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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 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 March 31, 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 May 6, 2024, there were 14,315,091 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 March 31, 2024
INDEX
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)
| |
| | | |
| | |
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 272 | | |
$ | 432 | |
Accounts receivable | |
| 7 | | |
| 4 | |
Inventory | |
| 44 | | |
| 50 | |
Prepaid research and development | |
| 159 | | |
| 210 | |
Prepaid expenses and other current assets | |
| 135 | | |
| 87 | |
Total current assets | |
| 617 | | |
| 783 | |
Property, plant and equipment, net | |
| 19 | | |
| 25 | |
Right-of-use assets, net | |
| 21 | | |
| 48 | |
Deferred financing costs | |
| 544 | | |
| 544 | |
Long-term prepaid contracts | |
| 1,214 | | |
| 1,214 | |
Total assets | |
$ | 2,415 | | |
$ | 2,614 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 890 | | |
$ | 445 | |
Accrued and other current liabilities | |
| 528 | | |
| 475 | |
Advance from private placement | |
| 301 | | |
| — | |
Convertible debt – related party | |
| 500 | | |
| — | |
Operating lease liability | |
| 21 | | |
| 48 | |
Total current liabilities | |
| 2,240 | | |
| 968 | |
| |
| | | |
| | |
Commitments and contingencies (Note 7) | |
| - | | |
| - | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Common stock, par value $0.01 per share, 60,000,000 shares authorized; 13,947,324 issued and outstanding at March 31, 2024 and December 31, 2023, respectively | |
| 139 | | |
| 139 | |
Additional paid-in capital | |
| 94,023 | | |
| 93,463 | |
Accumulated deficit | |
| (93,986 | ) | |
| (91,956 | ) |
Accumulated other comprehensive loss | |
| (1 | ) | |
| — | |
Total stockholders’ equity | |
| 175 | | |
| 1,646 | |
Total liabilities and stockholders’ equity | |
$ | 2,415 | | |
$ | 2,614 | |
See
accompanying notes to unaudited condensed consolidated financial statements.
HARVARD
APPARATUS REGENERATIVE TECHNOLOGY, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(in
thousands, except share and per share data)
| |
| | | |
| | |
| |
Three Months Ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
Product revenue | |
$ | 57 | | |
$ | — | |
| |
| | | |
| | |
Operating expenses: | |
| | | |
| | |
Cost of sales | |
| 12 | | |
| — | |
Research and development | |
| 840 | | |
| 509 | |
Sales and marketing | |
| 115 | | |
| — | |
General and administrative | |
| 1,111 | | |
| 2,378 | |
Total operating expenses | |
| 2,078 | | |
| 2,887 | |
| |
| | | |
| | |
Operating loss | |
| (2,021 | ) | |
| (2,887 | ) |
| |
| | | |
| | |
Other expense, net: | |
| | | |
| | |
Other expense, net | |
| (9 | ) | |
| (3 | ) |
| |
| | | |
| | |
Net loss | |
| (2,030 | ) | |
| (2,890 | ) |
Preferred stock dividends | |
| — | | |
| (80 | ) |
Net loss attributable to common stockholders | |
$ | (2,030 | ) | |
$ | (2,970 | ) |
| |
| | | |
| | |
Basic and diluted net loss per share attributable to common stockholders | |
$ | (0.15 | ) | |
$ | (0.24 | ) |
Weighted average common shares outstanding, basic and diluted | |
| 13,947,324 | | |
| 12,206,036 | |
| |
| | |
| |
Comprehensive loss: | |
| | |
| |
Net loss | |
$ | (2,030 | ) | |
$ | (2,890 | ) |
Foreign currency translation adjustments | |
| (1 | ) | |
| — | |
Comprehensive loss | |
| (2,031 | ) | |
| (2,890 | ) |
Less: Preferred stock dividends | |
| — | | |
| (80 | ) |
Comprehensive loss attributable to common stockholders | |
$ | (2,031 | ) | |
$ | (2,970 | ) |
See
accompanying notes to unaudited condensed consolidated financial statements.
HARVARD
APPARATUS REGENERATIVE TECHNOLOGY, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited)
(in
thousands, except share data)
| |
Stock | | |
Outstanding | | |
Stock | | |
Capital | | |
Deficit | |
|
Accumulated |
|
|
Deficit | |
| |
Series E Convertible Preferred | | |
Number of Common Shares | | |
Common | | |
Additional Paid-in | | |
Accumulated | |
|
Accumulated Other Comprehensive
|
|
|
Total Stockholders’ | |
| |
Stock | | |
Outstanding | | |
Stock | | |
Capital | | |
Deficit | |
|
Loss |
|
|
Equity | |
Balance at January 1, 2024 | |
$ | — | | |
| 13,947,324 | | |
$ | 139 | | |
$ | 93,463 | | |
$ | (91,956 | ) |
|
$ |
— |
|
|
$ | 1,646 | |
Share-based compensation | |
| — | | |
| — | | |
| — | | |
| 560 | | |
| — | |
|
|
— |
|
|
| 560 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| (2,030 | ) |
|
|
- |
|
|
| (2,030 | ) |
Other comprehensive loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
|
|
(1 |
) |
|
| (1 | ) |
Balance at March 31, 2024 | |
$ | — | | |
| 13,947,324 | | |
$ | 139 | | |
$ | 94,023 | | |
$ | (93,986 | ) |
|
$ |
(1 |
) |
|
$ | 175 | |
| |
Series E Convertible Preferred | | |
Number of Common Shares | | |
Common | | |
Additional Paid-in | | |
Accumulated | |
|
Accumulated Other Comprehensive |
| |
Total Stockholders’ | |
| |
Stock | | |
Outstanding | | |
Stock | | |
Capital | | |
Deficit | |
|
Loss |
| |
Deficit | |
Balance at January 1, 2023 | |
$ | 4,180 | | |
| 12,174,467 | | |
$ | 122 | | |
$ | 79,698 | | |
$ | (83,011 | ) |
|
$ |
— |
| |
$ | (3,191 | ) |
Beginning Balance | |
$ | 4,180 | | |
| 12,174,467 | | |
$ | 122 | | |
$ | 79,698 | | |
$ | (83,011 | ) |
|
|
|
| |
$ | (3,191 | ) |
Preferred stock dividends | |
| 80 | | |
| — | | |
| — | | |
| (80 | ) | |
| — | |
|
|
— |
| |
| (80 | ) |
Conversion of preferred stock for common stock | |
| (209 | ) | |
| 31,933 | | |
| — | | |
| 209 | | |
| — | |
|
|
— |
| |
| 209 | |
Issuance of common stock, net of offering costs | |
| — | | |
| 510,134 | | |
| 5 | | |
| 3,045 | | |
| — | |
|
|
— |
| |
| 3,050 | |
Share-based compensation | |
| — | | |
| — | | |
| — | | |
| 1,840 | | |
| — | |
|
|
— |
| |
| 1,840 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| (2,890 | ) |
|
|
— |
| |
| (2,890 | ) |
Balance at March 31, 2023 | |
$ | 4,051 | | |
| 12,716,534 | | |
$ | 127 | | |
$ | 84,712 | | |
$ | (85,901 | ) |
|
$ |
— |
| |
$ | (1,062 | ) |
Ending Balance | |
$ | 4,051 | | |
| 12,716,534 | | |
$ | 127 | | |
$ | 84,712 | | |
$ | (85,901 | ) |
|
|
|
| |
$ | (1,062 | ) |
See
accompanying notes to unaudited condensed consolidated financial statements
HARVARD
APPARATUS REGENERATIVE TECHNOLOGY, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(in
thousands)
| |
| | | |
| | |
| |
Three Months Ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
OPERATING ACTIVITIES | |
| | | |
| | |
Net loss | |
$ | (2,030 | ) | |
$ | (2,890 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Share-based compensation expense | |
| 560 | | |
| 1,840 | |
Depreciation | |
| 6 | | |
| 12 | |
Amortization of right-of-use assets | |
| 27 | | |
| 27 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (3 | ) | |
| — | |
Inventory | |
| 6 | | |
| — | |
Prepaid research and development | |
| 51 | | |
| 8 | |
Prepaid expenses and other current assets | |
| (48 | ) | |
| (12 | ) |
Deferred financing costs | |
| — | | |
| 66 | |
Accounts payable | |
| 445 | | |
| 73 | |
Operating lease liability | |
| (27 | ) | |
| (27 | ) |
Accrued and other current liabilities | |
| 53 | | |
| (110 | ) |
Net cash used in operating activities | |
| (960 | ) | |
| (1,013 | ) |
| |
| | | |
| | |
INVESTING ACTIVITIES | |
| | | |
| | |
Purchases of property, plant, and equipment | |
| — | | |
| (9 | ) |
Net cash used in investing activities | |
| — | | |
| (9 | ) |
| |
| | | |
| | |
FINANCING ACTIVITIES | |
| | | |
| | |
Advance from private placement | |
| 301 | | |
| — | |
Proceeds from convertible debt – related party | |
| 500 | | |
| — | |
Proceeds from issuance of common stock | |
| — | | |
| 3,050 | |
Net cash provided by financing activities | |
| 801 | | |
| 3,050 | |
Effect of exchange rate changes on cash | |
| (1 | ) | |
| — | |
Net (decrease) increase in cash and cash equivalents | |
| (160 | ) | |
| 2,028 | |
Cash and cash equivalents at the beginning of the year | |
| 432 | | |
| 1,241 | |
Cash and cash equivalents at the end of the period | |
$ | 272 | | |
$ | 3,269 | |
| |
| | | |
| | |
Supplemental disclosure of non-cash activities: | |
| | | |
| | |
Purchases of property and equipment in accounts payable or accrued expenses | |
$ | — | | |
$ | 9 | |
Preferred stock dividends | |
$ | — | | |
$ | 80 | |
Conversion of preferred stock into common stock | |
$ | — | | |
$ | 209 | |
See
accompanying notes to unaudited condensed consolidated financial statements.
