Bluejay Diagnostics Narrows Loss, Seeks $20M for Sepsis Test Development

TL;DR

**BJDX is burning cash while developing its sepsis diagnostic, making its ability to raise $20 million by 2027 a make-or-break situation for investors.**

AI Summary

Bluejay Diagnostics, Inc. (BJDX) reported a net loss of $1,597,632 for the three months ended September 30, 2025, a decrease from the $1,481,959 net loss in the prior-year quarter, and a net loss of $5,418,671 for the nine months ended September 30, 2025, an improvement from the $6,285,804 net loss in the same period of 2024. The company's cash and cash equivalents decreased to $3,082,268 as of September 30, 2025, from $4,301,945 at December 31, 2024. Research and development expenses decreased to $2,460,304 for the nine months ended September 30, 2025, from $2,917,674 in 2024, while general and administrative expenses increased to $3,030,921 from $2,759,817. BJDX is focused on developing its Symphony IL-6 test for sepsis, with plans to begin testing samples from its SYMON-II clinical trial by the end of 2026 and submit a 510(k) FDA application in 2027. The company needs to raise at least $20 million by the end of fiscal year 2027 to fund its operations and regulatory pathway.

Why It Matters

Bluejay Diagnostics' progress with its Symphony IL-6 test for sepsis could be a game-changer for critical care, potentially offering rapid, lab-quality results in ICUs and ERs. For investors, the company's ability to secure the projected $20 million in capital by 2027 is paramount, as current cash reserves are dwindling. Employees and customers are directly impacted by the success of the SYMON-II clinical trial and subsequent FDA approval, which would validate years of R&D. In a competitive diagnostics market, a successful IL-6 test could carve out a significant niche, but failure to secure funding or regulatory clearance would severely hinder its market entry and competitive standing.

Risk Assessment

Risk Level: high — Bluejay Diagnostics reported a net loss of $5,418,671 for the nine months ended September 30, 2025, and explicitly states it needs to raise at least $20 million of capital by the end of the 2027 fiscal year. Cash and cash equivalents decreased by $1,219,677 during the nine months ended September 30, 2025, indicating significant cash burn without a clear revenue stream, posing a substantial going concern risk.

Analyst Insight

Investors should exercise extreme caution and monitor BJDX's capital raising efforts closely. Given the significant funding requirement of $20 million by 2027 and current cash burn, new investments are highly speculative until concrete financing milestones are achieved and regulatory progress is more certain.

Key Numbers

• $3.08M — Cash and Cash Equivalents (Decreased from $4.30M at Dec 31, 2024, indicating significant cash burn.)
• $5.42M — Net Loss (9 months) (Improved from $6.29M in prior year, but still a substantial loss.)
• $1.60M — Net Loss (3 months) (Slightly increased from $1.48M in prior year quarter.)
• $20M — Capital Needed (Required by end of 2027 fiscal year to fund operations and FDA submission.)
• 1,814,133 — Common Stock Outstanding (Shares outstanding as of November 6, 2025.)
• $2.46M — Research and Development Expenses (9 months) (Decreased from $2.92M in prior year, reflecting R&D focus.)
• $3.03M — General and Administrative Expenses (9 months) (Increased from $2.76M in prior year, indicating rising overhead.)
• 2027 — Target FDA Submission Year (Goal for 510(k) regulatory application for Symphony IL-6 test.)
• 1,639,133 — Shares Issued and Outstanding (As of September 30, 2025, up from 554,012 at December 31, 2024.)
• $4,598,705 — Net Cash Used in Operating Activities (For the nine months ended September 30, 2025, highlighting cash burn.)

