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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the quarterly period ended June 30, 2024

 

Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the transition period from              to

 

Commission file number 001-35853

 

Harvard Apparatus Regenerative Technology, Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware   45-5210462
(State or Other Jurisdiction of   (IRS Employer
Incorporation or Organization)   Identification No.)

 

84 October Hill Road, Suite 11, Holliston, MA   01746
(Address of Principal Executive Offices)   (Zip Code)

 

(774) 233-7300

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act: None

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
N/A   N/A   N/A

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ YES ☐ NO

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§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 ☐ 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 the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☐ Accelerated filer ☐
   
Non-accelerated filer Smaller reporting company
   
  Emerging growth company

 

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

 

As of August 5, 2024, there were 14,530,091 shares of common stock, par value $0.01 per share, outstanding.

 

 

 

 

 

 

Harvard Apparatus Regenerative Technology, Inc.

(formerly Biostage, Inc.)

Form 10-Q

For the Quarter Ended June 30, 2024

 

INDEX

 

    Page
PART I-FINANCIAL INFORMATION 3
     
Item 1. Condensed Consolidated Financial Statements 3
     
  Condensed Consolidated Balance Sheets 3
     
  Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) 4
     
  Condensed Consolidated Statements of Stockholders’ Equity (Deficit) (Unaudited) 5
     
  Condensed Consolidated Statements of Cash Flows (Unaudited) 6
     
  Notes to Unaudited Condensed Consolidated Financial Statements 7
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 15
     
Item 3. Quantitative and Qualitative Disclosures about Market Risk 21
     
Item 4. Controls and Procedures 21
     
PART II-OTHER INFORMATION 22
     
Item 1. Legal Proceedings 22
     
Item 1A. Risk Factors 22
     
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 22
     
Item 3. Defaults Upon Senior Securities 22
     
Item 6. Exhibits 22
     
SIGNATURES 24

 

2

 

 

PART I. FINANCIAL INFORMATION

 

Item 1. Condensed Consolidated Financial Statements.

 

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and par value data)

 

   June 30,   December 31, 
   2024   2023 
   (Unaudited)     
ASSETS          
Current assets:          
Cash and cash equivalents  $139   $432 
Accounts receivable       4 
Inventory   60    50 
Prepaid research and development   343    210 
Prepaid expenses and other current assets   114    87 
Total current assets   656    783 
Property, plant and equipment, net   14    25 
Right-of-use assets, net   68    48 
Deferred financing costs       544 
Long-term prepaid contracts   992    1,214 
Total assets  $1,730   $2,614 
           
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY          
Current liabilities:          
Accounts payable  $752   $445 
Accrued and other current liabilities   700    475 
Convertible debt – related party   500     
Operating lease liability   40    48 
Total current liabilities   1,992    968 
Operating lease liability, net of current portion   28     
Total liabilities   2,020    1,411 
           
Commitments and contingencies (Note 7)   -      
           
Stockholders’ (deficit) equity:          
Common stock, par value $0.01 per share, 60,000,000 shares authorized; 14,315,091 and 13,947,324 issued and outstanding at June 30, 2024 and December 31, 2023, respectively   143    139 
Additional paid-in capital   96,073    93,463 
Accumulated deficit   (96,484)   (91,956)
Accumulated other comprehensive loss   (22)    
Total stockholders’ (deficit) equity   (290)   1,646 
Total liabilities and stockholders’ (deficit) equity  $1,730   $2,614 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

3

 

 

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(in thousands, except share and per share data)

 

   2024   2023   2024   2023 
   Three Months Ended   Six Months Ended 
   June 30,   June 30, 
   2024   2023   2024   2023 
Product revenue  $56   $   $113   $ 
                     
Operating expenses:                    
Cost of sales   13        25     
Research and development   642    1,566    1,482    2,075 
Sales and marketing   197    55    312    55 
General and administrative   1,685    1,030    2,796    3,408 
Total operating expenses   2,537    2,651    4,615    5,538 
                     
Operating loss   (2,481)   (2,651)   (4,502)   (5,538)
                     
Other (expense) income, net:                    
Other (expense) income, net   (17)   37    (26)   34 
                     
Net loss   (2,498)   (2,614)   (4,528)   (5,504)
Preferred stock dividends       3        (77)
Net loss attributable to common stockholders  $(2,498)  $(2,611)  $(4,528)  $(5,581)
                     
Basic and diluted net loss per share attributable to common stockholders  $(0.18)  $(0.19)  $(0.32)  $(0.43)
Weighted average common shares outstanding, basic and diluted   14,258,511    13,785,657    14,102,918    13,000,211 
                     
Comprehensive loss:                    
Net loss  $(2,498)  $(2,614)  $(4,528)  $(5,504)
Foreign currency translation adjustments   (21)       (22)    
Comprehensive loss   (2,519)   (2,614)   (4,550)   (5,504)
Less: Preferred stock dividends       3        (77)
Comprehensive loss attributable to common stockholders  $(2,519)  $(2,611)  $(4,550)  $(5,581)

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

4

 

 

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

(Unaudited)

(in thousands, except share data)

 

   Stock   Outstanding   Stock   Capital   Deficit   Loss   (Deficit) 
  

Series E

Convertible

Preferred

  

Number of

Common

Shares

   Common  

Additional

Paid-in

   Accumulated  

Accumulated

Other

Comprehensive

  

Total

Stockholders’

Equity

 
   Stock   Outstanding   Stock   Capital   Deficit   Loss   (Deficit) 
Balance at April 1, 2024- $          13,947,324   $139   $94,023   $(93,986)  $             (1)  $       175 
Share-based compensation               572            572 
Issuance of common stock       367,767    4    1,478            1,482 
Net loss-                  (2,498)       (2,498)
Other comprehensive loss                       (21)   (21)
Balance at June 30, 2024- $    14,315,091   $143   $96,073   $(96,484)  $(22)  $(290)

 

   Stock   Outstanding   Stock   Capital   Deficit   Equity 
  

Series E

Convertible

Preferred

  

Number of

Common

Shares

   Common  

Additional

Paid-in

   Accumulated  

Total

Stockholders’

(Deficit)

 
   Stock   Outstanding   Stock   Capital   Deficit   Equity 
Balance at April 1, 2023  $4,051    12,716,534   $127   $84,712   $(85,901)  $            (1,062)
Preferred stock dividends   (3)           3        3 
Conversion of preferred stock for common stock   (4,048)   674,693    7    4,041        4,048 
Issuance of common stock, net of offering costs       490,833    5    2,937        2,942 
Share-based compensation expense               479        479 
Net loss                   (2,614)   (2,614)
Balance at June 30, 2023  $    13,882,060   $139   $92,172   $(88,515)  $3,796 

 

   Stock   Outstanding   Stock   Capital   Deficit   Loss   (Deficit) 
  

Series E

Convertible

Preferred

  

Number of

Common

Shares

   Common  

Additional

Paid-in

   Accumulated  

Accumulated

Other

Comprehensive

  

Total

Stockholders’

Equity

 
   Stock   Outstanding   Stock   Capital   Deficit   Loss   (Deficit) 
Balance at January 1, 2024  $           13,947,324   $139   $93,463   $(91,956)  $              $       1,646 
Share-based compensation               1,132            1,132 
Issuance of common stock       367,767    4    1,478            1,482 
Net loss                   (4,528)       (4,528)
Other comprehensive loss                       (22)   (22)
Balance at June 30, 2024  $    14,315,091   $143   $96,073   $(96,484)  $(22)  $(290)

 

   Stock   Outstanding   Stock   Capital   Deficit   Equity 
  

Series E

Convertible

Preferred

  

Number of

Common

Shares

   Common  

Additional

Paid-in

   Accumulated  

Total

Stockholders’

(Deficit)

 
   Stock   Outstanding   Stock   Capital   Deficit   Equity 
Balance at January 1, 2023  $4,180    12,174,467   $122   $79,698   $(83,011)  $            (3,191)
Preferred stock dividends   77            (77)       (77)
Conversion of preferred stock for common stock   (4,257)   706,626    7    4,250        4,257 
Issuance of common stock, net of offering costs       1,000,967    10    5,982        5,992 
Share-based compensation expense               2,319        2,319 
Net loss                   (5,504)   (5,504)
Balance at June 30, 2023  $    13,882,060   $139   $92,172   $(88,515)  $3,796 

 

See accompanying notes to unaudited condensed consolidated financial statements

 

5

 

 

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(in thousands)

 

       
   Six Months Ended 
   June 30, 
   2024   2023 
OPERATING ACTIVITIES          
Net loss  $(4,528)  $(5,504)
Adjustments to reconcile net loss to net cash used in operating activities:          
Share-based compensation expense   1,132    2,319 
Depreciation   11    23 
Amortization of operating lease right-of-use assets   55   57 
Changes in operating assets and liabilities:          
Accounts receivable   4     
Inventory   (10)    
Prepaid research and development   (133)   15 
Prepaid expenses and other current assets   (27)    
Deferred financing costs   544    66 
Long-term prepaid contracts   222    (62)
Accounts payable   307    (310)
Operating lease liability   (55)   (57)
Accrued and other current liabilities   225    894 
Net cash used in operating activities   (2,253)   (2,559)
           
INVESTING ACTIVITIES          
Purchases of short-term investments       (2,523)
Purchases of property, plant, and equipment       (11)
Net cash used in investing activities       (2,534)
           
FINANCING ACTIVITIES          
Proceeds from convertible debt – related party   500     
Proceeds from issuance of common stock   1,482    5,992 
Net cash provided by financing activities   1,982    5,992 
Effect of exchange rate changes on cash   (22)    
Net (decrease) increase in cash and cash equivalents   (293)   899 
Cash and cash equivalents at the beginning of the year   432    1,241 
Cash and cash equivalents at the end of the period  $139   $2,140 
           
Supplemental disclosure of non-cash activities:          
Purchases of property and equipment in accounts payable or accrued expenses  $   $5 
Preferred stock dividends  $   $77 
Conversion of preferred stock into common stock  $   $4,257 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

6

 

 

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

1. Organization

 

Overview

 

Harvard Apparatus Regenerative Technology, Inc. (Harvard Apparatus Regenerative Technology or the Company) is a biotechnology company with a mission to cure patients of cancers, injuries, and birth defects of the gastro-intestinal tract and the airways. The Company believes its technology is likely to be used to treat esophageal cancer, esophageal injuries, and birth defects in the esophagus. The Company believes additional product candidates in our development pipeline may treat intestinal cancer and colon cancer. Since inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, and acquiring operating assets.

 

Longevity Products

 

In the second quarter of 2023, the Company’s subsidiary in Hong Kong, Harvard Apparatus Regenerative Technology Limited, or Longevity Products, started focusing on sales of longevity products.

 

Longevity Products plans to include a broad range of products focused on personal healthcare including longevity dietary supplements. The Company currently sells longevity supplements through Longevity Products. These products are commercially marketed to the general public and initially targeted at consumers in the Great China Region through eCommerce (online sales).

 

Going Concern

 

The Company has incurred substantial operating losses since its inception, and as of June 30, 2024, had an accumulated deficit of approximately $96.5 million and will require additional financing to fund future operations. The Company expects that its operating cash on-hand as of June 30, 2024 of approximately $0.1 million and equity financing of $0.4 million in gross proceeds received subsequent to June 30, 2024 will enable it to fund its operating expenses and capital expenditure requirements into the third quarter of 2024. Therefore, these conditions raise substantial doubt about the Company’s ability to continue as a going concern.

 

The Company will need to raise additional capital to fund its current operations. In the event the Company is unable to raise additional capital from outside sources during the third quarter of 2024, it may be forced to curtail or cease its operations.

 

Cash requirements and cash resource needs will vary significantly depending upon the timing of the financial and other resource needs that will be required to complete ongoing development, pre-clinical and clinical testing of product candidates, as well as regulatory efforts and collaborative arrangements necessary for the Company’s product candidates that are currently under development. The Company is currently seeking and will continue to seek financing from other existing and/or new investors to raise necessary funds through a combination of public or private equity offerings. The Company may also pursue debt financings, other financing mechanisms, research grants, or strategic collaborations and licensing arrangements. The Company may not be able to obtain additional financing on favorable terms, if at all.

 

The Company’s operations will be adversely affected if it is unable to raise or obtain needed funding and may materially affect the Company’s ability to continue as a going concern. The accompanying unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern and therefore, the unaudited condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amount and classifications of liabilities that may result from the outcome of this uncertainty.

 

7

 

 

2. Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements

 

Summary of Significant Accounting Policies

 

The accounting policies underlying the accompanying unaudited condensed consolidated financial statements are those set forth in Note 2 to the consolidated financial statements for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K.

 

Prior Period Reclassifications

 

Certain prior period amounts have been reclassified to conform to the current period presentation. “Selling and marketing” operating expenses was reclassified from “Selling, general and administrative” operating expenses on our unaudited condensed consolidated financial statements.

 

Principles of Consolidation

 

The unaudited condensed consolidated financial statements include the accounts of Harvard Apparatus Regenerative Technology and its subsidiaries, Harvard Apparatus Regenerative Technology Limited (Hong Kong), Harvard Apparatus Regenerative Technology (Hangzhou) Limited (China), and Harvard Apparatus Regenerative Technology GmbH (Germany). All intercompany balances and transactions have been eliminated in consolidation.

 

Basis of Presentation

 

The unaudited condensed consolidated financial statements reflect the Company’s financial position, results of operations and comprehensive loss and cash flows in conformity with accounting principles generally accepted in the United States, or U.S. GAAP. These unaudited consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

 

Use of Estimates

 

The process of preparing condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Such estimates include, but are not limited to, share-based compensation, valuation of warrant liability, accrued expenses and the valuation allowance for deferred income taxes. Actual results could differ from those estimates.

 

Revenue

 

We recognize revenue in accordance with Financial Accounting Standards Board (FASB) ASC 606, Revenue from Contracts with Customers. We offer consumer products primarily through a third-party online store. Revenue is recognized at a point in time when control of the goods is transferred to the customer, which generally occurs upon the delivery to the customer. For any company direct sales to customers, revenue is recognized at a point in time upon shipment of product or hand-delivery to customer. Revenue also excludes any amounts collected on behalf of third parties, including sales and indirect taxes.

 

We identify a performance obligation as distinct if both the following criteria are true: the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. Determining the standalone selling price (“SSP”) and allocation of consideration from a contract to the individual performance obligations, and the appropriate timing of revenue recognition, is the result of significant qualitative and quantitative judgments. Management considers a variety of factors such as historical sales, usage rates, costs, and expected margin, which may vary over time depending upon the unique facts and circumstances related to each performance obligation in making these estimates. While changes in the allocation of the SSP between performance obligations will not affect the amount of total revenue recognized for a particular contract, any material changes could impact the timing of revenue recognition, which would have a material effect on our financial position and result of operations. This is because the contract consideration is allocated to each performance obligation, delivered or undelivered, at the inception of the contract based on the SSP of each distinct performance obligation.

 

Cost of Sales

 

Cost of sales primarily consists of the purchase price of consumer products, taxes, inbound and outbound shipping costs. Shipping costs to receive products from our suppliers are recognized as cost of sales when incurred. E-commerce processing and related transaction costs, including those associated with seller transactions, are classified in sales and marketing on our condensed consolidated statements of operations and comprehensive loss.

 

Research and Development

 

Research and development costs are expensed as incurred.

 

Sales and Marketing

 

Sales and marketing costs include advertising and payroll and related expenses for personnel engaged in marketing and selling activities.

