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Item 9A. Controls and Procedures

2026-03-06 compared with 2025-03-31 · 1108 added, 795 removed, 297 unchanged (87% of the section changed)

CONTROLS AND PROCEDURES

of Disclosure Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our President and Chief Executive Officer, who

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Based on this evaluation, our President and Chief Executive Officer concluded

that our disclosure controls and procedures were not effective as of December 31, 2024.

Annual Report on Internal Control Over Financial Reporting

that our disclosure controls and procedures were effective as of December 31, 2025.

Management’s Annual Report on Internal Control Over Financial

Our management is responsible for establishing

1 unchanged sentence

Our President and Chief Executive Officer, who serves as our principal executive officer and our principal financial and accounting

officer, has conducted an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2024.

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 a result of a material weakness in internal control over financial reporting

arising from a lack of sufficient internal accounting expertise at the Company, our internal control over financial reporting was not

effective as of December 31, 2024.

The foregoing determination was made in connection

with the preparation and finalization of this Form 10-K.

In connection therewith, our independent registered public accounting firm identified

an issue with respect to the Company’s application of provisions of the Accounting Standards Codification of the FASB related to

the accounting and valuation of certain warrants.

In particular, in June 2024, the Company issued Class C and Class D warrants that contained

“reset” features that caused the exercise prices and number of shares of Company common stock issuable upon exercise of such

warrants to increase following stockholder approval of such warrants in August 2024 and changes in the market price of our common stock

that were measured in the period that immediately followed.

Under applicable accounting guidance, upon reset, the Company should have

recorded in its consolidated statement of operations the “deemed dividend on warrant modification” and “net loss applicable

to common stockholders,” in each case, below the presentation of net loss.

In addition, these non-book entry line items were not

included in the Company’s consolidated statement of operations for the three and nine months ended September 30, 2024 in the Company’s

Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2024.

Notwithstanding the material weaknesses, management

has concluded that the financial statements included elsewhere in this Form 10-K present fairly, in all material respects, our financial

position, results of operations, and cash flows in conformity with GAAP.

In addition, the Company intends to include an “out-of-period

adjustment” in its upcoming Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2025 to provide these additional

non-book entry line item amounts for the three and nine months ended September 30, 2024.

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.

Plan to Remediate Material Weakness

As noted above, our President and Chief Executive

Officer currently serves as our principal executive officer, and our principal financial and accounting officer, and has done so since

we separated with our prior Chief Financial Officer in October 2023 and our prior Interim Chief Financial Officer in March 2024.

Our President

and Chief Financial Officer, who is not a certified public accountant and does not have a prior background in public accounting, works

with external and internal consultants in preparing and reviewing the Company’s consolidated financial statements.

As a result of

the material weakness determination that occurred in connection with the preparation of this Form 10-K, we plan to enhance our processes

by designing and implementing controls to review the results of valuations and estimates, including the completeness and accuracy of relevant

data elements included in the valuation or estimate.

We also plan, subject to the availability of sufficient financial resources in the

future, to engage additional qualified resources and/or hire additional staff to ensure these incremental controls are properly implemented

and to ensure proper segregation of duties around the review of manual journal entries.

Management is currently evaluating steps to remediate

the material weaknesses, including enhanced processes to identify and appropriately apply applicable accounting requirements to better

evaluate and understand the nuances of the complex accounting standards that apply to our consolidated financial statements.

This includes

providing enhanced access to accounting literature, research materials, and documents, and increasing communication among our personnel

and third-party professionals with whom we consult regarding complex accounting applications.

When fully implemented and operational, we believe

the measures described above will remediate the underlying causes of the control deficiencies that gave rise to the material weakness

and will strengthen our internal control over financial reporting.

However, remediation efforts are expected to continue into future fiscal

Further, we will not be able to fully remediate this material weakness until these steps have been completed and have been operating

effectively for a sufficient period of time.

We may also identify additional measures that may be required to remediate the material weakness

in our internal control over financial reporting, necessitating further action.

in Internal Control Over Financial Reporting

Other than the material weakness determination

described above and the commencement of the Company’s remediation activities in connection therewith, 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.

Limitations of Controls

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

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.

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.

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.

OTHER INFORMATION

the three months ended December 31, 2024, 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.

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

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.

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT

Not applicable.

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

information required by this item is hereby incorporated by reference to our definitive proxy statement for our 2025 annual meeting of

stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2024.

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.

EXECUTIVE COMPENSATION

information required by this item is hereby incorporated by reference to our definitive proxy statement for our 2025 annual meeting of

stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2024.

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.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

information required by this item is hereby incorporated by reference to our definitive proxy statement for our 2025 annual meeting of

stockholders to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2024.

Authorized for Issuance under Equity Compensation Plans

following table sets forth information regarding our equity compensation plans at December 31, 2024:

of securities to be

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

average exercise

of securities

Number of securities

(by class) remaining

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issuance under

equity compensation

plans (excluding

securities reflected in

compensation plans approved by security holders (1)

compensation plans not approved by security holders (2)

(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

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 79 and 245, respectively.

