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 June 30, 2025
☐
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 001-38538
electroCore,
Inc.
(Exact
name of Registrant as specified in its charter)
Delaware
20-3454976
(State
or other jurisdiction of incorporation or organization)
(I.R.S.
Employer Identification No.)
200
Forge Way , Suite 205 , Rockaway , NJ 07866
(Address
of principal executive offices, including zip code)
(973)
290-0097
(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, par value $0.001 per share
ECOR
Nasdaq
Capital Market
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, smaller reporting company,
or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller
reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
filer
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No
As
of August 5, 2025, the registrant had 7,583,445
shares of
common stock outstanding.
PART
I. FINANCIAL INFORMATION
Page
Number
Cautionary Note Regarding Forward-Looking Statements
3
Item
1.
Financial
Statements
Condensed Consolidated Balance Sheets as of June 30, 2025 (Unaudited) and December 31, 2024
4
Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2025 and 2024 (Unaudited)
5
Condensed Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2025 and 2024 (Unaudited)
6
Condensed Consolidated Statements of Equity for the Three and Six Months Ended June 30, 2025 and 2024 (Unaudited)
7
Condensed
Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2025 and 2024 (Unaudited)
8
Notes to Condensed Consolidated Financial Statements (Unaudited)
9
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
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
25
Item
6.
Exhibits
27
Signatures
28
2
REFERENCES
TO ELECTROCORE
In
this Quarterly Report on Form 10-Q (this “Quarterly Report”), unless otherwise stated or the context otherwise requires,
references to the “Company,” “electroCore,” “we,” “us” and “our” refer to
electroCore, Inc. a Delaware corporation and its subsidiaries.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements that involve risks and uncertainties. Our actual
results could differ materially from those discussed in the forward-looking statements. The statements contained in this Quarterly Report
that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended,
or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements
are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,”
“continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“project,” “seek,” “should,” “strategy,” “target,” “will,” “would”
and similar expressions or variations intended to identify forward-looking statements. These statements are based on the beliefs and
assumptions of our management based on information currently available to them. Such forward-looking statements are subject to risks,
uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from
future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include,
but are not limited to risks and uncertainties included in our Form 10-Qs, our annual report on Form 10-K for the year ended December
31, 2024 (the “Annual Report”), in our other filings with the U.S. Securities and Exchange Commission (the “SEC”)
or in materials incorporated by reference therein, including the information in the sections entitled “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and Results of Operations” in such filings. Furthermore,
any such forward-looking statements in this Quarterly Report speak only as of the date of this Quarterly Report. Except as required by
law, we undertake no obligation to update or revise any forward-looking statements to reflect events or circumstances after the date
of such statements.
The
electroCore logo, gammaCore, Truvaga, TAC-STIM, NeuroMetrix, Quell, names, logos, and other trademarks of electroCore, Inc. appearing
in this Quarterly Report are the property of electroCore, Inc. All other trademarks, service marks and trade names in this Quarterly
Report are the property of their respective owners. We have omitted the ® and ™ designations, as applicable, for the trademarks
used in this Quarterly Report.
3
ELECTROCORE,
INC. AND SUBSIDIARIES
Condensed
Consolidated Balance Sheets
(unaudited)
(in
thousands, except share data)
June 30,
December 31,
2025
2024
Assets
Current assets:
Cash and cash equivalents
$ 3,373
$ 3,450
Restricted cash
250
250
Marketable securities
3,772
8,519
Accounts receivable, net
813
1,367
Inventories
1,427
1,676
Prepaid expenses and other current assets
922
1,038
Total current assets
10,557
16,300
Property and equipment, net
197
158
Operating lease right of use assets, net
3,663
3,739
Other assets, net
142
274
Total assets
$ 14,559
$ 20,471
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 2,567
$ 1,827
Accrued expenses and other current liabilities
6,646
6,964
Current portion of operating lease liabilities
405
361
Total current liabilities
9,618
9,152
Noncurrent liabilities:
Operating lease liabilities, noncurrent
3,828
3,775
Total liabilities
13,446
12,927
Contingencies (see Note 14)
-
-
Stockholders’ equity:
Common Stock, par value $ 0.001 per share; 500,000,000 shares authorized at June 30, 2025 and December 31, 2024; 7,466,425 shares issued and outstanding at June 30, 2025 and 6,650,854 shares issued and outstanding at December 31, 2024
7
7
Additional paid-in capital
185,741
184,513
Accumulated deficit
( 184,616 )
( 177,090 )
Accumulated other comprehensive income
( 19 )
114
Total stockholders’ equity
1,113
7,544
Total liabilities and stockholders’ equity
$ 14,559
$ 20,471
See
accompanying notes to unaudited condensed consolidated financial statements.
4
ELECTROCORE,
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Operations
(unaudited)
(in
thousands, except per share data)
2025
2024
2025
2024
Three Months Ended
June 30,
Six Months Ended
June 30,
2025
2024
2025
2024
Net sales
$ 7,381
$ 6,139
$ 14,100
$ 11,582
Cost of goods sold
939
838
1,952
1,726
Gross profit
6,442
5,301
12,148
9,856
Operating expenses
Research and development
511
635
1,153
1,034
Selling, general and administrative
9,437
7,257
18,323
15,262
Total operating expenses
9,948
7,892
19,476
16,296
Loss from operations
( 3,506 )
( 2,591 )
( 7,328 )
( 6,440 )
Other (income) expense
Interest and other income
( 68 )
( 55 )
( 151 )
( 280 )
Other expense
233
119
397
123
Total other expense (income)
165
64
246
( 157 )
Loss before income taxes
( 3,671 )
( 2,655 )
( 7,574 )
( 6,283 )
Benefit from income taxes
-
-
48
122
Net loss
$ ( 3,671 )
$ ( 2,655 )
$ ( 7,526 )
$ ( 6,161 )
Net loss per share of common stock – Basic and Diluted
( 0.44 )
( 0.38 )
( 0.91 )
( 0.90 )
Weighted average common shares outstanding – Basic and Diluted (see Note 12)
8,316
7,046
8,302
6,831
See
accompanying notes to unaudited condensed consolidated financial statements.
5
ELECTROCORE,
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Comprehensive Loss
(unaudited)
(in
thousands)
2025
2024
2025
2024
Three Months Ended
June 30,
Six Months Ended
June 30,
2025
2024
2025
2024
Net loss
( 3,671 )
( 2,655 )
( 7,526 )
( 6,161 )
Other comprehensive (loss) income:
Foreign currency translation adjustment
( 89 )
33
( 133 )
109
Other comprehensive (loss) income
( 89 )
33
( 133 )
109
Comprehensive loss
$ ( 3,760 )
$ ( 2,622 )
$ ( 7,659 )
$ ( 6,052 )
See
accompanying notes to unaudited condensed consolidated financial statements.
6
ELECTROCORE,
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Equity
For
the Six Months Ended June 30, 2025 and 2024
(unaudited)
(in
thousands)
Shares
Amount
capital
deficit
income (loss)
equity
Stockholders’ Equity
Accumulated
Common
Stock
Additional
paid-in
Accumulated
other
comprehensive
Total
stockholders’
Shares
Amount
capital
deficit
income (loss)
equity
Balances as of January 1, 2025
6,651
$ 7
$ 184,513
$ ( 177,090 )
$ 114
$ 7,544
Net loss
—
—
—
( 3,855 )
—
( 3,855 )
Other comprehensive income
—
—
—
—
( 44 )
( 44 )
Sale of common stock
14
—
217
—
—
217
Financing fees
—
—
( 38 )
—
—
( 38 )
Proceeds from the exercise of warrants
725
—
1
—
—
1
Issuance of stock related to employee compensation, net
30
—
—
—
—
—
Share based compensation
—
—
540
—
—
540
Balances as of March 31, 2025
7,420
7
$ 185,233
$ ( 180,945 )
$ 70
$ 4,365
Net loss
—
—
—
( 3,671 )
—
( 3,671 )
Other comprehensive income
—
—
—
—
( 89 )
( 89 )
Options exercised
10
—
45
—
—
45
Financing fees
—
—
( 42 )
—
—
( 42 )
Issuance of stock related to employee compensation, net
36
—
—
—
—
—
Share based compensation
—
—
505
—
—
505
Balances as of June 30, 2025
7,466
7
$ 185,741
$ ( 184,616 )
$ ( 19 )
$ 1,113
Balances as of January 1, 2024
6,003
$ 6
$ 172,704
$ ( 165,204 )
$ ( 64 )
$ 7,442
Net loss
—
—
—
( 3,506 )
—
( 3,506 )
Other comprehensive income
—
—
—
—
76
76
Issuance of stock related to employee compensation plan, net of forfeitures
3
—
—
—
—
—
Share based compensation
—
—
484
—
—
484
Balances as of March 31, 2024
6,006
$ 6
$ 173,188
$ ( 168,710 )
$ 12
$ 4,496
Balance
6,006
$ 6
$ 173,188
$ ( 168,710 )
$ 12
$ 4,496
Net loss
—
—
—
( 2,655 )
—
( 2,655 )
Other comprehensive income
—
—
—
—
33
33
Sale of common stock and warrants
438
—
9,306
—
—
9,306
Financing Fees
—
—
( 180 )
—
—
( 180 )
Issuance of stock related to employee compensation plan, net of forfeitures
3
—
—
—
—
—
Share based compensation
—
—
472
—
—
472
Balances as of June 30, 2024
6,447
$ 6
$ 182,786
$ ( 171,365 )
$ 45
$ 11,472
Balance
6,447
$ 6
$ 182,786
$ ( 171,365 )
$ 45
$ 11,472
See
accompanying notes to unaudited condensed consolidated financial statements.
7
ELECTROCORE,
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Cash Flows
(unaudited)
(in
thousands)
2025
2024
Six months ended June 30,
2025
2024
Cash flows from operating activities:
Net loss
$ ( 7,526 )
$ ( 6,161 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
1,045
956
Depreciation and amortization
276
407
Amortization of right of use assets
77
43
Amortization of operating lease liability
250
—
Increase (decrease) in provision for credit losses
541
—
Changes in operating assets and liabilities:
Accounts receivable
13
179
Inventories
249
( 93 )
Prepaid expenses and other assets
( 8 )
426
Accounts payable
714
299
Accrued expenses and other current liabilities
( 428 )
( 417 )
Operating lease liabilities
( 181 )
31
Net cash used in operating activities
( 4,978 )
( 4,330 )
Cash flows from investing activities:
Sale (purchase) of marketable securities
4,747
( 3,928 )
Purchase of equipment
( 62 )
—
Net cash provided by (used in) investing activities
4,685
( 3,928 )
Cash flows from financing activities:
Sale of common stock and warrants
217
8,300
Financing fees
( 80 )
( 180 )
Proceeds from the exercise of options
45
—
Proceeds from exercise of warrants
1
—
Net cash provided by financing activities
183
8,120
Effect of changes in exchange rates on cash and cash equivalents
33
109
Net decrease in cash and cash equivalents and restricted cash
( 77 )
( 29 )
Cash, cash equivalents, and restricted cash – beginning of period
3,700
10,581
Cash, cash equivalents, and restricted cash – end of period
$ 3,623
$ 10,552
Supplemental cash flows disclosures:
Proceeds from sale of state net operating losses
$ 48
122
Interest paid
$ 5
$ 7
Supplemental schedule of noncash activity:
Accounts payable paid through issuance of common stock and warrants
$ —
$ 1,006
Right-of-use asset and liability
$ —
$ 3,316
See
accompanying notes to unaudited condensed consolidated financial statements.
