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ThermoGenesis Holdings, Inc.

thmo · NASDAQ Healthcare
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FY2019 Annual Report · ThermoGenesis Holdings, Inc.
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UNITED STATES 
SECURITIES AND EXCHANGE COMMISSION 
WASHINGTON, D.C. 20549 

FORM 10-K 

[X] 

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

For the Fiscal Year Ended: December 31, 2019 

or 

[   ]     

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

Commission File Number: 000-16375 

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 
Common Stock, $0.001 par value 

Trading Symbol(s) 
THMO 

Name of each exchange on which registered 
Nasdaq Stock Market, LLC 

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

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes [  ]  No 
[X] 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes [   ]  
No [X] 

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 [X] 

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 (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that 
the registrant was required to submit such files.).  Yes [X]  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 definition of “large accelerated filer,” “accelerated filer”, “smaller 
reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.  

Large accelerated filer [  ] Accelerated filer [  ]  
Non-accelerated filer [X] 

  Smaller reporting company [X] 
  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 
[X] 

As of June 28, 2019, the aggregate market value of the common equity held by non-affiliates of the registrant was approximately 
$4,733,000 based on the closing sales price as reported on the NASDAQ Stock Market. As of March 19, 2020, there were 4,561,017 
shares of common stock outstanding. 

 
 
 
  
 
TABLE OF CONTENTS 

Part I 

ITEM 1.  Business ........................................................................................................................ 2 
ITEM 1A.  Risk Factors ................................................................................................................ 12 
ITEM 1B.  Unresolved Staff Comments ...................................................................................... 23 
ITEM 2. 
Properties .................................................................................................................... 23 
ITEM 3.  Legal Proceedings ...................................................................................................... 23 
ITEM 4.  Mine Safety Disclosures ............................................................................................. 24 

Page Number 

Part II 

ITEM 5.  Market for the Registrant’s Common Equity, Related Stockholder Matters  

and Issuer Purchases of Equity Securities  ................................................................. 25 
Selected Financial Data .............................................................................................. 25 

ITEM 6. 
ITEM 7.  Management’s Discussion and Analysis of Financial Condition and 

Results of Operations ........................................................................................... 25 
ITEM 7A.  Quantitative and Qualitative Disclosures about Market Risk .................................... 33 
ITEM 8. 
Financial Statements and Supplementary Data .......................................................... 33 
ITEM 9.  Changes in and Disagreements with Accountants on Accounting 

and Financial Disclosure ...................................................................................... 78 
ITEM 9A.  Controls and Procedures ............................................................................................. 78 
ITEM 9B.  Other Information ....................................................................................................... 78 

Part III 

ITEM 10.  Directors, Executive Officers and Corporate Governance ......................................... 79 
ITEM 11.  Executive Compensation ............................................................................................ 79 
ITEM 12.  Security Ownership of Certain Beneficial Owners and Management and Related  

Stockholder Matters ................................................................................................... 79 
ITEM 13.  Certain Relationships and Related Transactions, and Director Independence ........... 79 
ITEM 14.  Principal Accounting Fees and Services .................................................................... 79 

Part IV 

ITEM 15.  Exhibits and Financial Statement Schedules .............................................................. 80 
ITEM 16.  Form 10-K Summary .................................................................................................. 80 

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CAUTIONARY STATEMENT REGARDING FORWARD LOOKING STATEMENTS 

This Annual Report contains forward-looking statements within the meaning of the “safe harbor” provisions 
of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical 
fact included in this Annual Report, are forward-looking statements. Reference is made in particular to the 
description  of  our  plans  and  objectives  for  future  operations,  assumptions  underlying  such  plans  and 
objectives, and other forward-looking statements included in this Annual Report. Such statements may be 
identified  by  the  use  of  forward-looking  terminology  such  as  “may,”  “will,”  “expect,”  “believe,” 
“estimate,”  “anticipate,”  “intend,”  “continue,”  “plan,”  “predict,”  “seek,”  “should,”  “would,”  “could,” 
“potential,” “ongoing,” or similar terms, variations of such terms, or the negative of such terms, and include, 
but are not limited to, statements regarding projected results of operations, capital expenditures, earnings, 
management’s future strategic plans, development of new technologies and services, litigation, regulatory 
matters,  market  acceptance  and  performance  of  our  services,  the  success  and  effectiveness  of  our 
technologies  and  services,  our  ability  to  retain  and  hire  key  personnel,  the  competitive  nature  of  and 
anticipated  growth  in  our  markets,  market  position  of  our  services,  marketing  efforts  and  partnerships, 
liquidity  and  capital  resources,  our  accounting  estimates,  and  our  assumptions  and  judgments.  Such 
statements are based on management’s current expectations, estimates and projections about our industry, 
management’s beliefs, and certain assumptions made by us, all of which are subject to change.  

These forward looking statements are not guarantees of future results and are subject to a number of risks, 
uncertainties  and  assumptions  that  are  difficult  to  predict  and  that  could  cause  actual  results  to  differ 
materially and adversely from those described in the forward-looking statements, including: 

• 

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

•  our ability to remain listed on NASDAQ and remain in compliance with its listing standards; 
• 

the global perception of the clinical utility of banked cord blood and the amount of investment in 
research and development supporting clinical data for additional applications; 

the success of any collaborative arrangements to commercialize our products; 

•  delays in commencing or completing clinical testing of products; 
• 
•  our reliance on significant distributors or end users; 
• 

the availability and sufficiency of commercial scale manufacturing facilities and reliance on third 
party contract manufacturers;  

•  our ability to protect our patents and trademarks in the U.S. and other countries; and 
•  uncertainty regarding the impact of the COVID-19 pandemic on our business and operations. 

These forward-looking statements speak only as of the date of this Annual Report and we expressly disclaim 
any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements 
contained  herein  to reflect any  change in  the  expectations  with regard thereto  or  any  change in  events, 
conditions, or circumstances on which any such statement is based, except as otherwise required by law. 
Additional  factors  that  could  cause  such  results  to  differ  materially  from  those  described  in  the 
forward-looking statements are set forth in connection with the forward-looking statements. 

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TRADEMARKS 

This Annual Report contains references to our trademarks and to trademarks belonging to other entities. 
Solely for convenience, trademarks and trade names referred to in this Annual Report, including logos, 
artwork and other visual displays, may appear without the ® or TM symbols, but such references are not 
intended to indicate, in any way, that their respective owners will not assert, to the fullest extent under 
applicable law, their rights thereto. We do not intend our use or display of other companies’ trade names or 
trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies. 

ITEM 1.  BUSINESS 

PART I 

ThermoGenesis  Holdings, Inc.  (“ThermoGenesis  Holdings”,  the  “Company”,  “our”,  or  “we”),  formerly 
known as Cesca Therapeutics Inc.is a pioneer and market leader in the development and commercialization 
of automated cell processing technologies for the cell and gene therapy field. The company markets a full 
suite  of  solutions  for  automated  clinical  biobanking,  point-of-care  applications,  and  large-scale  cell 
processing  and  manufacturing  for  the  emerging  CAR-T  immunotherapy  market.  Since  the  1990’s 
ThermoGenesis  Holdings  has  been  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 incorporated in 1986 and is registered in the State of Delaware and headquartered in 
Rancho Cordova, CA. 

ThermoGenesis  Holdings  has  two  separately  reported  business  segments:  A  “Device  Segment”  and  a 
“Clinical Development Segment.”  The Device Segment develops and commercializes automated systems 
that are used for, clinical grade cell-banking, point-of-care applications, and large-scale cell processing.  
The Clinical Development Segment is developing autologous (utilizing the patient’s own cells) cell-based 
therapeutics  that  address  significant  unmet  medical  needs  for  the  vascular,  cardiology  and  orthopedic 
markets.   

Recent Corporate Name Change 

On November 1, 2019, Cesca Therapeutics Inc. changed its corporate name to ThermoGenesis Holdings, 
Inc.  in  order  to  better  reflect  its  new  strategic  focus  on  becoming  a  key  solution  provider  for  cell 
manufacturing  tools  and  services  in  the  cell  and  gene  therapy  markets.    In  conjunction  with  the  name 
change, the Company began trading under the new Nasdaq ticker symbol, THMO. In addition, the Company 
changed its CUSIP number to 88362L100. 

Our Business Strategy 

Our business strategy is to leverage our over 30 years of expertise, our strong intellectual property portfolio 
and  significant  know-how  in  the  development  and  commercialization  of  automated  cell  processing 
technologies for the cell and gene therapy field. The company markets a full suite of solutions for automated 
clinical biobanking, point-of-care applications, and large scale cell processing and manufacturing for the 
emerging CAR-T immunotherapy market. 

Clinical Bio-Banking 
ThermoGenesis is a market leader in the development and commercialization of automated technologies 
for cell-based therapeutics and bioprocessing. With over 300 BioArchive Systems and 500 AXP® Systems 
sold, we continue to be the critical supplier of devices and disposables used in the processing of cord blood 
samples  for  the  largest  and  most  prestigious  cord  blood  banks  worldwide.  Our  Systems  are  used  in  37 
countries and greater than 1,000,000 cord blood units have been processed using our technology to date. 

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Clinical Bio-Banking Applications: 

•  AXP® System – The innovative AXP System defines a new processing standard for isolating and 
retrieving over 97% of the stem and progenitor cells from collections of umbilical cord blood in an 
automated,  fully  closed,  sterile  system  in  30  minutes.  AXP  is  self-powered,  microprocessor-
controlled, and contains flow control optical sensors to achieve precise separation. 

•  BioArchive®  Cryopreservation  System  –  The  BioArchive  Cryopreservation  System  is  the 
industry’s leading, fully automated, robotic, liquid nitrogen controlled-rate-freezing (“CRF”) and 
cryogenic  storage  system  for  stem cell  samples and  clinical  products.  Using  proven,  computer-
controlled technology, it provides the ultimate performance and protection for today’s invaluable 
cord blood samples and future cell therapeutic products. BioArchive is the preferred system for the 
highest quality cord blood banks worldwide. A complete technical Master-File has been provided 
to the U.S. Food and Drug Administration (“FDA”) to support those highest quality cord blood 
banks which have been able to qualify for, and obtain, a Biological License from the FDA to allow 
their cord blood units to be used to treat patients with blood cancers. 

Point-of-Care Application 
The PXP® System is our point-of-care device utilizing technology for processing bone marrow concentrate 
and is highly innovative pairing both speed and performance. 

PXP® System – The PXP System is an automated, closed system that harvests a precise volume of cell 
concentrate from bone marrow aspirates. PXP can generate a concentration of bone marrow in less than 20 
minutes, with consistently high MNC and CD34+ stem cell progenitor recovery rates and greater than 98% 
depletion  of  contaminating  red  blood  cells (“RBCs”).  Processing data  is  captured  using  our  proprietary 
DataTrak™  software  to  assist  with  Good  Manufacturing  Practice  (“GMP”)  process  monitoring  and 
reporting information. 

CAR-TXpress Platform (Large Scale Cell Processing) 

With  revolutionary  cell-based  therapies,  such  as  CAR-T  (chimeric  antigen  receptor  T-cell)  for  cancer 
becoming a reality, developers must address a key challenge: how to manufacture high-quality, clinical-
grade cell therapies at commercial scale to provide these groundbreaking treatments to as many patients 
as  possible. Traditional  cell  processing  methodologies  are  manual  and  time  consuming,  presenting  an 
obstacle to large-scale manufactures of adoptive cell therapies. 

In  contrast,  ThermoGenesis  Holdings  is  keeping  up  with  the  fast-past  field  by  developing  the  CAR-
TXpress™ Platform designed to automate many of the manual steps involved in cell processing. The CAR-
TXpress  Platform  is  a  multi-system  package  that  provides  a  stream-lined  solution  for  cell  processing, 
selection, washing, and cryopreservation. The CAR-TXpress Platform can provide a comprehensive and 
commercially  viable,  semi-automated  cellular  manufacturing  and  control  (“CMC”)  solution  for  the 
development of CAR-T therapeutics. 

CAR-TXpress eliminates the use of density gradient media for isolation and replaces magnetic bead-based 
systems used for selection procedures, thereby dramatically reducing processing time and increasing cell 
recoveries,  in  order  to  significantly  reduce  the  overall  manufacturing  time  and  cost  and  increase  the 
yield/efficiency of high value samples. 

CAR-TXpress Processing Applications 

•  X-Lab® System for Cell Isolation – a semi-automated, functionally-closed, ficoll-free, system for 
the rapid isolation of mononuclear cells (“MNCs”) from collected units of peripheral blood, cord 
blood,  bone  marrow  aspirate  or  leukapheresis.    The  Company  had  filed  a  Device  Master  File 

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(“MAF”) with the FDA for the X-Lab.  The MAF contains all the relevant information that the 
FDA will need to allow principal investigators to include ThermoGenesis Holdings’ systems in 
their investigational new drug applications. 

•  X-Wash®  System  for  Washing  and  Reformulation  –  a  semi-automated,  functionally-closed 
system that separates, washes, and volume-reduces units of fresh or thawed units of blood, bone 
marrow, leukapheresis or cell cultures and presents these washed cells in a predetermined small 
volume. The Company has filed a MAF with the FDA for the X-Wash.  The MAF contains all the 
relevant  information  that  the  FDA  will  need  to  allow  principal  investigators  to  include 
ThermoGenesis Holdings’ systems in their investigational new drug applications. 

•  X-BACS™ System for Cell Purification – a semi-automated, functionally-closed system employs 
a microbubble/antibody reagent to isolate target cells by buoyancy-activated cell sorting (“BACS”). 
These microbubble/antibody reagents bind to user-selected target cells to increase their buoyancy 
and provide a complete separation from non-target cells during centrifugation, allowing the harvest 
of a highly purified population of target cells, with high recovery efficiency and cell viability. 

•  BioArchive® for Cryogenic Cellular Product Storage – an automated, controlled-rate-freezing, 
liquid  nitrogen  freezer  intended  for  the  cryopreservation  and  single-cassette  based  storage  of 
clinical  samples.  The  BioArchive®  provides  customers  who  need  to  store  therapeutic  cell 
populations  in  cryogenic  storage  (-196°C)  with  a  solution  that  combines  the  individualized 
controlled rate freezing of each sample, robotic storage and retrieval of each sample and real-time 
chain of custody management. 

Cell Manufacturing Services 

Through  our  TotipotentRX  subsidiary  in  Gurgaon,  India,  we  operate  an  advanced  clinical  cell 
manufacturing,  processing,  testing,  and  storage  facility,  compliant  with  current  GMP,  Good  Tissue 
Practices (“GTP”), and Good Laboratory Practices (“GLP”). We can support the production of  a small, 
personalized medicine cell prescription or a large-scale batch process. Patient samples, batch samples, and 
therapeutic aliquots are all labeled in accordance with ISBT 128 and stored in our own cryogenics’ facility. 
In  partnership  with  Fortis  Healthcare  we  also  operate  commercial  service  programs  supporting  bone 
marrow  transplantation  (hematopoietic  stem  cell  transplantation)  for  hematological  and  oncological 
disorders. 

Recent Key Events and Accomplishments 

• 

ImmuneCyte  Joint  Venture  formed  with  Healthbanks  Biotech  (USA)  Inc.    In  October  2019,  the 
Company entered into a Joint Venture Agreement with Healthbanks Biotech (USA) Inc., a stem 
cell bank network (Healthbanks), under which the Company and Healthbanks agreed to form a new 
company  named  ImmuneCyte  Life  Sciences  Inc.  (“ImmuneCyte”).    The  joint  venture  will 
commercialize ThermoGenesis’ 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). 

•  X-Series Supply Agreement.  In August 2019, the Company entered into a Supply Agreement with 
Corning  Incorporated  (“Corning”)  in  which  the  Company  will  distribute  its  X-Series®  cell 
processing products to Corning who will market them globally.  The X-Series products are major 
components  of  the  Company’s  CAR-TXpress™  platform,  a  semi-automated,  closed  cellular 
processing  platform  used  for  high  efficiency  cell  purification  and  cell  washing.   The  X-Series 
products,  when  used  in  combination  with  the  Company’s  proprietary  buoyancy  activated  cell 
sorting (“BACS”) technology, can be applied for both research and commercial manufacturing of 

4 

 
 
 
 
 
 
 
a large variety of cell-based therapeutics, including chimeric antigen receptor-T (“CAR-T”) cells.  
Under the renewable, five-year agreement, the global distributor will be responsible for marketing 
the X-Series products to customers, worldwide, with the exception of China for the first two years. 
As  per  the terms  of  the agreement, the  Company received  a  $2 million  upfront  exclusivity fee, 
which was paid by the distributor in October 2019.  

•  Next  Generation  PXP®  -  1000  System.  In  December  2019,  the  Company  completed  the 
development  process and  submitted  a  Letter to  the  Design  History  File  and  updated the  device 
listing  with  the  FDA  for  the  PXP®-1000  System.  The  PXP-1000  is  the  next  generation  of 
ThermoGenesis’  automated  systems  and  allows  fast,  automated  and  reproducible  separation  of 
cellular components from blood in a closed and sterile GMP compliant environment. 

•  Changed Name and Nasdaq Ticker Symbol.  Effective November 1, 2019, the Company changed 
its  name  to  ThermoGenesis  Holdings,  Inc.  in  order  to  better  reflect  its  new  strategic  focus  on 
becoming a key solution provider for cell manufacturing tools and services in the cell and gene 
therapy markets. In conjunction with the name change, the Company began trading under the new 
Nasdaq  ticker  symbol,  THMO.  In  addition,  the  Company  changed  its  CUSIP  number  to 
88362L100. 

•  Reverse  Stock  Split.    In  June  2019,  to  be  compliant  with  the  Nasdaq  Listing  Compliance 
requirement, the Company effected a one-for-ten reverse stock split of the Company’s common 
stock, par value $0.001 per share.  

•  Launched the AXP II System for Advanced Cord Blood Processing. We completed the commercial 
launch of the AXP II system for the advanced, isolation, collection and storage of hematopoietic 
stem  cell  concentrates  from  cord  blood  and  peripheral  blood.    AXP  II  introduced  important 
enhancements to the AXP device, docking station, and proprietary XpressTRAK® software that 
together  represent  a  significant  advancement  in  automated  cord  blood  processing.    America’s 
largest cord blood bank, CBR® updated to AXP II system.   

•  Enhanced X-Mini® Release. In April 2019, the Company enhanced its X-Mini CD3 Selection Kit 
for  the  research  market.  The  new  X-Mini  CD3  Selection  Kit  provides  distinct  advantages, 
expanding on the ability of the original X-Mini kit to select the CD3+ target cells from prepared 
mononuclear cell samples or from a sample of whole blood. Also included in the release of the new 
kit is the X-Mini Pressor accessory, used in conjunction with the X-Mini selection kits to eliminate 
the X-BACS™ reagent’s buoyancy during the final processing steps.    

Sales and Distribution Channels  

We  market  and  sell  our  products  through independent  distributors,  except  in  North  America and  India, 
where we sell direct to end-user customers.  

5 

 
 
 
 
 
 
 
 
 
 
 
Research and Development 

Our research and development activities for 2019 were geared towards expanding the automated platform 
for  the  immune-oncology  applications  while  maintaining  our  bio-banking  and  point-of-care  automation 
solutions.  In 2019, the Company released the enhanced X-Mini CD-3 Selection Kit for the research market 
and developed an enhanced PXP-1000 system.  We also improved our AXP®, and BioArchive® platforms 
with a focus on both performance improvements and ease of use. Emphasis was also placed on enhancing 
the  capabilities  of  our  contract  manufacturing  partners  and  building  on  our  product  quality  leadership 
position.  

Collectively,  research  and  development  expenses  were  $2,396,000  and  $3,012,000  for  the  years  ended 
December  31,  2019  and  2018,  respectively.    Research  and  development  activities  include  expenses 
associated with the engineering, regulatory, scientific and clinical affairs functions. 

Manufacturing and Raw Materials  

We  source  components  for  our  products  from  multiple  suppliers  that  manufacture  to  our  engineering 
specifications.  Our high-volume disposable products are manufactured using contract manufacturers.  AXP 
disposable bagsets are manufactured by Viant Medical and our manual processing bagsets are manufactured 
by  Pall  Medical  Corporation.  We  utilize  our  manufacturing  facility  in  Rancho  Cordova,  California  for 
production of our low volume, high complexity devices.  Additionally, in 2019, the Company completed 
the construction and qualification of an in-house clean room for the assembly of the X-Series disposable 
cartridges.  We used this facility for the manufacturing of all disposable cartridges in 2019.  Various raw 
materials are used to manufacture our products.  The raw materials are generally available from multiple 
sources.  We have not had significant difficulty in obtaining necessary raw materials. 

Quality System 

Our quality system is compliant with domestic and international standards and is appropriate for the specific 
devices we manufacture. Our corporate quality policies govern the methods used in, and the facilities and 
controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all 
finished devices intended for human use. Such policies are intended to ensure that the products we market 
are safe, effective, and otherwise in compliance with the FDA Quality System Regulation (“QSR”) (21 
C.F.R. Part 820) and the applicable rules of other governmental agencies.  

We and our contract manufacturers are subject to inspections by the FDA and other regulatory agencies to 
ensure  compliance  with  applicable  regulations,  codified  in  the  FDA’s  Quality  System  Regulations 
(“QSRs”).  Compliance  requirements  relate  to  manufacturing  processes,  product  testing,  documentation 
control and other quality assurance procedures. Our facilities have undergone International Organization of 
Standards (“ISO”) 13485:2016 and EU Medical Device Directive (“MDD”) (93/42/EEC) inspections and 
we  have  obtained  approval  to  CE-Mark  our  products.    We  have  received  our  updated  certificate 
demonstrating compliance to this standard under the Medical Device Single Audit Program (“MDSAP”).  

Regulatory Scheme and Strategy 

The  development,  manufacture  and  marketing  of  our  cell  therapy  products,  as  well  as  the  design  and 
implementation of our clinical trials, are subject to regulation by the FDA as well as the equivalent agencies 
of other countries including the countries of the European Union and India. 

The trials we conduct in India are compliant with the applicable rules of the Indian Council for Medical 
Research, Ministry of Health Order No. V.25011/375/2010-HR and requisite institutional ethics committee 
(“IEC”) and institutional committee for stem cell research and therapy (“IC-SCRT”) approvals. Both the 

6 

 
 
 
 
 
 
 
 
 
 
 
U.S. and E.U. regulatory agencies are experienced in dealing with and accepting Indian clinical trial data. 
Good Clinical Practice (“GCP”) guidelines necessitates review and approval by an Institutional Review 
Board  (“IRB”)  before  initiation  of  a  study,  continuing  review  of  an  ongoing  study  by  an  IRB,  and  the 
documented receipt of a freely given informed consent prior to participation in the study from each subject 
participant. 

We have a quality and regulatory compliance management system that meets the requirements of the ISO 
13485: 2003 standard, the FDA’s QSRs, the EU MDD, Canadian Medical Device Regulations (SOR 98-
282), and all other applicable local, state, national and international regulations. 

Medical Devices. The FDA regulates medical devices to ensure their safety and efficacy under the Federal 
Food Drug and Cosmetic Act (“FD&C”). Medical devices are defined by language within the FD&C Act 
which essentially states that a product is considered a medical device if it is intended to provide a diagnosis 
or basis for treatment. Once a company determines that its product is a medical device, it is required to 
comply with a number of federal regulations. These include the following:  

•  510(k) clearance or Premarket Approval Application (“PMA”) approval from the FDA, prior to 

commercialization (unless the device is classified as “exempt”); 

•  Registration of the company and listing of the medical device with the FDA (within 30 days prior 

to commercialization); 

•  Establishment and adherence to the FDA’s labeling requirements; and  
•  Establishment  and  adherence  to  the  FDA’s  Quality  Systems  and  Medical  Device  Reporting 

regulations.  

The FDA classifies medical devices into three groups: Class I, II or III. These are stratified from lowest to 
highest safety risk, and regulatory controls increase based on Class.  

Class I Devices 
Some of our products are considered to pose little or no risk when used as directed and have been deemed 
by the FDA to be “exempt” from FDA approval or clearance processes prior to commercialization. While 
pre-marketing  FDA  review  is  not  mandatory  for  Exempt  Class  I  medical  devices,  the  manufacturer’s 
compliance with QSR is nevertheless a requirement. 

7 

 
 
 
 
 
 
 
Class II Devices 
Several of our products, including the BioArchive and the AXP are categorized as U.S. Class II medical 
devices  and  require  premarket  notification,  also  known  as  a  section  510(k)  clearance,  prior  to 
commercialization. Data submitted as part of a 510(k) process must demonstrate a device is “substantially 
equivalent” with a predicate device that is already on the market. Once 510(k) clearance has been secured, 
the new medical device may be marketed for its intended use and distributed in the U.S. 

Class III Devices 
If  a  product  is  considered  a  Class  III  device,  the  FDA  approval  process  is  more  stringent  and  time-
consuming, and includes the following: 

•  Extensive pre-clinical laboratory and animal testing; 
•  Submission and approval of an Investigational Device Exemption (“IDE”) application prior to the 

conduct of a clinical study; 

•  Human clinical studies (or trials) to establish the safety and efficacy of the medical device for the 

intended use; and 

•  Submission and approval of a PMA application to the FDA. 

Pre-clinical  testing  typically  involves  in  vitro  laboratory  analysis  and  in  vivo  animal  studies  to  obtain 
information related to such things as product safety, feasibility, biological activity and reproducibility. The 
results of pre-clinical studies are submitted to the FDA as part of an IDE application and are reviewed by 
the Agency before human clinical trials can begin. 

Higher risk clinical trials conducted inside the U.S. are subject to FDA IDE regulation (21 C.F.R. Part 812), 
or an Investigational New Drug (“IND”) application (21 C.F.R. Part 312). Clinical trials conducted outside 
the U.S., and the data collected therefrom are allowed in accordance with applicable FDA requirements. 
The FDA or the sponsor may suspend a clinical trial at any time if either believes that study participants 
may be exposed to an unacceptable health risk. 

For certain Class III devices, data generated during product development, pre-clinical studies, and human 
clinical  studies  must  be  submitted  to  the  FDA  as  a  PMA  application  in  order  to  secure  approval  for 
commercialization  in  the  U.S.  The  FDA  may  deny  the  approval  of  a  PMA  application  if  applicable 
regulatory criteria are not satisfied and, in some cases, may mandate additional clinical testing. Product 
approvals, once obtained, can be withdrawn if compliance with regulatory standards is not maintained or if 
safety  concerns  arise after the product  reaches the  market.  The  FDA might also require  post-marketing 
testing and surveillance programs to monitor the safety and efficacy of a medical device and has the power 
to forbid or limit future marketing of the product based on the results of such programs. 

Other U.S. Regulatory Information 
Medical  device  manufacturers  must  register  with  the  FDA  and  submit  their  manufacturing  facilities  to 
biennial  inspections  to  ensure  compliance  with  applicable  regulations.  Failure  to  comply  with  FDA 
requirements can result in withdrawal of marketing clearances, fines, injunctions, civil penalties, recall or 
seizure of products, total or partial suspension of production or loss of distribution rights. In addition, device 
manufacturing facilities in the state of California must be registered with the California State Food and 
Drug Branch of the California Department of Public Health and submit to an annual inspection by the State 
of California to ensure compliance with applicable state regulations. We are also subject to a variety of 
environmental laws as well as workplace safety, hazardous material, and controlled substances regulations. 

Also, federal transparency requirements, sometimes referred to as the “Sunshine Act” under the Patient 
Protection  and  Affordable  Care  Act,  require  manufacturers  of  drugs,  devices,  biologics  and  medical 
supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to 

8 

 
 
 
 
 
 
 
 
report to the Department of Health and Human Services information related to physician payments and 
other transfers of value and physician ownership and investment interests. 

Changes in these laws at all levels of government are frequent and could increase our cost of doing business. 
If we fail to comply, even inadvertently, with any of these requirements, we could be required to alter our 
operations, refund payments to the government, lose our licensure or accreditation, enter into corporate 
integrity, deferred prosecution or similar agreements with state or federal government agencies, and become 
subject to significant civil and criminal penalties. 

