Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our President and Chief Executive Officer, who
serves as our principal executive officer and our principal financial and accounting officer, has conducted an evaluation of the effectiveness
of the design and operation of our disclosure controls and procedures as of December 31, 2025. The term “disclosure controls and
procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company
that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act
is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.
Disclosure controls and procedures include, without
limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or
submit under the Exchange Act is accumulated and communicated to our management, including our President and Chief Executive Officer,
to allow timely decisions regarding required disclosure. Based on this evaluation, our President and Chief Executive Officer concluded
that our disclosure controls and procedures were effective as of December 31, 2025.
Management’s Annual Report on Internal Control Over Financial
Reporting
Our management is responsible for establishing
and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange
Act). Our President and Chief Executive Officer, who serves as our principal executive officer and our principal financial and accounting
officer, assessed the effectiveness of our internal control over financial reporting as of December 31, 2025. In making this assessment,
our President and Chief Executive Officer used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission,
or COSO, in Internal Control—Integrated Framework. Based on that assessment and using the COSO criteria, our President and Chief
Executive Officer have concluded that, as of December 31, 2025, our internal control over financial reporting was effective.
Our independent registered public accounting firm
will not be required to formally attest to the effectiveness of our internal controls over financial reporting for as long as we are an
“emerging growth company” pursuant to the provisions of the Jumpstart Our Business Startups Act.
Changes in Internal Control Over Financial Reporting
There have been no changes in our internal control
over financial reporting during the most recent fiscal quarter, that has materially affected, or is reasonably likely to materially affect,
our internal control over financial reporting.
Inherent Limitations of Controls
Management does not expect that our disclosure
controls and procedures or our internal control over financial reporting will prevent or detect all errors and all fraud. Controls and
procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management
necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Because of the inherent
limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of
fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making
can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual
acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls
also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will
succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes
in conditions, or deterioration in the degree of compliance with the policies or procedures. Because of the inherent limitations in a
cost-effective control system, misstatements due to error or fraud may occur and not be detected.
ITEM 9B. OTHER INFORMATION
During the three months ended December 31, 2025,
no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1
trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT
INSPECTIONS
Not applicable.
37
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this item is hereby
incorporated by reference to our definitive proxy statement for our 2026 annual meeting of stockholders to be filed with the SEC within
120 days of the fiscal year ended December 31, 2025.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item is hereby
incorporated by reference to our definitive proxy statement for our 2026 annual meeting of stockholders to be filed with the SEC within
120 days of the fiscal year ended December 31, 2025.
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by this item is hereby
incorporated by reference to our definitive proxy statement for our 2026 annual meeting of stockholders to be filed with the Securities
and Exchange Commission within 120 days of the fiscal year ended December 31, 2025.
Securities Authorized for Issuance under Equity Compensation Plans
The following table sets forth information regarding
our equity compensation plans at December 31, 2025:
Plan category
Number of securities to be
issued upon
exercise of
outstanding
options,
warrants and
rights
(a)
Weighted-
average exercise
price
of
outstanding
options,
warrants and
rights
(b)
Number of securities
(by class) remaining
available for future
issuance under
equity compensation
plans (excluding
securities reflected in
column (a))
(c)
Equity compensation plans approved by security holders (1)
10
$ 46,400.00
34
Equity compensation plans not approved by security holders (2)
27
$ 28,720.00
-
(1) Represents shares of common
stock issuable upon exercise of outstanding stock options and rights under our 2018 Stock Incentive Plan (the “2018 Plan”)
and 2021 Stock Plan (the “2021 Plan”). Both plans permit the Company to grant incentive and nonqualified stock options for
the purchase of common stock, and restricted stock awards. The maximum number of shares of common stock reserved for issuance under the
2018 Plan and 2021 Plan are 20 and 61, respectively. At December 31, 2025 there were 9 and 25 shares of common stock available for grant
under the 2018 Plan and 2021 Plan, respectively.
(2) Consists of warrants issued
to placement agents, underwriters and consultants.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED
TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this item is hereby
incorporated by reference to our definitive proxy statement for our 2026 annual meeting of stockholders to be filed with the SEC within
120 days of the fiscal year ended December 31, 2025.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information required by this item is hereby
incorporated by reference to our definitive proxy statement for our 2026 annual meeting of stockholders to be filed with the SEC within
120 days of the fiscal year ended December 31, 2025.
38
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) The following documents are
filed as part of this report:
(1) Financial Statements—See
Index to Consolidated Financial Statements at Part II, Item 8 on page F-1 of this Form 10-K.
(2) All financial statement schedules
have been omitted because they are not applicable or not required or because the information is included elsewhere in the financial statements
or the Notes thereto.
(3) See the accompanying Index
to Exhibits filed as a part of this Form 10-K, which list is incorporated by reference in this Item.
(b) See the accompanying Index
to Exhibits filed as a part of this Form 10-K.
(c) Other schedules are not applicable.
INDEX TO EXHIBITS
Exhibit No.
Description of Document
3.1
Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
3.2
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Bluejay Diagnostics, Inc., filed with the Delaware Secretary of State on July 21, 2023 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 21, 2023).
3.3
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Bluejay Diagnostics, Inc., filed with the Delaware Secretary of State on May 14, 2024 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on May 16, 2024).
3.4
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Bluejay Diagnostics, Inc., filed with the Delaware Secretary of State on June 17, 2024 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on June 20, 2024).
3.5
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Bluejay Diagnostics, Inc., filed with the Delaware Secretary of State on August 28, 2024 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on August 23, 2024).
3.6
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Bluejay Diagnostics, Inc., filed with the Delaware Secretary of State on November 15, 2024 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on November 18, 2024).
3.7
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Bluejay Diagnostics, Inc., filed with the Delaware Secretary of State on January 27, 2026 and effective as of January 29, 2026 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on January 30, 2026).
3.8
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
3.9
Amendment No. 1 to Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on October 16, 2024).
4.1
Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
4.2
Form of Pre-Funded Common Stock Purchase Warrant for October 2025 Private Placement (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K (File No. 001-41031) filed on October 14, 2025).
39
4.3
Form of Series F Warrant for October 2025 Private Placement (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K (File No. 001-41031) filed on October 14, 2025).
4.4
Form of Placement Agent Warrant for October 2025 Private Placement (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K (File No. 001-41031) filed on October 14, 2025).
4.5
Form of Class E Common Stock Purchase Warrant for April 2025 Private Placement (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K (File No. 001-41031) filed on April 9, 2025).
4.6
Form of Class C Warrant for June 2024 Public Offering (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on June 28, 2024).
4.7
Form of Prefunded Common Stock Warrant (January 2024 Public Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on January 2, 2024).
4.8
Form of Common Stock Warrant for January 2024 Public Offering (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on January 2, 2024).
4.9
Form of Placement Agent Common Stock Warrant for January 2024 Public Offering (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed on January 2, 2024).
4.10
Form of Common Stock Warrant for August 2023 Offering (incorporated by reference to Exhibit 4.1 to the Company’s Form 8-K filed on August 28, 2023).
4.11
Form of Class A Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on November 16, 2021).
4.12
Form of Class B Warrant (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
4.13
Form of Warrant Agency Agreement (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
4.14
Form of IPO Underwriters’ Warrant (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
4.15
Description
of Securities of Bluejay Diagnostics, Inc. (incorporated by reference to Exhibit 4.10 to the Company’s Annual Report on Form 10-K filed on March 31, 2025).
10.1**
2021 Stock Plan (incorporated by reference to Exhibit 10.1 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
10.2**
Employment Agreement, dated July 1, 2021, between Neil Dey and Bluejay Diagnostics, Inc. (incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
10.3**
First Amendment to Employment Agreement, dated January 27, 2023, between Neil Dey and Bluejay Diagnostics, Inc. (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on January 27, 2023).
10.4**
Employment Agreement, dated July 1, 2021, between Jason Cook and Bluejay Diagnostics, Inc. * (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
10.5**
Separation and Release Agreement, entered into on May 28, 2025, by and between Bluejay Diagnostics, Inc. and Jason Cook (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on May 28, 2025).
10.6
Settlement Agreement and Release, dated as of May 8, 2025, by and among Bluejay Diagnostics, Inc. and Nanohybrids, Inc (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2025, filed on May 13, 2025).
40
10.7
Securities Purchase Agreement, dated October 9, 2025, between Bluejay Diagnostics, Inc. and the purchaser parties thereto (incorporated by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025, filed on November 7, 2025).
10.8
Registration Rights Agreement, dated October 9, 2025, between Bluejay Diagnostics, Inc. and the purchaser parties thereto (incorporated by reference to Exhibit 10.6 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025, filed on November 7, 2025).
10.9
Engagement Letter, entered into on August 29, 2025, between Bluejay Diagnostics, Inc. and Rodman & Renshaw LLC (incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-3 (File No. 291402) filed on October 23, 2025).
10.10
Form of Inducement Letter Agreement, by and between the Company and each purchaser identified on the signature pages thereto, dated as of April 7, 2025 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on April 9, 2025).
10.11
Master Supply Agreement dated July 30, 2021, between Bluejay Diagnostics, Inc. and Sanyoseiko Co., Ltd. (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025, filed on November 7, 2025).
10.12
Master Service Agreement dated July 30, 2021, between Bluejay Diagnostics, Inc. and Sanyoseiko Co., Ltd. (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on October 9, 2025).
10.13
Agreement to Amend Master Supply Agreement and Master Service Agreement, dated October 3, 2025, between Bluejay Diagnostics, Inc. and Sanyoseiko Co., Ltd. (Master Supply Agreement dated July 30, 2021, between Bluejay Diagnostics, Inc. and Sanyoseiko Co., Ltd. (incorporated by reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025, filed on November 7, 2025).
10.14
Amended and Restated License Agreement, entered into on October 23, 2023, by and between Bluejay Diagnostics, Inc. and Toray Industries, Inc. (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 26, 2023).