8
ELECTROCORE,
INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (unaudited)
Note
1. The Company
electroCore,
Inc. and its subsidiaries (“electroCore” or the “Company”) is a commercial stage bioelectronic technology company
whose mission is to improve health and quality of life through innovative non-invasive bioelectronic technologies.
electroCore,
headquartered in Rockaway, NJ, has three wholly owned subsidiaries: electroCore UK Ltd, electroCore Germany GmbH and NeuroMetrix, Inc.
(“NURO”). The Company has paused operations in Germany, with sales into the country and the rest of Europe being managed
by electroCore UK Ltd.
Note
2. Summary of Significant Accounting Policies
(a) Basis of Presentation
The
accompanying condensed consolidated financial statements were prepared in conformity with accounting principles generally accepted in
the United States of America (“U.S. GAAP”) and with instructions to Form 10-Q and Article 10 of Regulation S-X under the
Securities Exchange Act of 1934, as amended. In the opinion of management, the Company has made all necessary
adjustments, which include normal recurring adjustments necessary for a fair presentation of the Company’s condensed consolidated
financial position and results of operations for the interim periods presented. Certain information and disclosures normally included
in the annual consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These interim condensed
consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes
for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K
filed with the Securities and Exchange Commission on March 12, 2025. The results for the three and six months ended June 30, 2025, are
not necessarily indicative of the results to be expected for a full year, any other interim periods or any future year or period.
(b) Principles of Consolidation
The
accompanying condensed consolidated financial statements include the accounts of electroCore and its wholly owned subsidiaries. All intercompany
balances and transactions have been eliminated in consolidation.
(c) Use of Estimates
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial
statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Significant items subject to such estimates and assumptions include revenue, licensed products and loss contingencies.
(d) Cash, Cash Equivalents and Restricted Cash
The
following table provides a reconciliation of cash, cash equivalents and restricted cash to the balance reflected on the Condensed Consolidated
Statement of Cash Flows at June 30, 2025 and December 31, 2024:
Schedule of Cash, Cash Equivalents and Restricted Cash
(in thousands)
June 30,
2025
December 31,
2024
Cash and cash equivalents
$ 3,373
$ 3,450
Restricted cash
250
250
Total cash, cash equivalents and restricted cash
$ 3,623
$ 3,700
As
of June 30, 2025, cash equivalents represented funds held in an interest-bearing demand deposit account, U.S. treasury bills, and a money
market account.
The
Company’s restricted cash consists of cash that the Company is contractually obligated to maintain in accordance with the terms
of its corporate credit card arrangement with Citibank, N.A.
( e) Marketable Securities
Marketable
securities are carried at fair value, with unrealized gains and losses reported as accumulated other comprehensive income, except for
losses from impairments which are determined to be other than temporary. Realized gains and losses and declines in value judged to be
other-than-temporary are included in the determination of net loss and are included in interest and other income net. Fair values are
based on quoted market prices at the reporting date. Interest and dividends on available-for-sale securities are included in Interest
and other income. As of June 30, 2025, marketable securities amounted to $ 3.8 million and consist of U.S. treasury bills. The Company
held $ 8.5 million of marketable securities at December 31, 2024.
9
ELECTROCORE,
INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (unaudited)
(f) Recent Accounting Standards Pronouncements
In
December 2023, the FASB issued Accounting Standards Update (ASU) No. 2023-09, Income Taxes (Topic 740) , Improvements to Income
Tax Disclosures which will require companies to make additional income tax disclosures. The pronouncement is effective for annual
filings for the year ended December 31, 2025. The Company is still assessing the impact of the adoption of this standard but does not
expect it to have a material impact on its results of operations, financial position or cash flows.
On
November 2024, the FASB issued Accounting Standards Update (ASU) No. 2024-03, Income Statement (Topic 220): Reporting Comprehensive
Income - Expense Disaggregation Disclosures, Disaggregation of Income Statement Expenses , which requires public companies to disclose,
in interim and annual reporting periods, additional information about certain expenses in the financial statements. The amendments in
this pronouncement will be effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after
December 15, 2027. Early adoption is permitted and is effective on either a prospective basis or retrospective basis. The Company is
currently assessing the potential impacts of adoption on its consolidated financial statements and related disclosures.
Note
3. Liquidity, Significant Risks and Uncertainties
Liquidity
The
Company has experienced significant net losses, and it expects to continue to incur net losses for the near future as it works to
increase market acceptance of its prescription (Rx) products and general wellness and human performance products. The Company has
never been profitable and has incurred net losses and negative cash used in operations each year since its inception. The Company
incurred net losses of $ 7.5
million and $ 6.2
million and used cash in its operations of $ 5.0
million and $ 4.3
million for the six months ended June 30, 2025, respectively.
The
Company has historically funded its operations from the sale of its securities. During the six months ended June 30, 2025, the Company
received net proceeds of approximately $ 0.2 million from such sales and as of June 30, 2025, the Company’s cash, cash equivalents,
restricted cash and marketable securities totaled $ 7.4 million (“Cash Position”).
On
July 24, 2025, our Form S-3 registration statement (File No. 333-284477), or the 2025 Shelf Registration Statement, was declared effective
by the SEC. The 2025 Shelf Registration Statement relates to the potential offering and issuance from time to time of common stock, preferred
stock, warrants, rights, debt securities and units, up to an aggregate amount of $ 100.0
million. The proposed maximum offering price per unit and the
proposed maximum aggregate offering price per class of security in any future offering under the 2025 Shelf Registration Statement will
be determined from time to time by us in connection with the issuance by us of the securities registered under the 2025 Shelf Registration
Statement. As of the date of this Quarterly Report, we have $ 100.0
million remaining for potential issuance under the 2025 Shelf
Registration Statement (including $ 19.8 million under the Sales Agreement (as defined below)). If we raise additional funds by issuing equity or debt securities, either through
the sale of securities pursuant to a registration statement or by other means, our existing stockholders may experience dilution, and
the new equity or debt securities may have rights, preferences and privileges senior to those of our existing stockholders.
On
November 29, 2024, we entered into an At The Market Offering Agreement (the “Sales Agreement”) with H.C. Wainwright &
Co., LLC (“Wainwright”), whereby the Company may offer and sell shares of its common stock from time to time having an aggregate
offering price of up to $ 20 million by any method deemed to be an “at-the-market” offering (“ATM”) as defined
in Rule 415 of the Securities Act, or any other method specified in the Sales Agreement.
On August 4, 2025 (the “LSA Closing Date”), we, and our wholly
owned subsidiary, NURO, each as borrowers, entered into a Loan and Security Agreement (the “Loan and Security Agreement”),
with Avenue Venture Opportunities Fund II, L.P. (“Avenue”), as administrative agent and collateral agent, and as lender, that
is secured by a lien on substantially all of our assets, including a negative pledge on intellectual property, subject to limited exceptions,
pursuant to the Loan and Security Agreement. The Loan and Security Agreement provides for term loans in an aggregate principal amount
of up to $ 12.0 million (the “Loan Amount”) to be delivered in two tranches (the “Term Loans”). The tranches consist
of (i) a term loan advanced to the Company on the LSA Closing Date in an aggregate principal amount of $ 7.5 million (“Tranche 1”),
and (ii) subject to the achievement of certain performance milestones set forth in the Loan and Security Agreement, a right of the Company
to request that Avenue make additional term loan advances to the Company in an aggregate principal amount of up to $ 4.5 million (“Tranche
2”), which right expires on December 31, 2025 .
In
the second half of 2025, we intend to continue to make targeted investments in sales and marketing to continue driving commercial activities.
We have historically funded our operations from the sale of our common stock, and most recently the convertible debt financing with Avenue, and may continue to do so through utilization of the at-the-market
facility or other equity or debt transactions if needed. As of the date of this Quarterly Report, the Company had approximately $ 19.8
million of common stock remaining available for issuance under the Sales Agreement pursuant to the 2025 Shelf Registration Statement.
The
Company’s expected cash requirements for the next 12 months from the date these financial statements are issued and beyond are
largely based on the commercial success of its products. Based on its current assessment, the Company believes its cash, cash
equivalents, restricted cash, and marketable securities, plus the net proceeds from and expected cash flow from operations and
access to capital through use of the ATM and Tranche 2 of the Term Loan, will enable it to fund its operating expenses and capital
expenditure requirements, as currently planned, for at least the next 12 months from the date the accompanying financial statements
are issued. There remain significant risks and uncertainties regarding the Company’s business, financial condition and results
of operations. The Company’s future capital requirements are difficult to forecast and will depend on many factors that are
out of its control. If the Company is unable to achieve its planned operating results or maintain sufficient financial resources,
including through potential positive cash flow from operations or supplemental access to third-party debt, equity or hybrid capital,
its business, financial condition and results of operations may be materially and adversely affected.
Concentration
of Revenue Risks
The
Company earns a significant amount of its revenue in the United States from the United States Department of Veterans Affairs and United
State Department of Defense, or VA, pursuant to its qualifying contract under the Federal Supply Schedule, or FSS, and open market sales
to individual VA facilities. For the three months ended June 30, 2025 and 2024, sales to the VA accounted for 71.8 % and 74.5 % of net
sales, respectively. For the six months ended June 30, 2025 and 2024, sales to the VA accounted for 71.1 % and 72.9 % of net sales, respectively.
For
the three and six months ended June 30, 2025 and 2024, Lovell Government Services, or Lovell, accounted
for more than 10 % of our VA net sales . During the three and six months ended June 30, 2025, sales associated with no single facility
accounted for more than 10 % of the total VA net sales. One facility accounted for more than 10 % of the total VA net sales during the
three and six months ended June 30, 2024. During the three and six months ended June 30, 2025 and 2024, one facility accounted for more
than 10 % of net sales from the United Kingdom National Health Service (“NHS”).
Foreign
Currency Exchange
The
Company has foreign currency exchange risks related to revenue and operating expenses in currencies other than the local currencies in
which it operates. The Company is exposed to currency risk from the potential changes in the functional currency values of its assets,
liabilities, and cash flows denominated in foreign currencies.
10
ELECTROCORE,
INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (unaudited)
Note
4. Revenue
The
following tables present product net sales disaggregated by Channel and Geographic Market (in thousands):
Schedule of Net Sales Disaggregated By Channel
Channel:
2025
2024
Three months ended June 30,
Channel:
2025
2024
Rx gammaCore – VA
$ 5,185
$ 4,572
Rx gammaCore - U.S. Commercial
394
476
Rx Quell – VA
114
-
Quell – U.S. Commercial
48
-
Outside the United States
465
464
Truvaga
994
572
Total before TAC-STIM
7,200
6,084
TAC-STIM
181
55
Total Net Sales
$ 7,381
$ 6,139
Channel:
2025
2024
Six months ended June 30,
Channel:
2025
2024
Rx gammaCore – VA
$ 9,906
$ 8,447
Rx gammaCore - U.S. Commercial
683
909
Rx Quell – VA
114
-
Quell – U.S. Commercial
48
-
Outside the United States
978
913
Truvaga
2,100
957
Total before TAC-STIM
13,829
11,226
TAC-STIM
271
356
Total Net Sales
$ 14,100
$ 11,582
Schedule of Net Sales Disaggregated By Geographic Market
Product revenue
2025
2024
Geographic Market:
Three months ended June 30,
Product revenue
2025
2024
United States
$ 6,895
$ 5,675
United Kingdom
433
427
Other
36
22
License revenue
Japan
17
15
Total Net Sales
$ 7,381
$ 6,139
Product revenue
2025
2024
Geographic Market:
Six months ended June 30,
Product revenue
2025
2024
United States
$ 13,101
$ 10,669
United Kingdom
884
812
Other
83
67
License revenue
Japan
32
34
Total Net Sales
$ 14,100
$ 11,582
The
Company generally invoices the customer and recognizes revenue once its performance obligations are satisfied, at which point payment
is unconditional. Agreed upon payment terms with customers are within 30 days of shipment. Accordingly, contracts with customers do not
include a significant financing component.
Note
5. Cash, Cash Equivalents, Restricted Cash and Marketable Securities
The
following tables summarize the Company’s cash, cash equivalents, restricted cash and marketable securities as of June 30, 2025
and December 31, 2024.
Schedule of Cash, Cash Equivalents, Restricted Cash and Marketable Securities
As
of June 30, 2025
Amortized Cost
Unrealized Gain
Unrealized (Loss)
Fair Value
Cash, cash equivalents and restricted cash
$ 3,623
$ —
$ —
$ 3,623
Marketable Securities:
U.S. Treasury Bills
3,772
—
—
3,772
Total marketable securities
3,772
—
—
3,772
Total cash, cash equivalents, restricted cash and marketable securities
$ 7,395
$ —
$ —
$ 7,395
As of December 31, 2024
Amortized Cost
Unrealized Gain
Unrealized (Loss)
Fair Value
Cash, cash equivalents and restricted cash
$ 3,700
$ —
$ —
$ 3,700
Marketable Securities:
U.S. Treasury Bills
8,519
—
—
8,519
Total marketable securities
8,519
—
—
8,519
Total cash, cash equivalents, restricted cash and marketable securities
$ 12,219
$ —
$ —
$ 12,219
11
ELECTROCORE,
INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (unaudited)
Note
6. Fair Value Measurements
Financial
assets and liabilities carried at fair value are classified and disclosed in one of the following three levels of the fair value hierarchy:
●
Level
1—Quoted prices in active markets for identical assets or liabilities.
●
Level
2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities,
quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable
or can be corroborated by observable market data.
●
Level
3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value
of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
A
summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows:
Summary of Assets and Liabilities Carried at Fair Value
June 30, 2025
Total
Level 1
Level 2
Level 3
Fair Value Hierarchy
June 30, 2025
Total
Level 1
Level 2
Level 3
Assets
Cash, cash equivalents and restricted cash
$ 3,623
$ 3,623
$ —
$ —
Marketable Securities:
U.S. treasury bills
3,772
3,772
—
—
Total cash, cash equivalents, restricted cash and marketable securities
$ 7,395
$ 7,395
$ —
$ —
December 31, 2024
Total
Level 1
Level 2
Level 3
Fair Value Hierarchy
December 31, 2024
Total
Level 1
Level 2
Level 3
Assets
Cash, cash equivalents and restricted cash
$ 3,700
$ 3,700
$ —
$ —
Marketable Securities:
U.S. treasury bills
8,519
8,519
—
—
Total cash, cash equivalents and restricted cash
$ 12,219
$ 12,219
$ —
$ —
As
of June 30, 2025, the Company’s Marketable securities in the amount of $ 3.8 million were carried at fair value in accordance with
Level 1 as described above. As of June 30, 2025 and December 31, 2024, the Company had no financial assets or liabilities that required
valuation in accordance with the levels described above. The Company recognizes transfers between levels of the fair value hierarchy
as of the end of the reporting period. There were no transfers within the hierarchy during the three and six months ended June 30, 2025,
and year ended December 31, 2024. The carrying amount of the Company’s receivables and payables approximate their fair value due
to their maturity.
Note
7. Inventories
As
of June 30, 2025 and December 31, 2024, inventories consisted of the following:
Schedule of Inventories
(in thousands)
June 30, 2025
December 31, 2024
Raw materials
$ 1,010
$ 923
Work in process
28
193
Finished goods
389
560
Total inventories
$ 1,427
$ 1,676
The
reserve for obsolete inventory was $ 0.5 million and $ 0.6 million as of June 30, 2025 and December 31, 2024, respectively. The Company
records charges for obsolete inventory in cost of goods sold. Inventory classified under the category “Work in process” consists
of prefabricated assembled product.
Note
8. Leases
For
the three and six months ended June 30, 2025, the Company recognized lease expenses of approximately $ 178,000 and $ 356,000 , respectively.
For the three and six months ended June 30, 2024, the Company recognized lease expenses of approximately $ 61,000 and $ 99,000 , respectively.
This expense does not include non-lease components associated with the lease agreements as the Company elected not to include such charges
as part of the lease expense.
On
February 6, 2024, the Company entered into The First Amendment to Lease Agreement (the “Rockaway Amendment”) to extend its
Rockaway, New Jersey lease for an additional 10 years. The Rockaway Amendment was effective May 1, 2024 , and expires on July 31, 2034 ,
with a tenant option to renew for an additional five years . The increase in the term of the lease for the existing leased property was
accounted for as a lease modification, therefore, the associated operating lease right of use assets and operating lease liabilities
for the existing space were remeasured as of February 6, 2024. The Rockaway Amendment also includes the expansion of leased property
from 13,643 square feet to 22,557 square feet. The Company has accounted for the expansion space as an increase in lease right of use
assets effective with the Rockaway Amendment commencement date of June 1, 2024 .
On
May 1, 2025, the Company completed the acquisition of NURO, pursuant to the terms of the Agreement and Plan of Merger dated as of December
17, 2024 (the “Merger Agreement”), with NURO surviving as a wholly-owned subsidiary of the Company. On July 14, 2025, NURO
entered into the Amendment to Lease #1 to a lease with Cummings Properties, LLC providing for early termination of NURO’s Woburn,
Massachusetts lease on July 30, 2025, which otherwise would have expired on September 15, 2025.
12
ELECTROCORE,
INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (unaudited)
Supplemental
Balance Sheet Information for Operating Leases:
Schedule of Operating Leases
(in thousands)
June 30,
2025
December 31,
2024
Operating leases:
Operating lease right of use assets
$ 3,663
$ 3,739
Operating lease liabilities:
Current portion of operating lease liabilities
405
361
Noncurrent operating lease liabilities
3,828
3,775
Total operating lease liabilities
$ 4,233
$ 4,136
Weighted average remaining lease term (in years)
14.0
14.5
Weighted average discount rate
13.5 %
13.5 %
Future
lease payments as of June 30, 2025:
Schedule of Future Lease Payments
(in thousands)
Remainder of 2025
$ 187
2026
530
2027
625
2028
649
2029
663
2030 and thereafter
7,736
Total future lease payments
10,390
Less: Amounts representing interest
( 6,157 )
Total
$ 4,233
Note
9. Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities as of June 30, 2025 and December 31, 2024 consisted of the following:
Schedule of Accrued Expenses and Other Current Liabilities
(in thousands)
June 30, 2025
December 31, 2024
Accrued professional fees
$ 900
$ 598
Accrued bonuses and incentive compensation
1,856
2,886
Accrued litigation legal fees
1,155
1,163
Accrued insurance expense
—
205
Accrued research and development expenses
655
655
Accrued vacation and other employee related expenses
811
781
Accrued tax expenses
512
382
Deferred revenue
68
78
Accrued acquisition related expenses
349
—
Other
340
216
Accrued expenses and
other current liabilities
$ 6,646
$ 6,964
Finance
and Security Agreement
On
July 2, 2024, the Company entered into a Commercial Insurance Premium Finance and Security Agreement (the “2024 Agreement”).
The 2024 Agreement provides for a single borrowing of approximately $ 493,000 with a ten-month term and an annual interest rate of 8.75 %.
The proceeds from this transaction were used to partially fund the premiums due under certain of the Company’s insurance policies.
The amounts payable are secured by the Company’s rights under such policies. Beginning July 2024, the Company began paying monthly
installments of approximately $ 51,000 .
During
the three and six months ended June 30, 2025, the Company recognized $ 4,500 and $ 9,500 in aggregate interest expense related to the Company’s
finance and security agreements, respectively. During the three and six months ended June 30, 2024, the Company recognized $ 4,300 and
$ 8,500 in aggregate interest expense related to the Company’s finance and security agreements, respectively.
On
July 7, 2025, the Company and First Insurance Funding entered into a Commercial Insurance Premium Finance Agreement (the “2025
Finance Agreement”). The 2025 Finance Agreement provides for a single borrowing of approximately $ 452,000 with a ten-month term
and an annual interest rate of 6.55 %. The proceeds from this transaction were used to partially fund the premiums due under certain of
the Company’s insurance policies. The amounts payable are secured by the Company’s rights under such policies. Beginning
July 2025, the Company began paying monthly installments of approximately $ 45,000 .
Note
10. Shareholders’ Equity
At-the-Market
Facility
On
November 29, 2024, we entered into the Sales Agreement with Wainwright. Under the Sales Agreement, the Company may offer and sell shares
of its common stock, par value $ 0.001 per share, from time to time having an aggregate offering price of up to $ 20 million during the
term of the Sales Agreement through Wainwright, acting as sales agent. The Company intends to use the net proceeds from any offering
pursuant to the Sales Agreement to continue to fund sales and marketing, working capital and for other general corporate purposes. During
the six months ended June 30, 2025 the company sold 14,265 shares of common stock for gross proceeds of approximately $ 217,000 . This
amount has been offset by financing fees of approximately $ 80,000 .
13
ELECTROCORE,
INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (unaudited)
Stock
Purchase Warrants
The
following table presents a summary of stock purchase warrants outstanding as of June 30, 2025:
Schedule of Stock Purchase Warrants Outstanding
Number of Warrants
(in thousands)
Weighted Average Exercise Price
Weighted Average Remaining Contractual Term
(Years)
Aggregate Intrinsic Value (in thousands)
Outstanding, January 1, 2025
1,497
$ 5.31
4.2
$ 16,489
Stock purchase warrants granted
—
—
—
—
Exercised
—
—
—
—
Expired
—
—
—
—
Outstanding, June 30, 2025
1,497
$ 5.31
3.7
$ 832
Exercisable, June 30, 2025
1,497
$ 5.31
3.7
$ 832
A
total of 883,433 pre-funded warrants were excluded from this table. During the six months ended June 30, 2025 investors exercised 725,000
pre-funded warrants.
Note
11. Net Loss Per Share
Basic
net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the
period. Diluted loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding
adjusted to give effect to potentially dilutive securities. Due to their nominal exercise price of $ 0.001
per share, 883,433
and 1,608,433 pre-funded warrants are considered common stock equivalents during the three and six months ended June 30,
2025 and 2024, respectively, and are included in weighted average shares outstanding in the accompanying condensed consolidated
statement of operations as of the applicable purchase date. Stock unit awards, stock options, and warrants (other than the
pre-funded warrants) have not been included in the diluted loss per share calculation as their inclusion would have had an
anti-dilutive effect.
The
potential common stock equivalents that have been excluded from the computation of diluted loss per share consist of the following:
Schedule of Common Stock Equivalent from the Computation of Diluted Loss Per Share
(in thousands)
2025
2024
Three and Six months ended June
30,
(in thousands)
2025
2024
Stock options
530
498
Stock units
453
422
Stock purchase warrants
1,497
1,640
2,480
2,560
Note
12. Income Taxes
The
Company may be eligible, from time to time, to receive cash from the sale of its net operating losses under New Jersey’s Department
of the Treasury - Division of Taxation NOL Transfer Program. For the six months ended June 30, 2025 and 2024 the Company received net
cash payments of $ 48,000 and $ 122,000 , respectively from the sale of its New Jersey state net operating losses.
