UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): July 27, 2015
Bellerophon Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware |
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001-36845 |
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47-3116175 |
(State or Other Jurisdiction of |
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(Commission |
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(IRS Employer |
53 Frontage Road, Suite 301 |
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08827 |
(Address of Principal Executive Offices) |
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(Zip Code) |
Registrants 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):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition.
Although it has not finalized its full financial results for its second quarter ended June 30, 2015, Bellerophon Therapeutics, Inc. (the Company) will announce during a conference call on July 27, 2015 that it estimates that it had approximately $50.0 million in cash and cash equivalents as of June 30, 2015.
The information contained in this Item 2.02 is preliminary and unaudited, and does not present all information necessary for an understanding of the Companys results of operations for the second quarter ended June 30, 2015 and financial condition as of June 30, 2015.
The information in this Item 2.02 and in Exhibit 99.1 attached hereto shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the Securities Act), or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 7.01. Regulation FD Disclosure.
The Company issued a press release on July 27, 2015 announcing top-line results from its PRESERVATION I clinical trial for Bioabsorbable Cardiac Matrix. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information in this Item 7.01 and in Exhibit 99.1 attached hereto shall not be deemed filed for purposes of Section 18 of the Exchange Act, or incorporated by reference in any filing under the Securities Act 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 |
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Description |
99.1 |
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Press Release dated July 27, 2015 (furnished and not filed for purposes of Items 2.02 and 7.01) |
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.
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BELLEROPHON THERAPEUTICS, INC. | ||
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Date: July 27, 2015 |
By: |
/s/ Jonathan M. Peacock | |
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Name: Jonathan M. Peacock Title: Chairman and Chief Executive Officer |
EXHIBIT INDEX
Exhibit |
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Description |
99.1 |
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Press Release dated July 27, 2015 (furnished and not filed for purposes of Items 2.02 and 7.01) |
Exhibit 99.1
Bellerophon Therapeutics Announces Top-Line Results from PRESERVATION I Clinical Trial for Bioabsorbable Cardiac Matrix (BCM)
Management to Hold Conference Call This Morning at 8:30am ET
Hampton, NJ, July 27, 2015 Bellerophon Therapeutics, Inc. (Nasdaq: BLPH), a clinical stage biotherapeutics company with programs focused on the treatment of cardiopulmonary and cardiac diseases, today announced top-line results from its PRESERVATION I clinical trial for Bioabsorbable Cardiac Matrix (BCM), an investigational, implantable medical device being studied for the prevention of heart failure following an acute myocardial infarction (AMI), commonly known as a heart attack.
Topline results of the 303-patient, randomized, double-blind, placebo-controlled study, enrolled at 61 clinical sites in Australia, Europe, Israel and North America, showed no statistically significant treatment differences between patients treated with BCM and patients treated with placebo for both the primary and the secondary endpoints.
Safety data analyzed to date shows no significant difference in adverse event rates for patients in the BCM and placebo treatment groups.
The company plans to present detailed results from the trial on September 1, 2015 at the European Society of Cardiology meeting in London.
Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics, noted, We are clearly disappointed with the topline results from PRESERVATION I and will continue to investigate the full data set over the next few weeks and to reassess further clinical development of BCM. We continue to be enthusiastic about our pulmonary hypertension pipeline which leverages years of experience with Nitric Oxide therapy and a novel and proprietary delivery system for outpatient use. Of note, we are preparing to initiate the first of two Phase 3 trials for INOpulse® for the treatment of pulmonary arterial hypertension (PAH), a chronic and debilitating disease. We had approximately $50 million of cash on our balance sheet as of June 30, 2015 to fund this Phase 3 trial and we expect to enroll our first patient by the end of 2015. In addition, we are continuing to investigate the application of INOpulse for the treatment of pulmonary hypertension associated with COPD and Pulmonary Fibrosis
Conference Call
Management will hold a conference call this morning, July 27, 2015 to discuss todays announcement.
Time: 8:30 am ET
Dial-in numbers: (855) 539-0895 (US and Canada) or (412) 455-6027
Conference ID:95044590
Live webcast: www.bellerophon.com, under Investors tab
The teleconference replay will be available three hours after completion through August 1, 2015 at (404) 537-3406 or (855) 859-2056. The replay passcode is 95044590.
About BCM
Bellerophon Therapeutics BCM is a liquid medical device that is intended to prevent heart failure after a heart attack. BCM is administered through an injection into the coronary artery, leading to the damaged area of the heart, after an AMI. The injection is made during a minimally invasive procedure called percutaneous coronary intervention (PCI), a procedure which is commonly used when opening up cardiac blood vessels in patients and typically includes a stent placement.
Once BCM is deployed, it flows into damaged heart muscle where it forms a gel which acts as a protective meshwork, or scaffold, within the wall of the hearts left ventricle. This flexible scaffold provides physical support to the heart wall and is intended to prevent further damage, while the heart heals, after the AMI. BCM is bioabsorbable and eliminated from the body after the heart heals. Bellerophon has an exclusive worldwide license to BCM from BioLineRx Ltd.
About PRESERVATION I
PRESERVATION I evaluated the safety and effectiveness of BCM for the prevention of ventricular remodeling and heart failure when administered to patients who had successful PCI with stent placement after ST-Elevation Myocardial Infarction (STEMI). In the trial, patients were randomized to receive BCM (active treatment) or saline control (placebo treatment) in a 2:1 ratio two to five days following the initial PCI.
The primary endpoint for PRESERVATION I was the change in Left Ventricular End Diastolic Volume Index (LVEDVI) at six months compared to baseline. LVEDVI is an anatomic measurement of ventricular remodeling that was measured by 3-D and 2-D echocardiography.
The secondary endpoints for PRESERVATION I were Kansas City Cardiomyopathy Questionnaire (KCCQ) (summary score), six-minute walk test (6MWT), New York Heart Association (NYHA) functional classification (physician reported), time to cardiovascular death or non-fatal heart failure events or cardiovascular hospitalizations adjudicated by a Clinical Events Committee, and time to first re-hospitalization due to any cardiovascular event.
Safety was evaluated based on adjudication of cardiac serious adverse events by an independent Clinical Events Committee (CEC) and periodic reviews conducted by an independent Data Monitoring Committee (DMC).
About Bellerophon
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary and cardiac diseases. In addition to BCM, the Company is currently developing two product candidates under its INOpulse program, a proprietary pulsatile nitric oxide delivery device. The first is for the treatment of pulmonary arterial hypertension (PAH), for which the Company intends to commence Phase 3 clinical
trials in 2015, and the other for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD), which is in Phase 2 development.
For more information, visit www.bellerophon.com.
Forward-looking Statements
Any statements in this press release about Bellerophons future expectations, plans and prospects, including without limitation statements regarding the costs of Bellerophons clinical programs and the sufficiency of Bellerophons cash balance to fund operating expenses and capital expenditures, constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Bellerophons actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent Bellerophons views only as of the date of this press release. Bellerophon anticipates that subsequent events and developments will cause its views to change. While Bellerophon may elect to update these forward-looking statements at some point in the future, Bellerophon specifically disclaims any obligation to do so.
Contact
At Bellerophon: |
At Rx Communications Group: |
Amit Agrawal, Chief Operating Officer |
Melody Carey (Investors/Media), |
(908) 574-4841 |
(917) 322-2571 |
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