10.15
Amendment to License Agreement and Master Supply Agreement, entered into on July 23, 2025, by and between Bluejay Diagnostics, Inc. and Toray Industries, Inc. (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 28, 2025).
14.1
Code of Ethics (incorporated by reference to Exhibit 14.1 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
19.1
Insider Trading Policy (incorporated by reference to Exhibit 19.1 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed on March 31, 2025.
21.1
List of Subsidiaries. (incorporated by reference to Exhibit 21.1 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
31.1*
Certification of Principal Executive Officer pursuant to Rule 13a-14 of the Securities Exchange Act of 1934, as amended
31.2*
Certification of Principal Financial Officer pursuant to Rule 13a-14 of the Securities Exchange Act of 1934, as amended
32.1*
Certification of Principal Executive Officer Pursuant to Section 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 Section 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
97.1
Incentive Compensation Recovery Policy (incorporated by reference to Exhibit 97.1 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed on March 28, 2024)
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 included in Exhibit 101)
*
Filed herewith.
**
Management contract or compensatory plan, contract or arrangement.
ITEM 16. FORM 10-K SUMMARY.
None.
41
SIGNATURES
Pursuant to the requirements
of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized on March 6, 2026.
Bluejay Diagnostics, Inc.
By:
/s/ Neil Dey
Neil Dey
President, Chief Executive Officer and Director
Pursuant to the requirements
of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in
the capacities and on the dates indicated.
Signature
Title
Date
/s/ Neil Dey
President, Chief Executive Officer and Director
March 6, 2026
Neil Dey
(Principal Executive Officer and
Principal Financial and Accounting Officer)
/s/ Donald R. Chase
Chairman of the Board of Directors
March 6, 2026
Donald R. Chase
/s/ Douglas C. Wurth
Director
March 6, 2026
Douglas C. Wurth
/s/ Svetlana Dey
Director
March 6, 2026
Svetlana Dey
/s/ Fred S. Zeidman
Director
March 6, 2026
Fred S. Zeidman
42
Index to Consolidated Financial Statements
Contents
Report of Independent Registered Public Accounting Firm (PCAOB ID # 392 ) F-2
Consolidated Balance Sheets F-3
Consolidated Statements of Operations F-4
Consolidated Statements of Changes in Stockholders’ Equity F-5
Consolidated Statements of Cash Flows F-6
Notes to Consolidated Financial Statements F-7
F- 1
Report of Independent Registered Public Accounting
Firm
To the Shareholders and the Board of Directors of Bluejay Diagnostics,
Inc.:
Opinion on the Financial Statements
We have audited the accompanying
consolidated balance sheets of Bluejay Diagnostics, Inc. (the “Company”) as of December 31, 2025 and 2024, the related consolidated
statements of operations, stockholders’ equity and cash flows for the years then ended, and the related notes to the consolidated
financial statements (collectively, the “financial statements”). In our opinion, the financial statements present fairly,
in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and
its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Emphasis of Matter Regarding Going Concern
The accompanying financial
statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements,
the Company has incurred net losses since its inception, and has negative cash flows from operations and will need additional funding
to complete planned development efforts. This raises substantial doubt about the Company’s ability to continue as a going concern.
Management’s plans in regard to these matters also are described in Note 1. The financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements
are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial
statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United
States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in
accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance
about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to
have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required
to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness
of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing
procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management,
as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for
our opinion.
/s/ Wolf & Company, P.C.
We have served as the Company’s auditor since 2017.
Boston, Massachusetts
March 6, 2026
F- 2
Bluejay Diagnostics, Inc.
Consolidated Balance Sheets
December 31,
2025
2024
ASSETS
Current assets:
Cash and cash equivalents
$ 5,164,875
$ 4,301,945
Prepaid expenses and other current assets
275,957
596,938
Assets held for sale
22,770
-
Total current assets
5,463,602
4,898,883
Property and equipment, net
1,534,441
1,513,495
Operating lease right-of-use assets
113,289
209,788
Other non-current assets
7,905
35,257
Total assets
$ 7,119,237
$ 6,657,423
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 214,255
$ 145,122
Operating lease liability, current
100,000
113,260
Accrued expenses
804,942
551,986
Total current liabilities
1,119,197
810,368
Operating lease liability, non-current
20,211
108,989
Other non-current liabilities
4,540
8,567
Total liabilities
1,143,948
927,924
Commitments and contingencies (Note 10)
Stockholders’ equity:
Common stock, $ 0.0001 par value; 250,000,000 shares authorized; 604,534 and 138,503 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively
60
14
Additional paid-in capital
47,492,496
40,398,269
Accumulated deficit
( 41,517,267 )
( 34,668,784 )
Total stockholders’ equity
5,975,289
5,729,499
Total liabilities and stockholders’ equity
$ 7,119,237
$ 6,657,423
See report of independent registered public accounting
firm and notes to consolidated financial statements.
Reflects a 1-for 4 reverse stock split effective
January 29, 2026, a 1-for-50 reverse stock split effective November 18, 2024
and a 1-for-8 reverse stock split effective June 20, 2024.
F- 3
Bluejay Diagnostics, Inc.
Consolidated Statements of Operations
For Years Ended
December 31,
2025
2024
Operating expenses:
Research and development
$ 3,046,448
$ 3,471,671
General and administrative
3,906,524
3,689,648
Sales and marketing
-
8,297
Total operating expenses
6,952,972
7,169,616
Operating loss
( 6,952,972 )
( 7,169,616 )
Other income (expense):
Interest expense
( 839 )
( 823,028 )
Interest income
97,559
145,823
Other income, net
7,769
129,027
Total other income (expense), net
104,489
( 548,178 )
Net loss
( 6,848,483 )
( 7,717,794 )
Deemed dividend on warrant modification
-
13,223,053
Net loss applicable to common stockholders
$ ( 6,848,483 )
$ ( 20,940,847 )
Net loss per share to common stockholders - Basic and diluted
$ ( 15.25 )
$ ( 456.75 )
Weighted average common shares outstanding:
Basic and diluted
449,043
45,848
See report of independent registered public accounting
firm and notes to consolidated financial statements.
Reflects a 1-for-4 reverse stock split effective
January 29, 2026, a 1-for-50 reverse stock split effective November 18, 2024
and a 1-for-8 reverse stock split effective June
20, 2024.
F- 4
Bluejay Diagnostics, Inc.
Consolidated Statements of Changes in Stockholders’
Equity
Common Stock
Additional
Paid-In
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance as of December 31, 2023
774
$ -
$ 29,845,838
$ ( 26,950,990 )
$ 2,894,848
Stock-based compensation expense
-
-
20,094
-
20,094
Issuance of common stock in connection with January 2024 Offering, net of issuance costs of $ 711,031
1,683
-
2,788,969
-
2,788,969
Issuance of common stock in connection with Bridge Note Financing
363
-
307,563
-
307,563
Issuance of common stock in connection with June 2024 Offering, net of issuance costs of $ 1,133,419
26,839
3
7,435,653
-
7,435,656
Exercise of Series D Warrants
108,844
11
547
-
558
Cash for fractional shares from reverse stock split
-
-
( 395 )
-
( 395 )
Net loss
-
-
-
( 7,717,794 )
( 7,717,794 )
Balance as of December 31, 2024
138,503
14
40,398,269
( 34,668,784 )
5,729,499
Stock-based compensation expense
-
-
6
-
6
Issuance of common stock for vested restricted stock units
4
-
-
-
-
Issuance of common stock in connection April 2025 Warrant Inducement, net of issuance costs of $ 464,670 and warrant inducement cost of $ 2,706,645
271,277
27
675,350
-
675,377
Warrant inducement cost
-
-
2,706,645
-
2,706,645
Issuance of common stock in connection with October 2025 Private Placement, net of issuance costs of $ 787,755
43,750
4
3,712,241
-
3,712,245
Exercise of October 2025 Prefunded Warrants
151,000
15
( 15 )
-
-
Net loss
-
-
-
( 6,848,483 )
( 6,848,483 )
Balance as of December 31, 2025
604,534
$ 60
$ 47,492,496
$ ( 41,517,267 )
$ 5,975,289
See report of independent registered public accounting
firm and notes to consolidated financial statements.
Reflects a 1-for-4
reverse stock split effective January 29, 2026, a 1-for-50 reverse stock split effective November 18, 2024
and a 1-for-8 reverse
stock split effective June 20, 2024.
F- 5
Bluejay Diagnostics, Inc.
Consolidated Statements of Cash Flows
For the Years Ended
December 31,
2025
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 6,848,483 )
$ ( 7,717,794 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
74,182
75,618
Stock-based compensation expense
6
20,094
Amortization of right-of-use asset
96,499
123,479
Non-cash interest expense for note payable
-
307,563
Write-off and impairment of property and equipment
42,937
3,411
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
333,881
150,325
Deferred offering costs
-
265,081
Other non-current assets
27,352
( 6,594 )
Accounts payable
69,133
( 346,352 )
Accrued expenses and other current and non-current liabilities
150,918
( 695,653 )
Net cash used in operating activities
( 6,053,575 )
( 7,820,822 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
( 173,735 )
( 306,783 )
Net cash used in investing activities
( 173,735 )
( 306,783 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock, gross
8,346,692
12,069,075
Payment for issuance costs of common stock
( 1,252,425 )
( 1,844,450 )
Proceeds from issuance of notes payable
-
2,000,000
Repayment of notes payable
-
( 2,000,000 )
Proceeds from exercise of Class D warrants
-
558
Fractional shares adjustment for reverse stock split
-
( 395 )
Payment of finance lease
( 4,027 )
( 3,754 )
Net cash provided by financing activities
7,090,240
10,221,034
Net increase in cash and cash equivalents
862,930
2,093,429
Cash and cash equivalents, beginning of period
4,301,945
2,208,516
Cash and cash equivalents, end of period
$ 5,164,875
$ 4,301,945
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION AND NON-CASH INVESTING ACTIVITIES
Fair value of common stock issued in connection with notes payable
$ -
$ 307,563
See report of independent registered public accounting
firm and notes to consolidated financial statements.