Note
13. Stock Based Compensation
The
following table presents a summary of outstanding stock options as of June 30, 2025:
Schedule of Outstanding Stock Options
Number of Options (in thousands)
Weighted Average Exercise Price
Weighted Average Remaining Contractual Term (Years)
Aggregate Intrinsic Value
(in thousands)
Outstanding, January 1, 2025
548
$ 31.39
6.7
$ 510
Exercised
( 10 )
4.50
Cancelled
( 4 )
22.97
Expired
( 4 )
33.60
Outstanding, June 30, 2025
530
31.94
6.5
144
Exercisable, June 30, 2025
428
$ 38.33
6.1
$ 78
The
intrinsic value is calculated as the difference between the fair market value at June 30, 2025 and the exercise price per share of the
stock option. The options granted to employees generally vest over a three year period.
14
ELECTROCORE,
INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (unaudited)
The
following table presents a summary of activity related to restricted and deferred stock units (“Stock Units”) granted during
the six months ended June 30, 2025:
Schedule of Restricted and Deferred Stock Units
Number of
Shares
(in thousands)
Weighted
Average
Grant Date
Fair Value
Outstanding, January 1, 2025
459
$ 6.86
Granted
84
15.80
Vested and delivered
( 66 )
7.07
Cancelled
( 24 )
7.23
Outstanding, June 30, 2025
453
$ 8.46
In
general, Stock Units granted to employees vest over 2 two to 4 four-year periods.
Immediately
following the Company’s annual meeting of stockholders, the Company generally grants each non-employee director an equity award
that vests over a 12 -month period. Upon a non-employee director’s initial appointment or election to the board of directors, the
Company grants such non-employee director an equity award subject to vesting as determined by the board of directors.
The
Company recognized stock compensation expense for its equity awards as follows:
Schedule of Stock Compensation Expenses
(in thousands)
2025
2024
Three months ended June 30,
(in thousands)
2025
2024
Selling, general and administrative
$ 482
$ 440
Research and development
8
21
Cost of goods sold
15
11
Total expense
$ 505
$ 472
(in thousands)
2025
2024
Six months ended June 30,
(in thousands)
2025
2024
Selling, general and administrative
$ 982
$ 879
Research and development
31
56
Cost of goods sold
32
21
Total expense
$ 1,045
$ 956
Total
unrecognized compensation cost related to unvested awards as of June 30, 2025 was $ 2.1 million and is expected to be recognized over
the next two years .
Note
14. Commitments and Contingencies
The
Company may be a party to various legal proceedings and claims arising out of the ordinary course of its business. Although the final
results of all such matters and claims cannot be predicted with certainty, the Company currently believes that there are no current proceedings
or claims pending against it the ultimate resolution of which would have a material adverse effect on its financial condition or results
of operations. However, should the Company fail to prevail in any legal matter or should several legal matters be resolved against the
Company in the same reporting period, such matters could have a material adverse effect on the Company’s operating results and
cash flows for that particular period. In all cases, at each reporting period, the Company evaluates whether or not a potential loss
amount or a potential range of loss is probable and reasonably estimable under ASC 450 , “Contingencies.” Legal costs
are expensed as incurred.
2025
CVR Agreement
On
May 1, 2025 (the “Closing Date”), the Company completed its previously announced acquisition of NURO (following consummation
of the Merger, the “Surviving Corporation”), pursuant to the terms of the Merger Agreement by and among the Company, NURO,
and Nexus Merger Sub Inc., a Delaware corporation and a wholly owned subsidiary of the Company (“Merger Sub”).
Pursuant
to the Merger Agreement, on the Closing Date, Merger Sub merged with and into NURO, with NURO surviving as a wholly-owned subsidiary
of the Company (the “Merger”).
Immediately
prior to the effective time (the “Effective Time”) of the Merger, the Company entered into a contingent value rights agreement
(the “CVR Agreement”) with a rights agent (the “Rights Agent”), pursuant to which the holders (each, a “Holder”)
of (i) shares of common stock, par value $ 0.0001 per share, of NURO (the “NURO Common Stock”) outstanding immediately prior
to the Effective Time, outstanding awards of restricted stock with respect to shares of NURO Common Stock, outstanding at the Effective
Time, and each NURO restricted stock unit outstanding at the Effective Time, as well as all issued and outstanding shares of NURO’s
preferred stock, par value $ 0.001 per share, outstanding at the Effective Time, and each stock option granted by NURO to purchase NURO
Common Stock, outstanding and unvested immediately prior to the Effective Time, if and when applicable under the terms of the Merger
Agreement, may become entitled to contingent cash payments (each, a “Contingent Payment”) that net of, minus certain transaction
expenses, will equal (1) 8% of the Quell Net Sales (as defined in the CVR Agreement) during the first 12-month period after the Closing
Date, in an amount up to $500,000 (the “First Quell Net Sales Payment”), but if 8% of the Quell Net Sales during such period
is less than $25,000, the First Quell Net Sales Payment shall be zero; (2) 6% of the Quell Net Sales during the second 12-month period
after the Closing Date, an amount up to $500,000 minus the amount of the First Quell Net Sales Payment (the “Second Quell Net Sales
Payment”), but if 6% of the Quell Net Sales during such second period is less than $25,000, the Second Quell Net Sales Payment
shall be zero; and (3) the amounts received by the Company after the Effective Time pursuant to any Disposition Agreement (as defined
in the CVR Agreement) signed prior to the Effective Time with respect to NURO’s DPNCheck® Business.
15
ELECTROCORE,
INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (unaudited)
Under
the CVR Agreement, the Rights Agent has, and Holders of at least 20% of the CVRs then-outstanding have, certain rights to audit and enforcement
on behalf of all Holders of the CVRs. The Company shall cause NURO to use commercially reasonable efforts to consummate transactions
contemplated by any Disposition Agreement, as such efforts are further described in the CVR Agreement.
The
CVR Agreement has a term commencing on the Effective Date and ending on the earlier of (a) December 31 of the calendar year in which
Company shall have caused to be paid to the Holders pursuant to the terms of the CVR Agreement all Distributions (as defined in the CVR
Agreement) with respect to all payments (including any contingent payments) contemplated to be made by the applicable buyer pursuant
to any Disposition Agreement, and (b) December 31, 2030.
See
“Note 17 – Acquisition” for additional information about the Merger.
Note
15. Related Party Transactions
In
2023, an executive of the Company co-founded the Vagus Nerve Society, an academic society dedicated to the ongoing education and training
of scientists and clinicians and the power of the vagus nerve and its application in a broad spectrum of health-related conditions. During
the three and six months ended June 30, 2025, the Company incurred aggregate expenses of $ 30,000 and $ 90,000 , respectively, for unrestricted
and directed educational grants to the Vagus Nerve Society.
Note
16. Segment Reporting
Operating
segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief
operating decision-maker (CODM), or decision-making group, in deciding how to allocate resources and in assessing performance. electroCore
is a commercial stage bioelectronic technology company whose mission is to improve health and quality of life through innovative non-invasive
bioelectronic technologies. The Company views its operations and manages its business as one operating segment: Bioelectronic Innovations.
The accounting policies of the Bioelectronic Innovations segment are the same as those described in Note 2. Summary of Significant Accounting
Policies.
Our
CODM is our Chief Executive Officer. The CODM uses loss from operations, as reported on our Consolidated Statements of Operations, in
evaluating the performance of the Bioelectronic Innovations segment and in determining how to allocate resources to the Company as a
whole, The CODM does not review assets in evaluating the results of the Bioelectronic Innovations segment, and therefore, such information
is not presented below.
The
following table provides the non-GAAP operating financial results of the Bioelectronic Innovations segment:
Schedule of Operating Financial Segment
2025
2024
2025
2024
Three Months Ended
June 30,
Six Months Ended
June 30,
2025
2024
2025
2024
Net sales *
$ 7,381
$ 6,139
$ 14,100
$ 11,582
Cost of goods sold
939
838
1,952
1,726
Gross profit
6,442
5,301
12,148
9,856
Operating expenses
Research and development
511
635
1,153
1,034
General and administrative
4,552
3,542
8,885
7,512
Sales and marketing
4,885
3,715
9,438
7,750
Total operating expenses
9,948
7,892
19,476
16,296
Loss from operations
( 3,506 )
( 2,591 )
( 7,328 )
( 6,440 )
Other (income) expense
Interest and other income
( 68 )
( 55 )
( 151 )
( 280 )
Other expense
233
119
397
123
Total other expense (income)
165
64
246
( 157 )
Loss before income taxes
( 3,671 )
( 2,655 )
( 7,574 )
( 6,283 )
Benefit from income taxes
-
-
48
122
Net loss
$ ( 3,671 )
$ ( 2,655 )
$ ( 7,526 )
$ ( 6,161 )
*
See
Note 4 Revenue for geographical and disaggregation information.
Note
17. Acquisitions
On
the Closing Date, the Company completed its previously announced acquisition of NURO, pursuant to the terms of the Merger Agreement by
and among the Company, NURO, and Nexus Merger Sub Inc., a Delaware corporation and a wholly owned subsidiary of the Company.
Pursuant
to the Merger Agreement, on the Closing Date, Merger Sub merged with and into NURO, with NURO surviving as a wholly-owned subsidiary
of the Company.
See
“Note 14 – Commitments and Contingencies” for additional information.
Note
18. Legal Proceedings
UAB
Pulsetto v. electroCore, Inc.
On
June 11, 2025, UAB Pulsetto (“Pulsetto”) filed a declaratory judgment action against the Company in the United States District
Court for the District of New Jersey, captioned UAB Pulsetto v. electroCore, Inc., Civ. No. 25-10036 (D.N.J.), asserting that
its non-invasive vagus nerve stimulation product does not infringe the Company’s U.S. Patent No. 11,446,491 (the “491
Patent”).
On July 16, 2025, the Company filed a responsive pleading, answering the complaint and asserting counterclaims, that
Pulsetto’s non-invasive vagus nerve stimulation product infringes the ‘491 Patent, as well as the Company’s U.S. Patent
Nos. 8,948,873, 9,339,653, 10,874,857, 8,843,210, 9,242,092, 11,623,078, and 10,441,780, as well as claims that Pulsetto’s commercial
conduct has infringed and continues to infringe the Company’s Truvaga™ and gammaCore® trademarks, and committed acts of
false advertising and unfair competition in violation of state and federal law. The lawsuit is in its early stages as discovery has not
begun.
Note
19. Subsequent Events
See
“Note 3 – Liquidity, Significant Risks and Uncertainties” and “Item 5. Other Information” for information regarding
the Loan and Security Agreement entered into with Avenue on August 4, 2025, and related transactions.
See
“Note 18 – Legal Proceedings” for information regarding the Pulsetto action.
16
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION
AND RESULTS OF OPERATIONS
You
should read this section in conjunction with our unaudited interim condensed consolidated financial statements and related notes included
in this Quarterly Report and our Quarterly Report for the period ended March 31, 2025,and our audited consolidated financial statements
and related notes thereto and management’s discussion and analysis of financial condition and results of operations for the year
ended December 31, 2024 included in our Annual Report. As discussed in the section titled “Cautionary Note Regarding Forward-Looking
Statements,” the following discussion and analysis contains forward-looking statements that involve risks and uncertainties, as
well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from tho se
expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are
not limited to, those identified below, and those under the caption “Risk Factors” in the aforementioned Annual Report and
this Quarterly Report.
We
are a commercial stage bioelectronic technology company whose mission is to improve health and quality of life through innovative
non-invasive bioelectronic technologies. The Company’s two leading prescription products, gammaCore non-invasive vagus nerve
stimulation (“nVNS”) and Quell neurostimulator (“Quell”), treat chronic pain syndromes through non-invasive
neuromodulation technology Additionally, the Company commercializes its Truvaga products, handheld, personal use nVNS products,
utilizing bioelectronic technologies, to promote general wellness and human performance.
nVNS,
a form of bioelectronic technology, modulates neurotransmitters through its effects on both the peripheral and central nervous systems.