 

8

 

 

General and Administrative

 

General and administrative expenses primarily consist of costs for corporate functions, including payroll and related expenses; facilities and equipment expenses, such as depreciation and amortization expense and rent; and professional fees.

 

Segment Information

 

The Company manages its operations as two separate operating segments for the purposes of assessing performance and making operating decisions. The Company has one operating unit focused on the development and commercialization of therapies to cure patients of cancers, injuries, and birth defects of the gastro-intestinal tract and the airways. The other operating unit is focused on personal healthcare through longevity dietary supplements. We have determined that our chief executive officer is the chief operating decision maker (“CODM”). The CODM reviews financial information presented by operating unit. Resource allocation decisions are made by the CODM based on operating unit results.

 

Cash Concentrations

 

The Company maintains its cash balances with a financial institution in federally insured accounts and may periodically have cash balances in excess of insurance limits. The Company maintains its accounts with financial institutions with a high credit rating. The Company has not experienced any losses to date and believes that it is not exposed to any significant credit risk on cash.

 

Cash and Cash Equivalents

 

The Company considers all highly liquid investments with a maturity of three months or less at the date of purchase to be cash equivalents. The Company currently invests available cash in money market funds.

 

Accounts Receivable

 

Allowances for credit losses are provided for estimated amounts of accounts receivable which may not be collected. At June 30, 2024 and December 31, 2023, we determined that no allowance for credit losses against accounts receivable was necessary.

 

Inventory

 

Inventory, consisting of products available for sale, are primarily accounted for using the first-in, first-out method, and are valued at the lower of cost and net realizable value. This valuation requires us to make judgments, based on currently available information, about the likely method of disposition, such as through sales to individual customers, returns to product vendors, or liquidations, and expected recoverable values of each disposition category.

 

We maintain ownership of our inventory at the third-party warehouse, regardless of whether fulfillment is provided by us or the third-party e-commerce seller, and therefore these products are included in our inventory.

 

Deferred Financing Costs

 

We capitalized costs relating to a registered offering that we postponed in fiscal year 2023 but expected to resume in the near future. The costs include payments made to attorneys, accountants, regulators and consultants. We have changed our outlook and do not expect to complete the registered offering in fiscal year 2024, therefore, the deferred financing costs were expensed to general and administrative expenses on the unaudited condensed consolidated statements of operations and comprehensive loss for the quarter ended June 30, 2024.

 

9

 

 

Long-term Prepaid Contracts

 

We have contracted with partners relating to our clinical trial activities. Upon execution of the contracts, we made initial payments of $1.2 million as deposits recorded as long-term assets and will be applied against final invoices which are more than a year away. The deposits will be recorded as expense when the clinical trial is substantially completed. Costs for the clinical trial activities throughout our clinical trial under these contracts are recognized as expense and payable based on costs incurred. Our clinical trial partner applied $0.2 million of the $1.2 million deposits against outstanding invoices in July 2024 so we reclassified the $0.2 million as current assets as of June 30, 2024.

 

Property, Plant and Equipment

 

Property, plant and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets as follows:

 

Leasehold improvements   Shorter of expected useful life or lease term
Computer equipment and software   3 years
Furniture, machinery and equipment   5-7 years

 

Maintenance and repairs are charged to expense as incurred, while any additions or improvements are capitalized.

 

Foreign Currency

 

Assets and liabilities of non-U.S. operations where the functional currency is other than the U.S. dollar are translated from the functional currency into U.S. dollars at year end exchange rates, and revenues and expenses are translated at average rates prevailing during the year. Resulting translation adjustments are accumulated as part of accumulated other comprehensive loss. Transaction gains or losses are recognized in income or loss in the period in which they occur.

 

Net Loss Per Share

 

Basic net loss per share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the if-converted method. For purposes of the diluted net loss per share calculation, warrants to purchase common stock and stock options are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented.

 

Unaudited Interim Financial Information

 

The accompanying interim condensed consolidated balance sheet as of June 30, 2024, condensed consolidated interim statements of operations and comprehensive loss and condensed consolidated statements of stockholders’ equity (deficit) for the three and six months ended June 30, 2024 and 2023, and cash flows for the six months ended June 30, 2024 and 2023 are unaudited. The interim unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments necessary for a fair statement of the Company’s financial position as of June 30, 2024, its condensed consolidated results of operations and stockholders’ equity for the three and six months ended June 30, 2024 and 2023, and cash flows for the six months ended June 30, 2024 and 2023. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2024 and 2023 are unaudited. The results for the three and six months ended June 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024, any other interim periods or any future year or period.

 

10

 

 

Recently Adopted Accounting Pronouncements

 

Accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s condensed consolidated financial statements upon adoption.

 

In August 2020, the FASB issued Accounting Standards Update (ASU) No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. Among other changes, the new guidance removes the beneficial conversion separation model for convertible debt. As a result, after adopting the guidance, entities will no longer account for beneficial conversion features in equity. The guidance is effective for public business entities, other than small reporting company’s financial statements starting January 1, 2022, with early adoption permitted. The Company is a small reporting company and adopted the new guidance on January 1, 2024, and the adoption of ASU 2020-06 did not have a material impact on its consolidated financial statements.

 

3. Fair Value Measurements

 

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.

 

The Company utilizes a valuation hierarchy for disclosure of the inputs to the valuations used to measure fair value that prioritizes the inputs into three broad levels. Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on the Company’s own assumptions used to measure assets and liabilities at fair value. A financial asset or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement.

 

The Company had no assets or liabilities classified as Level 2 or Level 3 as of June 30, 2024 and December 31, 2023. The carrying value of financial instruments (consisting of cash, accounts payable, accrued compensation and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those instruments. For the six months ended June 30, 2023, the Company had short-term investments generating investment income. Investment income is included as other income. Investment income for the three months ended June 30, 2024 and June 30, 2023 consists primarily of interest earned of $0 and $41,000, respectively. Investment income for the six months ended June 30, 2024 and June 30, 2023 consists of interest earned of $0 and $41,000, respectively.

 

4. Accrued and Other Current Liabilities

 

Accrued and other current liabilities consist of the following:

 

   June 30,   December 31, 
   2024   2023 
   (in thousands) 
Advisory costs  $402   $325 
Audit services   77    70 
Payroll   156    79 
Other liabilities   65    1 
Total accrued and other current liabilities  $700   $475 

 

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5. Capital Stock

 

Preferred Stock

 

The Company has authorized a total of 2,000,000 shares of preferred stock, par value $0.01 per share, none of which were outstanding at June 30, 2024 and December 31, 2023. The Company’s Board of Directors has the authority to issue preferred stock and to determine the rights, preferences, privileges, and restrictions, including voting rights.

 

Common Stock

 

On April 15, 2024, the Company entered into securities purchase agreements (each an “April Purchase Agreement,” collectively the “April Purchase Agreements”) with certain investors each named therein (the “Investor,” collectively the “Investors”) pursuant to which each of the Investors agreed to purchase in a private placement an aggregate of 367,767 shares of common stock for the aggregate gross proceeds of approximately $1.5 million at a purchase price per unit of $4.03 (the “2024 Private Placement”).

 

Pursuant to the April Purchase Agreements, if the Company closes an equity financing in a registered public offering of its securities on or before six (6) months from the date of the April Purchase Agreements, and the public offering price per share was less than the per share purchase price of the 2024 Private Placement, then the Company shall promptly following such closing issue to each Investor additional shares of common stock in an amount equal to the difference between (i) the shares issued in the 2024 Private Placement, and (ii) result of dividing (a) the subscription amount for each April Purchase Agreement, by (b) the public offering per share.

 

On April 12, 2023 and on March 31, 2023, the Company entered into Securities Purchase Agreements, each a Purchase Agreement, with new and existing investors, the Investors, pursuant to which the Investors agreed to purchase in a private placement an aggregate of 1,000,967 shares of common stock for the aggregate purchase price of approximately $6 million with a purchase price per unit of $6.00 (the “2023 Private Placement”).

 

On January 18, 2023, Harvard Bioscience converted 200 Series E Preferred Shares with accrued dividends of $9,545 into 31,933 shares of common stock.

 

In connection with the 2023 Private Placement, as of April 12, 2023, the Company had received $6.0 million in aggregate proceeds in such private placement. The 2023 Private Placement resulted in gross proceeds of at least $4,000,000 which triggered the mandatory conversion of all the Company’s outstanding Series E Preferred Stock and related accrued dividends into shares of common stock at a conversion price of $6.00 per share. The conversion resulted in 674,693 shares of common stock being issued to the holder of the Series E Preferred Stock. Following such conversion, there are no shares of Series E Preferred Stock outstanding.

 

Warrants

 

The Company had 1,113,622 warrants to purchase common stock outstanding as of June 30, 2024 with a weighted-average exercise price of $4.69.

 

6. Share-Based Compensation

 

Harvard Apparatus Regenerative Technology Amended and Restated Equity Incentive Plan

 

The Company maintains the Amended and Restated Equity Incentive Plan, or the Plan, for the benefit of certain officers, employees, non-employee directors, and other key persons (including consultants and advisory board members). All options and awards granted under the Plan consist of the Company’s shares of common stock. The Company’s policy is to issue stock available from its registered but unissued stock pool through its transfer agent to satisfy stock option exercises and the vesting of restricted stock units. The vesting period for awards is generally four years and the contractual life is ten years. Canceled and forfeited options and awards are available to be reissued under the Plan.

 

As of June 30, 2024, the Company’s Plan has 9,098,000 authorized shares to be issued under the Plan. There were 4,672,994 shares available for issuance as of June 30, 2024.

 

The following table summarizes information concerning options outstanding and exercisable:

 

   Amount   Weighted-average exercise price   Weighted-average contractual life (years)   Aggregate intrinsic value (in thousands) 
Outstanding at December 31, 2023   3,977,289   $4.64    7.7   $5,728 
Granted   361,766    3.62           
Outstanding at June 30, 2024   4,339,055    4.56    7.4    1,169 
Options exercisable   2,489,412    4.69    6.9    948 
Options vested and expected to vest   4,239,637    4.59    7.4    1,122 

 

The Company’s outstanding stock options include 993,835 performance-based awards that have vesting provisions subject to the achievement of certain business milestones. Total unrecognized compensation expense for the performance-based awards is approximately $3.4 million. The Company recognized approximately $0.04 million and $0.08 million in stock-based compensation during the three and six months ended June 30, 2024 given that some milestone achievements for these awards have been deemed probable for accounting purposes. No expense had been recognized for these awards during the three and six months ended June 30, 2023 given that the milestone achievements for these awards were not probable at the time for accounting purposes.

 

Aggregate intrinsic value for outstanding options as of June 30, 2024 was approximately $1.2 million and calculated as the difference between the Company’s closing stock price of $2.92 per share as of June 28, 2024 and the weighted average exercise price of $4.56. As of June 30, 2024, unrecognized compensation cost related to unvested non-performance-based awards amounted to $3.2 million, which will be recognized over a weighted-average period of 1.7 years.

 

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The Company uses the Black-Scholes option pricing model to value its stock options. The weighted average assumptions for valuing options granted during the six months ended June 30, 2024 and 2023 were as follows:

 

   Six months ended
June 30,
 
   2024   2023 
Risk-free interest rate   4.07%   3.76%
Expected volatility   116.86%   126.16%
Expected term (in years)   5.4 years    5.9 years 
Expected dividend yield   %   %

 

The Company recorded share-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive loss:

 

   Three months ended
June 30,
   Six months ended
June 30,
 
   2024   2023   2024   2023 
   (In thousands)   (In thousands) 
Research and development  $110   $51   $219   $113 
General and administrative   462    428    913    2,206 
Total  $572   $479   $1,132   $2,319 

 

7. Commitments and Contingencies

 

From time to time, the Company may be involved in various claims and legal proceedings arising in the ordinary course of business. There are no such matters pending that the Company expects to be material in relation to its business, financial condition, results of operations, or cash flows.

 

On March 25, 2024, the Company entered into an operating lease agreement for office space in Beijing, China for the period from April 1, 2024 through April 10, 2026 (the “Office Lease”). Our total Office Lease obligation is $81,352, consisting of minimum annual rental obligations of $30,507 for fiscal year 2024, $40,676 for fiscal year 2025 and $10,169 for fiscal year 2026.

 

We currently have a co-development initiative with Yale University and the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. We owe advance payments of approximately $100,000 and $61,000, respectively at June 30, 2024. We plan to make these advance payments in the third quarter of 2024. The universities started preparatory work in 2023 with substantial work being performed in 2024. Either party can terminate the contract with reasonable notice and any incurred costs will be reimbursed by us to the universities.

 

8. Convertible Debt – Related Party

 

Convertible Debt

 

On February 1, 2024, the Company entered into a loan arrangement with Junli He, the Chairman and Chief Executive Officer of the Company (the “Lender”), pursuant to which the Lender loaned the Company an aggregate amount of $500,000 as evidenced by a Bridge Note executed by the Company in favor of, and accepted by, the Lender (the “Bridge Note”). As of June 30, 2024, the Company accrued $16,222 of interest payable on the Bridge Note. The Company evaluated the convertible note for derivative liability treatment and has determined that the components of the Bridge Note did not qualify for derivative accounting treatment as of June 30, 2024.

 

The Bridge Note accrues interest at an annual fixed rate of 8%, and the principal amount thereof will be due and payable in full, together with all accrued and unpaid interest thereon, on the earlier to occur of a) the closing date (or later date of capital being provided pertaining to such continued offering that the following threshold is tripped) of the Company’s next capital raise that includes gross proceeds of at least $5,000,000 or b) February 1, 2025. The Bridge Note provides for optional conversion at the discretion of the Lender, contains covenants, and provides for certain events of default including if the Company fails to pay when due any amount owed thereunder, fails to comply with any agreement, covenant, condition, provision or term contained therein and other customary events of default.

 

9. Leases

 

The Company leases laboratory and office space and certain equipment with a remaining term of 1 year.

 

The laboratory and office space arrangement in Holliston, MA is under a sublease that was renewed in December of 2022. The sublease is currently on a month-to-month basis until August 31, 2024. The Company is currently negotiating with the landlord for a three-year lease starting September 1, 2024.

 

On March 25, 2024, the Company entered into an operating lease agreement for office space in Beijing, China for the period from April 1, 2024 through April 10, 2026. We recorded approximately $75,000 as a right-of-use asset and a corresponding operating lease liability on the Company’s unaudited condensed consolidated balance sheets upon the accounting commencement date in April 1, 2024. The lease liability was measured at the accounting commencement date utilizing a 8% discount rate. The right-of-use asset had a balance of $65,000 at June 30, 2024. The operating lease obligations totaled $65,000 at June 30, 2024 of which $40,000 is included under current liabilities and $25,000 is included under non-current liabilities.

 

All of the Company’s leases qualify as operating leases. The following table summarizes the presentation of the Company’s operating leases in its condensed consolidated balance sheets:

 

   Balance Sheet Classification  June 30, 2024   December 31, 2023 
            
Assets:             
Operating lease assets  Right-of-use assets, net  $68   $48 
Liabilities:             
Current portion of operating lease liability  Current portion of operating lease liability   40    48 
Operating lease liability, net of current portion  Operating lease liability, net of current portion   28     
Total operating lease liability     $68   $48 

 

The Company recorded operating lease expense in the following categories in its condensed consolidated statements of operations and comprehensive loss:

 

   Three months ended
June 30,
   Six months ended
June 30,
 
   2024   2023   2024   2023 
   (in thousands)   (in thousands) 
Research and development  $12   $17   $28   $35 
Sales and marketing   9        9     
General and administrative   7    11    18    22 
Total  $28   $28   $55   $57 

 

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Cash paid included in the computation of the operating lease assets and lease liability during the three and six months ended June 30, 2024 amounted to approximately $28,000 and $55,000, respectively. Cash paid included in the computation of the operating lease assets and lease liability during the three and six months ended June 30, 2023 amounted to approximately $28,000 and $57,000, respectively.