International Regulatory Requirements 
International regulatory requirements differ somewhat from those of the U.S. In the EU, a single regulatory 
approval process has been created and approval is represented by CE-Marking. To be able to affix the CE-
Mark to our medical devices and distribute them in the EU, we must meet minimum standards for safety 
and quality (known as the essential requirements) and comply with one or more conformity rules. A notified 
body  assesses  our  quality  management  system  and  compliance  with  the  Medical  Device  Directive. 
Marketing authorization can be revoked by the applicable governmental agency or notified body in the 
event of an unsuccessful quality system annual audit. 

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

Patents and Proprietary Rights 

We  believe  that  patent  protection  is  important  for  our  products and  current  and  proposed business.  We 
currently have over 30 issued patents globally. The patent positions can be uncertain because they involve 
interpretation of complex factual information and an evolving legal environment. The coverage sought in 
a patent application can be denied or significantly reduced either before or after the patent is issued. There 
can be no assurance that any of our pending patent applications will actually result in an issued patent. 
Furthermore, there can be no assurance that any existing or future patent will provide significant protection 
or commercial advantage, or that any existing or future patent will not be circumvented by a more basic 
patent. Generally, patent applications can be maintained in secrecy for at least 18 months after their earliest 
priority date. In addition, publication of discoveries in the scientific or patent literature often lags behind 
actual discoveries. Therefore, we cannot be certain that we were the first to invent or the first to file a patent 
application for the subject matter covered by each of our pending U.S. and foreign patent applications. 

If a third-party files a patent application relating to an invention claimed in our patent application, we may 
be  required to  participate in  an  interference  or  derivation proceeding conducted  by  the  U.S.  Patent and 
Trademark  Office  to  determine  who  owns  the  patent.  Such  proceeding  could  involve  substantial 
uncertainties and cost, even if the eventual outcome is favorable to us. There can be no assurance that our 
patents, if issued, would be upheld as valid in court. 

Agreements 

The following are certain material agreements involving our business in effect as of December 31, 2019: 

Healthbanks Biotech (USA) Inc. 
On November 26, 2019 the Company entered into a joint venture agreement with HealthBanks Biotech 
(USA)  Inc.  (the  “JV  Agreement”)  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 

9 

 
 
 
 
 
 
 
 
 
 
(CMO/CDMO).    Under  the  terms  of  the  JV  Agreement,  ImmuneCyte  will  initially  be  owned  80%  by 
HealthBanks Biotech and 20% by ThermoGenesis.  ImmuneCyte will be among the first immune cell banks 
in the U.S. and offer customers the ability to preserve younger, healthier and uncontaminated immune cells 
for  future  potential  use  in dendritic  and  chimeric  antigen  receptor (“CAR-T”)  cell therapies, in  a  GMP 
compliant processing environment.  The Company’s principal contribution to ImmuneCyte will be a supply 
agreement under which ImmuneCyte will have the exclusive right to purchase the Company’s proprietary 
cell processing equipment in the immune cell banking business and a non-exclusive right to purchase it for 
other  cell-based  contract  development and  manufacturing (“CMO/CDMO”) services at  a  price  equal to 
115% of the Company’s cost. The Company will also contribute to ImmuneCyte intellectual property and 
trademarks relating to the Company’s clinical development assets as a result of the Company’s decision to 
discontinue its clinical development program. Healthbanks contributed to ImmuneCyte a paid-up, royalty 
free  license  to  use  its  proprietary  business  management  system,  customer  relationship  management 
software, and laboratory information statement, and it will also make available a $1,000,000 unsecured, 
non-convertible  line  of  credit  to  ImmuneCyte  to  provide  initial  operating  capital.    Healthbanks  is  a 
subsidiary of Boyalife Group, Inc. (USA), the owner of Boyalife Asset Holding II, Inc., which is the largest 
stockholder of the Company, and is owned by Dr. Xiaochun (Chris) Xu, the Company’s Chief Executive 
Officer and Chairman of our Board of Directors. 

Corning Incorporated 
On  August  30,  2019,  the  Company  entered  into  a  Supply  Agreement  with  Corning  (the  “Supply 
Agreement”).  The Supply Agreement has an initial term of five years with automatic two-year renewal 
terms, unless terminated by either party in accordance with the terms of the Supply Agreement (collectively, 
the “Term”). Pursuant to the Supply Agreement, the Company has granted to Corning exclusive worldwide 
distribution  rights  for  substantially  all  X-Series®  products  under  the  CAR-TXpress™  platform  (the 
“Products”) manufactured by its subsidiary, ThermoGenesis Corp., for the duration of the Term, subject to 
certain geographical and other exceptions. In addition, the Company has granted Corning rights of first 
refusal for the exclusive worldwide distribution of certain future products developed or introduced by the 
Company relating to cell isolation or cell selection, including any such products substantially related or 
similar to the Products (the “ROFR Products”). As consideration for the exclusive worldwide distribution 
rights for the Products and ROFR Products, Corning has agreed to pay a $2,000,000 fee, in addition to any 
amounts payable throughout the Term for the Products and any ROFR Products.  The Supply Agreement 
also  contains  an  option,  exercisable  by  Corning  at  any  time  following  January  1,  2021,  to  become  the 
manufacturer for all or any portion of the Products. 

IncoCell Tianjin Ltd 
On March 12, 2018, ThermoGenesis Corp. entered into a License Agreement (the “IncoCell Agreement”) 
with IncoCell Tianjin Ltd., a wholly-owned subsidiary of Boyalife Group (“IncoCell”). Boyalife Group is 
an affiliate of the Company’s Chief Executive Officer and Chairman of our Board of Directors, and Boyalife 
(Hong Kong) Limited.  Under the terms of the IncoCell Agreement, ThermoGenesis Corp. granted IncoCell 
an  exclusive  license  to  use  the  ThermoGenesis  Corp.  X-Series®  products  in  the  conduct  of  IncoCell’s 
contract manufacturing and development operations in the People’s Republic of China, Japan, South Korea, 
Taiwan, Hong Kong, Macau, Singapore, Malaysia, Indonesia and India (the “IncoCell Territories”).  

Pursuant  to  the  terms  of  the  IncoCell  Agreement,  ThermoGenesis  Corp.  granted  IncoCell  an  exclusive 
license to purchase and use, at a discounted purchase price, X-Series cellular processing research devices, 
consumables, and kits for use in the conduct of contract manufacturing and development services in the 
IncoCell  Territories.  In  exchange,  ThermoGenesis  Corp.  is  entitled  to  a  percentage  of  IncoCell’s  gross 
contract  development  revenues,  including  any  potential  upfront  payments,  future  milestones  or  royalty 
payments, during the term of the IncoCell Agreement. The term of the Agreement is ten years, provided 
that either party may terminate the Agreement earlier upon ninety (90) days’ prior notice to the other party.  
The Company recorded revenue of $83,000 related to product sales under this agreement for the year ended 
December  31,  2019,  and  $14,000  for  the  year  ended  December  31,  2018.    The  Company  recorded  no 

10 

 
 
 
 
revenue under the contract development portion of the Agreement for the years ended December 31, 2019 
and 2018. 

CBR Systems, Inc. (“CBR”) 
Effective May 15, 2017 we entered into a Manufacturing and Supply Agreement with CBR which replaced 
the prior December 31, 2013 Sale and Purchase Agreement in which we agreed to supply CBR with the 
AXP cord blood processing system and disposables. The term of the Manufacturing and supply Agreement 
is for three years and will automatically renew in one-year increments unless either party provides written 
notice of its intention not to renew six months prior to the end of the term.  

In June 2010, we entered into a License and Escrow Agreement in order to alleviate CBR’s concerns about 
potential long-term supply risk. We are the sole supplier of critical devices and disposables used in the 
processing  of  cord  blood  samples  in  CBR’s  operations.  Under  the  License  and  Escrow  Agreement,  we 
granted CBR a perpetual, non-exclusive, royalty-free license to certain intellectual property necessary for 
the  manufacture  of  AXP®  devices  and  disposables.  The  license  is  for  the  sole  and  limited  purpose  of 
ensuring continued supply of the AXP and related disposables for use by CBR. The licensed intellectual 
property is held in escrow and available to CBR only in the event of a default under the License and Escrow 
Agreement. Effective May 15, 2017 we entered into a Sixth Amended and Restated Technology License 
and Escrow Agreement with CBR. This amendment, among other things, changes the circumstances that 
constitute a “Default” thereunder and conditions the circumstances under which CBR may, upon a default 
by the Company, purchase licensed products  directly from the Company’s manufacturers and suppliers. 
The events or conditions of default include: a cash balance coupled with short-term investments net of debt 
or borrowed funds that are payable within one year of less than  $2,000,000 (amended to $1,000,000 in 
March 2020) at any month end or we fail to provide products pursuant to the Manufacturing and Supply 
Agreement. We were in compliance with the License and Escrow Agreement at December 31, 2019. 

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

Employees 

As of December 31, 2019, we and our subsidiaries had 50 employees, 45 of whom were employed in the 
U.S. and 5 of whom were employed in India. We also utilize temporary employees throughout the year to 
address  business  needs  and  significant  fluctuations  in  orders  and  product  manufacturing.  None  of  our 
employees are covered by a collective bargaining agreement, nor have we experienced any work stoppage. 

11 

 
 
 
 
 
 
 
 
 
Foreign Sales and Operations 

See Note 12 of our Notes to Consolidated Financial Statements for information on our sales and operations 
outside of the U.S. 

Where you can Find More Information 

We are required to file annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on 
Form  8-K  and  other  information,  including  our  proxy  statement,  with  the  Securities  and  Exchange 
Commission (“SEC”). The public can obtain copies of these materials by accessing the SEC’s website at 
http://www.sec.gov. In addition, as soon as reasonably practicable after these materials are filed with or 
furnished  to  the  SEC,  we  will  make  copies  available  to  the  public  free  of  charge  through  our  website, 
http://www.thermogenesis.com. The information on our website is not incorporated into, and is not part of, 
this Annual Report on Form 10-K or our other filings with the SEC. 

ITEM 1A.  RISK FACTORS 

An investment in our common stock is subject to risks inherent to our business. The material risks and 
uncertainties  that  management  believes  affect  us  are  described  below.  Before  making  an  investment 
decision, you should carefully consider the risks and uncertainties described below together with all of the 
other information included or incorporated by reference in this Annual Report. The risks and uncertainties 
described below are not the only ones we face. Additional risks and uncertainties that we are not aware of 
or focused on or that we currently deem immaterial may also impair our business operations. This Annual 
Report is qualified in its entirety by these risk factors. 

If  any  of  the  following  risks  actually  occur,  our  financial  condition  and  results  of  operations  could  be 
materially and adversely affected. If this were to happen, the value of our common stock could decline 
significantly, and you could lose all or part of your investment. 

Risks Related to Our Structure and Business 
A third party owns 20% of our subsidiary, CARTXpress Bio, Inc. (CARTXpress Bio), and  holds certain 
minority investor rights therein.  These rights could limit or delay our ability to take certain major actions 
relating to CARTXpress Bio. In January 2019, ThermoGenesis Corp. contributed its X-Series business into 
a  newly  formed  subsidiary  of  ThermoGenesis  Corp.,  CARTXpress  Bio.    Pursuant  to  the  terms  of  a 
reorganization and share exchange agreement, ThermoGenesis Holdings acquired a 20% equity ownership 
in ThermoGenesis Corp. from Bay City Capital Fund V, L.P. and certain of its affiliates (“Bay City”).  In 
exchange,  Bay  City  acquired  a  20%  ownership in  CARTXpress  Bio.   As a  result  of  these  transactions, 
ThermoGenesis  Corp.  became  a  wholly-owned  subsidiary  of  ThermoGenesis  Holdings,  and 
ThermoGenesis Corp. owns 80% of the outstanding equity of CARTXpress Bio, while Bay City owns the 
remaining 20% of the outstanding equity of CARTXpress Bio.  While we continue to indirectly own 80% 
of the outstanding capital stock of CARTXpress Bio, Bay City was granted certain minority investor rights 
in CARTXpress Bio. These rights include board representation rights, a right of first refusal over sales of 
CARTXpress Bio. stock by us, co-sale rights with respect to any sale of CARTXpress Bio stock by us, 
certain piggyback and Form S-3 registration rights in the event that CARTXpress Bio becomes a publicly 
traded company at any time in the future and other rights as detailed in the Investors’ Rights Agreement. In 
addition,  the  board  of  directors  of  CARTXpress  Bio  is  comprised  of  three  persons,  two  of  whom  are 
designated by us and one of whom is designated by Bay City. The foregoing minority investor rights in 
CARTXpress Bio could limit or delay our ability or flexibility to take certain major actions or make major 
decisions relating to CARTXpress Bio that might be beneficial to our stockholders, unless such actions or 
decisions  have  the  consent  or  support  of  Bay  City.  Accordingly,  the  minority  investor  rights  in 
CARTXpress Bio could have a negative impact on the market price of our common stock. 

12 

 
 
 
 
 
 
 
 
 
Our largest stockholder has significant influence over us which could limit your ability to influence the 
outcome of key transactions, including a change of control, and could negatively impact the market price 
of our common stock by discouraging third party investors. As of December 31, 2019, approximately 24% 
of our outstanding common stock is owned by Boyalife Asset Holding II, Inc (“Boyalife”). In addition, 
pursuant to the terms of the Amended Nomination Agreement we entered into with Boyalife in April 2018, 
Boyalife has the right to designate a number of members of our board of directors that is in proportion to 
the “Boyalife Ownership Percentage”, which is Boyalife and its affiliates’ combined percentage ownership 
of outstanding common stock, treating as outstanding any shares of common stock underlying convertible 
securities that are immediately exercisable by Boyalife and its affiliates’ (including under the debt facility) 
without any further payment. The Amended Nomination Agreement will terminate according to its terms 
when and if the Boyalife Ownership Percentage falls below 20%. 

Boyalife is 100% owned by Dr. Xiaochun Xu, our Chief Executive Officer and Chairman of our Board of 
Directors.  As  a  result  of  their  ownership  and  ability  to  designate  members  of  our  Board  of  Directors, 
Boyalife (including Dr. Xu) is able to exercise significant influence over all matters affecting us, including 
the election of directors, formation and execution of business strategy and approval of mergers, acquisitions 
and other significant corporate transactions, which may have an adverse effect on our stock price and ability 
to execute our strategic initiatives. Boyalife and/or Dr. Xu may have conflicts of interest and interests that 
are not aligned with those of other investors in all respects. As a result of the concentrated ownership of 
our common stock, Dr. Xu may be able to control matters requiring stockholder approval, including the 
election  of  directors,  the  adoption  of  amendments  to  our  certificate  of  incorporation  and  bylaws,  and 
approval  of  a  sale  of  our  Company,  and  other  significant  corporate  transactions.  This  concentration  of 
ownership may delay or prevent a change in control and may have a negative impact on the market price 
of our common stock by discouraging third party investors from investing or making tender offers for our 
shares. 

In addition, Boyalife is a material creditor of our company. We are a party to a revolving debt facility with 
Boyalife which has a maximum borrowing availability of $10,000,000 and an outstanding balance as of 
December  31,  2019  of  $8,713,000  in  principal  and  $1,869,000  in  accrued  interest.  In  February  2020, 
Boyalife converted $3.0 million of the outstanding balance of the convertible note into an aggregate of 1.67 
million shares of our common stock.   The debt facility matures on March 6, 2022, with accrued interest 
due annually on the last day of each calendar year. Because this debt facility is secured by all of our shares 
in our ThermoGenesis Corp. subsidiary, an event of default under the debt facility would have a material 
adverse  impact  on  our  interest  in  ThermoGenesis  Corp.  if  the  lender  under  the  debt  facility  elected  to 
foreclose on such security interest. 

We  utilize  debt  financing  from  outside  the  U.S.  and  an  inability  to  obtain  funds  when  requested  could 
adversely impact operations. We use debt financing for working capital and other cash requirements.  Our 
ability to use this funding source may be impacted by reasons such as default or foreign government policies 
that restrict or prohibit transferring funds.  In the event that we were not able to obtain funds as needed, it 
could result in delays to project funding or non-compliance with cash-based covenants. 

We may seek to enter into collaborative arrangements to develop and commercialize products which may 
not be successful.  We may seek to enter into collaborative arrangements to develop and commercialize 
some of our potential products and product candidates both in North America and international markets. 
There can be no assurance that we will be able to negotiate collaborative arrangements on favorable terms 
or at all or that current or future collaborative arrangements will be successful. 

A significant portion of revenue is derived from customers outside the United States.  We may lose revenues, 
market share, and profits due to exchange rate fluctuations and political and economic changes related to 
its foreign business. For the year ended December 31, 2019, sales to customers outside the U.S. comprised 
approximately 48% of revenues.  This compares to 50% for the year ended December 31, 2018. Our foreign 

13 

 
 
   
 
 
business is subject to economic, political and regulatory uncertainties and risks that are unique to each area 
of the world. Fluctuations in exchange rates may also affect the prices that foreign customers are willing to 
pay and may put us at a price disadvantage compared to other competitors. Potentially volatile shifts in 
exchange rates may negatively affect our financial position and results. 

The  loss  of  a  significant  distributor  or  end  user  customer  may  adversely  affect  financial  condition  and 
results of operations. Revenues from our largest customer comprised 28% of revenues for the year ended 
December 31, 2019. Revenues from our largest distributor comprised 11% of revenues for the year ended 
December 31, 2019.  The loss of a large customer or distributor may significantly decrease revenues.  

We may be exposed to liabilities under the foreign corrupt practices act and any determination that we 
violated these laws could have a material adverse effect on our business. We are subject to the Foreign 
Corrupt Practices Act (“FCPA”), and other laws that prohibit improper payments or offers of payments to 
foreign governments and their officials and political parties by U.S. persons and issuers as defined by the 
statute,  for  the  purpose  of  obtaining  or  retaining  business.  It  is  our  policy  to  implement  safeguards  to 
discourage  these  practices  by  our  employees.  However,  our  existing  safeguards  and  any  future 
improvements  may  prove  to  be  less  than  effective,  and  our  employees,  consultants,  sales  agents  or 
distributors may engage in conduct for which we might be held responsible. Violations of the FCPA may 
result in severe criminal or civil sanctions and we may be subject to other liabilities, which could negatively 
affect our business, operating results and financial condition.  

Adverse results of legal proceedings could have a material adverse effect on us. We are subject to, and may 
in the future be subject to, a variety of legal proceedings and claims that arise out of the ordinary conduct 
of our business. Results of legal proceedings cannot be predicted with certainty. Irrespective of their merits, 
legal  proceedings  may  be  both  lengthy  and  disruptive  to  our  operations  and  may  cause  significant 
expenditure and diversion of management attention. We may be faced with significant monetary damages 
or  injunctive  relief  against  us  that  could  have  a  material  adverse  effect  on  a  portion  of  our  business 
operations or a material adverse effect on our financial condition and results of operations. 

Risks Related to Our Operations 
We do not have commercial-scale manufacturing capability and have minimal commercial manufacturing 
experience.  We  operate  GMP  manufacturing  facilities  for  device  production;  however,  they  are  not  of 
sufficient size for large commercial production. We do not have experience in large scale manufacturing, 
and currently rely on third-party contract manufacturers for a significant portion of our device production. 
We expect to depend on these contract manufacturers for the foreseeable future. Any performance failure 
on the part of our contract manufacturers could delay production of our current or future products, depriving 
us of potential product revenues and resulting in additional losses. 

We have limited sales, marketing and distribution capabilities which may limit our ability to significantly 
increase sales quickly. We have limited internal capabilities in the sales, marketing, and distribution areas. 
There can be no assurance that we will be able to establish sales, marketing, and distribution capabilities 
internally or make arrangements with current collaborators or others to perform such activities or that such 
effort will be successful. If we decide to market any of our new products directly, we must either partner, 
acquire  or  internally  develop  a  marketing  and  sales  force  with  technical  expertise  and  with  supporting 
distribution  capabilities.  The  acquisition  or  development  of  a  sales,  marketing  and  distribution 
infrastructure would require substantial resources, which may not be available to us or, even if available, 
divert the attention of our management and key personnel, and have a negative impact on further product 
development efforts. 

Our inability to protect our patents, trademarks, trade secrets and other proprietary rights could adversely 
impact our competitive position. We believe that our patents, trademarks, trade secrets and other proprietary 
rights  are  important  to  our  success  and  our  competitive  position.  Accordingly,  we  commit  substantial 

14 

 
 
 
 
 
 
 
resources to the establishment and protection of our patents, trademarks, trade secrets and proprietary rights. 
We use various methods, including confidentiality agreements with employees, vendors, and customers, to 
protect our trade secrets and proprietary know-how for our products. We currently hold patents for products, 
and have patents pending in certain countries for additional products that we market or intend to market. 
However, our actions to establish and protect our patents, trademarks, and other proprietary rights may be 
inadequate to prevent imitation of our products by others or to prevent others from claiming violations of 
their trademarks and proprietary rights by us. If our products are challenged as infringing upon patents of 
other parties, we may be required to modify the design of the product, obtain a license, or litigate the issues, 
all of which may have an adverse business effect on us. 

We  may  be  subject  to claims  that our  products  or processes infringe  the  intellectual  property  rights  of 
others, which may cause us to pay unexpected litigation costs or damages, modify our products or processes 
or  prevent  us  from  selling  our  products.  Although  it  is  our  intention  to  avoid  infringing  or  otherwise 
violating the intellectual property rights of others, third parties may nevertheless claim that our processes 
and products infringe their intellectual property and other rights. Our strategies of capitalizing on growing 
international demand as well as developing new innovative products across multiple business lines present 
similar infringement claim risks both internationally and in the U.S. as we expand the scope of our product 
offerings  and  markets.  We  compete  with  other  companies  for  contracts  in  some  small  or  specialized 
industries, which increase the risk that the other companies will develop overlapping technologies leading 
to an increased possibility that infringement claims will arise. Whether or not these claims have merit, we 
may  be  subject  to  costly  and  time-consuming  legal  proceedings,  and  this  could  divert  management’s 
attention from operating our business. In order to resolve such proceedings, we may need to obtain licenses 
from these third parties or substantially re-engineer or rename our products in order to avoid infringement. 
In addition, we might not be able to obtain the necessary licenses on acceptable terms, or at all, or be able 
to re-engineer or rename our products successfully. 

We commercially, in co-branding with Fortis Healthcare, bank and store private cord blood stem cells in 
our TotipotentRX GMP facility. We could be subject to unexpected litigation costs or damages for loss of 
one or more family owned units of cord blood or if one of the cord blood units we store causes bodily injury. 
We  face  an  inherent  business  risk  of  exposure  to  product  liability  claims  if  our  products  or  product 
candidates are alleged or found to have caused injury or cannot be used for some reason within our control 
and are found to result in injury or death. While we believe that our current liability insurance coverage is 
adequate for our present clinical and commercial activities, we may not be able to maintain insurance on 
acceptable terms or at all. If we are unable to obtain insurance or any claims against us substantially exceed 
our coverage, then our business could be adversely impacted. 

We may not be able to protect our intellectual property in countries outside the United States. Intellectual 
property law outside the United States is uncertain and in many countries is currently undergoing review 
and revisions. The laws of some countries do not protect our patent and other intellectual property rights to 
the same extent as United States laws. This is particularly relevant to us as a significant amount of our 
current and projected future sales are outside of the United States. Third parties may attempt to oppose the 
issuance of patents to us in foreign countries by initiating opposition proceedings. Opposition proceedings 
against any of our patent filings in a foreign country could have an adverse effect on our corresponding 
patents that are issued or pending in the United States. It may be necessary or useful for us to participate in 
proceedings to determine the validity of our patents or our competitors’ patents that have been issued in 
countries other than the U.S. This could result in substantial costs, divert our efforts and attention from 
other aspects of our business, and could have a material adverse effect on our results of operations and 
financial condition. 

Any failure to achieve and maintain the high design and manufacturing standards that our products require 
may  seriously  harm  our  business.  Our  products  require  precise,  high-quality  manufacturing.  Achieving 
precision  and  quality  control  requires  skill  and  diligence  by  our  personnel  as  well  as  our  vendors.  Our 

15 

 
 
 
 
 
failure  to  achieve  and  maintain  these  high  manufacturing  standards,  including  the  incidence  of 
manufacturing errors, design defects or component failures could result in patient injury or death, product 
recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that 
could  seriously  hurt  our  business.  Additionally,  the  large  amount  of  AXP  disposable  inventory  certain 
distributors and end-users maintain may delay the identification of a manufacturing error and expand the 
financial impact. A manufacturing error or defect, or previously undetected design defect, or uncorrected 
impurity or variation in a raw material component, either unknown or undetected, could affect the product. 
Despite our very high manufacturing standards, we cannot completely eliminate the risk of errors, defects 
or  failures.  If  we  or  our  vendors  are  unable  to  manufacture  our  products  in  accordance  with  necessary 
quality standards, our business and results of operations may be negatively affected.  

Our revenues and operating results may be adversely affected as a result of our required compliance with 
the adopted EU directive on the restriction of the use of hazardous substances in electrical and electronic 
equipment, as well as other standards around the world. A number of domestic and foreign jurisdictions 
seek to restrict the use of various substances, a number of which have been or are currently used in our 
products  or  processes.  For  example,  the  EU  Restriction  of  Hazardous  Substances  in  Electrical  and 
Electronic Equipment (“RoHS”) Directive now requires that certain substances, which may be found in 
certain products we have manufactured in the past, be removed from all electronics  components. Other 
countries, such as China, have enacted or may enact laws or regulations similar to RoHS. Eliminating such 
substances  from  our  manufacturing  processes  requires  the  expenditure  of  additional  research  and 
development funds to seek alternative substances  for our products, as well as increased testing by third 
parties  to  ensure  the  quality  of  our  products  and  compliance  with  the  RoHS  Directive.  While  we  have 
implemented a compliance program to ensure our product offerings meet these regulations, there may be 
instances  where  alternative  substances  will  not  be  available  or  commercially  feasible,  or  may  only  be 
available from a single source, or may be significantly more expensive than their restricted counterparts. 
Therefore, we have focused our compliance efforts on those products and geographical areas in which we 
have the highest revenue potential. Our failure to comply with past, present and future similar laws could 
result  in  reduced  sales  of  our  products,  substantial  product  inventory  write-offs,  reputation  damage, 
penalties and other sanctions, any of which could harm our business and operating results.  

Our products may be subject to product recalls which may harm our reputation and divert our managerial 
and financial resources. The FDA and similar governmental authorities in other countries have the authority 
to order the mandatory recall of our products or order their removal from the market if the governmental 
entity  finds  our  products  might  cause  adverse  health  consequences  or  death.  The  FDA  may  also  seize 
product or prevent further distribution. A government-mandated or voluntary recall by us could occur as a 
result of component failures, manufacturing errors or design defects (including labeling defects). In the 
past, we have initiated voluntary recalls of some of our products and we could do so in the future. Any 
recall of our products may harm our reputation with customers, divert managerial and financial resources 
and negatively impact our profitability.  

We are dependent on our suppliers and manufacturers to meet existing regulations. Certain of our suppliers 
and manufacturers are subject to heavy government regulations, including FDA QSR compliance, in the 
operation of their facilities, products and manufacturing processes. Any adverse action by the FDA against 
our suppliers or manufacturers could delay supply or manufacture of component products required to be 
integrated  or  sold  with  our  products.  Although  we  attempt  to  mitigate  this  risk  through  inventory  held 
directly or through distributors, and audit our suppliers, there are no assurances we will be successful in 
identifying issues early enough to allow for corrective action or transition to an alternative supplier, or in 
locating an alternative supplier or manufacturer to meet product shipment or launch deadlines. As a result, 
our sales, contractual commitments and financial forecasts may be significantly affected by any such delays. 

Dependence on suppliers for custom components may impact the production schedule. We obtain products 
and custom components from a limited number of suppliers. If the supplier raises the price or discontinues 

16 

 
 
 
 
 
production, we may have to find another qualified supplier to provide the item or re-engineer the item. In 
the event that it becomes necessary for us to find another supplier, we would first be required to qualify the 
quality assurance systems and product quality of that alternative supplier. Any operational issues with re-
engineering or the alternative qualified supplier may impact the production schedule, therefore delaying 
revenues, and this may cause the cost of disposables or key components to increase. 

