Bluejay Diagnostics, Inc. Reports Second Quarter 2022 Financial Results

Rhea-AI Summary

Bluejay Diagnostics (NASDAQ: BJDX) reported financial results for Q2 2022, highlighting a net loss of $1.9 million, or $0.10 per share. Cash and cash equivalents fell to $15.3 million from $19.0 million at year-end 2021. The company is advancing its Symphony IL-6 Test, with plans for FDA marketing application submission in Q4 2022. Significant increases in R&D and G&A expenses reflect investment in clinical studies and scalable infrastructure. The Symphony System aims to deliver rapid testing results in 20 minutes, enhancing patient care for life-threatening diseases.

Positive

• Progressing towards FDA marketing application submission for Symphony IL-6 Test in Q4 2022.
• Clinical study results to be published at the 2022 AACC Annual Scientific Meeting.
• Investment in manufacturing infrastructure to support commercialization.

Negative

• Net loss increased to $1.9 million from $640,000 in Q2 2021.
• Cash and cash equivalents decreased from $19 million to $15.3 million.
• R&D expenses rose significantly, indicating higher spending without immediate revenue.

ACTON, Mass., July 26, 2022 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a medical diagnostics company focused on developing cost-effective, rapid, near-patient tests for triage and monitoring of disease progression, today announced financial results for the quarter and six months ended June 30, 2022.

Neil Dey, Chief Executive Officer, said, “This quarter was very exciting for Bluejay, announcing our plan to pursue a de Novo regulatory pathway and completion of our initial clinical studies for the Symphony IL-6 Test. In addition, we reported that results of our clinical studies will be published at the 2022 AACC Annual Scientific Meeting being held July 26^th to 28^th in Chicago.”

Mr. Dey concluded, “Achievement of these milestones highlights Bluejay’s progression towards our goal of bringing to the market rapid, near-patient tests, using whole blood samples, to aid in the care of patients with life-threatening diseases. We have continued to invest in our manufacturing infrastructure as we prepare our FDA marketing application for submission, expected in the fourth quarter of 2022.”

Financial Results for the Three Months Ended June 30, 2022

Cash and cash equivalents. Cash and cash equivalents on June 30, 2022 were $15.3 million, as compared to $19.0 million on December 31, 2021. The Company expects that its cash position will be sufficient to fund operations beyond the date of our anticipated regulatory approval and initial commercialization of the Symphony IL-6 Test.

Revenue/Gross Profit. Bluejay recognized a small sale to a foreign development partner, which we do not consider an entry to the market or indicative of expected margins.

Research and development expense. Research and development expenses for the three and six months ended June 30, 2022 were $756,000 and $1.5 million, respectively, as compared to $226,000 and $250,000, respectively, for the comparable periods in 2021. The increase in research and development expenses is due to the advancement of our clinical studies and to support scale-up manufacturing of the Symphony IL-6 Test.

General and administrative expense. General and administrative expenses for the three and six months ended June 30, 2022 were $1.2 million and $2.5 million, respectively, as compared to $390,000 and $530,000, respectively, for the comparable periods in 2021. The increase in general and administrative expenses reflects the Company’s investment in scalable infrastructure, as well as expenses to support public company operations due to the completion of our initial public offering in November 2021.

Sales and marketing expense. Sales and marketing expenses for the three and six months ended June 30, 2022 were $81,000 and $135,000, respectively, as compared to $50,000 and $119,000, respectively, for the comparable periods in 2021. While these expenses have been limited to date, we expect to increase these efforts when appropriate to support our commercial growth.

Net loss/Net loss per share. The net loss for the three and six months ended June 30, 2022 was $1.9 million and $4.0 million, or $0.10 and $0.20 per share, respectively, compared to $640,000 and $834,000, or $0.15 and $0.20 per share, respectively, for the comparable periods in 2021.

About the Symphony™ System:
Bluejay’s Symphony System (the “Symphony System”) is designed to address the need for simple, reliable, rapid, near-patient testing by providing quantitative measurements of specific biomarkers to determine the need for additional patient care and monitoring. The user-friendly Symphony System will not require any sample preparation or dedicated staff and was shown in published clinical studies to deliver results in approximately 20 minutes.

