UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM
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Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended |
or
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Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition from to . |
Commission File Number:
(Exact name of registrant as specified in its charter)
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(State of incorporation) |
(I.R.S. Employer Identification No.) |
(Address of principal executive offices) (Zip Code)
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading symbol(s) |
Name of each exchange on which registered |
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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.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ☐ | Accelerated filer ☐ | Smaller reporting company |
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| 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
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
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Class |
Outstanding at May 13, 2024 |
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Common stock, $.001 par value |
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ThermoGenesis Holdings, Inc.
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| PART I | FINANCIAL INFORMATION | ||
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ITEM 1. |
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ITEM 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
14 | |
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ITEM 3. |
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ITEM 4. |
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| PART II | OTHER INFORMATION | ||
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ITEM 1. |
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ITEM 1A. |
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ITEM 2. |
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ITEM 3. |
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ITEM 4. |
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ITEM 5. |
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ITEM 6. |
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| Signatures | 22 | ||
PART I - FINANCIAL INFORMATION
ThermoGenesis Holdings, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
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March 31, 2024 |
December 31, 2023 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ | $ | ||||||
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Accounts receivable, net of allowance for credit losses of $ |
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Inventories |
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Prepaid expenses and other current assets |
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Total current assets |
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Equipment and leasehold improvements, net |
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Right-of-use operating lease assets, net |
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Right-of-use operating lease assets – related party, net |
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Other assets |
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Total assets |
$ | $ | ||||||
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LIABILITIES AND STOCKHOLDERS’ EQUITY / (DEFICIT) |
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Current liabilities: |
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Accounts payable |
$ | $ | ||||||
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Accrued payroll and related expenses |
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Deferred revenue – short-term |
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Convertible promissory note – related party |
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Interest payable – related party |
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Convertible promissory note, net |
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Other current liabilities |
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Total current liabilities |
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Operating lease obligations – related party – long-term |
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Deferred revenue – long-term |
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Other noncurrent liabilities |
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Total liabilities |
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| Commitments and contingencies |
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Stockholders’ equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid in capital |
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Accumulated deficit |
( |
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Accumulated other comprehensive loss |
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Total ThermoGenesis Holdings, Inc. stockholders’ equity / (deficit) |
( |
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Noncontrolling interests |
( |
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Total equity / (deficit) |
( |
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Total liabilities and equity |
$ | $ | ||||||
See accompanying notes to the condensed consolidated financial statements.
ThermoGenesis Holdings, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
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Three Months Ended March 31, |
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2024 |
2023 |
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Net revenues |
$ | $ | ||||||
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Cost of revenues |
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Gross profit |
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Expenses: |
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Selling, general and administrative |
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Research and development |
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Total operating expenses |
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Loss from operations |
( |
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| Other income (expenses): | ||||||||
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Interest expense |
( |
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Loss on retirement of debt |
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Other income (expenses) |
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Total other expenses |
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Net loss |
$ | ( |
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Loss attributable to noncontrolling interests |
( |
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Net loss attributable to common stockholders |
$ | ( |
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COMPREHENSIVE LOSS |
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Net loss |
$ | ( |
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Other comprehensive loss: |
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Foreign currency translation adjustments gain (loss) |
( |
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Comprehensive loss |
( |
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Comprehensive loss attributable to non-controlling interests |
( |
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Comprehensive loss attributable to common stockholders |
( |
) | $ | ( |
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Per share data: |
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Basic and diluted net loss per common share |
$ | ( |
) | $ | ( |
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Weighted average common shares outstanding basic and diluted |
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See accompanying notes to the condensed consolidated financial statements.
ThermoGenesis Holdings, Inc.
Condensed Consolidated Statements of Equity / (Deficit)
For the Three Months Ended March 31, 2024 and 2023
(Unaudited)
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Shares |
Common Stock |
Paid in Capital in Excess of Par |
Accumulated Deficit |
AOCL* |
Non- Controlling Interests |
Total Equity |
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Balance at January 1, 2024 |
$ | $ | $ | ( |
) | $ | $ | ( |
) | $ | ( |
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Stock-based compensation expense |
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Related party convertible note price reset |
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Convertible note price reset |
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Conversion of note payable to common stock – related party |
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Issuance of common stock via at-the- market offering, net |
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Net loss |
- | ( |
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Balance at March 31, 2024 |
$ | $ | $ | ( |
) | $ | $ | ( |
) | $ | ( |
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Shares |
Common Stock |
Paid in Capital in Excess of Par |
Accumulated Deficit |
AOCL* |
Non- Controlling Interests |
Total Equity |
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Balance at January 1, 2023 |
$ | $ | $ | ( |
) | $ | $ | ( |
) | $ | ||||||||||||||||||
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Stock-based compensation expense |
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Related party convertible note price reset |
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Convertible note price reset |
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Conversion of note payable to common stock |
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Sale of common stock and warrants, net |
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Exercise of warrants |
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Foreign currency translation gain |
- | ( |
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Net loss |
- | ( |
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Balance at March 31, 2023 |
$ | $ | $ | ( |
) | $ | $ | ( |
) | $ | ||||||||||||||||||
* Accumulated other comprehensive loss.
See accompanying notes to the condensed consolidated financial statements.