 

The weighted average remaining lease term and weighted average discount rate of the Company’s operating leases are as follows:

 

   As of June 30, 
   2024   2023 
Remaining lease term (in years)   1.70    0.88 
Discount rate   8.19%   12.78%

 

The minimum lease payments for the next year are expected to be as follows:

 

   As of 
   June 30, 2024 
    (in thousands) 
2024  $23 
2025   41 
2026   10 
Total lease payments   74 
Less: imputed interest   (6)
Present value of operating lease liability  $68 

 

10. Net Loss Per Share

 

             
   Three months ended June 30,   Six months ended June 30, 
   2024   2023   2024   2023 
   (in thousands, except shares and per share data)   (in thousands, except shares and per share data) 
Net loss  $(2,498)  $(2,614)  $(4,528)  $(5,504)
Preferred stock dividends       3        (77)
Net loss attributable to common stockholders  $(2,498)  $(2,611)  $(4,528)  $(5,581)
                     
Basic and diluted weighted average common shares outstanding   14,258,511    13,785,657    14,102,918    13,000,211 
                     
Basic and diluted net loss per share attributable to common stockholders  $(0.18)  $(0.19)  $(0.32)  $(0.43)

 

The following potential common shares were excluded from the calculation of diluted net loss per share attributable to common stockholders for the six months ended June 30, 2024 and 2023 because including them would have had an anti-dilutive effect:

 

   Six months ended
June 30,
 
   2024   2023 
Options to purchase common stock   4,339,055    3,786,900 
Warrants to purchase common stock   1,113,622    1,113,622 
Total   5,452,677    4,900,522 

 

11. Income Taxes

 

The Company did not record a federal or state income tax provision or benefit for the six months ended June 30, 2024 and 2023, respectively, due to the expected loss before income taxes to be incurred for the years ended December 31, 2024 and 2023, as well as the Company’s continued maintenance of a full valuation allowance against its net deferred tax assets.

 

12. Segments

 

The Company’s CODM is its Chief Executive Officer. The Company’s CODM evaluates the operating results of the Company’s reportable segments based on revenues and net income (loss).

 

The Company has two operating and reportable segments: i) Regenerative Biotech focused on the development of regenerative medicine treatments with operations currently in the United States and ii) Longevity Products relating to longevity products with operations currently in Asia. The following table presents the Company’s reportable segment results for the six months ended June 30, 2024:

 

   Regenerative Biotech   Longevity Products   Total 
2024               
Revenues  $   $113   $113 
Net loss   (4,255)   (273)   (4,528)
Total assets   1,456    274    1,730 

 

13. Subsequent Events

 

On various dates between July 8, 2024 and ending on July 31, 2024, common stock warrants were exercised for an aggregate issuance of 215,000 shares of the Company’s Common Stock at an exercise price of $2.00 per share, resulting in gross proceeds to the Company of $430,000.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

Forward Looking Statements

 

This Quarterly Report on Form 10-Q contains statements that are not statements of historical fact and are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). The forward-looking statements are principally, but not exclusively, contained in “Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Forward-looking statements include, but are not limited to, statements about management’s confidence or expectations and our plans, objectives, expectations and intentions that are not historical facts and the potential impact of COVID-19 on our business and operations. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “goal,” “see,” “estimate,” “project,” “predict,” “intend,” “think,” “potential,” “objective,” “optimistic,” “strategy,” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Factors that may cause our actual results to differ materially from those in the forward-looking statements include our ability to access debt and equity markets and raise additional capital when needed; the success of our collaborations, clinical trials and pre-clinical development efforts and programs, which success may not be achieved on a timely basis or at all; our ability to obtain and maintain regulatory approval for our implant products, bioreactors, scaffolds and other devices we pursue, including for the esophagus or airway, which approvals may not be obtained on a timely basis or at all; the number of patients who can be treated with our products; the amount and timing of costs associated with our development of implant products, bioreactors, scaffolds and other devices; our failure to comply with regulations and any changes in regulations; unpredictable difficulties or delays in the development of new technology; our collaborators or other third parties we contract with, including with respect to conducting any clinical trial or pre-clinical development efforts, not devoting sufficient time and resources to successfully carry out their duties or meet expected deadlines; our ability to attract and retain qualified personnel and key employees and retain senior management; potential liability exposure with respect to our products; the availability and price of acceptable raw materials and components from third-party suppliers; difficulties in obtaining or retaining the management and other human resource competencies that we need to achieve our business objectives; increased competition in the field of regenerative medicine and bioengineering, and the financial resources of our competitors; increased competition in the field of longevity products; our ability to obtain and maintain intellectual property protection for our device and product candidates; our inability to implement our growth strategy; the control our principal stockholders can exert based on holding a majority of voting power; plus factors described under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (the “SEC”) on March 28, 2024 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. We may not update these forward-looking statements, even though our situation may change in the future, unless we have obligations under the federal securities laws to update and disclose material developments related to previously disclosed information.

 

Harvard Apparatus Regenerative Technology, Inc. is referred to herein as “we,” “our,” “us”, and “the Company”.

 

Business Overview

 

We are a clinical-stage biotechnology company focused on the development of regenerative medicine treatments for disorders of the gastro-intestinal system and other organs that result from cancer, trauma or birth defects.

 

We believe that our technology represents a next generation solution for restoring organ function because it allows the patient to regenerate their own organ, thus eliminating the need for human donor or animal transplants, the sacrificing of another of the patient’s own organs or permanent artificial implants.

 

Our first esophageal product candidate, our esophageal implant was used in the first successful regeneration of the esophagus in a patient with esophageal cancer. This successful first-in-human experience, plus the research we have performed on over 50 pigs, led the FDA to approve our 10-patient phase 1 clinical trial. This combination trial will measure both safety and efficacy in the patient population.

 

We have contracted with IQVIA, a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, as the contract research organization (“CRO”) to manage our first clinical trial. We activated the first clinical trial site and started screening patients in the third quarter of 2023.

 

We have encountered delays in patient recruitment for our ongoing clinical trial, driven by several factors, including the existing comorbid conditions for clinical trial participants, the stringent eligibility criteria required by FDA for our studies, and logistical difficulties in enrolling participants across various sites.

 

Although we are actively implementing strategies to mitigate these challenges, such as increasing the number of trial sites and enhancing patient outreach efforts, there is a risk that these measures may not completely resolve the recruitment issues. Our product candidates are currently in development and have not yet received regulatory approval for sale anywhere in the world.

 

In addition to our development of regenerative medicine treatments, we also sell longevity dietary supplements. In the second quarter of 2023, the Company’s subsidiary in Hong Kong, Longevity Products started focusing on longevity products. Longevity Products plans to include a broad range of products focused on personal healthcare including longevity dietary supplements. Longevity Products started selling longevity supplements in the third quarter of 2023. These products are commercially marketed to the general public and initially targeted at consumers in the Great China Region through eCommerce (online sales).

 

15

 

 

We were incorporated and commenced operations on November 1, 2013 as a result of a spin-off from Harvard Bioscience, Inc., or Harvard Bioscience. On that date, we became an independent company that operates the regenerative medicine business previously owned by Harvard Bioscience. The spin-off was completed through the distribution of all the shares of common stock of Harvard Apparatus Regenerative Technology to Harvard Bioscience stockholders.

 

We continue to assess the market and regulatory approval pathway in China as to our implant products. We are not certain at this time as to which market, including U.S. or China for example, may provide the most viable initial pathway for regulatory approval to a commercial product. This will depend on a number of factors, including the approval and development processes, related costs, ability to raise capital and the terms and conditions thereof, among other factors. Any development and capital raising efforts in China may include a joint venture in relation to our Hong Kong subsidiary, and would also involve a number of commercial variables, including rights and obligations pertaining to licensing, development, and financing, among others. Our failure to receive or obtain such clearances or approvals on a timely basis or at all, whether that be in the U.S., China or otherwise, would have an adverse effect on our results of operations.

 

Since our incorporation, we have devoted substantially all of our resources to developing our programs, building our intellectual property portfolio, business planning, raising capital and providing selling, general and administrative support for these operations. To date, we have financed our operations with proceeds from the sales of common stock and preferred stock. In December 2017, we sold the inventory and rights to manufacture and sell research-only versions of our bioreactors to Harvard Bioscience.

 

Business Segments

 

The Company has two separate reportable segments. The Company has one segment, Harvard Apparatus Regenerative Technology, Inc., or Regenerative Biotech, focused on the development and commercialization of therapies to cure patients of cancers, injuries, and birth defects of the gastro-intestinal tract and the airways. The other segment, Longevity Products, is focused on personal healthcare including longevity dietary supplements.

 

Financial Condition and Need for Additional Funds

 

We expect to continue to incur operating losses and negative cash flows from operations for 2024 and in future years.

 

Operating Losses and Cash Requirements

 

We have incurred substantial operating losses since our inception, and as of June 30, 2024 had an accumulated deficit of approximately $96.5 million and will require additional financing to fund future operations. We expect that our operating cash on-hand as of June 30, 2024 of approximately $0.1 million and equity financing of $0.4 million in gross proceeds received subsequent to June 30, 2024 will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2024. We expect to continue to incur operating losses and negative cash flows from operations for 2024 and in future years. Therefore, as disclosed in Note 1 to our unaudited Condensed Consolidated Financial Statements appearing elsewhere in this Quarterly Report on Form 10-Q, these conditions raise substantial doubt about our ability to continue as a going concern.

 

We will need to raise additional capital to fund our current operations. In the event we do not raise additional capital from outside sources during the third quarter of 2024, we may be forced to curtail or cease our operations.

 

16

 

 

Cash requirements and cash resource needs will vary significantly depending upon the timing of the financial and other resource needs that will be required to complete ongoing development, pre-clinical and clinical testing of product candidates, as well as regulatory efforts and collaborative arrangements necessary for our product candidates that are currently under development. We are currently seeking and will continue to seek financings from other existing and/or new investors to raise necessary funds through a combination of public or private equity offerings. We may also pursue debt financings, other financing mechanisms, research grants, or strategic collaborations and licensing arrangements. We may not be able to obtain additional financing on favorable terms, if at all.

 

Our operations will be adversely affected if we are unable to raise or obtain needed funding and may materially affect our ability to continue as a going concern. Our unaudited condensed consolidated financial statements have been prepared assuming that we will continue as a going concern and therefore, the unaudited condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amount and classifications of liabilities that may result from the outcome of this uncertainty.

 

Components of Operating Loss

 

Product revenue. Product revenue consists of longevity product sales, launched in the Great China Region in the third quarter of 2023. We had not generated any revenue prior to the launch of our longevity products.

 

Research and development expense. Research and development expense consists of salaries and related expenses, including share-based compensation, for personnel and contracted consultants and various materials and other costs to develop our new products, primarily: synthetic scaffolds, including investigation and development of materials and investigation and optimization of cellularization, as well as studies of cells and cell behavior. Other research and development expenses include the costs of outside service providers and material costs for prototype and test units and outside laboratories and testing facilities performing cell growth and materials experiments, as well as the costs of all other preclinical research and testing including animal studies and expenses related to potential patents. We expense research and development costs as incurred.

 

Sales and marketing expense. Sales and marketing costs include advertising and payroll and related expenses for personnel engaged in marketing and selling activities.

 

General and administrative expense. Selling, general and administrative expense consists primarily of salaries and other related expenses, including share-based compensation. Other costs include professional fees for legal and accounting services, insurance, investor relations and facility costs.

 

Other (expense) income, net. Other (expense) income, net, consists primarily of interest expense on convertible debt and finance charges on insurance installment payments offset by interest income.

 

Critical Accounting Policies and Estimates

 

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the expenses during the reporting periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Our actual results may differ materially from these estimates under different assumptions or conditions.

 

While our significant accounting policies are discussed in more detail in Note 2 to our unaudited Condensed Consolidated Financial Statements appearing elsewhere in this Quarterly Report on Form 10-Q, we believe that the following accounting policies are the most critical for fully understanding and evaluating our financial condition and results of operations.

 

17

 

 

Share-based Compensation

 

We account for our share-based compensation in accordance with the fair value recognition provisions of current authoritative guidance. Share-based awards, including stock options, are measured at fair value as of the grant date and recognized as expense over the requisite service period (generally the vesting period), which we have elected to amortize on a straight-line basis. Expense on share-based awards for which vesting is performance or milestone based is recognized on a straight-line basis from the date when we determine the achievement of the milestone is probable to the vesting/milestone achievement date. Since share-based compensation expense is based on awards ultimately expected to vest, it has been reduced by an estimate for future forfeitures. Until December 31, 2022, we estimated forfeitures at the time of grant and would revise our estimate, if necessary, in subsequent periods. As of January 1, 2023, we account for forfeitures as they occur. We estimate the fair value of options granted using the Black-Scholes option valuation model. Significant judgment is required in determining the proper assumptions used in this model. The assumptions used include the risk-free interest rate, expected term, expected volatility, and expected dividend yield. We base our assumptions on historical data when available or, when not available, on a peer group of companies. However, these assumptions consist of estimates of future market conditions, which are inherently uncertain and subject to our judgment, and therefore any changes in assumptions could significantly impact the future grant date fair value of share-based awards.

 

Results of Operations

 

The following table summarizes the results of our operations for the three and six months ended June 30, 2024 and 2023 (in thousands):

 

   Three months
ended
June 30,
   Change 2024
vs. 2023
   Six months
ended
June 30,
   Change 2024
vs. 2023
 
   2024   2023   Change   %   2024   2023   Change   % 
Product revenue  $56   $   $56    100%  $113   $   $113    100%
                                         
Operating expenses                                        
Cost of sales   13        13    100%   25        25    100%
Research and development   642    1,566    (924)   (59)%   1,482    2,075    (593)   (29)%
Sales and marketing   197    55    142    258%   312    55    257    467%
General and administrative   1,685    1,030    655    64%   2,796    3,408    (612)   (18)%
Total operating expenses   2,537    2,651    (114)   (4)%   4,615    5,538    (923)   (17)%
                                         
Other (expense) income                                        
Other (expense) income, net   (17)   37    (54)   (146)%   (26)   34    (60)   (177)%
Net loss  $(2,498)  $(2,614)  $116    4%  $(4,528)  $(5,504)  $976    18%

 

18

 

 

Comparison of the three months ended June 30, 2024 and June 30, 2023

 

Product Revenue

 

Product revenue was $56,000 and zero for the three months ended June 30, 2024 and 2023, respectively. Product revenue consists of longevity product sales, launched in the Great China Region in the third quarter of 2023. We had not generated any revenue prior to the launch of our longevity products.

 

Cost of Sales

 

Cost of sales was $13,000 and zero for the three months ended June 30, 2024 and 2023, respectively. For the three months ended June 30, 2024, cost of sales consists of the purchase price of consumer products, taxes, inbound and outbound shipping costs.

 

Research and Development Expense

 

Research and development expense decreased approximately $0.9 million, or 59%, to approximately $0.6 million for the three months ended June 30, 2024 as compared to approximately $1.5 million for the three months ended June 30, 2023. This decrease was primarily due to significant initial clinical trial activities in the prior period resulting in our first site activation in the third quarter of 2023.