At December 31, 2024 there were 35 and 101 shares of common stock available for grant under

the 2018 Plan and 2021 Plan, respectively.

of warrants issued to placement agents, underwriters and consultants.

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

information required by this item is hereby incorporated by reference to our definitive proxy statement for our 2025 annual meeting of

stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2024.

Equity compensation plans approved by security holders (1)

Equity compensation plans not approved by security holders (2)

(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.

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.

PRINCIPAL ACCOUNTANT FEES AND SERVICES

information required by this item is hereby incorporated by reference to our definitive proxy statement for our 2025 annual meeting of

stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2024.

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.

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

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.

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

the accompanying Index to Exhibits filed as a part of this Form 10-K, which list is incorporated

by reference in this Item.

the accompanying Index to Exhibits filed as a part of this Form 10-K.

schedules are not applicable.

(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.

INDEX TO EXHIBITS

Description of Document

6 unchanged sentences

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).

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).

Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form S-1 (File No.

4 unchanged sentences

333-260029), filed on October 4, 2021).

Form of Prefunded Common Stock Warrant (January 2024 Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on January 2, 2024).

Form of Common Stock Warrant (January 2024 Offering (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on January 2, 2024).

Form of Placement Agent Common Stock Warrant (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed on January 2, 2024).

Form of Common Stock (August 2023 Offering) (incorporated by reference to Exhibit 4.1 to the Company’s Form 8-K filed on August 28, 2023).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

5 unchanged sentences

333-260029), filed on October 4, 2021).

Description of Securities of Bluejay Diagnostics, Inc.

Form of Prefunded Warrant (incorporated by reference to Exhibit 4.11 to the Company’s Registration Statement on Form S-1 (File No.

333-280253), filed on June 17, 2024).

Form of Class C Warrant (incorporated by reference to Exhibit 4.12 to the Company’s Registration Statement on Form S-1 (File No.

333-280253), filed on June 17, 2024).

Form of Class D Warrant (incorporated by reference to Exhibit 4.13 to the Company’s Registration Statement on Form S-1 (File No.

333-280253), filed on June 17, 2024).

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).

2021 Stock Plan (incorporated by reference to Exhibit 10.1 to the Company’s Registration Statement on Form S-1 (File No.

8 unchanged sentences

333-260029), filed on October 4, 2021).

Form of Securities Purchase Agreement, dated December 27, 2023, between certain purchasers and Bluejay Diagnostics, Inc.

(incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on January 2, 2024).

Form of Securities Purchase Agreement, dated August 24, 2023, by and between the Company and each of the Purchasers signatory thereto (incorporated by reference to Exhibit 10.1 to the Company’s Registration Statement on Form S-1 (File No.

333-260029), filed on August 28, 2023).

Securities Purchase Agreement, dated June 7, 2021, between certain purchasers and Bluejay Diagnostics, Inc.

(incorporated by reference to Exhibit 10.7 to the Company’s Registration Statement on Form S-1 (File No.

333-260029), filed on October 4, 2021).

Registration Rights Agreement, dated June 7, 2021, between certain purchasers and Bluejay Diagnostics, Inc.

(incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form S-1 (File No.

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).

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).

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).

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).

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).

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).

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).

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).

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).

Amended and Restated License Agreement, entered into on October 23, 2023, by and between Bluejay Diagnostics, Inc.

1 unchanged sentence

(incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 26, 2023).

Master Supply Agreement, entered into on October 23, 2023, by and between Bluejay Diagnostics, Inc.

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 10.2 to the Company’s Current Report on Form 8-K filed on October 26, 2023).

Form of Note Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on May 31, 2024).

Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on May 31, 2024).

Form of Senior Secured Note (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on May 31, 2024).

Underwriting Agreement, dated June 27, 2024, between Aegis and Bluejay Diagnostics, Inc.

(incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed on June 28, 2024).

(incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 28, 2025).

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).

Insider Trading Policy.

List of Subsidiaries (incorporated by reference to Exhibit 21.1 to the Company’s Registration Statement on Form S-1 (File No.

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.

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).

5 unchanged sentences

Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Incentive Compensation Recovery Policy (incorporated by reference to Exhibit 97.1 to the Company’s Annual Report on Form 10-K filed March 28, 2024)

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)

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)

5 unchanged sentences

Cover Page Interactive Data File (formatted as Inline XBRL and included in Exhibit 101)

** Management

contract or compensatory plan, contract or arrangement.

Filed herewith.

Management contract or compensatory plan, contract or arrangement.

FORM 10-K SUMMARY.

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 31, 2025.

Diagnostics, Inc.

Chief Executive Officer and Director

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.

Chief Executive Officer and Director

Executive Officer and

Financial and Accounting Officer)

of the Board of Directors

Gary Gemignani

to Consolidated Financial Statements

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.

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.

President, Chief Executive Officer and Director

March 6, 2026

(Principal Executive Officer and

Principal Financial and Accounting Officer)

/s/ Donald R.