ThermoGenesis Holdings, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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Three Months Ended March 31, |
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2024 |
2023 |
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Cash flows from operating activities: |
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Net loss |
$ | ( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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Stock-based compensation expense |
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Amortization of debt discount/premium, net |
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Loss on retirement of debt |
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Reserve for excess and slow-moving inventories |
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Net change in operating assets and liabilities: |
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Accounts receivable |
( |
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Inventories |
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Prepaid expenses and other assets |
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Accounts payable |
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Interest payable - related party |
( |
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Accrued payroll and related expenses |
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Deferred revenue – short term |
( |
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Other current liabilities |
( |
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Long-term deferred revenue and other noncurrent liabilities |
( |
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Net cash used in operating activities |
( |
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Cash flows from investing activities: |
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Capital expenditures |
( |
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Net cash used in investing activities |
( |
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Cash flows from financing activities: |
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Proceeds from sale of common stock, net |
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| Payment on convertible promissory note | ( |
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Proceeds from exercise of warrants and pre-funded warrants |
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Net cash provided by financing activities |
( |
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Net increase (decrease) in cash and cash equivalents |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period |
$ | $ | ||||||
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Supplemental disclosures of cash flow information: |
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Cash paid for interest |
$ | $ | ||||||
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Cash paid for related party interest |
$ | $ | ||||||
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Fair value of January 2023 amended convertible note issued in connection with the extinguishment of original convertible note |
$ | |||||||
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Convertible note price reset |
$ | $ | ||||||
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Related party convertible note price reset |
$ | $ | ||||||
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Promissory note converted to common stock |
$ | |||||||
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Related party promissory note converted to common stock |
$ | |||||||
See accompanying notes to the condensed consolidated financial statements.
ThermoGenesis Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
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1. |
Description of Business |
Overview
ThermoGenesis Holdings, Inc. (“ThermoGenesis Holdings,” the “Company,” “we,” “our,” “us”) develops and commercializes a range of automated technologies for cell-banking, cell-processing, and cell-based therapeutics. Since the 1990’s, ThermoGenesis Holdings has been a pioneer in, and a leading provider of automated systems that isolate, purify and cryogenically store units of hematopoietic stem and progenitor cells for the cord blood banking industry. The Company was founded in 1986 and is incorporated in the State of Delaware and headquartered in Rancho Cordova, CA. Our common stock is traded on the Nasdaq Capital Market exchange under the ticker symbol “THMO”.
Medical Device Products for Automated Cell Processing
The Company provides the AutoXpress® and BioArchive® platforms for automated clinical bio-banking, PXP® platform for point-of-care cell-based therapies and X-Series® products for cell processing services. All product lines are reporting as a single reporting segment in the financial statements.
CDMO Business
The Company is expanding its business to include contract development and manufacturing services for cell and cell-based gene therapies. The Company is in the process of building out its capabilities to become a world-class Contract Development and Manufacturing Organization (“CDMO”) for cell and cell-based gene therapies. The Company opened a new facility in the Sacramento metro area, containing a total of twelve, class-7, ReadyStart cGMP Suites available for lease by early-stage life science and cell gene therapy companies. The ReadyStart Suites are located in a 35,500+ square foot cGMP facility that will meet the highest scientific, quality, and regulatory requirements. The CDMO facility was completed in October of 2023.
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2. |
Going Concern |
The Company has incurred historical losses from operations and expects to continue to incur operating losses in the near future. The Company will need to raise additional capital to grow its business, fund operating expenses and make interest payments. The Company’s ability to fund its liquidity needs is subject to various risks, many of which are beyond its control. The Company will seek additional funding through debt borrowings, sales of debt or equity securities or strategic partnerships. The Company cannot guarantee that such funding will be available on a timely basis, in needed quantities or on terms favorable to the Company, if at all. These factors and other indicators raise substantial doubt about the Company’s ability to continue as a going concern within one year from the filing date of this report.
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern.
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3. |
Summary of Significant Accounting Polices |
There have been no material changes in the Company’s significant accounting policies to those disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such Securities and Exchange Commission (“SEC”) rules and regulations and accounting principles applicable for interim periods. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Events subsequent to the balance sheet date have been evaluated for inclusion in the accompanying condensed consolidated financial statements through the date of issuance.
Operating results for the three months ended March 31, 2024 are not necessarily indicative of the results that may be expected for the Company’s fiscal year ending December 31, 2024. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto included in ThermoGenesis Holdings’ Annual Report on Form 10-K for the year ended December 31, 2023.
Principles of Consolidation
The consolidated financial statements include the accounts of ThermoGenesis Holdings and its wholly-owned subsidiaries, ThermoGenesis Corp. and TotipotentRX Cell Therapy, Pvt. Ltd and ThermoGenesis Corp’s majority-owned subsidiary, CARTXpress Bio, Inc. (“CARTXpress Bio”). All significant intercompany accounts and transactions have been eliminated upon consolidation.
The
Recently Issued Accounting Standards
In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures,” which is intended to enhance the transparency and decision usefulness of income tax disclosures. Notably, the ASU requires entities to disclose specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold, as well as disclosures of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for annual periods beginning after December 15, 2024 on a prospective basis. Retrospective application to each period presented in the financial statements is permitted. We are currently evaluating the impact of this standard on our consolidated financial statements.