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.
On
October 31, 2013, Harvard Bioscience, Inc., or Harvard Bioscience, contributed its regenerative medicine business assets, plus $15 million
of cash, into Harvard Apparatus Regenerative Technology, or the Separation. On November 1, 2013, the spin-off of the Company from Harvard
Bioscience was completed. On that date, the Company became an independent company that operates the regenerative medicine business previously
owned by Harvard Bioscience. The spin-off was completed through the distribution to Harvard Bioscience stockholders of all the shares
of common stock of Harvard Apparatus Regenerative Technology, or the Distribution.
The
Company filed an amendment (the “Certificate of Amendment”) to its Amended and Restated Certificate of Incorporation (the
“Certificate of Incorporation”) with the Secretary of State for the State of Delaware to change its name from Biostage, Inc.
to Harvard Apparatus Regenerative Technology, Inc. The Company also amended and restated its Amended and Restated Bylaws, solely to reflect
the name change (as amended, the “Third Amended and Restated Bylaws”). The Certificate of Amendment and the Third Amended
and Restated Bylaws each became effective on July 20, 2023.
In
connection with the name change, the Company traded on the OTCQB under the new ticker symbol “HRGN”. The new ticker symbol
was effective at the open of the market on July 20, 2023.
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 March 31, 2024 had an accumulated deficit of approximately
$94.0 million and will require additional financing to fund future operations. The Company expects that its operating cash on-hand as
of March 31, 2024 of approximately $0.3 million and equity financing of $1.2 million in gross proceeds received subsequent to March 31,
2024 will enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2024. Therefore, these
conditions present risks about the Company’s ability to continue as a going concern.
The
Company will need to raise additional funds to fund its operations. In the event the Company is unable to raise additional capital from
outside sources during the second 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 condensed consolidated financial statements have been prepared
assuming that the Company will continue as a going concern and therefore, the condensed consolidated financial statements do not include
any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amount and classifications
of liabilities that may result from the outcome of this uncertainty.
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.
Principles
of Consolidation
The
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
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. In March of 2024, the Company received cash
advances of approximately $0.3
million from a group of prospective investors pertaining to a potential private placement transaction.
Accounts
Receivable
Allowances
are provided for estimated amounts of accounts receivable which may not be collected. At March 31, 2024 and December 31, 2023, we determined that no
allowance 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 expect to resume in the near future.
The costs include payments made to attorneys, accountants, regulators and consultants. Once we complete the registered offering, the
deferred financing costs will be reclassified to stockholders’ equity on the condensed consolidated balance sheets to offset
the proceeds from the registered offering.
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.
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:
Schedule
of Property Plant and Equipment Estimated Useful Lives
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 March 31, 2024, condensed consolidated interim statements of
operations and comprehensive loss and stockholders’ equity for the three months ended March 31, 2024 and 2023, and cash flows
for the three months ended March 31, 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
March 31, 2024, its condensed consolidated results of operations and stockholders’ equity for the three months ended March 31,
2024 and 2023, and cash flows for the three months ended March 31, 2024 and 2023. The financial data and other information disclosed
in these notes related to the three months ended March 31, 2024 and 2023 are unaudited. The results for the three months ended March
31, 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.
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 March 31, 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.
4.
Accrued and Other Current Liabilities
Accrued
and other current liabilities consist of the following:
Schedule
of Accrued and Other Current Liabilities
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
(in thousands) | |
Advisory costs | |
$ | 376 | | |
$ | 325 | |
Audit services | |
| 53 | | |
| 70 | |
Payroll | |
| 82 | | |
| 79 | |
Other liabilities | |
| 17 | | |
| 1 | |
Total accrued and other current liabilities | |
$ | 528 | | |
$ | 475 | |
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 March
31, 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
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 510,134 shares of common stock
for the aggregate purchase price of approximately $3.1 million with a purchase price per unit of $6.00, the Private Placement.
On
January 18, 2023, Harvard Bioscience, Inc. converted 200 Series E Preferred Shares with accrued dividends of $9,545 into 31,933 shares
of common stock.
Warrants
The
Company had 1,113,622 warrants to purchase common stock outstanding as of March 31, 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 March 31, 2024, the Company’s Plan has 9,098,000 authorized shares to be issued under the Plan. There were 4,814,120 shares
available for issuance as of March 31, 2024.
The
following table summarizes information concerning options outstanding and exercisable:
Schedule
of Stock Option Activity
| |
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 | |
| 220,640 | | |
| 4.07 | | |
| | | |
| | |
Outstanding at March 31, 2024 | |
| 4,197,929 | | |
| 4.61 | | |
| 7.6 | | |
| 1,332 | |
Options exercisable | |
| 2,382,713 | | |
| 4.67 | | |
| 7.08 | | |
| 1,069 | |
Options vested and expected to vest | |
| 4,098,511 | | |
| 4.65 | | |
| 7.6 | | |
| 1,278 | |
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.
Expense of $0.04 million has been recognized for these awards for the three months ended March 31, 2024 given that some milestone achievements for these awards
have been deemed probable for accounting purposes.
