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BLPH

Bellerophon Therapeutics, Inc. Common Stock NASDAQ Global Market
$4.3
Open: $4.25 High: $4.3 Low: $4.02 Close: $4.03
Range: 2021-05-06 - 2021-05-07
Volume: 44,710
Market: Closed
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BLPH
Bellerophon Therapeutics, Inc. Common Stock 184 Liberty Corner Road Warren NJ, 7059 http://www.bellerophon.com
Bellerophon Therapeutics Inc is a clinical-stage biotherapeutics company. It develops products that are focused on the treatment of various types of pulmonary hypertension disorder.
  • CEO: Fabian Tenenbaum
  • Employees: 20
  • Sector: Healthcare
  • Industry: Biotechnology
BLPH News
Latest news about the BLPH
  • Bellerophon Provides Clinical Program Update and Reports Fourth Quarter and Full-Year 2020 Financial Results

    WARREN, N.J., March 11, 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 fourth quarter and year ended December 31, 2020. “Bellerophon continues to make significant progress in advancing its INOpulse® inhaled nitric oxide therapy in multiple indications,” said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. “In December 2020, we announced that the first patient had been enrolled in our pivotal Phase 3 REBUILD study for fibrotic interstitial lung disease (fILD) patients at risk of associated pulmonary hypertension. In addition, we expect top-line results from our Phase 2 dose escalation study of INOpulse in sarcoidosis (PH-Sarc) this year.” “Our balance sheet continues to be strong and provides us with the resources to support our ongoing clinical programs in fILD and PH-Sarc,” concluded Mr. Tenenbaum. Clinical Program Highlights:fILD REBUILD Phase 3 Study: In December, 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 will 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 a median survival of approximately five years after diagnosis. Similar to PH associated with fILD, there are currently no approved therapies to treat PH-Sarc. COVID-19 (Coronavirus) COViNOX Phase 3 Study: The randomized, placebo-controlled COViNOX study evaluated the efficacy and safety of the investigational INOpulse therapy in patients diagnosed with COVID-19 who require supplemental oxygen. In November 2020, the Company announced the results of a pre-specified interim analysis conducted by an independent Data Monitoring Committee (DMC). Based on the recommendation of the DMC, the COViNOX study was placed on clinical hold. Upon completion of the protocol defined monitoring period, the safety and efficacy analysis of the full 191 patients was reviewed by the DMC, and the DMC determined that there were no safety concerns attributed to INOpulse. However, based on the absence of an efficacy signal and the availability of multiple vaccines, the Company will not be continuing the COViNOX trial. Corporate Update: In 2020, a patent covering the shape of the nitric oxide pulse and valve configuration of our proprietary INOpulse drug delivery device was issued in the U.S. with an expiry date of June 2039. The issued patent builds upon the Company’s portfolio of over 100 issued and pending patent applications and the Orphan Drug Designation for nitric oxide for the treatment of idiopathic pulmonary fibrosis in the U.S., which can provide up to 7 years of exclusivity if the product is approved.In November 2020, the Company presented at the H.C. Wainwright 6th Annual Israel Conference.In January 2021, Bellerophon presented at the H.C. Wainwright Virtual BioConnect 2021 Conference. Fourth Quarter Financial Results:For the fourth quarter ended December 31, 2020, the Company reported a net loss of $8.0 million, or $(0.84) per share, compared to a net loss of $4.1 million, or $(0.89) per share, in the fourth quarter ended December 31, 2019. Net loss for the three months ended December 31, 2020 included income of $0.4 million due to a change in fair value of the Company’s common stock warrant liability, as compared to $0.2 million in the fourth quarter of 2019. Research and development expenses for the fourth quarter ended December 31, 2020 were $6.1 million, compared to $2.8 million in the prior year period. The increase was primarily due to costs related to the Phase 3 COVID-19 and fILD trials. General and administrative expenses for the fourth quarter ended December 31, 2020 were $2.0 million, compared to $1.5 million in the prior year period. The increase was primarily due to IP, consulting, and labor costs. 2020 Year End Financial Results:For the year ended December 31, 2020, the Company reported a net loss of $24.7 million, or $(3.17) per share, compared to net loss of $13.3 million, or $(2.95) per share, in the year ended December 31, 2019. Net loss for the year ended December 31, 2020 included an expense of $0.3 million due to a change in fair value of the Company’s common stock warrant liability, as compared to an income of $2.7 million in the year ended December 31, 2019. Research and development expenses for the year ended December 31, 2020 were $17.9 million, compared to $11.0 million in the year ended December 31, 2019. The increase was primarily due to costs related to the Phase 3 COVID-19 and fILD trials. General and administrative expenses for the year ended December 31, 2020 were $8.4 million, compared to $6.4 million for the year ended December 31, 2019. The increase was primarily due to IP, consulting, and labor costs. Balance SheetAs of December 31, 2020, the Company had cash and cash equivalents of $47.6 million, compared to cash and cash equivalents of $9.9 million at December 31, 2019. About BellerophonBellerophon 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 StatementsAny 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. ContactsLifeSci Advisors:Brian Ritchie (212) 915-2578britchie@lifesciadvisors.com BELLEROPHON THERAPEUTICS, INC. Consolidated Balance Sheets (Amounts in thousands, except share and per share data) December 31, 2020 December 31, 2019Assets Current assets: Cash and cash equivalents $47,557 $9,874 Restricted cash 103 103 Prepaid expenses and other current assets 420 405 Total current assets 48,080 10,382 Restricted cash, non-current 300 300 Right of use assets, net 1,504 2,110 Property and equipment, net 169 316 Other non-current assets 186 — Total assets $50,239 $13,108 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $3,725 $3,106 Accrued research and development 3,699 2,117 Accrued expenses 2,305 1,703 Current portion of operating lease liabilities 704 658 Total current liabilities 10,433 7,584 Long term operating lease liabilities 956 1,659 Common stock warrant liability 601 274 Total liabilities 11,990 9,517 Commitments and contingencies Stockholders' equity: Common stock, $0.01 par value per share; 200,000,000 shares authorized and9,491,111 and 4,580,127 shares issued and outstanding at December 31, 2020and December 31, 2019, respectively 95 46 Preferred stock, $0.01 par value per share; 5,000,000 shares authorized, zeroshares issued and outstanding at December 31, 2020 and December 31, 2019 — — Additional paid-in capital 252,645 193,308 Accumulated deficit (214,491) (189,763)Total stockholders' equity 38,249 3,591 Total liabilities and stockholders' equity $50,239 $13,108 BELLEROPHON THERAPEUTICS, INC. Consolidated Statements of Operations (Amounts in thousands, except share and per share data) Year Ended December 31, 2020 2019 Operating expenses: Research and development $17,890 $11,032 General and administrative 8,386 6,441 Total operating expenses 26,276 17,473 Loss from operations (26,276) (17,473) Change in fair value of common stock warrant liability (327) 2,682 Warrant amendment charge — (674) Interest income and financing expenses, net (250) 397 Pre-tax loss (26,853) (15,068) Income tax benefit 2,125 1,801 Net (loss) income $(24,728) $(13,267) Weighted average shares outstanding: Basic 7,797,130 4,503,375 Diluted 7,797,130 4,503,375 Net (loss) income per share: Basic $(3.17) $(2.95) Diluted $(3.17) $(2.95)

