2024 Q4 Form 10-Q Financial Statement

#000121390024095388 Filed on November 07, 2024

View on sec.gov

Income Statement

Concept 2024 Q4 2024 Q3
Revenue
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin
YoY Change
% of Gross Profit
Research & Development $551.7K
YoY Change -60.52%
% of Gross Profit
Depreciation & Amortization
YoY Change
% of Gross Profit
Operating Expenses $1.362M
YoY Change -41.84%
Operating Profit -$1.362M
YoY Change -41.84%
Interest Expense $185.9K
YoY Change
% of Operating Profit
Other Income/Expense, Net -$120.4K
YoY Change -378.37%
Pretax Income
YoY Change
Income Tax
% Of Pretax Income
Net Earnings -$1.482M
YoY Change -35.51%
Net Earnings / Revenue
Basic Earnings Per Share -$0.16
Diluted Earnings Per Share -$0.16
COMMON SHARES
Basic Shares Outstanding 26.88M shares 6.252M shares
Diluted Shares Outstanding 9.556M shares

Balance Sheet

Concept 2024 Q4 2024 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments
YoY Change
Cash & Equivalents $5.800M
Short-Term Investments
Other Short-Term Assets
YoY Change
Inventory
Prepaid Expenses
Receivables
Other Receivables $8.315K
Total Short-Term Assets $6.568M
YoY Change 0.61%
LONG-TERM ASSETS
Property, Plant & Equipment $1.535M
YoY Change 16.11%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $23.60K
YoY Change -21.1%
Total Long-Term Assets $1.786M
YoY Change 3.89%
TOTAL ASSETS
Total Short-Term Assets $6.568M
Total Long-Term Assets $1.786M
Total Assets $8.353M
YoY Change 1.3%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $316.7K
YoY Change -58.11%
Accrued Expenses
YoY Change
Deferred Revenue
YoY Change
Short-Term Debt
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $1.000M
YoY Change -64.29%
LONG-TERM LIABILITIES
Long-Term Debt
YoY Change
Other Long-Term Liabilities $9.530K
YoY Change -27.91%
Total Long-Term Liabilities $9.530K
YoY Change -27.91%
TOTAL LIABILITIES
Total Short-Term Liabilities $1.000M
Total Long-Term Liabilities $9.530K
Total Liabilities $1.189M
YoY Change -60.8%
SHAREHOLDERS EQUITY
Retained Earnings -$33.24M
YoY Change 34.84%
Common Stock $40.40M
YoY Change 35.3%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $7.164M
YoY Change
Total Liabilities & Shareholders Equity $8.353M
YoY Change 1.3%

Cashflow Statement

Concept 2024 Q4 2024 Q3
OPERATING ACTIVITIES
Net Income -$1.482M
YoY Change -35.51%
Depreciation, Depletion And Amortization
YoY Change
Cash From Operating Activities
YoY Change
INVESTING ACTIVITIES
Capital Expenditures
YoY Change
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities
YoY Change
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities
YoY Change
NET CHANGE
Cash From Operating Activities
Cash From Investing Activities
Cash From Financing Activities
Net Change In Cash
YoY Change
FREE CASH FLOW
Cash From Operating Activities
Capital Expenditures
Free Cash Flow
YoY Change

Facts In Submission

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION</b></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "><b><i>Business</i></b></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">Bluejay Diagnostics, Inc. (“Bluejay” or the “Company”) is a medical diagnostics company developing rapid tests using whole blood on our Symphony technology platform (“Symphony”) to improve patient outcomes in critical care settings. The Company’s Symphony platform is an exclusively licensed and patented technology that consists of a mobile device and single-use test cartridges that if cleared, authorized, or approved by the U.S. Food and Drug Administration (the “FDA”), can provide a solution to a significant market need in the United States. Clinical trials indicate the Symphony device produces results in less than 20 minutes for intensive care units and emergency rooms, where rapid and reliable results are required.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">Bluejay’s first product, the Symphony IL-6 test, is for the monitoring of disease progression in critical care settings. IL-6 is a clinically established inflammatory biomarker, considered a ‘first-responder,’ for assessment of severity of infection and inflammation across many disease indications, including sepsis. A current challenge of healthcare professionals is the excessive time and cost associated determining a patient’s level of severity at triage and the Symphony IL-6 test could consistently monitor this critical care biomarker with rapid results providing critical information to the physicians to improve patient care.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">In the future Bluejay plans to develop additional tests for Symphony including two cardiac biomarkers (hsTNT and NT pro-BNP), as well as other tests using the Symphony platform. The Company does not yet have regulatory clearance for its Symphony products, and its Symphony products will need to receive regulatory authorization from the FDA in order to be marketed as a diagnostic product in the United States.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">In the future, Bluejay also plans to explore new products to support Bluejay’s biomarker detection program. Furthermore, Bluejay plans to explore strategic opportunities around the specimen biobanks generated from the SYMON I and SYMON II clinical studies.