Bellerophon Therapeutics, Inc. (BLPH) SEC Filing 8-K Material Event for the period ending Thursday, March 31, 2022

Bellerophon Therapeutics, Inc.

CIK: 1600132 Ticker: BLPH

Exhibit 99.1


Bellerophon Provides Clinical Program Update and Reports Full-Year 2021 Financial Results

WARREN, N.J., March 31, 2022 – 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 year ended December 31, 2021.

“The development of our INOpulse® inhaled nitric oxide therapy platform remains our foremost priority, in order to address the significant unmet needs in fibrotic interstitial lung disease, or fILD, and pulmonary hypertension associated with sarcoidosis, or PH-Sarc,” said Naseem Amin, M.D., Chairman of Bellerophon’s Board of Directors. “Late in 2021, we were pleased to report positive top-line results from our Phase 2 proof-of-concept study of INOpulse in PH-Sarc, demonstrating that iNO provided a clinically meaningful reduction in pulmonary vascular resistance. We are working with our steering committee of pulmonary disease experts to assess next steps for our PH-Sarc program, including the design of a follow-up Phase 2b study to evaluate the longer-term benefits of iNO in this disease area. With our fILD program, our pivotal Phase 3 REBUILD study is continuing to enroll and we look forward to providing additional updates on the status of this clinical trial in the coming months. Our balance sheet, with $24.7 million in cash and cash equivalents, provides us with continued resources to advance our late-stage development programs.”

Clinical Program Highlights:


REBUILD Phase 3 Study: In December 2020, Bellerophon announced that the first patient had been enrolled in its Phase 3 REBUILD registrational study of INOpulse for the treatment of fILD. The REBUILD study plans to enroll 300 fILD patients who will be treated with either INOpulse at a dose of iNO45 or placebo. The primary endpoint is change in moderate to vigorous physical activity (MVPA). If approved, INOpulse would become the first therapy to treat a broad fILD population that includes patients at low-, intermediate- and high-risk of pulmonary hypertension.

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. Acute treatment with INOpulse showed benefit in multiple cardiopulmonary parameters, including pulmonary vascular resistance, which improved by 21%, and mean pulmonary arterial pressure, which improved by 12%. Chronic treatment with INOpulse at a dose of iNO45 assessed over four months showed an average improvement in MVPA of 20% as compared to placebo. The improvements in MVPA were supported by benefits in overall activity, as well as two patient reported questionnaires, the University of California, San Diego Shortness of Breath Questionnaire and the St. George’s Respiratory Questionnaire.

Pulmonary Hypertension-Sarcoidosis (PH-Sarc)

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). PH-Sarc is an unmet medical need with no approved therapies, and a median survival of approximately five years after


diagnosis. The Phase 2 trial was designed as a proof-of-concept study to determine if iNO could demonstrate hemodynamic benefit in PH-Sarc.

All eight subjects demonstrated decreases in mean pulmonary arterial pressure (mPAP) and pulmonary vascular resistance (PVR) across the doses of INOpulse utilized in the study. The dose of iNO45 (45 mcg/kg IBW/hr) resulted in a median drop of 20% (-54% to +22%) in PVR, compared to a median baseline PVR of 329 dyne/cm.sec-5; a reduction of 20% or more in PVR is generally considered to be clinically meaningful. Along with the improvements in PVR, mPAP decreased by a median of 6-10% across the doses of iNO30 to iNO125, compared to a median baseline mPAP of 37.2 mmHg. No treatment-emergent adverse events (TEAEs) or serious adverse events (TESAEs) occurred during the acute hemodynamic dose escalation phase of the study.

Corporate Update:

In January 2022, the Company presented at the H.C. Wainwright 2022 Conference.

2021 Year End Financial Results:

For the year ended December 31, 2021, the Company reported a net loss of $17.8 million, or $(1.87) per share, compared to net loss of $24.7 million, or $(3.17) per share, in the year ended December 31, 2020.

Net loss for the year ended December 31, 2021 included an income of $0.6 million due to a change in fair value of the Company’s common stock warrant liability, as compared to an expense of $0.3 million in the year ended December 31, 2020.

