Bluejay Diagnostics, Inc. (NASDAQ:BJDX) reported first quarter 2024 operational and financial results in a Form 10-Q on May 15th, 2024. Pilot study SYMON-I is underway and has completed enrollment, with 143 subjects entering the trial. Based on the recruitment information in SYMON-I’s clincaltrials.gov entry and management commentary, we expect the final data collection to be complete before the end of May and study completion in June.
Bluejay is targeting a major scientific conference to share its data; however, the company is also cognizant that a capital raise must be completed and investors will want to see the data. Based on the limited narrative provided in the most recent quarterly filing, the initial look at data suggests it is positive and supportive of the primary endpoint.
Recent highlights and to date include:
➢ Initiation of SYMON study evaluating Symphony IL-6 in sepsis patients – December 2023
➢ Close of $3.5 million public offering – January 2024
Bluejay generated no revenues in 1Q:24 and reported a net loss of ($2.3) million, or ($0.99) per share. For the quarter ending March 31st, 2024, and versus the same period in the prior year:
➢ Research & Development expenses totaled $1.3 million, down 1%. The Change was attributable to a reduction in technology transfer efforts which offset increases in clinical trial expenditures;
➢ General & Administrative expenses were $1.1 million, down 8% from $1.2 million primarily due to a focus on cost containment targeting personnel and insurance costs;
➢ Sales and Marketing costs were $6,000 vs. $148,000;
➢ Other income fell to $100,000 due to less interest income and lower related party income from NanoHybrids;
➢ Net loss was ($2.3) million or ($0.99) per share compared with net loss of ($2.5) million or ($2.49) per share, respectively.1
At year’s end, marketable securities, cash and equivalents totaled $2.7 million. Cash burn for 1Q:24 was ($2.3) million. Financing cash flows were $2.8 million and related to the proceeds from common stock issuance offset in part by repayment of a finance lease. Bluejay holds insufficient cash and equivalents to fund operations for the next 12 months. Future capital is expected to be raised in several tranches to support the pivotal trial and regulatory submission for the Symphony diagnostic measuring IL-6.
SYMON Trial
In December, Bluejay launched the SYMON (Multicenter Symphony IL-6 Monitoring Sepsis ICU Study) trial. The study has been listed on the clinicaltrials.gov website under the designator NCT06181604. The first subject was enrolled early in the new year and observations could be complete by the end of May.
Bluejay initially launched a trial that sought to effectively triage COVID patients using IL-6 as a marker and determine their need for mechanical assisted ventilation. However, due to the dramatic decline in severe COVID patients in 2022, the trial design needed to be changed. The primary endpoint is now 28-day mortality and risk stratification of hospitalized sepsis patients. Cutoff values that will be used for the study are now being determined. SYMON will be conducted in two parts. SYMON I, which has completed enrollment, and SYMON II which will serve as a validation study. SYMON II is expected to begin in July assuming sufficient capital can be raised. SYMON will compare IL-6 levels measured with the Symphony diagnostic and compare them with mortality outcomes to determine a correlation. These results will support a cutoff threshold which will be used to triage patients.
Several clinical trial sites have been secured with Tier 1 hospitals. This includes Beth Israel Deaconess Medical Center, Washington University of St. Louis, New York Presbyterian Brooklyn Methodist Hospital, Wake Forest School of Medicine, The Ohio State University/Wexler Medical Center, Vanderbilt University Medical Center and Intermountain Healthcare.
The inclusion criteria for the new trial requires that enrollees have a diagnosis of sepsis or septic shock as determined by a physician. Subjects must also be adults admitted or intended to be admitted to the ICU and provide a plasma sample within 12 hours of the earliest diagnosis of sepsis or septic shock. The plasma sample will be evaluated by the Symphony diagnostic.
The first subject in the SYMON trial was enrolled early in the year and enrollment has been progressing well. An interim readout of the trial is expected in the second half of the year. Our estimates call for both parts of the trial to be completed in 2024, followed shortly after by a regulatory submission using the 510(k) pathway. While topline data should be available in 2H:24, Bluejay will work hard to present full data from the trial in conjunction with a presentation at a highly regarded scientific conference or in a distinguished journal. We further anticipate that a grant of marketing authorization will emerge in 2025, followed by commercialization. Bluejay has identified its market and plans to engage a small team of sales and marketing personnel in combination with partners and distributors to sell the devices and cartridges.
Sepsis is a leading cause of death in hospitals and physicians require accurate data on patient status before treatment. Existing testing approaches frequently require several time-consuming steps before a diagnostic can be run, consuming valuable time. Transportation, preparing the sample and waiting in queue for sufficient volume to justify a test requires a 24 – 48 hour wait to produce a result. However, physicians need answers immediately for critical care decisions. Due to the lack of rapid testing alternatives, we think Symphony could catalyze a substantial increase in IL-6 test volume, especially at the price point anticipated, to help guide physician decision-making in the emergent care setting.
Based on preliminary observations from SYMON-I, Symphony was able to better predict mortality better than the Sequential Organ Failure Assessment (SOFA) score which is a medical tool used to assess the extent of a patient's organ function or rate of failure. The SOFA score is used primarily in intensive care units (ICUs) to determine the level of organ dysfunction in patients and to predict outcomes, such as mortality rates. It is also required as part of reimbursement from payors. If this improved prediction is able to hold in a pivotal trial, it will be a strong argument for the value of the Symphony device and for payor reimbursement.
SYMON Milestones:2
➢ Launch SYMON – December 2023
➢ SYMON Interim Analyses – 2H:24
➢ SYMON II clinical trials website NCT listing – June 2024
➢ Launch of SYMON II Validation Trial – 3Q:24
➢ SYMON Topline – 2H:24
➢ SYMON Journal Publication - 2H:24/2025
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1. Prior year earnings per share are adjusted for the August 2023 reverse share split.
