based therapiesat point-of-care situations, such as surgical centers or clinics.

CAR-TXpress (CXP)- a proprietary, automated system for the isolation and collection of cells derived from biological sources, for various laboratory based downstream applications.

BioArchive®- an automated, cryogenic system used by cord blood banks for the cryopreservation and storage of cord blood stem cell concentrate for future use.

Cesca’s Clinical Development Division

Using its proprietary AutoXpress® technology platform, Cesca is developing autologous (utilizing the patient’s own cells) stem cell-basedtherapeutics that Cesca believes will address significant unmet medical needs for applications within thevascular, cardiology and orthopedicmarkets.   

Vascular Diseases - Critical Limb Ischemia (“CLI”) –Cesca is currently in late stage development of its proprietary, point-of-care, autologous stem cell-based therapeutic for the treatment of patients with CLI. The Company’s 362 patient, multi-center pivotal Phase III Critical Limb Ischemia Rapid Stem Cell Treatment (“CLIRST”) trial is designed to evaluate the safety and efficacy of autologous stem cell-based therapy to stimulate the regeneration of blood vessels, promote wound healing and prevent amputation. Previous clinical studies using Cesca’s proprietary, point-of-care-technologies have successfully demonstrated the regeneration of blood vessels and improved blood circulation in the limbs, using a patient’s own bone marrow derived stem cells.The Company is actively seeking strategic partners to co-develop CLIRST.

Cardiology - Acute Myocardial Infarction – Cesca is developing a proprietary, point-of-care autologous stem cell-based therapy intended as an adjunct treatment for patients who have suffered an acute ST-elevated myocardial infarction (“STEMI”), the most serious type of heart attack. Such treatments are aimed at minimizing the adverse remodeling of the heart post-STEMI.

Orthopedics – OsteoArthritis (OA) -Cesca is in early stage development of an autologous stem cell based therapy intended to treat patients with cartilage tissue degeneration that may lead to progressive cartilage loss and painful joint diseases. Localized articular cartilage defects can potentially be repaired by transplantation of autologous cell therapy. Therapies in development using Cesca’s proprietary PXP™system are expected to delay further deterioration and repair the damaged joint cartilage. Treatment is typically via a single procedure in the hospital or clinic.

Results of Operations

The following is management’s discussion and analysis of certain significant factors which have affected our financial condition and results of operations during the periods included in the accompanying consolidated financial statements.

Results of Operations for theFiscal Year Ended June 30, 2017versus theFiscal Year Ended June 30, 2016

Net Revenues

Consolidated net revenues for 2017subsequent share exchange. No fractional shares were $14,525,000 compared to $11,929,000 for 2016, an increase of $2,596,000. Device segment revenues increased primarilyissued as a result of increased shipmentsthe reverse stock split, as fractional shares of AXP disposables to a single end-user customer and distributors in China and Europe. Also, contributingcommon stock were rounded up to the increase, we shipped three BioArchive devices duringnearest whole share.

Results of Operations

Year Ended December 31, 2022 Compared to the Year Ended December 31, 2021

Net Revenues

Net revenues for the year ended June 30, 2017 versus one duringDecember 31, 2022, were $10,483,000 compared to $9,294,000 for the year ended June 30, 2016. Clinical development revenues consistDecember 31, 2021, an increase of sales generated by our Totipotent subsidiaries.$1,189,000 or 13%. The decrease isincrease was due to domestic AXP disposable sales which were approximately $1.3 million higher in 2022. At the lossbeginning of 2021 our largest domestic customer made the decision to transition to just in time inventory and depleted their largest manual bag set customer.existing inventory in lieu of additional purchases decreasing our sales at the beginning of last year. In 2022, they purchased products based on demand. We anticipate AXP disposable domestic sales will be more in line with 2022 in future periods.

 

Revenues were comprised of the following for the years ended:following:

 

  

June 30,
2017

  

June 30,
2016

 

Device Segment:

        

AXP

 $8,715,000  $6,924,000 

BioArchive

  3,318,000   2,465,000 

Manual Disposables

  1,034,000   1,203,000 

Bone Marrow

  582,000   341,000 

Other

  384,000   350,000 
   14,033,000   11,283,000 

Clinical Development Segment:

        

Manual disposables

  161,000   305,000 

Bone Marrow

  163,000   117,000 

Other

  168,000   224,000 
   492,000   646,000 
  $14,525,000  $11,929,000 

  

Years Ended December 31,

 
  

2022

  

2021

 
         

AXP

 $6,391,000  $5,138,000 

BioArchive

  2,215,000   2,345,000 

CAR-TXpress

  1,129,000   1,284,000 

Manual Disposables

  655,000   421,000 

Other

  93,000   106,000 
  $10,483,000  $9,294,000 

 

Gross ProfitProfit

ConsolidatedThe Company’s gross profit was $5,839,000$2,710,000 or 40%26% of net revenues for 2017 compared to $2,744,000 or 23% of revenues for 2016. Our device segment gross profit margin increased from $2,672,000 or 24% to $5,813,000 or 41% for fiscal 2016 to fiscal 2017 primarily due to higher average sales prices on our mix of products sold and a reduction in our overhead costs during the year ended June 30, 2017. Additionally, in the prior year, there was an increase to our inventory reserves and a provision for expected losses on non-cancelable purchase commitments. Gross profit for our clinical segment decreased from $72,000 or 11 % to $26,000 or 5% due to product mix and lower sales volumes.

Sales and Marketing Expenses

Consolidated sales and marketing expenses were $1,531,000 for 2017,December 31, 2022, compared to $2,148,000$3,493,000 or 38% for 2016,the year ended December 31, 2021, a decrease of $617,000$783,000 or 29%22%. The decrease is driven primarily by our device segment and is due toOur gross profit percentage was 12% lower personnel costs during the year ended June 30, 2017 due to reorganizing the sales and marketing function in September 2016. Our clinical segment had an increase of $49,000 for 2017, due to higher costs related to our cord blood bank marketing in India.

Research and Development Expenses

Research and development expenses include costs associated with our engineering, regulatory, scientific and clinical functions.

Consolidated research and development expenses for 2017, were $2,497,0002022 as compared to $3,230,000 for 2016, a decrease of $733,000 or 23%.2021. The decrease was primarily due to lower salarieshigher costs from our AXP disposable contract manufacturer, with our costs increasing by approximately 28% in 2022. In part to obtain better pricing, we terminated our agreement with the contract manufacturer in 2022 and benefitsare in the clinical development segmentprocess of approximately $500,000transitioning to a new supplier for our AXP bagsets. The new supplier will provide lower pricing allowing us to decrease our AXP disposable costs by an estimated 10 – 15%. However, we do not expect to see the benefits of the lower pricing until 2024 as the Company will likely be selling the remaining inventory purchased from our original supplier for the majority of 2023. Additionally, gross profit percentage was lower in 2022 due to a decrease in headcount and a reduction in rent expenseexcess capacity charges in the clinical development segmentsecond half of approximately $350,000 associated with the consolidationyear as a result of our US operations into our Rancho Cordova facility. Research and development expenses arereduced manufacturing as the Company focused on its transition to being a CDMO service provider which is expected to increase when the Company initiates additional clinical trials which the Company intends to fund through strategic partnerships.launch in 2023.

 

Selling, General and Administrative Expenses

General and administrative expenses include costs associated with our accounting, finance, human resources, information system and executive functions.

ConsolidatedSelling, general and administrative expenses were $11,051,000$7,244,000 for 2017,the year ended December 31, 2022, as compared to $8,231,000$8,515,000 for 2016, an increasethe year ended December 31, 2021, a decrease of $2,510,000$1,271,000 or 30%15%. The increase isdecrease was driven by stock compensation expense, which decreased by approximately $2 million primarily due to the termination of our former Chief Executive Officer in November 2016 and our former Chief Financial Officer in March 2017 which resulted in $2,200,000 ofaccelerated expense for severance and acceleration ofthe stock options that were voluntarily surrendered by Company executives in 2021. This was offset by approximately $1 million in rent and restricted stock units. Additionally, legaloperating expenses increased $1.1 million largely as a result of attorney fees associated with the SynGen litigation,for our new CDMO facility which was settled on July 7, 2017. Thesewe began leasing in April 2022.

Research and Development Expenses

Research and development expenses were allocated among both of our segments.

Interest Expense

The increase in interest expense from $1,864,000$1,659,000 for the year ended June 30, 2016December 31, 2022, compared to $10,668,000$2,209,000 for the year ended June 30, 2017December 31, 2021, a decrease of $550,000 or 25%. The decrease was primarilydriven by reduced stock compensation expense related to the accelerated expense for the stock options that were voluntarily surrendered in 2021 and the Company not backfilling the Chief Technology Officer position which was vacated at the beginning of 2022.

Interest Expense

Interest expense decreased to $5,616,000 for the year ended December 31, 2022, as compared to $6,103,000 for the year ended December 31, 2021, a difference of $487,000. The decrease is due to lower interest expense related to the conversionportion of the Boyalife Convertible Promissory Note that was converted in June 2022.

Gain on Extinguishment of Debt

The Company recorded a gain of extinguishment of debt of $652,000 for the year ended December 31, 2021, related to the principal and accrued interest for the Paycheck Protection Program loan the Company received in 2020, which was forgiven in the first quarter of fiscal 2017 of all outstanding principal and non-cash interest accrued and otherwise payable under the debentures of $7,379,000 and additional non-cash interest expense of $3,153,000 recorded based on the fair market value of the common stock issued upon conversion.2021.

 

Benefit for Income Taxes

The deferred income tax benefit of $673,000 is due to changes in the state tax rate over the last several years. Approximately $559,000 of the benefit relates to state rate changes prior to fiscal 2017, which was all recognized in the current year, of which $157,000 relates to fiscal 2016 and $402,000 relates to years prior to fiscal 2016.

Non-GAAP Measures

In addition to the results reported in accordance with US GAAP, we also use a non-GAAP measure, adjusted EBITDA, to evaluate operating performance and to facilitate the comparison of our historical results and trends. This financial measure is not a measure of financial performance under US GAAP and should not be considered in isolation or as a substitute for loss as a measure of performance. The Company defines adjusted EBITDA as loss from operations and before other income (expenses) adjusted for non-cash items that impact operations, including depreciation and amortization, stock-based compensation expenses and impairment of intangible assets. The calculation of this non-GAAP measure may not be comparable to similarly titled measures used by other companies. Reconciliations to the most directly comparable US GAAP measure are provided below.

  

For the Year Ended June 30, 2017

 
  

Clinical Development

  

Device

  

Total

 

Loss from operations

 $(8,940,000) $(300,000) $(9,240,000)

Add:

            

Depreciation andamortization

  501,000   329,000   830,000 

Stock-based compensation expense

  970,000   491,000   1,461,000 

Impairment of intangible asset

  310,000   --   310,000 

Adjusted EBITDA

 $(7,159,000) $520,000  $(6,639,000)

  

For the Year Ended June 30, 2016

  

Clinical Development

  

Device

  

Total

Loss from operations

 $(8,240,000) $(2,625,000) $(10,865,000)
Add:            

Depreciation andamortization

  644,000   524,000   1,168,000 

Stock-based compensation expense

  548,000   194,000   742,000 

Adjusted EBITDA

 $(7,048,000) $(1,907,000) $(8,955,000)

Adjusted EBITDA

Our consolidated adjusted EBITDA loss was $6,639,000 for 2017, compared to $8,955,000 for 2016. The reduction in the adjusted EBITDA loss was due primarily to our higher revenues and resulting higher gross profit margin.

Liquidity and Capital Resources

 

At June 30, 2017,December 31, 2022, we had cash and cash equivalents of $3,623,000 and working capital of $6,658,000. This compared to cash and cash equivalents of $5,835,000 and working capital of $7,301,000 at June 30, 2016.$4,177,000. We have primarily financedused cash generated from operations throughand private and public placement of equity securities andas our lineprimary sources of credit facility.liquidity.

 

On March 6, 2017, Cesca entered intoThe Company has a Credit Agreementwith Boyalife Investment Fund II, Inc. (the “Lender”)which grants to the Company the right to borrow up to $5,000,000 in amounts of $500,000 per advance on an unsecured basis at any time prior to March 6, 2022.On September 13, 2017, we entered into an amendment to theRevolving Credit Agreement with the Lender increasing our maximum borrowing availability thereunder from $5.0 million to $10.0 million.Boyalife Group, Inc.  As of September 20, 2017December 31, 2022, the Company had drawn down $5,000,000$7,000,000 of the $10,000,000 that is available under the Revolving Credit Agreement.Agreement, which matures in December 2023.  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 2023.

 

On August 22, 2016, the Company elected to convert all outstanding principal and interest accrued and otherwise payable under the Company’s Secured Convertible Debentures aggregating $23,905,000 dating back to Cesca’s February 2016 financing. Upon conversion, 6,102,941 shares of common stock were issued and the debentures plus all related security interests and liens were terminated.

On August 3, 2016, the Company sold 600,000 shares of common stock at a price of $4.10 per share. 

The net proceeds to the Company from the sale and issuance of the shares, after deducting the offering expenses borne by the Company, were $2,092,000.

In February 2016 in exchange for aggregate proceeds of $15 million, the Company sold and issued to Boyalife Investment Inc. and Boyalife (Hong Kong) Limited (i) 735,294 shares of common stock at a purchase price of $3.40 per share (the “Stock Price”) for gross proceeds of $2.5 million, (ii) Secured Convertible Debentures for $12.5 million (the “Debentures”) convertible into 3,676,471 shares of common stock and (iii) warrants to purchase 3,529,412 additional shares of common stock at an exercise price of $8.00 per share for a period of five years.

On August 31, 2015, the Company sold senior secured convertible debentures in a financing to raise up to $15,000,000 (“Thirty-Year Debentures”), Series A warrants to purchase up to 1,102,942 shares of the Company’s common stock at an exercise price equal to $13.60 per share for a period of five and one-half years (“Series A warrants”) and Series B warrants to purchase up to 606,618 shares of the Company’s common stock at an exercise price equal to $13.60 per share for a period of eighteen months (“Series B warrants”). At the initial closing on August 31, 2015, the Company received gross proceeds of $5,500,000 and 404,412 Series A warrants vested and 222,427 Series B warrants vested. The second closing for up to an additional $9,500,000 was dependent on a number of items including receipt by the Company of approval from the California Institute for Regenerative Medicine (“CIRM”) for a grant in the amount of $10,000,000 to support the Company’s pivotal trial for CLIRST III. The Company applied for the CIRM grant in August 2015. However, the Company withdrew its application for the CIRM grant.

In connectionalso has an unsecured convertible promissory note with the February 2016 financing transaction described above, the Company concurrently entered into a Consent, Repayment and Release Agreement,an accredited investor pursuant to which the Company repaidissued and sold to such investor with an original principal amount of $1,000,000. As of March 2023, the Thirty-Year Debentures and all related interest and liquidated damages. Upon the Company’s payment of $7.5 million, the Thirty-Year Debentures were deemed repaid in full and cancelled, all liquidated damages due and payable were deemed paid and satisfied in full, the registration rights agreement was terminated and the exercise priceoutstanding balance of the Series A warrantsnote was changed from $13.60 to $8.00. 

Our net cash used in operating activities for the year ended June 30, 2017 was $7,215,000 compared to $9,625,000 for the year ended June 30, 2016. The improvement in net cash used in operating activities was primarily$397,000, which is due to the higher revenue volume and a higher gross profit margin on our mix of products sold.

Based upon the additional funds available to draw down under the amended Credit Agreement, the Company’s cash balance, historical trends, expected outflows and projections for revenues, management believes it will have sufficient cash to provide for its projected needs to maintain operations and working capital requirements for at least the next 12 months from the date of filing this annual report.July 31, 2023.

 

The Company has incurred historical losses from operations and expects to continue to incur operating losses in the near future. We anticipate opening our new CDMO facility in 2023 and increasing cash from operations. The Company will need to raise additional fundingcapital to supportgrow its operationsbusiness, fund operating expenses and its clinical development programs, in particular the Phase III Critical Limb Ischemia Rapid Stem Cell Treatment (“CLIRST III”) trial. Accordingly, management has been exploring additional funding sources, with a primary focus on strategic partner relationships.make interest payments. The Company cannot assure that such funding will be available on a timely basis, in needed quantities, or on favorable terms, if at all.

On July 7, 2017, the Company entered into a transaction in which its wholly owned subsidiary, ThermoGenesis, acquired the business and substantially all of the assets of SynGen Inc. (“SynGen”), a privately held Sacramento, California-based technology company that develops, markets, and sells advanced cell separation tools and accessories. In the transaction (the “SynGen Transaction”), ThermoGenesis acquired substantially all of SynGen’s operating assets, including its proprietary cell processing platform. In exchange, ThermoGenesis issued to SynGen shares of ThermoGenesis common stock that, after giving effect to the issuance, constitute 20% of ThermoGenesis’ outstanding common shares, and ThermoGenesis also made a one-time cash payment of $1.0 million to SynGen (together with the issuance of common stock, the “Transaction Consideration”).

OurCompany’s ability to fund our longer-term cashits liquidity needs is subject to various risks, many of which are beyond ourits control. Should we requireThe Company may seek additional funding we may need to raise the required additional funds through bankdebt borrowings, or public or private sales of debt or equity securities. Wesecurities 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 us,the Company, if at all (see Part I Item 1A – Risk Factors).

We generally do not require extensive capital equipmentall. These factors and other indicators raise substantial doubt about the Company’s ability to produce or sell our current cord blood banking products. In fiscal 2017 we spent $375,000 primarily for equipment to be used in our proposed clinical trials and improvements to our clinical laboratory in Rancho Cordovacontinue as a resultgoing concern within one year from the filing date of closing the Emeryville location. In fiscal 2016 we spent $710,000 primarily for tooling at a contract manufacturer and equipment to be used in our Point-of-Care development program.

At June 30, 2017, we had a distributor that accounted for 36% of accounts receivable. At June 30, 2016, we had three distributors/customers that accounted for 57% of accounts receivable.

Revenues from a customer totaled $3,263,000 or 22% and $2,475,000 or 21% for the years ended June 30, 2017 and 2016, respectively. Revenues from one distributor totaled $2,842,000 or 20% and $2,797,000 or 23% of net revenues for the years ended June 30, 2017 and 2016, respectively.this report.

 

We manage the concentration of credit risk with theseour customers and distributors through a variety of methods including, letters of credit with financial institutions, pre-shipment deposits, credit reference checks and credit limits. Although management believes that theseour 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 Policies and Estimates

The preparation of theseour 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, depreciation, fair values of intangibles and goodwill, bad debts, inventories, warranties, contingencies and litigation.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 accounting policies affect the moreand require significant judgments and estimates usedjudgement 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 preparationAccounting 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 its consolidated financial statements.the Performance Obligations (and Recognize Revenue).

 

Goodwill, Intangible AssetsRevenues are recorded net of discounts. Shipping and Impairment Assessments

Goodwill representshandling fees billed to customers are included in net revenues, while the excessrelated costs are included in cost of revenues. Most sales are made with FOB origin shipping terms, with title and control 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 three to ten years. Clinical protocols are not expected to provide economic benefit until they are introducedgoods passing to the marketplacecustomer at the time of shipment. Payments from domestic customers are normally due in two months or licensed to an independent entity. Each period we evaluateless after the estimated remaining useful lives of purchased intangible assets and whether eventstitle transfers, the service contract is executed, or changes in circumstances warrant a revision to the remaining periods of amortization.

The carrying amounts of these assets 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 toASC 350, Intangibles-Goodwill and Other, for goodwill and indefinite-lived intangible assets, we 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, a quantitative assessment must be performed. If the quantitative assessment determines that the fair value is less than the carrying amount, an impairment loss equal to the difference would be recorded.

Revenue Recognition

Revenues from the sale of our products are recognized when persuasive evidence of an arrangement exists, delivery has occurred (or services have been rendered),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 priceCompany’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 fixed or determinable, and collectability is reasonably assured. We generally ship products F.O.B. shipping point. There is no conditional evaluation on any product sold and recognized as revenue. Amounts billed in excess of revenue recognized are recorded as(as deferred revenue on the consolidated balance sheet.sheet).

 

ThereExcept 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, we considerthe Company considers a number of factors in determining whetherwhen revenue is recognized upon transfer of title to the distributor, or when payment is received.recognized. These factors include, but are not limited to, whether the payment terms offered to the distributor are considered to be non-standard, the distributordistributor’s history of adhering to the terms of its contractual arrangements with us, the level of inventories maintained byCompany, whether the distributor, whether we haveCompany 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. We currently recognize revenue primarily on the sell-in method with our distributors.

Revenue arrangements with multiple deliverables are divided into units of accounting if certain criteria are met, including whether the deliverable item(s) has (have) value to the customer on a stand-alone basis. Revenue for each unit of accounting is recognized as the unit of accounting is delivered. Arrangement consideration is allocated to each unit of accounting based upon the relative estimated selling prices of the separate units of accounting contained within an arrangement containing multiple deliverables. Estimated selling prices are determined using Vendor Specific Objective Evidence (VSOE), when available, or an estimate of selling price when VSOE is not available for a given unit of accounting. Significant inputs for the estimates of the selling price of separate units of accounting include market and pricing trends and a customer’s geographic location. We account for training and installation, and service agreements and the collection, processing and testing of the umbilical cord blood and the storage as separate units of accounting.

