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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 20549

 

FORM 10-Q

 

☒

Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended September 30, 2023.

 

or

 

☐

Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition from _____________ to _______________.

 

Commission File Number: 333-82900

thmo20230930_10qimg001.jpg

 

ThermoGenesis 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, $.001 par value

  

THMO

  

Nasdaq Capital Market

 

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. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions 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 ☐

Non-accelerated filer ☒

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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

 

Class

  

Outstanding at November 9, 2023

Common stock, $.001 par value

  

3,136,504

 

 
 

 

 

ThermoGenesis Holdings, Inc.

 

 

INDEX

 

    Page Number
PART I FINANCIAL INFORMATION  
     
ITEM 1. Financial Statements 1
     
ITEM 2.

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

 16
     
ITEM 3. Quantitative and Qualitative Disclosures about Market Risk 22
     
ITEM 4. Controls and Procedures 22
     
PART II OTHER INFORMATION  
     
ITEM 1. Legal Proceedings 22
ITEM 1A. Risk Factors 22
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 22
ITEM 3. Defaults upon Senior Securities 23
ITEM 4. Mine Safety Disclosure 23
ITEM 5. Other Information 23
ITEM 6. Exhibits 24
     
Signatures 25

 

i
 
 

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

 

ThermoGenesis Holdings, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

 

   

September 30,
2023

    

December 31,
2022

  

ASSETS

                

Current assets:

                

Cash and cash equivalents

   $ 4,018,000     $ 4,177,000  

Accounts receivable, net of allowance for credit losses of $2,000 ($149,000 at December 31, 2022)

     368,000       1,865,000  

Inventories

     1,821,000       3,334,000  

Prepaid expenses and other current assets

     718,000       1,508,000  

Total current assets

     6,925,000       10,884,000  
                 

Inventories, non-current

     772,000       1,003,000  

Equipment and leasehold improvements, net

     2,523,000       1,254,000  

Right-of-use operating lease assets, net

     190,000       372,000  

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

     3,213,000       3,550,000  

Goodwill

     781,000       781,000  

Intangible assets, net

     1,262,000       1,286,000  

Other assets

     255,000       256,000  

Total assets

   $ 15,921,000     $ 19,386,000  
                 

LIABILITIES AND STOCKHOLDERS’ EQUITY

                

Current liabilities:

                

Accounts payable

   $ 591,000     $ 820,000  

Accrued payroll and related expenses

     451,000       399,000  

Deferred revenue – short-term

     818,000       782,000  

Convertible promissory note – related party

     4,817,000       5,777,000  

Interest payable – related party

     225,000       1,492,000  

Convertible promissory note, net

     456,000       962,000  

Other current liabilities

     1,532,000       1,277,000  

Total current liabilities

     8,890,000       11,509,000  
                 

Operating lease obligations – long-term

     --       131,000  

Operating lease obligations – related party – long-term

     3,071,000       3,495,000  

Deferred revenue – long-term

     680,000       911,000  

Other noncurrent liabilities

     17,000       17,000  

Total liabilities

     12,658,000       16,063,000  
                 

Commitments and contingencies

            
                 

Stockholders’ equity:

                

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

             --  

Common stock, $0.001 par value; 350,000,000 shares authorized; 3,136,504 issued and outstanding (1,037,138 at December 31, 2022)

     3,000       1,000  

Additional paid in capital

     281,632,000       270,377,000  

Accumulated deficit

     (277,154,000 )     (266,193,000 )

Accumulated other comprehensive loss

     114,000       111,000  

Total ThermoGenesis Holdings, Inc. stockholders’ equity

     4,595,000       4,296,000  
                 

Noncontrolling interests

     (1,332,000 )     (973,000 )

Total equity

     3,263,000       3,323,000  

Total liabilities and equity

   $ 15,921,000     $ 19,386,000  

 

See accompanying notes to the condensed consolidated financial statements.

 

1
 

 

 

ThermoGenesis Holdings, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

 

   

Three Months Ended
September 30,

    

Nine Months Ended

September 30,

  
   

2023

    

2022

    

2023

    

2022

  
                                 

Net revenues

   $ 2,194,000     $ 2,115,000     $ 7,039,000     $ 7,807,000  

Cost of revenues

     1,799,000       1,678,000       5,070,000       5,491,000  
                                 

Gross profit

     395,000       437,000       1,969,000       2,316,000  
                                 

Expenses:

                                

Selling, general and administrative

     1,686,000       1,982,000       5,346,000       5,665,000  

Research and development

     266,000       470,000       955,000       1,317,000  
                                 

Total operating expenses

     1,952,000       2,452,000       6,301,000       6,982,000  
                                 

Loss from operations

     (1,557,000 )     (2,015,000 )     (4,332,000 )     (4,666,000 )
                                 
Other expenses:                                

Interest expense

     (2,118,000 )     (1,391,000 )     (6,689,000 )     (3,572,000 )

Loss on retirement of debt

     (87,000 )     --       (326,000 )     --  

Other income/(expense)

     22,000       3,000       27,000       (1,000 )
                                 

Total other expense

     (2,183,000 )     (1,388,000 )     (6,988,000 )     (3,573,000 )
                                 

Net loss

     (3,740,000 )     (3,403,000 )     (11,320,000 )     (8,239,000 )
                                 

Loss attributable to noncontrolling interests

     (125,000 )     (163,000 )     (359,000 )     (402,000 )
                                 

Net loss attributable to common stockholders

   $ (3,615,000 )   $ (3,240,000 )   $ (10,961,000 )   $ (7,837,000 )
                                 

COMPREHENSIVE LOSS

                                

Net loss

   $ (3,740,000 )   $ (3,403,000 )   $ (11,320,000 )   $ (8,239,000 )

Other comprehensive loss:

                                

Foreign currency translation adjustments gain

     9,000       22,000       3,000       67,000  

Comprehensive loss

     (3,731,000 )     (3,381,000 )     (11,317,000 )     (8,172,000 )

Comprehensive loss attributable to noncontrolling interests

     (125,000 )     (163,000 )     (359,000 )     (402,000 )

Comprehensive loss attributable to common stockholders

   $ (3,606,000 )   $ (3,218,000 )   $ (10,958,000 )   $ (7,770,000 )
                                 

Per share data:

                                
                                 

Basic and diluted net loss per common share

   $ (1.44 )   $ (4.66 )   $ (5.26 )   $ (18.49 )
                                 

Weighted average common shares outstanding – basic and diluted

     2,503,631       694,795       2,083,095       423,897  

 

See accompanying notes to the condensed consolidated financial statements.

 

2
 

 

 

ThermoGenesis Holdings, Inc.

Condensed Consolidated Statements of Equity

For the Three and Nine Months Ended September 30, 2023

(Unaudited)

 

   

Shares

    

Common

Stock

    

Paid in

Capital in

Excess of Par

    

Accumulated

Deficit

    

AOCL*

    

Non-

Controlling

Interests

    

Total Equity

  

Balance at January 1, 2023

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

Stock-based compensation expense

     --       --       10,000       --       --       --       10,000  

Related party convertible note price reset

     --       --       3,160,000       --       --       --       3,160,000  

Convertible note price reset

     --       --       43,000       --       --       --       43,000  

Conversion of note payable to common stock

     215,000       1,000       602,000       --       --       --       603,000  

Sale of common stock and warrants, net

     125,000       --       2,640,000       --       --       --       2,640,000  

Exercise of warrants

     158,731       --       421,000       --       --       --       421,000  

Foreign currency translation gain

     --       --       --       --       (6,000 )     --       (6,000 )

Net loss

     --       --       --       (5,086,000 )     --       (96,000 )     (5,182,000 )

Balance at March 31, 2023

     1,535,869     $ 2,000     $ 277,253,000     $ (271,279,000 )   $ 105,000     $ (1,069,000 )   $ 5,012,000  
                                                         

Stock-based compensation expense

     --       --       13,000       --       --       --       13,000  

Exercise of pre-funded warrants

     946,429       --       --       --       --       --       --  

Net loss

     --       --       --       (2,260,000 )     --       (138,000 )     (2,398,000 )

Balance at June 30, 2023

     2,482,298     $ 2,000     $ 277,266,000     $ (273,539,000 )   $ 105,000     $ (1,207,000 )   $ 2,627,000  
                                                         

Stock-based compensation expense

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

Related party convertible note converted to common stock

     654,206       1,000       699,000       --       --       --       700,000  

Related party convertible note price reset

     --       --       3,660,000       --       --       --       3,660,000  

Foreign currency translation gain

     --       --       --       --       9,000       --       9,000  

Net loss

     --       --       --       (3,615,000 )     --       (125,000 )     (3,740,000 )

Balance at September 30, 2023

     3,136,504     $ 3,000     $ 281,632,000     $ (277,154,000 )   $ 114,000     $ (1,332,000 )   $ 3,263,000  

 

3
 

 

ThermoGenesis Holdings, Inc.

Condensed Consolidated Statements of Equity

For the Three and Nine Months Ended September 30, 2022

 

   

Shares

    

Common

Stock

    

Paid in

Capital in

Excess of Par

    

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  
                                                         

Adoption of ASU 2020-06

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

Stock-based compensation expense

     --       --       42,000       --       --       --       42,000  

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

     20,407       --       594,000       --       --       --       594,000  

Related party convertible note price reset

                     213,000                               213,000  

Foreign currency translation gain

     --       --       --       --       14,000       --       14,000  

Net loss

     --       --       --       (1,910,000 )     --       (126,000 )     (2,036,000 )

Balance at March 31, 2022

     300,036     $ --     $ 258,627,000     $ (256,833,000 )   $ 45,000     $ (557,000 )   $ 1,282,000  
                                                         

Stock-based compensation expense

     --       --       72,000       --       --       --       72,000  

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

     97,726       --       1,450,000       --       --       --       1,450,000  

Related party convertible note price reset

     --       --       2,475,000       --       --       --       2,475,000  

Conversion of related party note payable to common stock

     234,495       1,000       2,999,000       --       --       --       3,000,000  

Foreign currency translation gain

     --       --       --       --       31,000       --       31,000  

Net loss

     --       --       --       (2,688,000 )     --       (113,000 )     (2,801,000 )

Balance at June 30, 2022

     632,257     $ 1,000     $ 265,623,000     $ (259,521,000 )   $ 76,000     $ (670,000 )   $ 5,509,000  
                                                         

Stock-based compensation expenses

     --       --       70,000       --       --       --       70,000  

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

     78,710       --       993,000       --       --       --       993,000  

Related party convertible note price reset

     --       --       1,075,000       --       --       --       1,075,000  

Foreign currency translation gain

     --       --       --       --       22,000       --       22,000  

Net loss

     --       --       --       (3,240,000 )     --       (163,000 )     (3,403,000 )

Balance at September 30, 2022

     710,967     $ 1,000     $ 267,761,000     $ (262,761,000 )   $ 98,000     $ (833,000 )   $ 4,266,000  

 

 

*

Accumulated other comprehensive loss.

 

See accompanying notes to the condensed consolidated financial statements.

 

4
 

 

 

ThermoGenesis Holdings, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

   

Nine Months Ended

September 30,

  
   

2023

    

2022

  

Cash flows from operating activities:

                

Net loss

   $ (11,320,000 )   $ (8,239,000 )

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

                

Depreciation and amortization

     816,000       666,000  

Stock based compensation expense

     30,000       184,000  

Amortization of debt discount/premium, net

     5,396,000       1,897,000  

Reserve for excess and slow-moving inventories

     480,000       654,000  

Loss on retirement of debt

     326,000       --  

Net change in operating assets and liabilities:

                

Accounts receivable

     1,496,000       (1,323,000 )

Inventories

     1,264,000       582,000  

Prepaid expenses and other assets

     791,000       757,000  

Accounts payable

     (226,000 )     (210,000 )

Interest payable – related party

     (289,000 )     (1,132,000 )

Accrued payroll and related expenses

     52,000       145,000  

Deferred revenue – short-term

     37,000       122,000  

Other current liabilities

     255,000       446,000  

Long-term deferred revenue and other noncurrent liabilities

     (786,000 )     (650,000 )
                 

Net cash used in operating activities

     (1,678,000 )     (6,101,000 )
                 

Cash flows from investing activities:

                

Capital expenditures

     (1,541,000 )     (308,000 )
                 

Net cash used in investing activities

     (1,541,000 )     (308,000 )
                 

Cash flows from financing activities:

                
                 

Proceeds from issuance of common stock, net of expenses

     2,640,000       3,037,000  

Proceeds from the exercise of warrants

     421,000       --  
                 

Net cash provided by financing activities

     3,061,000       3,037,000  
                 

Effects of foreign currency rate changes on cash and cash equivalents

     (1,000 )     (5,000 )

Net increase (decrease) in cash and cash equivalents

     (159,000 )     (3,377,000 )
                 

Cash and cash equivalents at beginning of period

     4,177,000       7,280,000  
Cash and cash equivalents at end of period   $ 4,018,000     $ 3,903,000  
                 

Supplemental disclosures of cash flow information:

                

Cash paid for related party interest

   $ 1,492,000     $ 2,628,000  

Cash paid for interest

   $ 140,000     $ 180,000  

Fair value of January 2023 amended convertible note issued in connection with the extinguishment of original convertible note

   $ 1,239,000       --  

Fair value of July 2023 amended convertible note issued in connection with the extinguishment of original convertible note

   $ 484,000       --  

Right-to-use asset acquired under operating lease, related party

     --     $ 3,863,000  

Convertible note price reset

   $ 43,000       --  

Related party convertible note converted to common stock

   $ 700,000     $ 3,000,000  

Related party convertible note price reset

   $ 6,820,000     $ 3,763,000  

Promissory note converted to common stock

   $ 603,000       --  

 

See accompanying notes to the condensed consolidated financial statements.

 

5
 

 

ThermoGenesis Holdings, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

 

1.

Description of Business

 

Overview

 

ThermoGenesis Holdings, Inc. (“ThermoGenesis Holdings,” the “Company,” “we,” “our,” “us”) develops and commercializes a range of automated technologies for cell-banking, cell-processing, and cell-based therapeutics. Since the 1990’s, ThermoGenesis Holdings has been a pioneer in, and a leading provider of automated systems that isolate, purify and cryogenically store units of hematopoietic stem and progenitor cells for the cord blood banking industry. The Company was founded in 1986 and is incorporated in the State of Delaware and headquartered in Rancho Cordova, CA. Our common stock is traded on the Nasdaq Capital Market under the ticker symbol “THMO”.

