BLPH Bellerophon Therapeutics Inc.

2.53
-0.06  -2%
Previous Close 2.59
Open 2.56
52 Week Low 2.34
52 Week High 9.185
Market Cap $24,051,240
Shares 9,506,419
Float 7,891,189
Enterprise Value $-3,526,760
Volume 46,894
Av. Daily Volume 1,115,692
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Drug Pipeline

Drug Stage Notes
INOpulse
Pulmonary Hypertension-Sarcoidosis (PH-Sarc)
Phase 2
Phase 2
Phase 2 top-line data reported that all 8 subjects demonstrated decreases in mean pulmonary arterial pressure (mPAP) and pulmonary vascular resistance (PVR). Treatment resulted in a median drop of 20% in PVR, compared to a median baseline PVR of 329 dyne/cm.sec-5; a reduction of 20% or more in PVR, noted December 17, 2021.
INOpulse delivery device - (REBUILD)
Pulmonary hypertension associated with Fibrotic Interstitial Lung Disease
Phase 3
Phase 3
Phase 3 initiation of dosing announced December 1, 2020.
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. 10, 2022 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced that Naseem Amin, M.D., Chairman of Bellerophon's Board of Directors, will present a corporate overview at the H.C. Wainwright BioConnect 2022 Conference, being held virtually January 10-13, 2022.

    The Company's presentation will be available on-demand beginning at 7:00 AM Eastern Time on Monday, January 10, 2022, 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…

    WARREN, N.J., Jan. 10, 2022 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced that Naseem Amin, M.D., Chairman of Bellerophon's Board of Directors, will present a corporate overview at the H.C. Wainwright BioConnect 2022 Conference, being held virtually January 10-13, 2022.

    The Company's presentation will be available on-demand beginning at 7:00 AM Eastern Time on Monday, January 10, 2022, 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 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

    LifeSci Advisors:

    Brian Ritchie

    (212) 915-2578



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  2. Phase 2 results provide clinically meaningful reduction in pulmonary vascular resistance; Company intends to design multi-dose Phase 2b trial

    Treatment was safe and well-tolerated, with no treatment-emergent adverse events observed during the acute hemodynamic dose escalation phase of the study

    WARREN, N.J., Dec. 17, 2021 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced positive top-line data from a recently completed Phase 2 dose escalation study (PULSE-PHPF-002) evaluating the acute hemodynamic benefit of INOpulse® via right heart catheterization for the treatment…

    Phase 2 results provide clinically meaningful reduction in pulmonary vascular resistance; Company intends to design multi-dose Phase 2b trial

    Treatment was safe and well-tolerated, with no treatment-emergent adverse events observed during the acute hemodynamic dose escalation phase of the study

    WARREN, N.J., Dec. 17, 2021 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced positive top-line data from a recently completed Phase 2 dose escalation study (PULSE-PHPF-002) evaluating the acute hemodynamic benefit of INOpulse® via right heart catheterization for the treatment of pulmonary hypertension associated with sarcoidosis (PH-Sarc).

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

    • All 8 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.
      • Increasing to the highest dose, iNO125 (125 mcg/kg IBW/hr), demonstrated further improvement in PVR, with a median drop of 29% (-43% to -5%), achieving statistical significance from baseline (p=0.02) and from the preceding lower dose of iNO75 (75 mcg/kg IBW/hr) (p=0.02). During the study, 7 out of 8 patients escalated to the highest dose, iNO125.
    • 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.

    "Sarcoidosis associated pulmonary hypertension has a median survival of approximately five years after development of the pulmonary hypertension. I am encouraged by the positive changes observed in multiple hemodynamic parameters in patients with sarcoidosis associated pulmonary hypertension being treated with long-term oxygen therapy and then acutely treated with INOpulse," said Robert Baughman, M.D., Professor of Medicine at the University of Cincinnati and one of the Principal Investigators for Study PULSE-PHPF-002. "These clinically meaningful improvements in PVR started at the iNO45 dose and were well tolerated with no clinically relevant deterioration in pulmonary capillary wedge pressure or other hemodynamic parameters, even at the higher iNO doses. The results from this cohort of patients support further evaluation of the potential of iNO to treat PH-Sarc patients who are in urgent need of safe and effective therapies."

