As filed with the Securities and Exchange
Commission on May 16, 2019
Registration
No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT UNDER
THE SECURITIES ACT OF 1933
BIO-PATH HOLDINGS, INC.
(Exact name of registrant as specified in
its charter)
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Delaware
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4710 Bellaire Boulevard, Suite 210
Bellaire, Texas 77401
(832) 742-1357
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87-0652870
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(State or other jurisdiction of
incorporation or organization)
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(Address, including zip code, and telephone
number, including
area code, of registrant’s principal
executive
offices)
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(I.R.S. Employer
Identification Number)
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Peter H. Nielsen
President and Chief Executive Officer
4710 Bellaire Boulevard, Suite 210
Bellaire, Texas 77401
(832) 742-1357
(Name, address, including zip code, and
telephone number,
including area code, of agent for service)
Copies To:
William R. Rohrlich, II
Winstead PC
600 Travis Street
Suite 5200
Houston, Texas 77002
Tel. (281) 681-5912
Fax (281) 681-5901
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.
¨
CALCULATION OF REGISTRATION FEE
Title
of Each Class of
Securities to be Registered
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Amount
to be
Registered(1)
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Proposed
Maximum
Offering
Price
Per Unit
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Proposed
Maximum
Aggregate
Offering
Price
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Amount
of
Registration
Fee
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Common Stock, par value $0.001
per share, issuable upon exercise of outstanding warrants
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5,149
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(2)
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$
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460.00
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$
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2,368,540
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Common Stock, par value $0.001 per share
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(3)
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(4)
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(4)
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—
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Preferred Stock, par value $0.001 per share
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(3)
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(4)
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(4)
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—
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Warrants
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(3)
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(4)
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(4)
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—
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Units
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(3)
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(4)
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(4)
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—
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Total Offering
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(3)
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$
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127,368,540
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$
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15,438
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(5)(6)(7)
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(1)
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Pursuant to Rule 416 under the Securities Act of 1933, as amended (the “Securities Act”), the shares being registered hereunder include such indeterminate number of shares of common stock and preferred stock as may be issuable with respect to the shares being registered hereunder as a result of stock splits, stock dividends or similar transactions.
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(2)
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Consists of shares of common stock issuable upon the exercise of outstanding warrants (including shares that may be issued to the holder in lieu of fractional shares).
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(3)
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In addition to the shares of common stock issuable upon the exercise of outstanding warrants described in footnote (2) above (the “Warrant Shares”), there are being registered hereunder such indeterminate number of shares of common stock and preferred stock, such indeterminate number of warrants to purchase common stock and preferred stock and such indeterminate number of units as shall have an aggregate initial offering price not to exceed $125,000,000. Any securities registered hereunder may be sold separately or in combination with the other securities registered hereunder. The securities registered also include such indeterminate numbers of common stock and preferred stock as may be issued upon conversion of or exchange for preferred stock that provide for conversion or exchange, upon exercise of warrants or pursuant to the anti-dilution provisions of any such securities.
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(4)
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The proposed maximum aggregate offering price per class of security will be determined from time to time by the registrant in connection with the issuance by the registrant of the securities registered hereunder and is not specified as to each class of security pursuant to General Instruction II.D of Form S-3 under the Securities Act.
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(5)
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Pursuant to Rule 415(a)(6) under the Securities Act, the securities registered hereunder include unsold securities previously registered pursuant to Registration Statement No. 333-215205, which was declared effective on January 9, 2017 (the “Prior Registration Statement”). The Prior Registration Statement registered the offer and sale of (i) common stock issuable upon exercise of outstanding warrants and (ii) such indeterminate number of shares of common stock and preferred stock, such indeterminate number of warrants to purchase common stock and preferred stock and such indeterminate number of units (collectively, the “Prior Securities”) with an aggregate initial offering price not to exceed $143,614,705, $115,071,063.24 of which Prior Securities remain unsold as of the date of filing of this registration statement. The registrant has determined to include in this registration statement unsold Prior Securities under the Prior Registration Statement with an aggregate offering price of $115,071,063.24 (the “Unsold Securities”), which includes the aggregate offering price of $2,368,540 with respect to the Warrant Shares as reflected in the table above. The registrant is also registering new shelf securities on this registration statement with an aggregate initial offering price of $12,297,476.76 (the “New Securities”), which aggregate offering price is not specified as to each class of security. To the extent that, after the filing date hereof and prior to the effectiveness of this registration statement, the registrant sells any Unsold Securities pursuant to the Prior Registration Statement, the registrant will identify in a pre-effective amendment to this registration statement the updated amount of Unsold Securities from the Prior Registration Statement to be included in this registration statement pursuant to Rule 415(a)(6) and the updated amount of New Securities to be registered on this registration statement. Pursuant to Rule 415(a)(6), the offering of the Unsold Securities under the Prior Registration Statement will be deemed terminated as of the date of effectiveness of this registration statement. The filing fee of $13,336.74 relating to the Unsold Securities under the Prior Registration Statement will continue to be applied to the Unsold Securities registered pursuant to this registration statement. A filing fee of $1,491 with respect to the New Securities is being paid in connection with the filing of this registration statement, provided that a portion of such filing fee is being offset pursuant to Rule 457(p) as described in footnote (6) below.
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(6)
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A filing fee of $1,446.07 was previously paid in connection with the registration statement on Form S-1 (File No. 333-229048), initially filed on December 27, 2018, which was subsequently withdrawn pursuant to Rule 477 under the Securities Act on April 12, 2019. Pursuant to Rule 457(p) under the Securities Act, the registrant is offsetting the registration fee of $1,491 that is due under this registration statement by such $1,446.07 filing fee that was previously paid.
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(7)
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Calculated pursuant to Rule 457(o), based on the Proposed
Maximum Aggregate Offering Price.
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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 three
prospectuses:
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a base prospectus covering the offering, issuance and sale of such indeterminate number of shares of common stock and preferred stock, such indeterminate number of warrants to purchase common stock and preferred stock and such indeterminate number of units as shall have an aggregate initial offering price not to exceed $125,000,000;
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a sales agreement prospectus covering the offering, issuance and sale of shares of our common stock with an aggregate offering price of up to $25,000,000 that may be issued and sold under the Controlled Equity Offering
SM
Sales Agreement we entered into with Cantor Fitzgerald & Co., dated June 24, 2015 (the “Sales Agreement”); and
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a warrant exercise prospectus covering the offering, issuance and sale of 5,149 shares of our common stock pursuant to the exercise of warrants to purchase shares of our common stock outstanding on May 16, 2019 (including shares that may be issued to the holder in lieu of fractional shares).
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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 under the sales agreement prospectus is included in the $125,000,000 of securities that
may be offered, issued and sold by us under the base prospectus. Upon termination of the Sales Agreement with Cantor Fitzgerald
& Co., any portion of the $25,000,000 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. The warrant
exercise prospectus immediately follows the sales agreement prospectus. The shares of our common stock that may be issued pursuant
to the warrant exercise prospectus are not included in the $125,000,000 of securities that may be offered, issued and sold by us
under the base prospectus.
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 it is not soliciting an offer to buy these securities
in any state where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED
MAY 16, 2019
PROSPECTUS
$125,000,000
COMMON STOCK
PREFERRED STOCK
WARRANTS
UNITS
We may from time to time offer and sell
up to $125,000,000 of common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of
the foregoing, either individually or in units, at prices and on terms described in one or more supplements to this prospectus.
We may also offer securities as may be issuable upon conversion, redemption, repurchase, exchange or exercise of any securities
registered hereunder, including any applicable anti-dilution provisions.
This prospectus provides the general terms
of the securities we may offer and the general manner in which these securities will be offered. Each time we offer to sell securities,
we will provide specific terms related to such offers in a supplement to this prospectus. The prospectus supplements may also add,
update or change information contained in this prospectus. Before you invest, you should carefully read this prospectus and the
applicable prospectus supplement, as well the documents incorporated by referenced in this prospectus. This prospectus may not
be used to consummate a sale of securities unless accompanied by the applicable prospectus supplement.
Our common stock is currently listed on
the Nasdaq Capital Market under the symbol “BPTH.” On May 14, 2019, the last reported sales price per share of our
common stock on the Nasdaq Capital Market was $18.00.
We will sell these securities directly,
through agents, dealers or underwriters as designated from time to time, or through a combination of these methods. For additional
information on the methods of sale, you should refer to the section titled “Plan of Distribution” in this prospectus.
If any agents, dealers or underwriters are involved in the sale of these securities, the applicable prospectus supplement will
set forth the names of the agents, dealers or underwriters and any applicable fees, commissions or discounts. The price to the
public of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a supplement
to this prospectus.
Investing in our securities involves
a high degree of risk. Before making an investment decision, you should review carefully and consider all of the information set
forth in this prospectus, the applicable prospectus supplement and the documents incorporated by reference in this prospectus
and applicable prospectus supplement. See “Risk Factors” on page 4 of this prospectus and under similar headings in
the other documents that are incorporated by reference into this prospectus.
Neither the Securities and Exchange Commission
nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful
or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 2019
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This prospectus is part of a registration
statement on Form S-3 that we filed with the Securities and Exchange Commission (the “SEC”) using a “shelf”
registration process. Under this shelf registration statement process, we may from time to time sell common stock, preferred stock,
warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, in one
or more offerings up to an offering amount of $125,000,000. This prospectus provides you with a general description of the securities
we may offer and the general manner in which these securities will be offered.
Each time we offer securities hereunder,
we will provide specific terms related to such offering in a supplement to this prospectus.
The prospectus supplements may add, update
or change any of the information contained in this prospectus or in the documents that we have incorporated by reference into this
prospectus. We urge you to read carefully this prospectus and the applicable prospectus supplement, together with the information
incorporated herein by reference as described under the sections titled “Where You Can Find More Information” and “Information
Incorporated by Reference” below. If there is any inconsistency between the information in this prospectus and any prospectus
supplement, you should rely on the information contained in that prospectus supplement.
This prospectus may not be used to consummate
a sale of securities unless it is accompanied by a prospectus supplement.
You should rely only on the information
we have provided or incorporated by reference in this prospectus and the applicable prospectus supplement. We have not authorized
anyone to provide you with different information. No dealer, salesperson or other person is authorized to give any information
or to represent anything not contained in this prospectus or the applicable prospectus supplement. You must not rely on any unauthorized
information or representation. This prospectus or any applicable supplement to this prospectus do not constitute an offer to sell
or the solicitation of an offer to buy any securities other than the registered securities to which they relate, nor do this prospectus
or any applicable supplement to this prospectus constitute an offer to sell or the solicitation of an offer to buy securities in
any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You should assume
that the information in this prospectus is accurate only as of the date on the front of the document and that any information we
have incorporated by reference is accurate only as of the date of the document incorporated by reference. Our business, financial
condition, results of operations and prospects may have changed since those dates.
This prospectus contains summaries of certain
provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information.
All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein
have been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus
is a part, and you may obtain copies of those documents as described below under the section titled “Where You Can Find More
Information.”
Unless the context requires otherwise, references
in this prospectus to “we,” “our,” “us,” “the Company” and “Bio-Path”
refer to Bio-Path Holdings, Inc. and its wholly-owned subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path,
Inc., is sometimes referred to herein as “Bio-Path Subsidiary.”
PROSPECTUS
SUMMARY
This prospectus summary highlights
selected information contained elsewhere in this prospectus or in documents incorporated by reference. This summary does not contain
all of the information that you should consider before making an investment decision. You should carefully read the entire prospectus,
the applicable prospectus supplement, including under the section titled “Risk Factors” and the documents incorporated
by reference into this prospectus, before making an investment decision.
Our Company
We are a clinical and preclinical stage
oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target
specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology,
called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended
to protect the DNA from destruction by the body’s enzymes when circulating
in vivo,
incorporated inside of a neutral
charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like
structures for delivery of the antisense drug substance into cells.
In vivo,
the DNAbilize® delivered antisense drug
substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases
and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize®
drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company.
Using DNAbilize® as a platform for drug
development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different
cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy
portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination
with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add
prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In
addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen
is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib.
Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend
to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019.
Our second drug candidate, Liposomal Bcl-2
(“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers.
We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate
a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval
from the U.S. Food and Drug Administration (FDA).
Our third drug candidate, Liposomal Stat3
(“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic
cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein
expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the
efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model.
Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending
treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical
trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020.
Our DNAbilize® technology-based products
are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing
protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template
in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug
candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic
delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination
with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance
for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases.
We have certain intellectual property as
the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing
RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where
targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors
with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design
and manufacture of antisense RNAi nanoparticle drug products.
Corporate Information
The Company was incorporated in May 2000
as a Utah corporation. In February 2008, Bio-Path Subsidiary completed a reverse merger with the Company, which at the time was
traded over the counter and had no current operations. The prior name of the Company was changed to Bio-Path Holdings, Inc. and
the directors and officers of Bio-Path Subsidiary became the directors and officers of Bio-Path Holdings, Inc. On March 10, 2014,
our common stock ceased trading on the OTCQX and commenced trading on the Nasdaq Capital Market under the ticker symbol “BPTH.”
Effective December 31, 2014, we changed our state of incorporation from Utah to Delaware through a statutory conversion pursuant
to the Utah Revised Business Corporation Act and the Delaware General Corporation Law. Our principal executive offices are located
at 4710 Bellaire Boulevard, Suite 210, Bellaire, Texas 77401, and our telephone number is (832) 742-1357.
On February 8, 2018, we effected a reverse
stock split of our outstanding shares of common stock at a ratio of 1-for-10, and our common stock began trading on the split-adjusted
basis on the Nasdaq Capital Market at the commencement of trading on February 9, 2018. In addition, on January 17, 2019, we effected
a reverse stock split of our outstanding shares of common stock at a ratio of 1-for-20, and our common stock began trading on the
split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on January 18, 2019. All common stock share and
per share amounts in this prospectus have been adjusted to give effect to both the 1-for-10 reverse stock split and the 1-for-20
reverse stock split, retrospectively.