F- 6
Bluejay Diagnostics, Inc.
Notes to the Consolidated Financial Statements
1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION
Business
Bluejay Diagnostics, Inc. (“Bluejay”
and/or the “Company”) is a medical diagnostics company focused on improving patient outcomes in critical care settings, with
a focus on sepsis. The Company is working on developing rapid, near-patient tests using whole blood on its Symphony technology platform
(“Symphony”), which consists of an analyzer and single-use protein detection cartridges. The Company does not yet have regulatory
clearance for Symphony, and it will need to receive regulatory authorization from the U.S. Food and Drug Administration (the “FDA”)
before Symphony can be marketed as a diagnostic product in the United States. The Company has completed the pre-clinical development of
the Symphony analyzer. During 2025, the Company transferred the intellectual property underlying the production of the Symphony cartridges
from the original developer and outside supplier, Toray Industries, to a contract manufacturing facility with FDA certification run by
Sanyoseiko. The Company is also working with Sanyoseiko to modify the manufacturing process of the Symphony cartridges to address certain
technical issues to bring Symphony to a level consistent with necessary performance and quality requirements for regulatory submission.
To achieve its plan, the Company expects to need to raise at least $ 20 million of further capital by the end of the 2027 fiscal year,
which the Company hopes to do in various tranches.
The Company’s Symphony platform is a combination
of Bluejay’s intellectual property (“IP”) and exclusively licensed and patented IP on the Symphony technology that the
Company believes if cleared, authorized, or approved by the FDA, could provide a solution to a significant market need in the United States.
The Symphony device candidate is designed to produce laboratory-quality results in approximately 20 minutes in critical care settings,
including Intensive Care Units (“ICUs”) and Emergency Rooms (“ERs”), where rapid and reliable results are required.
The Company’s first product candidate, the
Symphony IL-6 test, is an immunoassay for the measurement of interleukin-6 (IL-6) to be used for the monitoring of disease progression
in critical care settings. The Company is currently focused on pursuing the Symphony IL-6 test in the context of sepsis. IL-6 is a clinically
established inflammatory biomarker, and is considered a ‘first-responder,’ for assessment of severity of infection and inflammation
across many disease indications, including sepsis. A current challenge of healthcare professionals is the excessive time and cost associated
with determining a patient’s level of severity at triage and the Company believes that its Symphony IL-6 test, if ultimately successful
and approved, could have the ability to consistently monitor this critical care biomarker with rapid results.
If the Company succeeds with the foregoing plan,
in the future it hopes to develop additional tests for Symphony, including tests for myocardial infarction and congestive heart failure
(cardiac biomarkers hsTNT and NT pro-BNP) as well as other tests using the Symphony platform.
The Company was incorporated under the laws of
Delaware on March 20, 2015. Its headquarters are located in Acton, Massachusetts.
On June 4, 2021, the Company formed Bluejay Spinco,
LLC, a wholly-owned subsidiary of the Company, for purposes of further development of the Company’s ALLEREYE diagnostic test. ALLEREYE
is a point-of-care device offering healthcare providers a solution for diagnosing Allergic Conjunctivitis. The Company currently is not
actively pursuing development of the ALLEREYE diagnostic test.
FDA Regulatory Strategy
The design, development, manufacture, testing
and sale of the Company’s products in the U.S. are subject to regulation by numerous governmental authorities, principally the FDA,
and corresponding state and local regulatory agencies. Generally, the products we develop must be cleared by the FDA before they are marketed
in the United States. Before and after approval, authorization, or clearance in the United States, our products are subject to extensive
regulation by the FDA, as well as by other regulatory bodies. FDA regulations govern, among other things, the development, testing, manufacturing,
labeling, safety, storage, recordkeeping, market clearance, authorization or approval, labeling and promotion, import and export, marketing
and sales, and distribution of medical devices.
The Company’s current regulatory strategy
is designed to support commercialization of Symphony in the United States if and when the Company receives marketing authorization from
the FDA. In May 2023, the Company submitted a pre-submission application to the FDA presenting study designs to validate Symphony IL-6
for use with hospitalized sepsis patients. The Company participated in a pre-submission meeting with the FDA in August 2023, and at the
meeting the FDA provided feedback on the study design, determined that the submission of a 510(k) is the appropriate premarket submission
pathway, and requested that certain data be provided in the 510(k). Based on this feedback, the Company determined to proceed on this
basis, which considers the FDA’s feedback.
In the second quarter of 2024, the Company completed
a multicenter SYmphony IL-6 MONitoring Sepsis (“SYMON”) clinical study investigating the role of interleukin-6 (IL-6) in patients
diagnosed with sepsis and septic shock. This prospective study assessed the performance of IL-6 upon initial presentation to the intensive
care unit (ICU). A primary endpoint of the SYMON-I pilot clinical study (registered clinical trial number NCT06181604) suggested that
IL-6 levels within 24 hours of sepsis or septic shock diagnosis and admission to the ICU may predict patient mortality out to 28 days.
Furthermore, a secondary endpoint of the SYMON-I study suggested that IL-6 levels within 24 hours of sepsis or septic shock diagnosis
and admission to the ICU is a predictor of patient mortality during their hospitalization. Other secondary endpoints suggested that lactate
and Sequential Organ Failure Assessment (SOFA), standard clinical tests used for sepsis and septic shock patients, were not predictors
of patient mortality out to 28 days. We believe that the findings underscore the potential importance of IL-6 as a predictor and provide
new insights into the potential pathways for improving sepsis outcomes.
F- 7
Using the data analysis from the SYMON-I pilot
clinical study, the Company initiated the SYMON-II pivotal clinical study in the third quarter of 2024. The SYMON II clinical study has
three components: (1) collection, freezing, and biobanking of patient samples, (2) measuring IL-6 concentrations in the biobanked samples
near the end of patient enrollment or after the patient enrollment has completed, and (3) analysis of the IL-6 data with the patient outcomes
to see if the established IL-6 cutoff value has been validated for 28-day all-cause mortality. Patient enrollment started during the fourth
quarter of 2024. As of March 2, 2026, the Company has enrolled approximately 583 hospital patients among a target of 750 patients,
and it has collected, frozen and biobanked blood samples from the enrolled patients, while also obtaining all related patient data regarding
their disease progression and outcomes. The Company expects to complete patient enrollment in the study in the summer of 2026. The Company’s
goal is to use the Symphony IL-6 test to complete the testing in the SYMON-II clinical trial. The Company is not yet testing the samples
because it is simultaneously working with Sanyoseiko to manufacture the cartridges that will be used in the test, and these cartridges
are still being manufactured and verified to ensure that they meet FDA requirements for submission and commercial production. The Company’s
goal is to produce and verify these cartridges during 2026.
If the Company is able to complete the SYMON-II
clinical study and the results are positive, the Company intends to use the data generated from SYMON-II to support a 510(k) application
to the FDA. This application is currently expected to be based on the following intended use: “Symphony IL-6 is intended for use
to determine the IL-6 concentration as an aid in assessing the cumulative 28-day risk of all-cause mortality in conjunction with other
laboratory findings and clinical assessments for patients diagnosed with sepsis or septic shock in the ICU.” The Company also plans
to present the SYMON-I and SYMON-II results at future national scientific meetings and publish them in peer-reviewed journals, subject
to future completion of the SYMON-II study and the results being positive. Subject to achieving needed funding and successfully addressing
the manufacturing process challenges with its cartridges, the Company’s plan is to begin testing of samples it is collecting as
part of the SYMON-II clinical trial by the end of 2026, with a goal of being in position to submit a 510(k) regulatory application to
the FDA in 2027, and an objective of achieving FDA clearance thereafter.
The Company’s ability to engage in and complete
the activities needed for an FDA submission will be contingent upon it addressing these and other challenges, including possessing and/or
raising sufficient capital, remaining a going concern, and producing product capable of supporting our product requirements and meeting
analytical validation and clinical validation.
Product Manufacturing
The Company plans to manufacture its analyzers
and cartridges through Sanyoseiko Co. Ltd. (“Sanyoseiko”), as a contract manufacturing organization (“CMO”), and
the Company has entered into master supply and master service agreements with Sanyoseiko governing these matters. Pursuant to statements
of work that the Company will provide to Sanyoseiko under these agreements, Sanyoseiko will provide end-to-end support for the Symphony
platform, including supporting the manufacturing redevelopment process for analyzers and cartridges (with hardware, software, and design
updates), managing raw material sourcing and vendor compliance, and serving as the Company’s contract manufacturing organization
for analyzers, cartridges, and related components. In this capacity, Sanyoseiko will oversee fulfillment, kit assembly, labeling, packaging,
shipping, and quality control of manufactured products, while also providing regulatory and quality management support, and equipment
storage and maintenance.
Sanyoseiko had been selected as the Company’s
CMO due to their core competencies in manufacturing and quality systems recognized by the FDA. Sanyoseiko’s facilities are located
in Japan. The Company currently licenses the technology for the Symphony cartridges from Toray Industries, Inc. (“Toray”).
The Company’s license grants it exclusive global marketing rights, with the exception of Japan. The Company holds the rights to
manufacture the analyzers and the cartridges.
Risks and Uncertainties
As noted above, the Company will be reliant upon
its CMO, Sanyoseiko to provide analyzers and, once manufacturing processes have been redeveloped, cartridges, in sufficient quantity and
quality to complete the validations for its FDA application. The Company’s FDA application submission could be delayed if the Company
encounters any material supply interruptions. In addition, there can be no assurance that the Company will be able to obtain necessary
regulatory authorization for the manufacturing or marketing of the Symphony in the United States or elsewhere. There also can be no assurance
that the Company will successfully complete any clinical evaluations necessary to receive regulatory clearances, or that the clinical
study will demonstrate sufficient safety and effectiveness of the Symphony IL-6 test. The failure to adequately demonstrate the clinical
performance of the Symphony IL-6 test could delay or prevent regulatory clearance, which could prevent or result in delays to market launch
and could materially harm the Company’s business.