Chairman of the Board of Directors

March 6, 2026

/s/ Douglas C.

March 6, 2026

/s/ Svetlana Dey

March 6, 2026

Index to Consolidated Financial Statements

Report of Independent Registered Public Accounting Firm (PCAOB ID # 392 ) F-2

4 unchanged sentences

Notes to Consolidated Financial Statements F-7

of Independent Registered Public Accounting Firm

the Shareholders and the Board of Directors of Bluejay Diagnostics, Inc.:

on the Financial Statements

have audited the accompanying consolidated balance sheets of Bluejay Diagnostics, Inc.

(the “Company”) as of December 31,

2024 and 2023, 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, 2024 and

2023, 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.

of Matter Regarding Going Concern

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.

Report of Independent Registered Public Accounting

To the Shareholders and the Board of Directors of Bluejay Diagnostics,

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.

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.

securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

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.

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.

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.

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.

Wolf & Company, P.C.

have served as the Company’s auditor since 2017.

Massachusetts

Diagnostics, Inc.

Balance Sheets

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

/s/ Wolf & Company, P.C.

We have served as the Company’s auditor since 2017.

Boston, Massachusetts

March 6, 2026

Bluejay Diagnostics, Inc.

Consolidated Balance Sheets

Current assets:

1 unchanged sentence

Prepaid expenses and other current assets

Deferred offering costs

Assets held for sale

Total current assets

22 unchanged sentences

Total liabilities and stockholders’ equity

report of independent registered public accounting firm and notes to consolidated financial statements.

a 1-for-50 reverse stock split effective November 18, 2024 and 1-for-8 reverse stock split effective June 20, 2024.

Diagnostics, Inc.

Statements of Operations

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.

Bluejay Diagnostics, Inc.

Consolidated Statements of Operations

For Years Ended

19 unchanged sentences

Net loss per share to common stockholders - Basic and diluted

$ ( 3,631.48 )

Weighted average common shares outstanding:

Basic and diluted

report of independent registered public accounting firm and notes to consolidated financial statements.

a 1-for-50 reverse stock split effective November 18, 2024 and 1-for-8 reverse stock split effective June 20, 2024.

Diagnostics, Inc.

Statements of Changes in Stockholders’ Equity

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

Bluejay Diagnostics, Inc.

Consolidated Statements of Changes in Stockholders’

Stockholders’

2 unchanged sentences

Stock-based compensation expense

Issuance of common stock from exercised RSU’s, net of RSU tax withholding

Issuance of common stock to settle accrued bonus, net of shares withheld

Issuance of common stock, net of issuance costs of $ 413,544

( 9,953,888 )

Balance as of December 31, 2023

( 26,950,990 )

Stock-based compensation expense

Issuance of common stock in connection with January 2024 Offering, net of issuance costs of $ 711,031

7 unchanged sentences

( 34,668,784 )

report of independent registered public accounting firm and notes to consolidated financial statements.

a 1-for-50 reverse stock split effective November 18, 2024 and 1-for-8 reverse stock split effective June 20, 2024.

Diagnostics, Inc.

Statements of Cash Flows

Stock-based compensation expense

Issuance of common stock for vested restricted stock units

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

Warrant inducement cost

Issuance of common stock in connection with October 2025 Private Placement, net of issuance costs of $ 787,755

Exercise of October 2025 Prefunded Warrants

( 6,848,483 )

Balance as of December 31, 2025

$ ( 41,517,267 )

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.

Bluejay Diagnostics, Inc.

Consolidated Statements of Cash Flows

For the Years Ended

6 unchanged sentences

Amortization of right-of-use asset

Non-cash interest expense for finance lease

Non-cash interest expense for note payable

Loss on disposal of property and equipment

Write-off and impairment of property and equipment

Changes in operating assets and liabilities:

14 unchanged sentences

( 1,252,425 )

( 1,844,450 )

Proceeds from issuance of notes payable

3 unchanged sentences

Fractional shares adjustment for reverse stock split

Payment of deferred offering costs

Payment of tax withholding on obligations on restricted stock units

Payment of finance lease

Net cash provided by financing activities

Net increase (decrease) in cash and cash equivalents

( 7,906,474 )

Net increase in cash and cash equivalents

Cash and cash equivalents, beginning of period

1 unchanged sentence

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION AND NON-CASH INVESTING ACTIVITIES

Offering costs included in accounts payable and accrued expenses

Fair value of common stock issued in connection with notes payable

report of independent registered public accounting firm and notes to consolidated financial statements.

Diagnostics, Inc.

to the Consolidated Financial Statements

See report of independent registered public accounting

firm and notes to consolidated financial statements.

Bluejay Diagnostics, Inc.

Notes to the Consolidated Financial Statements

NATURE OF OPERATIONS AND BASIS OF PRESENTATION

Diagnostics, Inc.

(“Bluejay” and/or the “Company”) is a medical diagnostics company focused on improving patient

outcomes in critical care settings.

The Company is working on developing rapid tests using whole blood on its Symphony technology platform

(“Symphony”), which consists of an analyzer and cartridges.