In November 2023, the FASB issued ASU 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures,” which requires all public entities, including those that have a single reportable segment, to provide enhanced disclosures primarily about significant segment expenses. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The new guidance is required to be applied on a retrospective basis, with all required disclosures to be made for all prior periods presented in the financial statements. The segment expense categories and amounts disclosed in prior periods should be based on the significant segment expense categories identified and disclosed in the period of adoption. We are currently evaluating the impact of this standard on our consolidated financial statements.
In October 2023, the FASB issued ASU 2023-06, “Disclosure Improvements—Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative.” This ASU modifies the disclosure or presentation requirements of a variety of Topics in the Codification by aligning them with the SEC’s regulations. The amendments to the various Topics should be applied prospectively, and the effective date for the Company for each amendment will be determined based on the effective date of the SEC’s removal of the related disclosure from Regulation S-X or Regulation S-K. If the SEC has not removed the applicable requirement by June 30, 2027, then the related amendment in ASU 2023-06 will be removed from the Codification and will not become effective. Early adoption of this ASU is prohibited. We are currently evaluating the new ASU to determine if it will have an impact on the disclosures or presentation in our consolidated financial statements.
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4. |
Related Party Transactions |
Convertible Promissory Note and Revolving Credit Agreement
In March 2017, ThermoGenesis Holdings entered into a Credit Agreement with Boyalife Group (USA), Inc. (the “Lender”), which is owned and controlled by the Company’s Chief Executive Officer and Chairman of our Board of Directors. The Credit Agreement, as amended, grants the Company the right to borrow up to $
The Company performed a debt extinguishment vs. modification analysis on the Note Amendment and determined that it would be considered an extinguishment, due to an increase of more than 10% to the value of the embedded conversion option. However, no gain or loss was recorded in the condensed consolidated statements of operations for the quarter ended March 31, 2024 as it was determined that the fair value of the Note Amendment and accrued interest was $
On March 15, 2024, the Company received a conversion notice from the Lender to convert $
The Credit Agreement Amendment and the Note Amendment, provide that the principal and all accrued and unpaid interest under the Loan will be due and payable on the Maturity Date of December 31, 2024. The Loan bears interest at
The following summarizes the Note:
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Maturity Date |
Stated Interest Rate |
Conversion Price |
Face Value |
Debt Discount |
Carrying Value |
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March 31, 2024 |
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% | $ | $ | $ | ( |
) | $ | |||||||||||||
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December 31, 2023 |
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% | $ | $ | $ | $ | |||||||||||||||
The Note includes a down-round anti-dilution provision that lowers its conversion price if the Company sells shares of common stock or issues convertible debt at a lower price per share. In 2024, the down-round provision was triggered, as noted below:
For the three months ended March 31, 2024, when the conversion price of the Note was $
A Black-Scholes pricing model was utilized to determine the change in the before and after incremental value of the conversion option at each triggering event, with the following inputs:
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January 2024 |
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Conversion price before |
$ | |||
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Conversion price after |
$ | |||
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Term (years) |
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Volatility |
% | |||
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Dividend rate |
% | |||
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Risk free rate |
% | |||
The Company amortized $
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5. |
Related Party Lease |
Z3 Investment
On March 24, 2022, the Company entered into a Lease Agreement with Z3 Investment LLC, an affiliate of the Company’s Chairman and CEO, and COO, beginning April 1, 2022, for approximately
Operating Lease
Operating lease assets and liabilities are recognized at the lease commencement date. Operating lease liabilities represent the present value of lease payments not yet paid. Operating lease assets represent our right to use an underlying asset and are based upon the operating lease liabilities adjusted for prepayments or accrued lease payments, initial direct costs, lease incentives, and impairment of operating lease assets. To determine the present value of lease payments not yet paid, we use the Company’s cost of capital based on existing debt instruments. We recognize the expense for this lease on a straight-line basis over the lease term.