 

3425

 

Service revenue generated from contracts for providing maintenance of equipment is amortized over the life of the agreement. Revenue generated from storage contracts is deferred and recorded ratably over the life of the agreement, up to 21 years. All other service revenue is recognizedInventories

We value inventory at the timelower 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 service is completed.

Revenues are net of normal discounts. Shipping and handling fees billed to customers are included in net revenues, while the related costs are included in cost of revenues.

Stock-Based Compensation

We use the Black-Scholes-Merton option-pricing formula in determining the fairrealizable value of our options at the grant dateinventory, including an assessment of excess or obsolete inventory. Our determination of excess 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 assumptionsobsolete inventory requires judgement, which is based on historicalseveral 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 judgment regarding market factorsadversely 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 trends. If anylong 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 key assumptions change significantly, stock-based compensation expenseExchange Act, and as such, we are not required to provide the disclosure required under this item.

ITEM 8.

Financial Statements and Supplementary Data

Report of Independent Registered Public Accounting Firm (PCAOB ID #688)

27

Consolidated Balance Sheets at December 31, 2022 and 2021

28

Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2022 and 2021

29

Consolidated Statements of Equity for the years ended December 31, 2022 and 2021

30

Consolidated Statements of Cash Flows for the years ended December 31, 2022  and 2021

31

Notes to Consolidated Financial Statements

32

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Stockholders and Board of Directors of

ThermoGenesis Holdings, Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of ThermoGenesis Holdings, Inc. (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements of operations and comprehensive loss, equity and cash flows for new awards may differ materiallyeach of the two years in the future from that recordedperiod ended December 31, 2022, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the two years in the current period. period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.

Explanatory Paragraph Going Concern

The compensation expenseaccompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As more fully described in Note 2, the Company has incurred recurring operating losses and needs to raise additional capital to grow its business, fund operating expenses and make interest payments. These conditions raise substantial doubt about the Company's ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These financial statements are the responsibility of the Company's management. Our responsibility is then amortizedto express an opinion on the Company's financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the vesting period.purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.

Income Taxes

Our estimatesaudits included performing procedures to assess the risks of income taxesmaterial misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the significant items resulting in the recognition of deferred tax assetsamounts and liabilities reflect our assessment of future tax consequences of transactions that have been reflecteddisclosures in the financial statements or tax returnsstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for each taxing jurisdiction in which we operate.  We base our provision for income taxes on ouropinion.

Critical Audit Matters

The critical audit matter communicated below is a matter arising from the current period resultsaudit 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 we operate.  We recognize 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.  We establish valuation allowances when necessarystatements that was communicated or required to reduce the carrying amount of deferred income tax assetsbe communicated to the amountsaudit committee and that: (1) relates to accounts or disclosures that we believe are more likely thanmaterial to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not to be realized. We evaluate the need to retain all or a portion of the valuation allowance on recorded deferred tax assets.  When a changealter in the tax rate or tax law has an impact on deferred taxes, we apply the change basedany way our opinion on the yearsfinancial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which it relates.

Inventory Excess and Slow-Moving Inventory Reserve

Critical Audit Matter Description

As described in which the temporary differences are expectedNote 3 to reverse.  As we operate 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.  We record 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 our 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 our pre-existing deferred tax assets.

Inventory Valuation

We state inventories at lower of cost or market value determined on a first-in, first-out basis. We provide write-downs of inventory 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, we provideCompany 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 ourits customers and distributors and market conditions. Because some

We identified the inventory reserve as a critical audit matter as auditing management’s estimate of our products are highly dependent on governmentthe excess and third-party funding, current customer useslow-moving inventory reserve was subjective and validation,required significant judgment as the excess and completion of regulatory and field trials, thereslow-moving inventory reserve is a risk that we will forecast incorrectly and purchase or produce excess inventories. As a result, actual demand may differ from forecasts and we may be requiredsensitive to record additional inventory valuation allowances that could adversely impact our gross margins. Conversely, favorable changes in the Company’s operations and assumptions used to estimate the reserve including management’s assumptions with regards to projections of future product demand could resultand market conditions, which includes historical usage, expected future usage, and on-hand quantities of individual materials. This in higher gross margins when those products are sold.turn led to a high degree of auditor judgment, subjectivity and effort in performing procedures and evaluating management’s analysis and significant assumptions related to projections of future demand.

 

WarrantyHow the Critical Audit Matter Was Addressed in the Audit

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

Our audit procedures related to the estimated warranty liability could have a material impact on our financial position, cash flows or results of operations.excess and slow-moving inventory reserve included the following, among others:

We obtained an understanding of the design of controls associated with management’s evaluation of excess and slow-moving inventory reserve.

We tested completeness and accuracy of the underlying data used in developing the estimate for excess and slow-moving inventory reserve.

We audited management’s calculation of the inventory reserve by testing the mathematical accuracy of the Company’s reserve calculation.

We evaluated the appropriateness and consistency of management’s methodology and assumptions used in developing their estimate of the excess and slow-moving inventory reserve including consideration of projections of future customer demand, which involved consideration of historical performance of the products.

We compared actual write-off activity in the current year to the excess and slow-moving reserve estimated by the Company in the prior year to evaluate management’s ability to accurately estimate the reserve.

We looked for indications that the reserve for excess and slow-moving inventory may be understated by evaluating write-off activity of inventory subsequent to December 31, 2022.

We considered the existence of contradictory evidence based on consideration of internal communication to management and the board of directors, Company press releases, and any changes within the business.

 

Recent Accounting Standards

See footnote 2 “Summary of Significant Accounting Policies”./s/ Marcum LLP

 

Off Balance Sheet ArrangementsMarcum LLP

 

We have no off-balance sheet arrangements.

ITEM 7A.     QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are a smaller reporting companyserved as defined by Rule 12b-2 of the SEC Act of 1934 and are not required to provide information under this item.

ITEM 8.        FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Page Number

Report of Independent Registered Public Accounting Firm

37

Consolidated Balance Sheets at June 30, 2017 and 2016

38

Consolidated Statements of Operations and Comprehensive Loss for the years ended June 30, 2017 and 2016

39

Consolidated Statements of Stockholders’ Equity for the years ended June 30, 2017 and 2016

40

Consolidated Statements of Cash Flows for the years ended June 30, 2017 and 2016

41

Notes to Consolidated Financial Statements

42

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMCompany’s auditor since 2015.

 

 

To the Audit Committee of the

Board of Directors and Shareholders

of Cesca Therapeutics, Inc.

We have audited the accompanyingconsolidated balance sheets of Cesca Therapeutics, Inc. (the “Company”) as of June 30, 2017 and 2016, and the related consolidated statements of operations, comprehensive loss, changes in stockholders’ equity and cash flows for the years then ended. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States).  Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement.  The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.  An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation.  We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidatedfinancial position of Cesca Therapeutics, Inc., as of June 30, 2017 and 2016, and the consolidatedresults of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.

/s/Marcumllp

Marcumllp

New York, NY

September 21, 2017March 30, 2023

 

Cesca Therapeutics Inc.ThermoGenesis Holdings, Inc.

ConsolidatedConsolidated Balance Sheets

 

 

December 31,

 
 

June 30, 2017

  

June 30, 2016

  

2022

  

2021

 

ASSETS

         

Current assets:

         

Cash and cash equivalents

 $3,623,000  $5,835,000  $4,177,000  $7,280,000 

Accounts receivable, net of allowance for doubtful accounts of $102,000 ($49,000 at June 30, 2016)

  3,701,000   3,169,000 

Inventories, net of reserves of $1,230,000 ($1,437,000 at June 30, 2016)

  3,617,000   3,593,000 

Accounts receivable, net of allowance for doubtful accounts of $149,000 ($156,000 at December 31, 2021)

 1,865,000  733,000 

Inventories

 3,334,000  5,373,000 

Prepaid expenses and other current assets

  237,000   246,000   1,508,000   1,578,000 

Total current assets

  11,178,000   12,843,000  10,884,000  14,964,000 
         

Equipment, net

  2,330,000   2,962,000 

Inventories, non-current

 1,003,000  1,709,000 

Equipment and leasehold improvements, net

 1,254,000  1,261,000 

Right-of-use operating lease assets, net

 372,000  571,000 

Right-of-use operating lease assets – related party, net

 3,550,000  - 

Goodwill

  13,195,000   13,195,000  781,000  781,000 

Intangible assets, net

  20,165,000   20,821,000  1,286,000  1,318,000 

Other assets

  64,000   78,000   256,000   48,000 

Total assets

 $46,932,000  $49,899,000  $19,386,000  $20,652,000 
         

LIABILITIES AND STOCKHOLDERS’ EQUITY

         
        

Current liabilities:

         

Accounts payable

 $1,601,000  $2,648,000  $820,000  $1,280,000 

Accrued payroll and related expenses

  385,000   449,000  399,000  348,000 

Deferred revenue

  597,000   783,000 

Related party payable

  606,000   -- 

Deferred revenue – short-term

 782,000  719,000 

Convertible promissory note – related party

 5,777,000  - 

Interest payable – related party

 1,492,000  2,231,000 

Convertible promissory note, net

 962,000  813,000 

Other current liabilities

  1,331,000   1,662,000   1,277,000   957,000 

Total current liabilities

  4,520,000   5,542,000  11,509,000  6,348,000 
         

Long term debt-related party

  3,500,000   -- 

Derivative obligations

  730,000   670,000 

Convertible debentures, net

  --   2,489,000 

Noncurrent deferred tax liability

  6,968,000   7,641,000 

Convertible promissory note – related party, net

 -  9,245,000 

Operating lease obligations – long-term

 131,000  398,000 

Operating lease obligations – related party – long-term

 3,495,000  - 

Deferred revenue – long-term

 911,000  1,244,000 

Other noncurrent liabilities

  377,000   1,284,000   17,000   20,000 

Total liabilities

  16,095,000   17,626,000   16,063,000   17,255,000 
         

Commitments and contingencies

           
         

Stockholders’ equity:

         

Preferred stock, $0.001 par value; 2,000,000 shares authorized, none issued and outstanding at June 30, 2017 and 2016

  --   -- 
        

Common stock, $0.001 par value; 350,000,000 shares authorized; 9,915,868 issued and outstanding (3,010,687 at June 30, 2016)

  10,000   3,000 

Paid in capital in excess of par

  216,222,000   188,569,000 

Preferred stock, $0.001 par value; 2,000,000 shares authorized, none outstanding

 -  - 

Common stock, $0.001 par value; 350,000,000 shares authorized; 1,037,138 issued and outstanding (279,629 at December 31, 2021)

 1,000  - 

Additional paid in capital

 270,377,000  268,459,000 

Accumulated deficit

  (185,357,000)  (156,262,000) (266,193,000) (264,662,000)

Accumulated other comprehensive loss

  (38,000)  (37,000)  111,000   31,000 

Total ThermoGenesis Holdings, Inc. stockholders’ equity

 4,296,000  3,828,000 
         

Total stockholders’ equity

  30,837,000   32,273,000 
        

Total liabilities and stockholders’ equity

 $46,932,000  $49,899,000 

Noncontrolling interests

  (973,000)  (431,000)

Total equity

  3,323,000   3,397,000 

Total liabilities and equity

 $19,386,000  $20,652,000 

 

See accompanying notes to consolidated financial statements.

 

3828

 

Cesca TherapeuticsThermoGenesis Holdings, Inc.

Consolidated Statements ofOperations Operations and Comprehensive lossLoss

 

 

Years Ended December 31,

 
 For the years ended June 30  

2022

  

2021

 
 

2017

  

2016

  

Net revenues

 $14,525,000  $11,929,000  $10,483,000  $9,294,000 

Cost of revenues

  8,686,000   9,185,000   7,773,000   5,801,000 

Gross profit

  5,839,000   2,744,000   2,710,000   3,493,000 
         

Expenses:

         

Sales and marketing

  1,531,000   2,148,000 

Selling, general and administrative

 7,244,000  8,515,000 

Research and development

  2,497,000   3,230,000   1,659,000   2,209,000 

General and administrative

  11,051,000   8,231,000 
 

Total operating expenses

  15,079,000   13,609,000   8,903,000   10,724,000 
 

Loss from operations

  (9,240,000)  (10,865,000)  (6,193,000)  (7,231,000)
         

Other income (expense):

        
Other income / (expense): 

Interest expense

  (10,668,000)  (1,864,000) (5,616,000) (6,103,000)

Amortization of debt discount

  (9,851,000)  (6,127,000)

Fair value change of derivative instruments

  (60,000)  3,395,000 

Registration rights liquidated damages

  --   (1,100,000)

Loss on cashless exercise of warrants

  --   (1,039,000)

Loss on extinguishment of debt

  --   (795,000)

Loss on modification of Series A warrants

  --   (149,000)

Other income and (expenses)

  51,000   (44,000)

Total other income (expense)

  (20,528,000)  (7,723,000)

Gain on extinguishment of debt

 -  652,000 

Employee retention tax credit and other income / (expense)

  (3,000)  802,000 
         
Loss before benefit for income taxes  (29,768,000)  (18,588,000)
Benefit for income taxes  673,000   -- 

Total other expense

  (5,619,000)  (4,649,000)
 

Net loss

 $(29,095,000) $(18,588,000) $(11,812,000) $(11,880,000)
 

Loss attributable to non-controlling interests

  (542,000)  (501,000)

Net loss attributable to common stockholders

 $(11,270,000) $(11,379,000)
         
COMPREHENSIVE LOSS         

Net loss

 $(29,095,000) $(18,588,000) $(11,812,000) $(11,880,000)

Other comprehensive loss:

         

Foreign currency translation adjustments

  (1,000)  (32,000)  80,000   15,000 

Comprehensive loss

 $(29,096,000) $(18,620,000) (11,732,000) (11,865,000)

Comprehensive loss attributable to non-controlling interests

  (542,000)  (501,000)

Comprehensive loss attributable to common stockholders

 $(11,190,000) $(11,364,000)
         

Per share data:

         

Basic and diluted net loss per common share

 $(3.27) $(7.57) $(20.45) $(43.41)
         

Weighted average common shares outstanding – Basic and diluted

  8,904,508   2,455,548 

Weighted average common shares outstanding basic and diluted

  550,993   262,135 

 

See accompanying notes to consolidated financial statements.

 

3929

 

Cesca TherapeuticsThermoGenesis Holdings, Inc.

ConsolidatedStatements Statements of Stockholders' Equity

For the years ended December 31, 2022 and 2021

 

  Common Stock  

Paid in capital
in excess of

  Accumulated  Accumulated other comprehensive  Total stockholders’ 
  Shares  Amount  par  deficit  loss  equity 

Balance at June 30, 2015

  2,027,386  $2,000  $172,579,000  $(137,674,000) $(5,000) $34,902,000 
                         

Stock-based compensation expense, net of stock surrenders

  11,577   --   710,000   --   --   710,000 
                         

Discount due to beneficial conversion features

  --   --   7,262,000   --   --   7,262,000 
                         

Discount due to warrants

  --   --   4,434,000   --   --   4,434,000 
                         

Issuance of common shares and warrants in financing

  735,294   1,000   2,463,000   --   --   2,464,000 
                         

Issuance of common shares for exercise of Series B warrants

  231,710   --   1,097,000   --   --   1,097,000 
                         

Common stock issued to directors in lieu of cash compensation

  4,720   --   24,000   --   --   24,000 
                         

Foreign currency translation

  --   --   --   --   (32,000)  (32,000)
                         

Net loss

  --   --   --   (18,588,000)  --   (18,588,000)

Balance at June 30, 2016

  3,010,687   3,000   188,569,000   (156,262,000)  (37,000)  32,273,000 
                         

Stock-based compensation expense, net of stock surrenders

  125,368   --   1,445,000   --   --   1,445,000 
                         

Shares issued upon debt conversion

  6,102,941   6,000   23,897,000   --   --   23,903,000 
                         

Issuance of common shares in financing, net of offering costs

  600,000   1,000   2,091,000   --   --   2,092,000 
                         

Common stock issued to directors in lieu of cash compensation

  5,463   --   16,000   --   --   16,000 
                         

Common stock issued to employees for prior year bonus

  71,409   --   204,000   --   --   204,000 
                         

Foreign currency translation

  --   --   --   --   (1,000)  (1,000)
                         

Net Loss

  --   --   --   (29,095,000)  --   (29,095,000)

Balance at June 30, 2017

  9,915,868  $10,000  $216,222,000  $(185,357,000) $(38,000) $30,837,000 
  

Shares

  

Common

Stock

  

Additional

Paid in Capital

  

Accumulated

Deficit

  

AOCL*

  

Non-

Controlling

Interests

  

Total Equity

 

Balance at January 1, 2022

  279,629  $-  $268,459,000  $(264,662,000) $31,000  $(431,000) $3,397,000 
                             

Stock-based compensation expense

  -   -   267,000   -       -   267,000 

Adoption of ASU 2020-06

  -   -   (10,681,000)  9,739,000   -   -   (942,000)

Issuance of common stock via at- the-market offering, net

  196,843   -   3,037,000   -   -   -   3,037,000 

Related party convertible note price reset

  -   -   4,635,000   -   -   -   4,635,000 

Convertible note price reset

  -   -   112,000   -   -   -   112,000 
                             

Conversion of related party note payable to common stock

  234,495   1,000   2,999,000   -   -   -   3,000,000 
Sale of common stock and warrants, net  261,885   -   1,546,000   -   -   -   1,546,000 

Exercise of pre-funded warrants

  64,286       3,000               3,000 

Foreign currency translation gain

  -   -   -   -   80,000   -   80,000 

Net loss

  -   -   -   (11,270,000)  -   (542,000)  (11,812,000)

Balance at December 31, 2022

  1,037,138  $1,000  $270,377,000  $(266,193,000) $111,000  $(973,000) $3,323,000 

  

Shares

  

Common

Stock

  

Additional

Paid in Capital

  

Accumulated

Deficit

  

AOCL*

  

Non-

Controlling

Interests

  

Total Equity

 

Balance at January 1, 2021

  213,477  $-  $259,067,000  $(253,283,000) $16,000  $70,000  $5,870,000 
                             

Stock-based compensation expense

  -   -   2,560,000   -   -   -   2,560,000 

Issuance of common stock via at- the-market offering, net

  66,152   -   6,832,000   -   -   -   6,832,000 

Foreign currency translation gain

  -   -   -   -   15,000   -   15,000 

Net loss

  -   -   -   (11,379,000)  -   (501,000)  (11,880,000)

Balance at December 31, 2021

  279,629  $-  $268,459,000  $(264,662,000) $31,000  $(431,000) $3,397,000 

*Accumulated other comprehensive loss.

 

See accompanying notes to consolidated financial statements.

 

4030

 

Cesca TherapeuticsThermoGenesis Holdings, Inc.