Key Players & Entities

• Bluejay Diagnostics, Inc. (company) — registrant
• Symphony (company) — technology platform
• U.S. Food and Drug Administration (regulator) — regulatory body
• Symphony IL-6 test (company) — first product candidate
• SYMON-II clinical study (company) — pivotal clinical trial
• Sanyoseiko Co. Ltd. (company) — contract manufacturing organization
• $20 million (dollar_amount) — capital needed by 2027
• $3,082,268 (dollar_amount) — cash and cash equivalents as of September 30, 2025
• $5,418,671 (dollar_amount) — net loss for nine months ended September 30, 2025
• $1,597,632 (dollar_amount) — net loss for three months ended September 30, 2025

FAQ

Filing Documents

• ea0263951-10q_bluejay.htm (10-Q) — 648KB
• ea026395101ex10-2_bluejay.htm (EX-10.2) — 133KB
• ea026395101ex10-4_bluejay.htm (EX-10.4) — 40KB
• ea026395101ex10-5_bluejay.htm (EX-10.5) — 242KB
• ea026395101ex10-6_bluejay.htm (EX-10.6) — 135KB
• ea026395101ex31-1_bluejay.htm (EX-31.1) — 11KB
• ea026395101ex31-2_bluejay.htm (EX-31.2) — 11KB
• ea026395101ex32-1_bluejay.htm (EX-32.1) — 3KB
• ea026395101ex32-2_bluejay.htm (EX-32.2) — 3KB
• ex10-2_001.jpg (GRAPHIC) — 306KB
• 0001213900-25-107599.txt ( ) — 5780KB
• bjdx-20250930.xsd (EX-101.SCH) — 51KB
• bjdx-20250930_cal.xml (EX-101.CAL) — 34KB
• bjdx-20250930_def.xml (EX-101.DEF) — 234KB
• bjdx-20250930_lab.xml (EX-101.LAB) — 444KB
• bjdx-20250930_pre.xml (EX-101.PRE) — 250KB
• ea0263951-10q_bluejay_htm.xml (XML) — 477KB

FINANCIAL INFORMATION

PART I FINANCIAL INFORMATION Item 1. Condensed Consolidated Financial Statements (Unaudited) 1 Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024 1 Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2025 and 2024 2 Condensed Consolidated Statements of Changes in Stockholders' Equity for the Three and Nine Months Ended September 30, 2025 and 2024 3 Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 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 21 Item 3.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 28 Item 4.

Controls and Procedures

Controls and Procedures 28

OTHER INFORMATION

PART II OTHER INFORMATION Item 1.

Legal Proceedings

Legal Proceedings 29 Item 1A.

Risk Factors

Risk Factors 29 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 31 Item 3. Defaults Upon Senior Securities 31 Item 4. Mine Safety Disclosures 31 Item 5. Other Information 31 Item 6. Exhibits 32

Signatures

Signatures 33 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) September 30, 2025 December 31, 2024 ASSETS Current assets: Cash and cash equivalents $ 3,082,268 $ 4,301,945 Prepaid expenses and other current assets 169,421 596,938 Deferred offering costs 101,170 - Total current assets 3,352,859 4,898,883 Property and equipment, net 1,393,989 1,513,495 Operating lease right-of-use assets 134,683 209,788 Other non-current assets 8,727 35,257 Total assets $ 4,890,258 $ 6,657,423 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 161,162 $ 145,122 Operating lease liability, current 100,002 113,260 Accrued expenses and other current liabilities 887,749 551,986 Total current liabilities 1,148,913 810,368 Operating lease liability, non-current 42,990 108,989 Other non-current liabilities 5,573 8,567 Total liabilities 1,197,476 927,924 Commitments and Contingencies (See Note 10) Stockholders' equity: Common stock, $ 0.0001 par value; 250,000,000 shares authorized; 1,639,133 and 554,012 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively 164 55 Additional paid-in capital 43,780,073 40,398,228 Accumulated deficit ( 40,087,455 ) ( 34,668,784 ) Total stockholders' equity 3,692,782 5,729,499 Total liabilities and stockholders' equity $ 4,890,258 $ 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 September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Operating expenses: Research and development $ 785,608 $ 551,655 $ 2,460,304 $ 2,917,674 General and administrative 831,339 809,199 3,030,921 2,759,817 Sales and marketing - 753 - 7,481 Total operating expenses 1,616,947 1,361,607 5,491,225 5,684,972 Operating loss ( 1,616,947 ) ( 1,361,607 ) ( 5,491,225 ) ( 5,684,972 ) Other income (expense): Interest expense ( 200 ) ( 190,610 ) ( 652 ) ( 822,299 ) Interest income 18,961 61,692 66,016 107,191 Other income, net 554 8,566 7,190 114,276 Total other income (expense), net 19,315 ( 120,352 ) 72,554 ( 600,832 ) Net loss ( 1,597,632 ) ( 1,481,959 ) ( 5,418,671 ) ( 6,285,804 ) Deemed dividend on warrant modification - 13,223,053 - 13,223,053 Net loss applicable to common stockholders $ ( 1,597,632 ) $ ( 14,705,012 ) $ ( 5,418,671 ) $ ( 19,508,857 ) Net Loss per share to common stockholders – Basic and diluted $ ( 1.01 ) $ ( 76.94 ) $ ( 4.62 ) $ ( 283.18 ) Weighted average common shares outstanding – Basic and diluted 1,574,535 191,117 1,171,888 68,893 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 Stock-based compensation expense - - 183 - 183 Exercise of April 2025 Prefunded Warrants 144,951 15 ( 15 ) - - Net loss - - - ( 1,597,632 ) ( 1,597,632 ) Balance at September 30, 2025 1,639,133 $ 164 $ 43,780,073 $ ( 40,087,455 ) $ 3,692,782 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 ( 2