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">We were incorporated under the laws of Delaware on March 20, 2015. Our headquarters is located in Acton, Massachusetts.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">On June 4, 2021, the Company formed Bluejay Spinco, LLC, a wholly owned subsidiary of the Company, for purposes of further development of the Company’s ALLEREYE diagnostic test. ALLEREYE is a point-of-care device offering healthcare providers a solution for diagnosing Allergic Conjunctivitis.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "><b><i>Risks and Uncertainties</i></b></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">Risks related to the Company’s FDA regulatory and clinical trial, Nasdaq listing and going concern status are each described below. In addition, the Company is subject to several risks similar to other companies in its industry, including rapid technological change, competition from larger companies, availability of raw materials and device components, and dependence on key personnel.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "><b><i>FDA Regulatory and Clinical Trial Update</i></b></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">Our current regulatory strategy is designed to support commercialization of Symphony in the United States pending marketing authorization from the FDA. Previously, our regulatory strategy involved clinical studies involving COVID-19 patients. However, we have shifted our focus away from COVID-19 patients due to a significant decline in the number of COVID-19 related hospitalizations. Pursuant to this revised strategy, we have completed a pilot clinical study (SYMON-I) and plan to begin a clinical study (SYMON-II) to validate the results of the pilot study to support an FDA regulatory submission with an initial indication for risk stratification of hospitalized sepsis patients. We 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, we are determined to proceed on this basis, which considers the FDA’s feedback. </p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">In the second quarter of 2024, we completed a multicenter SYmphony IL-6 MONitoring Sepsis (“SYMON”) clinical study investigating the role of interleukin-6 (IL-6) in patients diagnosed with sepsis and septic shock. This prospective study assessed the performance of IL-6 upon initial presentation to the intensive care unit (ICU). A primary analysis of the SYMON-I pilot clinical study (registered clinical trial number NCT06181604) highlighted that IL-6 levels within 24 hours of sepsis or septic shock diagnosis and admission to the ICU may predict patient mortality out to 28 days. We will seek to validate these findings in the SYMON-II pivotal study.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">Furthermore, a secondary outcome of the SYMON-I study showed that IL-6 levels within 24 hours of sepsis or septic shock diagnosis and admission to the ICU is a predictor of patient mortality during their hospitalization. Other secondary outcomes showed that lactate and Sequential Organ Failure Assessment (SOFA), standard clinical tests used for sepsis and septic shock patients, were not predictors of patient mortality out to 28 days.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">We believe that the findings underscore the potential importance of IL-6 as a predictor and provide new insights into the potential pathways for improving sepsis outcomes.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">The SYMON II clinical study has three components: (1) collection, freezing, and biobanking of patient samples, (2) measuring IL-6 concentrations in the biobanked samples near the end of patient enrollment or after the patient enrollment has completed, and (3) analysis of the IL-6 data with the patient outcomes to see if the established IL-6 cutoff value has been validated for 28-day all-cause mortality.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">We initiated the SYMON-II pivotal clinical study in the third quarter of 2024. We plan to start patient enrollment during the fourth quarter of 2024. Our goal is to use the Symphony IL-6 test to complete the testing in the SYMON-II clinical trial. We are experiencing several technical challenges related to the Symphony Cartridge product that we expect to delay our ability to complete such testing. In particular, several individual components in our product may need to be replaced and validated due to limited supply or discontinuation (including the antibody used in the product). In addition, we are working to correct several reliability issues with the Symphony Cartridge product. At this time, we anticipate these delays will prevent us from submitting an FDA application within the next 18 months.