Consolidated StatementsStatements of Cash Flows

 

  

Years ended June 30,

 
  

2017

  

2016

 

Cash flows from operating activities:

        

Net loss

 $(29,095,000) $(18,588,000)

Adjustments to reconcile net loss to net cash used in operating activities:

        

Depreciation and amortization

  830,000   1,168,000 

Stock-based compensation expense

  1,461,000   742,000 

(Recovery of) reserve for excess and slow-moving inventories

  (203,000)  566,000 

Amortization of debt discount

  9,851,000   6,127,000 

Amortization of debt issue costs

  160,000   800,000 

Change in fair value of derivative

  60,000   (3,395,000)
Deferred income tax benefit  (673,000)  -- 

Non-cash accrued interest

  10,373,000   1,031,000 

Loss on disposal of equipment

  176,000   -- 

Impairment of intangible asset

  310,000   -- 

Loss on cashless exercise of warrants

  --   1,039,000 

Loss on extinguishment of debt

  --   795,000 

Loss on modification of Series A warrants

  --   149,000 

Net changes in operating assets and liabilities:

        

Accounts receivable

  (522,000)  1,956,000 

Inventories

  615,000   375,000 

Prepaid expenses and other assets

  24,000   (86,000)

Accounts payable

  (1,062,000)  (2,420,000)

Related party payable

  606,000   -- 

Accrued payroll and related expenses

  (63,000)  (256,000)

Deferred revenue

  (187,000)  148,000 

Other current liabilities

  26,000   160,000 

Other noncurrent liabilities

  98,000   64,000 

Net cash (used in) operating activities

  (7,215,000)  (9,625,000)

Cash flows from investing activities:

        

Capital expenditures

  (375,000)  (710,000)

Net cash (used in) investing activities

  (375,000)  (710,000)

Cash flows from financing activities:

        

Gross proceeds from convertible debentures

  --   18,000,000 

Proceeds from long term debt-related party

  3,500,000   -- 

Payment of financing cost – convertible debentures

  --   (961,000)

Repayment of convertible debentures

  --   (6,444,000)

Payment to extinguish derivative obligations

  --   (159,000)

Payments on capital lease obligations

  (84,000)  (67,000)

Proceeds from issuance of common stock, net

  2,092,000   2,463,000 

Repurchase of common stock

  (134,000)  (8,000)

Net cash provided by financing activities

  5,374,000   12,824,000 

Effects of foreign currency rate changes on cash and cash equivalents

  4,000   (11,000)

Net (decrease)increase in cash and cash equivalents

  (2,212,000)  2,478,000 

Cash and cash equivalents at beginning of year

  5,835,000   3,357,000 

Cash and cash equivalents at end of year

 $3,623,000  $5,835,000 

Supplemental non-cash financing and investing information:

        

Common stock issued for payment of convertible debenture and interest

 $23,903,000   -- 

Transfer of equipment to inventories

 $625,000   -- 

Derivative obligation related to issuance of warrants

  --  $4,282,000 

Retirement of equipment

  --  $1,109,000 
  

Year Ended December 31,

 
  

2022

  

2021

 
Cash flows from operating activities:        

Net loss

 $(11,812,000) $(11,880,000)

Adjustments to reconcile net loss to net cash used in operating activities:

        

Depreciation and amortization

  926,000   633,000 

Stock-based compensation expense

  267,000   2,560,000 

Amortization of debt discount/premium, net

  3,487,000   3,631,000 

Reserve for excess and slow-moving inventories

  667,000   864,000 

Reserve for bad debt expense

  2,000   (56,000)
Loss on disposal of equipment  11,000   - 

Gain on extinguishment of debt

  -   (652,000)
Net change in operating assets and liabilities:        

Accounts receivable

  (1,134,000)  703,000 

Inventories

  2,073,000   (1,031,000)

Prepaid expenses and other assets

  (139,000)  (700,000)

Accounts payable

  (386,000)  (74,000)

Interest payable - related party

  (738,000)  149,000 

Accrued payroll and related expenses

  51,000   (1,000)

Deferred revenue – short term

  63,000   111,000 

Other current liabilities

  330,000   (323,000)

Long-term deferred revenue and other noncurrent liabilities

  (951,000)  (554,000)
         

Net cash used in operating activities

  (7,283,000)  (6,620,000)
         
Cash flows from investing activities:        

Capital expenditures

  (400,000)  (93,000)
         

Net cash used in investing activities

  (400,000)  (93,000)
         
Cash flows from financing activities:        
Proceeds from sale of common stock and warrants, net  4,583,000   6,832,000 

Proceeds from exercise of warrants and pre-funded warrants

  3,000   - 
         

Net cash provided by financing activities

  4,586,000   6,832,000 
         
Effects of foreign currency rate changes on cash and cash equivalents  (6,000)  - 

Net increase (decrease) in cash, cash equivalents and restricted cash

  (3,103,000)  119,000 
         

Cash, cash equivalents and restricted cash at beginning of period

  7,280,000   7,161,000 

Cash, cash equivalents and restricted cash at end of period

 $4,177,000  $7,280,000 
         
Supplemental disclosures of cash flow information:        

Cash paid for interest

 $180,000  $240,000 

Cash paid for related party interest

 $2,628,000  $2,139,000 

Right-to-use asset acquired under operating lease

 $3,863,000  $- 

Convertible note price reset

 $112,000  $- 

Related party convertible note price reset

 $4,635,000  $- 

Related party promissory note converted to common stock

 $3,000,000  $- 

Transfer of inventories to equipment

 $-  $181,000 

 

See accompanying notes to consolidated financial statements.

 

31
41

 

Cesca TherapeuticsThermoGenesis Holdings, Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTSNotes 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.

 

1.    DescriptionMedical 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 the CAR-TXpress™ platform for large scale cell manufacturing services. All product lines are reporting as a single reporting segment in the financial statements.

Planned CDMO Business

In March 2022, our Board of BusinessDirectors approved the planned expansion of the Company’s business to include contract development and Basismanufacturing services for cell and cell-based gene therapies. The Company plans to develop and build-out the capabilities to become a Contract Development and Manufacturing Organization (“CDMO”) for cell and cell-based gene therapies by partnering with Boyalife Genomics Tianjin Ltd., a China-based CDMO (“Boyalife Genomics”), to in-license certain know-how and other intellectual property from Boyalife Genomics, and by leasing and building out a cell manufacturing facility in Sacramento, California. We intend to leverage our existing technology and combine it with the in-licensed technologies to develop a proprietary manufacturing platform for cell manufacturing activities and other cell manufacturing solutions for clients with therapeutic candidates in various stages of Presentationdevelopment.

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

2.

Going Concern

At December 31, 2022, the Company had cash and cash equivalents of $4,177,000 and negative working capital of $625,000. The Company has incurred historical losses from operations and expects to continue to incur operating losses in the near future. The Company may 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.

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

Organization and Basis of Presentation

Cesca Therapeutics Inc. (the “Company” or “Cesca”) develops and markets integrated cellular therapies and delivery systems that advance

The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the safe and effective practiceUnited States of regenerative medicine. Cesca’s product pipeline includes automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products.America (U.S. GAAP).

Reverse Stock Split

 

On March 4, 2016,December 22, 2022, the Company effected a one (1) for twenty (20)forty-five (45) reverse stock split of its issued and outstanding common stock. There were no changes to its authorizedThe total number of shares of common stock authorized for issuance by the Company of 350,000,000.350,000,000 shares did not change in connection with the reverse stock split.

 

Liquidity

On July 7, 2017,All historical share amounts disclosed herein have been retroactively restated to reflect the Company, thru its wholly-owned subsidiary, ThermoGenesis, acquired the businessreverse split and substantially allsubsequent share exchange. No fractional shares were issued as a result of the assets of SynGen Inc. (“SynGen”). In exchange, ThermoGenesis issued to SynGen shares of ThermoGenesis commonreverse stock that, after giving effect to the issuance, constitute 20% of ThermoGenesis’ outstanding common shares, and ThermoGenesis also made a one-time cash payment of $1.0 million to SynGen. (Refer to Note 14).

On March 6, 2017, the Company entered into a Revolving Credit Agreement (“Credit Agreement”) with Boyalife Investment Fund II, Inc. (the “Lender”) (Refer to Note 5). As of June 30, 2017, the Company had drawn down $3,500,000 of the $5,000,000 available under the Credit Agreement.The Company has drawn down an additional $1,500,000 subsequent to June 30, 2017 and through the date of this report. Boyalife Investment Fund II, Inc. is a wholly owned subsidiary of Boyalife Group Inc., which is owned and controlled by the Company’s Chief Executive Officer and Chairman of the Board. On September 13, 2017, the Company entered into an amendment to the Revolving Credit Agreement with the Lender to increase the Company’s maximum borrowing availability thereunder from $5.0 million to $10.0 million.

On August 22, 2016, the Company elected to convert all outstanding principal and interest accrued and otherwise payable under February 2016 debentures aggregating $23,903,000 dating back to Cesca’s February 2016 financing. Upon conversion, 6,102,941split, as fractional shares of common stock were issued androunded up to the Debentures plus all related security interests and liens were terminated.nearest whole share.

 

On August 3, 2016, the Company sold 600,000 sharesPrinciples of common stock at a price of $4.10 per share. 

The net proceeds to the Company from the sale and issuance of the shares, after deducting the offering expenses borne by the Company, were $2,092,000.Consolidation

 

At June 30, 2017, the Company had cash and cash equivalents of $3,623,000 and working capital of $6,658,000. The Company has incurred recurring operating losses and as of June 30, 2017 had an accumulated deficit of $185,357,000. The Company anticipates requiring additional capital in order to grow the Device business, initiate the Phase III Critical Limb Ischemia trial, to fund other operating expenses and to make interest payments on the line of credit with Boyalife. These conditions raised substantial doubt about the Company’s ability to meet its obligations. To alleviate the substantial doubt, management plans to use existing cash and cash equivalents balances, revenue generating activities and draw down on the available balance from the line of credit. Other sources of liquidity could include additional potential issuances of debt or equity securities in public or private financings and strategic partnerships.

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

1.     Description of Business and Basis of Presentation(Continued)

Liquidity (Continued)

Based upon the additional funds available to draw down under the amended Credit Agreement, the Company’s cash balance, historical trends, expected outflows and projections for revenues, management believes it will have sufficient cash to provide for its projected needs to maintain operations and working capital requirements for at least the next 12 months from the date of filing this annual report.

Principles of Consolidation

The consolidated financial statements include the accounts of Cesca TherapeuticsThermoGenesis Holdings, Inc. and its wholly ownedwholly-owned subsidiaries, ThermoGenesis Corp. (“ThermoGenesis”),and TotipotentRX Cell Therapy, Pvt. Ltd.Ltd and TotipotentSC Scientific Product Pvt. Ltd.ThermoGenesis Corp’s majority-owned subsidiary, CARTXpress Bio. All significant intercompany accounts and transactions have been eliminated upon consolidation.After completion

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 acquisitionafter-tax earnings or losses of SynGen by ThermoGenesis on July 7, 2017, ThermoGenesis was no longer a wholly owned subsidiary ofan affiliated company. The Company's consolidated balance sheets reflect non-controlling interests within the Company.equity section.

 

2.    Summary of Significant Accounting Policies

Use of Estimates

Preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) 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 doubtful accounts, slow-moving inventory reserves,carrying amounts of inventories, depreciation and amortization, warranty costs,obligations, assumptions made in valuing equityfinancial instruments issued for services or acquisitions,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. Events subsequent to the balance sheet date have been evaluated for inclusion in the accompanying consolidated financial statements through the date of issuance.

 

Revenue Recognition

Revenues from the sale of the Company’s products and services are recognized when persuasive evidence of an arrangement exists, delivery has occurred (or services have been rendered), the price is fixed or determinable, and collectability is reasonably assured. The Company generally ships products F.O.B. shipping point. There is no conditional evaluation on any product sold and recognized as revenue. Amounts billed in excess of revenue recognized are recorded as deferred revenue on the balance sheet.

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

2.     Summary of Significant Accounting Policies (Continued)

Revenue Recognition (Continued)

The Company’s sales are generally through distributors. There is no right of return provided for distributors. For sales of products made to distributors, the Company considers a number of factors in determining whether revenue is recognized upon transfer of title to the distributor, or when payment is received. 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, the level of inventories maintained by the distributor, 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 Company currently recognizes revenue primarily on the sell-in method with its distributors.

 

Revenue arrangements with multiple deliverables are divided into units of accounting if certain criteria are met, including whether the deliverable item(s) has (have) value to the customer on a stand-alone basis. Revenue for each unit of accounting is recognized based on the following five-step process as outlined in the unit of accounting is delivered. Arrangement consideration is allocated to each unit of accounting based uponAccounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers”: (i) Identify the relative estimated selling pricesContract 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 separate units of accounting contained within an arrangement containing multiple deliverables. Estimated selling prices are determined using vendor specific objective evidence of value (VSOE), when available, or an estimate of selling price when VSOE is not available for a given unit of accounting. Significant inputs for the estimates of the selling price of separate units of accounting include market and pricing trends and a customer’s geographic location. The Company accounts for training and installation, and service agreements and the collection, processing and testing of the umbilical cord blood and the storage as separate units of accounting.

Service revenue generated from contracts for providing maintenance of equipment is amortized over the life of the agreement. Revenue generated from storage contracts is deferred and recorded ratably over the life of the agreement, up to 21 years. All other service revenue is recognized at the time the service is completed.

Performance Obligations (and Recognize Revenue). Revenues are recorded net of normal 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 money market funds and certificates of deposits with reputable financial institutions that may at times exceed amounts covered by insurance provided by the U.S. Federal Deposit Insurance Corporation.Corporation (“FDIC”). The Company has cash and cash equivalents of $46,000$47,000 and $104,000$87,000 at June 30, 2017December 31, 2022 and 2016, respectively2021 in India. The Company has not experienced any realized losses on the Company’s deposits of cash and cash equivalents.

 

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

2.     Summary of Significant Accounting Policies (Continued)

Foreign Currency Translation

The Company’s reporting currency is the US dollar. The functional currency of the Company’s subsidiariessubsidiary in India is the Indian rupee (INR)(“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. A translation loss of $1,000 and $32,000 was recorded for the years ended June 30, 2017 and 2016, respectively, as a component of other comprehensive income.

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 three to ten years. Clinical protocols are not expected to provide economic benefit until they are introduced to the marketplace or licensed to an independent entity. 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, (clinical protocols), 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 Accounting Standard Codification (“ASC”) 350, 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 a quantitative assessment must be performed. If the quantitative assessment determines that the fair value is less thanby which the carrying amount an impairment loss equal toexceeds the difference would be recorded.reporting unit’s fair value.

 

The Company performed a quantitative assessment as of April 1, 2017 and performed a qualitative assessment through June 30, 2017 and computed a fair value based on a combination of the income approach and market approach, which determined that the fair value exceeded the carrying amount. Accordingly, there was no impairment of goodwill or the indefinite-lived intangible assets.

For the definite-lived intangible assets other than the covenants not to compete, there were no facts or changes in circumstances that indicated the carrying value may not be recoverable. As such, no assessment was required and there was no impairment of these assets. There was a $310,000 impairment of the covenants not to compete intangible assets during the year ended June 30, 2017 as the assumed revenues that were in the fair value estimate have been delayed due to the delay in the clinical trial.

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

2.     Summary of Significant Accounting Policies (Continued)

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.

Unobservable inputs reflecting the reporting entity’s own assumptions.

The carrying values of cash and cash equivalents, accounts receivable and accounts payable and accrued liabilities approximate fair value due to their short duration. The fair value of the Company’s derivative obligation liability is classified as Level 3 within the fair value hierarchy since the valuation model of the derivative obligation is based on unobservable inputs.

 

Accounts Receivable and Allowance for Doubtful Accounts

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 doubtful accounts, represents their estimated net realizable value. The Company estimates the allowance for doubtful accounts based on historical collection trends, age of outstanding receivables and existing economic conditions. If events or changes in circumstances indicate that a specific receivable balance may be impaired, further consideration is given to the collectability of those balances and the allowance is adjusted accordingly. 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.

 

Inventories

Inventories are stated at the lower of cost or marketnet realizable value and include the cost of material, labor and manufacturing overhead. Cost is determined on thea 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, and distributors and market conditions. Because some of the Company’s products are highly dependent on government and third-party funding, current customer use and validation, and completion of regulatory and field trials, there is a risk that

At times, the Company will forecast incorrectlypurchase 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, 2022 and purchase or produce excess inventories.

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

2.     Summary of Significant Accounting Policies (Continued)non-current inventory.

 

Inventories (Continued)

As a result, actual demand may differ from forecasts and the Company may be required to record additional inventory valuation allowances that could adversely impact its gross margins. Conversely, favorable changes in demand could result in higher gross margins when those products are sold.

Equipment and Leasehold Improvements, Net

Equipment consisting of office furniture, computer, machinery and equipment, computers and software, office equipment and leasehold improvements is recorded at cost less accumulated depreciation and amortization.depreciation. Repairs and maintenance costs are expensed as incurred. Depreciation for office furniture, computer, machinery and equipment, iscomputers and software and office furniture are computed under the straight-line method over the estimated useful lives. Leasehold improvements are amortized under the straight linestraight-line method over their estimated useful lives or the remaining lease period, whichever is shorter. When equipment isand 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 Other incomegeneral and (expenses)administrative expenses in the consolidated statement of operations for the period.

Warranty

The Company provides

We provide for the estimated cost of product warranties at the time revenue is recognized. The Company’sWhile we engage in extensive product quality programs and processes, including actively monitoring and evaluating the quality of our component suppliers, our warranty obligation is calculated based on estimatedaffected by product failure rates, material usage and estimated 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 to interest expense over the life of the associated debt instrument, using the straight-line method which approximates the interest rate method.

 

DebtStock-Based CompensationDiscount

The Company amortizes debt discount over the life of the associated debt instrument, using the straight-line method which approximates the interest rate method. Such amortized cost is included with the other income (expense) in the accompanying consolidated statements of operations.

 

Derivative Financial Instruments

In connection withWe use the sale of convertible debt and equity instruments, the Company may also issue freestanding warrants. If freestanding warrants are issued and accounted for as derivative instrument liabilities (rather than as equity), the proceeds are first allocated toBlack-Scholes-Merton option-pricing formula in determining the fair value of those instruments. The remaining proceeds, if any,our options at the grant date and apply judgment in estimating the key assumptions that are then allocatedcritical to the convertible instrument, usually resulting in that instrument being recorded at a discount from its face amount. Derivative financial instruments are initially measured at their fair value using a Binomial Lattice Valuation Modelmodel such as the expected term, volatility and then re-valued at each reporting date, with changesforfeiture 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 fair value reported as charges or credits to income.future from that recorded in the current period. The compensation expense is then amortized over the vesting period.

 

Stock-Based Compensation

The Company has three stock-based compensation plans, which are described more fully in Note 9.11.

 

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.

 

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

2.     Summary of Significant Accounting Policies (Continued)

Stock-Based Compensation (Continued)

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 correspondedcorrespond 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 zero value 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 clinical trials, costs of disposables, facility costs, contracted services and stock-based compensation from the engineering, regulatory scientific and clinicalscientific 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.

AcquiredAcquired In-Process Research and Development

Acquired in-process research and development (“clinical protocols”) 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 clinical protocolsintangible 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 clinical protocols intangible asset is less than itsit’s 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 clinical protocol intangible asset with itsits’ carrying value is performed. If the fair value is less than the carrying amount, an impairment loss is recognized in operating results. The Company conducted the fiscal 2017 annual impairment assessment as of April 1, 2017. As the fair value exceeded book value, the Company concluded there was no impairment of the subject clinical protocol.

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

2.     Summary of Significant Accounting Policies (Continued)

 

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.

Segment Reporting

Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the Chief Operating Decision Maker (“CODM”), or decision making group, whose function is to allocate resources to and assess the performance of the operating segments. The Company has identified its chief executive officer and chief operating officer as the CODM. In determining its reportable segments, the Company considered the markets and the products or services provided to those markets.

The Company has two reportable business segments:

The Clinical Development Division is developing autologous (utilizing the patient’s own cells) stem cell-basedtherapeutics that address significant unmet medical needs for applications within thevascular, cardiology and orthopedicmarkets.   

The Device Division is a pioneer and market leader in the development and commercialization ofautomated technologies for cell-based therapeutics and bio-processing.

Income Taxes

The tax years 1999-20152003-2021 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 no unrecognized 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 Company applies the change based on the years in which the temporarydifferencesdifferences 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.

 

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

2.     Summary of Significant Accounting Policies (Continued)

Income Taxes (Continued)

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

Net Loss per Share

Net loss per share is computed by dividingCertain prior period amounts have been reclassified to conform to the current period presentation. The reclassifications did not have an impact on net loss to common stockholdersas previously reported. As a result of the reverse stock split effected 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 potentialCompany on December 22, 2022, common stock equivalents is anti-dilutive dueand additional paid in capital amounts from prior periods were adjusted as to reflect if the Company’s net loss position for all periods presented. Anti-dilutive securities consisted ofreverse split had occurred in the following at June 30:prior periods.

 

  

2017

  

2016

 

Common stock equivalents of convertible debentures

  --   3,676,471 

Vested Series A warrants

  404,412   404,412 

Unvested Series A warrants

  698,529(1)  698,529(1)

Warrants – other

  3,725,782   3,725,782 

Stock options

  397,388   104,378 

Restricted stock units

  59,694   63,566 

Total

  5,285,805   8,673,138 

(1)

The unvested Series A warrants were subject to vesting based upon the amount of funds actually received by the Company in the second close of the August 2015 financing which never occurred. The warrants will remain outstanding but unvested until they expire in February 2021.

Recently Adopted AccountingStandards

In June 2014, the Financial Accounting Standards Board (“FASB”) issued

On January 1, 2022, we adopted Accounting Standards Update (“ASU”(ASU) No. 2014-12, 2020-06 Compensation - Stock Compensation (Topic 718);Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entitys Own Equity (Subtopic 815-40): Accounting for Share-BasedConvertible Instruments and Contracts in an Entitys Own Equity, Payments Whenusing the Termsmodified 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 Award Provide Thatentity’s own equity. Specifically, the ASU eliminated the need for the Company to assess whether a Performance Target Could Be Achieved aftercontract on the Requisite Service Period”.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 amendments inCompany recognized a cumulative effect of $9,739,000 of initially applying the ASU 2014-12 applyas an adjustment to all reporting entities that grant their employees share-based payments in which the termsJanuary 1, 2022 opening balance of accumulated deficit. Due to the recombination of the award provide that a performance target that affects vesting could be achieved afterequity conversion component of our convertible debt outstanding, the requisite service period. The amendments require that a performance target that affects vesting2022 opening balance of additional paid in capital was reduced by $10,681,000 and that could be achieved after the requisite service period be treated as a performance condition that affects the vestingdebt discounts of the award. The Company adopted ASU 2014-12 effective July 1, 2016. The Company applies the amendments in ASU 2014-12 prospectively to all awards granted or modified after the effective date. Adoption of the new update to ASU 2014-12 did not have any impact on the financial statements of the Company.

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)convertible promissory notes were reduced $942,000.

 

2.     Summary of Significant Accounting Policies (Continued)

Recently Issued AccountingStandards

In July 2017, the FASB issued ASU No. 2017-11, “Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815):  (Part I) Accounting for Certain Financial Instruments with Down Round Features; (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception”.  ASU 2017-11 allows companies to exclude a down round feature when determining whether a financial instrument (or embedded conversion feature) is considered indexed to the entity's own stock.  As a result, financial instruments (or embedded conversion features) with down round features may no longer be required to be accounted for as derivative liabilities.  A company will recognize the value of a down round feature only when it is triggered and the strike price has been adjusted downward.  For equity-classified freestanding financial instruments, an entity will treat the value of the effect of the down round as a dividend and a reduction of income available to common shareholders in computing basic earnings per share.  For convertible instruments with embedded conversion features containing down round provisions, entities will recognize the value of the down round as a beneficial conversion discount to be amortized to earnings.  ASU 2017-11 is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years.  Early adoption is permitted.  The guidance in ASU 2017-11 can be applied using a full or modified retrospective approach.  The Company has not yet determined the effect that ASU 2017-11 will have on its results of operations, statement of financial position or financial statement disclosures.

