Since our May initiation of Bluejay Diagnostics, Inc. (NASDAQ:BJDX), the company has regained compliance with the NASDAQ minimum bid price requirement following a reverse share split on July 24th. Bluejay is preparing to complete its pivotal trial and pursue a 510(k) FDA regulatory submission. The company prepared the new study design for evaluating the Symphony diagnostic in IL-6 detection and participated in a pre-submission meeting in mid-August where the pursuit of a 510(k) approval was confirmed. This report further reviews Bluejay’s second quarter financial performance and recent accomplishments. Following the second quarter report, a $1.6 million registered direct offering was priced at $7.37 per share which is expected to close on August 28th.
Highlights for 2023 include:
➢ Collaboration agreement with Blood Centers of America – February
➢ Bluejay regains compliance with NASDAQ minimum bid requirement – August
Bluejay generated no revenues during 2Q:23 and reported a net loss of ($2.8) million, or ($2.75) per share. For the quarter ending June 30, 2023 and versus the same period in the prior year:
➢ Revenues of $0 compared to $249,000 as the sale of five Symphony analyzers to Toray took place in the prior year period;
➢ Research & Development expense totaled $1.7 million, up 122% from $0.8 million. The increase was attributable to personnel costs and product development expenses;
➢ General & Administrative expenses were $1.1 million, down 10% from $1.2 million primarily due to a focus on cost containment while preparing to begin the pivotal study;
➢ Sales and Marketing costs were $154,000 vs. $81,000, up 90% due to increased personnel costs;
➢ Net loss was ($2.8) million or ($2.75) per share compared with net loss of ($1.9) million or ($1.92) per share, respectively.1
At quarter’s end, marketable securities, cash and equivalents totaled $5.1 million. Cash burn for 2Q:23 was ($1.7) million. Financing cash flows were minimal and represented repayment of a finance lease and tax withholding on restricted stock grants. Bluejay holds insufficient cash and equivalents to fund operations for the next 12 months. We anticipate that following the August 25th capital raise, Bluejay will need just under $14 million to support R&D and operations to obtain FDA clearance of the Symphony test which is expected at the end of 2024. Capital is expected to be raised in several tranches to support the pivotal trial and regulatory submission for the Symphony diagnostic measuring IL-6.
Returning to Compliance with NASDAQ Minimum Bid Price Requirements
On October 25, 2022, Bluejay received notification from the NASDAQ that the company’s shares had closed below $1.00 for the previous 30 consecutive business days. The letter required the shares to trade above $1.00 for ten business days in order to regain compliance. NASDAQ provided 180 days to regain compliance then extended the period by another 180 days which changed the required compliance date to October 23, 2023.
On July 24th Bluejay executed a 1:20 reverse stock split reducing the shares outstanding from approximately 20 million to approximately 1 million. Following the reverse split, on August 8th, NASDAQ notified Bluejay that it had regained compliance with minimum bid requirements.
Chief Technology Officer Interviews
Bluejay Chief Technology Officer Dr. Jason Cook participated in a series of interviews that discussed Bluejay’s Symphony diagnostic, its competitive advantage and the development program for the device. The discussion went further to look at what comes after a successful IL-6 test, the competitive environment and broader themes addressing diagnostic testing legislation, impacts of COVID and volatility in the small cap life sciences space.
➢ Resumption of IL-6 Symphony diagnostic pivotal trial – 4Q:23
➢ Completion of IL-6 Symphony diagnostic pivotal trial – 2024
➢ Submission of 510(k) application – 2H:24
➢ FDA response to 510(k) submission – 2025
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1. Prior year earnings per share are adjusted for the August 2023 reverse share split.
2. Screen shot from interview with Dr. Jason Cook, Bluejay Diagnostic Chief Technology Officer
