UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒ QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2026
or
☐ 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: 001-11460
Ernexa
Therapeutics Inc.
(Exact
name of registrant as specified in its charter)
Delaware
31-1103425
(State
of incorporation)
(I.R.S.
Employer Identification No.)
1035
Cambridge Street, Suite 18A
Cambridge ,
Massachusetts
02141
(Address
of principal executive offices)
(Zip
Code)
(617)
798-6700
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class
Trading
Symbol(s)
Name
of Each Exchange on Which Registered
Common
Stock, $0.005 par value
ERNA
The
Nasdaq Stock Market LLC
Common
Stock Purchase Warrants
ERNAW
The
Nasdaq Stock Market LLC
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 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 8, 2026, the registrant had outstanding 1,166,333 shares of common stock, $ 0.005 par value per share.
TABLE
OF CONTENTS
PART I. FINANCIAL INFORMATION
1
Item 1. Financial Statements
1
Condensed Consolidated Balance Sheets
1
Condensed Consolidated Statements of Operations
2
Condensed Consolidated Statements of Stockholders’ Equity (Deficit)
3
Condensed Consolidated Statements of Cash Flows
4
Notes to Condensed Consolidated Financial Statements
5
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
17
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
23
Item 4. Controls and Procedures.
23
PART II — OTHER INFORMATION
24
Item 1. Legal Proceedings.
24
Item
1A. Risk Factors.
24
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
24
Item 3. Defaults Upon Senior Securities.
24
Item 4. Mine Safety Disclosures.
24
Item 5. Other Information.
24
Item 6. Exhibits
25
Signatures
26
i
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q contains “forward-looking statements” as that term is defined under the Private Securities
Litigation Reform Act of 1995 (“PSLRA”), Section 27A of the Securities Act of 1933, as amended (the “Securities Act”),
and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements include
statements related to future events, results, performance, prospects and opportunities, including statements related to our strategic
plans, capital needs, and our financial position. Forward-looking statements are based on information currently available to us, on our
current expectations, estimates, forecasts, and projections about the industries in which we operate and on the beliefs and assumptions
of management. Forward looking statements often contain words such as “expects,” “anticipates,” “could,”
“targets,” “projects,” “intends,” “plans,” “believes,” “seeks,”
“estimates,” “may,” “will,” “would,” and similar expressions. In addition, any statements
that refer to projections of our future financial performance, our anticipated growth and trends in our business, and other characterizations
of future events or circumstances, are forward-looking statements. Forward-looking statements by their nature address matters that are,
to different degrees, subject to risks and uncertainties that could cause actual results to differ materially and adversely from those
expressed in any forward-looking statements. For us, particular factors that might cause or contribute to such differences include those
risks and uncertainties described in Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended
December 31, 2025 filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2026, in Part II, Item 1A “Risk
Factors” of this Quarterly Report on Form 10-Q, and in other documents we file from time to time with the SEC.
Readers
are urged not to place undue reliance on the forward-looking statements in this Quarterly Report on Form 10-Q, which speak only as of
the date of this Quarterly Report on Form 10-Q. We are including this cautionary note to make applicable, and take advantage of, the
safe harbor provisions of the PSLRA. Except as required by law, we do not undertake, and expressly disclaim any obligation, to disseminate,
after the date hereof, any updates or revisions to any such forward-looking statements to reflect any change in expectations or events,
conditions or circumstances on which any such statements are based.
We
believe that the expectations reflected in forward-looking statements in this Quarterly Report on Form 10-Q are based upon reasonable
assumptions at the time made. However, given the risks and uncertainties, you should not rely on any forward-looking statements as a
prediction of actual results, developments or other outcomes. You should read these forward-looking statements with the understanding
that we may be unable to achieve projected results, developments or other outcomes and that actual results, developments or other outcomes
may be materially different from what we expect.
Unless
stated otherwise or the context otherwise requires, all references in this Quarterly Report on Form 10-Q to “Ernexa” refer
to Ernexa Therapeutics Inc., and references to the “Company,” “we,” “us” or “our” refer
to Ernexa and its subsidiaries, including Ernexa TX2 Inc. and Novellus, Inc.
ii
PART
I. Financial Information
Item
1. Financial Statements
ERNEXA
THERAPEUTICS INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except par value amounts)
(unaudited)
March 31,
2026
December 31,
2025
ASSETS
Current assets:
Cash
$ 9,177
$ 1,884
Other receivables
95
95
Due from related party
-
750
Prepaid expenses and other current assets
724
404
Total current assets
9,996
3,133
Property and equipment, net
88
94
Right-of-use assets - operating leases, net
349
453
Goodwill
-
2,044
Other assets
110
110
Total assets
$ 10,543
$ 5,834
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 1,300
$ 1,125
Accrued expenses
1,481
898
Income taxes payable
4
3
Operating lease liabilities, current
163
213
Due to related party
250
750
Contingent consideration liability
41
41
Other current liabilities
218
83
Total current liabilities
3,457
3,113
Operating lease liabilities, non-current
226
277
Other liabilities
1
43
Total liabilities
3,684
3,433
Stockholders’ equity:
Preferred stock, $ 0.005 par value, 1,000 shares authorized, 156 designated and outstanding
of Series A convertible preferred stock at March 31, 2026 and December 31, 2025, $ 156 liquidation preference
1
1
Common stock, $ 0.005 par value, 150,000 shares authorized at March 31, 2026 and
December 31, 2025, 1,166 and 314 issued and outstanding at March 31, 2026 and December 31, 2025, respectively
6
2
Additional paid-in capital
257,994
248,034
Accumulated deficit
( 251,142 )
( 245,636 )
Total stockholders’ equity
6,859
2,401
Total liabilities and stockholders’ equity
$ 10,543
$ 5,834
The
accompanying notes are an integral part of these condensed consolidated financial statements.
1
ERNEXA
THERAPEUTICS INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except per share amounts)
(unaudited)
2026
2025
Three months ended March 31,
2026
2025
Operating expenses:
Research and development
$ 1,915
$ 1,309
General and administrative
1,631
1,421
Impairment of goodwill
2,044
-
Total operating expenses
5,590
2,730
Loss from operations
( 5,590 )
( 2,730 )
Other income (expense), net:
Forward sales contract expense
-
( 5,335 )
Change in fair value of warrant liabilities
-
1
Interest income, net
44
5
Other expense, net
-
( 135 )
Total other income (expense), net
44
( 5,464 )
Loss before income taxes
( 5,546 )
( 8,194 )
Benefit (provision) for income taxes
40
( 8 )
Net loss
$ ( 5,506 )
$ ( 8,202 )
Net loss per common share - basic and diluted
$ ( 6.95 )
$ ( 57.76 )
Weighted average shares outstanding - basic and diluted
792
142
The
accompanying notes are an integral part of these condensed consolidated financial statements.
2
ERNEXA
THERAPEUTICS INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
For
the three months ended March 31, 2026 and 2025 (unaudited)
(In
thousands)
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Series A
Preferred Stock
Common Stock
Additional
Paid-in
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balances at January 1, 2026
156
$ 1
314
$ 2
$ 248,034
$ ( 245,636 )
$ 2,401
Issuance of common stock, prefunded warrants and warrants
in connection with public offering, net
-
-
769
4
9,537
-
9,541
Issuance of common stock, prefunded warrants and warrants in connection with public offering, net
-
-
769
4
9,537
-
9,541
Issuance of common stock from the exercise of prefunded
warrants, net
-
-
80
-
18
-
18
Issuance of common stock from the exercise of prefunded warrants, net
-
-
80
-
18
-
18
Issuance of common stock to consultant for services
-
-
3
-
96
-
96
Stock-based compensation
-
-
-
-
309
-
309
Net loss
-
-
-
-
-
( 5,506 )
( 5,506 )
Balances at March 31, 2026
156
$ 1
1,166
$ 6
$ 257,994
$ ( 251,142 )
$ 6,859
Series A
Preferred Stock
Common Stock
Additional
Paid-in
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balances at January 1, 2025
156
$ 1
137
$ 1
$ 233,219
$ ( 231,536 )
$ 1,701
Balance
156
$ 1
137
$ 1
$ 233,219
$ ( 231,536 )
$ 1,701
Issuance of common stock from the exercise
of prefunded warrants
-
-
2
-
4
-
4
Issuance of common stock from the exercise of prefunded warrants
-
-
2
-
4
-
4
Issuance of common stock to consultant for services
-
-
-
-
45
-
45
Stock-based compensation
-
-
-
-
502
-
502
Net loss
-
-
-
-
-
( 8,202 )
( 8,202 )
Balances at March 31, 2025
156
$ 1
139
$ 1
$ 233,770
$ ( 239,738 )
$ ( 5,950 )
Balance
156
$ 1
139
$ 1
$ 233,770
$ ( 239,738 )
$ ( 5,950 )
The
accompanying notes are an integral part of these condensed consolidated financial statements.