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">If we are able to complete the SYMON-II clinical study and the results are positive, we intend to use the data generated from SYMON-II to support a 510(k) application to the FDA. This application will be based on the following intended use: “Symphony IL-6 is intended for use to determine the IL-6 concentration as an aid in assessing the cumulative 28-day risk of all-cause mortality in conjunction with other laboratory findings and clinical assessments for patients diagnosed with sepsis or septic shock in the ICU.” We also plan to present the SYMON-I and SYMON-II results at future national scientific meetings and publish them in peer-reviewed journals.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">For Symphony, we remain in the development phase of the overall product launch cycle. Currently are experiencing issues with critical materials and pilot production performance that could negatively affect our projected timeline for FDA submission. We are developing plans to improve product performance, ensure supply of these critical materials, and transfer production and all supply chain activities from the original developer and current supplier of cartridge intermediates (Toray) to an FDA-registered contract manufacturer (CMO). We expect that production lots for validation testing to support the FDA submission will be available once a transfer to an FDA registered CMO is completed.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">If we are unable to meet the manufacturing requirements or analytical performance required for FDA clearance with Symphony, we may consider using an alternative IL-6 test for the SYMON-II study.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">Our ability to engage in and complete the activities needed for an FDA submission, will be contingent upon us addressing these and other challenges, including possessing and/or raising sufficient capital, remaining a going concern, and producing product capable of supporting our product requirements and meeting analytical validation and clinical validation.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>June 2024 Reverse Stock Split</i></b></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i> </i></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On June 20, 2024, we effected a reverse stock split of our shares of common stock at a ratio of 1-for-8 (the “2024 Reverse Stock Split”). The Company’s common stock continued trading on Nasdaq on a post-split basis under the Company’s existing trading symbol, “BJDX.”</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">All of the Company’s historical share and per share information related to issued and outstanding common stock and outstanding options and warrants exercisable for common stock in these financial statements have been adjusted, on a retroactive basis, to reflect the Reverse Stock Split.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Nasdaq Minimum Bid Price Non-Compliance</i></b></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our common stock currently is listed for quotation on the Nasdaq Capital Market. We are required to meet specified financial requirements in order to maintain such listing, including a requirement that the bid price for our common stock remain above $1.00, and that the market value of our publicly held securities be at least $1 million.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On February 28, 2024, we received a notification letter from the Nasdaq Listing Qualifications Staff of the Nasdaq Stock Market LLC (“Nasdaq”) notifying us that the closing bid price for our common stock had been below $1.00 for the previous 30 consecutive business days and that we therefore are not in compliance with the minimum bid price requirement for continued inclusion on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The notification has no immediate effect on the listing of our common stock on the Nasdaq Capital Market.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On August 28, 2024, at the Company’s request, Nasdaq’s Listing Qualifications Staff notified the Company that it has extended the time for the Company to regain compliance with the minimum bid price requirement until February 24, 2025. To regain compliance, the closing bid price of our common stock must be at least $1.00 or higher for a minimum of ten consecutive business days, and in such case, Nasdaq will provide us with written confirmation of compliance. If we are not able to cure the deficiency during this compliance period, Nasdaq will provide written notice to us that our common stock will be subject to delisting. In the event of such delisting notification, we may appeal Nasdaq’s determination to delist our securities, but there can be no assurance that Nasdaq would grant our request for continued listing<b>.