Form 8-K

8-K — Bluejay Diagnostics, Inc.

Accession: 0001213900-26-080474

Filed: 2026-07-22

Period: 2026-07-21

CIK: 0001704287

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ea0298955-8k_bluejay.htm (Primary)

EX-99.1 — PRESS RELEASE, DATED JULY 21, 2026 (ea029895501ex99-1.htm)

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8-K — CURRENT REPORT

8-K (Primary)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

July 21, 2026

BLUEJAY DIAGNOSTICS, INC.

(Exact Name of Registrant as Specified in its Charter)

delaware

001-41031

47-3552922

(State or Other Jurisdiction of

Incorporation or Organization)

(Commission File No.)

(I.R.S. Employer

Identification No.)

360 Massachusetts Avenue, Suite 203

Acton,

01720

(Address of principal executive offices and zip

code)

(844) 327-7078

(Registrant’s telephone number, including

area code)

(Former

name or former address, if changed from last report)

Check

the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any

of the following provisions (see General Instruction A.2. below):

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(c))

Indicate by check mark whether the registrant

is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter)

or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check

mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting

standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Securities registered pursuant to Section 12(b)

of the Act:

Title of each class

Trading Symbol (s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

BJDX

The Nasdaq Stock Market LLC

Item 7.01 Regulation FD Disclosure.

On July 21, 2026, Bluejay

Diagnostics, Inc. issued a press release regarding the completion of patient enrollment in its ongoing SYMON-II clinical trial.

The information contained in

Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be “filed” for the

purpose of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference in any filing under the Exchange

Act or the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

99.1

Press Release, dated July 21, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant

to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the

undersigned, hereunto duly authorized.

Bluejay Diagnostics, Inc.

By:

/s/ Neil Dey

Neil Dey

President and Chief Executive Officer

Date: July 22, 2026

EX-99.1 — PRESS RELEASE, DATED JULY 21, 2026

EX-99.1

Filename: ea029895501ex99-1.htm · Sequence: 2

Exhibit 99.1

Bluejay Diagnostics Announces Successful Completion of Enrollment

in the SYMON-II Multicenter Clinical Validation Study

750 Patients Enrolled Ahead of Plan in Pivotal Study Evaluating

Symphony™ IL-6 for Early Assessment of 28-Day Sepsis Mortality Risk

ACTON, Mass., July 21, 2026 – Bluejay

Diagnostics, Inc. (NASDAQ: BJDX), a medical diagnostics company developing rapid, near-patient diagnostic technologies for critical

care, today announced the successful completion of patient enrollment in its SYMON-II multicenter clinical validation study. The study

achieved its targeted enrollment of 750 patients earlier than the Company had originally anticipated, representing an important operational

milestone in the development of the Company’s Symphony™ rapid diagnostic platform.

SYMON-II is a prospective, multicenter clinical validation study designed

to evaluate the ability of Bluejay’s Symphony™ IL-6 test to assist clinicians in the early assessment of 28-day all-cause mortality

risk in patients with sepsis who were admitted or intended for admission to the intensive care unit (ICU). The study enrolled patients

across leading U.S. healthcare institutions, and the Company expects that it will provide the clinical dataset needed to analyze whether

clinical evidence supports future regulatory submissions and commercialization efforts.

Preliminary observations from the enrolled population indicate an approximately

17% 28-day mortality rate, providing a robust clinical dataset for evaluating the prognostic utility of IL-6 in patients presenting with

sepsis. Bluejay believes this event rate represents a clinically meaningful population and underscores the importance of early identification

of patients at elevated risk of deterioration.

Dr. Mark Feinberg, Chief Medical Advisor of Bluejay Diagnostics, commented:

“Sepsis remains one of the leading causes of hospital mortality

worldwide, and timely identification of patients at greatest risk continues to be one of the most significant challenges in emergency

and critical care medicine. The successful completion of SYMON-II’s enrollment represents an important advancement in evaluating

the clinical utility of IL-6 as an early prognostic biomarker. The study’s large, well-characterized patient population and meaningful

number of mortality events are expected to provide a robust foundation for assessing the prognostic performance of IL-6. If supported

by the study results, rapid IL-6 testing could help clinicians identify high-risk patients earlier, improve risk stratification and triage

decisions, and potentially enable more timely therapeutic interventions.”