 

Medical Device Products for Automated Cell Processing

 

The Company provides the AutoXpress® and BioArchive® platforms for automated clinical bio-banking, PXP® platform for point-of-care cell-based therapies and the CAR-TXpress™ platform for large scale cell manufacturing services. All product lines are reporting as a single reporting segment in the financial statements.

 

CDMO Business

 

The Company is expanding its business to include contract development and manufacturing services for cell and cell-based gene therapies. The Company is in the process of building out the capabilities to become a world-class Contract Development and Manufacturing Organization (“CDMO”) for cell and cell-based gene therapies. The Company is building 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 companies. The ReadyStart Suites are located in a 35,500+ square foot cGMP facility that will meet the highest scientific, quality, and regulatory requirements. The CDMO facility was completed in October of 2023.

 

Reverse Stock Split

 

On December 22, 2022, we effected a one (1) for forty-five (45) reverse stock split of our issued and outstanding common stock. All historical share amounts disclosed in this quarterly report on Form 10-Q 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.

 

 

2.

Going Concern

 

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.

 

6
 

 

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 Polices

 

There have been no material changes in the Company’s significant accounting policies to those disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022.

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such Securities and Exchange Commission (“SEC”) rules and regulations and accounting principles applicable for interim periods. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair statement of the results for the periods presented have been included. Events subsequent to the balance sheet date have been evaluated for inclusion in the accompanying condensed consolidated financial statements through the date of issuance.

 

Operating results for the three and nine months ended September 30, 2023, are not necessarily indicative of the results that may be expected for the Company’s fiscal year ending December 31, 2023. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto included in ThermoGenesis Holdings’ Annual Report on Form 10-K for the year ended December 31, 2022.

 

Principles of Consolidation

 

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

 

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

 
7
 

 

Recently Adopted Accounting Standards

 

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

 

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

 

 

4.

Related Party Transactions

 

Convertible Promissory Note and Revolving Credit Agreement

 

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

 

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

 

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

 

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

 

8
 

 

The following summarizes the Note:

 

 

Maturity

Date

  

Stated

Interest

Rate

    

Conversion

Price

    

Face

Value

    

Debt

Discount

    

Carrying

Value

  

September 30, 2023

12/31/23

     22 %   $ 1.07     $ 7,278,000     $ (2,461,000 )   $ 4,817,000  

December 31, 2022

12/31/23

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

 

The Note includes a down-round anti-dilution provision that lowers its conversion price if the Company sells shares of common stock or issues convertible debt at a lower price per share. Through September 30, 2023, the down-round provision was triggered as noted below:

 

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

 

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

 

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

 

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

 

   

January

2023

    

March

2023

    

July

2023

  

Conversion price before

   $ 6.30     $ 2.87     $ 2.65  

Conversion price after

   $ 2.87     $ 2.65     $ 1.07  

Term (years)

     0.09       0.78       0.42  

Volatility

     167 %     168.9 %     156.8 %

Dividend rate

     0 %     0 %     0 %

Risk free rate

     4.46 %     4.20 %     4.22 %

 

For the three and nine months ended September 30, 2023, the Company amortized $1,720,000 and $5,582,000 of debt discount related to triggering events, compared to $940,000 and $1,897,000 for the three and nine months ended September 30, 2022. In addition to the amortization, the Company also recorded interest expense of $409,000 and $1,203,000 for the three and nine months ended September 30, 2023, compared to $394,000 and $1,496,000 for the three and nine months ended September 30, 2022, respectively. The interest payable balance as of September 30, 2023 and December 31, 2022 was $225,000 and $1,492,000, respectively.

 

9
 

 

Boyalife Genomics

 

On March 24, 2022, the Company entered into a License and Technology Access Agreement with Boyalife Genomics Tianjin Ltd. (“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 CDMO cell therapy manufacturing business through a division named TG Biosynthesis.

 

Under the terms of the agreement, the Company transferred its remaining 8.64% interest in ImmuneCyte, Inc. 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 three and nine months ended September 30, 2023, no sales were recorded under the license agreement and no royalty payments were made to Boyalife Genomics.

 

 

5.

Related Party Lease

 

Z3 Investment

 

On March 24, 2022, the Company entered into a five-year Lease Agreement with Z3 Investment LLC, an affiliate owned by the Company’s CEO and Chairman of the Board and the Company’s Chief Operating Officer who is also a Board Member, beginning April 1, 2022, for approximately 35,000 square feet of laboratory and office space in Rancho Cordova, California. Under the terms of the agreement, monthly rent is $104,000 per month (with a 4% annual increase). Additionally, the Company will pay all operating expenses as they become due estimated to be approximately $10,000 per month and will be expensed in the period incurred. The Company has the option to renew the lease for up to ten years after the commencement of the initial five-year term.

 

Operating Lease

 

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

 

The following summarizes the Company’s operating lease:

 

   

September 30,

2023

    

December 31,

2022

  

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

   $ 3,213,000     $ 3,550,000  

Current lease liability (included in other current liabilities)

     551,000       433,000  

Non-current lease liability – related party

     3,071,000       3,495,000  
                 

Weighted average remaining lease term

     4.0       4.8  

Discount rate

     22 %     22 %

 

10
 

 

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

 

2023 (Remaining)

   $ 324,000  

2024

     1,307,000  

2025

     1,359,000  

2026

     1,428,000  

Thereafter

     1,133,000  

Total lease payments

   $ 5,551,000  

Less: imputed interest

     (1,930,000 )

Present value of operating lease liabilities

   $ 3,621,000  

 

Statement of Cash Flows

 

Cash paid for amounts included in the measurement of operating lease liabilities was $932,000 and $277,000 for the nine months ended September 30, 2023 and 2022, respectively.

 

 

6.

Convertible Promissory Note

 

July 2019 Note

 

On July 23, 2019, the Company entered into a private placement with Orbrex (USA) Co. Limited (“Orbrex”), pursuant to which the Company issued and sold to Orbrex an unsecured convertible promissory note, as amended, in the original principal amount of $1,000,000 (the “July 2019 Note”). The July 2019 Note bears interest at a rate of twenty-four percent (24%) per annum and is payable in arrears on January 31 of each year. In the nine months ended September 30, 2023, the Company has amended the July 2019 Note two times:

 

 

●

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

●

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

 

The following summarizes the July 2019 Note:

 

 

Maturity

Date

  

Stated

Interest

Rate

    

Conversion

Price

    

Face
Value

    

Debt
Discount/
Premium

    

Carrying

Value

  

September 30, 2023

1/31/2024

     24%     $ 1.07     $ 397,000     $ 59,000     $ 456,000  

December 31, 2022

7/31/2023

     24%     $ 6.30     $ 1,000,000     $ (38,000 )   $ 962,000  

 

11
 

 

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

 

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

 

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

 

   

March

2023

  

Conversion price before

   $ 2.87  

Conversion price after

   $ 2.65  

Term (years)

     0.36  

Volatility

     182 %

Dividend rate

     0 %

Risk free rate

     4.20 %

 

The Company recorded amortization expense for the July 2019 Note of ($35,000) and ($186,000) for the three and nine months ended September 30, 2023, respectively. In addition to the amortization, the Company also recorded interest expense related to the July 2019 Note of $24,000 and $90,000 for the three and nine months ended September 30, 2023, compared to $60,000 and $180,000 for the three and nine months ended September 30, 2022, respectively.

 

 

7.

Stockholders’ Equity

 

Common Stock

 

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

 

In connection with the Offering, the Company entered into a Warrant Amendment Agreement (the "Warrant Amendment Agreement”), dated March 15, 2023, with the Investor, whereby the Company agreed to amend existing warrants, held by the Investor, to purchase up to an aggregate of 158,731 shares of common stock that were previously issued in October 2022. These warrants had an exercise price of $6.30 per share and pursuant to the Warrant Amendment Agreement have been amended to reduce the exercise price to $2.65 per share effective upon the closing of the Offering. During the nine months ended September 30, 2023, 158,731 common warrants were exercised. The Company received approximately $421,000 from the exercises of the warrants.

 

12
 

 

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

 

   

March

2023

  

Conversion price before

   $ 6.30  

Conversion price after

   $ 2.65  

Term (years)

     4.9  

Volatility

     123 %

Dividend rate

     0 %

Risk free rate

     4.20 %

 

On February 3, 2022, the Company entered into Amendment No. 2 to the At the Market Offering Agreement (the “Offering Agreement”) with H.C. Wainwright & Co., LLC to further increase the maximum aggregate offering price of shares of Common Stock that may be offered and sold from time to time under the Offering Agreement from $15,280,000 to $19,555,000, which enables the Company to sell an additional $4,275,000 of shares after taking into account prior sales under the Offering Agreement (the “Additional Shares”). In March 2022, the total offering price was updated to $18,573,000 based on the shares that were currently available on Company’s existing Form S-3. The terms and conditions of the Offering Agreement otherwise remain unchanged. For the nine months ended September 30, 2022, the Company sold a total of 196,843 shares of common stock under the Offering Agreement for aggregate gross proceeds of $3,293,000 at an average selling price of $16.55 per share, resulting in net proceeds of approximately $3,037,000 after deducting commissions and other transaction costs of approximately $256,000.

 

Net Loss Per Share

 

Net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding plus the pre-funded warrants. For the purpose of calculating basic net loss per share, the additional shares of common stock that are issuable upon exercise of the pre-funded warrants have been included since the shares are issuable for a negligible consideration and have no vesting or other contingencies associated with them. All pre-funded warrants previously issued have been exercised and none are outstanding. The calculation of the basic and diluted earnings per share is the same for all periods presented, as the effect of the potential common stock equivalents noted below is anti-dilutive due to the Company’s net loss position for all periods presented. Anti-dilutive securities consisted of the following at September 30:

 

   

2023

    

2022

  

Common stock equivalents of convertible promissory notes and accrued interest

     7,448,487       969,173  

Warrants

     1,238,869       14,518  

Stock options

     6,218       6,380  

Total

     8,693,574       990,071  

 

13
 

 

Warrants

 

A summary of warrant activity for the nine months ended September 30, 2023 is as follows:

 

   

Number of

Shares

    

Weighted-Average

Exercise Price Per

Share

    

Weighted-

Average

Remaining

Contract Term

  

Balance at December 31, 2022

     340,689     $ 19.40       1.90  

Warrants granted

     1,071,429                  

Warrants expired

     (14,518 )                

Pre-funded warrants granted

     946,429                  

Pre-funded warrants exercised

     (946,429 )                

Warrants exercised

     (158,731 )                

Exercisable and Outstanding at September 30, 2023

     1,238,869     $ 3.14       4.82  

 
 

8.

Revenue

 

The following table presents net sales by geographic areas:

 

   

Three Months Ended September 30,

    

Nine Months Ended September 30,

  
   

2023

    

2022

    

2023

    

2022

  

United States

   $ 1,500,000     $ 1,535,000     $ 4,589,000     $ 4,973,000  

China

     29,000       364,000       77,000       1,570,000  

United Arab Emirates

     259,000       --       439,000       --  

Other

     406,000       216,000       1,934,000       1,264,000  

Total

   $ 2,194,000     $ 2,115,000     $ 7,039,000     $ 7,807,000  

 

The following tables summarize the revenues by product line and type:

 

   

Three Months Ended September 30, 2023

  
   

Device

Revenue

    

Service

Revenue

    

Other

Revenue

    

Total

Revenue

  

AXP

   $ 1,486,000     $ 88,000     $ --     $ 1,574,000  

BioArchive

     131,000       322,000       --       453,000  

CAR-TXpress

     42,000       34,000       71,000       147,000  

Manual Disposables

     8,000       --       --       8,000  

Other

     6,000       --       6,000       12,000  

Total

   $ 1,673,000     $ 444,000     $ 77,000     $ 2,194,000  

 

   

Nine Months Ended September 30, 2023

  
   

Device

Revenue

    

Service

Revenue

    

Other

Revenue

    

Total

Revenue

  

AXP

   $ 4,245,000     $ 184,000     $ --     $ 4,429,000  

BioArchive

     879,000       1,020,000       --       1,899,000  

CAR-TXpress

     101,000       109,000       213,000       423,000  

Manual Disposables

     229,000       --       --       229,000  

Other

     41,000       --       18,000       59,000  

Total

   $ 5,495,000     $ 1,313,000     $ 231,000     $ 7,039,000  

 

14
 

 
   

Three Months Ended September 30, 2022

  
   

Device

Revenue

    

Service

Revenue

    

Other

Revenue

    

Total

Revenue

  

AXP

   $ 1,034,000     $ 75,000     $ --     $ 1,109,000  

BioArchive

     201,000       321,000       --       522,000  

CAR-TXpress

     190,000       44,000       72,000       306,000  

Manual Disposables

     150,000       --       --       150,000  

Other

     20,000       --       8,000       28,000  

Total

   $ 1,595,000     $ 440,000     $ 80,000     $ 2,115,000  

 

   

Nine Months Ended September 30, 2022

  
   

Device

Revenue

    

Service

Revenue

    

Other

Revenue

    

Total

Revenue

  

AXP

   $ 4,668,000     $ 171,000     $ --     $ 4,839,000  

BioArchive

     694,000       924,000       --       1,618,000  

CAR-TXpress

     551,000       146,000       214,000       911,000  

Manual Disposables

     357,000       --       --       357,000  

Other

     59,000       --       23,000       82,000  

Total

   $ 6,329,000     $ 1,241,000     $ 237,000     $ 7,807,000  

 

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 that were included in the beginning balance of deferred revenue during the three and nine months ended September 30, 2023 were $144,000 and $663,000, respectively. Short-term deferred revenues were $818,000 and $782,000 at September 30, 2023 and December 31, 2022, respectively. Long-term deferred revenues were $680,000 and $911,000 at September 30, 2023 and December 31, 2022, respectively.

