Bellerophon Therapeutics, Inc. (BLPH) 10-Q Quarterly Report August 2023

WARREN, N.J., May 15, 2023 – Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today provided a clinical program update and reported financial results for the first quarter ended March 31, 2023.

“We are pleased with the progress we have made to date in 2023, highlighted by the completion of the blinded treatment phase of our ongoing pivotal Phase 3 REBUILD trial,” said Peter Fernandes, Bellerophon’s Chief Executive Officer. “We expect to report top-line results from the study in the middle of this year, a critical milestone for the Company. Importantly, following the recent license agreement with Baylor Bioscience and having successfully completed a $5 million equity financing, we are well-capitalized through this critical milestone.”

Clinical Program Highlights:

Fibrotic Interstitial Lung Disease (fILD)

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REBUILD Phase 3 Study: The Company completed the blinded treatment phase of their pivotal Phase 3 REBUILD trial evaluating the safety and efficacy of INOpulse® for the treatment of patients with fILD and anticipates the availability of top-line results in mid-2023. A total of 145 fILD patients were enrolled and treated with either INOpulse at a dose of iNO45 or placebo. The Phase 3 program builds on positive top-line results from the Company’s previously reported Phase 2 studies for INOpulse® for the treatment of fILD which showed benefits in multiple cardiopulmonary parameters, including pulmonary vascular resistance and improvement in Moderate to Vigorous Physical Activity (MVPA) as measured by actigraphy after 16 weeks of chronic treatment. With a total of 145 patients enrolled, the study is powered >90%, (p-value of 0.01) for the primary endpoint of a change in MVPA measured by actigraphy. If approved, INOpulse would become the first therapy to treat a broad fILD population, including patients at low-, intermediate- and high-risk pulmonary hypertension.

Pulmonary Hypertension-Sarcoidosis (PH-Sarc)

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Phase 2 Clinical Study: In December 2021, Bellerophon reported positive top-line data from the completed Phase 2 dose escalation study of INOpulse® evaluating the acute hemodynamic benefit of INOpulse® via right heart catheterization for the treatment of pulmonary hypertension associated with sarcoidosis (PH-Sarc). Based on the benefits demonstrated in hemodynamic parameters and favorable safety profile, Bellerophon designed and submitted to the FDA a proposed exploratory Phase 2 double-blinded placebo-controlled study to investigate the safety and efficacy of iNO45 dosed chronically for six months in patients with PH-Sarc. Subsequently, the Company received FDA clearance to conduct the study and Bellerophon is currently assessing the next steps for the study.

The following information was filed by Bellerophon Therapeutics, Inc. (BLPH) on Monday, May 15, 2023 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Bellerophon Therapeutics, Inc.'s 10-Q Quarterly Report:

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If a contract is determined to be within the scope of ASC 606 at inception, we assess the goods or services promised within such contract, determines which of those goods and services are performance obligations, and assesses whether each promised good or service is distinct.

Financial - Expense Highlight
The increase is due to the one-time separation benefits costs associated with the reduction-in-force partially offset by the reduction in rent expenses related to the vacated office space combined with additional reductions in legal and consulting costs in connection with the termination of the Phase 3 clinical trial for fILD during the three months ended June 30, 2023.
M & A - Other Highlight
On July 19, 2023, we were notified by the Listing Qualifications Department (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") that in light of our previously disclosed workforce reduction plan and focus on exploring strategic alternatives, based upon the Staff's belief that we are a "public shell" as that term is defined in Nasdaq Listing Rule 5101 and our non-compliance with the $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2), we would be delisted from The Nasdaq Capital Market at the opening of business on July 28, 2023 unless we timely requested a hearing before a Nasdaq Hearings Panel (the "Panel") to address the deficiencies and present a plan to regain compliance.
Other - Other Highlight
The Offering was made pursuant to the Company's shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC"), originally filed on June 26, 2020 (File No. 333-239473), which the SEC declared effective on July 2, 2020, and a related prospectus supplement.
Financial - Shares Highlight
Registered Direct Offering On March 3, 2023, we entered into a subscription agreement with an institutional investor, pursuant to which we agreed to issue and sell in a registered direct offering (the "Offering") (i) an aggregate of 718,474 shares (the "Shares") of our common stock and (ii) pre-funded warrants (the "Pre-Funded Warrants") to purchase up to 1,781,526 shares of common stock.
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Financial Statements, Disclosures and Schedules

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Bellerophon Therapeutics, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32: Section 1350 Certification

Ticker: BLPH
CIK: 1600132
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-23-014867
Submitted to the SEC: Mon Aug 14 2023 4:30:39 PM EST
Accepted by the SEC: Mon Aug 14 2023
Period: Friday, June 30, 2023
Industry: Pharmaceutical Preparations

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