Overview
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- TickerBJDX on Nasdaq1
- IndustrySurgical & Medical Instruments & Apparatus1
- HeadquartersActon, Massachusetts1
- Incorporated inDE2
- Business address360 Massachusetts Avenue, Suite 203, Acton, Ma 017202
- Filer category, Emerging growth company2
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(“ICUs”) and Emergency Rooms (“ERs”), where rapid and reliable results are required.3 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2022
Where the money goes
Where each dollar of revenue went, fiscal 2022
- Cost of revenue4¢$200.1K
- Research and development86¢$4.2M
- Selling, general and admin9¢$451.4K
Out of $249.0K in revenue.4 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.10
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development | $3.0M | $3.5M |
| General and administrative | $3.9M | $3.7M |
| Sales and marketing | $8.3K | |
| Total operating expenses | $7.0M | $7.2M |
| Operating loss | -$7.0M | -$7.2M |
| Interest expense | -$839 | -$823.0K |
| Interest income | $97.6K | $145.8K |
| Other income, net | $7.8K | $129.0K |
| Total other income (expense), net | $104.5K | -$548.2K |
| Net loss | -$6.8M | -$7.7M |
| Deemed dividend on warrant modification | $13.2M | |
| Net loss applicable to common stockholders | -$6.8M | -$20.9M |
| Net Loss per share to common stockholders Basic (in Dollars per share) | -$15.25 | -$456.75 |
| Net Loss per share to common stockholders Diluted (in Dollars per share) | -$15.25 | -$456.75 |
| Weighted average common shares outstanding Basic (in Shares) | 449.0K shares | 45.8K shares |
| Weighted average common shares outstanding Diluted (in Shares) | 449.0K shares | 45.8K shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.10
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $5.2M | $4.3M | |
| Prepaid expenses and other current assets | $276.0K | $596.9K | |
| Assets held for sale | $22.8K | ||
| Total current assets | $5.5M | $4.9M | |
| Property and equipment, net | $1.5M | $1.5M | |
| Operating lease right-of-use assets | $113.3K | $209.8K | |
| Other non-current assets | $7.9K | $35.3K | |
| Total assets | $7.1M | $6.7M | |
| Accounts payable | $214.3K | $145.1K | |
| Operating lease liability, current | $100.0K | $113.3K | |
| Accrued expenses | $804.9K | $552.0K | |
| Total current liabilities | $1.1M | $810.4K | |
| Operating lease liability, non-current | $20.2K | $109.0K | |
| Other non-current liabilities | $4.5K | $8.6K | |
| Total liabilities | $1.1M | $927.9K | |
| Common stock, $0.0001 par value; 250,000,000 shares authorized; 604,534 and 138,503 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | $60 | $14 | |
| Additional paid-in capital | $47.5M | $40.4M | |
| Accumulated deficit | -$41.5M | -$34.7M | |
| Total stockholders equity | $6.0M | $5.7M | $2.9M |
| Total liabilities and stockholders equity | $7.1M | $6.7M | |
| Common stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized (in Shares) | 250.0M shares | 250.0M shares | |
| Common stock shares issued (in Shares) | 604.5K shares | 138.5K shares | |
| Common stock outstanding (in Shares) | 604.5K shares | 138.5K shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $5.2M | $4.3M | |
| Prepaid expenses and other current assets | $276.0K | $596.9K | |
| Assets held for sale | $22.8K | ||
| Total current assets | $5.5M | $4.9M | |
| Property and equipment, net | $1.5M | $1.5M | |
| Operating lease right-of-use assets | $113.3K | $209.8K | |
| Other non-current assets | $7.9K | $35.3K | |
| Total assets | $7.1M | $6.7M | |
| Accounts payable | $214.3K | $145.1K | |
| Operating lease liability, current | $100.0K | $113.3K | |
| Accrued expenses | $804.9K | $552.0K | |
| Total current liabilities | $1.1M | $810.4K | |
| Operating lease liability, non-current | $20.2K | $109.0K | |
| Other non-current liabilities | $4.5K | $8.6K | |
| Total liabilities | $1.1M | $927.9K | |
| Common stock, $0.0001 par value; 250,000,000 shares authorized; 604,534 and 138,503 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | $60 | $14 | |
| Additional paid-in capital | $47.5M | $40.4M | |
| Accumulated deficit | -$41.5M | -$34.7M | |
| Total stockholders equity | $6.0M | $5.7M | $2.9M |
| Total liabilities and stockholders equity | $7.1M | $6.7M | |
| Common stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized (in Shares) | 250.0M shares | 250.0M shares | |
| Common stock shares issued (in Shares) | 604.5K shares | 138.5K shares | |
| Common stock outstanding (in Shares) | 604.5K shares | 138.5K shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.10
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$6.8M | -$7.7M |
| Depreciation expense | $74.2K | $75.6K |
| Stock-based compensation expense | $6 | $20.1K |
| Amortization of right-of-use asset | $96.5K | $123.5K |
| Non-cash interest expense for note payable | $307.6K | |
| Write-off and impairment of property and equipment | $42.9K | $3.4K |
| Prepaid expenses and other current assets | $333.9K | $150.3K |
| Deferred offering costs | $265.1K | |
| Other non-current assets | $27.4K | -$6.6K |
| Accounts payable | $69.1K | -$346.4K |
| Accrued expenses and other current and non-current liabilities | $150.9K | -$695.7K |
| Net cash used in operating activities | -$6.1M | -$7.8M |
| Purchase of property and equipment | -$173.7K | -$306.8K |
| Net cash used in investing activities | -$173.7K | -$306.8K |
| Proceeds from issuance of common stock, gross | $8.3M | $12.1M |
| Payment for issuance costs of common stock | -$1.3M | -$1.8M |
| Proceeds from issuance of notes payable | $2.0M | |
| Repayment of notes payable | -$2.0M | |
| Proceeds from exercise of Class D warrants | $558 | |
| Fractional shares adjustment for reverse stock split | -$395 | |
| Payment of finance lease | -$4.0K | -$3.8K |
| Net cash provided by financing activities | $7.1M | $10.2M |
| Net increase in cash and cash equivalents | $862.9K | $2.1M |
| Fair value of common stock issued in connection with notes payable | $307.6K |
No quarter-by-quarter statement was filed.
Corporate structure
Bluejay Diagnostics, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Bluejay Diagnostics, Inc.
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G on Bluejay Diagnostics, Inc., latest Aug 14, 2026 (6 filings since Feb 14, 2024)
- Ayrton Capital LLC Filed SCHEDULE 13G on Bluejay Diagnostics, Inc., latest Aug 13, 2026
- INTRACOASTAL CAPITAL, LLC Filed SCHEDULE 13G on Bluejay Diagnostics, Inc., latest Jun 5, 2026 (3 filings since Oct 16, 2025)
- Lichti Braeden Filed SCHEDULE 13D/A on Bluejay Diagnostics, Inc., latest Jun 2, 2026 (3 filings since Feb 5, 2026)
- NORTHSTRIVE FUND II LP Filed SCHEDULE 13D/A on Bluejay Diagnostics, Inc., latest Jun 2, 2026 (4 filings since Feb 5, 2026)
- Anson Funds Management LP Filed SCHEDULE 13G/A on Bluejay Diagnostics, Inc., latest Feb 14, 2025 (2 filings since Nov 14, 2024)