 

In May 2017,June 2016, the FASB issued ASU No. 2017-09 “Compensation-Stock Compensation (Topic 718) Scope2016-13, Financial Instruments - Credit Losses (Topic 326). The ASU introduced a new accounting model, the Current Expected Credit Losses model (“CECL”), which requiresearlier recognition of Modification Accounting (ASU 2017-09).”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 2017-09 clarifies which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. The standard2016-13 is effective for interim and annual reporting periods beginning after December 15, 2017, with early adoption permitted. The Company is currently evaluating the impact of its adoption of this standard on its financial statements.

In January 2017, the FASB issued ASU 2017-04 which removes Step 2 from the goodwill impairment test. It is effective for annual and2022, including interim periods beginning after December 15, 2019. Early adoption is permitted for an interim or annual goodwill impairment test performed with a measurement date after January 1, 2017. The Company has not yet determined the effect that ASU 2017-04 will have on its results of operations, statement of financial position or financial statement disclosures.  

In March 2016, the FASB issued ASU 2016-09, “Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting”.ASU 2016-09 simplifies several aspects of the accounting for share-based payment award transactions, including: (a) income tax consequences; (b) classification of awards as either equity or liabilities; and (c) classification on the statement of cash flows. ASU 2016-09 is effective for annual periods beginning after December 15, 2016 and interimreporting periods within those annual reporting periods. Early adoption is permitted. The Company has not yet determinedis in the effect that ASU 2016-09 will have on its resultsprocess of operations, statementassessing the impact of financial position or financial statement disclosures.

In March 2016, the FASB issued ASU No. 2016-06, “Derivatives and Hedging (Topic 815): Contingent Put and Call Options in Debt Instruments” (“ASU 2016-06”). This new standard simplifies the embedded derivative analysis for debt instruments containing contingent call or put options by removing the requirement to assess whether a contingent event is related to interest rates or credit risks. ASU 2016-06 is effective for annual periods beginning after December 15, 2017, and interim periods within fiscal years beginning after December 15, 2018. The adoption of this standard is not expected to have an impactthe ASU on the Company’s financial position or results of operations.statements.

 

38
51

 

4.

Equipment and Leasehold Improvements

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)Equipment and leasehold improvements consisted of the following:

  

Year Ended December 31,

  

2022

  

2021

 

Estimated Useful Life (in years)

Machinery and equipment(1)

 $6,610,000  $6,270,000 

2.5

-10

Computer and software

  631,000   631,000 

2

-5

Office equipment

  256,000   256,000 

5

-10

Leasehold improvements

  932,000   932,000 

5 years or remaining lease term

Total equipment

  8,429,000   8,089,000    

Less accumulated depreciation

  (7,175,000)  (6,828,000)   

Total equipment and leasehold improvements, net

 $1,254,000  $1,261,000    


(1)

Includes $391,000 and $140,000 for cost related to construction in progress for the years ended December 31, 2022 and 2021, respectively.

Depreciation expense for the years ended December 31, 2022 and 2021 was $387,000 and $429,000, respectively.

5.Intangible Assets and Goodwill

 

2.     SummaryIn 2022, in accordance with ASC 350, the Company performed a qualitative analysis, which determined that it was not more likely than not that the fair value of Significant Accounting Policies (Continued)

Recently Issued AccountingStandards (Continued)

the reporting units or the fair value of the intangible assets was less than the carrying value of the goodwill and intangible assets recorded on the Company’s books as of December 31, 2022. As a result, no impairment was recorded and a quantitative analysis was not performed. In February 2016,performing the FASB issued ASU 2016-02,“Leases (Topic 842)”. ASU 2016-02 requiresassessment, the recognitionCompany used current market capitalization, discounted future cash flows, internal forecasts and other factors as the best evidence of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous GAAP. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018 and interim periods therein. The Company has not yet determined the effect that ASU 2016-02 will have on its results of operations, statement of financial position or financial statement disclosures.fair value. These assumptions represent Level 3 inputs.

 

In July 2015, the FASB issued ASU No. 2015-11, “Inventory: Simplifying the Measurement of Inventory”, that requires inventory not measured using either the last in, first out (LIFO) or the retail inventory method to be measured at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable cost of completion, disposal and transportation. The new standard will be effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years, and will be applied prospectively. Early adoption is permitted. The Company is evaluating the impact that this standard will have on its consolidated financial statements.

  

Intangible Assets

  

Goodwill

 
         

Balance at January 1, 2021, net

 $1,358,000  $781,000 

Amortization and foreign exchange

  (40,000)  - 
         

Balance at December 31, 2021, net

 $1,318,000  $781,000 

Amortization and foreign exchange

  (32,000)  - 
         

Balance at December 31, 2022, net

 $1,286,000  $781,000 

 

39

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

2.     Summary of Significant Accounting Policies (Continued)

Recently Issued Accounting Standards (Continued)

In May 2014, the FASB issued ASU 2014-09, “Revenue from Contracts with Customers (Topic 606)” (“ASU 2014-09”). ASU 2014-09 supersedes the revenue recognition requirements in ASC Topic 605, “Revenue Recognition” and some cost guidance included in ASC Subtopic 605-35, "Revenue Recognition- Construction-Type and Production-Type Contracts.” The core principle of ASU 2014-09 is that revenue is recognized when the transfer of goods or services to customers occurs in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. ASU 2014-09 requires the disclosure of sufficient information to enable readers of the Company’s financial statements to understand the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts. ASU 2014-09 also requires disclosure of information regarding significant judgments and changes in judgments, and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09 provides two methods of retrospective application. The first method would require the Company to apply ASU 2014-09 to each prior reporting period presented. The second method would require the Company to retrospectively apply ASU 2014-09 with the cumulative effect recognized at the date of initial application. ASU 2014-09 will be effective for the Company beginning in fiscal 2019 as a result of ASU 2015-14, "Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date," which was issued by the FASB in August 2015 and extended the original effective date by one year. The Company is currently evaluating the impact of adopting the available methodologies of ASU 2014-09 and 2015-14 upon its financial statements in future reporting periods. The Company has not yet selected a transition method. The Company is also in the process of evaluating the new standard against its existing accounting policies, including the timing of revenue recognition, and its contracts with customers to determine the effect the guidance will have on its financial statements and what changes to systems and controls may be warranted.

There have been four new ASUs issued amending certain aspects of ASU 2014-09, ASU 2016-08, "Principal versus Agent Considerations (Reporting Revenue Gross Versus Net)" was issued in March 2016 to clarify certain aspects of the principal versus agent guidance in ASU 2014-09. In addition, ASU 2016-10, "Identifying Performance Obligations and Licensing," issued in April 2016, amends other sections of ASU 2014-09 including clarifying guidance related to identifying performance obligations and licensing implementation. ASU 2016-12, "Revenue from Contracts with Customers - Narrow Scope Improvements and Practical Expedients" provides amendments and practical expedients to the guidance in ASU 2014-09 in the areas of assessing collectability, presentation of sales taxes received from customers, noncash consideration, contract modification and clarification of using the full retrospectiveapproach to adopt ASU 2014-09. Finally, ASU 2016-20, “Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers” was issued in December 2016, and provides elections regarding the disclosures required for remaining performance obligations in certain cases and also makes other technical corrections and improvements to the standard. With its evaluation of the impact of ASU 2014-09, the Company will also consider the impact on its financial statements related to the updated guidance provided by these four new ASUs.


Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

3.     Intangible Assets

 

Intangible assets consist of the following based on the Company’s determination of the fair value of identifiable assets acquired:

 

As of June 30, 2017

 
 

As of December 31, 2022

 
 

Weighted

Average

Amortization

Period

(in Years)

  

Gross

Carrying

Amount

  

Accumulated

Amortization

  

Impairment

  

Net

  

Weighted

Average

Amortization

Period

(in Years)

  

Gross

Carrying

Amount

  

Accumulated

Amortization

  

Net

 

Trade names

  7  $30,000  $14,000      $16,000  3  $49,000  $(49,000) $- 

Developed technology

 10  318,000  (175,000) 143,000 

Licenses

  7   482,000   233,000       249,000  7  377,000  (377,000) - 

Device registration

 7  71,000  (71,000) - 

Customer relationships

  3   443,000   443,000       --   3   387,000   (387,000)  - 

Device registration

  7   90,000   60,000       30,000 

Covenants not to compete

  5   955,000   645,000  $310,000   -- 

Amortizable intangible assets

      2,000,000   1,395,000   310,000   295,000     $1,202,000  $(1,059,000) $143,000 

Clinical protocols

      19,870,000   --       19,870,000 

In process technology

      1,143,000   -   1,143,000 

Total

     $21,870,000  $1,395,000  $310,000  $20,165,000     $2,345,000  $(1,059,000) $1,286,000 

 

As of June 30, 2016

 
 

As of December 31, 2021

 
 

Weighted

Average

Amortization

Period

(in Years)

  

Gross

Carrying

Amount

  

Accumulated

Amortization

  

Net

  

Weighted

Average

Amortization

Period

(in Years)

  

Gross

Carrying

Amount

  

Accumulated

Amortization

  

Net

 

Trade names

  7  $29,000  $10,000  $19,000  3  $52,000  $(52,000) $- 

Developed technology

 10  318,000  (143,000) 175,000 

Licenses

  7   462,000   157,000   305,000  7  418,000  (418,000) - 

Device registration

 7  78,000  (78,000) - 

Customer relationships

  3   424,000   335,000   89,000   3   425,000   (425,000)  - 

Device registration

  7   86,000   49,000   37,000 

Covenants not to compete

  5   955,000   454,000   501,000 

Amortizable intangible assets

      1,956,000   1,005,000   951,000     $1,291,000  $(1,116,000) $175,000 

Clinical protocols

      19,870,000   --   19,870,000 

In process technology

      1,143,000   --   1,143,000 

Total

     $21,826,000  $1,005,000  $20,821,000     $2,434,000  $(1,116,000) $1,318,000 

 

The change in the gross carrying amount is due to foreign currency exchange fluctuations. There was a $310,000 impairment of the covenants not to compete intangible assets during the year ended June 30, 2017 as the assumed revenues that were in the fair value estimate have been delayed due to the delay in the clinical trial. Amortization of intangible assets was $359,000 and $438,000 for the years ended June 30, 2017 and 2016. Clinical protocols haveIn process technology has not yet been introduced to the market place and areis therefore not yet subject to amortization. The Company’s estimated future amortization expense for amortizable intangible assets in subsequent years, are as follows:

 

Year Ended June 30,

    

2018

 $81,000 

2019

  81,000 

2020

  81,000 

2021

  52,000 

Total

 $295,000 

Year Ended December 31,

 

2023

 $32,000 

2024

  32,000 

2025

  32,000 

2026

  32,000 

2027

  15,000 

Total

 $143,000 

6.

Related Party Transactions

HealthBanks Biotech (USA) Inc.

On November 26, 2019, the Company entered into an agreement with HealthBanks Biotech (USA) Inc. (“HealthBanks”) to form a new company called ImmuneCyte, Inc. (“ImmuneCyte”) to commercialize the Company’s proprietary cell processing platform, CAR-TXpress™, for use in immune cell banking as well as for cell-based contract development and manufacturing services (CMO/CDMO). Under the terms of the agreement, ImmuneCyte was initially owned 80% by HealthBanks and 20% by the Company. Healthbanks is a subsidiary of the Boyalife Group (USA), Inc. which is owned by Dr. Xiaochun (Chris) Xu, the Company’s Chief Executive Officer and Chairman of our Board of Directors. Due to the significant influence the Company has over ImmuneCyte’s operations, the investment was accounted for by the Company using the equity method.

 

40
54

 

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)Between November 26, 2019 and September 30, 2020, ImmuneCyte closed on a series of investments with a private institution and qualified investors. After the investments, ImmuneCyte was owned 75.16% by HealthBanks, 18.79% by the Company and 6.05% by the private investors.

 

4.     Equipment, NetIn March 2021, ImmuneCyte completed an acquisition to acquire Boyalife’s Cellular Therapy Division, for 12,000,000 shares in ImmuneCyte and Shanghai KDW info Technology Co. Ltd. for 500,000 shares in ImmuneCyte. Following the acquisitions, the Company’s ownership percentage in ImmuneCyte decreased from 18.79% to 8.64%. The Company performed an analysis of the transaction and noted that none of the factors supporting significant influence changed as a result of the acquisition. Therefore, it was concluded that significant influence remains and the Company will continue to account for the transaction using the equity method. The Company recognized a dilution gain of $262,000 representing its share of the net assets acquired by ImmuneCyte. However, at the time of the acquisition, the Company had accumulated losses of $428,000 in its investment in ImmuneCyte. As the accumulated losses were greater than the dilution gain, no entry was recorded by the Company for its investment in ImmuneCyte following the transaction.

 

Equipment consisted of the following at June 30:

  

2017

  

2016

  

Estimated Useful Life (years)

 

Machinery and equipment

 $5,772,000  $6,604,000   2.5-10 

Computer and software

  733,000   397,000   2-5 

Office equipment

  427,000   260,000   5-10 

Leasehold improvements

  227,000   149,000   Shorter of 5 years or remaining lease term 
Total equipment  7,159,000   7,410,000       

Less accumulated depreciation and amortization

  (4,829,000)  (4,448,000)      
Total equipment, net $2,330,000  $2,962,000       

Depreciation and amortization expense for the years ended June 30, 2017 and 2016 was $408,000 and $630,000, respectively.Boyalife Genomics

 

5.Related Party Transactions

Bill Payment Arrangement

TheOn March 24, 2022, the Company entered into a bill payment arrangement wherebyLicense and Technology Access Agreement with Boyalife GroupGenomics Tianjin Ltd. (“Payor”Boyalife Genomics”), a China-based CDMO and an affiliate of ThermoGenesis’ Chairman and Chief Executive Officer, Chris Xu, Ph.D. The agreement provides for a U.S. license to certain existing and future know-how and other intellectual property relating to cell manufacturing and related processes. The Company plans to develop and operate the Company’s largest shareholder,CDMO cell therapy manufacturing business through a newly formed division named TG Biosynthesis.

Under the terms of the agreement, the Company transferred its remaining 8.64% interest in ImmuneCyte to Boyalife Genomics and agreed to pay a running royalty of 7.5% of its annual net sales of products and services that are covered by one or more of Boyalife Genomics’ granted U.S. patents and a royalty of 5.0% of other products and services covered by other licensed intellectual property. In the Company’s legal expenses payableyear ended December 31, 2022, no sales were recorded under the license agreement and no royalty payments were made to the Company’s attorney related to certain litigation involving SynGen Inc. (the “Bill Payment Arrangement”), although the Company remains jointlyBoyalife Genomics.

Convertible Promissory Note and severally liable for the payment of such legal fees. The terms of the Bill Payment Arrangement provided that the Company will reimburse Payor for any and all amounts paid by Payor in connection with the Bill Payment Arrangement under certain specified events. There is no interest payable on outstanding balance of related party payable. As the Company is using a different attorney than specified in the bill payment arrangement for this litigation, the arrangement is no longer active. As of June 30, 2017, invoices totaling $606,000 had been paid by Payor and are included in related party payable as the Company anticipates repaying this within a year.

Revolving Credit Agreement

On

In March 6, 2017, CescaThermoGenesis Holdings entered into thea Credit Agreement with Boyalife Investment Fund II, Inc.Group (USA) (the “Lender”). The Lender is a wholly owned subsidiary of Boyalife Group Inc., which is owned and controlled by the Company’s Chief Executive Officer and Chairman of theour Board of Directors. The Credit Agreement, as amended, grants to the Company the right to borrow up to $5,000,000 in amounts of $500,000 per advance on an unsecured basis$10,000,000 (the “Loan”) at any time prior to March 6, 20222023 (the “Maturity Date”). OnIn June 2022, the dateLender converted a total of $3,000,000 of the Credit Agreement,outstanding balance of the convertible note into 10,552,234 shares of our common stock. As of December 31, 2022, the Company madehad an initial drawoutstanding principal balance on the Loan of $1,500,000 and drew down an additional $2,000,000 during the quarter ended June 30, 2017, and $1,500,000 during the quarter ended September 30, 2017.$7,000,000.

 

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

5.Related Party Transactions (Continued)

Revolving Credit Agreement (Continued)

The Credit Agreement and the Convertible Promissory Note issued thereunder (the(as amended, the “Note”) 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, except that certain borrowed amounts usedinterest. The Company has five business days after the Lender demands payment to pay legal expenses under the bill payment arrangement will not bear interest.interest due before the Loan is considered in default. The NoteLoan can be prepaid in whole or in part by the Company at any time without penalty. If

The following summarizes the Note:

 

Maturity

Date

 

Stated

Interest Rate

  

Conversion

Price

  

Face
Value

  

Debt

Discount

  

Carrying

Value

 

At December 31, 2022

12/31/2023

  22% $6.30  $7,000,000  $(1,223,000) $5,777,000 

At December 31, 2021

3/6/2022

  22% $81.00  $10,000,000  $(755,000) $9,245,000 

The Credit Agreement includes a down-round provision that lowers the conversion price of the Note if the Company issues shares of common stock at a lower price per share. In 2022, the anti-dilution provision was triggered four times, as noted below:

In February 2022, when the conversion price of the Note was at $81.00 per share, the Company sold shares of common stock at $28.80 per share. This resulted in a triggering event lowering the conversion price of the Note to that value. The Company determined that it created an incremental value of $213,000 which was treated as a debt discount and amortized over the remaining term of the Note.

In June 2022, the Company sold shares of common stock at $12.60 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 $2,475,000 which was treated as a debt discount and will be amortized over the remaining term of the Note.

In July 2022, the Company modified a convertible debt agreement, lowering the conversion price of the debt to $9.45 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 $1,075,000 which was treated as a debt discount and will be amortized over the remaining term of the Note.

In October 2022, the Company sold shares of common stock at $6.30 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 $872,000 which was treated as a debt discount and will be amortized over the remaining term of the Note.

Subsequent to December 31, 2022, the Company entered into an Amendment No. 2 (the “Amendment to Note”) to its Second Amended and Restated Convertible Promissory Note with Boyalife Group Inc. (the “Note”), and an Amendment No. 3 (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 March 6, 2023 to December 31, 2023, and provides that interest accrued and unpaid as of March 6, 2023 will be added to the principal balance of the Note.

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:

  

February

2022

  

June

2022

  

July

2022

  

October

2022

 

Conversion price before

 $81.00  $28.80  $12.60  $9.45 

Conversion price after

 $28.80  $12.60  $9.45  $6.30 

Term (years)

  0.02   0.69   0.61   0.35 

Volatility

  39.53%  85.6%  99.5%  165%

Dividend rate

  0%  0%  0%  0%

Risk free rate

  1.97%  3.2%  2.8%  4.02%

The Company amortized a debt discount of $3,413,000 and $3,310,000 for the years ended December 31, 2022 and 2021, respectively. The debt discount for the period ended December 31, 2022 related to down round triggering events that occurred during the year.  The amortization included $742,000, which related to accelerated amortization for the portion of the Note that was converted in June 2022. In addition to the amortization, the Company also recorded interest expense of $1,890,000 and $2,231,000 for the years ended December 31, 2022 and 2021, respectively.  The interest payable balance as of December 31, 2022 and December 31, 2021 was $1,492,000 and $2,231,000, respectively.

7.

Convertible Promissory Note

July 2019 Note

On July 23, 2019, the Company entered into a private placement with the accredited investor, pursuant to which the Company issued and sold to such investor an unsecured convertible promissory note in the original principal amount of $1,000,000 (the “July 2019 Note”). The July 2019 Note is not repaid in full on or before the Maturity Date, the Lender has the right after the Maturity Date to convert any unpaid principal and accrued interestconvertible into shares of the Company’sCompany's common stock at a conversion price equal to the lower of (a) $81.00 per share or (b) 90% of the average daily volume-weighted average tradingclosing sale price of the Company’s common stock duringon the 10 trading days immediately priordate of conversion (subject to a floor conversion price of $22.50). The July 2019 Note bears interest at the rate of twenty-four percent (24%) per annum and is payable quarterly in arrears. Unless sooner converted in the manner described below, all principal under the July 2019 Note, together with all accrued and unpaid interest thereupon, will be due and payable three years from the date of the issuance on July 31, 2022.

On July 25, 2022, the Company entered into an amendment to the Maturity Date,July 2019 Note, which extended the maturity date of the July 2019 Note to January 31, 2023 and modified when interest is due from quarterly to January 31, 2023. The amendment also (i) deleted the market price-based conversion right, which previously allowed for the July 2019 Note to be converted at a conversion price of 90% of the Company’s stock price on the day of conversion (subject to a $22.50 floor); and (ii) changed to a fixed conversion price to $9.45 per share, provided that in the numberevent that the Company issues shares, options, warrants, or convertible securities, at an effective price per common share lower than $9.45, then the conversion price will be adjusted to such lower issuance price.

The Company performed a debt extinguishment vs. modification analysis on the amendment to the July 2019 Note and determined that the extension would be considered an extinguishment, due to an increase of shares issuable upon such conversion may not exceed 19.99%more than 10% to the value of the numberembedded conversion option. No gain or loss was recorded in the consolidated statement of outstandingoperations for the year ended December 31, 2022 as it was determined that the fair value of the amendment of the July 2019 Note and accrued interest was the same before and after the extension.

