Bluejay Diagnostics Provides Mid-Year Business and Corporate Update
Recent Business Highlights and Developments:
SYMON Clinical Program Update: The Company has initiated its pivotal SYMON-II clinical study, following the successful completion of the SYMON-I pilot study, for which a primary analysis highlighted that IL-6 levels within 24 hours of ICU admission may predict sepsis patient mortality out to 28 days. Currently, the Company is collecting, freezing and biobanking samples, with plans to subsequently measure IL-6 concentrations in the bio banked samples near the end of patient enrollment or after the patient enrollment has completed, and later analyze 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. Patient enrollment started during the fourth quarter of 2024 and is continuing. The Company's goal is to use the Symphony IL-6 test to complete the testing in the SYMON-II clinical trial, following completion of the Company's redevelopment of the cartridges used in the Symphony system.
Regulatory Pathway: Based on previous interactions with the U.S. Food and Drug Administration (FDA), the Company continues to plan for a 510(k) submission for its Symphony IL-6 test, with a goal of submitting a 510(k) regulatory application to the FDA in the fourth quarter of 2027 and an objective of achieving FDA approval as early as the third quarter of 2028.
Manufacturing Progress: Bluejay continues its collaboration with SanyoSeiko for manufacturing of the Symphony analyzer. The Company is also beginning the process of redeveloping aspects of the Symphony cartridges to address several technical challenges to bring Symphony to a level consistent with necessary performance and quality requirements. While the Company continues to explore the potential for conducting cartridge redevelopment at an in-house facility, it is now actively exploring other alternative pathways for how to pursue such redevelopment, including by outsourcing this work to a third-party contract manufacturing organization that would oversee this process and provide cartridge supply to the Company.
Recent Financial Results: As of April 30, 2025, the Company possessed cash and cash equivalents of approximately $ 5.7 million, while having current liabilities of approximately $1.0 million. The Company incurred losses of approximately $7.7 million for the fiscal year ended December 31, 2024, and $1.9 million for the fiscal quarter ended March 31, 2025.
April 2025 Private Placement: In April 2025, the Company raised gross proceeds of approximately $3.8 million via inducement agreements related to Class C warrant exercises and the issuance of new Class E warrants, strengthening the near-term balance sheet. The Company continues to seek further financing, with a goal of raising at least $30 million in the aggregate through the end of the 2027 fiscal year.
Downsizing of Organization: To preserve cash resources and seek to extend its cash runway, the Company has recently implemented a series of recent cost savings measures in its product development operations and has reduced its overall Company-wide full-time employee headcount to 5 persons following the recent departure of its Chief Technology Officer.
Upcoming 2025 Annual Meeting of Stockholders: The Company's 2025 annual meeting of stockholders (the '2025 Annual Meeting') is scheduled to be held at 1:00 p.m. Eastern Time on June 18, 2025. The Company's Board of Directors will be reduced from six to five seats as of the 2025 Annual Meeting, and the Board has nominated five currently serving directors to stand for re-election, three of whom are independent, non-employee directors. The Company has proposed the consideration of two reverse stock split proposals at the 2025 Annual Meeting, which are intended, if ultimately approved and implemented, to increase the price of the Company's common stock to assist the Company in continuing to meet the Nasdaq Stock Market's minimum price per share criteria for continued listing on that exchange. 'We continue to make focused progress despite a constrained capital environment,' said Neil Dey, Bluejay's President and Chief Executive Officer. 'Our SYMON-I clinical data underscored IL-6's potential to transform sepsis risk stratification and we look forward to the future completion of our SYMON-II clinical trial. We are actively engaged in identifying funding and strategic opportunities to advance Symphony's regulatory and commercial roadmap.'
For additional information, please refer to Bluejay's filings with the Securities and Exchange Commission (the 'SEC'), including its quarterly report on Form 10-Q for the period ended March 31, 2025, filed with the SEC on May 13, 2025 and available here.
About the Symphony IL-6 Test:
The Symphony Test platform is designed to determine patient acuity for triage and monitoring based on the measurement of a specific biomarker. The Symphony IL-6 Test to determine patient acuity for sepsis triage and monitoring ('Symphony IL-6 Test') is currently Bluejay's lead product candidate.
About the SYMON Clinical Study Program:
The SYMON Clinical Study Program includes SYMON-I I (clinicaltrials.gov ID NCT06181604) and SYMON-II (NCT06654895). SYMON-I is a pilot study to determine IL-6 levels associated with various endpoints, including, but not limited to 28-day all-cause mortality and in-hospital mortality. The SYMON-II study is the pivotal study to validate the outcomes of the SYMON-I study, which the Company plans to use to support a 510(k) application to the FDA.
About Bluejay Diagnostics: Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes using its Symphony System, a cost-effective, rapid, near-patient testing system for sepsis triage and monitoring of disease progression. Bluejay's first product candidate, an IL-6 Test for sepsis, is designed to provide accurate, reliable results in approximately 20 minutes from 'sample-to-result' to help medical professionals make earlier and better triage/treatment decisions. More information is available at www.bluejaydx.com.
.
Forward Looking Statements:
This press release contains statements that the Company believes are 'forward-looking statements' within the meaning of the Private Litigation Reform Act. Forward-looking statements in this press release include, without limitation, statements about the ongoing SYMON-II clinical trial, plans to redevelop the cartridges used in the Company's Symphony system, including the potential for working with a third-party contract manufacturing organization in connection with such redevelopment, the expected nature and timing of the Company's planned FDA submission and related plans for clinical study completion, whether the Company's cash position will be sufficient to fund operations needed to achieve regulatory approval and initial commercialization of the Symphony IL-6 Test, whether such regulatory approval will actually occur, the Company's plans for future fundraising, the continuation of the Company as a going concern, the Company's plans to hold its 2025 Annual Meeting on June 18, 2025 and request stockholder approval of two reverse stock split proposals and the re-election of five continuing directors, and the Company's ability to continue to have its common stock listed on the Nasdaq Capital Market in the future. Forward-looking statements may be identified by words such as 'anticipates,' 'believes,' 'estimates,' 'expects,' 'intends,' 'may,' 'plans,' 'projects,' 'seeks,' 'should,' 'suggest,' 'will,' and similar expressions. The Company has based these forward-looking statements on its current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements the Company makes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including market and other conditions and those discussed under Part I, Item 1A, 'Risk Factors' in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in Part II, Item 1A, 'Risk Factors' in its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2025, filed with the SEC on May 13, 2025. You should not place undue reliance on these forward-looking statements, as they are subject to risks and uncertainties, and actual results and performance in future periods may not occur or may be materially different from any future results or performance suggested by the forward-looking statements in this release. This press release speaks as of the date indicated above. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. The Company expressly disclaims any obligation to update or revise any forward-looking statements found herein to reflect any future changes in the Company's expectations of results or any future change in events, except as required by law.
Additional Information about the 2025 Annual Meeting and Where to Find It:
In connection with the 2025 Annual Meeting, Bluejay filed a Definitive Proxy Statement with the SEC on May 16, 2025. Only Bluejay stockholders of record at the close of business on May 15, 2025 are entitled to vote at the 2025 Annual Meeting or any adjournment or postponement thereof. The Definitive Proxy Statement and proxy card were mailed to Bluejay stockholders on or about May 22, 2025. BEFORE MAKING ANY VOTING DECISION, BLUEJAY STOCKHOLDERS ARE URGED TO READ IN THEIR ENTIRETY THE DEFINITIVE PROXY STATEMENT (INCLUDING ANY FUTURE AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER DOCUMENTS FILED WITH THE SEC IN CONNECTION WITH THE 2025 ANNUAL MEETING OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSALS BEING VOTED ON AT THE 2025 ANNUAL MEETING.
Investors and security holders may obtain free copies of the Definitive Proxy Statement, definitive additional materials and such other documents containing important information about the 2025 Annual Meeting at the SEC's web site at www.sec.gov, and on Bluejay's website at www.bluejaydx.com by clicking on the 'Investors' link and then reviewing the "SEC Filings" feed. Electronic Copies of the Definitive Proxy Statement and the Company's 2024 Annual Report on Form 10-K are also available at www.cstproxy.com/bluejaydx/2025. The contents of the websites referenced above are not deemed to be incorporated by reference into the Definitive Proxy Statement.
Participants in the 2025 Annual Meeting Solicitation:
Bluejay and its directors and executive officers may be deemed participants in the solicitation of proxies from Bluejay stockholders in connection with the 2025 Annual Meeting. Security holders may obtain information regarding Bluejay's directors and executive officers in the Definitive Proxy Statement referred to above (filed with the SEC on May 16, 2025), and in subsequent filings on Form 8-K.
Investor Contact:Investor RelationsBluejay Diagnostics, Inc.ir@bluejaydx.com
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Hill
a minute ago
- The Hill
Walmart recalls frozen shrimp over potential radioactive contamination
Walmart has recalled frozen, raw shrimp sold in 13 states because federal health officials say it could have potential radioactive contamination. The U.S. Food and Drug Administration asked Walmart to pull three lots of Great Value brand frozen shrimp from stores after federal officials detected Cesium-137, a radioactive isotope, in shipping containers and a sample of breaded shrimp imported from Indonesia. The products could pose a 'potential health concern' for people exposed to low levels of Cesium-137 over time, FDA officials said. 'If you have recently purchased raw frozen shrimp from Walmart that matches this description, throw it away,' FDA officials said in a statement. The risk from the recalled shrimp is 'quite low,' said Donald Schaffner, a food safety expert at Rutgers University. Cesium-137 is a byproduct of nuclear reactions, including nuclear bombs, testing, reactor operations and accidents. It's widespread around the world, with trace amounts found in the environment, including soil, food and air. The level detected in the frozen breaded shrimp was far lower than FDA intervention levels. However, the agency said that avoiding potentially contaminated products could reduce exposure to low-level radiation that could lead to health problems over time. The FDA is investigating reports of Cesium-137 contamination in shipping containers and products processed by P.T. Bahari Makmur Sejati, doing business as BMS Foods of Indonesia. U.S. Customs and Border Protection officials alerted FDA that they found Cesium-137 in shipping containers sent to U.S. ports in Los Angeles, Houston, Miami and Savannah, Georgia. FDA officials collected several product samples and detected contamination in one sample of frozen breaded shrimp. The shipping containers and products were denied entry into the U.S. However, the FDA then learned that Walmart had received potentially affected products imported after the first detection, from shipments that did not trigger contamination alerts. Walmart immediately recalled the products, a company spokesperson said. They include Great Value brand frozen raw shrimp with lot codes 8005540-1, 8005538-1 and 8005539-1, all with best-by dates of March 15, 2027. The shrimp was sold in Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Missouri, Mississippi, Ohio, Oklahoma, Pennsylvania, Texas and West Virginia. Consumers should discard the products or return them to any Walmart store for refund. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Los Angeles Times
30 minutes ago
- Los Angeles Times
Wall Street steadies after Nvidia, Palantir and other AI stars trim their losses
Stock indexes ended mixed on Wednesday after Nvidia, Palantir and other superstar stocks pared most of their steep losses from the morning. The S&P 500 dipped 0.2% after trimming a loss that reached 1.1% earlier in the day and remains near its all-time high set last week. The Dow Jones Industrial Average added 16 points, or less than 0.1%, and the Nasdaq composite fell 0.7%. The day's action centered again around stocks caught up in the mania around artificial-intelligence technology. Nvidia, whose chips are powering much of the world's move into AI, sank as much as 3.9% during the morning and was on track to be the heaviest weight on Wall Street following its 3.5% fall on Tuesday. But it clawed back nearly all of Wednesday's drop and finished with a dip of just 0.1%. As it pared its loss, so did broad market indexes because Nvidia is Wall Street's most influential stock by being its most valuable. Palantir Technologies, another AI darling, fell 1.1% to add to its 9.4% loss from the day before, but it had been down as much as 9.8% Wednesday morning. One possible contributor to the swoon was a study from MIT's Nanda Initiative that warned that most corporations are not yet seeing any measurable return from their generative AI investments, according to Ulrike Hoffmann-Burchardi, global head of equities at UBS Global Wealth Management. But the larger factor may be the simple criticism that prices for such stock simply shot too high, too fast, amid the furor around AI and became too expensive. Nvidia, whose profit report scheduled for next week is one of Wall Street's next major events, had soared 35.5% for the year so far heading into Tuesday. Palantir had surged even more, more than doubling. The tech stocks still have supporters, though, who say AI will bring the next generational revolution in business. Mixed profit reports from big U.S. retailers helped keep the rest of the market in check. TJX, the company behind the TJ Maxx and Marshalls stores, climbed 2.7% after beating analysts' forecasts for profit and revenue. It also raised its forecast for profit over its full fiscal year, while CEO Ernie Herrman said TJX is seeing 'strong demand at each of our U.S. and international businesses' and that its current quarter is off to a strong start. Lowe's added 0.3% after the home-improvement retailer delivered a profit for the latest quarter that topped analysts' expectations. Target, meanwhile, tumbled 6.3%. The struggling retailer said that CEO Brian Cornell plans to step down Feb. 1 and that an insider, 20-year veteran Michael Fiddelke, will replace him. He helped reenergize the company, but it has struggled to turn around weak sales in a more competitive post-COVID retail landscape. Estee Lauder dropped 3.7% after offering a forecast for profit this upcoming fiscal year that fell short of Wall Street's estimates. The beauty company said it expects tariffs to shave roughly $100 million off its upcoming earnings. La-Z-Boy sank 12.1% after the furniture maker's profit and revenue for the spring came up shy of analysts' expectations. All told, the S&P 500 fell 15.59 points to 6,395.78. The Dow Jones Industrial Average added 16.04 to 44,938.31, and the Nasdaq composite fell 142.10 to 21,172.86. The week's biggest news for Wall Street is likely arriving on Friday, when Federal Reserve Chair Jerome Powell will give a highly anticipated speech in Jackson Hole, Wyoming. The hope on Wall Street is that Powell will hint that cuts to interest rates are coming soon. The Fed has kept its main interest rate steady this year, primarily because of the fear of the possibility that President Donald Trump's tariffs could push inflation higher. But a surprisingly weak report on job growth across the country may be superseding that. Treasury yields have come down sharply on expectations for an easing of interest rates, and the yield on the 10-year Treasury fell to 4.29% from 4.30% late Tuesday. Trump has been angrily calling for lower interest rates, often insulting Powell personally while doing so. Trump on Wednesday called on a top official at the Federal Reserve, Lisa Cook, to resign after a member of his administration accused her of committing mortgage fraud. In stock markets abroad, indexes were mixed across Europe and Asia. London's FTSE 100 rose 1.1% despite a report that said inflation in the U.K. rose more than expected through July, in part due to soaring airfares and food prices. Hong Kong's Hang Seng added 0.2%. Shares that trade there of the Chinese toy company Pop Mart International Group soared 12.5% after its CEO said its annual revenue could top $4 billion this year and announced the release of a mini version of its popular Labubu dolls. Choe writes for the Associated Press.
Business Wire
30 minutes ago
- Business Wire
Cantor Equity Partners IV, Inc. Announces Pricing of $400 Million Initial Public Offering
NEW YORK--(BUSINESS WIRE)--Cantor Equity Partners IV, Inc. (Nasdaq: CEPF) (the 'Company') announced today the pricing of its initial public offering of 40,000,000 Class A ordinary shares at $10.00 per share. The shares are expected to be listed on the Nasdaq Global Market under the symbol 'CEPF' and begin trading on August 21, 2025. The underwriters have been granted a 45-day option to purchase up to an additional 6,000,000 shares offered by the Company to cover over-allotments, if any. The offering is expected to close on August 22, 2025, subject to customary closing conditions. Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering. About Cantor Equity Partners IV, Inc. Cantor Equity Partners IV, Inc. is a blank check company sponsored by Cantor Fitzgerald and led by Chairman and Chief Executive Officer Brandon Lutnick. Cantor Equity Partners IV, Inc. was formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. The Company's efforts to identify a prospective target business will not be limited to a particular industry or geographic region, but the Company intends to focus on a target in an industry where it believes the Company's management teams' and affiliates' expertise will provide the Company with a competitive advantage, including the financial services, digital assets, healthcare, real estate services, technology and software industries. A registration statement relating to these securities was declared effective by the Securities and Exchange Commission (the 'SEC') on August 20, 2025. The offering is being made only by means of a prospectus, copies of which may be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor New York, New York 10022; Email: prospectus@ Copies of the registration statement can be accessed through the SEC's website at This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, including with respect to the successful consummation of the Company's initial public offering and use of the net proceeds of the offering as described in the offering prospectus, are subject to risks and uncertainties including those set forth in the Risk Factors section of the Company's registration statement for the offering filed with the SEC, which could cause actual results to differ from the forward-looking statements. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.
