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Note 1 - Description of Business and Basis of Presentation
3 Months Ended
Mar. 31, 2020
Notes to Financial Statements  
Business Description and Basis of Presentation [Text Block]
1.
     
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
 
Organization and Basis of Presentation
ThermoGenesis Holdings, Inc. (“ThermoGenesis Holdings,” the “Company,” “we,” “our,” “us”), formerly known as Cesca Therapeutics 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. The Company was founded in
1986
and is registered in the State of Delaware and headquartered in Rancho Cordova, CA.
 
The Company previously had
two
reportable segments, a Device Segment and Clinical Development Segment. Due to the winding down of the Clinical Development Segment in
2019,
the Company
no
longer has any material revenues or expenses in that segment. As a result, the Company’s chief operating decision maker
no
longer reviews unconsolidated operating results. The Company will
no
longer report in
two
segments. The Company provides the AutoXpress
®
and BioArchive
®
platforms for automated clinical bio-banking, PXP platform for point-of-care cell-based therapies and CAR-TXpress™ platform under development for bio-manufacturing for immuno-oncology applications. The Company and its subsidiaries currently manufactures and markets the following products:
 
For Clinical Bio-Banking Applications:
 
AXP
®
Automated Cell Separation System – an automated, fully closed cell separation system for isolating and retrieving stem and progenitor cells from umbilical cord blood.
 
 
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.
 
For 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.
 
For Large Scale Cell Processing and Biomanufacturing:
 
X
-Series
®
Products:
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 buoyance-activated cell sorting (BACS) technology.
 
 
CAR-TXpress™ Platform – a modular designed, functionally closed platform that addresses the critical unmet need for large scale cellular processing and chemistry, manufacturing and controls (“CMC”) needs for manufacturing chimeric antigen receptor (“CAR”) T cell therapies. CAR-TXpress Bio, Inc. (“CARTXpress Bio”) is owned and developed through a subsidiary in which we own
80%
of the equity interest.
 
On
January 1, 2019,
the Company entered into a reorganization of the business and equity ownership of its majority-owned ThermoGenesis Corp. subsidiary. Pursuant to the reorganization, the assets acquired by ThermoGenesis Corp. from SynGen Inc. in
July 2017
were contributed to a newly formed Delaware subsidiary of ThermoGenesis Corp., CARTXpress Bio, and the
20%
interest in ThermoGenesis Corp. held by a
third
party was exchanged for a
20%
interest in CARTXpress Bio. As a result, the Company holds an
80%
equity interest in CARTXpress Bio and the Company has become the owner of
100%
of ThermoGenesis Corp. The purpose of the reorganization was to allow CARTXpress Bio to focus on the development and commercialization of the newly launched CARTXpress Bio cellular manufacturing platform.
 
In the reorganization, the Company reacquired the non-controlling interest shares in ThermoGenesis Corp., which had an accumulated deficit of
$1,711,000,
in exchange for a
20%
equity interest in the newly formed subsidiary, CARTXpress Bio, which amounted to approximately
$1,100,000.
The total amount of
$2,843,000
related to the reorganization of subsidiary and the related increase in non-controlling interest was offset by a charge to additional paid in capital in stockholders’ equity.
 
On
November 26, 2019
the Company entered into a joint venture agreement with HealthBanks Biotech Inc. (“HealthBanks”), an affiliate of the Boyalife Group, to form a new company called ImmuneCyte Life Sciences, Inc. (“ImmuneCyte”) to commercialize the Company’s proprietary cell processing platform, CAR-TXpress™, for use in immune cell banking as well as for cell-based contract development and manufacturing services (CMO/CDMO). Under the terms of the JV Agreement, ImmuneCyte was initially owned
80%
by HealthBanks and
20%
by the Company. The Company currently owns approximately
19%
of the equity of ImmuneCyte.
 
ThermoGenesis Holdings is an affiliate of the Boyalife Group, a global diversified life science holding company that focuses on stem cell technology and cell-based therapeutics.
 
Reverse Stock Split
On
June 4, 2019,
the Company effected a
one
(
1
) for
ten
(
10
) reverse split of its issued and outstanding common stock. The total number of shares of common stock authorized for issuance by the Company of
350,000,000
shares did
not
change in connection with the reverse stock split. All historical share amounts disclosed herein have been retroactively restated to reflect the reverse split and subsequent share exchange.
 
Liquidity
and Going Concern
The Company has a Revolving Credit Agreement (“Credit Agreement”) with Boyalife Asset Holding II, Inc. (Refer to Note
4
), allowing the Company to borrow up to
$10,000,000
in principal amount outstanding at any time. As of
March 31, 2020,
the Company had an outstanding balance of
$7,582,000
under the Credit Agreement. Boyalife Asset Holding II, Inc. is a wholly owned subsidiary of Boyalife Group Inc., which is owned and controlled by the Company’s Chief Executive Officer and Chairman of our Board of Directors.
 
At
March 31, 2020,
the Company had cash and cash equivalents of
$5,719,000
and working capital of
$6,914,000.
  The Company has incurred recurring operating losses and as of
March 31, 2020
had an accumulated deficit of
$241,534,000.
  These recurring losses raise substantial doubt about the Company’s ability to continue as a going concern within
one
year from the filing of this report. 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 cash 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.
 
The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern; however, the above conditions raise substantial doubt about the Company’s ability to do so. The condensed 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.
 
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. All significant intercompany accounts and transactions have been eliminated upon consolidation.
 
Non-controlling Interests
The
20%
ownership interest of CARTXpress Bio that is
not
owned by ThermoGenesis Holdings is accounted for as a non-controlling interest as the Company has an
80%
ownership interest in CARTXpress Bio. Earnings or losses attributable to other stockholders of a consolidated affiliated company are classified separately as "non-controlling interest" in the Company's consolidated statements of operations. Net loss attributable to non-controlling interests reflects only its share of the after-tax earnings or losses of an affiliated company. The Company's condensed consolidated balance sheets reflect non-controlling interests within the equity section.
 
Interim Reporting
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 presentation 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
-month period ended
March 31, 2020
are
not
necessarily indicative of the results that
may
be expected for the year ending
December 31, 2020.
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, 2019.