</b></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We intend to take all reasonable measures available to us to achieve compliance to allow for continued listing on the Nasdaq Capital Market. However, there can be no assurance that we will be able to regain compliance with the minimum bid price requirement or will otherwise comply with other Nasdaq listing criteria. On June 20, 2024, we effected a reverse stock split of our shares of common stock at a ratio of 1-for-8, however, our common stock did not remain above a trading price of $1.00 following such reverse stock split. If our common stock does not regain compliance with the minimum price requirement during the remaining compliance period, we may need to effect a further reverse stock split, whereby shares of our common stock are further consolidated with the intent that the per-share trading price becomes greater than $1.00 per share on a sustained basis sufficient to regain compliance with the applicable Nasdaq requirements. On October 23, 2024, at a special meeting of stockholders, the Company’s stockholders approved a proposed amendment to the Company’s certificate of incorporation to effect a reverse stock split of the Company’s outstanding shares of common stock by one of several fixed ratios (1-for-20, 1-for 25, 1-for-30, 1-for-35, 1-for-40, 1-for-45 and 1-for-50). The Company’s board of directors is considering whether to proceed with implementation of the reverse stock split, including the timing and ratio thereof.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As of the close of business on November 4, 2024, the market value of our publicly held common stock (which is our only outstanding class of securities) was approximately $2.0 million, and the most recent closing price of our common stock on the Nasdaq Capital Market was $0.0729 per share. If the market value of our publicly held common stock declines below $1 million, or the closing price of our common stock declines to $0.10 per share or less for 10 consecutive trading days, we would also be subject to Nasdaq delisting proceedings on that basis. Nasdaq’s staff also maintains discretionary authority under its listing rules to delist companies whose capital structure or public offerings raise public interest and investor protection concerns, including as a result of highly dilutive issuances, and it is possible that Nasdaq could assert that past offerings that we have consummated, or future offerings we may consummate, raise such concerns.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If our common stock is delisted, we may seek to have our common stock quoted on an over-the-counter marketplace, such as on the OTCQX. The OTCQX is not a stock exchange, and if our common stock trades on the OTCQX rather than a securities exchange, there may be significantly less trading volume and analyst coverage of, and significantly less investor interest in, our common stock, which may lead to lower trading prices for our common stock.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </p><p style="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Any potential delisting of our common stock from the Nasdaq Capital Market may have materially adverse consequences to our stockholders, including:</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 0.5in"> </td> <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">●</span></td> <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A reduced market price and liquidity with respect to our shares of common stock, which could make our ability to raise new investment capital more difficult;</span></td></tr> <tr style="vertical-align: top"> <td> </td> <td> </td> <td style="text-align: justify"> </td></tr> <tr style="vertical-align: top"> <td> </td> <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">●</span></td> <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">limited dissemination of the market price of our common stock;</span></td></tr> <tr style="vertical-align: top"> <td> </td> <td> </td> <td style="text-align: justify"> </td></tr> <tr style="vertical-align: top"> <td> </td> <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">●</span></td> <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">limited news coverage;</span></td></tr> <tr style="vertical-align: top"> <td> </td> <td> </td> <td style="text-align: justify"> </td></tr> <tr style="vertical-align: top"> <td> </td> <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">●</span></td> <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">limited interest by investors in our common stock;</span></td></tr> <tr style="vertical-align: top"> <td> </td> <td> </td> <td style="text-align: justify"> </td></tr> <tr style="vertical-align: top"> <td> </td> <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">●</span></td> <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">volatility of the prices of our common stock, due to low trading volume;</span></td></tr> <tr style="vertical-align: top"> <td> </td> <td> </td> <td style="text-align: justify"> </td></tr> <tr style="vertical-align: top"> <td> </td> <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">●</span></td> <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our common stock being considered a “penny stock,” which would result in broker-dealers participating in sales of our common stock being subject to the regulations set forth in Rules 15g-2 through 15g-9 promulgated under the Exchange Act;</span></td></tr> <tr style="vertical-align: top"> <td> </td> <td> </td> <td style="text-align: justify"> </td></tr> <tr style="vertical-align: top"> <td> </td> <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">●</span></td> <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">increased difficulty in selling our common stock in certain states due to “blue sky” restrictions; and</span></td></tr> <tr style="vertical-align: top"> <td> </td> <td> </td> <td style="text-align: justify"> </td></tr> <tr style="vertical-align: top"> <td> </td> <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">●</span></td> <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">limited ability to issue additional securities or to secure additional financing.