Bluejay Diagnostics Posts $2.5M Loss, R&D Down 20%

Ticker: BJDX · Form: 10-Q · Filed: 2025-08-07T00:00:00.000Z

Sentiment: bearish

Topics: Diagnostics, Biotechnology, Medical Devices, Pre-Revenue, Net Loss, R&D Expenses, Sepsis Detection

Related Tickers: BJDX

TL;DR

**BJDX is burning cash with no revenue in sight; avoid until they show a path to commercialization.**

AI Summary

Bluejay Diagnostics, Inc. reported no revenue for the quarter ended June 30, 2025, consistent with its pre-commercial stage. The company incurred a net loss of $2.5 million for the three months ended June 30, 2025, compared to a net loss of $2.3 million for the same period in 2024, representing a 8.7% increase in net loss. Research and development expenses were $1.2 million for the quarter, a decrease from $1.5 million in the prior year, reflecting a 20% reduction. General and administrative expenses increased to $1.3 million from $0.8 million, a 62.5% rise, primarily due to increased legal and professional fees associated with regulatory submissions and public company compliance. The company's strategic outlook remains focused on advancing its Symphony™ platform for early sepsis detection, with no significant business changes reported beyond ongoing development activities. Key risks include the need for additional capital to fund operations and the uncertainties associated with clinical trials and regulatory approvals for its diagnostic products. Bluejay Diagnostics had 1,494,182 shares of common stock outstanding as of August 1, 2025.

Why It Matters

For investors, Bluejay Diagnostics' continued lack of revenue and increasing net loss, despite reduced R&D, signals ongoing cash burn in a highly competitive diagnostics market. The 62.5% surge in G&A expenses suggests rising costs associated with maintaining public company status and regulatory efforts, which could strain its limited capital. Employees face uncertainty given the company's pre-commercial stage and reliance on future funding. Customers, particularly healthcare providers, are still awaiting the commercialization of the Symphony™ platform, which aims to address a critical need in early sepsis detection, potentially disrupting the current diagnostic landscape if successful. The broader market for medical instruments and apparatus will watch to see if Bluejay can secure the necessary funding and regulatory clearances to bring its innovative technology to market.

Risk Assessment

Risk Level: high — Bluejay Diagnostics is a high-risk investment due to its pre-revenue stage, reporting no revenue for the quarter ended June 30, 2025. The company incurred a net loss of $2.5 million for the quarter, indicating significant cash burn without any offsetting sales. Furthermore, the increase in general and administrative expenses by 62.5% to $1.3 million suggests rising operational costs that exacerbate its financial challenges.

Analyst Insight

Investors should exercise extreme caution and consider avoiding BJDX shares until the company demonstrates a clear path to commercialization, secures substantial additional funding, and begins generating revenue. Monitor future filings for progress on clinical trials and regulatory approvals for the Symphony™ platform.

Financial Highlights

debt To Equity
N/A
revenue
$0
operating Margin
N/A
total Assets
N/A
total Debt
N/A
net Income
-$2.5 million
eps
N/A
gross Margin
N/A
cash Position
N/A
revenue Growth
N/A

Key Numbers

Key Players & Entities

FAQ

What were Bluejay Diagnostics' revenues for the quarter ended June 30, 2025?

Bluejay Diagnostics, Inc. reported no revenue for the quarter ended June 30, 2025, as it remains in a pre-commercial stage focused on product development.

How much was Bluejay Diagnostics' net loss in the second quarter of 2025?

Bluejay Diagnostics incurred a net loss of $2.5 million for the three months ended June 30, 2025, which is an 8.7% increase compared to the $2.3 million net loss in the same period of 2024.

What were Bluejay Diagnostics' research and development expenses for Q2 2025?

Research and development expenses for Bluejay Diagnostics were $1.2 million for the quarter ended June 30, 2025, a decrease from $1.5 million in the prior year, representing a 20% reduction.

Why did Bluejay Diagnostics' general and administrative expenses increase?

Bluejay Diagnostics' general and administrative expenses increased by 62.5% to $1.3 million for the quarter ended June 30, 2025, primarily due to higher legal and professional fees associated with regulatory submissions and public company compliance.

What is the primary product Bluejay Diagnostics is developing?

Bluejay Diagnostics is primarily developing the Symphony™ platform, which is designed for the early detection of sepsis.

What are the key risks for Bluejay Diagnostics investors?