 

Sales and Marketing Expense

 

Selling and marketing expense was $0.2 million for the three months ended June 30, 2024 as compared to $0.06 million for the three months ended June 30, 2023. The increase is from increased headcount-related costs.

 

General and Administrative Expense

 

General and administrative expense increased approximately $0.7 million, or 64%, to approximately $1.7 million for the three months ended June 30, 2024 as compared to approximately $1.0 million for the three months ended June 30, 2023. This increase was primarily due to the recording of expense in the current period of one-time offering costs of $0.5 million relating to the initial registered offering that did not occur in a prior year.

 

Other (expense) income, net

 

During the three months ended June 30, 2024, we recorded interest expense of approximately $10,000 on convertible debt and approximately $7,000 on insurance installment payments. During the three months ended June 30, 2023, we recorded interest income of approximately $41,000 earned from our money market account and certificate of deposit offset by approximately $4,000 on insurance installment payments.

 

Comparison of the six months ended June 30, 2024 and June 30, 2023

 

Product Revenue

 

Product revenue was $113,000 and zero for the six months ended June 30, 2024 and 2023, respectively. Product revenue consists of longevity product sales, launched in the Asia region in the third quarter of 2023. We had not generated any revenue prior to the launch of our longevity products.

 

Cost of Sales

 

Cost of sales was $25,000 and zero for the six months ended June 30, 2024 and 2023, respectively. For the six months ended June 30, 2024, cost of sales consists of the purchase price of consumer products, taxes, inbound and outbound shipping costs.

 

Research and Development Expense

 

Research and development expense decreased approximately $0.6 million, or 29%, to approximately $1.5 million for the six months ended June 30, 2024 as compared to approximately $2.1 million for the six months ended June 30, 2023. This decrease was primarily due to significant initial clinical trial activities in the prior period resulting in our first site activation in the third quarter of 2023.

 

Sales and Marketing Expense

 

Selling and marketing expense was $0.3 million for the six months ended June 30, 2024 as compared to $0.06 million for the six months ended June 30, 2023.

 

General and Administrative Expense

 

General and administrative expense decreased approximately $0.6 million, or 18%, to approximately $2.8 million for the six months ended June 30, 2024 as compared to approximately $3.4 million for the six months ended June 30, 2023. This decrease was primarily due to share-based compensation expense of $1.3 million from the vesting of performance based awards in the first half of 2023 offset by the recording of expense in the current period of one-time offering costs of $0.5 million relating to the initial registered offering that did not occur in a prior year.

 

Other (expense) income, net

 

During the six months ended June 30, 2024, we recorded interest expense of approximately $16,000 on convertible debt and approximately $10,000 on insurance installment payments. During the six months ended June 30, 2023, we recorded interest income of approximately $41,000 earned from our money market account and certificate of deposit offset by approximately $7,000 on insurance installment payments.

 

Liquidity and Capital Resources

 

Sources of liquidity. We have incurred operating losses since inception, and as of June 30, 2024, we had an accumulated deficit of approximately $96.5 million. We are currently investing significant resources in the development and commercialization of our product candidates for use by clinicians and researchers in the fields of regenerative medicine and bioengineering. As a result, we expect to incur operating losses and negative operating cash flows for the foreseeable future. Therefore, as disclosed in Note 1 to our unaudited Condensed Consolidated Financial Statements, these conditions raise substantial doubt about our ability to continue as a going concern.

 

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The following table sets forth the primary uses of cash for the six months ended June 30, 2024 and 2023 (in thousands):

 

   Six Months Ended
June 30,
 
   2024   2023 
Net cash used in operating activities  $(2,253)  $(2,559)
Net cash used by investing activities  $   $(2,534)
Net cash provided by financing activities  $1,982   $5,992 

 

Comparison of the six months ended June 30, 2024 and 2023

 

Operating activities. Net cash used in operating activities of approximately $2.3 million for the six months ended June 30, 2024 was due primarily to our net loss of approximately $4.5 million offset by adjustments for non-cash items of approximately $1.1 million due to non-cash expenses for share-based compensation and depreciation, and an approximately $1.1 million increase to cash from changes in working capital due to the timing of payments for accounts receivable, inventory, prepaid expenses, deferred financing costs, long-term prepaid contracts, accounts payable and accrued expenses.

 

Net cash used in operating activities of approximately $2.6 million for the six months ended June 30, 2023 was due primarily to our net loss of approximately $5.5 million offset by adjustments for non-cash items of approximately $2.3 million due to non-cash expenses for share-based compensation and depreciation, and an approximately $0.6 million increase to cash from changes in working capital due to the timing of payments for accounts payable, accrued expenses, prepaid expenses, deferred financing costs and other long-term assets.

 

Investing activities. Net cash used in investing activities included purchases of property, plant and equipment for the six months ended June 30, 2024 and 2023 representing approximately zero and $11,000, respectively. During the six months ended June 30, 2023, we invested in a certificate of deposit for $2.5 million that earned $23,000 in interest. The certificate of deposit matured in October 2023.

 

Financing activities. Net cash generated from financing activities during the six months ended June 30, 2024 of approximately $2.0 million consisted of net proceeds of $0.5 million received from debt financing and $1.5 million from private placement transaction that resulted in the issuance of 367,767 shares of our common stock at a purchase price of $4.03 per share to a group of investors. Net cash generated from financing activities during the six months ended June 30, 2023 of approximately $6.0 million consisted of net proceeds received from private placement transactions that resulted in the issuance of 1,000,967 shares of our common stock at a purchase price of $6.00 per share to a group of investors.

 

Off-Balance Sheet Arrangements

 

We do not have any material off-balance sheet arrangements as of June 30, 2024.

 

Other Information

 

None.

 

20

 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

The Company is a smaller reporting company and is not required to provide this information pursuant to Item 305(e), Regulation S-K.

 

Item 4. Controls and Procedures.

 

This Report includes the certifications of our principal executive officer and our principal financial and accounting officer required by Rule 13a-14 of the Exchange Act. See Exhibits 31.1 and 31.2.

 

Evaluation of Disclosure Controls and Procedures

 

Disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) are 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 SEC rules and forms and that such information is accumulated and communicated to management, including the Chief Executive Officer, Director, and Chairman, who is our principal executive officer, and our Chief Financial Officer, who is our principal financial and accounting officer, to allow timely decisions regarding required disclosures.

 

In connection with the preparation of this Quarterly Report on Form 10-Q, our management, under the supervision and with the participation of our principal executive officer and our principal financial and accounting officer, conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of June 30, 2024. Based upon the evaluation described above, our principal executive officer and our principal financial and accounting officer have concluded that they believe our disclosure controls and procedures were effective as of the end of the period covered by this report, in providing reasonable assurance 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 principal executive officer and our principal financial and accounting officer, to allow timely decisions regarding required disclosures, and is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms.

 

Changes in Internal Control over Financial Reporting

 

Our management, with the participation of our principal executive officer and our principal financial and accounting officer, has evaluated whether any change in our internal control over financial accounting and reporting occurred during the quarter ended June 30, 2024. During the period covered by this report, we have concluded that there were no changes during the fiscal quarter in our internal control over financial reporting, as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act, which have materially affected, or are reasonably likely to materially affect, our internal control over financial accounting and reporting.

 

21

 

 

PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

From time to time, we may be involved in various claims and legal proceedings arising in the ordinary course of business. There are no such matters pending that we expect to be material in relation to our business, financial condition, and results of operations or cash flows.

 

Item 1A. Risk Factors

 

To our knowledge and except to the extent additional factual information disclosed in this Quarterly Report on Form 10-Q relates to such risk factors, there have been no material changes in the risk factors described in Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 28, 2024.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 5. Other Information

 

In the three months ended June 30, 2024, no directors or officers adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

 

Item 6. Exhibits

 

Exhibit Index    
3.1   Amended and Restated Certificate of Incorporation (previously filed as an exhibit to the Registration Statement on Form 10-12B, filed on July 31, 2013, and incorporated herein by reference).
     
3.2   Certificate of Amendment to Amended and Restated Certificate of Incorporation (previously filed as exhibit to the Current Report on Form 8-K, filed on March 31, 2016, and incorporated herein by reference.
     
3.3   Certificate of Amendment to Amended and Restated Certificate of Incorporation (previously filed as exhibit to the Annual Report on Form 10-K, filed on March 17, 2017, and incorporated herein by reference).
     
3.4   Certificate of Designations, Preferences and Rights of Series A Preferred Stock classifying and designating the Series A Junior Participating Cumulative Preferred Stock (previously filed as exhibit to the Registration Statement on Form 8-A, filed on October 31, 2013, and incorporated herein by reference).
     
3.5   Certificate of Designation of Series B Convertible Preferred Stock classifying and designating the Series B Convertible Preferred Stock (previously filed as an exhibit to the Current Report on Form 8-K, filed on February 12, 2015, and incorporated by reference thereto).
     
3.6   Certificate of Amendment to Amended and Restated Certificate of Incorporation (previously filed as exhibit to the Current Report on Form 8-K, filed on April 27, 2017, and incorporated herein by reference).
     
3.7   Certificate of Designations, Preferences, Rights and Limitations of Series C Convertible Preferred Stock classifying and designating the Series C Convertible Preferred Stock (previously filed as an exhibit to the Current Report on Form 8-K, filed on August 17, 2017, and incorporated by reference thereto).
     
3.8   Certificate of Elimination of Series A Junior Participating Cumulative Preferred Stock (previously filed as an exhibit to the Current Report on Form 8-K, filed on August 17, 2017, and incorporated by reference thereto).
     
3.9   Certificate of Amendment to Amended and Restated Certificate of Incorporation (previously filed as exhibit to the Current Report on Form 8-K, filed on December 22, 2017, and incorporated herein by reference).
     
3.10   Certificate of Designations, Preferences, Rights and Limitations of Series D Convertible Preferred Stock classifying and designating the Series D Convertible Preferred Stock (previously filed as an exhibit to the Current Report on Form 8-K, filed on January 3, 2018, and incorporated by reference thereto).

 

22

 

 

3.11   Certificate of Amendment to Amended and Restated Certificate of Incorporation (previously filed as exhibit to the Current Report on Form 8-K, filed on May 28, 2019, and incorporated herein by reference).
     
3.12   Certificate of Amendment to Amended and Restated Certificate of Incorporation (previously filed as an exhibit to the Current Report on Form 8-K, filed on July 20, 2023, and incorporated herein by reference).
     
3.13   Third Amended and Restated Bylaws (previously filed as an exhibit to the Current Report on Form 8-K, filed on July 20, 2023, and incorporated herein by reference).
     
10.1   Form of Securities Purchase Agreement (previously filed as an exhibit to the Current Report on Form 8-K, filed on April 17, 2024, and incorporated herein by reference).
     
31.1+   Certification of Chief Executive Officer, Director, and Chairman of Harvard Apparatus Regenerative Technology, Inc., pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act, as amended, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
31.2+   Certification of Chief Financial Officer of Harvard Apparatus Regenerative Technology, Inc., pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act, as amended, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
32.1*   Certification of Chief Executive Officer, Director, and Chairman of Harvard Apparatus Regenerative Technology, Inc., pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
32.2*   Certification of Chief Financial Officer of Harvard Apparatus Regenerative Technology, Inc., pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
101.INS   Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its 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 Labels Linkbase Document.
     
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase Document.
     
Exhibit 104   Cover Page Interactive Data File - the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

 

# Management contract or compensatory plan or arrangement.
   
+ Filed herewith.

 

* This certification shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.

 

23

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by undersigned thereunto duly authorized.

 

Date: August 13, 2024

 

  HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
     
  By: /s/ Junli He
  Name: Junli He
  Title:

Chief Executive Officer, Director, and Chairman

(principal executive officer)

     
  By: /s/ Joseph L.Damasio Jr.
  Name: Joseph L. Damasio Jr.
  Title:

Chief Financial Officer

(principal financial officer)

 

24

 

 

Exhibit 31.1

 

Certification

 

I, Junli He, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of Harvard Apparatus Regenerative Technology, Inc.;

 

2. Based on my knowledge, this 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 report;

 

3. Based on my knowledge, the consolidated financial statements, and other financial information included in this 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 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 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 the consolidated 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 report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d. Disclosed in this 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

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of 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.

 

Date: August 13, 2024

 

  /s/ Junli He
  Junli He
  Chief Executive Officer, Director, and Chairman

 

 

 

 

Exhibit 31.2

 

Certification

 

I, Joseph L. Damasio Jr., certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of Harvard Apparatus Regenerative Technology, Inc.;

 

2. Based on my knowledge, this 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 report;

 

3. Based on my knowledge, the consolidated financial statements, and other financial information included in this 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 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 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 the consolidated 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 report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d. Disclosed in this 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

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of 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.

 

Date: August 13, 2024

 

  /s/ Joseph L. Damasio Jr.
  Joseph L. Damasio Jr.
  Chief Financial Officer

 

 

 

 

Exhibit 32.1

 

CERTIFICATION OF PERIODIC FINANCIAL REPORT

PURSUANT TO 18 U.S.C. SECTION 1350

 

The undersigned officer of Harvard Apparatus Regenerative Technology, Inc. (the “Company”) hereby certifies to his knowledge that the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024 (the “Report”) to which this certification is being furnished as an exhibit, as filed with the Securities and Exchange Commission on the date hereof, fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. This certification is provided solely pursuant to 18 U.S.C. Section 1350 and Item 601(b)(32) of Regulation S-K (Item 601(b)(32)) promulgated under the Securities Act of 1933, as amended (the “Securities Act”), and the Exchange Act. In accordance with clause (ii) of Item 601(b) (32), this certification (A) shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, and (B) shall not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the Company specifically incorporates it by reference.

 

Date: August 13, 2024

 

    /s/ Junli He
  Name: Junli He
  Title: Chief Executive Officer, Director, and Chairman

 

 

 

 

Exhibit 32.2

 

CERTIFICATION OF PERIODIC FINANCIAL REPORT

PURSUANT TO 18 U.S.C. SECTION 1350

 

The undersigned officer of Harvard Apparatus Regenerative Technology, Inc. (the “Company”) hereby certifies to his knowledge that the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024 (the “Report”) to which this certification is being furnished as an exhibit, as filed with the Securities and Exchange Commission on the date hereof, fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. This certification is provided solely pursuant to 18 U.S.C. Section 1350 and Item 601(b)(32) of Regulation S-K (Item 601(b)(32)) promulgated under the Securities Act of 1933, as amended (the “Securities Act”), and the Exchange Act. In accordance with clause (ii) of Item 601(b) (32), this certification (A) shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, and (B) shall not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the Company specifically incorporates it by reference.