In October 2022, the Company sold shares of common stock at $6.30 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 $112,000 which was treated as a debt discount and will be amortized over the remaining term of the Note.

Subsequent to December 31, 2022, the Company onentered into an Amendment No. 3 to the July 2019 Note with Orbrex (USA) Co. Limited (the "July 2019 Note Amendment”). The July 2019 Note Amendment amends the July 2019 Note, dated July 23, 2019, as amended by Amendment No. 1 dated effective July 23, 2019, and Amendment No. 2 dated July 25, 2022, between the Company and Orbrex (USA) Co. Limited. The July 2019 Note Amendment extends the maturity date of the Credit Agreement (unlessJuly 2019 Note from January 31, 2023 to July 31, 2023. The Note Amendment also changed the fixed conversion price to $2.87 per share, provided that in the event that the Company obtains stockholder approval forissues shares, options, warrants, or convertible securities, subject to certain exceptions, at an effective price per common share lower than $2.87, then the conversion price will be adjusted to such lower issuance in the manner required by the Marketplace Rules of the Nasdaq Stock Market, Inc.). price.

 

The Maturity Date offollowing summarizes the Note is subject to acceleration at the option of the Lender upon customary events of default, which include a breach of the Loan documents, termination of operations, or bankruptcy. The Lender’s obligation to make advances under the Loan is subject to the Company’s representations and warranties in the Credit Agreement continuing to be true at all times and there being no continuing event of default under the Note. The Credit Agreement provides that if the Lender at any time in the future purchases the Company’s blood and bone marrow processing device business, the Lender would refund to the Company legal fees expended by the Company in connection with certain litigation expenses funded by the Company with proceeds of the Loan. No default has occurred through the date of filing.July 2019 Note:

 

Maturity

Date

 

Stated

Interest Rate

  

Conversion

Price

  Face
Value
  Debt
Discount
   

Carrying

Value 

 

At December 31, 2022

7/31/2023  24% $6.30  $1,000,000  $(38,000) $962,000 

At December 31, 2021

7/31/2022  24% $40.95  $1,000,000  $(187,000) $813,000 

 

The Company recorded interest expenseamortized a debt discount on the July 2019 Note of $122,000$74,000 and $321,000 for the yearyears ended June 30, 2017.December 31, 2022 and 2021, respectively. The debt discount for the period ended December 31, 2022 related to a down round triggering event that occurred during the year.  Interest expense related to the July 2019 Note was $240,000 for the years ended December 31, 2022 and 2021.  The interest payable balance as of December 31, 2022 and 2021 was $120,000 and $60,000, respectively. 

8.

Related Party Lease

Z3 Investment

 

On September 13, 2017,March 24, 2022, the Company entered into Amendment No. 1 to the Credita five year Lease Agreement (the “Amended Credit Agreement”). The Amended Credit Agreement amends the Credit Agreement originally entered into by the Company and Lender on March 6, 2017, by increasingwith Z3 Investment LLC, an affiliate of the Company’s maximum borrowing availability thereunder from $5.0 million to $10.0 million. In connection with such amendment, the CompanyChairman and Lender entered into an amendedCEO, and restated convertible promissory note to reflect the new aggregate maximum principal amountCOO, beginning April 1, 2022, for approximately 35,000 square feet of $10.0 million.

Distributor Agreementlaboratory and Subsequent Event

On August 21, 2017, ThermoGenesis entered into an International Distributor Agreement with Boyalife W.S.N.office space in Rancho Cordova, California. Under the terms of the agreement, Boyalife W.S.N. was grantedmonthly rent is $46,000 per month for the exclusive right, subjectfirst six months, then increasing to existing distributors$104,000 per month (with a 4% annual increase) thereafter. Additionally, the Company will pay all operating expenses as they become due estimated to be approximately $5,000 per month and customers (if any), to develop, sell to, and service a customer base for ThermoGenesis’ AXP® (AutoXpress®) System and BioArchive Systemwill be expensed in the People’s Republic of China (excluding Hong Kong and Taiwan), Singapore, Indonesia, andperiod incurred. The Company has the Philippines (the “Territories”). Boyalife W.S.N. is an affiliate of our Chief Executive Officer and Chairman of our Board of Directors, and Boyalife (Hong Kong) Limited, our largest stockholder. Boyalife W.S.N,’s rights under the agreement include the exclusive right to distribute AXP® Disposable Blood Processing Sets and use rights to the AXP®(AutoXpress®) System, BioArchive System and other accessories used for the processing of stem cells from cord blood in the Territories. Boyalife W.S.N. is also appointed as the exclusive service provider to provide repairs and preventative maintenance to ThermoGenesis products in the Territories.

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

5.Related Party Transactions (Continued)

Distributor Agreement and Subsequent Event(Continued)

The term of the agreement is for three years with ThermoGenesis having the rightoption to renew the agreementlease for successive two-year periods at its option. However, ThermoGenesis has the right to terminate the agreement early if Boyalife W.S.N. fails to meet specified minimum purchase requirements.

Revenues

During the year ended June 30, 2017, the Company recorded $308,000 of revenues from Boyalife and had an accounts receivable balance of $308,000 at June 30, 2017. As of September 5, 2017two 5-year periods. Additionally, the Company has collected all of this accounts receivable.

6.     Convertible Debentures

February 2016Financing Transaction

In February 2016 in exchange for aggregate proceeds of $15,000,000 the Company sold and issuedability to Boyalife Investment Inc. and Boyalife (Hong Kong) Limited (i) 735,294 shares of common stock at a purchase price of $3.40 per share (the “Stock Price”) for gross proceeds of $2,500,000 (ii) Secured Convertible Debentures for $12,500,000 (the “Debentures”) which are convertible into 3,676,471 shares of common stock, and (iii) warrants to purchase 3,529,412 additional shares of common stock at an exercise price of $8.00 per share for a period of five years. The amount of warrants was based on 80% coverageopt out of the shares issued orlease after one year if the CDMO facility is unable to be issued for the equity transaction in (i) and the debt transaction in (ii) above. The warrants were exercisable on August 13, 2016 and are outstanding at June 30, 2017.

On August 22, 2016, the Company notified Boyalife Investment Inc., that the Company elected to convert all outstanding principal and interest accrued and otherwise payable under the Debentures, which included the conversion of $12,500,000 of principal and $8,250,000 of interest up to and including the maturity date of the Debentures. Upon conversion, 6,102,941 shares of common stock were issued and the Debentures and all related security interest and liens were terminated. The 2,426,470 common shares that were issued for payment of the interest, had a fair market value of $11,403,000 on August 22, 2016. Accordingly, an additional $3,153,000 of interest expense was recorded on the date of conversion.

At the time of the conversion, the remaining debt discount of $9,538,000 and debt issue costs of $155,000 were fully amortized.

Thirty-Year Debenture Restructuring Transaction 

On August 31, 2015, the Company sold senior secured convertible debentures in a financing to raise up to $15,000,000 (“Thirty-Year Debentures”), Series A warrants to purchase up to 1,102,942 shares of the Company’s common stock at an exercise price equal to $13.60 per share for a period of five and one-half years (“Series A warrants”) and Series B warrants to purchase up to 606,618 shares of the Company’s common stock at an exercise price equal to $13.60 per share for a period of eighteen months (“Series B warrants”). At the initial closing on August 31, 2015, the Company received gross proceeds of $5,500,000 and 404,412 Series A warrants vested and 222,427 Series B warrants vested. The second closing for up to an additional $9,500,000 was dependent on a number of items including receipt by the Company of approval from the California Institute for Regenerative Medicine (“CIRM”) for a grant in the amount of $10,000,000 to support the Company’s pivotal trial for CLIRST III. The Company applied for the CIRM grant in August 2015. The Company withdrew its application for the CIRM grant.

For financial reporting purposes, the net proceeds of $4,720,000 was allocated first to the residual fair value of the Series A warrants, amounting to $3,385,000 then to the residual fair value of the obligation to issue the Series B warrants of $897,000 the remaining value to the intrinsic value of the beneficial conversion feature on the Thirty-Year Debentures of $438,000 resulting in an initial carrying value of the Thirty-Year Debentures of $0. The initial debt discount on the Thirty-Year Debentures totaled $4,720,000 and was amortized over the 30 year life of the convertible debentures.  

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

6.     Convertible Debentures (Continued)

Thirty-Year Debenture Restructuring Transaction(Continued)constructed as planned.

 

The Company entered into a registration rights agreement pursuant to which the Company agreed to register allperformed an analysis of the shares of common stock then issuedlease and issuable upon conversion in fulldetermined it to be an operating lease. A right-of-use asset and lease obligation were recorded at inception of the Thirty-Year Debentureslease.

Operating Lease

Operating lease assets and all warrant shares issuable upon exerciseliabilities are recognized at the lease commencement date. Operating lease liabilities represent the present value of the Series A warrantslease payments not yet paid. Operating lease assets represent our right to use an underlying asset and Series B warrants. The holders were entitled to receive liquidated damagesare based upon the occurrenceoperating lease liabilities adjusted for prepayments or accrued lease payments, initial direct costs, lease incentives, and impairment of a numberoperating lease assets. To determine the present value of events relating to filing, getting an effective and maintaining an effective registration statement, including the failure of the Company to have such registration statement declared effective by October 26, 2015. As the Company didlease payments not file an effective registration statement until November 24, 2015 and the Company was precluded by the SEC from registering all of the registrable securities on a single registration statement, management considered it probable that five months of liquidated damages would be due and accrued $1,100,000 during the year ended June 30, 2016. Management made one liquidated damages payment of $220,000 during the three months ended December 31, 2015.

In connection with the February 2016 financing transaction described above, the Company concurrently entered into a Consent, Repayment and Release Agreement, pursuant to which the Company repaid the Thirty-Year Debentures and all related interest and liquidated damages. Uponyet paid, we use the Company’s paymentcost of $7.5 million, the Thirty-Year Debentures were deemed repaid in full and cancelled, all liquidated damages due and payable were deemed paid and satisfied in full, the registration rights agreement was terminated and the exercise price of the Series A warrants was changed from $13.60 to $8.00. The Company recomputed the fair value of the Series A warrants before and after the modification using the Binomial option pricing model with the following assumptions: expected volatility of 91%, discount rate of 1.2%, contractual term of 5 years and dividend rate of 0%. The loss on modification of $149,000 was recorded in the accompanying consolidated statements of operations and comprehensive loss for the year ended June 30, 2016.

Pursuant to the terms of the Consent Repayment and Release Agreement, the holders of the Series B warrants made a single, one-time cashless exercise of Series B warrants for 125,000 shares of common stock. The Company recomputed the fair value of the Series B warrants using the Binomial option pricing model. All remaining Series B warrants valued at $159,000 were cancelled.

This restructuring transaction occurred on February 16, 2016 and the Company recorded a loss on extinguishment of debt of $795,000 during the year ended June 30, 2016. The loss on extinguishment was calculated as follows:

Payment

 $7,500,000 

Repayment of Thirty-Year debentures

  (5,500,000)

Payment of accrued liquidated damages and interest

  (897,000)

Loss on modification of Series A warrants

  (149,000)

Cancellation of Series B derivative obligation

  (159,000)

Loss on extinguishment of debt

 $795,000 

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

6.     Convertible Debentures (Continued)

Thirty-Year Debenture Restructuring Transaction(Continued)

At the time of the repayment, the remaining debt discount of $4,648,000 and debt issue costs of $765,000 were fully amortized. For the year ended June 30, 2016, the Company amortized $4,720,000 of debt discount and $777,000 of debt issue costs.

7.     Derivative Obligations

Series A Warrants

Series A warrants to purchase 404,412 common shares were issued and vested during the year ended June 30, 2016. At the time of issuance, the Company determined that because such warrants can be settled for cash at the holders’ option in a future fundamental transaction they constituted a derivative liability. The Company has estimated the fair value of the derivative liability, using a Binomial Lattice Valuation Model and the following assumptions:

  

Series A

 
  

June 30,

2017

  

June 30,

2016

 

Market price of common stock

 $3.17  $2.93 

Expected volatility

  110%  99%

Contractual term (years)

  3.7   4.7 

Discount rate

  1.66%  1.01%

Dividend rate

  0%  0%

Exercise price

 $8.00  $8.00 

Expected volatilities arecapital based on existing debt instruments. We recognize the historical volatility of the Company’s common stock. Contractual term is based on remaining term of the respective warrants. The discount rate represents the yield on U.S. Treasury bonds with a maturity equal to the contractual term.

The Company recorded a (loss)gain of ($60,000) and $3,395,000 during the years ended June 30, 2017 and 2016, respectively representing the net change in the fair value of the derivative liability, which is presented as fair value change of derivative instruments, in the accompanying consolidated statements of operations and comprehensive loss.

The following table represents the Company’s fair value hierarchyexpense for its financial liabilities measured at fair value on a recurring basis as of June 30, 2017 and 2016:

  

Balance at

June 30, 2017

  

Level 1

  

Level 2

  

Level 3

 
                 

Derivative obligation

 $730,000  $-  $-  $730,000 

  

Balance at

June 30, 2016

  

Level 1

  

Level 2

  

Level 3

 
                 

Derivative obligation

 $670,000  $-  $-  $670,000 

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

7.     Derivative Obligations (Continued)

Series A Warrants (Continued)

The following table reflects the change in fair value of the Company’s derivative liabilities for the year ended June 30, 2017:

  

Amount

 

Balance – July 1, 2016

 $670,000 

Change in fair value of derivative obligation

  60,000 

Balance – June 30, 2017

 $730,000 

8.     Commitments and Contingencies

Operating Leases

The Company leases the Rancho Cordova and Gurgaon, India facilities pursuant to operating leases, which contain scheduled rent increases. The leases expire in May 2019 and March 2018, respectively. The Company has terminated the existing Gurgaonthis lease and signed a new one which terminates September 14, 2023. However, either party can terminate the lease after September 2019 with three months notice. The Company recognizes rent expense on a straight-line basis over the termlease term.

The following summarizes the Company’s operating lease:

  

December 31,

2022

 

Right-of-use operating lease assets – related party, net

 $3,550,000 

Current lease liability (included in other current liabilities)

  433,000 

Non-current lease liability – related party

  3,495,000 
     

Weighted average remaining lease term

  4.8 

Discount rate

  22%

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

2023

 $1,256,000 

2024

  1,307,000 

2025

  1,359,000 

2026

  1,428,000 

2027

  1,133,000 

Total lease payments

 $6,483,000 

Less: imputed interest

  (2,555,000)

Present value of operating lease liabilities

 $3,928,000 

Operating Lease Costs

Lease costs recognized in consolidated statements of operations are summarized below:

  

December 31,

2022

 

Operating lease cost

 $964,000 

Variable lease cost

  71,000 

Total lease cost

 $1,035,000 

Statement of Cash Flows

Cash paid for amounts included in the measurement of operating lease liabilities was $587,000 for the year ended December 31, 2022.

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 annual future minimumlease 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 non-cancelablecost 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:

  

December 31,

2022

  

December 31,

2021

 

Right-of-use operating lease assets, net

 $372,000  $571,000 

Current lease liability (included in other current liabilities)

  267,000   206,000 

Non-current lease liability

  131,000   398,000 
         

Weighted average remaining lease term

  1.4   2.4 

Discount rate

  22%  22%

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

 

2018

  297,000 

2019

  279,000 

2020

  3,000 

Total

 $579,000 

2023

 $329,000 

2024

  139,000 

Total lease payments

 $468,000 

Less: imputed interest

  (70,000)

Present value of operating lease liabilities

 $398,000 

 

Rent expenseOperating Lease Costs

Lease costs recognized in consolidated statements of operations are summarized below:

  

December 31,

 
  

2022

  

2021

 

Operating lease cost

 $311,000  $311,000 

Variable lease cost

  111,000   105,000 

Total lease cost

 $422,000  $416,000 

Statement of Cash Flows

In January 2019, the Company signed an amendment to its Rancho Cordova, California lease. The amendment was $291,000accounted for as a modification and $657,000resulted 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 $319,000 and $310,000 for the years ended June 30, 2017December 31, 2022 and 2016,2021, 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, 2022 and 2021.

10.

Commitments and Contingences

Financial Covenants

Effective May 15, 2017,

On July 13, 2020, the Company, entered into a Sixth AmendedManufacturing and Restated Technology License and EscrowSupply Amending Agreement #2 with CbrCBR Systems, Inc. which modified(“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 covenantrequirement 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 must meet in order to avoid an event of default. The Company must maintain aCompany’s cash balance and short-term investments net of non-convertible debt orand borrowed funds that are payable within one year of not lessmust be greater than $2,000,000.$1,000,000 at any month end. The Company was in compliance with this financial covenantagreement as of June 30, 2017 and AugustDecember 31, 2017.2022.

Potential Severance Payments

The Company’s Chief Operating Officer (“COO”) has rights upon termination under her employment agreement. The agreement provides, among other things, for the payment of twelve months of severance compensation upon termination under certain circumstances. With respect to this agreement at June 30, 2017, potential severance amounted to $320,000.

 

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)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.

 

8.     Commitments and Contingencies (Continued)

Contingencies

In fiscal 2016, the Company signed an engagement letter with a strategic consulting firm. Included in the engagement letter was a success fee due upon the successful conclusion of certain strategic transactions. On May 4, 2017, a lawsuit was filed against the Company by the consulting firm as the consulting firm believes that it is owed a transaction fee of $1,000,000 under the terms of the engagement letter due to the conversion of the Boyalife Debentures in August 2016. The Company intends to defend the lawsuit vigorously and no accrual has been recorded for this contingent liability as of June 30, 2017.

 

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 June 30, 2017,December 31, 2022, 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.

 

Warranty

The Company offers a warranty on all

11.

Stockholders Equity

 

Changes in the Company’s product liability which is included in other current liabilities during the period are as follows:

  

For years ended June 30,

 
  

2017

  

2016

 

Beginning balance

 $566,000  $627,000 

Warranties issued during the period

  120,000   97,000 

Settlements made during the period

  (93,000)  (287,000)

Changes in liability for pre-existing warranties during the period

  (5,000)  129,000 

Ending balance

 $588,000  $566,000 

9.     Stockholders’ Equity

Common Stock

On August 22, 2016,February 3, 2022, the Company notified Boyalife Investment Inc.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 it electedmay be offered and sold from time to convert all outstanding principal and interest accrued and otherwise payabletime under the Debentures,Offering Agreement from $15,280,000 to $19,555,000, which includedenables the conversionCompany to sell an additional $4,275,000 of $12,500,000 of principalshares 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 $8,250,000 of interest up to and including the maturity dateconditions of the Debentures. Upon conversion, 6,102,941Offering Agreement otherwise remain unchanged. For the year ended of December 31, 2022, the Company sold a total of 196,843 shares of common stock were issuedunder 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 the Debentures and all related security interest and liens were terminated. (See note 6)other transaction costs of approximately $256,000.

 

On August 3, 2016,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 600,000 sharesin the Offering consisted of one share of the Company's common stock and one common warrant to purchase one share of common stock, and each Pre-Funded Unit consisted of one pre-funded warrant to purchase one share of common stock and one common warrant to purchase one share of common stock. The common warrants will be exercisable at aan exercise price of $4.10$6.30 per share. The net proceeds toshare beginning on the effective date of Company fromstockholder approval of the sale and issuance of the shares after deductingupon exercise of the offering expenses borne bywarrants (the "Warrant Stockholder Approval”) and will expire on the fifth anniversary 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 $369,000, were $2,092,000. December 31, 2022, all 64,286 pre-funded warrants sold in the Offering have been exercised and none are currently outstanding.

 

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

9.     Stockholders’ Equity (Continued)

In July 2016, the Compensation Committee of the Board of Directors granted 118,288 shares of fully vested common stock to employees in partial payment of amounts earned under the Company’s 2016 short term incentive plan. The election was made by some of the employees to satisfy the applicable federal income tax withholding obligation by a net share settlement, pursuant to which the Company withheld 46,879 shares and used the deemed proceeds from those shares to pay the income tax withholding. The net share settlement is deemed to be a repurchase by the Company of its common stock.

Warrants

A summary of warrant activity is as follows:

 

  

2017

  

2016

 
  

Number

of Shares

  

Weighted-

Average

Exercise

Price Per

Share

  

Number

of Shares

  

Weighted-

Average

Exercise

Price Per

Share

 

Beginning balance

  4,828,723  $9.37   252,620  $44.18 

Warrants granted

  --       5,238,971  $9.83 

Warrants exercised (cashless)

  --       (51,712) $13.60 

Warrants expired/canceled

  --       (611,156) $17.21 

Outstanding at June 30

  4,828,723  $9.37   4,828,723  $9.37 

Exercisable at June 30

  4,130,192  $9.60   600,782  $19.02 
  

Number

of

Shares

  

Weighted-

Average Exercise

Price Per Share

  

Weighted-

Average

Remaining

Contract Term

 

Balance at January 1, 2021

  24,814  $1,677.28   0.49 

Warrants granted

  -  $-     

Warrants exercised

  -  $-     

Warrants expired/canceled

  (10,296) $3,600.00     

Outstanding and Exercisable at December 31, 2021

  14,518  $313.71   1.44 
             

Balance at January 1, 2022

  14,518  $313.71   1.44 

Warrants granted(1)

  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 


(1)

Warrants are subject to stockholder approval and will remain outstanding but unvested until the Company receives such approval. Subsequent to December 31, 2022, the Company’s stockholders approved the warrants.