3
ERNEXA
THERAPEUTICS INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
(unaudited)
2026
2025
For the three months ended
March
31,
2026
2025
Cash flows from operating activities:
Net loss
$ ( 5,506 )
$ ( 8,202 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
8
18
Stock-based compensation
309
502
Amortization of right-of-use asset
78
51
Impairment of goodwill
2,044
-
Issuance of common stock to consultant for services
96
45
Accrued interest expense
-
6
Forward sales contract expense
-
5,335
Change in fair value of warrant liabilities
-
( 1 )
Changes in operating assets and liabilities:
Other receivables
-
281
Prepaid expenses and other current assets
( 320 )
49
Other non-current assets
-
1
Accounts payable and accrued expenses
759
( 98 )
Operating lease liability
( 75 )
( 52 )
Due from related party
750
-
Due to related party
( 500 )
-
Other liabilities
93
-
Net cash used in operating activities
( 2,264 )
( 2,065 )
Cash flows from investing activities:
Purchase of property and equipment
( 2 )
-
Net cash used in investing activities
( 2 )
-
Cash flows from financing activities:
Gross proceeds received from the sale of common stock, prefunded warrants and
Milestone Warrants in public offering
10,480
-
Fees related to public offering
( 939 )
-
Proceeds received from notes payable
-
2,250
Gross proceeds received from the exercise of prefunded warrants
20
4
Fee related to the exercise of prefunded warrants from public offering
( 2 )
-
Net cash provided by financing activities
9,559
2,254
Net increase in cash
7,293
189
Cash at beginning of period
1,884
1,729
Cash at end of period
$ 9,177
$ 1,918
Supplemental disclosure of non-cash investing and financing activities:
Remeasurment of ROU asset and lease liability
$ 26
$ -
The
accompanying notes are an integral part of these condensed consolidated financial statements.
4
ERNEXA
THERAPEUTICS INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Description
of Business and Basis of Presentation
Description
of Business
Ernexa
Therapeutics Inc. (the “Company”) is a preclinical-stage synthetic allogeneic iMSC therapy company. iMSCs are induced pluripotent
stem cell (“iPSC”)-derived mesenchymal stem cells. The Company envisions a future where cell therapies powered by synthetic
iMSCs can offer new options for patients with limited treatment paths and its mission is to transform the treatment of cancer and autoimmune
disease by developing scalable, affordable, off-the-shelf cell therapies that restore hope.
As
used herein, the “Company” or “Ernexa” refers collectively to Ernexa and its consolidated subsidiaries (Ernexa
TX2, Inc. and Novellus, Inc.) unless otherwise stated or the context otherwise requires. In March 2026, the Company dissolved Novellus
Therapeutics Limited, which had no operations.
Basis
of Presentation
The
accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles
generally accepted in the United States (“GAAP”) for interim financial statements and with the instructions to Form 10-Q
and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete
financial statements. In the opinion of management, the unaudited financial statements include all the normal recurring adjustments that
are necessary for a fair presentation of the financial position, results of operations and cash flows for the periods presented.
These
condensed consolidated financial statements should be read together with the audited consolidated financial statements and notes thereto
contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange
Commission (the “SEC”) on March 13, 2026. The accompanying condensed consolidated balance sheet as of December 31, 2025 has
been derived from the audited financial statements contained in the 2025 10-K but does not include all of the information and footnotes
required by GAAP for complete financial statements. The results of operations for the three months ended March 31, 2026 are not necessarily
indicative of the results to be anticipated for the entire year ending December 31, 2026, or any other period.
Reverse
Stock Split
As
approved on March 27, 2026 by written consent from approximately 53.34 % of Company’s stockholders (the “Consenting Stockholders),
on May 4, 2026, the Company effected a reverse stock split of its common stock at a ratio of 1-for-25 , as determined by the Company’s
Board of Directors within the parameters approved by the Consenting Stockholders (the “Reverse Stock Split”).
Upon
the effectiveness of the Reverse Stock Split, every twenty-five 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 150,000,000 shares. 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. The Company issued an aggregate of 203 shares for rounding up fractional shares
to whole shares.
All
share and per share data in this Quarterly Report on Form 10-Q have been adjusted for all periods presented to reflect the Reverse Stock
Split.
5
Reclassifications
Certain
reclassifications have been made to the statement of cash flows for the three months ended March 31, 2025 to conform to the current year
presentation. These reclassifications had no effect on the Company’s previously reported results of operations or accumulated deficit.
2. Liquidity
and Capital Resources
The
Company has incurred significant operating losses and has an accumulated deficit as a result of its efforts to develop product candidates
and provide general and administrative support for operations. As of March 31, 2026, the Company had a cash balance of approximately
$ 9.2 million and an accumulated deficit of approximately $ 251.1 million. For the three months ended March 31, 2026, the Company incurred
a net loss of $ 5.5 million, which includes a non-cash charge of $ 2.0 million for the impairment of goodwill, and it used cash of $ 2.3
million in operating activities.
On
February 10, 2026, the Company received approximately $ 9.5 million in net proceeds from a public offering (the “Public Offering”)
of (i) 0.8 million shares of the Company’s common stock or pre-funded warrants and (ii) accompanying warrants to purchase 0.8 million
shares of the Company’s common stock (the “Milestone Warrants”). See Note 8 for more information regarding the Public
Offering.
On
March 13, 2026, the Company filed a Registration Statement on Form S-3 with the SEC to offer and sell up to $ 50.0 million of its common
stock from time to time in one or more offerings (the “Universal Shelf”), which became effective on March 30, 2026. The Universal
Shelf includes a prospectus supplement providing for sales of up to $ 9.2 million of common stock pursuant to an At-the-Market (“ATM”)
program.
The
Company is subject to General Instruction I.B.6 of Form S-3 (the “baby shelf” rules), which limits the aggregate market value
of securities the Company may sell under the Universal Shelf to no more than one-third of its public float in any 12-month period while
its public float remains below $ 75.0 million. As of the filing of the Universal Shelf, one-third of the Company’s public float
was approximately $ 9.2 million, representing the maximum amount to be sold under the ATM. As of March 31, 2026, the Company has not sold
any securities under the ATM.
In
connection with preparing the financial statement as of and for the three months ended March 31, 2026, the Company evaluated whether
there are conditions and events, considered in the aggregate, that are known and reasonably knowable that would raise substantial doubt
about its ability to continue as a going concern within one year after the date that the financial statements are issued.
As of April 30, 2026, the Company had approximately $ 8.3 million in cash,
which is less than that needed to effect its current operating plan and forecasted cash requirements for the next twelve months. However,
management expects that its ability to access capital under its ATM will cover shortfalls in its cash resources over the next twelve months
from the issuance date of these financial statements.
If the Company’s cash is not sufficient to meet future
cash requirements, the Company may be required to reduce planned capital expenses, reduce operational cash uses or raise capital on terms
that are not as favorable to the Company as they otherwise might be. Any actions the Company may undertake to reduce planned capital
purchases or reduce expenses may be insufficient to cover shortfalls in available funds. If the Company requires additional capital,
it may be unable to secure additional financing on terms that are acceptable to the Company, or at all.
3. Fair
Value of Financial Instruments
Fair
value is defined as the price that would be received to sell an asset, or paid to transfer a liability, in an orderly transaction between
willing market participants. A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted
prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs. The fair value hierarchy
is as follows:
●
Level 1 Inputs – Valued based on quoted prices in active markets for identical assets or liabilities that the reporting entity
has the ability to access at the measurement date.
