Item 7. Management’s Discussion and Analysis
ITEM
7.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion should be read in conjunction with our consolidated financial statements and the notes thereto included in Part
II, Item 8 of this report. The following discussion contains forward-looking statements. See “CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS ” in Part I of this report .
Forward-looking statements are not guarantees of future activities or results. Many factors could cause our actual activities or results
to differ materially from those anticipated in forward-looking statements, including those discussed in “Item 1A. Risk Factors”
of Part I of this report.
Overview
We
are a preclinical-stage synthetic allogeneic iMSC therapy company. Our vision is to improve the lives of patients with difficult-to-treat
diseases through innovative, effective, and safe, but accessible cellular therapies, and our mission is to develop allogenic off-the-shelf
cellular therapies, leveraging induced pluripotent stem cell (“iPSC”)-derived mesenchymal stem cells (“iMSCs”)
to target solid tumors and autoimmune diseases.
September
2024 Transactions
Exchange
Transactions
Pursuant
to exchange agreements we entered into on September 24, 2024 with the holders of certain of our warrants and convertible notes, on October
29, 2024, we issued an aggregate of 38.3 million shares of our common stock in exchange for: (i) warrants to purchase an aggregate of
approximately 4.4 million shares of our common stock that we issued in December 2022 with an exercise price of $1.43 per share; (ii)
$8.7 million in the aggregate principal amount of convertible notes that we issued in July 2023 and warrants to purchase an aggregate
of approximately 6.1 million shares of our common stock that we issued in July 2023 with an exercise price of $1.43 per share; (iii)
$9.2 million in the aggregate principal amount of convertible notes that we issued in December 2023 and warrants to purchase an aggregate
of approximately 9.6 million shares of our common stock that we issued in December 2023 with an exercise price of $1.43 per share (the
“exchange transactions”).
The
holders of the warrants described in the paragraph above exchanged all their warrants for shares of our common stock at an exchange ratio
of 0.5 of a share of common stock for every one share of common stock issuable upon exercise of the applicable warrant (rounded up to
the nearest whole number), and the holders of the convertible notes described in the paragraph above exchanged all their convertible
notes for shares of our common stock at an exchange ratio equal to (A) the sum expressed in U.S. dollars of (1) the principal amount
of the applicable convertible note, plus (2) all accrued and unpaid interest thereon through the date the applicable convertible note
is exchanged plus (3) all interest that would have accrued through, but not including, the maturity date of applicable convertible note
if it was outstanding from the date such convertible note is exchanged through its maturity date, divided by (B) $1.00 (rounded up to
the nearest whole number).
Conversion
of Bridge Notes
On
September 24, 2024, we closed a private placement in which we sold an aggregate principal amount of approximately $3.9 million of 12.0%
senior convertible notes (the “bridge notes”).
On
October 29, 2024, in accordance with the terms of the bridge notes, approximately $3.0 million of the principal amount of the bridge
notes plus all accrued and unpaid interest thereon, plus such amount of interest that would have accrued on the principal amount through
December 24, 2024, was automatically converted at a conversion price of $0.50 into 6.2 million shares of our common stock, and approximately
$0.9 million of the principal amount of the bridge notes plus all accrued and unpaid interest thereon, plus such amount of interest that
would have accrued on the principal amount through December 24, 2024, was automatically converted at a conversion price of $0.50 into
pre-funded warrants to purchase 1.8 million shares of our common stock.
33
Private
Placement
Pursuant
to a securities purchase agreement we entered into with certain investors on September 24, 2024, on October 29, 2024, we closed a private
placement (the “common stock private placement” and together with the bridge notes and the exchange transactions, the “September
2024 Transactions”) in which we sold an aggregate of 1.4 million shares of our common stock and pre-funded warrants to purchase
0.1 million shares of our common stock at a purchase price of $0.75 per share of common stock and $0.745 per pre-funded warrant. We received
approximately $1.1 million in gross proceeds from the issuance of such securities. For additional information regarding this private
placement, see Note 6 to the accompanying consolidated financial statements.