    "We are pleased with the positive top-line data from this proof-of-concept study," said Naseem Amin, M.D., Chairman of Bellerophon's Board of Directors. "Based on these results, Bellerophon is working with its steering committee, which is comprised of multiple pulmonary disease experts, to assess next steps for this program, including the design of a multi-dose Phase 2b study to assess the chronic benefit of iNO in PH-Sarc patients. We look forward to continuing our development program in PH-Sarc, a rare disease with significant morbidity and mortality for which there are no approved treatment options. Bellerophon will continue to provide additional updates on our clinical activities in the coming year, including our ongoing Phase 3 program in fibrotic interstitial lung disease, the REBUILD 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 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



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  3. WARREN, N.J., Nov. 15, 2021 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2021.

    "We remain focused on advancing the development of our INOpulse® inhaled nitric oxide therapy in fibrotic interstitial lung disease, or fILD, and sarcoidosis, or PH-Sarc, which are two areas of severe unmet medical need," said Naseem Amin, M.D., Chairman of Bellerophon's Board of Directors. "Our pivotal Phase 3 REBUILD study in fILD is continuing to enroll. Importantly, INOpulse is the first…

    WARREN, N.J., Nov. 15, 2021 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2021.

    "We remain focused on advancing the development of our INOpulse® inhaled nitric oxide therapy in fibrotic interstitial lung disease, or fILD, and sarcoidosis, or PH-Sarc, which are two areas of severe unmet medical need," said Naseem Amin, M.D., Chairman of Bellerophon's Board of Directors. "Our pivotal Phase 3 REBUILD study in fILD is continuing to enroll. Importantly, INOpulse is the first potential therapy to treat a broad fILD population that includes patients at low, intermediate, and high risk of associated pulmonary hypertension. In addition, we are pleased to have concluded enrollment in our PH-Sarc Phase 2 dose escalation study and expect the availability of top-line results before the end of this year. Finally, with $28.7 million in cash and cash equivalents, we believe that we are in a strong financial position to continue advancing our late-stage development programs."

    Clinical Program Highlights:

    fILD

    • 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: Bellerophon has concluded enrollment in a Phase 2 dose escalation study in PH-Sarc and anticipates the availability of top-line data by the end of this year. 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 no approved therapies, and a median survival of approximately five years after diagnosis.

    Corporate Update:

    • In September 2021, the Company presented at the H.C. Wainwright 23rd Annual Global Investment Conference.

    Third Quarter Ended September 30, 2021 Financial Results

    For the three months ended September 30, 2021, the Company reported an operating loss of $4.8 million, compared to $8.3 million in the three months ended September 30, 2020.

    For the three months ended September 30, 2021, the Company reported a net loss of $4.6 million, or $(0.49) per basic and diluted share, compared to a net loss of $7.9 million, or $(0.84) per basic and diluted share, for the three months ended September 30, 2020.

    Research and development expenses for the three months ended September 30, 2021 were $3.0 million, compared to $6.1 million for the three months ended September 30, 2020. The decrease was primarily due to the close-out of activities related to the development of INOpulse for the treatment of COVID-19.

    General and administrative expenses for the three months ended September 30, 2021 were $1.8 million, compared to $2.2 million for the three months ended September 30, 2020. The decrease was primarily due to a decrease in consulting and stock-based compensation costs.

    Nine Months Ended September 30, 2021 Financial Results

    For the nine months ended September 30, 2021, the Company reported an operating loss of $15.9 million, compared to $18.1 million in the nine months ended September 30, 2020.



    For the nine months ended September 30, 2021, the Company reported a net loss of $13.5 million, or $(1.42) per basic and diluted share, compared to a net loss of $16.7 million, or $(2.31) per basic and diluted share, for the nine months ended September 30, 2020.  

    Net loss for the nine months ended September 30, 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 $0.8 million for the nine months ended September 30, 2020.

    Research and development expenses for the nine months ended September 30, 2021 were $9.9 million, compared to $11.8 million for the nine months ended September 30, 2020. The decrease was primarily due to the close-out of activities related to the development of INOpulse for the treatment of COVID-19.

    General and administrative expenses for the nine months ended September 30, 2021 were $6.0 million, compared to $6.4 million for the nine months ended September 30, 2020. The decrease was primarily due to a decrease in consulting and stock-based compensation costs.