●
Level 2 Inputs – Valued based on inputs other than quoted prices included in Level 1 that are observable for the asset or
liability, either directly or indirectly. These might include quoted prices for similar assets or liabilities in active markets,
quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that
are observable for the asset or liability (such as interest rates, volatilities, prepayment speeds, credit risks, etc.) or inputs
that are derived principally from or corroborated by market data by correlation or other means.
●
Level 3 Inputs – Valued based on inputs for which there is little or no market value, which require the reporting entity to
develop its own assumptions.
6
The
carrying amounts reported on the balance sheet for cash, other receivables, prepaid expenses and other current assets, accounts payable
and accrued expenses, other current liabilities and other liabilities approximate fair value based due to their short maturities.
The
Company issued 914 warrants in connection with a private placement during the first quarter of 2022 (the “Q1-22 warrants”),
which were determined to be classified as a liability. The Company has also recorded a three-year contingent consideration liability
related to an asset acquisition in April 2023, the obligation of which terminated in April 2026.
The
Company uses a Black-Scholes option pricing model to estimate the fair value of the Q1-22 warrant liabilities and a Monte Carlo simulation
model to estimate the fair value of the contingent consideration liability, both of which are considered a Level 3 fair value measurement.
The Company remeasures these liabilities at each reporting period and recognizes changes in their respective fair value in the accompanying
condensed consolidated statement of operations.
In
connection with the 2025 SPA (as defined in Note 8) that the Company entered into on March 31, 2025, the Company recorded a forward sales
contract liability at fair value and recognized $ 5.3 million of expense during the three months ended March 31, 2025 because the fair
value of the expected shares to be purchased by the investors exceeded the proceeds under the 2025 SPA.
The
Company determined the expense related to the forward sales contract as of March 31, 2025 by taking the difference between (i) the fair
value of the expected shares to be purchased by the investors as of the March 31, 2025 date the Company entered into the 2025 SPA and
(ii) the discounted purchase price of the shares. The forward sales contract liability was remeasured at fair value at each reporting
date or immediately prior to settlement, with changes in fair value recognized in the condensed consolidated statements of operations.
Upon settlement, the liability was reclassified as a component of stockholders’ equity. The 2025 SPA closed during the second
quarter of 2025, and as a result, there was no SPA liability remaining as of March 31, 2026 or December 31, 2025.
The
following table summarizes the liabilities that are measured at fair value as of March 31, 2026 and December 31, 2025 (in thousands):
Schedule of Liabilities Measured at Fair Value
Description
Level
March 31,
2026
December 31,
2025
Liabilities:
Contingent consideration
3
$ 41
$ 41
Liability fair value disclosure
3
$ 41
$ 41
Certain
inputs used in Black-Scholes and Monte Carlo models may fluctuate in future periods based upon factors that are outside of the Company’s
control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change
to the fair value of the Company’s warrant liabilities or contingent consideration liabilities, which could also result in material
non-cash gains or losses being reported in the Company’s condensed consolidated statement of operations.
The
Company remeasured the fair value of the Q1-22 warrants at March 31, 2026, and the result of the remeasurement was de minimis.
The Company assessed the fair value of the contingent consideration liability at each reporting period through March 31, 2026 and determined
that there were no material changes to the remeasurement that would have resulted in a material change to the liability at March 31,
2026. Therefore, the Company did not recognize a change in fair value of the contingent consideration liability for the three months
ended March 31, 2026.
7
4. Goodwill
The
Company recorded goodwill in the amount of $ 2.0 million related to a 2018 acquisition that was accounted for as a business combination.
Goodwill is not amortized but is tested for impairment annually, or more frequently if the Company becomes aware of any events occurring
or changes in circumstances that indicate that the fair value of the entity is less than its carrying value. The Company performed an
assessment as of March 31, 2026, and based on that assessment, 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 less than the carrying value as of March 31, 2026, and the goodwill
was considered fully impaired. Therefore, the Company recognized an impairment charge for $ 2.0 million in the accompanying condensed
consolidated statement of operations for the three months ended March 31, 2026. As of March 31, 2026, there was no goodwill balance.
5. Accrued
Expenses
Accrued
expenses at March 31, 2026 and December 31, 2025 consisted of the following (in thousands):
Schedule
of Accrued Expenses
March 31,
2026
December 31,
2025
Study Fees
$ 642
$ 156
Accrued compensation
497
12
Professional fees
68
379
Legal matters
-
336
Other
274
15
Total accrued expenses
$ 1,481
$ 898
6. Operating
Leases
As
of March 31, 2026, the Company had an operating lease for an office in Cambridge, Massachusetts (the “Cambridge Lease”),
which expires in 2028.
The
Company also leased an office in the Borough of Manhattan in New York, New York (the “Manhattan Office”), which was to
expire in January 2027, and was subleasing the Manhattan Office to a sublessee. The sublease was to expire in October 2026. On
February 16, 2026, the Company entered into a sublease termination agreement with the sublessee of the Manhattan Office effective
March 13, 2026. Pursuant to the sublease termination agreement, the sublessee agreed to surrender and vacate the premises in
exchange for a termination payment of approximately $ 60,000 , which represented the remaining sublease payments through October 2026.
As a result, the Company recognized a gain for the sublease termination of approximately $ 56,000 , which is included in general and
administrative expense in the accompanying condensed consolidated statement of operations for the three months ended March 31,
2026.
On
February 18, 2026, the Company entered into a lease termination agreement with the lessor of the Manhattan Office effective March 13,
2026. Pursuant to the lease termination agreement, the Company agreed to surrender and vacate the premises in exchange for a termination
payment of approximately $ 72,000 to the lessor.
The
lease termination agreement was accounted for as a modification to the Manhattan Office lease rather than as a lease termination
because the Company did not contemporaneously terminate the Manhattan Office lease upon the February 18, 2026 modification date and
had a continued right-of-use of the facility through March 13, 2026. As a result, the Company remeasured the remaining lease
payments, including the $ 72,000 termination fee, and reduced the lease liability the Company had on its balance sheet at the time of
the modification by approximately $ 26,000 to the present value of the remeasured lease liability of approximately $ 79,000 . For a
lease modification that is not accounted for as a separate contract, a lessee recognizes the amount of the remeasured lease
liability as an adjustment to the corresponding right-of-use (“ROU”) asset without affecting profit or loss. As a result, the Company
reduced the ROU asset by approximately $ 26,000 to approximately $ 31,000 , which was amortized through March 13, 2026. As of March 31,
2026, there was no lease liability or ROU asset for the Manhattan Office remaining.
8
For
the three months ended March 31, 2026 and 2025, the net operating lease expenses were as follows (in thousands):
Schedule of Net Operating Lease Expense
2026
2025
Three months ended March 31,
2026
2025
Operating lease expense
$ 89
$ 67
Sublease income
( 14 )
( 21 )
Gain on sublease termination
( 56 )
-
Variable lease expense
1
6
Total lease expense
$ 20
$ 52
The
tables below show the beginning balances of the operating ROU assets and lease liabilities as of January 1, 2026 and the ending balances
as of March 31, 2026, including the changes during the period (in thousands).
Schedule
of Operating
Lease Right-of-use Assets and Liabilities
Operating Lease
ROU Assets
Operating lease ROU assets at January 1, 2026
$ 453
Remeasurement of ROU asset
( 26 )
Amortization of operating lease ROU assets
( 78 )
Operating lease ROU assets at March 31, 2026
$ 349
Operating Lease
Liabilities
Operating lease liabilities at January 1, 2026
$ 490
Remeasurement of lease liability
( 26 )
Principal payments on operating lease liabilities
( 75 )
Operating lease liabilities at March 31, 2026
389
Less non-current portion
( 226 )
Current portion at March 31, 2026
$ 163
As
of March 31, 2026, the Company’s operating lease had a remaining life of 2.3 years with a discount
rate of 9.1 % The maturities of the operating lease liability are as follows (in thousands):
Maturities of Operating Lease Liabilities
As of
March 31,
2026
2026
$ 143
2027
190
2028
95
Total payments
428
Less imputed interest
( 39 )
Total operating lease liabilities
$ 389
9
7. Stock-Based
Compensation
Stock
Options
During
the three months ended March 31, 2026 and 2025, the Company granted options to purchase the number of shares of the Company’s common
stock set forth in the table below (in thousands):
Schedule of Stock Option Granted
2026
2025
Three months ended March 31,
2026
2025
Stock options granted
199
122
The
Company recognizes stock-based compensation expense for stock options granted to employees, directors and certain consultants. The Company
estimates the fair value of stock options using the Black-Scholes option pricing model. The fair value of stock options granted is recognized
as expense over the requisite service period on a straight-lined basis.