THE OFFERING
We may offer common stock, preferred stock,
warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, in one
or more offerings, with an aggregate initial offering price not to exceed $125,000,000. This prospectus describes the general terms
that may apply to the securities to be offered and the specific terms of any particular securities that we offer will be described
in a separate supplement to this prospectus, including, to the extent applicable:
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designation or classification;
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aggregate offering price;
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rates and times of payment of dividends, if any;
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redemption, conversion, exchange or sinking fund terms, if any;
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restrictive covenants, if any;
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voting or other rights, if any;
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conversion, exchange and exercise prices, if any; and
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important federal income tax considerations.
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We may offer and sell the securities directly,
through agents, dealers or underwriters as designated from time to time, or through a combination of these methods. The applicable
prospectus supplement will include any required information about the agents, dealers or underwriters we use and the applicable
fees, commissions or discounts we may pay them for their services.
This prospectus may not be used to consummate
a sale of securities unless it is accompanied by a prospectus supplement.
RISK
FACTORS
An investment in our company involves a
high degree of risk. Before you make a decision to invest in our securities, you should consider carefully the risks described
in or incorporated by reference in this prospectus, including the risks and uncertainties discussed under the section titled “Risk
Factors” in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or Current Reports
on Form 8-K, and all other documents incorporated by reference into this prospectus, as updated by our subsequent filings under
the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the risk factors and other information contained
in the applicable prospectus supplement.
Any of these risks could have a material
adverse effect on our business, prospects, financial condition and results of operations. In any such case, the trading price of
our securities could decline and you could lose all or part of your investment. Additional risks not presently known to us or that
we currently deem immaterial may also adversely affect our business operations.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated
by reference into this prospectus contain “forward-looking statements” within the meaning of Section 27A of the Securities
Act of 1933, as amended (the “Securities Act”), and Section 21E of the Exchange Act. Forward-looking statements can
be identified by words such as “anticipate,” “expect,” “intend,” “plan,” “believe,”
“seek,” “estimate,” “project,” “goal,” “strategy,” “future,”
“likely,” “may,” “should,” “will” and variations of these words and similar references
to future periods, although not all forward-looking statements contain these identifying words. Forward-looking statements are
neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and
assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the
economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks,
uncertainties, and changes in circumstances, including but not limited to risk factors contained in or incorporated by reference
under the section titled, “Risk Factors.” As a result, our actual results may differ materially from those expressed
or forecasted in the forward-looking statements, and you should not rely on such forward-looking statements. You should carefully
read this prospectus and any applicable supplement to this prospectus, together with the information incorporated herein by reference
as described under the section titled “Where You Can Find More Information,” completely and with the understanding
that our actual future results may be materially different from what we expect. We can give no assurances that any of the events
anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations
and financial condition. Forward-looking statements include, but are not limited to, statements about:
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our lack of significant revenue to date, our history of recurring operating losses and our expectation of future operating losses;
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our need for substantial additional capital and our need to delay, reduce or eliminate our drug development and commercialization efforts if we are unable to raise additional capital;
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the highly-competitive nature of the pharmaceutical and biotechnology industry and our ability to compete effectively;
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the success of our plans to use collaboration arrangements to leverage our capabilities;
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our ability to retain and attract key personnel;
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the risk of misconduct of our employees, agents, consultants and commercial partners;
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disruptions to our operations due to expansions of our operations;
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the costs we would incur if we acquire or license technologies, resources or drug candidates;
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risks associated with product liability claims;
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our reliance on information technology systems and the liability or interruption associated with cyber-attacks or other breaches of our systems;
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our ability to use net operating loss carryforwards;
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provisions in our charter documents and state law that may prevent a change in control;
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work slowdown or stoppage at government agencies could negatively impact our business
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our need to complete extensive clinical trials and the risk that we may not be able to demonstrate the safety and efficacy of our drug candidates;
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risks that that our clinical trials may be delayed or terminated;
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our ability to obtain domestic and foreign regulatory approval for our drug candidates;
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changes in existing laws and regulations affecting the healthcare industry;
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our reliance on third parties to conduct clinical trials for our drug candidates;
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our ability to maintain orphan drug exclusivity for our drug candidates;
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our reliance on third parties for manufacturing our clinical drug supplies;
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risks associated with the manufacture of our drug candidates;
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our ability to establish sales and marketing capabilities relating to our drug candidates;
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market acceptance of our drug candidates;
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third-party payor reimbursement practices;
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our ability to adequately protect the intellectual property of our drug candidates;
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infringement on the intellectual property rights of third parties;
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costs and time relating to litigation regarding intellectual property rights;
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our ability to adequately prevent disclosure by our employees or others of trade secrets and other proprietary information;
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the volatility of the trading price of our common stock;
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our common stock being thinly traded;
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our ability to issue shares of common or preferred stock without approval from our stockholders;
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our ability to pay cash dividends;
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costs and expenses associated with being a public company;
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a material weakness identified in our internal controls over financial reporting; and
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our ability to maintain compliance with the listing standards of the Nasdaq Capital Market.
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Any forward-looking statement made by us
in this prospectus, any applicable supplement to this prospectus and the documents incorporated by reference into this prospectus
is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation
to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise. However,
you should carefully review the risk factors set forth in other reports or documents we file from time to time with the SEC.
USE
OF PROCEEDS
Unless otherwise indicated in the applicable
prospectus supplement, we expect to use the net proceeds from the sale of securities offered pursuant to this prospectus for working
capital and general corporate purposes. Until the net proceeds are used for these purposes, we may deposit them in interest-bearing
accounts or invest them in short-term marketable securities.
DESCRIPTION
OF CAPITAL STOCK
The following description of our common
stock and preferred stock is a summary. It is not complete and is subject to and qualified in its entirety by our certificate of
incorporation and first amended and restated bylaws, each of which is incorporated by reference into this prospectus.
See the sections titled “Where You Can Find More Information” and “Information Incorporated by Reference.”
As of the date of this prospectus, our certificate of incorporation authorizes us to issue 200,000,000 shares of common stock,
par value $0.001 per share, and 10,000,000 shares of preferred stock, par value $0.001 per share. As of May 7, 2019, there were
2,831,356 shares of common stock issued and outstanding and no shares of preferred stock issued and outstanding.
Common Stock
Holders of common stock
are entitled to one vote for each share held in the election of directors and on all other matters submitted to a vote of stockholders.
Cumulative voting of shares of common stock is prohibited. Accordingly, holders of a majority of the shares of common stock entitled
to vote in any election of directors may elect all of the directors standing for election.
Subject to the prior
rights of the holders of any outstanding preferred stock, holders of common stock are entitled to receive dividends when, as and
if declared by our board of directors out of funds legally available therefor. Upon the liquidation, dissolution or winding up
of our company, the holders of common stock are entitled to receive ratably the assets of our company remaining after payment of
all liabilities and payment to holders of preferred stock if such preferred stock has an involuntary liquidation preference over
the common stock. Holders of common stock have no preemptive, subscription, redemption or conversion rights. The outstanding shares
of common stock are, and the shares offered by us in this offering will be, when issued and paid for, validly issued, fully paid
and nonassessable.
As of March 31, 2019,
there were approximately 227 holders of record of our common stock.
Preferred Stock
Our board of directors is authorized, without
any further notice to or action of the stockholders, to issue up to 10,000,000 shares of preferred stock in one or more series.
Our board of directors is further authorized, subject to limitations prescribed by law, to fix by resolution or resolutions the
designations, powers, preferences and rights, and the qualifications, limitations or restrictions thereof, of any wholly unissued
series of our preferred stock, including without limitation authority to fix by resolution or resolutions the dividend rights,
dividend rate, conversion rights, voting rights, rights and terms of redemption (including sinking fund provisions), redemption
price or prices, and liquidation preferences of any such series, and the number of shares constituting any such series and the
designation thereof, or any of the foregoing. The board of directors is further authorized to increase (but not above the total
number of authorized shares of the class) or decrease (but not below the number of shares of any such series then outstanding)
the number of shares of any series, the number of which was fixed by it, subsequent to the issuance of shares of such series then
outstanding, subject to the powers, preferences and rights, and the qualifications, limitations and restrictions thereof stated
in our certificate of incorporation or the resolution of our board of directors originally fixing the number of shares of such
series. If the number of shares of any series is so decreased, then the shares constituting such decrease shall resume the status
which they had prior to the adoption of the resolution originally fixing the number of shares of such series. As of the date of
this prospectus, no such shares had been designated.
The following briefly summarizes the material
terms of preferred stock that we may offer, other than pricing and related terms disclosed in a prospectus supplement. You should
read the particular terms of any series of preferred stock that we offer which we will describe in more detail in the applicable
prospectus supplement relating to such series. You should also read the more detailed provisions of our certificate of incorporation
and the statement with respect to shares relating to each particular series of preferred stock for provisions that may be important
to you. The statement with respect to shares relating to each particular series of preferred stock offered by the applicable prospectus
supplement and this prospectus will be filed as an exhibit to a document incorporated by reference in the prospectus. The prospectus
supplement will also state whether any of the terms summarized below do not apply to the series of preferred stock being offered.
Rank
. A series of preferred stock
will have the rank set forth in the relevant certificate of designation and described in the prospectus supplement relating to
the applicable series.
Voting Rights
. The holders of shares
of a series of preferred stock will have the voting rights provided by the applicable certificate of designation and as required
by applicable law. These voting rights will be described in the relevant prospectus supplement.
Dividends
. The certificate of designation
setting forth the terms of a series of preferred stock may provide that the holders of that series are entitled to receive dividends,
when, as and if authorized by our board of directors out of funds legally available for dividends, before any declaration or payment
of any dividends on securities ranking junior to such series relating to dividends. The rates and dates of payment of dividends
and any other terms applicable to the dividends will be set forth in the applicable certificate of designation and described in
the prospectus supplement relating to the relevant series. To the extent provided in the certificate of designation, dividends
will be payable to the holders of record of our preferred stock as they appear on our books on the record dates fixed by our board
of directors. Dividends on any series of our preferred stock may be cumulative or noncumulative and payable in cash or in kind.
Conversion and Exchange
. The certificate
of designation setting forth the terms of a series of our preferred stock may provide for, and the prospectus supplement for the
applicable series of preferred stock may describe, the terms, if any, on which shares of that series are convertible into or exchangeable
for shares of our common stock or securities of a third party.
Redemption
. If so specified in the
certificate of designation setting forth the terms of a series of our preferred stock, which will be described in the applicable
prospectus supplement, a series of our preferred stock may be redeemable at our or the holder’s option and/or may be mandatorily
redeemed partially or in whole.
Liquidation Preference
. Upon any
voluntary or involuntary liquidation, dissolution or winding up of our company, the holders of each series of our preferred stock
may be entitled to receive distributions upon liquidation. Those distributions will be made before any distribution is made on
any securities ranking junior to such series relating to liquidation. The terms and conditions of those distributions to the relevant
series of our preferred stock will be set forth in the applicable certificate of designation and described in the relevant prospectus
supplement.
Our board of directors may cause shares
of preferred stock to be issued in public or private transactions for any proper corporate purposes, and such issuance could adversely
affect the voting rights of the holders of our common stock. The issuance of our preferred stock could also affect the likelihood
that the holders of common stock will receive dividends or distributions upon liquidation. In addition, the rights of the holders
of the preferred stock offered may be adversely affected by the rights of the holders of any shares of our preferred stock that
may be issued in the future. The preferred stock could have the effect of acting as an anti-takeover device to prevent a change
in control of our company.
Unless the particular prospectus supplement
states otherwise, the holders of each series of our preferred stock will not have any preemptive or subscription rights to acquire
more of our capital stock.
The transfer agent, registrar, dividend
disbursing agent and redemption agent for shares of each series of preferred stock will be named in the prospectus supplement relating
to such series.
Limitation on Liability and Indemnification of Officers and
Directors
Our certificate of incorporation and first
amended and restated bylaws provide for indemnification of our officers and directors to the fullest extent permitted by Delaware
law. Our certificate of incorporation and first amended and restated bylaws limit the liability of our directors for monetary damages
to the fullest extent permitted by Delaware law. We maintain directors’ and officers’ liability insurance.
Anti-Takeover Effects of Provisions of Our Certificate of
Incorporation, Our Bylaws and Delaware Law
Some provisions of Delaware law and our
certificate of incorporation and our first amended and restated bylaws contain provisions that could have the effect of delaying,
deterring or preventing another party from acquiring or seeking to acquire control of us. These provisions are intended to discourage
certain types of coercive takeover practices and inadequate takeover bids and to encourage anyone seeking to acquire control of
us to negotiate first with our board of directors. However, these provisions may also delay, deter or prevent a change in control
or other takeover of our company that our stockholders might consider to be in their best interests, including transactions that
might result in a premium being paid over the market price of our common stock and also may limit the price that investors are
willing to pay in the future for our common stock. These provisions may also have the effect of preventing changes in our management.
Our certificate of incorporation and first
amended and restated bylaws include anti-takeover provisions that:
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authorize our board of directors, without further action by the stockholders, to issue shares of preferred stock in one or more series, and with respect to each series, to fix the number of shares constituting that series and establish the rights and other terms of that series;
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establish advance notice procedures for stockholders to submit nominations of candidates for election to our board of directors and other proposals to be brought before a stockholders meeting;
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provide that our first amended and restated bylaws may be amended by our board of directors without stockholder approval;
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limit our stockholders’ ability to call special meetings of stockholders;
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allow our directors to establish the size of the board of directors by action of the board, subject to a minimum of three members;
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provide that vacancies on our board of directors or newly created directorships resulting from an increase in the number of our directors may be filled only by a majority of directors then in office, even though less than a quorum; and
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do not give the holders of our common stock cumulative voting rights with respect to the election of directors.
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Business Combinations
Section 203 of the Delaware General Corporation
Law provides that we may not engage in certain “business combinations” with any “interested stockholder”
for a three-year period following the time that the person became an interested stockholder, unless:
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prior to the time that person became an interested stockholder, our board of directors approved either the business combination or the transaction which resulted in the person becoming an interested stockholder;
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upon consummation of the transaction which resulted in the person 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 certain shares; or
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at or subsequent to the time the person became an interested stockholder, the business combination is approved by the board of directors and by the affirmative vote of at least 66 2/3% of the outstanding voting stock which is not owned by the interested stockholder.
