Full Press Release Details
Bluejay Diagnostics,
Inc. Reports Second Quarter 2022 Financial Results
Acton, Massachusetts,
July 26, 2022 - 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."
"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 SymphonyTM 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:
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.
Bluejay Diagnostics, Inc.
Condensed Consolidated Balance Sheets
| 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
Reflects a 1-for-3.15 stock dividend effective June 7,
Bluejay Diagnostics, Inc.
Condensed Consolidated Statements of Operations
| 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
Reflects a 1-for-3.15 stock dividend effective June 7,