For
additional information regarding the September 2024 Transactions, see Note 6 to the accompanying consolidated financial statements.
In
total, the Company issued approximately 45.9 million shares of common stock and 1.9 million pre-funded warrants on October 29, 2024 pursuant
to the private placement, the exchange transactions and the conversion of the bridge notes discussed above and had 51.4 million shares
of common stock issued and outstanding after the closing of the September 2024 Transactions.
Termination
of Sublease
In
October 2022, we entered into a sublease for office and laboratory space in Somerville, Massachusetts. In connection with entering into
the sublease, we delivered a security deposit in the form of a letter of credit in the amount of $4.1 million. The letter of credit was
collateralized with $4.1 million of cash deposited in a restricted account.
On
August 5, 2024, the sublessor drew down on the letter of credit for the full $4.1 million to cover the approximately $4.0 million of
past due rent payments for February 2024 through August 2024, plus interest and penalties.
On
August 9, 2024, we and the sublessor entered into a sublease termination agreement pursuant to which the parties agreed to terminate
the sublease effective August 31, 2024. Pursuant to the sublease termination agreement, we agreed to surrender and vacate the premises,
all of our right, title and interest in all furniture, fixtures and laboratory equipment at the premises will become the property of
the sublessor, and both parties will be released of their obligations under the sublease. As a result of the sublease termination, we
recognized a gain on lease termination of approximately $1.6 million for the year ended December 31, 2024, and we expect to save approximately
$72 million in base rental payments, parking, operating expenses, taxes and utilities that we would have paid over the remaining lease
term.
Basis
of Presentation
Revenue
In
February 2023, we entered into an exclusive option and license agreement (the “Lineage Agreement”) with Lineage Cell Therapeutics,
Inc. (“Lineage”), under which we granted Lineage an option to obtain an exclusive sublicense to certain of our technology
for preclinical, clinical and commercial purposes in exchange for a non-refundable up-front payment to us of $0.3 million. In August
2023, Lineage requested that we begin developing certain induced pluripotent stem cell lines in exchange for a cell line customization
fee. Lineage paid us $0.4 million towards the customization fee, which we were recognizing ratably over the customization period.
On
September 24, 2024, we entered into an agreement with Factor Bioscience whereby we assigned the Lineage Agreement to Factor Bioscience
(the “Lineage Assignment Agreement”). The Lineage Assignment Agreement with Factor Bioscience. assigns all our rights and
obligations under that the Lineage Agreement to Factor Bioscience. Payments to us related to the Lineage Agreement will now be subject
to the Lineage Assignment Agreement, which provides for Factor Bioscience paying us thirty percent (30%) of all amounts it receives from
Lineage in the event that Lineage obtains a sublicense from Factor Bioscience. Upon receipt of future payments for the customization
activities set forth in the Lineage Agreement, Factor Bioscience will pay us twenty percent (20%) of all amounts Factor Bioscience receives
from Lineage. Because we have no further obligations under the agreement with Lineage, we have fully recognized as revenue amounts previously
recorded in deferred revenue of approximately $0.5 million for the year ended December 31, 2024. For additional information, see Note
5 to the accompanying consolidated financial statements. We have no other revenue generating contracts at this time.
34
Cost
of Revenues
We
recognize direct labor and supplies associated with generating our revenue as cost of revenues. As provided for in the A&R Factor
License Agreement discussed in Note 11 to the accompanying consolidated financial statements, we were obligated to pay Factor Limited
20% of any amounts we receive from a customer that was related to the licensed technology under the A&R Factor License Agreement,
which we also recognize as a cost of revenue.
Research
and Development Expenses
We
expense our research and development costs as incurred. Research and development expenses consist of costs incurred for company-sponsored
research and development activities. Upfront payments and milestone payments made for the licensing of technology are expensed as research
and development in the period in which they are incurred if the technology is not expected to have any alternative future uses other
than the specific research and development project for which it was intended.