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Generally, a business combination includes
a merger, consolidation, asset or stock sale or other transaction resulting in a financial benefit to the interested stockholder.
Subject to certain exceptions, an interested stockholder is a person who, together with that person’s affiliates and associates,
owns, or within the previous three years owned, 15% or more of our 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.
Listing
Our common stock is listed for trading on
the Nasdaq Capital Market under the symbol “BPTH.”
Transfer Agent and Registrar
The transfer agent and registrar for our
common stock is American Stock Transfer & Trust Company, LLC, 6201 15
th
Avenue, Brooklyn, New York 11219. Its phone
number is (800) 937-5449.
DESCRIPTION
OF WARRANTS
The following description, together with
the additional information we include in the applicable prospectus supplement, summarizes the material terms and provisions of
the warrants that we may offer under this prospectus. We may issue warrants for the purchase of shares of common stock and/or preferred
stock. We may issue warrants independently or together with shares of common stock and/or shares of preferred stock, and the warrants
may be attached to or separate from these securities. While the terms summarized below will apply generally to any warrants that
we may offer, we will describe the particular terms of any series of warrants in more detail in the applicable prospectus supplement.
The terms of any warrants offered under a prospectus supplement may differ from the terms described below.
Before the issuance of a series of warrants,
the form of warrant agreement, including a form of warrant certificate, if applicable, that describes the terms of the particular
series of warrants we are offering will be filed as an exhibit to the registration statement of which this prospectus is a part,
or incorporated by reference from reports that we file with the SEC. The following summaries of material provisions of the warrants
are subject to, and qualified in their entirety by reference to, all the provisions of the warrant agreement and warrant certificate
applicable to the particular series of warrants that we may offer under this prospectus and the applicable prospectus supplement.
We urge you to read the applicable prospectus supplements related to the particular series of warrants that we may offer under
this prospectus, as well as any related free writing prospectuses, and the complete warrant agreements and warrant certificates
that contain the terms of the warrants.
General
We will describe in the applicable prospectus
supplement the terms of the warrants that may be offered, including the following, where applicable:
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the title of the warrants;
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the aggregate number of the warrants offered;
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the price or prices at which the warrants will be issued;
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the securities, which may include shares of any class or series of common stock or preferred stock, for which the warrants are exercisable;
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in the case of warrants to purchase common stock or preferred stock, the number of shares of common stock or preferred stock, as the case may be, purchasable upon the exercise of one warrant and the price at which these shares may be purchased upon such exercise;
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the terms of any rights to redeem or call the warrants;
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the date on and after which the warrants and the related securities will be separately transferable;
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the effect of any merger, consolidation, sale or other disposition of our business on the warrant agreements and the warrants;
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the terms of any rights to force the exercise of the warrants;
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the dates on which the right to exercise the warrants will commence and the date on which the right will expire;
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the minimum or maximum number of warrants that may be exercised at any one time;
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the manner in which the warrant agreements and warrants may be modified;
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any provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants;
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information relating to book-entry procedures;
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the listing of the warrants on a securities exchange or automated quotation system;
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whether the warrants may be sold separately or with other securities as parts of units;
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a discussion of material United States federal income tax considerations of holding or exercising the warrants; and
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any other terms of the warrants, including terms, procedures and limitations relating to the exchange and exercise of the warrants.
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Before exercising their warrants, the holders
of warrants will not have any of the rights of the holders of the securities purchasable upon such exercise, including the right
to receive dividends, if any, or, payments upon our liquidation, dissolution or winding up or to exercise voting rights, if any.
Exercise of Warrants
Each warrant will entitle the holder to
purchase the securities that we specify in the applicable prospectus supplement at the exercise price that we describe in the applicable
prospectus supplement. Unless we otherwise specify in the applicable prospectus supplement, the holders of the warrants may exercise
the warrants at any time up to the specified time on the expiration date that we set forth in the applicable prospectus supplement.
After the close of business on the expiration date, unexercised warrants will become void.
Unless we otherwise specify in the applicable
prospectus supplement, the holders of the warrants may exercise the warrants by delivering the warrant certificate representing
the warrants to be exercised together with specified information, and paying the required amount to us or to the warrant agent
in immediately available funds, or, if provided in the applicable prospectus supplement, by cashless exercise. We will set forth
in the warrant agreement, on the reverse side of the warrant certificate and in the applicable prospectus supplement the information
that the holder of the warrant will be required to deliver to the warrant agent in connection with the exercise of the warrant.
Unless we otherwise specify in the applicable
prospectus supplement, upon receipt of the required exercise price and the warrant certificate properly completed and duly executed
at the corporate trust office of the warrant agent or any other office indicated in the applicable prospectus supplement, we will
issue and deliver the securities purchasable upon such exercise. If fewer than all of the warrants represented by the warrant certificate
are exercised, then we may issue a new warrant certificate for the remaining amount of warrants. If we so indicate in the applicable
prospectus supplement, the holders of the warrants may surrender securities as all or part of the exercise price for warrants.
Enforceability of Rights by Holders of Warrants
Any warrant agent will act solely as our
agent under the applicable warrant agreement and will not assume any obligation or relationship of agency or trust with any holder
of any warrant. A single bank or trust company may act as warrant agent for more than one issue of warrants. A warrant agent will
have no duty or responsibility in case of any default by us under the applicable warrant agreement or warrant, including any duty
or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us. Any holder of a warrant may,
without the consent of any related warrant agent or the holder of any other warrant, enforce by appropriate legal action its right
to exercise, and receive the securities purchasable upon exercise of, its warrants.
Warrant Adjustments
Unless the applicable prospectus supplement
states otherwise, the exercise price of, and the number of securities covered by, a warrant to purchase shares of common stock
or preferred stock will be adjusted proportionately if we subdivide or combine common stock or preferred stock, as applicable.
Warrant Agreement Will Not Be Qualified Under Trust Indenture
Act
No warrant agreement will be qualified as
an indenture, and no warrant agent will be required to qualify as a trustee, under the Trust Indenture Act. Therefore, holders
of warrants issued under a warrant agreement will not have the protection of the Trust Indenture Act with respect to their warrants.
Currently Outstanding Warrants
As of May 7, 2019, we had issued and outstanding
warrants to purchase 256,564 shares of our common stock with a weighted exercise price of $37.43 per share.
DESCRIPTION
OF UNITS
The following description, together with
the additional information we may 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.
However, no prospectus supplement will fundamentally change the terms that are set forth in this prospectus or offer a security
that is not registered and described in this prospectus at the time of its effectiveness.
Before the issuance of units, the form of
unit agreement that describes the terms of the series of units we are offering, and any supplemental agreements, will be filed
as an exhibit to the registration statement of which this prospectus is a part, or incorporated by reference from reports that
we file with the SEC. 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 sell 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, preferred stock and/or warrants 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
included security. 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, including:
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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;
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any provisions of the governing unit agreement that differ from those described below; and
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any provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units.
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The provisions described in this section,
as well as those described under “Description of Capital Stock” and “Description of Warrants” will apply
to each unit and to any common stock, preferred stock and/or warrant included in each unit, respectively.
Issuance in Series
We may issue units in such amounts and in
numerous distinct series as we determine.
Enforceability of Rights by Holders of Units
Any 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.
LEGAL
OWNERSHIP OF SECURITIES
We can issue securities in registered form
or in the form of one or more global securities. We describe global securities in greater detail below. We refer to those persons
who have securities registered in their own names on the books that we or any applicable trustee, depositary or warrant or unit
agent maintain for this purpose as the “holders” of those securities. These persons are the legal holders of the securities.
We refer to those persons who, indirectly through others, own beneficial interests in securities that are not registered in their
own names as “indirect holders” of those securities. As we discuss below, indirect holders are not legal holders and
investors in securities issued in book-entry form or in street name will be indirect holders.
Book-Entry Holders
We may issue securities in book-entry form
only, as we will specify in the applicable prospectus supplement. This means securities may be represented by one or more global
securities registered in the name of a financial institution that holds them as depositary on behalf of other financial institutions
that participate in the depositary’s book-entry system. These participating institutions, which are referred to as participants,
in turn, hold beneficial interests in the securities on behalf of themselves or their customers.
Only the person in whose name a security
is registered is recognized as the holder of that security. Securities issued in global form will be registered in the name of
the depositary or its participants. Consequently, for securities issued in global form, we will recognize only the depositary as
the holder of the securities, and we will make all payments on the securities to the depositary. The depositary passes along the
payments it receives to its participants, which in turn pass the payments along to their customers who are the beneficial owners.
The depositary and its participants do so under agreements they have made with one another or with their customers; they are not
obligated to do so under the terms of the securities.
As a result, investors in a book-entry security
will not own securities directly. Instead, they will own beneficial interests in a global security, through a bank, broker or other
financial institution that participates in the depositary’s book-entry system or holds an interest through a participant.
As long as the securities are issued in global form, investors will be indirect holders, and not holders, of the securities.
Street Name Holders
We may terminate a global security or issue
securities in non-global form. In these cases, investors may choose to hold their securities in their own names or in “street
name.” Securities held by an investor in street name would be registered in the name of a bank, broker or other financial
institution that the investor chooses, and the investor would hold only a beneficial interest in those securities through an account
he or she maintains at that institution.
For securities held in street name, we or
any applicable trustee or depositary will recognize only the intermediary banks, brokers and other financial institutions in whose
names the securities are registered as the holders of those securities, and we or any such trustee or depositary will make all
payments on those securities to them. These institutions pass along the payments they receive to their customers who are the beneficial
owners, but only because they agree to do so in their customer agreements or because they are legally required to do so. Investors
who hold securities in street name will be indirect holders, not holders, of those securities.
Legal Holders
Our obligations, as well as the obligations
of any applicable trustee and of any third parties employed by us or a trustee, run only to the legal holders of the securities.
We do not have obligations to investors who hold beneficial interests in global securities, in street name or by any other indirect
means. This will be the case whether an investor chooses to be an indirect holder of a security or has no choice because we are
issuing the securities only in global form.
For example, once we make a payment or give
a notice to the holder, we have no further responsibility for the payment or notice even if that holder is required, under agreements
with depositary participants or customers or by law, to pass it along to the indirect holders but does not do so.
Special Considerations for Indirect Holders
If you hold securities through a bank, broker
or other financial institution, either in book-entry form or in street name, you should check with your own institution to find
out:
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how it handles securities payments and notices;
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whether it imposes fees or charges;
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how it would handle a request for the holders’ consents, if ever required;
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whether and how you can instruct it to send you securities registered in your own name so you can be a registered holder, if that is permitted in the future;
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how it would exercise rights under the securities if there were a default or other event triggering the need for holders to act to protect their interests; and
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if the securities are in book-entry form, how the depositary’s rules and procedures will affect these matters.
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Global Securities
A global security is a security that represents
one or any other number of individual securities held by a depositary. Generally, all securities represented by the same global
securities will have the same terms.
Each security issued in book-entry form
will be represented by a global security that we deposit with and register in the name of a financial institution or its nominee
that we select. The financial institution that we select for this purpose is called the depositary. Unless we specify otherwise
in the applicable prospectus supplement, The Depository Trust Company, New York, New York, known as DTC, will be the depositary
for all securities issued in book-entry form.
A global security may not be transferred
to or registered in the name of anyone other than the depositary, its nominee or a successor depositary, unless special termination
situations arise. We describe those situations below under the section titled “Special Situations When a Global Security
Will Be Terminated” in this prospectus. As a result of these arrangements, the depositary, or its nominee, will be the sole
registered owner and holder of all securities represented by a global security, and investors will be permitted to own only beneficial
interests in a global security. Beneficial interests must be held by means of an account with a broker, bank or other financial
institution that in turn has an account with the depositary or with another institution that does. Thus, an investor whose security
is represented by a global security will not be a holder of the security, but only an indirect holder of a beneficial interest
in the global security.
If the prospectus supplement for a particular
security indicates that the security will be issued in global form only, then the security will be represented by a global security
at all times unless and until the global security is terminated. If termination occurs, we may issue the securities through another
book-entry clearing system or decide that the securities may no longer be held through any book-entry clearing system.
Special Considerations for Global Securities
The rights of an indirect holder relating
to a global security will be governed by the account rules of the investor’s financial institution and of the depositary,
as well as general laws relating to securities transfers. We do not recognize an indirect holder as a holder of securities and
instead deal only with the depositary that holds the global security.
If securities are issued only in the form
of a global security, an investor should be aware of the following:
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an investor cannot cause the securities to be registered in his or her name, and cannot obtain non-global certificates for his or her interest in the securities, except in the special situations we describe below;
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an investor will be an indirect holder and must look to his or her own bank or broker for payments on the securities and protection of his or her legal rights relating to the securities, as we describe above;
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an investor may not be able to sell interests in the securities to some insurance companies and to other institutions that are required by law to own their securities in non-book-entry form;
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an investor may not be able to pledge his or her interest in a global security in circumstances where certificates representing the securities must be delivered to the lender or other beneficiary of the pledge in order for the pledge to be effective;
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the depositary’s policies, which may change from time to time, will govern payments, transfers, exchanges and other matters relating to an investor’s interest in a global security. We and any applicable trustee have no responsibility for any aspect of the depositary’s actions or for its records of ownership interests in a global security. We and the trustee also do not supervise the depositary in any way;
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the depositary may, and we understand that DTC will, require that those who purchase and sell interests in a global security within its book-entry system use immediately available funds, and your broker or bank may require you to do so as well; and
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financial institutions that participate in the depositary’s book-entry system, and through which an investor holds its interest in a global security, may also have their own policies affecting payments, notices and other matters relating to the securities
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There may be more than one financial intermediary
in the chain of ownership for an investor. We do not monitor and are not responsible for the actions of any of those intermediaries.
Special Situations When a Global Security Will Be Terminated
In a few special situations described below,
the global security will terminate and interests in it will be exchanged for physical certificates representing those interests.