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  • Bellerophon to Present at the H.C. Wainwright Global Life Sciences Conference

    WARREN, N.J., March 02, 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 Global Life Sciences Conference, being held virtually March 9-10, 2021. The presentation will be available on-demand beginning on Tuesday, March 9, 2021, in the Investors section on the Company’s website at www.bellerophon.com. About BellerophonBellerophon 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) 915-2578jnormart@w2ogroup.combritchie@lifesciadvisors.com

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  • Bellerophon to Present at the H.C. Wainwright Virtual BioConnect 2021 Conference

    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 jnormart@w2ogroup.com britchie@lifesciadvisors.com

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  • Bellerophon Therapeutics Announces First Patient Enrolled in Phase 3 REBUILD Study Evaluating INOpulse® for the Treatment of Fibrotic Interstitial Lung Disease

    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 jnormart@w2ogroup.com At LifeSci Advisors: Brian Ritchie (212) 915-2578 britchie@lifesciadvisors.com

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  • Here is What Hedge Funds Think About Bellerophon Therapeutics, Inc. (BLPH)

    Although the masses and most of the financial media blame hedge funds for their exorbitant fee structure and disappointing performance, these investors have proved to have great stock picking abilities over the years (that’s why their assets under management continue to swell). We believe hedge fund sentiment should serve as a crucial tool of an […]