Aggregate
intrinsic value for outstanding options as of March 31, 2024 was approximately $1.3 million and calculated as the difference between
the Company’s closing stock price of $3.00 per share as of March 28, 2024 and the weighted average exercise price of $4.61. As
of March 31, 2024, unrecognized compensation cost related to unvested non-performance-based awards amounted to $3.4 million, which will
be recognized over a weighted-average period of 2.0 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 three months ended March 31, 2024 and 2023 were as follows:
Schedule
of Weighted Average Assumptions
| |
Three months ended
March 31, | |
| |
2024 | | |
2023 | |
Risk-free interest rate | |
| 3.92 | % | |
| 4.10 | % |
Expected volatility | |
| 117.0 | % | |
| 126.6 | % |
Expected term (in years) | |
| 5.5 years | | |
| 5.7 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:
Schedule
of Share-based Compensation Expense
| |
Three months ended March 31, | |
| |
2024 | | |
2023 | |
| |
(in thousands) | |
Research and development | |
$ | 109 | | |
$ | 62 | |
General and administrative | |
| 451 | | |
| 1,778 | |
Total | |
$ | 560 | | |
$ | 1,840 | |
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.
We
currently have a co-development initiative with Yale University and the McGowan Institute for Regenerative Medicine at the University
of Pittsburgh. We are required to make advance payments of approximately $130,000 and $61,000, respectively at inception of the contracts.
We plan to make these advance payments in the second quarter of 2024. The universities started preparatory work in 2023 with substantial
work to be done 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 has agreed to loan 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 March 31, 2024,
the Company accrued $6,111 of interest payable on the Bridge Note. The Company evaluated the convertible note for derivative liability
treatment and has determined that the Bridge Note did not qualify for derivative accounting treatment as of March 31, 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 is under a sublease that was renewed in December of 2022 and currently extends through May 31,
2024. The Company is currently negotiating with the landlord for a three-year lease.
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:
Schedule
of Operating Leases in Consolidated Balance Sheets
| |
Balance Sheet Classification | |
March 31, 2024 | | |
December 31, 2023 | |
| |
| |
(in thousands) | |
Assets: | |
| |
| | |
| |
Operating lease assets | |
Right-of-use asset, net | |
$ | 21 | | |
$ | 48 | |
Current Liabilities: | |
| |
| | | |
| | |
Operating lease liabilities | |
Operating lease liabilities | |
$ | 21 | | |
$ | 48 | |
The
Company recorded operating lease expense in the following categories in its condensed consolidated statements of operations
and comprehensive loss:
Schedule
of Operating Lease Expense Categories in Consolidated Statements of Operations and Comprehensive Loss
| |
Three months ended March 31, | |
| |
2024 | | |
2023 | |
| |
(in thousands) | |
Research and development | |
$ | 16 | | |
$ | 19 | |
General and administrative | |
| 11 | | |
| 11 | |
Total | |
$ | 27 | | |
$ | 30 | |
Cash
paid included in the computation of the operating lease assets and lease liabilities during the three months ended March 31, 2024 and
2023 amounted to approximately $27,000 and $30,000, respectively.
The
weighted average remaining lease term and weighted average discount rate of the Company’s operating leases are as follows:
Schedule
of Weighted Average Lease Term and Discount Rates
| |
As of March 31, | |
| |
2024 | | |
2023 | |
Remaining lease term (in years) | |
| 0.26 | | |
| 1.24 | |
Discount rate | |
| 14.47 | % | |
| 14.76 | % |
The
minimum lease payments for the next year are expected to be as follows:
Schedule
of Minimum Lease Payments
| |
As of | |
| |
March 31, 2024 | |
| |
| (in thousands) | |
2024 | |
$ | 22 | |
Total lease payments | |
| 22 | |
Less: imputed interest | |
| (1 | ) |
Present value of operating lease liabilities | |
$ | 21 | |
10.
Net Loss Per Share
Schedule
of Basic and Diluted Net Loss Per Share
| |
2024 | | |
2023 | |
| |
Three months ended
March 31, | |
| |
2024 | | |
2023 | |
| |
(in thousands, except shares and per share data) | |
Net loss | |
$ | (2,030 | ) | |
$ | (2,890 | ) |
Preferred stock dividends | |
| — | | |
| (80 | ) |
Net loss attributable to common stockholders | |
$ | (2,030 | ) | |
$ | (2,970 | ) |
| |
| | | |
| | |
Basic and diluted weighted average common shares outstanding | |
| 13,947,324 | | |
| 12,206,036 | |
| |
| | | |
| | |
Basic and diluted net loss per share attributable to common stockholders | |
$ | (0.15 | ) | |
$ | (0.24 | ) |
The
following potential common shares were excluded from the calculation of diluted net loss per share attributable to common stockholders
for the three months ended March 31, 2024 and 2023 because including them would have had an anti-dilutive effect:
Schedule
of Anti-dilutive Securities Excluded from Computation of Earnings per Share
| |
Three months ended
March 31, | |
| |
2024 | | |
2023 | |
Options to purchase common stock | |
| 4,197,929 | | |
| 2,802,185 | |
Warrants to purchase common stock | |
| 1,113,622 | | |
| 1,113,622 | |
Total | |
| 5,311,551 | | |
| 3,915,807 | |
11.
Income Taxes
The
Company did not record a federal or state income tax provision or benefit for the three months ended March 31, 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 three months ended March 31, 2024:
Schedule
of Reportable Segments
| |
Regenerative Biotech | | |
Longevity Products | | |
Total | |
2024 | |
| | | |
| | | |
| | |
Revenues | |
$ | — | | |
$ | 57 | | |
$ | 57 | |
Net loss | |
| (1,935 | ) | |
| (95 | ) | |
| (2,030 | ) |
Total assets | |
| 2,225 | | |
| 190 | | |
| 2,415 | |
13.
Subsequent Events
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 purchase price of $1.5 million
at a purchase price per unit of $4.03 (the
“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 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
Private Placement, and (ii) result of dividing (a) the subscription amount for each April Purchase Agreement, by (b) the public offering per share.
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,” “expects,” “plans,”
“anticipates,” “believes,” “goals,” “sees,” “estimates,”
“projects,” “predicts,” “intends,” “think,” “potential,”
“objectives,” “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 funds 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. 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).
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 March 31, 2024 had an accumulated deficit of approximately
$94.0 million and will require additional financing to fund future operations. We expect that our operating cash on-hand as of March
31, 2024 of approximately $0.3 million and equity financing of $1.2 million in gross proceeds received subsequent to March 31, 2024 will
enable us to fund our operating expenses and capital expenditure requirements into the second 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 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 funds to fund our operations. In the event we do not raise additional capital from outside sources before
or during the second quarter of 2024, we may be forced to curtail or cease our 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 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 condensed consolidated financial statements have been prepared assuming that we will continue as a going concern
and therefore, the condensed consolidated financial statements do not include any adjustments to reflect the possible future effects
on the recoverability and classification of assets or the 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, net. Other expense, net, consists primarily of interest expense on convertible debt and finance charges on insurance installment
payments.
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 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.
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 months ended March 31, 2024 and 2023 (in thousands):
| |
Three months ended March
31, | | |
Change 2024 vs. 2023 | |
| |
2024 | | |
2023 | | |
Change | | |
% | |
Product revenue | |
$ | 57 | | |
$ | — | | |
$ | 57 | | |
| 100 | % |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Cost of sales | |
| 12 | | |
| — | | |
| 12 | | |
| 100 | % |
Research and development | |
| 840 | | |
| 509 | | |
| 331 | | |
| 65 | % |
Sales and marketing | |
| 115 | | |
| — | | |
| 115 | | |
| 100 | % |
General and administrative | |
| 1,111 | | |
| 2,378 | | |
| (1,267 | ) | |
| (53 | )% |
Total operating expenses | |
| 2,078 | | |
| 2,887 | | |
| (809 | ) | |
| (28 | )% |
| |
| | | |
| | | |
| | | |
| | |
Other expense | |
| | | |
| | | |
| | | |
| | |
Other expense, net | |
| (9 | ) | |
| (3 | ) | |
| (6 | ) | |
| 200 | % |
Net loss | |
$ | (2,030 | ) | |
$ | (2,890 | ) | |
$ | (860 | ) | |
| (30 | )% |
Comparison
of the three months ended March 31, 2024 and March 31, 2023
Product
Revenue
Product
revenue was $57,000 and zero for the three months ended March 31, 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 $12,000 and zero for the three months ended March 31, 2024 and 2023, respectively. For the three months ended March 31,
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 increased approximately $0.3 million, or 65%, to approximately $0.8 million for the three months ended March 31,
2024 as compared to approximately $0.5 million for the three months ended March 31, 2023. This increase was primarily due to the addition
of preclinical trial activities to increase our product pipeline and increased clinical trial activities for the three months ended March
31, 2024.
