UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): March 31, 2020

Bellerophon Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware
001-36845
47-3116175
(State or Other Jurisdiction of Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)

184 Liberty Corner Road, Suite 302
Warren, New Jersey
07059
(Address of Principal Executive Offices)
(Zip Code)

Registrant’s telephone number, including area code: (908) 574-4770
 
(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, $0.01 par value per share
BLPH
The Nasdaq Capital Market
 
 
x
Emerging growth company
 
 
x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.






Item 7.01 Regulation FD Disclosure.

Bellerophon Therapeutics, Inc. has prepared an investor presentation relating to INOpulse® and COVID-19 to be presented to members of the investment community, a copy which is attached to this Current Report on Form 8-K as Exhibit 99.1.
 
In accordance with General Instruction B.2 on Form 8-K, the information set forth in this Item 7.01 and the investor presentation attached to this report as Exhibit 99.1 is “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, nor shall such information be deemed incorporated by reference in any filing under the Securities Exchange Act of 1934, as amended, or the Securities Act of 1933, as amended.
 
The investor presentation attached hereto as Exhibit 99.1 contains certain statements that may be deemed to be “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “continues,” “contemplates,” “potential,” “predicts,” “projects,” “targets,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or, in each case, their negative or other variations thereon or comparable terminology, although not all forward-looking statements contain these words.
By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in the presentation, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in the presentation as a result of, among other factors, the factors referenced in the “Risk Factors” section of our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 14, 2019, and the “Risk Factors” sections of our Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission on May 9, 2019, August 8, 2019 and November 6, 2019, respectively. In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in the presentation, they may not be predictive of results or developments in future periods. Any forward-looking statements that we make in the presentation speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of the presentation, except as required by law.
 
You should read carefully our “Cautionary Note Regarding Forward-Looking Statements” and the factors described in the “Risk Factors” sections of our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q to better understand the risks and uncertainties inherent in our business.

Item 9.01. Financial Statements and Exhibits.
(d) Exhibits:
Exhibit No.
 
Description
 




SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
 
 
 
 
 
 
 
 
 
 
BELLEROPHON THERAPEUTICS, INC.
 
 
 
 
Date: March 31, 2020
 
 
 
By:
 
/s/ Fabian Tenenbaum
 
 
 
 
 
 
Name: Fabian Tenenbaum
Title: Chief Executive Officer



3
bellerophoncovid19deckma
Bellerophon Therapeutics COVID-19 Overview I March 2020


 
Forward Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make due to a number of important factors, including risks and uncertainties relating to: the timing and outcomes of our ongoing and expected clinical trials for our product candidates; our ability to successfully develop, commercialize and market any of our product candidates; our ability to obtain, maintain and enforce intellectual property rights; competition; our reliance on third parties; our ability to obtain necessary financing; and those risk factors discussed in the “Risk Factors” section and elsewhere in our most recent Form 10-K and other periodic filings we make with the SEC. All forward-looking statements contained in this presentation reflect our current views with respect to future events. We assume no obligation, except as required by applicable law, to update any forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. 2


 
Bellerophon Therapeutics (BLPH) Company Profile • Focused on developing inhaled nitric oxide (iNO) based therapies for outpatient management of chronic Clinical-Stage cardiopulmonary diseases and COVID-19 Biotherapeutics • Portable, lightweight delivery system (INOpulse®) allows for chronic home use Company • Company spun-off from Ikaria • Multiple late stage programs in pulmonary hypertension associated with underlying lung disease (WHO Group 3 & WHO Group 5) Novel Therapy Addressing Unmet • Novel targeted vasodilation provides potential for first approved therapy in intended indications Medical Needs • Simplified regulatory approval pathway via existing nitric oxide NDA • Granted emergency expanded access from FDA for the use of INOpulse in COVID-19 Financial • Cash & Equivalents: $12.9(1,2), No Debt(1) Summary • Shares Outstanding = 4.6 million(1); Fully Diluted = 7.5 million(1) Notes: (1) As of September 30, 2019 (2) Does not include $15.3 million in gross proceeds to be received from registered direct offering priced on March 30, 2020 3


