As
filed with the Securities and Exchange Commission on April 7, 2020
Registration
No. 333-__________
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-3
REGISTRATION
STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Hancock
Jaffe Laboratories, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
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3841
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33-0936180
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(State
or other jurisdiction of
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(Primary
Standard Industrial
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(I.R.S.
Employer
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incorporation
or organization)
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Classification
Code Number)
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Identification
Number)
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70
Doppler
Irvine,
California 92618
(949)
261-2900
(Address,
including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Robert
A. Berman
Chief
Executive Officer
Hancock
Jaffe Laboratories, Inc.
70
Doppler
Irvine,
California 92618
(949)
261-2900
(Name,
address, including zip code, and telephone number, including area code, of agent for service)
Please
send a copy of all communications to:
Barry
I. Grossman, Esq.
Ellenoff
Grossman & Schole LLP
1345
Avenue of the Americas
New
York, New York 10105-0302
(212)
370-1300
Approximate
date of commencement proposed sale to the public: From time to time after the effective date of this Registration Statement.
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. ☒
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
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☐
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Accelerated
filer
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☐
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Non-accelerated
filer
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☒
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Smaller
reporting company
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☒
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Emerging
growth company
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☒
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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
Securities Act. ☐
CALCULATION
OF REGISTRATION FEE
Title of Each Class of Securities to be Registered (1)
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Amount to be
Registered
(2) (3)
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Proposed Maximum Aggregate Offering Price per Security
(2) (3)
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Proposed Maximum Aggregate Offering Price (2) (3)
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Amount of Registration Fee (4)
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Common Stock, par value $0.00001 per share
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—
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—
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—
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—
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Preferred Stock, par value $0.00001 per share
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—
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—
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—
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—
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Warrants to Purchase common stock, Preferred Stock or other Securities (5)
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—
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—
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—
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—
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Subscription Rights to Purchase common stock or Preferred Stock
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Debt Securities (which may be senior or subordinated, convertible or non-convertible, secured or unsecured)
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Units (6)
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—
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—
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—
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—
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TOTAL
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—
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—
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$
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75,000,000
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$
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9,735.00
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(1)
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Securities
registered hereunder may be sold separately, together or as units with other securities registered hereunder.
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(2)
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Not
specified as to each class of securities to be registered pursuant to Form S-3 General Instruction II.D.
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(3)
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The
Registrant is registering an indeterminate aggregate principal amount and number of securities of each identified class of
securities up to a proposed aggregate offering price of $75,000,000, which may be offered from time to time in unspecified
numbers and at indeterminate prices, and as may be issuable upon conversion, redemption, repurchase, exchange, or exercise
of any securities registered hereunder, including under any applicable anti-dilution provisions. In addition, pursuant to
Rule 416 under the Securities Act of 1933, as amended, 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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(4)
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The
registration fee is calculated in accordance with Rule 457(o) under the Securities Act of 1933, as amended.
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(5)
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Warrants
may represent rights to purchase debt securities, common stock, preferred stock or other securities registered hereunder.
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(6)
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Each
Unit consists of any combination of two or more of the securities being registered hereby.
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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 this Registration Statement shall become effective
on such date as the Commission, acting pursuant to said Section 8(a), may determine.
The
information in this prospectus is not complete and may be changed. We may not sell the securities until the Registration Statement
filed with the Securities and Exchange Commission, of which this prospectus is a part, is effective. This prospectus is not an
offer to sell these securities and is not soliciting an offer to buy these securities in any state where the offer or sale is
not permitted.
SUBJECT
TO COMPLETION, DATED APRIL 7, 2020
Prospectus
$75,000,000
COMMON
STOCK
PREFERRED
STOCK
WARRANTS
SUBSCRIPTION
RIGHTS
DEBT
SECURITIES
UNITS
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common
stock;
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preferred
stock;
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warrants
to purchase our securities;
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subscription
rights to purchase any of the foregoing securities;
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secured
or unsecured debt securities consisting of notes, debentures or other evidences of indebtedness which may be senior debt securities,
senior subordinated debt securities or subordinated debt securities, each of which may be convertible into equity securities;
or
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units
comprised of, or other combinations of, the foregoing securities.
