As filed with the Securities and Exchange Commission
on June 2, 2023
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933
BELLEROPHON THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware |
47-3116175 |
| (State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification Number) |
20 Independence Boulevard, Suite 402
Warren, New Jersey 07059
(908) 574-4770
(Address, including zip code, and telephone number,
including area code, of Registrant’s principal executive offices)
Peter Fernandes
Chief Executive Officer
Bellerophon Therapeutics, Inc.
184 Liberty Corner Road, Suite 302
Warren, New Jersey 07059
(908) 574-4770
(Name, address, including zip code, and telephone
number, including area code, of agent for service)
Copies to:
Kenneth R. Koch, Esq.
Jeffrey P. Schultz, Esq.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo P.C.
919 Third Avenue
New York, NY 10022
Tel: (212) 935-3000
Approximate
date of commencement of proposed sale to the public: From time to time after this registration statement becomes effective.
If the only securities being registered on this Form are
being offered pursuant to dividend or interest reinvestment plans, please check the following box: ¨
If
any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415
under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans,
check the following box: x
If this Form is
filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the
following box and list the Securities Act registration statement number of the earlier effective registration statement for the same
offering. ¨
If this Form is
a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities
Act registration statement number of the earlier effective registration statement for the same offering. ¨
If this Form is
a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon
filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ¨
If this
Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register
additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the
following box. ¨
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large
accelerated filer ¨ |
Accelerated
filer ¨ |
| Non-accelerated
filer x |
Smaller
reporting company x |
| |
Emerging
growth company ¨ |
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 7(a)(2)(B) of the Securities Act. ¨
The Registrant hereby amends this Registration
Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which
specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission acting pursuant to said
Section 8(a), may determine.
EXPLANATORY NOTE
This registration statement
contains two prospectuses:
| ● | a base prospectus which covers the offering, issuance and sale by the Registrant of up to $150,000,000
of the Registrant’s common stock, preferred stock, debt securities, warrants, rights and/or units; and |
| ● | a sales agreement prospectus covering the offering, issuance and sale by the Registrant of up to $40,000,000
of the Registrant’s common stock that may be issued and sold under a sales agreement with Jefferies LLC. |
The base prospectus immediately
follows this explanatory note. The specific terms of any securities to be offered pursuant to the base prospectus will be specified in
a prospectus supplement to the base prospectus. The sales agreement prospectus immediately follows the base prospectus. The common stock
that may be offered, issued and sold by the Registrant under the sales agreement prospectus is included in the $150,000,000 of securities
that may be offered, issued and sold by the Registrant under the base prospectus. Upon termination of the sales agreement with Jefferies LLC, any portion of the $40,000,000 included in the sales agreement prospectus
that is not sold pursuant to the sales agreement will be available for sale in other offerings pursuant to the base prospectus and a corresponding
prospectus supplement, and if no shares are sold under the sales agreement, the full $40,000,000 of securities may be sold in other offerings
pursuant to the base prospectus and a corresponding prospectus supplement.
The information in this prospectus
is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange
Commission is effective. This prospectus is not an offer to sell these securities and we are not soliciting offers to buy these securities
in any jurisdiction where the offer or sale is not permitted.
Subject to completion, dated
June 2, 2023
$150,000,000
PROSPECTUS
Common
Stock
Preferred
Stock
Debt
Securities
Warrants
Rights
Units
We may offer and sell securities
from time to time in one or more offerings of up to $150,000,000 in aggregate offering price. This prospectus describes the general terms
of these securities and the general manner in which these securities will be offered. We will provide the specific terms of these securities
in supplements to this prospectus. The prospectus supplements will also describe the specific manner in which these securities will be
offered and may also supplement, update or amend information contained in this document. You should read this prospectus, any applicable
prospectus supplement and any related free writing prospectus, as well as the documents incorporated by reference herein and therein,
carefully before you invest.
We may offer these securities
in amounts, at prices and on terms determined at the time of offering. The securities may be sold directly to you, through agents, or
through underwriters and dealers. If agents, underwriters or dealers are used to sell the securities, we will name them and describe their
compensation in a prospectus supplement.
Our common stock is listed
on The Nasdaq Capital Market under the symbol “BLPH”.
Investing
in these securities involves significant risks. See the information included under “Risk Factors” on page
8 of this prospectus and in any accompanying prospectus supplement, and under similar headings in the documents
incorporated by reference in this prospectus or any prospectus supplement, for a discussion of the factors you should carefully
consider before deciding to purchase these securities.
Neither the Securities and Exchange Commission
nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus.
Any representation to the contrary is a criminal offense.
The date of this prospectus is ____________, 2023
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This prospectus is part of
a registration statement that we filed with the Securities and Exchange Commission, which we refer to as the “SEC,” utilizing
a “shelf” registration process. Under this shelf registration process, we may from time to time sell any combination of the
securities described in this prospectus in one or more offerings for an aggregate initial offering price of up to $150,000,000.
This prospectus provides
you with a general description of the securities we may offer. Each time we sell securities, we will provide one or more prospectus supplements
that will contain specific information about the terms of the offering. The prospectus supplement may also add, update or change information
contained in this prospectus or in any documents that we have incorporated by reference into this prospectus and, accordingly, to the
extent inconsistent, information in this prospectus is superseded by the information in the prospectus supplement. You should read both
this prospectus and the accompanying prospectus supplement together with the additional information described under the heading “Where
You Can Find More Information.” You should rely only on the information contained in or incorporated by reference in this prospectus,
any accompanying prospectus supplement or in any related free writing prospectus filed by us with the SEC. We have not authorized anyone
to provide you with different information. This prospectus and any accompanying prospectus supplement do not constitute an offer to sell
or the solicitation of an offer to buy any securities other than the securities described in this prospectus or such accompanying prospectus
supplement or an offer to sell or the solicitation of an offer to buy such securities in any circumstances in which such offer or solicitation
is unlawful. You should assume that the information appearing in this prospectus, any prospectus supplement, the documents incorporated
by reference and any related free writing prospectus is accurate only as of their respective dates. Our business, financial condition,
results of operations and prospects may have changed materially since those dates.
Unless the context otherwise
indicates, references in this prospectus to the “Company,” “we,” “our” and “us” refer,
collectively, to Bellerophon Therapeutics, Inc., a Delaware corporation, and its consolidated subsidiaries.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly
and current reports, proxy statements and other information with the SEC. Our SEC filings are available to the public over the Internet
at the SEC’s website at www.sec.gov. Copies of certain information filed by us with the SEC are also available on our website at
www.bellerophon.com. Our website is not a part of this prospectus and is not incorporated by reference in this prospectus. This prospectus
is part of a registration statement we filed with the SEC. This prospectus omits some information contained in the registration statement
in accordance with SEC rules and regulations. You should review the information and exhibits in the registration statement for further
information about us and our consolidated subsidiaries and the securities we are offering. Statements in this prospectus concerning any
document we filed as an exhibit to the registration statement or that we otherwise filed with the SEC are not intended to be comprehensive
and are qualified by reference to these filings and the exhibits attached thereto. You should review the complete document to evaluate
these statements. You can obtain a copy of the registration statement from the SEC’s website.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to incorporate
by reference much of the information we file with the SEC, which means that we can disclose important information to you by referring
you to those publicly available documents. The information that we incorporate by reference in this prospectus is considered to be part
of this prospectus. Because we are incorporating by reference future filings with the SEC, this prospectus is continually updated and
those future filings may modify or supersede some of the information included or incorporated in this prospectus. This means that you
must look at all of the SEC filings that we incorporate by reference to determine if any of the statements in this prospectus or in any
document previously incorporated by reference have been modified or superseded. This prospectus incorporates by reference the documents
listed below (File No. 001-36845) and any future filings we make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the
Securities Exchange Act of 1934, as amended, or the Exchange Act (in each case, other than those documents or the portions of those documents
not deemed to be filed) between the date of the initial registration statement and the effectiveness of the registration statement and
following the effectiveness of the registration statement until the offering of the securities under the registration statement is terminated
or completed:
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Annual Report on Form 10-K for the fiscal year ended December 31, 2022 as filed with the SEC on March 31, 2023; |
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Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 28, 2023 to the extent incorporated by reference into our Annual Report on Form 10-K for the year ended December 31, 2022 (other than the portions thereof that are furnished and not filed); |
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Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023 as filed with the SEC on May 15, 2023; |
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Current Reports on Form 8-K (other than the portions thereof that are furnished and not filed) as filed with the SEC on January 5, 2023, January 18, 2023, February 9, 2023, March 3, 2023, March 6, 2023, April 25, 2023, May 5, 2023,
May 11, 2023, and May 11, 2023; |
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the description of our common stock contained in our registration statement on Form 8-A (file no. 001-36845) filed with the SEC on February 10, 2015, as updated by Exhibit 4.3 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, including
any amendments or reports filed for purpose of updating such description; and |
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all reports and other documents subsequently filed by us pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act after
the date of this prospectus supplement and prior to the termination or completion of the offering of securities under this prospectus
supplement shall be deemed to be incorporated by reference in this prospectus supplement and to be a part hereof from the date of filing
such reports and other documents. |
You may request a copy of these filings, at no
cost, by contacting: Investor Relations, Bellerophon Therapeutics, Inc., 20 Independence Boulevard, Suite 402, or calling (908)
574-4770
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
AND INDUSTRY DATA
This prospectus and the documents
incorporated by reference herein may contain forward looking statements that involve risks and uncertainties. All statements other than
statements of historical fact contained in this prospectus and the documents incorporated by reference herein, including statements regarding
future events, our future financial performance, business strategy, plans and objectives of management for future operations and the anticipated
use of the net proceeds from this offering, are forward-looking statements. We have attempted to identify forward-looking statements by
terminology including “anticipates,” “believes,” “can,” “continue,” “could,”
“estimates,” “expects,” “intends,” “may,” “plans,” “potential,”
“predicts,” “should,” or “will” or the negative of these terms or other comparable terminology. Although
we do not make forward looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy.
These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks outlined
under the section titled “Risk Factors” or elsewhere in this prospectus and the documents incorporated by reference herein,
which may cause our or our industry’s actual results, levels of activity, performance or achievements expressed or implied by these
forward-looking statements. Moreover, we operate in a highly regulated, very competitive, and rapidly changing environment. New risks
emerge from time to time and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our
business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from those contained
in any forward-looking statements.
We have based these forward-looking
statements largely on our current expectations and projections about future events and financial trends that we believe may affect our
financial condition, results of operations, business strategy, short term and long term business operations, and financial needs. These
forward-looking statements are subject to certain risks and uncertainties that could cause our actual results to differ materially from
those reflected in the forward looking statements. Factors that could cause or contribute to such differences include, but are not limited
to, those discussed in this prospectus, and in particular, the risks discussed below and under the section titled “Risk Factors”
and those discussed in other documents we file with the SEC. The following discussion should be read in conjunction with our audited consolidated
financial statements as of and for the years ended December 31, 2022 and 2021, and our interim unaudited consolidated financial statements
as of and for the quarter ended March 31, 2023, respectively, and related notes, incorporated by reference into the prospectus. In
light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this prospectus may not
occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statement. You
should understand that it is not possible to predict or identify all risk factors. Consequently, you should not consider any such list
to be a complete set of all potential risks or uncertainties.
You should not place undue
reliance on any forward-looking statement, each of which applies only as of the date on which it is made, which is the date of this prospectus
or the document incorporated by reference herein in which such statement appears, as applicable. Except as required by law, we undertake
no obligation to update or revise publicly any of the forward-looking statements after the date of this prospectus to conform our statements
to actual results or changed expectations. You are advised, however, to consult any further disclosures we make on related subjects in
our reports on Forms 10-K, 10-Q and 8-K filed with the SEC.
This prospectus and the information
incorporated by reference herein and therein may include statistical and other industry and market data that we obtained from industry
publications and research, surveys and studies conducted by third parties. All of the market data used in this prospectus and the information
incorporated by reference herein and therein involves a number of assumptions and limitations, and you are cautioned not to give undue
weight to such data. We believe that the information from these industry publications, surveys and studies is reliable.
ABOUT BELLEROPHON THERAPEUTICS, INC.
We are a clinical-stage therapeutics
company focused on developing innovative products that address significant unmet medical needs in the treatment of cardiopulmonary diseases.
Our focus is the continued development of our nitric oxide therapy for patients with or at risk of pulmonary hypertension, or PH, using
our proprietary pulsatile nitric oxide delivery platform, INOpulse.
In 2016, we began developing
INOpulse for the treatment of pulmonary hypertension associated with fibrotic interstitial lung disease (“fILD”), which includes
PH associated with idiopathic pulmonary fibrosis (“PH-IPF”) as well as other pulmonary fibrosing diseases. During May 2017,
we announced the completion of our Phase 2 clinical trial using INOpulse therapy to treat PH-IPF. The clinical data showed that INOpulse
was associated with clinically meaningful improvements in hemodynamics and exercise capacity in difficult-to-treat PH-IPF patients. The
PH-IPF trial was a proof of concept study (n=4) designed to evaluate the ability of pulsed inhaled nitric oxide, or iNO, to provide selective
vasodilation as well as to assess the potential for improvement in hemodynamics and exercise capacity in PH-IPF patients. The clinical
trial met its primary endpoint showing an average of 15.3% increase in blood vessel volume (p<0.001) during acute inhalation of iNO
as well as showing a significant association between ventilation and vasodilation, demonstrating the ability of INOpulse to provide selective
vasodilation to the better ventilated areas of the lung. The trial showed consistent benefit in hemodynamics with a clinically meaningful
average reduction of 14% in systolic pulmonary arterial pressure with acute exposure to iNO. The study assessed both the iNO 75 and iNO
30 dose.