 

Backlog of Remaining Customer Performance Obligations

 

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

 

   

Remainder

of 2023

    

2024

    

2025

    

2026

    

2027 and

beyond

    

Total

  

Service revenue

   $ 319,000     $ 741,000     $ 252,000     $ --     $ --     $ 1,312,000  

Device revenue (1)

     21,000       692,000       --       --       --       713,000  

Exclusivity fee

     71,000       286,000       286,000       190,000       --       833,000  

Other

     3,000       13,000       13,000       13,000       97,000       139,000  

Total

   $ 414,000     $ 1,732,000     $ 551,000     $ 203,000     $ 97,000     $ 2,997,000  

 

 

(1)

Represents the minimum purchase requirements under the distribution agreement the Company signed with its AXP distributor in China.

 

15
 

 
 

9.

Concentrations

 

The Company had certain customers whose individual revenue was material to the Company’s total revenue, or whose accounts receivable balances were material to the Company’s total accounts receivable balances. Those customers are listed as follows:

 

Accounts Receivable

 

   

September 30,

2023

    

December 31,

2022

  

Customer 1

     --       29%  

Customer 2

     --       27%  

Customer 3

     --       15%  

 

Revenues

 

   

Three Months Ended September 30,

    

Nine Months Ended September 30,

  
   

2023

    

2022

    

2023

    

2022

  

Customer 1

     41%       36%       36%       36%  

Customer 2

     1%       1%       1%       13%  

 
 

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Cautionary Note Regarding Forward‑Looking Statements

 

This report contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements contained herein. When used in this report, the words "anticipate," "believe," "estimate," "expect" and similar expressions as they relate to the Company or its management are intended to identify such forward-looking statements. Actual results, performance or achievements could differ materially from the results expressed in, or implied by these forward-looking statements. Readers should be aware of important factors that, in some cases, have affected, and in the future could affect, actual results to differ materially from those expressed in any forward-looking statements made by or on behalf of the Company. These factors include without limitation, the ability to obtain capital and other financing in the amounts and at the times needed to launch new products, market acceptance of new products, the nature and timing of regulatory approvals for both new products and existing products for which the Company proposes new claims, realization of forecasted revenues, expenses and income, initiatives by competitors, price pressures, failure to meet U.S. Food and Drug Administration (“FDA”) regulated requirements governing the Company’s products and operations (including the potential for product recalls associated with such regulations), risks associated with initiating manufacturing for new products, failure to meet Foreign Corrupt Practice Act regulations, legal proceedings, risks associated with expanding into the Company’s new CDMO business, and other risk factors listed from time to time in our reports with the Securities and Exchange Commission (“SEC”), including, in particular, those set forth in the Company’s Form 10-K for the year ended December 31, 2022.

 

16
 

 

Business Overview

 

ThermoGenesis Holdings, Inc. (“ThermoGenesis Holdings,” the “Company,” “we,” “our,” “us”), develops, commercializes and markets a range of automated technologies for CAR-T and other cell-based therapies. The Company currently markets a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology, including its semi-automated, functionally closed CAR-TXpress™ platform, which streamlines the manufacturing process for the emerging CAR-T immunotherapy market. The Company was founded in 1986 and is incorporated in the State of Delaware and headquartered in Rancho Cordova, CA.

 

Our business involves the manufacturing and related service of cell based medical devices, including the AutoXpress® and BioArchive® platforms for automated clinical bio-banking, PXP® platform for point-of-care cell-based therapies and CAR-TXpress platform for large scale cell manufacturing services. The Company and its subsidiaries currently manufacture and market the following products:

 

Clinical Bio-Banking Applications:

 

●

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

●

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

 

Point-of-Care Applications:

 

●

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

●

PXP-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 U.S. FDA 510(k) medical device.
 

●

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

 

Large Scale Cell Processing and Biomanufacturing:

 

●

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

●

CAR-TXpress Platform for Clinical Manufacturing – a modular designed, functionally closed manufacturing platform that addresses the critical unmet need for large scale cellular processing and chemistry, manufacturing and controls (“CMC”) needs for manufacturing cellular therapies, including chimeric antigen receptor (“CAR”) T cell therapies. The CAR-TXpress Platform is owned and developed through a subsidiary CAR-TXpress Bio, Inc. (“CARTXpress Bio”) in which the Company owns 80% of the equity interest.

 

17
 

 

Expansion of Business – Contract Development and Manufacturing Services for Cell and Cell-Based Gene Therapies

 

The Company expanded its business to include contract development and manufacturing services for cell and cell-based gene therapies. The Company is in the process of building out the capabilities to become a world-class Contract Development and Manufacturing Organization (“CDMO”) for cell and cell-based gene therapies. 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 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 will operate its new CDMO business through a newly formed 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 CDMO facility was completed in October of 2023.  The successful development and launch of TG Biosynthesis will require us to hire certain personnel needed to operate our leased Sacramento facility.  There is no assurance that the Company will be able to achieve market acceptance of the new CDMO business.  We will need to hire, train, and retain additional employees who have experience in the cell manufacturing field in order for our CDMO business to be successful.

 

18
 

 

Results of Operations

 

Three Months Ended September 30, 2023 as Compared
to the Three Months Ended September 30, 2022

 

Net Revenues

 

Net revenues increased by $79,000 or 4%, from $2,115,000 to $2,194,000 for the three months ended September 30, 2023 as compared to the three months ended September 30, 2022.  The increase in revenue was driven by a new distributor in the United Arab Emirates, offset by lower CAR-TXpress sales for the quarter ended September 30, 2023.

 

The following table summarizes revenue by product line:

 

   

September 30,

2023

    

September 30,

2022

  

AXP

   $ 1,574,000     $ 1,109,000  

BioArchive

     453,000       522,000  

CAR-TXpress

     147,000       306,000  

Manual Disposables

     8,000       150,000  

Other

     12,000       28,000  

Total

   $ 2,194,000     $ 2,115,000  

 

Gross Profit

 

The Company’s gross profit decreased by $42,000 to $395,000 or 18% of net revenues for the three months ended September 30, 2023, compared to $437,000 or 21% for three months ended September 30, 2022. The primary driver of the decrease was lower absorption driven by excess manufacturing capacity in the third quarter of 2023.

 

Selling, General and Administrative

 

Sales, general and administrative expenses for the three months ended September 30, 2023 were $1,686,000 compared to $1,982,000 for the three months ended September 30, 2022, a decrease of $296,000 or 15%.  The decrease was driven primarily by lower employee benefit expenses of approximately $200,000 and $70,000 in lower investor relations expenses.

 

Research and Development Expenses

 

Research and development expenses were $266,000 for the three months ended September 30, 2023 as compared to $470,000 for the three months ended September 30, 2022, a decrease of $204,000 or 43%. The decrease was primarily due to approximately $100,000 less in project expenses and approximately $50,000 in lower personnel expenses during the quarter.

 

Interest Expense

 

Interest expense for the three months ended September 30, 2023 was $2,118,000 compared to $1,391,000, for the three months ended September 30, 2022, an increase of $727,000. The increase was driven by an increase of approximately $700,000 in amortization expense related to triggering events from a decrease in the conversion price of the Note in the three months ended September 30, 2023 as compared to the same period in 2022.

 

19
 

 

Loss on Retirement of Debt

 

Loss on retirement of debt was $87,000 in the three months ended September 30, 2023 as a result of the July 2023 amendment to the July 2019 Note which extended the due date for six months and lowered the conversion price of the note.

 

Nine Months Ended September 30, 2023 as Compared to
the Nine Months Ended September 30, 2022

 

Net Revenues

 

Net revenues decreased by $768,000 or 10%, from $7,807,000 to $7,039,000 for the nine months ended September 30, 2023 as compared to the nine months ended September 30, 2022. The decrease in revenue was driven by lower AXP disposable sales to the Company’s distributor in China and lower CAR-TXpress sales which were offset by BioArchive device revenue and sales to the new distributor in the United Arab Emirates for the nine months ended September 30, 2023.

 

   

Nine Months Ended

September 30,

  
   

2023

    

2022

  

AXP

   $ 4,429,000     $ 4,839,000  

BioArchive

     1,899,000       1,618,000  

CAR-TXpress

     423,000       911,000  

Manual Disposables

     229,000       357,000  

Other

     59,000       82,000  

Total

   $ 7,039,000     $ 7,807,000  

 

Gross Profit

 

The Company’s gross profit was $1,969,000 or 28% of net revenues for the nine months ended September 30, 2023, compared to $2,316,000 or 30% of net revenues for the nine months ended September 30, 2022, a decrease of $347,000. The primary driver of the decrease was due to lower absorption driven by excess manufacturing capacity and lower sales in the nine months ended September 30, 2023.

 

Selling, General and Administrative

 

Sales, general and administrative expenses for the nine months ended September 30, 2023 were $5,346,000 compared to $5,665,000 for the nine months ended September 30, 2022, a decrease of $319,000 or 6%. The variance was driven primarily by lower employee benefit expenses of approximately $475,000, offset by increased operating expenses for the Company’s CDMO facility of approximately $175,000.

 

Research and Development Expenses

 

Research and development expenses were $955,000 for the nine months ended September 30, 2023, compared to $1,317,000 for the nine months ended September 30, 2022, a decrease of $362,000 or 27%. The decrease was driven by lower personnel expenses of approximately $100,000 and lower project expenses of approximately $275,000.

 

20
 

 

Interest Expense

 

Interest expense increased to $6,689,000 for the nine months ended September 30, 2023 as compared to $3,572,000 for the nine months ended September 30, 2022, an increase of $3,117,000. The increase was driven by an additional amortization expense of approximately $3,500,000 related to triggering events from a decrease in the conversion price of the Note, offset by $400,000 less in interest expenses to the Note and July 2019 Note in the nine months ended September 30, 2023 as compared to the same period in 2022.

 

Loss on Retirement of Debt

 

Loss on retirement of debt was $326,000 in the nine months ended September 30, 2023 as a result of the January and July 2023 amendments to the July 2019 Note which extended the due date for six months and lowered the conversion price of the note.

 

Liquidity and Capital Resources

 

The Company had cash and cash equivalents of $4,018,000 and $4,177,000 and working capital deficit of $1,965,000 and $625,000 at September 30, 2023 and December 31, 2022, respectively. We have primarily financed cash shortfalls from operations through private and public placement of equity and debt securities.

 

On March 15, 2023, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with an accredited investor (the “Investor”) pursuant to which the Company agreed to issue and sell to the Investor in a private placement (the “Offering”) (i) 125,000 shares of its common stock, $0.001 par value (the “Common Shares”), (ii) 946,429 pre-funded warrants to purchase Common Shares at a purchase price of $2.80, and (iii) common stock warrants to purchase up to an aggregate of 1,071,429 Common Shares. 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 Offering closed on March 20, 2023. As of September 30, 2023, all pre-funded warrants were exercised.

 

On July 31, 2023 the Company entered into an Amendment No. 4 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 to extend the maturity date of the July 2019 Note from July 31, 2023 to January 31, 2024. The July 2019 Note Amendment also changed the fixed conversion price under the July 2019 Note to $1.07 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 $1.07, then the conversion price will be adjusted to such lower issuance price.  As a result of the July 2019 Note Amendment, the conversion price of the Note with Lender was likewise reduced to $1.07 under the down-round conversion price adjustment provisions of such Note.

 

On September 28, 2023, the Company received a conversion notice from the Lender to convert a total of $700,000 of the outstanding accrued interest. The conversion resulted in an issuance of 654,206 shares of the Company’s common stock at a conversion price of $1.07 per share. Immediately following the conversion, the outstanding principal balance of the Note was $7,278,000 and accrued but unpaid interest of $225,000.

 

The Company has incurred historical losses from operations and expects to continue to incur operating losses in the near future.  We completed our new CDMO facility in October of 2023 and anticipate increasing cash from operations; however, 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.

 

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

 

21
 

 

ITEM 3. Quantitative and Qualitative Disclosures about Market Risk

 

ThermoGenesis Holdings is a smaller reporting company as defined by Rule 12b-2 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”) and is not required to provide information under this item.

 

ITEM 4. Controls and Procedures

 

The Company carried out an evaluation, under the supervision, and with the participation of management, including both the Company’s Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), of the effectiveness of the design and operation of the Company’s disclosure controls and procedures (as defined by Exchange Act Rule 13a-15(e) or 15d-15(e)) as of September 30, 2023. Disclosure controls and procedures cover controls and other procedures that are designed to ensure that information required to be disclosed by the Company 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 Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Based upon that evaluation, the Company’s Chief Executive Officer and Chief Financial Officer have both concluded that the Company’s disclosure controls and procedures were effective as of September 30, 2023.

 

There were no changes in the Company’s internal controls over financial reporting that occurred during the three months ended September 30, 2023 that have materially affected, or are reasonably likely to materially affect, the Company’s internal controls over financial reporting. Management believes 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.

 

PART II - OTHER INFORMATION

 

ITEM 1.

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, 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.

 

ITEM 1A.

Risk Factors

 

There have been no material changes to the risk factors relating to the Company set forth in, “Item IA. Risk Factors” of its Annual Report on Form 10-K for the year ended December 31, 2022.

 

ITEM 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

22
 

 

ITEM 3.

Defaults Upon Senior Securities

 

None.

 

ITEM 4.

Mine Safety Disclosure

 

Not applicable.

 

ITEM 5.

Other Information

 

 

(a)

None.
 

(b)

None.
 

(c)

During the three months ended September 30, 2023, none of the Company's directors or officers (as defined in Rule 16a-1(f) of the Securities Exchange Act of 1934) adopted, terminated or modified a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement (as such terms are defined in Item 408 of Regulation S-K).

 

23
 

 

 

ITEM 6.

Exhibits

 

Exhibit No.

Description

1.1

At the Market Offering Agreement, dated December 13, 2019, by and between ThermoGenesis Holdings, Inc. and H.C. Wainwright & Co., LLC, incorporated by reference to Exhibit 1.2 to the Registration Statement on Form S-3 (Registration No. 333-235509) filed on December 13, 2019.

1.2

Amendment No.1 to At the Market Offering Agreement dated May 19, 2020, by and between ThermoGenesis Holdings, Inc. and H.C. Wainwright & Co., LLC, incorporated by reference to Exhibit 1.1 to Form 8-K filed May 20, 2020.

1.3

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

3.1

Amended and Restated Certificate of Incorporation of ThermoGenesis Holdings, Inc. dated as of June 5, 2020, as amended December 21, 2022., incorporated by reference to Exhibit 3.1 to Form 10-K filed March 30, 2023.

3.2

Amended and Restated Bylaws of ThermoGenesis Holdings, Inc., incorporated by reference to Exhibit 3.2 to Form 8-K filed with the SEC on March 10, 2023.

