Full Press Release Details
Diagnostics, Inc. Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update
program underway for lead product candidate, the Symphony IL-6 Test, in support of an FDA Marketing Application, planned for Q3 2022
ended with approximately $19 million in cash expected to fund operations beyond the date of our anticipated regulatory approval and initial
commercialization of the IL-6 Test
Massachusetts, March 10, 2021 - Bluejay Diagnostics, Inc. (NASDAQ: BJDX) ("Bluejay", "the Company") a late-stage,
pre-revenue diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease
progression, today announced financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate
update, including on the Company's first product candidate, the IL-6 Test.
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 Neil Dey, Bluejay's Chief Executive Officer.
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.
Corporate Highlights:
Results for the Three Months Ended December 31, 2021 and Full Year 2021
and cash equivalents. Cash and cash equivalents on December 31, 2021 were $19,047,778 as compared to $912,361 on December 31, 2020.
The company expects its existing cash and cash equivalents to be sufficient to fund operations beyond the date of our anticipated regulatory
approval and initial commercialization of the IL-6 Test.
and development expense. Research and development expenses for the three months ended December 31, 2021 were $455,253 as compared
to $419,061 for the comparable period in 2020. Research and development expenses for 2021 were $1,147,955 compared to $527,253 for 2020.
increase relates to initiation of testing and manufacturing of the Symphony IL-6 Test.
and administrative expense. General and administrative expenses for the three months ended December 31, 2021 were $817,688 as compared
to $143,270 for the comparable period in 2020. General and administrative expenses for 2021 were $1,792,482 compared to $596,116 for
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.
and business development expense. Marketing and business development expenses for the three months ended December 31, 2021 were $99,961
as compared to $19,448 for the comparable period in 2020. Marketing and business development expenses for 2021 were $289,726 compared
to $73,022 for 2020.
increase is attributable to increased employee/consultant headcount to facilitate commercialization of the Symphony IL-6 Test.
loss/Net loss per share. The Net loss and Net loss per share for the three months ended December 31, 2021 was $1,460,493 and $0.09
compared to $544,025 and $0.17 for the comparable period in 2020. The Net loss and Net loss per share for 2021 was $3,488.298
and $0.41 compared to $1,158.285 and $0.37 for 2020.
financial tables are included below. For further details on Bluejay's financials, refer to its Form 10K, filed March 10, 2022 with
(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.
the Symphony IL-6 Test Program
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 January 2022, and the overall product development program. This testing program includes multiple studies,
all intended to establish the performance and safety of the IL-6 Test. This clinical program is continuing in anticipation of the company's
planned marketing application.
the SymphonyTM System:
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.
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.
Symphony IL-6 Test is a development stage product candidate for investigational use only. It is limited by United States law to
investigational use.
Bluejay Diagnostics:
Diagnostics, Inc. is a late-stage, pre-revenue diagnostics company focused on improving patient outcomes through the Symphony System,
a more cost-effective, rapid, near-patient product candidate for triage and monitoring of disease progression in hospital and long-term
acute care (LTAC) settings. Bluejay's first product candidate, an IL-6 Test for sepsis triage, is designed to provide accurate,
reliable results in approximately 24 minutes from sample-to-result' to help medical professionals make earlier and better
triage/treatment decisions. More information is available at www.bluejaydx.com.
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 Securities and
Exchange Commission ("SEC"), as updated by the Company's subsequent Quarterly Reports on Form 10-Q. You should not
place undue reliance on these 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 changes in the Company's expectations of results or any change in events.
Consolidated Balance Sheets
| December 31, | ||||||||
| 2021 | 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 19,047,778 | $ | 912,361 | ||||
| Inventory | - | 84,762 | ||||||
| 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 | - | ||||||
| Total assets | $ | 21,018,871 | $ | 1,517,332 | ||||
| LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 295,778 | $ | 374,928 | ||||
| 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 | ||||||
| Total liabilities | 637,162 | 1,845,390 | ||||||
| Commitments and Contingencies | ||||||||
| Series A redeemable, convertible preferred stock, $0.0001 par value; 10,600 shares authorized; 0 and 10,600 shares issued and outstanding at December 31, 2021 and 2020, respectively | - | 1,077,303 | ||||||
| Series B redeemable, convertible preferred stock, $0.0001 par value; 5,918 shares authorized; 0 and 5,187 shares issued and outstanding at December 31, 2021 and 2020, respectively | - | 1,800,347 | ||||||
| Series C redeemable, convertible preferred stock, $0.0001 par value; 636 shares authorized; 0 and 636 shares issued and outstanding at December 31, 2021 and 2020, respectively | - | 1,000,465 | ||||||
| Stockholders' equity (deficit): | ||||||||
| Common stock, $0.0001 par value; 100,000,000 shares authorized; 20,112,244 and 3,147,200 shares issued and outstanding at December 31, 2021 and 2020, respectively | 2,011 | 315 | ||||||
| Additional paid-in capital | 28,074,484 | - | ||||||
| Accumulated deficit | (7,694,786 | ) | (4,206,488 | ) | ||||
| 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 |
Consolidated Statements of Operations and Comprehensive Loss
| For the Years Ended December 31, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| 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 | ||||||
| Operating loss | (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 | - | ||||||
| Other income | 19,648 | 5,537 | ||||||
| Total other income (expense), net | (258,135 | ) | 38,106 | |||||
| Net loss | $ | (3,488,298 | ) | $ | (1,158,285 | ) | ||
| 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 |