The Company’s Symphony platform is a combination of Bluejay’s

intellectual property (“IP”) and exclusively licensed and patented IP that consists of a mobile device and single-use test

cartridges that if cleared, authorized, or approved by the U.S.

Food and Drug Administration (the “FDA”), could provide a

solution to a significant market need in the United States.

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.

Regulatory Strategy

Company’s current regulatory strategy is designed to support commercialization of Symphony in the United States pending 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.

We participated in a pre-submission meeting with the FDA on August 11, 2023,

and at the meeting the FDA provided feedback on the new 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.

the second quarter of 2024, we 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 analysis of the SYMON-I pilot clinical study (registered

clinical trial number NCT06181604) highlighted 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 outcome of the SYMON-I study showed 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 outcomes showed 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.

In the third quarter

of 2024, we initiated SYMON-II pivotal clinical study to validate the findings of the SYMON-I pilot clinical study.

a result of its lack of cash resources, the Company has recently slowed the timeline of this study to preserve cash resources in the

near-term, and the Company expects that these delays will prevent the Company from submitting an FDA application for its Symphony platform

before the fourth quarter of 2027.

Manufacturing

Company maintains contracts with Sanyoseiko Co.

Ltd (“Sanyoseiko”) to manufacture its analyzer.

Once redeveloped, the Company

plans to transfer manufacturing of its cartridges to Sanyoseiko, or other suitable CMO, to manufacture the cartridges.

and Uncertainties

noted above, Bluejay is reliant upon Sanyoseiko to provide analyzers in sufficient quantity and quality to complete the validations for

our FDA application.

Our FDA application submission could be delayed if the Company encounters any material supply interruptions.

addition, there can be no assurance that we 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 we will successfully complete any clinical evaluations

necessary to receive regulatory approvals, or that the clinical study will demonstrate sufficient safety and effectiveness of the Symphony

The failure to adequately demonstrate the clinical performance of the Symphony IL-6 test could delay or prevent regulatory

approval, which could prevent or result in delays to market launch and could materially harm our business.

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.

The Company is also impacted by inflationary pressures and global supply chain disruptions currently impacting many companies.

Stock Splits and Increase to Authorized Capital

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” and, together with the

July 2023 Reverse Stock Split and June 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-8,000 aggregate basis since

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.

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 .

of Presentation

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.

consolidated financial statements for the years ended December 31, 2024 and 2023 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.

Company had cash and cash equivalents of $ 4,301,945 and current liabilities of $ 810,368 as of December 31, 2024.

The Company has incurred

net losses since its inception, has incurred negative cash flows from operations and has an accumulated deficit of $ 34,668,784 as of

December 31, 2024.

The Company estimates cash resources will be sufficient to fund its operations up to the third quarter of 2025.

conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date these financial statements were issued.

Company continues to develop the Symphony device and its first test for the measurement of IL-6.

The Company remains committed to obtaining

FDA clearance and will conduct clinical studies to obtain sufficient data to support its FDA submission, while also continuing to build

its manufacturing operations with its contract manufacturing organizations.

Company expects that it will seek to raise additional capital through public or private equity offerings, grant financing and support

from governmental agencies, convertible debt, collaborations, strategic alliances and distribution arrangements.

Additional funds may

not be available when it needs them on terms that are acceptable to them, or at all.

If adequate funds are not available, it may be required

to delay its FDA regulatory strategy, and to delay or reduce the scope of its research or development programs, commercialization efforts

or manufacturing commitments and capacity, or even cease operations and enter into receivership.

In addition, if the Company raises additional

funds through collaborations, strategic alliances or distribution arrangements with third parties, it may have to relinquish valuable

rights to its technologies or future revenue streams.

Bluejay Diagnostics, Inc.

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

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.

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

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.

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

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.

(“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

The Company currently licenses the technology for the Symphony cartridges from Toray Industries, Inc.

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.

Reverse Stock Splits and Increase to Authorized

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”).

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

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

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.

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

2 unchanged sentences

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Use of Estimates

The preparation of financial statements in conformity

6 unchanged sentences

could differ from these estimates and assumptions, and those differences could be material to the consolidated financial statements.

and Cash Equivalents

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.

recognized interest income associated with cash equivalents of $ 145,823 and $ 164,900 for the years ended December 31, 2024 and 2023,

respectively.

Company accounts for its leases under the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification

(“ASC”) ASC 842, Leases (“ASC 842”).

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

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.

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

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.

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

The Company records rental expense on a straight-line basis over the identified lease term on contracts with rent escalation

Value Measurements

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:

inputs such as quoted prices in active markets.

other than the quoted prices in active markets that are observable either directly or indirectly.

inputs in which there is little or no market data, which require the reporting entity to develop its ow n assumptions.

Company determines fair value for cash equivalents with Level 1 inputs through the reference to the quoted market prices.