In addition to the FDA regulatory strategy risks
and uncertainties, the Company is subject to a number of risks similar to other companies in its industry, including rapid technological
change, competition from larger biotechnology companies and dependence on key personnel. Additional risk and uncertainties regarding the
Company are described in “Part I – Item 1A. Risk Factors” of this Annual Report on Form 10-K.
F- 8
Reverse Stock Splits and Increase to Authorized
Capital
On July 24, 2023, the Company effected the first
reverse stock split of its shares of common stock at a ratio of 1-for-20 (the “July 2023 Reverse Stock Split”). On June 20,
2024, the Company effected a second reverse stock split of its shares of common stock at a ratio of 1-for-8 (the “June 2024 Reverse
Stock Split”). On November 18, 2024, the Company effected a third reverse stock split of its shares of common stock at a ratio of
1-for-50 (the “November 2024 Reverse Stock Split”). On January 29, 2026, the Company effected a fourth reverse stock split
of its shares of common stock at a ratio of 1-for-4 (the “January 2026 Reverse Stock Split” and, together with the July 2023
Reverse Stock Split, June 2024 Reverse Stock Split, and the November 2024 Reverse Stock Split, the “Reverse Stock Splits”).
As such, collectively, the Company’s common stock has undergone reverse stock splits that have combined the shares on a 1-for-32,000
aggregate basis since July 2023. All of the Company’s historical share and per share information related to issued and outstanding
common stock and outstanding options and warrants exercisable for common stock in these financial statements have been adjusted, on a
retroactive basis, to reflect these reverse stock splits.
At the Company’s annual meeting of stockholders
on June 18, 2025, the Company’s stockholders provided the Company’s board of directors with authority to implement the January
2026 Reverse Stock Split, as well as an additional reverse stock split at a ratio of up to 1-for-20 (the “Additional Reverse Stock
Split”). The Additional Reverse Stock Split may not be implemented if it would reduce the number of publicly held shares of the
Company’s common stock to less than 500,000 . The Board’s authority to implement the Additional Reverse Stock expires on June
18, 2026.
On October 23, 2024, the stockholders of the Company
approved and adopted an amendment to the Company’s amended and restated certificate of incorporation, to increase the number of
authorized shares of the Company’s common stock to 250,000,000 .
Basis of Presentation
The accompanying consolidated financial statements
have been prepared in accordance with generally accepted accounting principles in the United States (“US GAAP”) and include
all adjustments necessary for the presentation of the Company’s consolidated financial position, results of operations and cash
flows for the periods presented. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary.
All intercompany balances and transactions have been eliminated in consolidation.
Going Concern
The consolidated financial statements for the
years ended December 31, 2025 and 2024 were prepared under the assumption that the Company will continue as a going concern, which contemplates
that the Company will be able to realize assets and discharge liabilities in the normal course of business.
The Company had cash and cash equivalents of $ 5,164,875
and current liabilities of $ 1,119,197 as of December 31, 2025. The Company has incurred net losses since its inception, has incurred negative
cash flows from operations and has an accumulated deficit of $ 41,517,267 as of December 31, 2025. The Company expects that its net cash
used in operating activities will continue to be negative over at least the next several years as it attempts to redevelop aspects of
the manufacturing process for Symphony cartridges and conducts clinical trial work and, if such redevelopment and trials are successful,
begins preparation of an FDA submission. These financial results and financial position, and the Company’s expected forward-looking
outlook of significant negative cash flow in the future, raise substantial doubt with respect to its ability to continue as a going concern.
The Company expects that it will not be in position to submit a 510(k) regulatory application to the FDA for Symphony until 2027, at the
earliest, if it is even able to generate sufficient clinical trial results to support such a submission. If the Company fails to obtain
sufficient future financing, its clinical trials and targeted FDA submission timeline could be delayed, and it could be forced to abandon
such activities entirely and cease operations, with the possible loss of such properties or assets. If the Company is unable to obtain
additional financing as it continues to generate negative cash flow, its board of directors could determine to cause the Company to undertake
a process of liquidation under Chapter 7 of applicable U.S. bankruptcy laws, or otherwise seek other protection under such laws. In such
event, holders of shares of the Company’s common stock could recoup little, if any, value in such process. The Company currently
estimates cash resources will be sufficient to fund its operations up to the third quarter of 2026.
These accompanying financial statements do not
include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of
liabilities that might result from the outcome of this uncertainty.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates
The preparation of financial statements in conformity
with US GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in these consolidated
financial statements and accompanying notes. Actual results could differ materially from those estimates. The Company evaluates its estimates
and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results
could differ from these estimates and assumptions, and those differences could be material to the consolidated financial statements.
F- 9
Cash and Cash Equivalents
The Company considers all highly liquid investments
with maturities of three months or less at the date of purchase to be cash equivalents. Cash equivalents, consisting of highly liquid
money market funds are carried at fair market value which approximates cost. The Company recognized interest income associated with cash
equivalents of $ 97,559 and $ 145,823 for the years ended December 31, 2025 and 2024, respectively.
Leases
The Company accounts for its leases under the
Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification (“ASC”) ASC 842, Leases
(“ASC 842”).
The Company has arrangements involving the lease
of facilities and the lease of copiers. Under ASC 842, at inception of the arrangement, the Company determines whether the contract is
or contains a lease and whether the lease should be classified as an operating or a financing lease. This determination, among other considerations,
involves an assessment of whether the Company can control the underlying asset and have the right to obtain substantially all of the economic
benefits or outputs from the asset. The Company accounts for the leases of less than 12 months as short-term leases.
The Company recognizes right-of-use (“ROU”)
assets and lease liabilities as of the lease commencement date based on the net present value of the future minimum lease payments over
the lease term. The Company amortizes the right-of-use assets over the remaining terms of the lease. ASC 842 requires the leases to use
the rate implicit in the lease unless it is not readily determinable and then it may use its incremental borrowing rate (“IBR”)
to discount the future minimum lease payments. Most of the Company’s leases do not provide an implicit rate; therefore, the Company
uses its IBR to discount the future minimum lease payments. The Company determines its IBR with its credit rating and other economic information
available as of the commencement date, as well as the identified lease term. During the assessment of the lease term, the Company considers
its renewal options and extensions within the arrangements and the Company includes these options when it’s reasonably certain to
extend the term of the lease.
The Company has lease arrangements that contain
incentives for tenant improvements as well as fixed rent escalation clauses. For contracts with tenant improvement incentives that are
determined to be leasehold improvements and the Company is reasonably certain to exercise, it records a reduction to the lease liability
and amortizes the incentive over the identified term of the lease as a reduction to rent expense. The Company records rental expense on
a straight-line basis over the identified lease term on contracts with rent escalation clauses.
Fair Value Measurements
The accounting guidance defines fair value, establishes
a consistent framework for measuring fair value and requires disclosure for each major asset and liability category measured at fair value
on either a recurring or non-recurring basis. Fair value is defined as an exit price, representing the amount that would be received to
sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based
measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis
for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs
used in measuring fair value as follows:
Level 1: Observable inputs such as
quoted prices in active markets.
Level 2: Inputs, other than the quoted
prices in active markets that are observable either directly or indirectly.
Level 3: Unobservable inputs in which
there is little or no market data, which require the reporting entity to develop its own assumptions.
The Company determines fair value for cash equivalents
with Level 1 inputs through the reference to the quoted market prices.
There were no liabilities measured at fair value
on a recurring basis, and no assets or liabilities measured at fair value on a non-recurring basis as of December 31, 2025 and 2024.
The carrying values of financial instruments such
as prepaid expenses, accounts payable, and accrued expenses approximated fair value as of December 31, 2025 and 2024 due to their short-term
maturities.
F- 10
Impairment of Property and Equipment
The Company evaluates its long-lived assets with
definite lives, such as fixed assets and right-of-use assets for impairment. The carrying value of fixed assets and right-of use assets
is reviewed on a regular basis for the existence of facts or circumstances, both internally and externally, that may suggest impairment.
Some factors which the Company considers to be triggering events for impairment review include classification of an asset as held for
sale, a significant decrease in the market value of an asset, a significant change in the extent or manner in which an asset is used,
a significant adverse change in the business climate that could affect the value of an asset, an accumulation of costs for an asset in
excess of the amount originally expected, a current period operating loss or cash flow decline combined with a history of operating loss
or cash flow uses or a projection that demonstrates continuing losses and a current expectation that, it is more likely than not, a long-lived
asset will be disposed of at a loss before the end of its estimated useful life. The factors that drive the estimate of the life are often
uncertain and are reviewed on a periodic basis or when events occur that warrant review. Recoverability is measured by comparison of the
assets’ book value to future net undiscounted cash flows that the assets are expected to generate. If the assets are not recoverable,
the impairment charge is measured as the amount by which the carrying value of the asset group exceeds the fair value.
During the year ended December 31, 2025, the
Company made the decision to close its internal lab and transferred the related fixed assets with a net book value of $ 62,376 to a third
party to be marketed and sold. The Company recognized an impairment charge of $ 26,706 which is included in research and development expenses.
There was no impairment charge in 2024.
Concentration of Credit Risk
Cash, and cash equivalents consist of financial
instruments that potentially subject the Company to a concentration of credit risk in the event of a default by the related financial
institution holding the securities, to the extent of the value recorded in the balance sheet. The Company invests cash that is not required
for immediate operating needs primarily in highly liquid instruments with lower credit risk.
Research and Development Expenses
Costs incurred in the research and development
of new products are expensed as incurred. Research and development costs include, but are not limited to, salaries, benefits, stock-based
compensation, laboratory supplies, fees for professional service providers and costs associated with product development efforts, including
preclinical studies and clinical trials.