Sales
and Marketing Expense
HRGN
Limited launched its longevity products business in the third quarter of 2023 so there were no prior comparable period costs. Selling
and marketing expense was $0.1 million for the three months ended March 31, 2024 as compared to zero for the three months ended March
31, 2023.
General
and Administrative Expense
General
and administrative expense decreased approximately $1.3 million, or 53%, to approximately $1.1 million for the three months ended March
31, 2024 as compared to approximately $2.4 million for the three months ended March 31, 2023. This decrease was primarily due to one-time share-based compensation expense of $1.5 million from the vesting of performance-based awards in the first quarter of
2023.
Other
expense, net
During
the three months ended March 31, 2024, we recorded interest expense of approximately $6,000 on convertible debt and approximately $3,000
on insurance installment payments. During the three months ended March 31, 2023, we recorded interest expense of approximately $3,000
on insurance installment payments.
Liquidity
and Capital Resources
Sources
of liquidity. We have incurred operating losses since inception, and as of March 31, 2024, we had an accumulated deficit of approximately
$94.0 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 Consolidated Financial Statements, these conditions raise substantial doubt about our ability
to continue as a going concern.
The
following table sets forth the primary uses of cash for the three months ended March 31, 2024 and 2023 (in thousands):
| |
Three Months Ended
March 31, | |
| |
2024 | | |
2023 | |
Net cash used in operating activities | |
$ | (960 | ) | |
$ | (1,013 | ) |
Net cash used by investing activities | |
$ | — | | |
$ | (9 | ) |
Net cash provided by financing activities | |
$ | 801 | | |
$ | 3,050 | |
Comparison
of the three months ended March 31, 2024 and 2023
Operating
activities. Net cash used in operating activities of approximately $1.0 million for the three months ended March 31, 2024 was due primarily
to our net loss of approximately $2.0 million offset by adjustments for non-cash items of approximately $0.5 million due to non-cash
expenses for share-based compensation and depreciation, and an approximately $0.5 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 $1.0 million for the three months ended March 31, 2023 was due primarily to our net
loss of approximately $2.9 million offset by adjustments for non-cash items of approximately $1.9 million due to non-cash expenses for
share-based compensation and depreciation.
Investing
activities. Net cash used in investing activities for the three months ended March 31, 2024 and 2023 totaled approximately zero and
$9,000, respectively, and represented purchases of property, plant and equipment.
Financing
activities. Net cash generated from financing activities during the three months ended March 31, 2024 of approximately $0.8 million
consisted of net proceeds of $0.5 million received from debt financing and $0.3 million from a group of prospective investors pertaining
to the private placement transaction closing on April 15, 2024. Net cash generated from financing activities during the three months
ended March 31, 2023 of approximately $3.1 million consisted of net proceeds received from a private placement transaction that resulted
in the issuance of 510,134 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 March 31, 2024.
Other
Information
None.
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. This Item 4 includes information concerning the controls and control evaluations
referred to in those certifications.
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 March 31, 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 March 31, 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.
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 March 31, 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). |
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# |
|
Amendment to Employment Agreement, dated as of July 10, 2023, by and between Biostage, Inc. and Junli He (previously filed as an exhibit to the Current Report on Form 8-K, filed on July 10, 2023, and incorporated herein by reference).
|
|
|
|
10.2# |
|
Third Amended and Restated Equity Incentive Plan, as amended (previously filed as exhibit to the Company’s Quarterly Report on Form 10-Q, filed on November 13, 2023, and incorporated by reference thereto). |
|
|
|
10.3 |
|
Bridge Note dated as of February 1, 2024, by Harvard Apparatus Regenerative Technology, Inc. in favor of Junli He (previously filed as an exhibit to the Current Report on Form 8-K, filed on February 6, 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. |
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:
May 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) |
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:
May 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:
May 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 March 31, 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:
May 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 March 31, 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:
May 13, 2024
|
|
/s/
Joseph L. Damasio Jr. |
|
Name: |
Joseph
L. Damasio Jr. |
|
Title: |
Chief
Financial Officer |
v3.24.1.1.u2
Cover - shares
|
3 Months Ended |
|
Mar. 31, 2024 |
May 06, 2024 |
Cover [Abstract] |
|
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Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Mar. 31, 2024
|
|
Document Fiscal Period Focus |
Q1
|
|
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
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Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
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v3.24.1.1.u2
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 272
|
$ 432
|
Accounts receivable |
7
|
4
|
Inventory |
44
|
50
|
Prepaid research and development |
159
|
210
|
Prepaid expenses and other current assets |
135
|
87
|
Total current assets |
617
|
783
|
Property, plant and equipment, net |
19
|
25
|
Right-of-use assets, net |
21
|
48
|
Deferred financing costs |
544
|
544
|
Long-term prepaid contracts |
1,214
|
1,214
|
Total assets |
2,415
|
2,614
|
Current liabilities: |
|
|
Accounts payable |
890
|
445
|
Accrued and other current liabilities |
528
|
475
|
Advance from private placement |
301
|
|
Operating lease liability |
21
|
48
|
Total current liabilities |
2,240
|
968
|
Commitments and contingencies (Note 7) |
|
|
Stockholders’ equity: |
|
|
Common stock, par value $0.01 per share, 60,000,000 shares authorized; 13,947,324 issued and outstanding at March 31, 2024 and December 31, 2023, respectively |
139
|
139
|
Additional paid-in capital |
94,023
|
93,463
|
Accumulated deficit |
(93,986)
|
(91,956)
|
Accumulated other comprehensive loss |
(1)
|
|
Total stockholders’ equity |
175
|
1,646
|
Total liabilities and stockholders’ equity |
2,415
|
2,614
|
Related Party [Member] |
|
|
Current liabilities: |
|
|
Convertible debt – related party |
$ 500
|
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|
Mar. 31, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
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$ 0.01
|
$ 0.01
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60,000,000
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60,000,000
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v3.24.1.1.u2
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3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Income Statement [Abstract] |
|
|
Product revenue |
$ 57
|
|
Operating expenses: |
|
|
Cost of sales |
12
|
|
Research and development |
840
|
509
|
Sales and marketing |
115
|
|
General and administrative |
1,111
|
2,378
|
Total operating expenses |
2,078
|
2,887
|
Operating loss |
(2,021)
|
(2,887)
|
Other expense, net: |
|
|
Other expense, net |
(9)
|
(3)
|
Net loss |
(2,030)
|
(2,890)
|
Preferred stock dividends |
|
(80)
|
Net loss attributable to common stockholders |
$ (2,030)
|
$ (2,970)
|
Basic net loss per share attributable to common stockholders |
$ (0.15)
|
$ (0.24)
|
Diluted net loss per share attributable to common stockholders |
$ (0.15)
|
$ (0.24)
|
Weighted average common shares, basic |
13,947,324
|
12,206,036
|
Weighted average common shares, diluted |
13,947,324
|
12,206,036
|
Comprehensive loss: |
|
|
Net loss |
$ (2,030)
|
$ (2,890)
|
Foreign currency translation adjustments |