Our nVNS treatment is delivered through a proprietary high-frequency burst waveform that safely and comfortably passes through the skin
and stimulates therapeutically relevant fibers in the vagus nerve. Various scientific publications suggest that nVNS works through a
variety of mechanistic pathways including the modulation of neurotransmitters.
Historically,
vagus nerve stimulation or VNS, required an invasive surgical procedure to implant a costly medical device. This has generally limited
VNS from being used by anyone other than the most severe patients. Our non-invasive bioelectronic nVNS technologies are self-administered
and intended for regular or intermittent use over many years.
Our
capabilities include product development, regulatory affairs and compliance, sales and marketing, product testing, electromechanical
assembly, fulfillment, and customer support. We derive revenues from the sale of products in the United States and select overseas markets.
We have two principal product categories:
●
Handheld,
personal use bioelectronic therapies for the management and treatment of certain medical conditions such as primary headache; and
●
Handheld,
personal use consumer products utilizing bioelectronic technologies to promote general wellness and human performance.
We
believe our bioelectronic technologies may be used in the future to effectively treat additional medical conditions.
Our
goal is to be a leader in non-invasive neuromodulation to deliver better health. To achieve this, we offer multiple propositions:
●
Prescription
gammaCore bioelectronic therapy for the treatment of certain prescription U.S. Food and Drug Administration (“FDA”) cleared
medical conditions such as primary headache;
●
Prescription
Quell Fibromyalgia authorized to treat the symptoms of fibromyalgia;
●
Truvaga
for the support of general health and wellbeing; and
●
TAC-STIM
for human performance.
Our
flagship gammaCore Sapphire is a prescription medical device using our bioelectronic therapy that is FDA cleared for a variety of primary
headache conditions. gammaCore is available by prescription only and Sapphire is a portable, reusable, rechargeable and reloadable personal
use option for patients to use at home or on the go. Prescriptions are written by a health care provider and dispensed from a specialty
pharmacy, through the patient’s healthcare system, or shipped directly to certain patients in the United States from our facility
in Rockaway, NJ. After the initial prescription is filled, access to additional therapy can be refilled for certain of our gammaCore
products through the input of a prescription-only authorization.
We
offer two versions of our bioelectronic technology to support general health and wellbeing. Truvaga 350 is a personal use consumer electronics
general wellness product and Truvaga Plus, which was launched in April 2024, is our next generation, app-enabled general wellness product.
Neither product requires a prescription, and are available direct-to-consumer from electroCore at www.truvaga.com or through online retailers.
The
TAC-STIM handset is a form of nVNS for human performance and has been developed in collaboration with the United States Department of
Defense Biotech Optimized for Operational Solutions and Tactics, or BOOST program. TAC-STIM handsets are available as a Commercial Off
the Shelf (COtS) solution to professional organizations and are the subject of ongoing research and evaluation within the United States
Air Force Special Operations Command, the United States Army Special Operations Command and at the United States Air Force Research Laboratory.
Truvaga
and TAC-STIM are intended for general wellness in compliance with the FDA guidance document entitled “General Wellness: Policy
for Low-Risk Devices; Guidance for Industry and FDA Staff, issued on September 27, 2019.” Truvaga and TAC-STIM handsets are not
intended to diagnose, treat, cure, or prevent any disease or medical condition.
In
2021, Quell received Breakthrough Device Designation from the FDA for a fibromyalgia indication. A pivotal double-blind, randomized,
sham-controlled clinical study of Quell Fibromyalgia was completed, and a, FDA 510(k) de novo marketing authorization was obtained from
the FDA in 2022.
17
See
“Item 1 – Business – De Novo Classification Process” and “Item 1.A – Risk Factors” of our Annual
Report for additional information on the FDA’s 510(k) de novo classification and marketing authorization processes.
Quell
Fibromyalgia is a prescription medical device sold in the United States and indicated for use as an aid for reducing the symptoms of
fibromyalgia in adults with high pain sensitivity. Quell is a wearable neuromodulation technology for chronic pain, has been refined
with feedback from over 200,000 chronic pain patients and is protected by over 20 U.S. utility patents. Patients control and personalize
the technology with a mobile phone app, and their utilization of the devices and certain clinical metrics may be tracked in the Quell
Health Cloud. Prescriptions for Quell Fibromyalgia are written by a health care provider and dispensed from a specialty pharmacy, through
the patient’s healthcare system, or shipped directly to certain patients in the United States from our facility in Rockaway, NJ.
After the initial prescription is filled, access to additional electrodes can be refilled without the need of a prescription. There is
also a small legacy customer base utilizing the Quell Relief over-the-counter product for broader pain.
Our
two largest customers by revenue are the United States Department of Veterans Affairs and United States Department of Defense, or VA,
and the United Kingdom National Health Service, or NHS, utilizing our FDA cleared and CE marked product, gammaCore. We began offering
Quell Fibromyalgia to our VA customers in May 2025.
Sales
to the VA comprised 71.8% and 71.1% of our revenue during the three and six months ended June 30, 2025, respectively. The majority of
our 2024 sales were made pursuant to our qualifying contract under the Federal Supply Schedule, or FSS, which was secured by us in December
2018 (the “Original FSS Contract”), as well as open market sales to individual facilities within the government channel.
In March 2025, we entered into a new FSS contract which became effective on June 15, 2025, and runs through June 14, 2030.
In
August 2023, we signed a non-exclusive distribution agreement with Lovell providing Lovell the right to list and distribute certain gammaCore
products into the federal market. Lovell is a Service-Disabled Veteran-Owned Small Business (SDVOSB) offering medical and pharmaceutical
goods and services to federal healthcare providers. Listing products with Lovell is intended to streamline the sales process to a variety
of government procurement channels through Lovell’s compliance with contracting regulations and its provision of logistical solutions
connected directly into government contracting portals, all of which are intended to help government agencies meet their SDVOSB procurement
goals. Customers for these vehicles are federal healthcare systems such as the Veterans Health Administration (VHA, which includes the
VA), the Military Health System (MHS), and Indian Health Services (IHS), which we believe serve up to approximately 21 million patients
combined. In May 2025, we added Quell Fibromyalgia to the Lovell contracting platform.
Between
November 2023 and January 2024, certain gammaCore products were added to the FSS, the VA Distribution and Pricing Agreement (DAPA), GSA
Advantage, and Defense Logistics Agency’s ECAT system procurement portals through the Lovell contract vehicles, enabling the purchase
of gammaCore products within the government channel and throughout the federal markets, including, but not limited to, the VA. The gammaCore
products offered through Lovell provide government customers with similar product configuration options to those currently sold through
our existing FSS contract, new FSS contract and open market sales made directly to individual VA facilities. We expect an increasing
portion of our 2025 sales will be made pursuant to the distribution agreement with Lovell and its contract vehicles as well as through
our new FSS contract, and our sales function in this channel is comprised of employees and an increasing number of independent contractors.
Sales
under the UK Med Tech Funding Mandate, or MTFM, for cluster headache in the UK comprised 4.9% and 5.1% of our revenue during the three
and six months ended June 30, 2025, respectively. We plan on continuing use of this program. In 2023, NHS granted a two-year extension
in which our prescription gammaCore therapy will continue to be listed in the NHS catalog. This extension is through March 17, 2026 with
an option for us to extend an additional two years. In 2025, we expect NICE to review the guidance document and any changes in recommendation
or pricing may adversely impact our ability to work with NHS England on the MTFM program and could have an adverse impact on our financial
results. We continue to utilize distribution partners to commercialize our nVNS technology in selected territories outside the United
States and United Kingdom.
We
believe there may be significant opportunities beyond these two areas. Specifically, we believe there may be a large commercial opportunity
for our gammaCore and Quell bioelectronic therapies with additional insurance covered lives, cash pay, physician dispense, and direct-to-consumer
approaches, along with wellness and human performance propositions through our Truvaga and TAC-STIM handsets. Therefore, we will continue
our investments to expand our efforts in these channels and markets in 2025.
On
May 1, 2025, we acquired NURO. NURO is a commercial stage healthcare company that develops and commercializes neurotechnology devices
to address unmet needs in the chronic pain market through its Quell® platform: a wearable, app and cloud-enabled neuromodulation
platform that is indicated for the treatment of fibromyalgia symptoms (Quell Fibromyalgia) and lower-extremity chronic pain (Quell 2.0).
The transaction closed on May 1, 2025. The transaction excluded NURO’s DPNCheck® technology and business, which was divested
by NURO prior to closing of the transaction.
We
face a variety of challenges and risks that we will need to address and manage as we pursue our strategies, including our ability to
develop and retain an effective sales force, achieve market acceptance of our gammaCore medical device among clinicians, patients, and
third-party payers, expand the use of our medical devices to additional therapeutic indications, and to develop our nascent wellness
and human performance businesses.
As
we continue to pursue opportunities in both U.S. and select international markets, we remain subject to evolving global economic conditions,
including uncertainties related to international trade policies, tariffs, and supply chain dynamics. Uncertainties and changes in trade
regulations, tariff structures, or logistical constraints could influence the cost, availability, or timing of materials and components
used in our manufacturing and assembly processes. We intend to monitor these developments and are actively implementing contingency plans,
including alternative sourcing strategies and supplier diversification, to support supply chain continuity, maintain operational efficiency,
and help mitigate potential future impacts.
We launched a direct-to-consumer wellness offering, Truvaga, and we remain subject to risks associated with the commercialization
of our Truvaga product offering, including those associated with selling Truvaga through ecommerce marketplaces. Selling products through
large, well established ecommerce marketplaces presents several risks including inventory management challenges, broader competition,
potential account suspensions, and the risk of losing control over brand identity, value perception, and customer relationships. While
we intend to monitor commercialization efforts through these marketplaces, there can be no assurance that we can respond adequately to
reviews on public forums, or at all on third-party forums, which may cause a loss of control over our brand identity, value perception
and customer relationships, and any inability to respond adequately may negatively impact our operating results.
Because
of the numerous risks and uncertainties associated with our commercialization efforts, as well as research and product development activities,
there may be uncertainty regarding our ability to achieve or maintain profitability. If we fail to become profitable or are unable to
sustain profitability, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
Our
expected cash requirements for the next 12 months and beyond are based on the commercial success of our products and our ability to control
operating expenses. There are significant risks and uncertainties as to our ability to achieve these operating results. Due to these
risks and uncertainties, we may need to reduce our activities significantly more than our current operating plan and cash flow projections
assume in order to fund operations for the next 12 months. There can be no assurance that we will have sufficient cash flow and liquidity
to fund our planned activities, which could force us to significantly reduce or curtail our activities and, ultimately potentially cease
operations. See also “Liquidity Outlook.”
18
Critical
Accounting Estimates
The
preparation of our financial statements is in accordance with accounting principles generally accepted in the United States of America,
or GAAP, which require us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses
and other related disclosures. While we believe our estimates, assumptions and judgments are reasonable, they are based on information
presently available. Actual results may differ significantly from these estimates due to changes in judgments, assumptions and conditions
as a result of unforeseen events or otherwise, which could have a material impact on our financial position and results of operations.
We
consider an accounting estimate to be critical if: (i) the accounting estimate requires us to make assumptions about matters that were
highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from
period to period or use of different estimates that we reasonably could have used in the current period, would have a material impact
on our financial condition or results of operations. The critical accounting estimates, that we believe have the greatest potential impact
on the condensed consolidated financial statements are disclosed in the section titled Critical Accounting Policies and Estimates in
Part II of our Annual Report.