The Company estimates preclinical study and clinical
trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations that
conduct and manage preclinical studies and clinical trials on its behalf. In accruing service fees, the Company estimates the time period
over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of
services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Payments made to third parties
under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered.
Stock-Based Compensation
Share-based compensation expense for all
share-based payment awards made to employees, directors and non-employees is measured based on the grant-date fair value of the award.
Share-based compensation expense for awards granted to non-employees is determined using the fair value of the consideration received
or the fair value of the equity instruments issued, whichever is more reliably measured.
The Company uses the Black-Scholes option pricing
model to determine the fair value of options granted. The Company recognizes the compensation cost of share-based awards on a straight-line
basis over the requisite service period. For stock awards for which vesting is subject to performance-based milestones, the expense is
recorded over the implied service period after the point when the achievement of the milestone is probable, or the performance condition
has been achieved.
The determination of the fair value of share-based
payment awards utilizing the Black-Scholes model is affected by the stock price and a number of assumptions, including expected volatility,
expected life, risk-free interest rate and expected dividends. The Company does not have a history of market prices of its common stock,
and as such, volatility is estimated using historical volatilities of similar public entities. The expected life of the awards is estimated
based on the simplified method for grants to employees and is based on the contractual term for non-employee awards. The risk-free interest
rate assumption is based on observed interest rates appropriate for the terms of the awards. The dividend yield assumption is based on
history and expectation of paying no dividends.
The Company recognizes forfeitures related to
employee share-based payments when they occur.
F- 11
Warrants
The Company accounts for warrants as either equity-classified
or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance
in the Financial Accounting Standards Board, or the FASB, ASC, 480, Distinguishing Liabilities from Equity, or ASC 480, and ASC 815, Derivatives
and Hedging, or ASC 815. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet
the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under
ASC 815, including whether the warrants are indexed to the Company’s own stock and whether the warrant holders could potentially
require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity
classification. Finally, the Company determines if the warrants meet the definition of a derivative based on their contractual terms.
This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent
quarterly period end date while the warrants are outstanding.
For issued or modified warrants that meet all
of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the
time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required
to be recorded at their initial fair value on the date of issuance, and at each balance sheet date thereafter. Changes in the estimated
fair value of liability-classified warrants are recognized as a non-cash gain or loss on the consolidated statements of operations. The
Company also evaluates if changes in contractual terms or other considerations would result in the reclassification of outstanding warrants
from liabilities to stockholders’ equity (or vice versa).
Segment Reporting
The Company follows the guidance in ASC 280, Segment
Reporting. Management has determined that the Company operates as one operating and reportable segment, as the Chief Executive Officer ,
who serves as the Chief Operating Decision Maker, evaluates performance of the operating segment and allocates resources based on amounts
as reported on the consolidated statements of operations and cash flows. Segment expenses are presented on the Company’s consolidated
statements of operations. The operating segment assets are reported on the consolidated balance sheets as total assets. The Company’s
operations consist solely of the development of its Symphony diagnostic platform, a near-patient diagnostic platform designed to provide
rapid results for critical care settings, and no discrete financial information is produced for separate business components. Accordingly,
the consolidated financial statements represent the Company’s single reportable segment.
Income Taxes
The Company follows accounting guidance regarding
the recognition, measurement, presentation and disclosure of uncertain tax positions in the consolidated financial statements. Tax positions
taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether
the tax positions are “more-likely-than-not” of being sustained by the applicable tax authorities. Tax positions not deemed
to meet a more-likely-than-not threshold would be recorded in the consolidated financial statements. There are no uncertain tax positions
that require accrual or disclosure as of December 31, 2025. Any interest or penalties are charged to expense. During the years ended December
31, 2025 and 2024, the Company had no significant interest and penalties. Tax years subsequent to December 31, 2022 are subject to examination
by federal and state authorities.
The Company recognizes deferred tax assets and
liabilities based on the impact of temporary differences between assets and liabilities recognized for tax and financial reporting purposes
measured by applying enacted tax rates and laws that will be in effect when the differences are expected to reverse, net operating loss
carryforwards and tax credits. Valuation allowances are provided when necessary to reduce net deferred tax assets to an amount that is
more likely than not to be realized. The deferred tax benefit or expense for the period represents the change in the deferred tax asset
or liability from the beginning to the end of the period.
Deferred Offering Costs
Deferred offering costs consist of underwriting,
legal, accounting and other expenses incurred through December 31, 2023 that are directly related to the January 2024 Offering and
that were charged to stockholders’ equity upon the completion of the January 2024 Offering.
F- 12
Net Loss per Share
Basic net loss per share to common stockholders
is computed by dividing the net loss applicable to common stockholders by the weighted-average number of shares of common stock outstanding
for the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net
loss by the weighted average number of shares of common stock and dilutive common stock equivalents outstanding for the period determined
using the treasury stock and if-converted methods. Dilutive common stock equivalents are comprised of options outstanding under the Company’s
stock option plan, restricted stock units, and warrants. For all periods presented, there is no difference in the number of shares used
to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities would be antidilutive.
Potentially dilutive securities not included in
the calculation of diluted net loss per share, because to do so would be anti-dilutive, are as follows (in common stock equivalent shares):
December 31,
2025
2024
Options to purchase common stock
5
18
Restricted stock units (RSUs)
-
-
Pre-2024 warrants for common stock
159
165
Class A warrants for common stock
77
77
Class B warrants for common stock
2
2
January 2024 warrants for common stock
1,682
1,682
January 2024 placement agent warrants for common stock
117
117
Class C warrants for common stock
71,873
343,147
Class E warrants for common stock
271,277
-
Class F warrants for common stock
1,125,000
-
Class F placement agent warrants for common stock
45,000
-
Recently Adopted Accounting Standards
Reportable Segment Disclosures
In November 2023, the FASB issued ASU 2023-07,
Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures. The change in the standard improves reportable segment
disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The changes improve financial reporting
by requiring disclosure of incremental segment information on an annual and interim basis for all public entities to enable investors
to develop more decision-useful financial analyses. The guidance will be effective for annual reporting periods beginning after December
15, 2023, and for interim periods beginning after December 15, 2024. Early adoption is permitted. The standard will be applied retrospectively.
Since the Company has one reportable segment, adoption of this new standard did not have a material impact on the Company’s
consolidated financial statements.
Income Taxes Disclosures
In December 2023, the FASB issued ASU 2023-09,
Income Taxes (Topic 740), Improvements to Income Tax Disclosures. This change requires enhanced income tax disclosures, primarily related
to existing rate reconciliation and income taxes paid information. The guidance will be effective for annual reporting periods beginning
after December 15, 2024. Adoption of this new standard increased disclosure in the notes to the Company’s consolidated financial statements.
Recently Issued Accounting Standards
Expense Disaggregation Disclosures
In November 2024, the FASB issued ASU 2024-03,
Reporting Comprehensive Income-Expense Disaggregation Disclosures. This change requires disaggregated disclosures of certain categories
of expenses that are included in expense line items on the face of the income statement. The disclosures are required on an annual and
interim basis. The guidance also requires the total amount of selling expenses to be disclosed and, on an annual basis, the definition
of selling expenses. The guidance will be effective for annual reporting periods beginning after December 15, 2026, and for interim periods
beginning after December 15, 2027. Early adoption is permitted. This new guidance will result in increased disclosures in the notes to
the financial statements.
F- 13
3. LICENSE AND SUPPLY AGREEMENT WITH TORAY INDUSTRIES
The Company depends on Toray’s
intellectual property for the Symphony cartridges upon which the Symphony platform relies. On October 6, 2020, the Company entered into
a License and Supply Agreement (the “License Agreement”) with Toray, providing the Company with an exclusive global license
(excluding Japan) to use Toray’s patents and know-how related to the Symphony detection cartridges for manufacturing, marketing
and sale of the products (as defined in the License Agreement). In exchange for the license, the Company committed to make two payments
of $ 120,000 each to Toray, both of which were made in 2021. In addition, following the first sale of the cartridges after regulatory clearance,
the Company is obligated to make royalty payments to Toray based on the net sales of the cartridges for the period that any underlying
patents exist or ten years after the first sale. Following the first sale after obtaining regulatory clearance, the Company will make
minimum annual royalty payments of $ 60,000 for the first year and $ 100,000 for each year thereafter, which shall be creditable against
any royalties owed to Toray in such calendar year.
On October 23, 2023, the Company and Toray entered
into an Amended and Restated License Agreement (the “New Toray License Agreement”) and a Master Supply Agreement (the “New
Toray Supply Agreement”). Under the New Toray License Agreement, the Company continues to license from Toray intellectual property
rights needed to manufacture single-use test cartridges, and the Company has received the right to sublicense certain Toray intellectual
property to Sanyoseiko in connection with Sanyoseiko’s ongoing agreement with the Company to manufacture the Company’s Symphony
analyzers and cartridges (including in connection with the Company’s clinical trials). In addition, the New Toray License Agreement
provided for the transfer of certain technology related to the cartridges to Sanyoseiko. The royalty payment percentage payable by the
Company to Toray was reduced under the New Toray License Agreement from 15 % to 7.5 % (or less in certain circumstances) of net sales of
certain cartridges for a term of 10 years. A 50 % reduction in the royalty rate applies upon expiry of applicable Toray patents on a product-by-product
and country-by-country basis. The New Toray License Agreement contemplates that applicable royalty payment obligations from the Company
to Toray for other products will be determined separately by the parties in the future.