After that exchange, the choice of whether to hold securities directly or in street name will be up to the investor. Investors
must consult their own banks or brokers to find out how to have their interests in securities transferred to their own name, so
that they will be direct holders. We have described the rights of the holders and street name investors above.
Unless we provide otherwise in the applicable
prospectus supplement, the global security will terminate when the following special situations occur:
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if the depositary notifies us that it is unwilling, unable or no longer qualified to continue as depositary for that global security and we do not appoint another institution to act as depositary within 90 days;
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if we notify any applicable trustee that we wish to terminate that global security; or
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if an event of default has occurred with regard to securities represented by that global security and has not been cured or waived.
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The applicable prospectus supplement may
also list additional situations for terminating a global security that would apply only to the particular series of securities
covered by the applicable prospectus supplement. When a global security terminates, the depositary, and not we or any applicable
trustee, is responsible for deciding the names of the institutions that will be the initial direct holders.
PLAN
OF DISTRIBUTION
We may sell the securities covered by this
prospectus from time to time in one or more offerings. Registration of the securities covered by this prospectus does not mean,
however, that those securities will necessarily be offered or sold.
We may sell our securities, separately or
together, in any one or more of the following ways:
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directly to investors, including through a specific bidding, auction or other process;
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to investors through agents;
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to or through brokers or dealers;
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to the public through underwriting syndicates led by one or more managing underwriters;
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in “at the market” offerings, within the meaning of Rule 415(a)(4) of the Securities Act or through a market maker or into an existing trading market on an exchange or otherwise;
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to one or more underwriters acting alone for resale to investors or to the public; and
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through any combination of the foregoing.
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Sales of securities may be effected from
time to time in one or more transactions, including negotiated transactions:
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at a fixed price or prices, which may be changed;
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at market prices prevailing at the time of sale;
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at prices related to prevailing market prices; or
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We will describe the method of distribution
of the securities and the terms of the offering in the prospectus supplement. Any discounts or concessions allowed or re-allowed
or paid to dealers may be changed from time to time.
If underwriters are used in the sale of
any securities, the securities will be acquired by the underwriters for their own account and may be resold from time to time in
one or more transactions described above. The securities may be either offered to the public through underwriting syndicates represented
by managing underwriters, or directly by underwriters. Generally, the underwriters’ obligations to purchase the securities
will be subject to conditions precedent and the underwriters will be obligated to purchase all of the securities if they purchase
any of the securities. We may use underwriters with whom we have a material relationship. We will describe in the prospectus supplement,
naming the underwriter, the nature of any such relationship.
We may authorize underwriters, dealers or
agents to solicit offers by certain purchasers to purchase the securities from us at the public offering price set forth in the
prospectus supplement pursuant to delayed delivery contracts providing for payment and delivery on a specified date in the future.
The contracts will be subject only to those conditions set forth in the prospectus supplement, and the prospectus supplement will
set forth any commissions we pay for solicitation of these contracts.
We may enter into derivative transactions
with third parties, or sell securities not covered by this prospectus to third parties in privately negotiated transactions. If
the applicable prospectus supplement indicates, in connection with those derivative transactions, the third parties may sell securities
covered by this prospectus and the applicable prospectus supplement, including in short sale transactions. If so, the third party
may use securities pledged by us or borrowed from us or others to settle those sales or to close out any related open borrowings
of stock, and may use securities received from us in settlement of those derivatives to close out any related open borrowings of
stock. The third party in such sale transactions will be an underwriter and will be identified in the applicable prospectus supplement
or in a post-effective amendment.
Underwriters, dealers and agents may be
entitled to indemnification by us against certain civil liabilities, including liabilities under the Securities Act, or to contribution
with respect to payments made by the underwriters, dealers or agents, under agreements between us and the underwriters, dealers
and agents.
We may grant underwriters who participate
in the distribution of securities an option to purchase additional securities to cover over-allotments, if any, in connection with
the distribution.
Underwriters, dealers or agents may receive
compensation in the form of discounts, concessions or commissions from us or our purchasers, as their agents in connection with
the sale of securities. These underwriters, dealers or agents may be considered to be underwriters under the Securities Act. As
a result, discounts, commissions or profits on resale received by the underwriters, dealers or agents may be treated as underwriting
discounts and commissions. The prospectus supplement will identify any such underwriter, dealer or agent and describe any compensation
received by them from us. Any initial public offering price and any discounts or concessions allowed or re-allowed or paid to dealers
may be changed from time to time.
Unless otherwise specified in the related
prospectus supplement, all securities we offer, other than common stock, will be new issues of securities with no established trading
market. Any underwriters may make a market in these securities, but will not be obligated to do so and may discontinue any market
making at any time without notice. Any common stock sold pursuant to a prospectus supplement will be listed on the Nasdaq Capital
Market or other principal market for our common stock. We may apply to list any series of preferred stock or warrants on an exchange,
but we are not obligated to do so. Therefore, there may not be liquidity or a trading market for any such series of preferred stock
or such warrants.
Any underwriter may engage in over-allotment
transactions, stabilizing transactions, short-covering transactions and penalty bids in accordance with Regulation M under the
Exchange Act. Over-allotment involves sales in excess of the offering size, which create a short position. Stabilizing transactions
permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specified maximum. Short covering
transactions involve purchases of the securities in the open market after the distribution is completed to cover short positions.
Penalty bids permit the underwriters to reclaim a selling concession from a dealer when the securities originally sold by the dealer
are purchased in a covering transaction to cover short positions. Those activities may cause the price of the securities to be
higher than it would otherwise be. If commenced, the underwriters may discontinue any of the activities at any time. We make no
representation or prediction as to the direction or magnitude of any effect that such transactions may have on the price of the
securities. For a description of these activities, see the information under the section titled “Underwriting” or “Plan
of Distribution” in the applicable prospectus supplement.
Underwriters, broker-dealers or agents who
may become involved in the sale of the common stock may engage in transactions with and perform other services for us in the ordinary
course of their business for which they receive compensation.
LEGAL
MATTERS
The validity of the issuance of the securities
offered hereby will be passed upon for us by Winstead PC, Houston, Texas. The validity of any securities will be passed upon for
any underwriters or agents by counsel that we will name in the applicable prospectus supplement.
EXPERTS
The consolidated financial statements as
of December 31, 2018 and 2017 and for the years then ended incorporated by reference in this prospectus have been so incorporated
in reliance on the report of BDO USA, LLP, an independent registered public accounting firm, incorporated herein by reference,
given on the authority of said firm as experts in auditing and accounting.
WHERE
YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports,
proxy statements and other information with the SEC. The SEC maintains an Internet site that contains reports, proxy and information
statements, and other information regarding issuers that file electronically with the SEC, including us. The SEC’s Internet
site can be found at
http://www.sec.gov
. In addition, we make available on or through our Internet site copies of these
reports as soon as reasonably practicable after we electronically file or furnished them to the SEC. Our Internet site can be found
at
http://www.biopathholdings.com
. The information contained in, or that can be accessed through, our website is not
incorporated by reference in, and is not part of, this prospectus.
INFORMATION
INCORPORATED BY REFERENCE
We are incorporating by reference into this
prospectus certain information that we file with the SEC, which means that we are disclosing important information to you by referring
you to those documents. The information incorporated by reference is deemed to be part of this prospectus, except for information
incorporated by reference that is superseded by information contained in this prospectus. This means that you must look at all
of the SEC filings that we incorporate by reference to determine if any statements in the prospectus or any document previously
incorporated by reference have been modified or superseded. This prospectus incorporates by reference the documents set forth below
that we have previously filed with the SEC:
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the description of our common stock contained in our registration statement on Form 8-A filed with the SEC on
March 5, 2014
, as updated by our Current Report on Form 8-K filed with the SEC on
January 6, 2015
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Any information in any of the foregoing
documents will automatically be deemed to be modified or superseded to the extent that information in this prospectus or in a later
filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such information.
We also incorporate by reference all documents
we file in the future pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act (i) after the date of the filing of the
registration statement of which this prospectus is a part and prior to the effectiveness of such registration statement or (ii)
after the date of this prospectus and until the offering of the securities made by this prospectus is terminated. These documents
include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (except,
in any such case, the portions furnished and not filed pursuant to Item 2.02, Item 7.01 or otherwise), as well as any proxy statements.
We will provide to each person, including
any beneficial owner, to whom a prospectus is delivered, without charge upon written or oral request, a copy of any or all of the
documents that are incorporated by reference into this prospectus but not delivered with the prospectus, including exhibits which
are specifically incorporated by reference into such documents. You may request a copy of these filings at no cost, by writing
to or telephoning us at the following address:
Bio-Path Holdings, Inc.
Attention: Secretary
4710 Bellaire Boulevard, Suite 210
Bellaire, Texas 77401
(832) 742-1357
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 it is not soliciting an offer to buy these securities
in any state where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED
MAY 16, 2019
PROSPECTUS
Up to $25,000,000 of Common Stock
We have entered into
a Controlled Equity Offering
SM
sales agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.
(“Cantor Fitzgerald”) relating to shares of common stock offered by this prospectus. In accordance with the terms of
the Sales Agreement, we may offer and sell up to $25,000,000 of our common stock from time to time through Cantor Fitzgerald, acting
as sales agent. As of the date of this prospectus, we have not issued nor sold any shares of our common stock pursuant to the Sales
Agreement, our Registration Statement on Form S-3 (File No. 333-215205) and our related prospectus dated January 9, 2017. Accordingly,
we may offer and sell shares of our common stock having an aggregate offering price of up to $25,000,000 pursuant to this prospectus.
Our common stock is
traded on the Nasdaq Capital Market under the symbol “BPTH.” The last reported sale price of our common stock on the
Nasdaq Capital Market on May 14, 2019 was $18.00 per share.
Sales of our common
stock, if any, under this prospectus may be made in sales deemed to be “at-the-market” equity offerings as defined
in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”). Subject to the terms of
the Sales Agreement, Cantor Fitzgerald will act as sales agent and use commercially reasonable efforts to sell on our behalf all
of the shares of common stock requested to be sold by us, consistent with its normal trading and sales practices, on mutually agreed
terms between Cantor Fitzgerald and us. There is no arrangement for funds to be received in any escrow, trust or similar arrangement.
Cantor Fitzgerald will
be entitled to compensation at a commission rate of 3.4% of the gross sales price per share sold. In connection with the sale of
our common stock on our behalf, Cantor Fitzgerald will be deemed to be an “underwriter” within the meaning of the Securities
Act and the compensation of Cantor Fitzgerald will be deemed to be underwriting commissions or discounts. We have also agreed to
provide indemnification and contribution to Cantor Fitzgerald with respect to certain liabilities, including liabilities under
the Securities Act or the Exchange Act of 1934, as amended (the “Exchange Act”).
Investing in our securities involves
a high degree of risk. Before making an investment decision, you should review carefully and consider all of the information set
forth in this prospectus and the documents incorporated by reference in this prospectus. See “Risk Factors” on page
4 of this prospectus and under similar headings in the other documents that are incorporated by reference into this prospectus.
Neither the Securities and Exchange Commission
(the “SEC”) nor any state securities commission has approved or disapproved of these securities or determined if this
prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 2019.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This prospectus relates to the offering
of our common stock. Before buying any of the common stock that we are offering, we urge you to carefully read this prospectus,
together with the information incorporated by reference as described under the headings “Where You Can Find More Information”
and “Information Incorporated By Reference” in this prospectus. These documents contain important information that
you should consider when making your investment decision.
This prospectus describes the specific terms
of the common stock we are offering and also adds to, and updates information contained in the documents incorporated by reference
into this prospectus. 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 into this prospectus that was filed with the SEC before
the date of this prospectus, on the other hand, you should rely on the information in this prospectus. You should rely only on
the information we have provided or incorporated by reference into this prospectus. 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
into this prospectus—the statement in the document having the later date modifies or supersedes the earlier statement. We
have not, and Cantor Fitzgerald has not, authorized anyone to provide you with different or additional information. No dealer,
salesperson or other person is authorized to give any information or to represent anything not contained in or incorporated by
reference into this prospectus. You must not rely on any unauthorized information or representation.
We are offering to sell and seeking offers
to buy shares of our common stock only in jurisdictions where offers and sales are permitted. You should assume that the information
in this prospectus is accurate only as of the dates on the front of this document and that any information we have incorporated
by reference is accurate only as of the date of the document incorporated by reference. Our business, financial condition, results
of operations and prospects may have changed since those dates. This prospectus does not constitute an offer, or a solicitation
on our behalf or on behalf of the underwriters, to subscribe for and purchase any of the common stock and may not be used for or
in connection with an offer or solicitation by anyone in any jurisdiction in which such an offer or solicitation is not authorized
or to any person to whom it is unlawful to make such an offer or solicitation.
You should read this prospectus and the
documents incorporated by reference in this prospectus when making your investment decision.
Unless the context requires otherwise, references
in this prospectus to “we,” “our,” “us,” “the Company” and “Bio-Path”
refer to Bio-Path Holdings, Inc. and its wholly-owned subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path,
Inc., is sometimes referred to herein as “Bio-Path Subsidiary.”
PROSPECTUS
SUMMARY
This prospectus summary highlights
selected information contained elsewhere in this prospectus or in documents incorporated by reference. This summary does not contain
all of the information that you should consider before making an investment decision. You should carefully read the entire prospectus,
including under the section titled “Risk Factors” and the documents incorporated by reference into this prospectus,
before making an investment decision.
Our Company
We are a clinical and preclinical stage
oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target
specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology,
called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended
to protect the DNA from destruction by the body’s enzymes when circulating
in vivo,
incorporated inside of a neutral
charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like
structures for delivery of the antisense drug substance into cells.
In vivo,
the DNAbilize® delivered antisense drug
substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases
and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize®
drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company.
Using DNAbilize® as a platform for drug
development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different
cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy
portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination
with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add
prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In
addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen
is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib.
Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend
to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019.
Our second drug candidate, Liposomal Bcl-2
(“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers.
