Form 8-K

8-K — Bluejay Diagnostics, Inc.

Accession: 0001213900-26-053295

Filed: 2026-05-07

Period: 2026-05-07

CIK: 0001704287

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0289580-8k_bluejay.htm (Primary)

EX-99.1 — PRESS RELEASE, DATED MAY 7, 2026 (ea028958001ex99-1.htm)

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8-K — CURRENT REPORT

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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): May 7, 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, MA 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 ☒

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

2.02 Results of Operations and Financial Condition.

May 7, 2026, Bluejay Diagnostics, Inc. issued a press release providing a corporate update, as well as certain financial results as of

and for the fiscal quarter ended March 31, 2026. A copy of that press release is furnished with this report as Exhibit 99.1.

The

information contained in Item 2.02 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 (“Exchange Act”), nor shall it be incorporated by reference

in any filing under the Exchange Act or the Securities Act of 1933, as amended (“Securities Act”), unless specifically identified

therein as being incorporated by reference.

Item 9.01. Financial Statements and Exhibits.

(d)

Exhibits

99.1

Press release, dated May 7, 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:

May 7, 2026

EX-99.1 — PRESS RELEASE, DATED MAY 7, 2026

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Exhibit 99.1

Bluejay Diagnostics Provides First Quarter 2026 Corporate Update

ACTON, Mass., May 7, 2026 — Bluejay Diagnostics, Inc. (“Bluejay”

or the “Company”), a medical diagnostics company focused on improving patient outcomes in critical care settings, today provided

a corporate update highlighting progress achieved during the first quarter of 2026 and recent operational developments related to its

Symphony™ near-patient diagnostic platform.

During the first quarter of 2026, Bluejay continued advancing the clinical,

manufacturing, and regulatory activities supporting the development of its Symphony IL-6 test for sepsis patient monitoring and risk assessment

in critical care settings.

Q1 2026 and Recent Highlights

● Continued enrollment progress in the ongoing SYMON-II pivotal

clinical study evaluating the role of IL-6 in sepsis and septic shock patients. As of May 5, 2026, approximately 680 patients have been

enrolled toward the target enrollment of 750 patients across participating clinical sites.

● Advanced manufacturing readiness activities for Symphony

cartridges in collaboration with Sanyoseiko Co. Ltd., Bluejay’s contract manufacturing organization. The Company successfully resolved

technical issues related to the Symphony cartridge manufacturing process and is progressing toward analytical and clinical validation

activities intended to support future regulatory submission.

● Continued execution of Bluejay’s FDA-focused regulatory

strategy for Symphony IL-6, with the Company maintaining its objective of preparing for a future 510(k) submission following completion

of required analytical and clinical validation activities.

● Continued development activities related to Bluejay’s

broader Symphony platform strategy, which includes future potential applications in additional critical care biomarkers and cardiovascular

disease monitoring.

Neil Dey, President and Chief Executive Officer of Bluejay Diagnostics,

commented, “We believe the first quarter of 2026 represented meaningful operational progress across several key areas of our Symphony

program. Most importantly, we continued strong enrollment momentum in our SYMON-II pivotal study while also advancing manufacturing readiness

activities intended to support future analytical and clinical validation. We are encouraged by the progress our team and partners have

made in positioning Symphony toward the next phase of development.”

Mr. Dey continued, “We believe Symphony has the potential to

address an important unmet need in critical care by enabling rapid, near-patient biomarker testing where time-sensitive clinical decisions

are essential. As we continue executing our clinical and manufacturing roadmap, we remain focused on progressing toward regulatory readiness

and future commercialization opportunities.”

Financial Highlights

As of March 31, 2026, Bluejay reported cash and cash equivalents of

approximately $3.7 million. The Company reported a net loss of approximately $1.9 million for the first quarter of 2026, compared to approximately

$1.9 million for the same period in 2025.

The Company believes it has continued to manage operating expenses

with financial discipline while prioritizing critical clinical, manufacturing, and regulatory activities supporting the Symphony program.

About the Symphony IL-6 Test:

The SymphonyTM Test platform is designed to determine patient

acuity for triage and monitoring based on the measurement of a specific biomarker. The SymphonyTM IL-6 Test to determine patient

acuity for sepsis triage and monitoring (“SymphonyTM IL-6 Test”) is currently Bluejay’s lead product candidate.

Note: Investigational device. 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.

ir@bluejaydx.com

978-631-0310

Website: www.bluejaydx.com

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