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, 2022.2023.

 

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 ☐


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 8, 20229, 2023

Common stock, $.001 par value

 

45,997,7923,136,504

 

 

 

 

ThermoGenesis Holdings, Inc.

 

 

INDEX

 

 Page Number
PART IFINANCIAL INFORMATION 
  
ITEM 1.Financial Statements1
  
ITEM 2.

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

1516
  
ITEM 3.Quantitative and Qualitative Disclosures about Market Risk2022
  
ITEM 4.Controls and Procedures2022
  

PART II

OTHER INFORMATION

 
  

ITEM 1.

Legal Proceedings

21

22

ITEM 1A.

Risk Factors

21

22

ITEM 2.

Unregistered Sales of Equity Securities and Use of Proceeds

21

22

ITEM 3.

Defaults upon Senior Securities

21

23

ITEM 4.

Mine Safety Disclosure

21

23

ITEM 5.

Other Information

21

23

ITEM 6.

Exhibits

22

24
  

Signatures

23

25

 

i

 

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

ThermoGenesis Holdings, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

 

 

September 30,

2022

  

December 31,

2021

  

September 30,
2023

  

December 31,
2022

 

ASSETS

  
Current assets:  

Cash and cash equivalents

 $3,903,000  $7,280,000  $4,018,000  $4,177,000 

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

 2,056,000  733,000 

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

 368,000  1,865,000 

Inventories

 4,912,000  5,373,000  1,821,000  3,334,000 

Prepaid expenses and other current assets

  612,000   1,578,000   718,000   1,508,000 

Total current assets

 11,483,000  14,964,000  6,925,000  10,884,000 
  

Inventories non-current, net

 930,000  1,709,000 

Inventories, non-current

 772,000  1,003,000 

Equipment and leasehold improvements, net

 1,271,000  1,261,000  2,523,000  1,254,000 

Right-of-use operating lease assets, net

 426,000  571,000  190,000  372,000 

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

 3,653,000  --  3,213,000  3,550,000 

Goodwill

 781,000  781,000  781,000  781,000 

Other intangible assets, net

 1,294,000  1,318,000 

Intangible assets, net

 1,262,000  1,286,000 

Other assets

  255,000   48,000   255,000   256,000 

Total assets

 $20,093,000  $20,652,000  $15,921,000  $19,386,000 
  

LIABILITIES AND EQUITY

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 
Current liabilities:  

Accounts payable

 $1,007,000  $1,280,000  $591,000  $820,000 

Accrued payroll and related expenses

 493,000  348,000  451,000  399,000 

Deferred revenue – short-term

 841,000  719,000  818,000  782,000 

Convertible promissory note – related party

 5,133,000  --  4,817,000  5,777,000 

Interest payable – related party

 1,099,000  2,231,000  225,000  1,492,000 

Convertible promissory note, net

 1,000,000  813,000  456,000  962,000 

Other current liabilities

  1,395,000   957,000   1,532,000   1,277,000 

Total current liabilities

 10,968,000  6,348,000  8,890,000  11,509,000 
  

Convertible promissory note – related party, net

 --  9,245,000 

Operating lease obligations – long-term

 205,000  398,000  --  131,000 

Operating lease obligations – related party – long-term

 3,622,000  --  3,071,000  3,495,000 

Deferred revenue – long-term

 1,014,000  1,244,000  680,000  911,000 

Other noncurrent liabilities

  18,000   20,000   17,000   17,000 

Total liabilities

  15,827,000   17,255,000   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; 31,321,362 issued and outstanding (11,911,784 at December 31, 2021)

 31,000  12,000 

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

 267,731,000  268,447,000  281,632,000  270,377,000 

Accumulated deficit

 (262,761,000) (264,662,000) (277,154,000) (266,193,000)

Accumulated other comprehensive loss

  98,000   31,000   114,000   111,000 

Total ThermoGenesis Holdings, Inc. stockholders’ equity

 5,099,000  3,828,000  4,595,000  4,296,000 
  

Noncontrolling interests

  (833,000)  (431,000)  (1,332,000)  (973,000)

Total equity

  4,266,000   3,397,000   3,263,000   3,323,000 

Total liabilities and equity

 $20,093,000  $20,652,000  $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,

  

Three Months Ended
September 30,

 

Nine Months Ended

September 30,

 
 

2022

  

2021

  

2022

  

2021

  

2023

  

2022

  

2023

  

2022

 
  

Net revenues

 $2,115,000  $3,158,000  

$

7,807,000  $6,876,000  $2,194,000  $2,115,000  $7,039,000  $7,807,000 

Cost of revenues

  1,678,000   2,043,000   

5,491,000

   4,067,000   1,799,000   1,678,000   5,070,000   5,491,000 
  

Gross profit

  437,000   1,115,000   

2,316,000

   2,809,000   395,000   437,000   1,969,000   2,316,000 
  
Expenses:  

Selling, general and administrative

 1,982,000  1,677,000  

5,665,000

  7,171,000  1,686,000  1,982,000  5,346,000  5,665,000 

Research and development

  470,000   543,000   

1,317,000

   1,544,000   266,000   470,000   955,000   1,317,000 
  

Total operating expenses

  2,452,000   2,220,000   

6,982,000

   8,715,000   1,952,000   2,452,000   6,301,000   6,982,000 
  

Loss from operations

 (2,015,000) (1,105,000) 

(4,666,000

) (5,906,000) (1,557,000) (2,015,000) (4,332,000) (4,666,000)
  
Other expenses:  

Interest expense

 (1,391,000) (1,530,000) 

(3,572,000

) (4,573,000) (2,118,000) (1,391,000) (6,689,000) (3,572,000)

Gain on extinguishment of debt

 --  --  --  652,000 

Loss on retirement of debt

 (87,000) --  (326,000) -- 

Other income/(expense)