On July 23, 2025, the Company entered into an
amendment (the “Amendment”) to the New Toray License Agreement and the New Toray Supply Agreement with Toray. The Amendment
provided that the deadline under the New Toray License Agreement for the Company to establish an alternative manufacturing site for the
Company’s Symphony cartridges would be extended from October 23, 2025 to October 23, 2026, and the Company has agreed to use its
best efforts to establish the site by such date. The Amendment confirms that Toray has provided to the Company all applicable know-how
required under the New Toray License Agreement and is not under any further obligation to provide know-how or technical assistance to
the Company. Pursuant to the Amendment, the Company paid $ 71,212 to Toray for a final supply of certain chip components prior to the expiration
of the New Toray Supply Agreement, which occurred on October 23, 2025. There were no sales of or revenues from the cartridges during the
years ended December 31, 2025 and 2024.
The Company has begun cartridge manufacturing
process redevelopment through Sanyoseiko, a third-party contractor who is managing such redevelopment. Such redevelopment is intended
to address several technical challenges to bring Symphony to a level consistent with necessary performance and quality requirements. After
the cartridge manufacturing process redevelopment is completed, the Company plans to have the manufacturing process occur at Sanyoseiko,
a FDA-registered CMO, including for verification and validation testing and commercial manufacturing. The manufacturing site will be established
by the Company without Toray’s technical assistance. If Toray were to assert that the Company has not used its best efforts to establish
the cartridge manufacturing site by October 2026, they could seek to terminate the license agreement as early as November 2026. If Toray
were to be successful in terminating the license agreement, the Company would lose access to certain technology required to produce the
cartridges that the Symphony system relies on to function, which would likely result in a material adverse effect on the Company’s
commercialization efforts. At December 31, 2025 and 2024, there were no amounts accrued related to the New Toray License Agreement or
the License Agreement.
4. FINANCINGS
October 2025 Private Placement
On October 9, 2025, the Company entered
into a securities purchase agreement with two institutional investors pursuant to which the Company sold in a private placement (i) an
aggregate of 43,750 shares of common stock and prefunded warrants to purchase up to 518,750 shares of common stock (the “October
2025 Prefunded Warrants”), and (ii) Series F warrants (the “Series F Warrants”) to purchase up to 1,125,000 shares of
common stock. The combined price of the securities sold in the private placement was $ 8.00 per share of common stock (or prefunded warrant
in lieu thereof, in which case such price was reduced by $ 0.0004 ) and accompanying Series F Warrants to acquire two shares of common stock.
The October 2025 Prefunded Warrants are exercisable for shares of common stock at an exercise price of $ 0.0004 per share, are immediately
exercisable and expire once exercised in full. The Series F Warrants are exercisable for shares of common stock at an exercise price of
$ 7.00 per share, are immediately exercisable and expire five and one-half years from the date of issuance.
The transaction closed on October 10, 2025. The
gross proceeds to the Company from the sale of the securities sold in the private placement were approximately $ 4.5 million. The Company
incurred total offering costs of $ 787,755 , including a 8 % financial advisory fee to Rodman and Renshaw LLC (“Rodman”), the
placement agent, of approximately $ 360,000 . Under the terms of the Company’s engagement letter with Rodman, the Company issue Rodman’s
designees warrants to purchase up to 45,000 of common stock at an exercise price of $ 10.00 per share, which expire 5.5 years from the
date of issuance (the “October 2025 Placement Agent Warrants”).
In connection with this private placement, on
November 26, 2025, the Company filed a prospectus under rule 424(b)(3) to register 1,732,500 shares of common stock for resale in public
markets.
Holders of the warrants will not have the right
to exercise any portion of such warrants if such holder, together with its affiliates, would beneficially own in excess of 4.99 % or 9.99 %
(at the initial election of the holder) of the number of shares of the Company’s common stock outstanding immediately after giving
effect to such exercise, provided that a holder may increase or decrease such beneficial ownership limitation up to, and no higher than,
9.99 %, by giving 61 calendar days’ notice to the Company.
F- 14
April 2025 Private Placement
On April 7, 2025, the Company entered into inducement
letter agreements with certain existing holders of the Company’s Class C warrants (the “Class C Warrants”), pursuant
to which such holders agreed to purchase an aggregate of 271,277 shares of the Company’s common stock (or, to the extent the applicable
holder would have exceeded a specified beneficial ownership limitation, prefunding the future exercise of such warrants, other than a
remaining $ 0.0004 per share exercise price). The Class C Warrants were originally issued on June 28, 2024 for an exercise price of $ 392.00
per share and were subsequently reduced to $ 65.20 per share pursuant to stockholder approval on August 21, 2024. Pursuant to the inducement
letter agreements, the applicable holders agreed to exercise their Series C Warrants at a reduced exercise price of $ 13.68 per share,
and to purchase an equivalent number of new Class E warrants (the “Class E Warrants”) for an additional $ 0.50 per share. The
Class E Warrants have an exercise price of $ 13.68 per share and expire on April 8, 2030.
The transaction closed on April 8, 2025. The exercise
of the Class C Warrants resulted in the Company issuing 170,551 shares of common stock at closing pursuant to the inducement letters,
and the exercise price of 100,726 of the Class C Warrants being amended to 0.0004 per share. As of December 31, 2025, all such reduced
exercise price Class C Warrants had been exercised.
The gross proceeds to the Company from the exercise
of the Class C Warrants and the sale of the new Class E Warrants were $ 3,846,707 . The Company incurred total cash offering costs of $ 464,670 ,
including a 10 % financial advisory fee to Aegis Capital Corp. of $ 384,670 .
The modification of the terms or conditions of
the Class C Warrants in this transaction is treated as an exchange of the original instrument for a new instrument. Using the Black Scholes
option pricing model, the fair value of the Series C Warrants immediately prior to the inducement transaction was $ 479,299 and immediately
after the inducement transaction was $ 1,590,930 . In addition, Series E Warrants with a fair value of $ 1,730,652 were provided as part
of the inducement transaction for a purchase price of $ 135,638 . The Company recorded additional equity issuance costs of $ 2,706,645 related
to the modification of the Series C Warrants and issuance of Series E Warrants related to the inducement transaction. As this equity issuance
cost was a non-cash transaction, the Company recorded an increase to additional paid-in capital to offset the expense.
June 2024 Public Offering
On June 28, 2024, the Company sold in a public
offering ( the “June 2024 Offering”), (i) 2,885 common units (the “Common Units”), each consisting of one share
of common stock, two Class C Warrants and one Class D Warrant and (ii) 23,953 prefunded units (the “Prefunded
Units”), each consisting of one prefunded warrant to purchase one share of common stock (each, a “June
2024 Prefunded Warrant”), two Class C Warrants and one Class D Warrant. The Common Units were sold at a price
of $ 326.00 per unit and the Prefunded Warrants were sold at a price of $ 325.98 per unit. Aegis Capital Corp. (“Aegis”)
partially exercised its over-allotment option in respect to 3,393 Class C Warrants and 1,696 Class D Warrants (the “Over-Allotment
Warrants). As of December 31, 2024, all Prefunded Warrants had been exercised in full.
Pursuant to an engagement letter dated June 6,
2024, by and between the Company and Aegis, the Company paid Aegis a total cash fee of $ 743,750 equal to 8.5 % of the gross proceeds received
in the June 2024 Offering.
The gross proceeds to the Company from the June
2024 Offering were $ 8,569,075 . The Company incurred offering costs of $ 1,133,419 .
May 2024 Bridge Note Financing
On May 31, 2024, the Company entered into a Note
Purchase Agreement with an accredited investor (the “NPA”), and a Securities Purchase Agreement with three accredited
investors (the “SPA”). This transaction closed on June 3, 2024. Debt issuance costs related to the NPA and SPA totaled $ 212,654 .
Under the terms of the NPA, the first investor provided the Company with a $ 1,000,000 cash subscription in exchange for the issuance
of a senior secured note (the “Bridge Note”). As of December 31, 2024, a total of $ 1,176,470 was repaid to the NPA investor
in full satisfaction of the Bridge Note. The difference between the Bridge Note and the subscription amount, initially recorded as a discount
on the notes, was the result of the discount factor included in the NPA of approximately 17.6 %.
Under the terms of the SPA, the three additional
investors agreed to collectively provide the Company with a separate $ 1,000,000 cash subscription in exchange for the issuance of
senior secured notes (the “SPA Notes”), and the collective issuance of 362 shares of the Company’s common
stock. The fair value of the common stock issued in connection with the SPA was $ 307,563 . As of December 31, 2024, a total of $ 1,111,110 has
been repaid to the SPA investors, in full satisfaction of the SPA Notes. The difference between the SPA Notes and the subscription amounts,
initially recorded as a discount on the SPA Notes, was the result of the discount factor included in the SPA of 11.11 %.
The interest expense recorded on the NPA and SPAs
was $ 807,797 for the year ended December 31, 2024, including debt issuance costs related to the NPA and SPA totaling $ 212,654 .
January 2024 Public Offering
On January 2, 2024, the Company sold in a public
offering (such transaction, the “January 2024 Offering”) (i) 336 shares of common stock and (ii) prefunded warrants to purchase
up to an aggregate 1,346 shares of common stock (the “January 2024 Prefunded Warrants”). The Shares and January 2024 Prefunded
Warrants were sold together with warrants to purchase up to an aggregate of 1,682 shares of common stock at an exercise price of $ 2,080.00
per share (the “January 2024 Warrants”). The combined public offering price was $ 2,080.00 per share of common stock and related
January 2024 Warrant and $ 2,079.84 per January 2024 Prefunded Warrant and related January 2024 Warrant.
As of December 31, 2024, all January 2024 Prefunded
Warrants had been exercised in full. The January 2024 Warrants were exercisable immediately and remain exercisable for a period of five
years following the date of issuance.
F- 15
Pursuant to an engagement letter, dated as of
August 7, 2023, as amended October 11, 2023, by and between the Company and the H.C. Wainwright & Co., LLC (“H.C. Wainwright”),
the Company paid H.C. Wainwright a total cash fee of $ 245,000 equal to 7.0 % of the gross proceeds received in the January 2024 Offering.
