Sign in

You're signed outSign in or to get full access.

BT

Bellerophon Therapeutics, Inc. (BLPH)·Q2 2022 Earnings Summary

Executive Summary

  • Q2 2022 was an execution quarter focused on advancing INOpulse in fILD and PH‑Sarc; the company reported a net loss of $4.1M ($0.43 per share) with higher R&D tied to Phase 3 REBUILD enrollment .
  • FDA cleared an exploratory Phase 2 chronic treatment study in PH‑Sarc, adding a clinical catalyst alongside ongoing REBUILD enrollment in fILD .
  • Balance sheet cash was $16.3M at quarter‑end, down from $24.7M at year‑end 2021 and $20.0M in Q1 2022, reflecting clinical trial spend .
  • Wall Street consensus estimates (EPS/revenue) from S&P Global were unavailable for BLPH this quarter; results are therefore assessed vs prior periods and program milestones (S&P Global consensus unavailable).

What Went Well and What Went Wrong

What Went Well

  • FDA clearance to conduct an exploratory Phase 2, double‑blinded, placebo‑controlled chronic treatment study in PH‑Sarc (six months), building on positive acute hemodynamic data (median PVR reduction ~20%) .
  • Continued enrollment progress in the pivotal Phase 3 REBUILD study in fILD; management reiterated the design (n=300, iNO45 vs placebo, MVPA primary endpoint) and the potential to be first therapy to treat broad fILD including varying PH risk .
  • Management tone emphasized steady advancement: “Enrollment is steadily proceeding in our Phase 3 REBUILD study… we recently received clearance… to conduct a follow‑up exploratory Phase 2 chronic treatment clinical trial [in PH‑Sarc]” — Chairman Naseem Amin, M.D. .

What Went Wrong

  • Net loss widened year over year to $4.1M vs $3.4M in Q2 2021, driven by higher R&D from Phase 3 activities; operating expenses rose to $6.5M vs $5.2M in Q2 2021 .
  • Cash declined sequentially to $16.3M from $20.0M in Q1 2022 and $24.7M at year‑end 2021, tightening funding flexibility amid continued trial execution .
  • No financial guidance or earnings call transcript available to frame near‑term OpEx trajectory or timing/milestones beyond the exploratory PH‑Sarc Phase 2 clearance and ongoing REBUILD enrollment (press release furnished without guidance) .

Financial Results

MetricQ2 2021Q1 2022Q2 2022
Net Loss ($USD Millions)$(3.389) $(5.641) $(4.105)
Diluted EPS ($)$(0.36) $(0.59) $(0.43)
Research & Development ($USD Millions)$3.239 $4.409 $4.488
General & Administrative ($USD Millions)$1.987 $1.233 $2.053
Total Operating Expenses ($USD Millions)$5.226 $5.642 $6.541

Balance Sheet Highlights

MetricDec 31, 2021Mar 31, 2022Jun 30, 2022
Cash & Cash Equivalents ($USD Millions)$24.736 $20.000 $16.328
Total Assets ($USD Millions)$26.875 $21.745 $17.730
Total Stockholders’ Equity ($USD Millions)$21.619 $16.170 $12.280
Accounts Payable ($USD Millions)$1.192 $2.193 $2.007

Clinical/Program KPIs

KPIQ4 2021 (FY context)Q1 2022Q2 2022
REBUILD Phase 3 (fILD) statusContinuing enrollment; MVPA primary endpoint; target n=300; iNO45 vs placebo Enrollment progressing post COVID moderation; reiteration of design Enrollment steadily proceeding; same design and endpoint
PH‑Sarc program statusPositive Phase 2 acute hemodynamics: median PVR −20%; mPAP −6–10%; no TEAEs/TESAEs in dose escalation Ongoing work on follow‑up chronic study design; intent to discuss with FDA FDA clearance for exploratory Phase 2 chronic treatment study (six months)

Segment breakdown: Not applicable; BLPH is a clinical‑stage biotherapeutics company with no commercial revenue lines reported in these periods .

Guidance Changes

No financial guidance (revenue, margins, OpEx, tax, dividends) was provided in Q2 2022; communications focused on clinical milestones and program execution .