  3,000   843,000   (1,000)  833,000   22,000   3,000   27,000   (1,000)
  

Total other expense

  (1,388,000)  (687,000)  (3,573,000)  (3,088,000)  (2,183,000)  (1,388,000)  (6,988,000)  (3,573,000)
  

Net loss

  (3,403,000)  (1,792,000)  

(8,239,000

)  (8,994,000)  (3,740,000)  (3,403,000)  (11,320,000)  (8,239,000)
  

Loss attributable to noncontrolling interests

  (163,000)  (18,000)  

(402,000

)  (269,000)  (125,000)  (163,000)  (359,000)  (402,000)
            

Net loss attributable to common stockholders

 $(3,240,000) $(1,774,000) 

$

(7,837,000) $(8,725,000) $(3,615,000) $(3,240,000) $(10,961,000) $(7,837,000)
  

COMPREHENSIVE LOSS

  

Net loss

 $(3,403,000) $(1,792,000) 

$

(8,239,000) $(8,994,000) $(3,740,000) $(3,403,000) $(11,320,000) $(8,239,000)
Other comprehensive loss:  

Foreign currency translation adjustments gain (loss)

  22,000   (1,000

)

  67,000   12,000 

Foreign currency translation adjustments gain

  9,000   22,000   3,000   67,000 

Comprehensive loss

 (3,381,000) (1,793,000) 

(8,172,000

) (8,982,000) (3,731,000) (3,381,000) (11,317,000) (8,172,000)

Comprehensive loss attributable to noncontrolling interests

  (163,000)  (18,000)  

(402,000

)  (269,000)  (125,000)  (163,000)  (359,000)  (402,000)

Comprehensive loss attributable to common stockholders

 $(3,218,000) $(1,775,000) 

$

(7,770,000) $(8,713,000) $(3,606,000) $(3,218,000) $(10,958,000) $(7,770,000)
  
Per share data:  
  

Basic and diluted net loss per common share

 $(0.10) $(0.15) 

$

(0.41) $(0.74) $(1.44) $(4.66) $(5.26) $(18.49)
  

Weighted average common shares outstanding – basic and diluted

  31,265,797   11,911,784   19,075,331   11,757,211   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, 2022 and 2021 2023

(Unaudited)

 

 

Shares

 

Common

Stock

 

Paid in Capital

in Excess of

Par

 

Accumulated

Deficit

 

AOCL*

 

Non-

Controlling

Interests

 

Total Equity

  

Shares

 

Common

Stock

 

Paid in

Capital in

Excess of Par

 

Accumulated

Deficit

 

AOCL*

 

Non-

Controlling

Interests

 

Total Equity

 

Balance at January 1, 2022

 11,911,784  $12,000  $268,447,000  $(264,662,000) $31,000  $(431,000) $3,397,000 

Balance at January 1, 2023

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

Adoption of ASU 2020-06

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

Stock-based compensation expense

 --  --  42,000  --  --  --  42,000  --  --  10,000  --  --  --  10,000 

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

 918,093  1,000  593,000  --  --  --  594,000 

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

      213,000         213,000  --  --  3,660,000  --  --  --  3,660,000 

Foreign currency translation gain

 --  --  --  --  14,000  --  14,000  --  --  --  --  9,000  --  9,000 

Net loss

  --  --  --  (1,910,000) --  (126,000) (2,036,000)  --  --  --  (3,615,000) --  (125,000) (3,740,000)

Balance at March 31, 2022

  12,829,877  $13,000  $258,614,000  $(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

 4,397,329  4,000  1,446,000  --  --  --  1,450,000 

Related party convertible note price reset

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

Conversion of related party note payable to common stock

 10,552,234  11,000  2,989,000  --  --  --  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

  27,779,440  28,000  265,596,000  (259,521,000) 76,000  (670,000) 5,509,000 
               

Stock-based compensation expense

 --  --  70,000  --  --  --  70,000 

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

 3,541,922  3,000  990,000  --  --  --  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

  31,321,362  $31,000  $267,731,000  $(262,761,000) $98,000  $(833,000) $4,266,000 

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

  

Shares

 

Common

Stock

 

Paid in

Capital in

Excess of Par

 

Accumulated

Deficit

 

AOCL*

 

Non-

Controlling

Interests

 

Total Equity

 

Balance at January 1, 2021

 8,934,952  $9,000  $259,058,000  $(253,283,000) $16,000  $70,000  $5,870,000 

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

 --  --  258,000  --  --  --  258,000  --  --  72,000  --  --  --  72,000 

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

 2,976,832  3,000  6,829,000  --  --  --  6,832,000  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

 --  --  --  --  1,000  --  1,000  --  --  --  --  31,000  --  31,000 

Net loss

  --  --  --  (2,413,000) --  (118,000) (2,531,000)  --  --  --  (2,688,000) --  (113,000) (2,801,000)

Balance at March 31, 2021

  11,911,784  $12,000  $266,145,000  $(255,696,000) $17,000  $(48,000) $10,430,000 

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 expense

 --  --  2,099,000  --  --  --  2,099,000 

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

 --  --  --  --  12,000  --  12,000  --  --  --  --  22,000  --  22,000 

Net loss

  --  --  --  (4,539,000) --  (133,000) (4,672,000)  --  --  --  (3,240,000) --  (163,000) (3,403,000)

Balance at June 30, 2021

  11,911,784  $12,000  $268,244,000  $(260,235,000) $29,000  $(181,000) $7,869,000 
               

Stock-based compensation expense

 --  --  92,000  --  --  --  92,000 

Foreign currency translation gain

 --  --  --  --  (1,000) --  (1,000)

Net loss

  --  --  --  (1,774,000) --  (18,000) (1,792,000)