- L1 Capital Global Opportunities Master Fund, Ltd. Filed SCHEDULE 13G/A on Bluejay Diagnostics, Inc., latest Feb 14, 2025 (2 filings since Jul 3, 2024)
- SABBY MANAGEMENT, LLC Filed SCHEDULE 13G/A on Bluejay Diagnostics, Inc., latest Jan 3, 2025 (4 filings since Nov 17, 2021)
- Douglas Clark Wurth Filed SC 13D on Bluejay Diagnostics, Inc., latest Dec 22, 2021
- Indranil Dey Filed SC 13D on Bluejay Diagnostics, Inc., latest Dec 22, 2021
- Bluejay Diagnostics, Inc. Acton, Massachusetts
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Bluejay Diagnostics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $1.7M10 Dec 31, 2025 | $1.7M10 Dec 31, 2024 | −1.7% |
| Accumulated depreciation | $144.6K10 Dec 31, 2025 | $195.0K10 Dec 31, 2024 | −25.8% |
| Property and equipment, net | $1.5M10 Dec 31, 2025 | $1.5M10 Dec 31, 2024 | +1.4% |
| Operating-lease assets (leased space) | $113.3K10 Dec 31, 2025 | $209.8K10 Dec 31, 2024 | −46.0% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $5.2M10 Dec 31, 2025 | $4.3M10 Dec 31, 2024 | +20.1% |
Properties, in its own words
We have leased two facilities in Acton, Massachusetts, one which is month-to-month beginning March 2025 and the other will expire in March 2027.
Our President and Chief Executive Officer and his spouse, who is also a director of our Company, serve as officers and/or directors of Laminar Pharma, Inc., a business that is unaffiliated with us, and we permit this entity to use our main facility as its registered business address.
Item 2 of the 10-K filed Mar 6, 2026.3
Leadership
Who has led Bluejay Diagnostics, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
- Chief executive officerIndranil Dey Feb 28, 2022 to now11
- PresidentIndranil Dey Feb 28, 2022 to now11
- Chief financial officerFrances P. Scally Oct 11, 2023 to Oct 11, 202312
- Chief financial officerGordon Winston Kinder Nov 9, 2021 to Mar 21, 202213
Board members and other officers (8)
- Chief Technology OfficerJason Cook Mar 16, 2023 to Mar 16, 202314
- Chief Technology OfficerIndranil Dey Nov 9, 2021 to Nov 9, 202115
- Board memberDonald R. Chase Nov 9, 2021 to now16
- Board memberDouglas Clark Wurth Nov 9, 2021 to now17
- Board memberFred S. Zeidman Nov 9, 2021 to now18
- Board memberIndranil Dey Nov 9, 2021 to now15
- Board memberSvetlana Dey Nov 9, 2021 to now19
- Board memberGary G. Gemignani Nov 24, 2021 to Feb 16, 202320
Timeline
- Oct 13, 20268-K Regulation FD disclosure21
- Oct 6, 20268-K Regulation FD disclosure22
- Sep 8, 20268-K Entered a material agreement; Regulation FD disclosure23
- Aug 13, 20268-K Regulation FD disclosure24
- Jul 22, 20268-K Regulation FD disclosure25
- Jun 9, 20268-K Executive or director change; Shareholder vote26
- Jun 8, 20268-K Entered a material agreement; Unregistered sale of shares; Other events27
- Jun 2, 20268-K Entered a material agreement; Regulation FD disclosure28
- May 7, 20268-K Results of operations29
- Apr 7, 20268-K Regulation FD disclosure30
- Mar 17, 20268-K Entered a material agreement; Unregistered sale of shares31
- Mar 16, 20268-K Regulation FD disclosure32
- Feb 28, 2022New chief executive Indranil Dey becomes CEO11
Calendar
Coming up
- Nov 6, 2026Reports results for the quarter ending Sep/202633
When it reported results
- May 7, 2026Reported quarterly or annual results29
- Mar 6, 2026Reported quarterly or annual results34