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial guidance (revenue/margins/OpEx)FY/Q2 2022None provided None provided Maintained (no guidance)
Clinical milestones2022REBUILD enrollment ongoing; PH‑Sarc follow‑up trial under discussion REBUILD enrollment ongoing; PH‑Sarc exploratory Phase 2 cleared by FDA Raised clarity (regulatory clearance)

Earnings Call Themes & Trends

No Q2 2022 earnings call transcript was available; strategic themes below reflect press releases across quarters.

TopicPrevious Mentions (Q4 2021)Previous Mentions (Q1 2022)Current Period (Q2 2022)Trend
INOpulse in fILDPhase 3 REBUILD continuing; MVPA endpoint; potential first broad fILD therapy Enrollment progressing; reiteration of positive Phase 2 signals Enrollment steadily proceeding in REBUILD Consistent execution
PH‑Sarc programPositive Phase 2 acute hemodynamics; median PVR −20% Designing chronic treatment trial; planning FDA discussion FDA clearance for exploratory chronic Phase 2 Advancing (regulatory progress)
R&D executionFY21 R&D $13.0M; COVID‑19 trial discontinuation lowered prior spend R&D increased due to Phase 3 fILD R&D increased y/y due to Phase 3 fILD Elevated spend for trials
Corporate/IRH.C. Wainwright conference in Jan 2022 Balance sheet commentary (cash $20M) ATS 2022 poster presentation in PH‑Sarc ; May ATS poster press release [Nasdaq link, May 12, 2022]Ongoing scientific engagement

Sources: and May ATS 2022 press release .

Management Commentary

  • “Enrollment is steadily proceeding in our Phase 3 REBUILD study in fILD… we recently received clearance from the FDA to conduct a follow‑up exploratory Phase 2 chronic treatment clinical trial to evaluate the safety and efficacy of INOpulse in PH‑Sarc patients.” — Naseem Amin, M.D., Chairman .
  • “We remain focused on the continued advancement of our late‑stage INOpulse… Enrollment is progressing in our pivotal Phase 3 REBUILD study… we are working with key pulmonary disease experts on the design of a follow‑up Phase 2 chronic treatment trial [PH‑Sarc].” — Naseem Amin, M.D. (Q1 release) .
  • Clinical rationale reinforced by prior data: acute INOpulse treatment improved PVR by 21% and mPAP by 12% in fILD Phase 2; chronic iNO45 showed ~20% average MVPA improvement vs placebo .

Q&A Highlights

  • No Q2 2022 earnings call transcript was available; the company furnished results via press release without hosting an identifiable call in filings/IR. Key clarifications came through the press release: R&D increases attributed to Phase 3 fILD trial; FDA clearance obtained for PH‑Sarc exploratory chronic study .

Estimates Context

  • S&P Global consensus estimates (EPS and revenue) for BLPH Q2 2022 were unavailable; as a result, results are assessed vs prior year and prior quarter and relative to program milestones (S&P Global consensus unavailable).

Key Takeaways for Investors

  • Clinical execution remains the central driver: Phase 3 REBUILD enrollment in fILD continued; any interim enrollment updates or data milestones are potential stock catalysts .
  • Regulatory advancement in PH‑Sarc: FDA clearance for an exploratory chronic Phase 2 study enhances the pipeline’s breadth and adds a nearer‑term newsflow item .
  • Operating expenses rose with trial activity; R&D spend increased y/y (Q2: $4.5M vs $3.2M) and total OpEx rose to $6.5M, underscoring continued cash usage during pivotal execution .
  • Cash declined to $16.3M at quarter‑end; investors should monitor financing needs and timing relative to trial milestones .
  • Prior Phase 2 signals (fILD MVPA +20%, PH‑Sarc PVR −20%) support the mechanistic rationale; successful execution/positive readouts could reshape risk‑reward .
  • Near‑term focus: enrollment cadence, trial site activity, and any updates around the PH‑Sarc chronic study initiation; absence of consensus estimates implies narrative‑driven stock moves tied to clinical/regulatory disclosures (S&P Global consensus unavailable).

Sources

  • Q2 2022 8‑K and press release (Exhibit 99.1): results, clinical program updates, financial statements .
  • Q1 2022 8‑K press release and financials: prior‑quarter context .
  • FY 2021 press release and financials: year‑end baseline .
  • External press coverage of Q2 release and ATS poster: GlobeNewswire and Nasdaq press release pages .