Bluejay Diagnostics Provides First Quarter 2026 Corporate Update

Bluejay Diagnostics (NASDAQ:BJDX) provided a Q1 2026 corporate update on May 7, 2026 covering progress on its Symphony™ near-patient diagnostic platform.

Rhea-AI Summary

Bluejay Diagnostics (NASDAQ:BJDX) provided a Q1 2026 corporate update on May 7, 2026 covering progress on its Symphony™ near-patient diagnostic platform.

Key points: SYMON-II enrollment at ~680 of 750 target patients as of May 5, 2026; resolved Symphony cartridge manufacturing issues with Sanyoseiko; maintaining objective to prepare a 510(k) submission after analytical and clinical validation; cash ~$3.7M and Q1 net loss ~$1.9M.

Positive

• SYMON-II enrollment at approximately 680/750 target patients
• Resolved technical issues in Symphony cartridge manufacturing
• Maintaining objective to prepare a 510(k) submission post-validation

Negative

• Cash and cash equivalents of approximately $3.7M
• Net loss of approximately $1.9M in Q1 2026

Argus May 8 session

-5.49% close to close Open Argus

Details

News Market Reaction – BJDX

On May 8, the first trading day after this news, BJDX closed 5.49% below the previous close.

Data tracked by StockTitan Argus for the May 8 session.

Key Figures

SYMON-II enrollment: approximately 680 patients SYMON-II target enrollment: 750 patients Cash and cash equivalents: approximately $3.7 million +2 more

SYMON-II enrollment

approximately 680 patients

As of May 5, 2026 in pivotal SYMON-II study

SYMON-II target enrollment

750 patients

Pivotal SYMON-II clinical study goal

Cash and cash equivalents

approximately $3.7 million

As of March 31, 2026

Net loss

approximately $1.9 million

Q1 2026

Net loss prior-year period

approximately $1.9 million

Q1 2025 comparison

Historical Context

5 past events · Latest: Apr 07

5 events

1. Apr 07

   Clinical enrollment update

   24h Move

   -0.5%

   Reported 624 of 750 patients enrolled in pivotal SYMON-II trial.

2. Mar 12

   Conference abstract news

   24h Move

   -2.5%

   SAEM abstract acceptance highlighting SYMON-I IL-6 pilot results.

3. Mar 06

   Strategic and financial update

   24h Move

   -2.1%

   Outlined 2026 priorities, FY2025 losses, and need to raise at least $20M.

4. Feb 20

   Warrant exercise update

   24h Move

   +1.5%

   All prefunded warrants exercised with ~972,000 common shares outstanding.

5. Feb 17

   Clinical and manufacturing progress

   24h Move

   +0.8%

   Reported 545 patients enrolled and key manufacturing milestones for cartridges.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pivotal clinical study, sepsis, septic shock, biomarker, +4 more

8 terms

pivotal clinical study medical

"Continued enrollment progress in the ongoing SYMON-II pivotal clinical study…"

A pivotal clinical study is the key, late-stage medical trial designed to show whether a drug or medical device works and is safe enough for regulators to approve it. Think of it as the final exam for a treatment: a strong pass typically clears the path to market access, while a failure can stop approval and materially affect expected sales, company value, and investor returns.

sepsis medical

"evaluating the role of IL-6 in sepsis and septic shock patients."

Sepsis is a dangerous medical condition in which an infection triggers the body's defenses to damage its own tissues and organs, often leading to organ failure and emergency hospital care. For investors it matters because sepsis drives demand for diagnostics, antibiotics, intensive-care treatments and hospital resources, affects healthcare costs and insurer payouts, and can influence the commercial prospects and valuation of companies developing related tests, drugs and devices.

septic shock medical

"evaluating the role of IL-6 in sepsis and septic shock patients."

