Executive Summary

Q1 2024 net revenue was $0 after revenue adjustments to older accounts; gross revenue before adjustments was $0.039M, with OpEx down 20% YoY to $9.1M and net loss narrowed 24% YoY to $8.1M [$0.00 EPS] .
Management shipped first ambient whole-blood collection kits and validated a new lab process expected to reduce COGS by up to 60% at scale and materially increase throughput and capacity, positioning for future revenue inflection pending PRIME and AVERT publications .
Cash, cash equivalents, and marketable securities were approximately $85.4M at March 31, 2024, reflecting strong liquidity and runway to invest prudently in commercial opportunities as prerequisites are met .
No formal financial guidance was provided; management reiterated a selective investment posture (including a previously discussed $5M potential investment pot) tied to ROI from study publications and awareness initiatives .
Wall Street consensus estimates (S&P Global) were unavailable at the time of request, limiting beat/miss comparisons; focus turns to evidence publication and payer/provider engagement as near-term stock catalysts .

What Went Well and What Went Wrong

What Went Well

Validated ambient whole blood collection and began shipping kits; management expects easier collection, faster turnaround, and up to 60% COGS reduction at scale, with a fivefold improvement in technician capacity and tenfold throughput increase .
Operating discipline: total OpEx fell 20% YoY to $9.1M; SG&A down 26% YoY and R&D down 10% YoY, narrowing net loss 24% YoY to $8.1M .
Evidence-building: submitted PRIME interim manuscript; advancing AVERT and PRIME publications to underpin guideline development and adoption; active engagement with KOLs and guideline bodies .
“We continue to make progress… 2024 is a foundational year… position the company for increased test adoption” – CEO Evguenia (Zhenya) Lindgardt .

What Went Wrong

Revenue headwind: net revenue was nil due to accounting estimate updates on older tests; gross revenue before adjustments fell to $0.039M (vs. $0.100M in Q1 2023) .
Commercial traction remains limited pending publications, coverage, and awareness; CFO emphasized optimized near-term commercial spend and preserving capital until prerequisites are achieved .
Regulatory uncertainty around FDA’s final LDT rule introduces potential compliance burdens for new entrants; while Sera views this as a competitive advantage, the landscape may delay industry adoption cycles .

Financial Results

Core P&L and Liquidity (oldest → newest)

Metric	Q3 2023	Q4 2023	Q1 2024
Revenue ($USD Millions)	$0.042	$0.041	$0.000 (net, after adjustments)
Gross Revenue Before Adjustments ($USD Millions)	N/A	N/A	$0.039
Net Loss ($USD Millions)	$(7.210)	$(7.925)	$(8.097)
Diluted EPS ($USD)	$(0.23)	$(0.25)	$(0.25)
Total Operating Expenses ($USD Millions)	$8.226	$8.889	$9.097
R&D ($USD Millions)	$3.539	$3.895	$3.683
SG&A ($USD Millions)	$4.643 (S&M $1.355; G&A $3.288)	$4.970 (S&M $1.304; G&A $3.666)	$5.397 (Selling & Mkt $1.227; G&A $4.170)
Cash, Cash Equivalents & Marketable Securities ($USD Millions)	~$85.0 (as of 9/30/2023)	~$79.9 (as of 12/31/2023)	~$85.4 (as of 3/31/2024)
Weighted Avg Shares (Millions)	31.286	31.414	32.220

Notes: Q1 2024 presents net revenue as nil after periodic estimate reviews; management disclosed gross revenue before adjustments to illustrate underlying order activity .

KPI and Balance Sheet Highlights

KPI	Q3 2023	Q4 2023	Q1 2024
Deferred Revenue ($USD Millions)	$9.039	$20.235	$20.231
Cash And Equivalents ($USD Millions)	$9.655	$3.880	$4.239
Marketable Securities – Current ($USD Millions)	$36.461	$45.199	$48.734
Marketable Securities – Long-term ($USD Millions)	$38.922	$30.841	$32.386
Cost of Revenue ($USD Millions)	$0.044	$0.024	$0.017

Margins vs. Prior Periods and Estimates

Margin Metric	Q3 2023	Q4 2023	Q1 2024	Vs. Estimates
EBIT Margin %	N/A (immaterial revenue base)	N/A	N/A	Consensus unavailable
Net Income Margin %	N/A (immaterial revenue base)	N/A	N/A	Consensus unavailable

Note: With minimal/zero reported revenue, margin percentages are not meaningful for Q3 2023–Q1 2024 . Wall Street consensus (S&P Global) was unavailable at the time of request.

Segment Breakdown

Not applicable; Sera operates a single commercial diagnostics offering (PreTRM Test). No segment disclosures provided .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Formal Revenue/EPS Guidance	FY 2024	None provided	None provided	Maintained
Additional Commercial Investments (Discretionary)	FY 2024	Discussed potential $5M incremental investments	Reiterated prudent, ROI-based deployment; campaigns already paid and low-cost	Maintained
Operating Posture	2024	Preserve capital until prerequisites achieved	Prepared to invest quickly into opportunities post-publications/awareness	Clarified

Management did not issue quantitative guidance for revenue, margins, OpEx beyond qualitative posture this quarter .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3 2023)	Previous Mentions (Q4 2023)	Current Period (Q1 2024)	Trend
Evidence Publications (PRIME/AVERT)	Shared AVERT findings; groundwork for reinvigorated commercial focus	PRIME interim met stopping criteria; preparing manuscripts; working with guideline groups	PRIME interim manuscript submitted; continued KOL/guideline engagement; planning final PRIME analysis	Strengthening evidence base; publication-driven adoption trajectory
Collection & Lab Process Innovation	Cost alignment and operations streamlining	Validations near completion; plans to launch simpler, cheaper collection methods	Validated ambient whole blood; fivefold tech capacity, tenfold throughput, ~50% faster TAT, up to 60% COGS reduction	Material operational scalability and unit economics improvement
Regulatory/LDT Landscape	N/A	N/A	FDA finalized LDT rule; Sera sees compliance as competitive moat; NY State CLEP precedent highlighted	Increased regulatory oversight likely favors established evidence players
Commercial Strategy & Awareness	Cost-effective institutional focus; care coordination	Targeted education across physicians/patients; Russell index inclusion improving visibility	TV programming (Viewpoint/Empowered) and low-cost campaigns; targeted state programs for health equity	Multi-channel awareness building progressing
Liquidity & Cash Runway	~$85M cash/securities; runway extension	~$79.9M as of 12/31/23; positioning for expansion	~$85.4M at 3/31/24; prudent investment posture tied to milestones	Stable liquidity; selective spend pending catalysts

Management Commentary

“We continue to make progress… 2024 is a foundational year… position the company for increased test adoption in the quarters ahead, while diligently preserving our strong balance sheet and cash position” – CEO Evguenia Lindgardt .
“We have validated ambient whole blood collection and have begun shipping our new kits… expected to yield… ease of collection, increased lab capacity… reduced cost of goods… approx fivefold improvement in sample processing capacity… tenfold increase in throughput… cuts turnaround time by about 50%… estimated cost of goods reduction of up to 60%” – CEO Evguenia Lindgardt .
“Net revenue for the first quarter of 2024 was nil… gross revenues before adjustments were approximately $39,000… this reduction… [reflects] optimizing our investment… and preserving capital… Total operating expenses… down 20%… Net loss… down 24%… cash, cash equivalents and available-for-sale securities of approximately $85.4 million” – CFO Austin Aerts .
“We share the goal of keeping patients safe with reasonable oversight of LDTs… we believe the higher bar set by stronger regulations could serve as a source of advantage for Sera” – CEO Evguenia Lindgardt .

Q&A Highlights

KOLs and guideline bodies: Active engagement; potential commentary post-PRIME publication, though timing and statements are not guaranteed .
Pipeline: Time-to-Birth product enhanced on ELISA; data expected before year-end or early next year, preceding launch .
Marketing spend vs. $5M optional investment: TV campaigns low-cost and already funded; $5M discretionary pool will be deployed prudently based on ROI and milestone-driven opportunities .
Commercial readiness: Building key account management, MSL capacity, and operations in revenue cycle/collections to support scale-up .

Estimates Context

Wall Street consensus estimates (S&P Global) for Q1 2024 revenue and EPS were unavailable at the time of request; therefore, comparison to consensus cannot be provided in this recap [Attempted retrieval; unavailable].
Implication: Given immaterial/zero reported revenues and early commercialization, we expect estimates to remain sparse until publication-driven adoption and payer coverage expand .

Key Takeaways for Investors

Near-term narrative hinges on PRIME and AVERT publications catalyzing guideline development and payer/provider adoption; watch for manuscript acceptance and conference timing as triggers .
Operational upgrades (ambient whole blood, new lab process) materially improve unit economics and capacity, positioning Sera for scalable demand; these should support gross margin expansion as volume ramps .
Strong liquidity (~$85.4M) enables selective investment into commercial opportunities without near-term capital raising; monitor deployment pace tied to ROI and milestones .
Revenue remains minimal and subject to adjustments; until coverage and awareness inflect, stock sensitivity may be higher to evidence, regulatory developments (LDT), and state health equity initiatives .
Deferred revenue elevated (~$20.2M) vs. Q3’23, indicating prepayments/contracted activity; track subsequent recognition patterns as publications and pilots translate to billed tests .
Tactical: Near-term trading likely correlates to publication news flow and payer programs; medium-term thesis depends on converting evidence into coverage, repeat ordering, and multi-channel adoption (self-pay/employer-paid) .
Risk/Reward: Regulatory scrutiny may slow new entrants; Sera’s evidence and approvals could be a competitive moat, but commercialization velocity remains the central execution risk .

SERA PROGNOSTICS, INC. (SERA)·Q1 2024 Earnings Summary