Executive Summary

Q2 2024 operating loss widened year over year on higher R&D/G&A tied to clinical trial activity, but net loss was modest ($3.24M) and far smaller than Q1 given favorable non-cash fair value movements; EPS was $(1.03) vs $(4.10) in Q2 2023 and $(0.19) in Q1 2024, with large share-count changes impacting per-share math .
Commercialization advanced materially after quarter-end: first QUELIMMUNE commercial shipment (Jul 12), first commercial patient treated (Jul 23), and $10M gross capital raise (Jul 10), with management planning a broader pediatric rollout in Q4 2024 .
Adult AKI pivotal trial momentum improved: CMS granted Category B coverage for trial expenses (July), sites increased to nine with 42 subjects enrolled, expected to expedite site activations and reduce trial costs .
Regulatory timeline updated: adult SCD PMA approval expected 1H26 with launch 2H26 (pushed out vs prior guidance of approval in 2H25 and launch 1H26), a key watch item for medium-term valuation .

What Went Well and What Went Wrong

What Went Well
- Initial commercialization milestones achieved post-quarter: “initial commercial sales of QUELIMMUNE … used to provide potentially life-saving therapy to two severely ill children,” with “a robust commercial rollout planned for the fourth quarter of this year.”
- Trial funding tailwind: CMS Category B coverage granted for adult AKI pivotal trial expenses (Medicare/Medicaid patients), expected to “substantially reduce our overall trial costs and accelerate the activation of new trial sites.”
- Strengthened balance sheet and governance: completed $10M direct offering in July and retired nearly all outstanding debt; added three new directors with industry experience .
What Went Wrong
- Operating expenses rose year over year as R&D/G&A increased on clinical and legal/accounting costs (R&D $2.33M vs $1.98M; G&A $2.34M vs $1.77M), pressuring operating loss .
- Regulatory timing extended for adult AKI: PMA approval now targeted 1H26 (from 2H25 prior), delaying adult revenue inflection and pushing commercialization to 2H26 .
- Limited cash at quarter-end ($1.18M), underscoring dependence on external capital; subsequent July financing boosted cash to ~$6.9M by Jul 31, 2024 but highlights ongoing funding needs .

Financial Results

Metric	Q2 2023	Q1 2024	Q2 2024
R&D Expense ($M)	$1.98	$1.70	$2.33
G&A Expense ($M)	$1.77	$2.25	$2.34
Total Operating Expenses ($M)	$3.75	$3.95	$4.67
Loss from Operations ($M)	$(3.75)	$(3.95)	$(4.67)
Total Other Income (Expense), net ($M)	$1.31	$(8.75)	$1.44
Net Loss ($M)	$(2.45)	$(12.70)	$(3.24)
Diluted EPS ($)	$(4.10)	$(0.19)	$(1.03)
Weighted Avg Shares (M)	0.60	67.11	3.15
Cash Balance ($M)	—	$5.02 (Mar 31, 2024)	$1.18 (Jun 30, 2024)
Cash incl. July Financing ($M)	—	—	~$6.90 (Jul 31, 2024)

Notes: The income statement presented shows no revenue line; management reported initial QUELIMMUNE commercial sales in July 2024, after Q2 quarter-end .

KPIs and Operating Metrics

Adult AKI pivotal trial enrollment/sites: 31 subjects at 8 sites (Q1 2024) → 42 subjects at 9 sites (Q2 2024) .
Reimbursement: CMS Category B coverage for certain trial expenses (July 2024) .
Pediatric launch: first commercial sale (Jul 12) and first commercial patient treated (Jul 23) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Adult SCD PMA Approval Timing	Adult AKI	2H 2025 approval	1H 2026 approval	Lowered/Pushed Out
Adult SCD Commercial Launch	Adult AKI	1H 2026 launch	2H 2026 launch	Lowered/Pushed Out
Pediatric QUELIMMUNE Rollout	Pediatric AKI	Evaluate use at initial hospitals; broader rollout 2H 2024	Robust commercial rollout planned Q4 2024	Clarified Timing

Earnings Call Themes & Trends

Note: No Q2 2024 earnings call transcript was found in the document corpus; we searched for an “earnings-call-transcript” for ICU in the quarter and found none. We also searched the open web and did not find a Q2 2024 transcript. Future transcripts appear from 2025 onward [ListDocuments returned none for Q2 2024 transcripts; InternetSearch surfaced only 2025 materials] .
Still, themes below reflect management commentary across recent disclosures.

Topic	Previous Mentions (Q-2: FY 2023 release Apr 17, 2024)	Previous Mentions (Q-1: Q1 2024, May 14)	Current Period (Q2 2024)	Trend
Regulatory timeline (Adult AKI)	Expected approval 2H 2025; launch 1H 2026	Same as FY update	Approval targeted 1H 2026; launch 2H 2026	Negative (delay)
Pediatric commercialization	Working to commercialize QUELIMMUNE with partner; HDE approval in Feb 2024	“Initial sales in coming weeks”; qualify first five children’s hospitals	First commercial shipment (Jul 12); first commercial patient (Jul 23); Q4 rollout	Positive
Clinical execution (Adult AKI trial)	24 subjects; 6 sites active	31 subjects; 8 sites	42 subjects; 9 sites; more sites imminent	Positive
Reimbursement	—	—	CMS Category B coverage for trial expenses (July)	Positive
Capital/Runway	$176k cash at YE 2023; $9M Jan 2024 offering	$5.0M cash at Mar 31, 2024	$1.18M cash at Jun 30; ~$6.9M as of Jul 31 post financing	Mixed (low quarter-end cash; improved post-raise)

Management Commentary

CEO framing on quarter and trajectory: “Our recent commercial, clinical and corporate achievements have significantly strengthened our company and support an active and exciting future.”
Pediatric milestones and commercialization plan: “Foremost were our initial commercial sales of QUELIMMUNE … We are working diligently to qualify a select group of prominent children’s hospitals … with a robust commercial rollout planned for the fourth quarter of this year.”
Adult AKI trial economics and pace: “CMS … granted Category B coverage … expected to substantially reduce our overall trial costs and accelerate the activation of new trial sites… We’ve now enrolled 42 subjects at nine sites, with additional prominent medical centers poised to come on board before the end of September.”
Market opportunity: “U.S. adult AKI patient population is 50 times larger than the pediatric population, representing a multibillion-dollar opportunity.”
Capital and governance: “We … completed a financing last month … enabling us to retire nearly all of our outstanding debt,” and added “three outstanding new directors.”

Q&A Highlights

No Q2 2024 earnings call transcript was available in filings or common transcript repositories; we searched the document corpus and the open web and found transcripts starting in 2025, but none for Q2 2024. Accordingly, there are no verifiable Q&A highlights for this quarter [ListDocuments showed no “earnings-call-transcript” for ICU in Q2 2024; Q2 2025 transcript exists] .

Estimates Context

S&P Global consensus estimates for Q2 2024 EPS and revenue could not be retrieved due to data-access limits at the time of request; ICU’s micro-cap profile often implies limited or no formal sell-side coverage. Treat beats/misses vs consensus as N/A for Q2 2024. Values would be retrieved from S&P Global if available.

Key Takeaways for Investors

Near-term commercial proof points are emerging in pediatrics (first shipment/patient treated; Q4 rollout), offering an initial revenue wedge while adult pivotal data matures .
Adult AKI remains the primary value driver; CMS coverage should lower trial costs/accelerate site activations, but approval and launch were pushed to 1H26/2H26—extend duration expectations and funding runway modeling accordingly .
Operating losses persist with rising R&D/G&A; however, the dramatic sequential improvement in net loss vs Q1 reflects non-cash fair value swings—focus on cash burn and financing cadence rather than GAAP volatility .
Balance sheet risk is real (low quarter-end cash) but was partially mitigated by the July raise; monitor additional capital needs through 2025 tied to adult trial completion and pediatric ramp .
Regulatory narrative shifted negatively on timing; any positive interim/efficacy signals or faster-than-expected adult enrollment could re-rate the path to PMA .
Trading setup: stock likely reacts to pediatric adoption pace (hospital onboarding/treatment counts) and adult trial updates (site adds, interim analyses), with financing overhang intermittently weighing until a clearer adult approval path is de-risked .

Appendix: Other Relevant Press Releases (Q2/Q3 timing around quarter)

First QUELIMMUNE commercial shipment (Jul 12, 2024) .
First pediatric patient treated commercially (Jul 23, 2024) .
$10M registered direct offering closed (Jul 11, 2024) .

Sources

Q2 2024 earnings press release (8-K Item 2.02 and Exhibit 99.1), financial tables, and program updates .
Q1 2024 earnings press release (8-K Item 2.02 and Exhibit 99.1) for sequential comparisons and program context .
FY 2023 press release (8-K Item 2.02 and Exhibit 99.1) for prior-quarter narrative and baselines .
Additional press releases validating Q2/Q3 operational milestones (shipments, first treatment, financing) .

SeaStar Medical Holding Corp (ICU)·Q2 2024 Earnings Summary