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.
32
Overview
We
are a preclinical-stage synthetic allogeneic iMSC therapy company. iMSCs are induced pluripotent stem cell-derived mesenchymal stem cells.
We envision a future where cell therapies powered by synthetic iMSCs can offer new options for patients with limited treatment paths,
and our mission is to transform the treatment of cancer and autoimmune disease by developing scalable, affordable, off-the-shelf cell
therapies that restore hope.
2026
Public Offering
On
February 6, 2026, we entered into a placement agency agreement (the “Placement Agency Agreement”) with Brookline Capital
Markets, a division of Arcadia Securities, LLC (the “Placement Agent”), pursuant to which we engaged the Placement Agent
for the public offering of (i) 19.0 million shares (the “Shares”) of our common stock and accompanying warrants to purchase 19.0 million shares of common stock (the “Milestone Warrants”), at a
combined offering price of $0.50 per share of common stock and accompanying Milestone Warrant and (ii) pre-funded warrants (the “Pre-Funded
Warrants”) to purchase 2.0 million shares of common stock and accompanying Milestone Warrants to purchase 2.0 million shares of
common stock, at a combined offering price of $0.49 per Pre-Funded Warrant and accompanying Milestone Warrant ( the “2026 Offering”).
In connection with the 2026 Offering, we also entered into a securities purchase agreement (each, a “Purchase Agreement”)
with certain investors who purchased Shares, Pre-Funded Warrants and Milestone Warrants in the 2026 Offering.
The
Pre-Funded Warrants are immediately exercisable subject to certain ownership limitations, have an exercise price of $0.01 per share,
and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. On February 11, 2026 and February 18, 2026, the holder of the Pre-Funded Warrants exercised 1.3 million and 0.7 million Pre-Funded Warrants,
respectively, for an aggregate exercise price of approximately $20,000. There are no remaining Pre-Funded Warrants related to the 2026
Offering outstanding.
On
February 6, 2026, the Milestone Warrants commenced trading on The Nasdaq Capital Market under the symbol “ERNAW.” The Milestone
Warrants are immediately exercisable subject to certain ownership limitations, have an exercise price of $0.68 per share, and expire
on the earlier of (i) the five (5)-year anniversary of the original issuance date or (ii) the 180 th calendar day following
the public release by us of clinical trial data from the first cohort of the Phase 1 study of ERNA-101.
Pursuant
to the Placement Agency Agreement, we paid the Placement Agent an aggregate cash fee of approximately $0.5 million, which was equal to
6.5% of the aggregate purchase price paid by investors in the Offering (or 1.5% with respect to certain existing investors). We will
also pay the Placement Agent a cash fee as compensation for gross proceeds we receive from any exercise of any Milestone Warrants sold
in connection with the 2026 Offering, payable quarterly on each January 1, April 1, July 1 and October 1 following the closing of the
2026 Offering (or the following business day if such day is not a business day), at the same percentage and as calculated in the manner
as set forth above. We also issued approximately 0.2 million shares of common stock to the Placement Agent, which was equal to 1.5% of
the aggregate number of Shares and Pre-Funded Warrants sold in the Offering (or 0.5% with respect to sales to certain existing investors).
In addition, we reimbursed the Placement Agent for its accountable offering-related legal expenses in an amount of $125,000.
The
2026 Offering closed on February 10, 2026, for aggregate gross proceeds of approximately $10.5 million before deducting Placement Agent
fees and other offering expenses payable by us. We intend to use the net proceeds from the 2026 Offering to support the advancement of
our development programs, working capital and general corporate purposes.
The
Placement Agency Agreement and the Purchase Agreements contain customary representations, warranties and agreements by us, customary
conditions to closing, indemnification obligations of us, the Placement Agent, or the investors, as the case may be, and other obligations
of the parties.