The
following weighted-average assumptions were used for stock options granted during the three months ended March 31, 2026 and 2025:
Schedule
of Weighted-Average Assumptions Used for Stock Options Granted
2026
2025
Three months ended March 31,
2026
2025
Weighted average risk-free rate
3.96 %
4.42 %
Weighted average volatility
123.21 %
116.69 %
Dividend yield
0.00 %
0.00 %
Expected term
8.82 years
5.98 years
The
per-share weighted average grant-date fair value of stock options granted during the three months ended March 31, 2026 and 2025 were
as follows:
Schedule of Weighted Average Grant-date Fair Value of Stock Options
2026
2025
Three months ended March 31,
2026
2025
Weighted average grant date fair value
$ 0.39
$ 4.32
Vesting
of all stock options is subject to continuous service with the Company through the applicable vesting date. As of March 31, 2026, there
were approximately 21,000 shares of the Company’s common stock subject to outstanding stock options.
Restricted
Stock Units
The
Company recognizes the fair value of RSUs as expense on a straight-line basis over the requisite service period. For performance-based
RSUs, the Company begins recognizing the expense once the achievement of the related performance goal is determined to be probable.
Outstanding
RSUs are settled in an equal number of shares of common stock on the vesting date of the award. An RSU award is settled only to the extent
vested. Vesting generally requires continued employment or service by the award recipient through the applicable vesting date. Because
RSUs are settled in an equal number of shares of common stock without any offsetting payment by the recipient, the measurement of cost
is based on the quoted market price of the stock at the measurement date, which is the grant date.
In
lieu of paying cash to satisfy withholding taxes due upon the settlement of vested RSUs, at the Company’s discretion, an employee
may elect to have shares of common stock withheld that would otherwise be issued at settlement, the value of which is equal to the amount
of withholding taxes payable. No RSUs vested during the three months ended March 31, 2026 and 2025. The Company did no t grant RSUs during
the three months ended March 31, 2026 and 2025, and as of March 31, 2026, there were no RSUs outstanding.
10
Stock-Based
Compensation Expense
For
the three months ended March 31, 2026 and 2025, the Company recognized stock-based compensation expense as follows (in thousands):
Schedule of Stock-based Compensation Expense
2026
2025
Three months ended March 31,
2026
2025
Research and development
$ 13
$ 16
General and administrative
295
486
Total
$ 308
$ 502
8. Equity
Transactions
2026
Public Offering
On
February 6, 2026, the Company entered into a placement agency agreement (the “Placement Agency Agreement”) with Brookline
Capital Markets, a division of Arcadia Securities, LLC (“Brookline” or the “Placement Agent”), pursuant to which
the Company engaged the Placement Agent for the 2026 Offering, which included the public offering of (i) 0.8 million shares of the Company’s
common stock (or pre-funded warrants in lieu of common stock) and accompanying Milestone Warrants to purchase 0.8 million shares of common
stock, at a combined offering price of $ 12.50 per share of common stock and accompanying Milestone Warrant (or $ 12.25 per pre-funded
warrant and accompanying Milestone Warrant). In connection with the Public Offering, the Company also entered into a securities purchase
agreement (each, a “Purchase Agreement”) with certain investors who purchased common stock and Milestone Warrants in the
Public Offering.
The
pre-funded warrants were immediately exercisable (subject to certain ownership limitations) had an exercise price of $ 0.25 per share
and did not expire until exercised in full. On February 11, 2026 and February 18, 2026, the Company issued approximately 53,000 and 27,000
shares of common stock, respectively, in connection with the exercise of the pre-funded warrants, for a total exercise price of approximately
$ 20,000 . There are no remaining pre-funded warrants outstanding related to the Public Offering.
The
Milestone Warrants are tradeable 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 $ 17.00 per share, and expire on the earlier of (i)
the five-year anniversary of the original issuance date or (ii) the 180 th calendar day following the public release by the
Company of clinical trial data from the first cohort of the Phase 1 study of ERNA-101.
Pursuant
to the Placement Agency Agreement, the Company 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).
The Company will also pay the Placement Agent a cash fee as compensation for gross proceeds the Company receives from any exercise of
any Milestone Warrants sold in connection with the Public Offering, payable quarterly on each January 1, April 1, July 1 and October
1 following the closing of the Public 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. The Company also issued approximately 9,000 shares of Common Stock to the Placement
Agent (the “Agent’s Shares”), which was equal to 1.5% of the aggregate number of Shares and pre-funded warrants sold
in the Public Offering (or 0.5% with respect to sales to certain existing investors). In addition, the Company reimbursed the Placement
Agent for its accountable offering-related legal expenses in an amount of $ 125,000 .
The
Public 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 the Company. The Company is using the net proceeds from the Public Offering to support the
advancement of its development programs and for working capital and general corporate purposes.
11
The
Placement Agency Agreement and the Purchase Agreements contain customary representations, warranties and agreements by the Company, customary
conditions to closing, indemnification obligations of the Company, 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, the Company has agreed that for a period of ninety (90) days
from the closing of the Public Offering, that neither the Company 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, unless waived by the Placement
Agent. The Company has 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 Public Offering, subject to certain exceptions, unless waived by the Placement Agent. In addition, as part of the Purchase Agreement,
subject to certain exceptions, the Company’s 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 Public
Offering.
Universal
Shelf and ATM
On
March 13, 2026, the Company filed the Universal Shelf to offer and sell up to $ 50.0 million of its common stock from time to time in
one or more offerings, which became effective on March 30, 2026. The Universal Shelf includes a prospectus supplement providing for sales
of up to $ 9.2 million of common stock pursuant to an ATM program under a sales agent agreement the Company entered into with Brookline.
The
Company is subject to the “baby shelf” rules, which limits the aggregate market value of securities the Company may sell
under the Universal Shelf to no more than one-third of its public float in any 12-month period while its public float remains below $ 75.0
million. As of the filing of the Universal Shelf, one-third of the Company’s public float was approximately $ 9.2 million, representing
the maximum amount to be sold under the ATM. As of March 31, 2026, the Company has not sold any securities under the ATM.
2025
Private Placement
On
March 31, 2025, the Company entered into a securities purchase agreement (the “2025 SPA”) with certain accredited investors
to sell in a private placement an aggregate of approximately 185,000 shares of common stock at a purchase price of $ 39.23 per share,
or pre-funded warrants in lieu of common stock at a purchase price of $ 37.35 per pre-funded warrant (the “2025 Private Placement”).
The pre-funded warrants will be exercisable until exercised in full at a nominal exercise of $ 1.88 per share of the Company’s outstanding
common stock, subject to certain ownership limitations.
The
2025 SPA represented a forward sale contract obligating the Company to sell a fixed number of shares of its common stock at a fixed price
per share and contained an adjustment to the settlement amount based on shareholder approval, which is not an input into the pricing
of a fixed-for-fixed forward on equity shares. The Company measured the fair value of the forward sale contract as the difference between
(i) the fair value of the expected shares to be purchased by the investors as of the date the Company entered into the 2025 SPA and (ii)
the discounted purchase price of the shares and recorded a liability of approximately $ 5.3 million at the contract inception date. The
Company also recognized a corresponding $ 5.3 million charge to expense on the contract inception date because the fair value of the expected
shares to be purchased by the investors exceeded the expected proceeds under the 2025 SPA. There were no shares sold and issued under
the 2025 SPA during the three months ended March 31, 2025, and the 2025 Private Placement closed during the second quarter of 2025.
12
Warrants
As
of March 31, 2026, the Company had the following warrants outstanding:
Schedule
of Warrants Outstanding
Warrants
Outstanding
Exercise
Price
Expiration
Date
Classification
Q1-22 Warrants
914
$ 14,329.47
09/09/27
Liability
December 2022 Warrants
377
$ 537.26
06/02/28
Equity
Milestone Warrants
840,000
$ 17.00
- *
Equity
Prefunded warrants
15,320
$ 1.88
None
Equity
856,611
* The
Milestone Warrants expire the earlier of (i) the five-year anniversary of the original issuance
date or (ii) the 180 th calendar day following the public release by the Company
of clinical trial data from the first cohort of the Phase 1 study of ERNA-101.