During August 2017,
we announced acceptance by the U.S. Food and Drug Administration (the “FDA”) of our Investigational New Drug (“IND”)
application for our Phase 2b (“iNO-PF”) clinical trial using INOpulse therapy in a broad population of patients with pulmonary
fibrosis, or PF, at both low and intermediate/high risk of PH. In January 2019, we announced top-line results from cohort 1 of our
iNO-PF trial. The results suggested directional improvements in multiple clinically meaningful exploratory endpoints as measured by a
wearable medical-grade activity monitor. In addition, these results suggested that iNO may have a favorable safety profile, supporting
the continuation into cohort 2. In April 2019, we announced that we reached an agreement with the FDA on modifying the ongoing Phase
2b trial into a seamless Phase 2/3 trial, with cohort 3 serving as the pivotal study, as well as an agreement on the primary endpoint
in cohort 3 of change in moderate to vigorous activity (“MVPA”) from baseline to month 4, measured by Actigraphy. Actigraphy
(medical wearable continuous activity monitoring) has the potential to provide highly sensitive objective real-world physical activity
data that we expect to correlate with clinically meaningful patient functional abilities and health outcomes. Actigraphy is currently
being utilized as the primary endpoint in multiple late-stage clinical programs in various cardiopulmonary diseases such as heart failure
and chronic obstructive pulmonary disease (“COPD”). In December 2019, we announced top-line results from cohort 2 of
the iNO-PF trial. Cohort 2 of iNO-PF suggested directionally favorable and potentially clinically meaningful placebo corrected improvement
in MVPA, in subjects treated with iNO45 (45 mcg/kg IBW/hr) versus placebo. The improvement in MVPA was underscored by benefits in overall
activity, as well as multiple patient reported outcomes. In March 2020, we announced that in consultation with the FDA, we had finalized
some of the key elements of our planned pivotal Phase 3 study for fILD, including the use of MVPA as the primary endpoint for approval,
the patient population of pulmonary fibrosis subjects at risk of PH, as well as the dose of iNO45. In December 2020, we announced
the first patient enrollment in this Phase 3 study called REBUILD. In September 2022, the FDA informed us that it had no objection
to our proposal to reduce the study size to 140 subjects which does not impact the trial’s principal objective or endpoints and
maintains power of >90% (p-value <0.01) for the primary endpoint of MVPA based on the effect size observed in our Phase 2 study.
The FDA did note that since our proposal to reduce the sample size was based on Phase 2b cohort 2 actigraphy data, there is always a concern
that such sample size reduction may further limit the acquisition of information on other important clinical endpoints in the trial. The
FDA agreement was based on its review of:
| ● | Analysis conducted on cohort 2 (Phase 2) data utilizing the statistical analysis methodology to be used
in REBUILD, including bi-weekly analysis of MVPA data and mixed models for repeated measures (“MMRM”) assessment of the last
half of the blinded treatment period, which showed the trial would be >90% powered for p<0.05 at 80 total patients and >90% powered
for a p<0.01 at 114 patients based on the effect size determined from cohort 2; |
| ● | Similar baseline MVPA distribution between cohort 2 and the first 80 randomized patients in REBUILD based
on a blinded assessment; and |
| ● | Independent Data Monitoring Committee unblinded safety review of the first 85 randomized patients in REBUILD
indicating no safety concern with regards to reduction of REBUILD to 140 patients. |
During January 2023,
we completed enrollment of the REBUILD study with a total of 145 patients enrolled. In May 2023, the last subject completed blinded
treatment in the REBUILD study. We expect to report pivotal top-line data results in mid-2023.
In 2018, we initiated an
ancillary Phase 2 open-label intra-patient dose escalation study that utilizes right heart catheterization to assess the hemodynamic effect
of INOpulse from a dose of iNO 30 to iNO 125 in PH-PF subjects. In February 2020, we announced the completion of the study and that
the top-line results demonstrated that INOpulse achieved clinically and statistically meaningful cardiopulmonary improvements in pulmonary
vascular resistance and mean pulmonary arterial pressure. The data suggested that inhaled nitric oxide was generally well tolerated and
may yield a favorable risk-benefit profile across doses.
In 2018, we also initiated
development of INOpulse for the treatment of PH associated with Sarcoidosis (“PH-Sarc”). Sarcoidosis is a multi-system disease
which is characterized by the growth of granulomas (inflammatory cells) in one or more organs. The most frequent organs involved are the
lungs and lymph nodes within the chest. Pulmonary hypertension may be present in as many as 74% of patients depending on the disease severity
and how the pulmonary hypertension (PH) is defined. The presence of PH in sarcoidosis is associated with a poor prognosis. There are a
number of different mechanisms linking PH with sarcoidosis. The primary treatment for sarcoidosis is corticosteroids; however, the outcome
of this treatment on the PH is unclear. There is no approved therapy for PH associated with sarcoidosis. Various PAH treatments have been
tried including iNO and IV prostacyclin with some clinical and functional improvement. The study was a Phase 2 open-label dose escalation
design that utilized right heart catheterization to assess the acute hemodynamic effect of INOpulse from a dose of iNO 30 to iNO 125 in
PH-Sarc subjects. In December 2021, we announced the completion of the acute dose escalation phase of the study and that the top-line
results demonstrated that INOpulse provided clinically meaningful improvements in pulmonary vascular resistance. Supported by the results
from this study, on June 21, 2022, we submitted to the FDA an exploratory Phase 2 double-blinded placebo-controlled study to investigate
the safety and efficacy of inhaled nitric oxide/INOpulse dosed chronically for six months in patients with PH-Sarc. Subsequently, on July 28,
2022, we received an FDA letter indicating that the FDA completed its review of our study protocol, with a minor recommendation to include
safety stopping rules. We have agreed to incorporate this recommendation into our periodic safety reviews. We are positioned to initiate
this Phase 2 study and are currently assessing the next steps for the study.
We completed a randomized,
placebo-controlled, double-blind, dose-confirmation Phase 2 clinical trial of INOpulse for pulmonary hypertension associated with chronic
obstructive pulmonary disease, or PH-COPD, in July 2014. The results from this trial showed that iNO 30 was a potentially safe and
effective dose for treatment of PH-COPD. Based on the results of this trial, we completed further Phase 2 testing to assess the targeted
vasodilation provided by INOpulse in this patient population. We presented the results of this trial in September 2015 at the European
Respiratory Society International Congress 2015 in Amsterdam. The data showed that INOpulse improved vasodilation in patients with PH-COPD.
In July 2016, the results were published in the International Journal of COPD in an article entitled “Pulmonary vascular effects
of pulsed inhaled nitric oxide in COPD patients with pulmonary hypertension.” During September 2017, we shared the results
of our Phase 2a PH-COPD trial that was designed to evaluate the acute effects of pulsed inhaled nitric oxide, or iNO, on vasodilation
as well as the chronic effect on hemodynamics and exercise tolerance. The trial showed a statistically significant increase (average 4.2%)
in blood vessel volume on iNO compared to baseline (p=0.03), and a statistically significant correlation in Ventilation-Vasodilation (p=0.01).
The chronic results demonstrated a statistically significant and clinically meaningful increase in six minute walk distance, or 6MWD,
of 50.7m (p=0.04) as well as a decrease of 19.9% in systolic pulmonary arterial pressure (p=0.02), as compared to baseline. The data suggested
that the dose may have a favorable safety profile. In May 2018, we announced that the FDA concurred with the design of our planned
Phase 2b study of INOpulse for treatment of PH-COPD. The study will assess the effect of INOpulse on various parameters including exercise
capacity, right ventricular function and oxygen saturation, as well as other composite endpoints. We continue to evaluate alternatives
for the funding and timing of this program.
In addition, other potential
indications for our INOpulse platform include: chronic thromboembolic PH, or CTEPH and PH associated with pulmonary edema from high altitude
sickness. However, we have not yet commenced any studies of the INOpulse platform with respect to such other indications.
We have devoted all of our
resources to our therapeutic discovery and development efforts, including performance of IND-enabling studies, conducting clinical trials
for our product candidates, protecting our intellectual property and the general and administrative support of these operations. We have
devoted significant time and resources to developing and optimizing our drug delivery system, INOpulse, which operates through the
administration of nitric oxide as brief, controlled pulses that are timed to occur at the beginning of a breath.
To date, we have generated
no revenue from product sales. We expect that it may be several years before we commercialize a product candidate, if ever.
Company Information
We were incorporated under
the laws of the State of Delaware on October 17, 2013 under the name Ikaria Development LLC. We changed our name to Bellerophon Therapeutics
LLC on January 27, 2014. On February 12, 2015, we converted from a Delaware limited liability company into a Delaware corporation
and changed our name to Bellerophon Therapeutics, Inc. We currently have three wholly-owned subsidiaries: Bellerophon BCM LLC, a
Delaware limited liability company; Bellerophon Pulse Technologies LLC, a Delaware limited liability company; and Bellerophon Services, Inc.,
a Delaware corporation. Our website address is www.bellerophon.com. The information contained on, or that can be accessed through, our
website does not constitute part of this prospectus. We have included our website address in this prospectus solely as an inactive textual
reference.
Our executive offices are
located at 20 Independence Boulevard, Suite 402, Warren, New Jersey 07059, and our telephone number is (908) 574-4770.
Smaller Reporting Company
We are a “smaller reporting
company” as defined in Rule 405 of the Securities Act. We will remain a smaller reporting company until the last day of the
fiscal year in which the aggregate market value of our common stock that is held by non-affiliates is at least $250 million or the last
day of the fiscal year in which we have at least $100 million in revenue and the aggregate market value of our common stock that is held
by non-affiliates is at least $700 million (in each case, with respect to the aggregate market value of our common stock held by non-affiliates,
as measured as of the last business day of the second quarter of such fiscal year).
RISK FACTORS
Investing in our securities
involves a high degree of risk. You should carefully review the risks and uncertainties described under the heading “Risk Factors”
contained in the applicable prospectus supplement and any related free writing prospectus, and under similar headings in our Annual Report on Form 10-K for the year ended December 31, 2022 and our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023, as updated by our subsequent filings, which are incorporated by reference into this prospectus, before deciding whether
to purchase any of the securities being registered pursuant to the registration statement of which this prospectus is a part. Each of
the risk factors could adversely affect our business, results of operations, financial condition and cash flows, as well as adversely
affect the value of an investment in our securities, and the occurrence of any of these risks might cause you to lose all or part of your
investment. Additional risks not presently known to us or that we currently believe are immaterial may also significantly impair our business
operations.
USE OF PROCEEDS
We cannot assure you that
we will receive any proceeds in connection with securities which may be offered pursuant to this prospectus. Unless otherwise indicated
in the applicable prospectus supplement, we intend to use any net proceeds from the sale of securities under this prospectus for our operations
and for other general corporate purposes, including, but not limited to, our internal research and development programs and the development
of new programs, general working capital and possible future acquisitions. We have not determined the amounts we plan to spend on any
of the areas listed above or the timing of these expenditures. As a result, our management will have broad discretion to allocate the
net proceeds, if any, we receive in connection with securities offered pursuant to this prospectus for any purpose. Pending application
of the net proceeds as described above, we may initially invest the net proceeds in short-term, investment-grade, interest-bearing securities
or apply them to the reduction of short-term indebtedness.
DESCRIPTION OF CAPITAL STOCK
As
of May 26, 2023, we had one class of securities registered under Section 12(b) of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”): Common Stock, $0.01 par value per share. Each of the Company’s securities registered
under Section 12(b) of the Exchange Act are listed on The Nasdaq Capital Market.
General
The following description
of our capital stock and provisions of our restated certificate of incorporation and amended and restated bylaws are summaries and are
qualified by reference to the restated certificate of incorporation and the amended and restated bylaws that are on file with the SEC.
Our authorized capital stock
consists of 200,000,000 shares of our common stock, $0.01 par value per share, and 5,000,000 shares of our preferred stock, $0.01 par
value per share, all of which preferred stock is undesignated.
As of March 31, 2023,
we had issued and outstanding:
| ● | 10,448,185 shares of our common stock held by 155 stockholders
of record; |
| ● | 311,210 shares of our common stock issuable upon the exercise
of stock options issued under our 2014 Equity Incentive Plan and 2015 Equity Plan at a weighted average exercise price of $12.49
per share; |
| ● | 52 shares of our common stock issuable upon the exercise of
stock options issued under our 2007 Ikaria Stock Option Plan and 2010 Long Term Incentive Plan at a weighted average exercise price of $131.55
per share; |
| ● | 585,139 shares of our common stock issuable upon the exercise
of warrants at a weighted average exercise price of $12.00 per share; |
| ● | 1,781,526 shares of our common stock issuable upon the exercise
of pre-funded warrants at a weighted average exercise price of $0.01 per share; and |
| ● | 148,000 shares of our common stock underlying unvested RSUs. |
Common Stock
Holders of our common stock
are entitled to one vote for each share held on all matters submitted to a vote of stockholders and do not have cumulative voting rights.
Each election of directors by our stockholders will be determined by a plurality of the votes cast by the stockholders entitled to vote
on the election. Holders of common stock are entitled to receive proportionately any dividends as may be declared by our board of directors,
subject to any preferential dividend rights of outstanding preferred stock.
In the event of our liquidation
or dissolution, the holders of our common stock are entitled to receive proportionately all assets available for distribution to stockholders
after the payment of all debts and other liabilities and subject to the prior rights of any of our outstanding preferred stock. Holders
of our common stock have no preemptive, subscription, redemption or conversion rights. The rights, preferences and privileges of holders
of our common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of our preferred
stock that we may designate and issue in the future.
Preferred Stock
Under the terms of our restated certificate of incorporation, our board of directors is authorized to issue shares of preferred
stock in one or more series without stockholder approval. Our board of directors has the discretion to determine the rights, preferences,
privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences,
of each series of preferred stock.
The purpose of authorizing our board of directors to issue preferred stock and determine its rights
and preferences is to eliminate delays associated with a stockholder vote on specific issuances. The issuance of preferred stock, while
providing flexibility in connection with possible acquisitions, future financings and other corporate purposes, could have the effect
of making it more difficult for a third party to acquire, or could discourage a third party from seeking to acquire, a majority of our
outstanding voting stock. There are no shares of preferred stock currently outstanding, and we have no present plans to issue any shares
of preferred stock.
