UNITED STATES
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WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01. Other Events.
On June 5, 2023, Bellerophon Therapeutics, Inc. (the “Company”) issued a press release announcing top-line data of its Phase 3 REBUILD clinical trial of INOpulse® for the treatment of fibrotic interstitial lung disease. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein. The Company also provided slides to be presented on an investor conference call to review these results, a copy of which is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein.
The Company will conduct the conference call to review these results on June 5, 2023, at 8:30 a.m., Eastern Time.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits:
| Exhibit No. | Description | |
| 99.1 | Press Release dated June 5, 2023. | |
| 99.2 | Slide Presentation dated June 5, 2023. | |
| 104 | Cover Page Interactive Data File (Formatted as Inline XBRL) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BELLEROPHON THERAPEUTICS, INC. | ||
| Date: June 5, 2023 | By: | /s/ Peter Fernandes |
| Name: Peter Fernandes Title: Chief Executive Officer | ||
Exhibit 99.1
Bellerophon Announces Top-Line Data from Phase 3 REBUILD Clinical Trial of INOpulse® for Treatment of Fibrotic Interstitial Lung Disease
| - | Trial did not meet its primary endpoint related to the change in moderate to vigorous physical activity |
| - | INOpulse® was safe and well-tolerated, consistent with the overall safety profile demonstrated in Phase 2 and other INOpulse® programs in PH-COPD and PH-Sarcoidosis |
| - | Company to host conference call and webcast with slides today at 8:30 AM ET |
WARREN, N.J., June 5, 2023 – Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced top-line results from its pivotal Phase 3 REBUILD clinical trial evaluating the safety and efficacy of INOpulse® for the treatment of fibrotic Interstitial Lung Disease (fILD).
The REBUILD clinical trial was designed as a randomized, double-blind, placebo-controlled Phase 3 study evaluating the safety and efficacy of INOpulse® for the treatment of patients with fILD. A total of 145 fILD patients were enrolled and treated with either INOpulse® at a dose of iNO45 or a placebo. The primary endpoint was the change in moderate to vigorous physical activity (MVPA) as measured by actigraphy after 16 weeks of chronic treatment.
The trial did not meet its primary endpoint, with iNO45 performing worse than placebo by 5.49 minutes per day (p=0.2646). The secondary endpoints demonstrated minimal difference between the two groups with none approaching statistical significance. Overall, INOpulse® was well-tolerated with no safety concerns, consistent with what has been observed in the prior Phase 2 studies.
Key REBUILD clinical trial secondary endpoints and safety outputs assessed over 16 weeks of blinded treatment included:
| · | Overall Activity showed 3.51 count/min benefit in favor of iNO45 (p=0.8572) |
| · | 6 Minute Walk Distance showed 0.19 meter benefit in favor of iNO45 (p=0.9866) |
| · | Patient reported outcomes (St. George’s Respiratory Questionnaire and UCSD Shortness of Breath) were slightly in favor of placebo, while time to event assessments (Clinical Worsening, Clinical Deterioration and Clinical Improvement) showed little difference and none were statistically significant |
| · | Subjects with treatment emergent adverse events was slightly in favor of placebo (84.0% vs 74.3%) |
| · | Subjects with serious treatment emergent adverse events was balanced (20% vs 21.4%) |
| · | Deaths were balanced (4.0% vs 4.3%) |
“The REBUILD study did not match the outcomes we saw in the exploratory Phase 2 study in this patient population; however, the overall outcome of this pivotal validation study is conclusive and we do not see a path forward for continuing the REBUILD trial,” said Peter Fernandes, Bellerophon’s Chief Executive Officer. “On behalf of Bellerophon, I would like to thank all the patients, clinical trial sites, and investigators for participating and supporting the conduct of this pivotal study, allowing us to bring closure to the REBUILD clinical study.”
For more information on the REBUILD Phase 3 clinical study of INOpulse for the treatment of fILD, please visit ClinicalTrials.gov and reference Identifier NCT0326710.
Conference Call and Webcast Information
Bellerophon management will host a conference call and webcst with slides today at 8:30 AM ET. The dial-in number for the conference call is 877-407-0792 (U.S./Canada) or 201-689-8263 (international). The conference ID for all callers is 13739289. The live webcast and replay may be accessed at https://viavid.webcasts.com/starthere.jsp?ei=1619849&tp_key=d528204b2c.