Dependence on contract manufacturers for disposable products.  We obtain the majority of our disposable 
products  from  contract manufacturers.   Production  halts  or  delays  by  these manufacturers  could  have a 
significant  impact  on  our  business.    Our  safety  stock  levels  are  generally  not  sufficient  to  handle  an 
unexpected shut-down or delay in production by these contract manufacturers.  In the event of a significant 
unplanned delay in production, we may need to find a new contract manufacturer, which could be a lengthy 
process and require a significant financial commitment, impacting our ability to fulfill customer orders and 
maintain current sales levels for a period of time until the new contract manufacturer can start production 
of our disposable products. 

Failure to meet the financial covenant in our Technology License and Escrow Agreement could decrease 
our AXP revenues. Under our License and Escrow Agreement with CBR. if we fail to meet the financial 
covenant of cash balance and short-term investments net of debt or borrowed funds that are payable within 
one year of not less than $2,000,000, they may take possession of the escrowed intellectual property and 
initiate manufacturing of the applicable device and disposables. If this were to occur, our revenues would 
be negatively impacted. In order to remain compliant, we may have to complete additional financings or 
provide consideration to the counter party to modify the obligations. 

Failure to retain or hire key personnel may adversely affect our ability to sustain or grow our business. 
Our  ability  to  operate  successfully  and  manage  our  potential  future  growth  depends  significantly  upon 
retaining key research, technical, clinical, regulatory, sales, marketing and managerial personnel. Our future 
success partially depends upon the continued services of key technical and senior management personnel. 
Our future success also depends on our continuing ability to attract, retain and motivate highly qualified 
managerial  and  technical  personnel.  The  inability  to  retain  or  attract  qualified  personnel  could  have  a 
significant negative effect upon our efforts and thereby materially harm our business and future financial 
condition.  

Most of our operations are conducted at a single location.   Any disruption at our facilities could delay 
revenues or increase our expenses. Our U.S. device operations are conducted at a single location although 
we  contract  the manufacturing  of  certain  devices,  disposables  and  components. We  take  precautions  to 
safeguard our facilities, through insurance, health and safety protocols, and off-site storage of computer 
data. However, a natural disaster, such as a fire, flood or earthquake, could cause substantial delays in our 
operations, damage or destroy our manufacturing equipment or inventory, and cause us to incur additional 
expenses. The insurance we maintain against fires, floods, and other natural disasters may not be adequate 
to cover our losses in any particular case. 

Failure to maintain and/or upgrade our information technology systems may have an adverse effect on our 
operations.  We rely on various information technology systems to manage our operations, and we evaluate 
these  systems  against  our  current  and  expected  requirements.    Although  we  have  no  current  plans  to 
implement modifications or upgrades to our systems, we will eventually be required to make changes to 
legacy  systems  and  acquire  new  systems  with  new  functionality.    Any  information  technology  system 
disruptions, if not anticipated and appropriately mitigated, could have an adverse effect on our business and 
operations. 

If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely 
financial statements could be impaired, which could harm our operating results, our ability to operate our 
business and investors’ views of us. We are required to establish and maintain adequate internal control 

17 

 
 
 
 
 
 
 
over  financial  reporting,  which  are  processes  designed  to  provide  reasonable  assurance  regarding  the 
reliability  of  financial  reporting  and  the  preparation  of  financial  statements  for  external  purposes  in 
accordance with generally accepted accounting principles. We are also required to comply with Section 
404 of the Sarbanes-Oxley Act of 2002, which (among other things) requires public companies to conduct 
an annual review and evaluation of their internal control over financial reporting. However, as a “smaller 
reporting company,” we are not required to obtain an auditor attestation regarding our internal control over 
financial reporting. If, in the future, we require an attestation report from our independent registered public 
accounting firm and that firm is unable to provide an unqualified attestation report on the effectiveness of 
our internal controls over financial reporting, investor confidence and, in turn, our stock price could be 
materially adversely affected. 

Security breaches and other disruptions could compromise our information and expose us to liability, which 
would cause our business and reputation to suffer. In the ordinary course of the Company’s business, the 
Company  collects  and  stores  sensitive  data,  including  intellectual  property,  our  proprietary  business 
information  and  that  of  our  customers,  suppliers  and  business  partners  and  personally  identifiable 
information  of  the  Company’s  employees  on  its  networks.  The  secure  processing,  maintenance  and 
transmission of this information is critical to the Company’s operations and business strategy. Despite the 
Company’s security measures, its information, technology and infrastructure may be vulnerable to attacks 
by hackers or breached due to employee error, malfeasance or other disruptions. Any such breach could 
compromise  the  Company’s  networks  and  the  information  stored  there  could  be  accessed,  publicly 
disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims 
or  proceedings  or  regulatory  penalties  and  could  disrupt  the  Company’s  operations  and  the  services  it 
provides to customers, damage the Company’s reputation, and cause a loss of confidence in the Company’s 
products and services, which could adversely affect the Company’s business. 

Our business and operations may be adversely affected by the recent 2019 Novel Coronavirus (COVID-
19)  outbreak  or  other  similar  outbreaks.    Any  outbreaks  of  contagious  diseases,  including  the  recent 
outbreak of the coronavirus and other adverse public health developments in countries where we operate 
could have a  material and adverse  effect  on  our  business, financial  condition and  results  of  operations. 
These  effects  could  include  disruptions  or  restrictions  on  our  employees’  ability  to  travel,  as  well  as 
temporary closures of our facilities or the facilities of our customers, suppliers, or other vendors in our 
supply  chain.  In  addition,  the  coronavirus  may result in  a  widespread  health  crisis that  could  adversely 
affect the economies and financial markets of many countries, resulting in an economic downturn that could 
affect demand for our products or our ability to obtain financing. Any of these events, which may result in 
disruptions to our supply chain or customer demand, could materially and adversely affect our business and 
our financial results. The extent to which the coronavirus will impact our business and our financial results 
will  depend  on  future  developments,  which  are  highly  uncertain  and  cannot  be  predicted.  Such 
developments may include the geographic spread of the virus, the severity of the disease, the duration of 
the outbreak, the actions that may be taken by various governmental authorities in response to the outbreak 
and the possible impact on the U.S. or global economy. As a result, at the time of this filing, it is impossible 
to predict the overall impact of the coronavirus on our business, liquidity, capital resources and financial 
results. 

Risks Related to Our Industry 
Our business is heavily regulated, resulting in increased costs of operations and delays in product sales. 
Many of our products require FDA approval or clearance to sell in the U.S. and will require approvals from 
comparable agencies to sell in foreign countries. These authorizations may limit the U.S. or foreign markets 
in which our products may be sold. Further, our products must be manufactured under requirements of our 
quality system for continued CE-Marking so they can continue to be marketed and sold in Europe. These 
requirements are similar to the QSR of both the FDA and California Department of Public Health. Failure 
to comply with or incorrectly interpret these quality system requirements and regulations may subject us to 
delays  in  production  while  we  correct  deficiencies  found  by  the  FDA,  the  State  of  California,  or  our 

18 

 
 
 
 
notifying body as a result of any audit of our quality system. If we are found to be out of compliance, we 
could receive a Warning Letter or an untitled letter from the FDA or even be temporarily shut down in 
manufacturing and product sales while the non-conformances are rectified. Also, we may have to recall 
products  and  temporarily  cease their manufacture  and  distribution,  which  would  increase  our  costs  and 
reduce our revenues. The FDA may also invalidate our PMA or 510(k) if appropriate regulations relative 
to  the  PMA  or  510(k)  products  are  not  met.  The  notified  bodies  may  elect  to  not  renew  CE-Mark 
certification. Any of these events would negatively impact our revenues and costs of operations.  

Changes in governmental regulations may reduce demand for our products or increase our expenses. We 
compete  in  many  markets  in  which  we  and  our  customers  must  comply  with  federal,  state,  local  and 
international  regulations,  such  as  environmental,  health  and  safety  and  food  and  drug  regulations.  We 
develop,  configure  and  market  our  products  to  meet  customer  needs  created  by  those  regulations.  Any 
significant  change  in  regulations  could  reduce  demand  for  our  products  or  increase  our  expenses.  For 
example, many of our instruments are marketed to the industry for enabling new regenerative therapies. 
Changes  in  the  FDA’s  regulation  of  the  devices  and  products  directed  at  regenerative  medicine,  and 
development process for new therapeutic applications could have an adverse effect on the demand for these 
products. 

To  sell  in  international  markets  are  subject  to  regulation  in  foreign  countries.  In  cooperation  with  our 
distribution partners, we market our current and future products both domestically and in many  foreign 
markets. A number of risks are inherent in international transactions. In order for us to market our products 
in certain non-U.S. jurisdictions, we need to obtain and maintain required regulatory approvals or clearances 
and must comply with extensive regulations regarding safety, manufacturing processes and quality. These 
regulations, including the requirements for approvals or clearances to market, may differ from the FDA 
regulatory  scheme.  International  sales  also  may  be  limited  or  disrupted  by  political  instability,  price 
controls, trade restrictions and changes in tariffs. Additionally, fluctuations in currency exchange rates may 
adversely affect demand for our products by increasing the price of our products in the currency of the 
countries in which the products are sold. 

There can be no assurance that we will obtain regulatory approvals or clearances in all of the countries 
where  we  intend  to  market  our  products,  or  that  we  will  not  incur  significant  costs  in  obtaining  or 
maintaining  foreign  regulatory  approvals  or  clearances,  or  that  we  will  be  able  to  successfully 
commercialize  current  or  future  products  in  various  foreign  markets.  Delays  in  receipt  of  approvals  or 
clearances to market our products in foreign countries, failure to receive such approvals or clearances or 
the future loss of previously received approvals or clearances could have a substantial negative effect on 
our results of operations and financial condition. 

Operating in foreign jurisdictions subjects us to regulation by non-U.S. authorities. We have operations in 
India, and as such are subject to Indian regulatory agencies. A number of risks are inherent in conducting 
business and clinical operations overseas. In order for us to operate as a majority owned foreign corporation 
in India, we are subject to financial regulations imposed by the Reserve Bank of India. This includes the 
rules specific to the capital funding, pledging of assets, repatriation of funds and payment of dividends from 
and to the foreign subsidiaries and from and to us in the U.S. 

In order for us to manufacture and/or market our services and products in India, we need to obtain and 
maintain required regulatory approvals or clearances and must comply with extensive regulations regarding 
safety, manufacturing processes and quality. These regulations, including the requirements for approvals 
or clearances to market, and/or export may differ from the FDA regulatory scheme. Additionally, in order 
for  us  to  complete  clinical  trials,  clinical  trial  services  and  cell  banking  in  India,  and  other  foreign 
jurisdictions,  we  need  to  obtain  and  maintain  approvals  and  licenses  which  comply  with  extensive 
regulations of the appropriate regulatory body. 

19 

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

If our competitors develop and market products that are more effective than our product candidates or 
obtain regulatory and market approval for similar products before we do, our commercial opportunity may 
be reduced or eliminated. The development and commercialization of new pharmaceutical products which 
target cardiovascular, orthopedic, chronic dermal wounds and other conditions addressed by our current 
and future products is competitive, and we will face competition from numerous sources, including major 
biotechnology  and  pharmaceutical  companies  worldwide.  Many  of  our  competitors  have  substantially 
greater financial and technical resources and development, production and marketing capabilities than we 
do. In addition, many of these companies have more experience than we do in pre-clinical testing, clinical 
trials and manufacturing of compounds, as well as in obtaining FDA and foreign regulatory approvals. As 
a  result,  there  is  a  risk  that  one  of  the  competitors  will  develop  a  more  effective  product  for  the  same 
indications for which we are developing a product or, alternatively, bring a similar product to market before 
we can. With regards to the BioArchive and AXP Systems, numerous larger and better-financed medical 
device manufacturers may choose to enter this market. 

Changes in healthcare policy could subject us to additional regulatory requirements that may delay the 
commercialization of our products and increase our costs.  The U.S. government and other governments 
have shown significant interest in pursuing healthcare reform. Any government-adopted reform measures 
could adversely impact the pricing of our diagnostic products and tests in the U.S. or internationally and 
the  amount  of  reimbursement  available  from  governmental  agencies  or  other  third-party  payors.  The 
continuing efforts of the U.S. and foreign governments, insurance companies, managed care organizations 
and other payors of healthcare services to contain or reduce healthcare costs may adversely affect our ability 
to set prices for our products and services that we believe are fair, which may impact our ability to generate 
revenues and achieve and maintain profitability.   

New  laws,  regulations  and  judicial  decisions,  or  new  interpretations  of  existing  laws,  regulations  and 
judicial decisions, that relate to healthcare availability, methods of delivery or payment for products and 
services, or sales, marketing or pricing, may limit our potential revenue or force us to revise our research 
and  development  programs.  The  pricing  and  reimbursement environment may  change in the  future  and 
become  more  challenging  for  several  reasons,  including  policies  advanced  by  the  current  executive 
administration  in  the  U.S.,  new  healthcare  legislation  or  fiscal  challenges  faced  by  government  health 
administration authorities. Specifically, in both the U.S. and certain foreign jurisdictions, there have been 
a number of legislative and regulatory proposals to change the healthcare system in ways that could affect 
our ability to sell our products profitably.   

For example, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education 
Reconciliation  Act  (“PPACA”),  have  substantially  changed  the  way  healthcare  is  financed  by  both 
government  health  plans  and  private  insurers.  The  PPACA  contains  a  number  of  provisions  that  are 
expected to  impact  our  business  and operations  in  ways  that may  negatively  affect  our revenues in  the 
future. While it is too early to predict all the specific effects the PPACA or any future healthcare reform 
legislation  will  have  on  our  business,  such  provisions  could  materially  adversely  affect  our  business, 
prospects and financial condition.   

The  Food  and  Drug  Administration  Amendments  Act  of  2007  gives the  FDA  enhanced  post-marketing 
authority, including the authority to require post-marketing studies and clinical studies of products, labeling 
changes based on new safety information, and compliance with risk evaluations and mitigation strategies 
approved by the FDA. The FDA’s exercise of this authority could result in delays or increased costs during 

20 

 
 
 
 
 
 
product  development,  clinical  studies  and  regulatory  review,  increased  costs  to  assure  compliance  with 
post-approval regulatory requirements, and potential restrictions on the sale and/or distribution of approved 
products, all of which could materially adversely affect our business, prospects and financial condition. 

Product  liability  and  uninsured  risks  may  adversely  affect the continuing operations. We  operate  in an 
industry  susceptible  to  significant  product  liability  claims.  We  may  be  liable  if  any  of  our  products  or 
services cause injury, illness, or death. These claims may be brought by individuals seeking relief or by 
groups seeking to represent a class. We also may be required to recall certain of our products should they 
become damaged or if they are defective. We are not aware of any material product liability claims against 
us. However, product liability claims may be asserted against us in the future based on events we are not 
aware  of  at  the  present  time.  We  maintain  a  product  liability  policy  and  a  general  liability  policy  that 
includes product liability coverage. However, a product liability claim against us could have a material 
adverse effect on our business or future financial condition. 

Risks Related to Operating Results and Financial Markets 
We have incurred net losses and we anticipate that our losses will continue. We have not been profitable 
for a significant period. For the years ended December 31, 2019 and 2018, we had a net loss of $10,099,000 
and $40,940,000 respectively and an accumulated deficit at December 31, 2019, of 236,932,000.  The report 
of  our  independent  auditors  on  our  December  31,  2019  financial  statements  includes  an  explanatory 
paragraph indicating there is substantial doubt about our ability to continue as a going concern.  We will 
continue to incur significant costs as we develop and market our current products and related applications. 
Although we are executing our business plan to develop, market and launch new products, continuing losses 
may impair our ability to fully meet our objectives for new product sales or threaten our ability to continue 
as a going concern in future years.  

We will likely need to raise additional capital to fund our operations and in furtherance of our business 
plan. Due to our recurring losses from operations and the expectation that we will continue to incur losses 
in the future, we may need to raise additional capital. We have historically relied upon private and public 
sales of our equity, as well as debt financings to fund our operations. In order to raise additional capital, we 
may seek to sell additional equity and/or debt securities or obtain a credit facility or other loan, which we 
may not be able to do on favorable terms, or at all. Our ability to obtain additional financing will be subject 
to a number of factors, including market conditions, our operating performance and investor sentiment. If 
we are unable to raise additional capital when required or on acceptable terms, we may have to significantly 
delay, scale back or discontinue the development and/or commercialization of one or more of our product 
candidates, restrict our operations or obtain funds by entering into agreements on unfavorable terms. 

We  may  incur  significant  non-operating,  non-cash  charges  resulting  from  changes  in  the  fair  value  of 
warrants.  Our warrants are a derivative  instrument; as such they have been recorded at their respective 
relative fair values at the issuance date and will be recorded at their respective fair values at each subsequent 
balance sheet date. Any change in value between reporting periods will be recorded as a non-operating, 
non-cash charge at each reporting date. The impact of these non-operating, non-cash charges could have an 
adverse effect on the Company’s financial results. The fair value of the warrants is tied in large part to our 
stock price. If the stock price increases between reporting periods, the warrants become more valuable. As 
such, there is no way to forecast what the non-operating, non-cash charges will be in the future or what the 
future impact will be on our financial statements. 

Risks Related to Our Common Stock 
If the  price  of  our common  stock  does  not  meet  the requirements  of the  NASDAQ  capital  market  stock 
Exchange  (“NASDAQ”),  our  shares  may  be  delisted.    Our  ability  to  publicly  or  privately  sell  equity 
securities and the liquidity of our common stock could be adversely affected if we are delisted.  The listing 
standards of NASDAQ provide, among other things, that a company may be delisted if the bid price of its 
stock drops below $1.00 for a period of 30 consecutive business days.  Delisting from NASDAQ could 

21 

 
 
 
 
 
 
adversely  affect  our  ability  to  raise  additional  financing  through  the  public  or  private  sale  of  equity 
securities, would significantly affect the ability of investors to trade our securities and would negatively 
affect  the  value  and  liquidity  of  our  common  stock.    Delisting  could  also  have  other  negative  results, 
including the potential loss of confidence by employees, the loss of institutional investor interest and fewer 
business development opportunities. 

Liquidity of our common stock. Although there is a public market for our common stock, trading volume 
has been historically low, which could impact the stock price and the ability to sell shares of our common 
stock. We can give no assurance that an active and liquid public market for the shares of the common stock 
will continue in the future. In addition, future sales of large amounts of common stock could adversely 
affect the market price of our common stock and our ability to raise capital. The price of our common stock 
could also drop as a result of the exercise of options for common stock or the perception that such sales or 
exercise of options could occur. These factors could also have a negative impact on the liquidity of our 
common stock and our ability to raise funds through future stock offerings.  

We do not pay cash dividends. We have never paid any cash dividends on our common stock and do not 
intend to pay cash dividends in the foreseeable future. Instead, we intend to apply earnings, if any, to the 
expansion and development of our business. Thus, the liquidity of your investment is dependent upon your 
ability to sell stock at an acceptable price. The price can go down as well as up and may limit your ability 
to realize any value from your investment, including the initial purchase price. 

Our Amended and Restated Bylaws provide that the Court of Chancery of the State of Delaware will be the 
sole and exclusive venue for certain litigation that may be initiated by our stockholders, which may limit a 
stockholder’s ability to obtain a favorable judicial forum for such disputes with us or our directors, officers 
or employees.   

Our  Amended  and  Restated  Bylaws  provide  that,  unless  we  consent  in  writing  to  the  selection  of  an 
alternative venue, the Court of Chancery of the State of Delaware will be the sole and exclusive venue for 
(i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim for breach of 
a fiduciary duty owed by any of our directors, officers, employees or agents to us or our stockholders, (iii) 
any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law, 
our certificate of incorporation or bylaws or (iv) any action asserting a claim governed by the internal affairs 
doctrine, in each case subject to the Court of Chancery of the State of Delaware having personal jurisdiction 
over the indispensable parties named as defendants therein. This choice of venue provision will not apply 
to actions or proceedings brought to enforce a duty or liability created by the Securities Act or the Exchange 
Act.  

This choice of venue provision may limit a stockholder’s ability to bring certain claims in a judicial forum 
that  it  finds  favorable  for  disputes  with  us  or  our  directors,  officers,  employees  or  agents,  which  may 
discourage the filing of lawsuits with respect to such claims.  If a court were to find this choice of venue 
provision to be inapplicable or unenforceable in an action, we may incur additional costs associated with 
resolving  such  action  in  another  jurisdiction,  which  could  adversely  affect  our  business  and  financial 
condition.  

ITEM 1B. 

UNRESOLVED STAFF COMMENTS 

None. 

ITEM 2.  PROPERTIES 

22 

 
 
     
 
 
 
 
We lease a facility with approximately 28,000 square feet of space located in Rancho Cordova, California. 
The facility is used by both our Clinical Development and Device Segments and is devoted to warehouse 
space,  manufacturing  of  products,  office  space,  a  biologics  lab,  a  clean  room,  and  a  research  and 
development lab. The lease expires May 31, 2024. 

In  Gurgaon  India  we  lease  approximately  1,500  square  feet  for  an  office  facility  for  our  Clinical 
Development Segment. The lease expires September 14, 2023 however; either party can terminate the lease 
with three months’ notice.  

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

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

ITEM 3.  LEGAL PROCEEDINGS 

In the normal course of operations, we may have disagreements or disputes with distributors, vendors or 
employees. Such potential disputes are seen by management as a normal part of business and while the 
outcome of such disagreements and disputes cannot be predicted with certainty, except as described below, 
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. 

In  fiscal  2016,  the  Company  signed  an  engagement  letter  with  a  strategic  consulting  firm,  Mavericks.  
Included  in  the  engagement  letter  was  a  success  fee  due  upon  the  successful  conclusion  of  certain 
transactions.  On May 4, 2017, a lawsuit was filed in California Superior Court against the Company and 
its CEO by the consulting firm as the consulting firm argues that it is owed a transaction fee of $1,000,000 
under the terms of the engagement letter due to the conversion of the Boyalife debentures in August 2016.  
In October 2017, to streamline the case by providing for the dismissal of claims against the Company’s 
CEO  based  on  alter  ego  theories  and  without  acknowledging  any  liability,  the  Company  deposited 
$1,000,000 with the Court.  The trial completed in February 2020 with an adverse jury verdict in favor of 
Mavericks in the total amount of $1,000,000.  The Action is now in the post-trial phase and no judgment 
has been entered as the parties are disputing whether the defense of equitable estoppel should bar entry of 
judgment at all and the proper per-judgment interest start date.  At present, the Court is already holding a 
$1,000,000 cash bond deposited by the Company early in the litigation.  After entry of judgment, the Court 
will permit release of those funds to the Mavericks.  As a result, the Company recorded a $1,400,000 loss 
in the quarter ended December 31, 2019.  The loss includes the $1,000,000 transaction fee and an estimated 
$400,000 in interest due. The final amount of interest due will be determined by the Court.  The $1,000,000 
deposited with the court will be used to settle the transaction fee.   

ITEM 4.  MINE SAFETY DISCLOSURES 

Not applicable. 

23 

 
 
 
 
 
 
 
 
 
PART II 

ITEM 5.  MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED 
STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY 
SECURITIES. 

Our common stock, $0.001 par value, is listed on the NASDAQ Capital Market under the symbol THMO.  

We have not paid cash dividends on our common stock and do not intend to pay a cash dividend in the 
foreseeable future. There were approximately 122 stockholders of record on January 31, 2020, not including 
beneficial owners who own their stock in street name through Cede & Co. and others. 

The Company did not repurchase any of its shares during the quarter ended December 31, 2019. 

ITEM 6.  SELECTED FINANCIAL DATA 

We are a “smaller reporting company” as defined by Rule 12b-2 of the Securities Exchange Act of 1934, 
as amended (the “Exchange Act”), and as such, we are not required to provide the disclosure required under 
this item. 

ITEM 7.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION 

AND RESULTS OF OPERATIONS 

Certain statements contained in this section and other parts of this Annual Report on Form 10-K which are 
not historical facts are forward looking statements and are subject to certain risks and uncertainties. Our 
actual  results  may  differ  significantly  from  the  projected  results  discussed  in  the  forward-looking 
statements. Factors that might affect actual results include, but are not limited to, those discussed in ITEM 
1A “RISK FACTORS” and other factors identified from time to time in our reports filed with the SEC. The 
following discussion should be read in conjunction with our consolidated financial statements contained in 
this Annual Report. 

24 

 
 
 
 
 
 
 
 
 
 
 
Overview  

ThermoGenesis Holdings, Inc. (“ThermoGenesis Holdings”, the “Company”, “our”, or “we”) 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 incorporated in 1986 and is registered in the 
State of Delaware and headquartered in Rancho Cordova, CA.  In July 2017, ThermoGenesis Holdings’ 
subsidiary, ThermoGenesis Corp., completed a strategic acquisition of the business and substantially all of 
the  assets  of  SynGen  Inc.  (“SynGen”),  a  research  and  development  company  for  automated  cellular 
processing.   

Following the acquisition of SynGen, we utilized the SynGen assets, together with our own proprietary 
technology, to develop a novel proprietary CAR-TXpress™ platform that addresses the critical unmet need 
for  better  efficiency  and  cost-effectiveness  for  the  emerging  immune-oncology  field,  in  particular,  the 
chimeric antigen receptor (“CAR”) T cell market. Since the first quarter of 2018, the Company developed 
and launched various X-Series® products, including: X-Lab®, X-Wash®, X-Mini® and X-BACS™. 

Recent Corporate Name Change 
On November 1, 2019, Cesca Therapeutics Inc. changed its corporate name to ThermoGenesis Holdings, 
Inc.  in  order  to  better  reflect  its  new  strategic  focus  on  becoming  a  key  solution  provider  for  cell 
manufacturing  tools  and  services  in  the  cell  and  gene  therapy  markets.    In  conjunction  with  the  name 
change, the Company began trading under the new Nasdaq ticker symbol, THMO. In addition, the Company 
changed its CUSIP number to 88362L100. 

Reverse Stock Split   
On June 4, 2019, the Company effected a one (1) for ten (10) reverse stock 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.    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. 

ThermoGenesis Holdings now has two separately reported business segments: A “Device Segment” and a 
“Clinical Development Segment.”  The Device Segment develops and commercializes automated systems 
that used for, clinical grade cell-banking, point-of-care applications, and large scale cell processing.  The 
Clinical  Development  Segment  is  developing  autologous  (utilizing  the  patient’s  own  cells)  cell-based 
therapeutics  that  address  significant  unmet  medical  needs  for  the  vascular,  cardiology  and  orthopedic 
markets.   

25 

 
 
 
 
 
 
 
 
 
 
 
ThermoGenesis Holdings’ Device Segment  
ThermoGenesis Holdings’ Device Segment  offers automated devices and technologies for cell-banking, 
point-of-care applications, and large scale cell processing. The automated devices include: 

Clinical Bio-Banking Applications: 

•  AXP® System – The innovative AXP System defines a new processing standard for isolating and 
retrieving over 97% of the stem and progenitor cells from collections of umbilical cord blood in an 
automated,  fully  closed,  sterile  system  in  30  minutes.  AXP  is  self-powered,  microprocessor-
controlled, and contains flow control optical sensors to achieve precise separation. 

•  BioArchive®  Cryopreservation  System  –  The  BioArchive  Cryopreservation  System  is  the 
industry’s leading, fully automated, robotic, liquid nitrogen controlled-rate-freezing (“CRF”) and 
cryogenic  storage  system  for  stem cell  samples and  clinical  products.  Using  proven,  computer-
controlled technology, it provides the ultimate performance and protection for today’s invaluable 
cord blood samples and future cell therapeutic products. BioArchive is the preferred system for the 
highest quality cord blood banks worldwide. A complete technical Master-File has been provided 
to the FDA to support those highest quality cord blood banks which have been able to qualify for, 
and obtain, a Biological License from the FDA to allow their cord blood units to be used to treat 
patients with blood cancers.  

Point-of-Care Applications: 

•  PXP® System – The PXP System is our newly launched point-of-care device. PXP is an automated, 
closed system that harvests a precise volume of cell concentrate from bone marrow aspirates. PXP 
can generate a concentration of bone marrow in less than 20 minutes, with consistently high MNC 
and CD34+ stem cell progenitor recovery rates and greater than 98% depletion of contaminating 
red blood cells (RBCs). Processing data is captured using our proprietary DataTrak™ software to 
assist with Good Manufacturing Practice (“GMP”) process monitoring and reporting information. 