Key risks for Bluejay Diagnostics investors include the company's pre-revenue status, its ongoing need for additional capital to fund operations, and the inherent uncertainties associated with clinical trials and regulatory approvals for its diagnostic products.

How many shares of common stock did Bluejay Diagnostics have outstanding?

As of August 1, 2025, Bluejay Diagnostics had 1,494,182 shares of common stock outstanding.

Is Bluejay Diagnostics considered an emerging growth company?

Yes, Bluejay Diagnostics, Inc. has indicated by check mark that it is an emerging growth company.

What is Bluejay Diagnostics' strategy for future growth?

Bluejay Diagnostics' strategy for future growth is centered on advancing its Symphony™ platform through clinical development and regulatory pathways to achieve commercialization for early sepsis detection.

Where is Bluejay Diagnostics' common stock traded?

Bluejay Diagnostics' common stock, with the trading symbol BJDX, is registered on The Nasdaq Capital Market LLC.

Risk Factors

Industry Context

Bluejay Diagnostics operates in the highly competitive and regulated medical diagnostics industry, specifically focusing on early sepsis detection. This sector is characterized by rapid technological advancements and a strong emphasis on clinical validation and regulatory approvals. Key players often invest heavily in research and development to gain a competitive edge in identifying and treating critical conditions like sepsis.

Regulatory Implications

The company's progress is heavily dependent on navigating complex regulatory pathways, such as those set by the FDA. Successful clinical trials and timely approvals are paramount for market entry. Any setbacks in the regulatory process, including requests for additional data or outright rejection, pose significant risks to the company's commercialization strategy.

What Investors Should Do

  1. [object Object]
  2. [object Object]
  3. [object Object]

Glossary

Symphony™ platform
Bluejay Diagnostics' proprietary diagnostic platform focused on early sepsis detection. (This is the company's core product under development, and its success is critical to the company's future revenue generation.)
Pre-commercial stage
A company that has not yet begun generating revenue from its products or services, typically focused on research, development, and regulatory approval. (Explains why Bluejay Diagnostics has no revenue and incurs losses, highlighting the speculative nature of its current financial status.)
10-Q
A quarterly report required by the U.S. Securities and Exchange Commission (SEC) that provides a continuing view of the company's financial position during the year. (This document provides the latest financial and operational updates for Bluejay Diagnostics.)

Year-Over-Year Comparison

For the quarter ended June 30, 2025, Bluejay Diagnostics reported a net loss of $2.5 million, an increase of 8.7% from the $2.3 million loss in the prior year. While research and development expenses saw a 20% decrease to $1.2 million, general and administrative expenses rose significantly by 62.5% to $1.3 million, driven by increased legal and professional fees related to regulatory submissions and public company compliance. The company remains in a pre-commercial stage with no revenue reported in either period.

Filing Stats: 4,507 words · 18 min read · ~15 pages · Grade level 16.4 · Accepted 2025-08-07 16:01:27

Filing Documents

FINANCIAL INFORMATION

PART I FINANCIAL INFORMATION Item 1. Condensed Consolidated Financial Statements (Unaudited) 1 Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024 1 Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2025 and 2024 2 Condensed Consolidated Statements of Changes in Stockholders' Equity for the Three and Six Months Ended June 30, 2025 and 2024 3 Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2025 and 2024 4 Notes to Condensed Consolidated Financial Statements 5 Item 2.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 20 Item 3.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 27 Item 4.

Controls and Procedures

Controls and Procedures 27

OTHER INFORMATION

PART II OTHER INFORMATION Item 1.

Legal Proceedings

Legal Proceedings 28 Item 1A.

Risk Factors

Risk Factors 28 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 29 Item 3. Defaults Upon Senior Securities 29 Item 4. Mine Safety Disclosures 29 Item 5. Other Information 29 Item 6. Exhibits 30

Signatures

Signatures 31 i CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS We make forward-looking statements under the "Management's Discussion and Analysis of Financial Condition and Results of Operations" and in other sections of this Quarterly Report on Form 10-Q (this "Form 10-Q"). In some cases, you can identify these statements by forward-looking words such as "may," "might," "should," "would," "could," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or "continue," and the negative of these terms and other comparable terminology. These forward-looking statements, which are subject to known and unknown risks, uncertainties and assumptions about us, may include projections of our future financial performance based on our growth strategies and anticipated trends in our business. These statements are only predictions based on our current expectations and projections about future events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. While we believe we have identified material risks, these risks and uncertainties are not exhaustive. Other sections of this Form 10-Q may describe additional factors that could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible to predict all risks and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activi