The following summarizes the Company’s operating lease:
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March 31, 2024 |
December 31, 2023 |
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Right-of-use operating lease assets – related party, net |
$ | $ | ||||||
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Current lease liability (included in other current liabilities) |
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Non-current lease liability – related party |
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Weighted average remaining lease term |
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Discount rate |
% | % | ||||||
Maturities of lease liabilities by year for our operating lease are as follows:
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2024 (Remaining) |
$ | |||
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2025 |
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2026 |
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2027 |
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Thereafter |
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Total lease payments |
$ | |||
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Less: imputed interest |
( |
) | ||
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Present value of operating lease liabilities |
$ |
Statement of Cash Flows
Cash paid for amounts included in the measurement of operating lease liabilities was $
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6. |
Convertible Promissory Note |
July 2019 Note
On July 23, 2019, the Company entered into a private placement with Orbrex (USA) Co. Limited (“Orbrex”), pursuant to which the Company issued and sold to Orbrex an unsecured convertible promissory note in the original principal amount of $
The Company performed a debt extinguishment vs. modification analysis on the Amendment No. 3 to the July 2019 Note and determined that the extension would be considered an extinguishment, due to an increase of more than 10% to the value of the embedded conversion option. The Company determined that the fair value of the July 2019 Note after the amendment was $
During the three months ended March 31, 2023, the holder of the July 2019 Note converted $
The following summarizes the July 2019 Note:
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Maturity Date |
Stated Interest Rate |
Conversion Price |
Face Value |
Debt Discount |
Carrying Value |
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December 31, 2023 |
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% | $ | $ | $ | ( |
) | $ | |||||||||||||
The Note includes a down-round anti-dilution provision that lowers its conversion price if the Company sells shares of common stock or issues convertible debt at a lower price per share. In 2024, the anti-dilution provision was triggered, as noted below:
In January 2024, through multiple transactions under the At The Market Agreement with Wainwright, the Company sold shares of its common stock with an average selling price of $
A Black-Scholes pricing model was utilized to determine the change in the before and after incremental value of the conversion option at each triggering event, with the following inputs:
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January 2024 |
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Conversion price before |
$ | |||
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Conversion price after |
$ | |||
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Term (years) |
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Volatility |
% | |||
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Dividend rate |
% | |||
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Risk free rate |
% | |||
The Company recorded amortization expense related to triggering events for the July 2019 Note of $
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7. |
Stockholders’ Equity |
Common Stock
On March 15, 2023, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with an accredited investor (the “Investor”) pursuant to which the Company agreed to issue and sell to the Investor in a private placement (the “Offering”) (i)
In connection with the Offering, the Company entered into a Warrant Amendment Agreement (the "Warrant Amendment Agreement”), dated March 15, 2023, with the Investor, whereby the Company agreed to amend existing warrants, held by the Investor, to purchase up to an aggregate of
The warrant repricing resulted in an immediate and incremental increase of approximately $
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March 2023 |
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Conversion price before |
$ | |||
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Conversion price after |
$ | |||
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Term (years) |
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Volatility |
% | |||
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Dividend rate |
% | |||
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Risk free rate |
% | |||
On November 22, 2023, the Company entered into an At The Market Offering Agreement (the "Offering Agreement”) with Wainwright with respect to an at-the-market offering program under which the Company may offer and sell, from time to time, shares of its common stock, $
Nasdaq’s listing standards provide 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. On January 8, 2024, we received written notice from the Nasdaq Listing Qualifications Department notifying the Company that it was not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market, due to the bid price of the Company’s common stock closing below the minimum $1.00 per share for the thirty (30) consecutive business days prior to the date of the Notification Letter. In accordance with listing rules, the Company was afforded 180 days, or until July 8, 2024, to regain compliance.
Net Loss Per Share
Net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding. For the purpose of calculating basic net loss per share, the additional shares of common stock that are issuable upon exercise of the pre-funded warrants have been included since the shares are issuable for a negligible consideration and have no vesting or other contingencies associated with them. All pre-funded warrants previously issued have been exercised and none are outstanding. The calculation of the basic and diluted earnings per share is the same for all periods presented, as the effect of the potential common stock equivalents noted below is anti-dilutive due to the Company’s net loss position for all periods presented. Anti-dilutive securities consisted of the following at March 31:
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2024 |
2023 |
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Common stock equivalents of convertible promissory note and accrued interest |
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Warrants |
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Stock options |
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Total |
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Warrants
A summary of warrant activity for the three months ended March 31, 2024 is as follows:
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Number of Shares |
Weighted-Average Exercise Price Per Share |
Weighted- Average Remaining Contract Term |
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Balance at December 31, 2023 |
$ | |||||||||||
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Warrants granted |
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Pre-funded warrants granted |
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Warrants exercised |
||||||||||||
|
Exercisable and Outstanding at March 31, 2024 |
$ | |||||||||||
|
8. |
Revenue |
The following table presents net sales by geographic areas for the three months ended March 31:
|
2024 |
2023 |
|||||||
|
United States |
$ | $ | ||||||
|
Singapore |
||||||||
|
Other |
||||||||
|
Total |
$ | $ | ||||||
The following tables summarize the revenues by product line and type:
|
Three Months Ended March 31, 2024 |
||||||||||||||||
|
Device Revenue |
Service Revenue |
Other Revenue |
Total Revenue |
|||||||||||||
|
AXP |
$ | $ | $ | $ | ||||||||||||
|
BioArchive |
||||||||||||||||
|
CAR-TXpress |
||||||||||||||||
|
Other |
||||||||||||||||
|
Total |
$ | $ | $ | $ | ||||||||||||
|
Three Months Ended March 31, 2023 |
||||||||||||||||
|
Device Revenue |
Service Revenue |
Other Revenue |
Total Revenue |
|||||||||||||
|
AXP |
$ | $ | $ | $ | ||||||||||||
|
BioArchive |
||||||||||||||||
|
CAR-TXpress |
||||||||||||||||
|
Other |
||||||||||||||||
|
Total |
$ | $ | $ | $ | ||||||||||||
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). The Company recognized revenues of $
Backlog of Remaining Customer Performance Obligations
The following table represents revenue expected to be recognized in the future from the backlog of performance obligations that are unsatisfied (or partially unsatisfied) at the end of the reporting period:
|
Remainder of |
|
|
|
2028 and
|
Total |
|||||||||||||||||||
|
Service revenue |
$ | $ | $ | $ | $ | $ | ||||||||||||||||||
|
Exclusivity fee |
||||||||||||||||||||||||
|
Other |
||||||||||||||||||||||||
|
Total |
$ | $ | $ | $ | $ | $ | ||||||||||||||||||
|
9. |
Concentrations |
The Company had certain customers whose revenue individually represented 10% or more of the Company’s total revenue, or whose accounts receivable balances individually represented 10% or more of the Company’s total accounts receivable as follows:
|
Accounts Receivable |
March 31, 2024 |
December 31, 2023 |
||||||
|
Customer 1 |
43% | |||||||
|
Customer 2 |
14% | |||||||
|
Customer 3 |
14% | |||||||
|
Three Months Ended March 31, |
||||||||
|
Revenues |
2024 |
2023 |
||||||
|
Customer 1 |
||||||||
|
Customer 2 |
||||||||
The Company utilizes contract manufacturers to produce AXP disposables. For the three months ended March 31, 2024, the Company obtained all of its AXP disposables from one supplier.