    Balance Sheet

    As of September 30, 2021, the Company had cash and cash equivalents of $28.7 million, compared to $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 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

                                                    

     
    BELLEROPHON THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands except share and per share data)
     As of As of
     September 30, 2021    December 31, 2020
     (Unaudited)   
    Assets     
    Current assets:     
    Cash and cash equivalents$28,714  $47,557 
    Restricted cash 103   103 
    Prepaid expenses and other current assets 898   420 
    Total current assets 29,715   48,080 
    Restricted cash, non-current 300   300 
    Right of use assets, net 1,026   1,504 
    Property and equipment, net 88   169 
    Other non-current assets 186   186 
    Total assets$31,315  $50,239 
    Liabilities and Stockholders' Equity     
    Current liabilities:     
    Accounts payable$1,278  $3,725 
    Accrued research and development 1,314   3,699 
    Accrued expenses 1,795   2,305 
    Current portion of operating lease liabilities 740   704 
    Total current liabilities 5,127   10,433 
    Long term operating lease liabilities 396   956 
    Common stock warrant liability 1   601 
    Total liabilities 5,524   11,990 
          
    Commitments and contingencies     
          
    Stockholders' equity:     
    Common stock, $0.01 par value per share; 200,000,000 shares

    authorized and 9,506,419 and 9,491,111 shares issued and outstanding

    at September 30, 2021 and December 31, 2020, respectively
     95   95 
    Preferred stock, $0.01 par value per share; 5,000,000 shares

    authorized, zero shares issued and outstanding at September 30, 2021

    and December 31, 2020
         
    Additional paid-in capital 253,671   252,645 
    Accumulated deficit (227,975)  (214,491)
    Total stockholders' equity 25,791   38,249 
    Total liabilities and stockholders' equity$31,315  $50,239 
            



    BELLEROPHON THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

    (in thousands except share and per share data)
                 
      Three Months Ended  Nine Months Ended
      September 30,  September 30, 
      2021  2020  2021  2020 
    Operating expenses:            
    Research and development $3,030  $6,065  $9,853  $11,754 
    General and administrative  1,773   2,196   6,035   6,376 
    Total operating expenses  4,803   8,261   15,888   18,130 
    Loss from operations  (4,803)  (8,261)  (15,888)  (18,130)
    Change in fair value of common stock warrant liability  167   319   600   (768)
    Interest and other income, net  2   9   4   50 
    Pre-tax loss  (4,634)  (7,933)  (15,284)  (18,848)
    Income tax benefit        1,800   2,125 
    Net loss $(4,634) $(7,933) $(13,484) $(16,723)
    Weighted average shares outstanding:            
    Basic  9,506,419   9,491,111   9,501,428   7,228,349 
    Diluted  9,506,419   9,491,111   9,501,428   7,228,349 
    Net loss per share:            
    Basic $(0.49) $(0.84) $(1.42) $(2.31)
    Diluted $(0.49) $(0.84) $(1.42) $(2.31)


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  4. WARREN, N.J., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced that Fabian Tenenbaum, Chief Executive Officer, will present a corporate overview at the H.C. Wainwright 23rd Annual Global Investment Conference, being held September 13-15, 2021.

    The presentation will be available on-demand beginning at 7:00 AM Eastern Time on Monday, September 13, 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…

    WARREN, N.J., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced that Fabian Tenenbaum, Chief Executive Officer, will present a corporate overview at the H.C. Wainwright 23rd Annual Global Investment Conference, being held September 13-15, 2021.

    The presentation will be available on-demand beginning at 7:00 AM Eastern Time on Monday, September 13, 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 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

    LifeSci Advisors:

    Brian Ritchie

    (212) 915-2578

                                                    

     



    Primary Logo

    View Full Article Hide Full Article
  5. WARREN, N.J., Aug. 05, 2021 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2021.

    "We continue to progress our INOpulse® inhaled nitric oxide therapy in multiple areas of significant unmet need," said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. "Our ongoing pivotal Phase 3 REBUILD study for fibrotic interstitial lung disease, or fILD, patients at risk of associated pulmonary hypertension is progressing well and continuing to enroll. In addition, we expect top-line…

    WARREN, N.J., Aug. 05, 2021 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2021.

    "We continue to progress our INOpulse® inhaled nitric oxide therapy in multiple areas of significant unmet need," said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. "Our ongoing pivotal Phase 3 REBUILD study for fibrotic interstitial lung disease, or fILD, patients at risk of associated pulmonary hypertension is progressing well and continuing to enroll. In addition, we expect top-line results from our Phase 2 dose escalation study of INOpulse in sarcoidosis, or PH-Sarc, later this year. With $34.3 million in cash and cash equivalents, we believe that we are well-positioned financially to continue executing on our promising late-stage clinical development programs."

    Clinical Program Highlights:

    fILD

    • 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: Bellerophon is continuing enrollment in a Phase 2 dose escalation study in PH-Sarc and anticipates the availability of top-line data during 2021. 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 no approved therapies, and a median survival of approximately five years after diagnosis.

    Corporate Update:

    • In May 2021, the Company announced the appointment of Naseem Amin, M.D. as Chairman of its Board of Directors.
    • In May 2021, the Company presented at the Jefferies Virtual Healthcare Conference.

