Form 8-K

8-K — Bluejay Diagnostics, Inc.

Accession: 0001213900-26-088701

Filed: 2026-08-13

Period: 2026-08-13

CIK: 0001704287

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ea0301888-8k_bluejay.htm (Primary)

EX-99.1 — PRESS RELEASE, DATED AUGUST 13, 2026 (ea030188801ex99-1.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):

August 13, 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 ☒

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 August 13, 2026, following

the filing on August 12, 2026 of its Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2026, Bluejay Diagnostics,

Inc. issued a press release providing a 2026 second quarter fiscal and business update. A copy of that press release is furnished with

this report as Exhibit 99.1.

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 August 13, 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: August 13, 2026

EX-99.1 — PRESS RELEASE, DATED AUGUST 13, 2026

EX-99.1

Filename: ea030188801ex99-1.htm · Sequence: 2

Exhibit 99.1

Bluejay Diagnostics Reports Q2 2026 Results; Strengthened Balance

Sheet Supports Advancement of Symphony™ IL-6 Toward Regulatory Submission and Commercialization

● SYMON-II pivotal clinical study completes targeted

enrollment of 750 patients

● Company advances toward planned 510(k) submission and

commercialization with US manufacturing contract signed to mitigate supply-chain risk

● Company ends second quarter with approximately $9.6

million in cash following significant financing

ACTON, Mass., August 13, 2026 – Bluejay Diagnostics, Inc. (NASDAQ:

BJDX) (“Bluejay” or the “Company”), a medical diagnostics company focused on improving patient outcomes in critical

care settings, today reported financial results for the quarter ended June 30, 2026 and provided an update on the Company’s clinical,

regulatory and manufacturing progress.

During the first half of 2026, Bluejay continued to advance several

key elements of its development strategy for the Symphony™ platform and its lead product candidate, the Symphony IL-6 test. The

Company completed the targeted enrollment of 750 hospital patients in its SYMON-II pivotal clinical validation study and is progressing

toward analytical and clinical validation activities intended to support a future FDA 510(k) submission.

At June 30, 2026, Bluejay had approximately $9.6 million in cash and

cash equivalents, compared with approximately $5.2 million at December 31, 2025. During the first six months of 2026, the Company generated

approximately $7.7 million of net cash from financing activities, including approximately $7.6 million of net proceeds from its June 2026

private placement.

“We believe the second quarter represented an important period

of execution for Bluejay as we strengthened our financial position while continuing to advance the clinical, regulatory and manufacturing

infrastructure required for Symphony,” said Neil Dey, President and Chief Executive Officer of Bluejay Diagnostics. “With

targeted enrollment of 750 patients in SYMON-II now completed, our focus is increasingly shifting towards manufacturing readiness and

the activities necessary to support our planned regulatory submission and commercialization.”

Dey continued, “Importantly, we believe our recent financing

provides us with additional resources to execute these near-term priorities. We ended the quarter with approximately $9.6 million in cash,

and our current cash resources are estimated to fund operations through the second quarter of 2027. We recognize that disciplined capital

allocation remains critical, and our objective is to concentrate our resources on activities that we believe can advance Symphony toward

regulatory clearance and commercial readiness.”

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 Reports on Form 10-Q for the fiscal quarters ended March 31, 2026 and June 30, 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

Website: www.bluejaydx.com

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