We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate
a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval
from the U.S. Food and Drug Administration (FDA).
Our third drug candidate, Liposomal Stat3
(“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic
cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein
expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the
efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model.
Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending
treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical
trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020.
Our DNAbilize® technology-based products
are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing
protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template
in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug
candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic
delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination
with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance
for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases.
We have certain intellectual property as
the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing
RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where
targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors
with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design
and manufacture of antisense RNAi nanoparticle drug products.
Corporate Information
The Company was incorporated in May 2000
as a Utah corporation. In February 2008, Bio-Path Subsidiary completed a reverse merger with the Company, which at the time was
traded over the counter and had no current operations. The prior name of the Company was changed to Bio-Path Holdings, Inc. and
the directors and officers of Bio-Path Subsidiary became the directors and officers of Bio-Path Holdings, Inc. On March 10, 2014,
our common stock ceased trading on the OTCQX and commenced trading on the Nasdaq Capital Market under the ticker symbol “BPTH.”
Effective December 31, 2014, we changed our state of incorporation from Utah to Delaware through a statutory conversion pursuant
to the Utah Revised Business Corporation Act and the Delaware General Corporation Law. Our principal executive offices are located
at 4710 Bellaire Boulevard, Suite 210, Bellaire, Texas 77401, and our telephone number is (832) 742-1357.
On February 8, 2018, we effected a reverse
stock split of our outstanding shares of common stock at a ratio of 1-for-10, and our common stock began trading on the split-adjusted
basis on the Nasdaq Capital Market at the commencement of trading on February 9, 2018. In addition, on January 17, 2019, we effected
a reverse stock split of our outstanding shares of common stock at a ratio of 1-for-20, and our common stock began trading on the
split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on January 18, 2019. All common stock share and
per share amounts in this prospectus have been adjusted to give effect to both the 1-for-10 reverse stock split and the 1-for-20
reverse stock split, retrospectively.
THE OFFERING
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Common stock offered by us
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Shares of our common stock having an aggregate offering price of up to $25,000,000.
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Common stock to be outstanding immediately after this offering (1)
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Up to 4,202,944 shares (as more fully described in footnote (1) below), assuming sales of
1,388,888 shares of our common stock in this offering at an offering price of $18.00 per share, which was the last reported sale
price of our common stock on the Nasdaq Capital Market on May 14, 2019. The actual number of shares issued will vary depending
on the sales price under this offering.
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Manner of offering
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“At-the-market” offering that may be made from time to time through our sales agent, Cantor Fitzgerald. See “Plan of Distribution” on page 10.
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Use of proceeds
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We currently expect to use the net proceeds from this offering, if any, for working capital
and general corporate purposes. See “Use of Proceeds” on page 7.
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Nasdaq Capital Market symbol
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“BPTH”
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Risk factors
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An investment in our company involves a high degree of risk. Please refer to the sections titled “Risk Factors,” “Special Note Regarding Forward-Looking Statements” and other information included or incorporated by reference in this prospectus for a discussion of factors you should carefully consider before investing in our securities.
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(1) The number of shares of common stock to be outstanding after
this offering is based on 2,814,056 shares of common stock outstanding as of March 31, 2019, which excludes as of such date:
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71,169 shares of common stock reserved for issuance upon the exercise of outstanding options granted under our equity incentive plans with a weighted average exercise price of $67.26 per share;
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5,474 additional shares of common stock reserved for future issuance under the Bio-Path Holdings, Inc. 2017 Stock Incentive Plan (the “2017 Stock Incentive Plan”); and
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273,864 shares of common stock issuable upon exercise of outstanding warrants with a weighted average exercise price of $35.23 per share.
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RISK FACTORS
An investment in our company involves
a high degree of risk. Before you make a decision to invest in our securities, you should consider carefully the risks described
below, as well as the risks described in or incorporated by reference in this prospectus, including the risks and uncertainties
discussed under the section titled “Risk Factors” in our most recent Annual Report on Form 10-K and any subsequent
Quarterly Reports on Form 10-Q or Current Reports on Form 8-K, and all other documents incorporated by reference into this prospectus,
as updated by our subsequent filings under the Exchange Act.
Any of these risks could have a material
adverse effect on our business, prospects, financial condition and results of operations. In any such case, the trading price of
our securities could decline and you could lose all or part of your investment. Additional risks not presently known to us or that
we currently deem immaterial may also adversely affect our business operations.
Resales of our common stock in the
public market following the offering may cause its market price to fall.
We will issue common stock from time to
time in connection with this offering. This issuance from time to time of these new shares of our common stock, 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. If our stockholders sell substantial amounts of our common stock in the
public market following this offering, the market price of our common stock could fall.
You will experience immediate and
substantial dilution in the net tangible book value per share of the common stock you purchase.
Since the price per share of our common
stock being offered is substantially higher than the net tangible book value per share of our common stock, you will suffer substantial
dilution in the net tangible book value of the common stock you purchase in this offering. Based on an assumed offering price
of $18.00 per share, if you purchase shares of common stock in this offering, you will suffer immediate and substantial dilution
of approximately $7.49 per share in the net tangible book value of the common stock. See the section titled “Dilution”
in this prospectus for a more detailed discussion of the dilution you will incur if you purchase common stock in this offering.
In addition, we have a significant number of stock options and warrants outstanding. To the extent that outstanding stock options
or warrants have been or may be exercised or other shares issued, you may experience further dilution.
There may be future sales of our securities
or other dilution of our equity, which may adversely affect the market price of our common stock.
With limited exceptions, we are generally
not restricted from issuing additional common stock, including any securities that are convertible into or exchangeable for, or
that represent the right to receive, common stock. The market price of our common stock could decline as a result of sales of common
stock or securities that are convertible into or exchangeable for, or that represent the right to receive, common stock after this
offering or the perception that such sales could occur.
Our management has significant flexibility
in using the net proceeds of this offering.
We currently intend generally to use the
net proceeds from this offering, if any, for working capital and general corporate purposes. Our management will have significant
flexibility in applying the net proceeds of this offering. Management’s failure to use these funds effectively would have
an adverse effect on the value of our common stock and could make it more difficult and costly to raise funds in the future.
Special Note
Regarding Forward-Looking Statements
This prospectus and the documents incorporated
by reference into this prospectus contain “forward-looking statements” within the meaning of Section 27A of the Securities
Act, and Section 21E of the Exchange Act. Forward-looking statements can be identified by words such as “anticipate,”
“expect,” “intend,” “plan,” “believe,” “seek,” “estimate,”
“project,” “goal,” “strategy,” “future,” “likely,” “may,”
“should,” “will” and variations of these words and similar references to future periods, although not all
forward-looking statements contain these identifying words. Forward-looking statements are neither historical facts nor assurances
of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our
business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because
forward-looking statements relate to the future, they are subject to inherent risks, uncertainties, and changes in circumstances,
including but not limited to risk factors contained in or incorporated by reference under the section titled, “Risk Factors.”
As a result, our actual results may differ materially from those expressed or forecasted in the forward-looking statements, and
you should not rely on such forward-looking statements. You should carefully read this prospectus, together with the information
incorporated herein by reference as described under the section titled “Where You Can Find More Information,” completely
and with the understanding that our actual future results may be materially different from what we expect. We can give no assurances
that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have
on our results of operations and financial condition. Forward-looking statements include, but are not limited to, statements about:
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our lack of significant revenue to date, our history of recurring operating losses and our expectation of future operating losses;
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our need for substantial additional capital and our need to delay, reduce or eliminate our drug development and commercialization efforts if we are unable to raise additional capital;
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the highly-competitive nature of the pharmaceutical and biotechnology industry and our ability to compete effectively;
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the success of our plans to use collaboration arrangements to leverage our capabilities;
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our ability to retain and attract key personnel;
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the risk of misconduct of our employees, agents, consultants and commercial partners;
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disruptions to our operations due to expansions of our operations;
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the costs we would incur if we acquire or license technologies, resources or drug candidates;
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risks associated with product liability claims;
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our reliance on information technology systems and the liability or interruption associated with cyber-attacks or other breaches of our systems;
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our ability to use net operating loss carryforwards;
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provisions in our charter documents and state law that may prevent a change in control;
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work slowdown or stoppage at government agencies could negatively impact our business
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our need to complete extensive clinical trials and the risk that we may not be able to demonstrate the safety and efficacy of our drug candidates;
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risks that that our clinical trials may be delayed or terminated;
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our ability to obtain domestic and foreign regulatory approval for our drug candidates;
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changes in existing laws and regulations affecting the healthcare industry;
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our reliance on third parties to conduct clinical trials for our drug candidates;
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our ability to maintain orphan drug exclusivity for our drug candidates;
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our reliance on third parties for manufacturing our clinical drug supplies;
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risks associated with the manufacture of our drug candidates;
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our ability to establish sales and marketing capabilities relating to our drug candidates;
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market acceptance of our drug candidates;
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third-party payor reimbursement practices;
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our ability to adequately protect the intellectual property of our drug candidates;
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infringement on the intellectual property rights of third parties;
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costs and time relating to litigation regarding intellectual property rights;
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our ability to adequately prevent disclosure by our employees or others of trade secrets and other proprietary information;
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the volatility of the trading price of our common stock;
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our common stock being thinly traded;
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our ability to issue shares of common or preferred stock without approval from our stockholders;
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our ability to pay cash dividends;
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costs and expenses associated with being a public company;
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a material weakness identified in our internal controls over financial reporting; and
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our ability to maintain compliance with the listing standards of the Nasdaq Capital Market.
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Any forward-looking statement made by us
in this prospectus and the documents incorporated by reference into this prospectus is based only on information currently available
to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement,
whether as a result of new information, future developments or otherwise. However, you should carefully review the risk factors
set forth in other reports or documents we file from time to time with the SEC.
Use
of Proceeds
The amount of proceeds
from this offering will depend upon the number of shares of our common stock sold and the market price at which they are sold.
There can be no assurance that we will be able to sell any shares under or fully utilize the Sales Agreement with Cantor Fitzgerald
as a source of financing.
We will retain broad
discretion over the use of the net proceeds from the sale of the securities offered hereby. We currently intend to use the net
proceeds from this offering, if any, for working capital and general corporate purposes. The amount and timing of these expenditures
will depend on a number of factors, such as the timing, scope, progress and results of our research and development efforts, the
timing and progress of any partnership efforts and the competitive environment for our drug candidates.
Dilution
If you invest in our
common stock, you will experience immediate and substantial dilution to the extent of the difference between the public offering
price of our common stock and the adjusted net tangible book value per share of our common stock immediately after the offering.
Our net tangible book
value per share is determined by subtracting our total liabilities from our total tangible assets, which is total assets less intangible
assets, and dividing this amount by the number of shares of common stock outstanding. The historical net tangible book value of
our common stock as of March 31, 2019 was approximately $20.1 million or $7.16 per share, based on 2,814,056 shares of our common
stock outstanding at March 31, 2019.
After giving effect to
our sale in this offering of shares of our common stock in the aggregate amount of $25,000,000 at an assumed public offering price
of $18.00 per share (the last reported sale price of our common stock on the Nasdaq Capital Market on May 14, 2019), and after
deducting the agent’s fee and our estimated offering expenses payable by us, our net tangible book value as of March 31,
2019, would have been approximately $44.2 million, or $10.51 per share of common stock. This represents an immediate increase
in net tangible book value of $3.35 per share to existing stockholders and an immediate dilution of $7.49 per share to new investors
purchasing shares of common stock in this offering at the assumed public offering price. The following table illustrates this
dilution on a per share basis:
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Assumed public offering price per share
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$ 18.00
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Historical net tangible book value per share as of March 31, 2019
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$
7.16
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Increase in net tangible book value per share attributable to new investors
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$ 3.35
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As adjusted net tangible book value per share after this offering
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$ 10.51
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Dilution per share to new investors
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$ 7.49
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The table above assumes
for illustrative purposes that an aggregate of 1,388,888 shares of our common stock are sold at a price of $18.00 per share, the
last reported sale price of our common stock on the Nasdaq Capital Market on May 14, 2019, for aggregate gross proceeds of approximately
$25,000,000. The shares sold in this offering, if any, will be sold from time to time at various prices. An increase of $0.50
per share in the price at which the shares are sold from the assumed public offering price of $18.00 per share shown in the table
above, assuming all of our common stock in the aggregate amount of approximately $25,000,000 is sold at that price, would increase
the dilution in net tangible book value per share to new investors in this offering to $7.89 per share, after deducting commissions
and estimated offering expenses payable by us. A decrease of $0.50 per share in the price at which the shares are sold from the
assumed public offering price of $18.00 per share shown in the table above, assuming all of our common stock in the aggregate
amount of approximately $25,000,000 is sold at that price, would decrease the dilution in net tangible book value per share to
new investors in this offering to $7.08 per share, after deducting commissions and estimated offering expenses payable by us.
This information is supplied for illustrative purposes only.
The above discussion and table are based on 2,814,056 shares
of common stock outstanding as of March 31, 2019, which excludes as of such date:
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71,169 shares of common stock reserved for issuance upon the exercise of outstanding options granted under our equity incentive plans with a weighted average exercise price of $67.26 per share;
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5,474 additional shares of common stock reserved for future issuance under the 2017 Stock Incentive Plan; and
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273,864 shares of common stock issuable upon exercise of outstanding warrants with a weighted average exercise price of $35.23 per share.
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The above illustration
of dilution per share to investors participating in this offering assumes no exercise of outstanding options to purchase our common
stock or outstanding warrants to purchase shares of our common stock. To the extent that any of these outstanding warrants or options
are exercised or we issue additional shares under our equity incentive plans, there will 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 additional capital is raised through the
sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.
Plan
of Distribution
We have entered into
a Controlled Equity Offering
SM
sales agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.