Balance at September 30, 2021

  11,911,784  $12,000  $268,336,000  $(262,009,000) $28,000  $(199,000) $6,168,000 

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,

  

Nine Months Ended

September 30,

 
 

2022

  

2021

  

2023

 

2022

 
Cash flows from operating activities:  

Net loss

 $(8,239,000) $(8,994,000) $(11,320,000) $(8,239,000)
Adjustments to reconcile net loss to net cash used in operating activities:  

Depreciation and amortization

 666,000  477,000  816,000  666,000 

Stock based compensation expense

 184,000  2,449,000  30,000  184,000 

Amortization of debt discount, net

 1,897,000  2,723,000 

Amortization of debt discount/premium, net

 5,396,000  1,897,000 

Reserve for excess and slow-moving inventories

 654,000  336,000  480,000  654,000 

Gain on extinguishment of debt

 --  (652,000)

Loss on retirement of debt

 326,000  -- 
Net change in operating assets and liabilities:  

Accounts receivable

 (1,323,000) (1,190,000) 1,496,000  (1,323,000)

Inventories

 582,000  (742,000) 1,264,000  582,000 

Prepaid expenses and other assets

 757,000  (260,000) 791,000  757,000 

Accounts payable

 (210,000) 145,000  (226,000) (210,000)

Interest payable – related party

 (1,132,000) (413,000) (289,000) (1,132,000)

Accrued payroll and related expenses

 145,000  111,000  52,000  145,000 

Deferred revenue – short-term

 122,000  334,000  37,000  122,000 

Other current liabilities

 446,000  (271,000) 255,000  446,000 

Long-term deferred revenue and other noncurrent liabilities

  (650,000)  (347,000)  (786,000)  (650,000)
  

Net cash used in operating activities

  (6,101,000)  (6,294,000)  (1,678,000)  (6,101,000)
  

Cash flows from investing activities:

  

Capital expenditures

  (308,000)  (64,000)  (1,541,000)  (308,000)
  

Net cash used in investing activities

  (308,000)  (64,000)  (1,541,000)  (308,000)
  

Cash flows from financing activities:

  
  

Proceeds from issuance of common stock, net of expenses

  3,037,000   6,832,000  2,640,000  3,037,000 

Proceeds from the exercise of warrants

  421,000   -- 
  

Net cash provided by financing activities

  3,037,000   6,832,000   3,061,000   3,037,000 
  

Effects of foreign currency rate changes on cash and cash equivalents

  (5,000)  

(1,000

)  (1,000)  (5,000)

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

 (3,377,000) 473,000 

Net increase (decrease) in cash and cash equivalents

 (159,000) (3,377,000)
  

Cash, cash equivalents and restricted cash at beginning of period

  7,280,000   7,161,000 

Cash, cash equivalents and restricted cash at end of period

 $3,903,000  $7,634,000 

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

 $2,628,000  $2,082,000  $1,492,000  $2,628,000 

Cash paid for interest

 $180,000  $180,000  $140,000  $180,000 

Right-to-use asset acquired under operating lease

 $3,863,000   -- 

Related party promissory note converted to common stock

 $3,000,000   -- 

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

 $3,763,000   --  $6,820,000  $3,763,000 

Transfer of inventory to fixed assets

  --  $181,000 

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.

 

Planned CDMO Business

 

In March 2022, our Board of Directors approved the planned expansion of the Company’sThe Company is expanding its business to include contract development and manufacturing services for cell and cell-based gene therapies. The Company plans to develop and build-outis 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 by partnering with Boyalife Genomics Tianjin Ltd., a China-based CDMO (“Boyalife Genomics”), to in-license certain know-how and other intellectual property from Boyalife Genomics, and by leasing andtherapies. The Company is building out a cell manufacturingnew facility in the Sacramento California. We intend to leverage our existing technologymetro area, containing a total of 12, class-7, ReadyStart cGMP Suites available for lease by early-stage life science and combine it withcell gene therapy companies. The ReadyStart Suites are located in a 35,500+ square foot cGMP facility that will meet the in-licensed technologies to develophighest scientific, quality, and regulatory requirements. The CDMO facility was completed in October of 2023.

Reverse Stock Split

On December 22, 2022, we effected a proprietary manufacturing platformone (1) for cell manufacturing activities and other cell manufacturing solutions for clients with therapeutic candidates in various stages of development. We are targeting the launchforty-five (45) reverse stock split of our CDMO servicesissued and outstanding common stock. All historical share amounts disclosed in this quarterly report on Form 10-Q have been retroactively restated to customers in 2023.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.

 

6

 

3.

Summary of Significant Accounting Polices

 

There have been no material changes in the Company’s significant accounting policies to those disclosed in the 2021Company’s Annual Report.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 presentationstatement 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, 20222023, are not necessarily indicative of the results that may be expected for the Company’s fiscal year endedending December 31, 2022.2023. 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, 2021.2022.

 

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.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 Entitys Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entitys 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.

 

7

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. The analysis on the Amendment to the Note and determined that the extensionamendment would be considered an extinguishment, from an accounting standpoint, due to the change inan increase of more than 10% to the value of the embedded conversion option. In June 2022,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 convertedto convert a total of $3,000,000$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 convertible note into 10,552,234 sharesNote was $7,278,000 and accrued but unpaid interest of our common stock. As of September 30, 2022 and December 31, 2021, the outstanding principle balance of the Loan was $7,000,000 and $10,000,000, respectively.$216,000.