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, 2024 and 2023.

carrying values of financial instruments such as prepaid expenses, accounts payable, and accrued expenses approximated fair value as

of December 31, 2024 and 2023 due to their short-term maturities.

of Property and Equipment

Company evaluates its long-lived assets with definite lives, such as fixed assets and right-of-use assets for impairment.

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

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.

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.

The Company accounts for its leases under the

Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification (“ASC”) ASC 842, Leases

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.

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:

Observable inputs such as

quoted prices in active markets.

Inputs, other than the quoted

prices in active markets that are observable either directly or indirectly.

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

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.

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.

Concentration

of Credit Risk

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.

Company invests cash that is not required for immediate operating needs primarily in highly liquid instruments with lower credit risk.

and Development Expenses

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.

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.

service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each

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.

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.

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.

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.

Company recognizes forfeitures related to employee share-based payments when they occur.

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

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.

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.

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).

has determined that the Company has one operating segment, which is consistent with the Company’s structure and how it manages

the business.

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, 2024.

Any interest or

penalties are charged to expense.

During the years ended December 31, 2024 and 2023, the Company had no significant interest and penalties.

Tax years subsequent to December 31, 2021 are subject to examination by federal and state authorities.

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.

Offering Costs

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.

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

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.

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.

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

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.

the consolidated financial statements represent the Company’s single reportable segment.

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.

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.

6 unchanged sentences

to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities would be antidilutive.

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):

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):

Options to purchase common stock

Restricted stock units

Warrants for common stock

Restricted stock units (RSUs)

Pre-2024 warrants for common stock

Class A warrants for common stock

Class B warrants for common stock

5-Year warrants for common stock

January 2024 warrants for common stock

January 2024 placement agent warrants for common stock

Class C warrants for common stock

Placement agent warrants

Issued Accounting Standards

Company does not believe that any recently issued but not yet effective accounting pronouncements will have a material effect on the

accompanying consolidated financial statements.

Class E warrants for common stock

Class F warrants for common stock

Class F placement agent warrants for common stock

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.

LICENSE AND SUPPLY AGREEMENT WITH TORAY INDUSTRIES

October 6, 2020, the Company entered into a License and Supply Agreement (“License Agreement”) with Toray Industries, Inc.

Under the License Agreement, the Company received the exclusive license (outside of Japan) to make and distribute

protein detection cartridges that have a function of automatic stepwise feeding of reagent (the “Cartridges”).

for the license, the Company committed to make two payments of $ 120,000 each, both of which were made in 2021.

In addition, following

the first sale of the Cartridges after regulatory approval, the Company will make royalty payments to Toray equal to 15 % of the net sales

of the Cartridges for the period that any underlying patents exist or five years after the first sale.

Following the first sale after

obtaining regulatory approval, 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.

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 its Symphony device and cartridges (including in connection with the Company’s clinical trials).

the New Toray License Agreement provides for the transfer of certain technology related to the cartridges to Sanyoseiko.

payments payable by the Company to Toray have been 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.

There were no sales of or revenues from the cartridges during the 12-month periods ended December 31, 2024 and 2023.

the New Toray Supply Agreement, Toray will manufacture in the near-term (through its wholly owned subsidiary Kamakura Techno- Science,

Inc.) certain product intermediate components for use in cartridges being manufactured for the Company by Sanyoseiko.

These cartridges

made using Toray intermediates are only suitable for the purpose of obtaining FDA approval and not for commercial sale.

The New Toray

Supply Agreement has a term ending on the earlier of October 23, 2025 or the date that the Company obtains FDA approval for its product,

and may be extended for up to six months by mutual agreement of the parties.

Once FDA approval has been obtained, the intermediates and

cartridges will be manufactured by SanyoSeiko under a separate supply agreement between the Company and SanyoSeiko.

December 31, 2024 and 2023, there were no amounts accrued related to the New Toray License Agreement or the License Agreement.

2024 Offering

June 28, 2024, the Company sold in a public offering ( the “June 2024 Offering”), (i) 11,541 common units (the

“Common Units”), each consisting of one share of common stock, two Class C Warrants and one Class

D Warrant and (ii) 95,815 prefunded units (the “Prefunded Units”), each consisting of one prefunded warrant

to purchase one share of common stock (each, a “Prefunded Warrant”), two Class C Warrants and one Class

The Common Units were sold at a price of $ 81.50 per unit and the Prefunded Warrants were sold at a price of $ 81.495 per

As of December 31, 2024, all Prefunded Warrants have been exercised in full.

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.

gross proceeds to the Company from the June 2024 Offering were $ 8,569,075 .

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

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.

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.

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.

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.

gross proceeds to the Company from the sale of the securities sold in the private placement were approximately $ 4.5 million.

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

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.

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.

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.

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.

partially exercised its over-allotment option in respect to 3,393 Class C Warrants and 1,696 Class D Warrants (the “Over-Allotment

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 .

2024 Bridge Note Financing

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”).

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 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 %.

the terms of the SPA, the three 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 1,451 shares

of the Company’s common stock.

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

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 %.

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 .

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.

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.

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.