4.1

Form of Common Stock Purchase Warrant, incorporated by reference to Exhibit 4.1 to Form 8-K filed with the SEC on March 28, 2018.

4.2

Investors’ Rights Agreement, dated January 1, 2019, among CARTXpress Bio, Inc., Bay City Capital Fund V, L.P., and Bay City Capital Fund V Co-Investment Fund, L.P., incorporated by referenced to Exhibit 10.3 to Form 8-K filed with the SEC on January 4, 2019.

4.3

Description of Securities Registered Under Section 12 of the Securities Exchange Act of 1934, as amended, incorporated by reference to Exhibit 4.4 to Annual Report on Form 10-K filed on March 30, 2023.

4.4

Form of Common Warrant (Incorporated by reference to Exhibit 10.40 to Amendment No. 3 to Form S-1 filed with the SEC on October 17, 2022).

4.5

Form of Common Warrant, incorporated by reference to Exhibit 4.1 to Form 8-K filed with the SEC on March 21, 2023. 

4.6

Form of Pre-Funded Warrant, incorporated by reference to 4.2 to Form 8-K filed with the SEC on March 21, 2023.

4.7

Form of Warrant Amendment Agreement, incorporated by reference to 4.3 to Form 8K filed with the SEC on March 21, 2023.

10.1

Amendment No. 4 to Convertible Promissory Note, dated July 31, 2023, between ThermoGenesis Holdings, Inc. and Orbrex (USA) Co Limited, incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on August 3, 2023.

31.1

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

31.2

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

32

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

101.INS

Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document

101.SCH

Inline XBRL Taxonomy Extension Schema Document

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

104

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

 

24
 

 

ThermoGenesis Holdings, Inc.

 

Signatures

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

ThermoGenesis Holdings, Inc.

(Registrant)
   
   

Dated: November 13, 2023

/s/ Xiaochun (Chris) Xu, Ph.D.
 

Xiaochun (Chris) Xu, Ph.D.

Chief Executive Officer

(Principal Executive Officer)
   
   

Dated: November 13, 2023

/s/ Jeffery Cauble
 

Jeffery Cauble

Chief Financial Officer

(Principal Financial Officer and Principal Accounting Officer)

 

25

Exhibit 31.1

 

PRINCIPAL EXECUTIVE OFFICER’S CERTIFICATION
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Xiaochun (Chris) Xu, certify that:

 

1. I have reviewed this report on Form 10-Q of ThermoGenesis Holdings, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this report is being prepared;

 

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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;

 

(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusion about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant's auditors and the Audit Committee of the registrant's Board of Directors (or persons performing the equivalent functions):

 

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Dated: November 13, 2023

/s/ Xiaochun (Chris) Xu, Ph.D.
 

Xiaochun (Chris) Xu, Ph.D.

Chief Executive Officer

(Principal Executive Officer)

 

 

Exhibit 31.2

 

PRINCIPAL FINANCIAL OFFICER’S CERTIFICATION
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Jeffery Cauble, certify that:

 

1. I have reviewed this report on Form 10-Q of ThermoGenesis Holdings, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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;

 

(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

 

5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the Audit Committee of the registrant's Board of Directors (or persons performing the equivalent functions):

 

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

 

Dated: November 13, 2023

/s/ Jeffery Cauble
 

Jeffery Cauble

Chief Financial Officer

(Principal Financial Officer and Principal Accounting Officer)

 

 

Exhibit 32

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the quarterly report of ThermoGenesis Holdings, Inc. (the "Company") on Form 10-Q for the period ended September 30, 2023, as filed with the Securities and Exchange Commission (the "Report"), we, Xiaochun (Chris) Xu, Chief Executive Officer and Jeffery Cauble, Principal Financial and Accounting Officer, of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of our knowledge:

 

(1)          the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)          the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

Dated: November 13, 2023

/s/ Xiaochun (Chris) Xu, Ph.D.

  
 

Xiaochun (Chris) Xu, Ph.D.

Chief Executive Officer

(Principal Executive Officer)

  
     

Dated: November 13, 2023

/s/ Jeffery Cauble

  
 

Jeffery Cauble

Chief Financial Officer

(Principal Financial Officer and Principal Accounting Officer)

  

 

 
v3.23.3
Document And Entity Information - shares
 9 Months Ended
Sep. 30, 2023
Nov. 09, 2023
Document Information [Line Items]    
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Sep. 30, 2023  
Document Transition Report false  
Entity File Number 333-82900  
Entity Registrant Name ThermoGenesis Holdings, Inc.  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 94-3018487  
Entity Address, Address Line One 2711 Citrus Road  
Entity Address, City or Town Rancho Cordova  
Entity Address, State or Province CA  
Entity Address, Postal Zip Code 95742  
City Area Code 916  
Local Phone Number 858-5100  
Title of 12(b) Security Common Stock, $.001 par value  
Trading Symbol THMO  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding (in shares)   3,136,504
Entity Central Index Key 0000811212  
Current Fiscal Year End Date --12-31  
Document Fiscal Year Focus 2023  
Document Fiscal Period Focus Q3  
Amendment Flag false  
v3.23.3
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($)
Sep. 30, 2023
Dec. 31, 2022
Current assets:    
Cash and cash equivalents $ 4,018,000 $ 4,177,000
Accounts receivable, net of allowance for credit losses of $2,000 ($149,000 at December 31, 2022) 368,000 1,865,000
Inventories 1,821,000 3,334,000
Prepaid expenses and other current assets 718,000 1,508,000
Total current assets 6,925,000 10,884,000
Inventories, non-current 772,000 1,003,000
Equipment and leasehold improvements, net 2,523,000 1,254,000
Right-of-use operating lease assets, net 190,000 372,000
Goodwill 781,000 781,000
Intangible assets, net 1,262,000 1,286,000
Other assets 255,000 256,000
Total assets 15,921,000 19,386,000
Accounts payable 591,000 820,000
Accrued payroll and related expenses 451,000 399,000
Deferred revenue – short-term 818,000 782,000
Convertible promissory note – related party 4,817,000 5,777,000
Interest payable – related party 225,000 1,492,000
Convertible promissory note, net 456,000 962,000
Other current liabilities 1,532,000 1,277,000
Total current liabilities 8,890,000 11,509,000
Operating lease obligations – long-term   131,000
Deferred revenue – long-term 680,000 911,000
Other noncurrent liabilities 17,000 17,000
Total liabilities 12,658,000 16,063,000
Commitments and Contingencies  
Common stock, $0.001 par value; 350,000,000 shares authorized; 3,136,504 issued and outstanding (1,037,138 at December 31, 2022) 3,000 1,000
Additional paid in capital 281,632,000 270,377,000
Accumulated deficit (277,154,000) (266,193,000)
Accumulated other comprehensive loss 114,000 111,000
Total ThermoGenesis Holdings, Inc. stockholders’ equity 4,595,000 4,296,000
Noncontrolling interests (1,332,000) (973,000)
Total equity 3,263,000 3,323,000
Total liabilities and equity 15,921,000 19,386,000
Lease Agreement with Z3 Investment LLC [Member]    
Current assets:    
Right-of-use operating lease assets, net 3,213,000 3,550,000
Operating lease obligations – long-term $ 3,071,000 $ 3,495,000
v3.23.3
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - USD ($)
Sep. 30, 2023
Dec. 31, 2022
Accounts receivable, allowance for doubtful accounts $ 2,000 $ 149,000
Preferred stock, par value (in dollars per share) $ 0.001 $ 0.001
Preferred stock, shares authorized (in shares) 2,000,000 2,000,000
Preferred stock, shares outstanding (in shares) 0 0
Common stock, par value (in dollars per share) $ 0.001 $ 0.001
Common stock, shares authorized (in shares) 350,000,000 350,000,000
Common Stock, Shares, Outstanding (in shares) 3,136,504 1,037,138
Common Stock, Shares, Issued (in shares) 3,136,504 1,037,138
v3.23.3
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
 3 Months Ended 9 Months Ended
Sep. 30, 2023
Sep. 30, 2022
Sep. 30, 2023
Sep. 30, 2022
Net revenues $ 2,194,000 $ 2,115,000 $ 7,039,000 $ 7,807,000
Cost of revenues 1,799,000 1,678,000 5,070,000 5,491,000
Gross profit 395,000 437,000 1,969,000 2,316,000
Selling, general and administrative 1,686,000 1,982,000 5,346,000 5,665,000
Research and development 266,000 470,000 955,000 1,317,000
Total operating expenses 1,952,000 2,452,000 6,301,000 6,982,000
Loss from operations (1,557,000) (2,015,000) (4,332,000) (4,666,000)
Other expenses:        
Interest expense (2,118,000) (1,391,000) (6,689,000) (3,572,000)
Loss on retirement of debt (87,000)   (326,000)  
Other income (expenses) (22,000) (3,000) (27,000) 1,000
Total other expenses (2,183,000) (1,388,000) (6,988,000) (3,573,000)
Net loss (3,740,000) (3,403,000) (11,320,000) (8,239,000)
Loss attributable to noncontrolling interests (125,000) (163,000) (359,000) (402,000)
Net loss attributable to common stockholders (3,615,000) (3,240,000) (10,961,000) (7,837,000)
Comprehensive Income (Loss), Net of Tax, Attributable to Parent [Abstract]        
Net loss (3,740,000) (3,403,000) (11,320,000) (8,239,000)
Other comprehensive loss:        
Foreign currency translation adjustments gain (loss) 9,000 22,000 3,000 67,000
Comprehensive loss (3,731,000) (3,381,000) (11,317,000) (8,172,000)
Comprehensive loss attributable to noncontrolling interests (125,000) (163,000) (359,000) (402,000)
Comprehensive loss attributable to common stockholders $ (3,606,000) $ (3,218,000) $ (10,958,000) $ (7,770,000)
Earnings Per Share [Abstract]        
Basic and diluted net loss per common share (in dollars per share) $ (1.44) $ (4.66) $ (5.26) $ (18.49)
Weighted average common shares outstanding basicand diluted (in shares) 2,503,631 694,795 2,083,095 423,897
v3.23.3
Condensed Consolidated Statements of Equity (Unaudited) - USD ($)
Common Stock [Member]
At The Market Offering Agreement [Member]
Common Stock [Member]
Additional Paid-in Capital [Member]
Cumulative Effect, Period of Adoption, Adjustment [Member]
Additional Paid-in Capital [Member]
Related Party Convertible Debt Price Reset [Member]
Additional Paid-in Capital [Member]
At The Market Offering Agreement [Member]
Additional Paid-in Capital [Member]
Retained Earnings [Member]
Cumulative Effect, Period of Adoption, Adjustment [Member]
Retained Earnings [Member]
AOCI Attributable to Parent [Member]
Noncontrolling Interest [Member]
Cumulative Effect, Period of Adoption, Adjustment [Member]
Related Party Convertible Debt Price Reset [Member]
At The Market Offering Agreement [Member]
Total
Balance (in shares) at Dec. 31, 2021   279,629                        
Balance (Accounting Standards Update 2020-06 [Member]) at Dec. 31, 2021     $ (10,681,000)       $ 9,739,000       $ (942,000)      
Balance at Dec. 31, 2021           $ 268,459,000   $ (264,662,000) $ 31,000 [1] $ (431,000)       $ 3,397,000
Stock-based compensation expense           42,000               42,000
Related party convertible note price reset       $ 213,000               $ 213,000    
Sale of common stock and warrants, net (in shares) 20,407                          
Sale of common stock and warrants, net         $ 594,000               $ 594,000  
Foreign currency translation gain                 14,000 [1]         14,000
Net loss               (1,910,000)   (126,000)       (2,036,000)
Balance (in shares) at Mar. 31, 2022   300,036                        
Balance at Mar. 31, 2022           258,627,000   (256,833,000) 45,000 [1] (557,000)       1,282,000
Balance (in shares) at Dec. 31, 2021   279,629                        
Balance (Accounting Standards Update 2020-06 [Member]) at Dec. 31, 2021     $ (10,681,000)       $ 9,739,000       $ (942,000)      
Balance at Dec. 31, 2021           268,459,000   (264,662,000) 31,000 [1] (431,000)       3,397,000
Foreign currency translation gain                           67,000
Balance (in shares) at Sep. 30, 2022   710,967                        
Balance at Sep. 30, 2022   $ 1,000       267,761,000   (262,761,000) 98,000 [1] (833,000)       4,266,000
Balance (in shares) at Mar. 31, 2022   300,036                        
Balance at Mar. 31, 2022           258,627,000   (256,833,000) 45,000 [1] (557,000)       1,282,000
Stock-based compensation expense           72,000               72,000
Related party convertible note price reset       2,475,000               2,475,000    
Conversion of note payable to common stock (in shares)   234,495                        
Conversion of note payable to common stock   $ 1,000       2,999,000               3,000,000
Sale of common stock and warrants, net (in shares) 97,726                          
Sale of common stock and warrants, net         1,450,000               1,450,000  
Foreign currency translation gain                 31,000 [1]         31,000
Net loss               (2,688,000)   (113,000)       (2,801,000)
Conversion of related party note payable to common stock (in shares)   234,495                        
Conversion of related party note payable to common stock   $ 1,000       2,999,000               3,000,000
Balance (in shares) at Jun. 30, 2022   632,257                        
Balance at Jun. 30, 2022   $ 1,000       265,623,000   (259,521,000) 76,000 [1] (670,000)       5,509,000
Stock-based compensation expense           70,000               70,000
Related party convertible note price reset       1,075,000               1,075,000    
Sale of common stock and warrants, net (in shares) 78,710                          
Sale of common stock and warrants, net         $ 993,000               $ 993,000  
Foreign currency translation gain                 22,000 [1]         22,000
Net loss               (3,240,000)   (163,000)       (3,403,000)
Balance (in shares) at Sep. 30, 2022   710,967                        
Balance at Sep. 30, 2022   $ 1,000       267,761,000   (262,761,000) 98,000 [1] (833,000)       4,266,000
Balance (in shares) at Dec. 31, 2022   1,037,138                        
Balance at Dec. 31, 2022   $ 1,000       270,377,000   (266,193,000) 111,000 (973,000)       3,323,000
Stock-based compensation expense           10,000               10,000
Related party convertible note price reset       3,160,000   43,000           3,160,000   43,000
Conversion of note payable to common stock (in shares)   215,000                        
Conversion of note payable to common stock   $ 1,000       602,000               603,000
Sale of common stock and warrants, net (in shares)   125,000                        
Sale of common stock and warrants, net           2,640,000               2,640,000
Exercise of warrants (in shares)   158,731                        
Exercise of warrants           421,000               421,000
Foreign currency translation gain                 (6,000)         (6,000)
Net loss               (5,086,000)   (96,000)       (5,182,000)
Conversion of related party note payable to common stock (in shares)   215,000                        
Conversion of related party note payable to common stock   $ 1,000       602,000               603,000
Balance (in shares) at Mar. 31, 2023   1,535,869                        
Balance at Mar. 31, 2023   $ 2,000       277,253,000   (271,279,000) 105,000 (1,069,000)       5,012,000
Balance (in shares) at Dec. 31, 2022   1,037,138                        
Balance at Dec. 31, 2022   $ 1,000       270,377,000   (266,193,000) 111,000 (973,000)       3,323,000
Related party convertible note price reset                       6,820,000    
Sale of common stock and warrants, net (in shares)                         196,843  
Foreign currency translation gain                           3,000
Balance (in shares) at Sep. 30, 2023   3,136,504                        
Balance at Sep. 30, 2023   $ 3,000       281,632,000   (277,154,000) 114,000 (1,332,000)       3,263,000
Balance (in shares) at Mar. 31, 2023   1,535,869                        
Balance at Mar. 31, 2023   $ 2,000       277,253,000   (271,279,000) 105,000 (1,069,000)       5,012,000
Stock-based compensation expense           13,000               13,000
Exercise of warrants (in shares)   946,429                        
Net loss               (2,260,000)   (138,000)       (2,398,000)
Balance (in shares) at Jun. 30, 2023   2,482,298                        
Balance at Jun. 30, 2023   $ 2,000       277,266,000   (273,539,000) 105,000 (1,207,000)       2,627,000
Stock-based compensation expense           7,000               7,000
Related party convertible note price reset       $ 3,660,000               $ 3,660,000    
Conversion of note payable to common stock (in shares)   654,206                        
Conversion of note payable to common stock   $ 1,000       699,000               700,000
Foreign currency translation gain                 9,000         9,000
Net loss               (3,615,000)   (125,000)       (3,740,000)
Conversion of related party note payable to common stock (in shares)   654,206                        
Conversion of related party note payable to common stock   $ 1,000       699,000               700,000
Balance (in shares) at Sep. 30, 2023   3,136,504                        
Balance at Sep. 30, 2023   $ 3,000       $ 281,632,000   $ (277,154,000) $ 114,000 $ (1,332,000)       $ 3,263,000
[1] Accumulated other comprehensive loss.
v3.23.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
 9 Months Ended
Sep. 30, 2023
Sep. 30, 2022
Net Cash Provided by (Used in) Operating Activities [Abstract]    
Net loss $ (11,320,000) $ (8,239,000)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 816,000 666,000
Stock based compensation expense 30,000 184,000
Amortization of debt discount/premium, net 5,396,000 1,897,000
Reserve for excess and slow-moving inventories 480,000 654,000
Loss on retirement of debt 326,000  
Net change in operating assets and liabilities:    
Accounts receivable 1,496,000 (1,323,000)
Inventories 1,264,000 582,000
Prepaid expenses and other assets 791,000 757,000
Accounts payable (226,000) (210,000)
Interest payable – related party (289,000) (1,132,000)
Accrued payroll and related expenses 52,000 145,000
Deferred revenue – short-term 37,000 122,000
Other current liabilities 255,000 446,000
Long-term deferred revenue and other noncurrent liabilities (786,000) (650,000)
Net cash used in operating activities (1,678,000) (6,101,000)
Net Cash Provided by (Used in) Investing Activities [Abstract]    
Capital expenditures (1,541,000) (308,000)
Net cash used in investing activities (1,541,000) (308,000)
Net Cash Provided by (Used in) Financing Activities [Abstract]    
Proceeds from issuance of common stock, net of expenses 2,640,000 3,037,000
Proceeds from the exercise of warrants 421,000  
Net cash provided by financing activities 3,061,000 3,037,000
Effects of foreign currency rate changes on cash and cash equivalents (1,000) (5,000)
Net increase (decrease) in cash and cash equivalents (159,000) (3,377,000)
Cash and cash equivalents at beginning of period 4,177,000 7,280,000
Cash and cash equivalents at end of period 4,018,000 3,903,000
Supplemental Cash Flow Information [Abstract]    
Cash paid for related party interest 1,492,000 2,628,000
Cash paid for interest 140,000 180,000
Right-to-use asset acquired under operating lease, related party   3,863,000
Related Party Convertible Debt Price Reset [Member]    
Supplemental Cash Flow Information [Abstract]    
Convertible note price reset 6,820,000  
Nonrelated Party [Member]    
Supplemental Cash Flow Information [Abstract]    
Convertible note price reset 43,000  
Related party convertible note converted to common stock 603,000  
Related Party [Member]    
Supplemental Cash Flow Information [Abstract]    
Related party convertible note converted to common stock 700,000 $ 3,000,000
January 2023 Convertible Note [Member]    
Supplemental Cash Flow Information [Abstract]    
Fair value of amended convertible note issued in connection with the extinguishment of original convertible note 1,239,000  
July 2023 Convertible Note [Member]    
Supplemental Cash Flow Information [Abstract]    
Fair value of amended convertible note issued in connection with the extinguishment of original convertible note $ 484,000  
v3.23.3
Note 1 - Description of Business
 9 Months Ended
Sep. 30, 2023
Notes to Financial Statements  
Business Description and Basis of Presentation [Text Block]

