Executive Summary

Q1 2023 was a pre‑revenue quarter focused on regulatory alignment for Symphony IL‑6; net loss widened to $2.54M with EPS of −$0.12, driven by higher R&D tied to clinical trials .
Management emphasized pivoting the clinical program to hospitalized sepsis patients, aiming to maintain a first‑half 2024 FDA submission timeline following FDA feedback .
Operating discipline intensified: G&A trimmed and sales/marketing kept minimal in 2023 to preserve liquidity; cash fell to $6.78M from $10.11M in Q4 2022, and the company flagged going‑concern and capital needs beyond Q4 2023 .
No earnings call transcript was available; guidance was conveyed via press releases and the 10‑Q, with Nasdaq minimum bid compliance extended to October 23, 2023, and reverse split considered if necessary .

What Went Well and What Went Wrong

Management executed a regulatory strategy pivot: amending clinical design to include hospitalized sepsis patients to accelerate enrollment and better align with FDA feedback, supporting an initial risk‑stratification indication .
Positive clinical validation continued: prior AACC data highlighted 98% NPV in identifying COVID‑19 patients at risk for severe illness, reinforcing Symphony’s potential to deliver rapid, near‑patient IL‑6 results (~20 minutes) .
Operating discipline: explicit plans to limit cash burn, minimize S&M in 2023, and pare G&A, aligning spend with commercialization timelines .

Cash runway compressed (cash and cash equivalents declined to $6.78M); management disclosed substantial doubt about going concern absent additional financing, estimating current resources fund operations into Q4 2023 .
R&D expenses rose materially (Q1 2023 R&D ~$1.35M vs ~$0.69M YoY) on clinical trial and personnel costs, increasing quarterly net loss vs prior year .
Regulatory timeline delay vs prior expectations: submission moved from anticipated 1H 2023 to 1H 2024 based on FDA feedback, implying extended funding needs and later commercialization .

Metric	Q3 2022	Q4 2022	Q1 2023
Revenue ($USD)	$0	$0 (no sales in Q4)	$0 (no revenue line in 10‑Q)
Net Loss ($USD)	$(2.96)M	N/A (not disclosed quarterly)	$(2.54)M
EPS (Basic & Diluted, $USD)	$(0.15)	N/A	$(0.12)
Total Operating Expenses ($USD)	$2.81M	N/A	$2.68M
Cash and Cash Equivalents ($USD)	$13.29M	$10.11M	$6.78M

Metric	Q1 2022	Q1 2023	Change
Revenue ($USD)	$0 (no revenue line)	$0 (no revenue line)	—
Net Loss ($USD)	$(2.01)M	$(2.54)M	−$0.53M
EPS (Basic & Diluted, $USD)	$(0.10)	$(0.12)	−$0.02
R&D Expense ($USD)	$0.695M	$1.355M	+$0.66M
G&A Expense ($USD)	$1.320M	$1.177M	−$0.14M
Sales & Marketing ($USD)	$0.054M	$0.148M	+$0.09M

Metric	Consensus	Actual	Surprise
Revenue ($USD)	N/A (S&P Global consensus unavailable)	$0	N/A
EPS ($USD)	N/A (S&P Global consensus unavailable)	$(0.12)	N/A

Note: Consensus data via S&P Global was unavailable for BJDX for Q1 2023.

Segment breakdown: BJDX operates a single segment; all assets located in the U.S. .

Metric	Period	Previous Guidance	Current Guidance	Change
Symphony IL‑6 FDA submission timeline	Regulatory	Submit in 1H 2023	Submit in 1H 2024 after FDA feedback	Delayed
Clinical trial design	Ongoing	Severe COVID‑19 cohort only (original design)	Broaden to hospitalized sepsis patients; pre‑submission in Q2 2023	Modified (broadened)
Sales & Marketing spend	2023	Expected to increase when appropriate	Minimal S&M in 2023 to align with market entry	Lowered
G&A spend	2023	Investment in scalable infrastructure (2022)	Continued paring of G&A to optimize alignment	Lowered
Cash burn	Near‑term	Slow cash burn (9/30/22 commentary)	Limit cash burn; closely monitor liquidity	Maintained/Intensified
Nasdaq listing compliance	2023	Under $1 bid price notice (Oct 2022)	Compliance period extended to Oct 23, 2023; reverse split if needed	Maintained plan, extended timeline

No earnings call transcript for Q1 2023 was found; themes are drawn from press releases and the 10‑Q.

Topic	Previous Mentions (Q3 2022 and FY 2022)	Current Period (Q1 2023)	Trend
Regulatory/legal (FDA)	Anticipated De Novo submission in 1H 2023 ; FDA feedback delayed timeline to 1H 2024	Align expanded study with FDA feedback; broaden to hospitalized sepsis; pre‑submission in Q2 2023	Broadening indication; timeline extended; pathway clarified
R&D execution	Expanding clinical program and manufacturing scale‑up	R&D focused on trial costs and regulatory strategy; increased R&D spend	Continued execution with higher spend
Product performance	AACC data: 98% NPV for severe COVID‑19 risk	Reiterated Symphony’s potential to deliver near‑patient lab‑quality IL‑6 results	Consistent validation
Liquidity/capital needs	Cash $13.3M; “sufficient for next 12 months” (9/30/22)	Cash $6.8M; going‑concern; funding needed beyond Q4 2023	Cash runway shortening; financing needed
Commercialization pacing	S&M limited but building awareness	Minimal S&M in 2023; G&A paring	More conservative spend pre‑clearance

“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 and efforts… focused on aligning our expanded clinical study with FDA feedback…” — Neil Dey, CEO .
“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… provides expanded utility of Symphony.” — Neil Dey, CEO (Regulatory strategy update) .

No Q1 2023 earnings call transcript was available; guidance clarifications came via press releases and 10‑Q disclosures .

Wall Street consensus estimates via S&P Global for Q1 2023 revenue and EPS were unavailable for BJDX; thus, no formal beat/miss assessment can be made. Actuals: revenue $0; EPS −$0.12 .

Near‑term catalyst path is regulatory: watch for pre‑submission interactions and progress on the broadened sepsis study supporting a 1H 2024 De Novo submission .
Operating discipline is tightening ahead of FDA clearance: minimal 2023 S&M and paring G&A, but R&D will remain elevated due to clinical trial demands .
Liquidity risk is elevated: cash $6.78M at 3/31; management disclosed going‑concern and expects funding needs into/after Q4 2023; monitor financing transactions and potential dilution .
No revenue yet; valuation hinges on clinical/regulatory milestones and their translation into commercialization in critical care settings (sepsis risk stratification) .
Nasdaq listing risk remains a watch item, with an extension to Oct 23, 2023 and potential reverse split if needed—a possible trading overhang .
R&D momentum and prior clinical validation (AACC data) support the thesis that Symphony can deliver rapid IL‑6 results at the point of care; the broadened study should help drive enrollment and regulatory clarity .

Sources: Q1 2023 8‑K press release and exhibit ; Q1 2023 10‑Q ; FY 2022 8‑K press release ; Q3 2022 8‑K press release .