As
of March 31, 2026, the weighted average remaining contractual life of expiring warrants outstanding was 4.86 years and the weighted average
exercise price for the expiring warrants was $ 32.78 .
The
following table shows the warrant activity from January 1, 2026 through March 31, 2026:
Schedule
of Warrants Activity
Outstanding
January 1,
2026
Granted
Exercised
Outstanding
March 31,
2026
Q1-22 Warrants
914
-
-
914
December 2022 Warrants
377
-
-
377
Milestone Warrants
-
840,000
-
840,000
Prefunded warrants
15,320
80,000
( 80,000 )
15,320
Total
16,611
920,000
( 80,000 )
856,611
On
February 11, 2026 and February 18, 2026, the Company issued approximately 53,000 and 27,000 shares of common stock, respectively, in
connection with the exercise of the pre-funded warrants from the Public Offering, for a total exercise price of approximately $ 20,000 .
There are no remaining pre-funded warrants outstanding related to the Public Offering.
Stock
Repurchase Program
In
November 2024, the Company’s Board of Directors authorized a stock repurchase program (the “Repurchase Program”) of
up to $ 1.0 million of the Company’s outstanding common stock. Under the Repurchase Program, the repurchases may be made by the
Company from time to time through open-market purchases, privately negotiated transactions or other means in accordance with applicable
securities laws. The timing and amount of repurchases will be determined by the Company, taking into consideration market conditions,
stock price, and other factors. The Repurchase Program does not have a set expiration date and may be suspended, modified or discontinued
at any time without prior notice. The Company did no t repurchase any of its shares under the Repurchase Program during the three months
ended March 31, 2026 and 2025.
9. Net
Loss Per Share
The
Company calculates basic and diluted net loss per share attributable to common stockholders in conformity with the two-class method required
for participating securities. Basic net loss per share is calculated by dividing net loss attributable to common stockholders by the
weighted-average number of shares of common stock outstanding during the period, including the weighted average effect of prefunded warrants,
and without consideration for potentially dilutive securities.
Diluted
net loss per share is calculated by dividing net loss attributable to common stockholders by the weighted-average number of shares of
common stock outstanding, including the weighted average effect of the prefunded warrants, plus dilutive securities. Shares of common
stock issuable upon exercise, conversion or vesting of stock options, restricted stock units, warrants and the outstanding Series A convertible
preferred stock are considered potential shares of common stock and are included in the calculation of diluted net loss per share using
the treasury method when their effect is dilutive. Diluted net loss per share is the same as basic net loss per share for periods in
which the effect of potentially dilutive shares of common stock is antidilutive.
13
The
following table presents the number of shares subject to outstanding stock options, warrants, and Series A convertible preferred stock
that were excluded from the computation of diluted net loss per share of common stock for the three months ended March 31, 2026 and 2025,
as their effect was anti-dilutive:
Schedule
of Securities Excluded from the Computation of Diluted Net Loss per Common Stock
2026
2025
Three months ended March 31,
2026
2025
Stock options
20,997
11,880
Warrants
841,291
1,291
Preferred stock converted into common stock
1,049
181
RSUs
-
2
Total potential common shares excluded from computation
863,337
13,354
10. Commitments
and Contingencies
Litigation
Matters
The
Company is involved in litigation and arbitrations from time to time in the ordinary course of business. Legal fees and other costs associated
with such actions are expensed as incurred. In addition, the Company assesses the need to record a liability for litigation and contingencies.
The Company reserves for costs relating to these matters when a loss is probable, and the amount can be reasonably estimated. The Company
is not currently party to any material legal proceedings.
Licensing
Agreements
The
Company has an exclusive license and collaboration agreement (“the Factor L&C Agreement”) with Factor Bioscience Limited
(“Factor Limited”). Under the Factor L&C Agreement, the Company has obtained exclusive licenses in the fields of cancer,
autoimmune disorders, and rare diseases with respect to certain licensed technology and has the right to develop the licensed technology
directly or enter into co-development agreements with partners who can help bring such technology to market. The Factor L&C Agreement
also provides for certain services and materials to be provided by Factor Bioscience to facilitate the development of the licensed technology
and to enable the Company to scale up production at third party facilities.
The
initial term of the Factor L&C Agreement was one year after the effective date, and it automatically renews yearly thereafter. The
Company may terminate the Factor L&C Agreement for any reason upon 90 days’ written notice to Factor Bioscience, and the parties
otherwise have customary termination rights, including in connection with certain uncured material breaches and specified bankruptcy
events.
Pursuant
to the Factor L&C Agreement, the Company paid Factor Bioscience approximately $ 0.2 million per month for the first twelve months
and approximately $ 0.1 million per month for the first nine months toward patent costs. The Company will also pay certain milestone payments,
royalty payments on net sales of commercialized products and sublicensing fee payments, when applicable.
Contingent
Consideration
The
Company previously recorded a three-year contingent consideration liability related to an asset acquisition in April 2023. If during
the three-year period since April 26, 2023, the Company’s market cap equals or exceeds $100 million for at least ten consecutive
trading days, then the Company will issue to the seller shares of the Company’s common stock equal to (a) $2.0 million divided
by (b) the quotient of $100 million divided by the Company’s then issued and outstanding shares of common stock. If during that
three-year period, the Company’s market cap equals or exceeds $200 million for at least ten consecutive trading days, then the
Company will issue to the seller additional shares of the Company’s common stock equal to (a) $2.0 million divided by (b) the quotient
of $200 million dividend by the number of the Company’s then issued and outstanding shares of common stock. As discussed in Note
3, the Company records the contingent consideration liability at its fair value, and as of March 31, 2026, the fair value of the liability
was approximately $ 41,000 . The contingent consideration obligation expired on April 26, 2026 .
14
Retirement
Savings Plan
The
Company offers to its eligible employees a defined contribution plan, organized under Section 401(k) of the Internal Revenue Code, through
its co-employment arrangement with its professional employer organization (“PEO”). Under this arrangement, the PEO serves
as the plan sponsor and administrator. Eligible employees may defer up to 100 % of their annual compensation or a specific amount imposed
by the Internal Revenue Service, whichever is less. The Company matches employees’ contributions at a rate of 100 % of the first
3 % of the employee’s contribution and 50 % of the next 2 % of the employee’s contribution, for a maximum Company match of 4 %.
11. Related
Party Transactions
Recent
Financings
Investors
who participated in the Public Offering and the 2025 Private Placement included Charles Cherington. Mr. Cherington participated in the
applicable financing under the same terms and subject to the same conditions as all the other investors. Mr. Cherington served on the
Company’s board of directors from March 2021 to July 6, 2023. As of March 31, 2026, Mr. Cherington owned approximately 23 % of the
Company’s outstanding common stock.
March
2025 Promissory Notes
On
March 11, 2025, the Company received $ 1.5 million for the issuance of a promissory note in the principal amount of $ 1.5 million to Mr.
Cherington, and on March 21, 2025 the Company received $ 0.8 million for the issuance of a second promissory note in the principal amount
of $ 0.8 million to Mr. Cherington. The promissory notes had a maturity date of the earlier of (i) June 15, 2025 or (ii) upon us receiving
$ 5 million in gross proceeds from a subsequent capital raise. Each of the promissory notes accrued interest at a rate of 5.0 % per annum,
payable at maturity. Upon issuance of the notes, Mr. Cherington owned approximately 32 % of our outstanding common stock and currently
owns approximately 23 % of our outstanding common stock.
As
a result of completing the 2025 Private Placement, the Company repaid the outstanding principal plus accrued interest on the notes in
full in the aggregate amount of $ 2.3 million, and as of March 31, 2026, there were no outstanding balances on the notes.
12. Segment
Reporting
The
Company operates within a single 1 reportable operating segment, the research and development of cellular therapies. The Company has
identified its president and chief executive officer as its chief operating decision maker (“CODM”), who regularly reviews
the Company’s performance and allocates resources based on information reported at the consolidated entity level.
The
CODM uses consolidated net loss as a measure of profit and loss and assesses Company performance through the achievement of its business
strategy goals. The CODM is regularly provided with forecasted expense information that is used to determine the Company’s liquidity
needs and cash allocation to execute its business strategy, and he uses cash as a measure of segment assets in managing the Company.
