Executive Summary

ProKidney reported Q2 2024 net loss per share of $0.16 and operating expenses of $43.1M; liquidity rose to $431.5M (cash, cash equivalents, marketable securities), extending cash runway into mid-2026 .
Manufacturing restarted in June; both Phase 3 studies (PROACT 1 and PROACT 2) resumed, and the company received a QP Declaration of Equivalence to EU GMPs enabling shipments to European sites .
Interim Phase 2 (REGEN-007) data presented in June showed 18-month stabilization of kidney function in advanced CKD patients treated with rilparencel, consistent with prior safety profile .
The quarter included a $140M upsized equity offering and a restart of trial enrollment under an amended protocol enriching for more severe CKD patients, which management views as better aligned with observed Phase 2 signals and payer feedback .
EPS beat/miss versus S&P Global consensus was unavailable at time of writing; third-party sources indicate consensus EPS of -$0.17 and actual EPS of -$0.16, implying a modest beat (+$0.01) and potential stock reaction catalysts around resumed Phase 3 execution and improved funding visibility .

What Went Well and What Went Wrong

What Went Well

Restarted manufacturing and resumed PROACT 1 and PROACT 2 with amended PROACT 1 inclusion criteria focused on higher-risk patients; management: “Manufacturing has restarted, both Phase 3 studies have resumed, and we completed a $140 million equity offering to extend our runway into mid-2026” .
REGEN-007 interim data showed 18-month stabilization in renal function among advanced CKD patients, reinforcing the Phase 3 focus; CEO: “The interim results of REGEN-007… support rilparencel’s potential to preserve kidney function” .
Liquidity strengthened to $431.5M, raising runway to mid-2026 vs Q1 guidance into Q4 2025 .

What Went Wrong

Operating expenses increased year over year (R&D up $3.0M to $29.4M; G&A up slightly to $13.7M) due to hiring, professional fees, and quality/manufacturing remediation, partially offset by lower equity comp and manufacturing improvement spending .
Net loss before noncontrolling interest widened YoY to $38.5M (vs $34.8M in Q2 2023), reflecting higher OpEx despite higher interest income .
S&P Global EPS and revenue consensus data was unavailable, limiting estimate benchmarking; transcript of the Q2 earnings call was also unavailable in our document system, reducing direct call-based insight [functions.ListDocuments earnings-call-transcript returned 0; functions.GetEstimates returned limit errors].

Financial Results

Metric	Q2 2023	Q1 2024	Q2 2024
Revenue ($USD Millions)	N/A	N/A	N/A
Net Loss Before Noncontrolling Interest ($USD Millions)	$(34.8)	$(35.3)	$(38.5)
Total Operating Expenses ($USD Millions)	$39.8	$40.1	$43.1
Diluted EPS (Class A) ($)	$(0.14)	$(0.16)	$(0.16)
Cash, Cash Equivalents & Marketable Securities ($USD Millions)	$363.0 (12/31/2023)	$329.0 (3/31/2024)	$431.5 (6/30/2024)

KPIs

KPI	Q2 2023	Q1 2024	Q2 2024
R&D Expense ($USD Millions)	$26.4	$27.2	$29.4
G&A Expense ($USD Millions)	$13.5	$12.8	$13.7
Interest Income ($USD Millions)	$6.0	$4.8	$4.5
Shares Outstanding (Class A + B, period-end)	228,178,263 (12/31/2023)	229,344,883 (3/31/2024)	289,674,830 (6/30/2024)

Estimates comparison

Metric	Period	Actual	Consensus (S&P Global)	Beat/Miss
EPS ($)	Q2 2024	$(0.16)	Unavailable; third-party indicates $(0.17)	Bold: Beat +$0.01 vs third-party consensus
Revenue ($USD Millions)	Q2 2024	N/A	N/A	N/A

Note: S&P Global consensus estimates were not retrievable due to temporary system limits; third-party consensus values are provided as directional context [functions.GetEstimates returned limit errors].

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Company Runway	Into Q4 2025	Into mid-2026	Raised runway
Manufacturing Status	Mid-2024	On schedule to resume manufacturing in mid-2024	Manufacturing restarted in June 2024	Achieved/resumed
PROACT 1 (REGEN-006)	Mid-2024	Resume enrollment; protocol amendment submitted to FDA	Trial resumed; enrolling under amended protocol focused on eGFR ≥20 to ≤35 ml/min/1.73m²	Executed protocol amendment/resumed
PROACT 2 (REGEN-016)	Mid-2024	Commence enrollment	Trial resumed	Resumed
Regulatory/Quality	July 2024	—	QP Declaration of Equivalence to EU GMPs received (enables EU shipments)	New positive regulatory milestone
Financing	June 2024	—	Closed $140M upsized underwritten public offering and concurrent registered direct offering	New capital secured

Earnings Call Themes & Trends

Note: A Q2 2024 earnings call transcript was not available in our document set; themes incorporate Q4 2023 and Q1 2024 press releases and the Sept 5, 2024 Morgan Stanley conference transcript.