The
major components of research and development costs include salaries and employee benefits, stock-based compensation expense, supplies
and materials, preclinical study costs, expensed licensed technology, consulting, scientific advisors and other third-party costs, as
well as allocations of various overhead costs related to our product development efforts.
We
have contracted with third parties to perform various studies. The financial terms of these agreements vary from contract to contract
and may result in uneven payment flows. We accrue for third party expenses based on estimates of the services received and efforts expended
during the reporting period. If the actual timing of the performance of the services or the level of effort varies from the estimate,
the accrual is adjusted accordingly. The expenses for some third-party services may be recognized on a straight-line basis if the expected
costs are expected to be incurred ratably during the period. Payments under the contracts depend on factors such as the achievement of
certain events or milestones, the allocation of responsibilities among the parties to the agreement, and the completion of portions of
the preclinical study or similar conditions.
General
and Administrative Expenses
Our
general and administrative expenses consist primarily of salaries, benefits and other costs, including equity-based compensation, for
our executive and administrative personnel, legal and other professional fees, travel, insurance, and other corporate costs.
35
Comparison
of the Years Ended December 31, 2024 and 2023
Year
ended December 31,
(in thousands)
2024
2023
Change
Revenue
$ 582
$ 68
$ 514
Cost of revenues
96
236
(140 )
Gross income (loss)
486
(168 )
654
Operating expenses:
Research and development
4,604
5,920
(1,316 )
General and administrative
13,132
14,587
(1,455 )
Gain on lease termination
(1,576 )
-
(1,576 )
Acquisition of Exacis
IPR&D
-
460
(460 )
Total operating expenses
16,160
20,967
(4,807 )
Loss from operations
(15,674 )
(21,135 )
5,461
Other (expense) income, net:
Loss on extinguishment of debt
(22,440 )
-
(22,440 )
Change in fair value of convertible notes
1,017
-
1,017
Change in fair value of bridge notes derivative
liability
(1,459 )
-
(1,459 )
Change in fair value of warrant liabilities
414
215
199
Change in fair value of contingent consideration
66
118
(52 )
Loss on non-controlling investment
-
(59 )
59
Interest income
249
138
111
Interest expense
(6,752 )
(614 )
(6,138 )
Other income (expense),
net
70
(334 )
404
Total
other expense, net
(28,835 )
(536 )
(28,299 )
Loss before income taxes
(44,509 )
(21,671 )
(22,838 )
(Provision) benefit for income taxes
(30 )
3
(33 )
Net loss
$ (44,539 )
$ (21,668 )
$ (22,871 )
Revenue
During
the years ended December 31, 2024 and 2023, we recognized revenue related to the cell line customization activities we performed for
Lineage. The increase in revenue is due to accelerating the recognition of approximately $0.5 million of deferred revenue related to
nonrefundable payments we received from Lineage due to the Lineage Assignment Agreement we entered into on September 24, 2024 with Factor
Bioscience discussed earlier. As of December 31, 2024, we did not have any deferred revenue balances on our consolidated balance sheet.
Cost
of Revenue
During
the years ended December 31, 2024 and 2023, our cost of revenues included direct labor and materials to perform the customization cell
line activities for Lineage. The decrease in cost of revenue was primarily related to a 20% license fee paid to Factor Bioscience during
the year ended December 31, 2023 related to the Lineage Agreement, which was not repeated in 2024.