Results
of Operations
Comparison
of the three months ended June 30, 2025 to the three months ended June 30, 2024
The
following table sets forth amounts from our condensed consolidated statements of operations for the three months ended June 30, 2025
and 2024:
For the three months
ended June 30,
2025
2024
Change
(in thousands)
Consolidated statements of operations:
Net sales
$ 7,381
$ 6,139
$ 1,242
Cost of goods sold
939
838
101
Gross profit
6,442
5,301
1,141
Gross margin
87 %
86 %
Operating expenses
Research and development
511
635
(124 )
Selling, general and administrative
9,437
7,257
2,180
Total operating expenses
9,948
7,892
2,056
Loss from operations
(3,506 )
(2,591 )
(915 )
Other (income) expense
Interest and other income
(68 )
(55 )
(13 )
Other expense
233
119
114
Total other expense (income)
165
64
(101 )
Loss before income taxes
(3,671 )
(2,655 )
(1,016 )
Benefit from income taxes
-
-
-
Net loss
$ (3,671 )
$ (2,655 )
$ (1,016 )
Net
Sales
Net
sales for the three months ended June 30, 2025 increased 20%, as compared to the three months ended June 30, 2024. The increase of $1.2
million is due to an increase in net sales of prescription products sold into the VA and revenue from the sales of our nonprescription
general wellness Truvaga and TAC-STIM products. We expect that the majority of our remaining 2025 fiscal year revenue will continue to
come from the prescription products sold into the VA and the Truvaga direct-to-consumer product offering. See the above Overview for
discussion regarding our FSS contract with the VA.
19
The
following table sets forth our product net sales:
(in thousands)
Three months ended June 30,
Product
2025
2024
Rx gammaCore - VA
$ 5,185
$ 4,572
Rx gammaCore - U.S. Commercial
394
476
Rx Quell - VA
114
-
Quell – U.S. Commercial
48
-
Outside the United States
465
464
Truvaga
994
572
Total before TAC-STIM
7,200
6,084
TAC-STIM
181
55
Total Revenue
$ 7,381
$ 6,139
Gross
Profit
Gross
profit increased by $1.1 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. Gross margin
was 87% and 86% for the three months ended June 30, 2025 and 2024, respectively. The increase in gross profit is attributable to the
increased net sales and product mix. Gross profit and gross margin for the remainder of 2025 will be largely dependent on revenue levels,
product mix, and any changes in the estimated useful lives of licensed devices.
Research
and Development
Research
and development expense in the second quarter of 2025 was $0.5 million, as compared to $0.6 million in the second quarter of 2024. This
decrease was primarily due to reduced development costs in the three months ended June 30, 2025, as compared to the three months ended
June 30, 2024. For the remainder of 2025, we expect our research and development expense to be higher than the comparable periods in
2024.
Selling,
General and Administrative
Selling,
general and administrative expense of $9.4 million for the three months ended June 30, 2025 increased by $2.1 million, or 30%, as compared
to $7.3 million for the previous year period. This increase was primarily due to our greater investment in selling and marketing costs
consistent with our increase in sales, $548,000 of bad debt expense associated with a TAC-STIM receivable, increased expenses
associated with professional fees, and increased rent expense associated
with the lease expansion. For the remainder of 2025, we plan on continuing to make targeted investments in sales and marketing to support
our commercial efforts, particularly around sales and marketing efforts across all major U.S. channels.
Other
Expense (Income)
Total
other expense was $165,000 for the three months ended June 30, 2025, which consisted primarily of non-recurring expenses, including
professional fees in connection with the NURO acquisition, as compared to total other expense of $64,000 for the three months ended
June 30, 2024, which consisted primarily of a one-time expense associated with termination of an agreement.
Comparison
of the six months ended June 30, 2025 to the six months ended June 30, 2024
The
following table sets forth amounts from our condensed consolidated statements of operations for the six months ended June 30, 2025 and
2024:
For the six months
ended June 30,
2025
2024
Change
(in thousands)
Consolidated statements of operations:
Net sales
$ 14,100
$ 11,582
$ 2,518
Cost of goods sold
1,952
1,726
226
Gross profit
12,148
9,856
2,292
Gross margin
86 %
85 %
Operating expenses
Research and development
1,153
1,034
119
Selling, general and administrative
18,323
15,262
3,061
Total operating expenses
19,476
16,296
3,180
Loss from operations
(7,328 )
(6,440 )
(888 )
Other (income) expense
Interest and other income
(151 )
(280 )
129
Other expense
397
123
274
Total other expense (income)
246
(157 )
403
Loss before income taxes
(7,574 )
(6,283 )
(1,291 )
Benefit from income taxes
48
122
(74 )
Net loss
$ (7,526 )
$ (6,161 )
$ (1,365 )
Net
Sales
Net
sales for the six months ended June 30, 2025 increased 22% as compared to the six months ended June 30, 2024. The increase of $2.5 million
is due to an increase in net sales of prescription products sold into the VA and outside the United States, and revenue from the sales
of our nonprescription general wellness Truvaga products. We expect that the majority of our remaining 2025 fiscal year revenue will
continue to come from the prescription products sold into the VA and the Truvaga direct-to-consumer product offering. See the above Overview
for discussion regarding our FSS contract with the VA.
20
The
following table sets forth our product net sales:
(in thousands)
Six months ended June 30,
Product
2025
2024
Rx gammaCore - VA
$ 9,906
$ 8,447
Rx gammaCore - U.S. Commercial
683
909
Rx Quell – V.A.
114
-
Quell – U.S. Commercial
48
-
Outside the United States
978
913
Truvaga
2,100
957
Total before TAC-STIM
13,829
11,226
TAC-STIM
271
356
Total Revenue
$ 14,100
$ 11,582
Gross
Profit
Gross
profit increased by $2.3 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. Gross margin
was 86% and 85% for the six months ended June 30, 2025 and 2024, respectively. The increase in gross profit is attributable to the increased
net sales and product mix. Gross profit and gross margin for the remainder of 2025 will be largely dependent on revenue levels, product
mix, and any changes in the estimated useful lives of licensed devices.
Research
and Development
Research
and development expense for the six months ended June 30, 2025 was $1.2 million, as compared to $1.0 million during the six months
ended June 30, 2024. This increase was primarily due to an increase in headcount and certain clinical trial activities in the first
quarter of 2025 as compared to the first quarter of 2024. For the remainder of 2025, we expect our research and development expense
to be higher than the comparable periods in 2024.
Selling,
General and Administrative
Selling,
general and administrative expense of $18.3 million for the six months ended June 30, 2025 increased by $3.0 million, or 20%, as
compared to $15.3 million for the previous year period. This increase was primarily due to our greater investment in selling and
marketing costs consistent with our increase in sales, an increase in separation costs associated with select headcount reductions,
bad debt expense associated with a TAC-STIM receivable, increased expenses associated with professional fees, and increased rent expense associated with the
lease expansion. For the remainder of 2025, we plan on continuing to make targeted investments in sales and marketing to support our
commercial efforts, particularly around sales and marketing efforts across all major U.S. channels.
Other
Expense (Income)
Total
other expense was $246,000 for the six months ended June 30, 2025, which consisted primarily of non-recurring expenses, including
professional fees in connection with the NURO acquisition, as compared to total other income of $157,000 for the six months
ended June 30, 2024, which consisted primarily of interest income.
Benefit
from Income Taxes
We
may be eligible, from time to time, to receive cash from the sale of our net operating losses under New Jersey’s Department of
the Treasury - Division of Taxation NOL Transfer Program. For the six months ended June 30, 2025 and 2024 the Company received net cash
payments of $48,000 and $122,000, respectively, from the sale of its New Jersey state net operating losses.
Cash
Flows
The
following table sets forth the significant sources and uses of cash for the periods noted below:
For the six months ended June 30,
2025
2024
(in thousands)
Net cash (used in) provided by
Operating activities
$ (4,978 )
$ (4,330 )
Investing activities
$ 4,685
$ (3,928 )
Financing activities
$ 183
$ 8,120
21
Operating
Activities
Net
cash used in operating activities was $5.0 million and $4.3 million for the six months ended June 30, 2025 and 2024, respectively. This
increase is primarily due to the decrease in our net loss adjusted for non-cash expense items and certain working capital changes consisting
primarily of decreases in accrued expenses and operating lease liabilities and increases in inventories and prepaid expenses and other
assets.
Investing
Activities
Net
cash provided by investing activities was $4.7 million and $3.9 million for the six months ended June 30, 2025 and 2024, respectively.
This increase is primarily due to proceeds from the sale of marketable securities.
Financing
Activities
During
the six months ended June 30, 2025, net cash provided by financing activities was $0.2 million attributable to utilization of our at-the-market
facility pursuant to the Sales Agreement. During the six months ended June 30, 2024, net cash provided by financing activities was $8.1
million which was attributable to the entering into a registered direct offering and concurrent private placements, which closed on June
5, 2024.
Liquidity
Outlook
We
have experienced significant net losses, and we expect to continue to incur net losses for the near future as we work to increase market
acceptance of our gammaCore therapy and general wellness and human performance products. We have never been profitable and we have incurred
net losses and negative cash used in operations in each year since our inception. We incurred net losses of $7.5 million and $6.2 million
and used cash in our operations of $5.0 million and $4.3 million for the six months ended June 30, 2025 and 2024, respectively.
We
have historically funded our operations from the sale of our securities. During the six months ended June 30, 2025, we received net proceeds
of approximately $0.2 million from such sales and as of June 30, 2025, our cash, cash equivalents, restricted cash and marketable securities
totaled $7.4 million.
On
November 29, 2024, we entered into an At The Market Offering Agreement (the “Sales Agreement”) with H.C. Wainwright &
Co., LLC (“Wainwright”), whereby the Company may offer and sell shares of its common stock from time to time having an aggregate
offering price of up to $20 million by any method deemed to be an “at-the-market” offering as defined in Rule 415 of the
Securities Act, or any other method specified in the Sales Agreement. During the six months ended June 30, 2025, the Company sold 14,265
shares of its common stock at a weighted average price of $15.20 per share, net of issuance costs for $0.2 million in net proceeds, pursuant
to the Sales Agreement.
On August 4, 2025, we, and our wholly owned subsidiary,
NURO, each as borrowers, entered into the Loan and Security Agreement with Avenue that is secured by a lien on substantially all of our
assets, including a negative pledge on intellectual property, subject to limited exceptions, pursuant to the Loan and Security Agreement.
The Loan and Security Agreement provides for term loans in an aggregate principal amount of up to $12.0 million (the “Loan Amount”)
to be delivered in two tranches (the “Term Loans”). The tranches consist of (i) a term loan advanced to the Company on August
4, 2025 in an aggregate principal amount of $7.5 million (“Tranche 1”), and (ii) subject to the achievement of certain performance
milestones set forth in the Loan and Security Agreement, a right of the Company to request that Avenue make additional term loan advances
to the Company in an aggregate principal amount of up to $4.5 million (“Tranche 2”) which right expires on December 31, 2025.
In
2025, we intend to continue to make targeted investments in sales and marketing to continue driving commercial activities. We have historically
funded our operations from the sale of our common stock, and most recently the convertible debt financing with Avenue, and may continue to do so through utilization of the at-the-market facility or
other equity or debt transactions if needed. As of the date of this Quarterly Report, the Company had approximately $19.8 million of
common stock remaining available for issuance under the Sales Agreement.