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  • Bellerophon Therapeutics Announces Results of Interim Analysis of Phase 3 COViNOX Study of INOpulse® for the Treatment of COVID-19

    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 jnormart@w2ogroup.combritchie@lifesciadvisors.com

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  • Bellerophon to Present at the H.C. Wainwright 6th Annual Israel Conference

    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 jnormart@w2ogroup.combritchie@lifesciadvisors.com

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  • Bellerophon Therapeutics (BLPH) Reports Q3 Loss, Lags Revenue Estimates

    Bellerophon Therapeutics (BLPH) delivered earnings and revenue surprises of -2.44% and -100.00%, respectively, for the quarter ended September 2020. Do the numbers hold clues to what lies ahead for the stock?

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  • Bellerophon Provides Clinical Program Update and Reports Third Quarter 2020 Financial Results

    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 ResultsFor 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 ResultsFor 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 SheetAs 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 jnormart@w2ogroup.com   britchie@lifesciadvisors.com                                                             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 9    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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  • Bellerophon to Present Results from its Phase 2 iNO-PF Study of INOpulse® for the Treatment of Fibrotic Interstitial Lung Disease at Upcoming Scientific Conferences

    WARREN, N.J., Oct. 29, 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, announced today that data from its Phase 2 randomized, double-blind, placebo-controlled clinical study (iNO-PF) of INOpulse® for the treatment of fibrotic Interstitial Lung Disease patients at risk for pulmonary hypertension will be presented at the American Thoracic Society Interstitial Lung Disease Mini Symposia and the 2020 Pulmonary Fibrosis Foundation Meeting. Details of the presentations are below:American Thoracic Society Mini Symposia Title:A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) in Subjects at Risk of Pulmonary Hypertension (PH) Associated with Fibrotic Interstitial Lung Disease (fILD) on Long Term Oxygen Therapy Presenter:Steven D. Nathan, M.D., F.C.C.P., Inova Fairfax Hospital Session:B16 and D13: Interstitial Lung Disease: Biomarkers and Treatment Date/Time:Thursday, November 5, 2020, 5:00 PM ET Registration:https://thoracic.zoom.us/meeting/register/tJUtd-2orDojGdGxW73yxtxhbSlaxLBmxBLJ?utm_medium=email&_hsenc=p2ANqtz-9L2C6wv0qcensr1DiI9rK3Zrn3ntXWRy4sbZFekcl6X17YBREYETPD0vRhgsfCIAKq-mAoHL8SlQOy4v0JR_MqVmr_xQ&_hsmi=97817596&utm_content=97817596&utm_source=hs_email&hsCtaTracking=93afa7e6-072c-4ceb-8f3d-d3d816dce462%7Cdd3cb66a-ba73-49a3-a3a5-a0ef649949c2       2020 Pulmonary Fibrosis Foundation Volunteer Meeting Title:Pulsed Outpatient Inhaled Nitric Oxide via INOpulse® for Patients with Pulmonary Fibrosis Presenter:Wassim Fares, M.D. M.Sc., Chief Medical Officer of Bellerophon Therapeutics Plenary Session:Updates from the PFF and Clinical Trial Innovation Series Part 1 Date/Time:Thursday, November 5, 2020, 1:00 PM – 2:00 PM ET Weblink:https://www.pulmonaryfibrosis.org/docs/default-source/default-document-library/2020-pff-volunteer-meeting-full-agenda.pdf 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 NormartBrian Ritchie (559) 974-3245(212) 915-2578 jnormart@w2ogroup.combritchie@lifesciadvisors.com

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  • Insider Buys Bellerophon Therapeutics Shares