January 2, 2024, the Company sold in a public offering (such transaction, the “January 2024 Offering”) (i) 1,344 shares of

the Company’s Common stock, par value $ 0.0001 per share and (ii) prefunded warrants to purchase up to an aggregate 5,386 shares

of Common Stock (the “Prefunded Warrants”).

The Shares and Prefunded Warrants were sold together with warrants to purchase

up to an aggregate of 6,730 shares of Common Stock at an exercise price of $ 520.00 per share (the “January 2024 Warrants”).

The combined public offering price was $ 520.00 per share of Common Stock and related January 2024 Warrant and $ 519.96 per Prefunded Warrant

and related January 2024 Warrant.

of December 31, 2024, all Prefunded Warrants have been exercised in full.

The January 2024 Warrants are exercisable immediately and for

a period of five years following the date of issuance.

to an engagement letter, dated as of August 7, 2023, as amended October 11, 2023 (the “Amended Engagement Letter”), by and

between the Company and the Placement Agent, the Company paid the Placement Agent 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 the Placement Agent in connection with the January Offering 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 the Placement Agent, warrants to purchase up to an aggregate 471 shares of Common

Stock (the “January 2024 Placement Agent Warrants”), which represents 7.0 % of the aggregate number of shares of Common Stock

and 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 $ 650.00 , or 125 %

of the offering price per share of Common Stock and related January 2024 Warrant sold in the January Offering and expire on the fifth

anniversary from the date of the commencement of sales in the January 2024 Offering.

gross proceeds to the Company from the January 2024 Offering were $ 3,500,000 .

The gross proceeds to the Company from the January 2024 Offering were

$ 3,500,000 .

The Company incurred offering costs of $ 711,031 .

2023 Offering

August 24, 2023, the Company entered into a securities purchase agreement with certain institutional and accredited investors (the “Purchase

Agreement”) relating to the registered direct offering and sale of 540 shares of the Company’s common stock at a purchase

price of $ 2,946.00 per share (the “August 2023 Offering”).

a concurrent private placement, the Company also issued to such institutional and accredited investors unregistered warrants to purchase

up to 540 shares of Common Stock (the “Warrants”).

Pursuant to the terms of the Purchase Agreement, for each share of Common

Stock issued in this offering an accompanying Warrant was issued to the purchaser thereof.

Each Warrant is exercisable for one share

of Common Stock (the “August 2023 Warrant Shares”) at an exercise price of $ 2,896.00 per share, is immediately exercisable

upon issuance and will expire five years from the date of issuance.

The Warrants were offered and sold at a purchase price of $ 50.00

per underlying warrant share, which purchase price is included in the offering price per share of Common Stock issued in the Offering

(the “Private Placement”).

to an engagement letter, dated as of August 7, 2023, between the Company and H.C.

Wainwright & Co., LLC (the “Placement Agent”)

the Company paid the placement agent a total cash fee of $ 111,359 equal to 7.0 % of the gross proceeds received in the Offering and the

Private Placement.

The Company also paid the placement agent the management fee equal to $ 15,908 or 1.0 % of the gross proceeds raised

in the Offering and Private Placement, $ 45,000 for non-accountable expenses, and $ 15,950 for clearing fees.

In addition, the Company

issued to the placement agent, warrants to purchase up to 36 shares of Common Stock (the “Placement Agent Warrants”), which

represents 7.0 % of the aggregate number of shares of Common Stock sold in the Offering.

The Placement Agent Warrants have substantially

the same terms as the Warrants, except that the Placement Agent Warrants have an exercise price equal to $ 3,684.00 , or 125 % of the offering

price per share of Common Stock sold in the Offering, and a term of five years from the commencement of the sales pursuant to the Offering.

gross proceeds to the Company from the August 2023 Offering and the August 2023 Private Placement are $ 1,590,840 .

The Company incurred

offering costs of $ 413,544 .

following table summarizes information with regard to warrants outstanding at December 31, 2024:

The following table summarizes information

with regard to warrants outstanding at December 31, 2025:

Shares Exercisable for Weighted

Price Weighted Average

June 2024 Class C Warrants 1,372,586 Common Stock $ 16.30 4.5

January 2024 Common Stock Warrants 6,730 Common Stock $ 520.00 4.0

January 2024 Placement Agent Warrants 471 Common Stock $ 650.00 4.0

August 2023 Common Stock Warrants 540 Common Stock $ 2,896.00 3.6

August 2023 Placement Agent Warrants 36 Common Stock $ 3,684.00 3.6

Class A Warrants 310 Common Stock $ 56,000.00 1.9

Class B Warrants 9 Common Stock $ 80,000.00 1.9

Other Pre-2024 Common Stock Warrants 84 Common Stock $ 27,327.00 1.4

2024 Common Stock Warrants and June 2024 Underwriter Warrants

a part of the June 2024 Offering, the Company issued 214,724 Class C Warrants and 107,362 Class D Warrants.