Large Scale Cell Processing Applications: 

•  X-Lab® System for Cell Isolation – a semi-automated, functionally-closed, ficoll-free, system for 
the rapid isolation of mononuclear cells (“MNCs”) from collected units of peripheral blood, cord 
blood,  bone  marrow  aspirate  or  leukapheresis.    The  Company  had  filed  a  Device  Master  File 
(“MAF”) with the FDA for the X-Lab.  The MAF contains all the relevant information that the 
FDA will need to allow principal investigators to include  ThermoGenesis Holdings’ systems in 
their investigational new drug applications.  

•  X-Wash®  System  for  Washing  and  Reformulation  –  a  semi-automated,  functionally-closed 
system that separates, washes, and volume-reduces units of fresh or thawed units of blood, bone 
marrow, leukapheresis or cell cultures and presents these washed cells in a predetermined small 
volume.  

•  X-BACS™ System for Cell Purification – a semi-automated, functionally-closed system employs 
a microbubble/antibody reagent to isolate target cells by buoyancy-activated cell sorting (“BACS”). 
These microbubble/antibody reagents bind to user-selected target cells to increase their buoyancy 
and  provide  a  complete  separation  from  non-target  cells  during  centrifugation  and  allowing the 
harvest  of  a  highly  purified  population  of  target  cells,  with  high  recovery  efficiency  and  cell 
viability.   

26 

 
 
 
 
 
 
 
 
 
 
 
 
 
ThermoGenesis Holdings’ Clinical Development Segment 
Using our proprietary automated point-of-care cellular processing technologies, ThermoGenesis Holdings 
utilizes  autologous  (utilizing  the  patient’s  own  cells)  stem  cell-based  therapeutics  for  the  vascular  and 
orthopedic markets that include: 

•  Cell  Manufacturing  Services –  Through  our  TotipotentRX  subsidiary  in  Gurgaon,  India,  we 
operate an advanced clinical cell manufacturing, processing, testing, and storage facility, compliant 
with current Good Manufacturing Practices (“GMP”), Good Tissue Practices (“GTP”), and Good 
Laboratory Practices (“GLP”). We can support the production of a small, personalized medicine 
cell prescription or a large scale batch process. Patient samples, batch samples, and therapeutic 
aliquots are all labeled in accordance with ISBT 128 and stored in our own cryogenics’ facility. In 
partnership with Fortis Healthcare we also operate commercial service programs supporting bone 
marrow  transplantation  (hematopoietic  stem  cell  transplantation)  for  hematological  and 
oncological disorders. 

•  Cell Banking Services – Our NovaCord Cord Blood Bank and Repository is a licensed umbilical 
cord  blood  and  tissue  bank.    It  is  a  collaborative  enterprise  between  TotipotentRX  and  Fortis 
Healthcare. The GMP facility of NovaCord is located inside multi-super specialty Fortis Memorial 
Research Institute, in Gurgaon, India where expertise is available for both stem cell banking and 
treating patients using advanced cellular therapies. 

27 

 
 
 
 
 
 
Results of Operations 

Year Ended December 31, 2019 Compared to the Year Ended December 31, 2018 (unaudited) 

Net Revenues 
Consolidated  net  revenues  for  the  year  ended  December  31,  2019  were  $13,047,000  compared  to 
$9,672,000 for the year ended December 31, 2018, an increase of $3,375,000 or 35%.  The increase was 
driven by AXP revenues which increased by $3,129,000 in 2019 with 688 more cases sold to a distributor 
in China, 435 more cases sold to domestic end users, 175 more cases sold to new customer in India and 83 
more  cases  sold  to  our  distributors  in  Europe  (resulting  in  approximately  $2,400,000  more  in  AXP 
disposables  revenue  in  the  current  year).    Additionally,  AXP  device  sales  increased  by  approximately 
$700,000 in 2019, driven by customers upgrading to AXP II devices in the current year.  CAR-TXpress 
sales increased by approximately $600,000 due to 2019 containing a full year of sales while 2018 only had 
a partial year due to relaunching the product line in the second half of 2018.  BioArchive sales decreased 
by approximately $200,000 due to one fewer device being sold in 2019.  Sales in the Clinical Development 
Segment were approximately $100,000 less than prior year due to reduced clinical services in India.   

Revenues were comprised of the following: 

Device Segment: 
  AXP 

BioArchive 

  Manual Disposables 
  CAR-TXpress 
  Other 

Clinical Development Segment: 
  Disposables 
  Other 

Year Ended December 31, 

2019 

2018 

$7,522,000 
2,910,000 
909,000 
1,565,000 
51,000 
12,957,000 

68,000 
22,000 
90,000 
$13,047,000 

$4,393,000 
3,098,000 
976,000 
907,000 
95,000 
9,469,000 

135,000 
68,000 
203,000 
$9,672,000 

Gross Profit 
The Company’s gross profit was $5,696,000 or 44% of net revenues for the year ended December 31, 2019 
compared to $2,193,000 or 23% for the year ended December 31, 2018, an increase of $3,503,000 or 156%. 
The increase was primarily due to AXP sales, generating approximately $1,925,000 more in gross profit 
from  disposables  and  approximately  $275,000  from  sales  of  AXP  II  devices.    The  increase  in  AXP 
disposable gross profit was due to approximately 1,375 more cases being sold in 2019 as compared to 2018 
and lower product costs through price efficiencies from contract manufacturers.  The other main driver of 
the increase is lower overhead costs of approximately $600,000 in 2019 as compared to 2018 as a result of 
the June 2018 reorganization.  The remainder of the increase is due to increased gross profit from service 
revenue of approximately $250,000 and additional sales of CAR-TXpress which resulted in approximately 
$300,000 more gross profit. 

Sales and Marketing Expenses 
Consolidated sales and marketing expenses were $1,656,000 for the  year ended  December 31, 2019, as 
compared to $1,359,000 for the  year ended December 31, 2018, an increase of $297,000 or 22%.  The 
increase was driven by stock compensation expense of approximately $125,000 for performance awards 
granted  and  achieved  by  employees  during  the  current  year  and  approximately  $200,000  in  increased 
salaries and benefits.   

28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Research and Development Expenses 
Consolidated research and development expenses were $2,396,000 for the year ended December 31, 2019, 
compared to $3,012,000 for the year ended December 31, 2018, a decrease of $616,000 or 20%.  Research 
and development in the Device Segment decreased by $406,000 and the Clinical Development Segment 
decreased by $210,000.  The decrease in both segments is primarily due to a decline in personnel costs 
related to corporate reorganization in June 2018. 

General and Administrative Expenses 
Consolidated general and administrative expenses for the year ended December 31, 2019 were $6,377,000, 
compared to $8,286,000 for the year ended December 31, 2018, a decrease of $1,909,000 or 23%.  The 
decrease was driven by a loss on the disposal of fixed assets in 2018 of approximately $1,300,000 related 
to medical devices purchased for clinical trials and implementation costs for a new ERP system as a result 
of  halting  the  clinical  programs  in  2018.    Additionally,  personnel  costs  decreased  by  approximately 
$630,000 due to the June 2018 reorganization and other headcount reductions in 2018, severance expenses 
of  approximately  $525,000  in  2018,  and a  one-time  legal settlement  of $150,000  in  2018.  In  2019, the 
Company  had  stock  compensation  expense,  patent  legal  expense  and  travel  expenses  of  approximately 
$300,000  less  combined  as  compared  to  2018.  India  general  and  administrative  expenses  were  also 
approximately $300,000 less in 2019 due to lower payroll expenses resulting from a reorganization in India 
in the first quarter of 2019  and a renegotiated settlement of an outstanding debt.  These decreases were 
offset by a $1,400,000 expense as the result of the verdict against the Company in the Mavericks lawsuit. 

Impairment Charges 
The Company incurred no impairment charges during the year ended December 31, 2019 as compared to 
impairment charges of $33,081,000 during the year ended December 31, 2018.  During the twelve months 
ended December 31, 2018, the Company experienced a significant and sustained decline in its stock price 
resulting in its market capitalization falling significantly below the recorded value of its consolidated assets.  
The  Company  performed  a  quantitative  assessment  which  determined  that  the  carrying  amount  for  the 
Company’s goodwill and indefinite lived intangible assets relating to the clinical protocols exceeded its 
estimated fair value.  As a result, impairment charges of $13,195,000 to goodwill and $19,886,000 to the 
Company’s intangible assets in the Clinical Development Segment were recorded during the twelve months 
ended December 31, 2018. 

Interest Expense 
Interest expense increased to $4,479,000 for the year ended December 31, 2019 as compared to $2,697,000 
for  the  year  ended  December  31,  2018,  a  difference  of  $1,782,000.    The  increase  is  driven  by  interest 
recorded and the amortization of the debt discount, interest expense and the loss on the extinguishment of 
debt  related  to  the  January  2019  Note  and  Amended  Note  of  approximately  $950,000,  as  well  as 
approximately $800,000 more in interest and amortization of the debt discount on the beneficial conversion 
feature related to the Revolving Credit Agreement with Boyalife, for which amortization started in May 
2018 and July 2019 Note interest of $105,000. 

Loss on Extinguishment of Debt 
The Company recorded a loss of extinguishment of debt of $840,000 for the year ended December 31, 2019 
as  compared  to  $0  for  the  year  ended  December  31,  2018.    The  increase  is  due  to  the  loss  on  the 
extinguishment of the January 2019 Note.   

Benefit for Income Taxes 
For the year ended December 31, 2019, the Company has no income tax benefit compared to $4,730,000 
for the year ended December 31, 2018.  The benefit for income tax for the year ended December 31, 2018 
was due to the impairment of the indefinite lived intangible assets for the clinical protocols and goodwill.  
The Company’s deferred tax liability is tied to the intangible assets and goodwill. 

29 

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

Year Ended December 31, 
2018 

2019 
$(10,099,000) 

Net Loss 

Deduct: 

Interest expense 

  Loss on extinguishment of debt 
  Fair value change of derivative instruments and other 
    Loss on equity method investments 
  Benefit for income taxes 
Loss from operations 

Add: 
  Depreciation and amortization 
  Stock-based compensation expense 
  Impairment of intangible asset 
Adjusted EBITDA 

(4,479,000) 
(840,000) 
(32,000) 
(15,000) 
-- 
$(4,733,000) 

805,000 
614,000 
-- 
$(3,314,000) 

$(40,940,000) 

(2,697,000) 
-- 
572,000 
-- 
4,730,000 
$(43,545,000) 

670,000 
652,000 
33,081,000 
$(9,142,000) 

The adjusted EBITDA loss was $3,314,000 for the year ended December 31, 2019 compared to a loss of 
$9,142,000 for the year ended December 31, 2018, an increase of $5,828,000 or 64%.  The increase was 
due to $3,441,000 in additional gross profit as the result of higher sales, decreasing overhead expenses and 
lowering  disposable  costs  through  price  efficiencies  from  contract  manufacturers.    Additionally,  the 
Company decreased salary related expenses in operating expenses by approximately $1,000,000 as a result 
of  the  June  2018  reorganization  and  the  elimination  of  other  positions  during  2018.    The  year  ended 
December 31, 2018 also included severance expenses of $525,000, a one-time legal settlement of $150,000 
and a loss on the disposal of fixed assets of approximately $1,300,000.  These decreases were offset by a 
$1,400,000 expense as the result of the verdict against the company in the Mavericks lawsuit. 

Liquidity and Capital Resources 

At December 31, 2019, we had cash and cash equivalents of $3,157,000 and working capital of $3,176,000.  
This compared to cash and cash equivalents of $2,400,000 and working capital of $2,261,000 at December 
31, 2018.  We have primarily financed operations through private and public placement of equity securities 
and our line of credit facility. 

For the year ended December 31, 2019, we used $3,260,000 of cash for operations primarily the result of 
the net loss $10,099,000 in 2019.  The loss was offset by approximately $4,800,000 of non-cash charges, 
related  to  the  amortization  of  debt  discount,  stock-based  compensation  expense,  depreciation  and 
amortization, reserves for slow-moving inventories and loss on the extinguishment of debt.  Other drivers 
of the cash from operations was an increase long term deferred revenue and other noncurrent liabilities of 
$1,492,000,  primarily  due  to  the  exclusivity  fee  received  from  Corning;  an  increase  in  other  current 

30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
liabilities of $1,143,000 primarily due to the short-term portion and an increase in interest payable and an 
increase  prepaid expenses and  other  assets  of  $540,000.    These increases  were offset by  a reduction in 
accounts payable and accrued payroll of $1,381,000 and a decrease in inventories of $610,000. 

Cash used in investing activities for the year ended December 31, 2019 was $182,000 as the result of capital 
purchases. 

Cash generated in financing activities for the year ended December 31, 2019 was $4,199,000, primarily due 
to $1,800,000 received from the issuance of long-term debt from convertible notes issued in January 2019 
and  July  2019,  $1,513,000  from  the  draw-down  of  funds  from  our  related  party  long-term  convertible 
promissory note, the issuance of 444,445 pre-funded warrants in April of 2019 for $756,000 and $154,000 
from the exercise of 18,764 warrants and 416,500 pre-funded warrants during the year. 

The Company has a Revolving Credit Agreement with Boyalife Asset Holding II, Inc.  As of December 31, 
2019, the Company had drawn down $8,713,000 of the $10,000,000 available under the Revolving Credit 
Agreement.  Future draw-downs may be limited for various reasons including default or foreign government 
policies that restrict or prohibit transferring funds.  At the time of this filing, we are currently unable to 
draw down on the line of credit.  This may change in the near future but there is no assurance that the line 
of credit will become available at such time when it is needed. Boyalife Investment Fund II, Inc. is a wholly-
owned subsidiary of Boyalife Group Inc., which is owned and controlled by the Company’s Chief Executive 
Officer and Chairman of our Board of Directors.  

The Company has incurred recurring operating losses and as of December 31, 2019 had an accumulated 
deficit of $236,932,000.  These conditions 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  anticipates  requiring 
additional capital to grow the business, to fund other operating expenses and to make interest payments on 
the line of credit with Boyalife.  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 bank borrowings 
or  public  or  private  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 us, if at all. 

One customer had an accounts receivable balance of $337,000 or 27% and $494,000 or 39% at December 
31, 2019 and 2018, respectively.  One distributor had an accounts receivable balance of $177,000 or 14% 
and $220,000 or 18% at December 31, 2019 and 2018, respectively.  A second distributor had an accounts 
receivable balance of $170,000 or 14% and $0 at December 31, 2019 and 2018, respectively. 

Revenues  from  one  customer  totaled  $3,575,000  or  28%  and  $2,120,000  or  22%  for  the  years  ended 
December 31, 2019 and 2018, respectively. Revenues from one distributor totaled $1,470,000 or 11%, and 
$460,000 or 4% for the year ended December 31, 2019 and the year ended December 31, 2018, respectively. 

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

31 

 
 
 
 
  
 
 
 
 
 
 
Critical Accounting Policies and Estimates 

The preparation of our consolidated financial statements requires us to make estimates and judgments that 
affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of contingent 
assets and liabilities. On an on-going basis, we evaluate our estimates, including those related to stock-
based  compensation,  depreciation,  fair  values  of  intangibles  and  goodwill,  bad  debts,  inventories, 
warranties, contingencies and  litigation.  We base  our estimates  on  historical experience and  on  various 
other assumptions that are believed to be reasonable under the circumstances, the results of which form the 
basis for making judgments about the carrying values of assets and liabilities that are not readily apparent 
from  other  sources.  Actual  results  may  differ  from  these  estimates  under  different  assumptions  or 
conditions.  See Note 2 “Summary of Significant Accounting Policies” to the Notes to the Consolidated 
Financial Statements contained in Item 8. 

We believe the following critical accounting policies affect the more significant judgments and estimates 
used by the Company in the preparation of its consolidated financial statements.  

We have no off-balance sheet arrangements. 

Off Balance Sheet Arrangements 

ITEM 7A.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 

We are a “smaller reporting company” as defined by Rule 12b-2 of the Exchange Act, and as such, we are 
not required to provide the disclosure required under this item. 

ITEM 8.  FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 

Report of Independent Registered Public Accounting Firm ................................................... 34 

Consolidated Balance Sheets at December 31, 2019 and 2018 ............................................... 35 

Consolidated Statements of Operations and Comprehensive Loss for the years ended 

  December 31, 2019 and 2018 .................................................................................................. 36 

Consolidated Statements of Equity for the years ended December 31, 2019  
and 2018 .................................................................................................................................. 37 

Consolidated Statements of Cash Flows for the years ended December 31, 2019   
and 2018 .................................................................................................................................. 38 

  Notes to Consolidated Financial Statements ........................................................................... 39 

32 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM 

To the Shareholders and Board of Directors of  
ThermoGenesis Holdings, Inc.  

Opinion on the Financial Statements 

We have audited the accompanying consolidated balance sheets of ThermoGenesis Holdings, Inc. (the “Company”), 
formerly known as Cesca Therapeutics Inc., as of December 31, 2019 and 2018, the related consolidated statements 
of operations and comprehensive loss, equity and cash flows for each of the two years in the period ended December 
31, 2019, and the related notes (collectively referred to as the “financial statements”).  In our opinion, the financial 
statements present fairly, in all material respects, the financial position of the Company as of December 31, 2019 and 
2018, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 
2019, in conformity with accounting principles generally accepted in the United States of America. 

Explanatory Paragraph – Going Concern  

The  accompanying  financial  statements  have  been  prepared  assuming  that  the  Company  will  continue  as  a  going 
concern. As more fully described in Note 1, the Company has incurred recurring losses. These recurring losses raise 
substantial doubt about the Company's ability to continue as a going concern. Management's plans regard to these 
matters are also described in Note 1. The financial statements do not include any adjustments that might result from 
the outcome of this uncertainty.  

Change in Accounting Principle 

As discussed in Note 2 to the consolidated financial statements, the Company has changed its method of accounting 
for leases in 2019 due to the adoption of the guidance in ASC Topic 842, Leases (“Topic 842”). 

Basis for Opinion 

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

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

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, 
whether  due  to  error  or  fraud,  and  performing  procedures  that  respond  to  those  risks.  Such  procedures  included 
examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also 
included  evaluating  the  accounting  principles  used  and  significant  estimates  made  by  management,  as  well  as 
evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis 
for our opinion. 

/s/ Marcum LLP 
Marcum LLP 

We have served as the Company’s auditor since 2015. 

New York, NY  
March 23, 2020  

33 

 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
CONSOLIDATED BALANCE SHEETS 

December 31, 

2019 

2018 

ASSETS 
Current assets: 
  Cash and cash equivalents 
    Restricted cash 
  Accounts receivable, net of allowance for doubtful accounts of $226,000  
    ($419,000 at December 31, 2018) 
  Inventories, net of reserves of $350,000 ($258,000 at December 31, 2018) 
  Prepaid expenses and other current assets 
    Total current assets 

Restricted cash – long term 
Equipment and leasehold improvements, net 
Right-of-use operating lease assets, net 
Goodwill 
Intangible assets, net 
Other assets 
Total assets 

LIABILITIES AND EQUITY 
  Current liabilities: 
    Accounts payable 
    Accrued payroll and related expenses 
    Deferred revenue – short term 
    Interest payable – related party 
    Other current liabilities 
    Total current liabilities 

Convertible promissory note – related party, less debt discount of  
$5,195,000 ($6,026,000 at December 31, 2018) 
Convertible promissory note, plus debt premium of $46,000 ($0 at December 31, 
2018) 
Note payable 
Operating lease obligations – long term 
Deferred revenue – long term 
Other noncurrent liabilities 
Total liabilities 

Commitments and contingencies  
Stockholders’ equity: 
  Preferred stock, $0.001 par value; 2,000,000 shares authorized; none issued  
    and outstanding  

$3,157,000 
1,000,000 

1,278,000 
3,824,000 
602,000 
9,861,000 

-- 
2,028,000 
859,000 
781,000 
1,467,000 
218,000 
$15,214,000 

$1,447,000 
288,000 
620,000 
1,869,000 
2,461,000 
6,685,000 

3,518,000 

413,000 
1,000,000 
761,000 
1,901,000 
20,000 
14,298,000 

$2,400,000 
-- 

1,509,000 
4,493,000 
224,000 
8,626,000 

1,000,000 
2,562,000 
-- 
781,000 
1,591,000 
51,000 
$14,611,000 

$2,423,000 
703,000 
485,000 
1,513,000 
1,241,000 
6,365,000 

1,174,000 

-- 
-- 
-- 
303,000 
38,000 
7,880,000 

-- 

-- 

  Common stock, $0.001 par value; 350,000,000 shares authorized;  
  2,843,601 issued and outstanding (2,168,337 at December 31, 2018) 
  Additional paid in capital 
  Accumulated deficit 
  Accumulated other comprehensive loss 
Total ThermoGenesis Holdings, Inc. stockholders’ equity 

3,000 
237,313,000 
(236,932,000) 
2,000 
386,000 

Noncontrolling interest 
  Total equity 
Total liabilities and equity 

530,000 
916,000 
$15,214,000 
See accompanying notes to consolidated financial statements. 

2,000 
235,888,000 
(227,435,000) 
(13,000) 
8,442,000 

(1,711,000) 
6,731,000 
$14,611,000 

34 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS 

Net revenues 
Net revenues – related party 
Total net revenues 
Cost of revenues 

Gross profit 

Expenses: 
  Sales and marketing 
  Research and development 
General and administrative 
Impairment charges 
    Total operating expenses 

  Loss from operations  

  Other income (expense): 
  Fair value change of derivative instruments 
  Interest expense 
  Loss on extinguishment of debt 
 Loss on equity method investments 
  Other expenses 
Total other expense 

Loss before benefit for income taxes 
Benefit for income taxes 
Net loss 

Loss attributable to non-controlling interests 
Net loss attributable to common stockholders 

COMPREHENSIVE LOSS 
Net loss 
Other comprehensive loss: 
  Foreign currency translation adjustments 
Comprehensive loss 
Comprehensive loss attributable to non-controlling interests 
Comprehensive loss attributable to common stockholders 

Per share data: 
Basic and diluted net loss per common share 

Year Ended December 31, 

2019 

2018 

$12,160,000 
887,000 
13,047,000 
7,351,000 
5,696,000 

1,656,000 
2,396,000 
6,377,000 
-- 
10,429,000 

$9,003,000 
669,000 
9,672,000 
7,479,000 
2,193,000 

1,359,000 
3,012,000 
8,286,000 
33,081,000 
45,738,000 

(4,733,000) 

(43,545,000) 

1,000 
(4,479,000) 
(840,000) 
(15,000) 
(33,000) 
(5,366,000) 

(10,099,000) 
-- 
(10,099,000) 

(602,000) 
$(9,497,000) 

596,000 
(2,697,000) 
-- 
-- 
(24,000) 
(2,125,000) 

(45,670,000) 
4,730,000 
(40,940,000) 

(1,224,000) 
$(39,716,000) 

$(10,099,000) 

$(40,940,000) 

15,000 
(10,084,000) 
(602,000) 
$(9,482,000) 

30,000 
(40,910,000) 
(1,224,000) 
$(39,686,000) 

$(3.36) 

$(21.57) 

Weighted average common shares outstanding Basic and diluted 

2,828,606 

1,841,281 

See accompanying notes to consolidated financial statements. 

35 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
CONSOLIDATED STATEMENTS OF EQUITY 

Balance at December 31, 2017 

Stock-based compensation 

expense 

Issuance of common stock and 

pre-funded warrants in 
financing, net of offering costs 

Exercise of warrants 
Discount due to beneficial 

conversion features 

Cumulative-effect adjustment 
from adoption of ASC 606 
Foreign currency translation 
Net loss 
Balance at December 31, 2018 

Stock-based compensation 
Exercise of pre-funded warrants 
Exercise of warrants 
Conversion of note payable to 

stock 

Reorganization of subsidiary and 

related change in non-controlling 
interest 

Discount due to beneficial 

conversion features 

Issuance of common stock pre-

funded warrants in financing, net 
of offering cost 

Foreign currency translation 
Net loss 
Balance at December 31, 2019 

Shares 
1,090,664 

Common 
Stock 

$1,000 

Paid in Capital 
in Excess of 
Par 
$221,381,000 

Accumulated 
Deficit 
$(187,640,000) 

AOCL* 
$(43,000) 

Non-
Controlling 
Interests 
$(487,000) 

Total Equity 
$33,212,000 

41 

-- 

652,000 

808,465 
269,167 

1,000 
-- 

6,628,000 
27,000 

-- 

-- 

7,200,000 

-- 

-- 
-- 

-- 

-- 

-- 
-- 

-- 

-- 

-- 
-- 

-- 

652,000 

6,629,000 
27,000 

7,200,000 

-- 
-- 
-- 
2,168,337 

-- 
416,500 
18,764 

240,000 

-- 

-- 

-- 
-- 
-- 
$2,000 

-- 
1,000 
-- 

-- 

-- 

-- 

-- 
-- 
-- 
$235,888,000 

(79,000) 
-- 
(39,716,000) 
$(227,435,000) 

-- 
30,000 
-- 
$(13,000) 

-- 
-- 
(1,224,000) 
$(1,711,000) 

(79,000) 
30,000 
(40,940,000) 
$6,731,000 

614,000 
41,000 
112,000 

432,000 

(2,843,000) 

2,313,000 

-- 
-- 
-- 

-- 

-- 

-- 

-- 
-- 
-- 

-- 

-- 

-- 

-- 
-- 
-- 

-- 

614,000 
42,000 
112,000 

432,000 

2,843,000 

-- 

-- 

2,313,000 

-- 
-- 
-- 
2,843,601 

-- 
-- 
-- 
$3,000 

756,000 
-- 
-- 
$237,313,000 

-- 
-- 
(9,497,000) 
$(236,932,000) 

-- 
15,000 
-- 
$2,000 

-- 
-- 
(602,000) 
$530,000 

756,000 
15,000 
(10,099,000) 
$916,000 

* Accumulated other comprehensive loss. 

See accompanying notes to consolidated financial statements. 

36 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
CONSOLIDATED STATEMENTS OF CASH FLOWS 

Cash flows from operating activities: 
  Net loss 
  Adjustments to reconcile net loss to net cash used in operating activities: 
    Depreciation and amortization 
    Stock-based compensation expense 
    Amortization of debt discount/premium, net 

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

    Change in fair value of derivative 
    Deferred income tax benefit 
    Loss on disposal of equipment 
    Loss on extinguishment of debt 
Impairment of intangible asset 

  Net change in operating assets and liabilities: 
    Accounts receivable 

Inventories 

    Prepaid expenses and other assets 
    Accounts payable 

Interest payable - related party 

    Accrued payroll and related expenses 
    Deferred revenue 
    Other current liabilities 
    Long term deferred revenue and other noncurrent liabilities 
  Net cash used in operating activities 
  Cash flows from investing activities: 
      Capital expenditures 
  Net cash used in investing activities 
  Cash flows from financing activities: 
    Proceeds from long-term debt  
    Proceeds from convertible promissory note-related party 
    Payments on finance lease obligations 
    Proceeds from issuance of common stock and pre-funded warrants 
    Proceeds from exercise of warrants and pre-funded warrants 
  Net cash provided by financing activities 
  Effects of foreign currency rate changes on cash and cash equivalents 
  Net decrease in cash, cash equivalents and restricted cash 
  Cash, cash equivalents and restricted cash at beginning of period 
  Cash, cash equivalents and restricted cash at end of period 
  Supplemental disclosures of cash flow information: 
    Cash paid for interest 
  Supplemental non-cash financing and investing information: 
    Recording of beneficial conversion feature on debt 
    Right-to-use asset acquired under operating lease 
    Conversion of debt to common stock 
    Fair value of amended convertible note issued in connection with the  

  extinguishment of original convertible note 

    Transfer of equipment to inventories 
    Transfer of inventories to equipment 

Year Ended December 31, 
2019 

 2018 

$(10,099,000) 

$(40,940,000) 

805,000 
614,000 
2,349,000 
92,000 
(60,000) 
(1,000) 
-- 
70,000 
840,000 
-- 

301,000 
610,000 
(525,000) 
(966,000) 
355,000 
(415,000) 
135,000 
1,143,000 
1,492,000 
(3,260,000) 

(182,000) 
(182,000) 

1,800,000 
1,513,000 
(24,000) 
756,000 
154,000 
4,199,000 
-- 
757,000 
3,400,000 
$4,157,000 

  670,000 
  652,000 
 1,174,000 
  (11,000) 
  153,000 
 (596,000) 
 (4,730,000) 
 1,360,000 
-- 
 33,081,000 

 1,045,000 
  61,000 
  370,000 
  214,000 
 (606,000) 
  172,000 
  24,000 
  922,000 
2,000 
 (6,983,000) 

 (1,238,000) 
 (1,238,000) 

-- 
  500,000 
  (45,000) 
 6,629,000 
  27,000 
 7,111,000 
  (3,000) 
 (1,113,000) 
 4,513,000 
 $3,400,000 

$177,000 

 $667,000 

$2,313,000 
$966,000 
$432,000 

$1,473,000 
$44,000 
$22,000 

 $7,200,000 
-- 
-- 

-- 
 $172,000 
 $420,000 

See accompanying notes to consolidated financial statements. 