Delaware Anti-Takeover Law and Certain Charter and Bylaw Provisions
Delaware Law
We are subject to Section 203
of the Delaware General Corporation Law, which prohibits a publicly-held Delaware corporation from engaging in a business combination
with an interested stockholder, generally a person which together with its affiliates owns, or within the last three years has owned,
15% of our voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder,
unless the business combination is approved in a prescribed manner. Subject to certain exceptions, Section 203 prevents a publicly
held Delaware corporation from engaging in a “business combination” with any “interested stockholder” for three
years following the date that the person became an interested stockholder, unless either the interested stockholder attained such status
with the approval of our board of directors, the business combination is approved by our board of directors and stockholders in a prescribed
manner or the interested stockholder acquired at least 85% of our outstanding voting stock in the transaction in which it became an interested
stockholder. A “business combination” includes, among other things, a merger or consolidation involving us and the “interested
stockholder” and the sale of more than 10% of our assets. In general, an “interested stockholder” is any entity or person
beneficially owning 15% or more of our outstanding voting stock and any entity or person affiliated with or controlling or controlled
by such entity or person. The restrictions contained in Section 203 are not applicable to any of our existing stockholders that owned
15% or more of our outstanding voting stock upon the closing of our IPO.
Staggered Board; Removal of Directors
Our restated certificate
of incorporation and our amended and restated bylaws divide our board of directors into three classes with staggered three-year terms.
In addition, a director may be removed only for cause and only by the affirmative vote of the holders of at least 75% of the outstanding
shares of our common stock. In addition, the authorized number of our directors may be changed only by resolution of our directors, and
any vacancy on our board of directors, including a vacancy resulting from an enlargement of our board of directors, may be filled only
by vote of a majority of our directors then in office.
The classification of our
board of directors and the limitations on the ability of our stockholders to change the authorized number of directors, remove directors
and fill vacancies could make it more difficult for a third party to acquire, or discourage a third party from seeking to acquire, control
of our company.
Stockholder Action; Special Meeting of Stockholders;
Advance Notice Requirements for Stockholder Proposals and Director Nominations
Our restated certificate
of incorporation and our amended and restated bylaws provide that any action required or permitted to be taken by our stockholders at
an annual meeting or special meeting of stockholders may only be taken if it is properly brought before such meeting and may not be taken
by written action in lieu of a meeting. Our restated certificate of incorporation and our amended and restated bylaws also provide that,
except as otherwise required by law, special meetings of the stockholders can only be called by the chairman of our board of directors,
our chief executive officer or our board of directors. In addition, our amended and restated bylaws establish an advance notice procedure
for stockholder proposals to be brought before an annual meeting of stockholders, including proposed nominations of candidates for election
to our board of directors. Stockholders at an annual meeting may only consider proposals or nominations specified in the notice of meeting
or brought before the meeting by or at the direction of our board of directors, or by a stockholder of record on the record date for the
meeting, who is entitled to vote at the meeting and who has delivered timely written notice in proper form to our secretary of the stockholder’s
intention to bring such business before the meeting. These provisions could have the effect of delaying until the next stockholder meeting
stockholder actions that are favored by the holders of a majority of our outstanding voting securities. These provisions also could discourage
a third party from making a tender offer for our common stock, because even if it acquired a majority of our outstanding voting stock,
it would be able to take action as a stockholder, such as electing new directors or approving a merger, only at a duly called stockholder
meeting and not by written consent.
Super-Majority Voting
The Delaware General Corporation
Law provides generally that the affirmative vote of a majority of the shares entitled to vote on any matter is required to amend a corporation’s
certificate of incorporation or bylaws, unless a corporation’s certificate of incorporation or bylaws, as the case may be, requires
a greater percentage. Our amended and restated bylaws may be amended or repealed by a majority vote of our board of directors or the affirmative
vote of the holders of at least 75% of the votes that all our stockholders would be entitled to cast in any annual election of directors.
In addition, the affirmative vote of the holders of at least 75% of the votes that all our stockholders would be entitled to cast in any
election of directors is required to amend, repeal or adopt any provisions inconsistent with any of the provisions of our restated certificate
of incorporation described above.
Exclusive Forum
Our restated certificate
of incorporation provides that the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for (i) any derivative
action or proceeding brought on behalf of our company, (ii) any action asserting a claim of breach of a fiduciary duty owed by any
of our directors or officers to the company or our stockholders, (iii) any action asserting a claim against our company arising pursuant
to any provision of the Delaware General Corporation Law or our restated certificate of incorporation or amended and restated bylaws or
(iv) any action asserting a claim against our company or any of our directors or officers governed by the internal affairs doctrine.
Although our restated certificate of incorporation contains the provision described above, it is possible that a court could rule that
such a provision is inapplicable for a particular claim or action or that such provision is unenforceable.
Corporate Opportunity
Our restated certificate
of incorporation provides that the doctrine of “corporate opportunity” does not apply to any of our stockholders or directors,
other than in the case of a corporate opportunity that is offered to such person in writing solely in his or her capacity as our director,
officer or employee. Accordingly, our stockholders and directors and their respective representatives have no duty to communicate or present
corporate opportunities to us and have the right to either hold any corporate opportunity for its (and its representatives’) own
account and benefit or to recommend, assign or otherwise transfer such corporate opportunity to persons other than us, other than in the
case of a corporate opportunity that is offered to such person in writing solely in his or her capacity as our director, officer or employee.
As a result, our stockholders, directors and their respective affiliates will not be prohibited from investing in competing businesses
or doing business with our customers.
Transfer Agent and Registrar
The transfer agent and registrar
for our common stock is Computershare Trust Company, N.A.
Nasdaq Capital Market Listing
Our common stock is publicly
traded on the Nasdaq Capital Market under the symbol “BLPH”.
DESCRIPTION OF DEBT SECURITIES
The following description,
together with the additional information we include in any applicable prospectus supplements, summarizes the material terms and provisions
of the debt securities that we may offer under this prospectus. While the terms we have summarized below will apply generally to any future
debt securities we may offer pursuant to this prospectus, we will describe the particular terms of any debt securities that we may offer
in more detail in the applicable prospectus supplement. If we so indicate in a prospectus supplement, the terms of any debt securities
offered under such prospectus supplement may differ from the terms we describe below, and to the extent the terms set forth in a prospectus
supplement differ from the terms described below, the terms set forth in the prospectus supplement shall control.
We may sell from time to
time, in one or more offerings under this prospectus, debt securities, which may be senior or subordinated. We will issue any such senior
debt securities under a senior indenture that we will enter into with a trustee to be named in the senior indenture. We will issue any
such subordinated debt securities under a subordinated indenture, which we will enter into with a trustee to be named in the subordinated
indenture. We use the term “indentures” to refer to either the senior indenture or the subordinated indenture, as applicable.
The indentures will be qualified under the Trust Indenture Act of 1939, as in effect on the date of the indenture. We use the term “debenture
trustee” to refer to either the trustee under the senior indenture or the trustee under the subordinated indenture, as applicable.
The following summaries of
material provisions of the senior debt securities, the subordinated debt securities and the indentures are subject to, and qualified in
their entirety by reference to, all the provisions of the indenture applicable to a particular series of debt securities.
General
Each indenture will provide
that debt securities may be issued from time to time in one or more series and may be denominated and payable in foreign currencies or
units based on or relating to foreign currencies. Neither indenture will limit the amount of debt securities that may be issued thereunder,
and each indenture will provide that the specific terms of any series of debt securities shall be set forth in, or determined pursuant
to, an authorizing resolution and/or a supplemental indenture, if any, relating to such series.
We will describe in each
prospectus supplement the following terms relating to a series of debt securities:
| ● | the title or designation; |
| ● | the aggregate principal amount and any limit on the amount that may be issued; |
| ● | the currency or units based on or relating to currencies in which debt securities of such series are denominated
and the currency or units in which principal or interest or both will or may be payable; |
| ● | whether we will issue the series of debt securities in global form, the terms of any global securities
and who the depositary will be; |
| ● | the maturity date and the date or dates on which principal will be payable; |
| ● | the interest rate, which may be fixed or variable, or the method for determining the rate and the date
interest will begin to accrue, the date or dates interest will be payable and the record dates for interest payment dates or the method
for determining such dates; |
| ● | whether or not the debt securities will be secured or unsecured, and the terms of any secured debt; |
| ● | the terms of the subordination of any series of subordinated debt; |
| ● | the place or places where payments will be payable; |
| ● | our right, if any, to defer payment of interest and the maximum length of any such deferral period; |
| ● | the date, if any, after which, and the price at which, we may, at our option, redeem the series of debt
securities pursuant to any optional redemption provisions; |
| ● | the date, if any, on which, and the price at which we are obligated, pursuant to any mandatory sinking
fund provisions or otherwise, to redeem, or at the holder’s option to purchase, the series of debt securities; |
| ● | whether the indenture will restrict our ability to pay dividends, or will require us to maintain any asset
ratios or reserves; |
| ● | whether we will be restricted from incurring any additional indebtedness; |
| ● | a discussion on any material or special U.S. federal income tax considerations applicable to a series
of debt securities; |
| ● | the denominations in which we will issue the series of debt securities, if other than denominations of
$1,000 and any integral multiple thereof; and |
| ● | any other specific terms, preferences, rights or limitations of, or restrictions on, the debt securities. |
We may issue debt securities
that provide for an amount less than their stated principal amount to be due and payable upon declaration of acceleration of their maturity
pursuant to the terms of the indenture. We will provide you with information on the federal income tax considerations and other special
considerations applicable to any of these debt securities in the applicable prospectus supplement.
Conversion or Exchange Rights
We will set forth in the
prospectus supplement the terms, if any, on which a series of debt securities may be convertible into or exchangeable for our common stock
or our other securities. We will include provisions as to whether conversion or exchange is mandatory, at the option of the holder or
at our option. We may include provisions pursuant to which the number of shares of our common stock or our other securities that the holders
of the series of debt securities receive would be subject to adjustment.
Information Concerning the Debenture Trustee
The debenture trustee, other
than during the occurrence and continuance of an event of default under the applicable indenture, undertakes to perform only those duties
as are specifically set forth in the applicable indenture. Upon an event of default under an indenture, the debenture trustee under such
indenture must use the same degree of care as a prudent person would exercise or use in the conduct of his or her own affairs. Subject
to this provision, the debenture trustee is under no obligation to exercise any of the powers given it by the indentures at the request
of any holder of debt securities unless it is offered reasonable security and indemnity against the costs, expenses and liabilities that
it might incur.
Payment and Paying Agents
Unless we otherwise indicate
in the applicable prospectus supplement, we will make payment of the interest on any debt securities on any interest payment date to the
person in whose name the debt securities, or one or more predecessor securities, are registered at the close of business on the regular
record date for the interest.
We will pay principal of
and any premium and interest on the debt securities of a particular series at the office of the paying agents designated by us, except
that unless we otherwise indicate in the applicable prospectus supplement, we will make interest payments by check which we will mail
to the holder. Unless we otherwise indicate in a prospectus supplement, we will designate the corporate trust office of the debenture
trustee in the City of New York as our sole paying agent for payments with respect to debt securities of each series. We will name in
the applicable prospectus supplement any other paying agents that we initially designate for the debt securities of a particular series.
We will maintain a paying agent in each place of payment for the debt securities of a particular series.
All money we pay to a paying
agent or the debenture trustee for the payment of the principal of or any premium or interest on any debt securities which remains unclaimed
at the end of two years after such principal, premium or interest has become due and payable will be repaid to us, and the holder of the
security thereafter may look only to us for payment thereof.
Governing Law
The indentures and the debt
securities will be governed by and construed in accordance with the laws of the State of New York, except to the extent that the Trust
Indenture Act is applicable.
Subordination of Subordinated Debt Securities
Our obligations pursuant
to any subordinated debt securities will be unsecured and will be subordinate and junior in priority of payment to certain of our other
indebtedness to the extent described in a prospectus supplement. The subordinated indenture does not limit the amount of senior indebtedness
we may incur. It also does not limit us from issuing any other secured or unsecured debt.
DESCRIPTION OF WARRANTS
General
We may issue warrants to
our stockholders to purchase shares of our common stock. We may offer warrants separately or together with one or more debt securities,
common stock or rights, or any combination of those securities in the form of units, as described in the applicable prospectus supplement.
Each series of warrants will be issued under a separate warrant agreement to be entered into between us and a bank or trust company, as
warrant agent. The warrant agent will act solely as our agent in connection with the certificates relating to the rights of the series
of certificates and will not assume any obligation or relationship of agency or trust for or with any holders of rights certificates or
beneficial owners of rights. The following description sets forth certain general terms and provisions of the rights to which any prospectus
supplement may relate. The particular terms of the warrant to which any prospectus supplement may relate and the extent, if any, to which
the general provisions may apply to the rights so offered will be described in the applicable prospectus supplement. To the extent that
any particular terms of the warrant, warrant agreement or warrant certificates described in a prospectus supplement differ from any of
the terms described below, then the terms described below will be deemed to have been superseded by that prospectus supplement. We encourage
you to read the applicable warrant agreement and warrant certificate for additional information before you decide whether to purchase
any of our rights.
We will provide in a prospectus
supplement the following terms of the warrants being issued:
| ● | the specific designation and aggregate number of, and the price at which we will issue, the warrants; |
| ● | the currency or currency units in which the offering price, if any, and the exercise price are payable; |
| ● | the designation, amount and terms of the securities purchasable upon exercise of the warrants; |
| ● | if applicable, the exercise price for shares of our common stock and the number of shares of common stock
to be received upon exercise of the warrants; |
| ● | if applicable, the exercise price for shares of our preferred stock, the number of shares of preferred
stock to be received upon exercise, and a description of that series of our preferred stock; |
| ● | if applicable, the exercise price for our debt securities, the amount of debt securities to be received
upon exercise, and a description of that series of debt securities; |
| ● | the date on which the right to exercise the warrants will begin and the date on which that right will
expire or, if you may not continuously exercise the warrants throughout that period, the specific date or dates on which you may exercise
the warrants; |
| ● | whether the warrants will be issued in fully registered form or bearer form, in definitive or global form
or in any combination of these forms, although, in any case, the form of a warrant included in a unit will correspond to the form of the
unit and of any security included in that unit; |
| ● | any applicable material U.S. federal income tax consequences; |
| ● | the identity of the warrant agent for the warrants and of any other depositaries, execution or paying
agents, transfer agents, registrars or other agents; |
| ● | the proposed listing, if any, of the warrants or any securities purchasable upon exercise of the warrants
on any securities exchange; |
| ● | if applicable, the date from and after which the warrants and the common stock, preferred stock and/or
debt securities will be separately transferable; |
| ● | if applicable, the minimum or maximum amount of the warrants that may be exercised at any one time; |
| ● | information with respect to book-entry procedures, if any; |
| ● | the anti-dilution provisions of the warrants, if any; |
| ● | any redemption or call provisions; |
| ● | whether the warrants may be sold separately or with other securities as parts of units; and |
| ● | any additional terms of the warrants, including terms, procedures and limitations relating to the exchange
and exercise of the warrants. |
Each warrant will entitle
the holder of rights to purchase for cash the principal amount of shares of common stock or other securities at the exercise price provided
in the applicable prospectus supplement. Warrants may be exercised at any time up to the close of business on the expiration date for
the rights provided in the applicable prospectus supplement.