|
10. |
Commitments and Contingencies |
The Company, entered into a Manufacturing and Supply Amending Agreement #2 with CBR Systems, Inc. (“CBR”) with an effective date of July 13, 2020 (the “Amendment”). The Amendment modified the Manufacturing and Supply Agreement entered into on May 15, 2017 and Amendment #1 dated March 16, 2020 by the Company and CBR. The Amendment, among other things, revised the amounts of certain products to be purchased, pricing of those products and removal of the safety stock requirement. In addition, the Amendment updated the financial requirement to exclude convertible debt from the definition of short-term debt under events or conditions that constitute a default. The Amendment states that the Company’s cash balance and short-term investments net of non-convertible debt and borrowed funds that are payable within one year must be greater than $
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 March 31, 2024, 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.
|
11. |
Subsequent Events |
On April 19, 2024, the Company received a notice (the “Nasdaq Notice”) from Nasdaq that the Company does not presently comply with Nasdaq’s Listing Rule 5550(b)(1) that requires the Company to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing. Additionally, as of the date of this report, the Company does not meet the alternatives of market value of listed securities or net income from continuing operations under Nasdaq Listing Rules.
The Nasdaq Notice does not have any immediate effect on the listing of the Company’s common stock on the Nasdaq Capital Market and the Company has 45 calendar days from the date of the Nasdaq Notice to submit a plan to Nasdaq to regain compliance with Nasdaq’s continued listing rules. If the Company’s plan is accepted, Nasdaq can grant the Company an extension of up to 180 calendar days from the date of the Nasdaq Notice for the Company to evidence compliance with its plan and with the relevant Nasdaq continued listing rules.
In connection with the Company’s plan, once submitted, Nasdaq staff will consider such things as the likelihood that the plan will result in compliance with Nasdaq’s continued listing criteria, the Company’s past compliance history, the reasons for the Company’s current non-compliance, other corporate events that may occur during staff’s review period, the Company’s overall financial condition, and the Company’s public disclosures. If, in the staff’s consideration of the Company’s plan, the staff were to determine that the Company would not be able to cure the deficiency, then Nasdaq would provide notice that the Company’s common stock would be subject to delisting. Upon such a notice, the Company would have the right to appeal that determination and the Company’s common stock would continue to remain listed on the Nasdaq Capital Market until the completion of the appeal process.
The Company is considering various actions that it may take in response to the Nasdaq Notice in order to provide to Nasdaq the required plan to regain compliance with the continued listing requirements, but the Company has not currently completed its internal analysis regarding the items to be included in its plan to be submitted to Nasdaq staff.
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Cautionary Note Regarding Forward‑Looking Statements
This report contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements contained herein. When used in this report, the words "anticipate," "believe," "estimate," "expect" and similar expressions as they relate to the Company or its management are intended to identify such forward-looking statements. Actual results, performance or achievements could differ materially from the results expressed in, or implied by these forward-looking statements. Readers should be aware of important factors that, in some cases, have affected, and in the future could affect, actual results to differ materially from those expressed in any forward-looking statements made by or on behalf of the Company. These factors include without limitation, the ability to obtain capital and other financing in the amounts and at the times needed to launch new products, market acceptance of new products, the nature and timing of regulatory approvals for both new products and existing products for which the Company proposes new claims, realization of forecasted revenues, expenses and income, initiatives by competitors, price pressures, failure to meet U.S. Food and Drug Administration (“FDA”) regulated requirements governing the Company’s products and operations (including the potential for product recalls associated with such regulations), risks associated with initiating manufacturing for new products, failure to meet Foreign Corrupt Practice Act regulations, legal proceedings, uncertainty associated with pandemics, wars or global crises, risks associated with our new CDMO business, and other risk factors listed from time to time in our reports with the Securities and Exchange Commission (“SEC”), including, in particular, those set forth in the Company’s Form 10-K for the year ended December 31, 2023, which was filed on April 15, 2024.
