Bluejay Diagnostics 宣布提前完成东丽许可协议下的 Symphony 试剂卡工厂建设里程碑，属无金额、无审批的软性运营进展

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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
☒
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
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).
1
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:
October 13, 2026
2

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EX-99.1
2
ea030840101ex99-1.htm
PRESS RELEASE, DATED OCTOBER 13, 2026
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