Pursuant
to the terms of the Purchase Agreements and the Placement Agency Agreement, we have agreed that for a period of ninety (90) days from
the closing of the 2026 Offering, that neither we nor any subsidiary may (i) issue, enter into any agreement to issue or announce the
issuance or proposed issuance of any shares of common stock or common stock equivalents or (ii) file any registration statement or prospectus,
or any amendment or supplement thereto, in each case, subject to certain exceptions. We have also agreed not to effect or enter into
an agreement to effect any issuance of common stock or common stock equivalents involving a Variable Rate Transaction, as defined in
the Purchase Agreements, for a period of ninety (90) days following the closing of the 2026 Offering, subject to certain exceptions,
unless waived by the Placement Agent. In addition, as part of the Purchase Agreement, subject to certain exceptions, our officers and
directors entered into lock-up agreements, pursuant to which they agreed not to sell or otherwise dispose of any of the common stock
for a period of ninety (90) days following the date of closing of the 2026 Offering.
33
On
February 10, 2026, we also entered into a Warrant Agent Agreement with the transfer agent
pursuant to which the transfer agent agreed to act as warrant agent with respect to the Milestone Warrants.
Amendments
to Restated Articles of Incorporation, as Amended
Effective
June 2, 2025, we filed a certificate of amendment to our Restated Certificate of Incorporation, as amended (the “Amended COI”),
with the Secretary of State of Delaware to increase the authorized shares of our common stock from 100 million to 150 million (the “Authorized
Shares Amendment”).
Also
effective June 2, 2025, we filed a certificate of amendment to our Amended COI with the Secretary of State of Delaware to allow for action
required or permitted to be taken by our stockholders to be effected by written consent of such stockholders in addition to duly called
annual or special meetings of such stockholders (“the Written Consent Amendment”)
On
June 10, 2025, we filed a certificate of amendment to our Amended COI with the Secretary of State of Delaware to effect a reverse stock
split of our common stock at a ratio of 1-for-15 effective at 12:01 a.m. (the “Reverse Stock Split”). Upon the effectiveness
of the Reverse Stock Split, every fifteen shares of the issued and outstanding common stock were automatically combined and reclassified
into one issued and outstanding share of common stock. The Reverse Stock Split did not alter the par value of the common stock, and the
number of authorized shares of common stock remains unchanged at 150 million. No fractional shares were issued in connection with the
Reverse Stock Split, and no cash or other consideration was paid in connection with any fractional shares. Stockholders who otherwise
would have held a fractional share after giving effect to the Reverse Stock Split instead owned one whole share of the post-reverse stock
split common stock. We issued an aggregate of 153 shares for rounding up fractional shares to whole shares.
All
share and per share data in this Annual Report have been adjusted for all periods presented to reflect the Reverse Stock Split.
The
Authorized Shares Amendment, Written Consent Amendment, and Reverse Stock Split Amendment were approved by our stockholders at our 2025
Annual Meeting of Stockholders on June 2, 2025 (the “Annual Meeting”).
2025
Private Placement of Equity
On
March 31, 2025, we entered into a securities purchase agreement (the “SPA”) with certain accredited investors and a related
registration rights agreement. Pursuant to the SPA, we agreed to issue and sell to the investors, and the investors agreed to purchase,
in a private placement, an aggregate of approximately 4,621,000 shares of common stock at a purchase price of $1.569 per share (or pre-funded
warrants in lieu of common stock at a purchase price of $1.494 per pre-funded warrant). The pre-funded warrants will be exercisable until
exercised in full at a nominal exercise of $0.075 per share and may not be exercised to the extent such exercise would cause the holder
to beneficially own more than 4.99% or 9.99%, as applicable, of our outstanding common stock.
Upon
the initial closing of the SPA on April 2, 2025 (the “First Closing”), we sold to the investors an aggregate of approximately
662,000 shares of common stock and 34,000 pre-funded warrants (such shares, including the shares underlying the pre-funded warrants,
equal to 19.99% of our outstanding shares as of March 31, 2025). Following shareholder approval at the Annual Meeting, on June 9, 2025,
we sold to the investors an aggregate of approximately 3,182,000 shares of common stock and 622,000 pre-funded warrants, and on June
27, 2025, we sold the remaining approximately 121,000 shares of common stock (the June 9, 2025 and June 27, 2025 issuances collectively
referred to as the “Second Closing”). The Company raised approximately $7.2 million in gross proceeds under the SPA.
