jobynimble
8 months ago
Press release on eps: https://www.sec.gov/Archives/edgar/data/1704287/000121390023085197/ea187862ex99-1_bluejay.htm
Bluejay Diagnostics, Inc. Reports Third Quarter 2023 Financial Results
Acton, Massachusetts, November 9, 2023 – Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a clinical-stage medical diagnostics company developing rapid, near-patient tests using whole blood on its Symphony platform to improve patient outcomes in critical care settings, today reported its financial results for the quarter and nine months ended September 30, 2023.
“Based on FDA’s feedback from the August 11, 2023, meeting, the Company focused on implementing the modified clinical strategy that puts us on the most efficient pathway and believes that it would submit for regulatory approval for Symphony IL-6 during the first half of 2024 as planned. Furthermore, we have re-negotiated our licensing agreement with Toray Industries, Inc. to include a reduced royalty payment from 15% to 7.5% of net sales of certain cartridges for a term of 10 years. A 50% reduction in the royalty rate applies upon expiry of applicable Toray patents on a product-by-product and country-by-country basis. The new license agreement contemplates that applicable royalty payment obligations from the Company to Toray for other products will be determined separately by the parties in the future. Overall, the re-negotiated licensing agreement provides Bluejay with more freedom to operate, and better secures long-term licensing of Toray’s patents and know-how around the Symphony technology In addition, we have re-negotiated our supply agreement with Toray Industries, Inc. to ensure critical Symphony Cartridge component supply that will sustain us through clinical studies,” said Neil Dey, CEO of Bluejay Diagnostics.
Symphony IL-6 has the potential to be an influential tool for the prediction of clinical deterioration in sepsis patients. Symphony IL-6 testing, in conjunction with clinical and other diagnostic findings, may enable healthcare providers to better prioritize appropriate care to help improve outcomes for those at high risk, and potentially avoid unnecessary investigations and treatments in those at low risk. IL-6 appears as a ‘first responder’ inflammatory biomarker in blood during inflammation, which is common in diseases and infections. A current unmet challenge for healthcare professionals is the amount of time it takes to identify sepsis in patients and to determine disease severity. Existing technologies typically take several hours to deliver IL-6 results, which can delay critical treatment decisions that could improve patient outcomes.
“We are confident that our planned clinical and analytical studies may support a 510(k) FDA regulatory submission with an initial indication for risk stratification of hospitalized sepsis patients. In order for us to realize this, we have continued to limit our cash burn while executing our clinical and regulatory strategy for the Symphony IL-6 test,” said Neil Dey, CEO of Bluejay Diagnostics.
Financial Results for the Three Months Ended September 30, 2023
Cash and cash equivalents. Cash and cash equivalents on September 30, 2023 were $5.08 million, as compared to $10.1 million on December 31, 2022. The Company has maintained a slow cash burn during its FDA submission process. The Company estimates cash resources will be sufficient to fund its operations into the first quarter of 2024. The Company will need additional capital to fund its planned operations for the next 12 months. The Company expects that it will seek to raise such additional capital through public or private equity offerings, grant financing and support from governmental agencies, convertible debt, collaborations, strategic alliances and distribution arrangements.
Research and development expense. Research and development expenses for the three and nine months ended September 30, 2023 were $1.39 million and $4.42 million, respectively, as compared to $1.37 million and $2.83 million, respectively, for the comparable periods in 2022. The increase in research and development expenses is due to the expansion of our clinical program and to support scale-up manufacturing of the Symphony technology platform and IL-6 Test.
General and administrative expense. General and administrative expenses for the three and nine months ended September 2023 were $0.96 million and $3.21 million, respectively, as compared to $1.28 million and $3.8 million, respectively, for the comparable periods in 2022. The decrease in general and administrative expenses reflects the Company’s focus on clinical program and manufacturing scale-up.
Sales and marketing expense. Sales and marketing expenses for the three and nine months ended September 30, 2023 were $(19,619) and $282,756, respectively, as compared to $146,102 and $281,144, respectively, for the comparable periods in 2022. While these expenses have been limited to date, we expect to increase these efforts when appropriate to support our commercial growth.
Net loss/Net loss per share. The net loss for the three and nine months ended September 30, 2023 was $2.29 million and $7.65 million, or $2.08 and $7.30 per share, respectively, compared to $2.9 million and $6.9 million, or $2.94 and $6.86 per share, respectively, for the comparable periods in 2022.
About the SymphonyTM System:
Bluejay’s Symphony System (the “Symphony System”) is designed to address the need for simple, reliable, rapid, near-patient testing by providing quantitative measurements of specific biomarkers to determine the need for additional patient care and monitoring. The user-friendly Symphony System will not require any sample preparation or dedicated staff and was shown in published clinical studies to deliver results in approximately 20 minutes.
The Symphony IL-6 Test is a development stage product candidate for investigational use only. It is limited by United States law to investigational use.
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 triage and monitoring of disease progression. Bluejay’s first product candidate, an IL-6 Test for sepsis triage, 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, the ability of the Company to submit a marketing application with the FDA in the first-half of 2024 whether the Company’s cash position will be sufficient to fund operations beyond the date of its anticipated regulatory approval and initial commercialization of the Symphony IL-6 Test, and whether such anticipated regulatory approval will actually occur. 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 those discussed under item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission, as updated by the Company’s subsequent Quarterly Reports on Form 10-Q. 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 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. 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.
Investor Contact:
Neil Dey
Bluejay Diagnostics, Inc.
Tel: 978-631-0310
Email: neil.dey@bluejaydx.com
jobynimble
11 months ago
8-K filing: https://www.sec.gov/Archives/edgar/data/1704287/000121390023071272/ea184305-8k_bluejay.htm
Item?1.01. Entry into a Material Definitive Agreement.
Securities Purchase Agreement
On August 24, 2023, Bluejay Diagnostics, Inc. (the “Company”) entered into a securities purchase agreement with certain institutional and accredited investors (the “Purchase Agreement”) relating to the registered direct offering and sale of 216,000 shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock”), at a purchase price of $7.365 per share (the “Offering”).
In a concurrent private placement, the Company also issued to such institutional and accredited investors unregistered warrants to purchase up to 216,000 shares of Common Stock (the “Warrants”). Pursuant to the terms of the Purchase Agreement, for each share of Common Stock issued in this offering, an accompanying Warrant was issued to the purchaser thereof. Each Warrant is exercisable for one share of Common Stock (the “Warrant Shares”) at an exercise price of $7.24 per share, will be immediately exercisable upon issuance and will expire five years from the date of issuance. The Warrants were offered and sold at a purchase price of $0.125 per underlying warrant share, which purchase price is included in the offering price per share of Common Stock issued in the Offering (the “Private Placement”). The gross proceeds to the Company from the Offering and the Private Placement are approximately $1.59 million, before deducting placement agent fees and offering expenses. Neither the Warrants nor the Warrant Shares, have been registered under the Securities Act of 1933, as amended.
Pursuant to an engagement letter, dated as of August 7, 2023 (the “Engagement Letter”), between the Company and H.C. Wainwright & Co., LLC, or the placement agent, the Company agreed to pay the placement agent a total cash fee equal to 7.0% of the gross proceeds received in the Offering and the Private Placement. The Company also agreed to pay the placement agent in connection with the Offering and the Private Placement a management fee equal to 1.0% of the gross proceeds raised in the Offering and Private Placement, $45,000 for non-accountable expenses, and $15,950 for clearing fees. In addition, the Company agreed to issue to the placement agent, or its designees, warrants to purchase up to 15,120 shares of Common Stock (the “Placement Agent Warrants”), which represents 7.0% of the aggregate number of shares of Common Stock sold in the Offering. The Placement Agent Warrants have substantially the same terms as the Warrants, except that the Placement Agent Warrants have an exercise price equal to $ 9.2063, or 125% of the offering price per share of Common Stock sold in the Offering, and a term of five years from the commencement of the sales pursuant to the Offering.
The Offering and Private Placement closed on August 28, 2023.
Pursuant to the terms of the Purchase Agreement, the Company is prohibited from entering into any agreement to issue or announcing the issuance or proposed issuance of any shares of Common Stock or securities convertible or exercisable into Common Stock for a period commencing on August 24, 2023 and expiring 15 days from the closing date of the Offering. Furthermore, the Company is also prohibited from entering into any agreement to issue Common Stock or Common Stock Equivalent (as defined in the Purchase Agreement) involving a Variable Rate Transaction (as defined in the Purchase Agreement), subject to certain exceptions, for a period commencing on August 24, 2023 and expiring one year from the closing date of the Offering.
If a Fundamental Transaction (as defined in the Warrants and Placement Agent Warrants) occurs, then the successor entity will succeed to, and be substituted for the Company, and may exercise every right and power that we may exercise and will assume all of the Company’s obligations under the Warrants and the Placement Agent Warrants with the same effect as if such successor entity had been named in the Warrants and the Placement Agent Warrants itself. If holders of shares of Common Stock are given a choice as to the securities, cash or property to be received in such a Fundamental Transaction, then the holder shall be given the same choice as to the consideration it would receive upon any exercise of the Warrants and the Placement Agent Warrants following such a Fundamental Transaction. Additionally, as more fully described in the Warrants and the Placement Agent Warrants, in the event of certain Fundamental Transactions, the holders of Private Warrants will be entitled to receive consideration in an amount equal to the Black Scholes value of the Private Warrants on the date of consummation of such Fundamental Transaction.
The 216,000 shares of Common Stock sold in the Offering (but not the Warrants or the Warrant Shares) were offered and sold pursuant to a prospectus supplement, dated August 24, 2023, and accompanying prospectus, in connection with a takedown from the Company’s shelf registration statement on Form S-3 (File No. 333-272432), which registration statement was filed on June 5, 2023 and declared effective on June 20, 2023. A copy of the opinion of Hogan Lovells US LLP relating to the validity of the securities issued in the Offering is filed herewith as Exhibit 5.1.
The Warrants, the Warrant Shares, the Placement Agent Warrants and the shares of Common Stock issuable thereunder were sold and issued without registration under the Securities Act of 1933, as amended (the “Securities Act”) in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as transactions not involving a public offering and Rule 506 promulgated under the Securities Act as sales to accredited investors.
Item 3.02. Unregistered Sales of Equity Securities.
The disclosures in Item 1.01 of this Form 8-K regarding the Warrants, and Warrant Shares, the Placement Agent Warrants and the shares of Common Stock issuable thereunder are incorporated by reference into this Item 3.02.
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