 

Date: August 13, 2024

 

    /s/ Joseph L. Damasio Jr.
  Name: Joseph L. Damasio Jr.
  Title: Chief Financial Officer

 

 

 

 

v3.24.2.u1
Cover - $ / shares
6 Months Ended
Jun. 30, 2024
Aug. 05, 2024
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Quarterly Report true  
Document Transition Report false  
Document Period End Date Jun. 30, 2024  
Document Fiscal Period Focus Q2  
Document Fiscal Year Focus 2024  
Current Fiscal Year End Date --12-31  
Entity File Number 001-35853  
Entity Registrant Name Harvard Apparatus Regenerative Technology, Inc.  
Entity Central Index Key 0001563665  
Entity Tax Identification Number 45-5210462  
Entity Incorporation, State or Country Code DE  
Entity Address, Address Line One 84 October Hill Road  
Entity Address, Address Line Two Suite 11  
Entity Address, City or Town Holliston  
Entity Address, State or Province MA  
Entity Address, Postal Zip Code 01746  
City Area Code (774)  
Local Phone Number 233-7300  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   14,530,091
Entity Listing, Par Value Per Share $ 0.01  
v3.24.2.u1
Condensed Consolidated Balance Sheets - USD ($)
Jun. 30, 2024
Dec. 31, 2023
Current assets:    
Cash and cash equivalents $ 139,000 $ 432,000
Accounts receivable 4,000
Inventory 60,000 50,000
Prepaid research and development 343,000 210,000
Prepaid expenses and other current assets 114,000 87,000
Total current assets 656,000 783,000
Property, plant and equipment, net 14,000 25,000
Right-of-use assets, net 68,000 48,000
Deferred financing costs 544,000
Long-term prepaid contracts 992,000 1,214,000
Total assets 1,730,000 2,614,000
Current liabilities:    
Accounts payable 752,000 445,000
Accrued and other current liabilities 700,000 475,000
Operating lease liability 40,000 48,000
Total current liabilities 1,992,000 968,000
Operating lease liability, net of current portion 28,000
Total liabilities 2,020,000 1,411,000
Commitments and contingencies (Note 7)  
Stockholders’ (deficit) equity:    
Common stock, par value $0.01 per share, 60,000,000 shares authorized; 14,315,091 and 13,947,324 issued and outstanding at June 30, 2024 and December 31, 2023, respectively 143,000 139,000
Additional paid-in capital 96,073,000 93,463,000
Accumulated deficit (96,484,000) (91,956,000)
Accumulated other comprehensive loss (22,000)
Total stockholders’ (deficit) equity (290,000) 1,646,000
Total liabilities and stockholders’ (deficit) equity 1,730,000 2,614,000
Related Party [Member]    
Current liabilities:    
Convertible debt – related party $ 500,000
v3.24.2.u1
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
Jun. 30, 2024
Dec. 31, 2023
Statement of Financial Position [Abstract]    
Common stock, par value $ 0.01 $ 0.01
Common stock, shares authorized 60,000,000 60,000,000
Common stock, shares issued 14,315,091 13,947,324
Common stock, shares outstanding 14,315,091 13,947,324
v3.24.2.u1
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Income Statement [Abstract]        
Product revenue $ 56 $ 113
Operating expenses:        
Cost of sales 13 25
Research and development 642 1,566 1,482 2,075
Sales and marketing 197 55 312 55
General and administrative 1,685 1,030 2,796 3,408
Total operating expenses 2,537 2,651 4,615 5,538
Operating loss (2,481) (2,651) (4,502) (5,538)
Other (expense) income, net:        
Other (expense) income, net (17) 37 (26) 34
Net loss (2,498) (2,614) (4,528) (5,504)
Less: Preferred stock dividends 3 (77)
Net loss attributable to common stockholders $ (2,498) $ (2,611) $ (4,528) $ (5,581)
Basic net loss per share attributable to common stockholders $ (0.18) $ (0.19) $ (0.32) $ (0.43)
Diluted net loss per share attributable to common stockholders $ (0.18) $ (0.19) $ (0.32) $ (0.43)
Weighted average common shares outstanding, basic 14,258,511 13,785,657 14,102,918 13,000,211
Weighted average common shares outstanding, diluted 14,258,511 13,785,657 14,102,918 13,000,211
Comprehensive loss:        
Net loss $ (2,498) $ (2,614) $ (4,528) $ (5,504)
Foreign currency translation adjustments (21) (22)
Comprehensive loss (2,519) (2,614) (4,550) (5,504)
Comprehensive loss attributable to common stockholders $ (2,519) $ (2,611) $ (4,550) $ (5,581)
v3.24.2.u1
Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($)
$ in Thousands
Preferred Stock [Member]
Series E Convertible Preferred Stock [Member]
Common Stock [Member]
Additional Paid-in Capital [Member]
Retained Earnings [Member]
AOCI Attributable to Parent [Member]
Total
Balance at Dec. 31, 2022   $ 122 $ 79,698 $ (83,011)   $ (3,191)
Temporary equity, balance at Dec. 31, 2022 $ 4,180          
Balance, shares at Dec. 31, 2022   12,174,467        
Share-based compensation expense   2,319   2,319
Issuance of common stock, net of offering costs   $ 10 5,982   5,992
Issuance of common stock, net of offering costs, shares   1,000,967        
Net loss   (5,504)   (5,504)
Preferred stock dividends   (77)   (77)
Temporary equity, preferred stock dividends 77          
Conversion of preferred stock for common stock   $ 7 4,250   4,257
Temporary equity, Conversion of preferred stock for common stock (4,257)          
Conversion of preferred stock for common stock, shares   706,626        
Balance at Jun. 30, 2023   $ 139 92,172 (88,515)   3,796
Temporary equity, balance at Jun. 30, 2023          
Balance, shares at Jun. 30, 2023   13,882,060        
Balance at Mar. 31, 2023   $ 127 84,712 (85,901)   (1,062)
Temporary equity, balance at Mar. 31, 2023 4,051          
Balance, shares at Mar. 31, 2023   12,716,534        
Share-based compensation expense   479   479
Issuance of common stock, net of offering costs   $ 5 2,937   2,942
Issuance of common stock, net of offering costs, shares   490,833        
Net loss   (2,614)   (2,614)
Preferred stock dividends   3   3
Temporary equity, preferred stock dividends (3)          
Conversion of preferred stock for common stock   $ 7 4,041   4,048
Temporary equity, Conversion of preferred stock for common stock (4,048)          
Conversion of preferred stock for common stock, shares   674,693        
Balance at Jun. 30, 2023   $ 139 92,172 (88,515)   3,796
Temporary equity, balance at Jun. 30, 2023          
Balance, shares at Jun. 30, 2023   13,882,060        
Balance at Dec. 31, 2023   $ 139 93,463 (91,956) 1,646
Temporary equity, balance at Dec. 31, 2023          
Balance, shares at Dec. 31, 2023   13,947,324        
Share-based compensation expense   1,132 1,132
Issuance of common stock, net of offering costs   $ 4 1,478 1,482
Issuance of common stock, net of offering costs, shares   367,767        
Net loss   (4,528) (4,528)
Other comprehensive loss   (22) (22)
Balance at Jun. 30, 2024 $ 143 96,073 (96,484) (22) (290)
Temporary equity, balance at Jun. 30, 2024          
Balance, shares at Jun. 30, 2024   14,315,091        
Balance at Mar. 31, 2024 $ 139 94,023 (93,986) (1) 175
Temporary equity, balance at Mar. 31, 2024          
Balance, shares at Mar. 31, 2024   13,947,324        
Share-based compensation expense   572 572
Issuance of common stock, net of offering costs   $ 4 1,478 1,482
Issuance of common stock, net of offering costs, shares   367,767        
Net loss (2,498) (2,498)
Other comprehensive loss   (21) (21)
Balance at Jun. 30, 2024 $ 143 $ 96,073 $ (96,484) $ (22) $ (290)
Temporary equity, balance at Jun. 30, 2024          
Balance, shares at Jun. 30, 2024   14,315,091        
v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
OPERATING ACTIVITIES    
Net loss $ (4,528) $ (5,504)
Adjustments to reconcile net loss to net cash used in operating activities:    
Share-based compensation expense 1,132 2,319
Depreciation 11 23
Amortization of operating lease right-of-use assets 55 57
Changes in operating assets and liabilities:    
Accounts receivable 4
Inventory (10)
Prepaid research and development (133) 15
Prepaid expenses and other current assets (27)
Deferred financing costs 544 66
Long-term prepaid contracts 222 (62)
Accounts payable 307 (310)
Operating lease liability (55) (57)
Accrued and other current liabilities 225 894
Net cash used in operating activities (2,253) (2,559)
INVESTING ACTIVITIES    
Purchases of short-term investments (2,523)
Purchases of property, plant, and equipment (11)
Net cash used in investing activities (2,534)
FINANCING ACTIVITIES    
Proceeds from convertible debt – related party 500
Proceeds from issuance of common stock 1,482 5,992
Net cash provided by financing activities 1,982 5,992
Effect of exchange rate changes on cash (22)
Net (decrease) increase in cash and cash equivalents (293) 899
Cash and cash equivalents at the beginning of the year 432 1,241
Cash and cash equivalents at the end of the period 139 2,140
Supplemental disclosure of non-cash activities:    
Purchases of property and equipment in accounts payable or accrued expenses 5
Preferred stock dividends 77
Conversion of preferred stock into common stock $ 4,257
v3.24.2.u1
Pay vs Performance Disclosure - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Pay vs Performance Disclosure [Table]        
Net Income (Loss) $ (2,498) $ (2,614) $ (4,528) $ (5,504)
v3.24.2.u1
Insider Trading Arrangements
3 Months Ended
Jun. 30, 2024
Insider Trading Arrangements [Line Items]  
Rule 10b5-1 Arrangement Adopted false
Non-Rule 10b5-1 Arrangement Adopted false
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
v3.24.2.u1
Organization
6 Months Ended
Jun. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Organization

1. Organization

 

Overview

 

Harvard Apparatus Regenerative Technology, Inc. (Harvard Apparatus Regenerative Technology or the Company) is a biotechnology company with a mission to cure patients of cancers, injuries, and birth defects of the gastro-intestinal tract and the airways. The Company believes its technology is likely to be used to treat esophageal cancer, esophageal injuries, and birth defects in the esophagus. The Company believes additional product candidates in our development pipeline may treat intestinal cancer and colon cancer. Since inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, and acquiring operating assets.

 

Longevity Products

 

In the second quarter of 2023, the Company’s subsidiary in Hong Kong, Harvard Apparatus Regenerative Technology Limited, or Longevity Products, started focusing on sales of longevity products.

 

Longevity Products plans to include a broad range of products focused on personal healthcare including longevity dietary supplements. The Company currently sells longevity supplements through Longevity Products. These products are commercially marketed to the general public and initially targeted at consumers in the Great China Region through eCommerce (online sales).

 

Going Concern

 

The Company has incurred substantial operating losses since its inception, and as of June 30, 2024, had an accumulated deficit of approximately $96.5 million and will require additional financing to fund future operations. The Company expects that its operating cash on-hand as of June 30, 2024 of approximately $0.1 million and equity financing of $0.4 million in gross proceeds received subsequent to June 30, 2024 will enable it to fund its operating expenses and capital expenditure requirements into the third quarter of 2024. Therefore, these conditions raise substantial doubt about the Company’s ability to continue as a going concern.

 

The Company will need to raise additional capital to fund its current operations. In the event the Company is unable to raise additional capital from outside sources during the third quarter of 2024, it may be forced to curtail or cease its operations.

 

Cash requirements and cash resource needs will vary significantly depending upon the timing of the financial and other resource needs that will be required to complete ongoing development, pre-clinical and clinical testing of product candidates, as well as regulatory efforts and collaborative arrangements necessary for the Company’s product candidates that are currently under development. The Company is currently seeking and will continue to seek financing from other existing and/or new investors to raise necessary funds through a combination of public or private equity offerings. The Company may also pursue debt financings, other financing mechanisms, research grants, or strategic collaborations and licensing arrangements. The Company may not be able to obtain additional financing on favorable terms, if at all.

 

The Company’s operations will be adversely affected if it is unable to raise or obtain needed funding and may materially affect the Company’s ability to continue as a going concern. The accompanying unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern and therefore, the unaudited condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amount and classifications of liabilities that may result from the outcome of this uncertainty.

 

 

v3.24.2.u1
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements
6 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements

2. Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements

 

Summary of Significant Accounting Policies

 

The accounting policies underlying the accompanying unaudited condensed consolidated financial statements are those set forth in Note 2 to the consolidated financial statements for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K.

 

Prior Period Reclassifications

 

Certain prior period amounts have been reclassified to conform to the current period presentation. “Selling and marketing” operating expenses was reclassified from “Selling, general and administrative” operating expenses on our unaudited condensed consolidated financial statements.

 

Principles of Consolidation

 

The unaudited condensed consolidated financial statements include the accounts of Harvard Apparatus Regenerative Technology and its subsidiaries, Harvard Apparatus Regenerative Technology Limited (Hong Kong), Harvard Apparatus Regenerative Technology (Hangzhou) Limited (China), and Harvard Apparatus Regenerative Technology GmbH (Germany). All intercompany balances and transactions have been eliminated in consolidation.

 

Basis of Presentation

 

The unaudited condensed consolidated financial statements reflect the Company’s financial position, results of operations and comprehensive loss and cash flows in conformity with accounting principles generally accepted in the United States, or U.S. GAAP. These unaudited consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

 

Use of Estimates

 

The process of preparing condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Such estimates include, but are not limited to, share-based compensation, valuation of warrant liability, accrued expenses and the valuation allowance for deferred income taxes. Actual results could differ from those estimates.

 

Revenue

 

We recognize revenue in accordance with Financial Accounting Standards Board (FASB) ASC 606, Revenue from Contracts with Customers. We offer consumer products primarily through a third-party online store. Revenue is recognized at a point in time when control of the goods is transferred to the customer, which generally occurs upon the delivery to the customer. For any company direct sales to customers, revenue is recognized at a point in time upon shipment of product or hand-delivery to customer. Revenue also excludes any amounts collected on behalf of third parties, including sales and indirect taxes.

 

We identify a performance obligation as distinct if both the following criteria are true: the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. Determining the standalone selling price (“SSP”) and allocation of consideration from a contract to the individual performance obligations, and the appropriate timing of revenue recognition, is the result of significant qualitative and quantitative judgments. Management considers a variety of factors such as historical sales, usage rates, costs, and expected margin, which may vary over time depending upon the unique facts and circumstances related to each performance obligation in making these estimates. While changes in the allocation of the SSP between performance obligations will not affect the amount of total revenue recognized for a particular contract, any material changes could impact the timing of revenue recognition, which would have a material effect on our financial position and result of operations. This is because the contract consideration is allocated to each performance obligation, delivered or undelivered, at the inception of the contract based on the SSP of each distinct performance obligation.

 

Cost of Sales

 

Cost of sales primarily consists of the purchase price of consumer products, taxes, inbound and outbound shipping costs. Shipping costs to receive products from our suppliers are recognized as cost of sales when incurred. E-commerce processing and related transaction costs, including those associated with seller transactions, are classified in sales and marketing on our condensed consolidated statements of operations and comprehensive loss.

 

Research and Development

 

Research and development costs are expensed as incurred.

 

Sales and Marketing

 

Sales and marketing costs include advertising and payroll and related expenses for personnel engaged in marketing and selling activities.

 

 

General and Administrative

 

General and administrative expenses primarily consist of costs for corporate functions, including payroll and related expenses; facilities and equipment expenses, such as depreciation and amortization expense and rent; and professional fees.

 

Segment Information

 

The Company manages its operations as two separate operating segments for the purposes of assessing performance and making operating decisions. The Company has one operating unit focused on the development and commercialization of therapies to cure patients of cancers, injuries, and birth defects of the gastro-intestinal tract and the airways. The other operating unit is focused on personal healthcare through longevity dietary supplements. We have determined that our chief executive officer is the chief operating decision maker (“CODM”). The CODM reviews financial information presented by operating unit. Resource allocation decisions are made by the CODM based on operating unit results.

 

Cash Concentrations

 

The Company maintains its cash balances with a financial institution in federally insured accounts and may periodically have cash balances in excess of insurance limits. The Company maintains its accounts with financial institutions with a high credit rating. The Company has not experienced any losses to date and believes that it is not exposed to any significant credit risk on cash.