Research
and Development Expenses
Years
ended December 31,
2024
2023
Change
(in
thousands)
Professional fees
$ 759
$ 1,181
$ (422 )
MSA/license expense
3,017
3,250
(233 )
Payroll-related
502
701
(199 )
Stock-based compensation
89
234
(145 )
Allocated occupancy expense
192
186
6
Other expenses, net
45
368
(323 )
Total
research and development expenses
$ 4,604
$ 5,920
$ (1,316 )
36
Total
research and development expenses decreased by approximately $1.3 million for the year ended December 31, 2024 compared to the year ended
December 31, 2023, primarily due to decreased professional fees due to a reduction in consultant services, MSA/license fees as a result
of the new Factor L&C Agreement, payroll-related expenses and stock-based compensation from a reduction in headcount, and other expenses
incurred during 2023 related to closing down a clinical trial we ended in 2022.
General
and Administrative Expenses
Years
ended December 31,
2024
2023
Change
(in
thousands)
Professional fees
$ 4,168
$ 6,464
$ (2,296 )
Insurance
497
1,140
(643 )
Payroll-related
1,607
2,045
(438 )
Stock-based compensation
1,431
1,008
423
Occupancy expense
5,074
3,306
1,768
Other expenses, net
355
624
(269 )
Total
general and administrative expenses
$ 13,132
$ 14,587
$ (1,455 )
Our
general and administrative expenses decreased by approximately $1.5 million for the year ended December 31, 2024 compared to the year
ended December 31, 2023 primarily due to decreases in professional fees related to legal services and consultants, insurance expense
due to lower premiums and payroll-related expenses resulting from less severance expense during the year ended December 31, 2024 compared
to the year ended December 31, 2023. These decreases were offset by increased occupancy expense related to our Somerville sublease that
we began to incur expense for in July 2023 and was terminated effective August 31, 2024, as well as increased stock-based compensation
due to stock option awards granted to the chief executive officer during the year ended December 31, 2024.
Gain
on Lease Termination
On
August 9, 2024, we and the sublessor of our Somerville sublease entered into a sublease termination agreement effective August 31, 2024.
Pursuant to the sublease termination agreement, we agreed to surrender and vacate the premises, all of our right, title and interest
in all furniture, fixtures and laboratory equipment at the premises will become the property of the sublessor, and both parties will
be released of their obligations under the sublease. As a result of the sublease termination, we recognized a gain on lease termination
of approximately $1.6 million for the year ended December 31, 2024. There was no similar transaction during the year ended December 31,
2023.
Acquisition
of Exacis In-Process Research and Development
In
April 2023, we acquired from Exacis substantially all of its intellectual property assets, including all of its right, title and interest
in an exclusive license agreement between Exacis and Factor Limited (the “Purchased License”). The Purchased License was
determined to be an in-process research and development (“IPR&D”) asset that has no alternative future use and no separate
economic value from its original intended purpose, which is therefore expensed in the period the cost is incurred. As a result, we expensed
the fair value of the Purchased License of approximately $0.5 million during the year ended December 31, 2023. For additional information,
see Note 4 to the accompanying financial statements included in this report. There was no similar transaction during the year ended December
31, 2024.
Loss
on Extinguishment of Debt
We
recognized a $22.4 million loss on extinguishment of debt for the year ended December 31, 2024 related to the exchange transaction and
common stock private placement entered into on September 24, 2024. There was no similar transaction during the year ended December 31,
2023. See Note 6 to the accompanying consolidated financial statements for more information on the exchange transaction and common stock
private placement.
Change
in Fair Value of Convertible Notes
Because
the modification of our convertible notes was accounted for as an extinguishment of debt and marked to fair value as of September
24, 2024 upon modification, we recognized income of approximately $1.0 million during the year ended December 31, 2024 related to
the change in fair value of the convertible notes. This was due to such convertible notes being marked to fair value as of October 29, 2024
when such convertible notes were converted to shares of common stock. There was no similar transaction during the year ended
December 31, 2023.
37
Change
in Fair Value of Bridge Notes Derivative Liability
We
recognized expense of $1.6 million related to the initial measurement at September 24, 2024 of the incremental fair value of the bridge
notes derivative liability over the carrying value due to bifurcation of the conversion feature (recognized as a derivative liability)
from the bridge notes. This was offset by $0.1 million in income recognized for the change in fair value of the bridge notes derivative
liability due to remeasuring the liability during the year ended December 31, 2024. There was no similar transaction during the year
ended December 31, 2023. See Note 6 to the accompanying consolidated financial statements for more information on the bridge notes.