1.

Description of Business

 

Overview

 

ThermoGenesis Holdings, Inc. (“ThermoGenesis Holdings,” the “Company,” “we,” “our,” “us”) develops and commercializes a range of automated technologies for cell-banking, cell-processing, and cell-based therapeutics. Since the 1990’s, ThermoGenesis Holdings has been a pioneer in, and a leading provider of automated systems that isolate, purify and cryogenically store units of hematopoietic stem and progenitor cells for the cord blood banking industry. The Company was founded in 1986 and is incorporated in the State of Delaware and headquartered in Rancho Cordova, CA. Our common stock is traded on the Nasdaq Capital Market under the ticker symbol “THMO”.

 

Medical Device Products for Automated Cell Processing

 

The Company provides the AutoXpress® and BioArchive® platforms for automated clinical bio-banking, PXP® platform for point-of-care cell-based therapies and the CAR-TXpress™ platform for large scale cell manufacturing services. All product lines are reporting as a single reporting segment in the financial statements.

 

CDMO Business

 

The Company is expanding its business to include contract development and manufacturing services for cell and cell-based gene therapies. The Company is in the process of building out the capabilities to become a world-class Contract Development and Manufacturing Organization (“CDMO”) for cell and cell-based gene therapies. The Company is building 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 companies. The ReadyStart Suites are located in a 35,500+ square foot cGMP facility that will meet the highest scientific, quality, and regulatory requirements. The CDMO facility was completed in October of 2023.

 

Reverse Stock Split

 

On December 22, 2022, we effected a one (1) for forty-five (45) reverse stock split of our issued and outstanding common stock. All historical share amounts disclosed in this quarterly report on Form 10-Q 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.
v3.23.3
Note 2 - Going Concern
 9 Months Ended
Sep. 30, 2023
Notes to Financial Statements  
Substantial Doubt about Going Concern [Text Block]

2.

Going Concern

 

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.
v3.23.3
Note 3 - Summary of Significant Accounting Policies
 9 Months Ended
Sep. 30, 2023
Notes to Financial Statements  
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Text Block]

3.

Summary of Significant Accounting Polices

 

There have been no material changes in the Company’s significant accounting policies to those disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022.

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such Securities and Exchange Commission (“SEC”) rules and regulations and accounting principles applicable for interim periods. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair statement of the results for the periods presented have been included. Events subsequent to the balance sheet date have been evaluated for inclusion in the accompanying condensed consolidated financial statements through the date of issuance.

 

Operating results for the three and nine months ended September 30, 2023, are not necessarily indicative of the results that may be expected for the Company’s fiscal year ending December 31, 2023. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto included in ThermoGenesis Holdings’ Annual Report on Form 10-K for the year ended December 31, 2022.

 

Principles of Consolidation

 

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

 

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

 

Recently Adopted Accounting Standards

 

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

 

In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (“Topic 326”). The ASU introduced a new accounting model, the Current Expected Credit Losses model (“CECL”), which requires earlier recognition of credit losses and additional disclosures related to credit risk. The CECL model utilizes a lifetime expected credit loss measurement objective for the recognition of credit losses at the time the financial asset is originated or acquired. ASU 2016-13 is effective for annual reporting periods beginning after December 15, 2022, including interim reporting periods within those annual reporting periods. The Company adopted the standard effective January 1, 2023. Based on the composition of the Company’s trade receivables and unbilled revenue, and expected future losses, the adoption of ASU 2016-13 did not have a material impact on its condensed consolidated financial statements.
v3.23.3
Note - 4 Related Party Transactions
 9 Months Ended
Sep. 30, 2023
Notes to Financial Statements  
Related Party Transactions Disclosure [Text Block]

4.

Related Party Transactions

 

Convertible Promissory Note and Revolving Credit Agreement

 

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

 

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

 

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

 

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

 

The following summarizes the Note:

 

 

Maturity

Date

  

Stated

Interest

Rate

    

Conversion

Price

    

Face

Value

    

Debt

Discount

    

Carrying

Value

  

September 30, 2023

12/31/23

     22 %   $ 1.07     $ 7,278,000     $ (2,461,000 )   $ 4,817,000  

December 31, 2022

12/31/23

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

 

The Note includes a down-round anti-dilution provision that lowers its conversion price if the Company sells shares of common stock or issues convertible debt at a lower price per share. Through September 30, 2023, the down-round provision was triggered as noted below:

 

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

 

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

 

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

 

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

 

   

January

2023

    

March

2023

    

July

2023

  

Conversion price before

   $ 6.30     $ 2.87     $ 2.65  

Conversion price after

   $ 2.87     $ 2.65     $ 1.07  

Term (years)

     0.09       0.78       0.42  

Volatility

     167 %     168.9 %     156.8 %

Dividend rate

     0 %     0 %     0 %

Risk free rate

     4.46 %     4.20 %     4.22 %

 

For the three and nine months ended September 30, 2023, the Company amortized $1,720,000 and $5,582,000 of debt discount related to triggering events, compared to $940,000 and $1,897,000 for the three and nine months ended September 30, 2022. In addition to the amortization, the Company also recorded interest expense of $409,000 and $1,203,000 for the three and nine months ended September 30, 2023, compared to $394,000 and $1,496,000 for the three and nine months ended September 30, 2022, respectively. The interest payable balance as of September 30, 2023 and December 31, 2022 was $225,000 and $1,492,000, respectively.

 

Boyalife Genomics

 

On March 24, 2022, the Company entered into a License and Technology Access Agreement with Boyalife Genomics Tianjin Ltd. (“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 CDMO cell therapy manufacturing business through a division named TG Biosynthesis.

 

Under the terms of the agreement, the Company transferred its remaining 8.64% interest in ImmuneCyte, Inc. 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 three and nine months ended September 30, 2023, no sales were recorded under the license agreement and no royalty payments were made to Boyalife Genomics.
v3.23.3
Note 5 - Related Party Lease
 9 Months Ended
Sep. 30, 2023
Notes to Financial Statements  
Lessee, Operating Leases [Text Block]

5.

Related Party Lease

 

Z3 Investment

 

On March 24, 2022, the Company entered into a five-year Lease Agreement with Z3 Investment LLC, an affiliate owned by the Company’s CEO and Chairman of the Board and the Company’s Chief Operating Officer who is also a Board Member, beginning April 1, 2022, for approximately 35,000 square feet of laboratory and office space in Rancho Cordova, California. Under the terms of the agreement, monthly rent is $104,000 per month (with a 4% annual increase). Additionally, the Company will pay all operating expenses as they become due estimated to be approximately $10,000 per month and will be expensed in the period incurred. The Company has the option to renew the lease for up to ten years after the commencement of the initial five-year term.

 

Operating Lease

 

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

 

The following summarizes the Company’s operating lease:

 

   

September 30,

2023

    

December 31,

2022

  

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

   $ 3,213,000     $ 3,550,000  

Current lease liability (included in other current liabilities)

     551,000       433,000  

Non-current lease liability – related party

     3,071,000       3,495,000  
                 

Weighted average remaining lease term

     4.0       4.8  

Discount rate

     22 %     22 %

 

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

 

2023 (Remaining)

   $ 324,000  

2024

     1,307,000  

2025

     1,359,000  

2026

     1,428,000  

Thereafter

     1,133,000  

Total lease payments

   $ 5,551,000  

Less: imputed interest

     (1,930,000 )

Present value of operating lease liabilities

   $ 3,621,000  

 

Statement of Cash Flows

 

Cash paid for amounts included in the measurement of operating lease liabilities was $932,000 and $277,000 for the nine months ended September 30, 2023 and 2022, respectively.
v3.23.3
Note 6 - Convertible Promissory Note
 9 Months Ended
Sep. 30, 2023
Notes to Financial Statements  
Debt Disclosure [Text Block]

6.

Convertible Promissory Note

 

July 2019 Note

 

On July 23, 2019, the Company entered into a private placement with Orbrex (USA) Co. Limited (“Orbrex”), pursuant to which the Company issued and sold to Orbrex an unsecured convertible promissory note, as amended, in the original principal amount of $1,000,000 (the “July 2019 Note”). The July 2019 Note bears interest at a rate of twenty-four percent (24%) per annum and is payable in arrears on January 31 of each year. In the nine months ended September 30, 2023, the Company has amended the July 2019 Note two times:

 

 

●

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

●

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

 

The following summarizes the July 2019 Note:

 

 

Maturity

Date

  

Stated

Interest

Rate

    

Conversion

Price

    

Face
Value

    

Debt
Discount/
Premium

    

Carrying

Value

  

September 30, 2023

1/31/2024

     24%     $ 1.07     $ 397,000     $ 59,000     $ 456,000  

December 31, 2022

7/31/2023

     24%     $ 6.30     $ 1,000,000     $ (38,000 )   $ 962,000  

 

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

 

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

 

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

 

   

March

2023

  

Conversion price before

   $ 2.87  

Conversion price after

   $ 2.65  

Term (years)

     0.36  

Volatility

     182 %

Dividend rate

     0 %

Risk free rate

     4.20 %

 

The Company recorded amortization expense for the July 2019 Note of ($35,000) and ($186,000) for the three and nine months ended September 30, 2023, respectively. In addition to the amortization, the Company also recorded interest expense related to the July 2019 Note of $24,000 and $90,000 for the three and nine months ended September 30, 2023, compared to $60,000 and $180,000 for the three and nine months ended September 30, 2022, respectively.
v3.23.3
Note 7 - Stockholders' Equity
 9 Months Ended
Sep. 30, 2023
Notes to Financial Statements  
Share-Based Payment Arrangement [Text Block]

7.

