Latest news with #Bluejay
Yahoo
6 days ago
- Business
- Yahoo
Bluejay Diagnostics Provides Mid-Year Business and Corporate Update
ACTON, Mass., June 03, 2025 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) ('Bluejay' or the 'Company'), a medical diagnostics company developing rapid near-patient testing solutions for critical care, today provided a 2025 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 ( 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 . 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 and on Bluejay's website at 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 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,
Yahoo
07-04-2025
- Business
- Yahoo
Bluejay Diagnostics Announces Entry into Warrant Inducement Transaction for Approximately $3.7 Million in Gross Proceeds
ACTON, Mass., April 07, 2025 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) ('Bluejay' or the 'Company'), a medical technology company developing rapid diagnostics on its Symphony platform to improve patient outcomes in critical care settings, today announced that it has entered into an agreement with institutional investors that are existing holders of warrants to purchase shares of common stock of the Company for cash (the 'Existing Warrants'), wherein the investors agreed to exercise the Existing Warrants to purchase up 1,085,106 shares of common stock at a reduced exercise price of $3.42 per share, resulting in gross proceeds of approximately $3.7 million, before deducting offering fees and other expenses payable by the Company. In consideration for the exercise of the Existing Warrants for cash, the investors received new warrants (the 'New Warrants') to purchase up to an aggregate of 1,085,106 shares of common stock. The New Warrants are exercisable immediately at an exercise price of $3.42 per common share and will expire five years from the issuance date. The Company issued and sold the New Warrants and any shares of common stock issuable upon exercise of the New Warrants in reliance on the exemption from the registration requirements of the Securities Act of 1933, as amended (the 'Securities Act') by virtue of Section 4(a)(2) thereof and Rule 506 of Regulation D thereunder. Aegis Capital Corp. acted as the exclusive financial advisor in connection with the transaction. Hogan Lovells US LLP acted as counsel to the Company for the transaction. Kaufman & Canoles, P.C. served as counsel to Aegis Capital Corp. for the transaction. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. 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 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 pertaining to the completion of the transaction and the intended use of proceeds from the transaction, 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, and the continuation of the Company as a going concern. 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 item 1A. 'Risk Factors' in our Form 10-K for the fiscal year ended December 31, 2024, as filed with the Securities and Exchange Commission on March 31, 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. Investor Contact:Neil DeyBluejay Diagnostics,
Yahoo
14-03-2025
- Business
- Yahoo
Bluejay Therapeutics Said to Weigh IPO as Soon as Next Month
(Bloomberg) -- Bluejay Therapeutics, a drug developer focused on serious viral and liver diseases, is considering a US initial public offering, according to people familiar with the matter. Trump DEI Purge Hits Affordable Housing Groups NYC Congestion Pricing Toll Gains Support Among City Residents Electric Construction Equipment Promises a Quiet Revolution Open Philanthropy Launches $120 Million Fund To Support YIMBY Reforms Prospect Medical's Pennsylvania Hospitals at Risk of Closure The company could list as soon as next month, the people said, asking not to be identified because the information is confidential. Bluejay is working with JPMorgan Chase & Co., Jefferies Financial Group Inc. and Cantor Fitzgerald on the potential IPO, which could raise at least $150 million, they said. Deliberations are ongoing and details of the IPO including size and timing may change, the people said. Representatives for Bluejay, Cantor Fitzgerald, JPMorgan and Jefferies declined to comment. A listing would come after a period when IPOs by drug developers have mostly fallen flat, even before increasing volatility and market uncertainty threatened to shutter the market. In May, the company raised $182 million in a Series C round co-led by Frazier Life Sciences and another investment firm, with the proceeds earmarked to develop BJT-778 for chronic hepatitis D. It counts RA Capital Management, T. Rowe Price, Wellington Management, Novo Holdings, RiverVest Venture Partners, Octagon Capital, Arkin Bio Ventures, HBM Healthcare Investments and Unicorn Capital among its investors, it said at the time. Bluejay's pipeline includes treatments being developed for hepatitis B among other disorders. Drug developer IPOs on US exchanges have raised $3.7 billion over the past 12 months, data compiled by Bloomberg show. However, the trading performances of that crop have been poor, with shares down a weighted average of 34%, the data show. (Updates with Cantor Fitzgerald response in third paragraph.) How America Got Hooked on H Mart How Natural Gas Became America's Most Important Export Germany Is Suffering an Identity Crisis 80 Years in the Making Disney's Parks Chief Sees Fortnite as Key to Its Future The Mysterious Billionaire Behind the World's Most Popular Vapes ©2025 Bloomberg L.P. Sign in to access your portfolio
Yahoo
12-02-2025
- Business
- Yahoo
Bluejay Therapeutics Appoints Mary Cromwell as Senior Vice President and Head of Technical Operations
REDWOOD CITY, Calif., Feb. 12, 2025 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases, today announced that Mary Cromwell, Ph.D., has joined its leadership team as Senior Vice President and Head of Technical Operations. "Mary is a seasoned biotech executive with a track record of exceptional leadership in manufacturing sciences, formulation, quality, supply chain management, process development and BLA submissions. She has played key roles in advancing therapeutic candidates from late-stage research through commercialization,' said Keting Chu, M.D., Ph.D., Founder and Chief Executive Officer of Bluejay Therapeutics. 'I am thrilled to welcome her to Bluejay Therapeutics as we continue our efforts to advance new therapeutic options for people living with chronic hepatitis D and chronic hepatitis B.' Dr. Cromwell has more than 30 years of experience in biotechnology operations and technical leadership. Most recently, she was Chief Technology Officer at Allakos, where she led technical operations and manufacturing strategy. Prior to that, Dr. Cromwell held a series of positions of increasing responsibility at Genentech/Roche, including Vice President and Head of Quality, Drug Substance, overseeing Quality Assurance and Quality Control for manufacturing. Her expertise spans end-to-end process and product technical development, quality and manufacturing. She was directly involved in the licensure of numerous Genentech/Roche products, including Avastin® and Perjeta® and served as a member of the Genentech Foundation Board. Dr. Cromwell holds a Ph.D. from the University of Colorado, Denver, a master's degree in biophysical chemistry from the University of California, Berkeley, and a bachelor's degree in chemistry from West Virginia University. Bluejay's lead product candidate brelovitug (BJT-778) recently received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for the treatment of chronic hepatitis delta (CHD). Brelovitug also previously received EMA's PRIME and Orphan designation. About Bluejay TherapeuticsBluejay Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases. The company is currently investigating brelovitug (BJT-778) for the treatment of chronic hepatitis D (CHD) and chronic hepatitis B (CHB) virus infections. Additionally, Bluejay is advancing several innovative programs with the goal of developing a combination regimen to achieve a functional cure for chronic hepatitis B, including a proprietary TLR9 agonist (cavrotolimod) and a liver-targeted hepatitis B virus (HBV) transcript inhibitor (BJT-628). For more information on Bluejay Therapeutics, please visit the company's website at or follow the company on LinkedIn. Media Contact: Dan Boyle Orangefiery media@ 818-209-1692 Investor Contact: Peter GarciaCFO, Bluejay Therapeuticsir@ in to access your portfolio