The Company also paid H.C. Wainwright a management fee of $ 35,000 equal to 1.0 % of the gross proceeds raised in the January 2024 Offering
and certain expenses incurred in connection with the January Offering. In addition, the Company issued to H.C. Wainwright’s designees,
warrants to purchase up to an aggregate 117 shares of common stock (the “January 2024 Placement Agent Warrants”), which represents
7.0 % of the aggregate number of shares of Common Stock and January 2024 Prefunded Warrants sold in the January 2024 Offering. The January
2024 Placement Agent Warrants have substantially the same terms as the January 2024 Warrants, except that the January 2024 Placement Agent
Warrants have an exercise price equal to $ 2,600.00 , or 125 % of the offering price per share of common stock and related January 2024 Warrant
sold in the January 2024 Public Offering and expire on the fifth anniversary from the date of the commencement of sales in the January
2024 Offering.
The gross proceeds to the Company from the January 2024 Offering were
$ 3,500,000 . The Company incurred offering costs of $ 711,031 .
5. WARRANTS
The following table summarizes information
with regard to warrants outstanding at December 31, 2025:
Shares Exercisable for Weighted
Average
Exercise
Price Weighted Average
Remaining
Life
(in Years)
October 2025 Prefunded warrants 367,750 Common Stock $ 0.0004 N/A
Class F warrants for common stock 1,125,000 Common Stock $ 7.00 5.3
Class F Placement Agent warrants for common stock 45,000 Common Stock $ 10.00 5.3
Class E warrants for common stock 271,277 Common Stock $ 13.68 4.3
June 2024 Class C warrants for common stock 71,873 Common Stock $ 65.20 3.5
January 2024 warrants for common stock 1,682 Common Stock $ 2,080.00 3.0
January 2024 Placement Agent warrants for common stock 117 Common Stock $ 2,600.00 3.0
August 2023 warrants for common stock 134 Common Stock $ 11,584.00 2.6
August 2023 Placement Agent warrants for common stock 8 Common Stock $ 14,736.00 2.6
Class A warrants for common stock 77 Common Stock $ 224,000.00 0.9
Class B warrants for common stock 2 Common Stock $ 320,000.00 0.9
Other Pre-2024 warrants for common stock 17 Common Stock $ 132,849.00 0.5
October 2025 Private Placement
On October 9, 2025, the Company entered into a
securities purchase agreement with two institutional investors pursuant to which the Company sold in a private placement (i) an aggregate
of 43,750 shares of common stock and prefunded warrants to purchase up to 518,750 shares of common stock (the “October 2025 Prefunded
Warrants”). The October 2025 Prefunded Warrants were exercisable for shares of common stock at an exercise price of $ 0.0004 per
share, were immediately exercisable and expired once exercised in full. As of December 31, 2025, 367,750 of the October 2025 Prefunded
Warrants remained unexercised. Between January 1, 2026 and February 19, 2026 , all of the remaining October 2025 Prefunded Warrants were
exercised in full.
October 2025 Class F Warrants
Pursuant to the October 2025 private placement,
the Company issued 1,125,000 Class F warrants for common stock with an exercise price of $ 7.00 per share and 45,000 Placement Agent Class
F warrants for common stock with an exercise price of $ 10.00 per share. The Class F warrants and Placement Agent Class F warrants became
exercisable immediately upon issuance and for a period of five and one half years following the date of issuance.
April 2025 Class E Warrants
Pursuant to the April 2025 private placement,
certain existing holders of the Company’s Class C Warrants agreed to purchase an aggregate of 271,277 shares of the Company’s
common stock. As a part of the April 2025 private placement, the Company sold 271,277 Series E Warrants to the Class C Warrant exercising
holders for $ 0.50 per warrant. The Class E warrants have an exercise price of $ 13.68 per share, became exercisable immediately upon issuance
and for a period of five years following the date of issuance.
F- 16
June 2024 Class C and Class D Warrants and
June 2024 Underwriter Over-Allotment Warrants
As a part of the June 2024 Offering, the Company
issued 53,680 Class C Warrants and 26,840 Class D Warrants. Aegis (the “Underwriter”) partially exercised its over-allotment
option with respect to 3,393 Class C Warrants and 1,696 Class D Warrants (the “Over-Allotment Warrants”).
Upon stockholder approval of the issuance of Class
C Warrants on August 21, 2024, the Class C Warrants, which had an initial exercise price of $ 392.00 per share of common stock, were adjusted
to be exercisable at an exercise price of $ 65.20 per share (the “floor price, which represented 20 % of the minimum price under Nasdaq’s
listing rules on the date of pricing of the June 2024 Offering), and the number of shares of common stock issuable upon exercise were
proportionately increased to 343,146 shares. In connection with the reset in the exercise price and number of shares issuable pursuant
to the Class C Warrants, the Company recorded a deemed dividend of $ 9,282,075 based on the excess of the fair value of the modified Class
C Warrants over the fair value of the Class C Warrants before the modification, the effect of which was an increase in the net loss attributable
to common shareholders in the statement of operations for the year ended December 31, 2024. The Class C Warrants may be exercised at any
time for a period of five (5) years following the date of stockholder approval in August 2024.
The Class D Warrants were immediately exercisable
at an exercise price of $ 0.02 per share of common stock for a period of five (5) years following the date of issuance. Upon stockholder
approval of the issuance of the Class D Warrants on August 21, 2024, the number of shares of common stock issuable upon exercise increased
to four shares per warrant for the remaining unexercised Class D Warrants as the weighted average price of our common stock over a rolling
five (5)-trading day period fell below $ 65.20 per share (the “floor” price, which represented 20 % of the “minimum price”
under Nasdaq’s listing rules on the date of pricing of the June 2024 Public Offering) following the issuance date. In connection
with the reset of the number of shares issuable pursuant to the Class D Warrants, the Company recorded a deemed dividend of $ 3,940,978
based on the excess of the fair value of the modified Class D Warrants over the fair value of the Class D Warrants before the modification,
the effect of which was an increase in the net loss attributable to common shareholders in the statement of operations for the year ended
December 31, 2024. As of December 31, 2024, all Class D Warrants have been exercised and none remain outstanding.
During 2024, the Company issued 108,844 shares
of common stock upon exercise of the June 2024 Class D Warrants. The Class D Warrants were exercised on either a cash basis at $ 0.02 per
share exercise price or on a proportional cashless basis.
January 2024 Common Stock Warrants and January
2024 Placement Agent Warrants
As part of the January 2024 Offering, the Company
issued January 2024 warrants to acquire 1,682 shares of common stock at an exercise price of $ 2,080.00 per share and January 2024 Placement
Agent Warrants to acquire 117 shares of common stock with an exercise price of $ 2,600.00 per share. The January 2024 warrants and January
2024 Placement Agent Warrants became exercisable immediately upon issuance for a period of five years following the date of issuance.
Fundamental Transaction
The warrants described above include certain rights
upon a “fundamental transaction” (as defined in such warrants), including the right of the holders thereof to receive from
the Company or a successor entity cash or the same type or form of consideration (and in the same proportion) that is being offered and
paid to the holders of common stock in such fundamental transaction in the amount of the Black Scholes value (as defined in such warrants)
of the unexercised portion of the applicable warrants on the date of the consummation of such fundamental transaction.
Warrant Accounting
Each of the Company’s warrants to acquire
shares of common stock were accounted for as equity classified financial instruments as they meet the requirements for equity classification
under ASC 815, Derivatives and Hedging .
6. STOCK COMPENSATION
Stock Incentive Plans
In 2018, the Company adopted the 2018
Stock Incentive Plan (the “2018 Plan”) for employees, consultants, and directors. The 2018 Plan, which is administered by
the Company’s Board of Directors, permits the Company to grant incentive and nonqualified stock options for the purchase of common
stock, and restricted stock awards. The maximum number of shares of common stock reserved for issuance under the 2018 Plan is 20 . At December
31, 2025 there were 9 shares of common stock available for grant under the 2018 Plan.
On July 6, 2021, the Company’s Board of
Directors and stockholders approved and adopted the Bluejay Diagnostics, Inc. 2021 Stock Plan (the “2021 Plan”). A total of
61 shares of common stock were approved to be initially reserved for issuance under the 2021 Stock Plan. At December 31, 2025 there were
25 shares of common stock available for grant under the 2021 Plan.
F- 17
Stock Award Activity
The following table summarizes the status of the
Company’s non-vested restricted stock awards for years ended December 31, 2025:
Non-vested
Restricted Stock Awards
Number of
Shares
Weighted
Average
Grant Date
Fair Value
Outstanding at December 31, 2024
-
$ 41,280
Granted
-
-
Vested
(- )
41,280
Cancelled / forfeited
-
-
Outstanding at December 31, 2025
-
$ -
Stock Option Plan Summary
The following is a summary of stock option activity for the year ended
December 31, 2025:
Number of
Stock
Options Weighted
Average
Exercise
Price Per
Share Weighted
Average
Remaining
Contractual
Life in
Years Aggregate
Intrinsic
Value
Outstanding at December 31, 2024 18 $ 59,864 5.8 $ -
Granted -
-
-
Exercised -
-
-
Cancelled / forfeited ( 13 ) 75,052 -
Outstanding at December 31, 2025 5 $ 20,376 3.0 $ -
Exercisable at December 31, 2025 5 $ 20,376 3.0 $ -
Stock-Based Compensation Expense
For the years ended December 31, 2025
and 2024, the Company recorded stock-based compensation expense as follows:
Year ended
December 31,
2025
2024
Research and development
$ ( 193 )
$ 16,648
General and administrative
199
3,446
Marketing and business development
-
-
Total stock-based compensation
$ 6
$ 20,094
At December 31, 2025, there was no
unrecognized compensation expense related to non-vested stock option awards and non-vested restricted stock awards.
F- 18
7. RELATED PARTY TRANSACTIONS
NanoHybrids, Inc.
