Executive Summary

Pre-revenue quarter; Q3 revenue was $0 while net loss narrowed to $2.30M (vs. $2.96M YoY) and improved sequentially from Q2’s $2.81M, aided by lower operating expenses .
Management maintained its target to submit a 510(k) for Symphony IL-6 in the first half of 2024 and expressed confidence in the clinical/analytical package; royalty terms with Toray were improved (15% → 7.5%) and supply secured via renegotiated agreements, enhancing long-term unit economics and supply continuity .
Cash and equivalents were $5.08M at 9/30/23; management estimates runway into Q1 2024 and indicated a need for additional capital to fund planned operations over the next 12 months .
No S&P Global consensus estimates were available to assess beats/misses this quarter (attempted but unavailable); focus for stock reaction remains on regulatory milestones and improved licensing economics .

What Went Well and What Went Wrong

What Went Well

Licensing and supply upgrades: “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… [and] re-negotiated our supply agreement… to ensure critical Symphony Cartridge component supply” .
Regulatory trajectory intact: “Based on FDA’s feedback… [we] believe that [we] would submit for regulatory approval for Symphony IL-6 during the first half of 2024 as planned.” Management added, “We are confident that our planned clinical and analytical studies may support a 510(k) FDA regulatory submission…” .
Operating discipline: G&A fell YoY ($0.96M vs. $1.28M), reflecting focus on clinical program/manufacturing scale-up; total operating expenses declined YoY ($2.34M vs. $2.81M), helping narrow net loss YoY ($2.30M vs. $2.96M) .

What Went Wrong

Limited runway and financing need: Cash was $5.08M at quarter-end; management expects runway into Q1 2024 and states it will need additional capital to fund the next 12 months of operations .
Still pre-revenue: Q3 revenue was $0; commercialization timing remains linked to regulatory clearance and subsequent ramp of commercial activities .
R&D intensity remains necessary: R&D expense was $1.40M (vs. $1.38M YoY), reflecting clinical program expansion and manufacturing scale-up to support IL-6 .

Financial Results

Q3 2023 vs. Q3 2022 (YoY)

Metric	Q3 2022	Q3 2023
Revenue ($)	$0	$0
Net Loss ($)	$(2,959,889)	$(2,297,998)
Diluted EPS ($)	$(2.94)	$(2.08)
Research & Development ($)	$1,379,665	$1,397,318
General & Administrative ($)	$1,284,411	$963,534
Sales & Marketing ($)	$146,102	$(19,619)
Total Operating Expenses ($)	$2,810,178	$2,341,233

Notes: Management attributes G&A decline to focus on clinical program and manufacturing scale-up .

Sequential Trend (2023)

Metric	Q1 2023	Q2 2023	Q3 2023
Net Loss ($)	$(2,539,843)	$(2,813,305)	$(2,297,998)
Diluted EPS ($)	$(0.12)	$(2.75)	$(2.08)
Research & Development ($)	$1,354,549	$1,676,256	$1,397,318
General & Administrative ($)	$1,176,977	$1,073,103	$963,534
Sales & Marketing ($)	$148,046	$154,329	$(19,619)
Total Operating Expenses ($)	$2,679,572	$2,903,688	$2,341,233
Cash & Cash Equivalents (end) ($)	$6,781,911	$5,100,407	$5,076,937

Context:

Q3 operating expenses declined sequentially and YoY, aiding loss reduction .
Q3 cash level and runway commentary indicate financing needs ahead of submission/commercialization .

Guidance Changes

Metric/Item	Period	Previous Guidance	Current Guidance	Change
Symphony IL-6 510(k) submission timing	Regulatory milestone	Targeted 1H 2024 (post FDA pre-sub feedback; Aug 11 meeting)	Targeted 1H 2024; maintained “as planned”	Maintained
Cash runway	Liquidity	— (Q2 noted intent to raise additional capital near-term)	Sufficient into Q1 2024; additional capital needed for next 12 months	Updated disclosure

Operational/strategic update (not formal financial guidance): Toray royalty on certain cartridges reduced to 7.5% from 15% for 10 years; supply agreement renegotiated to ensure component supply .

Earnings Call Themes & Trends

Note: No Q3 2023 earnings call transcript was located in the document set; themes drawn from press releases.

Topic	Previous Mentions (Q1 & Q2 2023)	Current Period (Q3 2023)	Trend
Regulatory/FDA path	Q1: Aligning expanded study with FDA feedback; update forthcoming . Q2: FDA pre-sub Aug 11; 510(k) is appropriate; timeline 1H 2024 .	Maintains plan to submit in 1H 2024; confident clinical/analytical studies support 510(k) .	Stable trajectory toward 1H 2024 submission.
Cash/runway	Q1: Limiting cash burn . Q2: Expects to raise additional capital near-term; cash $5.1M .	Cash $5.08M; runway into Q1 2024; needs additional capital for next 12 months .	Runway tightening; financing likely.
Licensing/supply	—	Royalty reduced to 7.5%; supply agreement secured for critical cartridge components .	Positive structural improvement/new in Q3.
R&D execution	Q1: R&D increase tied to personnel and clinical trial costs . Q2: Continued clinical focus .	R&D supports IL-6 studies; YoY increase due to clinical expansion and manufacturing scale-up .	Continued focus; quarter-to-quarter moderation.
Commercialization plans	Q1: Minimal S&M in 2023 . Q2: S&M increase due to personnel .	S&M expense minimal/negative; to increase when appropriate for commercial growth .	Pre-commercial; ramp post-clearance.
Product value proposition	Rapid near-patient IL-6 results (~20 minutes) highlighted in each release .	Reinforced as sepsis triage tool .	Consistent narrative.

Management Commentary

Strategic progress and licensing: “We have re-negotiated our licensing agreement with Toray… reduced royalty… for a term of 10 years… [and] re-negotiated our supply agreement… to ensure critical Symphony Cartridge component supply…” — Neil Dey, CEO .
Regulatory pathway: “Based on FDA’s feedback… [we] believe that [we] would submit for regulatory approval for Symphony IL-6 during the first half of 2024 as planned.” — Neil Dey, CEO .
Confidence and capital discipline: “We are confident that our planned clinical and analytical studies may support a 510(k)… In order for us to realize this, we have continued to limit our cash burn…” — Neil Dey, CEO .
Liquidity: Cash and cash equivalents were $5.08M at 9/30/23; runway into Q1 2024, with additional capital required to fund the next 12 months .

Q&A Highlights

No public Q3 2023 earnings call transcript was available in the filings/documents reviewed; no Q&A to summarize.

Estimates Context

Wall Street consensus (S&P Global) for Q3 2023 revenue/EPS was unavailable; therefore, we cannot assess beats/misses against consensus this quarter. We attempted to retrieve S&P Global estimates but none were available in our data access for BJDX during Q3 2023.

Key Takeaways for Investors

Regulatory catalyst intact: 510(k) submission for Symphony IL-6 targeted for 1H 2024, which is the primary near-term value inflection .
Improved unit economics: Royalty reduction to 7.5% on certain cartridges and secured supply should support better long-term gross margins and scale-up readiness post-clearance .
Operating discipline helping losses: Total operating expenses fell sequentially and YoY, narrowing Q3 net loss despite ongoing R&D programs .
Liquidity is the swing factor: ~$5.08M cash with runway into Q1 2024; expect financing prior to or around submission/commercialization .
Pre-revenue risk persists until clearance: Commercial efforts expected to ramp “when appropriate,” tying revenue visibility to regulatory outcomes .
Stock narrative likely hinges on regulatory progress and financing terms; a timely 510(k) submission and acceptable capital raise could de-risk execution timelines .

Sources: Q3 2023 8-K press release and financial statements ; Q2 2023 update ; Q1 2023 update .

Bluejay Diagnostics, Inc. (BJDX)·Q3 2023 Earnings Summary