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Form 8-K ThermoGenesis Holdings, For: Aug 11

August 11, 2022 2:44 PM EDT

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): August 11, 2022
 
THERMOGENESIS HOLDINGS, INC.
(Exact Name of Registrant as Specified in Charter)
 
 
Delaware
 
333-82900
 
94-3018487
         
(State or Other Jurisdiction
 
(Commission
 
(IRS Employer
of Incorporation)
 
File Number)
 
Identification No.)
 
 
2711 Citrus Road, Rancho Cordova, California
 
95742
     
(Address of Principal Executive Offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code: (916) 858-5100
 
(Former Name or Former Address, if Changed Since Last Report)
 
N/A
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
 

 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
 
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.          ☐
 

 

 
Item 2.02.          Results of Operations and Financial Condition.
 
On August 11, 2022, ThermoGenesis Holdings, Inc. (the “Company”) issued a press release announcing its results of operations and financial condition for the second quarter of calendar year 2022. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
 
Information contained in this Item 2.02 and in Exhibit 99.1 attached to this Current Report on Form 8-K is being furnished to the Securities and Exchange Commission and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, except as shall be expressly set forth in such a filing. 
 
 
Item 9.01.          Financial Statements and Exhibits.
 
Exhibit No.
 
Description
     
99.1
 
     
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
 

 
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 hereunto duly authorized.
 
   
THERMOGENESIS HOLDINGS, INC.
 
   
(Registrant)
 
       
Dated: August 11, 2022
 
/s/ Jeffery Cauble
 
   
Jeffery Cauble,
Chief Financial Officer
(Principal Financial Officer and Principal
Accounting Officer)
 
 
 

Exhibit 99.1

 tglogo.jpg

 

ThermoGenesis Holdings Announces Financial Results for the Second Quarter Ended June 30, 2022 and Provides Corporate Update

 

Driven by Sales of the AXP, Total Revenues for the Quarter Rose 38% Compared to Prior Year

 

Conference Call to be Held Today at 12:00 p.m. PT/3:00 p.m. ET

 

RANCHO CORDOVA, Calif., August 11, 2022 -- ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, today reported financial and operating results for the second quarter ended June 30, 2022 and provided a corporate strategic update.

 

“Clinical trials for CAR-T and other next-generation cell and gene therapeutics have continued unabated, while the industry continues to grapple with high manufacturing costs and serious capacity limits created by long CDMO wait times and the need for current good manufacturing practice (cGMP) facilities to bring these extremely complex, life saving personalized therapies to market,” stated Chris Xu, Ph.D., Chief Executive Officer of ThermoGenesis.

 

“During the second quarter, we took steps toward the launch of our TG Biosynthesis division, including starting to build-out the approximate 35,475 square feet of laboratory and office space leased earlier this year to create a state-of-the-art, cGMP compliant facility with 12 cGMP clean room suites to support the industry’s manufacturing requirements by leveraging our proprietary technology to more rapidly and cost efficiently produce these potentially life-saving drug candidates in development. In particular, we plan to utilize our proprietary CAR-TXpress™ platform technology and the numerous benefits it offers, including the ability to reduce critical cell processing time by 75%, improve cell recovery by 45% and reduce the costs related to CAR-T and other cell and gene therapies by up to 50%, to begin providing the industry with world-class CDMO services. This is expected to include 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 diverse stages of development. As previously stated, we intend to launch the TG Biosynthesis division and our CDMO services to customers later this year.”

 

Financial Results for the Quarter Ended June 30, 2022

 

Net revenues. Net revenues for the quarter ended June 30, 2022 rose to $3.0 million, compared to $2.2 million for the quarter ended June 30, 2021, an increase of approximately $0.8 million or 38%. The increase was driven by approximately $0.9 million in additional sales for AXP® offset by approximately $0.1 million less in CAR-TXpress revenues.

 

 

 

Gross profit. Gross profit for the quarter ended June 30, 2022, was $0.9 million, or 31% of net revenue, compared to $1.0 million, or 45% of net revenues, for the second quarter ended June 30, 2021, a decrease of $47,000. The decrease was driven by inventory reserves and higher costs from the Company’s AXP disposable manufacturer.

 

Selling, general and administrative expenses. Selling, general and administrative expenses were $2.0 million for the quarter ended June 30, 2022, as compared to $3.5 million for the quarter ended June 30, 2021, a decrease of $1.5 million or 43%. The decrease was driven by stock compensation expense which decreased by approximately $1.9 million primarily due to the accelerated expense for the stock options that were voluntarily surrendered by Company executives in the three months ended June 30, 2021, offset by increased rent expense of approximately $0.3 million for the new CDMO facility leased by the Company beginning in April 2022.

 

Research and development expenses. Research and development expenses were $0.4 million for the three months ended June 30, 2022, compared to $0.6 million for the three months ended June 30, 2021, a decrease of $0.2 million or 37%. The decrease was driven by approximately $0.2 million in stock compensation and BACS development expenses.

 

Interest expense. Interest expense for the second quarter ended June 30, 2022 was $1.3 million compared to $1.5 million for the quarter ended June 30, 2021, a decrease of $0.2 million or 11%. The decrease was driven by lower amortization of the debt discount on convertible promissory notes.

 

Net loss. For the quarter ended June 30, 2022, the Company reported a comprehensive loss attributable to common stockholders of $2.7 million, or ($0.20) per share, based on approximately 13.5 million weighted average basic and diluted common shares outstanding. This compares to a comprehensive net loss of $4.5 million, or ($0.36) per share, based on approximately 11.9 million weighted average basic and diluted common shares outstanding for the second quarter ended June 30, 2021.

