BLPH Bellerophon Therapeutics Inc.

6.35
-0.28  -4%
Previous Close 6.63
Open 6.51
52 Week Low 3.1859
52 Week High 26
Market Cap $60,310,884
Shares 9,497,777
Float 7,533,648
Enterprise Value $12,252,928
Volume 119,519
Av. Daily Volume 83,779
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Upcoming Catalysts

Drug Stage Catalyst Date
INOpulse
Pulmonary Hypertension-Sarcoidosis (PH-Sarc)
Phase 2
Phase 2
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INOpulse delivery device (REBUILD)
Pulmonary hypertension associated with Fibrotic Interstitial Lung Disease
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
INOpulse Inhaled Nitric Oxide
COVID-19
Phase 3
Phase 3
Phase 3 trial placed on clinical hold - November 23, 2020.
INOpulse delivery device
Pulmonary Arterial Hypertension (PAH)
Phase 3
Phase 3
Phase 3 trial stopped due to futility - August 7, 2018.

Latest News

  1. WARREN, N.J., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary and infectious diseases, today announced that Fabian Tenenbaum, Chief Executive Officer, will present a corporate overview at the H.C. Wainwright Virtual BioConnect 2021 Conference, being held January 11-14, 2021.

    The presentation will be available on-demand beginning on Monday, January 11, 2021, in the Investors section on the Company's website at www.bellerophon.com.

    About Bellerophon
    Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies that address significant…

    WARREN, N.J., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary and infectious diseases, today announced that Fabian Tenenbaum, Chief Executive Officer, will present a corporate overview at the H.C. Wainwright Virtual BioConnect 2021 Conference, being held January 11-14, 2021.

    The presentation will be available on-demand beginning on Monday, January 11, 2021, in the Investors section on the Company's website at www.bellerophon.com.

    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 and infectious 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.

    Contacts  
    At W2O Group: At LifeSci Advisors:
    Julie Normart Brian Ritchie
    (559) 974-3245 (212) 915-2578
     

     



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  2. WARREN, N.J., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary and infectious diseases, today announced that the first patient has been enrolled in its REBUILD Phase 3 registrational clinical study evaluating INOpulse®, a pulsed inhaled nitric oxide therapy, as a potential treatment for fibrotic interstitial lung disease (fILD).

    "Fibrotic ILD is a severe disease where patients face debilitating functional impairment, poor quality of life and limited life expectancy. Patients with fILD suffer severe mobility restrictions and often lack the ability to perform the most basic tasks such…

    WARREN, N.J., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary and infectious diseases, today announced that the first patient has been enrolled in its REBUILD Phase 3 registrational clinical study evaluating INOpulse®, a pulsed inhaled nitric oxide therapy, as a potential treatment for fibrotic interstitial lung disease (fILD).

    "Fibrotic ILD is a severe disease where patients face debilitating functional impairment, poor quality of life and limited life expectancy. Patients with fILD suffer severe mobility restrictions and often lack the ability to perform the most basic tasks such as walking, ascending stairs and managing daily housework," said Jeremy Feldman, MD, Director Pulmonary Hypertension Program, Arizona Pulmonary Specialists and a lead investigator for the Phase 3 study. "Nitric Oxide is a pulmonary vasodilator that improves ventilation-perfusion matching, which can be impaired by systemic vasodilators. The benefits we observed in the Phase 2 study and into open-label extension, including activity levels and patient reported outcomes, underscore INOpulse's potential to address this significant unmet medical need. I am excited to advance the Phase 3 study with the enrollment of the first patient, and look forward to the continued development of the promising INOpulse therapy for fILD."

    REBUILD is a Phase 3 randomized, double-blind, placebo-controlled clinical study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) [at a dose of 45 mcg/kg ideal body weight (IBW)/hour] versus placebo in fILD patients at risk of pulmonary hypertension (PH) on long-term oxygen therapy. The REBUILD trial is planned to enroll 300 patients who will receive either INOpulse or placebo for a 16-week blinded treatment period, after which patients are eligible to rollover into an open-label extension. The primary endpoint is change in moderate to vigorous physical activity (MVPA), as previously agreed upon with the U.S. Food and Drug Administration.