 

The Credit Agreement and the Convertible Promissory Note, issued thereunder, as amended (the “Note”) provide that the principal and all accrued and unpaid interest under the Loan will be 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, 2022

3/6/2023  22% $0.21  $7,000,000  $(1,867,000) $5,133,000 

December 31, 2021

3/6/2022  22% $1.80  $10,000,000  $(755,000) $9,245,000 
 

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. In 2022,Through September 30, 2023, the anti-dilutiondown-round provision was triggered three times, as noted below:

 

In February 2022,January 2023, when the conversion price of the Note was at $1.80$6.30 per share, the Company sold shares of common stock at $0.64 per share. This resultedamended a previously outstanding convertible note, resulting in a triggering event lowering the conversion price of the Note to that value.$2.87. The Company determined that it created an incremental value of $213,000$2,350,000 which was treated as a debt discount to the carrying amount of the Note and amortized over theits remaining term of the Note.term.

 

In June 2022,March 2023, the Company sold shares of common stock and warrants at $0.28$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 $2,475,000$810,000 which was treated as a debt discount to the carrying amount of the Note and will be amortized over theits remaining term of the Note.term.

 

In July 2022, the Company modified a convertible debt agreement, lowering2023, when the conversion price of the debt to $0.21Note was at $2.65 per share, the Company amended a previously outstanding convertible note, resulting in a down round triggering event lowering the conversion price of the Note to $1.07. The Company determined that value. The triggering eventit created an incremental value of $1,075,000$3,660,000 which was treated as a debt discount to the carrying amount of the Note and will be amortized over theits remaining term of the Note.term.

8

 

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

 

 

February

2022

  

June

2022

  

July

2022

  

January

2023

  

March

2023

  

July

2023

 

Conversion price before

 $1.80  $0.64  $0.28  $6.30  $2.87  $2.65 

Conversion price after

 $0.64  $0.28  $0.21  $2.87  $2.65  $1.07 

Term (years)

 0.02  0.69  0.61  0.09  0.78  0.42 

Volatility

 39.53% 85.6% 99.5% 167% 168.9% 156.8%

Dividend rate

 0% 0% 0% 0% 0% 0%

Risk free rate

 1.97% 3.2% 2.8% 4.46% 4.20% 4.22%

 

TheFor 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 of debt discount to interest expense for the three and nine months ended September 30, 2022. The amortization included $742,000, which related to accelerated amortization for the portion of the Note that was converted in June 2022. In addition to the amortization, the Company also recorded interest expense of $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, and $562,000 and $1,668,000 for the three and nine months ended September 30, 2021.respectively. The interest payable balance as of September 30, 20222023 and December 31, 20212022 was $1,099,000$225,000 and $2,231,000,$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 newly formed 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, 2022,2023, 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 fivefive-year year Lease Agreement with Z3 Investment LLC, an affiliate owned by the Company’s CEO and Chairman of the Board and the Company’s Chairman and CEO,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 $46,000 per month for the first six months, then increasing to $104,000 per month (with a 4% annual increase) thereafter.. Additionally, the Company will pay all operating expenses as they become due estimated to be approximately $5,000$10,000 per month and will be expensed in the period incurred. The Company has the option to renew the lease for two 5-year periods. Additionally,up to ten years after the Company has the ability to opt outcommencement of the lease after one year if the CDMO facility is unable to be constructed as planned.initial five-year term.

The Company performed an analysis of the lease and determined it to be an operating lease. A right-of-use asset and lease obligation were recorded at inception of the lease.

9

 

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,

2022

  

September 30,

2023

  

December 31,

2022

 

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

 $3,653,000  $3,213,000  $3,550,000 

Current lease liability (included in other current liabilities)

 397,000  551,000  433,000 

Non-current lease liability – related party

 3,622,000  3,071,000  3,495,000 
  

Weighted average remaining lease term

 5.00  4.0  4.8 

Discount rate

 22% 22% 22%

10

 

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

 

2022 (Remaining)

 $311,000 

2023

 1,256,000 

2023 (Remaining)

 $324,000 

2024

 1,307,000  1,307,000 

2025

 1,359,000  1,359,000 

2026

 1,428,000  1,428,000 

Thereafter

  1,133,000   1,133,000 

Total lease payments

 $6,794,000  $5,551,000 

Less: imputed interest

  (2,775,000)  (1,930,000)

Present value of operating lease liabilities

 $4,019,000  $3,621,000 

 

Statement of Cash Flows

 

Cash paid for amounts included in the measurement of operating lease liabilities was $138,000$932,000 and $277,000 for the three and 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 the Accredited Investor,Orbrex (USA) Co. Limited (“Orbrex”), pursuant to which the Company issued and sold to such investorOrbrex an unsecured convertible promissory note, as amended, in the original principal amount of $1,000,000 (the “July 2019 Note”). The July 2019 Note is convertible into shares of the Company's common stock at a conversion price equal to the lower of (a) $1.80 per share or (b) 90% of the closing sale price of the Company’s common stock on the date of conversion (subject to a floor conversion price of $0.50). The July 2019 Note bears interest at a rate of twenty-four percent (24%) per annum and is payable quarterly in arrears. Unless sooner converted inarrears on January 31 of each year. In the manner described below, all principal undernine months ended September 30, 2023, the Company has amended the July 2019 Note together with all accrued and unpaid interest thereupon, will be due and payable three years from the date of the issuance on July 31, 2022.two times:

 

10

On July 25, 2022, the Company entered into an amendment to the July 2019 Note, which extended the maturity date of the July 2019 Note to January 31, 2023 and modified when interest is due from quarterly to January 31, 2023. The amendment also (i) deleted the market price-based conversion right, which previously allowed for the July 2019 Note to be converted at a conversion price of 90% of the Company’s stock price on the day of conversion (subject to a $0.50 floor); and (ii) changed to a fixed conversion price to $0.21 per share, provided that in the event that the Company issues shares, options, warrants, or convertible securities, at an effective price per common share lower than $0.21, then the conversion price will be adjusted to such lower issuance price.