“Successfully completing enrollment ahead of schedule is an important

operational achievement and reflects the dedication of our clinical investigators, study coordinators, and Bluejay’s clinical and technical

teams,” said Neil Dey, President and Chief Executive Officer of Bluejay Diagnostics. “The enrollment of 750 patients provides

one of the largest prospective datasets focused on the role of IL-6 in early sepsis mortality risk assessment. We believe this study represents

an important step toward bringing clinicians a rapid, near-patient tool capable of supporting earlier and more informed clinical decision-making

in one of medicine’s most time-critical conditions.”

The Company expects to complete data cleaning, statistical analysis,

and clinical reporting over the coming months. Results from the study are anticipated to be a critical component of Bluejay’s planned

regulatory strategy for the Symphony™ IL-6 platform.

The Symphony™ platform is designed to provide rapid, quantitative

biomarker results directly at or near the patient’s bedside, supporting clinical decision-making in emergency departments, intensive care

units, and other critical care settings. The platform is intended to integrate seamlessly into existing clinical workflows while enabling

future expansion to additional biomarkers and AI-enabled clinical decision support capabilities.

Completion of SYMON-II enrollment represents another important milestone

in Bluejay’s broader strategy to advance Symphony™ toward regulatory submission and commercialization.

Note: The Company’s Symphony™ rapid diagnostic platform is

an investigational device and is limited by United States law to investigational use.

About the SYMON Clinical Study Program:

The SYMON Clinical Study Program includes SYMON-I (clinicaltrials.gov

ID NCT06181604), SYMON-II (NCT06654895), and SYMON-III (NCT07425587). SYMON-I is a pilot study to determine IL-6 levels associated with

various endpoints, including, but not limited to 28-day all-cause mortality and in-hospital mortality. The SYMON-II study is the pivotal

study to validate the outcomes of the SYMON-I study, which the Company plans to use to support a 510(k) application to the FDA. The SYMON-III

study is a pilot study to determine IL-6 levels associated with patients presenting with increasing severity of infection in the emergency

department and risk of developing sepsis.

About Bluejay Diagnostics:

Bluejay Diagnostics, Inc. is a medical diagnostics

company focused on improving patient outcomes using its Symphony System, a cost-effective, rapid, near-patient testing system for sepsis

triage and monitoring of disease progression. Bluejay does not yet have regulatory clearance for the Symphony System, and we will need

to receive regulatory authorization from the U.S. Food and Drug Administration before Symphony can be marketed as a diagnostic product

in the United States. Bluejay’s first product candidate, an IL-6 Test for sepsis, is designed to provide accurate, reliable results

in approximately 20 minutes from ’sample-to-result’ to help medical professionals make earlier and better triage/treatment

decisions. More information is available at www.bluejaydx.com.

Forward-Looking Statements:

This press release contains statements that

the Company believes are “forward-looking statements” within the meaning of the Private Litigation Reform Act. Forward-looking

statements may be identified by words such as “anticipates,” “believes,” “estimates,” “expects,”

“intends,” “may,” “plans,” “projects,” “seeks,” “should,” “suggest,”

“will,” and similar expressions. The Company has based these forward-looking statements on its current expectations and projections

about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed

in, or implied by, the forward-looking statements the Company makes. These statements are only predictions and involve known and unknown

risks, uncertainties, and other factors, including market and other conditions and those discussed under item 1A. “Risk Factors”

in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in Part II, Item 1A, “Risk

Factors” in its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2026. You should not place undue

reliance on these forward-looking statements, as they are subject to risks and uncertainties, and actual results and performance in future

periods may not occur or may be materially different from any future results or performance suggested by the forward-looking statements

in this release. This press release speaks as of the date indicated above. The Company undertakes no obligation to update any forward-looking

statements, whether as a result of new information, future events, or otherwise, except as required by law. The Company expressly disclaims

any obligation to update or revise any forward-looking statements found herein to reflect any future changes in the Company’s expectations

of results or any future change in events, except as required by law.

Investor Contact:

Neil Dey

Bluejay Diagnostics, Inc.

neil.dey@bluejaydx.com

Website: www.bluejaydx.com

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