37 

 
 
 
 
 
 
 
 
 
 
 
   
   
 
   
 
 
 
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 

1. 

Description of Business, Going Concern 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 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 is owned and developed through a subsidiary in which we own 80% of the equity interest. 

38 

 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 

1. 

Description of Business, Going Concern and Basis of Presentation (Continued) 

Organization and Basis of Presentation (Continued) 
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. named 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.   

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 stock 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.    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. 

Liquidity and Going Concern 
The Company has a Revolving Credit Agreement (the “Credit Agreement”) with Boyalife Asset Holding 
II,  Inc.  (See  Note  5).    As  of  December  31,  2019,  the  Company  had  drawn  down  $8,713,000  of  the 
$10,000,000 available under the Credit Agreement.  Future draw-downs may be limited for various reasons 
including default or foreign government policies that restrict or prohibit transferring funds.  At the time of 
this filing, the Company is currently unable to draw down on the line of credit.  This may change in the 
near future; however, there is no assurance that the line of credit will become available at such time when 
it is needed. 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.  

39 

 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 

1. 

Description of Business, Going Concern and Basis of Presentation (Continued) 

Liquidity and Going Concern (Continued) 
At December 31, 2019, the Company had cash and cash equivalents of $3,157,000 and working capital of 
$3,176,000.  The Company has incurred recurring operating losses and as of December 31, 2019 has an 
accumulated deficit of $236,932,000.  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 will need 
to raise additional capital to grow its device business, fund operating expenses and make interest payments 
that will become due under the line of credit with Boyalife Asset Holding II, Inc.  The Company’s ability 
to fund its cash needs is subject to various risks, many of which are beyond its control. The Company plans 
to  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 consolidated financial statements have been prepared assuming that the Company will 
continue as a going concern; however, the conditions  described herein raise substantial doubt about the 
Company’s ability to do so.  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  become necessary 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 the subsidiary. 
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  interest  reflects  only  its  share  of  the  after-tax  earnings  or  losses  of  an 
affiliated company. The Company's consolidated balance sheets reflect non-controlling interests within the 
equity section. 

40 

 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

2.  Summary of Significant Accounting Policies 

Use of Estimates 
Preparation  of  financial  statements  in  conformity  with  accounting  principles  generally  accepted  in  the 
United States of America (“GAAP”) and requires management to make estimates and assumptions that 
affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and 
the reported amounts of revenues and expenses during the reporting period. Estimates are used for, but not 
limited  to,  the  allowance  for  doubtful  accounts,  carrying  amounts  of  inventories,  depreciation  and 
amortization, warranty obligations, assumptions made in valuing financial instruments issued in various 
compensation and financing arrangements, deferred income taxes and related valuation allowance and the 
fair  values  of  intangibles  and  goodwill.  Actual  results  could  materially  differ  from  the  estimates  and 
assumptions used in the preparation of the Company’s consolidated financial statements.  

Revenue Recognition 
Revenue  is  recognized  based  on  the  five-step  process  outlined  in  Accounting  Standards  Codification 
(“ASC”) 606: 

Step 1 – Identify the Contract with the Customer – A contract exists when (a) the parties to the contract 
have approved the contract and are committed to perform their respective obligations, (b) the entity can 
identify each party’s rights regarding the goods or services to be transferred, (c) the entity can identify the 
payment terms for the goods or services to be transferred, (d) the contract has commercial substance and, 
(e) it is probable that the entity will collect substantially all of the consideration to which it will be entitled 
in exchange for the goods or services that will be transferred to the customer. 

Step 2 – Identify Performance Obligations in the Contract – Upon execution of a contract, the Company 
identifies as performance obligations each promise to transfer to the customer either (a) goods or services 
that are distinct or (b) a series of distinct goods or services that are substantially the same and have the same 
pattern of transfer to the customer.  To the extent a contract includes multiple promised goods or services, 
the Company must apply judgement to determine whether the goods or services are capable of being distinct 
within the context of the contract.  If these criteria are not met, the goods or services are accounted for as a 
combined performance obligation. 

Step 3 – Determine the Transaction Price – The contract terms and customary business practices are used 
to determine the transaction price.  The transaction price is the amount of consideration expected to be 
received in exchange for transferring goods or services to the customer.  The Company’s contracts include 
fixed consideration. 

Step 4 – Allocate the Transaction Price – After the transaction price has been determined, the next step is 
to allocate the transaction price to each performance obligation in the contract.  If the contract only has one 
performance obligation, the entire transaction price will be applied to that obligation.  If the contract has 
multiple performance obligations, the transaction price is allocated to the performance obligations based 
on the relative standalone selling price (“SSP”) at contract inception. 

Step  5  –  Satisfaction  of  the  Performance  Obligations  (and  Recognize  Revenue)  –  When  an  asset  is 
transferred  and  the  customer  obtains  control  of  the  asset  (or  the  services  are  rendered),  the  Company 
recognizes  revenue.    At  contract  inception,  the  Company  determines  if  each  performance  obligation  is 
satisfied at a point in time or over time.  For device sales, revenue is recognized at a point in time when the 
goods  are  transferred  to  the  customer  and  they  obtain  control  of  the  asset.    For  maintenance  contracts, 
revenue is recognized over time as the performance obligations in the contracts are completed. 

41 

 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

2.  Summary of Significant Accounting Policies (Continued) 

Revenue Recognition (Continued) 
Device Sales 
Device  sales  include  devices  and  consumables  for  BioArchive,  AXP,  CAR-TXpress  and  manual 
disposables.  Most devices are sold with contract terms stating that title  passes, and the customer takes 
control  at  the  time  of  shipment.    Revenue  is  then  recognized  when  the  devices  are  shipped,  and  the 
performance obligation has been satisfied.  If devices are sold under contract terms that specify that the 
customer does not take ownership until the goods are received, revenue is recognized when the Company 
confirms that the customer has received and taken physical possession of the goods. 

Service Revenue 
Service  revenue  principally  consists  of  maintenance  contracts  for  BioArchive,  AXP  and  CAR-TXpress 
products.  Devices sold have warranty periods of one to two years.  After the warranty expires, the Company 
offers separately priced annual maintenance contracts.  Under these contracts, customers pay in advance.  
These prepayments are recorded as deferred revenue and recognized over time as the contract performance 
obligations  are  satisfied.    For  AXP  and  CAR-TXpress  products,  the  Company  offers  one  type  of 
maintenance  contract  providing  preventative  maintenance  and  repair  services.    Revenue  under  these 
contracts is recognized ratably over time, as the customer has the right to use the service at any time during 
the annual contract period and services are unlimited.  For BioArchive, the Company offers three types of 
maintenance  contracts:  Gold,  Silver  and  Preventative  Maintenance  Only.    Under  the  Gold  contract, 
maintenance and repair services are unlimited and revenue is recognized ratably over time.  For the Silver 
and Preventative Maintenance contracts, available services are limited, and revenue is recognized during 
the contract period when the underlying performance obligations are satisfied.  If the services are not used 
during the contract period, any remaining revenue is recognized when the contract expires.  The renewal 
date  for  maintenance  contracts  varies  by  customer,  depending  when  the  customer  signed  their  initial 
contract. 

42 

 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

2.  Summary of Significant Accounting Policies (Continued) 

Revenue Recognition (Continued) 
Clinical Services 
Service revenue in our Clinical Development Segment includes point of care procedures and cord blood 
processing and storage.  Point of care procedures are recognized when the procedures are performed.  Cord 
blood processing and storage is recognized as the performance obligations are satisfied.  Processing revenue 
is  recognized  when  that  performance  obligation  is  completed  immediately  after  the  baby’s  birth,  with 
storage revenue recorded as deferred revenue and recognized ratably over time for up to 21 years.  As of 
December 31, 2019 and 2018, the total deferred cord blood storage revenue is $237,000 and $252,000, 
respectively.  As of December 31, 2019, those amounts were recorded as $14,000 in current liabilities and 
$223,000 in non-current liabilities.  As of December 31, 2018, those amounts were recorded as $14,000 in 
current liabilities and $238,000 in non-current liabilities.  The customer may pay for both services at the 
time of processing.  The amount of the transaction price allocated to each of the performance obligations is 
determined  by  using  the  standalone  selling  price  of  each  component,  which  the  Company  applies 
consistently to all such arrangements.  The Company did not process and store any new cord blood revenue 
in  2019.    Service  revenue  recognized  in  the  Clinical  Development  Segment  in  2019  related  entirely  to 
revenue deferred from previous years. 

The following table summarizes the revenues of the Company’s reportable segments for the year ended 
December 31, 2019:   

Device Segment: 
  AXP 

BioArchive 

  Manual Disposables 
CAR-TXpress 

  Other 
Total Device Segment 
Clinical Development Segment: 
  Disposables 
  Other 
Total Clinical Development 
Total 

Year Ended December 31, 2019 

Device 
Revenue 

Service 
Revenue 

Other 
Revenue 

Total 
Revenue 

$7,313,000 
1,472,000 
909,000 
1,457,000 
-- 
11,151,000 

68,000 
-- 
68,000 
$11,219,000 

$209,000 
1,438,000 
-- 
13,000 
-- 
1,660,000 

-- 
22,000 
22,000 
$1,682,000 

$7,522,000 
2,910,000 
909,000 
1,565,000 
51,000 
12,957,000 

$95,000 
51,000 
146,000 

-- 
-- 
-- 
$146,000 

68,000 
22,000 
90,000 
  $13,047,000 

43 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

2.  Summary of Significant Accounting Policies (Continued) 

Revenue Recognition (Continued) 
The following table summarizes the revenues of the Company’s reportable segments for the year ended 
December 31, 2018: 

Year Ended December 31, 2018 

Device 
Revenue 

Service 
Revenue 

Other 
Revenue 

Total 
Revenue 

Device Segment: 
  AXP 

BioArchive 

  Manual Disposables 
CAR-TXpress 

  Other 
Total Device Segment 
Clinical Development Segment: 

Bone Marrow 

  Other 
Total Clinical Development 
Total 

$4,131,000 
1,792,000 
976,000 
907,000 
-- 
7,806,000 

-- 
38,000 
38,000 
$7,844,000 

$262,000 
1,306,000 
-- 
-- 
-- 
1,568,000 

135,000 
30,000 
165,000 
$1,733,000 

$-- 
-- 
-- 
-- 
95,000 
95,000 

  $4,393,000 
3,098,000 
976,000 
907,000 
95,000 
9,469,000 

-- 
-- 
-- 
$95,000 

135,000 
68,000 
203,000 
  $9,672,000 

In 2019, there was no right of return provided for distributors or customers.  For distributors, the Company 
has no control over the movement of goods to the end customer.  The Company’s distributors control the 
timing, terms and conditions of the transfer of goods to the end customer.  Additionally, for sales of products 
made  to  distributors,  the  Company  considers  a  number  of  factors  in  determining  whether  revenue  is 
recognized upon transfer of title to the distributor, or when payment is received.  These factors include, but 
are not limited to, whether the payment terms offered to the distributor are considered to be non-standard, 
the distributor’s history of adhering to the terms of its contractual arrangements with the Company, whether 
the Company has a pattern of granting concessions for the benefit of the distributor, and whether there are 
other conditions that may indicate that the sale to the distributor is not substantive. 

Payments  from  domestic customers are  normally  due  in two months  or  less  after the  title transfers, the 
service contract is  executed,  or  the  services  have  been  rendered.    For international  customers, payment 
terms  may  extend  up  to  120  days.    All  sales  have  fixed  pricing  and  there  are  currently  no  variable 
components included in the Company’s revenue. 

44 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

2.  Summary of Significant Accounting Policies (Continued) 

Revenue Recognition (Continued) 
Contract Balances 
Generally, all sales are contract sales (with either an underlying contract or purchase order).  The Company 
does not have any material contract assets.  When invoicing occurs prior to revenue recognition a contract 
liability is recorded (as deferred revenue on the consolidated balance sheet).  Revenues recognized during 
the year ended December 31, 2019 that were included in the beginning balance of deferred revenue were 
$1,049,000.  Short term deferred revenues were $620,000 and $485,000 at December 31, 2019 and 2018, 
respectively.    Long term  deferred  revenue, included  in  other  noncurrent liabilities,  was  $1,901,000 and 
$303,000 at December 31, 2019 and 2018, respectively. 

Exclusivity Fee 
On  August  30,  2019,  the  Company  entered  into  a  Supply  Agreement  with  Corning  Incorporated  (the 
“Supply Agreement”).  The Supply Agreement has an initial term of five years with automatic two-year 
renewal terms, unless terminated by either party in accordance with the terms of the Supply Agreement 
(collectively,  the  “Term”).  Pursuant  to  the  Supply  Agreement,  the  Company  has  granted  to  Corning 
exclusive worldwide distribution rights for substantially all X-Series® products under the CAR-TXpress™ 
platform (the “Products”) manufactured by its subsidiary, ThermoGenesis Corp., for the duration of the 
Term, subject to certain geographical and other exceptions. As consideration for the exclusive worldwide 
distribution rights for the Products, Corning has agreed to pay a $2,000,000 exclusivity fee, in addition to 
any amounts payable throughout the Term for the Products. 

The Company performed an evaluation of the revenue recognition of the $2,000,000 fee under ASC 606.  
It determined that the $2,000,000 will be recognized over time, based on the term of the contract.  It was 
determined that the most likely outcome is the agreement is extended for one additional two-year 
term  after  the  initial  five-year  contract  is  complete.    Consequently,  the  term  to  recognize  the 
exclusivity fee is over seven years. The Company will allocate the upfront fee evenly to each daily 
performance obligation of providing exclusivity and recognize the revenue ratably over the seven-
year period. As each day passes, the Company will recognize the portion of the exclusivity fee 
allocated to that day.  For the year ended December 31, 2019, the Company recorded revenue of 
$96,000  related  to  the  exclusivity  fee.    The  remaining  balance  of  the  $2,000,000  payment  of 
$1,904,000 was recorded to deferred revenue, with $286,000 in short-term deferred revenue and 
$1,618,000 recorded in long-term deferred revenue. 

45 

 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

2.  Summary of Significant Accounting Policies (Continued) 

Revenue Recognition (Continued) 
Backlog of Remaining Customer Performance Obligations 
The following table includes revenue expected to be recognized and recorded as sales in the future from 
the  backlog  of  performance  obligations  that  are  unsatisfied  (or  partially  unsatisfied)  at  the  end  of  the 
reporting period. 

Service revenue 
Clinical revenue 
Exclusivity Fee 
Total 

2020 
$848,000 
14,000 
286,000 
$1,148,000 

2021  
$632,000 
14,000 
286,000 
$932,000 

2022 
$228,000 
$14,000 
286,000 
$528,000 

2023 
$90,000 
14,000 
286,000 
$390,000 

2024 and 
beyond 

$30,000 
181,000 
760,000 
$971,000 

Total 
$1,828,000 
237,000 
1,904,000 
$3,969,000  

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

Cash and Cash Equivalents  
The Company considers all highly liquid investments with a maturity of three months or less at the time of 
purchase  to  be  cash  equivalents.  Financial  instruments  that  potentially  subject  the  Company  to  a 
concentration of credit risk consist of cash and cash equivalents. The Company’s cash and cash equivalents 
is maintained in checking accounts, money market funds and certificates of deposits with reputable financial 
institutions that may at times exceed amounts covered by insurance provided by the U.S. Federal Deposit 
Insurance Corporation. The Company has cash and cash equivalents of $10,000 and $11,000 at December 
31,  2019  and  2018  in  India.  The  Company  has  not  experienced  any  realized  losses  on  the  Company’s 
deposits of cash and cash equivalents.  

Foreign Currency Translation 
The Company’s reporting currency is the US dollar. The functional currency of the Company’s subsidiaries 
in  India  is  the  Indian  rupee  (“INR”).  Assets  and  liabilities  are  translated  into  US  dollars  at  period  end 
exchange rates. Revenue and expenses are translated at average rates of exchange prevailing during the 
periods  presented.  Cash  flows  are  also  translated  at  average  exchange  rates  for  the  period,  therefore, 
amounts reported on the consolidated statement of cash flows do not necessarily agree with changes in the 
corresponding balances on the consolidated balance sheet. Equity accounts other than retained earnings are 
translated at the historic exchange rate on the date of investment. A translation gain (loss) of $15,000 and 
$30,000  was  recorded  at  December  31,  2019  and  2018,  respectively,  as  a  component  of  other 
comprehensive income. 

46 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

2.  Summary of Significant Accounting Policies (Continued) 

Goodwill, Intangible Assets and Impairment Assessments  
Goodwill represents the excess of the purchase price in a business combination over the fair value of net 
tangible and intangible assets acquired. Intangible assets that are not considered to have an indefinite useful 
life are amortized over their useful lives, which generally range from three to ten years. Each period the 
Company evaluates the estimated remaining useful lives of purchased intangible assets and whether events 
or changes in circumstances warrant a revision to the remaining periods of amortization.  

For  goodwill  and  indefinite-lived  intangible  assets,  the  carrying  amounts  are  periodically  reviewed  for 
impairment (at least annually) and whenever events or changes in circumstances indicate that the carrying 
value of these assets may not be recoverable. According to ASC 350,”Intangibles-Goodwill and Other”, 
the  Company can  opt  to  perform  a  qualitative  assessment  or  a  quantitative  assessment;  however, if the 
qualitative assessment determines that it is more likely than not (i.e., a likelihood of more than 50 percent) 
the fair value is less than the carrying amount; the Company would recognize an  impairment charge for 
the amount by which the carrying amount exceeds the reporting unit’s fair value. 

Fair Value of Financial Instruments 
In accordance with ASC 820, Fair Value Measurements and Disclosures, fair value is defined as the exit 
price, or the amount that would be received for the sale of an asset or paid to transfer a liability in an orderly 
transaction between market participants as of the measurement date. 

The guidance also establishes a hierarchy for inputs used in measuring fair value that maximizes the use of 
observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs 
be used when available. Observable inputs are inputs that market participants would use in valuing the asset 
or liability and are developed based on market data obtained from sources independent of the Company. 
Unobservable  inputs  are  inputs  that  reflect  the  Company’s  assumptions  about  the  factors  that  market 
participants would use in valuing the asset or liability. The guidance establishes three levels of inputs that 
may be used to measure fair value: 

Level 1: Quoted market prices in active markets for identical assets or liabilities. 
Level 2: Other observable inputs other than Level 1 prices such as quoted prices for similar assets 
or liabilities; quoted prices in markets that are not active; or other inputs that are observable 
or can be corroborated by observable market data. 

Level 3: Unobservable inputs reflecting the reporting entity’s own assumptions. 

The carrying values of cash and cash equivalents, accounts receivable and accounts payable approximate 
fair  value due to  their  short  duration.  The  fair  value of  the  Company’s  derivative  obligation  liability  is 
classified as Level 3 within the fair value hierarchy since the valuation model of the derivative obligation 
is based on unobservable inputs.  The impairment of goodwill and intangible assets is a non-recurring Level 
3 fair value measurement. 

47 

 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

2.  Summary of Significant Accounting Policies (Continued) 

Accounts Receivable and Allowance for Doubtful Accounts 
The Company’s receivables are recorded when billed and represent claims against third parties that will be 
settled in cash. The carrying value of the Company’s receivables, net of the allowance for doubtful accounts, 
represents their estimated net realizable value. The Company estimates the allowance for doubtful accounts 
based on historical collection trends, age of outstanding receivables and existing economic conditions. If 
events or changes in circumstances indicate that a specific receivable balance may be impaired, further 
consideration is given to the collectability of those balances and the allowance is adjusted accordingly. A 
customer’s receivable balance is considered past-due based on its contractual terms. Past-due receivable 
balances  are  written-off  when  the  Company’s  internal  collection  efforts  have  been  unsuccessful  in 
collecting the amount due. 

Inventories 
Inventories are stated at the lower of cost or net realizable value and include the cost of material, labor and 
manufacturing  overhead.  Cost  is  determined  on  the  first-in,  first-out  basis.  The  Company  writes-down 
inventory to its estimated net realizable value when conditions indicate that the selling price could be less 
than  cost  due  to  physical deterioration,  obsolescence,  changes  in  price levels,  or  other  causes,  which  it 
includes as a component of cost of revenues. Additionally, the Company provides valuation allowances for 
excess and slow-moving inventory on hand that are not expected to be sold to reduce the carrying amount 
of slow-moving inventory to its estimated net realizable value. The valuation allowances are based upon 
estimates about future demand from its customers and distributors and market conditions.  

Because some of the Company’s products are highly dependent on government and third-party funding, 
current customer use and validation, and completion of regulatory and field trials, there is a risk that the 
Company will forecast incorrectly and purchase or produce excess inventories.  As a result, actual demand 
may  differ  from  forecasts  and  the  Company  may  be  required  to  record  additional  inventory  valuation 
allowances that could adversely impact its gross margins. Conversely, favorable changes in demand could 
result in higher gross margins when those products are sold.  

Equipment and Leasehold Improvements 
Equipment  consisting  of  machinery  and  equipment,  computers  and  software,  office  equipment  and 
leasehold improvements is recorded at cost less accumulated depreciation. Repairs and maintenance costs 
are expensed as incurred. Depreciation for machinery and equipment, computers and software and office 
furniture  is  computed  under  the  straight-line  method  over  the  estimated  useful  lives.  Leasehold 
improvements  are  amortized  under  the  straight-line  method  over  their  estimated  useful  lives  or  the 
remaining lease period, whichever is shorter. When equipment  and leasehold improvements  are sold or 
otherwise disposed of, the asset account and related accumulated depreciation account are relieved, and the 
impact  of  any  resulting  gain  or  loss  is  recognized  within  general  and  administrative  expenses  in  the 
consolidated statement of operations for the period.  

Warranty 
We provide for the estimated cost of product warranties at the time revenue is recognized. While we engage 
in  extensive  product  quality  programs  and  processes,  including  actively  monitoring  and  evaluating  the 
quality of our component suppliers, our warranty obligation is affected by product failure rates, material 
usage and service delivery costs incurred in correcting a product failure. Should actual product failure rates, 
material  usage  or  service  delivery  costs  differ  from  our  estimates,  revisions  to  the  estimated  warranty 
liability could have a material impact on our financial position, cash flows or results of operations.  

48 

 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

2.  Summary of Significant Accounting Policies (Continued) 

Debt Discount and Issue Costs 
The Company amortizes debt discount and debt issue costs over the life of the associated debt instrument, 
using the straight-line method which approximates the interest rate method. 

Derivative Financial Instruments 
In  connection  with  the  sale  of  convertible  debt  and  equity  instruments,  the  Company  may  also  issue 
freestanding  warrants.  If  freestanding  warrants  are  issued  and  accounted  for  as  derivative  instrument 
liabilities (rather than as equity), the proceeds are first allocated to the fair value of those instruments. The 
remaining  proceeds,  if  any,  are  then  allocated  to  the  convertible  instrument,  usually  resulting  in  that 
instrument being recorded at a discount from its face amount. Derivative financial instruments are initially 
measured at their fair value using a Binomial Lattice Valuation Model and then re-valued at each reporting 
date, with changes in the fair value reported as charges or credits to income. 

Stock-Based Compensation 
We use the Black-Scholes-Merton option-pricing formula in determining the fair value of our options at 
the grant date and apply judgment in estimating the key assumptions that are critical to the model such as 
the expected term, volatility and forfeiture rate of an option. Our estimate of these key assumptions is based 
on historical information and judgment regarding market factors and trends. If any of the key assumptions 
change significantly, stock-based compensation expense for new awards may differ materially in the future 
from that  recorded in the current  period.  The compensation expense is then  amortized  over the  vesting 
period. 

The Company has three stock-based compensation plans, which are described more fully in Note 10.  

Valuation and Amortization Method – The Company estimates the fair value of stock options granted using 
the Black-Scholes-Merton option-pricing formula. This fair value is then amortized on a straight-line basis 
over the requisite service periods of the awards, which is generally the vesting period. The formula does 
not include a discount for post-vesting restrictions, as we have not issued awards with such restrictions.   

Expected Term – For options which the Company has limited available data, the expected term of the option 
is  based  on  the  simplified  method.  This  simplified  method  averages  an  award’s  vesting  term  and  its 
contractual  term.  For  all  other  options,  the  Company's  expected  term  represents  the  period  that  the 
Company's  stock-based  awards  are  expected  to  be  outstanding  and  was  determined  based  on  historical 
experience  of  similar  awards,  giving  consideration  to  the  contractual  terms  of  the  stock-based  awards, 
vesting schedules and expectations of future employee behavior.  

Expected Volatility – Expected volatility is based on historical volatility. Historical volatility is computed 
using daily pricing observations for recent periods that correspond to the expected term of the options.  

Expected  Dividend  –  The  Company  has  not  declared  dividends  and  does  not  anticipate  declaring  any 
dividends in the foreseeable future. Therefore, the Company uses a zero value for the expected dividend 
value factor to determine the fair value of options granted.   

49 

 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

2.  Summary of Significant Accounting Policies (Continued) 

Stock-Based Compensation (Continued) 
Risk-Free Interest Rate – The Company bases the risk-free interest rate used in the valuation method on the 
implied yield currently available on U.S. Treasury zero-coupon issues with the same expected term.  

Estimated  Forfeitures  – When  estimating forfeitures, the  Company considers voluntary  and  involuntary 
termination behavior as well as analysis of actual option forfeitures.  

Research and Development 
Research and  development costs, consisting of salaries and benefits, costs of disposables, facility costs, 
contracted services and stock-based compensation from the engineering, regulatory and scientific affairs 
departments,  that  are  useful  in  developing  and  clinically  testing  new  products,  services,  processes  or 
techniques, as well as expenses for activities that may significantly improve existing products or processes 
are expensed as incurred. Costs to acquire technologies that are utilized in research and development and 
that have no future benefit are expensed when incurred. 

Acquired In-Process Research and Development 
Acquired in-process research and development that the Company acquires through business combinations 
represents the fair value assigned to incomplete research projects which, at the time of acquisition, have not 
reached  technological  feasibility.  The  amounts  are  capitalized  and  are  accounted  for  as  indefinite-lived 
intangible  assets,  subject  to  impairment  testing  until  completion  or  abandonment  of  the  projects.  Upon 
successful completion of each project, the Company will make a determination as to the then useful life of 
the intangible asset, generally determined by the period in which the substantial majority of the cash flows 
are expected to be generated and begin amortization. The Company tests intangible assets for impairment 
at least annually, or more frequently if impairment indicators exist, by first assessing qualitative factors to 
determine whether it is more likely than not that the fair value of the intangible asset is less than it’s carrying 
amount. If the Company concludes it is more likely than not that the fair value is less than the carrying 
amount, a quantitative test that compares the fair value of the intangible asset with its’ carrying value is 
performed. If the fair value is less than the carrying amount, an impairment loss is recognized in operating 
results.  

Patent Costs 
The  costs  incurred  in  connection  with  patent  applications,  in  defending  and  maintaining  intellectual 
property rights and litigation proceedings are expensed as incurred. 

Credit Risk 
Currently, the Company primarily manufactures and sells cellular processing systems and thermodynamic 
devices  principally  to  the  blood  and  cellular  component  processing  industry  and  performs  ongoing 
evaluations of the credit worthiness of the Company’s customers. The Company believes that adequate 
provisions  for  uncollectible  accounts  have  been  made  in  the  accompanying  consolidated  financial 
statements. To date, the Company has not experienced significant credit related losses. 