The Company performed a debt extinguishment vs. modification analysis on the amendment to the July 2019 Note and determined that the extension would be considered an extinguishment, due to an increase of more than 10% to the value of the embedded conversion option. No gain or loss was recorded in the consolidated statement of operations for the quarter ended September 30, 2022 as it was determined that the fair value of the amendment of the July 2019 Note and accrued interest was $1,020,000 both before and after the extension.

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

  

Carrying

Value

 

September 30, 2022

1/31/2023

  24% $0.21  $1,000,000 

December 31, 2021

7/31/2022

  24% $0.91  $813,000 
 

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 of debt discount onexpense for the July 2019 Note of $80,000($35,000) and $241,000($186,000) for the three and nine months ended September 30, 2021. Interest2023, respectively. In addition to the amortization, the Company also recorded interest expense related to the July 2019 Note wasof $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, and 2021.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,$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”). After filing the Company’s 2021 Form 10-K inIn 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 8,857,344196,843 shares of common stock under the Offering Agreement for aggregate gross proceeds of $3,293,000 at an average selling price of $0.37$16.55 per share, resulting in net proceeds of approximately $3,037,000 after deducting commissions and other transaction costs of approximately $256,000.

11

Equity Plans

On January 13, 2022, the Company’s stockholders approved an amendment of the Company’s Amended 2016 Equity Incentive Plan to increase the aggregate number of shares of the Company’s common stock that may be issued under the plan from 392,500 shares to 1,200,000 shares.

 

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:

 

 

2022

  

2021

  

2023

  

2022

 

Common stock equivalents of convertible promissory notes and accrued interest

 43,612,759  7,071,241  7,448,487  969,173 

Warrants – other

 653,248  653,248 

Warrants

 1,238,869  14,518 

Stock options

  287,081   366,595   6,218   6,380 

Total

  44,553,088   8,091,084   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,

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
 

2022

  

2021

  

2022

  

2021

  

2023

  

2022

  

2023

  

2022

 

United States

 $1,535,000  $1,517,000  $4,973,000  $3,558,000  $1,500,000  $1,535,000  $4,589,000  $4,973,000 

China

 364,000  1,357,000  1,570,000  1,445,000  29,000  364,000  77,000  1,570,000 

Thailand

 2,000  --  10,000  400,000 

United Arab Emirates

 259,000  --  439,000  -- 

Other

  214,000   284,000   1,254,000   1,473,000   406,000   216,000   1,934,000   1,264,000 

Total

 $2,115,000  $3,158,000  $7,807,000  $6,876,000  $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, 2022

  

Three Months Ended September 30, 2023

 
 

Device

Revenue

  

Service

Revenue

  

Other

Revenue

  

Total

Revenue

  

Device

Revenue

  

Service

Revenue

  

Other

Revenue

  

Total

Revenue

 

AXP

 $1,034,000  $75,000  $--  $1,109,000  $1,486,000  $88,000  $--  $1,574,000 

BioArchive

 201,000  321,000  --  522,000  131,000  322,000  --  453,000 

CAR-TXpress

 190,000  44,000  72,000  306,000  42,000  34,000  71,000  147,000 

Manual Disposables

 150,000  --  --  150,000  8,000  --  --  8,000 

Other

  20,000   --   8,000   28,000   6,000   --   6,000   12,000 

Total

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

 

12
14

 

 

Nine Months Ended September 30, 2022

  

Three Months Ended September 30, 2022

 
 

Device

Revenue

  

Service

Revenue

  

Other

Revenue

  

Total

Revenue

  

Device

Revenue

  

Service

Revenue

  

Other

Revenue

  

Total

Revenue

 

AXP

 $4,668,000  $171,000  $--  $4,839,000  $1,034,000  $75,000  $--  $1,109,000 

BioArchive

 694,000  924,000  --  1,618,000  201,000  321,000  --  522,000 

CAR-TXpress

 551,000  146,000  214,000  911,000  190,000  44,000  72,000  306,000 

Manual Disposables

 357,000  --  --  357,000  150,000  --  --  150,000 

Other

  59,000   --   23,000   82,000   20,000   --   8,000   28,000 

Total

 $6,329,000  $1,241,000  $237,000  $7,807,000  $1,595,000  $440,000  $80,000  $2,115,000 

 

  

Three Months Ended September 30, 2021

 
  

Device

Revenue

  

Service

Revenue

  

Other

Revenue

  

Total

Revenue

 

AXP

 $2,217,000  $72,000  $21,000  $2,310,000 

BioArchive

  221,000   297,000   --   518,000 

CAR-TXpress

  160,000   31,000   71,000   262,000 

Manual Disposables

  55,000   --   --   55,000 

Other

  9,000   --   4,000   13,000 

Total

 $2,662,000  $400,000  $96,000  $3,158,000 

 

Nine Months Ended September 30, 2021

  

Nine Months Ended September 30, 2022

 
 

Device

Revenue

  

Service

Revenue

  

Other

Revenue

  

Total

Revenue

  

Device

Revenue

  

Service

Revenue

  

Other

Revenue

  

Total

Revenue

 

AXP

 $3,490,000  $159,000  $21,000  $3,670,000  $4,668,000  $171,000  $--  $4,839,000 

BioArchive

 652,000  1,165,000  --  1,817,000  694,000  924,000  --  1,618,000 

CAR-TXpress

 702,000  89,000  214,000  1,005,000  551,000  146,000  214,000  911,000 

Manual Disposables

 300,000  --  --  300,000  357,000  --  --  357,000 

Other

  46,000   --   38,000   84,000   59,000   --   23,000   82,000 

Total

 $5,190,000  $1,413,000  $273,000  $6,876,000  $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 recognized during the three and nine months ended September 30, 2022 that were included in the beginning balance of deferred revenue during the three and nine months ended September 30, 2023 were $144,000 and $620,000,$663,000, respectively. Short-term deferred revenues were $841,000$818,000 and $719,000$782,000 at September 30, 20222023 and December 31, 2021,2022, respectively. Long-term deferred revenue was $1,014,000revenues were $680,000 and $1,244,000$911,000 at September 30, 20222023 and December 31, 2021,2022, respectively.