The Company operates in the United States, and all of its assets are located in the United States.
The
table below provides a breakdown of the Company’s significant operating expenses for the three months ended March 31, 2026 and
2025, with a reconciliation to net loss for each of those years.
15
The
Company’s purchases of property and equipment were approximately $ 2,000 for the three months ended March 31, 2026. There were no
purchases of property and equipment for the three months ended March 31, 2025. Depreciation and amortization expense was approximately
$ 9,000 and $ 18,000 for the three months ended March 31, 2026 and 2025, respectively. During the three months ended March 31, 2025, the
Company recognized $ 5.3 million in other expense related to the forward sales contract liability under the 2025 SPA. The Company recognized
$ 44,000 and $ 5,000 in interest income, net, for the three months ended March 31, 2026 and 2025, respectively.
Schedule
of Breakdown of Significant Operating Expenses
2026
2025
Three months ended March 31,
2026
2025
Operating expenses:
Research and development by significant expense:
Study fees
$ 1,267
$ 352
Payroll and related
236
112
Professional fees
164
156
MSA/license fees
69
637
Other 1
179
52
Research and development
1,915
1,309
General and administrative by significant expense:
Payroll and related 2
802
394
Professional fees 2
447
386
Stock-based compensation
296
486
Other 2
86
155
General and administrative
1,631
1,421
Impairment of goodwill
2,044
-
Total operating expenses
5,590
2,730
Loss from operations
( 5,590 )
( 2,730 )
Forward sales contract expense
-
( 5,335 )
Change in fair value of warrant liabilities
-
1
Interest income (expense), net
44
5
Other expense, net
-
( 135 )
Total other income (expense), net
44
( 5,464 )
Loss before income taxes
( 5,546 )
( 8,194 )
Benefit (provision) for income taxes
40
( 8 )
Net loss
$ ( 5,506 )
$ ( 8,202 )
March
31, 2025
December 31, 2025
Cash
$ 9,177
$ 1,884
1 Other includes certain lab
supply expenses, travel expenses, stock-based compensation, allocated occupancy costs, and depreciation.
2 Other includes expenses
related to insurance, occupancy expense, information technology, travel, depreciation and other miscellaneous expenses.
13. Recent
Accounting Pronouncements
No
new Accounting Standards Updates have been issued by the Financial Accounting Standards Board since January 1, 2026 that would apply
to the Company and were not disclosed in the 2025 10-K.
16
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You
should read this discussion together with the unaudited interim condensed consolidated financial statements, related notes, and other
financial information included elsewhere in this Quarterly Report on Form 10-Q (“Quarterly Report”) together with our audited
consolidated financial statements, related notes, and other information contained in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2025 filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2026 (the “2025
10-K”). The following discussion contains or is based on assumptions, estimates and other forward-looking statements that involve
a number of risks and uncertainties, including those discussed under “Risk Factors,” in this report and in Part I, Item 1A
of the 2025 10-K and as described from time to time in our other filings with the SEC. These risks could cause our actual results to
differ materially from those anticipated in these forward-looking statements.
Overview
We
are a pre-clinical-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.
Objectives and Business
Strategy
Our lead product
candidate ERNA-101 is allogenic IL-7 and IL-15-secreting iMSCs. ERNA-101 capitalizes on the intrinsic tumor-homing ability of MSCs
to slip through the tumor’s defenses and to deliver potent pro-inflammatory factors directly to the tumor microenvironment
(“TME”), limiting systemic exposure and potential toxicity while potentially unleashing potent anti-cancer immune
responses including enhancement of T-cell anti-tumor activity. Our initial focus is to develop ERNA-101 in platinum-resistant
ovarian cancer. We collaborated with the University of Texas MD Anderson Cancer Center (“MDACC”) to investigate the
ability of ERNA-101 to induce and modulate antitumor immunity in an ovarian cancer model. In preclinical study, ERNA-101 exhibited
reduction of tumor growth and a statistically significant survival advantage in the ovarian cancer model as compared to the control
group, and as announced in May 2026, preclinical data demonstrates that when ERNA-101 is used in combination with PD-1 blockade, it
drives complete tumor clearance and 100% long-term survival in syngeneic ovarian cancer models. We have filed Patent Application No. 63/991,024 related to the use of ERNA-101
in combination with PD-1 blockade, which remains pending. It is possible that the pending application, and any that may be filed in the
future, will not lead to an issued patent. Additionally, MDACC has filed a patent application based on research conducted under our collaboration
agreement (the “MDACC Application”), and we were informed that none of our employees were identified as inventors on the MDACC
Application. We have not yet received the MDACC Application and have not evaluated inventorship, ownership or assignment rights as of
the filing of this Quarterly Report.
During the fourth quarter
of 2025, we had a successful pre-Investigational New Drug (“IND”) meeting with the Food and Drug Administration (“FDA”),
which resulted in regulatory alignment with our development approach. We expect to complete the Investigational New Drug (“IND”)
enabling studies and IND submission in 2026 and to subsequently enter a Phase I investigator sponsored clinical trial in the second half
of 2026.
We are also investigating
anti-inflammatory cytokine (e.g., IL-10)-secreting iMSCs in autoimmune disorders like rheumatoid arthritis, which we refer to as ERNA-201.
MSCs have an intrinsic ability to home to inflamed tissue and have been shown to dampen inflammation and drive healing through multiple
secreted mediators and cell-cell interactions. We are investigating the ability of ERNA-201 to turbocharge these anti-inflammatory and
regenerative effects.
We have also been accepted
as one of only ten global companies for the Japan External Trade Organization acceleration program, which will allow us to receive expert-led
mentoring and market-entry guidance focused on Japan’s regulatory, clinical and commercial landscape. The program also provides
direct engagement opportunities with leading Japanese research and development organizations to explore potential collaborations across
development, manufacturing and clinical execution.
Additionally, to
expand our developmental opportunities and raise non-dilutive capital, we are actively seeking strategic partnerships to co-develop or
out-license therapeutic assets and engage with potential collaborators, and we are currently applying for research grants, some of which
will be used for research conducted at our Texas subsidiary, Ernexa TX2, Inc.
Recent
Developments
Reverse
Stock Split
As
approved on March 27, 2026 by written consent from approximately 53.34% of our stockholders (the “Consenting Stockholders), on
May 4, 2026, we effected a reverse stock split of our common stock at a ratio of 1-for-25, as determined by our Board of Directors within
the parameters approved by the Consenting Stockholders (the “Reverse Stock Split”).
Upon
the effectiveness of the Reverse Stock Split, every twenty-five 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 150,000,000 shares. 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 203 shares for rounding up fractional shares to whole
shares.
All
share and per share data in this Quarterly Report on Form 10-Q have been adjusted for all periods presented to reflect the Reverse Stock
Split.
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 (“Brookline” or the “Placement Agent”), pursuant to which we engaged
the Placement Agent for the public offering of 0.8 million shares of our common stock (or pre-funded warrants in lieu of common stock)
and accompanying warrants to purchase 0.8 million shares of common stock (the “Milestone Warrants”), at a combined offering
price of $12.50 per share of common stock and accompanying Milestone Warrant (or a combined offering price of $12.25 per share of pre-funded
warrant and accompanying Milestone Warrants) (the “Public Offering”). In connection with the Public Offering, we also entered
into a securities purchase agreement (each, a “Purchase Agreement”) with certain investors who purchased shares of common
stock and Milestone Warrants in the Public Offering.
The
pre-funded warrants were immediately exercisable (subject to certain ownership limitations) had an exercise price of $0.25 per share
and did not expire until exercised in full. On February 11, 2026 and February 18, 2026, we issued 53,000 and 27,000 shares of common
stock, respectively, in connection with the exercise of the pre-funded warrants, for a total exercise price of approximately $20,000.
There are no remaining pre-funded warrants outstanding related to the Public Offering.
17
The
Milestone Warrants are tradeable 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 $17.00 per share, and expire on the earlier of (i)
the five-year anniversary of the original issuance date or (ii) the 180 th calendar day following our public release 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 Public Offering, payable quarterly on each January 1, April 1, July 1 and October 1 following the closing of the
Public 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 9,000 shares of common stock to the Placement Agent, which was equal to 1.5% of the
aggregate number of shares of common stock and pre-funded warrants sold in the Public 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
Public 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 are using the net proceeds from the Public Offering to support the advancement of
our development programs and for 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 Public 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, unless waived by the Placement Agent. 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 Public 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 Public Offering.
