Executive Summary

Q3 revenue remained de minimis at $0.03M, down vs prior year ($0.04M) and modestly up vs Q2 ($0.02M); net loss was $7.9M and EPS was $(0.24), largely reflecting continued investment ahead of expected 2025 commercialization push .
Management emphasized “prerequisites” for growth: PRIME database lock with publication targeted around early-2025 conferences, activation of TV and digital awareness campaigns, web-enabled ordering (with home collection), and ambient whole-blood workflow to lower COGS and scale lab throughput .
Cash, cash equivalents and marketable securities were ~$74.3M at 9/30/24; management projects ~$(<) $30M gross cash expense in 2024, plans to allocate relatively more to commercial activities in 2025, and expects year-end cash of ~$68M with runway into 2027 before assuming new revenues .
No explicit revenue or EPS guidance; estimates from S&P Global were unavailable this quarter, so beat/miss analysis versus consensus could not be assessed. Near-term catalysts are PRIME peer-reviewed publication and potential initial guideline body commentary, along with payer-economics modeling updates .

What Went Well and What Went Wrong

What Went Well

PRIME pivotal study dataset locked; company is seeking abstract acceptance at key pregnancy and maternal health conferences in early 2025 and submission to a high‑quality peer‑reviewed journal—management frames this as a core catalyst for awareness, guidelines, and payer coverage .
Commercial enablement advanced: nationwide ambient whole-blood collection, web ordering (home collection) launched Oct 1, plus TV/documentary awareness and digital campaigns to drive physician and consumer demand .
Evidence base strengthened: AVERT study (published July 2024) showed a 18% reduction in severe neonatal morbidity/mortality, 7‑day reduction in neonatal LOS, +2.48 weeks gestational age improvement for <32 week births, and 28‑day LOS reduction for <32 week births under PreTRM test-and-treat strategy—data expected to support payers and guideline bodies .

What Went Wrong

Revenue remains immaterial (Q3: $0.03M), down vs prior year ($0.04M), underscoring that commercial inflection has not yet materialized pending publications, guidelines, and payer coverage .
Operating expenses rose 8% YoY (to $8.9M) with net loss up to $7.9M, with management citing non‑cash stock comp as a key driver—losses suggest continued burn ahead of expected commercialization .
Consensus estimates unavailable through S&P Global this quarter, limiting beat/miss benchmarking and potentially contributing to investor uncertainty near term; the company did not provide quantitative revenue guidance .

Financial Results

Income Statement and EPS (oldest → newest)

Metric	Q3 2023	Q1 2024	Q2 2024	Q3 2024
Revenue ($USD Millions)	$0.04	$0.00 (net)	$0.02	$0.03
Total Operating Expenses ($M)	$8.23	$9.10	$9.28	$8.89
Net Loss ($M)	$(7.21)	$(8.10)	$(8.30)	$(7.92)
Diluted EPS ($)	$(0.23)	$(0.25)	$(0.25)	$(0.24)
R&D Expense ($M)	$3.54	$3.68	$4.41	$3.50
Selling & Marketing ($M)	$1.36	$1.23	$1.10	$1.18
General & Administrative ($M)	$3.29	$4.17	$3.75	$4.20

Notes: Management also cites SG&A of ~$5.4M in Q3 (sum of Selling & Marketing and G&A) .

Liquidity and Balance Sheet Indicators

Metric	Q1 2024	Q2 2024	Q3 2024
Cash, Cash Equivalents & Marketable Securities ($M)	~$85.4	~$80.9	~$74.3
Deferred Revenue ($M)	~$20.23	~$20.23	~$20.23