    "We are pleased to have enrolled the first patient in our Phase 3 REBUILD study, as it marks an important milestone in our efforts to develop the first potential therapy to treat a broad fILD population that includes patients at risk of pulmonary hypertension," said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. "The REBUILD study builds on the positive results from our Phase 2 trial that demonstrated the safety and efficacy of INOpulse in improving MVPA, multiple quality of life measures and key hemodynamic parameters. Importantly, our current balance sheet provides us with the resources to continue advancing this program through the availability of these Phase 3 data and we look forward to sharing top-line results from this important study in 2022."

    Bellerophon previously reported positive top-line results from its iNO-PF Phase 2 study, a randomized, double-blind, placebo-controlled clinical study of INOpulse for the treatment of fILD. The Phase 2 studies established iNO45 as the preferred dose for the REBUILD Phase 3 study, with patients who received iNO45 over 16 weeks demonstrating clinically meaningful and statistically significant improvement in MVPA of 20% over baseline compared to placebo (p=0.02). Improvements in MVPA were further supported by placebo-corrected benefits in other key parameters, as measured by two patient-reported questionnaires, the University of California, San Diego Shortness of Breath Questionnaire, and the St. George's Respiratory Questionnaire. The safety and tolerability profile of INOpulse in the double-blind period of iNO-PF has been maintained in the ongoing open-label extension period.

    The Company also previously reported positive top-line data from PHPF-002, an ancillary dose escalation study assessing the acute hemodynamic effect of INOpulse in fILD via right heart catheterization. The study demonstrated that acute treatment with INOpulse provided clinically meaningful and statistically significant improvements in pre-specified hemodynamic parameters, including a 21% reduction in pulmonary vascular resistance, with increased benefit (p<0.01) on dose escalation from iNO30 to iNO45, and a 12% reduction in mean pulmonary arterial pressure. The acute hemodynamic benefits underpin the chronic benefit in exercise capacity demonstrated in the iNO-PF study and further support utilizing the iNO45 dose in the REBUILD Phase 3 study.

    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 and infectious 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® not proving to be an effective treatment for COVID-19 or approved for marketing by the FDA, 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 
    At W2O Group:

    Julie Normart

    (559) 974-3245



    At LifeSci Advisors:

    Brian Ritchie

    (212) 915-2578

        



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  3. WARREN, N.J., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary and infectious diseases, today announced that the independent Data Monitoring Committee (DMC) has completed its pre-specified interim analysis from the first 100 patients randomized in the Phase 3 COViNOX study of INOpulse® for the treatment of COVID-19.

    The interim analysis, as requested by the U.S. Food and Drug Administration, was limited to the evaluation of safety and a single efficacy endpoint of respiratory failure or death (RFD).

    "Based on the recommendation of the DMC, we have put the COViNOX study on clinical…

    WARREN, N.J., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary and infectious diseases, today announced that the independent Data Monitoring Committee (DMC) has completed its pre-specified interim analysis from the first 100 patients randomized in the Phase 3 COViNOX study of INOpulse® for the treatment of COVID-19.

    The interim analysis, as requested by the U.S. Food and Drug Administration, was limited to the evaluation of safety and a single efficacy endpoint of respiratory failure or death (RFD).

    "Based on the recommendation of the DMC, we have put the COViNOX study on clinical hold. To date, we have recruited close to 200 patients, of which 100 were included in the interim analysis. Of note, the interim analysis included 10 RFD events, representing a small sample size for evaluation of the RFD endpoint. We intend to complete the study procedures for the remaining patients and evaluate the full data set, which will include additional clinically important endpoints, such as change in clinical status and duration of hospitalization, in order to assess potential next steps in our COVID-19 program," said Fabian Tenenbaum, Chief Executive Officer of Bellerophon Therapeutics.