    Shares of Bellerophon Therapeutics Inc (NASDAQ:BLPH) gained by 5.4% from the previous closing price. A Form 4 filing filed with the SEC on Monday, September 14 showed that Fares Wassim bought 4,000 shares at an average price of $10.18. The transaction moved the executive's stake in Bellerophon Therapeutics Inc. to 4,000 shares.The Importance of Insider Transactions While transactions from an insider shouldn't be used as the sole item to make an investment or trading decision, an insider buying or selling stock in their company can be a good added factor that leads to more conviction in a decision.When an insider buys stock after an important sell off, that can indicate the insider's faith in the success of the organization. Henceforth, if the stock is bought at new highs, it might be because the insider feels that the stock is not overvalued. Conversely, insiders who are selling stock at new lows can potentially indicate some kind of capitulation moment. Insiders selling at new highs can indicate that exec wants to "take some profit" and "lock in a gain."Important Transaction Codes Wall Street tends to focus on insider transactions which take place in the open market, viewed inside a Form 4 filing via codes P for purchase and S for sale. An open-market transaction means the insider went into the market of their own volition and made an active decision about the potential path for a company and its stock moving forward.Transaction codes other than P or S are often viewed with less conviction as they are often not tied to a decision by the exec. As an example, transaction code C indicates the conversion of an option. Transaction code A indicates the insider may have been forced to sell shares in order to receive compensation the exec was promised upon being hired by a company.See more from Benzinga * Benzinga's Top Upgrades, Downgrades For August 12, 2020 * Benzinga's Top Upgrades, Downgrades For August 11, 2020(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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  • Bellerophon to Present at Two September Investor Conferences

    WARREN, N.J., Sept. 14, 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, announced today that Fabian Tenenbaum, Chief Executive Officer, will present at two investor conferences in September: H.C. Wainwright 22nd Annual Global Investment Conference and Cantor Fitzgerald Virtual Global Healthcare Conference. H.C. Wainwright 22nd Annual Global Investment ConferenceDate:Monday, September 14, 2020 Time:5:00 PM ET Cantor Fitzgerald Virtual Global Healthcare ConferenceDate:Thursday, September 17, 2020 Time:2:40 PM ET 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 jnormart@w2ogroup.combritchie@lifesciadvisors.com

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  • Bellerophon Appoints Cardiopulmonary Disease Expert Wassim Fares, M.D., MSCR, as Chief Medical Officer

    WARREN, N.J., Aug. 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, announced today that it has appointed Wassim Fares, M.D., MSCR, as Chief Medical Officer. “We are thrilled to welcome Wassim, a seasoned industry leader, to Bellerophon to lead our clinical development at such an important time for the company,” said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. “Wassim’s deep cardiopulmonary disease expertise as a pulmonologist and principal clinical trial investigator will prove critical to Bellerophon as we advance our two late-stage INOpulse® programs in Pulmonary Hypertension associated with Pulmonary Fibrosis (PH-PF) and COVID 19, as well as our other clinical-stage programs in sarcoidosis and chronic obstructive pulmonary disease.”Dr. Fares is a board-certified pulmonologist and intensive care specialist with over 20 years of experience as a physician, principal investigator, associate professor, and pharmaceutical industry executive. Most recently, Dr. Fares was Senior Medical Director at Janssen Pharmaceutical Company and a member of Janssen’s Pulmonary Hypertension therapeutic area development leadership team where he led developments across a broad range of potential indications, including fostering the design and execution of multiple Phase 1 through Phase 3 pivotal registration trials. Prior to Janssen, he consulted on clinical trial strategy for Actelion (Janssen/J&J), Bayer, Gilead, and United Therapeutics. Previously, Dr. Fares served in increasingly senior roles at Yale University, most recently as Director, a nationally-accredited Pulmonary Vascular Disease Center.“I am excited to join the Bellerophon team and lead the clinical development of the Company’s promising INOpulse therapy program,” said Dr. Fares. “The compelling positive results from Bellerophon’s Phase 2 PH-PF trial as well as the patient outcomes observed in the Company’s completed COVID-19 Expanded Access Program, highlight INOpulse’s potential to improve outcomes for patients suffering from a number of pulmonary conditions. I look forward to supporting the Company in further advancing the ongoing COVID-19 COViNOX Phase 3 trial and initiating the Phase 3 REBUILD study in PH-PF.”Dr. Fares completed his post-graduate fellowship program in Pulmonary Disease and Critical Care Medicine at the University of North Carolina and his residency in Internal Medicine at St. Vincent Charity Medical Center. He earned medical and undergraduate degrees from the American University of Beirut, and a master’s degree in clinical research from the University of North Carolina.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 NormartBrian Ritchie (559) 974-3245(212) 915-2578 jnormart@w2ogroup.com britchie@lifesciadvisors.com

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  • Bellerophon Provides Clinical Program Update and Reports Second Quarter 2020 Financial Results