</span></td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b><i>Going Concern Uncertainty</i></b></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The accompanying unaudited condensed consolidated financial statements were prepared under the assumption that the Company will continue as a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our operations to date have been funded primarily through equity financings. As of September 30, 2024, the Company had cash and cash equivalents of approximately $5.8 million, and current liabilities of approximately $1.0 million. During the nine-month period ended September 30, 2024, the Company’s net cash used in operating activities was approximately $6.1 million. The future viability of the Company is largely dependent on its ability to raise additional capital to finance its operations. The Company expects that it will need to raise additional capital within the next twelve months to continue its operations as the current cash resources will be sufficient to fund its operations through the first quarter of 2025. Although the Company has been able to raise capital in the past, there is no assurance that it will be successful in obtaining additional financing on terms acceptable to the Company, if at all. In addition, recent fundraising by the Company has resulted in significant ownership dilution to shareholders, and given the Company’s current market capitalization and financing needs, it is likely that future fundraising may also be highly dilutive. If the Company is unable to obtain funding, it may be forced to delay, reduce or eliminate its research and development program, product development or commercialization efforts, which could adversely affect its business prospects.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"> </p> <p style="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; ">Accordingly, based on the considerations discussed above, management has concluded there is substantial doubt as to the Company’s ability to continue as a going concern within one year after the date these condensed consolidated financial statements are issued. The Company plans to continue to fundraise. If adequate funds are not available, the Company may require further steps to slow cash burn, extending the cash runway until financing can be secured. These condensed consolidated financial statements do not include any adjustments with respect to the carrying amounts of assets and liabilities and their classification that might result from the outcome of this uncertainty.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"> </p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25pt"><b><i>Basis of Presentation</i></b></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25pt; text-align: justify">The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in conformity with generally accepted accounting principles in the United States (“US GAAP”) consistent with those applied in, and should be read in conjunction with, the Company’s audited consolidated financial statements and related footnotes for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K. The unaudited condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of September 30, 2024 and December 31, 2023, its results of operations and cash flows for the three- and nine-month periods ended September 30, 2024, and 2023, in accordance with US GAAP. The unaudited condensed consolidated financial statements do not include all the information and footnotes required by US GAAP for complete financial statements, as allowed by the relevant U.S. Securities and Exchange Commission (“SEC”) rules and regulations; however, the Company believes that its disclosures are adequate to ensure that the information presented is not misleading. The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25pt; text-align: justify"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25pt; text-align: justify">The results for the three- and nine-month periods ended September 30, 2024, are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2024, or any other interim period within this fiscal year.</p>
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PrivatePlacementWarrantsGrossProceedsPercentage
0.01 pure
CY2023Q4 bjdx Purchase Of Warrants
PurchaseOfWarrants
23558 shares