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We
may offer and sell these securities separately or together, in one or more series or classes and in amounts, at prices and on
terms described in one or more offerings. We may offer securities through underwriting syndicates managed or co-managed by one
or more underwriters or dealers, through agents or directly to purchasers. The prospectus supplement for each offering of securities
will describe in detail the plan of distribution for that offering. For general information about the distribution of securities
offered, please see “Plan of Distribution” in this prospectus.
Each
time our securities are offered, we will provide a prospectus supplement containing more specific information about the particular
offering and attach it to this prospectus. The prospectus supplements may also add, update or change information contained in
this prospectus. This prospectus may not be used to offer or sell securities without a prospectus supplement which includes
a description of the method and terms of this offering.
Our
common stock is quoted on The NASDAQ Capital Market under the symbol “HJLI.” The last reported sale price of our common
stock on The NASDAQ Capital Market on April 6, 2020 was $0.28 per share. The aggregate market value of our outstanding
common stock held by non-affiliates is approximately $13,659,380 based on 19,132,138 shares of outstanding common
stock, of which 19,104,028 shares are held by non-affiliates, and a per share price of $0.715 which was
the closing sale price of our common stock as quoted on The NASDAQ Capital Market on March 2, 2020. During the 12 calendar
month period that ends on, and includes, the date of this prospectus, we have not offered and sold any of our securities pursuant
to General Instruction I.B.6 of Form S-3.
If
we decide to seek a listing of any preferred stock warrants, subscriptions rights, debt securities or units offered by this prospectus,
the related prospectus supplement will disclose the exchange or market on which the securities will be listed, if any, or where
we have made an application for listing, if any.
Investing
in our securities involves certain risks. See “Risk Factors” beginning on page 8 and the risk factors in our
most recent Annual Report on Form 10-K, which is incorporated by reference herein, as well as in any other recently filed
quarterly or current reports and, if any, in the relevant prospectus supplement. We urge you to carefully read this
prospectus and the accompanying prospectus supplement, together with the documents we incorporate by reference, describing
the terms of these securities before investing.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The
date of this Prospectus is ___________
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, or SEC,
utilizing a “shelf” registration process. Under this shelf registration process, we may offer and sell, either individually
or in combination, in one or more offerings, any of the securities described in this prospectus, for total gross proceeds of up
to $75,000,000. This prospectus provides you with a general description of the securities we may offer. Each time we offer
securities under this prospectus, we will provide a prospectus supplement to this prospectus that will contain more specific information
about the terms of that offering. We may also authorize one or more free writing prospectuses to be provided to you that may contain
material information relating to these offerings. The prospectus supplement and any related free writing prospectus that we may
authorize to be provided to you may also 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, any applicable prospectus supplement and any free writing prospectuses we have authorized
for use in connection with a specific offering, together with the information incorporated herein by reference as described under
the heading “Incorporation of Documents by Reference,” before investing in any of the securities being offered. You
should rely only on the information contained in, or incorporated by reference into, this prospectus and any applicable prospectus
supplement, along with the information contained in any free writing prospectuses we have authorized for use in connection with
a specific offering. We have not authorized anyone to provide you with different or additional information. This prospectus is
an offer to sell only the securities offered hereby, but only under circumstances and in jurisdictions where it is lawful to do
so.
The
information appearing in this prospectus, any applicable prospectus supplement or any related free writing prospectus is accurate
only as of the date on the front of the document and any information we have incorporated by reference is accurate only as of
the date of the document incorporated by reference, regardless of the time of delivery of this prospectus, any applicable prospectus
supplement or any related free writing prospectus, or any sale of a security.
