Full Press Release Details
Date: December 16, 2021
Bluejay Diagnostics,
Inc. Reports Third Quarter 2021 Financial Results
IL-6 test for sepsis
triage on Track for January 2022 FDA Pre-Submission Filing
Program Planned for Q1-Q3 2022
million Gross Proceeds in an Upsized IPO
Acton, Massachusetts,
Dec. 16, 2021 - Bluejay Diagnostics, Inc. (NASDAQ: BJDX) ("Bluejay") a late-stage, pre-revenue diagnostics/medical device
company focused on developing cost-effective, rapid, near-patient products for triage, diagnosis and monitoring of disease progression,
today announced financial results for the third quarter ended September 30, 2021 and provided a corporate update on the Company's
first product candidate, the IL-6 test for sepsis triage.
substantial progress since our S-1 filing in July 2021. We completed an upsized $21.6 million Initial Public Offering and initiated the
clinical testing program for the IL-6 test for sepsis triage," said Indranil "Neil" Dey, CEO. "These two important
milestones will help to bring us closer to fulfilling Bluejay's mission of developing the first whole-blood, cost-effective, rapid,
near-patient product to help medical professionals make earlier and better decisions in sepsis care."
Overview, Initial Testing Plan and Next Steps for the IL-6 test for sepsis triage Product Candidate
Financial Results for the Three Months Ended September 30, 2021
Research and Development Expense. Research
and development expenses for the three months ended September 30, 2021 were $442,527 as compared to $2,723 for the comparable period in
2020. The increase was primarily due to expenses in connection with clinical trial preparations and manufacturing costs.
General and Administrative Expense. General
and administrative expenses for the three months ended September 30, 2021 were $445,050 as compared to $131,094 for the comparable period
in 2020. The increase was attributable to increased operating expenses related to the Company's transition to a public company,
including accounting legal and audit related expenses as well as an increase in general and administration headcount.
Net Loss/Loss per share. The Net Loss and Net Loss per Share
for the three months ended September 30, 2021 was $1,193,381 and $0.11 compared to $127,988 and $0.04 for the comparable period in 2020.
Cash and Cash Equivalents and Marketable
Securities. Cash, cash equivalents, and marketable securities on September 30, 2021 were $2,330,138 as compared to $912,361 on
December 31, 2020. Subsequent to the end of the third quarter, the company completed a successful IPO, raising $18.8 million in net
proceeds (after underwriters' and other related expenses).
For further details on Bluejay's financials, refer to its
Form 10Q filed December 16, 2021 with the S.E.C.
About the Symphony System:
Bluejay's Symphony System
is intended to address the need for simple, reliable, rapid near-patient testing. 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 system does not require any sample prep and was shown
in published clinical studies to deliver results in about 24 minutes.
The Symphony System is based on a well-accepted
test method (ELISA, Enzyme-Linked Immunosorbent Assay) using advances in nanotechnology and new approaches to microfluidics. Bluejay has
an exclusive license to the Symphony System from Toray Industries (Toray), a multinational company with more than 96 years of manufacturing
experience, located in Japan. The product is manufactured by Toray and Sanyoseiko. Sanyoseiko is an FDA-registered manufacturer with more
than 50 years of global experience in medical devices manufacturing, located in Japan.
About Bluejay Diagnostics:
Bluejay Diagnostics, Inc. is a late-stage, pre-revenue
diagnostics/medical device company focused on improving patient outcomes through the Symphony System, a more cost-effective, rapid, near-patient
product candidate for triage, diagnosis 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.
Forward Looking Statements:
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 completion of the Company's
clinical studies and potential submissions to the FDA. 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 in the Company's filings with the Securities and Exchange Commission, including as set forth in the "Risk
Factors" section of the Company's final prospectus, which was filed with the Securities and Exchange Commission on November
11, 2021, 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.
Bluejay Diagnostics,
Condensed Consolidated
Balance Sheets (Unaudited)
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 2,330,138 | $ | 912,361 | ||||
| Inventory | - | 84,762 | ||||||
| Deferred offering costs | 482,308 | - | ||||||
| Prepaid expenses and other current assets | 451,407 | 61,071 | ||||||
| Total current assets | 3,263,853 | 1,058,194 | ||||||
| Property and equipment, net | 358,845 | 459,138 | ||||||
| Total assets | $ | 3,622,698 | $ | 1,517,332 | ||||
| LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 242,856 | $ | 374,928 | ||||
| Due to related party | 115,102 | 125,102 | ||||||
| Accrued expenses | 371,288 | 133,820 | ||||||
| Notes payable, net | - | 1,041,186 | ||||||
| Convertible debentures | 3,974,374 | - | ||||||
| Note payable, Paycheck Protection Program | - | 14,725 | ||||||
| Derivative warrant liability | - | 155,629 | ||||||
| Total liabilities | 4,703,620 | 1,845,390 | ||||||
| Commitments and Contingencies (See Note 6) | ||||||||
| Series A redeemable, convertible preferred stock, $0.0001 par value; 10,600 shares authorized; 0 and 10,600 shares issued and outstanding at September 30, 2021 and December 31, 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 September 30, 2021 and December 31, 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 September 30, 2021 and December 31, 2020, respectively | - | 1,000,465 | ||||||
| Stockholders' deficit: | ||||||||
| Common stock, $0.0001 par value; 30,000,000 shares authorized; 10,534,265 and 3,147,200 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 1,054 | 315 | ||||||
| Additional paid-in capital | 5,152,314 | - | ||||||
| Accumulated deficit | (6,234,290 | ) | (4,206,488 | ) | ||||
| Total stockholders' deficit | (1,080,922 | ) | (4,206,173 | ) | ||||
| Total liabilities, redeemable, convertible preferred stocks and stockholders' deficit | $ | 3,622,698 | $ | 1,517,332 |
Bluejay Diagnostics,
Condensed Consolidated
Statements of Operations and Comprehensive Loss (Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 442,527 | $ | 2,723 | $ | 692,702 | $ | 108,192 | ||||||||
| General and administrative | 445,050 | 131,094 | 974,791 | 452,846 | ||||||||||||
| Marketing and business development | 70,411 | 14,352 | 189,765 | 53,574 | ||||||||||||
| Total operating expenses | 957,988 | 148,169 | 1,857,258 | 614,612 | ||||||||||||
| Operating loss | (957,988 | ) | (148,169 | ) | (1,857,258 | ) | (614,612 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Derivative warrant liability gain (loss) | - | 4,344 | 9,676 | (45,323 | ) | |||||||||||
| Interest income (expense), net of amortization of premium | (237,429 | ) | 15,833 | (269,545 | ) | 40,443 | ||||||||||
| State grant revenue | - | - | 75,000 | - | ||||||||||||
| Other income | 2,036 | 4 | 14,325 | 5,232 | ||||||||||||
| Total other income (expense), net | (235,393 | ) | 20,181 | (170,544 | ) | 352 | ||||||||||
| Net loss | $ | (1,193,381 | ) | $ | (127,988 | ) | $ | (2,027,802 | ) | $ | (614,260 | ) | ||||
| Net loss per share - Basic and diluted | $ | (0.11 | ) | $ | (0.04 | ) | $ | (0.32 | ) | $ | (0.20 | ) | ||||
| Weighted average common shares outstanding: | ||||||||||||||||
| Basic and diluted | 10,491,978 | 3,147,200 | 6,321,493 | 3,147,200 |