Bellerophon Therapeutics

Conference Call I June 5, 2023

Forward Looking Statements

This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make due to a number of important factors, including risks and uncertainties relating to: INOpulse® not proving to be an effective treatment or approved for marketing by the FDA, the timing and outcomes of our ongoing and expected clinical trials for our product candidates; our ability to successfully develop, commercialize and market any of our product candidates; our ability to obtain, maintain and enforce intellectual property rights; competition; our reliance on third parties; our ability to obtain necessary financing; and those risk factors discussed in the "Risk Factors" section and elsewhere in our most recent Form 10-K and other periodic filings we make with the SEC.

All forward-looking statements contained in this presentation reflect our current views with respect to future events. We assume no obligation, except as required by applicable law, to update any forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Bellerophon Therapeutics Overview | June 2023

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Pivotal Phase 3 Trial Design

145 patients

fILD patients

at risk for

associated PH

Pulsed iNO45 µg/kg

1:1

Placebo

4 months

Open label extension

patients continue on iNO45 or switch

from placebo to iNO45

4 months

Primary Endpoint

  • Change in MVPA assessed by Actigraphy

Additional Endpoints

  • Change in Overall Activity assessed by Actigraphy
  • Patient Reported Outcomes (SGRQ, UCSD)
  • Time to Clinical Worsening

Safety

Bellerophon Therapeutics Overview | June 2023

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REBUILD Demographics

Demographics were balanced between the arms

INO45

Placebo

Total Patients

75

70

Intermediate/High Probability of PH

31 (41.3%)

29 (41.4%)

Low Probability of PH

44 (58.7%)

41 (58.6%)

Age - Mean (SD)

67.8 (9.5)

68.7 (9.4)

Male (%)

64.0%

60.0%

Race (%)

White

81.3%

80.0%

Black or African American

10.7%

14.3%

Asian

2.7%

2.9%

Other

5.3%

2.9%

BMI - Mean (SD)

29.20 (4.87)

29.41 (4.36)

Baseline MVPA - Mean (SD)

66.3 (46.8)

67.9 (53.4)

Baseline 6 minute walk distance - Mean (SD)

267.3 (69.2)

266.3 (75.9)

MVPA in minutes per day; 6 minute walk distance in meters

Bellerophon Therapeutics Overview | June 2023

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REBUILD Primary Endpoint (MVPA)

Trial did not meet its primary endpoint of change in MVPA (moderate to vigorous physical activity)

iNO45

Placebo

Placebo Corrected Change

Change from Baseline LS Mean (SE)

-9.22 (3.51)

-3.74 (3.76)

-5.49

min/day

min/day

min/day

(p=0.2646*)

Analysis based on all randomized subjects who received at least one dose of study treatment (defined as minimum use of 12 hours); Statistical analysis are calculated from MMRM (mixed model repeat measures) including the treatment group, visit, treatment-by-visit interaction, stratification factors (PH, CTD, PDE5) and baseline as fixed effects.

*p-value calculated based MMRM analysis of log-transformed MVPA as specified in statistical analysis plan

Bellerophon Therapeutics Overview | June 2023

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Bellerophon Therapeutics Inc. published this content on 05 June 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 05 June 2023 16:18:31 UTC.