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 entitled “Where You Can Find Additional Information.”
This
prospectus contains, or incorporates by reference, trademarks, tradenames, service marks and service names of Hancock Jaffe Laboratories,
Inc.
CAUTIONARY
NOTE REGARDING FORWARD LOOKING STATEMENTS
This
prospectus and any accompanying prospectus supplement and the documents incorporated by reference herein may contain forward looking
statements that involve risks and uncertainties. All statements other than statements of historical fact contained in this prospectus
and any accompanying prospectus supplement and the documents incorporated by reference herein, including statements regarding
future events, our future financial performance, business strategy, and plans and objectives of management for future operations,
are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,”
“believes,” “can,” “continue,” “could,” “estimates,” “expects,”
“intends,” “may,” “plans,” “potential,” “predicts,” “should,”
or “will” or the negative of these terms or other comparable terminology. These statements relate to future events
or our future financial performance or condition and involve known and unknown risks, uncertainties and other factors that could
cause our actual results, levels of activity, performance or achievement to differ materially from those expressed or implied
by these forward-looking statements. Although we do not make forward looking statements unless we believe we have a reasonable
basis for doing so, we cannot guarantee their accuracy. These forward-looking statements include, but are not limited to, statements
about:
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failure
to obtain U.S. Food and Drug Administration (“FDA”) approval to commercially sell our product candidates in a
timely manner or at all;
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whether
surgeons and patients in our target markets accept our product candidates, if approved;
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the
expected growth of our business and our operations, and the capital resources needed to progress our business plan;
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failure
to scale up of the manufacturing process of our product candidates in a timely manner, or at all;
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failure
to manufacture our product candidates at a competitive price;
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our
ability to retain and recruit key personnel, including the development of a sales and marketing infrastructure;
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reliance
on third party suppliers for certain components of our product candidates;
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reliance
on third parties to commercialize and distribute our product candidates in the United States and internationally;
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changes
in external competitive market factors;
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uncertainties
in generating sustained revenue or achieving profitability;
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unanticipated
working capital or other cash requirements;
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changes
in FDA regulations, including testing procedures, of medical devices and related promotional and marketing activities;
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our
estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for, or ability to obtain, additional
financing;
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our
ability to obtain and maintain intellectual property protection for our product candidates;
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our ability to regain compliance with the continued
listing requirements of the Nasdaq Capital Market or otherwise maintain the listing of our securities on the Nasdaq Capital
Market; and
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changes
in our business strategy or an inability to execute our strategy due to unanticipated changes in the medical device industry.
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These
statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks outlined
under “Risk Factors” or elsewhere in this prospectus and the documents incorporated by reference herein, which may
cause our or our industry’s actual results, levels of activity, performance or achievements expressed or implied by these
forward-looking statements. Moreover, we operate in a highly regulated, very competitive, and rapidly changing environment. New
risks emerge from time to time and it is not possible for us to predict all risk factors, nor can we address the impact of all
factors on our business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially
from those contained in any forward-looking statements.
We
have based these forward-looking statements largely on our current expectations and projections about future events and financial
trends that we believe may affect our financial condition, results of operations, business strategy, short term and long term
business operations, and financial needs. These forward-looking statements are subject to certain risks and uncertainties that
could cause our actual results to differ materially from those reflected in the forward looking statements. Factors that could
cause or contribute to such differences include, but are not limited to, those discussed in this prospectus, and in particular,
the risks discussed below and under the heading “Risk Factors” and those discussed in other documents we file with
the SEC. The following discussion should be read in conjunction with the consolidated financial statements for the fiscal years
ended December 31, 2019 and 2018 and notes incorporated by reference herein. We undertake no obligation to revise
or publicly release the results of any revision to these forward-looking statements, except as required by law. In light of these
risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this prospectus may not occur
and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statement.