(1)
|
|
Comprehensive loss |
(2,031)
|
(2,890)
|
Less: Preferred stock dividends |
|
(80)
|
Comprehensive loss attributable to common stockholders |
$ (2,031)
|
$ (2,970)
|
X |
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v3.24.1.1.u2
Condensed Consolidated Statements of Stockholders' Equity (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 |
Beginning Balance at Dec. 31, 2022 |
$ 4,180
|
$ 122
|
$ 79,698
|
$ (83,011)
|
|
$ (3,191)
|
Temporary equity, beginning balance at Dec. 31, 2022 |
4,180
|
|
|
|
|
|
Beginning Balance, shares at Dec. 31, 2022 |
|
12,174,467
|
|
|
|
|
Share-based compensation |
|
|
1,840
|
|
|
1,840
|
Net loss |
|
|
|
(2,890)
|
|
(2,890)
|
Preferred stock dividends |
80
|
|
(80)
|
|
|
(80)
|
Temporary equity, beginning balance |
80
|
|
|
|
|
|
Conversion of preferred stock for common stock |
(209)
|
|
209
|
|
|
209
|
Temporary equity, beginning balance |
(209)
|
|
|
|
|
|
Beginning Balance, shares |
|
31,933
|
|
|
|
|
Issuance of common stock, net of offering costs |
|
$ 5
|
3,045
|
|
|
3,050
|
Beginning Balance, shares |
|
510,134
|
|
|
|
|
Ending Balance at Mar. 31, 2023 |
4,051
|
$ 127
|
84,712
|
(85,901)
|
|
(1,062)
|
Temporary equity, ending balance at Mar. 31, 2023 |
4,051
|
|
|
|
|
|
Ending Balance, shares at Mar. 31, 2023 |
|
12,716,534
|
|
|
|
|
Beginning Balance at Dec. 31, 2023 |
|
$ 139
|
93,463
|
(91,956)
|
|
1,646
|
Temporary equity, beginning balance at Dec. 31, 2023 |
|
|
|
|
|
|
Beginning Balance, shares at Dec. 31, 2023 |
|
13,947,324
|
|
|
|
|
Share-based compensation |
|
|
560
|
|
|
560
|
Net loss |
|
|
|
(2,030)
|
|
(2,030)
|
Other comprehensive loss |
|
|
|
|
(1)
|
(1)
|
Ending Balance at Mar. 31, 2024 |
|
$ 139
|
$ 94,023
|
$ (93,986)
|
$ (1)
|
$ 175
|
Temporary equity, ending balance at Mar. 31, 2024 |
|
|
|
|
|
|
Ending Balance, shares at Mar. 31, 2024 |
|
13,947,324
|
|
|
|
|
X |
- DefinitionAmount of decrease in additional paid in capital (APIC) resulting from dividends legally declared (or paid) in excess of retained earnings balance.
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v3.24.1.1.u2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
OPERATING ACTIVITIES |
|
|
Net loss |
$ (2,030)
|
$ (2,890)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Share-based compensation expense |
560
|
1,840
|
Depreciation |
6
|
12
|
Amortization of right-of-use assets |
27
|
27
|
Changes in operating assets and liabilities: |
|
|
Accounts receivable |
(3)
|
|
Inventory |
6
|
|
Prepaid research and development |
51
|
8
|
Prepaid expenses and other current assets |
(48)
|
(12)
|
Deferred financing costs |
|
66
|
Accounts payable |
445
|
73
|
Operating lease liability |
(27)
|
(27)
|
Accrued and other current liabilities |
53
|
(110)
|
Net cash used in operating activities |
(960)
|
(1,013)
|
INVESTING ACTIVITIES |
|
|
Purchases of property, plant, and equipment |
|
(9)
|
Net cash used in investing activities |
|
(9)
|
FINANCING ACTIVITIES |
|
|
Advance from private placement |
301
|
|
Proceeds from convertible debt – related party |
500
|
|
Proceeds from issuance of common stock |
|
3,050
|
Net cash provided by financing activities |
801
|
3,050
|
Effect of exchange rate changes on cash |
(1)
|
|
Net (decrease) increase in cash and cash equivalents |
(160)
|
2,028
|
Cash and cash equivalents at the beginning of the year |
432
|
1,241
|
Cash and cash equivalents at the end of the period |
272
|
3,269
|
Supplemental disclosure of non-cash activities: |
|
|
Purchases of property and equipment in accounts payable or accrued expenses |
|
9
|
Preferred stock dividends |
|
80
|
Conversion of preferred stock into common stock |
|
$ 209
|
X |
- DefinitionIncrease decrease in deferred financing costs.
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v3.24.1.1.u2
Organization
|
3 Months Ended |
Mar. 31, 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.
On
October 31, 2013, Harvard Bioscience, Inc., or Harvard Bioscience, contributed its regenerative medicine business assets, plus $15 million
of cash, into Harvard Apparatus Regenerative Technology, or the Separation. On November 1, 2013, the spin-off of the Company from Harvard
Bioscience was completed. On that date, the Company became an independent company that operates the regenerative medicine business previously
owned by Harvard Bioscience. The spin-off was completed through the distribution to Harvard Bioscience stockholders of all the shares
of common stock of Harvard Apparatus Regenerative Technology, or the Distribution.
The
Company filed an amendment (the “Certificate of Amendment”) to its Amended and Restated Certificate of Incorporation (the
“Certificate of Incorporation”) with the Secretary of State for the State of Delaware to change its name from Biostage, Inc.
to Harvard Apparatus Regenerative Technology, Inc. The Company also amended and restated its Amended and Restated Bylaws, solely to reflect
the name change (as amended, the “Third Amended and Restated Bylaws”). The Certificate of Amendment and the Third Amended
and Restated Bylaws each became effective on July 20, 2023.
In
connection with the name change, the Company traded on the OTCQB under the new ticker symbol “HRGN”. The new ticker symbol
was effective at the open of the market on July 20, 2023.
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 March 31, 2024 had an accumulated deficit of approximately
$94.0 million and will require additional financing to fund future operations. The Company expects that its operating cash on-hand as
of March 31, 2024 of approximately $0.3 million and equity financing of $1.2 million in gross proceeds received subsequent to March 31,
2024 will enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2024. Therefore, these
conditions present risks about the Company’s ability to continue as a going concern.
The
Company will need to raise additional funds to fund its operations. In the event the Company is unable to raise additional capital from
outside sources during the second 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 condensed consolidated financial statements have been prepared
assuming that the Company will continue as a going concern and therefore, the condensed consolidated financial statements do not include
any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amount and classifications
of liabilities that may result from the outcome of this uncertainty.
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v3.24.1.1.u2
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements
|
3 Months Ended |
Mar. 31, 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.
Principles
of Consolidation
The
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
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. In March of 2024, the Company received cash
advances of approximately $0.3
million from a group of prospective investors pertaining to a potential private placement transaction.
Accounts
Receivable
Allowances
are provided for estimated amounts of accounts receivable which may not be collected. At March 31, 2024 and December 31, 2023, we determined that no
allowance 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 expect to resume in the near future.
The costs include payments made to attorneys, accountants, regulators and consultants. Once we complete the registered offering, the
deferred financing costs will be reclassified to stockholders’ equity on the condensed consolidated balance sheets to offset
the proceeds from the registered offering.
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.
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:
Schedule
of Property Plant and Equipment Estimated Useful Lives
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 March 31, 2024, condensed consolidated interim statements of
operations and comprehensive loss and stockholders’ equity for the three months ended March 31, 2024 and 2023, and cash flows
for the three months ended March 31, 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
March 31, 2024, its condensed consolidated results of operations and stockholders’ equity for the three months ended March 31,
2024 and 2023, and cash flows for the three months ended March 31, 2024 and 2023. The financial data and other information disclosed
in these notes related to the three months ended March 31, 2024 and 2023 are unaudited. The results for the three months ended March
31, 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.