34
Basis
of Presentation
Revenue
Revenue
is related to an exclusive option and license agreement we had with a customer, under which we granted the customer 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. We also began developing certain induced pluripotent stem cell lines in exchange for a cell line
customization fee. The customer paid us $0.4 million towards the customization fee, which we were recognizing ratably over the customization
period for the year ended December 31, 2024. The Company did not recognize any revenue during the year ended December 31, 2025.
In
September 2024, we entered into an agreement with Factor Limited (and together with Factor Bioscience Inc. and its other affiliates,
“Factor Bioscience”) whereby we assigned the customer contract to Factor Bioscience (the “Assignment Agreement”).
The Assignment Agreement with Factor Bioscience assigned all our rights and obligations under the customer contract to Factor Bioscience.
Payments to us related to the customer contract will now be subject to the Assignment Agreement, which provides for Factor Bioscience
paying us thirty percent (30%) of all amounts it receives from the customer in the event that the customer obtains a sublicense from
Factor Bioscience. Upon receipt of future payments for the customization activities set forth in the customer contract, Factor Bioscience
will pay us twenty percent (20%) of all amounts Factor Bioscience receives from the customer. For the year ended December 31, 2025, we
received approximately $0.5 million from Factor Bioscience under the Assignment Agreement, which is recognized as other income in the
consolidated statements of operations, as this income did not qualify as revenue.
Because
we have no further obligations under the agreement with the customer, there is no revenue recognized for the year ended December 31,
2025. For additional information, see Note 4 to the accompanying consolidated financial statements. We have no other revenue generating
contracts at this time.
Cost
of Revenues
We
recognize direct labor and supplies associated with generating our revenue as cost of revenues. We were also obligated to pay Factor
Bioscience 20% of any amounts we received from the customer contract discussed above under a previous license agreement we had
with Factor Bioscience, which has since been terminated, and such costs were also recognized as cost of revenues.
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 services. 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.
35
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.
Comparison
of the Years Ended December 31, 2025 and 2024
Year
ended December 31,
(In thousands)
2025
2024
Change
Revenue
$ -
$ 582
$ (582 )
Cost of revenues
-
96
(96 )
Gross
profit
-
486
(486 )
Operating expenses:
Research and development
4,156
4,604
(448 )
General and administrative
5,163
13,132
(7,969 )
Gain on lease termination
-
(1,576 )
1,576
Total operating expenses
9,319
16,160
(6,841 )
Loss from operations
(9,319 )
(15,674 )
6,355
Other expense, net:
Forward sales contract expense
(5,847 )
-
(5,847 )
Gain (loss) on extinguishment of debt
765
(22,440 )
23,205
Change in fair value of convertible notes
-
1,017
(1,017 )
Change in fair value to bridge notes derivative
liability
-
(1,459 )
1,459
Change in fair value of warrant liabilities
1
414
(413 )
Change in fair value of contingent consideration
-
66
(66 )
Interest income
83
249
(166 )
Interest expense
(27 )
(6,752 )
6,725
Other income, net
215
70
145
Total other expense, net
(4,810 )
(28,835 )
24,025
Loss before income taxes
(14,129 )
(44,509 )
30,380
Benefit (provision) for income taxes
45
(30 )
75
Net loss
$ (14,084 )
$ (44,539 )
$ 30,455
Revenue
During
the year ended December 31, 2024, we recognized revenue related to the cell line customization activities we performed for a customer,
including the acceleration of recognizing approximately $0.5 million of deferred revenue related to nonrefundable payments we received
from the customer due to the Assignment Agreement we entered into on September 24, 2024 with Factor Limited discussed earlier. We did
not have any revenue recognizing contracts during the year ended December 31, 2025.
Cost
of Revenue
During
the year ended December 31, 2024, our cost of revenues included direct labor and materials to perform customization cell line activities
for a customer. We did not have any cost of revenues during the year ended December 31, 2025.