- Nov 9, 2023Reported quarterly or annual results35
- Aug 16, 2023Reported quarterly or annual results36
- May 10, 2023Reported quarterly or annual results37
- Mar 20, 2023Reported quarterly or annual results38
- Nov 8, 2022Reported quarterly or annual results39
- Jul 26, 2022Reported quarterly or annual results40
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
238 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 67 major events, 59 insider forms, 27 large holders, 63 other. The latest 20:
- Oct 13, 20268-K CURRENT REPORT EDGAR
- Oct 6, 20268-K CURRENT REPORT EDGAR
- Sep 8, 20268-K CURRENT REPORT EDGAR
- Aug 18, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
- Aug 18, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
- Aug 18, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
- Aug 18, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
- Aug 18, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
- Aug 14, 2026SCHEDULE 13G EDGAR
- Aug 13, 2026SCHEDULE 13G EDGAR
- Aug 13, 20268-K CURRENT REPORT EDGAR
- Aug 12, 2026S-8 REGISTRATION STATEMENT EDGAR
- Aug 12, 202610-Q QUARTERLY REPORT EDGAR
- Jul 22, 20268-K CURRENT REPORT EDGAR
- Jul 22, 20264 PRIMARY DOCUMENT EDGAR
- Jul 22, 20263 PRIMARY DOCUMENT EDGAR
- Jul 13, 20264 PRIMARY DOCUMENT EDGAR
- Jul 13, 20263 PRIMARY DOCUMENT EDGAR
- Jul 10, 20264 PRIMARY DOCUMENT EDGAR
- Jul 10, 20263 PRIMARY DOCUMENT EDGAR
The 238 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
21 open-market trades by officers, directors and large owners since October 2021: 20 buys and 1 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Jul 10, 2026 | HRT FINANCIAL LP10% owner | Sale | 34,938 | $1.40 | $48.9K | Form 4 |
| Jul 9, 2026 | HRT FINANCIAL LP10% owner | Buy | 64,047 | $1.51 | $96.7K | Form 4 |
| Mar 14, 2026 | Wurth Douglas ClarkDirector | Buy | 12,500 | $2.00 | $25.0K | Form 4 |
| Mar 14, 2026 | Dey IndranilPresident and CEO | Buy | 12,500 | $2.00 | $25.0K | Form 4 |
| Mar 14, 2026 | CHASE DONALD RDirector | Buy | 12,500 | $2.00 | $25.0K | Form 4 |
| Mar 14, 2026 | ZEIDMAN FRED SDirector | Buy | 12,500 | $2.00 | $25.0K | Form 4 |
| Mar 14, 2026 | Dey SvetlanaDirector | Buy | 12,500 | $2.00 | $25.0K | Form 4 |
| Dec 13, 2023 | Dey SvetlanaDirector | Buy | 500 | $3.07 | $1.5K | Form 4 |
| Dec 13, 2023 | Dey IndranilPresident and CEO | Buy | 500 | $3.27 | $1.6K | Form 4 |
| Mar 28, 2023 | Dey IndranilPresident and CEO | Buy | 2,000 | $0.44 | $880 | Form 4 |
| Mar 27, 2023 | Dey IndranilPresident and CEO | Buy | 8,000 | $0.44 | $3.5K | Form 4 |
| Mar 24, 2023 | Dey SvetlanaDirector | Buy | 10,000 | $0.44 | $4.4K | Form 4 |
| Aug 26, 2022 | Fisher Kenneth RChief Financial Officer | Buy | 20,000 | $1.03 | $20.6K | Form 4 |
| Apr 25, 2022 | Fisher Kenneth RChief Financial Officer | Buy | 20,000 | $0.99 | $19.8K | Form 4 |
| Mar 17, 2022 | Kinder Gordon WinstonChief Financial Officer | Buy | 2,500 | $1.16 | $2.9K | Form 4 |
| Mar 17, 2022 | Dey SvetlanaDirector | Buy | 10,000 | $1.18 | $11.8K | Form 4 |
| Mar 17, 2022 | Wurth Douglas ClarkDirector | Buy | 40,000 | $1.18 | $47.2K | Form 4 |
| Mar 16, 2022 | Wurth Douglas ClarkDirector | Buy | 60,000 | $1.09 | $65.4K | Form 4 |
| Mar 16, 2022 | Kinder Gordon WinstonChief Financial Officer | Buy | 5,000 | $1.02 | $5.1K | Form 4 |
| Mar 15, 2022 | Kinder Gordon WinstonChief Financial Officer | Buy | 500 | $0.91 | $455 | Form 4 |
All 21 trades can be filtered by person here when JavaScript is on.
