Executive Summary

Q4 2024 EPS of -$0.07 beat S&P Global consensus of -$0.16 by $0.09, driven primarily by a $1.023m non-cash gain on warrant liability within other income; revenue was $0 vs. $0 consensus and $0.281m in Q4 2023 . EPS consensus figures from S&P Global: -$0.16 estimate, 3 EPS/revenue estimates; actual EPS -$0.07*.
Operating discipline improved: combined R&D+SG&A fell to $3.0m from $4.6m in Q4 2023, with non-GAAP operating expenses (ex-SBC) at $2.77m (vs. $4.25m in Q4 2023), lowering loss from operations to $3.0m from $4.3m YoY .
Regulatory/clinical de-risking: FDA approved reducing NEPHRO CRRT study size from 166 to 70 patients (90% power on primary endpoint) and broadened inclusion criteria; management now targets completing the registrational study by end of 2025 and submitting the PMA early 2026 .
Liquidity bolstered: year-end cash/investments of $8.9m plus an up-to-$14.8m three-tranche private placement (first tranche ~$4.925m expected in early April) expected to fund through targeted study completion by late 2025, subject to enrollment and share price milestones .
2025 expense guidance: cash operating expenses (R&D+SG&A ex-SBC) guided to $18–$19m to execute and complete NEPHRO CRRT by year-end 2025; key stock catalysts include enrollment progress to 17/35-patient milestones, completion of the 70-patient study, and PMA submission timing .

Note: Items marked with an asterisk (*) are values retrieved from S&P Global.

What Went Well and What Went Wrong

What Went Well

FDA alignment and de-risking: study size reduced to 70 (from 166) with primary endpoint still 90% powered; inclusion criteria broadened (allow CRRT >48 hours; remove heparin-intolerance documentation at certain institutions) to accelerate enrollment .
Cost control: combined R&D+SG&A fell to $3.0m in Q4 (vs. $4.6m Q4’23), with non-GAAP opex ex-SBC at $2.77m (vs. $4.25m), improving net loss from continuing ops to $1.87m (vs. $4.51m) .
Financing runway: up to $14.8m private placement (3 tranches of ~$4.925m) led by existing investors, expected to support completion of the NEPHRO study by end of 2025 when combined with $8.9m YE cash .

“Importantly, we announced that the FDA approved our request for a reduction in the size of the NEPHRO trial from 166 patients down to 70… the primary endpoint remains powered at 90%.” — CEO Vince Angotti .
“These developments… support our belief that we will complete the study by the end of 2025.” — CEO Vince Angotti .

What Went Wrong

Revenue remained $0 with no commercial contribution; YoY comparison declines off prior-year one-time revenues ($0.281m in Q4’23) .
EPS beat driven by non-operating items: $1.023m gain on change in fair value of warrant liability boosted other income ($1.126m), not reflective of core operations .
Enrollment execution historically constrained at some legacy sites; management acknowledged earlier site profile mismatches and is shifting toward nephrologist-led, high-volume medical ICUs to improve pace .

Financial Results

Quarterly Trend (QoQ)

Metric (USD)	Q2 2024	Q3 2024	Q4 2024
Revenue ($m)	$0.00	$0.00	$0.00
R&D Expense ($m)	$1.91	$2.05	$1.32
SG&A Expense ($m)	$2.36	$1.70	$1.67
Total Operating Expenses ($m)	$4.27	$3.75	$3.00
Loss from Operations ($m)	$(4.27)	$(3.75)	$(3.00)
Other Income, net ($m)	$0.44	$0.40	$1.13
Net Loss – Continuing Ops ($m)	$(3.83)	$(3.35)	$(1.87)
Diluted EPS – Continuing Ops ($)	$(0.15)	$(0.13)	$(0.07)
Shares Used (m)	26.20	26.21	26.24

Note: Margins not meaningful due to zero revenue across periods.

Year-over-Year (Q4 2024 vs Q4 2023)

Metric (USD)	Q4 2023	Q4 2024
Revenue ($m)	$0.28	$0.00
Combined R&D + SG&A ($m)	$4.56	$3.00
Net Loss – Continuing Ops ($m)	$(4.51)	$(1.87)
Diluted EPS – Continuing Ops ($)	$(0.25)	$(0.07)
Non-GAAP Opex ex-SBC ($m)	$4.25	$2.77

Versus S&P Global Consensus (Q4 2024)

Metric	Consensus	Actual	Commentary
Revenue ($m)	$0.00*	$0.00	In line; no commercial revenue
EPS ($)	$(0.16)*	$(0.07)	Beat by $0.09; aided by $1.023m non-cash warrant liability gain

Non-GAAP disclosure: Operating expenses excluding SBC were $2.77m in Q4 2024 vs $4.25m in Q4 2023 .

Operational KPIs (Clinical/Corporate)

KPI	Q2 2024	Q3 2024	Q4 2024 / Recent
Study design/size	166 patients; up to 14 sites	166 patients; 5 active, 2 more expected; first patient enrolled Aug’24	Reduced to 70 patients (90% power); inclusion criteria broadened
Sites	Agreement terms with 8 large academic institutions; FDA allowed up to 14 sites	5 activated screening; 2 more expected; targeting up to 14	8 enrollment-ready; 2 just started screening; 6 more expected in 1H
Patients completed	—	“Multiple” completed	6 completed (5 from top site)
Cash & investments	$14.0m (Jun 30)	$11.1m (Sep 30)	$8.9m (Dec 31)
Financing	—	—	Up to $14.8m private placement; 3 tranches of $4.925m

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash operating expenses (R&D+SG&A ex-SBC)	FY 2025	n/a	$18m–$19m	Initiated
NEPHRO CRRT study completion target	FY 2025 (end)	Anticipated “next year” (from Q3’24)	Target completion by end of 2025	Refined/affirmed timeline
PMA submission timing	Early 2026	n/a	Planned submission early 2026 (CEO: “first quarter of next year”)	Initiated

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 2024, Q3 2024)	Current Period (Q4 2024)	Trend
Regulatory path / Study size	Q2: Screening initiated; 166 patients; up to 14 sites . Q3: Enrollment building; 166 patients .	FDA approved cut to 70 patients; primary endpoint still 90% powered .	Positive de-risking
Inclusion criteria	Q2/Q3: No change disclosed .	FDA broadened criteria: allow >48h on CRRT; remove heparin-intolerance documentation at certain institutions .	Positive for enrollment
Site strategy	Q3: 5 active; 2 more expected .	Pivot to nephrologist-led, high-volume medical ICUs; 8 enrollment-ready; 6 more expected 1H .	Acceleration potential
Financing / Runway	Q2/Q3: Not highlighted .	Up to $14.8m private placement in 3 tranches to fund through completion with YE cash .	Improved liquidity
Product positioning	Q3: Clinician dissatisfaction with heparin/citrate .	Emphasis on nafamostat as regional anticoagulant vs systemic heparin; clinician enthusiasm noted .	Reinforced thesis
Timelines	Q3: Expected completion next year .	Target study completion by end-2025; PMA early 2026 .	Clearer timing

Management Commentary

“The FDA approved our request for a reduction in the size of the NEPHRO trial from 166 patients down to 70… This was a major step forward for the timely development of Niyad.” — CEO Vince Angotti .
“With 70 patients, the primary endpoint is powered at 90%… we will complete the study by the end of 2025.” — CEO Vince Angotti .
“We are now allowed to enroll patients that have been on CRRT for over 48 hours… and [remove] documentation of heparin intolerance at certain institutions.” — Management on protocol changes .
“The financing… in 3 equal tranches of $4.925 million… combined with the $8.9 million in cash… supports the completion of the study anticipated by the end of the year.” — CFO Raffi Asadorian .
“Nephrologists… want nafamostat available for their patients… they don’t have to throw away these circuits every 6 to 8 hours.” — CMO Dr. Shakil Aslam .

Q&A Highlights

Protocol rationale: Prior 48-hour CRRT limit and heparin-intolerance documentation were legacy choices; not necessary for Niyad’s primary endpoint and misaligned with real-world practice at many sites; FDA agreed to broaden criteria .
Financing mechanics: Three tranches of ~$4.925m; milestones at 17 and 35 patients and a $0.7325 five-day VWAP condition; no time limit on achieving milestones; CEO personally participated .
Site optimization: Moving responsibility to nephrologists; potential deactivation of underperforming sites as new high-volume sites come online .
Enrollment cadence: Too early to quantify post-change rate, but 25 previously screened-out patients were excluded by the two now-relaxed criteria; highest-volume sites see 90–100 CRRT patients/month vs ~20 at current leader, expanding the addressable pool .
Status: Six patients have completed the study, five from a single high-performing site .

Estimates Context

Q4 2024 EPS beat: Actual -$0.07 vs S&P Global consensus -$0.16; beat of $0.09. Revenue in line at $0 (consensus $0)*. The beat was aided by a $1.023m non-cash gain in warrant liability fair value within other income .
Coverage depth: Three estimates for EPS and revenue in the quarter, implying thin coverage and higher potential estimate volatility*.
Implications: With 2025 cash opex guided to $18–$19m and study size reduced to 70, Street models may adjust cash burn and timeline assumptions as enrollment trends become observable .