13

 

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 2022

 

2023

 

2024

 

2025

 

2026 and

beyond

 

Total

  

Remainder

of 2023

 

2024

 

2025

 

2026

 

2027 and

beyond

 

Total

 

Service revenue

 $407,000

0.25

 $1,089,000

1

 $664,000

1

 $176,000

1

 $--

1

 $2,336,000  $319,000  $741,000  $252,000  $--  $--  $1,312,000 

Device revenue (1)

 21,000

0.25

 733,000

1

 41,000

1

 --

1

 --

1

 795,000  21,000  692,000  --  --  --  713,000 

Exclusivity fee

 71,000

0.25

 286,000

1

 286,000

1

 286,000

1

 190,000

1

 1,119,000  71,000  286,000  286,000  190,000  --  833,000 

Other

  3,000

0.25

 13,000

1

 13,000

1

 13,000

1

 122,000

1

 164,000   3,000  13,000  13,000  13,000  97,000  139,000 

Total

 $502,000

0.25

 $2,121,000

1

 $1,004,000

1

 $475,000

1

 $312,000

1

 $4,414,000  $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.

 


 

9.

Concentrations

 

The Company had certain customers whose individual revenue individually represented 10% or more ofwas material to the Company’s total revenue, or whose accounts receivable balances individually represented 10% or more ofwere material to the Company’s total accounts receivable balances. Those customers are listed as follows:

 

Accounts Receivable

 

  

September 30, 2022

  

December 31, 2021

 

Customer 1

  49%  --

%

Customer 2

  15%  28

%

Customer 3

  13%  --%

Customer 4

  1%  27%

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,

 
  

2022

  

2021

  

2022

  

2021

 

Customer 1

  36%  22%  36%  15%

Customer 2

  14%  1%  6%  1

%

Customer 3

  1%  44%  14%  20%

10.

Subsequent Events

On October 25, 2022, the Company announced the pricing of a public offering (the "Offering") of an aggregate of 11,783,572 units (the "Units") and 2,892,858 pre-funded units (the "Pre-Funded Units”) for a purchase price of $0.14 per unit, resulting in aggregate gross proceeds of approximately $2,055,000. The Offering closed on October 28, 2022. Each Unit sold in the Offering consisted of one share of the Company's common stock and one common warrant to purchase one share of common stock, and each Pre-Funded Unit consisted of one pre-funded warrant to purchase one share of common stock and one common warrant to purchase one share of common stock. The common warrants will be exercisable at an exercise price of $0.14 per share beginning on the effective date of Company stockholder approval of the issuance of the shares upon exercise of the warrants (the "Warrant Stockholder Approval”) and will expire on the fifth anniversary of the effective date of the Warrant Stockholder Approval. The 2,892,858 pre-funded warrants sold in the Offering were exercised on October 25, 2022.

14

  

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. Managements Discussion and Analysis of Financial Condition and Results of Operations

 

Cautionary Note Regarding ForwardLooking 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, uncertainty associated with the COVID-19 pandemic, risks associated with expanding into the Company’s plannednew 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, 2021.2022.

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™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.

15

 

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™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

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

 

In March 2022, our Board of Directors approved the planned expansion of the Company’sThe Company expanded its business to include contract development and manufacturing services for cell and cell-based gene therapies. The Company plans to develop and build-outis in the process of building out the capabilities to become a world-class CDMOContract Development and Manufacturing Organization (“CDMO”) for cell and cell-based gene therapies by partnering with Boyalife Genomics Tianjin Ltd., a China-based CDMO (“Boyalife Genomics”), to in-license certain know-how and other intellectual property from Boyalife Genomics, and by leasing and buildingtherapies. The Company is rolling out a cell manufacturingnew facility in the Sacramento California.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 plans to develop andwill operate its plannednew 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.

 

We are targeting the launchThe CDMO facility was completed in October of our CDMO services to customers in 2023.  The successful development and launch of TG Biosynthesis will require us to raise additional capital, acquire various equipment for the planned operations, hire certain personnel needed to launch the operation, and timely complete the build-out ofoperate our leased Sacramento facility.  There is no assurance that wethe Company will be able to successfully obtain such additional capital resources, as such capital may not be available on reasonable terms, or available at all.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.

 

16


 

Results of Operations

 

Three Months Ended September 30, 20222023 as Compared
to the Three Months Ended September 30, 20212022

 

Net Revenues

Net revenues decreasedincreased by $1,043,000$79,000 or 33%4%, from $3,158,000$2,115,000 to $2,115,000$2,194,000 for the three months ended September 30, 20222023 as compared to the three months ended September 30, 2021.2022.  The increase in revenue decrease was due to $1,201,000driven by a new distributor in the United Arab Emirates, offset by lower CAR-TXpress sales for AXP driven by approximately $1,300,000 less AXP disposable sales to our distributors in China offset by $95,000 more in manual disposable sales.the quarter ended September 30, 2023.