KPIs and Commercial Readiness

KPI	Q2 2024	Q3 2024
Email campaign engagement to physicians (3‑email series: open/deep engagement rates)	First series: deep engagement 23.4% on platform; multichannel physician outreach ongoing	Second campaign launched mid‑Oct; early data: 9% targeted contacts “deeply engaged”
Website traffic (pretrm.com)	Not disclosed	+227% vs Sep LY after web ordering launch and media coverage
Ambient whole‑blood collection rollout	Kits shipping; conditional NY State approval received	Driving improved access and lower COGS; integrated into consumer ordering flow
TV/documentary campaign reach	Planned distribution to public TV in all 50 states; prime-time short segments in >84M homes	Activated; same distribution targets reiterated

Guidance Changes

Metric	Period	Previous Guidance (Q2 2024)	Current Guidance (Q3 2024)	Change
Cash Operating/Gross Cash Expenses	FY 2024	“Cash operating expenses around $26M”	“Gross cash expense expected to be < $30M”	Reframed/maintained discipline (different definitions; ceiling reiterated)
Year‑end Cash Balance	FY 2024	Not provided	“Projected year‑end cash ≈ $68M”	New
Cash Runway	Multi‑year	“Well into 2027”	“Into 2027 (before assuming future revenues)”	Maintained
2025 Spend Mix	FY 2025	Not specified	“Target gross cash expenses under 2024 threshold, allocate more to commercial activity”	New directional allocation
Revenue/EPS	FY/Qtr	No guidance	No guidance	Maintained

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 & Q2 2024)	Current Period (Q3 2024)	Trend
Evidence/publications (AVERT, PRIME)	AVERT top‑line and PRIME interim outlined; PRIME interim submitted; PRIME deliveries complete; AVERT published in July with strong outcomes	PRIME database locked; aiming for early‑2025 conference abstracts and peer‑review publication; AVERT framed as key validator	Strengthening toward 2025 catalysts
Payer coverage & economics	Elevance modeling and payer engagements planned; economic model being updated; specialist market access firm retained	“Program minimum” is PRIME peer‑review; plan to present payer economic modeling including Elevance analyses on PRIME subset	Building evidence; payer dialogues intensifying post‑publication
Awareness/marketing	Digital physician campaigns; TV programs planned with broad reach	TV/docu programs activated; web ordering launched; Time feature; >200% web traffic uplift	Accelerating
Sample collection & COGS/scalability	Ambient whole blood validated; NY conditional approval; expected COGS down up to ~60%; throughput gains	Continued rollout; expected lower COGS and higher capacity reiterated	Executing/benefits accruing
Regulatory (LDT/FDA)	FDA LDT rule context framed as potential moat due to evidence/NY CLEP; supportive of patient safety	Monitoring legal challenges; preparing to ensure compliance; confidence in quality controls	Prepared/monitoring
Cash discipline & runway	Cash ~$85.4M; 2024 cash OpEx ~ $26M; runway well into 2027	Cash ~$74.3M at 9/30; 2024 gross cash expense < $30M; year‑end cash ~ $68M; runway into 2027	Runway intact; spend shift toward commercial in 2025
Pipeline: predictive analytics; Time‑to‑Birth	Predictive analytics alpha; Time‑to‑Birth on ELISA; data expected late 2024/early 2025	Predictive analytics now in beta as digital “front door” to biomarker tests	Progressing

Management Commentary

“We are successfully putting in place the key prerequisites for commercial success in anticipation of our full PRIME study results achieving publication... Once expanded awareness and care guidelines have occurred, our multi‑pronged approach... is expected to create a sales inflection... coupled with more profitable margin and revenue growth” — Zhenya (Evguenia) Lindgardt, CEO .
“Net revenue for the third quarter of 2024 was $29,000... total operating expenses... $8.9 million... Net loss... $7.9 million... As of September 30, 2024, the company had cash, cash equivalents and available‑for‑sale securities of approximately $74.3 million... projected year‑end cash balance of approximately $68 million... cash into 2027 before assuming any future revenues” — Austin Aerts, CFO .
On payer coverage: “Program minimum is a quality peer‑reviewed publication... coupled with AVERT... strong evidence base... economic modeling (e.g., Elevance) shows ~$1,600 savings per member tested... we’ll provide payers tools to model their own economics” — CEO .
On guideline timing: “The first meaningful milestone to look out for [post‑publication] would be a commentary letter... then practice advisories/bulletins from societies like SMFM/ACOG... the #1 lever is the quality of our data” — CEO .

Q&A Highlights

Guideline pathway and timing: Management outlined a sequence from peer‑reviewed publication to potential society commentary, followed by advisories/bulletins; while timing is not fully controllable, the company is preparing with experts and believes data quality is the main lever .
Payer adoption levers: PRIME peer‑review plus payer economic models (including Elevance’s prior work and PRIME subset analyses) and a customizable ROI tool for payers were highlighted as key triggers for coverage decisions .
Regulatory preparedness: Company is tracking LDT rule challenges and enhancing regulatory expertise to ensure ongoing compliance, expressing confidence in quality systems and test reliability .

Estimates Context

Wall Street consensus (S&P Global) for Q3 2024 revenue and EPS was unavailable due to data access limits; as a result, beats/misses versus consensus could not be determined this quarter. S&P Global consensus data not retrieved.
The company did not provide quantitative revenue or EPS guidance; investor focus remains on 2025 catalysts: PRIME publication, early guideline signals, and payer coverage progress .

Key Takeaways for Investors

Near-term catalysts are publication of PRIME in early 2025 conference windows and peer‑reviewed journals, which could spur guideline commentary, payer coverage traction, and a demand inflection through 2025 .
Commercial enablement is in place: ambient whole‑blood kits (access, capacity, COGS), web ordering with home collection, and broad awareness campaigns—including national TV/docu and Time Magazine coverage—already driving outsized web traffic growth (+227% YoY in September) .
Unit economics should structurally improve with new lab processes and collection methods; management has discussed expected 35–50%+ COGS reductions versus prior workflow as volumes ramp .
Liquidity appears sufficient to fund the 2025 commercialization push: ~$74.3M cash and marketable securities at 9/30/24, year‑end cash targeted at ~$68M, runway into 2027 before assuming future revenues .
Risk skew remains on execution of evidence-to-coverage-to-adoption flywheel: revenue remains immaterial ($0.03M in Q3) until publications, guidelines, and payers catalyze adoption; timing of society actions and payer decisions is uncertain .
Watch for payer-economics updates (e.g., Elevance PRIME subset) and any early society commentary post‑publication—both could be stock catalysts ahead of broader guideline updates .

Financial Results Detail (Cross‑reference vs prior quarters and year)

Revenue and Loss Bridge (Narrative)

Revenue: $0.03M in Q3 2024 vs $0.02M in Q2 2024 and $0.00M (net) in Q1 2024; down vs $0.04M in Q3 2023 .
Net loss: $(7.9)M in Q3 2024 vs $(8.3)M in Q2 2024 and $(8.1)M in Q1 2024; $(7.2)M in Q3 2023 .
Operating expenses: $8.9M in Q3 2024 vs $9.3M in Q2 2024 and $9.1M in Q1 2024; $8.2M in Q3 2023 .

Segment Breakdown

No formal business segments disclosed; PreTRM remains substantially all revenue .

Additional Relevant Press Releases in Q3 2024

AVERT publication (July 9, 2024) detailed stronger clinical outcomes under a PreTRM test‑and‑treat approach, bolstering the evidence base for guideline and payer discussions .

Appendix: Source Documents

Q3 2024 Press Release (Nov 6, 2024) ; 8‑K referencing press release (Item 2.02) .
Q3 2024 Earnings Call Transcript (Nov 6, 2024) .
Q2 2024 Press Release and Call (Aug 7, 2024) .
Q1 2024 Press Release and Call (May 8, 2024) .

Notes on estimates: S&P Global consensus for Q3 2024 was unavailable this quarter; thus no beat/miss comparison is presented.

SERA PROGNOSTICS, INC. (SERA)·Q3 2024 Earnings Summary