Change
in Fair Value of Warrant Liabilities
We
recognized income of $0.4 million and $0.2 million for the years ended December 31, 2024 and 2023, respectively, for the change in the
fair value of our warrant liabilities. The change in fair value of warrant liabilities for the year ended December 31, 2024 includes
certain warrants that were reclassified to a liability in September 2024 and then exchanged for shares of common stock in October 2024
as part of the September 2024 Transactions described above. See Note 6 to the accompanying consolidated financial statements for more
information on the exchanged warrants.
Change
in Fair Value of Contingent Consideration
On
the closing date of the acquisition of assets from Exacis in April 2023, we recognized a contingent consideration liability of $0.2 million
for future payments that may be payable to Exacis, which was included as part of the $0.5 million fair value of the Purchased License
asset and expensed as IPR&D during the year ended December 31, 2023. This contingent consideration liability is remeasured at each
period end, and any change in the fair value of the contingent liability is recognized in the statement of operations. As of December
31, 2024 and 2023, we remeasured the contingent liability and recognized income of $0.1 million for each of the years ended December
31, 2024 and 2023 due to the decrease in the fair value of the contingent consideration liability.
Loss
on Non-Controlling Investment
We
account for our 25% non-controlling investment in NoveCite, Inc. (“NoveCite”) under the equity method. We have not guaranteed
any obligations of NoveCite, nor are we otherwise committed to providing further financial support for NoveCite. Therefore, we only record
25% of NoveCite’s losses up to our investment carrying amount. As a result, we did not recognize additional losses related to NoveCite
for the year ended December 31, 2024. We recognized a loss of approximately $0.1 million for the year ended December 31, 2023.
Interest
Income
We
recognized an increase in interest income for the year ended December 31, 2024 compared to the year ended December 31, 2023 due to having
our cash into interest bearing accounts for the full year of 2024 compared to 2023.
Interest
Expense
We
recognized an increase in interest expense for the year ended December 31, 2024 of approximately $6.1 million compared to the year ended
December 31, 2023 primarily due to interest expense and amortization of debt issuance costs associated with the 2023 convertible note
financings and the 2024 bridge notes.
Other
Income (Expense), Net
Years
ended December 31,
2024
2023
Change
(in
thousands)
SEPA fees
$ -
$ (280 )
$ 280
Other income (expense),
net
70
(54 )
124
Total
expense, net
$ 70
$ (334 )
$ 404
For
the year ended December 31, 2024, we recognized other income related to amounts earned from Factor Bioscience under the Lineage Assignment
Agreement entered into in September 2024. For the year ended December 31, 2023, we recognized (a) commitment fees and other fees related
to the SEPA we entered into with Lincoln Park in April 2023 and (b) other miscellaneous expense.
38
Provision
for Income Taxes
During
2024, we expect to incur state income tax liabilities related to our operations. We have established a full valuation allowance for all
deferred tax assets, including our net operating loss carryforwards, since we could not conclude that we were more likely than not able
to generate future taxable income to realize these assets. The effective tax rate differs from the statutory tax rate due primarily to
our full valuation allowance.
Liquidity
and Capital Resources
As
of December 31, 2024, we had cash of approximately $1.7 million, and we had an accumulated deficit of approximately $231.5 million. We
have to date incurred operating losses, and we expect these losses to continue in the future. For the year ended December 31, 2024, we
incurred a net loss of $44.5 million, and we used $15.8 million of cash in operating activities.
On March 11, 2025,
we received $1.5 million in exchange for the issuance of a promissory note with an aggregate principal amount of $1.5 million to an investor.
The promissory note matures on the earlier of (i) June 15, 2025 or (ii) upon us receiving greater than $5 million in aggregate proceeds
from a subsequent capital raise. Interest accrues at a rate of 5.0% per annum, payable at maturity.
On
October 29, 2024, we also received approximately $1.1 million upon the closing of the common stock private placement. Other than the
proceeds raised under the bridge notes and the common stock private placement, our sole source of liquidity is through sales of our common
stock under the SEPA, pursuant to which Lincoln Park committed to purchase up to $10.0 million of our common stock. Such sales of common
stock by us, if any, are subject to certain conditions and limitations set forth in the SEPA, including a condition that we may not direct
Lincoln Park to purchase any shares of common stock under the SEPA if such purchase would result in Lincoln Park beneficially owning
more than 4.99% of our issued and outstanding shares of common stock. Sales under the SEPA may occur from time to time, at our sole discretion,
through April 2025. To date, we have issued and sold approximately 214,000 shares of our common stock to Lincoln Park, including approximately
74,000 commitment shares, and have received approximately $0.3 million in gross proceeds from such sales. We sold no shares under the
SEPA during the year ended December 31, 2024.
Based
on our current financial condition and forecasts of available cash, we will not have sufficient capital to fund our operations for the
12 months following the issuance date of the accompanying consolidated financial statements. We can provide no assurance that we will
be able to obtain additional capital when needed, on favorable terms, or at all. If we cannot raise capital when needed, on favorable
terms or at all, we will need to reevaluate our planned operations and may need to reduce expenses, file for bankruptcy, reorganize,
merge with another entity, or cease operations. If we become unable to continue as a going concern, we may have to liquidate our assets,
and might realize significantly less than the values at which they are carried on our financial statements, and stockholders may lose
all or part of their investment in our common stock. See the risk factor in Item 1A of Part II of this report titled, “We will
require substantial additional capital to fund our operations, and if we fail to obtain the necessary financing, we may not be able to
pursue our business strategy.”
Historically,
the cash used to fund our operations has come from a variety of sources and predominantly from sales of shares of our common stock and
convertible notes. We will continue to evaluate and plan to raise additional funds to support our working capital needs through public
or private equity offerings, debt financings, strategic partnerships, out-licensing our intellectual property or other means. There can
be no assurance that capital will be available when needed or that, if available, it will be obtained on terms favorable to us and our
stockholders. Our ability to raise capital through sales of our common stock will depend on a variety of factors including, among others,
market conditions, the trading price and volume of our common stock, and investor sentiment. In addition, macroeconomic factors and volatility
in the financial market, which may be exacerbated in the short term by concerns over inflation, interest rates, impacts of the wars in
Ukraine and the Middle East, strained relations between the U.S. and several other countries, and social and political discord and unrest
in the U.S., among other things, may make equity or debt financings more difficult, more costly or more dilutive to our stockholders.
In
addition, equity or debt financings may have a dilutive effect on the holdings of our existing stockholders, and debt financings may
subject us to restrictive covenants, operational restrictions and security interests in our assets. If we raise capital through collaborative
arrangements, we may be required to relinquish some rights to our technologies or grant sublicenses on terms that are not favorable to
us.
We
prepared the accompanying condensed consolidated financial statements on a going concern basis, which assumes that we will realize our
assets and satisfy our liabilities in the normal course of business. As discussed above, there is substantial doubt about our ability
to continue as a going concern because we do not have sufficient cash to satisfy our working capital needs and other liquidity requirements
over at least the next 12 months from the date of issuance of the accompanying condensed consolidated financial statements. The accompanying
condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability
and reclassification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty
of our ability to remain a going concern.
39
In
addition, while we are not presently pursuing product development, we may do so in the future. Developing product candidates, conducting
clinical trials and commercializing products requires substantial capital, and we would need to raise substantial additional funds if
we were to pursue the development of one or more product candidates.