Business Overview
ThermoGenesis Holdings, Inc. (“ThermoGenesis Holdings,” the “Company,” “we,” “our,” “us”) develops and commercializes a range of automated technologies for cell-banking, cell-processing, and cell-based therapeutics. Since the 1990’s, ThermoGenesis Holdings has been a pioneer in, and a leading provider of, automated systems that isolate, purify and cryogenically store units of hematopoietic stem and progenitor cells for the cord blood banking industry. The Company was founded in 1986 and is incorporated in the State of Delaware and headquartered in Rancho Cordova, CA.
Our business involves the manufacturing and related service of cell based medical devices, including the AutoXpress® and BioArchive® platforms for automated clinical bio-banking, PXP® platform for point-of-care cell-based therapies and X-Series® products for cell processing services. The Company and its subsidiaries currently manufacture and market the following products:
Clinical Bio-Banking Applications:
|
● |
AXP® II Automated Cell Separation System – an automated, fully closed cell separation system for isolating stem and progenitor cells from umbilical cord blood, registered as a U.S. FDA 510(k) medical device. |
|
|
● |
BioArchive® Automated Cryopreservation System – an automated, robotic, liquid nitrogen controlled-rate-freezing and cryogenic storage system for cord blood samples and cell therapeutic products used in clinical applications, registered as a U.S. FDA 510(k) medical device. |
Point-of-Care Applications:
|
● |
PXP® Point-of-Care System – an automated, fully closed, sterile system allows for the rapid, automated processing of autologous peripheral blood or bone marrow aspirate derived stem cells at the point-of-care, such as surgical centers or clinics, registered as a U.S. FDA 510(k) medical device. |
|
● |
PXP-1000 System – an automated, fully closed system that provides fast, reproducible separation of multiple cellular components from blood with minimal red blood cell contamination, registered as a U.S. FDA 510(k) medical device. |
Cell Processing:
|
● |
X-Series® Products for general laboratory use: X-Lab® for cell isolation, X-Wash® System for cell washing and reformulation, and X-Mini® for high efficiency small scale cell purification. |
Expansion of Business – Contract Development and Manufacturing Services for Cell and Cell-Based Gene Therapies
The Company expanded its business to include contract development and manufacturing services for cell and cell-based gene therapies. In October 2023, the Company announced the completion of its new state-of-the-art facility, housing ISO 7 cGMP cleanroom suites, along with research and development labs giving it the capabilities to become a world-class Contract Development and Manufacturing Organization (“CDMO”) for cell and cell-based gene therapies. The ReadyStart cGMP Cleanrooms and IncuStart Wet Labs are an incubator facility which provide the cleanroom environment, equipment, and services needed for R&D and cGMP manufacturing of cell and gene therapies and other life science products. The ReadyStart Cleanrooms consist of twelve leasable cGMP compliant ISO 7 cleanroom suites. Each private cGMP suite comes fully equipped and can be configured to meet the client’s specific needs. Within the cGMP facility are the IncuStart Wet Labs. The facility will be maintained and supported by the Company’s operations, quality, regulatory and scientific staff, with more than 25 years of industry experience.
The Company believes that CDMO cell manufacturing services are becoming increasingly important for cell therapies to make their way through clinical trials. One of the major issues with moving cell therapy products from “bench to bedside” has been manufacturing bottlenecks. The heterogeneous nature of cell therapy products has introduced manufacturing complexity and regulatory concerns, as well as scale-up complexities that are not present within traditional pharmaceutical manufacturing. Additionally, establishing a manufacturing facility for cell therapies requires specific expertise and significant capital which can delay clinical trials. These factors often result in a significant number of cell therapy-based companies seeking CDMOs for their cell manufacturing needs. The Company believes that it can leverage its current proprietary automated and semi-automated cell processing technologies to more effectively develop CDMO capabilities.
Results of Operations
Three Months Ended March 31, 2024 as Compared to the Three Months Ended March 31, 2023
Net Revenues
Net revenues increased by $165,000 or 6%, from $2,572,000 to $2,737,000 for the three months ended March 31, 2024 as compared to the three months ended March 31, 2023. The increase in revenue was primarily driven by higher AXP disposable sales, with 184 more cases sold in the current year, offset by lower BioArchive device and Other sales.
The following table summarizes revenue by product line:
|
March 31, 2024 |
March 31, 2023 |
|||||||
|
AXP |
$ | 1,964,000 | $ | 1,539,000 | ||||
|
BioArchive |
522,000 | 657,000 | ||||||
|
CAR-TXpress |
146,000 | 146,000 | ||||||
|
Other |
105,000 | 230,000 | ||||||
|
Total |
$ | 2,737,000 | $ | 2,572,000 | ||||
Gross Profit
The Company’s gross profit increased by $97,000 to $1,202,000 or 9% of net revenues for the three months ended March 31, 2024, compared to $1,105,000 or 43% for three months ended March 31, 2023. The primary driver of the increase is additional AXP sales at higher margins as compared to our other product lines in the current year.
Selling, General and Administrative
Sales, general and administrative expenses for the three months ended March 31, 2024 were $1,548,000 compared to $1,844,000 for the three months ended March 31, 2023, a decrease of $296,000 or 16%. The reduced expenses were primarily due to cost cutting initiatives implemented by the Company at the end of 2023. Specifically, public company related expenses decreased by approximately $105,000, salaries and benefits by approximately $95,000, and professional fees by approximately $85,000.