    "We continue to be enthusiastic about our lead program in fibrotic interstitial lung disease (fILD) and other pulmonary hypertension (PH) programs, which leverage years of experience with inhaled nitric oxide as a targeted and potent vasodilator to address the underlying vascular resistance and improve hemodynamics, ventilation/perfusion mismatch, quality of life, and exercise capacity in these patients. These indications represent significant unmet medical needs for which there are currently no approved therapies. Importantly, following the positive results from our Phase 2 studies, we expect to enroll the first patient in our Phase 3 REBUILD study in fILD shortly, and our ongoing Phase 2b trial in PH associated with sarcoidosis is progressing well, with top-line results anticipated around the end of 2020," concluded Mr. Tenenbaum.

    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 and infectious 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® not proving to be an effective treatment for COVID-19 or approved for marketing by the FDA, 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

    At W2O Group:At LifeSci Advisors:
    Julie NormartBrian Ritchie
    (559) 974-3245(212) 915-2578



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  4. WARREN, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary and infectious diseases, today announced that Fabian Tenenbaum, Chief Executive Officer, will present a corporate overview at the H.C. Wainwright 6th Annual Israel Conference.

    Presentation Details
    Date:Thursday, November 12, 2020
    Time:3:30 PM Eastern Time

    A live audio webcast and replay of the presentations will be available in the Investors section on the Company's website at www.bellerophon.com.

    About Bellerophon
    Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies…

    WARREN, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary and infectious diseases, today announced that Fabian Tenenbaum, Chief Executive Officer, will present a corporate overview at the H.C. Wainwright 6th Annual Israel Conference.

    Presentation Details
    Date:Thursday, November 12, 2020
    Time:3:30 PM Eastern Time

    A live audio webcast and replay of the presentations will be available in the Investors section on the Company's website at www.bellerophon.com.

    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 and infectious 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.

    Contacts
    At W2O Group:At LifeSci Advisors:
    Julie NormartBrian Ritchie
    (559) 974-3245(212) 915-2578

     

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  5. WARREN, N.J., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary and infectious diseases, today provided a clinical program update and reported financial results for the third quarter ended September 30, 2020.

    "Bellerophon continues to advance multiple development programs for its INOpulse® inhaled nitric oxide therapy," said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. "We are pleased with the rate of enrollment in our ongoing COViNOX Phase 3 clinical trial of INOpulse for the treatment of COVID-19. The results of a planned interim analysis are expected shortly, as…

    WARREN, N.J., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary and infectious diseases, today provided a clinical program update and reported financial results for the third quarter ended September 30, 2020.

    "Bellerophon continues to advance multiple development programs for its INOpulse® inhaled nitric oxide therapy," said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. "We are pleased with the rate of enrollment in our ongoing COViNOX Phase 3 clinical trial of INOpulse for the treatment of COVID-19. The results of a planned interim analysis are expected shortly, as the first 100 patients have now completed their 28-day assessment period. In support of our development and manufacturing plans in COVID-19, we have applied for government funding and are in discussions with a number of federal agencies, including Operation Warp Speed."   

    "In our pivotal Phase 3 REBUILD trial for fibrotic interstitial lung disease (fILD) patients at risk of associated pulmonary hypertension, we initiated the first clinical research sites, allowing us to begin patient enrollment," continued Mr. Tenenbaum. "The Phase 3 trial builds upon our successful Phase 2 studies, and we look forward to presenting both our Phase 2 results and the design of our Phase 3 REBUILD trial this week at the American Thoracic Society (ATS) Interstitial Lung Disease Mini Symposia and the Pulmonary Fibrosis Foundation (PFF) Meeting."

    "Moreover, we continue to operate from a position of financial strength. Importantly, our current balance sheet provides us with the resources to progress our INOpulse development program through upcoming near-term catalysts and top-line results from the Phase 3 REBUILD trial," concluded Mr. Tenenbaum.

    Clinical Program Highlights:

    COVID-19 (Coronavirus)

    • COViNOX Phase 3 Study: Bellerophon continues to enroll patients in the Company's ongoing Phase 3 clinical study of INOpulse inhaled nitric oxide (iNO) therapy for the treatment of COVID-19 and anticipates the availability of the results from a planned interim analysis shortly. The Phase 3 randomized, placebo-controlled COViNOX study is evaluating the efficacy and safety of the investigational INOpulse therapy in patients diagnosed with COVID-19 who require supplemental oxygen. The COViNOX protocol utilizes an adaptive design and aims to enroll up to 500 patients with COVID-19 who will be treated with either INOpulse or placebo at major U.S. hospitals. The primary endpoint will assess the proportion of subjects that had respiratory failure or mortality, which should allow the trial to serve as a registrational study for approval. In parallel, Bellerophon has applied for government funding and remains in ongoing discussions with multiple federal agencies to support the Company's development and manufacturing plans in COVID-19.

    fILD

    • REBUILD Phase 3 Study: Bellerophon successfully completed its End-of-Phase 2 meetings with the U.S. Food and Drug Administration and finalized its Phase 3 REBUILD registrational study of INOpulse for the treatment of fILD. The first research sites in the Phase 3 REBUILD study have been initiated, allowing the Company to begin recruiting patients into the trial. The REBUILD study will enroll 300 fILD patients who will be treated with either INOpulse 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.



      Bellerophon reported positive top-line results from its Phase 2 randomized, double-blind, placebo-controlled clinical study (iNO-PF) of INOpulse for the treatment of fILD. Subjects treated with the higher dose of iNO45 chronically over four months demonstrated clinically and statistically significant improvement in MVPA of 14 minutes per day, representing a 20% improvement (p=0.02). Improvements in MVPA were supported by benefits in other activity parameters, as well as two patient reported questionnaires, the University of California, San Diego Shortness of Breath Questionnaire and the St. George's Respiratory Questionnaire.



      The results from Cohort 1 of the iNO-PF study were published in the August 2020 edition of the peer-reviewed CHEST journal. These results established the safety of the iNO30 dose and confirmed the potential for INOpulse to provide clinically meaningful benefits in levels of daily activity in this patient population.



      The results from Cohort 2 of the iNO-PF study will be presented at the ATS Interstitial Lung Disease Mini Symposia. These results demonstrated the safety and efficacy of the iNO45 dose and established the dose and endpoints for the pivotal REBUILD Phase 3 study. In addition, Bellerophon will present its planned Phase 3 REBUILD study at the upcoming 2020 PFF Meeting.

    Pulmonary Hypertension-Sarcoidosis (PH-Sarc)

    • Phase 2 Clinical Study: Bellerophon is continuing enrollment in a Phase 2 dose escalation study in PH-Sarc, and anticipates the availability of top-line data around the end of 2020. The safety and efficacy study is assessing the acute hemodynamic benefit of INOpulse via right heart catheterization. PH-Sarc is an unmet medical need with a median survival of approximately five years after diagnosis. Similar to PH-PF and PH-ILD, PH-Sarc cannot be treated with currently available systemic vasodilators.

    Corporate Update:

    • In August 2020, Bellerophon strengthened its management team through the appointment of cardiopulmonary disease expert, Wassim Fares, M.D., MSCR, as Chief Medical Officer.
    • In September 2020, the Company presented at the Cantor Fitzgerald Virtual Global Healthcare Conference and H.C. Wainwright 22nd Annual Global Investment Conference.

    Third Quarter Ended September 30, 2020 Financial Results

    For the three months ended September 30, 2020, the Company reported an operating loss of $8.3 million, compared to $4.6 million in the three months ended September 30, 2019.

    For the three months ended September 30, 2020, the Company reported a net loss of $7.9 million, or $(0.84) per basic and diluted share, compared to a net loss of $4.3 million, or $(0.94) per basic and diluted share, for the three months ended September 30, 2019.

    Research and development expenses for the three months ended September 30, 2020 were $6.1 million, compared to $3.3 million in the prior year period. The increase was primarily due to increased activities related to the development of INOpulse for the treatment of COVID-19 and fILD patients.

    General and administrative expenses for the three months ended September 30, 2020 were $2.2 million, compared to $1.3 million in the prior year period. The increase was primarily due to higher expenses related to financing, IP and legal fees.

