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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

 

DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED): August 16, 2023

 

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 August 16, 2023, Bluejay Diagnostics, Inc. (the “Company”) issued a press release announcing its financial results for the six months ended June 30, 2023 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.   Description
     
99.1   Press release dated August 16, 2023
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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SIGNATURE

 

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: August 16, 2023

 

 

2

 

Exhibit 99.1

 

 

Bluejay Diagnostics Announces Clinical Update and

Reports Second Quarter 2023 Financial Results

 

ACTON, Mass., August 16, 2023 – Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a medical technology company developing rapid diagnostics on its Symphony platform to improve patient outcomes in critical care settings, announced financial results for the six months ended June 30, 2023.

 

“We continued to limit our cash burn during the quarter while executing our clinical strategy for the Symphony IL-6 test and are confident that our planned clinical and analytical studies may support a 510(k) FDA regulatory submission with an initial indication for risk stratification of hospitalized sepsis patients,” said Neil Dey, CEO of Bluejay Diagnostics. “We are excited to now have a clear pathway to obtain regulatory clearance of our Symphony IL-6 test, which will serve to demonstrate the vast capabilities of our rapid, near-patient Symphony technology platform.”

 

Symphony IL-6 has the potential to be an influential tool for the prediction of clinical deterioration in sepsis patients. Symphony IL-6 testing, in conjunction with clinical and other diagnostic findings, may enable healthcare providers to better prioritize appropriate care for those at high risk to help prevent adverse outcomes, and potentially avoid unnecessary investigations and treatments in those at low risk. IL-6 appears as a ‘first responder’ biomarker in the blood during early stages of inflammations and/or infection. A current unmet challenge for healthcare professionals to overcome is the amount of time it takes to identify sepsis in patients and determine disease severity. Existing technologies typically take several hours to deliver IL-6 results, which can delay critical treatment decisions that could improve patient outcomes.

 

The Company submitted a pre-submission application to the FDA presenting the new study design in May 2023 and participated in a pre-submission meeting on August 11, 2023. At the meeting, the FDA provided feedback on the new study design, determined that the submission of a 510(k) is the appropriate premarket submission pathway, and requested that certain data be provided in the 510(k). Based on this feedback, the Company intends to proceed as planned while taking into account the FDA’s feedback. The Company has targeted large, well-known medical and academic institutions for its study, which the Company believes will help support initial commercialization and market penetration. The Company believes that it will maintain the previously disclosed Symphony IL-6 regulatory submission timeline of the first half of 2024.

 

Financial Results for the Six Months Ended June 30, 2023:

 

Cash and cash equivalents. Cash and cash equivalents on June 30, 2023 were $5.1 million, as compared to $10.1 million on December 31, 2022. The Company closely monitors the management of its liquidity and expects to raise additional capital in the near-term to fund its planned operations.

 

Research and development expense. Research and development expenses for the six months ended June 30, 2023 were $3.0 million, as compared $1.5 million, for the same period in 2022. The increase in research and development expenses was primarily due to an increase in personnel costs and product development expenses. We expect future research and development expenses to be focused on our clinical trial program and any necessary manufacturing improvements.

 

General and administrative expense. General and administrative expenses for the six months ended June 30, 2023 were $2.3 million, as compared to $2.5 million for the comparable period in 2022. The minor decrease in general and administrative expenses is due to continued efforts to preserve capital by limiting our investment in infrastructure commensurate with our commercialization timeline.

 

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Sales and marketing expense. Sales and marketing expenses for the six months ended June 30, 2023 were $302,000, as compared to $135,000 for the comparable period in 2022. The increase in sales and marketing expenses was primarily due to increased personnel costs.

 

Net loss/Net loss per share. The net loss for the six months ended June 30, 2023 was $5.4 million, or $5.24 per share, compared to $4.0 million, or $2.00 per share for the comparable period in 2022.

 

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:

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 expected nature and timing of the Company’s planned FDA submission and related plans for clinical study expansion, whether the Company’s cash position will be sufficient to fund operations needed to achieve regulatory approval and initial commercialization of the Symphony IL-6 Test, and whether such 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 not occur or 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

  

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Bluejay Diagnostics, Inc.

Condensed Consolidated Balance Sheets
(Unaudited)

 

   June 30,
2023
   December 31,
2022
 
ASSETS        
Current assets:        
Cash and cash equivalents  $5,100,407   $10,114,990 
Prepaid expenses and other current assets   1,481,512    1,673,480 
Total current assets   6,581,919    11,788,470 
           
Property and equipment, net   1,464,125    1,232,070 
Operating lease right-of-use assets   400,609    465,514 
Other non-current assets   31,675    35,211 
Total assets  $8,478,328   $13,521,265 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable  $271,488   $635,818 
Operating lease liability, current   168,713    168,706 
Accrued expenses and other current liabilities   1,392,378    835,730 
Total current liabilities   1,832,579    1,640,254 
           
Operating lease liability, non-current   255,306    323,915 
Other non-current liabilities   14,104    15,823 
Total liabilities   2,101,989    1,979,992 
           
Commitments and Contingencies (See Note 13)          
           
Stockholders’ equity:          
Common stock, $0.0001 par value; 7,500,000 shares authorized; 1,023,345 and 1,010,764 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively   102    101 
Additional paid-in capital   28,726,487    28,538,274 
Accumulated deficit   (22,350,250)   (16,997,102)
Total stockholders’ equity   6,376,339    11,541,273 
Total liabilities and stockholders’ equity  $8,478,328   $13,521,265 

 

See notes to unaudited condensed consolidated financial statements.

Reflects a 1-for-20 reverse stock split effective July 24, 2023.

 

3

 

 

Bluejay Diagnostics, Inc.

Condensed Consolidated Statements of Operations
(Unaudited)

 

   Three Months Ended
June 30,
   Six Months Ended
June 30,
 
   2023   2022   2023   2022 
Revenue  $-   $249,040   $-   $249,040 
Cost of sales   -    200,129    -    200,129 
Gross profit   -    48,911    -    48,911 
                     
Operating expenses:                    
Research and development   1,676,256    756,283    3,030,805    1,451,040 
General and administrative   1,073,103    1,196,996    2,250,080    2,516,815 
Sales and marketing   154,329    81,357    302,375    135,042 
Total operating expenses   2,903,688    2,034,636    5,583,260    4,102,897 
                     
Operating loss   (2,903,688)   (1,985,725)   (5,583,260)   (4,053,986)
                     
Other income:                    
Other income, net   90,383    48,323    230,112    103,181 
Total other income, net   90,383    48,323    230,112    103,181 
                     
Net loss  $(2,813,305)  $(1,937,402)  $(5,353,148)  $(3,950,805)
                     
Net loss per share - Basic and diluted  $(2.75)  $(2.00)  $(5.24)  $(2.00)
                     
Weighted average common shares outstanding:                    
Basic and diluted   1,023,052    1,007,115    1,020,865    1,007,115 

 

See notes to unaudited condensed consolidated financial statements.

Reflects a 1-for-20 reverse stock split effective July 24, 2023.

 

 

4

 

 

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Aug. 16, 2023
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Entity Registrant Name Bluejay Diagnostics, Inc.
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Entity Tax Identification Number 47-3552922
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 360 Massachusetts Avenue
Entity Address, Address Line Two Suite 203
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Elected Not To Use the Extended Transition Period false

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