    WARREN, N.J., Aug. 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 second quarter ended June 30, 2020.“Bellerophon has achieved significant clinical and regulatory progress advancing our development program for the INOpulse® inhaled nitric oxide therapy,” said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. “We are pleased to have treated the first patient with INOpulse in our COViNOX Phase 3 clinical trial for the treatment of COVID-19 and are excited to work with leading hospitals across the U.S. to enroll patients as expeditiously as possible. The trial initiation follows highly encouraging preliminary data generated from 180 hospitalized COVID-19 patients treated under our recently completed Emergency Expanded Access Program (EAP).”   “Turning to our Pulmonary Fibrosis program, we have recently completed our End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) to align on study design and endpoints and look forward to initiating our pivotal Phase 3 REBUILD trial of INOpulse in Pulmonary Hypertension associated with Pulmonary Fibrosis (PH-PF),” continued Mr. Tenenbaum. “Importantly, results from Cohort 1 of the Phase 2 Study were published in the August 2020 edition of the peer-reviewed CHEST journal and the results from Cohort 2 are being presented at the upcoming American Thoracic Society (ATS) virtual conference.”   “Our strong balance sheet, enhanced by our recently closed $59.0 million from public and registered direct offerings, provides us with the resources necessary to efficiently advance our INOpulse development program and achieve our planned clinical milestones,” concluded Mr. Tenenbaum.Clinical Program Highlights:COVID-19 (Coronavirus) * COViNOX Phase 3 Study: Bellerophon announced that the first patient has been treated in the Company’s Phase 3 clinical study of INOpulse inhaled nitric oxide (iNO) therapy for the treatment of COVID-19. The Phase 3 randomized, placebo-controlled COViNOX study will evaluate 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 potential approval. Bellerophon has also applied for federal funding, through the Biomedical Advanced Research and Development Authority and the National Institutes of Health, to support the clinical study. * Emergency Expanded Access: Under the recently completed EAP, 180 patients at 18 hospitals across the U.S. received treatment with INOpulse for COVID-19 under emergency expanded access granted by the FDA. The program allowed INOpulse to be used for the treatment of specific patients with COVID-19 under the care and supervision of their physician. Preliminary data demonstrated a 73.0% recovery rate and 6.3% mortality rate at day 14 from treatment initiation. Importantly, INOpulse was well-tolerated with no safety concerns related to the therapy observed by the treating physicians.PH-PF * REBUILD Phase 3 Study: Bellerophon successfully completed its End-of-Phase 2 meetings with the FDA and finalized key elements of its Phase 3 REBUILD registrational study (iNO-PF Cohort 3) of INOpulse for the treatment of PH-PF. The REBUILD study will enroll 300 PH-PF patients who will be treated with either INOpulse or placebo. The primary endpoint is change in moderate to vigorous physical activity (MVPA). The Company expects to initiate the REBUILD study in the second half of 2020. If approved, INOpulse would become the first therapy to treat a broad PH-PF population that includes patients at low-, intermediate- and high-risk of pulmonary hypertension.   * iNO-PF Phase 2 Study:  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 PH-PF. Subjects treated with INOpulse (iNO30 or iNO45) maintained their activity levels, including MVPA, while subjects on placebo deteriorated. 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 improved by 5 points and the St. George’s Respiratory Questionnaire (SGRQ) total score improved by 3 points, with the Activity and Impacts domains improving by 5 and 6 points, respectively. An anchoring analysis between MVPA and the SGRQ Activity domain established a minimally important difference for MVPA of 4.8 minutes per day.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 are being presented as an e-Poster, available from August 5, 2020 to November 10, 2020, at the 2020 ATS virtual conference. These results demonstrated the safety and efficacy of the iNO45 dose and established the dose and endpoints for the pivotal REBUILD Phase 3 study.Pulmonary Hypertension-Sarcoidosis (PH-Sarc) * Phase 2 Clinical Study: Bellerophon is conducting a Phase 2 dose escalation study in PH-Sarc. 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 April 2020, the Company closed a registered direct offering for total gross proceeds of approximately $15.3 million, before deducting placement agent fees and offering expenses. * In May 2020, the Company closed a public offering of common stock and a concurrent registered direct offering for total gross proceeds of approximately $43.7 million, before deducting placement agent fees and offering expenses.   * In June 2020, the Company was added to the Russell 3000® and Microcap® Indexes.Second Quarter Ended June 30, 2020 Financial ResultsFor the three months ended June 30, 2020, the Company reported an operating loss of $5.8 million, compared to $4.2 million in the three months ended June 30, 2019.For the three months ended June 30, 2020, the Company reported a net loss of $3.8 million, or $(0.51) per basic and diluted share, compared to a net loss of $4.1 million, or $(0.90) per basic and diluted share, for the three months ended June 30, 2019. Net loss for the three months ended June 30, 2020 included $2.1 million of tax income from the sale of the New Jersey state 2018 net operating losses and an expense of $0.2 million due to a change in fair value of common stock warrant liability, as compared to an income of $0.7 million for the three months ended June 30, 2019.Research and development expenses for the three months ended June 30, 2020 were $3.5 million, compared to $2.6 million in the prior year period. The increase was primarily due to increased activities related to the development of INOpulse.General and administrative expenses for the three months ended June 30, 2020 were $2.3 million, compared to $1.6 million in the prior year period. The increase was primarily due to higher consulting fees.Six Months Ended June 30, 2020 Financial ResultsFor the six months ended June 30, 2020, the Company reported an operating loss of $9.9 million, compared to $8.6 million in the six months ended June 30, 2019. For the six months ended June 30, 2020, the Company reported a net loss of $8.8 million, or $(1.44) per basic and diluted share, compared to a net loss of $4.9 million, or $(1.10) per basic and diluted share, in the six months ended June 30, 2019.  Net loss for the six months ended June 30, 2020 included an expense of $1.1 million due to a change in fair value of the Company’s common stock warrant liability, as compared to an income of $2.3 million for the six months ended June 30, 2019.Research and development expenses for the six months ended June 30, 2020 were $5.7 million, compared to $4.9 million in the prior year period. The increase was primarily due to increased activities related to the development of INOpulse.General and administrative expenses for the six months ended June 30, 2020 were $4.2 million, compared to $3.6 million in the prior year period. The increase was primarily due to higher consulting fees.Balance Sheet As of June 30, 2020, the Company had cash and cash equivalents of $59.3 million, compared to $9.9 million at December 31, 2019. In the second quarter of 2020, Bellerophon closed a public offering of common stock and two registered direct offerings, with gross proceeds of approximately $59.0 million.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                                                                        jnormart@w2ogroup.com                                                          At LifeSci Advisors: Brian Ritchie (212) 915-2578 britchie@lifesciadvisors.com BELLEROPHON THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands except share and per share data)  As of As of   June 30, 2020 December 31, 2019   (Unaudited)   Assets     Current assets:     Cash and cash equivalents $59,307  $9,874  Restricted cash 103  103  Prepaid expenses and other current assets 903  405  Total current assets 60,313  10,382  Restricted cash, non-current 300  300  Right of use assets, net 1,811  2,110  Property and equipment, net 228  316  Total assets $62,652  $13,108  Liabilities and Stockholders’ Equity     Current liabilities:     Accounts payable $2,838  $3,106  Accrued research and development 1,843  2,117  Accrued expenses 1,216  1,703  Current portion of operating lease liabilities 680  658  Total current liabilities 6,577  7,584  Long term operating lease liabilities $1,314  $1,659  Common stock warrant liability 1,361  274      Total liabilities 9,252  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 June 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 June 30, 2020 and December 31, 2019 —  —  Additional paid-in capital 251,858  193,308  Accumulated deficit (198,553) (189,763) Total stockholders’ equity 53,400  3,591  Total liabilities and stockholders’ equity $62,652  $13,108  BELLEROPHON THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (in thousands except share and per share data)   Three Months Ended June 30, Six Months Ended June 30,   2020 2019 2020 2019 Operating expenses:         Research and development $3,451  $2,629  $5,689  $4,934  General and administrative 2,308  1,596  4,180  3,633  Total operating expenses 5,759  4,225  9,869  8,567  Loss from operations (5,759) (4,225) (9,869) (8,567) Change in fair value of common stock warrant liability (193) 673  (1,087) 2,289  Warrant amendment charge —  (674) —  (674) Interest and other income, net 7  121  41  251  Pre-tax loss (5,945) (4,105) (10,915) (6,701) Income tax benefit 2,125  —  2,125  1,801  Net loss $(3,820) $(4,105) $(8,790) $(4,900) Weighted average shares outstanding:         Basic 7,554,023  4,543,993  6,084,534  4,445,597  Diluted 7,554,023  4,543,993  6,084,534  4,445,597  Net loss per share:         Basic $(0.51) $(0.90) $(1.44) $(1.10) Diluted $(0.51) $(0.90) $(1.44) $(1.10)

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