36
Research
and Development Expenses
Years
ended December 31,
2025
2024
Change
(in thousands)
MSA/license fees
$ 1,847
$ 3,017
$ (1,170 )
Payroll-related
502
591
(89 )
Professional fees
812
291
521
Study fees
667
468
199
Other expenses, net
328
237
91
Total
research and development expenses
$ 4,156
$ 4,604
$ (448 )
Total
research and development expenses decreased by approximately $0.5 million for the year ended December 31, 2025 compared to the year ended
December 31, 2024, primarily due to decreased MSA/license fees as a result of the new Factor L&C Agreement and payroll-related expenses,
offset by increased professional fees due to an increase in consulting services, third party study fees related to our development programs,
and other expenses incurred for the year ended December 31, 2025 compared to the year ended December 31, 2024.
General
and Administrative Expenses
Years
ended December 31,
2025
2024
Change
(in thousands)
Occupancy expense
$ 29
$ 5,074
$ (5,045 )
Professional fees
1,668
4,168
(2,500 )
Insurance
269
497
(228 )
Payroll-related
1,431
1,607
(176 )
Stock-based compensation
1,433
1,431
2
Other expenses, net
333
355
(22 )
Total general and administrative
expenses
$ 5,163
$ 13,132
$ (7,969 )
Our
general and administrative expenses decreased by approximately $8.0 million for the year ended December 31, 2025 compared to the year
ended December 31, 2024 primarily due to decreases in occupancy expense as a result of terminating our Somerville sublease effective
August 31, 2024, professional fees related to a reduction in legal services for litigation matters and consultants, insurance expense
due to lower premiums and payroll-related expenses during the year ended December 31, 2025 compared to the year ended December 31, 2024.
Gain
on Lease Termination
In
August 2024, we and the sublessor of our Somerville sublease entered into a sublease termination agreement effective August 31, 2024.
Pursuant to this 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,
2025.
Forward
sales contract expense
For
the year ended December 31, 2025, we recognized $5.8 million in expense related to a forward sales contract for the sale of shares of
the Company’s common stock and prefunded warrants (the “2025 Private Placement”), $5.3 million of which was initially
recognized at the contract inception date because the fair value of the shares that were expected to be issued under a securities purchase
agreement (the “2025 SPA”) exceeded the proceeds, and the remaining $0.5 million loss was related to the change in fair value
that was remeasured immediately prior to the respective settlement of the shares issued under the 2025 SPA. See Note 15 to the accompanying
consolidated financial statements for more information on the 2025 Private Placement. There was no similar transaction for the year ended
December 31, 2024.
37
Gain
(Loss) on Extinguishment of Debt
During
the year ended December 31, 2025, we recognized a gain on extinguishment of debt of approximately $0.8 million related to liabilities
that have been deemed to be time-barred from collection under the respective state laws. See Note 10 to the accompanying consolidated
financial statements for more information.
During
the year ended December 31, 2024, we recognized a $22.4 million loss on extinguishment of debt related to (i) agreements to exchange
certain convertible notes and warrants into shares of our common stock (the “Exchange Agreements”) and (ii) a securities
purchase agreement for the sale of common stock (the “2024 Private Placement”), both of which were entered into on September
24, 2024. See Note 15 to the accompanying consolidated financial statements for more information on these transactions.
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 upon entering into
the Exchange Agreements, 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,
2025.
Change
in Fair Value of Bridge Notes Derivative Liability
We
recognized expense of $1.6 million during the year ended December 31, 2024 related to the initial measurement of the incremental fair
value of a derivative liability for convertible bridge notes we entered into (the “Bridge Notes”) over the carrying value
of the Bridge Notes due to bifurcation of an embedded conversion feature. This expense was offset by a $0.2 million credit for the change
in fair value of the Bridge Notes derivative liability due to remeasuring the liability at each reporting period or immediately prior
to converting the Bridge Notes into shares of our common stock. There was no similar transaction during the year ended December 31, 2025.
See Note 11 to the accompanying consolidated financial statements for more information on the Bridge Notes.