The Company’s expected cash requirements for the next 12 months from the date these financial statements are issued and beyond are
largely based on the commercial success of its products. Based on its current assessment, the Company believes its cash, cash equivalents,
restricted cash, and marketable securities, plus the net proceeds from Tranche 1 of the Term Loan, and expected cash flow from operations
and access to capital through the use of the ATM and Tranche 2 of the Term Loan will enable it to fund its operating expenses and capital
expenditure requirements, as currently planned, for at least the next 12 months from the date the accompanying financial statements are
issued. There remain significant risks and uncertainties regarding the Company’s business, financial condition and results of operations.
The Company’s future capital requirements are difficult to forecast and will depend on many factors that are out of its control.
If the Company is unable to achieve its planned operating results or maintain sufficient financial resources, including through potential
positive cash flow from operations or supplemental access to third-party debt, equity or hybrid capital, its business, financial condition
and results of operations may be materially and adversely affected.
22
Item
3. Quantitative and Qualitative Disclosures About Market Risk
We
develop our products in the United States and sell those products into several countries. As a result, our financial results could be
affected by factors such as changes in foreign currency exchange rates or weak economic conditions in foreign markets. Most of our sales
in UK are denominated in British Pound Sterling and our license agreement with Teijin Limited is denominated in Japanese Yen. As our
sales in currencies other than the U.S. dollar increase, our exposure to foreign currency fluctuations may increase. In addition, changes
in exchange rates also may affect the end-user prices of our products compared to those of our foreign competitors, who may be selling
their products based on local currency pricing. These factors may make our products less competitive in some countries.
If
the U.S. dollar uniformly increased or decreased in strength by 10% relative to the foreign currencies in which our sales were denominated,
our net income would have correspondingly increased or decreased by an immaterial amount for the three and six months ended June 30,
2025.
Our
exposure to market interest rate risk is confined to our cash and cash equivalents and marketable securities. The goals of our investment
policy are preservation of capital, fulfillment of liquidity needs and fiduciary control of cash and investments. We also seek to maximize
income from our investments without assuming significant risk. To achieve our goals, we may maintain a portfolio of cash equivalents
and investments in a variety of securities of high credit quality. The securities in our investment portfolio, if any, are not leveraged,
are classified as available for sale and are, due to their very short-term nature, subject to minimal interest rate risk. We currently
do not hedge interest rate exposure. Because of the short-term maturities of our cash equivalents, we do not believe that an increase
in market rates would have any material negative impact on interest income recognized in our statement of operations. We have no investments
denominated in foreign currencies and therefore our investments are not subject to foreign currency exchange risk. We contract with investigational
sites, suppliers and other vendors in Europe and internationally. In addition, our license agreement requires payments to us to be denominated
in Japanese Yen. We are subject to fluctuations in foreign currency rates in connection with these agreements. We do not hedge our foreign
currency exchange rate risk.
All
of the potential changes noted above are based on sensitivity analyses performed on our financial position as of June 30, 2025.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under
the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the rules and forms, and that
such information is accumulated and communicated to us, including our Chief Executive Officer and Chief Financial Officer, as appropriate,
to allow timely decision making regarding required disclosure. In designing and evaluating our disclosure controls and procedures, we
recognize that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving
the desired control objectives, as ours are designed to do, and we apply our judgment in evaluating whether the benefits of the controls
and procedures that we adopt outweigh their costs.
As
required by Rule 13a-15(b) and 15d-15(f) of the Exchange Act, an evaluation as of June 30, 2025 was conducted under the supervision and
with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of
our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act). Based on this evaluation, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures, as of June 30, 2025 were effective for the
purposes stated above.
Changes
in Internal Control over Financial Reporting
There
was no change in our internal control over financial reporting as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange
Act, that occurred during the six months ended June 30, 2025 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 in Note 18. Legal Proceedings of the condensed consolidated financial statements included in this Quarterly
Report is incorporated here by reference to this Part II Item 1.
Item
1A.
RISK
FACTORS
You
should carefully consider the risk factors included in Item 1A. of the Annual Report, in addition to the following risk factors, and
the other information in this Quarterly Report, including the section of this Quarterly Report titled “Management’s Discussion
and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes. If any of the events
described in the Annual Report, the following risk factors and the risks described elsewhere in this Quarterly Report occur, our business,
operating results and financial condition could be seriously harmed. This Quarterly Report also contains forward-looking statements that
involve risks and uncertainties. Our actual results could differ materially from those anticipated in the forward-looking statements
as a result of factors that are described in the Annual Report, below and elsewhere in this Quarterly Report.
The
terms of our Loan and Security Agreement with Avenue Venture Opportunities Fund II, L.P. require us to meet certain operating covenants
and place certain restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the
terms of any new debt could further restrict our ability to operate our business.
On
August 4, 2025, we, and our wholly owned subsidiary, NURO, each
as borrowers, entered the Loan and Security Agreement with Avenue, as administrative agent and collateral agent, and as lender, that is secured by a lien on substantially
all of our assets, including a negative pledge on intellectual property, subject to limited exceptions, pursuant to the Loan and Security
Agreement.
The
Loan and Security Agreement contains customary affirmative and negative covenants and events of default. We could in the future incur
additional indebtedness beyond our borrowings under the Loan and Security Agreement. If we raise any additional debt financing, the terms
of such additional debt could further restrict our operating and financial flexibility. These restrictions may include, among other things,
limitations on the incurrence of additional debt and specific restrictions on the use of our assets, as well as prohibitions on our ability
to create liens, pay dividends, redeem capital stock or make investments. If we default under the terms of the Loan and Security Agreement,
Avenue may accelerate all of our repayment obligations and take control of our pledged assets, potentially requiring us to renegotiate
our agreement on terms less favorable to us or to immediately cease operations. Further, if we were to be liquidated, Avenue’s
rights to repayment would be senior to the rights of the holders of our common stock. Avenue could declare an event of default upon the
occurrence of any circumstance or circumstances that could reasonably be expected to have a Material Adverse Effect (as defined under
the Loan and Security Agreement). Any declaration by Avenue of an event of default could significantly harm our business and prospects
and could cause the price of our common stock to decline.
Our
existing or future debt could have significant adverse consequences, including:
● requiring
us to dedicate a substantial portion of cash flow from operations or cash on hand to the
payment of interest on, and principal of, our debt, which will reduce the amounts available
to fund working capital, capital expenditures, product development efforts, and other general
corporate purposes;
● subjecting
us to restrictive covenants that may reduce our ability to take certain corporate actions
or obtain further debt or equity financing; and
● limiting
our flexibility in planning for, or reacting to, changes in our business and our industry;
and placing us at a competitive disadvantage compared to our competitors that have less debt
or better debt servicing options.
In
order to satisfy our current and future debt service obligations, we will be required to raise funds from external sources. We may be
unable to arrange for additional financing to pay the amounts due under our existing debt. Funds from external sources may not be available
on acceptable terms, if at all. Our failure to satisfy our current and future debt obligations could adversely affect our financial condition
and results of operations.
Risks
of doing business through e-commerce marketplaces.
We
have recently launched a direct-to-consumer wellness offering, Truvaga, and we remain subject to risks associated with the commercialization
of our Truvaga product offering, including those associated with selling Truvaga through e-commerce marketplaces. Selling products through
large, well established e-commerce marketplaces presents several risks including inventory management challenges, broader competition,
potential account suspensions, and the risk of losing control over brand identity, value perception, and customer relationships. While
we intend to monitor commercialization efforts through these marketplaces, there can be no assurance that we can respond adequately to
reviews on public forums that may cause a loss of control over our brand identity, value perception and customer relationships, and any
inability to respond adequately may negatively impact our financial results. In addition, our business may be adversely affected if online
marketplaces, such as has been the case recently with Amazon, remove our products on the basis that they are classified as medical devices
requiring FDA clearance or registration. Such removal can significantly disrupt our sales channels, reduce product visibility, and impair
revenue generation, particularly if online sales constitute a substantial portion of our sales and marketing strategy. While we intend
to appeal Amazon’s decision, the appeals process is uncertain, time-consuming, and may not result in reinstatement. Prolonged or
permanent removal could lead to inventory write-downs, loss of market share, reputational harm, and increased compliance costs. Additionally,
similar actions by other e-commerce platforms or heightened regulatory scrutiny could further restrict market access, adversely impacting
our business, financial condition, and results of operations.
Our
failure to meet Nasdaq’s continued listing standards could result in a delisting of our common stock, which could negatively impact
the market price and liquidity of our common stock and our ability to access the capital markets.
Pursuant
to Nasdaq Listing Rule 5550(b), in order to maintain our listing on Nasdaq, we are required to continue to meet one of the following
continued listing standards: (i) net income from continuing operations (in the most recently completed fiscal year or in two of the three
most recently completed fiscal years) of at least $500,000 (the “Net Income Standard”); (ii) market value of listed securities
of at least $35 million (the “Market Value Standard”); or (iii) stockholders’ equity of at least $2.5 million (the
“Equity Standard”).
As
of June 30, 2025, our stockholders’ equity was less than $2.5 million and therefore less than the Equity Standard. As a result,
if Nasdaq determines that we do not meet either of the Net Income Standard or the Market Value Standard, we may receive a deficiency
letter from Nasdaq. Upon receipt of such deficiency letter, we will have a period of time to resolve such deficiency and, if necessary,
will have the opportunity to present a plan to regain compliance.
There
can be no assurance that Nasdaq will accept our plan to regain compliance or that we will meet the Equity Standard during any compliance
period, if one is provided to us. If our common stock is de-listed from Nasdaq, it will have material negative impact on the actual and
potential liquidity of our securities, as well as material negative impact on our ability to raise future capital.
If,
for any reason, Nasdaq should delist our common stock from trading on its exchange and we are unable to obtain listing on another national
securities exchange or take action to restore our compliance with the Nasdaq continued listing requirements, a reduction in some or all
of the following may occur, each of which could have a material adverse effect on our stockholders:
● the
liquidity of our common stock;
● the
market price of our common stock;
● our
ability to obtain financing for the continuation of our operations;
● the
number of institutional and general investors that will consider investing in our common
stock;
● the
number of investors in general that will consider investing in our common stock;
● the
number of market makers in our common stock;
● the
availability of information concerning the trading prices and volume of our common stock;
and
● the number of broker-dealers
willing to execute trades in shares of our common stock.
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.
24
Item
5. OTHER INFORMATION
(a)
Avenue
Loan and Security Agreement
On
the LSA Closing Date, we, and our wholly owned subsidiary, NURO, each as borrowers, entered into the Loan and Security Agreement with
Avenue as administrative agent and collateral agent, and as lender.
Amount .
The Loan and Security Agreement provides for term loans in an aggregate principal amount of up to $12.0 million (the “Loan
Amount”) to be delivered in two tranches (the “Term Loans”). The tranches consist of (i) a term loan advanced to
the Company on the LSA Closing Date in an aggregate principal amount of $7.5 million (“Tranche 1”), and (ii) subject to the achievement of certain performance milestones set forth in the Loan and Security Agreement, a right of
the Company to request that Avenue make additional term loan advances to the Company in an aggregate principal amount of up to $4.5
million (“Tranche 2”), which right expires on December 31, 2025. The Company intends to use the proceeds of the Term
Loans for working capital and general corporate purposes.
Maturity .
The Term Loans mature on August 1, 2029 (the “Maturity Date”).
Interest
Rate and Amortization . The principal balance of the Term Loans bears interest at a variable rate per annum equal to the greater
of (i) the sum of 5.0% and the prime rate as reported in The Wall Street Journal , provided that, in the event such prime
rate of interest is less than zero, such rate shall be deemed to be zero, and (ii) twelve and one-half percent (12.50%) (the
“Interest Rate”). Interest only shall be payable at the Interest Rate during the period following the LSA Closing Date
and continuing until the first day of the first full calendar month following the 18 month anniversary of the LSA Closing
Date, provided, however, that such period shall be extended for six months if as of the 18 month anniversary of
the LSA Closing Date, the Company has achieved certain milestones, as provided in the Supplement to the Loan and Security Agreement
dated August 4, 2025, by and among the Company, NURO and Avenue (the “Supplement”); provided, further, however, that the such
interest only period shall not exceed 24 months. Thereafter, principal and interest of the Term Loans shall be fully
amortized and paid, in equal, monthly principal installments, plus interest at the Interest Rate for such month, through the
Maturity Date, subject to the terms and conditions of the Supplement.