 

Equity Plans and Agreements

The Company recorded stock-based compensation of $1,461,000 and $742,000 for the years ended June 30, 2017 and 2016.

 

On May 5, 2017, the stockholders approved theThe Amended 2016 Equity Incentive Plan (“Amended(the “Amended 2016 Plan”) was approved by the stockholders in May 2017, under which up to 600,0001,334 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 June 30, 2017, 254,224December 31, 2022, 60,197 awards were available for issuance under the Amended 2016 Plan.

 

The 2012 Independent DirectorOn December 29, 2017, the Board of Directors of ThermoGenesis Corp. adopted the ThermoGenesis Corp. 2017 Equity Incentive Plan (“2012(the “ThermoGenesis Plan”) permitsand on the grant of stock orsame day granted options to independent directors. A totalpurchase an aggregate of 25,000280,000 shares wereof ThermoGenesis Corp. common stock to employees, directors, consultants, and advisors of ThermoGenesis Corp. The ThermoGenesis Plan was unanimously approved by the ThermoGenesis stockholders for(including the Company) on December 29, 2017. The ThermoGenesis Plan authorizes the issuance under the 2012 Plan. Optionsof up to 1,000,000 shares of ThermoGenesis common stock. There are granted at prices that are equal to 100% of the fair market value on the date of grant, and expire over a term not to exceed ten years. Options generally vest in monthly increments over one year, unless otherwise determined by the Board of Directors. As of June 30, 2017, there were 19440,000 shares available for issuance.

The 2006 Equity Incentiveissuance as of December 31, 2022. As the ThermoGenesis Plan (“2006 Plan”) permittedis for the grant of options, restricted stock units, stock bonuses and stock appreciation rights to employees, directors and consultants. The 2006 Plan, butCompany’s subsidiary it was not affected by the awards granted thereunder, expired in 2016. As of June 30, 2017, 134,164 option and restricted stock unit awards remained outstanding.reverse split effected on December 22, 2022.

 

On July 7, 2016, theStock Based Compensation Committee also adopted a short term incentive program under which cash awards and shares

The Company recorded stock-based compensation of common stock may be granted to employees of the Company (the “Short Term Program”). The aggregate amount of the cash awards issuable pursuant to the Short Term Plan is approximately $276,000. Up to 104,000 shares of common stock from the Company’s 2006 Plan, subject to vesting, are issuable pursuant to the Short Term Program. On July 26, 2016, 98,417 shares and$266,000 of cash awards were granted under the Short Term Program. The cash awards granted pursuant to the Short Term Program were payable and the shares of common stock issued pursuant to the Short Term Program fully vested on July 1, 2017, provided, that such award recipients were employed by the Company as of July 1, 2017 or immediately if terminated without cause. Three of the eight employees were terminated without cause during$267,000 for the year ended June 30, 2017,December 31, 2022 and $2,560,000 for the year ended December 31, 2021, as such, 51,636 shares vested. The remaining 46,781 shares vested on July 1, 2017.comprised of the following:

 

  

Year Ended December 31,

 
  

2022

  

2021

 

Cost of revenues

 $18,000  $17,000 

Selling, general and administrative

  229,000   2,275,000 

Research and development

  20,000   268,000 
  $267,000  $2,560,000 

 

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

9.     Stockholders’ Equity (Continued)

Equity PlansOn June 4, 2020, the Chief Executive Officer, Chief Financial Officer and Agreements (Continued)

Upon the termination of the employmentother employees were granted 12,567 options to purchase shares of the Company’s Chief Executive Officer (“CEO”) in November 2016 and Chief Financial Officer (“CFO”) in March 2017, in accordance with their employment agreements, all outstanding options and restricted stock unit awards immediately vested. As a result, the Company recognized (i) $539,000 of stock compensation expense in general and administrative for the quarter ended December 31, 2016, as the vesting accelerated on the CEO’s options to purchase 72,496 shares of common stock and 79,720 restricted stock unit awards, and (ii) $94,000 of stock compensation expense in general and administrative for the quarter ended March 31, 2017 as the vesting accelerated on the CFO’s options to purchase 16,248 shares of common stock and 15,914 restricted stock unit awards. Additionally, the terms of the options were modified upon the executives’ termination such that the options were deemed to be exercisable for longer than 90 days from the date of termination. There was no incremental compensation cost recorded for this modification as the fair-value-based measure of the modified award on the date of modification was less than the fair-value-based measure of the original award immediately before the modification. 

On February 24, 2017, the Company appointed a Chief Operating Officer. As part of the terms of her employment agreement, she received an annual grant of 25,000 restricted stock units (“RSUs”) and options to purchase 25,000 common shares under the 2016 Equity Incentive Plan (“2016 Plan”). The annual grant of RSUs and stock options will vest in four equal installments: 25% on March 31, 25% on June 30, 25% on September 30 and 25% on December 31 of each year. The stock options granted in February 2017 haveat an exercise price of $2.89, which was$267.30 per share. In May 2021, five Company executives voluntarily surrendered the closing price onoptions they were awarded. At the date of grant.

In December 2016,time they were surrendered, the Compensation Committee of the Board of Directors granted 50,000 options to the Company’s CEO under the 2016 Plan. The options have an exercise price of $2.91, the closing price onoptions was underwater. No payment or other consideration was paid to the dateCompany executives for surrendering the options. In total 10,889 options were cancelled. As a result of grant, they vestthe cancellation, the remaining unamortized expense of $2,008,000 was accelerated and expensed in five equal installments on each ofthe year ended December 16, 2016, February 4, 2017, May 4, 2017, August 4, 2017 and November 4, 2017 and have a seven year life.

31, 2021.

 

48
63

 

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

9.     Stockholders’ Equity (Continued)

Stock Options

The Company issues new shares of common stock upon exercise of stock options. The following is a summary of option activity for the Company’s stock option plans:

 

  

Number of

Shares

  

Weighted-

Average

Exercise

Price

  

Weighted-

Average

Remaining

Contractual Life

  

Aggregate

Intrinsic

Value

 

Outstanding at June 30, 2016

  104,378  $14.85         
                 

Granted

  318,324  $2.98         

Forfeited/cancelled

  (22,814) $6.39         

Expired

  (2,500) $18.46         

Exercised

  --   --         

Outstanding at June 30, 2017

  397,388  $5.80   6.2  $69,000 

Vested and Expected to Vest at June 30, 2017

  376,595  $5.94   6.2  $64,000 

Exercisable at June 30, 2017

  242,073  $7.38   5.5  $43,000 
  

Number

of Shares

  

Weighted-

Average

Exercise

Price

  

Weighted-

Average

Remaining

Contractual

Life

 

Outstanding at January 1, 2022

  7,885  $546.10   6.8 
             
             

Granted

  -   -     

Expired

  (129) $7,361.38     

Forfeited/cancelled

  (1,353) $443.23     

Outstanding at December 31, 2022

  6,403  $430.53   5.93 

Vested and Expected to Vest at December 31, 2022

  6,246  $435.36   5.89 

Exercisable at December 31, 2022

  6,048  $441.00   5.84 

 

The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the quoted price of the Company’s common stock. There were no options that were exercised during the years ended June 30, 2017 and 2016.

On July 7, 2016, the Compensation Committee of the Board of Directors granted options to purchase a total of 156,100 common shares to various employees under the 2016 Plan. The options have an exercise price of $2.86, the closing price on the date of grant, vest ratably every six months over a three year period, and have a seven year life.

 

Non-vested stock option activity for the year ended June 30, 2017,December 31, 2022, is as follows:

 

  

Non-vested Stock

Options

  

Weighted-Average

Grant Date Fair Value

 

Outstanding at June 30, 2016

  43,107  $7.46 

Granted

  318,325  $2.16 

Vested

  (185,019) $3.07 

Forfeited

  (21,097) $3.31 

Outstanding at June 30, 2017

  155,316  $2.39 

The fair value of the Company’s stock options granted for the years ended June 30, 2017 and 2016 was estimated using the following weighted-average assumptions:

  

2017

  

2016

 

Expected life (years)

  4   5 

Risk-free interest rate

  1.3%  1.5%

Expected volatility

  102%  80%

Dividend yield

  0%  0%

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

9.     Stockholders’ Equity (Continued)

The weighted average grant date fair value of options granted during the years ended June 30, 2017 and 2016 was $2.16 and $5.75, respectively.

  

Non-vested Stock

Options

  

Weighted-Average

Grant Date Fair Value

 

Outstanding at January 1, 2022

  1,643  $266.84 

Granted

  -     

Vested

  (983) $280.95 

Cancelled/forfeited

  (305) $278.55 

Outstanding at December 31, 2022

  355  $217.71 

 

At June 30, 2017,December 31, 2022, the total compensation cost related to options granted under the Company’s stock option plans but not yet recognized was $275,000.$30,000. This cost will be amortized on a straight-line basis over a weighted-average period of approximately one and a half yearsyear and will be adjusted for subsequent changes in estimated forfeitures. The total fair value of options vested during the years ended June 30, 2017 and 2016 was $572,000 and $354,000.

Common Stock Restricted Awards

The following is a summary of restricted stock unit activity:

  

2017

  

2016

 
  

Number of

Shares

  

Weighted-

Average

Grant Date

Fair Value

  

Number of

Shares

  

Weighted-

Average

Grant Date

Fair Value

 

Balance at June 30

  63,566  $14.96   72,589  $22.40 

Granted

  123,417  $4.55   10,000  $2.98 

Vested

  (125,513) $9.47   (6,120) $28.94 

Forfeited

  (1,776) $27.05   (12,903) $41.15 

Outstanding at June 30

  59,694  $4.62   63,566  $14.96 

In connection with the vesting of the restricted stock unit awards, the election was made by some of the employees to satisfy the applicable federal income tax withholding obligation by a net share settlement, pursuant to which the Company withheld 145 and 1,300 shares for the years ended June 30, 2017 and 2016, respectively and used the deemed proceeds from those shares to pay the income tax withholding. The net share settlement is deemed to be a repurchase by the Company of its common stock.

 

AsNet Loss Per Share

Net loss per share is computed by dividing the net loss by the weighted average number of June 30, 2017,common shares outstanding. The calculation of the Company had $43,000 in total unrecognized compensation expense relatedbasic 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 restricted stock unit awards, which will benet loss position for all periods presented. Anti-dilutive securities consisted of the following at December 31:

  

2022

  

2021

 

Common stock equivalents of convertible promissory notes and accrued interest

  1,525,751   176,907 

Warrants

  340,689   14,518 

Stock options

  6,403   7,885 

Total

  1,872,843   199,310 

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 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 a weighted average period of approximately seven months.time as the contract performance obligations are satisfied.

 

10.     Concentrations

One distributor had an accounts receivable balanceRevenue 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 $1,388,000 or 36% and $901,000 or 28% at June 30, 2017 and 2016, respectively. The Company did not renew the contract with this distributor in August 2017 and signed a contract with a new distributor. A customer had an accounts receivable balance of $259,000 or 7% and $620,000 or 19% at June 30, 2017 and 2016, respectively. A second distributor had an accounts receivable balance of $304,000 or 8% and $320,000 or 10% at June 30, 2017 and 2016, respectively.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 customer totaled $3,263,000contract 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 22%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 $2,475,000 or 21%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 years ended June 30, 2017benefit of the distributor, and 2016, respectively. Revenues from onewhether there are other conditions that may indicate that the sale to the distributor totaled $2,842,000 or 20% and $2,797,000 or 23% of net revenues for the years ended June 30, 2017 and 2016, respectively. The Company didis not renew the contract with this distributor in August 2017 and replaced it with a different distributor.

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

10.     Concentrations (Continued)substantive.

 

The following represents the Company’s revenuestable presents net sales by product platform for the years ended June 30:geographic areas:

 

  

2017

  

2016

 

AXP

 $8,715,000  $6,932,000 

BioArchive

  3,318,000   2,465,000 

Manual Disposables

  1,195,000   1,507,000 

Bone Marrow

  745,000   459,000 

Other

  552,000   566,000 
  $14,525,000  $11,929,000 

The Company had sales to customers as follows for the years ended June 30:

  

2017

  

2016

 

United States

 $6,675,000  $5,122,000 

China

  3,296,000   2,797,000 

Asia – other

  1,951,000   1,955,000 

Europe

  1,739,000   1,343,000 

Other

  864,000   712,000 
  $14,525,000  $11,929,000 

The Company attributes revenue to different geographic areas based on where items are shipped or services are performed.

Two suppliers accounted for 64% and 20% of total inventory purchases during the year ended June 30, 2017. Two suppliers accounted for 65% and 21% of total inventory purchases during the year ended June 30, 2016.

The Company has a contract manufacturer in Costa Rica that produces certain disposables. The Company’s equipment, net of accumulated depreciation, is summarized below by geographic area:

  

June 30, 2017

  

June 30, 2016

 

United States

 $1,559,000  $2,030,000 

Costa Rica

  322,000   367,000 

India

  261,000   279,000 

All other countries

  188,000   286,000 

Total equipment, net

 $2,330,000  $2,962,000 

11.     Segment Reporting

Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the Chief Operating Decision Maker (“CODM”), or decision making group, whose function is to allocate resources to and assess the performance of the operating segments. The Company has identified its Chief Executive Officer and Chief Operating Officer as the CODM. In determining its reportable segments, the Company considered the markets and the products or services provided to those markets.

  

Years Ended December 31,

 
  

2022

  

2021

 

United States

 $6,641,000  $5,304,000 

China

  1,984,000   1,771,000 

Portugal

  211,000   548,000 

Thailand

  9,000   401,000 

South Korea

  325,000   222,000 

Vietnam

  515,000   332,000 

Other

  798,000   716,000 

Total

 $10,483,000  $9,294,000 

 

50
66

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

11.     Segment Reporting (Continued)

During the quarter ended June 30, 2017, the Company developed a plan to begin separately operating its device and therapeutics businesses. The Company identified the following two reportable segments, which are the same as its operating segments:

The Clinical Development Division is developing autologous (utilizing the patient’s own cells) stem cell-basedtherapeutics that address significant unmet medical needs for applications within thevascular, cardiology and orthopedicmarkets.   

The Device Division is a pioneer and market leader in the development and commercialization ofautomated technologies for cell-based therapeutics and bio-processing.

 

The following table summarizes the operating resultsrevenues by product line and type:

  

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 

CAR-TXpress

  654,000   190,000   285,000   1,129,000 

Manual Disposables

  655,000   -   -   655,000 

Other

  64,000   -   29,000   93,000 

Total

 $8,531,000  $1,638,000  $314,000  $10,483,000 

  

Year Ended December 31, 2021

 
  

Device

Revenue

  

Service

Revenue

  

Other

Revenue

  

Total

Revenue

 
                 

AXP

 $4,940,000  $198,000  $-  $5,138,000 

BioArchive

  827,000   1,518,000   -   2,345,000 

CAR-TXpress

  875,000   123,000   286,000   1,284,000 

Manual Disposables

  421,000   -   -   421,000 

Other

  65,000   -   41,000   106,000 

Total

 $7,128,000  $1,839,000  $327,000  $9,294,000 

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, 2022 and 2021 that were included in the beginning balance of deferred revenue were $719,000 and $608,000, respectively. Short-term deferred revenues were $782,000 and $719,000 at December 31, 2022 and 2021, respectively. Long-term deferred revenue was $911,000 and $1,244,000 at December 31, 2022 and 2021, 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 five years with Corning having two options to renew for an additional two-years (up to four years total), unless terminated by either party in accordance with the terms of the Company’s reportable segments: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 under the CAR-TXpress™ platform (the “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. The Company recorded $286,000 in revenue for the years ended December 31, 2022 and 2021.

 

 

  

Year Ended June 30, 2017

     
  

Clinical Development

  

Device

  

Total

 

Net revenues

 $492,000  $14,033,000  $14,525,000 

Cost of revenues

  466,000   8,220,000   8,686,000 

Gross profit

  26,000   5,813,000   5,839,000 
             

Operating expenses

  8,966,000   6,113,000   15,079,000 

Operating profit (loss)

 $(8,940,000) $(300,000) $(9,240,000)
             

Depreciation and amortization

 $501,000  $329,000  $830,000 

Stock-based compensation expense

 $970,000  $491,000  $1,461,000 

Distribution Agreement

  

Year Ended June 30, 2016

     
  

Clinical Development

  

Device

  

Total

 

Net revenues

 $646,000  $11,283,000  $11,929,000 

Cost of revenues

  574,000   8,611,000   9,185,000 

Gross profit

  72,000   2,672,000   2,744,000 
             

Operating expenses

  8,312,000   5,297,000   13,609,000 

Operating profit (loss)

 $(8,240,000) $(2,625,000) $(10,865,000)
             

Depreciation and amortization

 $644,000  $524,000  $1,168,000 

Stock-based compensation expense

 $548,000  $194,000  $742,000 

 

The Company has not yet allocatedsigned a new agreement with its AXP distributor in China through 2023. The new 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, 2022 and 2021, the Company recorded $82,000 and $41,000 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:

  

2023

  

2024

  

2025

  

2026 and

beyond

  

Total

 

Service revenue1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

 $1,157,000  $637,000  $244,000  $-  $2,038,000 

Device revenue (1)

  845,000   41,000   -   -   886,000 

Exclusivity fee

  286,000   286,000   286,000   189,000   1,047,000 

Clinical revenue

  13,000   13,000   13,000   118,000   157,000 

Total

 $2,301,000  $977,000  $543,000  $307,000  $4,128,000

 

(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, 2022.

13.

Concentrations

The Company had accounts receivable balances or revenues in excess of 10% for the years ended December 31, 2022 and 2021 as shown in the table below:

Accounts Receivable

 

2022

  

2021

 

Customer 1

  29%  0

%

Customer 2

  27%  0

%

Customer 3

  15%  6%

Revenues

 

2022

  

2021

 

Customer 1

  33%  22%

Customer 2

  15%  16%

One supplier accounted for 70% and 71% of total inventory purchases during the years ended December 31, 2022 and 2021, respectively.

14.

Employee Retention Tax Credit

Employee Retention Tax Credits (“ERTC”), created in the March 2020 CARES Act and then subsequently amended by the Consolidated Appropriation Act (“CAA”) of 2021 and the American Rescue Plan Act (“ARPA”) of 2021, is a refundable payroll credit for qualifying businesses keeping employees on their payroll during the COVID-19 pandemic. Under CAA and ARPA amendments, employers can claim a refundable tax credit against the employer share of social security tax equal to 70% of the qualified wages (including certain health care expenses) paid to employees from January 1, 2021 to September 30, 2021. Qualified wages are limited to $10,000 per employee per quarter in 2021 so the maximum ERTC available is $7,000 per employee per quarter.

The Company was eligible to receive the ERTC credits under the gross receipts decline test when comparing the first, second and third quarters of 2021 to the same quarters in 2019, which qualified the Company to claim ERTC the first three quarters of 2021 under the amended ERTC program. The Company qualified for a refundable payroll tax credit totaling $842,000 for the first three quarters of 2021, which is recorded in other income on the Company’s consolidated statement of operations for the year ended December 31, 2021, and prepaid and other current assets on a segment basis.the Company’s consolidated balance sheet as of December 31, 2021.

 

12.     Income Taxes

15.

Income Taxes

 

Loss before income tax benefits waswere comprised of $29,005,000$11,752,000 from USU.S. and $763,000$60,000 from foreign jurisdictions in 2017for the year ended December 31, 2022 and $17,789,000$11,850,000 from USU.S. and $799,000$30,000 from foreign jurisdictions in 2016.

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

12.     Income Taxes (Continued)for the year ended December 31, 2021.

 

The reconciliation of federal income tax attributable to operations computed at the federal statutory tax rate of 34% to income tax benefit is as follows for the years ended June 30:the:

 

  

2017

  

2016

 

Statutory federal income tax benefit

 $(10,121,000) $(6,300,000)
         

Unbenefited net operating losses and credits

  2,281,000   3,391,000 

Disallowed financing costs

  6,959,000   2,607,000 

State and local taxes

  88,000   69,000 

Other

  120,000   233,000 
         

Total income tax benefit

 $(673,000 $-- 

The deferred income tax benefit of $673,000 is due to changes in the state tax rate over the last several years. Approximately $559,000 of the benefit relates to state rate changes prior to fiscal 2017, which was all recognized in the current year, of which $157,000 relates to fiscal 2016 and $402,000 relates to years prior to fiscal 2016. The Company believes these amounts are quantitatively and qualitatively immaterial to the balance sheets as of June 30, 2015 and June 30, 2016, as well as the statements of operations and comprehensive loss for the years then ended, and to fiscal 2017. A valuation allowance is provided when it is more likely than not that some portion of the deferred tax assets will not be realized.