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) Nine Months Ended September 30, 2025 2024 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ ( 5,418,671 ) $ ( 6,285,804 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation expense 46,767 55,843 Stock-based compensation expense ( 68 ) 22,676 Amortization of right-of-use asset 75,105 105,772 Non-cash interest expense for notes payable - 307,563 Write-off and impairment of property and equipment 37,069 925 Changes in operating assets and liabilities: Deferred offering costs ( 101,170 ) 265,081 Prepaid expenses and other current assets 463,187 ( 64,682 ) Other non-current assets 26,530 5,065 Accounts payable 16,040 ( 174,824 ) Accrued expenses and other current liabilities 256,506 ( 607,092 ) Net cash used in operating activities ( 4,598,705 ) ( 6,369,477 ) CASH FLOWS FROM INVESTING ACTIVITIES: Purchase of property and equipment - ( 305,658 ) Net cash used in investing activities - ( 305,658 ) 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 - ( 2,000,000 ) Proceeds from exercise of Class D warrants - 526 Payment of finance lease ( 2,994 ) ( 2,791 ) Net cash provided by financing activities 3,379,028 10,222,360 Increase in cash and cash equivalents ( 1,219,677 ) 3,547,225 Cash and cash equivalents, beginning of period 4,301,945 2,208,516 Cash and cash equivalents, end of period $ 3,082,268 $ 5,755,741 SUPPLEMENTAL DISCLOSURES OF CA

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, near-patient tests using whole blood on its Symphony technology platform ("Symphony"), which consists of an analyzer and single-use protein detection cartridges. 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") before Symphony can be marketed as a diagnostic product in the United States. The Company has completed the pre-clinical development of the Symphony analyzer. The Company is redeveloping the manufacturing processes for cartridges through a third-party contractor who is managing such redevelopment. Such redevelopment is intended to address manufacturing 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 $ 20 million of capital between the date of this filing 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 clearance 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 significant mar

financial statements have been adjusted, on a retroactive basis, to reflect these reverse stock splits

financial statements have been adjusted, on a retroactive basis, to reflect these reverse stock splits. At the Company's annual meeting of stockholders on June 18, 2025, the Company's stockholders provided the Company's board of directors with authority to implement a reverse stock split at a ratio of up to 1-for-20, as well as an additional reverse stock split at a ratio of up to 1-for-20, and the Company's board of directors is currently evaluating whether and when to implement any such reverse stock split. On October 23, 2024, the stockholders of the Company approved and adopted an amendment to the Company's amended and restated certificate of incorporation, to increase the number of authorized shares of the Company's Common Stock to 250,000,000 . Basis of Presentation 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") for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Pursuant to these rules and regulations, certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. In the opinion of management, all adjustments (consisting of normal recurring items) considered necessary for a fair statement have been included. These condensed consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements and related notes (the "2024 Audited Financial Statements") contained in the Company's Annual Repor