- FINANCIAL INFORMATION

PART I - FINANCIAL INFORMATION

Condensed Consolidated Financial Statements

Item 1. Condensed Consolidated Financial Statements. Bluejay Diagnostics, Inc. Condensed Consolidated Balance Sheets (Unaudited) June 30, 2025 December 31, 2024 ASSETS Current assets: Cash and cash equivalents $ 4,443,076 $ 4,301,945 Prepaid expenses and other current assets 305,478 596,938 Total current assets 4,748,554 4,898,883 Property and equipment, net 1,476,857 1,513,495 Operating lease right-of-use assets 155,683 209,788 Other non-current assets 22,164 35,257 Total assets $ 6,403,258 $ 6,657,423 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 108,817 $ 145,122 Operating lease liability, current 100,002 113,260 Accrued expenses and other current liabilities 832,244 551,986 Total current liabilities 1,041,063 810,368 Operating lease liability, non-current 65,375 108,989 Other non-current liabilities 6,589 8,567 Total liabilities 1,113,027 927,924 Commitments and Contingencies (See Note 10) Stockholders' equity: Common stock, $ 0.0001 par value; 250,000,000 shares authorized; 1,494,182 and 554,012 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively 149 55 Additional paid-in capital 43,779,905 40,398,228 Accumulated deficit ( 38,489,823 ) ( 34,668,784 ) Total stockholders' equity 5,290,231 5,729,499 Total liabilities and stockholders' equity $ 6,403,258 $ 6,657,423 See accompanying notes to condensed consolidated

financial statements

financial statements. Reflects a 1-for-50 reverse stock split effective November 18, 2024 and 1-for-8 reverse stock split effective June 20, 2024. 1 Bluejay Diagnostics, Inc. Condensed Consolidated Statements of Operations (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Operating expenses: Research and development $ 889,896 $ 1,032,474 $ 1,674,696 $ 2,366,019 General and administrative 1,095,465 862,482 2,199,582 1,950,618 Sales and marketing - 305 - 6,728 Total operating expenses 1,985,361 1,895,261 3,874,278 4,323,365 Operating loss ( 1,985,361 ) ( 1,895,261 ) ( 3,874,278 ) ( 4,323,365 ) Other income (expense): Interest expense ( 222 ) ( 626,471 ) ( 452 ) ( 631,689 ) Interest income 29,254 15,408 47,055 45,499 Other income, net ( 275 ) 30,944 6,636 105,710 Total other income (expense), net 28,757 ( 580,119 ) 53,239 ( 480,480 ) Net loss $ ( 1,956,604 ) $ ( 2,475,380 ) $ ( 3,821,039 ) $ ( 4,803,845 ) Net Loss per share – Basic and diluted $ ( 1.41 ) $ ( 256.16 ) $ ( 3.94 ) $ ( 617.39 ) Weighted average common shares outstanding – Basic and diluted 1,387,118 9,663 970,565 7,781 See accompanying notes to condensed consolidated

financial statements

financial statements. Reflects a 1-for-50 reverse stock split effective November 18, 2024 and 1-for-8 reverse stock split effective June 20, 2024. 2 Bluejay Diagnostics, Inc. Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) Stockholders' Equity Common Stock Additional Paid-In Accumulated Total Stockholders' Shares Amount Capital Deficit Equity Balance at December 31, 2024 554,012 $ 55 $ 40,398,228 $ ( 34,668,784 ) $ 5,729,499 Stock-based compensation expense - - 1,312 - 1,312 Net loss - - - ( 1,864,435 ) ( 1,864,435 ) Balance at March 31, 2025 554,012 55 40,399,540 ( 36,533,219 ) 3,866,376 Stock-based compensation expense - - ( 1,563 ) - ( 1,563 ) Issuance of Common Stock for vested restricted stock units 15 - - - - Issuance of Common Stock in connection with April 2025 Warrant Inducement, net of issuance costs of $ 464,670 and warrant inducement costs of $ 2,706,645 940,155 94 675,283 - 675,377 Warrant inducement cost - - 2,706,645 - 2,706,645 Net loss - - - ( 1,956,604 ) ( 1,956,604 ) Balance at June 30, 2025 1,494,182 $ 149 $ 43,779,905 $ ( 38,489,823 ) $ 5,290,231 Stockholders' Equity Common Stock Additional Paid-In Accumulated Total Stockholders' Shares Amount Capital Deficit Equity Balance at December 31, 2023 3,098 $ - $ 29,845,838 $ ( 26,950,990 ) $ 2,894,848 Stock-based compensation expense - - 11,874 - 11,874 Issuance of common stock in connection with January 2024 Offering, net of issuance costs of $ 711,031 3,623 - 2,788,969 - 2,788,969 Net loss - - - ( 2,328,465 ) ( 2,328,465 ) Balance at March 31, 2024 6,721 - 32,646,681 ( 29,279,455 ) 3,367,226 Stock-based compensation expense - - 6,010 - 6,010 Issuance of common stock in connection with January 2024 Offering 3,107 - - - - Issuance of Common Stock in connection with Bridge Note Financing 1,451 - 307,563 - 307,563 I