50 

 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

2.  Summary of Significant Accounting Policies (Continued) 

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

The Company has two reportable business segments: 

•  The  Device  Segment,  engages  in  the  development  and  commercialization  of  automated 
technologies  for  cell-based  therapeutics  and  bio-processing.  The  device  division  is  operated 
through the Company’s ThermoGenesis Corp. subsidiary.   

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

Income Taxes 
The  tax  years  1999-2018  remain  open  to  examination  by  the  major  taxing  jurisdictions  to  which  the 
Company  is  subject;  however,  there  is  no  current  examination.  The  Company’s  policy  is  to  recognize 
interest and penalties related to the underpayment of income taxes as a component of income tax expense. 
To date, there have been no interest or penalties charged to the Company in relation to the underpayment 
of income taxes. There were no unrecognized tax benefits during the periods presented. 

The Company’s estimates of income taxes and the significant items resulting in the recognition of deferred 
tax assets and liabilities reflect the Company’s assessment of future tax consequences of transactions that 
have  been  reflected  in  the  financial  statements  or  tax  returns  for  each  taxing  jurisdiction  in  which  the 
Company operates. The Company bases the provision for income taxes on the Company’s current period 
results of operations, changes in deferred income tax assets and liabilities, income tax rates, and changes in 
estimates  of  uncertain  tax  positions  in  the  jurisdictions  in  which  the  Company  operates.  The  Company 
recognizes deferred tax assets and liabilities when there are temporary differences between the financial 
reporting basis and tax basis of assets and liabilities and for the expected benefits of using net operating 
loss and tax credit loss carryforwards. The Company establishes valuation allowances when necessary to 
reduce the carrying amount of deferred income tax assets to the amounts that the Company believes are 
more  likely  than  not  to  be  realized. The  Company  evaluates  the  need  to  retain  all  or  a  portion  of  the 
valuation allowance on recorded deferred tax assets. When a change in the tax rate or tax law has an impact 
on deferred taxes, the differences are expected to reverse. As the Company operates in more than one state, 
changes in the state apportionment factors, based on operational results, may affect future effective tax rates 
and the value of recorded deferred tax assets and liabilities. The Company records a change in tax rates in 
the consolidated financial statements in the period of enactment. 

51 

 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

2.  Summary of Significant Accounting Policies (Continued) 

Income Taxes (Continued) 
Income tax consequences that arise in connection with a business combination include identifying the tax 
basis  of  assets  and  liabilities  acquired  and  any  contingencies  associated  with  uncertain  tax  positions 
assumed or resulting from the business combination. Deferred tax assets and liabilities related to temporary 
differences of an acquired entity are recorded as of the date of the business combination and are based on 
the Company’s estimate of the appropriate tax basis that will be accepted by the various taxing authorities 
and its determination as to whether any of the acquired deferred tax liabilities could be a source of taxable 
income to realize the Company’s pre-existing deferred tax assets. 

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.  There were 324,445 pre-funded warrants included in the year ended 
December 31, 2019 calculation. 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 December 31: 

Common stock equivalents of convertible promissory     
  note and accrued interest 
Vested Series A warrants 
Unvested Series A warrants(1) 
Warrants – other 
Stock options 
Total 

Year Ended December 31, 
2019 

2018 

6,683,646 
40,441 
69,853 
1,281,327 
291,807 
8,367,074 

4,840,556 
40,441 
69,853 
1,616,227 
302,364 
6,869,441 

(1) 

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

Reclassifications 
Certain prior period amounts have been reclassified to conform to the current period presentation.   The 
reclassifications did not have an impact on net loss as previously reported. 

52 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

2.  Summary of Significant Accounting Policies (Continued) 

Recently Adopted Accounting Standards 
On January 1, 2018, the Company adopted ASU No. 2014-09, “Revenue from Contracts with Customers 
(“Topic 606”)” (“ASC606”) and related updates.  Using the modified retrospective method applied to those 
contracts which were not completed as of January 1, 2018. Results for the reporting period beginning after 
January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to 
be reported in accordance with our historic accounting under “Revenue Recognition” (“Topic 605”). The 
Company  recorded  a  net  increase  to  accumulated  deficit  of  $79,000  as  of  January  1,  2018  due  to  the 
cumulative impact of adopting ASC 606, with the impact related to service obligations requiring deferral. 
ASC  606  requires  the  Company  to  defer  costs  related  to  obligations  on  service  contracts  with  limited 
performance obligations. Under previous guidance, these service obligations were amortized on a straight-
line basis. 

In June 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 
(“ASU”) 2018-07, “Compensation-Stock Compensation (“Topic 718”):  Improvements to Nonemployee 
Share-Based  Payment  Accounting”,  which  simplifies  the  accounting  for  nonemployee  share-based 
payment  transactions.    The  amendments  specify  that  Topic  718  applies  to  all  share-based  payment 
transactions  in  which  a  grantor  acquires  goods  or  services  to  be  used  or  consumed  in  a  grantor’s  own 
operations by issuing share-based payment awards.  The Company adopted the standard on January 1, 2019.  
The adoption of this standard had an immaterial impact on the Company’s financial statements. 

In  February  2016,  the  FASB  issued  ASU  2016-02  “Leases,”  which  increases  transparency  and 
comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet 
and disclosing key information about leasing arrangements.  The Company adopted the standard on January 
1, 2019. 

The new standard requires lessees to recognize both the right-of-use assets and lease liabilities in the balance 
sheet for most leases, whereas under previous GAAP only finance lease liabilities (previously referred to 
as capital leases) were recognized in the balance sheet.  In addition, the definition of a lease has been revised 
which may result in changes to the classification of an arrangement as a lease.  Under the new standard, an 
arrangement that conveys the right to control the use of an identified asset by obtaining substantially all of 
its economic benefits and directing how it is used as a lease, whereas the previous definition focuses on the 
ability to control the use of the asset or to obtain its output.  Quantitative and qualitative disclosures related 
to the amount, timing and judgements of an entity’s accounting for leases and the related cash flows are 
expanded.  Disclosure requirements apply to both lessees and lessors, whereas previous disclosures related 
only to lessees.  The recognition, measurement, and presentation of expenses and cash flows arising from 
a lease by a lessee have not significantly changed from previous GAAP.  Lessor accounting is also largely 
unchanged. 

53 

 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

2.  Summary of Significant Accounting Policies (Continued) 

Recently Adopted Accounting Standards (Continued) 
The new standard provides a number of transition practical expedients, which the Company has elected, 
including: 

•  A “package of three” expedients that must be taken together and allow entities to (1) not reassess 
whether existing contracts contain leases, (2) carryforward the existing lease classification, and (3) 
not reassess initial direct costs associated with existing leases, and  

•  An  implementation  expedient  which  allows  the  requirements  of  the  standard  in  the  period  of 

adoption with no restatement of prior periods. 

The  impact  of  adoption  did  not  have  a  material  impact  to  the  Company  as  of  January  1,  2019  as  the 
Company’s finance leases are immaterial and its operating leases had remaining terms of less than one year.  
In  January  2019,  the  Company  signed  an  amendment  to  its  lease  for  office  space  at  its  corporate 
headquarters  in  Rancho  Cordova,  CA.    The amendment extended  the  lease  term  by five  years  and  was 
accounted for as a modification.  At that time, the Company recorded lease assets and liabilities of $966,000 
and no cumulative effect adjustment to retained earnings. 

Recently Issued Accounting Standards 
In  December  2019,  the  Financial  Accounting  Standards  Board  (“FASB”)  issued  Accounting  Standards 
Update (“ASU”) 2019-12 “Income Taxes (Topic 740): Simplifying the Accounting of Income Taxes”, which 
is  intended  to  simplify  various  aspects  related  to  accounting  for  income  taxes.    ASU  2019-12  removes 
certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to 
improve consistent application.  This guidance is effective for fiscal years and interim periods within those 
fiscal years, beginning after December 15, 2020, with early adoption permitted.  The Company is currently 
evaluating the impact of this standard on its financial statements and related disclosures.   

In August 2018, the FASB issued ASU 2018-13, “Fair Value Measurement (“Topic 820”):  Disclosure 
Framework-Changes to the Disclosure Requirements for Fair Value Measurement.”  This ASU eliminates, 
adds  and  modifies  certain  disclosure  requirements  for  fair  value  measurements  as  part  of  its  disclosure 
framework project.  The standard is effective for all entities for financial statements issued for fiscal years 
beginning  after  December  15,  2019,  and  interim  periods  within  those  fiscal  years.    Early  adoption  is 
permitted.    The  adoption  of  this guidance  is  not  expected to have  a material  impact on the  Company’s 
financial statements.   

In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (“Topic 326”). The 
ASU  introduces  a new accounting model,  the  Current  Expected  Credit  Losses model  (“CECL”),  which 
requires earlier recognition of credit losses and additional disclosures related to credit risk.  The CECL 
model utilizes a lifetime expected credit loss measurement objective for the recognition of credit losses at 
the time the financial asset is originated or acquired. ASU 2016-13 is effective for annual period beginning 
after December 15, 2022, including interim reporting periods within those annual reporting periods. We 
expect that the impact of adoption will not have a material impact. 

54 

 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

3. 

Intangible Assets and Goodwill 

U.S.  GAAP  requires  that  goodwill  and  intangible  assets  with  indefinite  lives  be  assessed  annually  for 
impairment. The Company completed its annual impairment test for 2019 in the fiscal fourth quarter.  In 
performing the assessment, the Company used current market capitalization, discounted future cash flows, 
internal forecasts and other factors as the best evidence of fair value.  These assumptions represent Level 3 
inputs.  The assessment determined that the carrying amount for the Company’s fair value of its intangible 
assets and goodwill exceeded its carrying value and no impairment loss existed for the year ended December 
31,  2019.    Future impairment  tests  will  be  performed  annually in  the  fiscal  fourth  quarter,  or  sooner if 
conditions exist that may represent an impairment.  

During the year ended December 31, 2018, the Company experienced a significant and sustained decline 
in its stock price.  The decline resulted in the Company’s market capitalization falling significantly below 
the  recorded  value  of  its  consolidated  net  assets.    As  a  result,  the  Company  performed  a  quantitative 
assessment  as  of  June  30,  2018  and  computed  a  fair  value  for  its  intangible  assets  and  goodwill.    The 
assessment determined that the carrying amount for the Company’s goodwill exceeded the estimated fair 
value  in  2018.    Additionally,  the  Company’s  indefinite-lived  intangible  assets,  relating  to  the  clinical 
protocols was also determined to be impaired.  Also, the Company has significantly reduced its operating 
activities  in  India  and  impaired  the  remaining  goodwill  and  substantially  all  of  the  intangible  assets 
including  the  remainder  of  the  clinical  protocols,  associated  with  the  acquisition  of  our  Totipotent 
subsidiaries.  As a result, the Company recorded an impairment loss in the year ended December 31, 2018.   

Balance at December 31, 2017, net 

Intangible Assets 
$21,629,000 

Goodwill 

$13,976,000 

  Amortization and foreign exchange  

(152,000) 

-- 

  Impairment loss 

(19,886,000) 

(13,195,000) 

Balance at December 31, 2018, net 

$1,591,000 

$781,000 

  Amortization and foreign exchange  

(124,000) 

-- 

Balance at December 31, 2019, net 

$1,467,000 

$781,000 

55 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

3. 

Intangible Assets and Goodwill (Continued) 

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

Weighted 
Average 
Amortization 
Period 
(in Years) 
3 
10 
7 
7 
3 

Weighted 
Average 
Amortization 
Period 
(in Years) 
3 
10 
7 
7 
3 

As of December 31, 2019 

Gross 
Carrying 
Amount 

$53,000 
318,000 
437,000 
66,000 
443,000 
1,317,000 
1,143,000 
-- 
$2,460,000 

Accumulated 
Amortization 
$45,000 
79,000 
367,000 
66,000 
436,000 
993,000 
-- 
-- 
$993,000 

As of December 31, 2018 

Impairment 
$-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
$-- 

Net 
$8,000 
239,000 
70,000 
-- 
7,000 
324,000 
1,143,000 
-- 
$1,467,000 

Gross 
Carrying 
Amount 

$54,000 
318,000 
448,000 
84,000 
451,000 
1,355,000 
1,143,000 
19,870,000 
  $22,368,000 

Accumulated 
Amortization 
$38,000 
48,000 
307,000 
68,000 
430,000 
891,000 
-- 
-- 
$891,000 

Impairment 

$16,000 
-- 
16,000 
-- 
19,870,000 
$19,886,000 

Net 
$16,000 
270,000 
141,000 
-- 
21,000 
448,000 
1,143,000 
-- 
$1,591,000 

Trade names 
Developed technology 
Licenses 
Device registration 
Customer relationships 
Amortizable intangible assets 
In process technology 
Clinical protocols 
Total 

Trade names 
Developed technology 
Licenses 
Device registration 
Customer relationships 
Amortizable intangible assets 
In process technology 
Clinical protocols 
Total 

The change in the gross carrying amount is due to foreign currency exchange fluctuations and the write-off 
of assets for impairment. Amortization of intangible assets was $124,000 for the year ended December 31, 
2019  and  $131,000  for  the  year  ended  December  31,  2018.  In  process  technology  has  not  yet  been 
introduced to the market place and is therefore not yet subject to amortization. Clinical protocols were not 
introduced to the market place and is therefore were not subject to amortization prior to being written off 
during  the  year  ended  December  31,  2018.  The  Company’s  estimated  future  amortization  expense  for 
amortizable intangible assets in subsequent years, are as follows: 

Year Ended December 31, 

2020 
2021 
2022 
2023 
2024 
Thereafter 
Total 

56 

109,000 
40,000 
32,000 
32,000 
32,000 
79,000 
$324,000 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

4.  Equipment and Leasehold Improvements, Net 

Equipment and leasehold improvements consisted of the following: 

Machinery and equipment 
Computer and software 
Office equipment 

Leasehold improvements 
Total equipment 
Less accumulated depreciation  
Total equipment and leasehold 
improvements, net 

2019 
$6,107,000 
631,000 
256,000 

932,000 
7,926,000 
(5,898,000) 

Year Ended December 31, 

  Estimated Useful Life  

2.5-10 years 
2-5 years 
5-10 years 

  Shorter of 5 years or 
remaining lease term 

2018 
$6,136,000 
664,000 
264,000 

931,000 
7,995,000 
(5,433,000) 

$2,028,000 

$2,562,000 

Depreciation expense for the years ended December 31, 2019 and 2018 were $574,000 and $539,000, 
respectively. 

5.  Related Party Transactions 

Healthbanks Biotech (USA) Inc. 
On November 26, 2019 the Company entered into a joint venture agreement with HealthBanks Biotech 
(USA)  Inc.  (the  “JV  Agreement”)  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  will  initially  be  owned  80%  by 
HealthBanks Biotech and 20% by ThermoGenesis.  ImmuneCyte will be among the first immune cell banks 
in the U.S. and offer customers the ability to preserve younger, healthier and uncontaminated immune cells 
for  future  potential  use  in dendritic  and  chimeric  antigen  receptor (“CAR-T”)  cell therapies, in  a  GMP 
compliant processing environment.  The Company’s principal contribution to ImmuneCyte was a supply 
agreement under which ImmuneCyte will have the exclusive right to purchase the Company’s proprietary 
cell processing equipment in the immune cell banking business and a non-exclusive right to purchase it for 
other  cell-based  contract  development and  manufacturing (“CMO/CDMO”) services at  a  price  equal to 
115%  of  the  Company’s  cost.  The  Company  also  contributed  to  ImmuneCyte  intellectual  property  and 
trademarks  relating  to  the  Company’s  clinical  development  assets  which  were  fully  impaired  by  the 
Company in 2018 and had no book value.  Healthbanks contributed to ImmuneCyte a paid-up, royalty free 
license to use its proprietary business management system, customer relationship management software, 
and  laboratory  information  statement,  and  it  will  also  make  available  a  $1,000,000  unsecured,  non-
convertible line of credit to ImmuneCyte to provide initial operating capital.  Healthbanks is a subsidiary 
of  Boyalife  Group,  Inc.  (USA),  the  owner  of  Boyalife  Asset  Holding  II,  Inc.,  which  is  the  largest 
stockholder of the Company, and is owned by Dr. Xiaochun (Chris) Xu, the Company’s Chief Executive 
Officer and Chairman of our Board of Directors.   

57 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

5.  Related Party Transactions (Continued) 

Healthbanks Biotech (USA) Inc. (Continued) 
In  December  2019,  ImmuneCyte  closed  a  $3,000,000  equity  investment  with  a  private  institution.  The 
investor  received  600,000  shares  of  Class  A  common  stock  at  $5.00  per  share,  representing  a  5.66% 
ownership in the joint venture.  As a result of this equity investment in ImmuneCyte, the Company’s equity 
in the joint venture is no longer subject to the anti-dilution provision.  After this investment, ImmuneCyte 
is  owned  75.47%  by  HealthBanks,  18.87%  by  ThermoGenesis  Holdings  and  5.66%  by  the  private 
institution. 

The Company initially determined that ImmuneCyte would be considered a variable interest entity, as a 
result  of the  significant  influence the  Company  has  over  operations and  its’ lack  of sufficient equity at 
inception.    After  the  additional  investment  of  $3,000,000,  ImmuneCyte’s  equity  at  risk  was  considered 
sufficient and the Company determined it would no longer be classified as a variable interest entity.  The 
Company’s  investment  in  ImmuneCyte  will  be  accounted  for  under  the  equity  method  based  on 
management’s conclusion that the Company can exercise significant influence over ImmuneCyte via its 
equity interest and the related Supply Agreement.  The Company recorded the investment initially at the 
value of the nonfinancial assets contributed of $28,000, which consisted of the book value of certain assets 
contributed at the time of formation. 

For  2019,  ImmuneCyte  had  no  revenue  or  gross  profit  and  net  income  was  a  loss  of  $78,000.    The 
Company’s portion of that was 18.87% or $15,000.  On the Balance Sheet, ImmuneCyte had $3,000,000 in 
current assets and $8,000 in non-current assets, as well as $14,000 in current liabilities and $0 in non-current 
liabilities.  

Convertible Promissory Note and Revolving Credit Agreement 
In March 2017, ThermoGenesis Holdings entered into a Credit Agreement with Boyalife Investment Fund 
II, Inc., which later merged into Boyalife Asset Holding II, Inc. (the “Lender”). The Lender is a wholly 
owned subsidiary of Boyalife Group Inc., which is owned and controlled by the Company’s Chief Executive 
Officer and Chairman of our Board of Directors. The Credit Agreement and its subsequent amendments, 
grants to the Company the right to borrow up to $10,000,000 (the “Loan”) at any time prior to March 6, 
2022 (the “Maturity Date”). The Company has drawn down a total of $8,713,000 and $7,200,000 as of 
December  31,  2019  and  2018,  respectively.    The  Company’s  ability  to  draw-down  the  remaining 
$1,287,000  may  be  impacted  by  reasons  such  as  default  or  foreign  government  policies  that  restrict  or 
prohibit transferring funds.  At the time of this filing, we are currently unable to draw down on the line of 
credit.  This may change in the near future but there is no assurance that the line of credit will become 
available at such time when it is needed. 

The Credit Agreement and the Convertible Promissory Note issued thereunder (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.  Subsequent to December 31, 2019, the 
Lender has not demanded and the Company has not paid the interest due as of December 31, 2019.  The 
Note can be prepaid in whole or in part by the Company at any time without penalty. 

58 

 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

5.  Related Party Transactions (Continued) 

Convertible Promissory Note and Revolving Credit Agreement (Continued) 
The Maturity Date of the Note is subject to acceleration at the option of the Lender upon customary events 
of default, which include; a breach of the Loan documents, termination of operations, or bankruptcy. The 
Lender’s  obligation  to  make  advances  under  the  Loan  is  subject  to  the  Company’s  representations  and 
warranties in the Credit Agreement continuing to be true at all times and there being no continuing event 
of default under the Note. 

The Credit Agreement and Note were amended in April 2018.  The amendment granted the Lender the right 
to convert, at any time, outstanding principal and accrued but unpaid interest into shares of Common Stock 
at a conversion price of $16.10 per share and if the Company issues shares of Common Stock at a lower 
price per share, the conversion price of the Note is lowered to the reduced amount.  The Company completed 
two transactions in 2018, lowering the conversion price to $1.80.  

It was concluded that the conversion option contained a beneficial conversion feature and as a result of the 
modifications to the conversion price, the Company recorded a debt discount in the amount of $7,200,000 
in 2018 and added $1,513,000 to the debt discount as a result of the draw-down during the quarter ended 
March 31, 2019.   Such discount represented the fair value of the incremental shares up to the proceeds 
received from the convertible notes.   The Company amortized $2,344,000 and $1,174,000 of such debt 
discount to interest expense for the years ended December 31, 2019 and 2018, respectively.  In addition to 
the amortization, the Company also recorded interest expense of $1,869,000 and $1,513,000 for the years 
ended December 31, 2019 and 2018, respectively.   

Distributor Agreement 
On  August  21,  2017,  ThermoGenesis  Corp.  entered  into  an  International  Distributor  Agreement  with 
Boyalife  W.S.N.  Under  the  terms  of  the  agreement,  Boyalife  W.S.N.  was  granted  the  exclusive  right, 
subject to existing distributors and customers (if any), to develop, sell to, and service a customer base for 
the ThermoGenesis Corp’s AXP AutoXpress System and BioArchive System in the People’s Republic of 
China (excluding Hong Kong and Taiwan), Singapore, Indonesia, and the Philippines (the “Territories”). 
Boyalife W.S.N. is related to our Chief Executive Officer and Chairman of our Board of Directors, and an 
affiliate  of  Boyalife  (Hong  Kong)  Limited.  Boyalife  W.S.N,’s  rights  under  the  agreement  include  the 
exclusive right to distribute AXP Disposable Blood Processing Sets and use rights to the AXP AutoXpress 
System, BioArchive System and other accessories used for the processing of stem cells from cord blood in 
the Territories. Boyalife W.S.N. is also appointed as the exclusive service provider to provide repairs and 
preventative maintenance to ThermoGenesis Corp. products in the Territories.  

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

Revenues 
During the year ended December 31, 2019, the Company recorded $794,000 of revenues from Boyalife 
W.S.N. and it’s affiliates and had an accounts receivable balance of $20,000 at December 31, 2019.  For 
the year ended December 31, 2018, the Company recorded $665,000 of revenues from Boyalife and had an 
accounts receivable balance of $0 at December 31, 2018.  

59 

 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

5.  Related Party Transactions (Continued) 

License Agreement 
On  March  12,  2018,  ThermoGenesis  Corp.  entered  into  a  License  Agreement  (the  “Agreement”)  with 
IncoCell Tianjin Ltd., a Chinese company and wholly-owned subsidiary of China-based Boyalife Group 
(“IncoCell”). Boyalife Group is an affiliate of the Company’s Chief Executive Officer and Chairman of our 
Board of Directors, and Boyalife (Hong Kong) Limited.  Under the terms of the Agreement, IncoCell was 
granted  the  exclusive  license  to  use  the  ThermoGenesis  Corp.  X-Series  products  in  the  conduct  of 
IncoCell’s contract manufacturing and development operations in the People’s Republic of China, Japan, 
South Korea, Taiwan, Hong Kong, Macau, Singapore, Malaysia, Indonesia and India (the “Territories”).  

Pursuant to the terms of the Agreement, ThermoGenesis Corp. has granted IncoCell an exclusive license to 
purchase  and  use,  at  a  discounted  purchase  price,  X-Series  cellular  processing  research  devices, 
consumables, and kits for use in the conduct of contract manufacturing and development services in the 
Territories.  In  exchange,  ThermoGenesis  Corp.  is  entitled  to  a  percentage  of  IncoCell’s  gross  contract 
development revenues, including any potential upfront payments, future milestones or royalty payments, 
during the term of the Agreement. The term of the Agreement is ten years, provided that either party may 
terminate the Agreement earlier upon ninety (90) days’ prior notice to the other party.  For the years ended 
December 31, 2019 and 2018, the Company recorded $83,000 and $14,000 of revenues from IncoCell and 
had an accounts receivable balance of $83,000 and $14,000 at December 31, 2019 and 2018, respectively. 

6.  Convertible Promissory Note 

On January 29, 2019, the Company agreed to issue and sell an unsecured note payable to an accredited 
investor (the “Accredited Investor”) for an aggregate of $800,000 face value (the “January 2019 Note”) 
that, after six months, 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 (2) 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 January 2019 Note bears interest at the rate of twenty-four percent (24%) per annum and is payable 
quarterly in arrears. Unless sooner converted in the manner described below, all principal under the January 
2019 Note, together with all accrued and unpaid interest thereupon, will be due and payable eighteen (18) 
months from the date of the issuance of the January 2019 Note.  The January 2019 Note may be prepaid 
without penalty at any time after it becomes convertible (at which time the holder will have the right to 
convert it before prepayment thereof).  

On the date that is six months after the issuance of the January 2019 Note, and for so long thereafter as any 
principal and accrued but unpaid interest under the January 2019 Note remains outstanding, the holder of 
the January 2019 Note may convert such holder’s January 2019 Note, in whole or in part, into a number of 
shares of the Company’s common stock equal to (i) the principal amount being converted, together with 
any  accrued  or  unpaid  interest  thereon,  divided  by  (ii)  the  conversion  price  in  effect  at  the  time  of 
conversion.    The  January  2019  Note  has  customary  conversion  blockers  at  4.99%  and  9.99%  unless 
otherwise  agreed  to  by  the  Company  and  the  holder.  It  was  concluded  that  the  conversion  option  was 
beneficial.    Accordingly,  the  Company  recorded  a  debt  discount  in  the  amount  of  $800,000,  upon 
stockholder approval of the conversion feature, which occurred on May 30, 2019.  The discount represented 
the fair value of the incremental shares up to the proceeds received from the convertible note.   

60 

 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

6.  Convertible Promissory Note (Continued) 

The January 2019 Note contains customary events of default, including the suspension or failure of the 
Company’s  common stock  to be traded  on a trading platform,  the  Company’s  failure  to  pay  interest  or 
principal when due, or if the Company files for bankruptcy or takes some other similar action for the benefit 
of  creditors.    In  the  event  of  any  default  under  the  January  2019  Note,  the  holder  may  accelerate  all 
outstanding interest and principal due on the January 2019 Note. 

On  July  23,  2019,  the  Company  entered  into  Amendment  No.  1  to  the  January  2019  Note  (“Amended 
Note”). Under the terms of the amendment, the maturity date of the January 2019 Note was extended from 
July 29, 2020 to July 31, 2022.  All other terms of the January 2019 Note remain the same.  The Amended 
Note was accounted for as an extinguishment of the January 2019 Note as the change in the fair value of 
the  embedded  conversion  option  featured  in  the  January  2019  Note  immediately  before  and  after  the 
amendment exceeded 10% of the carrying amount of the January 2019 Note. Accordingly, the Company 
recorded a loss on the constructive extinguishment of this debt in the amount of $840,000 for the year ended 
December 31, 2019.  The fair value of the Amended Note, which amounted to $1,473,000 was recorded as 
liability.    The  Company  also  evaluated  the  conversion  option  embedded  in  the  Amended  Note  and 
determined  it  was  beneficial.    Accordingly,  the  Company  recorded  a  debt  discount  in  the  amount  of 
$556,000 on the Amended Note for the year ended December 31, 2019.  The Company amortized $77,000 
of the debt discount for the January 2019 Note to interest expense for the year ended December 31, 2019. 
The Company utilized a Monte Carlo simulation model to determine the fair value of the Amended Note.  
The key assumptions used in the simulation model were: 

Stock price at date of issuance 
Exercise price(1) 
Risk-free interest rate 
Expected dividend yield 
Expected term (in years) 
Expected volatility 

$3.05 
$1.80 
1.8% 
-- 
3.02 
93% 

__________________ 
(1)  For the exercise price, the model inputs also accounted for the fair value protection under the Amended 
Note, which allows for the holder to convert at the lower of $1.80 share or 90% of the listed price of the 
stock on the day of conversion, whichever is lower (subject to a floor of $0.50). 

During the year ended December 31, 2019, the holder converted a portion of the face value of the note into 
shares  of  common  stock.    In  total,  $432,000  was  converted  into  240,000  shares  of  common  stock.  
Additionally,  the  unamortized  premium  for  the  portion  of  the  note  that  was  converted  of  $60,000  was 
recorded to interest income during the year ended December 31, 2019.   

