1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Valuation
Discussion
Symbol
BJDX
Event Date
2021-11-10
IPO Date (Actual)
2021-11-11
Sector
Health Care
Subsector
Health Care Equipment & Supplies
Offer Range
—
Shares Offered
2.16M
20.15M
$201.5M
10.7%
Implied Upside vs Midpoint
Description
We are a late-stage pre-revenue company focused on improving patient outcomes through a more cost efficient, rapid, near patient product for triage, diagnosis and monitoring of disease progression. We believe there is a market need for an on-site and rapid diagnostic system that can be employed for testing and monitoring. Our diagnostic system, which we refer to as “Symphony,” is an exclusively licensed, patented, low-cost, system that consists of a small footprint instrument and single-use indication specific test cartridges, that we believe, if cleared, authorized, or approved by the U.S. Food and Drug Administration (“FDA”), can provide a solution to this market need rapidly and with laboratory quality results in approximately 24 minutes, in the clinic, Intensive Care Unit (“ICU”), Emergency Room (“ER”) and in other hospital and clinical setting settings where rapid and reliable results are required. Currently, testing is generally performed in a laboratory, and the transportation and logistics of transporting the samples to the lab and obtaining the result takes between 8-48 hours. Our platform is a sample-to-result system that has been shown in a clinical study to provide results in 24 minutes. Our business model is to generate revenue from the sale of the table-top Symphony instrument, and from the sale of single-use indication specific cartridges that are used by the Symphony instrument for the diagnostic test. Once the test material (generally a small volume blood sample) is transferred to a single-use indication specific Symphony cartridge, no additional sample preparation or pre-processing is required. If our Symphony system is able to replicate the results from prior clinical studies and receives FDA clearance, we believe Symphony could eliminate the time required for transportation and logistics and will eliminate the number of operational ‘touch-points’ from ‘sample-to-result’ from six to two. Our technology is the result of more than 12 years of development by our development partner and investor, Toray Industries, Inc. (“Toray”). Toray holds 100,081 shares of our common stock, which they acquired in 2020 for approximately $1.0 million. The core technology used in our Symphony platform and test cartridge product candidates are licensed from Toray. For the past three years, Toray has used the technology successfully as a Research Use Only (“RUO”) product in Japan by selected clinical institutions for measurement of Interleukin-6 (“IL-6”) in rheumatoid arthritis to monitor disease progression. Based in part on this extensive development of the Symphony platform, we believe we are positioned now to complete the last stages of development needed to move to commercialization in the United States. Our initial regulatory pathway is to label and distribute Symphony as an RUO product in the U.S. Certain laboratories may choose to utilize the RUO Symphony in laboratory developed tests, or LDTs. An LDT is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. In parallel, we are pursuing 510(k) clearance from the FDA to use Symphony for in vitro diagnostic use. In order to expedite the submission of our 510(k), we may seek to obtain data from laboratories using the RUO Symphony in LDTs. Prior to seeking 510(k) clearance for Symphony, we will need to complete additional clinical trials, which commenced in September 2021. In January 2022, we plan to submit a pre-submission application to the FDA presenting our study design and the data from our first set of studies. We will use the FDA’s feedback, if necessary, to modify the ongoing studies and to construct the 510(k) premarket notification clearance application. We plan to submit our 510(k) premarket notification at the end of the third quarter of 2022. Our first diagnostic test in development is for triage of sepsis in patients utilizing IL-6 as the target biomarker. According to a report by Market Data Forecast (February 2020), the total market for IL-6 testing for sepsis triage was $934 million in 2020 and is estimated to reach $1.4 billion by 2025 growing at a CAGR of 8.5%. IL-6 has important roles in both innate and adaptive immunity. IL-6 is one of the principle inflammatory cytokines released during trauma or infection. Measuring IL-6 can serve as an early warning sign of a patient’s prognosis and inform quicker and more accurate healthcare. Unlike the conventional downstream biomarkers typically used for sepsis, IL6 is released hours to days before procalcitonin (“PCT”) and c-reactive protein (“CRP”). However, due to long wait times to receive lab results, IL-6 has had limited utility in healthcare. IL-6 is an inflammatory biomarker, also considered as a ‘first-responder,’ that is elevated in patients with infection, sepsis, and septicemia. Reports have shown IL-6 concentrations correlate with severity of sepsis, progression of cancer, rheumatoid arthritis and many other severe conditions as defined by clinical and laboratory parameters. IL-6 is a clinically established biomarker for assessment of severity of infection and inflammation across many disease indications. IL-6 is a biomarker that appears early on as a ‘first responder’ during infection or inflammation. We believe detection of IL-6 early on might allow physicians to make better therapeutic and treatment decisions. Due to the clinical significance of IL-6 testing, hospital systems and centralized testing labs routinely utilize IL-6 testing. The importance of IL-6 testing has been further highlighted during the COVID-19 pandemic, and IL-6 concentrations in blood have been found to be heightened in patients with COVID-19-associated systemic inflammation and hypoxic respiratory failure. In addition, certain of the institutions that we are working with on our clinical studies have Clinical Laboratory Improvement Amendments (“CLIA”) certified labs. These CLIA certified laboratories might adopt Symphony IL-6 tests for their clinical testing as laboratory developed tests. We intend to submit an emergency use authorization (“EUA”) application with the FDA for this indication. We are further developing a pipeline of diagnostic tests for Symphony including triage of myocardial infarction (“MI”), congestive heart failure (“CHF”), neutropenic sepsis in cancer, and other disease diagnostic indications using the same Symphony platform. We intend to pursue the general diagnostic marketplace following a sufficient clinical trial to support a 510(k) submission with the FDA, with the initial indication as a general diagnostic test for sepsis in triage of patients. We do not currently have any regulatory cleared products and our products will need to receive regulatory authorization from FDA in order to be marketed as a diagnostic product in the United States. Our operations to date have been funded primarily through sales of preferred stock and convertible notes. We expect to incur increasing expenses over the next two years to develop additional diagnostic tests, to expand our sales and marketing infrastructure, and our research and development activities. We believe the proceeds from this offering will be sufficient to reach commercialization. --- We were incorporated under the laws of Delaware on March 20, 2015. Our principal executive offices are located at 360 Massachusetts Avenue, Suite 203, Acton, MA 01720 and our telephone number is (844) 327-7078. Our corporate website address is bluejaydx.com.
Bluejay Diagnostics, Inc. annual income statement and balance sheet, FY 2021 to FY 2025, as reported in SEC filings.
| Metric | FY 2021 | FY 2022 | FY 2024 | FY 2025 |
|---|---|---|---|---|
| Revenue | — | $249K | — | — |
| Gross profit | — | $48.9K | — | — |
| Operating income | ($3.2M) | ($9.3M) | ($7.2M) | ($7.0M) |
| Net income | ($3.5M) | ($9.3M) | ($7.7M) | ($6.8M) |
| Metric | FY 2021 | FY 2022 | FY 2024 | FY 2025 |
|---|---|---|---|---|
| Total assets | $21.0M | $13.5M | $6.7M | $7.1M |
| Total liabilities | $637K | $2.0M | $928K | $1.1M |
| Total equity | $20.4M | $11.5M | $5.7M | $6.0M |
| Cash & equivalents | $19.0M | $10.1M | $4.3M | $5.2M |