 

Cash and Cash Equivalents

 

The Company considers all highly liquid investments with a maturity of three months or less at the date of purchase to be cash equivalents. The Company currently invests available cash in money market funds.

 

Accounts Receivable

 

Allowances for credit losses are provided for estimated amounts of accounts receivable which may not be collected. At June 30, 2024 and December 31, 2023, we determined that no allowance for credit losses against accounts receivable was necessary.

 

Inventory

 

Inventory, consisting of products available for sale, are primarily accounted for using the first-in, first-out method, and are valued at the lower of cost and net realizable value. This valuation requires us to make judgments, based on currently available information, about the likely method of disposition, such as through sales to individual customers, returns to product vendors, or liquidations, and expected recoverable values of each disposition category.

 

We maintain ownership of our inventory at the third-party warehouse, regardless of whether fulfillment is provided by us or the third-party e-commerce seller, and therefore these products are included in our inventory.

 

Deferred Financing Costs

 

We capitalized costs relating to a registered offering that we postponed in fiscal year 2023 but expected to resume in the near future. The costs include payments made to attorneys, accountants, regulators and consultants. We have changed our outlook and do not expect to complete the registered offering in fiscal year 2024, therefore, the deferred financing costs were expensed to general and administrative expenses on the unaudited condensed consolidated statements of operations and comprehensive loss for the quarter ended June 30, 2024.

 

 

Long-term Prepaid Contracts

 

We have contracted with partners relating to our clinical trial activities. Upon execution of the contracts, we made initial payments of $1.2 million as deposits recorded as long-term assets and will be applied against final invoices which are more than a year away. The deposits will be recorded as expense when the clinical trial is substantially completed. Costs for the clinical trial activities throughout our clinical trial under these contracts are recognized as expense and payable based on costs incurred. Our clinical trial partner applied $0.2 million of the $1.2 million deposits against outstanding invoices in July 2024 so we reclassified the $0.2 million as current assets as of June 30, 2024.

 

Property, Plant and Equipment

 

Property, plant and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets as follows:

 

Leasehold improvements   Shorter of expected useful life or lease term
Computer equipment and software   3 years
Furniture, machinery and equipment   5-7 years

 

Maintenance and repairs are charged to expense as incurred, while any additions or improvements are capitalized.

 

Foreign Currency

 

Assets and liabilities of non-U.S. operations where the functional currency is other than the U.S. dollar are translated from the functional currency into U.S. dollars at year end exchange rates, and revenues and expenses are translated at average rates prevailing during the year. Resulting translation adjustments are accumulated as part of accumulated other comprehensive loss. Transaction gains or losses are recognized in income or loss in the period in which they occur.

 

Net Loss Per Share

 

Basic net loss per share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the if-converted method. For purposes of the diluted net loss per share calculation, warrants to purchase common stock and stock options are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented.

 

Unaudited Interim Financial Information

 

The accompanying interim condensed consolidated balance sheet as of June 30, 2024, condensed consolidated interim statements of operations and comprehensive loss and condensed consolidated statements of stockholders’ equity (deficit) for the three and six months ended June 30, 2024 and 2023, and cash flows for the six months ended June 30, 2024 and 2023 are unaudited. The interim unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments necessary for a fair statement of the Company’s financial position as of June 30, 2024, its condensed consolidated results of operations and stockholders’ equity for the three and six months ended June 30, 2024 and 2023, and cash flows for the six months ended June 30, 2024 and 2023. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2024 and 2023 are unaudited. The results for the three and six months ended June 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024, any other interim periods or any future year or period.

 

 

Recently Adopted Accounting Pronouncements

 

Accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s condensed consolidated financial statements upon adoption.

 

In August 2020, the FASB issued Accounting Standards Update (ASU) No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. Among other changes, the new guidance removes the beneficial conversion separation model for convertible debt. As a result, after adopting the guidance, entities will no longer account for beneficial conversion features in equity. The guidance is effective for public business entities, other than small reporting company’s financial statements starting January 1, 2022, with early adoption permitted. The Company is a small reporting company and adopted the new guidance on January 1, 2024, and the adoption of ASU 2020-06 did not have a material impact on its consolidated financial statements.

 

v3.24.2.u1
Fair Value Measurements
6 Months Ended
Jun. 30, 2024
Fair Value Disclosures [Abstract]  
Fair Value Measurements

3. Fair Value Measurements

 

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.

 

The Company utilizes a valuation hierarchy for disclosure of the inputs to the valuations used to measure fair value that prioritizes the inputs into three broad levels. Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on the Company’s own assumptions used to measure assets and liabilities at fair value. A financial asset or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement.

 

The Company had no assets or liabilities classified as Level 2 or Level 3 as of June 30, 2024 and December 31, 2023. The carrying value of financial instruments (consisting of cash, accounts payable, accrued compensation and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those instruments. For the six months ended June 30, 2023, the Company had short-term investments generating investment income. Investment income is included as other income. Investment income for the three months ended June 30, 2024 and June 30, 2023 consists primarily of interest earned of $0 and $41,000, respectively. Investment income for the six months ended June 30, 2024 and June 30, 2023 consists of interest earned of $0 and $41,000, respectively.

 

v3.24.2.u1
Accrued and Other Current Liabilities
6 Months Ended
Jun. 30, 2024
Payables and Accruals [Abstract]  
Accrued and Other Current Liabilities

4. Accrued and Other Current Liabilities

 

Accrued and other current liabilities consist of the following:

 

   June 30,   December 31, 
   2024   2023 
   (in thousands) 
Advisory costs  $402   $325 
Audit services   77    70 
Payroll   156    79 
Other liabilities   65    1 
Total accrued and other current liabilities  $700   $475 

 

 

v3.24.2.u1
Capital Stock
6 Months Ended
Jun. 30, 2024
Equity [Abstract]  
Capital Stock

5. Capital Stock

 

Preferred Stock

 

The Company has authorized a total of 2,000,000 shares of preferred stock, par value $0.01 per share, none of which were outstanding at June 30, 2024 and December 31, 2023. The Company’s Board of Directors has the authority to issue preferred stock and to determine the rights, preferences, privileges, and restrictions, including voting rights.

 

Common Stock

 

On April 15, 2024, the Company entered into securities purchase agreements (each an “April Purchase Agreement,” collectively the “April Purchase Agreements”) with certain investors each named therein (the “Investor,” collectively the “Investors”) pursuant to which each of the Investors agreed to purchase in a private placement an aggregate of 367,767 shares of common stock for the aggregate gross proceeds of approximately $1.5 million at a purchase price per unit of $4.03 (the “2024 Private Placement”).

 

Pursuant to the April Purchase Agreements, if the Company closes an equity financing in a registered public offering of its securities on or before six (6) months from the date of the April Purchase Agreements, and the public offering price per share was less than the per share purchase price of the 2024 Private Placement, then the Company shall promptly following such closing issue to each Investor additional shares of common stock in an amount equal to the difference between (i) the shares issued in the 2024 Private Placement, and (ii) result of dividing (a) the subscription amount for each April Purchase Agreement, by (b) the public offering per share.

 

On April 12, 2023 and on March 31, 2023, the Company entered into Securities Purchase Agreements, each a Purchase Agreement, with new and existing investors, the Investors, pursuant to which the Investors agreed to purchase in a private placement an aggregate of 1,000,967 shares of common stock for the aggregate purchase price of approximately $6 million with a purchase price per unit of $6.00 (the “2023 Private Placement”).

 

On January 18, 2023, Harvard Bioscience converted 200 Series E Preferred Shares with accrued dividends of $9,545 into 31,933 shares of common stock.

 

In connection with the 2023 Private Placement, as of April 12, 2023, the Company had received $6.0 million in aggregate proceeds in such private placement. The 2023 Private Placement resulted in gross proceeds of at least $4,000,000 which triggered the mandatory conversion of all the Company’s outstanding Series E Preferred Stock and related accrued dividends into shares of common stock at a conversion price of $6.00 per share. The conversion resulted in 674,693 shares of common stock being issued to the holder of the Series E Preferred Stock. Following such conversion, there are no shares of Series E Preferred Stock outstanding.

 

Warrants

 

The Company had 1,113,622 warrants to purchase common stock outstanding as of June 30, 2024 with a weighted-average exercise price of $4.69.

 

v3.24.2.u1
Share-Based Compensation
6 Months Ended
Jun. 30, 2024
Share-Based Payment Arrangement [Abstract]  
Share-Based Compensation

6. Share-Based Compensation

 

Harvard Apparatus Regenerative Technology Amended and Restated Equity Incentive Plan

 

The Company maintains the Amended and Restated Equity Incentive Plan, or the Plan, for the benefit of certain officers, employees, non-employee directors, and other key persons (including consultants and advisory board members). All options and awards granted under the Plan consist of the Company’s shares of common stock. The Company’s policy is to issue stock available from its registered but unissued stock pool through its transfer agent to satisfy stock option exercises and the vesting of restricted stock units. The vesting period for awards is generally four years and the contractual life is ten years. Canceled and forfeited options and awards are available to be reissued under the Plan.

 

As of June 30, 2024, the Company’s Plan has 9,098,000 authorized shares to be issued under the Plan. There were 4,672,994 shares available for issuance as of June 30, 2024.

 

The following table summarizes information concerning options outstanding and exercisable:

 

   Amount   Weighted-average exercise price   Weighted-average contractual life (years)   Aggregate intrinsic value (in thousands) 
Outstanding at December 31, 2023   3,977,289   $4.64    7.7   $5,728 
Granted   361,766    3.62           
Outstanding at June 30, 2024   4,339,055    4.56    7.4    1,169 
Options exercisable   2,489,412    4.69    6.9    948 
Options vested and expected to vest   4,239,637    4.59    7.4    1,122 

 

The Company’s outstanding stock options include 993,835 performance-based awards that have vesting provisions subject to the achievement of certain business milestones. Total unrecognized compensation expense for the performance-based awards is approximately $3.4 million. The Company recognized approximately $0.04 million and $0.08 million in stock-based compensation during the three and six months ended June 30, 2024 given that some milestone achievements for these awards have been deemed probable for accounting purposes. No expense had been recognized for these awards during the three and six months ended June 30, 2023 given that the milestone achievements for these awards were not probable at the time for accounting purposes.

 

Aggregate intrinsic value for outstanding options as of June 30, 2024 was approximately $1.2 million and calculated as the difference between the Company’s closing stock price of $2.92 per share as of June 28, 2024 and the weighted average exercise price of $4.56. As of June 30, 2024, unrecognized compensation cost related to unvested non-performance-based awards amounted to $3.2 million, which will be recognized over a weighted-average period of 1.7 years.

 

 

The Company uses the Black-Scholes option pricing model to value its stock options. The weighted average assumptions for valuing options granted during the six months ended June 30, 2024 and 2023 were as follows:

 

   Six months ended
June 30,
 
   2024   2023 
Risk-free interest rate   4.07%   3.76%
Expected volatility   116.86%   126.16%
Expected term (in years)   5.4 years    5.9 years 
Expected dividend yield   %   %

 

The Company recorded share-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive loss:

 

   Three months ended
June 30,
   Six months ended
June 30,
 
   2024   2023   2024   2023 
   (In thousands)   (In thousands) 
Research and development  $110   $51   $219   $113 
General and administrative   462    428    913    2,206 
Total  $572   $479   $1,132   $2,319 

 

v3.24.2.u1
Commitments and Contingencies
6 Months Ended
Jun. 30, 2024
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

7. Commitments and Contingencies

 

From time to time, the Company may be involved in various claims and legal proceedings arising in the ordinary course of business. There are no such matters pending that the Company expects to be material in relation to its business, financial condition, results of operations, or cash flows.

 

On March 25, 2024, the Company entered into an operating lease agreement for office space in Beijing, China for the period from April 1, 2024 through April 10, 2026 (the “Office Lease”). Our total Office Lease obligation is $81,352, consisting of minimum annual rental obligations of $30,507 for fiscal year 2024, $40,676 for fiscal year 2025 and $10,169 for fiscal year 2026.

 

We currently have a co-development initiative with Yale University and the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. We owe advance payments of approximately $100,000 and $61,000, respectively at June 30, 2024. We plan to make these advance payments in the third quarter of 2024. The universities started preparatory work in 2023 with substantial work being performed in 2024. Either party can terminate the contract with reasonable notice and any incurred costs will be reimbursed by us to the universities.

 

v3.24.2.u1
Convertible Debt – Related Party
6 Months Ended
Jun. 30, 2024
Debt Disclosure [Abstract]  
Convertible Debt – Related Party

8. Convertible Debt – Related Party

 

Convertible Debt

 

On February 1, 2024, the Company entered into a loan arrangement with Junli He, the Chairman and Chief Executive Officer of the Company (the “Lender”), pursuant to which the Lender loaned the Company an aggregate amount of $500,000 as evidenced by a Bridge Note executed by the Company in favor of, and accepted by, the Lender (the “Bridge Note”). As of June 30, 2024, the Company accrued $16,222 of interest payable on the Bridge Note. The Company evaluated the convertible note for derivative liability treatment and has determined that the components of the Bridge Note did not qualify for derivative accounting treatment as of June 30, 2024.

 

The Bridge Note accrues interest at an annual fixed rate of 8%, and the principal amount thereof will be due and payable in full, together with all accrued and unpaid interest thereon, on the earlier to occur of a) the closing date (or later date of capital being provided pertaining to such continued offering that the following threshold is tripped) of the Company’s next capital raise that includes gross proceeds of at least $5,000,000 or b) February 1, 2025. The Bridge Note provides for optional conversion at the discretion of the Lender, contains covenants, and provides for certain events of default including if the Company fails to pay when due any amount owed thereunder, fails to comply with any agreement, covenant, condition, provision or term contained therein and other customary events of default.

 

v3.24.2.u1
Leases
6 Months Ended
Jun. 30, 2024
Leases  
Leases

9. Leases

 

The Company leases laboratory and office space and certain equipment with a remaining term of 1 year.

 

The laboratory and office space arrangement in Holliston, MA is under a sublease that was renewed in December of 2022. The sublease is currently on a month-to-month basis until August 31, 2024. The Company is currently negotiating with the landlord for a three-year lease starting September 1, 2024.

 

On March 25, 2024, the Company entered into an operating lease agreement for office space in Beijing, China for the period from April 1, 2024 through April 10, 2026. We recorded approximately $75,000 as a right-of-use asset and a corresponding operating lease liability on the Company’s unaudited condensed consolidated balance sheets upon the accounting commencement date in April 1, 2024. The lease liability was measured at the accounting commencement date utilizing a 8% discount rate. The right-of-use asset had a balance of $65,000 at June 30, 2024. The operating lease obligations totaled $65,000 at June 30, 2024 of which $40,000 is included under current liabilities and $25,000 is included under non-current liabilities.

 

All of the Company’s leases qualify as operating leases. The following table summarizes the presentation of the Company’s operating leases in its condensed consolidated balance sheets:

 

   Balance Sheet Classification  June 30, 2024   December 31, 2023 
            
Assets:             
Operating lease assets  Right-of-use assets, net  $68   $48 
Liabilities:             
Current portion of operating lease liability  Current portion of operating lease liability   40    48 
Operating lease liability, net of current portion  Operating lease liability, net of current portion   28     
Total operating lease liability     $68   $48 

 

The Company recorded operating lease expense in the following categories in its condensed consolidated statements of operations and comprehensive loss:

 

   Three months ended
June 30,
   Six months ended
June 30,
 
   2024   2023   2024   2023 
   (in thousands)   (in thousands) 
Research and development  $12   $17   $28   $35 
Sales and marketing   9        9     
General and administrative   7    11    18    22 
Total  $28   $28   $55   $57 

 

 

Cash paid included in the computation of the operating lease assets and lease liability during the three and six months ended June 30, 2024 amounted to approximately $28,000 and $55,000, respectively. Cash paid included in the computation of the operating lease assets and lease liability during the three and six months ended June 30, 2023 amounted to approximately $28,000 and $57,000, respectively.