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- ARMISTICE CAPITAL, LLCSCHEDULE 13G, 6 filings Feb 14, 2024 to Aug 14, 202641
- Ayrton Capital LLCSCHEDULE 13G, 1 filing Aug 13, 202642
- INTRACOASTAL CAPITAL, LLCSCHEDULE 13G, 3 filings Oct 16, 2025 to Jun 5, 202643
- Lichti BraedenSCHEDULE 13D/A, 3 filings Feb 5, 2026 to Jun 2, 202644
- NORTHSTRIVE FUND II LPSCHEDULE 13D/A, 4 filings Feb 5, 2026 to Jun 2, 202645
- Anson Funds Management LPSCHEDULE 13G/A, 2 filings Nov 14, 2024 to Feb 14, 202546
- L1 Capital Global Opportunities Master Fund, Ltd.SCHEDULE 13G/A, 2 filings Jul 3, 2024 to Feb 14, 202547
- SABBY MANAGEMENT, LLCSCHEDULE 13G/A, 4 filings Nov 17, 2021 to Jan 3, 202548
- Douglas Clark WurthSC 13D, 1 filing Dec 22, 202149
- Indranil DeySC 13D, 1 filing Dec 22, 202150
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2025 | Neil Dey | $328.2K | $473.6K51 | |
| 2025 | Jason Cook | $111.6K | $326.2K51 | |
| 2024 | President & Chief Executive Officer | $283.8K | $290.9K51 | |
| 2024 | Chief Technology Officer | $241.8K | $251.1K51 |
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Armistice Capital, LLC | 131,000 | $157.2K | 0.0% | New |
| Heights Capital Management, Inc | 35,400 | $42.5K | 0.0% | New |
| Boothbay Fund Management, LLC | 27,130 | $32.6K | 0.0% | New |
| Bank Of America Corp /de/ | 10,337 | $12.4K | 0.0% | New |
| Vanguard Fiduciary Trust Co | 10,225 | $12.3K | 0.0% | New |
| Tower Research Capital LLC (TRC) | 1,907 | $2.3K | 0.0% | +178 |
| L1 Global Manager Pty Ltd | 120 | $144 | 0.0% | No change |
| Caitong International Asset Management Co., Ltd | 1 | $1 | 0.0% | −2 |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Bluejay Diagnostics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARBluejay Diagnostics, Inc.1
- CIK0001704287
- Employer ID (EIN)47-35529223
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
- Incorporated inDelaware3
- Fiscal year endsDecember 311
- Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
- SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
- Business address360 Massachusetts Avenue, Suite 203, Acton, MA 017201
- Phone(978) 631-01521
- Shares outstanding4,468,051 as of Aug 7, 20269
- Public float$2.6M as of Jun 30, 20253
- AuditorWolf & Company, P.C., Boston, Massachusetts PCAOB ID 392; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceApr 19, 20171
- Filings248 in all: 8-K (67), 4 (44), 10-Q (15), 3 (13), CORRESP (11), SCHEDULE 13G (8), DEF 14A (7), EFFECT (7)1
All 36 form types
UPLOAD (7), PRE 14A (6), 10-K (5), D (5), S-1/A (5), SC 13G (5), SCHEDULE 13G/A (5), S-3 (4), 424B3 (3), S-1 (3), SCHEDULE 13D (3), 10-K/A (2), 4/A (2), 424B4 (2), DEFA14A (2), S-8 (2), SC 13D (2), SC 13G/A (2), SCHEDULE 13D/A (2), 424B1 (1), 424B5 (1), 8-A12B (1), CERT (1), DRS (1), DRS/A (1), DRSLTR (1), FWP (1), S-1MEF (1)
- Latest filingsAnnual report (10-K) Mar 6, 2026
Quarterly report (10-Q) Aug 12, 2026
Proxy statement (DEF 14A) Apr 30, 2026
Latest 8-K (8-K) Oct 13, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001 per share | BJDX | The Nasdaq Stock Market LLC |
From the cover page of the 10-K filed Mar 6, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Bluejay Diagnostics, Inc. names in Item 1A of its 10-K filed Mar 6, 2026: 56 risks under these headings, as written.3
- Risks Related to Our Financial Condition and Capital Requirements
- We have incurred significant losses since our inception, do not currently generate any operating income, and expect to continue incurring losses as we work to obtain product approval, and thus we may never achieve or maintain profitability.
- We expect to need to raise at least $20 million between the date of this filing and the end of the 2027 fiscal year, and failure to do so could require us to undertake a process of liquidation under U.S. bankruptcy laws, which could cause holders of our common stock to recoup little, if any, value for their shares.
- Since the initial public offering of our common stock in November 2021, the market price of our common stock has fallen by more than 99.9%, and we expect to need additional funding amounts substantially greater than the current market capitalization of our common stock, which may result in future dilution that coincides with further declines in the trading price of our common stock beyond the substantial declines that have occurred in recent years.
- 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. In addition, Nasdaq has recently proposed a new $5 million market value of listed securities requirement that we would not currently satisfy and therefore could cause our common stock be delisted by Nasdaq on an imminent basis, if approved by the SEC.
- Our ability to raise additional capital via a registered public offering on Form S-3 will be limited in the near-term as a result of the SEC’s “baby shelf” rules.
- We may be obligated to current and/or prior financial advisors under engagement letters that we enter into from time to time, and we are currently subject to such an obligation.
- Risks Related to Our Business
- To preserve cash resources, we downsized our organization in 2025, which may reduce business continuity, affect our ability to apply for certain patents, and affect our product development and timelines.
- We are subject to the risks associated with new businesses.
- Our agreements with Toray, which relate to the license of the core technology used in our Symphony cartridges and for Sanyoseiko to manufacture cartridges for Bluejay, are subject to significant risks that may threaten our viability or otherwise have a material adverse effect on us and our business, assets and its prospects.
- As an intermediate step to regulatory submission, we need to demonstrate that our collected clinical samples do not degrade over time.
The other 46 risks
- There is a risk that validation of the primary outcome measure of our SYMON-I study will not achieve statistical significance.
- There is a risk of our cartridges not passing analytical validation, one of the key requirements of FDA clearance.
- FDA requirements could change prior to submission and lead to delays and additional costs.
- The FDA could request additional data or testing after our application submission, requiring additional costs and delaying approval.
- We depend on, and are liable for, Sanyoseiko as our Symphony analyzer and cartridge contract manufacturing organization (CMO), so its inability or failure to perform appropriately in that capacity may threaten our viability or have a material adverse effect on us and our business, assets and its prospects.
- We have not yet launched any products and the ability to do so will depend on the acceptance of our Symphony platform in the healthcare market.
- We cannot accurately predict the volume or timing of any sales, making the timing of any revenues difficult to predict.
- If third-party payors do not provide coverage and reimbursement for the use of our platform, our business and prospects may be negatively impacted.
- Our Symphony platform, including its software and systems, may contain undetected errors, which could limit our ability to provide our products and diminish the attractiveness of our offerings.
- We will rely on the proper function, security and availability of our information technology systems and data to operate our business, and a breach, cyber-attack or other disruption to these systems or data could materially and adversely affect our business, results of operations, financial condition, cash flows, reputation, or competitive position.
- If we are not able to attract and retain highly skilled managerial, scientific and technical personnel, we may not be able to implement our business model successfully, and our limited cash resources could require us to make further cost reductions.
- We do not have a meaningful amount of authorized shares remaining under our equity compensation plans and therefore cannot incentivize our directors and employees with non-cash compensation, and our cash compensation obligations for directors and officers are substantial relative to our market capitalization.
- If we or our manufacturers fail to comply with the regulatory quality system regulations or any applicable equivalent regulations, our proposed operations could be interrupted, and our operating results would suffer.
- Product liability suits, whether or not meritorious, could be brought against us due to an alleged defective product or for the misuse of our Symphony platform or test cartridges. These suits could result in expensive and time-consuming litigation, payment of substantial damages, and an increase in our insurance rates.
- If we are found to have violated laws protecting the confidentiality of patient health information, we could be subject to civil or criminal penalties, which could increase our liabilities and harm our reputation or our business.
- Significant raw material shortages, supplier capacity constraints, supplier disruptions, and sourcing issues may adversely impact or limit our products sales and or impact our product margins.
- Specific raw materials used in the production of Symphony IL-6 cartridges are being limited in supply and the process of finding a suitable substitute could be expensive, use important resources, reduce the efficacy of the platform, or lead to other delays and setbacks.
- We might not be able to resolve certain causes of a Symphony performance reproducibility issue, and if the issues persist we might have to take a different approach.
- If there is a shift in customer demand for the type of near-patient diagnostic test that we are working to develop, we would be left without a commercially marketable product in the pipeline.
- Our relationships with customers, health care professionals, and patients may be subject to applicable healthcare laws, which could expose us to penalties, including administrative, civil or criminal penalties, damages, fines, imprisonment, exclusion from participation in federal healthcare programs such as Medicare and Medicaid, reputational harm, the curtailment or restructuring of our operations and diminished future profits and earnings.
- Healthcare legislative reform measures could have a material adverse effect on our business, future revenue, if any, and results of operations.
- Risks Related to Product Development and Regulatory Clearance
- We adapted our clinical trial design in 2023 to obtain more patient data to reflect recent FDA feedback, and our regulatory pathway remains subject to further FDA review and feedback and the results of ongoing and future clinical studies.
- The regulatory clearance process which we may be required to navigate may be expensive, time-consuming, and uncertain and may prevent us from obtaining clearance for our planned products.
- Product clearances and approvals can often be denied or significantly delayed.
- Clinical data obtained in the future may not meet the required objectives, which could delay, limit or prevent any regulatory clearance.
- We may be unable to complete required clinical evaluations, or we may experience significant delays in completing such clinical evaluations, which could prevent or significantly delay our targeted product launch timeframe and impair our viability and business plan.
- We and our suppliers may not meet regulatory quality standards applicable to our manufacturing processes, which could have an adverse effect on our business, financial condition, and results of operations.
- We may be liable if the FDA or another regulatory agency concludes that we have engaged in the off-label promotion of our products.
- Our products may be subject to recalls after receiving FDA or foreign approval or clearance or cause or contribute to a death or a serious injury or malfunction in certain ways prompting voluntary corrective actions or agency enforcement actions, which could divert managerial and financial resources, harm our reputation, and adversely affect our business.
- Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance or approval of any future products and to manufacture, market and distribute our products after clearance or approval is obtained.
- Risks Related to Our Intellectual Property
- We depend on intellectual property licensed from Toray, and any dispute over the license would significantly harm our business.
- We will depend primarily on Toray to file, prosecute, maintain, defend and enforce intellectual property that we license from it and that is material to our business.
- We and Toray may be unable to protect or enforce the intellectual property rights licensed to us, which could impair our competitive position.
- We and/or Toray may be subject to claims alleging the violation of the intellectual property rights of others.
- We and Toray may be subject to claims challenging the invention of the intellectual property that we license from Toray.
- Risks Related to Our Industry
- We face intense competition in the diagnostic testing market, particularly in the IL-6 space, and as a result we may be unable to effectively compete in our industry.
- If we or Toray fail to respond quickly to technological developments, our products may become uncompetitive and obsolete.
- Risks Related to Ownership of Our Common Stock
- Sales of substantial amounts of our securities in the public market could depress the market price of our common stock.
- We could issue “blank check” preferred stock without stockholder approval with the effect of diluting interests of then-current stockholders and impairing their voting rights, and provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable.
- We do not currently intend to pay dividends on our common stock in the foreseeable future, and consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
- If securities industry analysts do not publish research reports on us, or publish unfavorable reports on us, then the market price and market trading volume of our common stock could be negatively affected.
- As an “emerging growth company” under applicable law, we are subject to lessened disclosure requirements, which could leave our stockholders without information or rights available to stockholders of other public companies that are not “emerging growth companies.”
- Because we have elected to use the extended transition period for complying with new or revised accounting standards for an “emerging growth company” our financial statements may not be comparable to companies that comply with public company effective dates.
- Anti-takeover provisions in our charter documents and Delaware law could discourage, delay or prevent a change in control of our Company and may affect the trading price of our common stock.
- We will continue incurring increased costs as a result of operating as a public company, and our management is now required to devote substantial time to new compliance initiatives and corporate governance practices.
- Our amended and restated certificate of incorporation will provide, subject to limited exceptions, that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for certain stockholder litigation matters, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or stockholders.
Legal proceedings
From time to time in the ordinary course of our business, we may be involved in legal proceedings, the outcomes of which may not be determinable. The results of litigation are inherently unpredictable. Any claims against us, whether meritorious or not, could be time consuming, result in costly litigation, require significant amounts of management time and result in diversion of significant resources. We have insurance policies covering any potential losses where such coverage is cost effective.
The Company records accruals for outstanding legal proceedings, investigations, or claims when it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. The Company evaluates developments in legal proceedings, investigations, and claims that could affect the amount of any accrual, as well as any developments that would make a loss contingency both probable and reasonably estimable on a quarterly basis. When a loss contingency is not both probable and reasonably estimable, the Company does not accrue the loss. However, if the loss (or an additional loss in excess of the accrual) is at least a reasonable possibility and material, then the Company discloses a reasonable estimate of the possible loss or range of loss, if such reasonable estimate can be made. If the Company cannot make a reasonable estimate of the possible loss, or range of loss, then that is disclosed. In addition, legal fees and other directly related costs are expensed as incurred.
Shareholder Complaint Filed in New Jersey Civil Court
On December 8, 2025, the Company received by certified mail copy of a complaint filed in the New Jersey Special Civil Division (Sussex County) by a New Jersey resident. In the complaint, the plaintiff asserted claims for negligent misrepresentation, misrepresentation, and consumer deception against the Company and its former Chief Financial Officer, Kenneth Fisher, and sought total damages of $20,000.
The opening of Item 3, Legal Proceedings.3
Sources
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- 14SEC EDGARJason Cook, Chief Technology Officer
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- 16SEC EDGARDonald R. Chase, Board member
- 17SEC EDGARDouglas Clark Wurth, Board member
- 18SEC EDGARFred S. Zeidman, Board member
- 19SEC EDGARSvetlana Dey, Board member
- 20SEC EDGARGary G. Gemignani, Board member
- 21SEC EDGARRegulation FD disclosure
- 22SEC EDGARRegulation FD disclosure
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- 24SEC EDGARRegulation FD disclosure
- 25SEC EDGARRegulation FD disclosure
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- 29SEC EDGARResults of operations
- 30SEC EDGARRegulation FD disclosure
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- 32SEC EDGARRegulation FD disclosure
- 33NasdaqNasdaq calendar
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