  

Year Ended December 31,

 
  

2022

  

2021

 

Statutory federal income tax benefit

 $(2,481,000) $(2,495,000)

Intangible assets

  -   - 

PPP loan forgiveness

      (137,000)

Incentive stock options

  -   257,000 

Change in valuation allowance

  (284,000)  (72,000)

Expiration of net operating losses

  1,356,000   1,242,000 

Disallowed financing costs

  1,179,000   1,282,000 

State and local taxes

  200,000   (195,000)

Foreign rate differential

  11,000   26,000 

Other

  19,000   92,000 

Total income tax expense

 $-  $- 

 

At June 30, 2017, the CompanyDecember 31, 2022, we had federal net operating loss carryforwards for federal and state income tax purposes of $118,956,000 and $42,922,000 respectively that are availableapproximately $123,182,000 to offset future income. The federal taxable income, with $96,250,000 available through 2037 and $26,931,000 available indefinitely. We also had state net operating loss carryforwards expire in various years between 2018 and 2037.of approximately $46,750,000 that may offset future state taxable income through 2042. We also had foreign net operating loss carryforwards of approximately $426,000 that may offset future foreign taxable income through 2030.

 

At June 30, 2017,December 31, 2022, the Company has research and experimentation credit carryforwards of $1,458,000$1,459,000 for federal tax purposes that expire in various years between 20192023 and 2037,2042, and $1,456,000$1,618,000 for state income tax purposes that do not have an expiration date.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,

 
 

June 30, 2017

  

June 30, 2016

  

2022

  

2021

 

Deferred tax assets:

         

Net operating loss carryforwards

 $43,687,000  $41,023,000  $26,465,000  $27,088,000 

Income tax credit carryforwards

  2,419,000   2,367,000  2,738,000  2,797,000 

Stock compensation

  1,047,000   874,000  421,000  437,000 

Lease obligation

 908,000  127,000 

Deferred revenue

 251,000  313,000 

Inventory Reserve

 517,000  449,000 

Sec. 174 Capitalized R&D

 317,000  - 

Other

  1,124,000   1,858,000   159,000   213,000 

Total deferred tax assets

  48,277,000   46,122,000  31,776,000  31,424,000 
         

Deferred tax liabilities

         

Indefinite lived intangible assets

  (6,968,000)  (7,641,000)

Depreciation and amortization

  (176,000)  (230,000) (252,000) (320,000)

Lease asset

  (824,000)  (120,000)

Total deferred tax liabilities

  (7,144,000)  (7,871,000) (1,076,000) (440,000)

Valuation allowance

  (48,101,000)  (45,892,000)  (30,700,000)  (30,984,000)

Net deferred taxes

 $(6,968,000) $(7,641,000) $-  $- 

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 increaseddecreased by $2,209,000 in 2017. As of June 30, 2017,$284,000 and decreased by $72,000 during the Company has a benefit of $215,000 related to stock option deductions, which will be credited to paid-in capital when realized.

Cesca Therapeutics Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

12.     Income Taxes (Continued)years ended December 31, 2022 and 2021, respectively.

 

In August 2016, the conversion of the Boyalife Debenturesdebentures 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 imitationslimitations 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 – 2022.

 

13On March 27, 2020, the Coronavirus, Aid, Relief and Economic Stimulus Act (“CARES Act”) was enacted. The CARES Act made various tax law changes including among other things (i) increasing the limitation under Section 163(j) of the Internal Revenue Code of 1986, as amended (the “IRC”) for 2019 and 2020 to permit additional expensing of interest (ii) enacting a technical correction so that qualified improvement property can be immediately expensed under IRC Section 168(k), (iii) making modifications to the federal net operating loss rules including permitting federal net operating losses incurred in 2018, 2019, and 2020 to be carried back to the five preceding taxable years in order to generate a refund of previously paid income taxes, and (iv) enhancing the recoverability of alternative minimum tax credits. As of December 31, 2020, the Company has taken advantage of the PPP loan provided by the CARES Act. The PPP loan was forgiven in 2021 and forgiveness income has been fully reversed as per federal guidance. The provisions of the CARES Act have had no impact on the Company.

On December 22, 2017, the U.S. enacted comprehensive tax legislation (the “Tax Act”). Employee Retirement PlanThe 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 sponsors an does not have any uncertain tax positions at December 31, 2022 or December 31, 2021.  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.

16.

Employee Retirement Plan

401(k) Plan generally available to all employees,

The Company provides a retirement plan, in accordance with Section 401(k) of the Internal Revenue Code.Code, to all eligible employees. Employees may elect to contribute up to the Internal Revenue Service maximum annual contribution limit. Under this Plan, at the discretion of the Board of Directors, the Company may match a portion of the employees’ contributions. The Company made no discretionary or matchingmatches employee contributions up to the Plana maximum of 4% per year. The Company recognized an expense of $132,000 and $135,000 for the years ended June 30, 2017December 31, 2022 and 2016.2021, respectively, related to matching contributions.

17.

Subsequent Events

On January 31, 2023, the Company entered into an Amendment No. 3 to the July 2019 Note with Orbrex (USA) Co. Limited (the "July 2019 Note Amendment”). The July 2019 Note Amendment amends the July 2019 Note, dated July 23, 2019, as amended by Amendment No. 1 dated effective July 23, 2019, and Amendment No. 2 dated July 25, 2022, between the Company and Orbrex (USA) Co. Limited. The July 2019 Note Amendment extends the maturity date of the July 2019 Note from January 31, 2023 to July 31, 2023. The Note Amendment also changed the fixed conversion price to $2.87 per share, provided that in the event that the Company issues shares, options, warrants, or convertible securities, subject to certain exceptions, at an effective price per common share lower than $2.87, then the conversion price will be adjusted to such lower issuance price.

 

14.     Subsequent EventThe Company held a Special Meeting of Stockholders on February 23, 2023, at which time the Company’s stockholders approved the 326,171 warrants that were issued in the October 2022 Offering. As a result of the approval of the warrants, they are now exercisable as of February 23, 2023 and will be exercisable for a period of five (5) years thereafter, subject to the terms and conditions of the warrants.

In February and March of 2023 through several conversions, the holder of the July 2019 Note converted $603,000 of the Note for 215,000 shares. The current outstanding balance of the Note is $397,000.

 

On July 7, 2017,March 6, 2023, the Company entered into an Amendment No. 2 (the “Amendment to Note”) to its Second Amended and Restated Convertible Promissory Note with Boyalife Group Inc. (the “Note”), and an Amendment No. 3 (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 March 6, 2023 to December 31, 2023, and provides that interest accrued and unpaid as of March 6, 2023 will be added to the principal balance of the Note, resulting in an outstanding principal balance of $7,278,000 as of March 6, 2023.

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) warrants to purchase up to an aggregate 1,071,429 Common Shares were issued. The warrants have an exercise price of $2.65 per share and are exercisable immediately upon issuance and expire five and one-half years following the issuance for a total net proceeds of approximately $2.6 million, excluding legal and transaction fees. The transaction triggered the down round provision in which its wholly owned subsidiary, ThermoGenesis, acquired the businessJuly 2019 Note Amendment and substantially allthe Amendment to the Note lowering the conversion price of both notes to $2.65. The Offering closed on March 20, 2023.

As part of the assets of SynGen Inc. (“SynGen”), a privately held Sacramento, California-based technology company that develops, markets, and sells advanced cell separation tools and accessories. In the transaction (the “SynGen Transaction”), ThermoGenesis acquired substantially all of SynGen’s operating assets, including its proprietary cell processing platform. In exchange, ThermoGenesis issued to SynGen shares of ThermoGenesis common stock that, after giving effect to the issuance, constitute 20% of ThermoGenesis’ outstanding common shares, and ThermoGenesis also made a one-time cash payment of $1.0 million to SynGen (together with the issuance of common stock, the “Transaction Consideration”). The preliminary purchase price is not available as the Company is in process of completing the valuation of the ThermoGenesis stock. The final determination of the fair value of certain assets acquired and the ThermoGenesis stock issued will be completed within the 12-month measurement period from the date of acquisition as required. Immediately prior to the SynGen Transaction, the Company contributed the assets, business, and current liabilities of its blood and bone-marrow processing device business to ThermoGenesis and will operate such business (together with the acquired business) through the ThermoGenesis subsidiary.

On September 13, 2017,Offering, the Company entered into Amendment No. 1a Registration Rights Agreement, dated March 15, 2023, with the Investor, pursuant to the Credit Agreement (the “Amended Credit Agreement”). The Amended Credit Agreement amends the Credit Agreement originally entered into bywhich the Company agreed to register the resale of the shares of Common Stock sold in the Offering and Lender on March 6, 2017, by increasing the Company’s maximum borrowing availability thereunder from $5.0 million to $10.0 million. In connection with such amendment,shares of Common Stock issuable upon exercise of the CompanyCommon Warrants and Lender entered into an amended and restated convertible promissory note to reflect the new aggregate maximum principal amount of $10.0 million.Pre-Funded Warrants.

 

In August 2017,connection with the Board of Directors approved changing the Company’s fiscal year from June 30 to a calendar year ending December 31. As a result,Offering, the Company will fileentered into a transition report on Form 10-K forWarrant Amendment Agreement (the “Warrant Amendment Agreement”), dated March 15, 2023, with the six month period ending December 31, 2017. Prior to filing the transition report,Investor, whereby the Company will file a quarterly report on Form 10-Q foragreed to amend existing warrants, held by the quarter ending September 30, 2017.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. On March 21, 2023, the 158,731 warrants were exercised in full.

 

55
69

 

ITEM 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ONACCOUNTING AND FINANCIAL DISCLOSURE.

Changes In and Disagreements with Accountants on Accounting and Financial Disclosure

 

None.

 

ITEM 9A.CONTROLSAND PROCEDURES.

Controls and Procedures

 

DisclosureDisclosure Controls and Procedures

We carried out an evaluation, under the supervision and with the participation of management, including our Chief Executive Officer and our PrincipalChief Financial and Accounting Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined by Exchange Act Rule 13a-15(e) and 15d-15(e)) as of the end of our last fiscal quarter pursuant to Exchange Act Rule 13a-15. The term “disclosure controls and procedures” means controls and other procedures designed to ensure that information required to be disclosed in reports filed or submitted 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 such information is accumulated and communicated to management, including the Chief Executive Officer and the PrincipalChief Financial and Accounting Officer, as appropriate, to allow timely decisions regarding required disclosure. Based upon that evaluation, our Chief Executive Officer and PrincipalChief Financial and Accounting Officer concluded that our disclosure controls and procedures were effective as of June 30, 2017.December 31, 2022.

 

Management’sManagements Report on Internal Control over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including our Chief Executive Officer and PrincipalChief Financial and Accounting Officer, we conducted an evaluation of the effectiveness of its internal control over financial reporting as of June 30, 2017December 31, 2022 based on criteria established in the framework inInternal Control Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission in 2013. Based on this evaluation, our management concluded that our internal control over financial reporting was effective as of June 30, 2017.December 31, 2022.

 

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.

 

Attestation Report of Independent Registered Public Accounting Firm

Not applicable.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

There have been no changes in our internal controls over financial reporting that occurred during the fiscal quarter ended June 30, 2017,December 31, 2022, that have materially affected, or are reasonably likely to materially affect our internal controls over financial reporting. We believe that a control system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the control system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within any company have been detected.

 

ITEM 9B.     OTHER INFORMATION.

ITEM 9B.

Other Information

 

None.

 

ITEM 9C.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Not applicable.

7057

 

PART III

ITEM 10.

Directors, Executive Officers and Corporate Governance

Directors

 

ITEM 10.     DIRECTORSSet forth below is the name, age, and certain biographical information for each of our current directors.

Age*

Xiaochun (Chris) Xu, Ph.D.

51

Vivian Liu

61

Russell Medford, Ph.D.

68

Jeff Thomis, Ph.D.

77

Haihong Zhu

57

* Age as of March 15, 2023.

Biographies

Xiaochun (Chris) Xu, PhD, MBA

Director since March 2016

Dr. Xu joined our Board in March 2016. On November 13, 2017, the Board elected Dr. Xu as President and Chief Executive Officer (“CEO”) (transitioning from interim Chief Executive Officer as of November 2016; he currently serves as Chairman of the Board). Dr. Xu is also a member of the Board of Directors of our wholly-owned subsidiary, ThermoGenesis Corp. Dr. Xu has been the Founder, Chairman and CEO of Boyalife Group Ltd., EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.China since July 2009. From 2008 to 2009, he was Vice President at Founder Group, a major Chinese technology conglomerate with interests in information technology, pharmaceuticals, real estate, finance, and commodities trading. From 2000 to 2008, Dr. Xu served in various management positions at Pfizer Inc. and two Nasdaq publicly traded bio-pharmaceutical companies. Dr. Xu received his B.SC. in Biochemistry from the University of Saskatchewan, his Ph.D. degree in Immunology from Washington University School of Medicine (St. Louis, Missouri, USA) and an Executive MBA degree from Emory University (Atlanta, Georgia, 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.

Vivian Liu

Director since June 2022

Ms. Liu was appointed to the Board of Directors in June 2022. Since October 2018, Ms. Liu has served as Head of Corporate Affairs for PREMIA Holdings (HK) Limited, a developer and manager of clinical-genomic oncology databases in Asia and service provider to pharmaceutical companies seeking to operate clinical trials throughout Asia. Ms. Liu currently serves as member of the Board of Directors of Aytu BioPharma, Inc. (“AYTU”). Ms. Liu served as a member of the Board of Directors and as President and Chief Executive Officer and previously as Chief Financial Officer for Innovus Pharmaceuticals, Inc., (OTCQB: INNV) from December 2011 to February 2020 and from December 2011 to January 22, 2013, respectively. From January 2011 to December 2011, she served as the President and Chief Executive Officer of FasTrack Pharmaceutical, which was later acquired by Innovus Pharmaceuticals. Ms. Liu was the Chief Operating Officer and a member of the Board of Directors of ThermoGenesis Holdings, Inc. from February 2017 to October 2018 and November 2016 to October 2018, respectively. From February 2013 to March 2017, Ms. Liu served as Managing Director of OxOnc Services Company, an oncology development company. In 1995, Ms. Liu co-founded NexMed, Inc. (“NexMed”), which in 2010 was renamed Apricus BioSciences, Inc. (Nasdaq: APRI). Ms. Liu was NexMed’s President and Chief Executive Officer from 2007 to 2009. Prior to her appointment as President of NexMed, Ms. Liu served in several executive capacities at NexMed, including Executive Vice President, Chief Operating Officer, Chief Financial Officer and Vice President of Corporate Affairs. She was appointed as a director of NexMed in 2007 and served as Chairman of its Board of Directors from 2009 to 2010. Ms. Liu has an M.P.A. from the University of Southern California and has a B.A. from the University of California, Berkeley. Ms. Liu 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 Ms. Liu is qualified to serve as one of our directors because of her experience as a director of public companies, as well as her executive leadership experience and experience in the pharmaceutical industry, and we believe that Ms. Liu will be a valuable asset to the Company and our Board.

Russell Medford, MD, PhD

Director since February 2017

Dr. Medford joined our Board in February 2017. Dr. Medford is Chairman and Chief Executive Officer of Covanos, Inc., a medical device company, since 2017 and a Managing Partner of the Salutramed Group, LLC, a life sciences management consultancy, since 2012. Dr. Medford has also served as the CEO of healthEgames, Inc., a digital healthcare company, and as the Chairman of ViaMune, Inc., an immuno-oncology therapeutics company, in each case since 2014. From 1993 to 2009, Dr. Medford served as co-founder, President, CEO and Director of AtheroGenics, Inc. (“AGIX”). Dr. Medford was a founding member of the Board of Directors of Inhibitex, Inc. (“INHX”) until it was acquired by Bristol-Myers-Squibb in 2012. Dr. Medford is a board-certified physician and currently holds numerous trustee or board positions including with the Georgia Global Health Alliance, Inc. and Georgia BIO. Dr. Medford has served on the faculties of both the Harvard Medical School and Emory University School of Medicine and obtained his M.D. and Ph.D. from the Albert Einstein College of Medicine. 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. Dr. Medford 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).

Joseph (Jeff) Thomis, PhD

Director since January 2017

Dr. Thomis joined our Board in January 2017. Since 2012, Dr. Thomis has been the CEO at Thomis Consulting BVBA. From 1976 until 1997 he held a number of R&D positions at Bristol-Myers Squibb. In the period 1997-2012 he was employed at Quintiles Transnational where he held numerous positions including Chairman of the American Management Board, President of Global Clinical Development Services and President of European Clinical Development Services. He has been a partner in OxOnc Development LP, an oncology product development company. Additionally, Dr Thomis has held several Board positions. He was non-executive director of PDP Courier services; Chairman of the Board of Idis Pharma and of WEP Clinical, two global companies providing unlicensed medicines to patients with unmet medical needs. Chairman of the Board and member of the Audit Committee of Quotient Sciences, a translational pharmaceutics company and a non-executive director at NovaQuest LLC, a private equity company. He is currently the Chairman of the Board of Glasgow Memory Clinic Holdings, a site management company. Dr. Thomis received his Ph.D. in Pharmaceutical Sciences from the University of Leuven in Belgium. 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. Dr. Thomis is one of our independent directors pursuant to applicable Nasdaq rules.

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. 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 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. We believe Ms. Zhu is well qualified to serve as a director due to her extensive experience in the stem cell banking and cell and gene therapy fields. As a director, Ms. Zhu will continue to be a valuable asset to the Company and its Board by providing insight and knowledge with respect to the Company’s commercial operation activities.

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

51

Haihong Zhu

Chief Operating Officer

57

Jeff Cauble, CPA

Chief Financial Officer

50

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 Dr. Russell Medford, Dr. Joseph Thomis and Ms. Vivian Liu 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 two directors: Dr. Russell Medford (Governance and Nominating Committee Chairman) and Dr. 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: Ms. Liu (Audit Committee Chairman), Dr. Medford and Dr. Thomis, each of whom has been determined to be independent under applicable Nasdaq and SEC rules by the Board. The Board has further determined that Ms. Liu and Dr. Medford are qualified as Audit Committee Financial Experts 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 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. Thomis (Compensation Committee Chairman), Dr. Medford and Ms. Liu 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, 2022, the Board met six (6) times, the Audit Committee met four (4) times, the Compensation Committee met four (4) times, and the Governance and Nominating Committee met five (5) times. During the calendar year ended December 31, 2022, 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 15, 2022, attended the meeting in person.

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 this Item will be includedthe 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 is hereby incorporated by reference from an amendment to this Annual Reportother demographic factors. The Company does not impose formal term limits on Form 10-K which we intendits directors.

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 within 120 days aferreports regarding ownership of, and transactions in, our securities with the endSEC and to provide us with copies of those filings. Based solely on our fiscal yearreview of the copies of such forms received by us we believe that during the twelve months ended June 30, 2017. December 31, 2022, all filing requirements applicable to our officers, directors and greater than 10% beneficial owners were filed timely, except for the Form 3 filed by Haihong Zhu on January 27, 2022.

Code of Ethics

We have adopted a Codecode of Ethics applicableethics that applies to all employees, including our CEO and Principal Financial and Accounting Officer.CFO, Controller or any person performing similar functions. A copy of our code of ethical conduct can be found on our website at www.thermogenesis.com. We will satisfy the Codedisclosure requirements under Item 5.05 of Ethics is availableForm 8-K regarding any material amendment to our code of ethics, and any waiver from a provision of our code of ethics that applies to all employees, including our CEO and CFO, Controller or any person performing similar functions, by posting such information on our website at www.cescatherapeutics.com.the internet website address set forth above. The code of ethics will be provided without charge upon request submitted to hr@thermogenesis.com. The Company will report any amendment or waiver to the code of ethics on our website within four (4) business days.

 

ITEM 11.     EXECUTIVE COMPENSATION.

ITEM 11.

Executive Compensation

Named Executive Officers Summary Compensation Table

 

The following table sets forth certain information requiredregarding the compensation paid to our named executive officers (“NEOs”) for the fiscal years ended December 31, 2022 and 2021:

Name and Principal Position

Year

 

Salary ($)

  

Bonus ($)

  

Stock

Awards

($)

  

Option

Awards

($)

  

All

Other

($)

  

Total

($)

 

Chris Xu, Ph.D., MBA

2022

  519,000   180,000   -   -   -   699,000 

Chief Executive Officer

2021

  500,000   248,000   -   -   -   748,000 
                          

Haihong Zhu (1)

2022

  458,000   96,000   -   -   -   554,000 

Chief Operating Officer

                         
                          

Jeffery Cauble, CPA

2022

  264,000   61,000   -   -   -   325,000 

Chief Financial Officer

2021

  254,000   95,000   -   -   -   349,000 


(1)

Ms. Zhu became an executive officer in January 2022.

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 of 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 this Itemthe Board may range from 0% to higher than 100% of his base salary. Either of 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 includedentitled 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 hereby incorporatedterminated by reference froman amendmentthe Company without Cause or he resigns for Good Reason, in each case, within three months prior to this Annual Reportor 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.

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, 2022.

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.

  3   -   1,890.00 

09-Mar-2023

   667   -   1,350.00 

29-Dec-2027

   112   -   1,309.50 

14-Dec-2023

   3   -   1,287.00 

01-Jul-2023

   356   -   134.06 

14-Dec-2028

   1,423   -   134.06 

14-Dec-2028

   30,000(1)  -   1.50 

29-Dec-2027

              

Haihong Zhu

  5   -   1,876.50 

01-Sept-2023

   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

  9   -   1,287.00 

07-Jul-2023

   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 Form 10-Kwhich we intenda case-by-case basis, to filewithin 120 days afterprovide NEOs with the endability to make appropriate, informed decisions on strategy and direction of our fiscalthe 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, 2022, 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   129,000   102,000   1,011,000 

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 June 30, 2017.December 31, 2022.