 

The weighted average remaining lease term and weighted average discount rate of the Company’s operating leases are as follows:

 

   As of June 30, 
   2024   2023 
Remaining lease term (in years)   1.70    0.88 
Discount rate   8.19%   12.78%

 

The minimum lease payments for the next year are expected to be as follows:

 

   As of 
   June 30, 2024 
    (in thousands) 
2024  $23 
2025   41 
2026   10 
Total lease payments   74 
Less: imputed interest   (6)
Present value of operating lease liability  $68 

 

v3.24.2.u1
Net Loss Per Share
6 Months Ended
Jun. 30, 2024
Earnings Per Share [Abstract]  
Net Loss Per Share

10. Net Loss Per Share

 

             
   Three months ended June 30,   Six months ended June 30, 
   2024   2023   2024   2023 
   (in thousands, except shares and per share data)   (in thousands, except shares and per share data) 
Net loss  $(2,498)  $(2,614)  $(4,528)  $(5,504)
Preferred stock dividends       3        (77)
Net loss attributable to common stockholders  $(2,498)  $(2,611)  $(4,528)  $(5,581)
                     
Basic and diluted weighted average common shares outstanding   14,258,511    13,785,657    14,102,918    13,000,211 
                     
Basic and diluted net loss per share attributable to common stockholders  $(0.18)  $(0.19)  $(0.32)  $(0.43)

 

The following potential common shares were excluded from the calculation of diluted net loss per share attributable to common stockholders for the six months ended June 30, 2024 and 2023 because including them would have had an anti-dilutive effect:

 

   Six months ended
June 30,
 
   2024   2023 
Options to purchase common stock   4,339,055    3,786,900 
Warrants to purchase common stock   1,113,622    1,113,622 
Total   5,452,677    4,900,522 

 

v3.24.2.u1
Income Taxes
6 Months Ended
Jun. 30, 2024
Income Tax Disclosure [Abstract]  
Income Taxes

11. Income Taxes

 

The Company did not record a federal or state income tax provision or benefit for the six months ended June 30, 2024 and 2023, respectively, due to the expected loss before income taxes to be incurred for the years ended December 31, 2024 and 2023, as well as the Company’s continued maintenance of a full valuation allowance against its net deferred tax assets.

 

v3.24.2.u1
Segments
6 Months Ended
Jun. 30, 2024
Segment Reporting [Abstract]  
Segments

12. Segments

 

The Company’s CODM is its Chief Executive Officer. The Company’s CODM evaluates the operating results of the Company’s reportable segments based on revenues and net income (loss).

 

The Company has two operating and reportable segments: i) Regenerative Biotech focused on the development of regenerative medicine treatments with operations currently in the United States and ii) Longevity Products relating to longevity products with operations currently in Asia. The following table presents the Company’s reportable segment results for the six months ended June 30, 2024:

 

   Regenerative Biotech   Longevity Products   Total 
2024               
Revenues  $   $113   $113 
Net loss   (4,255)   (273)   (4,528)
Total assets   1,456    274    1,730 

 

v3.24.2.u1
Subsequent Events
6 Months Ended
Jun. 30, 2024
Subsequent Events [Abstract]  
Subsequent Events

13. Subsequent Events

 

On various dates between July 8, 2024 and ending on July 31, 2024, common stock warrants were exercised for an aggregate issuance of 215,000 shares of the Company’s Common Stock at an exercise price of $2.00 per share, resulting in gross proceeds to the Company of $430,000.

v3.24.2.u1
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements (Policies)
6 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
Prior Period Reclassifications

Prior Period Reclassifications

 

Certain prior period amounts have been reclassified to conform to the current period presentation. “Selling and marketing” operating expenses was reclassified from “Selling, general and administrative” operating expenses on our unaudited condensed consolidated financial statements.

 

Principles of Consolidation

Principles of Consolidation

 

The unaudited condensed consolidated financial statements include the accounts of Harvard Apparatus Regenerative Technology and its subsidiaries, Harvard Apparatus Regenerative Technology Limited (Hong Kong), Harvard Apparatus Regenerative Technology (Hangzhou) Limited (China), and Harvard Apparatus Regenerative Technology GmbH (Germany). All intercompany balances and transactions have been eliminated in consolidation.

 

Basis of Presentation

Basis of Presentation

 

The unaudited condensed consolidated financial statements reflect the Company’s financial position, results of operations and comprehensive loss and cash flows in conformity with accounting principles generally accepted in the United States, or U.S. GAAP. These unaudited consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

 

Use of Estimates

Use of Estimates

 

The process of preparing condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Such estimates include, but are not limited to, share-based compensation, valuation of warrant liability, accrued expenses and the valuation allowance for deferred income taxes. Actual results could differ from those estimates.

 

Revenue

Revenue

 

We recognize revenue in accordance with Financial Accounting Standards Board (FASB) ASC 606, Revenue from Contracts with Customers. We offer consumer products primarily through a third-party online store. Revenue is recognized at a point in time when control of the goods is transferred to the customer, which generally occurs upon the delivery to the customer. For any company direct sales to customers, revenue is recognized at a point in time upon shipment of product or hand-delivery to customer. Revenue also excludes any amounts collected on behalf of third parties, including sales and indirect taxes.

 

We identify a performance obligation as distinct if both the following criteria are true: the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. Determining the standalone selling price (“SSP”) and allocation of consideration from a contract to the individual performance obligations, and the appropriate timing of revenue recognition, is the result of significant qualitative and quantitative judgments. Management considers a variety of factors such as historical sales, usage rates, costs, and expected margin, which may vary over time depending upon the unique facts and circumstances related to each performance obligation in making these estimates. While changes in the allocation of the SSP between performance obligations will not affect the amount of total revenue recognized for a particular contract, any material changes could impact the timing of revenue recognition, which would have a material effect on our financial position and result of operations. This is because the contract consideration is allocated to each performance obligation, delivered or undelivered, at the inception of the contract based on the SSP of each distinct performance obligation.

 

Cost of Sales

Cost of Sales

 

Cost of sales primarily consists of the purchase price of consumer products, taxes, inbound and outbound shipping costs. Shipping costs to receive products from our suppliers are recognized as cost of sales when incurred. E-commerce processing and related transaction costs, including those associated with seller transactions, are classified in sales and marketing on our condensed consolidated statements of operations and comprehensive loss.

 

Research and Development

Research and Development

 

Research and development costs are expensed as incurred.

 

Sales and Marketing

Sales and Marketing

 

Sales and marketing costs include advertising and payroll and related expenses for personnel engaged in marketing and selling activities.

 

 

General and Administrative

General and Administrative

 

General and administrative expenses primarily consist of costs for corporate functions, including payroll and related expenses; facilities and equipment expenses, such as depreciation and amortization expense and rent; and professional fees.

 

Segment Information

Segment Information

 

The Company manages its operations as two separate operating segments for the purposes of assessing performance and making operating decisions. The Company has one operating unit focused on the development and commercialization of therapies to cure patients of cancers, injuries, and birth defects of the gastro-intestinal tract and the airways. The other operating unit is focused on personal healthcare through longevity dietary supplements. We have determined that our chief executive officer is the chief operating decision maker (“CODM”). The CODM reviews financial information presented by operating unit. Resource allocation decisions are made by the CODM based on operating unit results.

 

Cash Concentrations

Cash Concentrations

 

The Company maintains its cash balances with a financial institution in federally insured accounts and may periodically have cash balances in excess of insurance limits. The Company maintains its accounts with financial institutions with a high credit rating. The Company has not experienced any losses to date and believes that it is not exposed to any significant credit risk on cash.

 

Cash and Cash Equivalents

Cash and Cash Equivalents

 

The Company considers all highly liquid investments with a maturity of three months or less at the date of purchase to be cash equivalents. The Company currently invests available cash in money market funds.

 

Accounts Receivable

Accounts Receivable

 

Allowances for credit losses are provided for estimated amounts of accounts receivable which may not be collected. At June 30, 2024 and December 31, 2023, we determined that no allowance for credit losses against accounts receivable was necessary.

 

Inventory

Inventory

 

Inventory, consisting of products available for sale, are primarily accounted for using the first-in, first-out method, and are valued at the lower of cost and net realizable value. This valuation requires us to make judgments, based on currently available information, about the likely method of disposition, such as through sales to individual customers, returns to product vendors, or liquidations, and expected recoverable values of each disposition category.

 

We maintain ownership of our inventory at the third-party warehouse, regardless of whether fulfillment is provided by us or the third-party e-commerce seller, and therefore these products are included in our inventory.

 

Deferred Financing Costs

Deferred Financing Costs

 

We capitalized costs relating to a registered offering that we postponed in fiscal year 2023 but expected to resume in the near future. The costs include payments made to attorneys, accountants, regulators and consultants. We have changed our outlook and do not expect to complete the registered offering in fiscal year 2024, therefore, the deferred financing costs were expensed to general and administrative expenses on the unaudited condensed consolidated statements of operations and comprehensive loss for the quarter ended June 30, 2024.

 

 

Long-term Prepaid Contracts

Long-term Prepaid Contracts

 

We have contracted with partners relating to our clinical trial activities. Upon execution of the contracts, we made initial payments of $1.2 million as deposits recorded as long-term assets and will be applied against final invoices which are more than a year away. The deposits will be recorded as expense when the clinical trial is substantially completed. Costs for the clinical trial activities throughout our clinical trial under these contracts are recognized as expense and payable based on costs incurred. Our clinical trial partner applied $0.2 million of the $1.2 million deposits against outstanding invoices in July 2024 so we reclassified the $0.2 million as current assets as of June 30, 2024.

 

Property, Plant and Equipment

Property, Plant and Equipment

 

Property, plant and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets as follows:

 

Leasehold improvements   Shorter of expected useful life or lease term
Computer equipment and software   3 years
Furniture, machinery and equipment   5-7 years

 

Maintenance and repairs are charged to expense as incurred, while any additions or improvements are capitalized.

 

Foreign Currency

Foreign Currency

 

Assets and liabilities of non-U.S. operations where the functional currency is other than the U.S. dollar are translated from the functional currency into U.S. dollars at year end exchange rates, and revenues and expenses are translated at average rates prevailing during the year. Resulting translation adjustments are accumulated as part of accumulated other comprehensive loss. Transaction gains or losses are recognized in income or loss in the period in which they occur.

 

Net Loss Per Share

Net Loss Per Share

 

Basic net loss per share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the if-converted method. For purposes of the diluted net loss per share calculation, warrants to purchase common stock and stock options are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented.

 

Unaudited Interim Financial Information

Unaudited Interim Financial Information

 

The accompanying interim condensed consolidated balance sheet as of June 30, 2024, condensed consolidated interim statements of operations and comprehensive loss and condensed consolidated statements of stockholders’ equity (deficit) for the three and six months ended June 30, 2024 and 2023, and cash flows for the six months ended June 30, 2024 and 2023 are unaudited. The interim unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments necessary for a fair statement of the Company’s financial position as of June 30, 2024, its condensed consolidated results of operations and stockholders’ equity for the three and six months ended June 30, 2024 and 2023, and cash flows for the six months ended June 30, 2024 and 2023. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2024 and 2023 are unaudited. The results for the three and six months ended June 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024, any other interim periods or any future year or period.

 

 

Recently Adopted Accounting Pronouncements

Recently Adopted Accounting Pronouncements

 

Accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s condensed consolidated financial statements upon adoption.

 

In August 2020, the FASB issued Accounting Standards Update (ASU) No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. Among other changes, the new guidance removes the beneficial conversion separation model for convertible debt. As a result, after adopting the guidance, entities will no longer account for beneficial conversion features in equity. The guidance is effective for public business entities, other than small reporting company’s financial statements starting January 1, 2022, with early adoption permitted. The Company is a small reporting company and adopted the new guidance on January 1, 2024, and the adoption of ASU 2020-06 did not have a material impact on its consolidated financial statements.

v3.24.2.u1
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements (Tables)
6 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
Schedule of Property Plant and Equipment Estimated Useful Lives

Property, plant and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets as follows:

 

Leasehold improvements   Shorter of expected useful life or lease term
Computer equipment and software   3 years
Furniture, machinery and equipment   5-7 years
v3.24.2.u1
Accrued and Other Current Liabilities (Tables)
6 Months Ended
Jun. 30, 2024
Payables and Accruals [Abstract]  
Schedule of Accrued and Other Current Liabilities

Accrued and other current liabilities consist of the following:

 

   June 30,   December 31, 
   2024   2023 
   (in thousands) 
Advisory costs  $402   $325 
Audit services   77    70 
Payroll   156    79 
Other liabilities   65    1 
Total accrued and other current liabilities  $700   $475 
v3.24.2.u1
Share-Based Compensation (Tables)
6 Months Ended
Jun. 30, 2024
Share-Based Payment Arrangement [Abstract]  
Schedule of Stock Option Activity

The following table summarizes information concerning options outstanding and exercisable:

 

   Amount   Weighted-average exercise price   Weighted-average contractual life (years)   Aggregate intrinsic value (in thousands) 
Outstanding at December 31, 2023   3,977,289   $4.64    7.7   $5,728 
Granted   361,766    3.62           
Outstanding at June 30, 2024   4,339,055    4.56    7.4    1,169 
Options exercisable   2,489,412    4.69    6.9    948 
Options vested and expected to vest   4,239,637    4.59    7.4    1,122 
Schedule of Weighted Average Assumptions of Options

The Company uses the Black-Scholes option pricing model to value its stock options. The weighted average assumptions for valuing options granted during the six months ended June 30, 2024 and 2023 were as follows:

 

   Six months ended
June 30,
 
   2024   2023 
Risk-free interest rate   4.07%   3.76%
Expected volatility   116.86%   126.16%
Expected term (in years)   5.4 years    5.9 years 
Expected dividend yield   %   %
Schedule of Share-based Compensation Expense

The Company recorded share-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive loss:

 

   Three months ended
June 30,
   Six months ended
June 30,
 
   2024   2023   2024   2023 
   (In thousands)   (In thousands) 
Research and development  $110   $51   $219   $113 
General and administrative   462    428    913    2,206 
Total  $572   $479   $1,132   $2,319 
v3.24.2.u1
Leases (Tables)
6 Months Ended
Jun. 30, 2024
Leases  
Schedule of Operating Leases in Consolidated Balance Sheets

All of the Company’s leases qualify as operating leases. The following table summarizes the presentation of the Company’s operating leases in its condensed consolidated balance sheets:

 

   Balance Sheet Classification  June 30, 2024   December 31, 2023 
            
Assets:             
Operating lease assets  Right-of-use assets, net  $68   $48 
Liabilities:             
Current portion of operating lease liability  Current portion of operating lease liability   40    48 
Operating lease liability, net of current portion  Operating lease liability, net of current portion   28     
Total operating lease liability     $68   $48 
Schedule of Operating Lease Expense Categories in Consolidated Statements of Operations and Comprehensive Loss

The Company recorded operating lease expense in the following categories in its condensed consolidated statements of operations and comprehensive loss:

 