Septic shock is a life-threatening condition caused by a severe bodily response to infection that leads to dangerously low blood pressure and failing organs. Think of it like a city’s emergency systems collapsing after a major storm: hospitals need intensive care, special drugs and equipment, and longer stays. For investors, its incidence and treatment options matter because they affect demand for drugs, medical devices, hospital resources, trial outcomes, regulatory attention and potential liability costs.

biomarker medical

"by enabling rapid, near-patient biomarker testing where time-sensitive clinical…"

A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

510(k) submission regulatory

"objective of preparing for a future 510(k) submission following completion…"

A 510(k) submission is a regulatory packet sent to the U.S. Food and Drug Administration showing a medical device is substantially similar to an already-allowed device so it can be marketed without a full, new safety review. For investors, clearance via 510(k) cuts time and cost to bring a device to market and reduces regulatory risk—think of it as proving a new model is close enough to a trusted one to sell it more quickly.

cardiovascular disease medical

"includes future potential applications in additional critical care biomarkers and cardiovascular disease monitoring."

A group of conditions that affect the heart and blood vessels, such as heart attacks, strokes and clogged arteries. Think of the cardiovascular system as a body’s plumbing and engine: when pipes narrow or the pump fails, treatment, devices and long-term care become necessary. Investors watch these diseases because their prevalence drives demand for drugs, devices and services, influences healthcare costs and insurer payouts, and affects workforce productivity and regulatory risk.

near-patient diagnostic platform medical

"developments related to its Symphony™ near-patient diagnostic platform."

A near-patient diagnostic platform is a compact testing system designed to run medical tests close to where patients are seen—such as a clinic, pharmacy, or bedside—rather than in a distant central laboratory. Like a small lab on location, it delivers faster results that can change treatment decisions immediately; for investors, this can mean quicker adoption, recurring consumable sales, and exposure to healthcare efficiency and reimbursement trends that drive commercial value.

critical care settings medical

"for sepsis patient monitoring and risk assessment in critical care settings."

Units where patients with life-threatening conditions receive continuous, high-intensity medical monitoring and treatment—commonly known as intensive care or ICU-level care—using specialized equipment and staff trained to manage organ failure, breathing support, and complex drug regimens. Investors care because these settings drive demand for expensive devices, drugs, staffing and facility services, influence reimbursement and regulatory risk, and can materially affect the revenue and cost profile of healthcare companies.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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ACTON, Mass., May 07, 2026 (GLOBE NEWSWIRE) -- 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 Symphony^TM Test platform is designed to determine patient acuity for triage and monitoring based on the measurement of a specific biomarker. The Symphony^TM IL-6 Test to determine patient acuity for sepsis triage and monitoring (“Symphony^TM 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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How many patients has Bluejay Diagnostics (BJDX) enrolled in the SYMON-II pivotal study as of May 5, 2026?

Approximately 680 patients have been enrolled as of May 5, 2026. According to the company, the SYMON-II study is targeting 750 total patients to evaluate IL-6 in sepsis and septic shock patients across participating clinical sites.

What did Bluejay (BJDX) report about Symphony cartridge manufacturing progress in Q1 2026?

Bluejay reports it resolved technical issues in the Symphony cartridge manufacturing process. According to the company, work with contract manufacturer Sanyoseiko progressed toward analytical and clinical validation activities for future regulatory submission.

What regulatory pathway is Bluejay (BJDX) pursuing for the Symphony IL-6 test?

Bluejay intends to prepare a 510(k) submission following validation activities. According to the company, this FDA-focused strategy depends on completing required analytical and clinical validation first.

What were Bluejay Diagnostics' (BJDX) cash and net loss figures for Q1 2026?

Bluejay reported approximately $3.7M in cash and cash equivalents and a net loss of about $1.9M. According to the company, Q1 2026 net loss was comparable to Q1 2025.

How does the SYMON-II enrollment progress affect Bluejay's (BJDX) development timeline?

Enrollment at ~680 of 750 target patients indicates progress toward study completion. According to the company, continued enrollment momentum supports planned clinical validation steps needed before regulatory submission.

Will Symphony be developed for biomarkers beyond IL-6 according to Bluejay (BJDX)?

Yes, Bluejay is developing a broader Symphony platform for additional critical care biomarkers and cardiovascular monitoring. According to the company, these efforts are part of a longer-term platform strategy beyond the IL-6 application.