Testing program underway for lead product candidate, the Symphony IL-6 Test, in support of an FDA Marketing Application, planned for Q3 2022
2021 ended with approximately
“Bluejay had a very productive 2021. We substantially advanced our lead product candidate, the Symphony IL-6 Test, into several clinical studies at highly respected study sites, completed an upsized IPO, and started to build out our team and the systems to support the company as we prepare for commercial launch in the U.S.,” said
“Bluejay’s Symphony platform was designed to provide rapid test results, using whole blood samples, in near-patient settings to aid in the care of patients with life-threatening diseases. Looking ahead in 2022, we plan to complete the clinical and analytical studies to support the company’s planned marketing application with the FDA and to continue our preparations for commercial launch of the Symphony IL-6 Test in the U.S.,” continued Neil.
- Overview of the IL-6 test for sepsis triage. Bluejay’s IL-6 Test was designed to measure IL-6 levels in whole blood samples in near-patient settings. Interleukin-6 (IL-6) is an established biomarker of immune system activation. It is elevated in infection, inflammation and cancer. IL-6 presents as an early “first responder” and needs to be measured quickly and reliably.
- Clinical testing program underway. Bluejay is conducting a comprehensive clinical testing program for its IL-6 Test product candidate. The program is expected to be complete in Q3:22. Results will form the basis of the Company’s planned marketing submission. The Company plans to incorporate any necessary feedback from the FDA, which may be received as part of the pre-submission process, to modify these studies and construct a potential FDA marketing authorization process.
- FDA Pre-Marketing Application planned for Q3:22. Bluejay plans to complete and file its marketing submission for the Symphony IL-6 Test in Q3:22. While the specific type of submission has yet to be determined, it could be a 510(K) notice or de novo request, or an alternative path, such as an Emergency Use Authorization (EUA).
Recent Corporate Highlights:
- FDA Pre-submission Filing. In
January 2022, we presented a pre-submission briefing package to the FDA for the Symphony IL-6 Test.
- Completed 90 Subjects in Multicenter Clinical Study for Symphony IL-6 Test. In
January 2022, we announced enrollment of 90 subjects at two study sites in Dallas, Texas.
Mark Feinberg M.D. as Chief Medical Advisor. In January 2022, we announced the appointment of Mark Feinberg, a respected physician-scientist from the Brigham and Women’s Hospital and Harvard Medical School, in Boston, as Chief Medical Advisor. Dr. Feinberghas been involved with several clinical trials and has served as an advisor to a number of global pharmaceutical companies.
- Appointment of
Gary Gemignanito the Board of Directors. In November, Gary Gemignanijoined Bluejay’s Board of Directors. Mr. Gemignanibrings extensive experience in life sciences, public companies, accounting and finance, based on a career of senior executive and leadership roles at Acacia Pharma Group plc, Synergy Pharmaceuticals Inc., Biodel Inc., Prudential Financial, Gentium, Novartis, Wyeth and Arthur Andersen & Co.
- Completed an Upsized IPO with Gross Proceeds of
$21.6 million. On November 10, 2021, Bluejay announced the pricing of an upsized $21.6 millionunderwritten Initial Public Offering of 2,160,000 units, at a combined price per unit of $10.00.
Financial Results for the Three Months Ended
Cash and cash equivalents. Cash and cash equivalents on
Research and development expense. Research and development expenses for the three months ended
The increase relates to initiation of testing and manufacturing of the Symphony IL-6 Test.
General and administrative expense. General and administrative expenses for the three months ended
The increase is attributable to the transition from a private to a public company, including the accounting, legal and audit related expenses. Compensation and benefit costs also increased as a result of increased headcount.
Marketing and business development expense. Marketing and business development expenses for the three months ended
The increase is attributable to increased employee/consultant headcount to facilitate commercialization of the Symphony IL-6 Test.
Net loss/Net loss per share. The Net loss and Net loss per share for the three months ended
Full financial tables are included below. For further details on Bluejay’s financials, refer to its Form 10K, filed
Interleukin-6 (IL-6) is an established biomarker of immune system activation. It is elevated in infection, inflammation, and cancer. IL-6 presents as an early “first responder” and needs to be measured quickly and reliably.
About the Symphony IL-6 Test Program
Bluejay’s initial testing program is proceeding as planned to support the pre-submission process with the FDA, with the Company’s initial pre-submission submitted in
About the Symphony™ System:
Bluejay’s Symphony System (the Symphony System) is designed to address the need for simple, reliable, rapid near-patient testing. The Symphony System is designed to provide quantitative measurements of specific biomarkers to determine the need for additional patient care and monitoring, when used in combination with other test and laboratory measurements. The system does not require any sample prep and was shown in published clinical studies to deliver results in about 24 minutes.
This user-friendly system is expected to fit into ICU/near-patient settings without the need for dedicated staff to run a test. The system has been designed to measure test analytes using whole blood. Samples are collected and loaded into proprietary, test-specific cartridges.
The Symphony IL-6 Test is a development stage product candidate for investigational use only. It is limited by
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. These statements include, but are not limited to, statements relating to the expected timeline for the planned clinical studies and the planned 510(k) marketing application submission and expectation that the Company’s existing cash, cash equivalents and marketable securities will be sufficient to fund operations beyond the date of our anticipated regulatory approval and initial commercialization of the IL-6 Test. Forward-looking statements are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “suggest”, “will,” and variations of such words or similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). 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 those discussed under item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||19,047,778||$||912,361|
|Prepaid expenses and other current assets||1,612,708||61,071|
|Total current assets||20,660,486||1,058,194|
|Property and equipment, net||337,366||459,138|
|Other non-current assets||21,019||-|
|LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)|
|Due to related party||2,000||125,102|
|Accrued expenses and other current liabilities||339,384||133,820|
|Notes payable, net||-||1,041,186|
|Note payable, Paycheck Protection Program||-||14,725|
|Derivative warrant liability||-||155,629|
|Commitments and Contingencies|
|Series A redeemable, convertible preferred stock,
|Series B redeemable, convertible preferred stock,
|Series C redeemable, convertible preferred stock,
|Stockholders’ equity (deficit):|
|Additional paid-in capital||28,074,484||-|
|Total stockholders’ equity (deficit)||20,381,709||(4,206,173||)|
|Total liabilities, redeemable, convertible preferred stocks and stockholders’ equity (deficit)||$||21,018,871||$||1,517,332|
Condensed Consolidated Statements of Operations and Comprehensive Loss
|For the Years Ended
|Research and development||$||1,147,955||$||527,253|
|General and administrative||1,792,482||596,116|
|Marketing and business development||289,726||73,022|
|Total operating expenses||3,230,163||1,196,391|
|Other income (expense):|
|Gain on forgiveness of note payable, Paycheck Protection Program||5,000||102,000|
|Derivative warrant liability gain (loss)||9,676||(42,434||)|
|Interest expense, net of amortization of premium||(367,459||)||(26,997||)|
|State grant income||75,000||-|
|Total other income (expense), net||(258,135||)||38,106|
|Net loss per share - Basic and diluted||$||(0.41||)||$||(0.37||)|
|Weighted average common shares outstanding:|
|Basic and diluted||8,522,422||3,147,200|
Source: Bluejay Diagnostics