About Bellerophon
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The Company is currently developing multiple product candidates under its INOpulse® program, a proprietary pulsatile nitric oxide delivery system. For more information, please visit www.bellerophon.com.
Forward-looking Statements
Any statements in this press release about Bellerophon’s future expectations, plans, and prospects, including statements about the clinical development of its product candidates, regulatory actions with respect to the Company’s clinical trials, and expectations regarding the sufficiency of the Company’s cash balance to fund clinical trials, operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks and uncertainties relating to INOpulse®, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary or interim results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, the FDA’s substantial discretion in the approval process, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and in subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent Bellerophon’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.
Contacts
LifeSci Advisors:
Brian Ritchie
(212) 915-2578
britchie@lifesciadvisors.com
Exhibit 99.2
Conference Call I June 5, 2023 Bellerophon Therapeutics
Bellerophon Therapeutics Overview | June 2023 2 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 3 Pivotal Phase 3 Trial Design Open label extension patients continue on iNO45 or switch from placebo to iNO45 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 145 patients fILD patients at risk for associated PH 4 months 4 months 1:1 Pulsed iNO45 µg/kg Placebo
Bellerophon Therapeutics Overview | June 2023 4 Demographics were balanced between the arms REBUILD Demographics INO45 Placebo Total Patients • Intermediate/High Probability of PH • Low Probability of PH 75 31 (41.3%) 44 (58.7%) 70 29 (41.4%) 41 (58.6%) Age – Mean (SD) 67.8 (9.5) 68.7 (9.4) Male (%) 64.0% 60.0% Race (%) • White • Black or African American • Asian • Other 81.3% 10.7% 2.7% 5.3% 80.0% 14.3% 2.9% 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 5 Trial did not meet its primary endpoint of change in MVPA (moderate to vigorous physical activity) REBUILD Primary Endpoint (MVPA) Analysis based on all randomized subjects who received at least one dose of study treatment (defined as minimum use of 12 hou rs) ; 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 iNO45 Placebo Placebo Corrected Change Change from Baseline LS Mean (SE) - 9.22 (3.51) min/day - 3.74 (3.76) min/day - 5.49 min/day (p=0.2646*)
Bellerophon Therapeutics Overview | June 2023 6 Minimal difference between the two groups REBUILD Secondary Endpoints Analysis based on all randomized subjects who received at least one dose of study treatment (defined as minimum use of 12 hou rs) ; 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 UCSD SOBQ (University of California Shortness of Breath Questionnaire); SGRQ (St. George’s Respiratory Questionnaire); higher sc ores indicate deterioration Endpoint INO45 Placebo Placebo Corrected Change p - value Overall Activity - 74.36 counts/min - 77.88 counts/min +3.51 count/min 0.8572* UCSD SOBQ +4.27 points - 0.25 points +4.52 points 0.1397 SGRQ – Total +4.83 points +3.97 points +0.86 points 0.6929 SGRQ – Activity +4.77 points +1.97 points +2.79 points 0.2198 SGRQ – Impacts +5.21 points +4.12 points +1.09 points 0.6910 6 minute walk distance - 12.36 meters - 12.54 meters +0.19 meters 0.9866
Bellerophon Therapeutics Overview | June 2023 7 REBUILD Secondary Endpoints (time to event) Time to event, defined as first event, otherwise censored to the end date of the double - blind period. Log - Rank p - value is calculated from log rank test comparing INOpulse treatment group to placebo. Time to Clinical Worsening Time to Clinical Deterioration Time to Clinical Improvement p=0.7466 p=0.8583 p=0.9152
Bellerophon Therapeutics Overview | June 2023 8 Overall Safety profile was balanced REBUILD Safety Assessment Safety analysis based on all subjects who received at least one dose post randomization (defined as exposure to INOpulse of a ny duration) of treatment intervention. TEAE (treatment emergent adverse event) is defined as an AE with onset after the administration of treatment intervention thr oug h the end of the study or any event that was present at baseline but worsened in intensity or was subsequently considered drug - related by the investigator through the end of the stu dy. If a subject experienced more than 1 event in a given category, that subject is counted only once in that category. INO45 Placebo Subjects with TEAE 84.0% 74.3% Subject with Serious TEAE 20.0% 21.4% Death 4.0% 4.3%
Investor Contacts Bellerophon Investor Relations BTInvestorRelations@bellerophon.com Brian Ritchie I LifeSci Advisors britchie@lifesciadvisors.com 212 - 915 - 2578