 
Investment Highlights Established iNO Therapeutic Benefit ✓ Approved for acute treatment of persistent pulmonary hypertension in neonates ✓ Positive results from multiple Phase 2 studies support INOpulse MoA and benefit Advanced Clinical Stage Product INOpulse technology focused on several large unmet orphan indications PH-PF PH-COPD / PH-Sarc COVID-19 First patient dosed via emergency expanded Successful Phase 2 studies in PH-IPF PH-COPD: Successful Phase 2 study completed access Positive results for Phase 2/3 study in PH-COPD: Phase 2b study design finalized in Expansion to additional sites ongoing Cohorts 1 and 2 agreement w/ FDA Pivotal Phase 3 cohort to initiate in 2Q2020 with PH-Sarc: Phase 2 results expected in Applying for larger IND to allow patients to enroll FDA agreement on primary endpoint 1H2020 into randomized study Proprietary INOpulse Technology Strong IP protection on core programs through 2033 and ability to extend coverage into 2039 4


 
Highly Experienced Leadership Team Jonathan Peacock 10 years experience as CFO at Amgen and Novartis Chairman Pharma Fabian Tenenbaum 15 years of executive-level experience in finance, BD Chief Executive Officer and operations Hunter Gillies, M.D. 20 years experience in clinical research specializing Acting Chief Medical Officer in cardiometabolic and pulmonary vascular diseases Peter Fernandes 25 years experience in global regulatory affairs Chief Regulatory & Safety Officer specializing in respiratory products Assaf Korner 15 years of financial experience in medical device Chief Financial Officer and consumer product companies Parag Shah, PhD 12 years experience in pharmaceutical product VP, Business Operations development Amy Edmonds 20 years experience global clinical operations and VP, Clinical Operations & Administration training Martin Dekker 17 years experience in new product development and VP, Device Engineering & Manufacturing launch 5


 
INOpulse Delivery System Overview Portable Delivery System Allows Chronic iNO Therapy Antifungal Immuno-modulator Antiviral Vasodilator Antibacterial Wound Healing Promotor Nitric Oxide Novel drug-device combination therapy with multiple mechanisms of action Well established vasodilator approved for acute • Targeted pulmonary vasodilation treatment of persistent pulmonary hypertension Portable pulsatile iNO • Ventilation/Perfusion (V/Q) matching in neonates delivery system • Improved oxygen saturation Broad spectrum antiviral that plays a key role in • Antiviral potential suppressing viral replication • Portable delivery system allows out-patient use 6


 
INOpulse Delivery System Lightweight, Portable and User Friendly Cannula Drug & Battery Key & Connector Power Indicators Alarm Swing engagement with drug 01 cartridge Intuitive and simple user 02 interface Oxygen Sources Tri-lumen cannula allows direct 03 connection with oxygen Lightweight portable design 04 allows ease of transport 7


 
Pulsatile Inhaled Nitric Oxide: Potential Treatment Option for COVID-19 • FDA granted emergency expanded access for pulsatile inhaled nitric oxide for treating Coronavirus (COVID- 19); first patient has initiated treatment - Also known as compassionate use, administered on a per-patient basis, at times when clinical trials are infeasible and there are no available alternatives • Inhaled nitric oxide has demonstrated potential benefit for SARS Coronavirus (SARS-CoV) which has genetic similarities to COVID-19 - NO reduces the viral load and prevents replication of SARS-CoV in vitro - iNO improves arterial oxygenation, reduces need for ventilation support, and reduces pneumonia infiltrates in patients with SARS-CoV • INOpulse delivery system is designed for outpatient use, which may be critical to preventing the further spread and alleviating the mounting impact on hospitals and intensive care units • Bellerophon has over 200 patient years of data verifying the ability to safely dose pulsatile inhaled nitric oxide needed to provide antimicrobial and antiviral activity 8


 
COVID-19 Treatment Paradigm Inhaled Nitric Oxide: Potential Therapy for Stage II Patients Stage I Stage II Stage III (Early infection) (Pulmonary Phase) (Hyperinflammation Phase) IIA IIB Viral response phase Host inflammatory response phase Severity of illness Severity Time Course Mild constitutional symptoms ARDS Shortness of Breath Clinical Symptoms Fever > 99.6ºF SIRS/Shock Hypoxia (PaO2/Fi02≤300mmHg) Dry Cough, diarrhea, headache Cardiac Failure Abnormal chest imaging Elevated inflammatory markers Lymphopenia, increased prothrombin time, Clinical Signs Transaminitis (CRP, LDH, IL-6, D-dimer, ferritin) increased D-Dimer and LDH (mild) Low-normal procalcitonin Troponin, NT-proBNP elevation INOpulse Potential Therapies Remdesivir, chloroquine, hydroxychloroquine, convalescent plasma transfusions Reduce immunosuppression Corticosteroids, human immunoglobulin, IL-6 inhibitors, IL-2 inhibitors, JAK inhibitors Image recreated from H. Siddiqi et al., COVID-19 Illness in Native and Immunosuppressed States: A Clinical-Therapeutic Staging Proposal, J. of Heart and Lung Transplantation, 2020, DOI: 10.1016/j.healun.2020.03.012 9