Research and Development Expenses
Research and development expenses were $211,000 for the three months ended March 31, 2024 as compared to $306,000 for the three months ended March 31, 2023, a decrease of $95,000 or 31%. The decrease was driven by lower personnel and project expenses.
Interest Expense
Interest expense for the three months ended March 31, 2024 was $1,452,000 compared to $3,903,000, for the three months ended March 31, 2023, a decrease of $2,451,000. The decrease was driven by lower amortization expenses of approximately $2,600,000 related to down round triggering events that occurred in the three months ended March 31, 2023 for the Company’s convertible note payable with Boyalife Group, Inc, which was offset by approximately $150,000 more in amortization and interest expense related to the July 2019 Note.
Liquidity and Capital Resources
The Company had cash and cash equivalents of $1,176,000 and $2,000,000 and a working capital deficit of $3,953,000 and $6,582,000 at March 31, 2024 and December 31, 2023, respectively. We have primarily financed cash shortfalls from operations through private and public placement of equity and debt securities.
Effective January 5, 2024, the Company entered into an Amendment No. 3 (the "Amendment to Note”) to its Second Amended and Restated Convertible Promissory Note with Boyalife Group Inc. (the "Note”), and an Amendment No. 4 (the "Amendment to Credit Agreement”) to its First Amended and Restated Revolving Credit Agreement with Boyalife Group Inc. (the "Credit Agreement”). The Amendment to Note amends and extends the maturity date of the Note from December 31, 2023 to December 31, 2024, and provides that beginning January 1, 2024, accrued and unpaid interest of approximately $634,293 shall be due and payable on or before July 1 and December 31 of each year. Accrued and unpaid interest as of December 31, 2023, (the "December 2023 Capitalized Amount”) shall be paid in six (6) equal installments of approximately $106,000 each on or before the first day of each of January, February, March, April, May, and June of 2024. Any unpaid portion of the December 2023 Capitalized Amount shall bear interest at an annual rate of twenty-two percent (22%), and accrued and unpaid interest on the December 2023 Capitalized Amount shall be due and payable on July 1, 2024. The Amendment to Credit Agreement amends the Credit Agreement to change the defined term "Termination Date” to December 31, 2024.
On March 15, 2024, the Company received a conversion notice from Boyalife Group Inc. to convert $1,278,000 of the outstanding principal and $285,000 of the outstanding accrued interest for a total of $1,563,000. As of March 31, 2024, the outstanding principal and accrued interest of the Note was approximately $6,424,000.
The Company also had an unsecured convertible promissory note with an accredited investor pursuant to which the Company issued and sold to such investor with an original principal amount of $1,000,000. As of December 31, 2023, the outstanding balance of the note was $397,000. The note matured on January 31, 2024, at which time the Company paid the outstanding balance of the note.
The Company has incurred historical losses from operations and expects to continue to incur operating losses in the near future. The Company will need to raise additional capital to grow its business, fund operating expenses and make interest payments. The Company’s ability to fund its liquidity needs is subject to various risks, many of which are beyond its control. The Company may seek additional funding through debt borrowings, sales of debt or equity securities or strategic partnerships. The Company cannot guarantee that such funding will be available on a timely basis, in needed quantities or on terms favorable to the Company, if at all. These factors and other indicators raise substantial doubt about the Company’s ability to continue as a going concern within one year from the filing date of this report.
We manage the concentration of credit risk with our customers and distributors through a variety of methods including, pre-shipment deposits, credit reference checks and credit limits. Although management believes that our customers and distributors are sound and creditworthy, a severe adverse impact on their business operations could have a corresponding material effect on their ability to pay timely and therefore on our net revenues, cash flows and financial condition.
ITEM 3. Quantitative and Qualitative Disclosures about Market Risk
ThermoGenesis Holdings is a smaller reporting company as defined by Rule 12b-2 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”) and is not required to provide information under this item.
ITEM 4. Controls and Procedures
The Company carried out an evaluation, under the supervision, and with the participation of management, including both the Company’s Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), of the effectiveness of the design and operation of the Company’s disclosure controls and procedures (as defined by Exchange Act Rule 13a-15(e) or 15d-15(e)) as of December 31, 2023. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Based on this evaluation, and in light of the weakness in our internal control over financial reporting described below, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective as of March 31, 2024.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act). Our Chief Executive Officer and Chief Financial Officer assessed the effectiveness of our internal control over financial reporting as of December 31, 2023. In making this assessment, our Chief Executive Officer and Chief Financial Officer used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in Internal Control—Integrated Framework. Based on that assessment and using the COSO criteria, our Chief Executive Officer and Chief Financial Officer have concluded that, as of March 31, 2024, our internal controls over financial reporting were not effective because of the material weaknesses described below.
A material weakness is defined as “a deficiency, or a combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.”
As of March 31, 2024, the following material weaknesses have been identified:
Segregation of Duties: We did not design and maintain effective segregation of duties due to limited staffing in our accounting function. Specifically, we do not have sufficient resources in our accounting department, which restricts our ability to segregate roles and access to ensure effective segregation of duties. This also results in an ineffective review process of the information used to prepare the financial statements.
