Executive Summary

Q4 2024 was primarily a regulatory and clinical execution quarter: FDA confirmed accelerated approval pathway availability for rilparencel (eGFR slope may qualify as a surrogate), and reiterated that the single Phase 3 REGEN-006 (PROACT 1) could be sufficient for a BLA; management now expects further details mid-2025 .
Liquidity remained strong: cash, cash equivalents, and marketable securities were $358.3M at 12/31/24, supporting operations into mid-2027 .
Wall Street EPS consensus for Q4 was -$0.148*, with actual EPS at -$0.17* (miss), while revenue printed $0.076M* versus $0.00* consensus (beat), reflecting minimal revenue recognition typical of a pre-commercial biotech. Values retrieved from S&P Global.
Stock reaction catalyst: acceleration path clarity (surrogate endpoint acceptance) and upcoming Phase 2 REGEN-007 Group 1 full data in Q2 2025 are key narrative drivers; discontinuation of PROACT 2 to prioritize PROACT 1 streamlines the route to potential approval .

What Went Well and What Went Wrong

FDA confirmed accelerated approval pathway is available and that eGFR slope may be acceptable as a surrogate; PROACT 1 could be sufficient for full approval, tightening pathway to market .
Manufacturing restarted with process improvements and EU QP Declaration supporting study drug shipments to Europe; Phase 3 trials resumed with enriched protocol for advanced CKD patients .
Strong funding: closed $140M equity offering in Q2 2024 extending runway; ended Q4 with $358.3M in liquidity to mid-2027 .
Quote (CEO): “Our objective is clear: expedite rilparencel’s path to market in the U.S. to bring a new therapeutic option to patients with advanced CKD and diabetes...” .

Continued operating losses: FY 2024 operating loss was $(183.7)M with elevated R&D ($127.7M) and G&A ($56.1M); net loss before NCI $(163.3)M, wider year-over-year .
Greensboro facility impairment charge ($5.3M) and increased operating costs tied to QMS remediation added to G&A and R&D expenses .
Discontinuation of PROACT 2 (ex-U.S.) reduces near-term geographic breadth, though it focuses resources on FDA-aligned U.S. PROACT 1 .

Quarterly trend (oldest → newest):

Metric	Q2 2024	Q3 2024	Q4 2024
Revenue ($USD Millions)	n/a	n/a	$0.076*
EPS ($USD)	$(0.16)	$(0.14)	$(0.17)*
Cash and Cash Equivalents ($USD Millions)	$214.5	$108.1	$99.1
R&D Expense ($USD Millions)	$29.4	$31.3	n/a
G&A Expense ($USD Millions)	$13.7	$17.7	n/a
Shares Outstanding (Class A + B)	289,674,830	291,661,950	291,748,124

Q4 vs Wall Street consensus:

Metric	Consensus	Actual	Beat/Miss
EPS ($USD)	$(0.148)*	$(0.17)*	Miss
Revenue ($USD Millions)	$0.000*	$0.076*	Beat

Notes: Values marked with * retrieved from S&P Global.

Margins: Not meaningful given negligible/no product revenue; company remains pre-commercial .

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	As of Q2 2024	Into mid-2026	Into 2027 (Q3)	Raised/Extended
Cash Runway	As of Q4 2024	Into 2027	Into mid-2027	Clarified (extended to mid-2027)
Regulatory Pathway	Q3 2024	PROACT 1 may be sufficient for BLA; accelerated approval pathway available (eGFR slope may qualify)	FDA reconfirmed accelerated pathway availability; expect surrogate endpoint details mid-2025	Maintained, timeline updated
Phase 3 Strategy	Q4 2024	Two Phase 3 trials (PROACT 1 and 2)	Discontinued PROACT 2; focus on single, large PROACT 1 per FDA feedback	Streamlined program

Topic	Previous Mentions (Q2 2024, Q3 2024)	Current Period (Q4 2024)	Trend
Regulatory/Accelerated Approval	Q2: Restarted manufacturing/protocol enrichment; Q3: FDA confirmed PROACT 1 sufficiency and accelerated pathway; eGFR slope considered	FDA reconfirmed accelerated pathway availability; eGFR slope may be surrogate; more detail expected mid-2025	Positive momentum; clearer path
Manufacturing/Quality	Q2: Restarted manufacturing; EU QP Declaration; remediation efforts noted	Manufacturing improvements cited as part of 2024 progress	Improved readiness
Phase 3 Execution	Q2: PROACT 1/2 resumed; enriched for advanced CKD	Focus shifted to single PROACT 1; PROACT 2 discontinued	Sharpened focus
R&D/Clinical Data	Q2: Interim REGEN-007 showed 18-month kidney function stabilization	Full REGEN-007 Group 1 data expected Q2 2025	Upcoming data catalyst
Liquidity/Runway	Q2: $431.5M; runway mid-2026	Q3: $406.8M; runway 2027 ; Q4: $358.3M; runway mid-2027	Adequate funding horizon
Organizational/Facilities	Q3: Greensboro impairment charge; staffing adds	Continued scale-up across functions	Scaling with costs

CEO strategic message: “2024 was a pivotal year... refined our Phase 3 program... engaged in discussions with the FDA... improved and restarted our manufacturing process, and secured $140 million in equity funding... Looking ahead, 2025 will be a critical inflection point...” .
Regulatory stance: “FDA agrees that the Phase 3 PROACT 1 study could be sufficient to support a potential BLA submission... accelerated approval pathway is available... could consider eGFR slope as a surrogate endpoint...” .
Clinical execution: Interim REGEN-007 results showing 18-month stabilization in kidney function for advanced CKD patients; full Group 1 dataset targeted for Q2 2025 .

No Q4 2024 earnings call transcript was available in our document set; management disclosures were via 8-K press releases and financial statements .

Q4 2024 EPS: Consensus mean $(0.148)* vs actual $(0.17)* → miss of $(0.02); revenue consensus $0.000* vs actual $0.076M* → beat. Values retrieved from S&P Global.
of estimates: EPS (5); Revenue (2). Values retrieved from S&P Global.

FDA’s confirmation of accelerated approval pathway and PROACT 1 sufficiency is the central de-risking event; next inflection mid-2025 on surrogate endpoint details .
Liquidity provides multi-year runway into mid-2027, supporting completion of key trials and regulatory interactions without near-term financing needs .
Program focus sharpened by discontinuing PROACT 2; resource concentration on PROACT 1 aligns with FDA feedback and should streamline execution .
Near-term catalysts: full Group 1 REGEN-007 data in Q2 2025; FDA Type B meeting update mid-2025 regarding accelerated approval pathway specifics .
Operating losses persist as typical for pre-commercial biotech; watch R&D/G&A trajectories and any further facility/impairment impacts .
Trading implications: headline sensitivity around accelerated approval pathway details and Phase 2 readout; narrative remains binary around regulatory acceptance of surrogate and Phase 3 enrollment/progress .

Additional detailed data extracted:

Full-year 2024 financials:

Liquidity at 12/31/24: $358.3M; net loss before NCI: $(163.3)M; R&D: $127.7M; G&A: $56.1M .
Cash and cash equivalents at 12/31/24: $99.1M; cash flow used in operations FY 2024: $(126.4)M .

Clinical program definitions:

PROACT 1: single, large, multi-center, sham-controlled Phase 3; primary composite endpoint includes ≥40% eGFR decline, eGFR <15, chronic dialysis/transplant, or renal/CV death .
REGEN-007: Phase 2 open-label randomized two arms; Group 1 mimics PROACT 1 dosing; Group 2 uses trigger-based dosing; purpose is safety/efficacy/durability of up to two injections .

Notes:

Values marked with * retrieved from S&P Global.
No Q4 earnings call transcript found in our document catalog; analysis relies on 8-K press releases and financial statements.

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