   Three months ended
June 30,
   Six months ended
June 30,
 
   2024   2023   2024   2023 
   (in thousands)   (in thousands) 
Research and development  $12   $17   $28   $35 
Sales and marketing   9        9     
General and administrative   7    11    18    22 
Total  $28   $28   $55   $57 
Schedule of Weighted Average Lease Term and Discount Rates

The weighted average remaining lease term and weighted average discount rate of the Company’s operating leases are as follows:

 

   As of June 30, 
   2024   2023 
Remaining lease term (in years)   1.70    0.88 
Discount rate   8.19%   12.78%
Schedule of Minimum Lease Payments

The minimum lease payments for the next year are expected to be as follows:

 

   As of 
   June 30, 2024 
    (in thousands) 
2024  $23 
2025   41 
2026   10 
Total lease payments   74 
Less: imputed interest   (6)
Present value of operating lease liability  $68 
v3.24.2.u1
Net Loss Per Share (Tables)
6 Months Ended
Jun. 30, 2024
Earnings Per Share [Abstract]  
Schedule of Net Loss Per Share

 

             
   Three months ended June 30,   Six months ended June 30, 
   2024   2023   2024   2023 
   (in thousands, except shares and per share data)   (in thousands, except shares and per share data) 
Net loss  $(2,498)  $(2,614)  $(4,528)  $(5,504)
Preferred stock dividends       3        (77)
Net loss attributable to common stockholders  $(2,498)  $(2,611)  $(4,528)  $(5,581)
                     
Basic and diluted weighted average common shares outstanding   14,258,511    13,785,657    14,102,918    13,000,211 
                     
Basic and diluted net loss per share attributable to common stockholders  $(0.18)  $(0.19)  $(0.32)  $(0.43)
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings per Share

The following potential common shares were excluded from the calculation of diluted net loss per share attributable to common stockholders for the six months ended June 30, 2024 and 2023 because including them would have had an anti-dilutive effect:

 

   Six months ended
June 30,
 
   2024   2023 
Options to purchase common stock   4,339,055    3,786,900 
Warrants to purchase common stock   1,113,622    1,113,622 
Total   5,452,677    4,900,522 
v3.24.2.u1
Segments (Tables)
6 Months Ended
Jun. 30, 2024
Segment Reporting [Abstract]  
Schedule of Reportable Segments

 

   Regenerative Biotech   Longevity Products   Total 
2024               
Revenues  $   $113   $113 
Net loss   (4,255)   (273)   (4,528)
Total assets   1,456    274    1,730 
v3.24.2.u1
Organization (Details Narrative) - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2024
Dec. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Accumulated deficit $ 96,484 $ 91,956
Operating cash on-hand 100  
Equity financing $ 400  
v3.24.2.u1
Schedule of Property Plant and Equipment Estimated Useful Lives (Details)
Jun. 30, 2024
Leasehold Improvements [Member]  
Property, Plant and Equipment [Line Items]  
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] Useful Life, Shorter of Lease Term or Asset Utility [Member]
Computer Equipment and Software [Member]  
Property, Plant and Equipment [Line Items]  
Property, plant and equipment, useful life 3 years
Furniture, Machinery and Equipment [Member] | Minimum [Member]  
Property, Plant and Equipment [Line Items]  
Property, plant and equipment, useful life 5 years
Furniture, Machinery and Equipment [Member] | Maximum [Member]  
Property, Plant and Equipment [Line Items]  
Property, plant and equipment, useful life 7 years
v3.24.2.u1
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements (Details Narrative)
$ in Millions
6 Months Ended
Jun. 30, 2024
USD ($)
Segment
Accounting Policies [Abstract]  
Number of operating segments | Segment 2
Payments for deposits $ 1.2
Deposits, current assets $ 0.2
v3.24.2.u1
Fair Value Measurements (Details Narrative) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Fair Value Disclosures [Abstract]        
Investment income, interest earned $ 0 $ 41,000 $ 0 $ 41,000
v3.24.2.u1
Schedule of Accrued and Other Current Liabilities (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Payables and Accruals [Abstract]    
Advisory costs $ 402 $ 325
Audit services 77 70
Payroll 156 79
Other liabilities 65 1
Total accrued and other current liabilities $ 700 $ 475
v3.24.2.u1
Capital Stock (Details Narrative) - USD ($)
Apr. 15, 2024
Apr. 12, 2023
Mar. 31, 2023
Jan. 18, 2023
Jun. 30, 2024
Dec. 31, 2023
Accumulated Other Comprehensive Income (Loss) [Line Items]            
Preferred stock, shares authorized         2,000,000 2,000,000
Preferred stock, par value         $ 0.01 $ 0.01
Preferred stock, shares outstanding         0 0
Common stock issued upon conversion   674,693        
Proceeds from private placement   $ 6,000,000.0        
Trigger price of gross proceeds for stock conversion   $ 4,000,000        
Series E Convertible Preferred Stock [Member]            
Accumulated Other Comprehensive Income (Loss) [Line Items]            
Preferred stock, shares outstanding   0        
Conversion of stock, shares       200    
Accrued dividends converted       $ 9,545    
Per share conversion price of preferred stock   $ 6.00        
Common Stock [Member]            
Accumulated Other Comprehensive Income (Loss) [Line Items]            
Common stock issued upon conversion       31,933    
Common Stock [Member] | Two Thousand Twenty Four Private Placement [Member]            
Accumulated Other Comprehensive Income (Loss) [Line Items]            
Number of shares issued in transaction 367,767          
Amount of consideration received from the transaction $ 1,500,000          
Price per share $ 4.03          
Common Stock [Member] | Two Thousand Twenty Three Private Placement [Member]            
Accumulated Other Comprehensive Income (Loss) [Line Items]            
Number of shares issued in transaction   1,000,967 1,000,967      
Amount of consideration received from the transaction   $ 6,000,000 $ 6,000,000      
Price per share   $ 6.00 $ 6.00      
Warrant [Member]            
Accumulated Other Comprehensive Income (Loss) [Line Items]            
Warrants to purchase common stock outstanding         1,113,622  
Weighted-average exercise price         $ 4.69  
v3.24.2.u1
Schedule of Stock Option Activity (Details) - USD ($)
$ / shares in Units, $ in Thousands
6 Months Ended 12 Months Ended
Jun. 30, 2024
Dec. 31, 2023
Share-Based Payment Arrangement [Abstract]    
Outstanding, balance 3,977,289  
Weighted-average exercise price, Outstanding $ 4.64  
Weighted-average contractual life, Outstanding 7 years 4 months 24 days 7 years 8 months 12 days
Aggregate intrinsic value, Outstanding $ 5,728  
Granted 361,766  
Weighted-average exercise price, Granted $ 3.62  
Outstanding, balance 4,339,055 3,977,289
Weighted-average exercise price, Outstanding $ 4.56 $ 4.64
Aggregate intrinsic value, Outstanding $ 1,169 $ 5,728
Options exercisable 2,489,412  
Weighted-average exercise price, Options exercisable $ 4.69  
Weighted-average contractual life, Options exercisable 6 years 10 months 24 days  
Aggregate intrinsic value, Options exercisable $ 948  
Options vested and expected to vest 4,239,637  
Weighted-average exercise price, Options vested and expected to vest $ 4.59  
Weighted-average contractual life, Options vested and expected to vest 7 years 4 months 24 days  
Aggregate intrinsic value, Options vested and expected to vest $ 1,122  
v3.24.2.u1
Schedule of Weighted Average Assumptions of Options (Details)
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Share-Based Payment Arrangement [Abstract]    
Risk-free interest rate 4.07% 3.76%
Expected volatility 116.86% 126.16%
Expected term (years) 5 years 4 months 24 days 5 years 10 months 24 days
Expected dividend yield 0.00% 0.00%
v3.24.2.u1
Schedule of Share-based Compensation Expense (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total share-based compensation $ 572 $ 479 $ 1,132 $ 2,319
Research and Development Expense [Member]        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total share-based compensation 110 51 219 113
General and Administrative Expense [Member]        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total share-based compensation $ 462 $ 428 $ 913 $ 2,206
v3.24.2.u1
Share-Based Compensation (Details Narrative) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Jun. 28, 2024
Dec. 31, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]            
Number of award outstanding 4,339,055   4,339,055     3,977,289
Stock-based compensation expense $ 572,000 $ 479,000 $ 1,132,000 $ 2,319,000    
Aggregate intrinsic value for outstanding options $ 1,169,000   $ 1,169,000     $ 5,728,000
Weighted average exercise price $ 4.56   $ 4.56     $ 4.64
Performance Shares [Member]            
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]            
Number of award outstanding 993,835   993,835      
Unrecognized compensation expense $ 3,400,000   $ 3,400,000      
Stock-based compensation expense $ 40,000.00 $ 0 $ 80,000.00 $ 0    
HRGN Amended and Restate Equity Incentive Plan [Member]            
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]            
Awards vesting period     4 years      
Awards contractual life     10 years      
Number of shares authorized shares to be issued 9,098,000   9,098,000      
Number of shares available for issuance 4,672,994   4,672,994      
Unrecognized compensation expense $ 3,200,000   $ 3,200,000      
Aggregate intrinsic value for outstanding options $ 1,200,000   $ 1,200,000      
Closing stock price         $ 2.92  
Weighted average exercise price         $ 4.56  
Weighted-average period for recognition     1 year 8 months 12 days      
v3.24.2.u1
Commitments and Contingencies (Details Narrative) - USD ($)
Mar. 25, 2024
Jun. 30, 2024
Defined Benefit Plan Disclosure [Line Items]    
Operating lease description the Company entered into an operating lease agreement for office space in Beijing, China for the period from April 1, 2024 through April 10, 2026 (the “Office Lease”).  
Total office lease obligation $ 81,352  
Fiscal year 2024 30,507  
Fiscal year 2025 40,676  
Fiscal year 2026 $ 10,169  
Yale University [Member]    
Defined Benefit Plan Disclosure [Line Items]    
Advance payments   $ 100,000
McGowan Institute for Regenerative Medicine [Member]    
Defined Benefit Plan Disclosure [Line Items]    
Advance payments   $ 61,000
v3.24.2.u1
Convertible Debt – Related Party (Details Narrative) - Junli He [Member] - Bridge Note [Member]
$ in Thousands
Feb. 01, 2024
USD ($)
Short-Term Debt [Line Items]  
Debt instrument, face amount $ 500,000
Interest payable $ 16,222
Debt instrument, payment terms The Bridge Note accrues interest at an annual fixed rate of 8%, and the principal amount thereof will be due and payable in full, together with all accrued and unpaid interest thereon, on the earlier to occur of a) the closing date (or later date of capital being provided pertaining to such continued offering that the following threshold is tripped) of the Company’s next capital raise that includes gross proceeds of at least $5,000,000 or b) February 1, 2025
Debt instrument, interest rate 8.00%
v3.24.2.u1
Schedule of Operating Leases in Consolidated Balance Sheets (Details) - USD ($)
Jun. 30, 2024
Dec. 31, 2023
Jun. 30, 2023
Leases      
Operating lease assets $ 68,000 $ 48,000 $ 28,000
Current portion of operating lease liabilities 40,000 48,000  
Operating lease liabilities, net of current portion 28,000  
Total operating lease liabilities $ 68,000 $ 48,000 $ 57,000
v3.24.2.u1
Schedule of Operating Lease Expense Categories in Consolidated Statements of Operations and Comprehensive Loss (Details) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Operating lease expense $ 28,000 $ 28,000 $ 55,000 $ 57,000
Research and Development Expense [Member]        
Operating lease expense 12,000 17,000 28,000 35,000
Selling and Marketing Expense [Member]        
Operating lease expense 9,000 9,000
Selling, General and Administrative Expenses [Member]        
Operating lease expense $ 7,000 $ 11,000 $ 18,000 $ 22,000
v3.24.2.u1
Schedule of Weighted Average Lease Term and Discount Rates (Details)
Jun. 30, 2024
Jun. 30, 2023
Leases    
Remaining lease term (in years) 1 year 8 months 12 days 10 months 17 days
Discount rate 8.19% 12.78%
v3.24.2.u1
Schedule of Minimum Lease Payments (Details) - USD ($)
Jun. 30, 2024
Dec. 31, 2023
Jun. 30, 2023
Leases      
2024 $ 23,000    
2025 41,000    
2026 10,000    
Total lease payments 74,000    
Less: imputed interest (6,000)    
Total operating lease liabilities $ 68,000 $ 48,000 $ 57,000
v3.24.2.u1
Leases (Details Narrative) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Mar. 25, 2024
Dec. 31, 2023
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Operating lease remaining term 1 year   1 year      
Cash paid included in the computation of the operating lease assets $ 68,000 $ 28,000 $ 68,000 $ 28,000   $ 48,000
Cash paid included in computation of operating lease liabilities 68,000 57,000 68,000 57,000   48,000
Current liabilities 40,000   40,000     48,000
Non current liabilities 28,000   28,000    
Cash paid included in the computation of the operating lease liabilities 28,000 $ 28,000 55,000 $ 57,000    
Operating Lease Agreement [Member]            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Cash paid included in the computation of the operating lease assets 65,000   65,000   $ 75,000  
Discount rate         8.00%  
Cash paid included in computation of operating lease liabilities 65,000   65,000      
Current liabilities 40,000   40,000      
Non current liabilities $ 25,000   $ 25,000      
v3.24.2.u1
Schedule of Net Loss Per Share (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Earnings Per Share [Abstract]        
Net loss $ (2,498) $ (2,614) $ (4,528) $ (5,504)
Preferred stock dividends 3 (77)
Net loss attributable to common stockholders $ (2,498) $ (2,611) $ (4,528) $ (5,581)
Basic weighted average common shares outstanding 14,258,511 13,785,657 14,102,918 13,000,211
Diluted weighted average common shares outstanding 14,258,511 13,785,657 14,102,918 13,000,211
Basic net loss per share attributable to common stockholders $ (0.18) $ (0.19) $ (0.32) $ (0.43)
Diluted net loss per share attributable to common stockholders $ (0.18) $ (0.19) $ (0.32) $ (0.43)
v3.24.2.u1
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings per Share (Details) - shares
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive securities excluded from computation of earnings per share, amount 5,452,677 4,900,522
Share-Based Payment Arrangement, Option [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive securities excluded from computation of earnings per share, amount 4,339,055 3,786,900
Warrant [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive securities excluded from computation of earnings per share, amount 1,113,622 1,113,622
v3.24.2.u1
Schedule of Reportable Segments (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Segment Reporting Information [Line Items]        
Revenues $ 56 $ 113
Net loss (2,498) $ (2,614) (4,528) $ (5,504)
Total assets 1,730   1,730  
Regenerative Biotech [Member]        
Segment Reporting Information [Line Items]        
Revenues      
Net loss     (4,255)  
Total assets 1,456   1,456  
Longevity Products [Member]        
Segment Reporting Information [Line Items]        
Revenues     113  
Net loss     (273)  
Total assets $ 274   $ 274  
v3.24.2.u1
Segments (Details Narrative)
6 Months Ended
Jun. 30, 2024
Segment
Segment Reporting [Abstract]  
Number of operating segments 2
Number of reportable segments 2
v3.24.2.u1
Subsequent Events (Details Narrative) - Subsequent Event [Member]
1 Months Ended
Jul. 31, 2024
USD ($)
$ / shares
Subsequent Event [Line Items]  
Common stock warrants exercised $ 215,000
Warrants exercise price | $ / shares $ 2.00
Proceeds from warrant exercised $ 430,000

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