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v3.24.1.1.u2
Fair Value Measurements
|
3 Months Ended |
Mar. 31, 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 March 31, 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.
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Accrued and Other Current Liabilities
|
3 Months Ended |
Mar. 31, 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:
Schedule
of Accrued and Other Current Liabilities
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
(in thousands) | |
Advisory costs | |
$ | 376 | | |
$ | 325 | |
Audit services | |
| 53 | | |
| 70 | |
Payroll | |
| 82 | | |
| 79 | |
Other liabilities | |
| 17 | | |
| 1 | |
Total accrued and other current liabilities | |
$ | 528 | | |
$ | 475 | |
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v3.24.1.1.u2
Capital Stock
|
3 Months Ended |
Mar. 31, 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 March
31, 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
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 510,134 shares of common stock
for the aggregate purchase price of approximately $3.1 million with a purchase price per unit of $6.00, the Private Placement.
On
January 18, 2023, Harvard Bioscience, Inc. converted 200 Series E Preferred Shares with accrued dividends of $9,545 into 31,933 shares
of common stock.
Warrants
The
Company had 1,113,622 warrants to purchase common stock outstanding as of March 31, 2024 with a weighted-average exercise price of $4.69.
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v3.24.1.1.u2
Share-Based Compensation
|
3 Months Ended |
Mar. 31, 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 March 31, 2024, the Company’s Plan has 9,098,000 authorized shares to be issued under the Plan. There were 4,814,120 shares
available for issuance as of March 31, 2024.
The
following table summarizes information concerning options outstanding and exercisable:
Schedule
of Stock Option Activity
| |
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 | |
| 220,640 | | |
| 4.07 | | |
| | | |
| | |
Outstanding at March 31, 2024 | |
| 4,197,929 | | |
| 4.61 | | |
| 7.6 | | |
| 1,332 | |
Options exercisable | |
| 2,382,713 | | |
| 4.67 | | |
| 7.08 | | |
| 1,069 | |
Options vested and expected to vest | |
| 4,098,511 | | |
| 4.65 | | |
| 7.6 | | |
| 1,278 | |
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.
Expense of $0.04 million has been recognized for these awards for the three months ended March 31, 2024 given that some milestone achievements for these awards
have been deemed probable for accounting purposes.
Aggregate
intrinsic value for outstanding options as of March 31, 2024 was approximately $1.3 million and calculated as the difference between
the Company’s closing stock price of $3.00 per share as of March 28, 2024 and the weighted average exercise price of $4.61. As
of March 31, 2024, unrecognized compensation cost related to unvested non-performance-based awards amounted to $3.4 million, which will
be recognized over a weighted-average period of 2.0 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 three months ended March 31, 2024 and 2023 were as follows:
Schedule
of Weighted Average Assumptions
| |
Three months ended
March 31, | |
| |
2024 | | |
2023 | |
Risk-free interest rate | |
| 3.92 | % | |
| 4.10 | % |
Expected volatility | |
| 117.0 | % | |
| 126.6 | % |
Expected term (in years) | |
| 5.5 years | | |
| 5.7 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:
Schedule
of Share-based Compensation Expense
| |
Three months ended March 31, | |
| |
2024 | | |
2023 | |
| |
(in thousands) | |
Research and development | |
$ | 109 | | |
$ | 62 | |
General and administrative | |
| 451 | | |
| 1,778 | |
Total | |
$ | 560 | | |
$ | 1,840 | |
|
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v3.24.1.1.u2
Commitments and Contingencies
|
3 Months Ended |
Mar. 31, 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.
We
currently have a co-development initiative with Yale University and the McGowan Institute for Regenerative Medicine at the University
of Pittsburgh. We are required to make advance payments of approximately $130,000 and $61,000, respectively at inception of the contracts.
We plan to make these advance payments in the second quarter of 2024. The universities started preparatory work in 2023 with substantial
work to be done in 2024. Either party can terminate the contract with reasonable notice and any incurred costs will be reimbursed by
us to the universities.
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v3.24.1.1.u2
Convertible Debt – Related Party
|
3 Months Ended |
Mar. 31, 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 has agreed to loan 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 March 31, 2024,
the Company accrued $6,111 of interest payable on the Bridge Note. The Company evaluated the convertible note for derivative liability
treatment and has determined that the Bridge Note did not qualify for derivative accounting treatment as of March 31, 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.
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v3.24.1.1.u2
Leases
|
3 Months Ended |
Mar. 31, 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 is under a sublease that was renewed in December of 2022 and currently extends through May 31,
2024. The Company is currently negotiating with the landlord for a three-year lease.
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:
Schedule
of Operating Leases in Consolidated Balance Sheets
| |
Balance Sheet Classification | |
March 31, 2024 | | |
December 31, 2023 | |
| |
| |
(in thousands) | |
Assets: | |
| |
| | |
| |
Operating lease assets | |
Right-of-use asset, net | |
$ | 21 | | |
$ | 48 | |
Current Liabilities: | |
| |
| | | |
| | |
Operating lease liabilities | |
Operating lease liabilities | |
$ | 21 | | |
$ | 48 | |
The
Company recorded operating lease expense in the following categories in its condensed consolidated statements of operations
and comprehensive loss:
Schedule
of Operating Lease Expense Categories in Consolidated Statements of Operations and Comprehensive Loss
| |
Three months ended March 31, | |
| |
2024 | | |
2023 | |
| |
(in thousands) | |
Research and development | |
$ | 16 | | |
$ | 19 | |
General and administrative | |
| 11 | | |
| 11 | |
Total | |
$ | 27 | | |
$ | 30 | |
Cash
paid included in the computation of the operating lease assets and lease liabilities during the three months ended March 31, 2024 and
2023 amounted to approximately $27,000 and $30,000, respectively.
The
weighted average remaining lease term and weighted average discount rate of the Company’s operating leases are as follows:
Schedule
of Weighted Average Lease Term and Discount Rates
| |
As of March 31, | |
| |
2024 | | |
2023 | |
Remaining lease term (in years) | |
| 0.26 | | |
| 1.24 | |
Discount rate | |
| 14.47 | % | |
| 14.76 | % |
The
minimum lease payments for the next year are expected to be as follows:
Schedule
of Minimum Lease Payments
| |
As of | |
| |
March 31, 2024 | |
| |
| (in thousands) | |
2024 | |
$ | 22 | |
Total lease payments | |
| 22 | |
Less: imputed interest | |
| (1 | ) |
Present value of operating lease liabilities | |
$ | 21 | |
|
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- DefinitionThe entire disclosure for operating leases of lessee. Includes, but is not limited to, description of operating lease and maturity analysis of operating lease liability.
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v3.24.1.1.u2
Net Loss Per Share
|
3 Months Ended |
Mar. 31, 2024 |
Earnings Per Share [Abstract] |
|
Net Loss Per Share |
10.
Net Loss Per Share
Schedule
of Basic and Diluted Net Loss Per Share
| |
2024 | | |
2023 | |
| |
Three months ended
March 31, | |
| |
2024 | | |
2023 | |
| |
(in thousands, except shares and per share data) | |
Net loss | |
$ | (2,030 | ) | |
$ | (2,890 | ) |
Preferred stock dividends | |
| — | | |
| (80 | ) |
Net loss attributable to common stockholders | |
$ | (2,030 | ) | |
$ | (2,970 | ) |
| |
| | | |
| | |
Basic and diluted weighted average common shares outstanding | |
| 13,947,324 | | |
| 12,206,036 | |
| |
| | | |
| | |
Basic and diluted net loss per share attributable to common stockholders | |
$ | (0.15 | ) | |
$ | (0.24 | ) |
The
following potential common shares were excluded from the calculation of diluted net loss per share attributable to common stockholders
for the three months ended March 31, 2024 and 2023 because including them would have had an anti-dilutive effect:
Schedule
of Anti-dilutive Securities Excluded from Computation of Earnings per Share
| |
Three months ended
March 31, | |
| |
2024 | | |
2023 | |
Options to purchase common stock | |
| 4,197,929 | | |
| 2,802,185 | |
Warrants to purchase common stock | |
| 1,113,622 | | |
| 1,113,622 | |
Total | |
| 5,311,551 | | |
| 3,915,807 | |
|
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- DefinitionThe entire disclosure for earnings per share.