(“Cantor Fitzgerald”), under which we may issue and sell shares of our common stock having an aggregate gross sales
price of up to $25,000,000 from time to time through Cantor Fitzgerald acting as agent. As of the date of this prospectus, we have
not issued nor sold any shares of our common stock pursuant to the Sales Agreement, our Registration Statement on Form S-3 (File
No. 333-215205) and our related prospectus dated January 9, 2017. Accordingly, we may offer and sell shares of our common stock
having an aggregate offering price of up to $25,000,000 pursuant to this prospectus. The Sales Agreement was filed as Exhibit 1.1
to our Current Report on Form 8-K filed with the SEC on June 25, 2014, and is incorporated by reference in this prospectus.
Upon delivery of a
placement notice and subject to the terms and conditions of the Sales Agreement, Cantor Fitzgerald may sell our common stock by
any method permitted by law deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities
Act. We may instruct Cantor Fitzgerald not to sell common stock if the sales cannot be effected at or above the price designated
by us from time to time. We or Cantor Fitzgerald may suspend the offering of common stock upon notice and subject to other conditions.
We will pay Cantor
Fitzgerald commissions, in cash, for its services in acting as agent in the sale of our common stock. Cantor Fitzgerald will be
entitled to compensation at a commission rate of 3.4% of the aggregate gross sales price per share sold. 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. We have also agreed to reimburse Cantor Fitzgerald for certain specified expenses,
including the fees and disbursements of its legal counsel, in an amount not to exceed $50,000. We estimate that the total expenses
for the offering, excluding compensation and reimbursements payable to Cantor Fitzgerald under the terms of the Sales Agreement,
will be approximately $100,000.
Settlement for sales
of common stock will occur on the third trading day following the date on which any sales are made, or on some other date that
is agreed upon by us and Cantor Fitzgerald in connection with a particular transaction, in return for payment of the net proceeds
to us. Sales of our 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 Cantor Fitzgerald may agree upon. There is no arrangement for funds to be received in
an escrow, trust or similar arrangement.
Cantor Fitzgerald will
use its commercially reasonable efforts, consistent with its normal trading and sales practices, to solicit offers to purchase
the common stock shares under the terms and subject to the conditions set forth in the Sales Agreement. In connection with the
sale of the common stock on our behalf, Cantor Fitzgerald will be deemed to be an “underwriter” within the meaning
of the Securities Act and the compensation of Cantor Fitzgerald will be deemed to be underwriting commissions or discounts. We
have agreed to provide indemnification and contribution to Cantor Fitzgerald against certain civil liabilities, including liabilities
under the Securities Act.
Cantor Fitzgerald has
entered into a fee sharing agreement with Maxim Group LLC (“Maxim”), pursuant to which Maxim will be entitled to receive
compensation from Cantor Fitzgerald of approximately 1.0% of the gross sales price per share of our common stock sold under the
Sales Agreement in consideration for Maxim’s services to us as a financial advisor under this offering. Other than serving
as a financial advisor to us, Maxim will have no other obligations or responsibility in connection with the sale of common stock
covered by this prospectus.
The offering of our
common stock pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all shares of our common stock
subject to the Sales Agreement, or (ii) termination of the Sales Agreement as permitted therein. We and Cantor Fitzgerald may each
terminate the Sales Agreement at any time upon ten days’ prior notice.
Cantor Fitzgerald and
its affiliates may in the future provide various investment banking, commercial banking and other financial services for us and
our affiliates, for which services they may in the future receive customary fees. To the extent required by Regulation M, Cantor
Fitzgerald will not engage in any market making activities involving our common stock while the offering is ongoing under this
prospectus.
This prospectus in
electronic format may be made available on a website maintained by Cantor Fitzgerald and Cantor Fitzgerald may distribute this
prospectus electronically.
DESCRIPTION
OF CAPITAL STOCK
The following description of our common
stock and preferred stock is a summary. It is not complete and is subject to and qualified in its entirety by our certificate of
incorporation and first amended and restated bylaws, each of which is incorporated by reference into this prospectus.
See the sections titled “Where You Can Find More Information” and “Information Incorporated by Reference.”
As of the date of this prospectus, our certificate of incorporation authorizes us to issue 200,000,000 shares of common stock,
par value $0.001 per share, and 10,000,000 shares of preferred stock, par value $0.001 per share. As of May 7, 2019, there were
2,831,356 shares of common stock issued and outstanding and no shares of preferred stock issued and outstanding.
Common Stock
Holders of common stock
are entitled to one vote for each share held in the election of directors and on all other matters submitted to a vote of stockholders.
Cumulative voting of shares of common stock is prohibited. Accordingly, holders of a majority of the shares of common stock entitled
to vote in any election of directors may elect all of the directors standing for election.
Subject to the prior
rights of the holders of any outstanding preferred stock, holders of common stock are entitled to receive dividends when, as and
if declared by our board of directors out of funds legally available therefor. Upon the liquidation, dissolution or winding up
of our company, the holders of common stock are entitled to receive ratably the assets of our company remaining after payment of
all liabilities and payment to holders of preferred stock if such preferred stock has an involuntary liquidation preference over
the common stock. Holders of common stock have no preemptive, subscription, redemption or conversion rights. The outstanding shares
of common stock are, and the shares offered by us in this offering will be, when issued and paid for, validly issued, fully paid
and nonassessable.
As of March 31, 2019,
there were approximately 227 holders of record of our common stock.
Preferred Stock
The board of directors is authorized, without
any further notice to or action of the stockholders, to issue 10,000,000 shares of preferred stock in one or more series and to
determine the relative rights, preferences and privileges of the shares of any such series.
Limitation on Liability and Indemnification of Officers and
Directors
Our certificate of incorporation and first
amended and restated bylaws provide for indemnification of our officers and directors to the fullest extent permitted by Delaware
law. Our certificate of incorporation and first amended and restated bylaws limit the liability of our directors for monetary damages
to the fullest extent permitted by Delaware law. We maintain directors’ and officers’ liability insurance.
Anti-Takeover Effects of Provisions of Our Certificate of
Incorporation, Our Bylaws and Delaware Law
Some provisions of Delaware law and our
certificate of incorporation and our first amended and restated bylaws contain provisions that could have the effect of delaying,
deterring or preventing another party from acquiring or seeking to acquire control of us. These provisions are intended to discourage
certain types of coercive takeover practices and inadequate takeover bids and to encourage anyone seeking to acquire control of
us to negotiate first with our board of directors. However, these provisions may also delay, deter or prevent a change in control
or other takeover of our company that our stockholders might consider to be in their best interests, including transactions that
might result in a premium being paid over the market price of our common stock and also may limit the price that investors are
willing to pay in the future for our common stock. These provisions may also have the effect of preventing changes in our management.
Our certificate of incorporation and first
amended and restated bylaws include anti-takeover provisions that:
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authorize our board of directors, without further action by the stockholders, to issue shares of preferred stock in one or more series, and with respect to each series, to fix the number of shares constituting that series and establish the rights and other terms of that series;
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establish advance notice procedures for stockholders to submit nominations of candidates for election to our board of directors and other proposals to be brought before a stockholders meeting;
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provide that our first amended and restated bylaws may be amended by our board of directors without stockholder approval;
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limit our stockholders’ ability to call special meetings of stockholders;
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allow our directors to establish the size of the board of directors by action of the board, subject to a minimum of three members;
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provide that vacancies on our board of directors or newly created directorships resulting from an increase in the number of our directors may be filled only by a majority of directors then in office, even though less than a quorum; and
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do not give the holders of our common stock cumulative voting rights with respect to the election of directors.
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Business Combinations
Section 203 of the Delaware General Corporation
Law provides that we may not engage in certain “business combinations” with any “interested stockholder”
for a three-year period following the time that the person became an interested stockholder, unless:
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prior to the time that person became an interested stockholder, our board of directors approved either the business combination or the transaction which resulted in the person becoming an interested stockholder;
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upon consummation of the transaction which resulted in the person 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 certain shares; or
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at or subsequent to the time the person became an interested stockholder, the business combination is approved by the board of directors and by the affirmative vote of at least 66 2/3% of the outstanding voting stock which is not owned by the interested stockholder.
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Generally, a business combination includes
a merger, consolidation, asset or stock sale or other transaction resulting in a financial benefit to the interested stockholder.
Subject to certain exceptions, an interested stockholder is a person who, together with that person’s affiliates and associates,
owns, or within the previous three years owned, 15% or more of our 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.
Listing
Our common stock is listed for trading on
the Nasdaq Capital Market under the symbol “BPTH.”
Transfer Agent and Registrar
The transfer agent and registrar for our
common stock is American Stock Transfer & Trust Company, LLC, 6201 15
th
Avenue, Brooklyn, New York 11219. Its phone
number is (800) 937-5449.
Legal
Matters
The validity of the issuance of the securities
offered hereby will be passed upon for us by Winstead PC, Houston, Texas. Cantor Fitzgerald is being represented in connection
with this offering by Latham & Watkins LLP, San Diego, California.
Experts
The consolidated financial statements as
of December 31, 2018 and 2017 and for the years then ended incorporated by reference in this prospectus have been so incorporated
in reliance on the report of BDO USA, LLP, an independent registered public accounting firm, incorporated herein by reference,
given on the authority of said firm as experts in auditing and accounting.
Where
You Can Find More Information
We file annual, quarterly and current reports,
proxy statements and other information with the SEC. The SEC maintains an Internet site that contains reports, proxy and information
statements, and other information regarding issuers that file electronically with the SEC, including us. The SEC’s Internet
site can be found at
http://www.sec.gov
. In addition, we make available on or through our Internet site copies of these
reports as soon as reasonably practicable after we electronically file or furnished them to the SEC. Our Internet site can be found
at
http://www.biopathholdings.com
. The information contained in, or that can be accessed through, our website is not
incorporated by reference in, and is not part of, this prospectus.
INFORMATION
INCORPORATED BY REFERENCE
We are incorporating by reference into this
prospectus certain information that we file with the SEC, which means that we are disclosing important information to you by referring
you to those documents. The information incorporated by reference is deemed to be part of this prospectus, except for information
incorporated by reference that is superseded by information contained in this prospectus. This means that you must look at all
of the SEC filings that we incorporate by reference to determine if any statements in the prospectus or any document previously
incorporated by reference have been modified or superseded. This prospectus incorporates by reference the documents set forth below
that we have previously filed with the SEC:
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the description of our common stock contained in our registration statement on Form 8-A filed with the SEC on
March 5, 2014
, as updated by our Current Report on Form 8-K filed with the SEC on
January 6, 2015
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Any information in any of the foregoing
documents will automatically be deemed to be modified or superseded to the extent that information in this prospectus or in a later
filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such information.
We also incorporate by reference all documents
we file in the future pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act (i) after the date of the filing of the
registration statement of which this prospectus is a part and prior to the effectiveness of such registration statement or (ii)
after the date of this prospectus and until the offering of the securities made by this prospectus is terminated. These documents
include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (except,
in any such case, the portions furnished and not filed pursuant to Item 2.02, Item 7.01 or otherwise), as well as any proxy statements.
We will provide to each person, including
any beneficial owner, to whom a prospectus is delivered, without charge upon written or oral request, a copy of any or all of the
documents that are incorporated by reference into this prospectus but not delivered with the prospectus, including exhibits which
are specifically incorporated by reference into such documents. You may request a copy of these filings at no cost, by writing
to or telephoning us at the following address:
Bio-Path Holdings, Inc.
Attention: Secretary
4710 Bellaire Boulevard, Suite 210
Bellaire, Texas 77401
(832) 742-1357
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 it is not soliciting an offer
to buy these securities in any state where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED
MAY 16, 2019
PROSPECTUS
5,149 Shares of Common Stock
This prospectus relates to the issuance
by us of up to 5,149 shares of our common stock, par value $0.001 per share, issuable upon the exercise of outstanding warrants
(including shares that may be issued to the holder in lieu of fractional shares) with an exercise price of $460.00 per share (the
“Warrants”) that were originally issued by us on July 5, 2016, pursuant to a prospectus dated January 13, 2014, and
a related prospectus supplement dated June 29, 2016. Each Warrant is exercisable at any time after January 5, 2017 until its expiration
date, which date is five years from January 5, 2017.
We will receive the proceeds from the exercise
of the Warrants, but not from the sale of the underlying shares of common stock.
Our common stock is traded on the Nasdaq
Capital Market under the symbol “BPTH.” The last reported sale price of our common stock on the Nasdaq Capital Market
on May 14, 2019 was $18.00 per share. The Warrants are not listed, and we do not intend to apply to list them, on the Nasdaq
Capital Market or any other national securities exchange.
Investing in our securities involves
a high degree of risk. Before making an investment decision, you should review carefully and consider all of the information set
forth in this prospectus and the documents incorporated by reference in this prospectus. See “Risk Factors” on page
4 of this prospectus and under similar headings in the other documents that are incorporated by reference into this prospectus.
Neither the Securities and Exchange Commission
(the “SEC”) nor any state securities commission has approved or disapproved of these securities or determined if this
prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 2019.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This prospectus relates to the offering
of our common stock issuable upon the exercise of the outstanding Warrants. Before buying any of the common stock that we are offering,
we urge you to carefully read this prospectus, together with the information incorporated by reference as described under the headings
“Where You Can Find More Information” and “Information Incorporated By Reference” in this prospectus. These
documents contain important information that you should consider when making your investment decision.
You should rely only on the information
we have provided or incorporated by reference in this prospectus. We have not authorized anyone to provide you with different information.
No dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus.
You must not rely on any unauthorized information or representation. You should assume that the information in this prospectus
is accurate only as of the dates on the front of this document and that any information we have incorporated by reference is accurate
only as of the date of the document incorporated by reference. Our business, financial condition, results of operations and prospects
may have changed since those dates.
You should read this prospectus and the
documents incorporated by reference in this prospectus when making your investment decision.
Unless the context requires otherwise, references
in this prospectus to “we,” “our,” “us,” “the Company” and “Bio-Path”
refer to Bio-Path Holdings, Inc. and its wholly-owned subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path,
Inc., is sometimes referred to herein as “Bio-Path Subsidiary.”
PROSPECTUS
SUMMARY
This prospectus summary highlights
selected information contained elsewhere in this prospectus or in documents incorporated by reference. This summary does not contain
all of the information that you should consider before making an investment decision. You should carefully read the entire prospectus,
the applicable prospectus supplement, including under the section titled “Risk Factors” and the documents incorporated
by reference into this prospectus, before making an investment decision.