 

Liquidity and capital resources. At June 30, 2022, the Company had cash and cash equivalents totaling $4.0 million, compared with $7.8 million at December 31, 2021. Working capital was $1.8 million at June 30, 2022, as compared to $8.6 million at December 31, 2021.

 

 

Conference Call and Webcast Information

ThermoGenesis will host a conference call today at 12:00 p.m. PT/3:00 p.m. ET. To participate in the conference call, please dial 1-844-889-4331 (domestic), 1-412-380-7406 (international) or 1-866-605-3852 (Canada). To access a live webcast of the call, please visit: https://thermogenesis.com/investors/news-and-events/events-webcasts.

 

 

 

A webcast replay will also be available on ThermoGenesis’ website for three months. To access the replay, please visit: https://thermogenesis.com/investors/news-and-events/events-webcasts.

 

About ThermoGenesis Holdings, Inc.

ThermoGenesis Holdings, Inc. 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. For more information about ThermoGenesis, please visit: www.thermogenesis.com.

 

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning 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 press release, 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 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, 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 ThermoGenesis Holdings’ Form 10-K for the year ended December 31, 2021.

 

Company Contact:
Wendy Samford
916-858-5191
[email protected]

 

Investor Contact:
Paula Schwartz, Rx Communications
917-322-2216
[email protected]

 

 

 

 

Financials

 

 

ThermoGenesis Holdings, Inc.

Condensed Consolidated Balance Sheets

 

   

June 30,

2022

   

December 31,

2021

 
   

(Unaudited)

         

ASSETS

               

Current assets:

               

Cash and cash equivalents

  $ 4,001,000     $ 7,280,000  

Accounts receivable, net

    2,309,000       733,000  

Inventories

    5,493,000       5,373,000  

Prepaid expenses and other current assets

    681,000       1,578,000  

Total current assets

    12,484,000       14,964,000  
                 

Inventories, non-current

    994,000       1,709,000  

Equipment and leasehold improvements, net

    1,279,000       1,261,000  

Right-of-use operating lease assets, net

    477,000       571,000  

Right-of-use operating lease assets – related party

    3,754,000       --  

Goodwill

    781,000       781,000  

Other intangible assets, net

    1,302,000       1,318,000  

Other assets

    256,000       48,000  

Total assets

  $ 21,327,000     $ 20,652,000  
                 

LIABILITIES AND EQUITY

               

Current liabilities:

               

Accounts payable

  $ 1,240,000     $ 1,280,000  

Other current liabilities

    9,451,000       5,068,000  

Total current liabilities

    10,691,000       6,348,000  
                 

Long-term liabilities

    5,127,000       10,907,000  
                 

ThermoGenesis Holdings, Inc. stockholders' equity

    6,179,000       3,828,000  
                 

Noncontrolling interests

    (670,000 )     (431,000 )

Total liabilities and equity

  $ 21,327,000     $ 20,652,000  

 

 

 

 

ThermoGenesis Holdings, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

 

   

Three Months Ended
June 30,

   

Six Months Ended
June 30,

 
   

2022

   

2021

   

2022

   

2021

 

Net revenues

  $ 3,029,000     $ 2,201,000     $ 5,692,000     $ 3,718,000  

Cost of revenues

    2,090,000       1,215,000       3,813,000       2,024,000  
                                 

Gross profit

    939,000       986,000       1,879,000       1,694,000  
                                 

Expenses:

                               

Selling, general and administrative

    1,989,000       3,502,000       3,682,000       5,494,000  

Research and development

    392,000       622,000       847,000       1,001,000  
                                 

Total operating expenses

    2,381,000       4,124,000       4,529,000       6,495,000  
                                 

Loss from operations

    (1,442,000 )     (3,138,000 )     (2,650,000 )     (4,801,000 )
                                 

Other expenses

                               
                                 

Interest expense

    (1,359,000 )     (1,524,000 )     (2,182,000 )     (3,043,000 )

Other income (expenses)

    --       (10,000 )     (4,000 )     (11,000 )

Gain on extinguishment of debt

    --       --       --       652,000  

Total other expense

    (1,359,000 )     (1,534,000 )     (2,186,000 )     (2,402,000 )
                                 

Net loss

    (2,801,000 )     (4,672,000 )     (4,836,000 )     (7,203,000 )
                                 

Loss attributable to noncontrolling interests

    (113,000 )     (133,000 )     (239,000 )     (251,000 )

Net loss attributable to common stockholders

  $ (2,688,000 )   $ (4,539,000 )   $ (4,597,000 )   $ (6,952,000 )

 

 

 

 

ThermoGenesis Holdings, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

   

Six Months Ended

June 30,

 
   

2022

   

2021

 

Cash flows from operating activities:

               

Net cash used in operating activities

  $ (5,101,000 )   $ (5,244,000 )
                 

Cash flows from investing activities:

               

Capital expenditures

    (219,000 )     (80,000 )

Cash flows from financing activities:

               

Proceeds from issuance of common stock, net of expenses

    2,044,000       6,832,000  
                 

Net cash provided by financing activities

    2,044,000       6,832,000  
                 

Effects of foreign currency rate changes on cash and cash equivalents

    (3,000 )     (1,000 )

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

    (3,279,000 )     1,507,000  
                 

Cash, cash equivalents and restricted cash at beginning of period

    7,280,000       7,161,000  

Cash, cash equivalents and restricted cash at end of period

  $ 4,001,000     $ 8,668,000  

 

 



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