Topic	Previous Mentions (Q4 2023, Q1 2024)	Current Period (Q2 2024)	Trend
R&D execution (Phase 2/3)	RMCL-002 interim data positive; focus PROACT 1 eGFR range change; REGEN-007 interim read mid-2024	REGEN-007 interim showed 18-month stabilization; PROACT 1/2 resumed; enrollment under amended protocol	Improving execution momentum
Regulatory interactions (RMAT, EU)	RMAT designation; protocol amendments; manufacturing pause to optimize for EU/global standards	QP EU GMP equivalence received; enabling EU shipments	Positive regulatory progress
Manufacturing/Quality	Pause and remediation; preparing for commercial transition	Manufacturing restarted; quality remediation costs noted in OpEx	Restarted, with elevated costs
Clinical targeting (severe CKD)	Shift PROACT 1 to eGFR ≥20 to ≤35; align with RMCL-002 signals	Enriched PROACT 1 protocol executed; management confirms severity focus improves alignment and potential benefit	Strategic focus sharpened
Financing runway	$363M YE23; runway into Q4 2025	$431.5M liquidity; runway into mid-2026; $140M offering	Strengthened runway
FDA engagement	—	RMAT facilitates engagements; planning Type B meetings on endpoints/CMC; confirmatory evidence considerations	Increasing regulatory dialogue

Management Commentary

“The interim results of REGEN-007 as presented in June support rilparencel’s potential to preserve kidney function in patients with diabetes and advanced CKD.” — Bruce Culleton, M.D., CEO .
“Manufacturing has restarted, both Phase 3 studies have resumed, and we completed a $140 million equity offering to extend our runway into mid-2026.” — Bruce Culleton, M.D., CEO .
On Phase 3 protocol amendment: “We looked at the most severe patients… those treated with rilparencel seem to stabilize… we amended [PROACT 1] and started to activate sites under that amended protocol in May.” — Bruce Culleton (Morgan Stanley conference) .
On readthrough from REGEN-007: “Of those 10… we saw… essentially a stabilization of kidney function over 18 months.” — Bruce Culleton .
On FDA/RMAT: “RMAT allows us to have more engagements… we need to formalize where we are and what we need to do with the FDA as well.” — Bruce Culleton .

Q&A Highlights

Phase 3 enrichment rationale: Management detailed subgroup data (Stage 4 CKD, A3 albuminuria) informing PROACT 1 amendment; severe patients treated with rilparencel stabilized vs continued decline in untreated controls .
REGEN-007 next steps: Expect more mature data with longer follow-up; focus on change in eGFR over time and event reporting in the first half of next year .
FDA pathway and RMAT: Company planning engagements on endpoints (eGFR slope as a potential surrogate), confirmatory evidence, and CMC under RMAT framework .
Standard of care context: Management emphasized unmet need despite RAS inhibitors, SGLT2s, MRAs, GLP‑1s, particularly in Stage 3b/4 CKD with heavy albuminuria, supporting rationale for rilparencel .

Estimates Context

S&P Global consensus estimates could not be retrieved due to temporary system limits, so a formal vs-consensus comparison is unavailable at this time [functions.GetEstimates errors].
Third-party sources indicate Q2 2024 consensus EPS of -$0.17 and reported EPS of -$0.16, implying a modest beat (+$0.01)* .
Revenue was not reported, consistent with the company’s development-stage status .

*Note: S&P Global consensus was unavailable at time of writing; third‑party figures are directional context rather than the default SPGI source.

Key Takeaways for Investors

Execution re-accelerated: Manufacturing restart and Phase 3 resumption under an amended protocol de-risk near-term operational trajectory .
Strengthened liquidity/runway to mid-2026 via $140M equity raise and cash balance growth to $431.5M, reducing financing overhang in the medium term .
Clinical thesis tightening: Enrichment toward severe CKD (eGFR ≥20–≤35) aligns with Phase 2 signals; management commentary suggests stabilization benefits in severe subgroups, a key narrative for Phase 3 success .
Regulatory path: QP EU GMP equivalence supports ex-U.S. logistics; RMAT-enabled FDA dialogue on endpoints/CMC is a key 2024–2025 inflection for approval strategy .
Cost profile: OpEx increased YoY given quality remediation and hiring; monitor R&D and G&A trajectory vs runway as PROACT 1 scales .
Near-term catalysts: Continued Phase 3 enrollment progress and more mature REGEN-007 data in 1H next year; estimate revisions could skew positive if stabilization signals persist (SPGI consensus unavailable now) .
Trading lens: Positive operational updates and liquidity can support sentiment; watch for regulatory updates and any interim data disclosures that validate eGFR slope stabilization, which could be stock-moving .

Additional detail references:

Q2 2024 8‑K press release: business updates, liquidity, OpEx, net loss, shares .
Q1 2024 8‑K press release: prior liquidity and guidance, planned resumption timelines .
FY 2023 8‑K press release: program updates, prior context on manufacturing pause and protocol amendments .
Morgan Stanley conference transcript (Sept 5, 2024): protocol amendment details, REGEN-007 expectations, FDA engagement, SoC context .

PROKIDNEY CORP. (PROK)·Q2 2024 Earnings Summary