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Bluejay Diagnostics, Inc. Reports Second Quarter 2022 Financial Results

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Bluejay Diagnostics, Inc.
Bluejay Diagnostics, Inc.

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 26th to 28th 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.