The Underwriter partially

exercised its over-allotment option with respect to 13,573 Class C Warrants and 6,787 Class D Warrants (the “Over-Allotment Warrants”).

stockholder approval of the issuance of Class C Warrants on August 21, 2024, the Class C Warrants, which had an initial exercise price

of $ 98.00 per share of common stock, were adjusted to be exercisable at an exercise price of $ 16.30 per share (representing 20 % of the

Nasdaq Minimum Price), and the number of shares issuable upon exercise were proportionately adjusted to 1,372,586 shares.

In connection with this reset price and number of Class C Warrants,

we 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.

Warrants may be exercised at any time for a period of five (5) years following the first exercisable date.

Class D Warrants were immediately exercisable at an exercise price of $ 0.0001 per share of common stock for a period of five (5)

years following the date of issuance.

Upon stockholder approval of issuance of Class D Warrants on August 21, 2021, the number of

shares of common stock issuable under the Class D Warrants 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 $ 16.30 per share

(representing 20 % of the Nasdaq Minimum Price) following the issuance date.

In connection with this reset price and number of Class

D Warrants, we 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.

2024, the Company issued 435,377 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 $ 0.0001 per share exercise price or on a proportional cashless basis.

During the years ended December 31, 2024

and 2023, no other warrants were exercised.

2024 Common Stock Warrants and January 2024 Placement Agent Warrants

part of the January 2024 Offering, the Company issued 6,730 Common Stock Warrants with an exercise price of $ 520.00 per share and 471

Placement Agent Warrants with an exercise price of $ 650.00 per share.

The January 2024 Warrants became exercisable immediately upon issuance

for a period of five years following the date of issuance.

2023 Common Stock Warrants and August 2023 Placement Agent Warrants

part of the August 2023 Offering that occurred during the year ended December 31, 2023, the Company issued 540 Warrants with a purchase

price of $ 2,896.00 per share and 36 Placement Agent Warrants with an exercise price of $ 3,684.00 per share.

Company’s warrants were accounted for as equity classified financial instruments as they meet the requirements for equity

classification under ASC 815, Derivatives and Hedging .

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

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.

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 .

STOCK COMPENSATION

Incentive Plans

2018, the Company adopted the 2018 Stock Incentive Plan (the “2018 Plan”) for employees, consultants, and directors.

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 79 .

At December 31, 2024 there were 35 shares of common stock available for grant under the 2018 Plan.

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 245 shares of common stock were approved to be initially reserved for issuance under the 2021

At December 31, 2024 there were 101 shares of common stock available for grant under the 2021 Plan.

Award Activity

following table summarizes the status of the Company’s non-vested restricted stock awards for years ended December 31, 2024:

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 .

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”).

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.

Stock Award Activity

The following table summarizes the status of the

Company’s non-vested restricted stock awards for years ended December 31, 2025:

Restricted Stock Awards

2 unchanged sentences

Outstanding at December 31, 2025

February 2023, the Company issued 47 fully vested restricted stock units to certain employees in lieu of cash to satisfy their 2022 accrued

bonuses of $ 164,860 .

Of the 47 restricted stock units issued, 16 shares were withheld for tax liabilities with a fair value of $ 57,625 .

The number of restricted stock unit awards issued was determined based on the approved bonus amount divided by the market price of the

Company’s common stock on the date of grant.

Option Plan Summary

following is a summary of stock option activity for the year ended December 31, 2024:

Stock Option Plan Summary

The following is a summary of stock option activity for the year ended

December 31, 2025:

Options Weighted

5 unchanged sentences

Exercisable at December 31, 2025 5 $ 20,376 3.0 $ -

weighted average grant date fair value of options granted during the year ended December 31, 2023 was $ 4,240.00 per share.

determined the grant-date fair value of stock option awards granted during the year ended December 31, 2023 using the Black-Scholes model

with the following assumptions:

Risk-free interest rate 3.63 %

Expected dividend yield 0.00 %

Volatility factor 108.78 %

Expected life of option (in years) 6.00

Compensation Expense

the years ended December 31, 2024 and 2023, the Company recorded stock-based compensation expense as follows:

Year ended December 31,

Stock-Based Compensation Expense

For the years ended December 31, 2025

and 2024, the Company recorded stock-based compensation expense as follows:

Research and development

2 unchanged sentences

Total stock-based compensation

December 31, 2024, there was approximately $ 1,996 of unrecognized compensation expense related to non-vested stock option awards that

are expected to be recognized over a weighted-average period of 0.83 years.

At December 31, 2024, there was approximately $ 944 of unrecognized

compensation expense related to non-vested restricted stock awards that are expected to be recognized over a weighted-average period

of 0.44 years.

At December 31, 2025, there was no

unrecognized compensation expense related to non-vested stock option awards and non-vested restricted stock awards.

RELATED PARTY TRANSACTIONS

December 2021, the Company entered into an agreement with NanoHybrids, Inc.

(“NanoHybrids”) to utilize the Company’s

research and development staff and laboratory facility when available to perform work for NanoHybrids.

Any hours worked by Company employees

for NanoHybrids is billed to NanoHybrids at a bill rate of the respective employee’s fully burdened personnel cost plus 10 %.