Universal
Shelf and ATM
On
March 13, 2026, we filed a Registration Statement on Form S-3 with the SEC to offer and sell up to $50.0 million of our common stock
from time to time in one or more offerings (the “Universal Shelf”), which became effective on March 30, 2026. The Universal
Shelf includes a prospectus supplement providing for sales of up to $9.2 million of common stock pursuant to an At-the-Market (“ATM”)
program under a sales agent agreement we entered into with Brookline.
We
are subject to General Instruction I.B.6 of Form S-3 (the “baby shelf” rules), which limits the aggregate market value of
securities we may sell under the Universal Shelf to no more than one-third of our public float in any 12-month period while our public
float remains below $75.0 million. As of the filing of the Universal Shelf, one-third of our public float was approximately $9.2 million,
representing the maximum amount to be sold under the ATM. As of March 31, 2026, we have not sold any securities under the ATM.
Nasdaq
Compliance
Our
common stock is listed on The Nasdaq Capital Market (“Nasdaq”). Nasdaq requires that listed companies satisfy certain continued
listing requirements, including Listing Rule 5550(a)(2), which requires that listed companies maintain a minimum bid price of their common
stock of at least $1.00 per share (the “Bid Price Rule”).
18
On
March 18, 2026, we received written notice from Nasdaq indicating that our common stock failed to maintain the Bid Price Rule for 30
consecutive business days. While companies are typically afforded a 180-calendar day compliance period, as specified under Nasdaq Listing
Rule 5810(c)(3)(A), to comply with the Bid Price Rule, Nasdaq concluded that we are not eligible for the compliance period pursuant to
Nasdaq Listing Rule 5810(c)(3)(A)(iv) due to the fact that we effected a reverse stock split over the prior one-year period. Accordingly,
we requested a hearing before the Nasdaq Hearing Panel (the “Panel”), which automatically stayed any suspension or delisting
action pending the hearing and the expiration of any additional extension period granted by the Panel following the hearing. Our hearing
was held on April 28, 2026, during which we requested an extension for continued listing on Nasdaq
through May 15, 2026, the date we expected to demonstrate compliance with the Bid Price Rule (as discussed further below).
On May 5, 2026, the Panel granted our request for continued listing on
Nasdaq, subject to the following conditions: (i) on or before May 15, 2026, we shall demonstrate compliance with the
Bid Price Rule; (ii) from the date of the Panel decision until September 14, 2026 (the end of the Panel’s
jurisdiction in this matter), we shall maintain compliance with all Nasdaq Listing Rules; and (iii) we will be subject to a mandatory panel
monitor for a period of one year from the date of this determination pursuant to Rule 5815(d)(4)(B). If we do not maintain compliance
with all Nasdaq Listing Rules through September 14, 2026, the Panel will immediately delist our securities from Nasdaq. Additionally,
should we become deficient again with the Bid Price Rule during the one-year period ending May 5, 2027, Nasdaq will immediately issue
us a delisting determination
On
May 4, 2026, we effected the Reverse Stock Split and our stock price has since been closing above the minimum bid price of $1.00 per
share. To regain compliance with the Bid Price Rule, we must achieve a closing bid price of at least $1.00 for a minimum of 10 consecutive
business days, or through May 15, 2026, and we expect to regain compliance with the
Bid Price Rule as of such date.
Basis
of Presentation
Revenues
and Cost of Revenues
We
are a pre-clinical stage company and do not currently have any revenues from product sales or cost of revenues. We will not have revenues
from product sales or cost of revenues until such time as we receive regulatory approval of our product candidates and successfully commercialize
our products.
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 preclinical study costs, salaries and employee benefits, stock-based compensation
expense, supplies and materials, 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 stock-based compensation, for
our executive and administrative personnel, legal and other professional fees, travel, insurance, and other corporate costs.
19
Results
of Operations
Comparison
of the Three Months Ended March 31, 2026 and 2025
Three months ended March 31,
(In thousands)
2026
2025
Change
Operating expenses:
Research and development
$ 1,915
$ 1,309
$ 606
General and administrative
1,631
1,421
210
Impairment of goodwill
2,044
-
2,044
Total operating expenses
5,590
2,730
2,860
Loss from operations
(5,590 )
(2,730 )
(2,860 )
Other income (expense), net:
Forward sales contract expense
-
(5,335 )
5,335
Change in fair value of warrant liabilities
-
1
(1 )
Interest income, net
44
5
39
Other expense, net
-
(135 )
135
Total other income (expense), net
44
(5,464 )
5,508
Loss before income taxes
(5,546 )
(8,194 )
2,648
Benefit (provision) for income taxes
40
(8 )
48
Net loss
$ (5,506 )
$ (8,202 )
$ 2,696
Revenues
and Cost of Revenues
We
had no revenues or cost of revenues for the three months ended March 31, 2026 or 2025.
Research
and Development Expenses
Three months ended March 31,
2026
2025
Change
(in thousands)
Study fees
$ 1,267
$ 352
$ 915
Payroll and related
236
112
124
Professional fees
164
156
8
MSA/license fees
69
637
(568 )
Other
179
52
127
Total research and development expenses
$ 1,915
$ 1,309
$ 606
Total
research and development expenses increased for the three months ended March 31, 2026 compared to the three months ended March 31,
2025, primarily due to increased study fees related to ERNA-101 as well as increased payroll due to an increase in our research and
development headcount and increased other expenses, which includes travel, supplies and allocated rent. These increases were offset by a reduction in expenses related to our Master Service Agreement
(“MSA”) and the license and collaboration agreement (“the Factor L&C Agreement”) with Factor Bioscience
Limited (“Factor Limited”). Pursuant to the Factor L&C Agreement, we paid Factor Bioscience approximately $0.2
million per month from September 2024 through August 2025, and we paid approximately $0.1 million per month from September 2024
through May 2025. The Company will also pay certain milestone payments, royalty payments on net sales of commercialized products and
sublicensing fee payments, when applicable.
20
General
and Administrative Expenses
Three months ended March 31,
2026
2025
Change
(in thousands)
Payroll and related2
$ 802
$ 394
$ 408
Professional fees2
447
386
61
Stock-based compensation
296
486
(190 )
Other
86
155
(69 )
Total general and administrative expenses
$ 1,631
$ 1,421
$ 210
Our
general and administrative expenses for the three months ended March 31, 2026 increased by approximately $0.2 million primarily due to
increases in payroll related to certain accrued bonuses and in professional fees related to certain legal matters, offset by a reduction
in stock based compensation due to a reduction in the fair values of the equity awards that are amortizing during the three months ended
March 31, 2026 compared to the three months ended March 31, 2025, as well as decreased other expenses for occupancy costs, depreciation
and amortization, and reduced insurance premiums.
Impairment
of Goodwill
During
the three months ended March 31, 2026, we recognized a $2.0 million impairment charge of the goodwill we had on our balance sheet from
a 2018 acquisition because we concluded that the fair value of the reporting unit was less than the carrying value as of March 31, 2026,
and the goodwill was considered fully impaired. As of March 31, 2026, there was no remaining goodwill balance. We did not recognize a
similar expense during the three months ended March 31, 2025.
Forward
sales contract expense
During
the three months ended March 31, 2025, we recognized expense of $5.3 million related to a forward sales contract because the fair value
of the shares that were expected to be issued under a securities purchase agreement entered into on March 31, 2025 (the “2025 SPA”)
exceeded the expected proceeds. There was no similar transaction for the three months ended March 31, 2026.
Change
in Fair Value of Warrant Liabilities
The
change in the fair value of the warrant liabilities for the three months ended March 31, 2025 was de minimis. There was no change
in the fair value of the warrant liabilities recognized for the three months ended March 31, 2026.
Interest
Income (Expense), net
For
the three months ended March 31, 2026, we recognized approximately $39,000 more in interest income due to an increase of cash in interest-bearing
accounts compared to the three months ended March 31, 2025.
Other
Expense, net
During
the three months ended March 31, 2025, we recognized approximately $0.1 million of expenses related to the 2025 SPA transaction entered
into on March 31, 2025. There was no comparable expense for the three months ended March 31, 2026.
Benefit
(provision) for Income Taxes
During
2026, 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.
21
Liquidity
and Capital Resources
As
of March 31, 2026, we had cash of approximately $9.2 million, and we had an accumulated deficit of approximately $251.1 million. We have
to date incurred operating losses, and we expect these losses to continue in the future. For the three months ended March 31, 2026, we
incurred a net loss of $5.5 million, which includes the $2.0 million non-cash goodwill impairment charge, and we used $2.3 million of
cash in operating activities.
On
February 10, 2026, we received approximately $9.5 million in net proceeds from the Public Offering. On March 13, 2026, we filed the Universal
Shelf, which included a prospectus for a $9.2 million ATM. The Universal Shelf is subject to the baby shelf rules, and as of the filing
of the Universal Shelf, one-third of our public float was approximately $9.2 million, representing the maximum amount to be sold under
the ATM. As of March 31, 2026, we have not sold any securities under the ATM.
In
connection with preparing the financial statement as of and for the three months ended March 31, 2026, we evaluated whether there are
conditions and events, considered in the aggregate, that are known and reasonably knowable that would raise substantial doubt about our
ability to continue as a going concern within one year after the date that the financial statements are issued.
As of April 30, 2026, we had approximately $8.3 million in cash, which
is less than that needed to effect our current operating plan and forecasted cash requirements for the next twelve months. However, we
expect that our ability to access capital under our ATM will cover shortfalls in our cash resources over the next twelve months from the
issuance date of these financial statements.
If our cash is not
sufficient to meet future cash requirements, we may be required to reduce planned capital expenses, reduce operational cash uses or raise
capital on terms that are not as favorable to us as they otherwise might be. Any actions we may undertake to reduce planned capital purchases
or reduce expenses may be insufficient to cover shortfalls in available funds. If we require additional capital, we may be unable to
secure additional financing on terms that are acceptable to us, or at all.
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 three months ended March
31,
(in thousands)
2026
2025
Change
Cash (used in) provided by:
Operating activities
$ (2,264 )
$ (2,065 )
$ (199 )
Investing activities
(2 )
-
(2 )
Financing activities
9,559
2,254
7,305
Net increase in cash and cash equivalents
$ 7,293
$ 189
$ 7,104
Net
Cash Used in Operating Activities
There
was an increase of approximately $0.2 million in cash used in operating activities for the three months ended March 31, 2026 compared
to the three months ended March 31, 2025. This change was due a $0.8 million increase in net loss, after giving effect to adjustments
made for non-cash transactions, offset by a decrease of $0.6 million in cash used in operating assets and liabilities for the three months
ended March 31, 2026 when compared to the three months ended March 31, 2025.
22
Net
Cash Used in Investing Activities
We
used approximately $2,000 in cash for the purchases of property and equipment during the three months ended March 31, 2026, and we made
no purchases of property and equipment during the three months ended March 31, 2025.
Net
Cash Provided by Financing Activities
Net
cash provided by financing activities for the three months ended March 31, 2026 includes net proceeds of $9.5 million received from the
Public Offering, including proceeds from the exercise of prefunded warrants issued in the Public Offering. Net cash provided by financing
activities for the three months ended March 31, 2025 includes $2.3 million of gross proceeds received from the issuance of two promissory
notes as well as an immaterial amount received from the exercise of prefunded warrants.
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
There
were no significant changes in our critical accounting estimates during the three months ended March 31, 2026 from those described in
“Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of the 2025 10-K.
Recent
Accounting Pronouncements
See
Note 13 to the accompanying condensed consolidated financial statements.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
Under
the rules and regulations of the SEC, as a smaller reporting company we are not required to provide the information otherwise required
by this item.
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
We
maintain “disclosure controls and procedures,” as such term is defined under Rule 13a-15(e) promulgated under the Exchange
Act, designed to ensure that information required to be disclosed in our reports filed pursuant to the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated
and communicated to our management, including our principal executive officer and our principal financial officer, as appropriate, to
allow timely decisions regarding required disclosures.
In
designing and evaluating the disclosure controls and procedures, we recognized that any controls and procedures, no matter how well designed
and operated, can provide only reasonable assurance of achieving the desired control objectives, and we were required to apply our judgment
in evaluating the cost-benefit relationship of possible controls and procedures. We have carried out an evaluation as of the end of the
period covered by this Quarterly Report under the supervision, and with the participation, of our management, including our President
and Chief Executive Officer (who serves as our principal executive officer) and our Senior Vice President of Finance (who serves as our
principal financial officer) of the effectiveness of the design and operation of our disclosure controls and procedures.
Based
on that evaluation, our Chief Executive Officer and Senior Vice President of Finance concluded that our disclosure controls and procedures
were effective as of the end of the period covered by this Quarterly Report in providing reasonable assurance of achieving the desired
control objectives.
Changes
in Internal Control over Financial Reporting
There
was no change in our internal control over financial reporting during the most recent fiscal quarter that has materially affected, or
is reasonably likely to materially affect, our internal control over financial reporting.
23
PART
II — OTHER INFORMATION
Item
1. Legal Proceedings.
The
information set forth under “Note 10—Commitments and Contingencies—Litigation Matters” to the accompanying condensed
consolidated financial statements included in this Quarterly Report is incorporated in this Item 1 by reference.
From
time to time, we may become involved in legal proceedings arising in the ordinary course of business. We are not currently party to any
material legal proceedings.
Item
1A. Risk Factors.
An
investment in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described under
Part I, Item 1A, “Risk Factors,” in our 2025 10-K, in addition to other information in this report, when evaluating our business
and before deciding whether to purchase, hold or sell shares of our common stock. Each of these risks and uncertainties, as well as additional
risks and uncertainties not presently known to us or that we currently consider immaterial, could harm our business, financial condition,
results of operations and/or growth prospects, as well as adversely affect the market price of our common stock, in which case you may
lose all or part of your investment. There have been no material changes to the risk factors described in the 2025 10-K.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item
3. Defaults Upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
Applicable.
Item
5. Other Information.
(a)
None.
(b)
None.
(c)
During the quarter covered by this report, none of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act)
adopted or terminated any Rule 10b5-1 trading arrangement (as defined in Item 408(a)(1)(i) of Regulation S-K) or any non-Rule 10b5-1
trading arrangement (as defined in Item 408(c) of Regulation S-K).
24
Item
6. Exhibits
Exhibit
Description
Incorporated
By Reference
4.1
Form of Pre-Funded Warrant.
Exhibit
4.1 to Form 8-K filed on February 11, 2026
4.2
Form of Common Warrant (“Milestone Warrant”).
Exhibit
4.2 to Form 8-K filed on February 11, 2026
10.1
Form of Securities Purchase Agreement, by and between Ernexa Therapeutics Inc. and certain investors, dated as of February 6, 2026.
Exhibit
10.1 to Form 8-K filed on February 11, 2026
10.2
Warrant Agent Agreement, by and among Ernexa Therapeutics Inc., Computershare Inc. and Computershare Trust Company, N.A., dated as of February 10, 2026.
Exhibit
10.2 to Form 8-K filed on February 11, 2026
10.3
Sales Agreement, dated March 13, 2026, by and between the Company and Brookline Capital Markets, a division of Arcadia Securities, LLC
Exhibit
1.1 to Form 8-K filed on March 16, 2026
10.4
Placement Agency Agreement, by and between Ernexa Therapeutics Inc. and Brookline Capital Markets, a division of Arcadia Securities, LLC, dated as of February 6, 2026.
Exhibit 1.1 to Form 8-K filed on February 11, 2026
31.1
Certification
of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Filed
herewith
31.2
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Filed
herewith
32.1
Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Furnished
herewith
32.2
Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Furnished
herewith
101
Inline
XBRL Document Set for the financial statements and accompanying notes in Part I, Item 1, of this Quarterly Report on Form 10-Q.
Filed
herewith
104
Cover
Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101).
25
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
the undersigned hereunto duly authorized.
ERNEXA
THERAPEUTICS INC.
Date:
May 11, 2026
By:
/s/
Sanjeev Luther
Sanjeev
Luther
President
and Chief Executive Officer
(Principal
Executive Officer)
Date:
May 11, 2026
By:
/s/
Sandra Gurrola
Sandra
Gurrola
Senior
Vice President of Finance
(Principal
Financial Officer and Principal Accounting Officer)
26
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.