Stockholders’ Equity

 

Common Stock

 

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

 

In connection with the Offering, the Company entered into a Warrant Amendment Agreement (the "Warrant Amendment Agreement”), dated March 15, 2023, with the Investor, whereby the Company agreed to amend existing warrants, held by the Investor, to purchase up to an aggregate of 158,731 shares of common stock that were previously issued in October 2022. These warrants had an exercise price of $6.30 per share and pursuant to the Warrant Amendment Agreement have been amended to reduce the exercise price to $2.65 per share effective upon the closing of the Offering. During the nine months ended September 30, 2023, 158,731 common warrants were exercised. The Company received approximately $421,000 from the exercises of the warrants.

 

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

 

   

March

2023

  

Conversion price before

   $ 6.30  

Conversion price after

   $ 2.65  

Term (years)

     4.9  

Volatility

     123 %

Dividend rate

     0 %

Risk free rate

     4.20 %

 

On February 3, 2022, the Company entered into Amendment No. 2 to the At the Market Offering Agreement (the “Offering Agreement”) with H.C. Wainwright & Co., LLC to further increase the maximum aggregate offering price of shares of Common Stock that may be offered and sold from time to time under the Offering Agreement from $15,280,000 to $19,555,000, which enables the Company to sell an additional $4,275,000 of shares after taking into account prior sales under the Offering Agreement (the “Additional Shares”). In March 2022, the total offering price was updated to $18,573,000 based on the shares that were currently available on Company’s existing Form S-3. The terms and conditions of the Offering Agreement otherwise remain unchanged. For the nine months ended September 30, 2022, the Company sold a total of 196,843 shares of common stock under the Offering Agreement for aggregate gross proceeds of $3,293,000 at an average selling price of $16.55 per share, resulting in net proceeds of approximately $3,037,000 after deducting commissions and other transaction costs of approximately $256,000.

 

Net Loss Per Share

 

Net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding plus the pre-funded warrants. For the purpose of calculating basic net loss per share, the additional shares of common stock that are issuable upon exercise of the pre-funded warrants have been included since the shares are issuable for a negligible consideration and have no vesting or other contingencies associated with them. All pre-funded warrants previously issued have been exercised and none are outstanding. The calculation of the basic and diluted earnings per share is the same for all periods presented, as the effect of the potential common stock equivalents noted below is anti-dilutive due to the Company’s net loss position for all periods presented. Anti-dilutive securities consisted of the following at September 30:

 

   

2023

    

2022

  

Common stock equivalents of convertible promissory notes and accrued interest

     7,448,487       969,173  

Warrants

     1,238,869       14,518  

Stock options

     6,218       6,380  

Total

     8,693,574       990,071  

 

Warrants

 

A summary of warrant activity for the nine months ended September 30, 2023 is as follows:

 

   

Number of

Shares

    

Weighted-Average

Exercise Price Per

Share

    

Weighted-

Average

Remaining

Contract Term

  

Balance at December 31, 2022

     340,689     $ 19.40       1.90  

Warrants granted

     1,071,429                  

Warrants expired

     (14,518 )                

Pre-funded warrants granted

     946,429                  

Pre-funded warrants exercised

     (946,429 )                

Warrants exercised

     (158,731 )                

Exercisable and Outstanding at September 30, 2023

     1,238,869     $ 3.14       4.82  

 
v3.23.3
Note 8 - Revenue
 9 Months Ended
Sep. 30, 2023
Notes to Financial Statements  
Revenue from Contract with Customer [Text Block]

8.

Revenue

 

The following table presents net sales by geographic areas:

 

   

Three Months Ended September 30,

    

Nine Months Ended September 30,

  
   

2023

    

2022

    

2023

    

2022

  

United States

   $ 1,500,000     $ 1,535,000     $ 4,589,000     $ 4,973,000  

China

     29,000       364,000       77,000       1,570,000  

United Arab Emirates

     259,000       --       439,000       --  

Other

     406,000       216,000       1,934,000       1,264,000  

Total

   $ 2,194,000     $ 2,115,000     $ 7,039,000     $ 7,807,000  

 

The following tables summarize the revenues by product line and type:

 

   

Three Months Ended September 30, 2023

  
   

Device

Revenue

    

Service

Revenue

    

Other

Revenue

    

Total

Revenue

  

AXP

   $ 1,486,000     $ 88,000     $ --     $ 1,574,000  

BioArchive

     131,000       322,000       --       453,000  

CAR-TXpress

     42,000       34,000       71,000       147,000  

Manual Disposables

     8,000       --       --       8,000  

Other

     6,000       --       6,000       12,000  

Total

   $ 1,673,000     $ 444,000     $ 77,000     $ 2,194,000  

 

   

Nine Months Ended September 30, 2023

  
   

Device

Revenue

    

Service

Revenue

    

Other

Revenue

    

Total

Revenue

  

AXP

   $ 4,245,000     $ 184,000     $ --     $ 4,429,000  

BioArchive

     879,000       1,020,000       --       1,899,000  

CAR-TXpress

     101,000       109,000       213,000       423,000  

Manual Disposables

     229,000       --       --       229,000  

Other

     41,000       --       18,000       59,000  

Total

   $ 5,495,000     $ 1,313,000     $ 231,000     $ 7,039,000  

 

   

Three Months Ended September 30, 2022

  
   

Device

Revenue

    

Service

Revenue

    

Other

Revenue

    

Total

Revenue

  

AXP

   $ 1,034,000     $ 75,000     $ --     $ 1,109,000  

BioArchive

     201,000       321,000       --       522,000  

CAR-TXpress

     190,000       44,000       72,000       306,000  

Manual Disposables

     150,000       --       --       150,000  

Other

     20,000       --       8,000       28,000  

Total

   $ 1,595,000     $ 440,000     $ 80,000     $ 2,115,000  

 

   

Nine Months Ended September 30, 2022

  
   

Device

Revenue

    

Service

Revenue

    

Other

Revenue

    

Total

Revenue

  

AXP

   $ 4,668,000     $ 171,000     $ --     $ 4,839,000  

BioArchive

     694,000       924,000       --       1,618,000  

CAR-TXpress

     551,000       146,000       214,000       911,000  

Manual Disposables

     357,000       --       --       357,000  

Other

     59,000       --       23,000       82,000  

Total

   $ 6,329,000     $ 1,241,000     $ 237,000     $ 7,807,000  

 

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 that were included in the beginning balance of deferred revenue during the three and nine months ended September 30, 2023 were $144,000 and $663,000, respectively. Short-term deferred revenues were $818,000 and $782,000 at September 30, 2023 and December 31, 2022, respectively. Long-term deferred revenues were $680,000 and $911,000 at September 30, 2023 and December 31, 2022, respectively.

 

Backlog of Remaining Customer Performance Obligations

 

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

 

   

Remainder

of 2023

    

2024

    

2025

    

2026

    

2027 and

beyond

    

Total

  

Service revenue

   $ 319,000     $ 741,000     $ 252,000     $ --     $ --     $ 1,312,000  

Device revenue (1)

     21,000       692,000       --       --       --       713,000  

Exclusivity fee

     71,000       286,000       286,000       190,000       --       833,000  

Other

     3,000       13,000       13,000       13,000       97,000       139,000  

Total

   $ 414,000     $ 1,732,000     $ 551,000     $ 203,000     $ 97,000     $ 2,997,000  

 

 

(1)

Represents the minimum purchase requirements under the distribution agreement the Company signed with its AXP distributor in China.

 

 
v3.23.3
Note 9 - Concentrations
 9 Months Ended
Sep. 30, 2023
Notes to Financial Statements  
Concentration Risk Disclosure [Text Block]

9.

Concentrations

 

The Company had certain customers whose individual revenue was material to the Company’s total revenue, or whose accounts receivable balances were material to the Company’s total accounts receivable balances. Those customers are listed as follows:

 

Accounts Receivable

 

   

September 30,

2023

    

December 31,

2022

  

Customer 1

     --       29%  

Customer 2

     --       27%  

Customer 3

     --       15%  

 

Revenues

 

   

Three Months Ended September 30,

    

Nine Months Ended September 30,

  
   

2023

    

2022

    

2023

    

2022

  

Customer 1

     41%       36%       36%       36%  

Customer 2

     1%       1%       1%       13%  

 
v3.23.3
Significant Accounting Policies (Policies)
 9 Months Ended
Sep. 30, 2023
Accounting Policies [Abstract]  
Basis of Accounting, Policy [Policy Text Block]

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such Securities and Exchange Commission (“SEC”) rules and regulations and accounting principles applicable for interim periods. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair statement of the results for the periods presented have been included. Events subsequent to the balance sheet date have been evaluated for inclusion in the accompanying condensed consolidated financial statements through the date of issuance.

 

Operating results for the three and nine months ended September 30, 2023, are not necessarily indicative of the results that may be expected for the Company’s fiscal year ending December 31, 2023. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto included in ThermoGenesis Holdings’ Annual Report on Form 10-K for the year ended December 31, 2022.

 
Consolidation, Policy [Policy Text Block]

Principles of Consolidation

 

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

 

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

 
New Accounting Pronouncements, Policy [Policy Text Block]

Recently Adopted Accounting Standards

 

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

 

In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (“Topic 326”). The ASU introduced a new accounting model, the Current Expected Credit Losses model (“CECL”), which requires earlier recognition of credit losses and additional disclosures related to credit risk. The CECL model utilizes a lifetime expected credit loss measurement objective for the recognition of credit losses at the time the financial asset is originated or acquired. ASU 2016-13 is effective for annual reporting periods beginning after December 15, 2022, including interim reporting periods within those annual reporting periods. The Company adopted the standard effective January 1, 2023. Based on the composition of the Company’s trade receivables and unbilled revenue, and expected future losses, the adoption of ASU 2016-13 did not have a material impact on its condensed consolidated financial statements.
v3.23.3
Note - 4 Related Party Transactions (Tables)
 9 Months Ended
Sep. 30, 2023
Notes Tables  
Schedule of Related Party Transactions [Table Text Block]
 

Maturity

Date

  

Stated

Interest

Rate

    

Conversion

Price

    

Face

Value

    

Debt

Discount

    

Carrying

Value

  

September 30, 2023

12/31/23

     22 %   $ 1.07     $ 7,278,000     $ (2,461,000 )   $ 4,817,000  

December 31, 2022

12/31/23

     22 %   $ 6.30     $ 7,000,000     $ (1,223,000 )   $ 5,777,000  
Fair Value Measurement Inputs and Valuation Techniques [Table Text Block]
   

January

2023

    

March

2023

    

July

2023

  

Conversion price before

   $ 6.30     $ 2.87     $ 2.65  

Conversion price after

   $ 2.87     $ 2.65     $ 1.07  

Term (years)

     0.09       0.78       0.42  

Volatility

     167 %     168.9 %     156.8 %

Dividend rate

     0 %     0 %     0 %

Risk free rate

     4.46 %     4.20 %     4.22 %
v3.23.3
Note 5 - Related Party Lease (Tables)
 9 Months Ended
Sep. 30, 2023
Notes Tables  
Lease, Cost [Table Text Block]
   

September 30,

2023

    

December 31,

2022

  

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

   $ 3,213,000     $ 3,550,000  

Current lease liability (included in other current liabilities)

     551,000       433,000  

Non-current lease liability – related party

     3,071,000       3,495,000  
                 

Weighted average remaining lease term

     4.0       4.8  

Discount rate

     22 %     22 %
Lessee, Operating Lease, Liability, to be Paid, Maturity [Table Text Block]

2023 (Remaining)

   $ 324,000  

2024

     1,307,000  

2025

     1,359,000  

2026

     1,428,000  

Thereafter

     1,133,000  

Total lease payments

   $ 5,551,000  

Less: imputed interest

     (1,930,000 )

Present value of operating lease liabilities

   $ 3,621,000  
v3.23.3
Note 6 - Convertible Promissory Note (Tables)
 9 Months Ended
Sep. 30, 2023
Notes Tables  
Convertible Debt [Table Text Block]
 

Maturity

Date

  

Stated

Interest

Rate

    

Conversion

Price

    

Face
Value

    

Debt
Discount/
Premium

    

Carrying

Value

  

September 30, 2023

1/31/2024

     24%     $ 1.07     $ 397,000     $ 59,000     $ 456,000  

December 31, 2022

7/31/2023

     24%     $ 6.30     $ 1,000,000     $ (38,000 )   $ 962,000  
Fair Value Measurement Inputs and Valuation Techniques [Table Text Block]
   

January

2023

    

March

2023

    

July

2023

  

Conversion price before

   $ 6.30     $ 2.87     $ 2.65  

Conversion price after

   $ 2.87     $ 2.65     $ 1.07  

Term (years)

     0.09       0.78       0.42  

Volatility

     167 %     168.9 %     156.8 %

Dividend rate

     0 %     0 %     0 %

Risk free rate

     4.46 %     4.20 %     4.22 %
Convertible Debt [Member]  
Notes Tables  
Fair Value Measurement Inputs and Valuation Techniques [Table Text Block]
   

March

2023

  

Conversion price before

   $ 2.87  

Conversion price after

   $ 2.65  

Term (years)

     0.36  

Volatility

     182 %

Dividend rate

     0 %

Risk free rate

     4.20 %
v3.23.3
Note 7 - Stockholders' Equity (Tables)
 9 Months Ended
Sep. 30, 2023
Notes Tables  
Fair Value Measurement Inputs and Valuation Techniques [Table Text Block]
   

January

2023

    

March

2023

    

July

2023

  

