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Bluejay Diagnostics, Inc.

(Exact Name of Registrant as Specified in its Charter)

delaware   001-41031   47-3552922
(State or Other Jurisdiction of Incorporation or Organization)   (Commission File No.)   (I.R.S. Employer Identification No.)


360 Massachusetts Avenue, Suite 203

Acton, MA 01720

(Address of principal executive offices and zip code)


(844) 327-7078

(Registrant’s telephone number, including area code)

(Former name or former address, if changed from last report)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(c)).

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Securities registered pursuant to Section 12(b) of the Act:

Title of each class   Trading Symbol (s)   Name of each exchange on which registered
Common Stock, par value $0.0001 per share   BJDX   The NASDAQ Stock Market LLC








Item 2.02   Results of Operations and Financial Condition.


On November 8, 2022, Bluejay Diagnostics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2022 and a corporate update. A copy of the press release is attached to this report as Exhibit 99.1 and is incorporated by reference herein.


Item 9.01.   Financial Statements and Exhibits


 (d) Exhibits


Exhibit No. Exhibit Description
99.1 Press release dated November 8, 2022
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)







Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

  Bluejay Diagnostics Inc.
  By: /s/ Kenneth Fisher
    Kenneth Fisher
    Chief Financial Officer


Dated: November 8, 2022





Exhibit 99.1



Description automatically generated with medium confidence

Bluejay Diagnostics, Inc. Reports Third Quarter 2022 Financial Results


Acton, Massachusetts, October 25, 2022 – Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a clinical-stage medical diagnostics company developing rapid, near-patient tests using whole blood on its Symphony platform to improve patient outcomes in critical care settings, today reported its financial results for the quarter and nine months ended September 30, 2022.


“The last quarter focused on increasing awareness of Bluejay’s Symphony IL-6 test by directly engaging the medical community to build a network of champions that will direct product development and drive initial commercialization,” said Neil Dey, CEO. “In August, Bluejay held a KOL event with clinicians in emergency and critical care who shared their perspectives on Symphony’s potential to guide patient care and acute intervention through monitoring of quantitative IL-6 measurements on a simple, reliable, efficient platform.”


“During July, the Company published positive clinical results for its Symphony IL-6 test presented at AACC, which demonstrated 98% NPV to identify COVID-19 patients at risk for severe illness,” continued Dey. “We are also currently expanding our clinical program, adding additional test sites in support of the Company’s planned De Novo marketing application with the FDA for our Symphony IL-6 test, with an anticipated submission during the first half of 2023.”


Financial Results for the Three and Nine Months Ended September 30, 2022


Cash and cash equivalents. Cash and cash equivalents on September 30, 2022 were $13.3 million, as compared to $19.0 million on December 31, 2021. The Company has maintained a slow cash burn during its FDA submission process and currently expects that its cash position will be sufficient to fund operations for the next 12 months.


Revenue and Gross Profit. Revenue and gross profit increased approximately $250,000 and $49,000 respectively, for the nine month periods ended September 30, 2022, as compared to the same period in 2021. We recognized a small, non-recurring sale to a foreign development partner in the second quarter of 2022, which it does not consider an entry to the market or indicative of expected margins. As expected, there were no sales in the third quarter. 


Research and Development. Research and development expenses for the three and nine months ended September 30, 2022 were $1.4 million and $2.8 million, respectively, as compared to $443,000 and $693,000, respectively, for the comparable periods in 2021. The increase in research and development expenses was due to the expansion of our clinical program and supporting scale-up manufacturing of the Symphony technology platform and IL-6 test.


General and Administrative. General and administrative expenses for the three and nine months ended September 2022 were $1.3 million and $3.8 million, respectively, as compared to $445,000 and $975,000, respectively, for the comparable periods in 2021. The increase in general and administrative expenses reflects our 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. Sales and marketing expenses for the three and nine months ended September 30, 2022 were $146,000 and $281,000, respectively, as compared to $70,000 and $190,000, 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 its commercial growth.


Net loss/Net loss per share. The net loss for the three and nine months ended September 30, 2022 was $3.0 million and $6.9 million, or $0.15 and $0.34 per share, respectively, compared to $1.2 million and $2.0 million, or $0.11 and $0.32 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 does not require any sample preparation or dedicated staff and has been 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.





Bluejay Diagnostics, Inc.

Condensed Consolidated Balance Sheets


   September 30,   December 31, 
   2022   2021 
Current assets:        
Cash and cash equivalents  $13,289,365   $19,047,778 
Prepaid expenses and other current assets   646,894    1,612,708 
Total current assets   13,936,259    20,660,486 
Property and equipment, net   1,238,352    337,366 
Operating lease right-of-use assets   497,618    - 
Other non-current assets   33,479    21,019 
Total assets  $15,705,708   $21,018,871 
Current liabilities:          
Accounts payable  $443,035   $295,778 
Accrued expenses   1,079,665    341,384 
Total current liabilities   1,522,700    637,162 
Non-current liabilities:          
Operating lease liability, non-current   356,523    - 
Other non-current liabilities   15,420    - 
Total liabilities   371,943    637,162 
 Commitments and Contingencies (See Note 9)          
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 September 30, 2022 and December 31, 2021, respectively   2,015    2,011 
Additional paid-in capital   28,419,898    28,074,484 
Accumulated deficit   (14,610,848)   (7,694,786)
Total stockholders’ equity   13,811,065    20,381,709 
Total liabilities, redeemable and stockholders’ equity  $15,705,708   $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


   Three Months Ended
September 30,
   Nine Months Ended
September 30,
   2022   2021   2022   2021 
Revenue  $-   $-   $249,040   $- 
Cost of sales   -    -    200,129    - 
Gross profit   -    -    48,911    - 
Operating expenses:                    
Research and development   1,379,665    442,527    2,830,705    692,702 
General and administrative   1,284,411    445,050    3,801,226    974,791 
Sales and marketing   146,102    70,411    281,144    189,765 
Total operating expenses   2,810,178    957,988    6,913,075    1,857,258 
Operating loss   (2,810,178)   (957,988)   (6,864,164)   (1,857,258)
Other income (expenses):                    
Interest income (expense), net of amortization of premium   -    (237,429)   -    (269,545)
Grant income   -    -    -    75,000 
Impairment of property and equipment   (210,117)   -    (210,117)   - 
Other income, net   60,406    2,036    163,587    24,001 
Total other expenses, net   (149,711)   (235,393)   (46,530)   (170,544)
Net loss  $(2,959,889)  $(1,193,381)  $(6,910,694)  $(2,027,802)
Net loss per share - Basic and diluted  $(0.15)  $(0.11)  $(0.34)  $(0.32)
Weighted average common shares outstanding:                    
Basic and diluted   20,152,344    10,491,978    20,148,908    6,321,493 



See notes to unaudited condensed consolidated financial statements.

Reflects a 1-for-3.15 stock dividend effective June 7, 2021.