    Nine Months Ended September 30, 2020 Financial Results

    For the nine months ended September 30, 2020, the Company reported an operating loss of $18.1 million, compared to $13.2 million in the nine months ended September 30, 2019.



    For the nine months ended September 30, 2020, the Company reported a net loss of $16.7 million, or $(2.31) per basic and diluted share, compared to a net loss of $9.2 million, or $(2.05) per basic and diluted share, in the nine months ended September 30, 2019.  

    Net loss for the nine months ended September 30, 2020 included an expense of $0.8 million due to a change in fair value of the Company's common stock warrant liability, as compared to an income of $2.5 million for the nine months ended September 30, 2019.

    Research and development expenses for the nine months ended September 30, 2020 were $11.8 million, compared to $8.2 million in the prior year period. The increase was primarily due to increased activities related to the development of INOpulse for the treatment of COVID-19 and fILD patients.  

    General and administrative expenses for the nine months ended September 30, 2020 were $6.4 million, compared to $5.0 million in the prior year period. The increase was primarily due to higher expenses related to financing, IP and legal fees.

    Balance Sheet

    As of September 30, 2020, the Company had cash and cash equivalents of $54.0 million, compared to $9.9 million at December 31, 2019.

    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 and infectious 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: 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  
    At W2O Group: At LifeSci Advisors:
    Julie Normart  Brian Ritchie
    (559) 974-3245 (212) 915-2578
        

                                                               

    BELLEROPHON THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands except share and per share data)

      As of As of
      September 30, 2020 December 31, 2019
      (Unaudited)  
    Assets    
    Current assets:    
    Cash and cash equivalents $53,970    $9,874   
    Restricted cash 103    103   
    Prepaid expenses and other current assets 633    405   
    Total current assets 54,706    10,382   
    Restricted cash, non-current 300    300   
    Right of use assets, net 1,659    2,110   
    Property and equipment, net 198    316   
    Other non-current assets 177    —   
    Total assets $57,040    $13,108   
    Liabilities and Stockholders' Equity    
    Current liabilities:    
    Accounts payable $3,820    $3,106   
    Accrued research and development 3,097    2,117   
    Accrued expenses 1,380    1,703   
    Current portion of operating lease liabilities 692    658   
    Total current liabilities 8,989    7,584   
    Long term operating lease liabilities 1,136    1,659   
    Common stock warrant liability 1,042    274   
    Total liabilities 11,167    9,517   
    Commitments and contingencies    
    Stockholders' equity:    
    Common stock, $0.01 par value per share; 200,000,000 shares authorized and 9,497,777 and 4,580,127 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively 95    46   
    Preferred stock, $0.01 par value per share; 5,000,000 shares authorized, zero shares issued and outstanding at September 30, 2020 and December 31, 2019 —    —   
    Additional paid-in capital 252,264    193,308   
    Accumulated deficit (206,486)  (189,763) 
    Total stockholders' equity  45,873    3,591   
    Total liabilities and stockholders' equity  $57,040    $13,108   



    BELLEROPHON THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

    (in thousands except share and per share data)

      Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
      2020 2019 2020 2019
    Operating expenses:        
    Research and development $6,065    $3,259    $11,754    $8,193   
    General and administrative 2,196    1,332    6,376    4,965   
    Total operating expenses 8,261    4,591    18,130    13,158   
    Loss from operations (8,261)  (4,591)  (18,130)  (13,158) 
    Change in fair value of common stock warrant liability 319    215    (768)  2,504   
    Warrant amendment charge —    —    —    (674) 
    Interest and other income, net    89    50    340   
    Pre-tax loss (7,933)  (4,287)  (18,848)  (10,988) 
    Income tax benefit —    —    2,125    1,801   
    Net loss $(7,933)  $(4,287)  $(16,723)  $(9,187) 
    Weighted average shares outstanding:        
    Basic 9,491,111    4,553,535    7,228,349    4,481,972   
    Diluted 9,491,111    4,553,535    7,228,349    4,481,972   
    Net loss per share:        
    Basic $(0.84)  $(0.94)  $(2.31)  $(2.05) 
    Diluted $(0.84)  $(0.94)  $(2.31)  $(2.05) 

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