Executive Summary

Bellerophon reported Q3 2022 net loss of $5.07M (–9.4% y/y to $(0.53) EPS) as R&D spend remained focused on the Phase 3 REBUILD trial in fibrotic ILD; cash and cash equivalents were $11.32M at quarter-end .
The FDA accepted a reduction in REBUILD’s sample size from 300 to 140 patients, maintaining >90% power on MVPA; management now expects enrollment completion in Q1 2023 and pivotal top-line data in Q3 2023—an important de-risking and timeline acceleration for the program .
Operating expenses decreased sequentially (R&D $3.75M; G&A $1.37M), yet net loss widened q/q due to the absence of a $2.42M income tax benefit that aided Q2 results .
No financial guidance was issued; the key near-term stock catalysts are REBUILD enrollment completion and top-line data timing, along with financing visibility given the cash balance trajectory .

What Went Well and What Went Wrong

FDA accepted study size reduction to 140 patients in REBUILD without changing objectives/endpoints and with >90% power, accelerating timelines; “we are well-positioned to accelerate the completion… expect to complete enrollment in Q1 2023… pivotal top-line data in Q3 2023” .
Enrollment progress strong: “now approximately 85% enrolled,” supporting Q1 2023 completion and Q3 2023 readout .
Cost discipline in G&A: G&A fell to $1.37M vs $1.77M y/y, driven by lower labor and stock-based compensation costs .

Cash burn: cash and cash equivalents decreased to $11.32M from $24.74M at year-end 2021, reflecting funding needs for Phase 3 REBUILD .
Sequential net loss widened to $5.07M vs $4.11M in Q2 despite lower opex, as Q2 benefited from a $2.42M income tax benefit that did not recur in Q3 .
No revenue and ongoing operating losses continue until clinical milestones translate to regulatory/partnering outcomes; total operating expenses were $5.12M in Q3 (vs $4.80M y/y) as development progressed .

Metric	Q1 2022	Q2 2022	Q3 2022
Net Loss ($MM)	$5.64	$4.11	$5.07
Diluted EPS ($)	$(0.59)	$(0.43)	$(0.53)
R&D Expense ($MM)	$4.41	$4.49	$3.75
G&A Expense ($MM)	$1.23	$2.05	$1.37
Total Operating Expenses ($MM)	$5.64	$6.54	$5.12
Income Tax Benefit ($MM)	$0.00	$2.42	$0.00
Cash & Cash Equivalents (end-period, $MM)	$20.00	$16.33	$11.32

Notes:

The company reported no revenue; statements present operating expenses and net loss without a revenue line .

KPI	Q1 2022	Q2 2022	Q3 2022
REBUILD Phase 3 Enrollment Status	Enrollment progressing	Enrollment continuing	~85% enrolled; completion expected Q1 2023
REBUILD Study Size	Planned 300	Planned 300	Reduced to 140; >90% power on MVPA
Top-line Timing (REBUILD)	Not provided	Not provided	Q3 2023 anticipated

Metric	Period	Previous Guidance	Current Guidance	Change
REBUILD Study Size (patients)	Study design	300 (Phase 3 plan)	140 (FDA-accepted)	Raised/Lowered: Lowered sample size; statistical power maintained
REBUILD Enrollment Completion	Program timeline	Not provided	Q1 2023 completion expected	New timeline
REBUILD Top-line Readout	Program timeline	Not provided	Q3 2023 anticipated	New timeline

No revenue/margin/OpEx financial guidance was issued in the quarter .

Note: No earnings call transcript was available in our document set for Q3 2022; themes are derived from company 8-K press releases.

Topic	Previous Mentions (Q1 2022, Q2 2022)	Current Period (Q3 2022)	Trend
REBUILD Phase 3 Enrollment	“Enrollment is continuing/progressing” with MVPA primary endpoint	~85% enrolled; completion Q1 2023	Accelerating; clear completion timeline
Regulatory Interactions	Planning and ongoing dialogue; Phase 3 design reiterated	FDA accepted reducing study size to 140, maintaining >90% power	Positive regulatory update; de-risked trial execution
PH-Sarc Program	Positive Phase 2 acute hemodynamic data; FDA-cleared exploratory chronic study design	Next steps under assessment	Pause/assessment; remains optionality beyond fILD
Operating Expenses	R&D elevated for REBUILD; G&A trending lower	R&D $3.75M; G&A $1.37M; total opex down q/q	Cost discipline in G&A; R&D tied to Phase 3 cadence
Liquidity/Cash	Cash $20.0M (Q1)	Cash $11.32M (Q3)	Lower cash; financing visibility increasingly important

“We continue to achieve important progress in advancing the ongoing REBUILD Phase 3 trial of INOpulse… approximately 85% enrolled. We expect that enrollment will conclude in the first quarter of 2023, with the reporting of pivotal top-line data in third quarter of 2023.” — Peter Fernandes, Principal Executive Officer .
“With this study size change, we believe that we are well-positioned to accelerate the completion of our Phase 3 REBUILD study… anticipate the availability of pivotal top-line data in the third quarter of 2023.” — Naseem Amin, Chairman .
“The target of 140 subjects maintains a statistical power of greater than 90% for MVPA… accepted by the FDA as the primary endpoint for the Phase 3 REBUILD study.” — Peter Fernandes .
“The revised study size is based on an effect size generated from Phase 2 study data in 44 patients… the trial remains adequately powered to demonstrate a statistically significant result on MVPA.” — Dr. Steven D. Nathan, Chair of REBUILD Steering Committee .

No Q3 2022 earnings call transcript was available in our dataset; no Q&A details could be reviewed or corroborated from primary sources.

S&P Global (Capital IQ) Wall Street consensus for Q3 2022 was unavailable via the estimates tool for BLPH at the time of analysis.
Third-party source indicates EPS of $(0.53) vs consensus $(0.59), a ~$0.06 beat; revenue not applicable given no reported revenue .
Given the unavailability of S&P Global data, investors should treat third-party estimate references as indicative and confirm with broker or S&P feeds.

FDA acceptance of the REBUILD sample size reduction to 140 patients, while maintaining >90% power on MVPA, is a meaningful de-risking and timeline acceleration into Q3 2023 top-line data—an identifiable binary catalyst window .
Execution remains solid: ~85% enrolled with clear line of sight to Q1 2023 completion; operational focus has shifted to efficient trial closure .
P&L dynamics reflect trial cadence: opex down q/q, but Q2’s $2.42M tax benefit non-recurring drove a sequential widening of net loss in Q3; expect variability around non-operating items to continue .
Liquidity tightening: cash fell to $11.32M; absent partnering/non-dilutive funding, financing needs are likely prior to top-line—monitor capital raises and associated dilution risk .
Secondary asset optionality in PH-Sarc persists (positive Phase 2 acute data; FDA-cleared exploratory chronic study), but near-term valuation largely hinges on REBUILD readout .
With no revenue and non-GAAP adjustments not emphasized, the trading setup is catalyst-driven; positioning should reflect binary risk around Q3 2023 top-line and interim financing outcomes .
Absent an earnings call transcript, communication has been primarily via press releases; any future conference or KOL updates could influence sentiment ahead of readout .