 
Nitric Oxide Plays a Key Role in Suppressing Viral Replication Naturally produced immune response to invading pathogens Endogenous NO production is upregulated by macrophages as a defense mechanism against pathogen infections Virus replication has been shown to correlate with NO production with inhibition of NO synthesis resulting in increased proliferation iNOS expression due to viral infection is typically Exogenous NO confers the ability to suppress viral regulated via induction of pro-inflammatory cytokines replication supporting the necessity and capability such as interferon-γ (IFN-γ). In some cases, such as for NO to provide a substantial antiviral effect HIV gp41, direct iNOS induction may also occur. T. Akaike et al., Immunology, 101, 2000, 300-308 M.A. De Groote et al., Clinical Infectious Disease, 21, 1995, S162-S165 10


 
In Vitro Testing Verifies Antiviral Effect of NO on SARS Coronavirus SNAP (NO donor) reduces viral load and inhibits viral replication of SARS-CoV SNAP (NO donor) reduces viral load after 24 hours SNAP (NO donor) stops RNA production Cells infected with SARS CoV and treated with different Cells infected with SARS-CoV and treated with 400µM NO concentrations of NO donor (S-nitroso-N-acetylpenicillamine donor (S-nitroso-N-acetylpenicillamine - SNAP ●) or control - SNAP ●) and control (N-acetylpenicillamine - NAP ○) (N-acetylpenicillamine - NAP ○); hpi = hour post infection S. Akerstrom et al., J. of Virology, 79, 2005, 1966-1969 11


 
NO Improves Survival of SARS Infected Cells SNAP (NO donor) concentration over 250µM improves cellular survival Increased survival rate of SARS infected cells by the treatment Percent protection achieved in SARS-CoV infected cells. of SNAP. Optical density (492nm) was measured to determine Bars indicate SD. mitochondrial activity. Data are expressed as means ± S.D. E. Keyaerts et al., Int. J. of Infectious Disease, 8, 2004, 223-226 12


 
Inhaled NO Provides Benefit in Patients Infected with SARS-CoV iNO improves arterial oxygenation and reduces pneumonia infiltrates in SARS patients Patients demonstrated improved arterial oxygenation Progression of pneumonia (May 29-June 2); Effect of iNO therapy and reduced need for ventilation support demonstrating a decrease in the pneumonia infiltrates (June 4 – 10) L. Chen et al., Clinical Infectious Disease, 39, 2004, 1531-1535 13


 
Inhaled NO Provides Benefit in Patients Infected with SARS-CoV iNO reduces need for mechanical ventilation post-treatment and improves chest x-ray Need For Ventilatory Support Post- Chest X-Ray Treatment 90% 70% 80% 60% 70% 60% 50% 50% 40% 40% 30% 30% 20% 20% 10% 10% 0% 0% iNO Control Improved No Change Worsened iNO Control L. Chen et al., Clinical Infectious Disease, 39, 2004, 1531-1535 14


 
Next Steps in COVID-19 FDA has granted emergency expanded access to allow pulsatile inhaled nitric oxide to be used as supportive treatment for COVID-19 Access allows treatment under the care and supervision of a physician on a named patient basis, with first patient dosed in March 2020 Bellerophon is in process of applying for a larger IND to allow patients to be enrolled into randomized study: Study Population: Patients with suspected or diagnosed COVID-19 who require supplemental oxygen Study Objective: Verify the safety and efficacy of inhaled nitric oxide in subjects with COVID-19 as determined by: • Reduction in need for mechanical ventilation, need for intubation, etc. • Reduction in oxygen requirement or an improvement in oxygen saturation • Reduction in mortality/morbidity • Negative conversion of COVID-19 RT-PCR from upper respiratory tract Study Funding: Engaged in evaluating BARDA and NIH collaborations 15


 
Investor Contacts Fabian Tenenbaum Chief Executive Officer BTInvestorRelations@bellerophon.com Brian Ritchie LifeSci Advisors britchie@lifesciadvisors.com 212-915-2578