Executive Summary

Q2 2023 delivered no revenue vs $0.25M in Q2 2022; net loss widened to $2.81M with diluted EPS of $(2.75) post reverse split; operating loss rose to $2.90M .
FDA feedback confirmed 510(k) as the appropriate pathway for Symphony IL-6; management intends to maintain the previously disclosed submission timeline of 1H 2024 and is engaging large academic institutions to support initial commercialization .
Cash and equivalents declined to $5.10M (vs $6.78M in Q1 2023 and $10.11M at FY22); management expects near‑term capital raising to fund planned operations .
Corporate actions/catalysts: 1-for-20 reverse split effective July 24; Nasdaq minimum bid price compliance regained Aug 8; registered direct offering closed Aug 28 for ~$1.59M gross proceeds .

What Went Well and What Went Wrong

What Went Well

Regulatory clarity: FDA determined 510(k) is the appropriate pathway; Bluejay plans clinical/analytical studies to support 510(k) submission in 1H 2024 .
Cost discipline in overhead: G&A decreased YoY for the six months; management emphasized limiting cash burn and preserving capital .
Listing compliance restored: Company executed a reverse split and subsequently regained Nasdaq minimum bid price compliance, closing the deficiency matter .
- “We continued to limit our cash burn during the quarter while executing our clinical strategy for the Symphony IL-6 test and are confident that our planned clinical and analytical studies may support a 510(k) FDA regulatory submission...” — Neil Dey, CEO .

What Went Wrong

No revenue in Q2 2023 versus a small non-recurring sale in Q2 2022; gross profit fell to zero .
Losses widened: operating loss increased to $2.90M (vs $2.68M in Q1 2023 and $1.99M in Q2 2022); net loss rose to $2.81M (vs $2.54M in Q1 2023 and $1.94M in Q2 2022) .
Liquidity pressure intensified: cash declined to $5.10M by quarter-end; management signaled the need to raise capital in the near term .

Financial Results

P&L Comparison (oldest → newest)

Metric	Q2 2022	Q1 2023	Q2 2023
Revenue ($USD)	$249,040	Not reported (no revenue line)	$0
Gross Profit ($USD)	$48,911	Not reported	$0
Operating Loss ($USD)	$(1,985,725)	$(2,679,572)	$(2,903,688)
Other Income, net ($USD)	$48,323	$139,729	$90,383
Net Loss ($USD)	$(1,937,402)	$(2,539,843)	$(2,813,305)
Diluted EPS ($)	$(2.00)	$(0.12)	$(2.75)
Weighted Avg Shares (Basic & Diluted)	1,007,115	20,375,092	1,023,052

Note: Q2 2023 financials reflect a 1-for-20 reverse split effective July 24, 2023; comparability of EPS/share counts vs prior periods is impacted . The small Q2 2022 sale was described as non-recurring and not indicative of expected margins .

Operating Expenses Breakdown

Metric ($USD)	Q2 2022	Q1 2023	Q2 2023
R&D Expense	$756,283	$1,354,549	$1,676,256
G&A Expense	$1,196,996	$1,176,977	$1,073,103
Sales & Marketing	$81,357	$148,046	$154,329
Total OpEx	$2,034,636	$2,679,572	$2,903,688

Liquidity Snapshot

Metric ($USD)	FY 2022 (12/31)	Q1 2023 (3/31)	Q2 2023 (6/30)
Cash & Equivalents	$10,114,990	$6,781,911	$5,100,407
Total Assets	$13,521,265	$10,888,449	$8,478,328
Total Liabilities	$1,979,992	$1,725,031	$2,101,989
Stockholders’ Equity	$11,541,273	$9,163,418	$6,376,339

No segment reporting or recurring commercial revenue; Symphony IL-6 remains a development-stage product candidate .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Regulatory Path	Symphony IL-6	de novo pathway accepted by FDA pre-submission (2022)	FDA indicated 510(k) is appropriate; studies planned to support 510(k)	Path shifted to 510(k)
Submission Timeline	Symphony IL-6	Targeting 1H 2024 submission	Maintain 1H 2024 submission timeline	Maintained
Clinical Focus	Indication & enrollment	COVID-19 severe cohort; expanded program required	Modified trials to hospitalized sepsis risk stratification to expedite enrollment	Broadened indication/enrollment
Sales & Marketing	2023 activities	Minimal sales/marketing expected in 2023	Minimal near-term sales efforts reiterated; focus on clinical and manufacturing	Maintained
Liquidity/Capital	Near-term funding	Manage cash burn during FDA process	Expects to raise additional capital in near term	Raised capital need
Listing Compliance	Nasdaq	Minimum bid price deficiency disclosed Oct 2022	Reverse split executed; regained compliance Aug 8, 2023	Resolved deficiency

Earnings Call Themes & Trends

No Q2 2023 earnings call transcript found after targeted searches; management updates were provided via 8-K press releases .

Topic	Previous Mentions (Q4 2022 & Q1 2023)	Q2 2023 Current Period	Trend
Regulatory Strategy	FDA accepted de novo pathway; expanded clinical program; 1H24 target	FDA indicated 510(k) path; submission timeline maintained	Improving clarity
Clinical Indication	COVID-19 cohort; broadened program required	Shift to hospitalized sepsis risk stratification; KOL engagement	Broader utility
Liquidity Management	Limit cash burn; monitor liquidity	Cash fell to $5.1M; expects capital raise	Deteriorating liquidity
Commercialization Prep	Early market awareness; minimal sales/marketing	Focus on clinical/manufacturing; targeting leading institutions	Preparatory focus
Listing/Capital Markets	Bid price deficiency (Oct 2022)	Reverse split; compliance regained; ~$1.59M offering	Stabilized listing; modest funding

Management Commentary

“We continued to limit our cash burn during the quarter while executing our clinical strategy for the Symphony IL-6 test… [and] planned clinical and analytical studies may support a 510(k) FDA regulatory submission… We are excited to now have a clear pathway to obtain regulatory clearance…” — Neil Dey, CEO (press release dated Aug 16, 2023) .
“We believe that our updated clinical strategy puts us on the most efficient pathway to obtain regulatory clearance for Symphony IL-6… [broadened] patient eligibility… maintain the previously disclosed Symphony IL-6 regulatory submission timeline of the first half of 2024.” — Neil Dey, CEO (press release dated May 19, 2023) .
“Symphony’s potential to be a rapid near-patient testing platform providing laboratory quality results has already been affirmed by IL-6 data… all resources… focused on aligning our expanded clinical study with FDA feedback…” — Neil Dey, CEO (press release dated May 10, 2023) .

Q&A Highlights

The company did not publish a Q2 2023 earnings call transcript; no analyst Q&A is available. Updates were communicated via press releases and 8-K filings .

Estimates Context

We attempted to retrieve Wall Street consensus EPS and revenue estimates for Q2 2023 via S&P Global’s GetEstimates but were unable to obtain values during this session; as a result, comparisons vs consensus are unavailable for BJDX this quarter. Values would have been retrieved from S&P Global if available.

Key Takeaways for Investors

Regulatory de‑risking: FDA’s indication that 510(k) is appropriate reduces pathway uncertainty; maintaining 1H24 submission timeline anchors the near‑term catalyst path .
Liquidity runway tightening: Cash fell to $5.10M; management expects near‑term capital raising—watch financing terms and potential dilution as clinical work scales .
Operating profile: No commercial revenue in Q2; operating loss and net loss widened QoQ/YoY as R&D spend increases to support clinical program .
Capital markets/Listing: Reverse split and regained Nasdaq compliance mitigate delisting risk; modest ~$1.59M direct offering provides incremental funding but not a full runway solution .
Execution watch‑items: Enrollment pace at targeted institutions, analytical/clinical study readouts, and FDA interactions ahead of the planned 510(k) submission; these are likely to drive narrative and stock reaction .
Commercialization readiness: With minimal near‑term sales efforts, initial market penetration will hinge on clinical evidence and partnerships with leading medical centers .
Risk balance: Regulatory clarity is a positive offset to financing and pre‑revenue operational risks; traders should monitor 8‑K updates for study milestones and capital raising events .

Bluejay Diagnostics, Inc. (BJDX)·Q2 2023 Earnings Summary