Cash
Flows
Cash
flows from operating, investing and financing activities, as reflected in the accompanying condensed consolidated statements of cash
flows, are summarized as follows:
For
the years ended
December 31,
(in
thousands)
2024
2023
Change
Cash (used in) provided by:
Operating activities
$ (15,836 )
$ (20,408 )
$ 4,572
Investing activities
(365 )
(19 )
(346 )
Financing
activities
6,260
16,556
(10,296 )
Net decrease in cash
and cash equivalents
$ (9,941 )
$ (3,871 )
$ (6,070 )
Net
Cash Used in Operating Activities
There
was a decrease of approximately $4.6 million in cash used in operating activities for the year ended December 31, 2024 compared to the
year ended December 31, 2023. This change was due a $4.5 million decrease in net loss, after giving effect to adjustments made for non-cash
transactions, primarily due to an increase in recognition of revenue as well as a reduction in professional and consulting expenses,
offset by a slight increase of $0.1 million in cash used in operating assets and liabilities for the year ended December 31, 2024 compared
to the year ended December 31, 2023.
Net
Cash Used in Investing Activities
We
used approximately $0.4 million to pay for the purchases of property and equipment during the year ended December 31, 2024. There was
an immaterial amount of investing activities during the year ended December 31, 2023.
Net
Cash Provided by Financing Activities
Net
cash provided by financing activities for the year ended December 31, 2024 includes approximately $6.4 million of gross proceeds received
from the convertible note financing, the bridge note financing and the common stock private placement that occurred in January 2024,
September 2024 and October 2024, respectively. Net cash provided by financing activities for the year ended December 31, 2023 includes
approximately $16.5 million of gross proceeds from convertible note financings and $0.3 million of proceeds received from selling approximately
214,000 shares to Lincoln Park under the SEPA. The Company did not sell any shares under the SEPA during the year ended December 31,
2024.
Off-Balance
Sheet Arrangements
We
did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under applicable
SEC rules.
40
Critical
Accounting Estimates
Our
discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which
have been prepared in accordance with U.S. GAAP. The preparation of these consolidated financial statements requires us to make judgments,
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 consolidated financial statements, as well as the reported expenses during the reporting periods. We continually evaluate
our judgments, estimates and assumptions. We base our estimates on the terms of underlying agreements, our expected course of development,
historical experience and other factors we believe are reasonable based on the circumstances, the results of which form our management’s
basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual
results may differ from these estimates. We believe the following critical accounting estimates affect our more significant judgments
and estimates used in the preparation of our consolidated financial statements.
Goodwill
Impairment
Goodwill
represents the excess of the purchase price over the fair value of identifiable assets acquired and the liabilities assumed. Goodwill
is not amortized but is tested for impairment annually or more frequently if events occur or circumstances indicate it is more likely
than not that the fair value of a reporting unit is less than its carrying value. Events that would indicate impairment and trigger an
interim impairment assessment include, but are not limited to, macroeconomic conditions, industry and market considerations, cost factors,
overall financial performance and other relevant events. Management evaluates our company as a single reporting unit, therefore, our
goodwill is tested for impairment at the entity level. Goodwill is tested for impairment as of December 31 st of each year,
or more frequently as warranted by events or changes in circumstances mentioned above. Accounting guidance also permits an optional qualitative
assessment for goodwill to determine whether it is more likely than not that the carrying value of a reporting unit exceeds its fair
value. If, after this qualitative assessment, we determine that it is not more likely than not that the fair value of a reporting unit
is less than its carrying amount, then no further quantitative testing would be necessary. A quantitative assessment is performed if
the qualitative assessment results in a more likely than not determination or if a qualitative assessment is not performed. The quantitative
assessment considers whether the carrying amount of a reporting unit exceeds its fair value, in which case an impairment charge is recorded
to the extent the reporting unit’s carrying value exceeds its fair value.
