Form 8-K

8-K — Bluejay Diagnostics, Inc.

Accession: 0001213900-26-108779

Filed: 2026-10-13

Period: 2026-10-13

CIK: 0001704287

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ea0308401-8k_bluejay.htm (Primary)

EX-99.1 — PRESS RELEASE, DATED OCTOBER 13, 2026 (ea030840101ex99-1.htm)

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8-K — CURRENT REPORT

8-K (Primary)

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0001704287

2026-10-13

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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): October 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 ☒

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.

October 13, 2026, Bluejay Diagnostics, Inc. issued a press release regarding, among other things, the completion of certain manufacturing-related

contractual obligations.

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 October 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

President

and Chief Executive Officer

Date:

October 13, 2026

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

EX-99.1

Filename: ea030840101ex99-1.htm · Sequence: 2

Exhibit 99.1

Bluejay Achieves Toray Contractual Manufacturing Milestone, Advancing

Supply-Chain Resilience and Commercialization Readiness

Company Achieves Toray Contractual Milestone with Establishment

of Manufacturing Site

ACTON, Mass. October 13, 2026 — Bluejay Diagnostics, Inc.

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

through its Symphony™ near-patient diagnostic platform, today announced that it has completed the establishment of a manufacturing

site for Symphony™ cartridges, achieving a critical contractual milestone as the Company advances toward regulatory submission and

potential commercialization.

The milestone was achieved ahead of the October 23, 2026 contractual

deadline established under Bluejay’s amended license agreement with Toray Industries, Inc. (“Toray”). Bluejay has formally

notified Toray that the Company has fulfilled its obligation to substantially complete establishment of a manufacturing site. Bluejay’s

manufacturing strategy is being developed around complementary manufacturing capabilities at SanyoSeiko Co., Ltd. in Japan and ALURIS

Sciences, (previously Argonaut Manufacturing Services) in the United States. SanyoSeiko serves as the manufacturing site established under

Bluejay’s agreement with Toray and is an important component of the Company’s Symphony cartridge manufacturing infrastructure.

Together, these initiatives are intended to provide Bluejay with a

more diversified and resilient manufacturing infrastructure, reducing reliance on a single manufacturing pathway while increasing operational

flexibility as the Company prepares for potential commercialization. The Company believes that achieving this manufacturing milestone

represents an important step in reducing business and commercial execution risk as Bluejay advances toward regulatory submission and potential

commercialization.

“Achieving this manufacturing milestone is an important accomplishment

for Bluejay and another tangible step in our progression toward regulatory and commercial readiness,” said Neil Dey, President and

Chief Executive Officer of Bluejay Diagnostics. “Our manufacturing strategy is designed to extend beyond a single facility or geography.

With the establishment of our manufacturing capability at SanyoSeiko and our strategic U.S. manufacturing relationship with ALURIS, we

are working to build complementary manufacturing pathways that can provide greater flexibility, redundancy and supply-chain resilience.”

Bluejay continues to advance its manufacturing scale-up activities

alongside its regulatory program for the Symphony™ IL-6 Test, the Company’s first product candidate.

The Symphony™ IL-6 Test has not been cleared or approved

by the U.S. Food and Drug Administration (“FDA”) and is not currently available for commercial clinical use in the United

States. The 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 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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