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v3.24.1.1.u2
Income Taxes
|
3 Months Ended |
Mar. 31, 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 three months ended March 31, 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.
|
X |
- DefinitionThe entire disclosure for income tax.
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v3.24.1.1.u2
Segments
|
3 Months Ended |
Mar. 31, 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 three months ended March 31, 2024:
Schedule
of Reportable Segments
| |
Regenerative Biotech | | |
Longevity Products | | |
Total | |
2024 | |
| | | |
| | | |
| | |
Revenues | |
$ | — | | |
$ | 57 | | |
$ | 57 | |
Net loss | |
| (1,935 | ) | |
| (95 | ) | |
| (2,030 | ) |
Total assets | |
| 2,225 | | |
| 190 | | |
| 2,415 | |
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- DefinitionThe entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.
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v3.24.1.1.u2
Subsequent Events
|
3 Months Ended |
Mar. 31, 2024 |
Subsequent Events [Abstract] |
|
Subsequent Events |
13.
Subsequent Events
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 purchase price of $1.5 million
at a purchase price per unit of $4.03 (the
“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 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
Private Placement, and (ii) result of dividing (a) the subscription amount for each April Purchase Agreement, by (b) the public offering per share.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.24.1.1.u2
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements (Policies)
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Principles of Consolidation |
Principles
of Consolidation
The
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
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. In March of 2024, the Company received cash
advances of approximately $0.3
million from a group of prospective investors pertaining to a potential private placement transaction.
|
Accounts Receivable |
Accounts
Receivable
Allowances
are provided for estimated amounts of accounts receivable which may not be collected. At March 31, 2024 and December 31, 2023, we determined that no
allowance 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 expect to resume in the near future.
The costs include payments made to attorneys, accountants, regulators and consultants. Once we complete the registered offering, the
deferred financing costs will be reclassified to stockholders’ equity on the condensed consolidated balance sheets to offset
the proceeds from the registered offering.
|
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.
|
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:
Schedule
of Property Plant and Equipment Estimated Useful Lives
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 March 31, 2024, condensed consolidated interim statements of
operations and comprehensive loss and stockholders’ equity for the three months ended March 31, 2024 and 2023, and cash flows
for the three months ended March 31, 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
March 31, 2024, its condensed consolidated results of operations and stockholders’ equity for the three months ended March 31,
2024 and 2023, and cash flows for the three months ended March 31, 2024 and 2023. The financial data and other information disclosed
in these notes related to the three months ended March 31, 2024 and 2023 are unaudited. The results for the three months ended March
31, 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.
|
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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.
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v3.24.1.1.u2
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements (Tables)
|
3 Months Ended |
Mar. 31, 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:
Schedule
of Property Plant and Equipment Estimated Useful Lives
Leasehold improvements | |
Shorter of expected useful life or lease term |
Computer equipment and software | |
3 years |
Furniture, machinery and equipment | |
5-7 years |
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v3.24.1.1.u2
Accrued and Other Current Liabilities (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued and Other Current Liabilities |
Accrued
and other current liabilities consist of the following:
Schedule
of Accrued and Other Current Liabilities
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
(in thousands) | |
Advisory costs | |
$ | 376 | | |
$ | 325 | |
Audit services | |
| 53 | | |
| 70 | |
Payroll | |
| 82 | | |
| 79 | |
Other liabilities | |
| 17 | | |
| 1 | |
Total accrued and other current liabilities | |
$ | 528 | | |
$ | 475 | |
|
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v3.24.1.1.u2
Share-Based Compensation (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Stock Option Activity |
The
following table summarizes information concerning options outstanding and exercisable:
Schedule
of Stock Option Activity
| |
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 | |
| 220,640 | | |
| 4.07 | | |
| | | |
| | |
Outstanding at March 31, 2024 | |
| 4,197,929 | | |
| 4.61 | | |
| 7.6 | | |
| 1,332 | |
Options exercisable | |
| 2,382,713 | | |
| 4.67 | | |
| 7.08 | | |
| 1,069 | |
Options vested and expected to vest | |
| 4,098,511 | | |
| 4.65 | | |
| 7.6 | | |
| 1,278 | |
|
Schedule of Weighted Average Assumptions |
The
Company uses the Black-Scholes option pricing model to value its stock options. The weighted average assumptions for valuing options
granted during the three months ended March 31, 2024 and 2023 were as follows:
Schedule
of Weighted Average Assumptions
| |
Three months ended
March 31, | |
| |
2024 | | |
2023 | |
Risk-free interest rate | |
| 3.92 | % | |
| 4.10 | % |
Expected volatility | |
| 117.0 | % | |
| 126.6 | % |
Expected term (in years) | |
| 5.5 years | | |
| 5.7 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:
Schedule
of Share-based Compensation Expense
| |
Three months ended March 31, | |
| |
2024 | | |
2023 | |
| |
(in thousands) | |
Research and development | |
$ | 109 | | |
$ | 62 | |
General and administrative | |
| 451 | | |
| 1,778 | |
Total | |
$ | 560 | | |
$ | 1,840 | |
|
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v3.24.1.1.u2
Leases (Tables)
|
3 Months Ended |
Mar. 31, 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:
Schedule
of Operating Leases in Consolidated Balance Sheets
| |
Balance Sheet Classification | |
March 31, 2024 | | |
December 31, 2023 | |
| |
| |
(in thousands) | |
Assets: | |
| |
| | |
| |
Operating lease assets | |
Right-of-use asset, net | |
$ | 21 | | |
$ | 48 | |
Current Liabilities: | |
| |
| | | |
| | |
Operating lease liabilities | |
Operating lease liabilities | |
$ | 21 | | |
$ | 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:
Schedule
of Operating Lease Expense Categories in Consolidated Statements of Operations and Comprehensive Loss
| |
Three months ended March 31, | |
| |
2024 | | |
2023 | |
| |
(in thousands) | |
Research and development | |
$ | 16 | | |
$ | 19 | |
General and administrative | |
| 11 | | |
| 11 | |
Total | |
$ | 27 | | |
$ | 30 | |
|
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:
Schedule
of Weighted Average Lease Term and Discount Rates
| |
As of March 31, | |
| |
2024 | | |
2023 | |
Remaining lease term (in years) | |
| 0.26 | | |
| 1.24 | |
Discount rate | |
| 14.47 | % | |
| 14.76 | % |
|
Schedule of Minimum Lease Payments |
The
minimum lease payments for the next year are expected to be as follows:
Schedule
of Minimum Lease Payments
| |
As of | |
| |
March 31, 2024 | |
| |
| (in thousands) | |
2024 | |
$ | 22 | |
Total lease payments | |
| 22 | |
Less: imputed interest | |
| (1 | ) |
Present value of operating lease liabilities | |
$ | 21 | |
|
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v3.24.1.1.u2
Net Loss Per Share (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Earnings Per Share [Abstract] |
|
Schedule of Basic and Diluted Net Loss Per Share |
Schedule
of Basic and Diluted Net Loss Per Share
| |
2024 | | |
2023 | |
| |
Three months ended
March 31, | |
| |
2024 | | |
2023 | |
| |
(in thousands, except shares and per share data) | |
Net loss | |
$ | (2,030 | ) | |
$ | (2,890 | ) |
Preferred stock dividends | |
| — | | |
| (80 | ) |
Net loss attributable to common stockholders | |
$ | (2,030 | ) | |
$ | (2,970 | ) |
| |
| | | |
| | |
Basic and diluted weighted average common shares outstanding | |
| 13,947,324 | | |
| 12,206,036 | |
| |
| | | |
| | |
Basic and diluted net loss per share attributable to common stockholders | |
$ | (0.15 | ) | |