 

The following table summarizes revenue by product line:

 

 

September 30,

2022

  

September 30,

2021

  

September 30,

2023

  

September 30,

2022

 

AXP

 $1,109,000  $2,310,000  $1,574,000  $1,109,000 

BioArchive

 522,000  518,000  453,000  522,000 

CAR-TXpress

 306,000  262,000  147,000  306,000 

Manual Disposables

 150,000  55,000  8,000  150,000 

Other

  28,000   13,000   12,000   28,000 

Total

 $2,115,000  $3,158,000  $2,194,000  $2,115,000 

 

Gross Profit

The Company’s gross profit decreased by $678,000$42,000 to $437,000$395,000 or 21%18% of net revenues for the three months ended September 30, 2022,2023, compared to $1,115,000$437,000 or 35%21% for three months ended September 30, 2021.2022. The primary driver of the decrease was the decline in revenues, which reduced gross profit by approximately $300,000. The remainder of the variance islower absorption driven by higher costs from our AXP disposable contract manufacturer of approximately $100,000 and increased overhead charges of approximately $275,000 due to lower absorptionexcess manufacturing capacity in the three months ended September 30, 2022.third quarter of 2023.

 

Selling, General and Administrative

Sales, general and administrative expenses for the three months ended September 30, 20222023 were $1,982,000$1,686,000 compared to $1,677,000$1,982,000 for the three months ended September 30, 2021, an increase2022, a decrease of $305,000$296,000 or 18%15%.  The increasedecrease was driven primarily by rent expenselower employee benefit expenses of approximately $325,000 for the new CDMO facility leased by the Company beginning$200,000 and $70,000 in April 2022.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, as compared to $543,000 for the three months ended September 30, 2021, a decrease of $73,000$204,000 or 13%43%. The decrease was driven byprimarily due to approximately $80,000$100,000 less in salariesproject expenses and benefits.approximately $50,000 in lower personnel expenses during the quarter.

 

Interest Expense

Interest expense for the three months ended September 30, 20222023 was $1,391,000,$2,118,000 compared to $1,530,000,$1,391,000, for the three months ended September 30, 2021,2022, 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 of $139,000 or 9%. The decrease is due to approximately $900,000 less in debt discount from the adoption of ASU 2020-06 and approximately $170,000 in lower interest expense due to the portionconversion price of the Boyalife Convertible Promissory Note that was converted in June 2022. This was offset by the down round triggering events of approximately $940,000 that occurred in 2022 relating to the Boyalife Convertible Promissory Note.

17

Other Income / Expense

Other income decreased in the three months ended September 30, 2022 due2023 as compared to the Employee Retention Tax Credits recorded by the Companysame period in 2022.

19

Loss on Retirement of Debt

Loss on retirement of debt was $87,000 in the three months ended September 30, 2021.2023 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, 20222023 as Compared to
the Nine Months Ended September 30, 20212022

 

Net Revenues

Net revenues increaseddecreased by $931,000$768,000 or 14%10%, from $6,876,000$7,807,000 to $7,807,000$7,039,000 for the nine months ended September 30, 20222023 as compared to the nine months ended September 30, 2021.2022. The decrease in revenue increase was driven by additionallower AXP disposable sales of $1,169,000 related to increasedthe Company’s distributor in China and lower CAR-TXpress sales from our domestic customers of approximately $1,650,000. The increase is alsowhich were offset by a decreaseBioArchive device revenue and sales to the new distributor in sales $199,000 in BioArchive and $94,000 in CAR-TXpress sales. the United Arab Emirates for the nine months ended September 30, 2023.

 

The following table summarizes revenue by product line:

 

Nine Months Ended September 30,

  

Nine Months Ended

September 30,

 
 

2022

  

2021

  

2023

  

2022

 

AXP

 $4,839,000  $3,670,000  $4,429,000  $4,839,000 

BioArchive

 1,618,000  1,817,000  1,899,000  1,618,000 

CAR-TXpress

 911,000  1,005,000  423,000  911,000 

Manual Disposables

 357,000  300,000  229,000  357,000 

Other

  82,000   84,000   59,000   82,000 

Total

 $7,807,000  $6,876,000  $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, compared to $2,809,000 or 41% of net revenues for the nine months ended September 30, 2021, a decrease of $493,000.$347,000. The primary driver of the decrease was due to lower absorption driven by approximately $300,000 more in inventory reservesexcess manufacturing capacity and higher costs from our AXP disposable contract manufacturer of approximately $575,000; offset by approximately $275,000 in gross profit from additionallower sales in the nine months ended September 30, 2022.2023.

 

Selling, General and Administrative

Sales, general and administrative expenses for the nine months ended September 30, 20222023 were $5,665,000$5,346,000 compared to $7,171,000$5,665,000 for the nine months ended September 30, 2021,2022, a decrease of $1,506,000$319,000 or 21%6%. The decreasevariance was driven primarily by stock compensation expense, which decreasedlower employee benefit expenses of approximately $475,000, offset by approximately $2,050,000 primarily due to the accelerated expenseincreased operating expenses for the stock options thatCompany’s CDMO facility of approximately $175,000.

Research and Development Expenses

Research and development expenses were voluntarily surrendered by Company executives in$955,000 for the nine months ended September 30, 2021. This was offset by approximately $650,000 for the new CDMO facility leased by the Company beginning in April 2022.

Research and Development Expenses

Research and development expenses were2023, compared to $1,317,000 for the nine months ended September 30, 2022, compareda 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.

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Interest Expense

Interest expense increased to $1,544,000$6,689,000 for the nine months ended September 30, 2021, a decrease of $227,000 or 15%. The decrease was driven by approximately $225,000 less in stock compensation expense.

Interest Expense

Interest expense decreased2023 as compared to $3,572,000 for the nine months ended September 30, 2022, as comparedan increase of $3,117,000. The increase was driven by an additional amortization expense of approximately $3,500,000 related to $4,573,000 for the nine months ended September 30, 2021triggering events from a decrease in the conversion price of $1,001,000 or 22%. The decrease is due to approximately $2,700,000the Note, offset by $400,000 less in debt discount from the adoption of ASU 2020-06 and approximately $170,000 in lower interest expense dueexpenses to the portion of the Boyalife Convertible Promissory Note that was converted in June 2022. This was offset by the down round triggering events of approximately $1,900,000 that occurred in 2022 relating to the Boyalife Convertible Promissory Note.