Research and development expenses for the year ended December 31, 2021 were $13.0 million, compared to $17.9 million in the year ended December 31, 2020. The decrease was primarily attributable to the decrease in expenses related to the discontinuation of the COVID-19 trial in 2021.

General and administrative expenses for the year ended December 31, 2021 were $7.1 million, compared to $8.4 million for the year ended December 31, 2020. The decrease was primarily due to reduced consulting and labor costs.

Balance Sheet
As of December 31, 2021, the Company had cash and cash equivalents of $24.7 million, compared to cash and cash equivalents of $47.6 million at December 31, 2020. 

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


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.


LifeSci Advisors:

Brian Ritchie

(212) 915-2578


Bellerophon Therapeutics, Inc.

Consolidated Balance Sheets

(Amounts in thousands, except share and per share data)


December 31, 2021


December 31, 2020






Current assets:





Cash and cash equivalents





Restricted cash





Prepaid expenses and other current assets





Total current assets





Restricted cash, non-current





Right of use assets, net





Property and equipment, net





Other non-current assets



Total assets





Liabilities and Stockholders' Equity





Current liabilities:





Accounts payable





Accrued research and development





Accrued expenses





Current portion of operating lease liabilities





Total current liabilities





Long term operating lease liabilities





Common stock warrant liability





Total liabilities





Commitments and contingencies





Stockholders' equity:





Common stock, $0.01 par value per share; 200,000,000 shares authorized and 9,545,451 and 9,491,111 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively





Preferred stock, $0.01 par value per share; 5,000,000 shares authorized, zero shares issued and outstanding at December 31, 2021 and December 31, 2020



Additional paid-in capital





Accumulated deficit





Total stockholders' equity





Total liabilities and stockholders' equity






Bellerophon Therapeutics, Inc.

Consolidated Statement of Operations and Comprehensive Loss

(Amounts in thousands, except share and per share data)

Year Ended

December 31, 



Operating expenses:




Research and development





General and administrative





Total operating expenses





Loss from operations





Change in fair value of common stock warrant liability





Warrant amendment charge



Interest income and financing expenses, net





Pre-tax loss





Income tax benefit





Net loss and comprehensive loss





Weighted average shares outstanding:















Net loss per share:






















Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): March 31, 2022

Bellerophon Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)






(State or Other Jurisdiction of Incorporation)

File Number)

(IRS Employer
Identification No.)

184 Liberty Corner Road, Suite 302
Warren, New Jersey



(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code: (908) 574-4770

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class


Trading Symbol(s)


Name of each exchange on which registered

Common Stock, $0.01 par value per share


The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Item 2.02. Results of Operations and Financial Condition.

On March 31, 2022, Bellerophon Therapeutics, Inc. issued a press release announcing its financial and operational results for the year ended December 31, 2021. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits:

Exhibit No.




Press Release dated March 31, 2022 (furnished and not filed for purposes of Item 2.02)


Cover Page Interactive Data File (Formatted as Inline XBRL)



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.


Date: March 31, 2022


/s/ Nicholas Laccona

Name: Nicholas Laccona
Title: Principal Financial Officer and Principal Accounting Officer


View differences made from one to another to evaluate Bellerophon Therapeutics, Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 8-K Corporate News to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Bellerophon Therapeutics, Inc..


Assess how Bellerophon Therapeutics, Inc.'s management team is paid from their Annual Proxy

Definitive Proxy Statement (Form DEF 14A)
Screenshot example of actual Proxy Statement

Bellerophon Therapeutics, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2022 10-K Annual Report includes:

  • Voting Procedures
  • Board Members
  • Executive Team
  • Salaries, Bonuses, Perks
  • Peers / Competitors



Financial Statements, Disclosures and Schedules

Inside this 8-K Corporate News

Material Contracts, Statements, Certifications & more

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

Ticker: BLPH
CIK: 1600132
Form Type: 8-K Corporate News
Accession Number: 0001600132-22-000009
Submitted to the SEC: Thu Mar 31 2022 4:04:09 PM EST
Accepted by the SEC: Thu Mar 31 2022
Period: Thursday, March 31, 2022
Industry: Pharmaceutical Preparations
  1. Earnings Release
  2. Financial Exhibit

External Resources:
Stock Quote
Social Media

Bookmark the Permalink: