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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 27, 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) |
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| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
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| ☐ |
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 1.01 Entry into a Material Definitive Agreement.
On May 27, 2026, Bluejay Diagnostics,
Inc. (the “Company”) entered into an agreement and statement of work (together, the “Agreement”) with Argonaut
Manufacturing Services c/o Argonaut, Inc. (“Argonaut”) regarding the provision by Argonaut to the Company of certain manufacturing
services to support the Company’s Symphony™ platform. The services include planning, engineering, sourcing, supply chain management,
formulation, filling, finishing, quality control testing, procurement of capital equipment and product storage, delivery and distribution
relating to the Company’s IL-6 testing products. All services under the Agreement are to be performed pursuant to terms contained
in purchase orders to be provided by the Company to Argonaut from time-to-time.
The foregoing description of
the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of such agreement, which
is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 7.01 Regulation FD Disclosure.
On June 2, 2026, the Company
issued a press release in connection with the matters discussed herein under item 1.01. 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
| 10.1 |
|
Agreement dated May 27, 2026, between Bluejay Diagnostics, Inc. and Argonaut Manufacturing Services |
| 99.1 |
|
Press Release, dated June 2, 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. |
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|
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By: |
/s/ Neil Dey |
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Neil Dey |
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President and Chief Executive Officer |
Date: June 2, 2026
Exhibit 99.1
Bluejay Diagnostics and Argonaut Manufacturing Services Announce
Strategic Partnership
ACTON, MA/CARLSBAD, CA., June 2, 2026 — Bluejay Diagnostics,
Inc. (“Bluejay” or the “Company”) (NASDAQ: BJDX), a medical diagnostics company focused on near-patient testing
for critical care, today announced a strategic partnership with Argonaut Manufacturing Services (“Argonaut”) to support the
advancement of Bluejay’s Symphony™ platform.
This partnership is designed to support Bluejay’s broader efforts
to establish scalable U.S.-based manufacturing capabilities aligned with its ongoing clinical development programs and future commercialization
objectives. In addition, the partnership is intended to strengthen Bluejay’s future commercial infrastructure by supporting broader
product distribution across the United States, enhancing supply chain resilience, and reducing potential risks associated with international
sourcing and import tariffs. The collaboration is also intended to mitigate risks associated with Bluejay’s current reliance on
overseas manufacturing by establishing domestic manufacturing capabilities that can provide greater operational control, business continuity,
and supply chain security. By leveraging U.S.-based manufacturing and distribution capabilities, Bluejay aims to improve operational flexibility,
support future market demand, and further enhance its ability to commercialize innovative near-patient diagnostic solutions for critical
care settings.
“We are pleased to partner with Argonaut as we continue to advance
the Symphony™ platform,” said Neil Dey, President and Chief Executive Officer of Bluejay Diagnostics. “This collaboration
reflects our commitment to building a scalable and quality-focused operational foundation as we progress toward key commercial milestones.”
“Argonaut is committed to partnering with innovative companies
to support the advancement of differentiated diagnostic technologies,” said Rick Hancock, Chief Executive Officer of Argonaut Manufacturing
Services. “We value this collaboration with Bluejay Diagnostics and look forward to supporting their efforts as they continue to
develop solutions aimed at improving clinical decision-making in critical care settings.”
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.
About Argonaut Manufacturing Services:
Argonaut
Manufacturing Services is a contract manufacturing organization focused on supporting life sciences and diagnostics companies with
high-quality manufacturing solutions. Founded by former executives from companies such as Thermo Fisher Scientific, Affymetrix, and Allergan,
Argonaut was built to provide a better, customer-focused approach to contract manufacturing.
The company’s mission is centered on improving the human condition
by helping partners bring innovative healthcare products to market efficiently and reliably. Drawing from decades of industry experience,
Argonaut emphasizes quality, operational excellence, and strong customer collaboration to help clients achieve their commercial and development
goals in the health and life sciences industries.
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