Our Company
We are a clinical and preclinical stage
oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target
specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology,
called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended
to protect the DNA from destruction by the body’s enzymes when circulating
in vivo,
incorporated inside of a neutral
charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like
structures for delivery of the antisense drug substance into cells.
In vivo,
the DNAbilize® delivered antisense drug
substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases
and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize®
drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company.
Using DNAbilize® as a platform for drug
development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different
cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy
portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination
with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add
prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In
addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen
is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib.
Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend
to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019.
Our second drug candidate, Liposomal Bcl-2
(“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers.
We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate
a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval
from the U.S. Food and Drug Administration (FDA).
Our third drug candidate, Liposomal Stat3
(“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic
cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein
expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the
efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model.
Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending
treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical
trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020.
Our DNAbilize® technology-based products
are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing
protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template
in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug
candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic
delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination
with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance
for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases.
We have certain intellectual property as
the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing
RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where
targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors
with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design
and manufacture of antisense RNAi nanoparticle drug products.
Corporate Information
The Company was incorporated in May 2000
as a Utah corporation. In February 2008, Bio-Path Subsidiary completed a reverse merger with the Company, which at the time was
traded over the counter and had no current operations. The prior name of the Company was changed to Bio-Path Holdings, Inc. and
the directors and officers of Bio-Path Subsidiary became the directors and officers of Bio-Path Holdings, Inc. On March 10, 2014,
our common stock ceased trading on the OTCQX and commenced trading on the Nasdaq Capital Market under the ticker symbol “BPTH.”
Effective December 31, 2014, we changed our state of incorporation from Utah to Delaware through a statutory conversion pursuant
to the Utah Revised Business Corporation Act and the Delaware General Corporation Law. Our principal executive offices are located
at 4710 Bellaire Boulevard, Suite 210, Bellaire, Texas 77401, and our telephone number is (832) 742-1357.
On February 8, 2018, we effected a reverse
stock split of our outstanding shares of common stock at a ratio of 1-for-10, and our common stock began trading on the split-adjusted
basis on the Nasdaq Capital Market at the commencement of trading on February 9, 2018. In addition, on January 17, 2019, we effected
a reverse stock split of our outstanding shares of common stock at a ratio of 1-for-20, and our common stock began trading on the
split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on January 18, 2019. All common stock share and
per share amounts in this prospectus have been adjusted to give effect to both the 1-for-10 reverse stock split and the 1-for-20
reverse stock split, retrospectively.
THE OFFERING
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Common stock offered by us
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5,149 shares of our common stock, par value $0.001
per share, issuable at an exercise price of $460.00 per share upon the exercise of the Warrants (including shares that may
be issued to the holder in lieu of fractional shares).
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Common stock to be outstanding immediately after this offering (1)
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2,819,205 shares (assuming the exercise of all Warrants).
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Use of proceeds
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We currently expect to use the net proceeds from this offering,
if any, for working capital and general corporate purposes. See “Use of Proceeds” on page 7.
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NASDAQ Capital Market symbol
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“BPTH”
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Risk factors
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An investment in our company involves a high degree of risk.
Please refer to the sections titled “Risk Factors,” “Special Note Regarding Forward-Looking Statements”
and other information included or incorporated by reference in this prospectus for a discussion of factors you should carefully
consider before investing in our securities.
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(1) The number of shares of common stock to be outstanding after
this offering is based on 2,814,056 shares of common stock outstanding as of March 31, 2019, which excludes as of such date:
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71,169 shares of common stock reserved for issuance upon the exercise of outstanding options granted under our equity incentive plans with a weighted average exercise price of $67.26 per share;
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5,474 additional shares of common stock reserved for future issuance under the Bio-Path Holdings, Inc. 2017 Stock Incentive Plan (the “2017 Stock Incentive Plan”); and
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273,864 shares of common stock issuable upon exercise of outstanding warrants with a weighted average exercise price of $35.23 per share.
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RISK FACTORS
An investment in our company involves
a high degree of risk. Before you make a decision to invest in our securities, you should consider carefully the risks described
below, as well as the risks described in or incorporated by reference in this prospectus, including the risks and uncertainties
discussed under the section titled “Risk Factors” in our most recent Annual Report on Form 10-K and any subsequent
Quarterly Reports on Form 10-Q or Current Reports on Form 8-K, and all other documents incorporated by reference into this prospectus,
as updated by our subsequent filings under the Exchange Act.
Any of these risks could have a material
adverse effect on our business, prospects, financial condition and results of operations. In any such case, the trading price of
our securities could decline and you could lose all or part of your investment. Additional risks not presently known to us or that
we currently deem immaterial may also adversely affect our business operations.
You will experience immediate and
substantial dilution in the net tangible book value per share of the common stock you purchase pursuant to the exercise of the
Warrants.
Since the price per share of our common
stock being offered is substantially higher than the net tangible book value per share of our common stock, you will suffer substantial
dilution in the net tangible book value of the common stock you purchase in this offering pursuant to the exercise of the Warrants.
Assuming that all 5,149 shares of our common stock are sold in this offering upon the exercise of the Warrants (including shares
that may be issued to the holder in lieu of fractional shares), you will suffer immediate and substantial dilution of approximately
$452.01 per share in the net tangible book value of the common stock. See the section titled “Dilution” in this prospectus
for a more detailed discussion of the dilution you will incur if you purchase common stock in this offering pursuant to the exercise
of the Warrants.
There may be future sales of our securities
or other dilution of our equity, which may adversely affect the market price of our common stock.
With limited exceptions, we are generally
not restricted from issuing additional common stock, including any securities that are convertible into or exchangeable for, or
that represent the right to receive, common stock. The market price of our common stock could decline as a result of sales of common
stock or securities that are convertible into or exchangeable for, or that represent the right to receive, common stock after this
offering or the perception that such sales could occur.
Our management has significant flexibility
in using the net proceeds of this offering.
We currently intend generally to use the
net proceeds from this offering, if any, for working capital and general corporate purposes. Our management will have significant
flexibility in applying the net proceeds of this offering. Management’s failure to use these funds effectively would have
an adverse effect on the value of our common stock and could make it more difficult and costly to raise funds in the future.
Special
Note Regarding Forward-Looking Statements
This prospectus and the documents incorporated
by reference into this prospectus contain “forward-looking statements” within the meaning of Section 27A of the Securities
Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”). Forward-looking statements can be identified by words such as “anticipate,” “expect,”
“intend,” “plan,” “believe,” “seek,” “estimate,” “project,”
“goal,” “strategy,” “future,” “likely,” “may,” “should,”
“will” and variations of these words and similar references to future periods, although not all forward-looking statements
contain these identifying words. Forward-looking statements are neither historical facts nor assurances of future performance.
Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans
and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements
relate to the future, they are subject to inherent risks, uncertainties, and changes in circumstances, including but not limited
to risk factors contained in or incorporated by reference under the section titled, “Risk Factors.” As a result, our
actual results may differ materially from those expressed or forecasted in the forward-looking statements, and you should not rely
on such forward-looking statements. You should carefully read this prospectus, together with the information incorporated herein
by reference as described under the section titled “Where You Can Find More Information,” completely and with the understanding
that our actual future results may be materially different from what we expect. We can give no assurances that any of the events
anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations
and financial condition. Forward-looking statements include, but are not limited to, statements about:
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our lack of significant revenue to date, our history of recurring operating losses and our expectation of future operating losses;
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our need for substantial additional capital and our need to delay, reduce or eliminate our drug development and commercialization efforts if we are unable to raise additional capital;
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the highly-competitive nature of the pharmaceutical and biotechnology industry and our ability to compete effectively;
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the success of our plans to use collaboration arrangements to leverage our capabilities;
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our ability to retain and attract key personnel;
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the risk of misconduct of our employees, agents, consultants and commercial partners;
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disruptions to our operations due to expansions of our operations;
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the costs we would incur if we acquire or license technologies, resources or drug candidates;
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risks associated with product liability claims;
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our reliance on information technology systems and the liability or interruption associated with cyber-attacks or other breaches of our systems;
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our ability to use net operating loss carryforwards;
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provisions in our charter documents and state law that may prevent a change in control;
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work slowdown or stoppage at government agencies could negatively impact our business
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our need to complete extensive clinical trials and the risk that we may not be able to demonstrate the safety and efficacy of our drug candidates;
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risks that that our clinical trials may be delayed or terminated;
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our ability to obtain domestic and foreign regulatory approval for our drug candidates;
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changes in existing laws and regulations affecting the healthcare industry;
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our reliance on third parties to conduct clinical trials for our drug candidates;
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our ability to maintain orphan drug exclusivity for our drug candidates;
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our reliance on third parties for manufacturing our clinical drug supplies;
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risks associated with the manufacture of our drug candidates;
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our ability to establish sales and marketing capabilities relating to our drug candidates;
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market acceptance of our drug candidates;
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third-party payor reimbursement practices;
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our ability to adequately protect the intellectual property of our drug candidates;
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infringement on the intellectual property rights of third parties;
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costs and time relating to litigation regarding intellectual property rights;
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our ability to adequately prevent disclosure by our employees or others of trade secrets and other proprietary information;
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the volatility of the trading price of our common stock;
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our common stock being thinly traded;
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our ability to issue shares of common or preferred stock without approval from our stockholders;
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our ability to pay cash dividends;
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costs and expenses associated with being a public company;
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a material weakness identified in our internal controls over financial reporting; and
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our ability to maintain compliance with the listing standards of the Nasdaq Capital Market.
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Any forward-looking statement made by us
in this prospectus and the documents incorporated by reference into this prospectus is based only on information currently available
to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement,
whether as a result of new information, future developments or otherwise. However, you should carefully review the risk factors
set forth in other reports or documents we file from time to time with the SEC.
Use
of Proceeds
We will retain broad discretion over the
use of the net proceeds from the sale of the securities offered hereby. We currently intend to use the net proceeds from this offering,
if any, for working capital and general corporate purposes. The amount and timing of these expenditures will depend on a number
of factors, such as the timing, scope, progress and results of our research and development efforts, the timing and progress of
any partnership efforts and the competitive environment for our drug candidates.
Dilution
If you purchase shares of our common stock
upon the exercise of your Warrant, you will experience immediate and substantial dilution to the extent of the difference between
the exercise price per share and the adjusted net tangible book value per share of our common stock immediately after the offering.
Our net tangible book value per share is
determined by subtracting our total liabilities from our total tangible assets, which is total assets less intangible assets, and
dividing this amount by the number of shares of common stock outstanding. The historical net tangible book value of our common
stock as of March 31, 2019 was approximately $20.1 million or $7.16 per share, based on 2,814,056 shares of our common stock outstanding
at March 31, 2019.
After giving effect to our sale of 5,149
shares of common stock issuable upon the exercise of the Warrants at an exercise price of $460.00 per share, our net tangible book
value as of March 31, 2019 would have been approximately $22.5 million, or $7.99 per share of common stock. This represents an
immediate increase in net tangible book value of $0.83 per share to existing stockholders and an immediate dilution of $452.01
per share to new investors in this offering. The following table illustrates this dilution on a per share basis:
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Exercise
price per share
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$
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460.00
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Historical
net tangible book value per share as of March 31, 2019
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$
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7.16
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Increase
in net tangible book value per share attributable to this offering
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$
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0.83
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As
adjusted net tangible book value per share after this offering
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$
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7.99
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Dilution
per share to investors in this offering upon exercise of the Warrants
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$
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452.01
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The above discussion and table are based on the exercise price
of the Warrants and on 2,814,056 shares of common stock outstanding as of March 31, 2019, which excludes as of such date:
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71,169 shares of common stock reserved for issuance upon the exercise of outstanding options granted under our equity incentive plans with a weighted average exercise price of $67.26 per share;
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5,474 additional shares of common stock reserved for future issuance under the 2017 Stock Incentive Plan; and
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273,864 shares of common stock issuable upon exercise of outstanding warrants with a weighted average exercise price of $35.23 per share.
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The above illustration of dilution per share
to investors participating in this offering assumes no exercise of outstanding options to purchase our common stock or outstanding
warrants to purchase shares of our common stock, other than the Warrants. To the extent that any of these outstanding warrants
or options are exercised or we issue additional shares under our equity incentive plans, there will 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 additional capital is raised
through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to
our stockholders.
Plan
of Distribution
The common stock referenced
on the cover page of this prospectus will be offered solely by us and will be issued and sold upon the exercise of the Warrants
described herein (including shares that may be issued to the holder in lieu of fractional shares). For the holders of Warrants
to exercise the Warrants, the shares issuable upon exercise must either be registered under the Securities Act or exempt from registration.
If a registration statement registering the issuance of the shares of common stock underlying the Warrants under the Securities
Act is not effective or available for the issuance of such shares, the holder may, in its sole discretion, elect to exercise the
Warrant through a cashless exercise, in which case the holder would receive upon such exercise the net number of shares of common
stock determined according to the formula set forth in the Warrant. No fractional shares of common stock will be issued in connection
with the exercise of a Warrant. In lieu of fractional shares, we will, at our discretion, either pay a cash adjustment in respect
of such final fraction in an amount equal to such fraction multiplied by the exercise price or round up to the next whole share.
DESCRIPTION
OF CAPITAL STOCK
The following description of our common
stock and preferred stock is a summary. It is not complete and is subject to and qualified in its entirety by our certificate of
incorporation and first amended and restated bylaws, each of which is incorporated by reference into this prospectus.
See the sections titled “Where You Can Find More Information” and “Information Incorporated by Reference.”
As of the date of this prospectus, our certificate of incorporation authorizes us to issue 200,000,000 shares of common stock,
par value $0.001 per share, and 10,000,000 shares of preferred stock, par value $0.001 per share. As of May 7, 2019, there were
2,831,356 shares of common stock issued and outstanding and no shares of preferred stock issued and outstanding.