18

Gain on Extinguishment of Debt

The Company recorded no gain on the extinguishment of debtand July 2019 Note in the nine months ended September 30, 20222023 as compared to a gain of $652,000 for the nine months ended September 30, 2021. The gain was related to the principal and accrued interest for the Paycheck Protection Program loan the Company receivedsame period in 2020 and forgiven in March 2021.2022.

 

Other Income / ExpenseLoss on Retirement of Debt

Other income decreased

Loss on retirement of debt was $326,000 in the nine months ended September 30, 2022 due2023 as a result of the January and July 2023 amendments to the Employee Retention Tax Credits recorded byJuly 2019 Note which extended the Company indue date for six months and lowered the nine months ended September 30, 2021.conversion price of the note.

 

Liquidity and Capital Resources

 

At September 30, 2022, theThe Company had cash and cash equivalents of $3,903,000$4,018,000 and $4,177,000 and working capital deficit of $515,000. This compares to cash$1,965,000 and cash equivalents of $7,280,000$625,000 at September 30, 2023 and working capital of $8,616,000 at December 31, 2021.2022, 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 our lineaccrued but unpaid interest of credit facility.$225,000.

 

The Company has incurred historical losses from operations and expects to continue to incur operating losses in the near future.  TheWe completed our new CDMO facility in October of 2023 and anticipate increasing cash from operations; however, the Company willmay need to raise additional capital to grow its business, fund operating expenses and make interest payments, as well as to fund its planned expansion into CDMO business.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.

 

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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, 2022.2023. 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, 2022.2023.

 

There were no changes in the Company’s internal controls over financial reporting that occurred during the three months ended September 30, 20222023 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.

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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 other than noted below, for the year ended December 31, 2021.

If we are uable to comply with the continued listed standard of the Nasdaq Capital Market Stock Exchange (Nasdaq), our shares may be delisted; which could adversely affect the price of our common stock and its liquidity. Our common stock is currently listed on Nasdaq. We must comply with Nasdaq’s continued listing requirements related to, among other things, stockholders’ equity, market value, minimum bid price, and corporate governance in order to remain so listed. There can be no assurances that we will be able to comply with the applicable listing requirements.  As previously noted on March 7, 2022, the Company received written notice ("Notification Letter”) from the Nasdaq Listing Qualifications Department ("NASDAQ”) notifying the Company that it was not in compliance with the minimum bid price requirements set forth in NASDAQ Listing Rule 5550(a)(2) for continued listing on the Capital Market, due to the bid price of the Company’s common stock closing below the minimum $1 per share for the thirty (30) consecutive business days prior to the date of the Notification Letter. In accordance with listing rules, the Company was afforded 180 days, or until September 5, 2022, to regain compliance.  The Company was unable to regain compliance with the bid price requirement by September 5, 2022. However, on September 7, 2022, the Company received a notice from NASDAQ granting the Company an additional 180 calendar days, or until March 6, 2023, to regain compliance with the minimum $1.00 bid price per share requirement for continued listing on the Capital Market. NASDAQ determined that the Company is eligible for the second compliance period due to the Company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on the Capital Market, with the exception of the bid price requirement, and the Company’s written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary.

 

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).

 

21


 

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 8-K10-K filed June 6, 2020.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 October 30, 2019.March 10, 2023.

3.3

First Amendment to the Amended and Restated Bylaws of ThermoGenesis Holdings, Inc., incorporated by reference to Exhibit 3.1 to Form 8-K filed December 17, 2021.

3.4Second Amendment to Amended and Restated Bylaws of ThermoGenesis Holdings, Inc. dated June 30, 2022, incorporate by reference to Exhibit 3.1 to Form 8-K filed July 6, 2022.

4.1

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

4.2

Form of Common Warrant, incorporated by reference to Exhibit 10.37 of amended Registration Statement on Form S-1 filed with the SEC on May 14, 2018.

4.3

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

4.44.3

FormDescription of Convertible Promissory Note, datedSecurities Registered Under Section 12 of the Securities Exchange Act of 1934, as of July 23, 2019, between ThermoGenesis Holdings, Inc. and Orbrex USA Co.,amended, incorporated by reference to Exhibit 4.14.4 to Annual Report on Form 8-K10-K filed with the SEC on July 29, 2019.March 30, 2023.

4.5

4.4

Form of Pre-Funded Warrant (Incorporated by reference to Exhibit 10.41 to Amendment No. 1 to Form S-1 filed with the SEC on April 29, 2022).
4.6

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

DescriptionForm of Securities Registered Under Section 12 of the Securities Exchange Act of 1934, as amended,Warrant Amendment Agreement, incorporated by reference to Exhibit 4.84.3 to Form 10-K8K filed with the SEC on March 24, 2020.21, 2023.

10.1

Form of Securities Purchase Agreement (IncorporatedAmendment No. 4 to Convertible Promissory Note, dated July 31, 2023, between ThermoGenesis Holdings, Inc. and Orbrex (USA) Co Limited, incorporated by reference to Exhibit 10.39 to Amendment No. 310.1 to Form S-18-K filed with the SEC on October 17, 2022).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 Inline 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 (embedded within the(formatted as Inline XBRL and contained in Exhibit 101)

 

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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 10, 202213, 2023

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

 

Xiaochun (Chris) Xu, Ph.D.

Chief Executive Officer

(Principal Executive Officer)

  
  

Dated: November 10, 202213, 2023

/s/ Jeffery Cauble

 

Jeffery Cauble

Chief Financial Officer

(Principal Financial Officer and Principal Accounting Officer)

 

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