Change
in Fair Value of Warrant Liabilities
The
change in the fair value of the warrant liabilities for the year ended December 31, 2025 was de minimis. We recognized income
of $0.4 million for the year ended December 31, 2024 for the change in the fair value of our warrant liabilities, which includes certain
warrants under the Exchange Agreements that were reclassified to a liability in September 2024 and then exchanged for shares of common
stock in October 2024. See Note 15 to the accompanying consolidated financial statements for more information on the exchanged warrants.
Change
in Fair Value of Contingent Consideration
As
of December 31, 2024, we remeasured a contingent liability and recognized a credit of less than $0.1 million for the year ended December
31, 2024 due to a decrease in the fair value of the liability. There were no amounts recognized for the year ended December 31, 2025.
The contingent consideration liability will expire in April 2026.
Interest
Income
We
recognized a decrease in interest income of approximately $0.2 million for the year ended December 31, 2025 compared to the year ended
December 31, 2024 due to lower cash balances in interest-bearing accounts.
Interest
Expense
We
recognized a decrease in interest expense for the year ended December 31, 2025 of approximately $6.7 million compared to the year ended
December 31, 2024 primarily due to no longer having convertible notes outstanding during the year ended December 31, 2025 as a result
of the Exchange Agreements entered into during the year ended December 31, 2024.
38
Other
Income, Net
During
the year ended December 31, 2025, we recognized approximately $0.5 million of income from Factor Limited as a result of the Assignment
Agreement, offset by approximately $0.2 million of financing fees that we expensed for the 2025 Private Placement, as the related securities
purchase agreement was accounted for as a liability until its settlement. See Note 15 to the accompanying consolidated statement of operations
for more information on the 2025 Private Placement.
For
the year ended December 31, 2024, we recognized other income related to amounts earned from Factor Limited under the Assignment Agreement
of approximately $0.1 million.
Benefit
(Provision) for Income Taxes
For
the year ended December 31, 2025, we incurred state minimum income tax liabilities related to our operations. However, we recognized
an overall income tax benefit due to a reduction of a deferred tax liability, which was recorded through the accompanying consolidated
statement of operations. We continue to maintain 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, 2025, we had cash of approximately $1.9 million, and we had an accumulated deficit of approximately $245.6 million. We
have to date incurred operating losses, and we expect these losses to continue in the future. For the year ended December 31, 2025, we
incurred a net loss of $14.1 million, and we used $7.0 million of cash in operating activities.
On
March 11, 2025 and March 20, 2025, we received $1.5 million and $0.8 million, respectively, for the issuance of two promissory notes
with an aggregate principal amount of $2.3 million to an investor. The promissory notes had a maturity date of 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 accrued at
a rate of 5.0% per annum, payable at maturity. During the year ended December 31, 2025, the Company repaid the notes in full for $2.3
million, including accrued interest.
During
the year ended December 31, 2025, we raised $7.2 million in gross proceeds from the 2025 Private Placement. We used a portion of the
proceeds from this financing to repay the notes, as discussed above.
On
May 1, 2025, our $10.0 million standby equity purchase agreement (“SEPA”) with Lincoln Park Capital Fund, LLC
(“Lincoln Park”) expired. The Company did not sell any shares of common stock under the SEPA during either of the years
ended December 31, 2025 or 2024. We do not currently have a new SEPA in place.
On
February 10, 2026, we received approximately $9.6 million in net proceeds from the 2026 Offering of (i) 21.0 million shares of the Company’s
common stock or pre-funded warrants and (ii) accompanying warrants to purchase 21.0 million shares of the Company’s common stock
(the “Milestone Warrants”).
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.”
39
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, grants 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 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 consolidated financial statements. The accompanying 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.
Cash
Flows
Cash
flows from operating, investing and financing activities, as reflected in the accompanying consolidated statements of cash flows, are
summarized as follows:
For
the years ended
December
31,
(in
thousands)
2025
2024
Change
Cash (used in) provided by:
Operating activities
$ (7,017 )
$ (15,836 )
$ 8,819
Investing activities
(37 )
(365 )
328
Financing activities
7,209
6,260
949
Net increase (decrease)
in cash and cash equivalents
$ 155
$ (9,941 )
$ 10,096
Net
Cash Used in Operating Activities
There
was a decrease of approximately $8.8 million in cash used in operating activities for the year ended December 31, 2025 compared to the
year ended December 31, 2024. This change was due a $6.8 million decrease in net loss, after giving effect to adjustments made for non-cash
transactions, primarily due to a decrease in occupancy expense and professional fees, and by a decrease of $2.0 million in cash used
in operating assets and liabilities for the year ended December 31, 2025 compared to the year ended December 31, 2024 primarily related
to terminating our facility sublease and reduced payments to Factor limited.