Additionally,

the Company may purchase certain lab supplies for NanoHybrids and rebill these costs to NanoHybrids.

The Company’s Chief Technology

Officer is the majority shareholder of NanoHybrids.

The table below summarizes the amounts earned for the years ended December 31, 2024

and 2023 and balances due from NanoHybrids as of December 31, 2024 and 2023:

from NanoHybrids included in Other Income

receipts from NanoHybrids

of December 31,

receivable from NanoHybrids included in Prepaids and Other Current Assets

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

Additionally, the Company purchased certain lab supplies for NanoHybrids and rebilled those costs to NanoHybrids.

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:

Income from NanoHybrids included in Other Income

Cash receipts from NanoHybrids

As of December 31,

Amounts receivable from NanoHybrids included in Prepaids and Other Current Assets

PROPERTY AND EQUIPMENT

and equipment consisted of the following at December 31, 2024 and 2023:

Property and equipment consisted of

the following at December 31, 2025 and 2024:

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

5 unchanged sentences

Property and equipment, net $ 1,534,441 $ 1,513,495

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.

As a result of this review in 2023, the Company revised the useful life of certain lab equipment

in the first quarter of 2023 due to a change in expectations of the time the equipment will be used which resulted in approximately $ 382,795

of additional depreciation recorded in the year ended December 31, 2023.

in process consists of symphony cartridge manufacturing equipment.

There are no commitments in place to complete construction in process

as of December 31, 2024.

Company primarily enters into lease arrangements for office, laboratory space, and copiers.

A summary of supplemental lease information

is as follows:

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.

The Company primarily enters into lease arrangements

for office, laboratory space, and copiers.

A summary of supplemental lease information is as follows:

Weighted average remaining lease term - operating leases (in years) 1.2 2.1

4 unchanged sentences

Operating cash flows from finance leases $ 780 $ 1,053

summary of the Company’s lease assets and liabilities are as follows:

A summary of the Company’s lease assets and liabilities are as

Operating lease right-of-use asset $ 113,289 $ 209,788

6 unchanged sentences

Total lease liabilities $ 129,558 $ 235,623

following table reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the consolidated balance sheet

as of December 31, 2024:

The following table reconciles the undiscounted lease liabilities to

the total lease liabilities recognized on the consolidated balance sheet as of December 31, 2025:

Operating Lease

3 unchanged sentences

COMMITMENTS AND CONTINGENCIES

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, 2024.

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

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.

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.

SUPPLEMENTAL BALANCE SHEET INFORMATION

expenses and other current assets consist of the following:

Prepaid expenses and other current

assets consist of the following:

Prepaid insurance

2 unchanged sentences

Total prepaid expenses and other current assets

expenses and other current liabilities consist of the following:

Accrued expenses and other current

liabilities consist of the following:

Accrued personnel costs

Goods received but unpaid

Accrued expenses for CFO separation agreement

Accrued legal fees

1 unchanged sentence

Accrued board of director fees

Accrued Delaware franchise tax

Accrued other

Total accrued expenses and other current liabilities

provision for federal income taxes has been recorded for the years ended December 31, 2024 and 2023 due to net losses and the valuation

allowance established.

components of the Company’s deferred tax assets are as follows:

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,

8 unchanged sentences

Deferred tax asset, net of allowance

reconciliation of the statutory tax rates and the effective tax rates for the years ended December 2024 and 2023 is as follows:

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,

Federal statutory rate

State income taxes, net of federal benefit and tax credits

Research tax credits

Nontaxable and nondeductible items

Change in valuation allowance

Permanent differences and other

Effective tax rate

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.

Company continues to maintain a full valuation allowance against its deferred tax assets.

During the years ended December 31, 2024 and

2023, 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, 2024 and 2023 will not be realized given the Company’s history of operating losses.

valuation allowance against deferred tax assets increased by approximately $ 2.3 million and $ 3.1 million during 2024 and 2023, respectively,

related to a full valuation allowance recorded against capitalized research expenditures, additional net operating losses and tax credits

generated in the year.

of December 31, 2024, the Company had federal net operating losses of approximately $ 23.4 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 2024 totaling approximately $ 22.7 million can be carried forward indefinitely but are limited to 80 % utilization against future taxable

income each year.

As of December 31, 2023, the Company had federal net operating losses of $ 16,772,000 , which may be available

to offset future federal income tax liabilities.

of December 31, 2024, the Company had post-apportioned state 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, 2023, the Company had post-apportioned

Massachusetts net operating losses of approximately $ 16.3 million that can generally be carried forward 20 years and will expire at various

dates through 2043.

of December 31, 2024, the Company had $ 569,000 and $ 307,000 of federal and state research and development credits, respectively,

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

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

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.

As of December 31, 2023, the Company had $ 381,000 and $ 208,000 of federal and state

research and development credits, respectively, which will expire at various dates through 2043.

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

367,750 shares of common stock were

issued for October 2025 prefunded warrant exercises in January and February 2026.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures