Dawson James - Bluejay Diagnostics (BJDX)
A Rapid Point of Care Test for Sepsis Triage: Razors & Blades - Launching with a Buy Rating and a $10.0 Price Target
Bluejay Diagnostics is focused on improving patient outcomes in the critical care setting using the company’s Symphony diagnostic platform. The goal is to deliver a rapid, cost-efficient, point of care product for IL-6 (a key inflammation marker) in diseases like Sepsis and even Covid, too, in an easy, cost-effective, and rapid manner. In doing so, we see Symphony as driving a paradigm shift.
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A Paradigm Shift – A Rapid Point of Care Test for IL-6: Bluejay’s IL-6 test for sepsis triage is intended to measure IL-6 levels in whole blood samples in near-patient settings. Interleukin-6 (IL-6) is an established biomarker of immune system activation. It is elevated in infection, inflammation, and cancer. IL-6 presents as an early “first responder” and needs to be measured quickly and reliably.
What is Symphony? Symphony is an automated diagnostic system consisting of a fluorescence immuno-analyzer that uses a single-use diagnostic test cartridge with reagents integrated into the cartridge. Symphony utilizes a ‘sample-to-result’ format, which means that once a specimen is taken from the patient, it is placed in the cartridge. Then the cartridge is placed inside the analyzer, where the test is run in minutes without further technician intervention or additional reagent.
Initial Testing Program and Planned Commercialization. This month the Company expects to have a pre-submission filing. Bluejay initiated the start of the clinical testing program for the IL-6 test for sepsis triage in October 2021 under a single protocol at three sites, two sites in the University of Texas Southwestern Medical Center (the William P. Clements Jr. University Hospital and the Zale Lipshy Pavilion Hospital) and the third site at the Parkland Memorial Hospital. Results from this program should form the basis of the FDA Pre-Submission application expected to be filed early this year. The results from this program form the basis of the Company’s planned 510(k) marketing application, intended to be filed in Q322. The Company plans to incorporate feedback from the FDA pre-submission to modify these studies to support premarket clearance (which could be through a traditional 510(k) or de novo application). The Company may also consider alternative regulatory paths, including, for example, an Emergency Use Authorization (EUA).
A Successful IPO – $21.6M (upsized) Funds Raised – Funded through next series of key events. Cash on hand is critical at this stage for both the development and commercialization plans. While we anticipate no immediate need for capital, we do model a future raise to execute the “water-fall” commercial sales strategy in the future.
Valuation: We project our model out to 2030. We apply a conservative 30% success probability to our projected revenues in our Symphony product model in addition to our 30% risk rate applied in our Free Cash Flow to the Firm (FCFF), discounted EPS (dEPS), and Sum-of-the-Parts (SOP) models, which are then equal-weighted and averaged and rounded to the nearest whole number to derive our 12-month projected price target of $10.0
Risks to our thesis include: 1. Regulatory Approvals; 2. Clinical Science 3. Dependence on OEM suppliers; 4. Development of the target markets 5. Intellectual Capital 6. Dilutio
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Recent BJDX News
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 09/10/2024 10:04:42 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 08/30/2024 09:52:10 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/28/2024 09:24:42 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/21/2024 06:17:35 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 08:45:04 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 07/16/2024 08:13:11 PM
- Bluejay Diagnostics Announces Closing of $8.75 Million Underwritten Public Offering • GlobeNewswire Inc. • 06/28/2024 03:32:47 PM
- Bluejay Diagnostics Announces Pricing of $8.75 Million Underwritten Public Offering • GlobeNewswire Inc. • 06/27/2024 12:58:01 PM
- SYMON-I Study of Symphony IL-6 Suggests Prediction of Mortality in Sepsis Patients • GlobeNewswire Inc. • 06/26/2024 12:00:00 PM
- Bluejay Diagnostics Announces Reverse Stock Split • GlobeNewswire Inc. • 06/17/2024 12:00:00 PM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 06/17/2024 11:10:07 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/31/2024 09:24:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/16/2024 01:25:01 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 08:58:54 PM
- Bluejay Diagnostics Announces Closing of $3.5 Million Public Offering • GlobeNewswire Inc. • 01/02/2024 10:58:51 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/02/2024 10:21:42 PM
- Form 424B4 - Prospectus [Rule 424(b)(4)] • Edgar (US Regulatory) • 12/29/2023 10:06:56 PM
- Bluejay Diagnostics Announces Pricing of $3.5 Million Public Offering • GlobeNewswire Inc. • 12/28/2023 01:00:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 12/28/2023 05:15:12 AM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 12/27/2023 07:29:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/27/2023 02:14:38 PM
- Bluejay Diagnostics, Inc. Announces Initiation of Multicenter Clinical Study Evaluating Symphony IL-6 in Sepsis Patients (SYMON Study) • GlobeNewswire Inc. • 12/27/2023 02:00:00 PM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 12/21/2023 10:20:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/14/2023 09:17:42 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/14/2023 09:16:33 PM
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