Name

 

Fees Earned
or Paid in Cash

($)

  

Option

Awards

($)

  

Total

($)

 

Russell Medford, Ph.D.

 $54,500   -  $54,500 

Jeff Thomis, Ph.D.

 $56,000   -  $56,000 

Vivian Liu(1)

 $28,000   -  $28,000 

Debra Donaghy, CPA(2)

 $26,250   -  $26,250 

(1)

Ms. Liu joined the Board in June 2022.

(2)

Ms. Donaghy resigned as a member of our Board of Directors effective June 12, 2022.

The following table sets forth the aggregate number of option awards held by each non-employee director as of December 31, 2022:

Name

Aggregate Number of

Option Awards

Russell Medford, Ph.D.

375

Jeff Thomis, Ph.D.

375

Vivian Liu(1)

-

Debra Donaghy, CPA(2)

251

(1)

Ms. Liu joined the Board in June 2022.

(2)

Ms. Donaghy resigned as a member of our Board of Directors effective June 12, 2022.

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.

 

ITEM 12.     SECURITYAll 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, 2022.

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

  6,403  $430.53   60,197 

Equity compensation plans not approved by security holders

  -   -   - 

Total

  6,403       60,197 

On October 6, 2022, the Board of Directors of the Company approved and adopted an amendment (the “Plan Amendment”) to the Company’s 2016 Equity Incentive Plan (the “2016 Plan”) to increase the aggregate number of shares that may be issued under the 2016 Plan from 26,667 to 66,667 shares. The Plan Amendment was approved by the Company’s stockholders at its annual stockholder meeting held on December 15, 2022.

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 OWNERSHIPOF CERTAIN BENEFICIAL OWNERS ANDMANAGEMENT AND RELATED STOCKHOLDER MATTERS.OF THERMOGENESIS HOLDINGS, INC.

 

The Company has only one class of stock outstanding, our Common Stock. The following table sets forth certain information requiredas of March 15, 2023, 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 15, 2023, there were 1,137,138 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

  2,824,767(2)  77%
         

Russell Medford, Ph.D.

  375(3)  * 
         

Jeff Thomis, Ph.D.

  375(3)  * 
         

Vivian Liu (4)

  -   * 
         

Haihong Zhu

  1,007(3)  * 
         

Jeffery Cauble, CPA

  474(5)  * 
         

Officers & Directors as a Group (6 persons)

  2,826,998   77%
         

Name and Address of 5% Beneficial Owners

        

Boyalife Group Inc.

  2,822,206(6)  77%

*

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 thisthat 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) 2,561 shares issuable upon the exercise of options; (ii) 2,549,291 shares issuable as of March 15, 2023 upon the conversion of the Second Amended and Restated Convertible Promissory Note payable by the Company to Boyalife Group Inc.; and (iii) 272,915 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 15, 2023 or within 60 days thereafter.

(4)    Ms. Liu joined the Board in June 2022.

(5)    Includes 20 common shares and 454 shares issuable upon the exercise of options that are vested as of March 15, 2023 or within 60 days thereafter.

(6)    Consists of 272,915 common shares owned by Boyalife Group Inc. and 2,549,291 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, 2022 and 2021, 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, the Company entered into a Credit Agreement with Boyalife Asset Holding II, Inc., which assigned the Credit Agreement to Boyalife Group (the “Lender”) in July 2022. The Lender is owned and controlled by the Company’s Chief Executive Officer and Chairman of our Board of Directors. The Credit Agreement, as amended, grants to the Company the right to borrow up to $10,000,000 (the “Loan”) at any time prior to December 31, 2023 (the “Maturity Date”). As of December 31, 2022, the Company had an outstanding principal balance on the Loan of $7,000,000.

The Credit Agreement and the Convertible Promissory Note issued thereunder (as amended, the “Note”) provide that the principal and all accrued and unpaid interest under the Loan will be included indue and is hereby incorporated by reference froman amendmentpayable on the Maturity Date, with payments of interest-only due on the last day of each calendar year (but with accrued interest as of March 6, 2023 being capitalized to this Annual Report on Form 10-Kwhich we intend to filewithin 120principal). The Loan bears interest at 22% per annum, simple interest. The Company has five business days after the endLender 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 Company paid $2,628,000 and $2,082,000 for interest related to the Note in the years ended December 31, 2022 and 2021, respectively. Additionally, a payment of our fiscal$1,492,000 was paid in January 2023 relating to interest accrued on the Note during year ended June 30, 2017.

ITEM 13.     CERTAIN RELATIONSHIPSAND RELATEDTRANSACTIONS, AND DIRECTORINDEPENDENCE.December 31, 2022.

 

The information required by this Item willMaturity Date of the Note is subject to acceleration at the option of the Lender upon customary events of default, which include a breach of the Loan documents, termination of operations, or bankruptcy. The Lender’s obligation to make advances under the Loan is subject to the Company’s representations and warranties in the Credit Agreement continuing to be included intrue at all times and is hereby incorporated by reference froman amendment to this Annual Report on Form 10-Kwhich we intend to filewithin 120 days afterthere being no continuing event of default under the end of our fiscal year ended June 30, 2017.

ITEM 14.     PRINCIPAL ACCOUNTING FEES AND SERVICES.Note.

 

The information requiredCredit Agreement includes a down-round provision that lowers the conversion price of the Note if the Company issues shares of common stock at a price per share lower than the conversion price then in effect. At December 31, 2022, the conversion price was $6.30 per share. Additionally, the Company extended the July 2019 Note in January 2023, further lowering the conversion price of the Note to $2.87 as of January 31, 2023.

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 this ItemBoyalife and its affiliates’ (including under the Boyalife Note (as defined below)) without any further payment (the “Boyalife Ownership Percentage”). The Restated Nomination Agreement will be includedterminate according to its terms when and if the Boyalife Ownership Percentage falls below 20%.

Lease Agreement

On March 24, 2022, we entered into a Lease Agreement (the “CDMO Facility Lease”), with Z3 Investment LLC (“Lessor”) for approximately 35,475 square feet of space in the Sacramento, California area in which we plan to partner with the Lessor to build out into a state-of-the-art current good manufacturing practice (cGMP) compliant facility with 12 cGMP clean room suites (with the Lessor paying to the related build-out costs). The CDMO Facility Lease provides for a lease term beginning on April 1, 2022 and ending on September 30, 2027, with a right of the Company to extend the lease for 2 additional periods of 5 years each.  Lessor is hereby incorporated by reference froman amendment to this Annual Report on Form 10-Kwhich we intend to filewithin 120 days after the endan affiliate of our fiscalChairman and CEO, Dr. Xu, and COO, Ms. Zhu.  Total payments for the year ended June 30, 2017.December 31, 2022 were $587,000 and $207,000 for a security deposit. 

 

69
71

 

PART IVDirector Independence

 

Our Board of Directors has concluded that Dr. Medford, Dr. Thomis, and Ms. Liu 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 2022

  

Fiscal 2021

 

Audit Fees(1)

 $443,000  $323,000 

Audit-Related Fees

  -   - 

Tax Fees

  -   - 

All Other Fees

  -   - 

Total Fees

 $443,000  $323,000 

(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.

ITEM 15.     PART IVEXHIBITSAND FINANCIALSTATEMENT SCHEDULES

ITEM 15.

Exhibits and Financial Statement Schedules

 

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

 

Page Number

Page Number

(a)  (1)

Financial Statements

Report of Independent Registered Public Accounting Firm (PCAOB ID #688)

37

27
  

Consolidated Balance Sheets at June 30, 2017December 31, 2022 and 20162021

38

29
  

Consolidated Statements of Operations and Comprehensive Loss for the years endedJune 30, 2017Years Ended December 31, 2022 and 20162021

3930
  

Consolidated Statements of Stockholders’ Equity for the yearsended June 30, 2017Years Ended December 31, 2022 and 20162021

4031
  

Consolidated Statements of Cash Flows for the years endedJune 30, 2017Years Ended December 31, 2022 and 20162021 32

4132
  

Notes to Consolidated Financial Statements

42

33

 

Management’s Report on Internal Control over Financial Reporting is contained as part of this reportAnnual 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.

 

ITEM16.     FORM 10-K SUMMARYExhibits 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.

None.

 

7271

 

EXHIBIT INDEX

 

Exhibit No.

Document Description

Incorporation by Reference

2.11.1

Plan of MergerAt the Market Offering Agreement, dated December 13, 2019, by and Reorganization Agreement between ThermoGenesis Corp.Holdings, Inc. and TotipotentRX, dated July 15, 2013

IncorporatedH.C. Wainwright & Co., LLC, incorporated by reference to Exhibit 2.11.2 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 withMay 20, 2020.

1.3

Amendment No. 2 to At the SEC July 16Market Offering Agreement dated May 19, 2020, by and between ThermoGenesis Holdings, Inc. and H.C. Wainwright & Co.,2013. LLC, incorporated by reference to Exhibit 1.3 to Form 8-K filed February 3, 2022.

3.1

Sixth 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 of Registration Statement on Form S-8 filed with the SEC on May 18, 2017.

3.2

Amended and Restated Bylaws of Cesca TherapeuticsThermoGenesis Holdings, Inc.

Incorporated, incorporated by reference to Exhibit 99.13.2 to Form 8-K filed with the SEC on October 30, 2014.March 10, 2023.

3.44.1

CertificateForm of Merger

IncorporatedCommon Stock Purchase Warrant, incorporated by reference to Exhibit 3.44.1 to Form 8-K filed with the SEC on February 21, 2014.March 28, 2018.

10.14.2

Amended and Restated 2006 Equity Incentive Plan

IncorporatedForm of Common Warrant, incorporated by reference to Exhibit 10.6.110.37 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 May 1, 2014.January 4, 2019.

10.2+4.4

Product Purchase and International DistributionDescription of Securities Registered Under Section 12 of the Securities Exchange Act of 1934, as amended.

4.5

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).

10.1

Form of Stock Option Award Agreement, between ThermoGenesis Corp. and Golden Meditech Holdings Limited

Incorporatedincorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on August 24, 2012 and amended October 24, 2012.January 3, 2020.

10.310.2

2012 Independent Director Plan

Incorporated by reference to Exhibit AManufacturing and Supply Amending Agreement #1, effective as of the Company’s Definitive Proxy Statement filed with the SEC on October 23, 2012.

10.4+

Sales and Purchase AgreementMarch 16, 2020, between ThermoGenesis Corp. and CBR Systems, Inc. dated December 31, 2013

Incorporated, incorporated by reference to Exhibit 10.1810.1 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 7, 2014.4, 2019.

10.510.6

EmploymentVoting Agreement, with Robin C. Stracey

Incorporateddated 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 referencereferenced to Exhibit 10.1910.2 to Form 8-K filed with the SEC on June 15, 2015.January 4, 2019.

10.610.7

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 of Series A Warrant8-K filed with the SEC on January 4, 2019.

10.8

IncorporatedInvestors’ 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 September 1, 2015.January 4, 2019.

10.6.110.9

FormAmended and Restated Certificate of Series A Warrant Amendment

IncorporatedIncorporation of CARTXpress Bio, Inc., incorporated by reference to Exhibit 10.710.5 to Form 8-K filed with the SEC on February 3, 2016.January 4, 2019.

10.710.10

General ReleaseSupply Agreement, dated as of August 30, 2019, between Corning Incorporated and Waiver between the Company and Kenneth L. Harris

IncorporatedThermoGenesis Holdings, Inc., incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on September 30, 2015.6, 2019.

10.810.11

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 incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on May 31, 2017.2017.

10.910.16#

Employment Agreement with Michael Bruch

IncorporatedAmended and Restated 2006 Equity Incentive Plan, incorporated by reference to Exhibit 10.210.6.1 to Form 8-K filed with the SEC on October 28, 2015.

10.10

Purchase Agreement between the Company and Boyalife Investment Inc. and Boyalife (Hong Kong) LimitedMay 1, 2014.

Incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on February 3, 2016.

10.11

Form of Debenture between the Company and Boyalife Investment Inc. and Boyalife (Hong Kong) Limited

Incorporated by reference to Exhibit 10.2 to Form 8-K filed with the SEC on February 3, 2016.

10.12

Form of Warrant

Incorporated by reference to Exhibit 10.3 to Form 8-K filed with the SEC on February 3, 2016.

10.13

Form of Nomination and Voting Agreement

Incorporated by reference to Exhibit 10.4 to Form 8-K filed with the SEC on February 3, 2016.

10.14

Form of Security Agreement

Incorporated by reference to Exhibit 10.5 to Form 8-K filed on February 3, 2016.

Exhibit No.

Document Description

Incorporation by Reference

10.15

Form of Securities Purchase Agreement between Cesca Therapeutics Inc. and certain institutional accredited investors, dated August 3, 2016

Incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on August 4, 2016.

10.16

Form of Placement Agency Agreement between Cesca Therapeutics Inc. and Maxim Group LLC, dated August 3, 2016

Incorporated by reference to Exhibit 10.2 to Form 8-K filed with the SEC on August 4, 2016.

10.17

General Release and Waiver dated November 7, 2016 by and between Cesca Therapeutics, Inc. and Robin Stracey

Incorporated by reference to Exhibit 10.2 to Form 8-K/A filed with the SEC on November 17, 2016.

10.18

Employment Agreement dated December 14, 2016 by and between Cesca Therapeutics Inc. and Dr. Xiaochun (Chris) Xu

Incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on December 20, 2016.

10.19

Form of Indemnification Agreement,

Incorporated incorporated by reference to Exhibit 10.1 to Form 8-K/A filed with the SEC on November 17, 2016.

10.2010.18#

Cesca Therapeutics Inc. 2016 Equity Incentive Plan, as amended

IncorporatedForm of Notice of Grant of Stock Options and Option Agreement, incorporated by reference to Exhibit 10.1 to Registration Statement on Form S-88-K filed with the SEC on May 18,11, 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

General ReleaseFirst Amended and WaiverRestated Revolving Credit Agreement, dated April 16, 2018, between Mr. Michael Bruch and Cesca Therapeutics Inc. and Boyalife Asset Holding II, Inc., effective February 28, 2017incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on April 18, 2018.

10.22

IncorporatedSecond 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, Second Amended and Restated Convertible Promissory Note, dated April 16, 2018, issued by ThermoGenesis Holdings, Inc. to Boyalife Group, Inc., incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on March 2, 2017.8, 2022.

10.2210.24

Employment Agreement between Ms. Vivian LiuAmendment No. 2 to Second Amended and Cesca Therapeutics Inc., effective February 24, 2017

Incorporated by reference to Exhibit 10.2 to Form 8-K filed with the SEC on March 2, 2017.

10.23

Revolving Credit Agreement,Restated Convertible Promissory Note, dated March 6, 2017,2023, between Cesca TherapeuticsThermoGenesis Holdings, Inc. and Boyalife Investment Fund II,Group Inc.

Incorporated, incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on March 10, 2017.2023.

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.

10.2410.26

Convertible Promissory Note,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, 2017, issued by Cesca Therapeutics2023, between ThermoGenesis Holdings, Inc. toand Boyalife Investment Fund II,Group, Inc.

Incorporated, incorporated by reference to Exhibit 10.2 to Form 8-K filed with the SEC on March 10, 2017.2023.

10.2510.29#

Asset AcquisitionForm of Stock Option Agreement, dated July 7, 2017, between ThermoGenesis Corp. and SynGen Inc.

Incorporatedincorporated by reference to Exhibit 2.110.2 to Form 8-K filed with the SEC on July 11, 2017.December 19, 2018.

10.2610.30

VotingLicense and Technology Access Agreement, dated July 7, 2017, among the Company,March 24, 2022, between ThermoGenesis Corp.Holdings, Inc. and Boyalife Genomics Tianjin Ltd., Bay City Capital Fund V. L.P. and Bay City Capital Fund Co-Investment Fund, L.P.incorporated by reference to Exhibit 10.1 to Form 8-K filed on March 28, 2022.

10.31

IncorporatedLease 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 11, 2017.28, 2022.

10.2710.34

Right of First RefusalAmendment No. 3 to Convertible Promissory Note, dated January 31, 2023, between ThermoGenesis Holdings, Inc. and Co-Sale Agreement, dated July 7, 2017, among the Company, ThermoGenesis Corp., Bay City Capital Fund V. L.P. and Bay City Capital Fund Co-Investment Fund, L.P.

IncorporatedOrbrex (USA) Co Limited, incorporated by reference to Exhibit 10.310.1 to Form 8-K filed with the SEC on July 11, 2017.February 6, 2023.

10.2810.35

Amended and Restated CertificateForm of Incorporation of ThermoGenesis Corp.

IncorporatedSecurities Purchase Agreement (Incorporated by reference to Exhibit 10.410.39 to Amendment No. 3 to Form 8-KS-1 filed with the SEC on July 11, 2017.October 17, 2022).

10.29#21.1

International Distributor Agreement, dated August 21, 2017, betweenSubsidiaries of ThermoGenesis Corp. and Boyalife W.S.N.Holdings, Inc., incorporated by reference to Exhibit 21.1 to Form 10-K filed on March 28, 2022.

Filed herewith

23.1

Consent of Marcum LLP, Independent Registered Public Accounting Firm

Filed herewith.

31.1

Certification by the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

Filed herewith.

Exhibit No.

Document Description

Incorporation by Reference

31.2

Certification by the Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

Filed herewith.

32

Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002

Filed herewith.

101.INS

Inline XBRL Instance Document‡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‡Document

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document‡Document

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document‡Document

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document‡Document

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document‡Document

104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

Footnotes to Exhibit Index

#

XBRL information is furnished and not filed for purpose of Sections 11 and 12 of the Securities Act of 1933 and Section 18 of the Securities Exchange Act of 1934, and is not subject to liability under those sections, is not part of any registration statementRepresents a management contract or prospectus to which it relates and is not incorporatedcompensatory plan, contract or deemed to be incorporated by reference into any registration statement, prospectus or other document.arrangement.

+

The SEC has granted confidential treatment with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.

#*

Confidential treatment has been requested for certain confidential portions of this exhibit pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.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 omitted from this exhibitredacted because the Company has determined that such information (i) is not material and filed separately with(ii) would likely cause competitive harm to the SEC.Company if it were to be publicly disclosed.

 

74
75

 

GLOSSARY OF CERTAIN TECHNICAL TERMS

510(k): Formal notification to FDA to obtain clearance to market the medical device. The device must be substantially equivalent to devices manufactured prior to 1976, or which have been found substantially equivalent after that date.

ADULT STEM CELLS: All non-embryonic stem cells.

AUTOLOGOUS: Autogenous; related to self; originating within an organism itself, as obtaining blood from the patient for use in the same patient.

CRITICAL LIMB ISCHEMIA (“CLI”): A severe obstruction of the arteries that seriously decreases blood flow to the extremities (arms, hands, legs, feet) and has progressed to the point of severe pain and even skin ulcers of sores.

CRYOPRESERVATION: Maintaining the life of excised tissue or organs by freezing and storing at very low temperatures.

HEMATOPOIETIC: The formation of blood.

IN VITRO: Occurring in an artificial environment outside a living organism.

IN VIVO: Occurring or made to occur within a living organism or natural setting.

ISCHEMIA: Deficient supply of blood and oxygen to a body part.

PERIPHERAL BLOOD: A term used to describe the blood that is contained in the body’s circulatory system. It can be collected by a health care professional by inserting a needle into a vein.

PMA Classification:The most stringent type of medical device marketing application required by the FDA (one category above 510(k) pre-market notification). Unlike the 510(k) pathway, the manufacturer must submit an exhaustive application to the FDA and must receive approval prior to beginning commercial marketing of a device. The PMA application includes information on how the device was designed and manufactured, as well as preclinical and clinical studies, demonstrating that it is safe and effective for its intended use.

REGENERATIVE MEDICINE: The process of creating living, functional tissues to repair or replace tissue or organ function lost due to age, disease, damage, or congenital defects.

STEM CELLS: Undifferentiated, primitive cells in the bone marrow or cord blood with the ability both to multiply and to differentiate into specific blood or tissue cells.

SIGNATURES

 

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

 

   

Cesca TherapeuticsThermoGenesis Holdings, Inc.

Dated: September 21, 2017March 30, 2023

 

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 JeffJeffery 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 reportAnnual 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: September 21, 2017March 30, 2023

 

Chris Xu,

Chief Executive Officer and Chairman of the Board

(Principal Executive Officer)

  
    

By:/s/

JeffJeffery Cauble

 

Dated: September 21, 2017March 30, 2023

 

JeffJeffery Cauble, PrincipalChief Financial and Accounting Officer

(Principal Financial Officer and Principal Accounting Officer)

  
    

By:/s/ /s/

Vivian Liu

 

Dated: September 21, 2017March 30, 2023

 

Vivian Liu, Chief Operating Officer and Director

  
    

By: /s/

Russell Medford

 

Dated: September 21, 2017March 30, 2023

 

Russell Medford, Director

  
    

By: /s/

Mahendra S. Rao

Dated: September 21, 2017

Mahendra S. Rao, Director

By: /s/

Joseph Thomis

 

Dated: September 21, 2017March 30, 2023

 

Joseph Thomis, Director

  
    

By: /s/

Mark WestgateHaihong Zhu

 

Dated: September 21, 2017March 30, 2023

 

Mark Westgate,Haihong Zhu, Director

  
    

By: /s/

James Xu

Dated: September 21, 2017

James Xu, Director

 

77