Conversion price before

   $ 6.30     $ 2.87     $ 2.65  

Conversion price after

   $ 2.87     $ 2.65     $ 1.07  

Term (years)

     0.09       0.78       0.42  

Volatility

     167 %     168.9 %     156.8 %

Dividend rate

     0 %     0 %     0 %

Risk free rate

     4.46 %     4.20 %     4.22 %
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]
   

2023

    

2022

  

Common stock equivalents of convertible promissory notes and accrued interest

     7,448,487       969,173  

Warrants

     1,238,869       14,518  

Stock options

     6,218       6,380  

Total

     8,693,574       990,071  
Schedule of Warrant Activity [Table Text Block]
   

Number of

Shares

    

Weighted-Average

Exercise Price Per

Share

    

Weighted-

Average

Remaining

Contract Term

  

Balance at December 31, 2022

     340,689     $ 19.40       1.90  

Warrants granted

     1,071,429                  

Warrants expired

     (14,518 )                

Pre-funded warrants granted

     946,429                  

Pre-funded warrants exercised

     (946,429 )                

Warrants exercised

     (158,731 )                

Exercisable and Outstanding at September 30, 2023

     1,238,869     $ 3.14       4.82  
Warrants [Member]  
Notes Tables  
Fair Value Measurement Inputs and Valuation Techniques [Table Text Block]
   

March

2023

  

Conversion price before

   $ 6.30  

Conversion price after

   $ 2.65  

Term (years)

     4.9  

Volatility

     123 %

Dividend rate

     0 %

Risk free rate

     4.20 %
v3.23.3
Note 8 - Revenue (Tables)
 9 Months Ended
Sep. 30, 2023
Notes Tables  
Disaggregation of Revenue [Table Text Block]
   

Three Months Ended September 30,

    

Nine Months Ended September 30,

  
   

2023

    

2022

    

2023

    

2022

  

United States

   $ 1,500,000     $ 1,535,000     $ 4,589,000     $ 4,973,000  

China

     29,000       364,000       77,000       1,570,000  

United Arab Emirates

     259,000       --       439,000       --  

Other

     406,000       216,000       1,934,000       1,264,000  

Total

   $ 2,194,000     $ 2,115,000     $ 7,039,000     $ 7,807,000  
   

Three Months Ended September 30, 2023

  
   

Device

Revenue

    

Service

Revenue

    

Other

Revenue

    

Total

Revenue

  

AXP

   $ 1,486,000     $ 88,000     $ --     $ 1,574,000  

BioArchive

     131,000       322,000       --       453,000  

CAR-TXpress

     42,000       34,000       71,000       147,000  

Manual Disposables

     8,000       --       --       8,000  

Other

     6,000       --       6,000       12,000  

Total

   $ 1,673,000     $ 444,000     $ 77,000     $ 2,194,000  
   

Nine Months Ended September 30, 2023

  
   

Device

Revenue

    

Service

Revenue

    

Other

Revenue

    

Total

Revenue

  

AXP

   $ 4,245,000     $ 184,000     $ --     $ 4,429,000  

BioArchive

     879,000       1,020,000       --       1,899,000  

CAR-TXpress

     101,000       109,000       213,000       423,000  

Manual Disposables

     229,000       --       --       229,000  

Other

     41,000       --       18,000       59,000  

Total

   $ 5,495,000     $ 1,313,000     $ 231,000     $ 7,039,000  
   

Three Months Ended September 30, 2022

  
   

Device

Revenue

    

Service

Revenue

    

Other

Revenue

    

Total

Revenue

  

AXP

   $ 1,034,000     $ 75,000     $ --     $ 1,109,000  

BioArchive

     201,000       321,000       --       522,000  

CAR-TXpress

     190,000       44,000       72,000       306,000  

Manual Disposables

     150,000       --       --       150,000  

Other

     20,000       --       8,000       28,000  

Total

   $ 1,595,000     $ 440,000     $ 80,000     $ 2,115,000  
   

Nine Months Ended September 30, 2022

  
   

Device

Revenue

    

Service

Revenue

    

Other

Revenue

    

Total

Revenue

  

AXP

   $ 4,668,000     $ 171,000     $ --     $ 4,839,000  

BioArchive

     694,000       924,000       --       1,618,000  

CAR-TXpress

     551,000       146,000       214,000       911,000  

Manual Disposables

     357,000       --       --       357,000  

Other

     59,000       --       23,000       82,000  

Total

   $ 6,329,000     $ 1,241,000     $ 237,000     $ 7,807,000  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Table Text Block]
   

Remainder

of 2023

    

2024

    

2025

    

2026

    

2027 and

beyond

    

Total

  

Service revenue

   $ 319,000     $ 741,000     $ 252,000     $ --     $ --     $ 1,312,000  

Device revenue (1)

     21,000       692,000       --       --       --       713,000  

Exclusivity fee

     71,000       286,000       286,000       190,000       --       833,000  

Other

     3,000       13,000       13,000       13,000       97,000       139,000  

Total

   $ 414,000     $ 1,732,000     $ 551,000     $ 203,000     $ 97,000     $ 2,997,000  
v3.23.3
Note 9 - Concentrations (Tables)
 9 Months Ended
Sep. 30, 2023
Notes Tables  
Schedules of Concentration of Risk, by Risk Factor [Table Text Block]
   

September 30,

2023

    

December 31,

2022

  

Customer 1

     --       29%  

Customer 2

     --       27%  

Customer 3

     --       15%  
   

Three Months Ended September 30,

    

Nine Months Ended September 30,

  
   

2023

    

2022

    

2023

    

2022

  