Final
Payment . The Company will pay final payment at a fee of 3.5% of the Loan Amount, due upon the earlier of the Maturity Date or
prepayment in full of the Term Loans.
Prepayment
Fee . The Company may, at its option at any time, prepay the Term Loans in their entirety by paying the then outstanding principal
balance and all accrued and unpaid interest on the Term Loans, subject to a prepayment fee equal to (i) 3.0% of the principal amount
outstanding if the prepayment occurs on or prior to the first anniversary following the LSA Closing Date, (ii) 2.0% of the principal
amount outstanding if the prepayment occurs after the first anniversary following the LSA Closing Date, but on or prior to the second
anniversary following the LSA Closing Date, and (iii) 1.0% of the principal amount outstanding if the prepayment occurs after the second
anniversary following the LSA Closing Date, but on or prior to the Maturity Date.
Security .
The Loan and Security Agreement is collateralized by substantially all of the Company’s assets in which Avenue is granted a senior
secured lien. The Company also grants Avenue a negative pledge on the Company’s intellectual property, subject to limited exceptions,
pursuant to the Loan and Security Agreement.
Covenants;
Representations and Warranties; Other Provisions . The Loan and Security Agreement contains customary representations, warranties
and covenants, including covenants by the Company limiting certain additional indebtedness, liens (including a negative pledge on intellectual
property and other assets, subject to limited exceptions), guaranties, substantial asset sales, investments and loans, certain corporate
changes, transactions with affiliates and fundamental changes.
Default
Provisions . The Loan and Security Agreement provides for events of default customary for term loans of this type, including but not
limited to non-payment, breaches or defaults in the performance of covenants, insolvency, bankruptcy and the occurrence of a material
adverse effect on the Company. After the occurrence of an event of default, Avenue may (i) accelerate payment of all obligations, impose
an increased rate of interest, and terminate Avenue commitments under the Loan and Security Agreement and (ii) exercise any other right
or remedy provided by contract or applicable law.
Conversion
Right . Additionally, subject to certain exceptions, Avenue has the right to convert (the “Conversion Right”) an
aggregate amount of up to $2.5 million of the outstanding Loan Amount into shares of the Company’s common stock at a
conversion price per share equal to $8.4625, representing 125% of the lower of (i) the five-day volume-weighted average price of
Company’s common stock as calculated on the day prior to the LSA Closing Date, or (ii) the closing price of Company’s
common stock on the date prior to the LSA Closing Date ($6.77). In the event the Company elects to prepay the Term Loans in full, the
Company shall provide no less than five business days’ prior written notice to Avenue; provided, however, if Avenue has not
yet exercised the Conversion Right, the Company shall provide written notice of prepayment at least 10 days in advance of the
proposed prepayment date and Avenue shall have the option, with respect to the Conversion Right, to exercise the Conversion Right by
delivering written notice to the Company at least two business days in advance of the proposed prepayment date.
25
Right
to Invest. Avenue shall have the right, but not the obligation, to invest up to an aggregate of $1 million in equity securities of
the Company on the same terms, conditions, and pricing offered by the Company to other investors in connection with any offering of the
Company’s equity securities to third party investors for capital raising purposes occurring after the Closing Date, on the terms
and conditions set forth in the Supplement.
The
foregoing summary of the Loan and Security Agreement and the Supplement do not purport to be complete and are qualified in their entirety
by reference to the full text of Loan and Security Agreement and the Supplement, which are filed herewith as Exhibits 10.1 and 10.2,
and are incorporated by reference herein. The representations, warranties and covenants in the Loan and Security Agreement and the Supplement
were made only for purposes of such agreement and as of specific dates and were solely for the benefit of the parties to such agreements.
Avenue
Subscription Agreement
In
connection with the entry into the Loan and Security Agreement, the Company entered into a Subscription Agreement (the “Subscription
Agreement”) between the Company and Avenue, pursuant to which the Company issued 106,351 shares (the “Subscription Shares”)
of the Company’s common stock to Avenue for no additional consideration. The issuance of the Subscription Shares was made in reliance
on the exemption from registration contained in Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities
Act”), and Rule 506 of Regulation D thereunder, because the offer and sale of such securities does not involve
a “public offering” as defined in Section 4(a)(2) of the Securities Act, and other applicable requirements are met.
Pursuant
to the Subscription Agreement, the Company shall use its commercially reasonable efforts to prepare and file with the SEC within 60
days of the LSA Closing Date a registration statement on Form S-3, or if the Company is not then eligible to register for resale securities
on Form S-3, on another appropriate form of registration statement, registering the resale of the Subscription Shares, and the shares
of the Company’s common stock issuable upon the Conversion Right pursuant to the Loan and Security Agreement.
The
foregoing summary of the Subscription Agreement does not purport to be complete and is qualified in its entirety by reference to the
full text of Subscription Agreement, which is filed herewith as Exhibit 10.3 and is incorporated by reference herein. The representations,
warranties and covenants Subscription Agreement were made only for purposes of such agreement and as of specific dates and were solely
for the benefit of the parties to such agreement.
Appointment
of New Director
On
August 1, 2025, the Company’s Board of Directors (the “Board”) appointed James C. Theofilos as a new Class II member of the Board. The term of each Class II director lasts until the Company’s 2026 annual meeting of
stockholders. In connection with the appointment of Mr. Theofilos to the Board, the size of the Board was increased by resolution of
the Board from seven members to eight members on August 1, 2025.
James
C. Theofilos, 30, has been a Senior Finance Manager within the Azure and artificial intelligence division of Microsoft Corporation (“Microsoft”)
since October 2023. In this role, Mr. Theofilos is the Go-to-Market (“GTM”) Finance Lead across Microsoft’s AI Apps
& Agents team, which includes all of Microsoft’s AI models, GitHub Copilot, Copilot Studio, and other products that aim to
deliver the full value of AI & Agents. Previously, Mr. Theofilos held various finance positions at Microsoft including his position
as the Finance Lead for Microsoft’s Global Healthcare & Life Sciences Sales team, which included exposure to the Health Providers,
Payors, Pharma and Med Tech industry verticals. Prior to that, Mr. Theofilos consulted as a Group Project Manager at VICI Properties
Inc., a publicly traded Real Estate Investment Trust primarily engaged in the business of owning and acquiring gaming, hospitality, wellness,
entertainment, and leisure destinations, based in New York City. Mr. Theofilos holds an M.S. in Finance and a B.S.B.A. in Finance from
Washington University in Saint Louis. The Board believes that Mr. Theofilos’ business experience, and his knowledge of the finance
and technology industries, qualify him to serve on the Board.
There
are no arrangements or understandings between Mr. Theofilos and any other persons pursuant to which he was selected as a director of
the Company. As required to be disclosed under Item 404(a) of Regulation S-K, Happy Holstein Management, LLC (“Happy Holstein”),
of which Mr. Theofilos’ mother, Kathryn Theofilos, is the manager, participated as an investor in the Company’s June 2024
private placement. Happy Holstein purchased (i) warrants to purchase up to 385,059 shares of common stock, par value $0.001 per share,
of the Company (the “Common Stock”), and (ii) and pre-funded warrants to purchase 770,119 shares of Common Stock, in the
private placement, the terms of which were described in a registration statement on Form S-1, originally filed by the Company with the
SEC on July 10, 2024. The registration statement on Form S-1 covers the resale of certain securities issuable in connection with the
private placement, and was declared effective by the SEC on July 22, 2024.
In
connection with his appointment to the Board, Mr. Theofilos will receive the Company’s standard non-employee director compensation,
and has been granted an inaugural equity award effective August 1, 2025, pursuant to the Company’s Non-Employee Director Compensation
Policy, a copy of which was filed with the SEC as Exhibit 10.13 to the Company’s Registration Statement on Form S-1 on August 24,
2023. Additionally, Mr. Theofilos and the Company will enter into the Company’s standard indemnification agreement for directors
and executive officers, the form of which was filed with the SEC as Exhibit 10.14 to the Company’s Registration Statement on Form
S-1/A on May 21, 2018.
Resignation
and Reappointment of a Director
Consistent
with the amended and restated certificate of incorporation and amended and restated bylaws of the Company, and in order to achieve a
more equal balance of membership among the three classes of members of the Board, the Board has determined that one of the Class II directors
with a term expiring at the Company’s 2026 annual meeting of stockholders should move to Class III with a term expiring at the
Company’s 2027 annual meeting of stockholders. Accordingly, on August 1, 2025, Thomas M. Patton resigned as a Class II director
with a term expiring at the Company’s 2026 annual meeting of stockholders, and was immediately reappointed to the Board as a Class
III director with a term expiring at the Company’s 2027 annual meeting of stockholders. The resignation and reappointment of Mr.
Patton was not due to any disagreement with the Company, the Board or the management of the Company. For all other purposes, including
equity award vesting and other compensation matters, Mr. Patton’s service on the Board is deemed to have continued uninterrupted.
Mr. Patton will continue as the Chair of the Audit Committee of the Board.
(b)
Not applicable.
(c)
Trading Plans.
During
the quarter ended June 30, 2025, no director or Section 16 officer adopted or terminated any Rule 10b5-1 trading arrangements or non-Rule
10b5-1 trading arrangements (in each case, as defined in Item 408(a) of Regulation S-K promulgated by the SEC).
26
Item
6. EXHIBITS
Exhibit
Number
Description
10.1*#
Loan and Security Agreement by and among electroCore, Inc., NeuroMetrix, Inc., and Avenue Venture Opportunities Fund II, L.P., dated August 4, 2025.
10.2*^
Supplement to Loan and Security Agreement by and among electroCore, Inc., NeuroMetrix, Inc., and Avenue Venture Opportunities Fund II, L.P., dated August 4, 2025.
10.3*^
Subscription
Agreement between electroCore, Inc. and Avenue Venture Opportunities Fund II, L.P., dated August 4, 2025
31.1*
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS
Inline
XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within
the Inline XBRL document.
101.SCH
Inline
XBRL Taxonomy Extension Schema Document
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
*
Filed
herewith.
**
The
certifications attached as Exhibits 32.1 and 32.2 that accompany this Annual Report are not deemed filed with the SEC and are not
to be incorporated by reference into any filing of electroCore, Inc. under the Securities Act of 1933 or the Securities Exchange
Act of 1934, whether made before or after the date of this Annual Report, irrespective of any general incorporation language contained
in such filing.
#
Pursuant to Item 601(a)(5) of Regulation S-K, certain schedules and exhibits to this exhibit have been omitted from this Quarterly Report on Form 10-Q and will be furnished to the Securities and Exchange Commission supplementally upon request.
^
Certain confidential portions of this exhibit have been redacted from the publicly filed document because such portions are (i) not material and (ii) would be competitively harmful of publicly disclosed.
27
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Quarterly Report to be signed on its
behalf by the undersigned thereunto duly authorized.
Company
Name
Date:
August 6, 2025
By:
/s/
DANIEL S. GOLDBERGER
Daniel
S. Goldberger
Chief
Executive Officer
(Principal
Executive Officer)
Date:
August 6, 2025
By:
/s/
JOSHUA S. LEV
Joshua
S. Lev
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
28
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.