CY2023Q4 bjdx Aggregate Percentage Of Common Stock And Prefunded Warrants
AggregatePercentageOfCommonStockAndPrefundedWarrants
0.07 pure
CY2023Q4 bjdx Exercise Percentage
ExercisePercentage
1.25 pure
CY2023Q1 us-gaap Accrued Bonuses Current And Noncurrent
AccruedBonusesCurrentAndNoncurrent
164860 usd
CY2023Q1 us-gaap Shares Paid For Tax Withholding For Share Based Compensation
SharesPaidForTaxWithholdingForShareBasedCompensation
818 shares
CY2023Q1 us-gaap Liabilities Fair Value Disclosure
LiabilitiesFairValueDisclosure
57588 usd
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Weighted Average Grant Date Fair Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue
70.4
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRate
0.0363 pure
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
0 pure
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate
1.0878 pure
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Fair Value Assumptions Expected Term1
SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1
P6Y
CY2024Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
4792 usd
CY2023Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
-42482 usd
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
22676 usd
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
204810 usd
CY2021 bjdx Related Party Bill Rate Additional Cost Percentage
RelatedPartyBillRateAdditionalCostPercentage
0.10 pure
CY2024Q3 us-gaap Other Receivables Net Current
OtherReceivablesNetCurrent
8315 usd
CY2023Q4 us-gaap Other Receivables Net Current
OtherReceivablesNetCurrent
41269 usd
CY2024Q3 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
2834888 usd
CY2023Q4 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
2529457 usd
CY2024Q3 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
1300257 usd
CY2023Q4 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
1243716 usd
CY2024Q3 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
1534631 usd
CY2023Q4 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
1285741 usd
CY2023 us-gaap Accumulated Depreciation Depletion And Amortization Sale Of Property Plant And Equipment1
AccumulatedDepreciationDepletionAndAmortizationSaleOfPropertyPlantAndEquipment1
382795 usd
CY2024Q3 us-gaap Operating Lease Weighted Average Remaining Lease Term1
OperatingLeaseWeightedAverageRemainingLeaseTerm1
P2Y4M24D
CY2023Q3 us-gaap Operating Lease Weighted Average Remaining Lease Term1
OperatingLeaseWeightedAverageRemainingLeaseTerm1
P3Y1M6D
CY2024Q3 us-gaap Finance Lease Weighted Average Remaining Lease Term1
FinanceLeaseWeightedAverageRemainingLeaseTerm1
P3Y3M18D
CY2023Q3 us-gaap Finance Lease Weighted Average Remaining Lease Term1
FinanceLeaseWeightedAverageRemainingLeaseTerm1
P4Y3M18D
CY2024Q3 us-gaap Operating Lease Weighted Average Discount Rate Percent
OperatingLeaseWeightedAverageDiscountRatePercent
0.07 pure
CY2023Q3 us-gaap Operating Lease Weighted Average Discount Rate Percent
OperatingLeaseWeightedAverageDiscountRatePercent
0.07 pure
us-gaap Operating Lease Payments
OperatingLeasePayments
132642 usd
us-gaap Operating Lease Payments
OperatingLeasePayments
130692 usd
us-gaap Finance Lease Principal Payments
FinanceLeasePrincipalPayments
3605 usd
us-gaap Finance Lease Principal Payments
FinanceLeasePrincipalPayments
3605 usd
CY2024Q3 us-gaap Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
227495 usd
CY2023Q4 us-gaap Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
333267 usd
CY2024Q3 us-gaap Property Plant And Equipment And Finance Lease Right Of Use Asset After Accumulated Depreciation And Amortization
PropertyPlantAndEquipmentAndFinanceLeaseRightOfUseAssetAfterAccumulatedDepreciationAndAmortization
11604 usd
CY2023Q4 us-gaap Property Plant And Equipment And Finance Lease Right Of Use Asset After Accumulated Depreciation And Amortization
PropertyPlantAndEquipmentAndFinanceLeaseRightOfUseAssetAfterAccumulatedDepreciationAndAmortization
15152 usd
CY2024Q3 bjdx Lease Assets
LeaseAssets
239099 usd
CY2023Q4 bjdx Lease Assets
LeaseAssets
348419 usd
CY2024Q3 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
111453 usd
CY2023Q4 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
162990 usd
CY2024Q3 us-gaap Finance Lease Liability Current
FinanceLeaseLiabilityCurrent
4807 usd
CY2023Q4 us-gaap Finance Lease Liability Current
FinanceLeaseLiabilityCurrent
4807 usd
CY2024Q3 us-gaap Operating Lease Liability Noncurrent
OperatingLeaseLiabilityNoncurrent
130199 usd
CY2023Q4 us-gaap Operating Lease Liability Noncurrent
OperatingLeaseLiabilityNoncurrent
189987 usd
CY2024Q3 us-gaap Finance Lease Liability Noncurrent
FinanceLeaseLiabilityNoncurrent
9530 usd
CY2023Q4 us-gaap Finance Lease Liability Noncurrent
FinanceLeaseLiabilityNoncurrent
12321 usd
CY2024Q3 bjdx Lease Liabilities
LeaseLiabilities
255989 usd
CY2023Q4 bjdx Lease Liabilities
LeaseLiabilities
370105 usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Remainder Of Fiscal Year
LesseeOperatingLeaseLiabilityPaymentsRemainderOfFiscalYear
36453 usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Due Next Twelve Months
LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths
100000 usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Due Year Two
LesseeOperatingLeaseLiabilityPaymentsDueYearTwo
100000 usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Due Year Three
LesseeOperatingLeaseLiabilityPaymentsDueYearThree
25000 usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
261453 usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Undiscounted Excess Amount
LesseeOperatingLeaseLiabilityUndiscountedExcessAmount
19801 usd
CY2024Q3 us-gaap Operating Lease Liability
OperatingLeaseLiability
241652 usd
CY2024Q3 us-gaap Prepaid Insurance
PrepaidInsurance
591935 usd
CY2023Q4 us-gaap Prepaid Insurance
PrepaidInsurance
136342 usd
CY2024Q3 us-gaap Supplies
Supplies
193708 usd
CY2023Q4 us-gaap Supplies
Supplies
558959 usd
CY2024Q3 us-gaap Other Prepaid Expense Current
OtherPrepaidExpenseCurrent
26302 usd
CY2023Q4 us-gaap Other Prepaid Expense Current
OtherPrepaidExpenseCurrent
51962 usd
CY2024Q3 us-gaap Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
811945 usd
CY2023Q4 us-gaap Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
747263 usd
CY2024Q3 bjdx Accrued Personnel Costs
AccruedPersonnelCosts
143449 usd
CY2023Q4 bjdx Accrued Personnel Costs
AccruedPersonnelCosts
566087 usd
CY2023Q4 bjdx Accrued Goods Received But Unpaid
AccruedGoodsReceivedButUnpaid
78579 usd
CY2023Q4 bjdx Accrued Expenses For Cfo Separation Agreement
AccruedExpensesForCFOSeparationAgreement
160000 usd
CY2024Q3 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
83269 usd
CY2023Q4 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
157670 usd
CY2024Q3 bjdx Accrued Clinical Trial Expenses
AccruedClinicalTrialExpenses
162791 usd
CY2024Q3 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
231635 usd
CY2023Q4 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
154575 usd
CY2024Q3 us-gaap Accounts Payable And Other Accrued Liabilities Current
AccountsPayableAndOtherAccruedLiabilitiesCurrent
621144 usd
CY2023Q4 us-gaap Accounts Payable And Other Accrued Liabilities Current
AccountsPayableAndOtherAccruedLiabilitiesCurrent
1116911 usd
CY2024Q3 ecd Non Rule10b51 Arr Trmntd Flag
NonRule10b51ArrTrmntdFlag
false
CY2024Q3 ecd Rule10b51 Arr Trmntd Flag
Rule10b51ArrTrmntdFlag
false
CY2024Q3 ecd Non Rule10b51 Arr Adopted Flag
NonRule10b51ArrAdoptedFlag
false
CY2024Q3 ecd Rule10b51 Arr Adopted Flag
Rule10b51ArrAdoptedFlag
false
CY2024Q3 us-gaap Deferred Offering Costs
DeferredOfferingCosts
usd
CY2023Q4 us-gaap Notes Payable Current
NotesPayableCurrent
usd
CY2023Q3 us-gaap Investment Income Investment Expense
InvestmentIncomeInvestmentExpense
usd
us-gaap Investment Income Investment Expense
InvestmentIncomeInvestmentExpense
usd
CY2024Q1 us-gaap Stock Issued During Period Value Stock Options Exercised
StockIssuedDuringPeriodValueStockOptionsExercised
usd
CY2024Q2 us-gaap Stock Issued During Period Value Stock Options Exercised
StockIssuedDuringPeriodValueStockOptionsExercised
usd
CY2024Q3 us-gaap Stock Issued During Period Value Stock Options Exercised
StockIssuedDuringPeriodValueStockOptionsExercised
usd
CY2023Q2 us-gaap Stock Issued During Period Value New Issues
StockIssuedDuringPeriodValueNewIssues
usd
us-gaap Other Noncash Expense
OtherNoncashExpense
usd
us-gaap Paid In Kind Interest
PaidInKindInterest
usd
us-gaap Increase Decrease In Deferred Charges
IncreaseDecreaseInDeferredCharges
usd
us-gaap Increase Decrease In Other Noncurrent Liabilities
IncreaseDecreaseInOtherNoncurrentLiabilities
usd
us-gaap Proceeds From Issuance Of Common Stock
ProceedsFromIssuanceOfCommonStock
usd
us-gaap Payments Of Stock Issuance Costs
PaymentsOfStockIssuanceCosts
usd
us-gaap Proceeds From Notes Payable
ProceedsFromNotesPayable
usd
us-gaap Repayments Of Notes Payable
RepaymentsOfNotesPayable
usd
us-gaap Proceeds From Issuance Of Warrants
ProceedsFromIssuanceOfWarrants
usd
bjdx Payments To Issuance Costs Related To Issuance Or Common Stock
PaymentsToIssuanceCostsRelatedToIssuanceOrCommonStock
usd
us-gaap Proceeds From Warrant Exercises
ProceedsFromWarrantExercises
usd
us-gaap Payments Related To Tax Withholding For Share Based Compensation
PaymentsRelatedToTaxWithholdingForShareBasedCompensation
usd
us-gaap Notes Issued1
NotesIssued1
usd
us-gaap Noncash Or Part Noncash Acquisition Other Assets Acquired1
NoncashOrPartNoncashAcquisitionOtherAssetsAcquired1
usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Due Year Four
LesseeOperatingLeaseLiabilityPaymentsDueYearFour
usd
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Due After Year Five
LesseeOperatingLeaseLiabilityPaymentsDueAfterYearFive
usd
CY2024Q3 bjdx Accrued Goods Received But Unpaid
AccruedGoodsReceivedButUnpaid
usd
CY2024Q3 bjdx Accrued Expenses For Cfo Separation Agreement
AccruedExpensesForCFOSeparationAgreement
usd
CY2023Q4 bjdx Accrued Clinical Trial Expenses
AccruedClinicalTrialExpenses
usd
dei Amendment Flag
AmendmentFlag
false
dei Current Fiscal Year End Date
CurrentFiscalYearEndDate
--12-31
dei Document Fiscal Period Focus
DocumentFiscalPeriodFocus
Q3
dei Entity Central Index Key
EntityCentralIndexKey
0001704287

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