In December 2021, the Company entered
into an agreement with NanoHybrids, Inc. (“NanoHybrids”), an entity in which the Company’s former Chief Technology Officer,
Jason Cook, served as Chief Executive Officer of prior to becoming employed by the Company, to enable NonoHybrids to utilize the Company’s
research and development staff and laboratory facility (the “Sharing and Services Agreement”). Any hours worked by Company
employees for NanoHybrids were billed to NanoHybrids at a bill rate of the respective employee’s fully burdened personnel cost plus
10 %. Additionally, the Company purchased certain lab supplies for NanoHybrids and rebilled those costs to NanoHybrids. Dr. Cook was the
majority shareholder of NanoHybrids during the time of this arrangement. The table below summarizes the amounts earned for the years ended
December 31, 2025 and 2024 and balances due from NanoHybrids as of December 31, 2025 and 2024:
Year Ended
December 31,
2025
2024
Income from NanoHybrids included in Other Income
$ 6,873
$ 127,079
Cash receipts from NanoHybrids
$ 21,437
$ 153,783
As of December 31,
2025
2024
Amounts receivable from NanoHybrids included in Prepaids and Other Current Assets
$ -
$ 14,564
8. PROPERTY AND EQUIPMENT
Property and equipment consisted of
the following at December 31, 2025 and 2024:
December 31,
Depreciable lives 2025 2024
Construction in process $ 1,279,173 $ 1,351,179
Manufacturing equipment 3 - 5 years 239,872 -
Furniture, fixtures, and equipment 3 - 5 years 116,782 136,312
Software 3 years - 4,457
Lab equipment 3 - 5 years - 173,268
Leasehold improvements Life of lease 43,231 43,231
1,679,058 1,708,447
Less: accumulated depreciation ( 144,617 ) ( 194,952 )
Property and equipment, net $ 1,534,441 $ 1,513,495
The Company reviews long-lived assets
for impairment when events, expectations, or changes in circumstances indicate that the asset’s carrying value may not be recoverable.
During the year ended December 31, 2025, the Company made the decision to close its internal lab and transferred the related fixed assets
with a net book value of $ 62,376 to a third party to be marketed and sold. The Company wrote-off $ 9,549 of lab equipment and recognized
an impairment charge of $ 26,706 , both of which are included in research and development expenses. As of December 31, 2025, the expected
realizable value of the remaining assets held for sale of $ 22,770 is recorded as assets held for sale in the Company’s balance sheets.
Construction in process consists of
symphony cartridge manufacturing equipment. The Company placed $ 239,872 of manufacturing equipment into service in 2025 and expects to
place the remaining construction in process into service in 2026 to support its SYMON II clinical study. All of the Company’s construction
in process and manufacturing equipment is held and operated by Sanyoseiko Co. LTD, its contract manufacturing organization in Japan.
F- 19
9. LEASES
The Company primarily enters into lease arrangements
for office, laboratory space, and copiers. A summary of supplemental lease information is as follows:
December 31,
2025 2024
Weighted average remaining lease term - operating leases (in years) 1.2 2.1
Weighted average remaining lease term - finance leases (in years) 2.1 3.1
Weighted average discount rate – operating leases 7.0 % 7.0 %
Weighted average discount rate – finance leases 7.0 % 7.0 %
Operating cash flows from operating leases $ 113,259 $ 177,081
Operating cash flows from finance leases $ 780 $ 1,053
A summary of the Company’s lease assets and liabilities are as
follows:
December 31,
2025 2024
Operating lease right-of-use asset $ 113,289 $ 209,788
Finance leases in Property and Equipment 5,689 10,421
Total lease assets $ 118,978 $ 220,209
Current portion of operating lease liability $ 100,000 $ 113,260
Current portion of finance lease liability included in accrued expenses 4,807 4,807
Noncurrent operating lease liabilities 20,211 108,989
Noncurrent finance lease liabilities 4,540 8,567
Total lease liabilities $ 129,558 $ 235,623
The following table reconciles the undiscounted lease liabilities to
the total lease liabilities recognized on the consolidated balance sheet as of December 31, 2025:
Year
Operating Lease
Finance
Lease
2026
$ 100,000
$ 4,807
2027
25,000
4,807
2027
-
400
Total future lease payments
125,000
10,014
Less: Imputed interest
4,789
667
Present value of lease liability
$ 120,211
$ 9,347
10. COMMITMENTS AND CONTINGENCIES
Legal Proceedings
Information pertaining to legal proceedings and related contingencies
can be found in “Item 3. Legal Proceedings” of this Annual Report on Form 10-K.
Minimum Royalties
As required under the License Agreement
(see Note 3), following the first sale of cartridges, the Company will also make royalty payments to Toray equal to 7.5 % of the net sales
of the cartridges for a term of 10 years. A 50 % reduction in the royalty rate applies upon expiry of applicable Toray patents on a product-by-product
and country-by-country basis. There were no sales of or revenues from the cartridges through December 31, 2025.
Indemnification
The Company has certain agreements
with service providers with which it does business that contain indemnification provisions pursuant to which the Company typically agrees
to indemnify the party against certain types of third-party claims. The Company accrues for known indemnification issues when a loss is
probable and can be reasonably estimated. The Company would also accrue for estimated incurred but unidentified indemnification issues
based on historical activity. As the Company has not incurred any indemnification losses to date, there were no accruals for or expenses
related to indemnification issues for any period presented.
F- 20
11. SUPPLEMENTAL BALANCE SHEET INFORMATION
Prepaid expenses and other current
assets consist of the following:
December 31,
2025
2024
Prepaid insurance
$ 183,211
$ 489,174
Vendor prepayments
-
21,946
Prepaid other
92,746
85,818
Total prepaid expenses and other current assets
$ 275,957
$ 596,938
Accrued expenses and other current
liabilities consist of the following:
December 31,
2025
2024
Accrued personnel costs
$ 47,117
$ 100,974
Accrued legal fees
43,077
48,860
Accrued clinical trial expenses
274,532
191,673
Accrued board of director fees
147,500
95,000
Accrued Delaware franchise tax
136,149
-
Accrued other
156,567
115,479
Total accrued expenses and other current liabilities
$ 804,942
$ 551,986
12. INCOME TAX
No provision for federal income taxes
has been recorded for the years ended December 31, 2025 and 2024 due to net losses and the valuation allowance established.
Significant components of the Company’s
deferred tax assets are as follows:
As of December 31,
2025
2024
Deferred tax assets:
Net operating losses
$ 8,696,586
$ 6,356,812
Tax credits
1,005,896
812,541
Intangible assets
47,562
52,813
Capitalized R&D expenses
2,140,990
2,619,730
Fixed assets
9,246
-
Other
189,326
193,197
Total deferred tax assets
12,089,606
10,035,093
Valuation allowance
( 12,089,606 )
( 10,035,093 )
Deferred tax asset, net of allowance
$ -
$ -
F- 21
A reconciliation of the statutory tax
rates and the effective tax rates for the years ended December 2025 and 2024 is as follows:
Year Ended December 31,
2025
2024
Federal statutory rate
21.00 %
21.00 %
Research tax credits
2.22 %
2.43 %
Nontaxable and nondeductible items
( 0.05 )%
( 0.08 )%
Other
( 0.02 )%
( 0.20 )%
Change in valuation allowance
( 23.15 )%
( 23.16 )%
Effective tax rate
0.00 %
0.00 %
The Company regularly assesses the need for a
valuation allowance against its deferred tax assets. In making that assessment, the Company considers both positive and negative evidence
related to the likelihood of realization of the deferred tax assets to determine, based on the weight of available evidence, whether it
is more-likely-than-not that some or all of the deferred tax assets will not be realized. In assessing the realizability of deferred tax
assets, the Company considers taxable income in prior carryback years, as permitted under the tax law, forecasted taxable earnings, tax
planning strategies, and the expected timing of the reversal of temporary differences. This determination requires significant judgment,
including assumptions about future taxable income that are based on historical and projected information and is performed on a jurisdiction-by-jurisdiction
basis.
The Company continues to maintain a full valuation
allowance against its deferred tax assets. During the years ended December 31, 2025 and 2024, management assessed the positive and negative
evidence in its operations, and concluded that it is more likely than not that its deferred tax assets as of December 31, 2025 and 2024
will not be realized given the Company’s history of operating losses. The valuation allowance against deferred tax assets increased
by approximately $ 2.1 million and $ 2.3 million during 2025 and 2024, respectively, related to a full valuation allowance recorded against
capitalized research expenditures, additional net operating losses and tax credits generated in the year.
As of December 31, 2025, the Company had
federal net operating losses of approximately $ 32.0 million. The Company’s federal net operating losses incurred prior to 2018 totaling
$ 713,000 expire through 2037, while its federal net operating losses incurred in 2018 to 2025 totaling approximately $ 31.3 million can
be carried forward indefinitely but are limited to 80 % utilization against future taxable income each year. As of December 31,
2024, the Company had federal net operating losses of $ 23.4 million, which may be available to offset future federal income tax liabilities.
As of December 31, 2025, the Company
had post-apportioned state net operating losses of approximately $ 31.3 million that can generally be carried forward 20 years and will
expire at various dates through 2045. As of December 31, 2024, the Company had post-apportioned Massachusetts net operating losses
of approximately $ 22.8 million that can generally be carried forward 20 years and will expire at various dates through 2044.
As of December 31, 2025, the Company
had $ 721,000 and $ 359,000 of federal and state research and development credits, respectively, which will expire at various dates through
2045. As of December 31, 2024, the Company had $ 569,000 and $ 307,000 of federal and state research and development credits, respectively,
which will expire at various dates through 2044.
13. SUBSEQUENT EVENTS
January 2026 Reverse Stock Split
On January 12, 2026, the Board of Directors
approved a 1-for-4 reverse stock split of the Company’s shares of common stock. This 1-for-4 reverse stock split became effective
on January 29, 2026.
Additional Exercises of Prefunded
Warrants
367,750 shares of common stock were
issued for October 2025 prefunded warrant exercises in January and February 2026.
F- 22
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.