$ | (0.24 | ) |
|
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 three months ended March 31, 2024 and 2023 because including them would have had an anti-dilutive effect:
Schedule
of Anti-dilutive Securities Excluded from Computation of Earnings per Share
| |
Three months ended
March 31, | |
| |
2024 | | |
2023 | |
Options to purchase common stock | |
| 4,197,929 | | |
| 2,802,185 | |
Warrants to purchase common stock | |
| 1,113,622 | | |
| 1,113,622 | |
Total | |
| 5,311,551 | | |
| 3,915,807 | |
|
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v3.24.1.1.u2
Segments (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Segment Reporting [Abstract] |
|
Schedule of Reportable Segments |
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 three months ended March 31, 2024:
Schedule
of Reportable Segments
| |
Regenerative Biotech | | |
Longevity Products | | |
Total | |
2024 | |
| | | |
| | | |
| | |
Revenues | |
$ | — | | |
$ | 57 | | |
$ | 57 | |
Net loss | |
| (1,935 | ) | |
| (95 | ) | |
| (2,030 | ) |
Total assets | |
| 2,225 | | |
| 190 | | |
| 2,415 | |
|
X |
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- DefinitionCash includes currency on hand as well as demand deposits with banks or financial institutions. It also includes other kinds of accounts that have the general characteristics of demand deposits in that the customer may deposit additional funds at any time and effectively may withdraw funds at any time without prior notice or penalty. Cash equivalents, excluding items classified as marketable securities, include short-term, highly liquid Investments that are both readily convertible to known amounts of cash, and so near their maturity that they present minimal risk of changes in value because of changes in interest rates. Generally, only investments with original maturities of three months or less qualify under that definition. Original maturity means original maturity to the entity holding the investment. For example, both a three-month US Treasury bill and a three-year Treasury note purchased three months from maturity qualify as cash equivalents. However, a Treasury note purchased three years ago does not become a cash equivalent when its remaining maturity is three months. Short-term investments, exclusive of cash equivalents, generally consist of marketable securities intended to be sold within one year (or the normal operating cycle if longer) and may include trading securities, available-for-sale securities, or held-to-maturity securities (if maturing within one year), as applicable.
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Mar. 31, 2024 |
Computer Equipment and Software [Member] |
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Property, Plant and Equipment [Line Items] |
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Property, plant and equipment, useful life |
3 years
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5 years
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Capital Stock (Details Narrative) - USD ($)
|
Mar. 31, 2023 |
Jan. 18, 2023 |
Mar. 31, 2024 |
Dec. 31, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
Preferred stock, shares authorized |
|
|
2,000,000
|
2,000,000
|
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|
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$ 0.01
|
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|
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0
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0
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|
|
|
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|
|
|
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|
200
|
|
|
Accrued dividends |
|
$ 9,545
|
|
|
Common Stock [Member] |
|
|
|
|
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|
|
|
|
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|
31,933
|
|
|
Common Stock [Member] | Private Placement [Member] |
|
|
|
|
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|
|
|
|
Number of shares issued in transaction |
510,134
|
|
|
|
Amount of consideration received from the transaction |
$ 3,100,000
|
|
|
|
Price per share |
$ 6.00
|
|
|
|
Warrants to purchase common stock outstanding |
|
|
1,113,622
|
|
Weighted-average exercise price |
|
|
$ 4.69
|
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v3.24.1.1.u2
Schedule of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
12 Months Ended |
Mar. 31, 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 7 months 6 days
|
7 years 8 months 12 days
|
Aggregate intrinsic value, Outstanding |
$ 5,728
|
|
Granted |
220,640
|
|
Weighted-average exercise price, Granted |
$ 4.07
|
|
Outstanding, balance |
4,197,929
|
3,977,289
|
Weighted-average exercise price, Outstanding |
$ 4.61
|
$ 4.64
|
Aggregate intrinsic value, Outstanding |
$ 1,332
|
$ 5,728
|
Options exercisable |
2,382,713
|
|
Weighted-average exercise price, Options exercisable |
$ 4.67
|
|
Weighted-average contractual life, Options exercisable |
7 years 29 days
|
|
Aggregate intrinsic value, Options exercisable |
$ 1,069
|
|
Options vested and expected to vest |
4,098,511
|
|
Weighted-average exercise price, Options vested and expected to vest |
$ 4.65
|
|
Weighted-average contractual life, Options vested and expected to vest |
7 years 7 months 6 days
|
|
Aggregate intrinsic value, Options vested and expected to vest |
$ 1,278
|
|
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v3.24.1.1.u2
Schedule of Share-based Compensation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
Total share-based compensation |
$ 560
|
$ 1,840
|
Research and Development Expense [Member] |
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
Total share-based compensation |
109
|
62
|
Selling, General and Administrative Expenses [Member] |
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
Total share-based compensation |
$ 451
|
$ 1,778
|
X |
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v3.24.1.1.u2
Share-Based Compensation (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
|
|
Mar. 31, 2024 |
Mar. 28, 2024 |
Dec. 31, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Number of award outstanding |
4,197,929
|
|
3,977,289
|
Share-based compensation arrangement by share-based payment award, options, outstanding, intrinsic value |
$ 1,332
|
|
$ 5,728
|
Weighted average exercise price |
$ 4.61
|
|
$ 4.64
|
Performance Shares [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Number of award outstanding |
993,835
|
|
|
Unrecognized compensation expense |
$ 3,400
|
|
|
Share based compensation arrangement by share based payment award unrecognized compensation costs |
$ 40
|
|
|
HRGN Amended And Restate Equity Incentive Plan [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Share-based compensation arrangement by share-based payment award, number of shares authorized |
10 years
|
|
|
Share-based compensation arrangement by share-based payment award, number of shares authorized |
9,098,000
|
|
|
Number of shares available for issuance |
4,814,120
|
|
|
Unrecognized compensation expense |
$ 3,400
|
|
|
Share-based compensation arrangement by share-based payment award, options, outstanding, intrinsic value |
$ 1,300
|
|
|
Share price |
|
$ 3.00
|
|
Weighted average exercise price |
|
$ 4.61
|
|
Employee service share-based compensation, nonvested awards, compensation cost not yet recognized, period for recognition |
2 years
|
|
|
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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 |
$ 6,111
|
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 $5,000,000 or b) February 1, 2025
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Schedule of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Earnings Per Share [Abstract] |
|
|
Net loss |
$ (2,030)
|
$ (2,890)
|
Preferred stock dividends |
|
(80)
|
Net loss attributable to common stockholders |
$ (2,030)
|
$ (2,970)
|
Basic weighted average common shares outstanding |
13,947,324
|
12,206,036
|
Diluted weighted average common shares outstanding |
13,947,324
|
12,206,036
|
Basic net loss per share attributable to common stockholders |
$ (0.15)
|
$ (0.24)
|
Diluted net loss per share attributable to common stockholders |
$ (0.15)
|
$ (0.24)
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Schedule of Anti-dilutive Securities Excluded from Computation of Earnings per Share (Details) - shares
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount |
5,311,551
|
3,915,807
|
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 |
4,197,929
|
2,802,185
|
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
|
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