Privileged access and user access review controls over financial applications were not effectively designed or implemented to ensure appropriate access, authorization and segregation of duties. In addition, service providers for financial reporting were not properly monitored.
Planned Remediation
During 2024, the Company intends to work to remediate the material weaknesses identified above, which are expected to be the addition of accounting and financial personnel allowing the Company to have sufficient segregation of duties. In addition, the Company will work with available application and service providers to upgrade our information technology resources. However, our current financial position could make it difficult for us to add the necessary resources.
We are currently working to improve and simplify our internal processes and implement enhanced controls, as discussed above, to address the material weakness in our internal controls over financial reporting and to remedy the ineffectiveness of our disclosure controls and procedures. These material weaknesses will not be considered to be remediated until the applicable remediated controls are operating for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively.
Despite the existence of these material weaknesses, we believe that the financial statements included in this filing for the period ended March 31, 2024 fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented in conformity with U.S. generally accepted accounting principles.
|
ITEM 1. |
Legal Proceedings |
In the normal course of operations, we may have disagreements or disputes with distributors, vendors or employees. Such potential disputes are seen by management as a normal part of business and while the outcome of such disagreements and disputes cannot be predicted with certainty, we do not believe that any pending legal proceedings are material. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
|
ITEM 1A. |
Risk Factors |
There have been no material changes to the risk factors relating to the Company set forth in, “Item IA. Risk Factors” of its Annual Report on Form 10-K for the year ended December 31, 2023, except as noted below.
We may not be able to maintain our listing on The Nasdaq Capital Market and it may become more difficult to sell our stock in the public market.
On April 19, 2024, we received a notice (the “Nasdaq Notice”) from the Listing Qualifications Department of Nasdaq stating that the Company does not presently comply with Nasdaq’s Listing Rule 5550(b)(1) that requires the Company to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing (“Minimum Equity Requirement”).
The Nasdaq Notice had no immediate effect on the listing of our common stock and we have 45 calendar days from the date of the Nasdaq Notice to submit a plan to Nasdaq to regain compliance with Nasdaq’s continued listing rules.
If our plan is accepted, Nasdaq can grant us an extension of up to 180 calendar days from the date of the Nasdaq Notice for us to evidence compliance with the plan and with the relevant Nasdaq continued listing rules.
There can be no assurance that Nasdaq will accept our plan, that Nasdaq will grant an extension, that we will be able to achieve any required milestones in the plan or evidence compliance with the Minimum Equity Requirement within the timeframe required by Nasdaq, or that we will be able to maintain compliance with the other Nasdaq Listing Rules. If we are unable to timely regain compliance with the Minimum Equity Requirement, or if we fall out of compliance with one or more of the other Nasdaq Listing Rules, Nasdaq could seek to delist our common stock, in which case we would have the right to appeal such determination. If our common stock ultimately is delisted, our shareholders could face significant adverse consequences, including:
|
● |
Limited availability of market quotations for our common stock; |
|
● |
Reduced liquidity of our common stock; |
|
● |
Determination that shares of our common stock are “penny stock”, which would require brokers trading in our common stock to adhere to more stringent rules; |
|
● |
Limited amount of news and analysts’ coverage of our common stock; and |
| ● | Decreased ability for us to issue additional equity securities or obtain additional equity or debt financing in the future. |
|
ITEM 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
None.
|
Defaults Upon Senior Securities |
None.
|
ITEM 4. |
Mine Safety Disclosure |
Not applicable.
|
Other Information |
|
(a) |
None. |
|
|
(b) |
None. |
|
|
(c) |
During the three months ended March 31, 2024, of the Company's directors or officers (as defined in Rule 16a-1(f) of the Securities Exchange Act of 1934) adopted, terminated or modified a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement (as such terms are defined in Item 408 of Regulation S-K). |
|
ITEM 6. |
Exhibits |
EXHIBIT INDEX
|
Exhibit No. |
Description |
|
1.1 |
|
|
1.2 |
|
|
1.3 |
|
|
1.4 |
|
|
3.1 |
|
|
3.2 |
|
|
4.1 |
|
|
4.2 |
|
|
4.3 |
|
|
4.4 |
|
|
4.5 |
|
|
4.6 |
|
|
4.7 |
|
|
10.1 |
|
|
10.2 |
Amendment No. 4 to First Amended and Restated Revolving Credit Agreement, dated January 5, 2024, between ThermoGenesis Holdings, Inc. and Boyalife Group, Inc., incorporated by reference to Exhibit 10.2 to Form 8-K filed with the SEC on January 10, 2024. |
|
31.1 |
|
|
31.2 |
|
|
32 |
|
|
101.INS |
XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
|
101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
|
101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
|
101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
|
101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document |
|
101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
|
104 |
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101). |
ThermoGenesis Holdings, Inc.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
ThermoGenesis Holdings, Inc. (Registrant) |
||
|
Dated: May 17, 2024 |
/s/ Xiaochun (Chris) Xu, Ph.D. |
|
|
Xiaochun (Chris) Xu, Ph.D. Chief Executive Officer (Principal Executive Officer) |
||
|
Dated: May 17, 2024 |
/s/ Jeffery Cauble |
|
|
Jeffery Cauble Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |