Executive Summary

Q1 2024 was an operational quarter focused on clinical execution and manufacturing readiness; cash, cash equivalents and marketable securities were $329.0M, with runway into Q4 2025 maintained .
The company highlighted final RMCL-002 Phase 2 results (Late-Breaking ERA presentation) and confirmed mid-2024 timing to resume PROACT 1 enrollment, commence PROACT 2, and deliver REGEN-007 interim data, setting multiple near-term catalysts .
EPS was $(0.16), flat year over year vs Q1 2023 and improved vs Q3 2023’s $(0.18); operating loss narrowed vs Q3 2023 on lower G&A, though R&D rose modestly YoY due to staffing and quality remediation .
Wall Street consensus (S&P Global) for Q1 2024 was unavailable at request time; estimate comparisons are not provided. Consensus should update alongside interim clinical data and Phase 3 resumption (values unavailable; attempted retrieval via S&P Global).
Potential stock reaction catalysts: ERA late-breaker data recap, REGEN-007 interim readout, manufacturing restart, and resumption of Phase 3 enrollments, plus continued emphasis on Stage 4 CKD focus and payer-aligned inclusion criteria .

What Went Well and What Went Wrong

What Went Well

Final RMCL-002 Phase 2 results presented in ERA late-breaker; management reiterated evidence of eGFR stabilization post-treatment in high-risk Stage 4 CKD with severe albuminuria, supporting Phase 3 focus .
Clinical and technical leadership strengthened (EVP Technical Operations and SVP Global Clinical Operations), enhancing readiness for manufacturing scale-up and Phase 3 execution .
Cash runway into Q4 2025 maintained despite operating spend; management reaffirmed multiple mid-2024 milestones (manufacturing/protocol changes complete; PROACT 1/2 enrollment resume) .

Quote: “Rilparencel has the potential to be meaningful in this high-risk patient population where there are limited therapeutic options for care.” — CEO Bruce Culleton .

What Went Wrong

Manufacturing pause following EU Qualified Person audit findings required documentation and quality system remediation, delaying PROACT 1 enrollment and pushing manufacturing restart into mid-2024 .
Protocol amendment narrowed PROACT 1 eGFR inclusion to 20–35 ml/min/1.73m², necessitating enrollment interruption and FDA notification process; enrollment expected to resume mid-2024 .
S&P Global consensus estimates were unavailable at request time, preventing a beat/miss analysis this quarter (values unavailable; attempted retrieval via S&P Global).

Financial Results

Note: PROK is pre-revenue; no revenue line is presented in the statements of operations .

Metric	Q1 2023	Q3 2023	Q1 2024
Revenue ($USD Millions)	—	—	—
R&D Expense ($USD Millions)	$25.6	$32.2	$27.2
G&A Expense ($USD Millions)	$15.3	$14.4	$12.8
Total Operating Expenses ($USD Millions)	$40.9	$46.6	$40.1
Operating Loss ($USD Millions)	$(40.9)	$(46.6)	$(40.1)
Net Loss Before NCI ($USD Millions)	$(36.9)	$(42.0)	$(35.3)
Net Loss EPS ($USD)	$(0.16)	$(0.18)	$(0.16)

Segment breakdown: Not applicable; company reports consolidated results only .

KPIs and Balance Sheet Metrics

Metric	Sep 30 2023	Dec 31 2023	Mar 31 2024
Cash & Equivalents ($USD Millions)	$191.4	$60.6	$84.4
Marketable Securities ($USD Millions)	$204.9	$302.3	$244.6
Total Current Assets ($USD Millions)	$406.4	$374.1	$340.2
Total Liabilities ($USD Millions)	$23.6	$29.2	$24.7
Shares Outstanding (Total)	235,434,630	228,178,263	229,344,883

Operational drivers:

R&D YoY increase primarily driven by added personnel in clinical/quality/manufacturing/biostatistics and professional fees for quality documentation remediation, partially offset by lower Phase 3 spend due to enrollment pause .
G&A YoY decrease driven by lower equity-based compensation, partially offset by higher cash comp and professional fees .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Through Q4 2025	Into Q4 2025 (as of Sep 30 2023)	Into Q4 2025 (as of Mar 31 2024)	Maintained
PROACT 1 eGFR Inclusion	Phase 3 protocol	≥20 to ≤50 ml/min/1.73m²	≥20 to ≤35 ml/min/1.73m²	Lowered upper bound
PROACT 1 Enrollment	Timing	Resume H1 2024 (post-modification)	Resume mid-2024	Maintained window
PROACT 2 Enrollment	Timing & Criteria	≥20 to ≤44 ml/min/1.73m²; commence H1 2024	Commence mid-2024; criteria unchanged	Maintained
Manufacturing Status	Readiness	Pause; resume H1 2024 after QP audit remediation	On schedule to resume mid-2024	Maintained timeline
RMCL-002 Final Readout	Disclosure	Full results expected 1H 2024	Presented as Late-Breaker at ERA; KOL recap May 28	Executed
REGEN-007 Interim	Readout	Mid-2024	Mid-2024	Maintained

No financial guidance on revenue, margins, OpEx beyond qualitative runway commentary was provided .

Earnings Call Themes & Trends

Note: No Q1 2024 earnings call transcript was available; we use the May 28, 2024 KOL event transcript and Q3 2023 call for thematic continuity .

Topic	Previous Mentions (Q-2: Q3 2023; FY update)	Current Period (Q1 2024)	Trend
Focus on high-risk Stage 4 CKD	Plan to enrich PROACT 1 to eGFR 20–35; strongest potential benefit seen in Stage 4 with severe albuminuria	Reiterated; protocol amendment submitted; central IRB approval; emphasis on preserving function in Stage 4	Intensifying focus
Manufacturing/QP audit remediation	Pause and system improvements to meet EU/global standards; resume H1 2024	On schedule to resume mid-2024; team upgrades (EVP Technical Ops)	Resolving
Enrollment cadence & criteria	~80 enrolled in PROACT 1; targeting 600 incremental; expectation of faster enrollment with sicker patients	Resume PROACT 1 and commence PROACT 2 mid-2024	Resuming
Comparative therapy landscape (SGLT2/GLP-1/MRA)	Stage 4 underserved; residual risk remains; potential complementary role for REACT	KOLs: residual progression persists; compliance issues; GLP-1 FLOW reduces risk but not <1 ml/min/yr slopes; need new options	Reinforced
eGFR slope durability/redosing	Durability may tail off after ~18–24 months; possible need to redose	REGEN-007 to inform bilateral dosing; cohort designs address triggers	Under evaluation
Cash runway/catalysts	~$396M as of Q3; runway into Q4 2025; multiple data readouts ahead	$329M as of Q1; runway into Q4 2025; ERA/REGEN-007/protocol restart	Maintained

Management Commentary

“With the full results of RMCL-002… and the upcoming interim readout of REGEN-007 in mid-2024, we look forward to further elucidating the effect of rilparencel in preserving kidney function…” — CEO Bruce Culleton .
“We believe the data in hand demonstrate the potential for preservation of kidney function… most notable in the sickest patients, those who had Stage 4 CKD with a high UACR.” — CEO Bruce Culleton (KOL event) .
“We are also pausing manufacturing to address the very recent EU qualified person audit… We expect to resume manufacturing in the first half of 2024.” — CEO Bruce Culleton (Q3 call) .
“Focusing… to the sicker patients, 20 to 35 is beneficial on many fronts… it’s going to accelerate the enrollment of the trial.” — Chairman Pablo Legorreta (Q3 call) .

Q&A Highlights

Protocol amendment and enrollment impact: ~80 PROACT 1 patients enrolled; ~50 meet new criteria; targeting 600 incremental; interim analysis timing under review .
Manufacturing remediation: Documentation deficiencies (QP audit) driving pause; no clinical safety events; restart planned H1/mid-2024 .
GLP-1/SGLT2 context: FLOW and SGLT2 trials reduce risk but leave residual progression and compliance challenges; REACT positioned as complementary, aiming for <1 ml/min/yr eGFR decline .
Durability/redosing: Benefit may tail off after ~18–24 months; Phase 3/REGEN-007 to inform bilateral injections and potential redosing triggers .
Stage 4 focus rationale: Clinical need, payer dynamics, and event accrual rate support focusing 20–35 ml/min cohort; expected to improve enrollment kinetics and probability of success .

Estimates Context

S&P Global consensus for Q1 2024 EPS and revenue was unavailable at the time of request despite attempts to retrieve; therefore, beat/miss analysis versus Street is not provided (values unavailable; attempted retrieval via S&P Global).
As a pre-revenue, late-stage biotech, revenue comparisons are not meaningful; EPS comparisons are driven by OpEx, interest income, and equity-based compensation variances rather than top-line performance .

Key Takeaways for Investors

Multiple near-term catalysts: ERA late-breaker (completed), KOL recap, REGEN-007 interim (mid-2024), manufacturing restart, and resumption of PROACT 1/2 enrollment — collectively important for narrative momentum and potential financing windows .
Strategic focus on Stage 4 CKD aligns with strongest Phase 2 signals and payer priorities; narrowed eGFR inclusion (20–35) should accelerate event accrual and enrollment .
Operational readiness improving: Leadership hires in Technical and Clinical Operations aim to de-risk manufacturing scale-up and trial execution .
Cash runway into Q4 2025 maintained; liquidity of $329.0M supports clinical milestones; monitor burn as PROACT restarts .
Manufacturing/QP remediation is the key execution risk near term; successful restart is critical to sustain Phase 3 momentum .
Estimates visibility limited this quarter; expect Street to update models around interim data and enrollment resumption (S&P Global consensus unavailable at time of request).
Medium-term thesis hinges on demonstrating Phase 3 efficacy in high-risk CKD, durability of effect, and operational excellence in autologous cell therapy manufacturing .

Notes:
- No Q1 2024 earnings call transcript was available; themes draw from the May 28, 2024 KOL event and prior Q3 2023 call **[1850270_PROK_3390976_0]** **[1850270_PROK_3367124_0]**.
- No non-GAAP financial measures were presented; statements reflect GAAP operating expenses and losses **[1850270_0000950170-24-057443_prok-ex99_1.htm:5]** **[1850270_0000950170-23-063326_prok-ex99_1.htm:5]**.

PROKIDNEY CORP. (PROK)·Q1 2024 Earnings Summary