Holders may exercise warrants
as described in the applicable prospectus supplement. Upon receipt of payment and the warrant certificate properly completed and duly
executed at the corporate trust office of the rights agent or any other office indicated in the prospectus supplement, we will, as soon
as practicable, forward the shares of common stock or other securities, as applicable, purchasable upon exercise of the rights. If less
than all of the warrants issued in any rights offering are exercised, we may offer any unsubscribed securities directly to persons other
than stockholders, to or through agents, underwriters or dealers or through a combination of such methods, including pursuant to standby
arrangements, as described in the applicable prospectus supplement.
Warrant
Agent
The warrant agent for any
warrants we offer will be set forth in the applicable prospectus supplement.
DESCRIPTION OF RIGHTS
General
We may issue rights to our
stockholders to purchase shares of our common stock or the other securities described in this prospectus. We may offer rights separately
or together with one or more additional rights, debt securities, common stock or warrants, or any combination of those securities in the
form of units, as described in the applicable prospectus supplement. Each series of rights will be issued under a separate rights agreement
to be entered into between us and a bank or trust company, as rights agent. The rights agent will act solely as our agent in connection
with the certificates relating to the rights of the series of certificates and will not assume any obligation or relationship of agency
or trust for or with any holders of rights certificates or beneficial owners of rights. The following description sets forth certain general
terms and provisions of the rights to which any prospectus supplement may relate. The particular terms of the rights to which any prospectus
supplement may relate and the extent, if any, to which the general provisions may apply to the rights so offered will be described in
the applicable prospectus supplement. To the extent that any particular terms of the rights, rights agreement or rights certificates described
in a prospectus supplement differ from any of the terms described below, then the terms described below will be deemed to have been superseded
by that prospectus supplement. We encourage you to read the applicable rights agreement and rights certificate for additional information
before you decide whether to purchase any of our rights.
We will provide in a prospectus
supplement the following terms of the rights being issued:
| ● | the date of determining the stockholders entitled to the rights distribution; |
| ● | the aggregate number of shares of common stock or other securities purchasable upon exercise of the rights; |
| ● | the aggregate number of rights issued; |
| ● | whether the rights are transferrable and the date, if any, on and after which the rights may be separately
transferred; |
| ● | the date on which the right to exercise the rights will commence, and the date on which the right to exercise
the rights will expire; |
| ● | the method by which holders of rights will be entitled to exercise; |
| ● | the conditions to the completion of the offering, if any; |
| ● | the withdrawal, termination and cancellation rights, if any; |
| ● | whether there are any backstop or standby purchaser or purchasers and the terms of their commitment, if
any; |
| ● | whether stockholders are entitled to oversubscription rights, if any; |
| ● | any applicable U.S. federal income tax considerations; and |
| ● | any other terms of the rights, including terms, procedures and limitations relating to the distribution,
exchange and exercise of the rights, as applicable. |
Each right will entitle the
holder of rights to purchase for cash the principal amount of shares of common stock or other securities at the exercise price provided
in the applicable prospectus supplement. Rights may be exercised at any time up to the close of business on the expiration date for the
rights provided in the applicable prospectus supplement.
Holders may exercise rights
as described in the applicable prospectus supplement. Upon receipt of payment and the rights certificate properly completed and duly executed
at the corporate trust office of the rights agent or any other office indicated in the prospectus supplement, we will, as soon as practicable,
forward the shares of common stock or other securities, as applicable, purchasable upon exercise of the rights. If less than all of the
rights issued in any rights offering are exercised, we may offer any unsubscribed securities directly to persons other than stockholders,
to or through agents, underwriters or dealers or through a combination of such methods, including pursuant to standby arrangements, as
described in the applicable prospectus supplement.
Rights
Agent
The rights agent for any
rights we offer will be set forth in the applicable prospectus supplement.
DESCRIPTION OF UNITS
The following description,
together with the additional information that we include in any applicable prospectus supplements summarizes the material terms and provisions
of the units that we may offer under this prospectus. While the terms we have summarized below will apply generally to any units that
we may offer under this prospectus, we will describe the particular terms of any series of units in more detail in the applicable prospectus
supplement. The terms of any units offered under a prospectus supplement may differ from the terms described below.
We will incorporate by reference
from reports that we file with the SEC, the form of unit agreement that describes the terms of the series of units we are offering, and
any supplemental agreements, before the issuance of the related series of units. The following summaries of material terms and provisions
of the units are subject to, and qualified in their entirety by reference to, all the provisions of the unit agreement and any supplemental
agreements applicable to a particular series of units. We urge you to read the applicable prospectus supplements related to the particular
series of units that we may offer under this prospectus, as well as any related free writing prospectuses and the complete unit agreement
and any supplemental agreements that contain the terms of the units.
General
We may issue units consisting
of common stock, one or more debt securities, warrants or rights for the purchase of common stock and/or debt securities in one or more
series, in any combination. Each unit will be issued so that the holder of the unit is also the holder of each security included in the
unit. Thus, the holder of a unit will have the rights and obligations of a holder of each security included in the unit. The unit agreement
under which a unit is issued may provide that the securities included in the unit may not be held or transferred separately, at any time
or at any time before a specified date.
We will describe in the applicable
prospectus supplement the terms of the series of units being offered, including:
| ● | the designation and terms of the units and of the securities comprising the units, including whether and
under what circumstances those securities may be held or transferred separately; |
| ● | any provisions of the governing unit agreement that differ from those described below; and |
| ● | any provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities
comprising the units. |
The provisions described
in this section, as well as those set forth in any prospectus supplement or as described under “Description of Capital Stock,”
“Description of Debt Securities,” “Description of Warrants” and “Description of Rights” will apply
to each unit, as applicable, and to any common stock, debt security, warrant or right included in each unit, as applicable.
Unit Agent
The name and address of the
unit agent for any units we offer will be set forth in the applicable prospectus supplement.
Issuance in Series
We may issue units in such
amounts and in such numerous distinct series as we determine.
Enforceability of Rights by Holders of Units
Each unit agent will act
solely as our agent under the applicable unit agreement and will not assume any obligation or relationship of agency or trust with any
holder of any unit. A single bank or trust company may act as unit agent for more than one series of units. A unit agent will have no
duty or responsibility in case of any default by us under the applicable unit agreement or unit, including any duty or responsibility
to initiate any proceedings at law or otherwise, or to make any demand upon us. Any holder of a unit may, without the consent of the related
unit agent or the holder of any other unit, enforce by appropriate legal action its rights as holder under any security included in the
unit.
Provisions
of Delaware Law Governing Business Combinations
We are subject to the “business
combination” provisions of Section 203 of the DGCL. In general, such provisions prohibit a publicly held Delaware corporation
from engaging in any “business combination” transactions with any “interested stockholder” for a period of three
years after the date on which the person became an “interested stockholder,” unless:
| ● | prior to such date, the board of directors approved either the “business combination” or the
transaction which resulted in the “interested stockholder” obtaining such status; or |
| ● | upon consummation of the transaction which resulted in the stockholder becoming an “interested stockholder,”
the “interested stockholder” owned at least 85% of the voting stock of the corporation outstanding at the time the transaction
commenced, excluding for purposes of determining the voting stock outstanding (but not the outstanding voting stock owned by the “interested
stockholder”) those shares owned by (a) persons who are directors and also officers and (b) employee stock plans in which
employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a
tender or exchange offer; or |
| ● | at or subsequent to such time the “business combination” is approved by the board of directors
and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2/3%
of the outstanding voting stock which is not owned by the “interested stockholder.” |
A “business combination”
is defined to include mergers, asset sales and other transactions resulting in financial benefit to a stockholder. In general, an “interested
stockholder” is a person who, together with affiliates and associates, owns 15% or more of a corporation’s voting stock or
within three years did own 15% or more of a corporation’s voting stock. The statute could prohibit or delay mergers or other takeover
or change in control attempts with respect to us and, accordingly, may discourage attempts to acquire us.
Limitations on Liability and Indemnification
of Officers and Directors
Section 145 of the DGCL
authorizes a court to award, or a corporation’s board of directors to grant, indemnity to directors and officers in terms sufficiently
broad to permit such indemnification under certain circumstances for liabilities (including reimbursement for expenses incurred) arising
under the Securities Act of 1933. Our amended and restated certificate of incorporation limits the liability of our officers and directors
to the fullest extent permitted by the DGCL, and our amended and restated certificate of incorporation provides that we will indemnify
our officers and directors to the fullest extent permitted by such law.
Insofar as indemnification
for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers or persons controlling the registrant
pursuant to the foregoing provisions, the registrant has been informed that in the opinion of the SEC such indemnification is against
public policy as expressed in the Securities Act and is therefore unenforceable.
PLAN OF DISTRIBUTION
We may sell securities:
| ● | directly to purchasers; or |
| ● | through a combination of any of these methods of sale. |
In addition, we may issue
the securities as a dividend or distribution or in a subscription rights offering to our existing security holders. This prospectus may
be used in connection with any offering of our securities through any of these methods or other methods described in the applicable prospectus
supplement.
We may directly solicit offers
to purchase securities, or agents may be designated to solicit such offers. We will, in the prospectus supplement relating to such offering,
name any agent that could be viewed as an underwriter under the Securities Act, and describe any commissions that we must pay. Any such
agent will be acting on a best efforts basis for the period of its appointment or, if indicated in the applicable prospectus supplement,
on a firm commitment basis.
The distribution of the securities
may be effected from time to time in one or more transactions:
| ● | at a fixed price, or prices, which may be changed from time to time; |
| ● | at market prices prevailing at the time of sale; |
| ● | at prices related to such prevailing market prices; or |
Each prospectus supplement
will describe the method of distribution of the securities and any applicable restrictions.
The prospectus supplement
with respect to the securities of a particular series will describe the terms of the offering of the securities, including the following:
| ● | the name of the agent or any underwriters; |
| ● | the public offering or purchase price and the proceeds we will receive from the sale of the securities; |
| ● | any discounts and commissions to be allowed or re-allowed or paid to the agent or underwriters; |
| ● | all other items constituting underwriting compensation; |
| ● | any discounts and commissions to be allowed or re-allowed or paid to dealers; and |
| ● | any exchanges on which the securities will be listed. |
If any underwriters or agents
are utilized in the sale of the securities in respect of which this prospectus is delivered, we will enter into an underwriting agreement
or other agreement with them at the time of sale to them, and we will set forth in the prospectus supplement relating to such offering
the names of the underwriters or agents and the terms of the related agreement with them.
If a dealer is utilized in
the sale of the securities in respect of which this prospectus is delivered, we will sell such securities to the dealer, as principal.
The dealer may then resell such securities to the public at varying prices to be determined by such dealer at the time of resale.
If we offer securities in
a subscription rights offering to our existing security holders, we may enter into a standby underwriting agreement with dealers, acting
as standby underwriters. We may pay the standby underwriters a commitment fee for the securities they commit to purchase on a standby
basis. If we do not enter into a standby underwriting arrangement, we may retain a dealer-manager to manage a subscription rights offering
for us.
Remarketing firms, agents,
underwriters, dealers and other persons may be entitled under agreements which they may enter into with us to indemnification by us against
certain civil liabilities, including liabilities under the Securities Act, and may be customers of, engage in transactions with or perform
services for us in the ordinary course of business.
If so indicated in the applicable
prospectus supplement, we will authorize underwriters or other persons acting as our agents to solicit offers by certain institutions
to purchase securities from us pursuant to delayed delivery contracts providing for payment and delivery on the date stated in the prospectus
supplement. Each contract will be for an amount not less than, and the aggregate amount of securities sold pursuant to such contracts
shall not be less nor more than, the respective amounts stated in the prospectus supplement. Institutions with whom the contracts, when
authorized, may be made include commercial and savings banks, insurance companies, pension funds, investment companies, educational and
charitable institutions and other institutions, but shall in all cases be subject to our approval. Delayed delivery contracts will not
be subject to any conditions except that:
| ● | the purchase by an institution of the securities covered under that contract shall not at the time of
delivery be prohibited under the laws of the jurisdiction to which that institution is subject; and |
| ● | if the securities are also being sold to underwriters acting as principals for their own account, the
underwriters shall have purchased such securities not sold for delayed delivery. The underwriters and other persons acting as our agents
will not have any responsibility in respect of the validity or performance of delayed delivery contracts. |
Certain agents, underwriters
and dealers, and their associates and affiliates may be customers of, have borrowing relationships with, engage in other transactions
with, and/or perform services, including investment banking services, for us or one or more of our respective affiliates in the ordinary
course of business.
In order to facilitate the
offering of the securities, any underwriters may engage in transactions that stabilize, maintain or otherwise affect the price of the
securities or any other securities the prices of which may be used to determine payments on such securities. Specifically, any underwriters
may overallot in connection with the offering, creating a short position for their own accounts. In addition, to cover overallotments
or to stabilize the price of the securities or of any such other securities, the underwriters may bid for, and purchase, the securities
or any such other securities in the open market. Finally, in any offering of the securities through a syndicate of underwriters, the underwriting
syndicate may reclaim selling concessions allowed to an underwriter or a dealer for distributing the securities in the offering if the
syndicate repurchases previously distributed securities in transactions to cover syndicate short positions, in stabilization transactions
or otherwise. Any of these activities may stabilize or maintain the market price of the securities above independent market levels. Any
such underwriters are not required to engage in these activities and may end any of these activities at any time.
Under Rule 15c6-1 of
the Exchange Act, trades in the secondary market generally are required to settle in two business days, unless the parties to any such
trade expressly agree otherwise. The applicable prospectus supplement may provide that the original issue date for your securities may
be more than two scheduled business days after the trade date for your securities. Accordingly, in such a case, if you wish to trade securities
on any date prior to the second business day before the original issue date for your securities, you will be required, by virtue of the
fact that your securities initially are expected to settle in more than two scheduled business days after the trade date for your securities,
to make alternative settlement arrangements to prevent a failed settlement.