On July 23, 2019, the Company entered into a private placement with the Accredited Investor, pursuant to 
which  the  Company  issued  and  sold  to  such  investor  an  unsecured  convertible  promissory  note  in  the 
original principal amount of $1,000,000 (the “July 2019 Note”).   After six months and subject to the receipt 
of stockholder approval of the conversion feature of the July 2019 Note, such 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 the rate of twenty-four percent (24%) per 
annum and is payable quarterly in arrears.   Unless sooner converted in the manner described below, all 
principal under the July 2019 Note, together with all accrued and unpaid interest thereupon, will be due and 
payable three years from the date of the issuance on July 31, 2022.   

61 

 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

6.  Convertible Promissory Note (Continued) 

However, if stockholder approval of the conversion feature of the July 2019 Note is not obtained at the 
Company’s next annual meeting of stockholders (expected to be in the second quarter of 2020), the maturity 
date will accelerate to the date that is fourteen days after the next annual meeting.   

The July 2019 Note may be prepaid without penalty at any time after it becomes convertible (at which time 
the holder will have the right to convert it before prepayment thereof). On the date that is six months after 
the  issuance  of  the  July  2019  Note  and  after  receiving  stockholder  approval  of  the  conversion  feature 
described above, the holder may convert the July 2019 Note, in whole or in part, into a number of shares of 
the Company’s common stock equal to (i) the principal amount being converted, together with any accrued 
or unpaid interest thereon, divided by (ii) the conversion price in effect  at the time of conversion.  The 
Company has accounted for the July 2019 Note as a debt instrument until such time the conversion feature 
is approved by the Company’s stockholders. The Company will account for the conversion feature at the 
time of its effectiveness if approved. 

On August 28, 2018, the Company completed a private placement transaction with an accredited investor, 
in which the Company sold 100,000 shares of Common Stock for a purchase price of $1.80 per share and 
296,500 pre-funded warrants for a purchase price of $1.70 per pre-funded warrant.  Each pre-funded warrant 
is immediately exercisable for one share of Common Stock at an exercise price of $0.10 per share and will 
remain exercisable until exercised in full.  The Company received $684,000 in gross proceeds, net proceeds 
of $623,000 after deducting offering expenses of $61,000.  As of December 31, 2019, all of the pre-funded 
warrants issued in the August 2018 private placement have been exercised.  In addition, subject to certain 
exceptions,  in  the  event  the  Company  sold  or  issued  any  shares  of  Common  Stock  or  common  stock 
equivalents at a lower price through February 26, 2019, the Company was required to issue the investor a 
number  of  shares  of  Common  Stock  (or  additional  pre-funded  warrants  to  purchase  shares  of  common 
stock) equal to the number of shares the investor would have received had the purchase price for such shares 
been at such lower purchase price.  The Company did not sell or issue any shares at a lower price prior to 
February  26,  2019.    The  Company  evaluated  the  pre-funded  warrants  issued  and  determined  that  the 
warrants should be classified as equity instruments.   

62 

 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

7.  Derivative Obligations 

Series A Warrants 
Series A warrants to purchase 40,441 common shares were issued and vested during the year ended June 
30, 2016. At the time of issuance, the Company determined that because such warrants can be settled for 
cash at the holders’ option in a future fundamental transaction, they constituted a derivative liability. The 
Company has estimated the fair value of the derivative liability, using a Binomial Lattice Valuation Model 
and the following assumptions: 

Market price of common stock 
Expected volatility 
Contractual term (years) 
Discount rate 
Dividend rate 
Exercise price 

Year Ended December 31, 
2018 
2019 
$2.70 
$4.40 
94% 
96% 
2.2 
1.2 
2.48% 
1.59% 
0% 
0% 
$80.00 
$80.00 

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

The Company recorded a gain (loss) of $1,000 during the year ended December 31, 2019 and $596,000 
during the year ended December 31, 2018, representing the net change in the fair value of the derivative 
liability,  which  is  presented  as  fair  value  change  of  derivative  instruments,  in  the  accompanying 
consolidated statements of operations and comprehensive loss. 

The following table represents the Company’s fair value hierarchy for its financial liabilities measured at 
fair value on a recurring basis as of December 31, 2019 and 2018: 

 Derivative Obligation 
Balance 
Level 1 
Level 2 
Level 3 

Year Ended December 31, 
2018 
$1,000 
$- 
$- 
$1,000 

2019 
$-- 
$- 
$- 
$-- 

The following table reflects the change in fair value of the Company’s derivative liability: 

Balance – December 31, 2017 
  Change in fair value of derivative obligation 
Balance – December 31, 2018 

  Change in fair value of derivative obligation 

Balance – December 31, 2019 

Amount 

$597,000 
(596,000) 
1,000 
(1,000) 
$-- 

63 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
 
  
  
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

8.  Commitments and Contingencies  

Financial Covenants 
Effective May 15, 2017, the Company entered into a Sixth Amended and Restated Technology License and 
Escrow Agreement with CBR Systems, Inc. which modified the financial covenant that the Company must 
meet in order to avoid an event of default. The Company must maintain a  cash balance and short-term 
investments net of debt or borrowed funds that are payable within one year of not less than $2,000,000 
(amended to $1,000,000 in March 2020). The Company was in compliance with this financial covenant as 
of December 31, 2019.  

Potential Severance Payments 
The Company’s  Chief Executive Officer has rights upon termination under  his employment  agreement. 
With respect to his agreement at December 31, 2019, potential severance amounted to $2.3 million. 

Contingencies and Restricted Cash 
In fiscal 2016, the Company signed an engagement letter with a strategic consulting firm (“Mavericks”).  
Included  in  the  engagement  letter  was  a  success  fee  due  upon  the  successful  conclusion  of  certain 
transactions.  On May 4, 2017, a lawsuit was filed in California Superior Court against the Company and 
its  Chief  Executive  Officer  by  the  consulting  firm,  which  argued  that  it  was  owed  a  transaction  fee  of 
$1,000,000 under the terms of the engagement letter due to the conversion of the Boyalife debentures in 
August 2016.  In October 2017, to streamline the case by providing for the dismissal of claims against the 
Company’s Chief Executive Officer based on alter ego theories and without acknowledging any liability, 
the Company deposited $1,000,000 with the Court, which was recorded as restricted cash.  The Company 
filed a Motion for Summary Judgment, which was denied by the Court on June 26, 2018. On September 
24, 2018, Mavericks filed an amended complaint, adding back the Company’s Chief Executive Officer as 
a named defendant, as well as Boyalife Investment, Inc. (a dissolved company) and Boyalife (Hong Kong) 
Limited under new theories of liability, namely intentional interference with contract and inducement of 
breach of contract.   On July 22, 2019, Mavericks filed a Request for Dismissal requesting the Court to 
dismiss the served Boyalife entities and the Company’s Chief Executive Officer as well as the intentional 
interference with performance of contract and inducing breach of contract causes of action from the lawsuit.  
As such, the only remaining claim at present is the original breach of contract claim against the Company.  
The trial completed in February 2020 with an adverse jury verdict in favor of Mavericks in the total amount 
of $1,000,000.  The Action is now in the post-trial phase and no judgment has been entered as the parties 
are disputing whether the defense of equitable estoppel should bar entry of judgment at all and the proper 
per-judgment interest start date.  At present, the Court is already holding a $1,000,000 cash bond deposited 
by the Company early in the litigation.  After entry of judgment, the Court will permit release of those funds 
to the Mavericks.  As a result, the Company recorded in other current liabilities a $1,400,000 loss in general 
and administrative for the year ended December 31, 2019.  The loss includes the $1,000,000 transaction fee 
and an estimated $400,000 in interest due. The $1,000,000 deposited with the court will be used to settle 
the transaction fee.   

In  the  normal  course  of  operations,  the  Company  may  have  disagreements  or  disputes  with  customers, 
employees or vendors. Such potential disputes are seen by management as a normal part of business. As of 
December 31, 2019, except as disclosed, management believes any liability that may ultimately result from 
the  resolution  of  these  matters  will  not  have  a  material  adverse  effect  on  the  Company’s  consolidated 
financial position, operating results or cash flows. 

64 

 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

8.  Commitments and Contingencies (Continued)  

Warranty 
The  Company  offers  a  warranty  on  all  its  non-disposable  products  of  one  to  two  years.  The  Company 
warrants  disposable  products  through  their  expiration  date.  The  Company  periodically  assesses  the 
adequacy of the warranty reserves and adjusts as necessary. 

Changes in the Company’s warranty reserve, which is included in other current liabilities in the 
accompanying consolidated balance sheet is as follows: 

Beginning balance 
Warranties originated during the year 
Claims settled made during the year 
Changes in reserve estimate 
Ending balance 

Year Ended December 31, 
2019 
2018 
$186,000 
254,000 
(154,000) 
(9,000) 
$277,000 

$291,000 
199,000 
(252,000) 
(52,000) 
$186,000 

Coronavirus (COVID-19) 
In  December  2019,  a  novel  strain  of  coronavirus  was  reported  in  Wuhan,  China.  The  World  Health 
Organization has declared the outbreak to constitute a “Public Health Emergency of International Concern.” 
The COVID-19 outbreak is disrupting supply chains and affecting production and sales across a range of 
industries. The extent of the impact of COVID-19 on our operational and financial performance will depend 
on  certain  developments,  including  the  duration  and  spread  of  the  outbreak,  impact  on  our  customers, 
employees and vendors all of which are uncertain and cannot be predicted. At this point, the extent to which 
COVID-19 may impact our financial condition or results of operations is uncertain. 

9.  Leases 

Operating Leases 
The Company leases the Rancho Cordova, California and Gurgaon, India facilities pursuant to operating 
leases. The Rancho Cordova lease expires in May 2024.  The Gurgaon lease expires in September 2023; 
however,  either  party  can  terminate  after  September  2019  with  three  months’  notice.    As  such  it  was 
accounted for as a short-term lease. 

Operating  lease  assets  and  liabilities  are  recognized  at  the  lease  commencement  date.    Operating  lease 
liabilities  represent  the  present  value  of  remaining  minimum  lease  payments.    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.  Our material leases typically contain rent escalations over the 
lease term.  We recognize expense for these leases on a straight-line basis over the lease term. 

65 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

9.  Leases (Continued) 

Operating Leases (Continued) 
The following summarizes the Company’s operating leases: 

Right-of-use operating lease assets, net 
Current lease liability 
Non-current lease liability 

Weighted average remaining lease term 
Discount rate 

December 31,  
2019 
$859,000 
118,000 
761,000 

4.4 
22% 

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

2020 
2021 
2022 
2023 
2024 
Thereafter 
Total lease payment 
Less: imputed interest 
Present value of operating lease liabilities 

301,000 
310,000 
319,000 
328,000 
139,000 
-- 
$1,397,000 
(538,000) 
$859,000 

Statement of Cash Flows 
In  January  2019,  the  Company  signed  an  amendment  to  its  lease  for  office  space  at  its  corporate 
headquarters in Rancho Cordova, CA.  The amendment was accounted for as a modification and resulted 
in a right-of-use asset of $966,000 being recognized as a non-cash addition on the date of the amendment.  
Cash  paid  for  amounts  included  in  the  measurement  of  operating  lease  liabilities  in  cash  flows  from 
operating activities were $291,000 for the years ended December 31, 2019. 

Operating Lease Costs 
Operating lease costs were $410,000 during the year ended December 31, 2019, which included $204,000 
for interest expense, $108,000 in amortization expense, $72,000 in variable lease costs and $26,000 for 
short term lease costs.  These costs are primarily related to long-term operating leases, but also include 
immaterial amounts for variable lease costs and short-term leases with terms greater than 30 days. 

Finance Leases 
Finance leases are included in equipment and other current and non-current liabilities in the accompanying 
condensed consolidated balance sheet.  The amortization and interest expense are included in general and 
administrative expense and interest expense, respectively in the accompanying statements of operations.  
These leases are not material as of December 31, 2019. 

66 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

10.  Stockholders’ Equity 

Common Stock 
On December 13, 2019, the Company entered into an At The Market Offering Agreement, by and between 
the Company and H.C. Wainwright & Co., LLC, as agent (“H.C. Wainwright”) (the “ATM Agreement”), 
pursuant to which the Company may offer and sell, from time to time through H.C. Wainwright, shares of 
Common Stock, having an aggregate offering price of up to $4.4 million (the “HCW Shares”). The offer 
and sale of the HCW Shares is made pursuant to a shelf registration statement on Form S-3 and the related 
prospectus (File No. 333-235509).  Pursuant to the ATM Agreement, H.C. Wainwright may sell the HCW 
Shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415 of 
the  Securities  Act,  including  sales  made  by  means  of  ordinary  brokers’  transactions,  including  on  The 
NASDAQ Capital Market, at market prices or as otherwise agreed with H.C. Wainwright. H.C. Wainwright 
will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the 
HCW Shares from time to time, based upon instructions from the Company, including any price or size 
limits  or  other  customary  parameters  or  conditions  the  Company  may  impose.    The  Company  is  not 
obligated to make any sales of the HCW Shares under the ATM Agreement. The offering of HCW Shares 
pursuant to the ATM Agreement will terminate upon the earliest of (a) the sale of all of the HCW Shares 
subject to the ATM Agreement, (b) the termination of the ATM Agreement by H.C. Wainwright or the 
Company,  as  permitted  therein,  or  (c)  August  9,  2022.  The  Company  will  pay  H.C.  Wainwright  a 
commission rate equal to 3% of the aggregate gross proceeds from each sale of HCW Shares and have 
agreed to provide H.C. Wainwright with customary indemnification and contribution rights. The Company 
will also reimburse H.C. Wainwright for certain specified expenses in connection with entering into the 
ATM Agreement. Subsequent to December 31, 2019, the Company has sold a total of 50,746 shares of 
Common Stock for aggregate gross proceeds of $280,000 at an average selling price of $5.44 per share, 
resulting in net proceeds of approximately $113,000 after deducting legal expenses, audit fees, commissions 
and other transaction costs of approximately $167,000. 

On April 18, 2019, the Company entered into a Securities Purchase Agreement with an accredited investor 
pursuant to which the Company agreed to issue and sell to such investor (the “April Offering”) 444,445 
pre-funded warrants to purchase shares of  Common Stock for a purchase price of $1.70 per pre-funded 
warrant.  Each pre-funded warrant is immediately exercisable for one share of Common Stock at an exercise 
price  of  $0.10  per  share  and  will  remain  exercisable  until  exercised  in  full.    The  gross  proceeds  to  the 
Company, excluding the proceeds, if any, from the exercise of the pre-funded warrants, was approximately 
$756,000.  The April Offering closed on April 26, 2019 and the pre-funded warrants were accounted for as 
equity by the Company.  Subject to certain exceptions, in the event the Company sells or issues any shares 
of common stock or common stock equivalents at a lower price during the period beginning on the closing 
date of the April Offering and ending on the date that is three-hundred and sixty-five (365) days following 
such date, the Company is required to issue the investor a number of shares of common stock (or additional 
pre-funded warrants to purchase shares of common stock) equal to the number of shares the investor would 
have received had the purchase price for such shares been at such lower purchase price.  As December 31, 
2019, 120,000 of the pre-funded warrants issued in the April Offering had been exercised, leaving 324,445 
pre-funded warrants outstanding.   

67 

 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

10.  Stockholders’ Equity (Continued) 

Common Stock (Continued) 
On August 28, 2018, the Company completed a private placement transaction with an accredited investor, 
in which the Company sold 100,000 shares of Common Stock for a purchase price of $1.80 per share and 
296,500 pre-funded warrants for a purchase price of $1.70 per pre-funded warrant.  Each pre-funded warrant 
is immediately exercisable for one share of Common Stock at an exercise price of $0.10 per share and will 
remain exercisable until exercised in full.  The Company received $623,000 in net proceeds after deducting 
offering expenses of $61,000.  In addition, subject to certain exceptions, in the event the Company sells or 
issues any shares of Common Stock or common stock equivalents at a lower price through February 26, 
2019, the Company is required to issue the investor a number of shares of Common Stock (or additional 
pre-funded warrants to purchase shares of common stock) equal to the number of shares the investor would 
have received had the purchase price for such shares been at such lower purchase price.  The Company did 
not issue any shares at a lower price prior to February 26, 2019.  The Company determined that the pre-
warrants should be classified as equity instruments.   As of December 31, 2019, all 296,500 of the pre-
funded warrants issued in the August 2018 private placement have been exercised. 

On May 18, 2018, the Company completed a public offering for 647,501 Units and 269,167 Pre-Funded 
Units  for  a  purchase  price  of  $6.00  per  Unit,  resulting  in  aggregate  gross  proceeds  of  approximately 
$5,473,000,  net  proceeds  of  $4,792,000  after  deducting  the  offering  expenses  of  $679,000.    Each  Unit 
consists of one share of Common Stock, and one common warrant to purchase one share of Common Stock, 
and each Pre-Funded Unit consists 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 included in the Units 
and Pre-Funded Units were immediately exercisable at a price of $6.00 per share of Common Stock, subject 
to adjustment in certain circumstances, and will expire five years from the date of issuance.  The Company 
evaluated  the  warrants  issued  and  determined  that  they  should  be  classified  as  equity  instruments.    All 
269,167 Pre-Funded units issued in the May 2018 public offering were exercised in the second quarter of 
fiscal 2018. 

On March 28, 2018, the Company sold 60,964 shares of Common Stock at a price of $22.70 per share.  The 
net proceeds to the Company from the sale and issuance of the shares, after deducting the offering expenses 
borne by the Company of approximately $171,000, were $1,213,000.  Additionally, the investors received 
unregistered  warrants  in  a simultaneous  private  placement  to  purchase  up  to  30,482  shares  of  common 
stock.  The warrants have an exercise price of $26.80 per share and were exercisable six months following 
the issuance date, or September 28, 2018, and have a term of 5.5 years and were accounted for as equity by 
the Company. 

68 

 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

10.  Stockholders’ Equity (Continued) 

Warrants 
A summary of warrant activity is as follows: 

Beginning balance  
Warrants granted 
Warrants exercised 
Warrants expired/canceled 
Outstanding 
Exercisable 

Number of 
Shares 
1,726,522 
444,445 
(435,264) 
(19,637) 
1,716,066 
1,646,214 

Year Ended December 31, 

2019 

Weighted-
Average Exercise 
Price Per Share 

$29.88 
$0.10 
$0.35 

$25.23 
$22.91 

2018 

Weighted-
Average Exercise 
Price Per Share 

$93.70 
$4.20 
$0.10 

$29.88 
$27.80 

Number of 
Shares 

482,873 
1,512,816 
(269,167) 
-- 
1,726,522 
1,656,668 

Equity Plans and Agreements 
The Amended 2016 Equity Incentive Plan (the “Amended 2016 Plan”) was approved by the stockholders 
in May 2017, under which up to 600,000 shares may be issued pursuant to  grants of shares, options, or 
other forms of incentive compensation. On June 22, 2018, the stockholders approved an amendment to the 
Amended 2016 Plan to increase the number of shares that may be issued to 1,325,000 shares. On May 30, 
2019, the shareholders approved an amendment to the Amended 2016 Plan to increase the number of shares 
that may be issued from 1,325,000 shares to 3,925,000 shares.  As of December 31, 2019, 103,803 awards 
were available for issuance under the Amended 2016 Plan. 

The 2012 Independent Director Plan (the “2012 Plan”) permits the grant of stock or options to independent 
directors.  A  total  of  2,500 shares  were  approved  by the  stockholders  for issuance  under  the  2012  Plan. 
Options are granted at prices that are equal to 100% of the fair market value on the date of grant and expire 
over a term not to exceed ten years. Options generally vest in monthly increments over one year, unless 
otherwise determined by our Board of Directors. As of December 31, 2019, there were 234 shares available 
for issuance. 

The 2006 Equity Incentive Plan (the “2006 Plan”) permitted the grant of options, restricted stock units, 
stock bonuses and stock appreciation rights to employees, directors and consultants. The 2006 Plan, but not 
the awards granted thereunder, expired in 2016. As of December 31, 2019, 3,865 option awards remained 
outstanding. 

On December 29, 2017, the Board of Directors of ThermoGenesis Corp. adopted the ThermoGenesis Corp. 
2017 Equity Incentive Plan (the “ThermoGenesis Plan”) and on the same day granted options to purchase 
an  aggregate  of  280,000  shares  of  ThermoGenesis  Corp.  common  stock  to  employees,  directors, 
consultants, and advisors of ThermoGenesis Corp. The ThermoGenesis Plan was unanimously approved 
by the ThermoGenesis stockholders (including the Company) on December 29, 2017.  The ThermoGenesis 
Plan authorizes the issuance of up to 1,000,000 shares of ThermoGenesis common stock.  There are 20,000 
shares available for issuance as of December 31, 2019.  

69 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

10.  Stockholders’ Equity (Continued) 

Equity Plans and Agreements (Continued) 
On April 7, 2019, two employees were granted performance-based options to  purchase an aggregate of 
800,000 shares of Thermo Genesis Corp. common stock at an exercise price of $0.65 if certain milestones 
were met.  One milestone was met resulting in 300,000 options vesting in the year ended December 31, 
2019. 

On December 14, 2018, the CEO, the CFO and other employees were granted 214,000 options to purchase 
shares of the Company’s common stock at an exercise price of $2.979 per share.  The options vest in five 
equal installments on the date of grant and the first four anniversaries of the grant date.  A portion of the 
grant,  169,934  shares  were  subject  to  approval  of  the  2016  Plan  Amendment  by  the  Company’s 
stockholders, which was approved on May 30, 2019.   

Stock Based Compensation 
The Company recorded stock-based compensation of $614,000 for the year ended December 31, 2019 and 
$652,000 for the year ended December 31, 2018, as comprised of the following: 

Cost of revenues 
Sales and marketing 
Research and development 
General and administrative 

Year Ended December 31, 

2019 

$3,000 
185,000 
98,000 
328,000 
$614,000 

2018 

$15,000 
63,000 
136,000 
438,000 
$652,000 

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

  Weighted- 
Average 
Remaining 
Contractual 
Life 

Weighted- 
Average 
Exercise 
Price 
$13.99 

Aggregate 
Intrinsic 
Value 

$4.38 
$9.42 
$13.96 

$15.72 
$19.79 

8.3 

8.2 
7.9 

$280,000 

$203,000 
$115,000 

Outstanding at January 1, 2019 

Granted 
Forfeited/cancelled 
Outstanding at December 31, 2019 
Vested and Expected to Vest at 
  December 31, 2019 
Exercisable at December 31, 2019 

Number 
of Shares 
302,368 

11,450 
(22,011) 
291,807 

224,102 
147,124 

70 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

10.  Stockholders’ Equity (Continued) 

Stock Options (Continued) 
The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying 
awards and the quoted price of the Company’s common stock. There were no options that were exercised 
during the years ended December 31, 2019 and 2018.   

Non-vested stock option activity for the year ended December 31, 2019, is as follows: 

Outstanding at January 1, 2019 
Granted 
Vested 
Cancelled/forfeited 
Outstanding at December 31, 2019 

Non-vested Stock 
Options 

212,172 
11,450 
(63,675) 
(15,264) 
144,683 

  Weighted-Average 

Grant Date Fair Value 
$6.39 
$3.30 
$6.73 
$2.74 
$6.38 

The fair value of the Company’s stock options granted for the year ended December 31, 2019 and year 
ended December 31, 2018 was estimated using the following weighted-average assumptions: 

Expected life (years) 
Risk-free interest rate 
Expected volatility 
Dividend yield 

Year Ended December 31, 

2019 
5 
1.68% 
103% 
0% 

2018 
6 
2.7% 
103% 
0% 

The weighted average grant date fair value of options granted during the years ended December 31, 2019 
and 2018 was $3.30 and $3.20 respectively. 

At December 31, 2019, the total compensation cost related to options granted under the Company’s stock 
option plans but not yet recognized was $1,051,000. This cost will be amortized on a straight-line basis 
over a weighted-average period of approximately three years and will be adjusted for subsequent changes 
in estimated forfeitures. The total fair value of options vested during the year ended December 31, 2019 
and year ended December 31, 2018 was $428,000 and $633,000 respectively. 

71 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

11.  Concentrations 

One customer had an accounts receivable balance of $337,000 or 26% and $494,000 or 33% at December 
31, 2019 and 2018, respectively.  Revenues from that customer totaled $3,575,000 or 28% and $2,120,000 
or 22% for the years ended December 31, 2019 and 2018, respectively. One distributor had an accounts 
receivable balance of $177,000 or 14% and $229,000 or 15% at December 31, 2019 and 2018, respectively.  
Revenues  from  that  distributor  totaled  $1,470,000  or  11%  and  $861,000  or  9%  for  the  years  ended 
December 31, 2019 and 2018, respectively.  A second distributor had an accounts receivable balance of 
$170,000 or 13% and $220,000 or 15% at December 31, 2019 and 2018, respectively. 

Two suppliers accounted for 57% and 18% of total inventory purchases during the year ended December 
31, 2019.  Two suppliers accounted for 43% and 14% of total inventory purchases during the year ended 
December 31, 2018.  

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

United States 
Costa Rica 
India 
All other countries 
Total equipment, net 

Year Ended December 31, 
2019 
$1,108,000 
582,000 
225,000 
113,000 
$2,028,000 

2018 
$1,614,000 
601,000 
211,000 
136,000 
$2,562,000 

72 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

12.  Segment Reporting 

The Company has two reportable segments, which are the same as its operating segments: 

The  Device  Segment,  engages  in  the  development  and  commercialization  of  automated 
technologies  for  cell-based  therapeutics  and  bio-processing.  The  device  division  is  operated 
through the Company’s ThermoGenesis Corp. subsidiary.   

The  Clinical  Development  Segment,  utilizes  autologous  (utilizing  the  patient’s  own  cells)  stem 
cell-based therapeutics through the Company’s TotipotentRX subsidiary in Gurgaon, India.  

The following table summarizes the operating results of the Company’s reportable segments: 

Net revenues 
Cost of revenues 
Gross profit 

Operating expenses 
Operating loss 

Depreciation and amortization 
Stock-based compensation expense 
Goodwill 
Total assets 

Net revenues 
Cost of revenues 
Gross profit 

Operating expenses 
Operating loss 

Year Ended December 31, 2019 

Device 

$12,957,000 
7,175,000 
5,782,000 

7,081,000 
$(1,299,000) 

$530,000 
$393,000 
$781,000 
$13,420,000 

Clinical 
Development 

$90,000 
176,000 
(86,000) 

Total 

$13,047,000 
7,351,000 
5,696,000 

3,348,000 
$(3,434,000) 

10,429,000 
$(4,733,000) 

$275,000 
$221,000 
$-- 
$1,794,000 

$805,000 
$614,000 
$781,000 
$15,214,000 

Year Ended December 31, 2018 

Device 

$9,469,000 
7,205,000 
2,264,000 

Clinical 
Development 

$203,000 
274,000 
(71,000) 

Total 
$9,672,000 
7,479,000 
2,193,000 

8,398,000 
$(6,134,000) 

37,340,000 
$(37,411,000) 

45,738,000 
$(43,545,000) 

Depreciation and amortization 
Stock-based compensation expense 
Goodwill 
Total assets 

$398,000 
$179,000 
$781,000 
$10,815,000 

$272,000 
$473,000 
-- 
$3,796,000 

$670,000 
$652,000 
$781,000 
$14,611,000 

73 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

12.  Segment Reporting (Continued) 

The Company had sales in the following geographical areas for the: 

United States 
Asia – other 
Europe 
China 
Other 

Year Ended December 31, 
2019 
$6,787,000 
2,108,000 
1,233,000 
2,346,000 
573,000 
$13,047,000 

2018 
$4,854,000 
1,717,000 
1,165,000 
1,143,000 
793,000 
$9,672,000 

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

13. 

Income Taxes 

Loss  before  income  tax  benefits  was  comprised  of  $9,934,000  from  US  and  $150,000  from  foreign 
jurisdictions for the year ended December 31, 2019 and $45,458,000 from US and $212,000 from foreign 
jurisdictions for the year ended December 31, 2018. 