Customer 1

     41%       36%       36%       36%  

Customer 2

     1%       1%       1%       13%  
v3.23.3
Note 1 - Description of Business (Details Textual)
Dec. 22, 2022
Stockholders' Equity Note, Stock Split, Conversion Ratio 45
v3.23.3
Note 3 - Summary of Significant Accounting Policies (Details Textual) - USD ($)
Sep. 30, 2023
Jun. 30, 2023
Mar. 31, 2023
Dec. 31, 2022
Sep. 30, 2022
Jun. 30, 2022
Mar. 31, 2022
Jan. 01, 2022
Dec. 31, 2021
Equity, Including Portion Attributable to Noncontrolling Interest $ 3,263,000 $ 2,627,000 $ 5,012,000 $ 3,323,000 $ 4,266,000 $ 5,509,000 $ 1,282,000   $ 3,397,000
Retained Earnings [Member]                  
Equity, Including Portion Attributable to Noncontrolling Interest (277,154,000) (273,539,000) (271,279,000) (266,193,000) (262,761,000) (259,521,000) (256,833,000)   (264,662,000)
Additional Paid-in Capital [Member]                  
Equity, Including Portion Attributable to Noncontrolling Interest $ 281,632,000 $ 277,266,000 $ 277,253,000 $ 270,377,000 $ 267,761,000 $ 265,623,000 $ 258,627,000   268,459,000
Accounting Standards Update 2020-06 [Member] | Cumulative Effect, Period of Adoption, Adjustment [Member]                  
Equity, Including Portion Attributable to Noncontrolling Interest                 (942,000)
Accounting Standards Update 2020-06 [Member] | Cumulative Effect, Period of Adoption, Adjustment [Member] | Convertible Debt [Member]                  
Debt Instrument, Unamortized Discount               $ (942,000)  
Accounting Standards Update 2020-06 [Member] | Cumulative Effect, Period of Adoption, Adjustment [Member] | Retained Earnings [Member]                  
Equity, Including Portion Attributable to Noncontrolling Interest               9,739,000 9,739,000
Accounting Standards Update 2020-06 [Member] | Cumulative Effect, Period of Adoption, Adjustment [Member] | Additional Paid-in Capital [Member]                  
Equity, Including Portion Attributable to Noncontrolling Interest               $ (10,681,000) $ (10,681,000)
CAR-TXpress [Member]                  
Subsidiary, Ownership Percentage, Noncontrolling Owner 20.00%                
Subsidiary, Ownership Percentage, Parent 80.00%                
v3.23.3
Note - 4 Related Party Transactions (Details Textual) - USD ($)
 3 Months Ended 9 Months Ended
Sep. 28, 2023
Mar. 24, 2022
Sep. 30, 2023
Sep. 30, 2022
Sep. 30, 2023
Sep. 30, 2022
Jul. 31, 2023
Mar. 31, 2023
Mar. 06, 2023
Jan. 31, 2023
Dec. 31, 2022
Mar. 31, 2017
Amortization of Debt Discount (Premium)         $ 5,396,000 $ 1,897,000            
Interest Paid, Excluding Capitalized Interest, Operating Activities         $ 140,000 180,000            
ImmuneCyte [Member]                        
Percent of Ownership Interest Transferred   8.64%                    
Royalty, Percent of Annual Net Sales, US Patents   7.50%                    
Royalty, Percent of Annual Net Sales, Other Licensed Intellectual Property   5.00%                    
Revolving Credit Facility [Member] | Boyalife Asset Holding II [Member]                        
Line of Credit Facility, Maximum Borrowing Capacity                       $ 10,000,000
Long-Term Line of Credit $ 7,278,000               $ 7,278,000      
Debt Conversion, Original Debt, Amount $ 700,000                      
Debt Conversion, Converted Instrument, Shares Issued 654,206                      
Debt Instrument, Convertible, Conversion Price $ 1.07   $ 1.07   $ 1.07   $ 1.07 $ 2.65   $ 6.30 $ 6.30  
Interest Payable $ 216,000   $ 225,000   $ 225,000           $ 1,492,000  
Debt Instrument, Interest Rate, Stated Percentage     22.00%   22.00%           22.00%  
Share Price (in dollars per share)               $ 2.65   $ 2.87    
Debt Instrument, Unamortized Discount     $ 2,461,000   $ 2,461,000         $ 2,350,000 $ 1,223,000  
Amortization of Debt Discount (Premium)     1,720,000 $ 940,000 5,582,000 1,897,000            
Interest Paid, Excluding Capitalized Interest, Operating Activities     $ 409,000 $ 394,000 $ 1,203,000 $ 1,496,000            
Revolving Credit Facility [Member] | Boyalife Asset Holding II [Member] | Incremental Value Increase [Member]                        
Debt Instrument, Unamortized Discount             $ 3,660,000 $ 810,000        
v3.23.3
Note 4 - Related Party Transactions - Schedule of Related Party Transactions (Details) - Revolving Credit Facility [Member] - Boyalife Asset Holding II [Member] - USD ($)
 9 Months Ended 12 Months Ended
Sep. 30, 2023
Dec. 31, 2022
Sep. 28, 2023
Jul. 31, 2023
Mar. 31, 2023
Jan. 31, 2023
Debt Instrument, Maturity Date Dec. 31, 2023 Dec. 31, 2023        
Stated interest rate 22.00% 22.00%        
Conversion price (in dollars per share) $ 1.07 $ 6.30 $ 1.07 $ 1.07 $ 2.65 $ 6.30
Face value $ 7,278,000 $ 7,000,000        
Debt discount (2,461,000) (1,223,000)       $ (2,350,000)
Carrying value $ 4,817,000 $ 5,777,000        
v3.23.3
Note 4 - Related Party Transactions - Fair Value Inputs (Details)
Jul. 01, 2023
Mar. 31, 2023
Jan. 01, 2023
Measurement Input, Conversion Price Before [Member]      
Conversion price before 2.65 2.87 6.30
Measurement Input, Conversion Price [Member]      
Conversion price before 1.07 2.65 2.87
Measurement Input, Expected Term [Member]      
Conversion price before 0.42 0.78 0.09
Measurement Input, Price Volatility [Member]      
Conversion price before 1.568 1.689 1.67
Measurement Input, Expected Dividend Rate [Member]      
Conversion price before 0 0 0
Measurement Input, Risk Free Interest Rate [Member]      
Conversion price before 0.0422 0.0420 0.0446
v3.23.3
Note 5 - Related Party Lease (Details Textual) - Lease Agreement with Z3 Investment LLC [Member]
 9 Months Ended
Mar. 24, 2022
USD ($)
ft²
Sep. 30, 2023
USD ($)
Sep. 30, 2022
USD ($)
Lessee, Operating Lease, Term of Contract 5 years    
Area of Real Estate Property | ft² 35,000    
Second Six Months, Rental Expense, Operating Lease $ 104,000    
Percent Increase, Annual Rental Expense 4.00%    
Operating lease, Operating Expenses, Per Month $ 10,000    
Operating Lease, Payments   $ 932,000 $ 277,000
v3.23.3
Note 5 - Related Party Lease - Lease Cost (Details) - USD ($)
Sep. 30, 2023
Dec. 31, 2022
Right-of-use operating lease assets, net $ 190,000 $ 372,000
Operating lease obligations – long-term   131,000
Lease Agreement with Z3 Investment LLC [Member]    
Right-of-use operating lease assets, net 3,213,000 3,550,000
Current lease liability (included in other current liabilities) 551,000 433,000
Operating lease obligations – long-term $ 3,071,000 $ 3,495,000
Weighted average remaining lease term (Year) 4 years 4 years 9 months 18 days
Discount rate 22.00% 22.00%
v3.23.3
Note 5 - Related Party Lease - Lease Liability Maturity (Details)
Sep. 30, 2023
USD ($)
2023 (Remaining) $ 324,000
2024 1,307,000
2025 1,359,000
2026 1,428,000
Thereafter 1,133,000
Total lease payments 5,551,000
Less: imputed interest (1,930,000)
Present value of operating lease liabilities $ 3,621,000
v3.23.3
Note 6 - Convertible Promissory Note (Details Textual) - USD ($)
 3 Months Ended 9 Months Ended
Jul. 31, 2023
Jan. 31, 2023
Sep. 30, 2023
Sep. 30, 2022
Sep. 30, 2023
Sep. 30, 2022
Mar. 31, 2023
Dec. 31, 2022
Jul. 23, 2019
Amortization of Debt Discount (Premium)         $ 5,396,000 $ 1,897,000      
The July 2019 Note [Member] | Convertible Debt [Member]                  
Debt Instrument, Face Amount     $ 397,000   $ 397,000     $ 1,000,000 $ 1,000,000
Debt Instrument, Interest Rate, Stated Percentage     24.00%   24.00%     24.00% 24.00%
Debt Instrument, Convertible, Conversion Price $ 1.07 $ 2.87 $ 1.07   $ 1.07   $ 2.65 $ 6.30  
Long-Term Debt, Fair Value $ 538,000 $ 1,239,000              
Liabilities, Fair Value Adjustment $ 87,000 $ 239,000              
Debt Instrument, Unamortized Discount             $ 43,000    
Interest Expense, Debt     $ 24,000 $ 60,000 $ 90,000 $ 180,000      
Antidilutive Triggering Event [Member] | Convertible Debt [Member]                  
Amortization of Debt Discount (Premium)     $ 35,000   $ 190,000        
v3.23.3
Note 6 - Convertible Promissory Note- Schedule of Convertible Debt (Details) - The July 2019 Note [Member] - Convertible Debt [Member] - USD ($)
 9 Months Ended 12 Months Ended
Sep. 30, 2023
Dec. 31, 2022
Jul. 31, 2023
Mar. 31, 2023
Jan. 31, 2023
Jul. 23, 2019
Debt Instrument, Maturity Date Jan. 31, 2024 Jul. 31, 2023        
Stated interest rate 24.00% 24.00%       24.00%
Conversion price (in dollars per share) $ 1.07 $ 6.30 $ 1.07 $ 2.65 $ 2.87  
Face value $ 397,000 $ 1,000,000       $ 1,000,000
Debt Instrument, Unamortized Discount (Premium), Net 59,000 (38,000)        
Carrying value $ 456,000 $ 962,000        
v3.23.3
Note 6 - Convertible Promissory Note - Fair Value Inputs (Details)
Sep. 30, 2023
Jul. 01, 2023
Mar. 31, 2023
Jan. 01, 2023
Measurement Input, Conversion Price Before [Member]        
Conversion price before   2.65 2.87 6.30
Measurement Input, Conversion Price [Member]        
Conversion price before   1.07 2.65 2.87
Measurement Input, Expected Term [Member]        
Conversion price before   0.42 0.78 0.09
Measurement Input, Price Volatility [Member]        
Conversion price before   1.568 1.689 1.67
Measurement Input, Expected Dividend Rate [Member]        
Conversion price before   0 0 0
Measurement Input, Risk Free Interest Rate [Member]        
Conversion price before   0.0422 0.0420 0.0446
Convertible Debt [Member] | Measurement Input, Conversion Price Before [Member]        
Conversion price before 2.87      
Convertible Debt [Member] | Measurement Input, Conversion Price [Member]        
Conversion price before 2.65      
Convertible Debt [Member] | Measurement Input, Expected Term [Member]        
Conversion price before 0.36      
Convertible Debt [Member] | Measurement Input, Price Volatility [Member]        
Conversion price before 1.82      
Convertible Debt [Member] | Measurement Input, Expected Dividend Rate [Member]        
Conversion price before 0      
Convertible Debt [Member] | Measurement Input, Risk Free Interest Rate [Member]        
Conversion price before 0.0420      
v3.23.3
Note 7 - Stockholders' Equity (Details Textual) - USD ($)
 3 Months Ended 9 Months Ended
Mar. 15, 2023
Sep. 30, 2023
Sep. 30, 2023
Sep. 30, 2022
Dec. 31, 2022
Mar. 31, 2022
Feb. 03, 2022
Stock Issued During Period, Shares, New Issues 125,000            
Common Stock, Par or Stated Value Per Share $ 0.001 $ 0.001 $ 0.001   $ 0.001    
Class of Warrant or Right, Outstanding   1,238,869 1,238,869   340,689    
Class of Warrant or Right, Exercise Price of Warrants or Rights   $ 3.14 $ 3.14   $ 19.40    
Warrants and Rights Outstanding, Term   4 years 9 months 25 days 4 years 9 months 25 days   1 year 10 months 24 days    
Proceeds from Issuance or Sale of Equity $ 2,640,000,000,000            
Payments of Stock Issuance Costs $ 360,000,000            
Warrants Exercised     158,731        
Proceeds from Warrant Exercises     $ 421,000        
Proceeds from Issuance of Common Stock, Net     $ 2,640,000 $ 3,037,000      
Warrant Amendment Agreement [Member]              
Stock Issued During Period, Shares, New Issues 158,731            
Class of Warrant or Right, Exercise Price of Warrants or Rights $ 6.30 $ 2.65 $ 2.65        
Warrants Exercised     158,731        
Proceeds from Warrant Exercises     $ 421,000        
At The Market Offering Agreement [Member]              
Stock Issued During Period, Shares, New Issues     196,843        
Payments of Stock Issuance Costs     $ 256,000        
Maximum Offering Price for Issuance of Common Stock           $ 18,573,000  
Additional Common Stock, Shares Authorized             $ 4,275,000
Proceeds from Issuance of Common Stock     $ 3,293,000        
Shares Issued, Average Price Per Share     $ 16.55        
Proceeds from Issuance of Common Stock, Net     $ 3,037,000        
At The Market Offering Agreement [Member] | Minimum [Member]              
Maximum Offering Price for Issuance of Common Stock             15,280,000
At The Market Offering Agreement [Member] | Maximum [Member]              
Maximum Offering Price for Issuance of Common Stock             $ 19,555,000
Pre-funded Warrant [Member]              
Class of Warrant or Right, Outstanding 946,429            
Share Price (in dollars per share) $ 2.80            
Class of Warrant or Right, Number of Securities Called by Warrants or Rights 1,071,429            
Class of Warrant or Right, Exercise Price of Warrants or Rights $ 2.65            
Warrants and Rights Outstanding, Term 5 years 6 months            
Warrants Exercised   946,429 946,429        
Warrants Issued in Connection with Underwritten Public Offering [Member]              
Fair Value Adjustment of Warrants     $ 50,000        
v3.23.3
Note 7 - Stockholders' Equity - Fair Value Valuation (Details)
Sep. 30, 2023
Measurement Input, Conversion Price Before [Member]  
Conversion price before 6.30
Measurement Input, Conversion Price [Member]  
Conversion price before 2.65
Measurement Input, Expected Term [Member]  
Conversion price before 4.9
Measurement Input, Price Volatility [Member]  
Conversion price before 1.23
Measurement Input, Expected Dividend Rate [Member]  
Conversion price before 0
Measurement Input, Risk Free Interest Rate [Member]  
Conversion price before 0.0420
v3.23.3
Note 7 - Stockholders' Equity - Antidilutive Securities (Details) - shares
 9 Months Ended
Sep. 30, 2023
Sep. 30, 2022
Antidilutive securities (in shares) 8,693,574 990,071
Convertible Debt Securities [Member]    
Antidilutive securities (in shares) 7,448,487 969,173
Warrant [Member]    
Antidilutive securities (in shares) 1,238,869 14,518
Share-Based Payment Arrangement, Option [Member]    
Antidilutive securities (in shares) 6,218 6,380
v3.23.3
Note 7 - Stockholders' Equity - Warrant Activity (Details) - $ / shares
 3 Months Ended 9 Months Ended
Sep. 30, 2023
Sep. 30, 2023
Mar. 15, 2023
Dec. 31, 2022
Balance, shares (in shares)   340,689    
Balance, exercise price (in dollars per share)   $ 19.40    
Balance, term (Year) 4 years 9 months 25 days 4 years 9 months 25 days   1 year 10 months 24 days
Warrants granted, shares (in shares)   1,071,429    
Warrants expired (in shares)   (14,518)    
Warrants exercised (in shares)   (158,731)    
Exercisable, shares (in shares) 1,238,869 1,238,869    
Balance, exercise price (in dollars per share) $ 3.14 $ 3.14    
Pre-funded Warrant [Member]        
Balance, term (Year)     5 years 6 months  
Warrants granted, shares (in shares)   946,429    
Warrants exercised (in shares) (946,429) (946,429)    
v3.23.3
Note 8 - Revenue 1 (Details Textual) - USD ($)
 3 Months Ended 9 Months Ended
Sep. 30, 2023
Sep. 30, 2023
Dec. 31, 2022
Contract with Customer, Liability, Revenue Recognized $ 144,000 $ 663,000  
Contract with Customer, Liability, Current 818,000 818,000 $ 782,000
Contract with Customer, Liability, Noncurrent $ 680,000 $ 680,000 $ 911,000
v3.23.3
Note 8 - Revenue 2 (Details Textual)
Sep. 30, 2023
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 6 months
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2025-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2026-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2027-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Service [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 6 months
Service [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Service [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2025-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Service [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2026-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Service [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2027-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Device Revenue [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 6 months
Device Revenue [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Device Revenue [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2025-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Device Revenue [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2026-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Device Revenue [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2027-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Exclusivity Fee [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 6 months
Exclusivity Fee [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Exclusivity Fee [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2025-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Exclusivity Fee [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2026-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Exclusivity Fee [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2027-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Product and Service, Other [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 6 months
Product and Service, Other [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Product and Service, Other [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2025-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Product and Service, Other [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2026-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
Product and Service, Other [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2027-01-01  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period (Year) 1 year
v3.23.3
Note 8 - Revenue - Disaggregation of Revenue (Details) - USD ($)
 3 Months Ended 9 Months Ended
Sep. 30, 2023
Sep. 30, 2022
Sep. 30, 2023
Sep. 30, 2022
Net revenues $ 2,194,000 $ 2,115,000 $ 7,039,000 $ 7,807,000
Device [Member] | AXP [Member]        
Net revenues 1,574,000 1,109,000 4,429,000 4,839,000
Device [Member] | BioArchive [Member]        
Net revenues 453,000 522,000 1,899,000 1,618,000
Device [Member] | CAR-TXpress [Member]        
Net revenues 147,000 306,000 423,000 911,000
Device [Member] | Manual Disposables [Member]        
Net revenues 8,000 150,000 229,000 357,000
Device [Member] | Other Subsegments [Member]        
Net revenues 12,000 28,000 59,000 82,000
Device Revenue [Member]        
Net revenues 1,673,000 1,595,000 5,495,000 6,329,000
Device Revenue [Member] | Device [Member] | AXP [Member]        
Net revenues 1,486,000 1,034,000 4,245,000 4,668,000
Device Revenue [Member] | Device [Member] | BioArchive [Member]        
Net revenues 131,000 201,000 879,000 694,000
Device Revenue [Member] | Device [Member] | CAR-TXpress [Member]        
Net revenues 42,000 190,000 101,000 551,000
Device Revenue [Member] | Device [Member] | Manual Disposables [Member]        
Net revenues 8,000 150,000 229,000 357,000
Device Revenue [Member] | Device [Member] | Other Subsegments [Member]        
Net revenues 6,000 20,000 41,000 59,000
Service [Member]        
Net revenues 444,000 440,000 1,313,000 1,241,000
Service [Member] | Device [Member] | AXP [Member]        
Net revenues 88,000 75,000 184,000 171,000
Service [Member] | Device [Member] | BioArchive [Member]        
Net revenues 322,000 321,000 1,020,000 924,000
Service [Member] | Device [Member] | CAR-TXpress [Member]        
Net revenues 34,000 44,000 109,000 146,000
Other [Member]        
Net revenues 77,000 80,000 231,000 237,000
Other [Member] | Device [Member] | CAR-TXpress [Member]        
Net revenues 71,000 72,000 213,000 214,000
Other [Member] | Device [Member] | Other Subsegments [Member]        
Net revenues 6,000 8,000 18,000 23,000
UNITED STATES        
Net revenues 1,500,000 1,535,000 4,589,000 4,973,000
CHINA        
Net revenues 29,000 364,000 77,000 1,570,000
UNITED ARAB EMIRATES        
Net revenues 259,000   439,000  
All Other Countries [Member]        
Net revenues $ 406,000 $ 216,000 $ 1,934,000 $ 1,264,000
v3.23.3
Note 8 - Revenue - Remaining Performance Obligations (Details)
Sep. 30, 2023
USD ($)
Remaining $ 2,997,000
Service [Member]  
Remaining 1,312,000
Device Revenue [Member]  
Remaining 713,000 [1]
Exclusivity Fee [Member]  
Remaining 833,000
Other [Member]  
Remaining $ 139,000
[1] Represents the minimum purchase requirements under the distribution agreement the Company signed with its AXP distributor in China.
v3.23.3
Note 8 - Revenue - Remaining Performance Obligations 2 (Details)
Sep. 30, 2023
USD ($)
Remaining $ 2,997,000
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01  
Remaining 414,000
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-01-01  
Remaining 1,732,000
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2025-01-01  
Remaining 551,000
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2026-01-01  
Remaining 203,000
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2027-01-01  
Remaining 97,000
Service [Member]  
Remaining 1,312,000
Service [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01  
Remaining 319,000
Service [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-01-01  
Remaining 741,000
Service [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2025-01-01  
Remaining 252,000
Device Revenue [Member]  
Remaining 713,000 [1]
Device Revenue [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01  
Remaining 21,000 [1]
Device Revenue [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-01-01  
Remaining 692,000 [1]
Exclusivity Fee [Member]  
Remaining 833,000
Exclusivity Fee [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01  
Remaining 71,000
Exclusivity Fee [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-01-01  
Remaining 286,000
Exclusivity Fee [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2025-01-01  
Remaining 286,000
Exclusivity Fee [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2026-01-01  
Remaining 190,000
Other [Member]  
Remaining 139,000
Other [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01  
Remaining 3,000
Other [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-01-01  
Remaining 13,000
Other [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2025-01-01  
Remaining 13,000
Other [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2026-01-01  
Remaining 13,000
Other [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2027-01-01  
Remaining $ 97,000
[1] Represents the minimum purchase requirements under the distribution agreement the Company signed with its AXP distributor in China.
v3.23.3
Note 9 - Concentrations - Accounts Receivables and Revenues 2 (Details) - Customer Concentration Risk [Member]
 3 Months Ended 9 Months Ended
Sep. 30, 2023
Sep. 30, 2022
Sep. 30, 2023
Sep. 30, 2022
Revenue from Contract with Customer Benchmark [Member] | Customer 1 [Member]        
Concentration 41.00% 36.00% 36.00% 36.00%
Revenue from Contract with Customer Benchmark [Member] | Customer 2 [Member]        
Concentration 1.00% 1.00% 1.00% 13.00%
Accounts Receivable [Member] | Customer 1 [Member]        
Concentration       29.00%
Accounts Receivable [Member] | Customer 2 [Member]        
Concentration       27.00%
Accounts Receivable [Member] | Customer 3 [Member]        
Concentration       15.00%
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