The securities may be new
issues of securities and may have no established trading market. The securities may or may not be listed on a national securities exchange.
We can make no assurance as to the liquidity of or the existence of trading markets for any of the securities.
LEGAL MATTERS
Unless the applicable prospectus
supplement indicates otherwise, the validity of the securities in respect of which this prospectus is being delivered will be passed upon
by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
EXPERTS
The financial statements
of Bellerophon Therapeutics, Inc. incorporated by reference in this Prospectus, have been audited by KPMG LLP, an independent registered
public accounting firm, as stated in their report. Such financial statements are incorporated by reference in reliance upon the report
of such firm, given their authority as experts in accounting and auditing.
$150,000,000
Common Stock
Preferred Stock
Debt Securities
Warrants
Rights
Units
PROSPECTUS
,
2023
The information in
this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and we are not soliciting offers
to buy these securities in any jurisdiction where the offer or sale is not permitted.
SUBJECT TO COMPLETION,
DATED JUNE 2, 2023
PROSPECTUS
Bellerophon Therapeutics, Inc.
Up to $40,000,000
Common Stock
We previously entered into
an Open Market Sale AgreementSM, dated July 17, 2020, or the sales agreement, with Jefferies LLC, or Jefferies, relating
to the sale of shares of our common stock, $0.01 par value per share. In accordance with the terms of the sales agreement, under this
prospectus we may offer and sell shares of our common stock having an aggregate offering price of up to $40,000,000 from time to time
through Jefferies, acting as our sales agent. As of the date of this prospectus, we have not issued or sold any shares of our common
stock pursuant to the sales agreement. We will not make any offers or sales of our common stock pursuant to the prior prospectus supplements
dated January 19, 2023 and May 31, 2023 and the accompanying prospectus dated July 2, 2020 related to shares that may be issued pursuant to the sales agreement.
Our common stock is listed
on The Nasdaq Capital Market under the trading symbol “BLPH”. On May 26, 2023, the last sale price of our common stock
as reported on The Nasdaq Capital Market was $7.44 per share.
Sales of our common stock,
if any, under this prospectus may be made by any method permitted by law that is deemed to be an “at the market offering”
as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, or the Securities Act. Jefferies is not required
to sell any specific number or dollar amount of securities, but will act as our sales agent using commercially reasonable efforts, consistent
with its normal trading and sales practices, on mutually agreed terms between Jefferies and us. There is no arrangement for funds to
be received in an escrow, trust or similar arrangement.
Jefferies will be entitled
to compensation at a commission rate equal to 3.0% of the gross proceeds of the shares of common stock sold under the sales agreement.
In connection with the sale of the common stock on our behalf, Jefferies will be deemed to be an “underwriter” within the
meaning of the Securities Act and the compensation of Jefferies will be deemed to be underwriting commissions or discounts. We have also
agreed to provide indemnification and contribution to Jefferies with respect to certain liabilities, including civil liabilities under
the Securities Act and the Securities and Exchange Act of 1934, as amended. See “Plan of Distribution” beginning on page S-16
of this prospectus for additional information regarding the compensation to be paid to Jefferies.
Investing in our common stock involves
significant risks. See “Risk Factors” beginning on page S-7 of this prospectus and in the documents
incorporated by reference in this prospectus for a discussion of the factors you should carefully consider before deciding to
purchase our common stock.
Neither the Securities and Exchange Commission
nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus.
Any representation to the contrary is a criminal offense.
Jefferies
The date of this prospectus is ,
2023
TABLE OF CONTENTS
Page
ABOUT THIS PROSPECTUS
This prospectus is part
of a registration statement that we filed with the Securities and Exchange Commission, or the SEC, utilizing a “shelf”
registration process. Under this shelf registration process, we may from time to time sell shares of our common stock having an
aggregate offering price of up to $150,000,000. Under this prospectus, we may from time to time offer and sell shares of our common
stock having an aggregate offering price of up to $40,000,000, at prices and on terms to be determined by market conditions at the time of
the offering. The $40,000,000 of shares of our common stock that may be sold under this prospectus are included in the $150,000,000
of shares of common stock that may be sold under the registration statement.
To the extent there is a
conflict between the information contained in this prospectus, on the one hand, and the information contained in any document incorporated
by reference in this prospectus, on the other hand, you should rely on the information in this prospectus, provided that if any statement
in one of these documents is inconsistent with a statement in another document having a later date - for example, a document
incorporated by reference in this prospectus - the statement in the document having the later date modifies or supersedes
the earlier statement.
Before buying any of the
common stock that we are offering, we urge you to carefully read this prospectus and all of the information incorporated by reference
herein, as well as documents to which we have referred you in the sections entitled “Where You Can Find More Information”
and “Incorporation of Certain Documents by Reference.” These documents contain important information that you should consider
when making your investment decision.
We further note that the
representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated
by reference herein were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating
risk among the parties to such agreements, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such
representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and
covenants should not be relied on as accurately representing the current state of our affairs.
We have not, and Jefferies
has not, authorized anyone to provide you with any information other than that contained or incorporated by reference in this prospectus
or any related prospectus supplement or related free writing prospectus to which we have referred you. We and Jefferies take no responsibility
for, and can provide no assurance as to the reliability of, any other information that others may give you. You should assume that the
information appearing in this prospectus, the documents incorporated by reference and any related free writing prospectus is accurate
only as of their respective dates. Our business, financial condition, results of operations and prospects may have changed materially
since those dates.
We are offering to sell,
and seeking offers to buy, shares of our common stock only in jurisdictions where offers and sales are permitted. The distribution of
this prospectus and the offering of the common stock in certain jurisdictions may be restricted by law. Persons outside the United States
who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the
common stock and the distribution of this prospectus outside the United States. This prospectus does not constitute, and may not be used
in connection with, an offer to sell, or a solicitation of an offer to buy, any securities offered by this prospectus by any person in
any jurisdiction in which it is unlawful for such person to make such an offer or solicitation.
Unless the context otherwise
indicates, references in this prospectus to “Bellerophon” “we,” “our,” “us” and “the
Company” refer, collectively, to Bellerophon Therapeutics, Inc., a Delaware corporation, and its consolidated subsidiaries.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
AND INDUSTRY DATA
This prospectus and the
documents incorporated by reference herein may contain forward looking statements that involve risks and uncertainties. All statements
other than statements of historical fact contained in this prospectus and the documents incorporated by reference herein, including statements
regarding future events, our future financial performance, business strategy, plans and objectives of management for future operations
and the anticipated use of the net proceeds from this offering, are forward-looking statements. We have attempted to identify forward-looking
statements by terminology including “anticipates,” “believes,” “can,” “continue,” “could,”
“estimates,” “expects,” “intends,” “may,” “plans,” “potential,”
“predicts,” “should,” or “will” or the negative of these terms or other comparable terminology. Although
we do not make forward looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy.
These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks outlined
under the section titled “Risk Factors” or elsewhere in this prospectus and the documents incorporated by reference herein,
which may cause our or our industry’s actual results, levels of activity, performance or achievements expressed or implied by these
forward-looking statements. Moreover, we operate in a highly regulated, very competitive, and rapidly changing environment. New risks
emerge from time to time and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our
business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from those contained
in any forward-looking statements.
We have based these forward-looking
statements largely on our current expectations and projections about future events and financial trends that we believe may affect our
financial condition, results of operations, business strategy, short term and long term business operations, and financial needs. These
forward-looking statements are subject to certain risks and uncertainties that could cause our actual results to differ materially from
those reflected in the forward looking statements. Factors that could cause or contribute to such differences include, but are not limited
to, those discussed in this prospectus, and in particular, the risks discussed below and under the section titled “Risk Factors”
and those discussed in other documents we file with the SEC. The following discussion should be read in conjunction with our audited
consolidated financial statements as of and for the years ended December 31, 2022 and 2021, and our interim unaudited consolidated
financial statements as of and for the quarter ended March 31, 2023, respectively, and related notes, incorporated by reference
into the prospectus. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in
this prospectus may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking
statement. You should understand that it is not possible to predict or identify all risk factors. Consequently, you should not consider
any such list to be a complete set of all potential risks or uncertainties.
You should not place undue
reliance on any forward-looking statement, each of which applies only as of the date on which it is made, which is the date of this prospectus
or the document incorporated by reference herein in which such statement appears, as applicable. Except as required by law, we undertake
no obligation to update or revise publicly any of the forward-looking statements after the date of this prospectus to conform our statements
to actual results or changed expectations. You are advised, however, to consult any further disclosures we make on related subjects in
our reports on Forms 10-K, 10-Q and 8-K filed with the SEC.
This prospectus and the
information incorporated by reference herein and therein may include statistical and other industry and market data that we obtained
from industry publications and research, surveys and studies conducted by third parties. All of the market data used in this prospectus
and the information incorporated by reference herein and therein involves a number of assumptions and limitations, and you are cautioned
not to give undue weight to such data. We believe that the information from these industry publications, surveys and studies is reliable.
PROSPECTUS SUMMARY
This summary
highlights selected information contained elsewhere in this prospectus and in the documents we incorporate by reference herein. This
summary does not contain all of the information you should consider before making an investment decision. You should read this entire
prospectus carefully, especially the risks of investing in our common stock discussed under “Risk Factors” beginning on page S-7 of this prospectus, and the “Risk Factor Summary” and “Risk Factors” sections of our most recent Annual Report
on Form 10-K and our Quarterly Reports on Form 10-Q, along with our consolidated financial statements and notes to those consolidated
financial statements and the other information incorporated by reference in this prospectus.
Our Business
We are a clinical-stage therapeutics
company focused on developing innovative products that address significant unmet medical needs in the treatment of cardiopulmonary diseases.
Our focus is the continued development of our nitric oxide therapy for patients with or at risk of pulmonary hypertension, or PH, using
our proprietary pulsatile nitric oxide delivery platform, INOpulse.
In 2016, we began developing INOpulse
for the treatment of pulmonary hypertension associated with fibrotic interstitial lung disease (“fILD”), which includes PH
associated with idiopathic pulmonary fibrosis (“PH-IPF”) as well as other pulmonary fibrosing diseases. During May 2017,
we announced the completion of our Phase 2 clinical trial using INOpulse therapy to treat PH-IPF. The clinical data showed that INOpulse
was associated with clinically meaningful improvements in hemodynamics and exercise capacity in difficult-to-treat PH-IPF patients. The
PH-IPF trial was a proof of concept study (n=4) designed to evaluate the ability of pulsed inhaled nitric oxide, or iNO, to provide selective
vasodilation as well as to assess the potential for improvement in hemodynamics and exercise capacity in PH-IPF patients. The clinical
trial met its primary endpoint showing an average of 15.3% increase in blood vessel volume (p<0.001) during acute inhalation of iNO
as well as showing a significant association between ventilation and vasodilation, demonstrating the ability of INOpulse to provide selective
vasodilation to the better ventilated areas of the lung. The trial showed consistent benefit in hemodynamics with a clinically meaningful
average reduction of 14% in systolic pulmonary arterial pressure with acute exposure to iNO. The study assessed both the iNO 75 and iNO
30 dose.
During August 2017,
we announced acceptance by the U.S. Food and Drug Administration (the “FDA”) of our Investigational New Drug (“IND”)
application for our Phase 2b (“iNO-PF”) clinical trial using INOpulse therapy in a broad population of patients with pulmonary
fibrosis, or PF, at both low and intermediate/high risk of PH. In January 2019, we announced top-line results from cohort 1 of our
iNO-PF trial. The results suggested directional improvements in multiple clinically meaningful exploratory endpoints as measured by a
wearable medical-grade activity monitor. In addition, these results suggested that iNO may have a favorable safety profile, supporting
the continuation into cohort 2. In April 2019, we announced that we reached an agreement with the FDA on modifying the ongoing Phase
2b trial into a seamless Phase 2/3 trial, with cohort 3 serving as the pivotal study, as well as an agreement on the primary endpoint
in cohort 3 of change in moderate to vigorous activity (“MVPA”) from baseline to month 4, measured by Actigraphy. Actigraphy
(medical wearable continuous activity monitoring) has the potential to provide highly sensitive objective real-world physical activity
data that we expect to correlate with clinically meaningful patient functional abilities and health outcomes. Actigraphy is currently
being utilized as the primary endpoint in multiple late-stage clinical programs in various cardiopulmonary diseases such as heart failure
and chronic obstructive pulmonary disease (“COPD”). In December 2019, we announced top-line results from cohort 2 of
the iNO-PF trial. Cohort 2 of iNO-PF suggested directionally favorable and potentially clinically meaningful placebo corrected improvement
in MVPA, in subjects treated with iNO45 (45 mcg/kg IBW/hr) versus placebo. The improvement in MVPA was underscored by benefits in overall
activity, as well as multiple patient reported outcomes. In March 2020, we announced that in consultation with the FDA, we had finalized
some of the key elements of our planned pivotal Phase 3 study for fILD, including the use of MVPA as the primary endpoint for approval,
the patient population of pulmonary fibrosis subjects at risk of PH, as well as the dose of iNO45. In December 2020, we announced
the first patient enrollment in this Phase 3 study called REBUILD. In September 2022, the FDA informed us that it had no objection
to our proposal to reduce the study size to 140 subjects which does not impact the trial’s principal objective or endpoints and
maintains power of >90% (p-value <0.01) for the primary endpoint of MVPA based on the effect size observed in our Phase 2 study.
The FDA did note that since our proposal to reduce the sample size was based on Phase 2b cohort 2 actigraphy data, there is always a
concern that such sample size reduction may further limit the acquisition of information on other important clinical endpoints in the
trial. The FDA agreement was based on its review of:
| · | Analysis
conducted on cohort 2 (Phase 2) data utilizing the statistical analysis methodology to be
used in REBUILD, including bi-weekly analysis of MVPA data and mixed models for repeated
measures (“MMRM”) assessment of the last half of the blinded treatment period,
which showed the trial would be >90% powered for p<0.05 at 80 total patients and >90%
powered for a p<0.01 at 114 patients based on the effect size determined from cohort 2; |
| · | Similar
baseline MVPA distribution between cohort 2 and the first 80 randomized patients in REBUILD
based on a blinded assessment; and |
| · | Independent
Data Monitoring Committee unblinded safety review of the first 85 randomized patients in
REBUILD indicating no safety concern with regards to reduction of REBUILD to 140 patients. |
During January 2023, we
completed enrollment of the REBUILD study with a total of 145 patients enrolled. In May 2023, the last subject completed blinded
treatment in the REBUILD study. We expect to report pivotal top-line data results in mid-2023.