Common Stock
Holders of common stock
are entitled to one vote for each share held in the election of directors and on all other matters submitted to a vote of stockholders.
Cumulative voting of shares of common stock is prohibited. Accordingly, holders of a majority of the shares of common stock entitled
to vote in any election of directors may elect all of the directors standing for election.
Subject to the prior
rights of the holders of any outstanding preferred stock, holders of common stock are entitled to receive dividends when, as and
if declared by our board of directors out of funds legally available therefor. Upon the liquidation, dissolution or winding up
of our company, the holders of common stock are entitled to receive ratably the assets of our company remaining after payment of
all liabilities and payment to holders of preferred stock if such preferred stock has an involuntary liquidation preference over
the common stock. Holders of common stock have no preemptive, subscription, redemption or conversion rights. The outstanding shares
of common stock are, and the shares offered by us in this offering will be, when issued and paid for, validly issued, fully paid
and nonassessable.
As of March 31, 2019,
there were approximately 227 holders of record of our common stock.
Preferred Stock
The board of directors is authorized, without
any further notice to or action of the stockholders, to issue 10,000,000 shares of preferred stock in one or more series and to
determine the relative rights, preferences and privileges of the shares of any such series.
Limitation on Liability and Indemnification of Officers and
Directors
Our certificate of incorporation and first
amended and restated bylaws provide for indemnification of our officers and directors to the fullest extent permitted by Delaware
law. Our certificate of incorporation and first amended and restated bylaws limit the liability of our directors for monetary damages
to the fullest extent permitted by Delaware law. We maintain directors’ and officers’ liability insurance.
Anti-Takeover Effects of Provisions of Our Certificate of
Incorporation, Our Bylaws and Delaware Law
Some provisions of Delaware law and our
certificate of incorporation and our first amended and restated bylaws contain provisions that could have the effect of delaying,
deterring or preventing another party from acquiring or seeking to acquire control of us. These provisions are intended to discourage
certain types of coercive takeover practices and inadequate takeover bids and to encourage anyone seeking to acquire control of
us to negotiate first with our board of directors. However, these provisions may also delay, deter or prevent a change in control
or other takeover of our company that our stockholders might consider to be in their best interests, including transactions that
might result in a premium being paid over the market price of our common stock and also may limit the price that investors are
willing to pay in the future for our common stock. These provisions may also have the effect of preventing changes in our management.
Our certificate of incorporation and first
amended and restated bylaws include anti-takeover provisions that:
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authorize our board of directors, without further action by the stockholders, to issue shares of preferred stock in one or more series, and with respect to each series, to fix the number of shares constituting that series and establish the rights and other terms of that series;
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establish advance notice procedures for stockholders to submit nominations of candidates for election to our board of directors and other proposals to be brought before a stockholders meeting;
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provide that our first amended
and restated bylaws may be amended by our board of directors without stockholder approval;
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limit our stockholders’
ability to call special meetings of stockholders;
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allow our directors to establish
the size of the board of directors by action of the board, subject to a minimum of three members;
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provide that vacancies on
our board of directors or newly created directorships resulting from an increase in the number of our directors may be filled
only by a majority of directors then in office, even though less than a quorum; and
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do not give the holders of
our common stock cumulative voting rights with respect to the election of directors.
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Business Combinations
Section 203 of the Delaware General Corporation
Law provides that we may not engage in certain “business combinations” with any “interested stockholder”
for a three-year period following the time that the person became an interested stockholder, unless:
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prior to the time that person became an interested stockholder, our board of directors approved either the business combination or the transaction which resulted in the person becoming an interested stockholder;
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upon consummation of the transaction which resulted in the person 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 certain shares; or
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at or subsequent to the time the person became an interested stockholder, the business combination is approved by the board of directors and by the affirmative vote of at least 66 2/3% of the outstanding voting stock which is not owned by the interested stockholder.
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Generally, a business combination includes
a merger, consolidation, asset or stock sale or other transaction resulting in a financial benefit to the interested stockholder.
Subject to certain exceptions, an interested stockholder is a person who, together with that person’s affiliates and associates,
owns, or within the previous three years owned, 15% or more of our 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.
Listing
Our common stock is listed for trading on
the Nasdaq Capital Market under the symbol “BPTH.”
Transfer Agent and Registrar
The transfer agent and registrar for our
common stock is American Stock Transfer & Trust Company, LLC, 6201 15
th
Avenue, Brooklyn, New York 11219. Its phone
number is (800) 937-5449.
Legal
Matters
The validity of the issuance of the securities
offered hereby will be passed upon for us by Winstead PC, Houston, Texas.
Experts
The consolidated financial statements as
of December 31, 2018 and 2017 and for the years then ended incorporated by reference in this prospectus have been so incorporated
in reliance on the report of BDO USA, LLP, an independent registered public accounting firm, incorporated herein by reference,
given on the authority of said firm as experts in auditing and accounting.
Where
You Can Find More Information
We file annual, quarterly and current reports,
proxy statements and other information with the SEC. The SEC maintains an Internet site that contains reports, proxy and information
statements, and other information regarding issuers that file electronically with the SEC, including us. The SEC’s Internet
site can be found at
http://www.sec.gov
. In addition, we make available on or through our Internet site copies of these
reports as soon as reasonably practicable after we electronically file or furnished them to the SEC. Our Internet site can be found
at
http://www.biopathholdings.com
. The information contained in, or that can be accessed through, our website is not
incorporated by reference in, and is not part of, this prospectus.
INFORMATION
INCORPORATED BY REFERENCE
We are incorporating by reference into this
prospectus certain information that we file with the SEC, which means that we are disclosing important information to you by referring
you to those documents. The information incorporated by reference is deemed to be part of this prospectus, except for information
incorporated by reference that is superseded by information contained in this prospectus. This means that you must look at all
of the SEC filings that we incorporate by reference to determine if any statements in the prospectus or any document previously
incorporated by reference have been modified or superseded. This prospectus incorporates by reference the documents set forth below
that we have previously filed with the SEC:
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the description of our common stock contained in our registration statement on Form 8-A filed with the SEC on
March 5, 2014
, as updated by our Current Report on Form 8-K filed with the SEC on
January 6, 2015
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Any information in any of the foregoing
documents will automatically be deemed to be modified or superseded to the extent that information in this prospectus or in a later
filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such information.
We also incorporate by reference all documents
we file in the future pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act (i) after the date of the filing of the
registration statement of which this prospectus is a part and prior to the effectiveness of such registration statement or (ii)
after the date of this prospectus and until the offering of the securities made by this prospectus is terminated. These documents
include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (except,
in any such case, the portions furnished and not filed pursuant to Item 2.02, Item 7.01 or otherwise), as well as any proxy statements.
We will provide to each person, including
any beneficial owner, to whom a prospectus is delivered, without charge upon written or oral request, a copy of any or all of the
documents that are incorporated by reference into this prospectus but not delivered with the prospectus, including exhibits which
are specifically incorporated by reference into such documents. You may request a copy of these filings at no cost, by writing
to or telephoning us at the following address:
Bio-Path Holdings, Inc.
Attention: Secretary
4710 Bellaire Boulevard, Suite 210
Bellaire, Texas 77401
(832) 742-1357
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The following table sets forth an estimate
of the fees and expenses payable by the registrant in connection with the issuance and distribution of the securities being registered.
All amounts are estimated except the SEC registration fee. All of the expenses below will be paid by us.
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AMOUNT
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SEC registration fee
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$
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15,438
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Printing and related expenses
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**
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Legal fees and expenses
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**
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Accounting fees and expenses
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**
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Miscellaneous expenses
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**
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Total
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$
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* Includes the $13,336.74 previously paid in connection with
unsold securities pursuant to Rule 415(a)(6) and the $1,446.07 previously paid in connection with unsold securities pursuant to
Rule 457(p).
** The amount of securities and the number of offerings are
indeterminable and the expenses cannot be estimated at this time.
Item 15. Indemnification of Directors and Officers.
Section 102(b)(7) of
the Delaware General Corporation Law (the “DGCL”) permits a corporation to eliminate or limit the personal liability
of its directors 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 certificate of incorporation provides that to the fullest extent elimination or limitation of
personal liability of directors is permitted by the DGCL, no director of the Company shall be liable to the Company or its stockholders
for monetary damages for breach of fiduciary duty as a director.
Section 145 of the
DGCL permits a corporation to indemnify a director, officer, employee or agent of the corporation and certain other persons serving
at the request of the corporation 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 is party or is threatened to be made a party 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 first amended and
restated bylaws and our certificate of incorporation provide that each person (and the heirs, executors or administrators of such
person) who was or is made or is threatened to be made a party or is otherwise involved in any action, suit or proceeding, whether
civil, criminal, administrative or investigative, by reason of the fact that such person is or was a director or officer of the
Company shall be indemnified and held harmless by the Company to the fullest extent permitted by applicable law. Our certificate
of incorporation also states that we will pay or reimburse the reasonable expenses incurred in defending any such action, suit
or proceeding in advance of its final disposition if we have received an undertaking by the person receiving such payment or reimbursement
to repay all amounts advanced if it should be ultimately determined that he or she is not entitled to be indemnified.
We have entered into
indemnification agreements with each of our directors. The contractual rights to indemnification provided by these indemnity agreements
are subject to the limitations and conditions specified in such agreements.
The effect of the foregoing
is to require us to indemnify our officers and directors for any claim arising against such persons in their official capacities
if such person acted in good faith and in a manner that he or she reasonably believed to be in or not contrary to the best interests
of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct
was unlawful. Insofar as indemnification for liabilities arising under the Securities Act may be permitted to our directors and
officers, we have been advised that in the opinion of the SEC, such indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable.
We have directors and officers insurance
which includes insurance for claims against these persons brought under securities laws.
Item 16. Exhibits.
The following documents are filed as exhibits
to this registration statement:
Exhibit
Number
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Exhibit
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1.1*
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Form of Underwriting Agreement.
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1.2
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Controlled Equity Offering
SM
Sales Agreement, dated June 24, 2015, by and between the Company and Cantor Fitzgerald & Co. (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed on June 25, 2015).
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2.1
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Agreement and Plan of Merger and Reorganization dated September 27, 2007, by and among the Company, Biopath Acquisition Corp., a Utah corporation and wholly owned subsidiary of the registrant, and Bio-Path, Inc., a Utah corporation (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on September 27, 2007).
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4.1
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Certificate of Incorporation (incorporated by reference to Exhibit 3.3 to the Company’s Current Report on Form 8-K filed on January 6, 2015).
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4.2
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Certificate of Amendment to the Certificate of Incorporation of Bio-Path Holdings, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on February 9, 2018).
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4.3
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First Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on June 7, 2017).
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4.4
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Certificate of Amendment to the Certificate of Incorporation of Bio-Path Holdings, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on January 16, 2019).
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4.5
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Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Company’s Annual Report on Form 10-K filed on March 16, 2015).
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4.6
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Form of Warrant issued to certain investors (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on June 30, 2016).
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4.7*
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Specimen Preferred Stock Certificate and Form of Certificate of Designation of Preferred Stock.
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4.8*
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Form of Common Stock Warrant Agreement and Common Stock Warrant Certificate.
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4.9*
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Form of Preferred Stock Warrant Agreement and Preferred Stock Warrant Certificate.
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4.10*
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Form of Unit Agreement.
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5.1+
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Opinion of Winstead PC.
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23.1+
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Consent of BDO USA, LLP.
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23.2+
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Consent of Winstead PC (included in Exhibit 5.1).
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24.1+
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Powers of Attorney (included in Signature Page).
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* To be filed by amendment hereto or as an exhibit to a report
filed pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, and incorporated herein by reference,
if applicable.
+ Filed herewith
Item 17. Undertakings.
(a) The undersigned registrant hereby undertakes:
(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;
(ii) To reflect in the prospectus any facts
or events arising after the effective date of the 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 the 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 a prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes
in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation
of Registration Fee” table in the effective registration statement;
(iii) To include any material information
with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such
information in the registration statement;
Provided, however,
that paragraphs (a)(1)(i), (a)(1)(ii)
and (a)(1)(iii) of this section 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 SEC by the registrant pursuant to section 13 or section 15(d)
of the Exchange Act that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed
pursuant to Rule 424(b) that is part of the 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 that 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 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 undersigned 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 Section 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 the 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) 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 foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the SEC 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.
(d) The undersigned registrant hereby undertakes
that:
(1) For purposes of determining any liability
under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance
upon Rule 430A and contained in a form of prospectus filed by the registration pursuant to Rule 424(b)(1) or (4) or 497(h) under
the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.
(2) For the purpose of determining any liability
under the Securities Act, each post-effective amendment that contains a form of prospectus 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.
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 the City of Bellaire, State of Texas, on May 16, 2019.
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BIO-PATH HOLDINGS, INC.
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By:
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/s/ Peter H. Nielsen
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Peter H. Nielsen
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President
Chief Executive Officer
(Principal Executive Officer)
Chief Financial Officer
(Principal Financial Officer and Principal Accounting
Officer)
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POWER OF ATTORNEY
KNOW ALL PERSONS BY
THESE PRESENTS, that each person whose signature appears below constitutes and appoints Peter H. Nielsen his or her true and lawful
attorney-in-fact, with the power of substitution and resubstitution, for him or her and in his or her name, place and stead, in
any and all capacities, to sign any and all amendments (including pre-effective amendments and post-effective amendments) to this
registration statement, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities
and Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to do and perform each and every
act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he or she might
or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent or his substitutes or substitute,
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 below by the following persons in the capacities
and on the dates indicated.
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/s/ Peter H. Nielsen
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Peter H. Nielsen
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May 16, 2019
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President, Chief Executive Officer (Principal Executive Officer), Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) and Director
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/s/ Heath W. Cleaver
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Heath W. Cleaver
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May 16, 2019
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Director
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/s/ Mark P. Colonnese
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Mark P. Colonnese
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May 16, 2019
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Director
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/s/ Paul D. Aubert
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Paul D. Aubert
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May 16, 2019
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Director
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/s/ Douglas P. Morris
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Douglas P. Morris
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May 16, 2019
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Director and Secretary
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