•

Emergency Expanded Access: To date, over 50 patients at 12 hospitals across the U.S. have received treatment with INOpulse for COVID-19 under emergency expanded access granted by the FDA. The program allows INOpulse to be used for the treatment of specific patients with COVID-19 under the care and supervision of their physician. The investigational INOpulse therapy is the only system designed to deliver precise doses of nitric oxide by autonomously adjusting to the patient’s breathing pattern to ensure accurate and consistent drug delivery into the airways. Nitric oxide is a naturally produced molecule that is both a powerful vasodilator, improving oxygenation in the bloodstream, and an immune response to pathogens, playing a key role in preventing viral replication.

•

PULSE-CVD19-001 Phase 3 Study: Bellerophon announced FDA acceptance of its Investigational New Drug (IND) application, allowing the Company to initiate its Phase 3 study of INOpulse inhaled nitric oxide (iNO) therapy in up to 500 patients infected with COVID-19. The Phase 3 randomized, placebo-controlled study, called PULSE-CVD19-001, will evaluate the efficacy and safety of INOpulse in patients diagnosed with COVID-19 who require supplemental oxygen before the disease progresses to necessitate mechanical ventilation support. The PULSE-CVD19-001 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. 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, the Company has applied for federal funding, through BARDA and NIH, to support the clinical study.

•	Planned Pivotal Phase 3 Study: Bellerophon successfully completed its End-of-Phase 2 meetings with the FDA and finalized key elements of its planned pivotal Phase 3 study of INOpulse for the treatment of PH-PF. 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.

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iNO-PF Phase 2 Study: Bellerophon reported positive top-line results from Phase 2 of its ongoing Phase 2/3 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 moderate to vigorous physical activity (MVPA), while subjects on placebo deteriorated. Subjects treated with the higher dose of iNO45 chronically over four months demonstrated 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 total score improved by 3 points, with the Activity and Impacts domains improving by 5 and 6 points, respectively.

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PHPF-002 (ancillary study to iNO-PF): Bellerophon reported positive top-line data from PHPF-002, an ancillary dose escalation study assessing the acute hemodynamic effect of INOpulse in PH-PF via right heart catheterization. The study demonstrated that acute treatment with INOpulse provided statistically and clinically 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 support utilizing the dose of iNO45 in the planned Phase 3 trial.

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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.

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In April 2020, the Company closed a registered direct offering of 1,275,000 shares of its common stock at a purchase price of $12.00 per share for total gross proceeds of $15.3 million, before deducting placement agent fees and offering expenses. In May 2020, the Company received $2.0 million from the sale of its New Jersey state 2018 net operating losses (NOLs) and research and development credits.

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Bellerophon Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(in thousands except share and per share data)
		As of				As of
		March 31, 2020				December 31, 2019
		(Unaudited)
Assets
Current assets:
Cash and cash equivalents		$	8,595			$	9,874
Restricted cash		103				103
Prepaid expenses and other current assets		349				405
Total current assets		9,047				10,382
Restricted cash, non-current		300				300
Right of use asset, net		1,961				2,110
Property and equipment, net		270				316
Total assets		$	11,578			$	13,108
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	2,220			$	3,106
Accrued research and development		1,785				2,117
Accrued expenses		2,101				1,703
Current portion of operating lease liability		669				658
Total current liabilities		6,775				7,584
Long-term operating lease liability		1,489				1,659
Common stock warrant liability		1,168				274
Total liabilities		9,432				9,517
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.01 par value per share; 200,000,000 shares authorized, 4,857,393 and 4,580,127 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively		49				46
Preferred stock, $0.01 par value per share; 5,000,000 shares authorized, zero shares issued and outstanding at March 31, 2020 and December 31, 2019		—				—
Additional paid-in capital		196,830				193,308
Accumulated deficit		(194,733		)		(189,763		)
Total stockholders’ equity		2,146				3,591
Total liabilities and stockholders’ equity		$	11,578			$	13,108

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Bellerophon Therapeutics, Inc.
Condensed Consolidated Statement of Operations (Unaudited)
(in thousands except share and per share data)
	Three Months Ended March 31,
	2020				2019
Operating expenses:
Research and development	$	2,238			$	2,305
General and administrative	1,872				2,037
Total operating expenses	4,110				4,342
Loss from operations	(4,110		)		(4,342		)
Change in fair value of common stock warrant liability	(894		)		1,616
Interest income and other, net	34				130
Pre-tax loss	(4,970		)		(2,596		)
Income tax benefit	—				1,801
Net loss	$	(4,970	)		$	(795	)
Weighted average shares outstanding:
Basic	4,615,046				4,346,109
Diluted	4,615,046				4,346,109
Net loss per share:
Basic	$	(1.08	)		$	(0.18	)
Diluted	$	(1.08	)		$	(0.18	)