In 2018, we initiated an ancillary
Phase 2 open-label intra-patient dose escalation study that utilizes right heart catheterization to assess the hemodynamic effect of
INOpulse from a dose of iNO 30 to iNO 125 in PH-PF subjects. In February 2020, we announced the completion of the study and that
the top-line results demonstrated that INOpulse achieved clinically and statistically meaningful cardiopulmonary improvements in pulmonary
vascular resistance and mean pulmonary arterial pressure. The data suggested that inhaled nitric oxide was generally well tolerated and
may yield a favorable risk-benefit profile across doses.
In 2018, we also
initiated development of INOpulse for the treatment of PH associated with Sarcoidosis (“PH-Sarc”). Sarcoidosis is a multi-system
disease which is characterized by the growth of granulomas (inflammatory cells) in one or more organs. The most frequent organs involved
are the lungs and lymph nodes within the chest. Pulmonary hypertension may be present in as many as 74% of patients depending on the
disease severity and how the pulmonary hypertension (PH) is defined. The presence of PH in sarcoidosis is associated with a poor prognosis.
There are a number of different mechanisms linking PH with sarcoidosis. The primary treatment for sarcoidosis is corticosteroids; however,
the outcome of this treatment on the PH is unclear. There is no approved therapy for PH associated with sarcoidosis. Various PAH treatments
have been tried including iNO and IV prostacyclin with some clinical and functional improvement. The study was a Phase 2 open-label dose
escalation design that utilized right heart catheterization to assess the acute hemodynamic effect of INOpulse from a dose of iNO 30
to iNO 125 in PH-Sarc subjects. In December 2021, we announced the completion of the acute dose escalation phase of the study and
that the top-line results demonstrated that INOpulse provided clinically meaningful improvements in pulmonary vascular resistance. Supported
by the results from this study, on June 21, 2022, we submitted to the FDA an exploratory Phase 2 double-blinded placebo-controlled
study to investigate the safety and efficacy of inhaled nitric oxide/INOpulse dosed chronically for six months in patients with PH-Sarc.
Subsequently, on July 28, 2022, we received an FDA letter indicating that the FDA completed its review of our study protocol, with
a minor recommendation to include safety stopping rules. We have agreed to incorporate this recommendation into our periodic safety reviews.
We are positioned to initiate this Phase 2 study and are currently assessing the next steps for the study.
We completed a
randomized, placebo-controlled, double-blind, dose-confirmation Phase 2 clinical trial of INOpulse for pulmonary hypertension associated
with chronic obstructive pulmonary disease, or PH-COPD, in July 2014. The results from this trial showed that iNO 30 was a potentially
safe and effective dose for treatment of PH-COPD. Based on the results of this trial, we completed further Phase 2 testing to assess
the targeted vasodilation provided by INOpulse in this patient population. We presented the results of this trial in September 2015
at the European Respiratory Society International Congress 2015 in Amsterdam. The data showed that INOpulse improved vasodilation in
patients with PH-COPD. In July 2016, the results were published in the International Journal of COPD in an article entitled “Pulmonary
vascular effects of pulsed inhaled nitric oxide in COPD patients with pulmonary hypertension.” During September 2017, we shared
the results of our Phase 2a PH-COPD trial that was designed to evaluate the acute effects of pulsed inhaled nitric oxide, or iNO, on
vasodilation as well as the chronic effect on hemodynamics and exercise tolerance. The trial showed a statistically significant increase
(average 4.2%) in blood vessel volume on iNO compared to baseline (p=0.03), and a statistically significant correlation in Ventilation-Vasodilation
(p=0.01). The chronic results demonstrated a statistically significant and clinically meaningful increase in six minute walk distance,
or 6MWD, of 50.7m (p=0.04) as well as a decrease of 19.9% in systolic pulmonary arterial pressure (p=0.02), as compared to baseline.
The data suggested that the dose may have a favorable safety profile. In May 2018, we announced that the FDA concurred with the
design of our planned Phase 2b study of INOpulse for treatment of PH-COPD. The study will assess the effect of INOpulse on various parameters
including exercise capacity, right ventricular function and oxygen saturation, as well as other composite endpoints. We continue to evaluate
alternatives for the funding and timing of this program.
In addition, other
potential indications for our INOpulse platform include: chronic thromboembolic PH, or CTEPH and PH associated with pulmonary edema from
high altitude sickness. However, we have not yet commenced any studies of the INOpulse platform with respect to such other indications.
We have devoted
all of our resources to our therapeutic discovery and development efforts, including performance of IND-enabling studies, conducting
clinical trials for our product candidates, protecting our intellectual property and the general and administrative support of these
operations. We have devoted significant time and resources to developing and optimizing our drug delivery system, INOpulse, which
operates through the administration of nitric oxide as brief, controlled pulses that are timed to occur at the beginning of a breath.
To date, we have
generated no revenue from product sales. We expect that it may be several years before we commercialize a product candidate, if
ever.
Company Information
We were incorporated
under the laws of the State of Delaware on October 17, 2013 under the name Ikaria Development LLC. We changed our name to Bellerophon
Therapeutics LLC on January 27, 2014. On February 12, 2015, we converted from a Delaware limited liability company into a Delaware
corporation and changed our name to Bellerophon Therapeutics, Inc. We currently have three wholly-owned subsidiaries: Bellerophon
BCM LLC, a Delaware limited liability company; Bellerophon Pulse Technologies LLC, a Delaware limited liability company; and Bellerophon
Services, Inc., a Delaware corporation. Our website address is www.bellerophon.com. The information contained on, or that can be
accessed through, our website does not constitute part of this prospectus supplement. We have included our website address in this prospectus
solely as an inactive textual reference.
Our executive offices
are located at 20 Independence Boulevard, Suite 402, Warren, New Jersey 07059, and our telephone number is (908) 574-4770.
Smaller Reporting Company
We are a “smaller
reporting company” as defined in Rule 405 of the Securities Act. We will remain a smaller reporting company until the last
day of the fiscal year in which the aggregate market value of our common stock that is held by non-affiliates is at least $250 million
or the last day of the fiscal year in which we have at least $100 million in revenue and the aggregate market value of our common stock
that is held by non-affiliates is at least $700 million (in each case, with respect to the aggregate market value of our common stock
held by non-affiliates, as measured as of the last business day of the second quarter of such fiscal year).
THE OFFERING
Common
Stock Offered by Us
|
Shares
of our common stock having an aggregate offering price of up to $40,000,000. |
| Common
Stock to be Outstanding After this Offering |
Up
to 15,824,529 shares, assuming sales of 5,376,344 shares of our common stock in the offering at a price of $7.44 per share, which
was the last sale price of our common stock on The Nasdaq Capital Market on May 26, 2023. The actual number of shares issued
will vary depending on the sales price under this offering. |
| |
|
| Plan
of Distribution |
“At
the market offering” that may be made from time to time through our sales agent, Jefferies. See “Plan of Distribution”
in this prospectus. |
| |
|
Use
of Proceeds
|
We
intend to use the net proceeds from this offering, if any, for working capital and general corporate purposes. See “Use of
Proceeds” in this prospectus. |
| |
|
| Risk
Factors |
You
should read the “Risk Factors” section of this prospectus, the “Risk Factor Summary” and “Risk Factors”
sections of our most recent annual report on Form 10-K and our quarterly reports on Form 10-Q, and the other information
included in, or incorporated by reference into, this prospectus for a discussion of factors to consider carefully before deciding
to invest in shares of our common stock. |
| |
|
| Nasdaq
Capital Market Symbol |
“BLPH” |
| |
The
number of shares of common stock to be outstanding after this offering is based on 10,448,185
shares of common stock outstanding as of March 31, 2023 and excludes the following:
· 311,210
shares of our common stock issuable upon the exercise of stock options issued under our 2014 Equity Incentive Plan and 2015 Equity Plan
outstanding as of March 31, 2023, at a weighted average exercise price of $12.49 per share;
· 52
shares of our common stock issuable upon the exercise of stock options issued under our 2007 Ikaria Stock Option Plan and 2010 Long
Term Incentive Plan outstanding as of March 31, 2023, at a weighted average exercise price of $131.55 per share;
· 585,139
shares of our common stock issuable upon the exercise of warrants outstanding at March 31, 2023, at a weighted average exercise
price of $12.00 per share;
· 1,781,526
shares of our common stock issuable upon the exercise of pre-funded warrants outstanding at March 31, 2023, at a weighted average
exercise price of $0.01 per share;
· 148,000
shares of our common stock underlying unvested RSUs outstanding at March 31, 2023; and
· 65,834
additional shares of our common stock available for future issuance as of March 31, 2023, under our 2015 Equity Incentive Plan. |
RISK FACTORS
Investing in our common
stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below and under the sections
captioned “Risk Factor Summary” and “Risk Factors” contained in our most recent annual report on Form 10-K,
our quarterly reports on Form 10-Q and other filings we make with the SEC from time to time, which are incorporated by reference
herein in their entirety, together with other information in this prospectus and the information and documents incorporated by reference
herein, before deciding to invest in our common stock. If any of the following risks actually occur, our business, prospects, operating
results and financial condition could suffer materially. In such event, the trading price of our common stock could decline and you might
lose all or part of your investment. The risks and uncertainties we have described are not the only ones facing our company. Additional
risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our business operations.
Risks Related to This Offering
The actual number of shares of common stock
we will issue under the sales agreement and the gross proceeds resulting from those sales is uncertain.
Subject to certain limitations
in the sales agreement and compliance with applicable law, we have the discretion to request Jefferies to sell on our behalf shares of
common stock at any time throughout the term of the sales agreement, and Jefferies has agreed to use commercially reasonable efforts
to sell the shares. The number of shares that are sold by Jefferies after we request that sales be made will fluctuate based on the market
price of our common stock during the sales period and the limits we set with Jefferies. Because the price per share of the common stock
sold will fluctuate based on the market price of our common stock during the sales period, it is not possible to predict the number of
shares of common stock that will ultimately be issued by us under the sales agreement or the amount of gross proceeds to be raised in
connection with those sales.
The common stock offered hereby will be
sold in “at the market offerings,” and investors who buy shares at different times will likely pay different prices.
Investors who purchase shares
in this offering at different times will likely pay different prices, and accordingly may experience different levels of dilution and
different outcomes in their investment results. We will have discretion, subject to market demand and the terms of the sales agreement,
to vary the timing, prices and number of shares sold in this offering. In addition, subject to the final determination by our board of
directors (or any committee thereof) or any restrictions we may place in any applicable placement notice, there is no minimum or maximum
sales price for shares to be sold in this offering. Investors may experience a decline in the value of the shares they purchase in this
offering as a result of sales made at prices lower than the prices they paid.
Sale of a substantial number of shares
of our common stock, including by us, could cause the market price of our common stock to drop significantly, even if our business is
doing well.
Sales of a substantial number
of shares of our common stock in the public market, or the perception in the market that the holders of a large number of shares intend
to sell shares, could reduce the market price of our common stock. Shares of our common stock may be freely sold in the public market
at any time to the extent permitted by Rules 144 and 701 under the Securities Act, or to the extent such shares have already been
registered under the Securities Act and are held by non-affiliates of ours. If our stockholders sell, or indicate an intention to sell,
substantial amounts of our common stock in the public market, the trading price of our common stock could decline. In addition, we have
filed or intend to file registration statements registering all shares of common stock that we may issue under our equity compensation
plans or pursuant to equity awards made to newly hired employees outside of equity compensation plans. These shares can be freely sold
in the public market upon issuance, subject to volume limitations applicable to affiliates.
Our management may invest or spend the
proceeds of this offering in ways with which you may not agree or in ways which may not yield a significant return, if any.
Our management will have
broad discretion in the application of the net proceeds from this offering and could spend the proceeds in ways that do not improve our
results of operations or enhance the value of our common stock. The failure by our management to apply these funds effectively could
result in financial losses that could cause the price of our common stock to decline and delay the development of our product candidates.
Pending their use, we may invest the net proceeds from this offering in a manner that does not produce income or that loses value.
In addition, the issuance
from time to time of shares of our common stock in this offering, or our ability to issue these shares of common stock in this offering,
could result in resales of our common stock by our current stockholders concerned about the potential dilution of their holdings. In
turn, these resales could have the effect of depressing the market price for our common stock.
Purchasers will experience immediate dilution
in the book value per share of the common stock purchased in the offering and may experience future dilution as a result of future equity
offerings.
The shares sold in this
offering, if any, will be sold from time to time at various prices. However, we expect that the offering price of our common stock will
be substantially higher than the pro forma as adjusted net tangible book value per share of our outstanding common stock. After giving
effect to the sale of shares of our common stock in the aggregate amount of $40,000,000 at an assumed offering price of $7.44 per share,
the last sale price of our common stock on May 26, 2023 on The Nasdaq Capital Market, and after deducting estimated commissions
and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of March 31, 2023 would have
been approximately $49.2 million, or approximately $3.11 per share. This represents an immediate dilution in pro forma as adjusted net
tangible book value of approximately $4.33 per share to purchasers of our common stock in this offering. See “Dilution” in
this prospectus for more information.
In addition to this offering,
subject to market conditions and other factors, we may pursue additional equity financings in the future, including future public offerings
or future private placements of equity securities or securities convertible into or exchangeable for equity securities at prices that
may be higher or lower than the price per share in this offering. Further, the exercise of outstanding options or warrants and the vesting
of restricted stock units could result in further dilution to investors and any additional shares issued in connection with acquisitions
will result in dilution to investors. In addition, the market price of our common stock could fall as a result of resales of any of these
shares of common stock due to an increased number of shares available for sale in the market.