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, 2025.
Net
Cash Provided by Financing Activities
Net
cash provided by financing activities for the year ended December 31, 2025 includes $2.3 million of gross proceeds received from the
issuance of two promissory notes and $4.9 million of proceeds received from the 2025 Private Placement, net of offsetting $2.3 million
of a receivable related to 2025 Private Placement due from a related party with the outstanding notes payable, including accrued interest,
due to the same related party.
40
Net
cash provided by financing activities for the year ended December 31, 2024 includes $6.3 million of gross proceeds received from (i)
the issuance of convertible notes in January 2024 and the fees related to such issuance and (ii) proceeds received from the Bridge Notes
and 2024 Private Placement.
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.
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 Evaluation
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
in an amount equal to the excess fair value.
The
Company performed its annual qualitative assessments as of December 31, 2025 and 2024, and based on those assessments, the Company was
unable to conclude that it was more likely than not that the fair value of the entity exceeded its carrying value as of such date. As
a result, the Company performed a step-one quantitative assessment and concluded that the fair value of the reporting unit was greater
than the carrying value as of December 31, 2025 and 2024, and the goodwill was considered not impaired. Therefore, the Company did not
recognize an impairment charge during the years ended December 31, 2025 and 2024. However, the decline in the Company’s stock price
during the first quarter of 2026 has increased the likelihood that the fair value of the reporting unit may be below its carrying value
as of March 31, 2026, which could result in the recognition of a goodwill impairment charge for the three months ended March 31, 2026.
41
Recent
Accounting Pronouncements
Recently
Adopted Accounting Standards
In
December 2023, the Financial Accounting Standard Board (the “FASB”) issued Accounting Standards Update (“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 was effective for fiscal years beginning after December 15, 2024 and allowed for adoption on a prospective basis, with a
retrospective option. We adopted this ASU on a prospective basis, and it did not have an impact to our consolidated financial statements,
but it did result in additional disclosures made in the notes to the consolidated financial statements.
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. We do not expect the amendments in 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.
In
September 2025, the FASB issued ASU No. 2025-06, Intangibles—Goodwill and Other—Internal-Use
Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software. This ASU modernizes the accounting
for internal-use software costs by removing all references to prescriptive and sequential software development stages and instead requires
capitalization when (i) management has authorized and committed to funding the software project and (ii) it is probable that the project
will be completed and the software will be used to perform the function intended have both occurred. ASU No. 2025-06 is effective for
fiscal years beginning after December 15, 2027, and interim reporting periods, with early adoption permitted. We do not expect the amendments
in this ASU to have a material impact on our consolidated financial statements.
In
December 2025, the FASB issued ASU No. 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements. This ASU includes a
disclosure principle that requires entities to disclose events since the end of the last reporting period that have a material impact
on the entity, which is modeled after the SEC disclosure requirement. This ASU also clarifies the applicability of Topic 270, the types
of interim reporting, and the form and content of interim financial statements in accordance with GAAP. For public business entities,
this ASU is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027. Early adoption
is permitted. We do not expect the amendments in this ASU to have a material impact on our consolidated financial statements.
In
December 2025, the FASB issued ASU No. 2025-12, Codification Improvements. The amendments in this update represent changes to
the Codification that (1) clarify, (2) correct errors, or (3) make minor improvements. The amendments in this ASU are varied in nature
and may affect the application of guidance in cases in which the original guidance may have been unclear. This ASU is effective for all
entities for annual reporting periods beginning after December 15, 2026, and interim reporting periods within those annual reporting
periods. We do not expect the amendments in this ASU to have a material impact on our consolidated financial statements.
42
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.