The reconciliation of federal income tax attributable to operations computed at the federal statutory tax rate 
to income tax benefit is as follows for the: 

Statutory federal income tax benefit 
Intangible assets 
Change in valuation allowance 
Expiration of net operating losses 
United States tax reform rate change 
Disallowed financing costs 
State and local taxes 
Other 
Total income tax benefit 

Year Ended December 31, 
2018 
2019 

$(2,118,000) 
673,000 
(681,000) 
1,187,000 
-- 
1,119,000 
(205,000) 
25,000 
$-- 

$(9,591,000) 
3,119,000 
(2,084,000) 
1,271,000 
-- 
240,000 
2,344,000 
(29,000) 
$(4,730,000) 

For the year ended December 31, 2019, the Company had no tax expense compared to $4,730,000 of tax 
benefit for the year ended December 31, 2018.  The income tax expense in 2019 is due to state minimum 
taxes.  The income tax benefit for the year ended December 31, 2018 was due to the impairment of the 
indefinite  lived  intangible  assets  for  the  clinical  protocols  and  goodwill.    The  Company’s  deferred  tax 
liability is tied to the intangible assets and goodwill. 

74 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

13. 

Income Taxes (Continued) 

At December 31, 2019, we had federal net operating loss carryforwards of approximately $121,195,000 to 
offset future federal taxable income, with $109,293,000 available through 2037 and $11,902,000 available 
indefinitely. We also had state net operating loss carryforwards of approximately $43,870,000 that may 
offset future state taxable income through 2039.  We also had foreign net operating loss carryforwards of 
approximately $2,495,000 that may offset future foreign taxable income through 2027.   

At December 31, 2019, the Company has research and experimentation credit carryforwards of $1,591,000 
for  federal  tax  purposes  that  expire  in  various  years  between  2020  and  2039,  and  $1,476,000  for  state 
income tax purposes that do not have an expiration date.  

Significant components of the Company’s deferred tax assets and liabilities for federal and state income 
taxes are as follows: 

Deferred tax assets: 
  Net operating loss carryforwards 
Income tax credit carryforwards 
Stock compensation 
Lease Obligation 
  Deferred Revenue 
  Other 
Total deferred tax assets 

Deferred tax liabilities 

Indefinite lived intangible assets 

  Depreciation and amortization 

Lease asset 
Total deferred tax liabilities 

  Valuation allowance 
  Net deferred taxes  

Year Ended December 31, 
2019 

2018 

$26,758,000 
2,757,000 
384,000 
185,000 
419,000 
943,000 
31,446,000 

-- 
(408,000) 
(180,000) 
(588,000) 
(30,858,000) 
$-- 

$27,312,000 
2,769,000 
850,000 
-- 
-- 
1,027,000 
31,958,000 

-- 
(419,000) 
-- 
(419,000) 
(31,539,000) 
$-- 

ASC  740  requires  that  the  tax  benefit  of  net  operating  losses,  temporary  differences  and  credit 
carryforwards be recorded as an asset to the extent that management assesses that realization is "more likely 
than not." Realization of the future tax benefits is dependent on the Company's ability to generate sufficient 
taxable  income  within  the  carryforward  period.  Because  of  the  Company's  recent  history  of  operating 
losses, management believes that recognition of the deferred tax assets arising from the above-mentioned 
future tax benefits is currently not likely to be realized and, accordingly, has provided a valuation allowance. 

The valuation allowance decreased by $681,000 and $2,266,000 during the years ended December 31, 2019 
and 2018, respectively. 

75 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THERMOGENESIS HOLDINGS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 

13. 

Income Taxes (Continued) 

The transition tax is based on total post-1986 earnings and profits which were previously deferred from 
U.S. income taxes.  At December 31, 2019, the Company did not have any undistributed earnings of our 
foreign subsidiaries.  As a result, no additional income or withholding taxes have been provided for.  The 
Company does not anticipate any impacts of the global intangible low taxed income (“GILTI”) and base 
erosion anti-abuse tax (“BEAT”) and as such, the Company has not recorded any impact associated with 
either GILTI or BEAT. 

In August 2016, the conversion of the Boyalife debentures effected an “ownership change” as defined under 
the provisions of the Tax Reform Act of 1986. As a result, any net operating loss and credit carryovers 
existing at that date will be subject to an annual limitation regarding their utilization against taxable income 
in  future  periods.  Additionally,  before  the  conversion  of  the  debentures,  it  is  possible  that  “ownership 
changes” occurred, which could create additional limitations on the use of our net operating losses and 
credit  carryovers.  Additionally,  ownership  changes  may  have  occurred  in  the  periods  after  2016  which 
could limit our utilization of losses and credits generated in the years 2016 – 2019.   

14.  Employee Retirement Plan 

The Company sponsors an Employee Retirement Plan, generally available to all employees, in accordance 
with Section 401(k) of the Internal Revenue Code. Employees may elect to contribute up to the Internal 
Revenue Service annual contribution limit. Under this Plan, at the discretion of the Company’s Board of 
Directors,  the  Company  may  match  a  portion  of  the  employees’  contributions.  The  Company  made  no 
discretionary or matching contributions to the Plan for the year ended December 31, 2019 and year ended 
December 31, 2018. 

15. Subsequent Events 

The Company has evaluated events subsequent to the balance sheet date for inclusion in the accompanying 
consolidated financial statements through the date of issuance and determined that no subsequent events 
have occurred that would require recognition in the consolidated financial statements or disclosures in the 
notes thereto other than as disclosed below.  

On  February  13,  2020,  the  Company  received  a  conversion  notice  from  Boyalife  to  convert  a  total  of 
$3,000,000 of the outstanding balance of the Second Amended and Restated Convertible Promissory Note 
(the “Note”) issued by the Company to Boyalife on April 16, 2018. The amount converted represents the 
unpaid accrued interest as of December 31, 2019 of $1,869,000 and $1,131,000 of the outstanding principal 
balance. The conversion resulted in the issuance of 1,666,670 shares of the Company’s common stock at a 
conversion  price  of  $1.80  per  share.  Immediately  after  the  conversion,  the  new  outstanding  principal 
balance of the Note was $7,582,000.  

On  March  17,  2020,  the  Company’s  wholly  owned  subsidiary  ThermoGenesis  Corp.  entered  into  a 
Manufacturing and Supply Amending Agreement #1 with CBR with an effective date of March 16, 2020 
(the “Amendment”).  The Amendment amends the Manufacturing and Supply Agreement entered into on 
May  15,  2017  by  the  Company  and  CBR  (the  “Original  Agreement”).    The  Amendment,  among  other 
things, amends the Original Agreement by lowering the default threshold under which CBR may, upon a 
default  by  the  Company,  purchase  licensed  products  directly  from  the  Company’s  manufacturers  and 
suppliers from $2,000,000 to $1,000,000 for a cash balance coupled with short-term investments net of debt 
or borrowed funds that are payable within one year at any month end unless the Company cures such default 
within thirty (30) days of the end of such month.  

76 

 
 
 
  
 
 
 
 
 
 
ITEM 9. 
ACCOUNTING AND FINANCIAL DISCLOSURE. 

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON 

None. 

ITEM 9A.  CONTROLS AND PROCEDURES. 

Disclosure Controls and Procedures 
We carried out an evaluation, under the supervision and with the participation of management, including 
our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation 
of our disclosure controls and procedures (as defined by Exchange Act Rule 13a-15(e) and 15d-15(e)) as 
of the end of our last fiscal quarter pursuant to Exchange Act Rule 13a-15. The term “disclosure controls 
and procedures” means controls and other procedures designed to ensure that information required to be 
disclosed in reports filed or submitted under the Exchange Act is recorded, processed, summarized and 
reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures 
include,  without  limitation,  controls  and  procedures  designed  to  ensure  that  such  information  is 
accumulated  and  communicated  to  management,  including  the  Chief  Executive  Officer  and  the  Chief 
Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Based upon that 
evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls 
and procedures were effective as of December 31, 2019. 

Management’s Report on Internal Control over Financial Reporting 
Management  is  responsible  for  establishing  and  maintaining  adequate  internal  control  over  financial 
reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and 
with  the  participation  of  our  management,  including  our  Chief  Executive  Officer  and  Chief  Financial 
Officer, we conducted an evaluation of the effectiveness of its internal control over financial reporting as 
of  December  31,  2019  based  on  criteria  established  in  the  framework  in  Internal  Control  –  Integrated 
Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission in 2013. 
Based on this evaluation, our management concluded that our internal control over financial reporting was 
effective as of December 31, 2019. 

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

Attestation Report of Independent Registered Public Accounting Firm 
We are a “non-accelerated filer” as defined by Rule 12b-2 of the Exchange Act, and as such, we are not 
required to provide an attestation report on the Company’s internal control over financial reporting. 

Changes in Internal Control over Financial Reporting  
There have been no changes in our internal controls over financial reporting that occurred during the quarter 
ended December 31, 2019, that have materially affected, or are reasonably likely to materially affect our 
internal controls over financial reporting. We believe that a control system, no matter how well designed 
and operated, cannot provide absolute assurance that the objectives of the control system are met, and no 
evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, 
within any company have been detected. 

ITEM 9B.  OTHER INFORMATION. 

None. 

77 

 
 
 
 
 
 
 
 
 
 
PART III 

ITEM 10.  DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.  

The information required by this Item will be included in and is hereby incorporated by reference from our 
definitive proxy statement relating to our  2019 annual meeting of stockholders, which we intend to file 
within 120 days after the end of our fiscal year ended December 31, 2019. 

ITEM 11.  EXECUTIVE COMPENSATION. 

The information required by this Item will be included in and is hereby incorporated by reference from our 
definitive proxy statement relating to our  2019 annual meeting of stockholders, which we intend to file 
within 120 days after the end of our fiscal year ended December 31, 2019. 

ITEM 12.  SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND 

MANAGEMENT AND RELATED STOCKHOLDER MATTERS. 

The information required by this Item will be included in and is hereby incorporated by reference from our 
definitive proxy statement relating to our  2019 annual meeting of stockholders, which we intend to file 
within 120 days after the end of our fiscal year ended December 31, 2019. 

ITEM 13.  CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR 

INDEPENDENCE. 

The information required by this Item will be included in and is hereby incorporated by reference from our 
definitive proxy statement relating to our 2019 annual meeting of stockholders, which we intend to file 
within 120 days after the end of our fiscal year ended December 31, 2019. 

ITEM 14.  PRINCIPAL ACCOUNTING FEES AND SERVICES. 

The information required by this Item will be included in and is hereby incorporated by reference from our 
definitive proxy statement relating to our  2019 annual meeting of stockholders, which we intend to file 
within 120 days after the end of our fiscal year ended December 31, 2019. 

78 

 
 
 
 
 
 
 
 
 
 
 
ITEM 15.  EXHIBITS AND FINANCIAL STATEMENT SCHEDULES  

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

PART IV 

Page Number 

(a)  (1)  Financial Statements 

Report of Independent Registered Public Accounting Firm ................................................... 34 

Consolidated Balance Sheets at December 31, 2019 and 2018 ............................................... 35 

Consolidated Statements of Operations and Comprehensive Loss for the Year Ended 

  December 31, 2019 and Year Ended December 31, 2018 ....................................................... 36 

Consolidated Statements of Equity for the Year Ended December 31, 2019 and  

  Year Ended December 31, 2018 .............................................................................................. 37 

Consolidated Statements of Cash Flows for the Year Ended December 31, 2019 and the Year  
Ended December 31, 2018 ...................................................................................................... 38 

  Notes to Consolidated Financial Statements ........................................................................... 39 

Management’s Report on Internal Control over Financial Reporting is contained as part of this Annual 
Report under Item 9A “Controls and Procedures.” 

(a)  (2)  Financial Statement Schedules 

Financial statement schedules have been omitted because they are not required. 

(b)   

Exhibits 

Exhibits required by Item 601 of Regulation S-K are listed in the Exhibit Index on the next page, 
which are incorporated herein by this reference. 

ITEM 16.  FORM 10-K SUMMARY 

None.  

79 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exhibit 
No. 
3.1 

3.2 

3.3 

3.4 

4.1 

4.2 

4.3 

4.4 

4.5 

4.6 

4.7 

4.8 

10.1 

10.2 

10.3 

EXHIBIT INDEX 

Document Description 
Sixth Amended and Restated Certificate of 
Incorporation of ThermoGenesis Holdings, Inc., 
as amended. 
Certificate of Amendment to the Sixth 
Amended and Restated Certificate of 
Incorporation of ThermoGenesis Holdings, Inc. 

Certificate of Amendment to the Sixth 
Amended and Restated Certificate of 
Incorporation of ThermoGenesis Holdings, Inc. 

Amended and Restated Bylaws of 
ThermoGenesis Holdings, Inc. 
Form of Pre-Funded Common Stock Purchase 
Warrant. 
Form of Convertible Promissory Note 

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. 
Form of Convertible Promissory Note. 

Form of Convertible Promissory Note, dated as 
of July 23, 2019, between ThermoGenesis 
Holdings, Inc. and Orbrex USA Co. 
Form of Indenture, dated December 13, 2019, 
between ThermoGenesis Holdings, Inc. and the 
Purchaser identified on the signature page 
thereto. 
Form of Pre-Funded Warrant, dated as of April 
26, 2019, between ThermoGenesis Holdings, 
Inc. and Yuan Lan Fang. 
Description of Securities Registered Under 
Section 12 of the Securities Exchange Act of 
1934, as amended. 
Reorganization and Share Exchange 
Agreement, dated January 1, 2019, among 
ThermoGenesis Corp., ThermoGenesis 
Holdings, Inc., CARTXpress Bio, Inc., Bay 
City Capital Fund V. L.P. and Bay City Capital 
Fund V. Co-Investment Fund, L.P. 
Voting Agreement, dated January 1, 2019, 
among CARTXpress Bio, Inc., ThermoGenesis 
Corp., Bay City Capital Fund V, L.P., and Bay 
City Capital Fund V Co-Investment Fund, L.P. 
Right of First Refusal and Co-Sale Agreement, 
dated January 1, 2019, among CARTXpress 

80 

Incorporation by Reference 
Incorporated by reference to Exhibit 3.1 to Form S-8 
filed with the SEC on September 12, 2019 

Incorporated by reference to Exhibit 3.1 to Form 8-K 
filed with the SEC on June 4, 2019. 

Incorporated by reference to Exhibit 3.1 to Form 8-K 
filed with the SEC on October 31, 2019. 

Incorporated by reference to Exhibit 3.2 to Form 8-K 
filed with the SEC on October 30, 2019. 
Incorporated by reference to Exhibit 4.1 to Form 8-K 
filed with the SEC on April 25, 2019.  
Incorporated by reference to Exhibit 4.1 to Form 8-K 
filed with the SEC on January 31, 2019.  
Incorporated by referenced to Exhibit 10.3 to Form 8-
K filed with the SEC on January 4, 2019 

Incorporated by reference to Exhibit 4.1 to Form 8-K 
filed with the SEC on July 29, 2019. 
Incorporated by reference to Exhibit 4.1 to Form 8-K 
filed with the SEC on July 29, 2019. 

Incorporated by reference to Exhibit 4.5 to the Form 
S-3 filed with the SEC on December 13, 2019. 

Incorporated by reference to Exhibit 4.1 to Form 8-
K/A filed with the SEC on September 24, 2019. 

Filed herewith. 

Incorporated by referenced to Exhibit 10.1 to Form 8-
K filed with the SEC on January 4, 2019 

Incorporated by referenced to Exhibit 10.2 to Form 8-
K filed with the SEC on January 4, 2019 

Incorporated by referenced to Exhibit 10.4 to Form 8-
K filed with the SEC on January 4, 2019 

 
 
10.4 

10.5 

10.6 

10.7 

10.8 

10.9 

10.10 

10.11 

10.12 

10.13 

10.14 

10.15 

10.16 

Bio, Inc., ThermoGenesis Corp., Bay City 
Capital Fund V, L.P., and Bay City Capital 
Fund V Co-Investment Fund, L.P. 
Investors’ Rights Agreement, dated January 1, 
2019, between CARTXpress Bio, Inc., Bay 
City Capital Fund V, L.P. and Bay City Capital 
Fund V Co-Investment Fund, L.P.  
Amended and Restated Certificate of 
Incorporation of CARTXpress Bio, Inc. 
Securities Purchase Agreement, dated January 
29, 2019, between ThermoGenesis Holdings, 
Inc. and the Purchaser identified on the 
signature pages thereto. 
Securities Purchase Agreement, dated April 18, 
2019, between ThermoGenesis Holdings, Inc. 
and the Purchaser identified on the signature 
pages thereto. 

Third Amendment to ThermoGenesis Holdings, 
Inc. Amended 2016 Equity Incentive Plan 
Dated December 14, 2018. 

Amendment No. 1 dated July 23, 2019, to the 
Convertible Note, dated July 29, 2019, between 
ThermoGenesis Holdings, Inc. and Orbrex USA 
Co. Limited 
Securities Purchase Agreement, dated July 23, 
2019, between ThermoGenesis Holdings, Inc. 
and the Purchaser identified on the signature 
page thereto. 
Securities Purchase Agreement dated as of July 
23, 2019, between ThermoGenesis Holdings, 
Inc, and the Purchaser identified on the 
signature pages thereto. 
Supply Agreement, dated as of August 30, 
2019, between Corning Incorporated and 
ThermoGenesis Holdings, Inc. 
Supply Agreement, dated November 22, 2019 
between ThermoGenesis Holdings, Inc and 
ImmuneCyte Life Sciences Inc. 
Contribution Agreement, dated November 22, 
2019 between ThermoGenesis Holdings, Inc 
and ImmuneCyte Life Sciences Inc. 
Stockholder’s Agreement, dated November 22, 
2019 between ThermoGenesis Holdings, Inc 
and ImmuneCyte Life Sciences Inc. 
Joint Venture Agreement, dated October 21, 
2019, between ThermoGenesis Holdings, Inc. 
and Healthbanks Biotech (USA) Inc., and 
ImmuneCyte Life Sciences, Inc. 

81 

Incorporated by reference to Exhibit 10.3 to Form 8-
K filed with the SEC on January 4, 2019. 

Incorporated by reference to Exhibit 10.5 to Form 8-
K filed with the SEC on January 4, 2019 
Incorporated by reference to Exhibit 10.1 to Form 8-
K filed with the SEC on January 31, 2019. 

Incorporated by reference to Exhibit 10.1 to Form 8-
K filed with the SEC on April 25, 2019. 

Incorporated by reference to Exhibit 10.1 to Form 8-
K filed with the SEC on June 4, 2019 

Incorporated by reference to Exhibit 10.1 to Form 8-
K filed with the SEC on July 29, 2019 

Incorporated by reference to Exhibit 10.1 to Form 8-
K filed with the SEC on July 29, 2019 

Incorporated by reference to Exhibit 10.1 to Form 8-
K filed with the SEC on July 29, 2019. 

Incorporated by reference to Exhibit 10.1 to Form 8-
K filed with the SEC on September 6, 2019. 

Incorporated by reference to Exhibit 10.1 to Form 8-
K filed with the SEC on November 22, 2019. 

Incorporated by reference to Exhibit 10.2 to Form 8-
K filed with the SEC on November 22, 2019. 

Incorporated by reference to Exhibit 10.3 to Form 8-
K filed with the SEC on November 22, 2019. 

Incorporated by reference to Exhibit 10.1 to Form 8-
K filed with the SEC on October 22, 2019. 

 
 
Incorporated by reference to Exhibit 10.4 to Form 10-
Q filed with the SEC on August 13, 2019. 

Incorporated by reference to Exhibit 10.5 to Form 10-
Q filed with the SEC on August 13, 2019. 
Incorporated by reference to Exhibit 10.1 to Form 8-
K filed with the SEC on March 20, 2020 

10.17 

10.18 

10.19 

21.1 

23.1 

31.1 

31.2 

32 
101.INS 
101.SCH 
101.CAL 
101.DEF 
101.LAB 
101.PRE 

Amendment No.1, dated August 12, 2019 but 
effective as of July 23, 2019, to the Convertible 
Promissory Note, dated July 23, 2019 between 
ThermoGenesis Holdings, Inc. and Orbrex 
(USA) Co. Limited 
ThermoGenesis Holdings, Inc. Amended 2016 
Equity Incentive Plan 
Manufacturing and Supply Amending 
Agreement #1, effective as of March 16, 2020, 
between ThermoGenesis Corp. And CBR 
Systems, Inc. 
Subsidiaries of ThermoGenesis Holdings, Inc. 
Consent of Marcum LLP, Independent 
Registered Public Accounting Firm  
Certification by the Principal Executive Officer 
pursuant to Section 302 of the Sarbanes-Oxley 
Act of 2002 
Certification by the Principal Financial Officer 
pursuant to Section 302 of the Sarbanes-Oxley 
Act of 2002 
Certification of Principal Executive Officer and 
Principal Financial Officer pursuant to Section 
906 of the Sarbanes Oxley Act of 2002 
XBRL Instance Document‡ 
XBRL Taxonomy Extension Schema Document‡ 
XBRL Taxonomy Extension Calculation Linkbase Document‡ 
XBRL Taxonomy Extension Definition Linkbase Document‡ 
XBRL Taxonomy Extension Label Linkbase Document‡ 
XBRL Taxonomy Extension Presentation Linkbase Document‡ 

Filed herewith. 

Filed herewith. 

Filed herewith. 

Filed herewith. 

Filed herewith. 

Footnotes to Exhibit Index 
^  Schedules have been omitted pursuant to Item 601(b)(2) of Regulation S-K.  A copy of any omitted schedule or 

exhibit will be furnished supplementally to the Securities and Exchange Commission upon request. 

#  Represents a management contract or compensatory plan, contract or arrangement. 
*  Confidential treatment has been requested for certain confidential portions of this exhibit pursuant to Rule 24b-
2 under the Exchange Act. In accordance with Rule 24b-2, these confidential portions have been omitted from 
this exhibit and filed separately with the SEC. 

‡  XBRL information is furnished and not filed for purpose of Sections 11 and 12 of the Securities Act of 1933 

and Section 18 of the Securities Exchange Act of 1934, and is not subject to liability under those sections, is not 
part of any registration statement or prospectus to which it relates and is not incorporated or deemed to be 
incorporated by reference into any registration statement, prospectus or other document. 

82 

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

SIGNATURES 

Dated: March 23, 2020 

By:/s/ 

ThermoGenesis Holdings, Inc. 

Xiaochun “Chris” Xu 
Xiaochun “Chris” Xu, Chief 
Executive Officer  
(Principal Executive Officer) 

KNOW ALL THESE PERSONS BY THESE PRESENTS, that each person whose signature appears below 
constitutes and appoints Xiaochun “Chris” Xu and Jeffery Cauble and each of them, jointly and severally, 
his attorneys-in-fact, each with full power of substitution, for him in any and all capacities, to sign any and 
all amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other 
documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and 
confirming all that each said attorneys-in-fact or his substitute or substitutes, may do or cause to be done 
by virtue hereof.  

Pursuant to the requirements of the Securities Exchange Act of 1934, this Annual Report has been signed 
below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. 

By:/s/  Chris Xu 

  Dated: March 23, 2020 

Chris Xu, Chief Executive Officer and 
Chairman of the Board 
(Principal Executive Officer)  

By:/s/ 

Jeffery Cauble 
Jeffery Cauble, Chief Financial Officer 
(Principal Financial Officer and 
Principal Accounting Officer) 

  Dated: March 23, 2020 

By: /s/  Debra Donaghy 

Debra Donaghy, Director 

  Dated: March 23, 2020 

By: /s/  Russell Medford 

  Dated: March 23, 2020 

Russell Medford, Director 

By: /s/ 

Joseph Thomis 
Joseph Thomis, Director 

By: /s/  Mark Westgate 

Mark Westgate, Director 

  Dated: March 23, 2020 

  Dated: March 23, 2020 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exhibit 23.1 

INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENT 

We consent to the incorporation by reference in the Registration Statement of ThermoGenesis Holdings, Inc., formerly 
known as Cesca Therapeutics Inc. on Form S-3 (File No. 333-235509), Form S-8 (File No. 333-233731) pertaining to 
Amended 2016 Equity Incentive Plan, Form S-3 (File No. 333-231526), Form S-8 (File No. 333-227425) pertaining 
to 2016 Equity Incentive Plan, as amended and restated, Form S-8 (File No. 333-218082) pertaining to 2016 Equity 
Incentive Plan, Form S-8 (File No. 333-206996) pertaining to 2006 Equity Incentive Plan, Form S-8 (File No. 333-
187197) pertaining to 2006 Equity Incentive Plan and 2012 Independent Director Equity Plan, Form S-8 (File No. 
333-171564) pertaining to 2006 Equity Incentive Plan, Form S-8 (File No. 333-140668) pertaining to 2006 Equity 
Incentive Plan, Form S-8 (File No. 333-82900) pertaining to Amended 1998 Employee Equity Incentive Plan, 2002 
Independent  Directors  Equity  Incentive  Plan,  and  Non-  Qualified  Independent  Director  Stock  Option  Agreement, 
Form S-3 (File No. 333-227426), Form S-3, as amended (File No. 333-215638), and Form S-3, as amended (File No. 
333-212314) of our report dated March 23, 2020, which includes an explanatory paragraph as to the Company’s ability 
to continue as a going concern, with respect to our audits of the consolidated financial statements of ThermoGenesis 
Holdings, Inc. as of December 31, 2019 and 2018 and for each of the two years in the period ended December 31, 
2019, which report is included in this Annual Report on Form 10-K of ThermoGenesis Holdings, Inc. for the year 
ended December 31, 2019. 

Our report on the consolidated financial statements refers to a change in the method of accounting for leases due to 
the adoption of the guidance in ASC Topic 842 effective January 1, 2019. 

/s/ Marcum LLP 

Marcum LLP 
New York, NY 
March 23, 2020 

 
 
 
 
 
 
 
 
  
 
Exhibit 31.1 

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

I, Chris Xu, certify that: 

1. 

I have reviewed this Annual Report on Form 10-K of ThermoGenesis Holdings, Inc.; 

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

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

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

(a)  

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

(b)  

Designed  such  internal  control  over  financial  reporting,  or  caused  such  internal  control 
over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the 
reliability  of  financial  reporting  and  the  preparation  of  financial  statements  for  external  purposes  in 
accordance with generally accepted accounting principles; 

(c)  

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

(d)  

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

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

(a)  

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

(b)  

Any  fraud,  whether  or  not  material,  that  involves  management  or  other  employees  who  have  a 

significant role in the registrant's internal control over financial reporting.  

Dated: March 23, 2020 

/s/ Chris Xu 
Chris Xu 
Chief Executive Officer 

 
 
 
 
 
 
 
 
 
 
 
Exhibit 31.2 

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

I, Jeffery Cauble, certify that: 

1. 

I have reviewed this Annual Report on Form 10-K of ThermoGenesis Holdings, Inc.; 

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

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

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

(a)  

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

(b)  

Designed  such  internal  control  over  financial  reporting,  or  caused  such  internal  control 
over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the 
reliability  of  financial  reporting  and  the  preparation  of  financial  statements  for  external  purposes  in 
accordance with generally accepted accounting principles; 

(c)  

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

(d)  

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

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

(a)  

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

(b)  

Any  fraud,  whether  or  not  material,  that  involves  management  or  other  employees  who  have  a 

significant role in the registrant's internal control over financial reporting.  

Dated: March 23, 2020 

/s/ Jeffery Cauble 
Jeffery Cauble 
Chief Financial Officer 

 
 
 
 
 
 
 
 
 
 
 
 
CERTIFICATION PURSUANT TO 
18 U.S.C. SECTION 1350, 
AS ADOPTED PURSUANT TO 
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 

Exhibit 32 

In connection with the Annual Report of ThermoGenesis Holdings, Inc. (the “Company”) on Form 10-
K for the period ended December 31, 2019, as filed with the Securities and Exchange Commission on the 
date hereof (the “Annual Report”), each of the undersigned officers of the Company certifies, pursuant to 
18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to such officer’s 
knowledge: 

(1)   The Annual Report fully complies with the requirements of Section 13(a) or 15(d) of the 

Securities Exchange Act of 1934; and 

(2)   The information contained in the Annual Report fairly presents, in all material respects, the 
financial condition and results of operations of the Company as of the dates and for the periods 
expressed in the Annual Report. 

Dated: March 23, 2020 

/s/Chris Xu 
Chris Xu  
Chief Executive Officer 

Dated: March 23, 2020 

/s/ Jeffery Cauble 
Jeffery Cauble 
Chief Financial Officer