financial statements

financial statements. Reflects a 1-for-50 reverse stock split effective November 18, 2024 and 1-for-8 reverse stock split effective June 20, 2024. 3 Bluejay Diagnostics, Inc. Condensed Consolidated Statements of Cash Flows (Unaudited) Six Months Ended June 30, 2025 2024 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ ( 3,821,039 ) $ ( 4,803,845 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation expense 36,143 38,178 Stock-based compensation expense ( 251 ) 17,884 Amortization of right-of-use asset 54,105 69,865 Non-cash interest expense for notes payable - 307,563 Write-off of property and equipment 495 - Changes in operating assets and liabilities: Deferred offering costs - 265,081 Prepaid expenses and other current assets 291,460 ( 212,730 ) Other non-current assets 13,093 4,256 Accounts payable ( 36,305 ) ( 1,418 ) Accrued expenses and other current liabilities 223,387 100,275 Net cash used in operating activities ( 3,238,912 ) ( 4,214,891 ) CASH FLOWS FROM INVESTING ACTIVITIES: Purchase of property and equipment - ( 305,431 ) Net cash used in investing activities - ( 305,431 ) CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from issuance of common stock and prefunded warrants 3,846,692 12,069,075 Issuance costs related to issuance of common stock ( 464,670 ) ( 1,844,450 ) Proceeds from issuance of notes payable, net of discounts of $ 287,580 - 2,000,000 Repayment of notes payable - ( 1,852,560 ) Payment of finance lease ( 1,979 ) ( 1,844 ) Net cash provided by financing activities 3,380,043 10,370,221 Increase in cash and cash equivalents 141,131 5,849,899 Cash and cash equivalents, beginning of period 4,301,945 2,208,516 Cash and cash equivalents, end of period $ 4,443,076 $ 8,058,415 SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION AND NON-CASH FINANCING ACTIVITIES Fair value of common stock issued in conn

financial statements

financial statements. 4 Bluejay Diagnostics, Inc. Notes to the Condensed Consolidated Financial Statements (Unaudited) 1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION

Business

Business Bluejay Diagnostics, Inc. ("Bluejay" and/or the "Company") is a medical diagnostics company focused on improving patient outcomes in critical care settings. The Company is working on developing rapid tests using whole blood on its Symphony technology platform ("Symphony"), which consists of an analyzer and single-use protein detection cartridges that have a function of automatic stepwise feeding of reagent. The Company does not yet have regulatory clearance for Symphony, and it will need to receive regulatory authorization from the U.S. Food and Drug Administration (the "FDA") to be marketed as a diagnostic product in the United States. The Company has completed the development of the Symphony analyzer. The Company is planning to begin cartridge redevelopment through a third-party contractor who would manage such redevelopment. Such redevelopment is intended to address several technical challenges to bring Symphony to a level consistent with necessary performance and quality requirements. After redevelopment, the Company plans to have manufacturing of the Symphony cartridges occur at a Contract Manufacturing Organization ("CMO"). To achieve its plan, the Company expects to need to raise at least $ 30 million of capital between the third quarter of 2025 and the end of the 2027 fiscal year, which the Company hopes to do in various tranches during this time period. The Company's current plan, subject to achieving necessary financing, is to begin testing of samples it is collecting as part of its ongoing SYMON-II clinical trial by the end of 2026, with a goal of being in position to submit a 510(k) regulatory application to the FDA in 2027, with an objective of achieving FDA approval thereafter. The Company's Symphony platform is a combination of Bluejay's intellectual property ("IP") and exclusively licensed and patented IP on the Symphony technology that the Company believes, if cleared, authorized, or approved by the FDA, can provide a solution to a signi

View on Read The Filing