You
should not place undue reliance on any forward-looking statement, each of which applies only as of the date of this prospectus.
Except as required by law, we undertake no obligation to update or revise publicly any of the forward-looking statements after
the date of this prospectus to conform our statements to actual results or changed expectations. Any forward-looking statement
you read in this prospectus, any prospectus supplement or any document incorporated by reference reflects our current views with
respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, operating
results, growth strategy and liquidity. You should not place undue reliance on these forward-looking statements because such statements
speak only as to the date when made. We assume no obligation to publicly update or revise these forward-looking statements for
any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements,
even if new information becomes available in the future, except as otherwise required by applicable law. You are advised, however,
to consult any further disclosures we make on related subjects in our reports on Forms 10-Q, 8-K and 10-K filed with the SEC.
You should understand that it is not possible to predict or identify all risk factors. Consequently, you should not consider any
such list to be a complete set of all potential risks or uncertainties.
PROSPECTUS
SUMMARY
This
summary highlights selected information contained elsewhere in this prospectus. This summary does not contain all the information
that you should consider before investing in our Company. You should carefully read the entire prospectus, including all documents
incorporated by reference herein. In particular, attention should be directed to our “Risk Factors,” “Information
With Respect to the Company,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
and the financial statements and related notes thereto contained herein or otherwise incorporated by reference hereto, before
making an investment decision.
As
used herein, and any amendment or supplement hereto, unless otherwise indicated, “we,” “us,” “our,”
the “Company,” “HJLI” or similar terminology means Hancock Jaffe Laboratories, Inc.
Overview
Hancock
Jaffe Laboratories, Inc. is a medical device company developing tissue based solutions that are designed to be life sustaining
or life enhancing for patients with cardiovascular disease, and peripheral arterial and venous disease. The Company’s products
are being developed to address large unmet medical needs by either offering treatments where none currently exist or by substantially
increasing the current standards of care. Our two lead products which we are developing are: the VenoValve®, a porcine based
device to be surgically implanted in the deep venous system of the leg to treat a debilitating condition called chronic venous
insufficiency (“CVI”); and the CoreoGraft®, a bovine based conduit to be used to revascularize the heart during
coronary artery bypass graft (“CABG”) surgeries. Both of our current products are being developed for approval by
the U.S. Food and Drug Administration (“FDA”). We currently receive tissue for development of our products from one
domestic supplier and one international supplier. Our current business model is to license, sell, or enter into strategic alliances
with large medical device companies with respect to our products, either prior to or after FDA approval. Our current senior management
team has been affiliated with more than 50 products that have received FDA approval or CE marking. We currently lease a 14,507
sq. ft. manufacturing facility in Irvine, California, where we manufacture products for our clinical trials and which has previously
been FDA certified for commercial manufacturing of product.
Each of our product
candidates will be required to successfully complete clinical trials and other testing to demonstrate the safety and efficacy
of the product candidate before it will be approved by the FDA. The completion of these clinical trials and testing will require
a significant amount of capital and the hiring of additional personnel.
Products
VenoValve
Background
Chronic venous disease
(“CVD”) is the world’s most prevalent chronic disease. CVD is generally classified using a standardized system
known as CEAP (clinical, etiological, anatomical, and pathophysiological). The CEAP system consists of seven clinical classifications
(C0 to C6) with C5 to C6 being the most severe cases of CVD.
Chronic Venous Insufficiency
(“CVI”) is a subset of CVD and is generally used to describe patients with C4 to C6 CVD. CVI is a condition that affects
the venous system of the leg causing pain, swelling, edema, skin changes, and ulcerations. The venous vasculature of the human
leg includes the superficial venous system, the deep vein system, and the perforator system which connects the superficial veins
and deep veins. In order for blood to return to the heart from the foot, ankle, and lower leg, the calf muscle pushes the blood
up the veins of the leg and through a series of one-way valves. Each valve is supposed to open as blood passes through, and then
close as blood moves up the leg to the next valve. CVI has two primary causes: obstruction, which occurs when a blood clot in
the veins of the leg hardens and prevents the free flow of blood; and valvular incompetence which is usually the result of injury
to the valves from blood clots, which occurs when the one-way valves in the leg do not close as they should, causing blood to
flow in the wrong direction (reflux) and to pool in the lower leg, resulting in increased venous pressure (venous hypertension).