USE OF PROCEEDS
We currently expect to use
the net proceeds from this offering for funding our ongoing clinical trials, for working capital and general corporate purposes. This
expected use of the net proceeds from this offering and our existing cash and cash equivalents represents our intentions based upon our
current plans and business conditions, which could change in the future as our plans and business conditions evolve. As of the date of
this prospectus supplement, we cannot predict with certainty all of the particular uses for the net proceeds to be received upon the
completion of this offering or the amounts that we will actually spend on the uses set forth above. As a result, our management will
retain broad discretion over the allocation of the net proceeds from this offering.
DIVIDEND POLICY
We have not declared or
paid cash dividends on our common stock. We currently intend to retain all available funds and any future earnings to fund the development
and expansion of our business and we do not anticipate paying any cash dividends in the foreseeable future. Any future determination
to declare and pay dividends will be made at the discretion of our board of directors and will depend on then-existing conditions, including
our results of operations, financial condition, contractual restrictions, capital requirements, business prospects and other factors
our board of directors may deem relevant.
DILUTION
Our net tangible book value
as of March 31, 2023 was $10.6 million, or approximately $1.01 per share of common stock. Net tangible book value is determined
by taking total assets, less total right of use (ROU) assets, less total liabilities. Net tangible book value per share is determined
by dividing net tangible book value by the number of shares of our common stock outstanding as of March 31, 2023. Our adjusted pro
forma net tangible book value as of March 31, 2023 was $49.2 million, or $3.11 per share of common stock. Dilution in net tangible
book value per share represents the difference between the assumed public offering price per share to be paid by purchasers of shares
of common stock in this offering of $7.44 per share and the pro forma as adjusted net tangible book value per share of our common stock
immediately after giving effect to this offering.
After giving effect to the
assumed sale of 5,376,344 shares of our common stock by us in this offering at an assumed public offering price of $7.44 per share, which
was the last reported sale price of our common stock on The Nasdaq Capital Market on May 26, 2023, after deducting commissions and
estimated offering expenses of $1.4 million payable by us, our pro forma as adjusted net tangible book value as of March 31, 2023
would have been $49.2 million, or $3.11 per share. This would represent an immediate increase in net tangible book value per share of
$2.10 to existing stockholders and immediate dilution of $4.33 in the pro forma as adjusted net tangible book value per share to new
investors purchasing common stock in this offering at the assumed public offering price.
The following table illustrates
this dilution on a per share basis. The as adjusted information is illustrative only and will change based on the actual price to the
public, the actual number of shares sold and other terms of this offering determined at the time shares of our common stock are sold
pursuant to this prospectus. The as adjusted information assumes that all of our common stock in the aggregate amount of $40.0 million
is sold at the assumed public offering price of $7.44 per share, the last reported sale price of our common stock on The Nasdaq Capital
Market on May 26, 2023. The shares sold in this offering, if any, will be sold from time to time at various prices.
| Assumed public offering price per share | |
| | | |
$7.44 |
|
| Net tangible book value per share as of March 31, 2023 | |
$ | 1.01 | |
|
|
|
| Increase in net tangible book value per share attributable to new investors purchasing shares in this offering | |
| 2.10 | |
|
|
|
| Pro forma as adjusted net tangible book value per share after giving effect to this offering | |
| | | |
3.11 |
|
| Dilution in net tangible book value per share to new investors in this offering | |
| | | |
$4.33 |
|
An increase of $1.00 per
share in the price at which the shares are sold from the assumed public offering price of $7.44 per share shown in the table above, assuming
that the aggregate dollar amount of shares sold by us remains at $40.0 million, would increase our pro forma as adjusted net tangible
book value per share after this offering to $3.24 per share and would increase the dilution in net tangible book value per share to new
investors to $5.20 per share, after deducting commissions and estimated aggregate offering expenses payable by us. A decrease of $1.00
per share in the price at which the shares are sold from the assumed public offering price of $7.44 per share shown in the table above,
assuming that the aggregate dollar amount of shares sold by us remains at $40.0 million, would decrease our pro forma as adjusted net
tangible book value per share after this offering to $2.95 per share and would decrease the dilution in net tangible book value per share
to new investors to $3.49 per share, after deducting commissions and estimated aggregate offering expenses payable by us. The information
discussed above is illustrative only and will adjust based on the actual public offering price, the actual number of shares that we offer
in this offering, and other terms of this offering determined at the time of each offer and sale.
The foregoing discussion
and table are based on 10,448,185 shares of our common stock outstanding as of March 31, 2023. Each calculation and the table above
exclude the following:
| · | 311,210
shares of our common stock issuable upon the exercise of stock options issued under our 2014
Equity Incentive Plan and 2015 Equity Plan outstanding as of March 31, 2023, at a weighted
average exercise price of $12.49 per share; |
| · | 52
shares of our common stock issuable upon the exercise of stock options issued under our 2007
Ikaria Stock Option Plan and 2010 Long Term Incentive Plan outstanding as of March 31,
2023, at a weighted average exercise price of $131.55 per share; |
| · | 585,139
shares of our common stock issuable upon the exercise of warrants outstanding at March 31,
2023, at a weighted average exercise price of $12.00 per share; |
| · | 1,781,526
shares of our common stock issuable upon the exercise of pre-funded warrants outstanding
at March 31, 2023, at a weighted average exercise price of $0.01 per share; |
| · | 148,000
shares of our common stock underlying unvested RSUs outstanding at March 31, 2023; and |
| · | 65,834
additional shares of our common stock available for future issuance as of March 31,
2023, under our 2015 Equity Incentive Plan. |
To the extent that any of
the outstanding options are exercised there could be further dilution to new investors. In addition, we may choose to raise additional
capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating
plans. To the extent that we raise additional capital through the sale of equity securities, the issuance of such securities could result
in further dilution to our stockholders.
PLAN OF DISTRIBUTION
We previously entered into
an Open Market Sale AgreementSM, dated July 17, 2020, or the sales agreement, with Jefferies LLC, or Jefferies, relating
to the sale of shares of our common stock. In accordance with the terms of the sales agreement, under this prospectus we may offer and
sell shares of our common stock having an aggregate offering price of up to $40,000,000 from time to time through Jefferies, acting as
our sales agent. As of the date of this prospectus, we have not issued or sold any shares of our common stock pursuant to the sales agreement.
We will not make any offers or sales of our common stock pursuant to the prior prospectus supplements dated January 19, 2023 and May 31, 2023 and the accompanying prospectus
dated July 2, 2020 related to shares that may be issued pursuant to the sales agreement.
Sales of our shares of common
stock, if any, under this prospectus will be made by any method that is deemed to be an “at the market offering” as defined
in Rule 415(a)(4) under the Securities Act.
Each time we wish to issue
and sell shares of common stock under the sales agreement, we will notify Jefferies of the number of shares to be issued, the dates on
which such sales are anticipated to be made, any limitation on the number of shares to be sold in any one day and any minimum price below
which sales may not be made. Once we have so instructed Jefferies, unless Jefferies declines to accept the terms of such notice, Jefferies
has agreed to use its commercially reasonable efforts consistent with its normal trading and sales practices to sell such shares up to
the amount specified on such terms. The obligations of Jefferies under the sales agreement to sell our shares of common stock are subject
to a number of conditions that we must meet.
The settlement of sales
of shares between us and Jefferies is generally anticipated to occur on the second trading day following the date on which the sale was
made. Sales of our shares of common stock as contemplated in this prospectus will be settled through the facilities of The Depository
Trust Company or by such other means as we and Jefferies may agree upon. There is no arrangement for funds to be received in an escrow,
trust or similar arrangement.
We will pay Jefferies a
commission equal to 3.0% of the aggregate gross proceeds we receive from each sale of our shares of common stock. Because there is no
minimum offering amount required as a condition to close this offering, the actual total public offering amount, commissions and proceeds
to us, if any, are not determinable at this time. In addition, we have agreed to reimburse Jefferies for the fees and disbursements of
its counsel, which was payable upon execution of the sales agreement, in an amount not to exceed $50,000, in addition to certain ongoing
disbursements of its legal counsel, unless we and Jefferies otherwise agree. We estimate that the total expenses for the offering, excluding
any commissions or expense reimbursement payable to Jefferies under the terms of the sales agreement, will be approximately $228,000.
The remaining sale proceeds, after deducting any other transaction fees, will equal our net proceeds from the sale of such shares.
Jefferies will provide written
confirmation to us before the open on The Nasdaq Capital Market on the day following each day on which shares of our common stock are
sold under the sales agreement. Each confirmation will include the number of shares sold on that day, the aggregate gross proceeds of
such sales and the proceeds to us.
In connection with the sale
of the shares of common stock on our behalf, Jefferies will be deemed to be an “underwriter” within the meaning of the Securities
Act, and the compensation of Jefferies will be deemed to be underwriting commissions or discounts. We have agreed to indemnify Jefferies
against certain civil liabilities, including liabilities under the Securities Act. We have also agreed to contribute to payments Jefferies
may be required to make in respect of such liabilities.
The offering of our shares
of common stock pursuant to the sales agreement will terminate upon the earlier of (1) the sale of all shares of common stock subject
to the sales agreement and (2) the termination of the sales agreement as permitted therein.
This summary of the material
provisions of the sales agreement does not purport to be a complete statement of its terms and conditions. A copy of the sales agreement
has been filed as Exhibit 10.1 to our current report on Form 8-K as filed with the SEC on July 17, 2020 under the Exchange
Act and is incorporated by reference in this prospectus.
Jefferies and its affiliates
may in the future provide various investment banking, commercial banking, financial advisory and other financial services for us and
our affiliates, for which services they may in the future receive customary fees. In the course of its business, Jefferies may actively
trade our securities for its own account or for the accounts of customers, and, accordingly, Jefferies may at any time hold long or short
positions in such securities.
This prospectus in electronic
format may be made available on a website maintained by Jefferies, and Jefferies may distribute this prospectus electronically.
LEGAL MATTERS
The validity of the shares
of common stock offered hereby will be passed upon for us by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., New York, New York.
Jefferies LLC is being represented in connection with this offering by Cooley LLP, New York, New York.
EXPERTS
The financial statements
of Bellerophon Therapeutics, Inc. incorporated by reference in this prospectus, have been audited by KPMG LLP, an independent registered
public accounting firm, as stated in their report. Such financial statements are incorporated by reference in reliance upon the report
of such firm, given their authority as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly
and current reports, proxy statements and other information with the SEC. Our SEC filings are available to the public over the Internet
at the SEC’s website at www.sec.gov. Copies of certain information filed by us with the SEC are also available on our website at
www.bellerophon.com. Our website is not a part of this prospectus and the information contained on, or accessible through, our website
is not incorporated by reference in this prospectus.
This prospectus is part
of a registration statement we filed with the SEC. This prospectus omits some information contained in the registration statement in
accordance with SEC rules and regulations. You should review the information and exhibits in the registration statement for further
information about us and our consolidated subsidiaries and the securities we are offering. Statements in this prospectus concerning any
document we filed as an exhibit to the registration statement or that we otherwise filed with the SEC are not intended to be comprehensive
and are qualified by reference to these filings and the exhibits attached thereto. You should review the complete document to evaluate
these statements. You can obtain a copy of the registration statement from the SEC’s website.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to incorporate
by reference much of the information we file with the SEC, which means that we can disclose important information to you by referring
you to those publicly available documents. The information that we incorporate by reference in this prospectus supplement is considered
to be part of this prospectus supplement. Because we are incorporating by reference future filings with the SEC, this prospectus supplement
is continually updated and those future filings may modify or supersede some of the information included or incorporated in this prospectus
supplement. This means that you must look at all of the SEC filings that we incorporate by reference to determine if any of the statements
in this prospectus supplement or in any document previously incorporated by reference have been modified or superseded. This prospectus
supplement and the registration statement of which this prospectus supplement is a part incorporates by reference the documents listed
below (File No. 001-38150) and any future filings we make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange
Act (in each case, other than those documents or the portions of those documents not deemed to be filed) between the date of the initial
registration statement and the effectiveness of the registration statement and following the effectiveness of the registration statement
until the offering of the securities offered hereby is terminated or completed:
· Annual
Report on Form 10-K for the fiscal year ended December 31, 2022 as filed with the SEC on March 31, 2023;
· Definitive
Proxy Statement on Schedule 14A, filed with the SEC on April 28, 2023 to the extent incorporated by reference into our Annual
Report on Form 10-K for the year ended December 31, 2022 (other than the portions thereof that are furnished and not filed);
· Quarterly
Report on Form 10-Q for the quarterly period ended March 31, 2023 as filed with the SEC on May 15, 2023;
· Current
Reports on Form 8-K (other than the portions thereof that are furnished and not filed) as filed with the SEC on January 5,
2023, January 18,
2023, February 9,
2023, March 3,
2023, March 6,
2023, April 25,
2023, May 5,
2023, May 11,
2023, and May 11,
2023;
· the
description of our common stock contained in our registration statement on Form 8-A
(file no. 001-36845) filed with the SEC on February 10, 2015, as updated by Exhibit 4.3
to our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, including any amendments or reports filed
for purpose of updating such description; and
· all
reports and other documents subsequently filed by us pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act after the
date of this prospectus supplement and prior to the termination or completion of the offering of securities under this prospectus supplement
shall be deemed to be incorporated by reference in this prospectus supplement and to be a part hereof from the date of filing such reports
and other documents.
You may request a copy of
these filings, at no cost, by contacting: Investor Relations, Bellerophon Therapeutics, Inc., 20 Independence Boulevard, Suite 402,
or calling (908) 574-4770.
Up to $40,000,000
Common Stock
PROSPECTUS
Jefferies
,
2023
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
Set forth below are estimates (except in the
case of the SEC registration fee) of the amount of fees and expenses to be incurred in connection with the issuance
and distribution of the offered securities, other than underwriting discounts and commissions.
| SEC registration fee | |
$ | 551.00 | * |
| Printing and engraving | |
| | (1) |
| Accounting services | |
| | (1) |
| Legal fees of registrant’s counsel | |
| | (1) |
| Transfer agent’s, trustee’s and depositary’s fees and expenses | |
| | (1) |
| Miscellaneous | |
| | (1) |
| Total | |
$ | | (1) |
| (1) | These
fees and expenses are calculated based on the securities offered and the number of issuances
and accordingly are not estimated at this time and will be reflected in the applicable prospectus
supplement. |
* Excludes the
registration fee previously paid in connection with unsold securities pursuant to Rule 415(a)(6).
Item 15. Indemnification of Directors and
Officers.
Section 102 of the Delaware General Corporation
Law, or the DGCL, permits a corporation to eliminate the personal liability of directors of a corporation to the corporation or its stockholders
for monetary damages for a breach of fiduciary duty as a director, except where the director breached his or her duty of loyalty, failed
to act in good faith, engaged in intentional misconduct or knowingly violated a law, authorized the payment of a dividend or approved
a stock repurchase in violation of Delaware corporate law or obtained an improper personal benefit. Our restated certificate of incorporation
provides that no director shall be personally liable to us or our stockholders for monetary damages for any breach of fiduciary duty
as a director, notwithstanding any provision of law imposing such liability, except to the extent that the DGCL prohibits the elimination
or limitation of liability of directors for breaches of fiduciary duty.
Section 145 of the DGCL provides that a
corporation has the power to indemnify a director, officer, employee, or agent of the corporation, or a person serving at the request
of the corporation for another corporation, partnership, joint venture, trust or other enterprise in related capacities against expenses
(including attorneys’ fees), judgments, fines and amounts paid in settlements actually and reasonably incurred by the person in
connection with an action, suit or proceeding to which he or she was or is or is threatened to be made a party to any threatened, pending,
or completed action, suit or proceeding by reason of such position, if such person acted in good faith and in a manner he or she reasonably
believed to be in or not opposed to the best interests of the corporation, and, in any criminal action or proceeding, had no reasonable
cause to believe his or her conduct was unlawful, except that, in the case of actions brought by or in the right of the corporation,
no indemnification shall be made with respect to any claim, issue or matter as to which such person shall have been adjudged to be liable
to the corporation unless and only to the extent that the Court of Chancery or other adjudicating court determines that, despite the
adjudication of liability but in view of all of the circumstances of the case, such person is fairly and reasonably entitled to indemnification
for such expenses which the Court of Chancery or such other court shall deem proper.
Our restated certificate of incorporation provides
that we will indemnify each person who was or is a party or threatened to be made a party to any threatened, pending or completed action,
suit or proceeding (other than an action by or in the right of us), by reason of the fact that he or she is or was, or has agreed to
become, our director or officer, or is or was serving, or has agreed to serve, at our request as a director, officer, partner, employee
or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise (all such persons
being referred to as an Indemnitee), or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses
(including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred in connection with
such action, suit or proceeding and any appeal therefrom if such Indemnitee acted in good faith and in a manner he or she reasonably
believed to be in, or not opposed to, our best interests, and, with respect to any criminal action or proceeding, he or she had no reasonable
cause to believe his or her conduct was unlawful.
Our restated certificate of incorporation also
provides that we will indemnify any Indemnitee who was or is a party to an action or suit by or in the right of us to procure a judgment
in our favor by reason of the fact that the Indemnitee is or was, or has agreed to become, our director or officer, or is or was serving,
or has agreed to serve, at our request as a director, officer, partner, employee or trustee of, or in a similar capacity with, another
corporation, partnership, joint venture, trust or other enterprise, or by reason of any action alleged to have been taken or omitted
in such capacity, against all expenses (including attorneys’ fees) and, to the extent permitted by law, amounts paid in settlement
actually and reasonably incurred in connection with such action, suit or proceeding, and any appeal therefrom, if the Indemnitee acted
in good faith and in a manner he or she reasonably believed to be in, or not opposed to, our best interests, except that no indemnification
shall be made with respect to any claim, issue or matter as to which such person shall have been adjudged to be liable to us, unless
a court determines that, despite such adjudication but in view of all of the circumstances, he or she is entitled to indemnification
of such expenses. Notwithstanding the foregoing, to the extent that any Indemnitee has been successful, on the merits or otherwise, he
or she will be indemnified by us against all expenses (including attorneys’ fees) actually and reasonably incurred in connection
therewith. Expenses must be advanced to an Indemnitee under certain circumstances.
We have entered into indemnification agreements
with all of our directors and executive officers. These indemnification agreements may require us, among other things, to indemnify directors
and executive officers for some expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by a director
or executive officer in any action or proceeding arising out of his or her service as one of our directors or executive officers, or
any of our subsidiaries or any other company or enterprise to which the person provides services at our request.
We maintain a general liability insurance policy
that covers certain liabilities of our directors and officers arising out of claims based on acts or omissions in their capacities as
directors or officers.
Item 16. Exhibits.
Exhibit Index
Exhibit
No. | | Description |
| 1.1* | |
Form of Underwriting Agreement |
| | | |
| 1.2 |
| Open
Market Sale AgreementSM, dated July 17, 2020, by and between Bellerophon
Therapeutics, Inc. and Jefferies LLC (incorporated by reference to Exhibit 10.1
to the Registrant’s Current Report on Form 8-K (File No. 001-36845) filed
with the SEC on July 17, 2020) |
| | | |
| 3.1 |
|
Restated
Certificate of Incorporation of the Registrant, as amended, dated July 30, 2018 (incorporated by reference to Exhibit 3.1
to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-36845) filed with the SEC on November 7, 2018) |
| |
|
|
| 3.2 |
|
Certificate
of Amendment to the Restated Certificate of Incorporation of Bellerophon Therapeutics, Inc., filed with the Secretary of State
of the State of Delaware on February 5, 2020 (incorporated by reference to Exhibit 3.1 to the Registrant’s Current
Report on Form 8-K (File No. 001-36845) filed with the SEC on February 7, 2020) |
| |
|
|
| 3.3 |
|
Amended
and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on
Form 8-K (File No. 001-36845) filed with the SEC on February 25, 2015) |
| |
|
|
| 4.1 |
|
Form of
Specimen Stock Certificate |
| |
|
|
| 4.2* |
|
Form of
Senior Debt Security |
| |
|
|
| 4.3* |
|
Form of
Subordinated Debt Security |
| |
|
|
| 4.4 |
|
Form of
Senior Indenture |
| |
|
|
| 4.5 |
|
Form of
Subordinated Indenture |
| |
|
|
| 4.6* |
|
Form of
Warrant Agreement and Warrant Certificate |
| |
|
|
| 4.7* |
|
Form of
Rights Agreement and Right Certificate |
| |
|
|
| 4.8* |
|
Form of
Unit Agreement and Unit. |
| |
|
|
| 5.1 |
|
Opinion
of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. |
| |
|
|
| 23.1 |
|
Consent
of KPMG LLP, independent registered public accounting firm for the Registrant |
| |
|
|
| 23.2 |
|
Consent
of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (included in Exhibit 5.1) |
| |
|
|
| 24.1 |
|
Powers
of Attorney (included in the signature pages to the Registration Statement) |
| |
|
|
| 25.1* |
|
Statement
of Eligibility on Form T-1 under the Trust Indenture Act of 1939, as amended, of the Trustee under the Senior Indenture |
| |
|
|
| 25.2* |
|
Statement
of Eligibility on Form T-1 under the Trust Indenture Act of 1939, as amended, of the Trustee under the Subordinated Indenture |
| |
|
|
| 107 |
|
Filing
Fee Table |
* To be filed by amendment or by a Current Report
on Form 8-K.
Item 17. Undertakings.
The undersigned Registrant
hereby undertakes:
(a)(1) To file,
during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
| (i) | to
include any prospectus required by Section 10(a)(3) of the Securities Act of 1933,
as amended (the “Securities Act”); |
| (ii) | to
reflect in the prospectus any facts or events arising after the effective date of this registration
statement (or the most recent post-effective amendment thereof) which, individually or in
the aggregate, represent a fundamental change in the information set forth in this registration
statement. Notwithstanding the foregoing, any increase or decrease in volume of securities
offered (if the total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum offering
range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if,
in the aggregate, the changes in volume and price represent no more than a 20 percent change
in the maximum aggregate offering price set forth in the “Calculation of Registration
Fee” table in the effective registration statement; and |
| (iii) | to
include any material information with respect to the plan of distribution not previously
disclosed in this registration statement or any material change to such information in this
registration statement; |
provided,
however, that paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) do not apply if the information required to be included
in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the Registrant
pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
that are incorporated by reference in this registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that
is part of this registration statement.
(2) That,
for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new
registration statement relating to the securities offered therein, and the offering of such securities at the time shall be deemed to
be the initial bona fide offering thereof.
(3) To
remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination
of the offering.
(4) That,
for the purpose of determining liability under the Securities Act to any purchaser:
| (i) | each
prospectus filed by the Registrant pursuant to Rule 424(b)(3) shall be deemed to
be part of the registration statement as of the date the filed prospectus was deemed part
of and included in the registration statement; and |
| (ii) | each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as
part of a registration statement in reliance on Rule 430B relating to an offering made
pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the
information required by Section 10(a) of the Securities Act of 1933 shall be deemed
to be part of and included in the registration statement as of the earlier of the date such
form of prospectus is first used after effectiveness or the date of the first contract of
sale of securities in the offering described in the prospectus. As provided in Rule 430B,
for liability purposes of the issuer and any person that is at that date an underwriter,
such date shall be deemed to be a new effective date of the registration statement relating
to the securities in the registration statement to which that prospectus relates, and the
offering of such securities at that time shall be deemed to be the initial bona fide
offering thereof;. provided, however, that no statement made in a registration statement
or prospectus that is part of the registration statement or made in a document incorporated
or deemed incorporated by reference into the registration statement or prospectus that is
part of the registration statement will, as to a purchaser with a time of contract of sale
prior to such effective date, supersede or modify any statement that was made in the registration
statement or prospectus that was part of the registration statement or made in any such document
immediately prior to such effective date. |
(5) That,
for the purpose of determining liability of the Registrant under the Securities Act to any purchaser in the initial distribution of the
securities, the undersigned Registrant undertakes that in a primary offering of securities of the undersigned Registrant pursuant to
this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are
offered or sold to such purchaser by means of any of the following communications, such undersigned Registrant will be a seller to the
purchaser and will be considered to offer or sell such securities to such purchaser:
| (i) | any
preliminary prospectus or prospectus of the undersigned Registrant relating to the offering
required to be filed pursuant to Rule 424; |
| (ii) | any
free writing prospectus relating to the offering prepared by or on behalf of the undersigned
Registrant or used or referred to by the undersigned Registrant; |
| (iii) | the
portion of any other free writing prospectus relating to the offering containing material
information about the undersigned Registrant or its securities provided by or on behalf of
the undersigned Registrant; and |
| (iv) | any
other communication that is an offer in the offering made by the undersigned Registrant to
the purchaser. |
(6) That, for the purpose of determining liability of the registrant under the Securities Act to any purchaser in the initial distribution
of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant
to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities
are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to
the purchaser and will be considered to offer or sell such securities to such purchaser:
| (i) | any preliminary prospectus or prospectus of
the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; |
| | | |
| | (ii) | any free writing prospectus relating
to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant; |
| | | |
| | (iii) | the
portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant
or its securities provided by or on behalf of the undersigned registrant; and |
| | | |
| | (iv) | any other communication that is an offer in the offering
made by the undersigned registrant to the purchaser. |
(b) The
undersigned Registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of the
Registrant’s annual report pursuant to Section 13(a) or 15(d) of the Exchange Act (and, where applicable, each filing
of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference
in this registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(c) The
undersigned Registrant hereby undertakes to file an application for the purpose of determining the eligibility of the trustee to act
under subsection (a) of Section 310 of the Trust Indenture Act in accordance with the rules and regulations prescribed
by the Commission under Section 305(b)(2) of the Trust Indenture Act.
(d) Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of
the Registrant pursuant to the indemnification provisions described herein, or otherwise, the Registrant has been advised that in the
opinion of the Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.
In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred
or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is
asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless
in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final
adjudication of such issue.
SIGNATURES
Pursuant to the requirements of the Securities
Act of 1933, as amended, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for
filing on Form S-3 and has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in Warren, New Jersey, on June 2, 2023.
BELLEROPHON THERAPEUTICS, INC.
| By: | /s/ Peter Fernandes | |
| | Name: |
Peter Fernandes | |
| | Title: |
Chief Executive Officer, Principal Financial and Accounting Officer | |
SIGNATURES AND POWER
OF ATTORNEY
We, the undersigned officers
and directors of Bellerophon Therapeutics, Inc., hereby severally constitute and appoint each of Peter Fernandes and Naseem Amin
as our true and lawful attorney-in-fact and agent, with full power of substitution and re-substitution for him and in his name, place
and stead, and in any and all capacities, to sign any and all amendments (including post-effective amendments) to this registration statement
(or any other registration statement for the same offering that is to be effective upon filing pursuant to Rule 462(b) under
the Securities Act of 1933), and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities
and Exchange Commission, granting unto each said attorney-in-fact and agent, full power and authority to do and perform each and every
act and thing requisite or necessary to be done in and about the premises, as full to all intents and purposes as he might or could do
in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or any of them or their or his substitute or substitutes
may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities
Act of 1933, as amended, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated.
| Signature |
|
Title |
|
Date |
| |
|
|
|
|
| /s/ Peter Fernandes |
|
Chief Executive Officer, Principal Financial and Accounting Officer |
|
|
| Peter Fernandes |
|
(Principal Executive Officer and Principal Financial and Accounting Officer) |
|
June 2, 2023 |
| |
|
|
|
|
| /s/ Naseem Amin |
|
|
|
|
| Naseem Amin |
|
Chairman of the Board of Directors |
|
June 2, 2023 |
| |
|
|
|
|
| /s/ Scott P. Bruder |
|
|
|
|
| Scott P. Bruder |
|
Director |
|
June 2, 2023 |
| |
|
|
|
|
| /s/ Mary Ann Cloyd |
|
|
|
|
| Mary Ann Cloyd |
|
Director |
|
June 2, 2023 |
| |
|
|
|
|
| /s/ Crispin Teufel |
|
|
|
|
| Crispin Teufel |
|
Director |
|
June 2, 2023 |
| |
|
|
|
|
| /s/ Ted Wang |
|
|
|
|
| Ted Wang |
|
Director |
|
June 2, 2023 |
Grafico Azioni Bellerophon Therapeutics (NASDAQ:BLPH)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Bellerophon Therapeutics (NASDAQ:BLPH)
Storico
Da Giu 2023 a Giu 2024