Recent
Accounting Pronouncements
Recently
Adopted Accounting Standards
In
June 2022, the Financial Accounting Standard Board (the “FASB”) issued Accounting
Standards Update (“ASU”) No. 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities
Subject to Contractual Sale Restrictions (“ASU 2022-03”). The FASB issued ASU 2022-03 to (1) clarify the guidance
in Topic 820, Fair Value Measurement, when measuring the fair value of an equity security subject to contractual restrictions that prohibit
the sale of an equity security, (2) to amend a related illustrative example, and (3) to introduce new disclosure requirements for equity
related securities subject to contractual sale restrictions that are measured at fair value in accordance with Topic 820. ASU 2022-03
clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity
security and, therefore, is not considered in measuring fair value. The guidance was effective for fiscal years beginning after December
15, 2023, and interim periods within those fiscal years with early adoption permitted. The adoption of this ASU did not have a material
impact to our consolidated financial statements.
In
November 2023, the FASB issued ASU No. 2023-07, Segment Reporting – Improvements to Reportable Segment Disclosures , which
provides updates to qualitative and quantitative reportable segment disclosure requirements, including enhanced disclosures about significant
segment expenses and increased interim disclosure requirements, among others. ASU No. 2023-07 was effective for fiscal years beginning
after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024. Early adoption was permitted, and the
amendments should be applied retrospectively. The adoption of this ASU did not have an impact to our consolidated financial statements,
but did result in additional disclosures made in the notes to the consolidated financial statements.
41
Recently
Issued Accounting Standards to be Adopted
In
October 2023, the FASB issued ASU No. 2023-06, Disclosure Improvements – Codification Amendment in Response to the SEC’s
Disclosure Update and Simplification Initiative. This ASU modified the disclosure and presentation requirements of a variety of codification
topics by aligning them with the SEC’s regulations. The amendments to the various topics should be applied prospectively, and the
effective date will be determined for each individual disclosure based on the effective date of the SEC’s removal of the related
disclosure. If the SEC has not removed the applicable requirements from Regulation S-X or Regulation S-K by June 30, 2027, then this
ASU will not become effective. Early adoption is prohibited. The Company does not expect the amendments in this ASU to have a material
impact on its consolidated financial statements.
In
December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures , which requires disclosure of disaggregated
income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income
tax-related disclosures. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a
prospective basis, with a retrospective option. Early adoption is permitted. We do not expect the adoption of this ASU to have a material
impact on our consolidated financial statements.
In
November 2024, the FASB issued ASU No. 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation
Disclosures (Subtopic 220-40). This ASU is intended to improve disclosures about a public business entity’s expenses by requiring
disaggregated disclosure, in the notes to the financial statements, of prescribed categories of expenses within relevant income statement
captions. ASU No. 2024-03 is effective for fiscal years beginning after December 15, 2026 and interim periods within fiscal years beginning
after December 15, 2027 (as clarified in ASU No. 2025-01, Income Statement – Reporting Comprehensive Income – Expense
Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date) . Early adoption is permitted. The new standard may be
applied either on a prospective or retrospective basis. We do not expect the adoption of this ASU to have a material impact on our consolidated
financial statements.
In
November 2024, the FASB issued ASU No. 2024-04, Debt – Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions
of Convertible Debt Instruments. This ASU clarifies the requirements for determining whether certain settlements of convertible debt
instruments should be accounted for as an induced conversion. ASU No. 2024-04 is effective for annual reporting periods beginning
after December 15, 2025 and interim reporting periods within those annual reporting periods. Early adoption is permitted, and the amendments
may be applied on either a prospective or retrospective basis. We do not expect the amendments in this ASU to have a material impact
on our consolidated financial statements.
ITEM
7A. Quantitative
and Qualitative Disclosures about Market Risk
Under
SEC rules and regulations, as a smaller reporting company we are not required to provide the information otherwise required by this item.
ITEM
8. Financial
Statements and Supplementary Data
See
“Index to Consolidated Financial Statements” on page F-1 for the consolidated financial statements filed with this report.
ITEM
9. Changes
in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
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