    Second Quarter Ended June 30, 2021 Financial Results

    For the three months ended June 30, 2021, the Company reported an operating loss of $5.2 million, compared to $5.8 million in the three months ended June 30, 2020.

    For the three months ended June 30, 2021, the Company reported a net loss of $3.4 million, or $(0.36) per basic and diluted share, compared to a net loss of $3.8 million, or $(0.51) per basic and diluted share, for the three months ended June 30, 2020. 

    Research and development expenses for the three months ended June 30, 2021 were $3.2 million, compared to $3.5 million in the prior year period. The decrease was primarily due to the close-out of the COVID-19 trial.

    General and administrative expenses for the three months ended June 30, 2021 were $2.0 million, compared to $2.3 million in the prior year period. The decrease was primarily due to a reduction in intellectual property and consulting costs.

    Six Months Ended June 30, 2021 Financial Results

    For the six months ended June 30, 2021, the Company reported an operating loss of $11.1 million, compared to $9.9 million in the six months ended June 30, 2020.



    For the six months ended June 30, 2021, the Company reported a net loss of $8.9 million, or $(0.93) per basic and diluted share, compared to a net loss of $8.8 million, or $(1.44) per basic and diluted share, in the six months ended June 30, 2020.

    Research and development expenses for the six months ended June 30, 2021 were $6.8 million, compared to $5.7 million in the prior year period. The increase was primarily due to investment related to improvement of the delivery system manufacturing process.

    General and administrative expenses for the six months ended June 30, 2021 were $4.3 million, compared to $4.2 million in the prior year period. The increase was primarily due to consulting costs, partially offset by a decrease in stock-based compensation and legal costs.

    Balance Sheet



    As of June 30, 2021, the Company had cash and cash equivalents of $34.3 million, compared to $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 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



    BELLEROPHON THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands except share and per share data)

      As of As of
      June 30, 2021 December 31, 2020
      (Unaudited)   
    Assets      
    Current assets:      
    Cash and cash equivalents $34,300  $47,557 
    Restricted cash  103   103 
    Prepaid expenses and other current assets  890   420 
    Total current assets  35,293   48,080 
    Restricted cash, non-current  300   300 
    Right of use assets, net  1,188   1,504 
    Property and equipment, net  112   169 
    Other non-current assets  186   186 
    Total assets $37,079  $50,239 
    Liabilities and Stockholders' Equity      
    Current liabilities:      
    Accounts payable $2,484  $3,725 
    Accrued research and development  1,139   3,699 
    Accrued expenses  1,877   2,305 
    Current portion of operating lease liabilities  728   704 
    Total current liabilities  6,228   10,433 
    Long term operating lease liabilities  586   956 
    Common stock warrant liability  168   601 
    Total liabilities  6,982   11,990 
           
    Commitments and contingencies      
           
    Stockholders' equity:      
    Common stock, $0.01 par value per share; 200,000,000 shares authorized and

    9,506,419 and 9,491,111 shares issued and outstanding at June 30, 2021 and

    December 31, 2020, respectively
      95   95 
    Preferred stock, $0.01 par value per share; 5,000,000 shares authorized, zero

    shares issued and outstanding at June 30, 2021 and December 31, 2020
          
    Additional paid-in capital  253,343   252,645 
    Accumulated deficit  (223,341)  (214,491)
    Total stockholders' equity  30,097   38,249 
    Total liabilities and stockholders' equity $37,079  $50,239 



    BELLEROPHON THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

    (in thousands except share and per share data)

      Three Months Ended  Six Months Ended
      June 30,  June 30, 
      2021  2020  2021  2020 
    Operating expenses:            
    Research and development $3,239  $3,451  $6,823  $5,689 
    General and administrative  1,987   2,308   4,262   4,180 
    Total operating expenses  5,226   5,759   11,085   9,869 
    Loss from operations  (5,226)  (5,759)  (11,085)  (9,869)
    Change in fair value of common stock warrant liability  36   (193)  433   (1,087)
    Interest and other income, net  1   7   2   41 
    Pre-tax loss  (5,189)  (5,945)  (10,650)  (10,915)
    Income tax benefit  1,800   2,125   1,800   2,125 
    Net loss $(3,389) $(3,820) $(8,850) $(8,790)
    Weighted average shares outstanding:            
    Basic  9,506,419   7,554,023   9,498,892   6,084,534 
    Diluted  9,506,419   7,554,023   9,498,892   6,084,534 
    Net loss per share:            
    Basic $(0.36) $(0.51) $(0.93) $(1.44)
    Diluted $(0.36) $(0.51) $(0.93) $(1.44)


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