The Symphony IL-6 Test is a development stage product candidate for investigational use only. It is limited by United States law to investigational use.

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 triage and monitoring of disease progression. Bluejay’s first product candidate, an IL-6 Test for sepsis triage, 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 in this press release include, without limitation, the ability of the Company to submit a marketing application with the FDA in the fourth quarter of 2022, whether the Company’s cash position will be sufficient to fund operations beyond the date of its anticipated regulatory approval and initial commercialization of the Symphony IL-6 Test, and whether such anticipated regulatory approval will actually occur. 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 those discussed under item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission, as updated by the Company’s subsequent Quarterly Reports on Form 10-Q. 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 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. 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.

Investor Contact:
Alexandra Schuman
LifeSci Advisors
alex@lifesciadvisors.com
t: 646-876-3647

Bluejay Diagnostics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)

		June 30,				December 31,
		2022				2021
ASSETS
Current assets:
Cash and cash equivalents		$	15,341,862			$	19,047,778
Inventories			671,250				-
Prepaid expenses and other current assets			1,037,145				1,612,708
Total current assets			17,050,257				20,660,486
Property and equipment, net			409,070				337,366
Operating lease right-of-use assets			573,040				-
Other non-current assets			35,075				21,019
Total assets		$	18,067,442			$	21,018,871
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	196,108			$	295,778
Accrued expenses			783,482				341,384
Total current liabilities			979,590				637,162
Non-current liabilities:
Operating lease liability, non-current			430,116				-
Total liabilities			1,409,706				637,162
Commitments and Contingencies
Stockholders’ equity
Common stock, $0.0001 par value; 30,000,000 shares authorized; 20,152,344 and 20,112,244 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively			2,015				2,011
Additional paid-in capital			28,306,680				28,074,484
Accumulated deficit			(11,650,959	)			(7,694,786	)
Total stockholders’ equity			16,657,736				20,381,709
Total liabilities and stockholders’ equity		$	18,067,442			$	21,018,871

See notes to unaudited condensed consolidated financial statements.
Reflects a 1-for-3.15 stock dividend effective June 7, 2021.

Bluejay Diagnostics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)

		Three Months Ended June 30,								Six Months Ended June 30,
		2022				2021				2022				2021
Revenue		$	249,040			$	-		$	249,040			$	-
Cost of sales			200,129				-			200,129				-
Gross profit			48,911				-			48,911				-
Operating expenses:
Research and development			756,283				225,992			1,451,040				250,175
General and administrative			1,196,996				389,830			2,516,815				529,741
Sales and marketing			81,357				50,250			135,042				119,354
Total operating expenses			2,034,636				666,072			4,102,897				899,270
Operating loss			(1,985,725)				(666,072)			(4,053,986)				(899,270)
Other income:
Interest expense, net			-				(59,167)			-				(32,116)
Grant income			-				75,000			-				75,000
Other income, net			48,323				10,006			103,181				21,965
Total other income, net			48,323				25,839			103,181				64,849
Net loss		$	(1,937,402)			$	(640,233)		$	(3,950,805)			$	(834,421)
Net loss per share - Basic and diluted		$	(0.10)			$	(0.15)		$	(0.20)			$	(0.20)
Weighted average common shares outstanding:
Basic and diluted			20,151,969				4,201,688			20,151,969				4,201,688

See notes to unaudited condensed consolidated financial statements.
Reflects a 1-for-3.15 stock dividend effective June 7, 2021.

FAQ

What were Bluejay Diagnostics' Q2 2022 financial results?

Bluejay Diagnostics reported a net loss of $1.9 million for Q2 2022, compared to $640,000 in Q2 2021.

When is Bluejay Diagnostics' Symphony IL-6 Test expected to receive FDA approval?

The FDA marketing application for the Symphony IL-6 Test is expected to be submitted in Q4 2022.

What is the cash position of Bluejay Diagnostics as of June 30, 2022?

As of June 30, 2022, Bluejay Diagnostics had cash and cash equivalents of $15.3 million.

How much did Bluejay spend on research and development in Q2 2022?

Bluejay incurred research and development expenses of $756,000 in Q2 2022, up from $226,000 in Q2 2021.