CVI can occur in the superficial vein system, the deep vein system, or in both. The initial version of the VenoValve is being
developed to treat CVI resulting from valvular incompetence in the deep vein system of the leg.
Estimates indicate
that approximately 4.8 million people in the U.S. have C5 to C6 CVI including patients that develop venous leg ulcers from CVI
(C6 patients). Over one million new severe cases of CVI occur each year in the U.S., mostly from patients who have experienced
a deep vein thrombosis (blood clot). Of those patients suffering from severe CVI, approximately 55% (2.4 million) have reflux
in the deep vein system, or both the deep vein system and the superficial vein system. The average patient seeking treatment of
a venous ulcer spends as much as $30,000 a year on wound care, and the total direct medical costs from venous ulcer sufferers
in the U.S. has been estimated to exceed $38 billion a year. Aside from the direct medical costs, severe CVI sufferers experience
a significantly reduced quality of life. Daily activities such as preparing meals, housework, and personal hygiene (washing and
bathing) become difficult due to reduced mobility. For many severe CVI sufferers, intense pain, which frequently occurs at night,
prevents patients from getting adequate sleep. Severe CVI sufferers are known to miss about 40% more work days than the average
worker. A high percentage of venous ulcer patients also experience severe itching, leg swelling, and an odorous discharge. Wound
dressing changes which occur several times a week can be extremely painful. In addition, venous ulcers are very difficult to heal,
and a significant percentage of venous ulcers remain unhealed for more than a year. Even if healed, recurrence rates for venous
ulcers are known to be high (20% to 40%) within the first year.
The Opportunity
The
VenoValve is a porcine based valve developed at HJLI to be implanted in the deep vein system of the leg to treat CVI. CVI
occurs when the valves in the veins of the leg fail, causing blood to flow backwards and pool in the lower leg and ankle. The
backwards flow of the blood is called reflux. Reflux results in increased pressure in the veins of the leg, known as venous hypertension.
Venous hypertension leads to swelling, discoloration, severe pain, and open sores called venous ulcers. By reducing reflux, and
lowering venous hypertension, the VenoValve has the potential to reduce or eliminate the symptoms of deep venous, severe CVI,
including venous leg ulcers. The VenoValve is designed to be surgically implanted into the patient on an outpatient basis via
a 5 to 6 inch incision in the upper thigh.
There
are presently no FDA approved medical devices to address valvular incompetence, or effective treatments for deep venous CVI. Current
treatment options include compression garments, or constant leg elevation. These treatments are generally ineffective for
patients with severe deep venous CVI, as they attempt to alleviate the symptoms of CVI without addressing the underlying causes
of the disease. In addition, we believe that compliance with compression garments and leg elevation is extremely low, especially
among the elderly. Valve transplants from other parts of the body have been attempted, but with very-poor results. Many attempts
to create substitute valves have also failed, usually resulting in early thromboses. The premise behind the VenoValve is that
by reducing the underlying causes of CVI, reflux and venous hypertension, the debilitating symptoms of CVI will decrease, resulting
in improvement in the quality of the lives of CVI sufferers.
There are approximately
2.4 million people in the U.S. that suffer from severe deep venous CVI due to valvular incompetence. The average person
with a venous ulcer spends approximately $30,000 per year on wound care, resulting in approximately $38 billion
of direct medical costs. For those venous ulcers that do heal, there is a 20% to 40% recurrence rate within one year.
Clinical
Status
After consultation with
the FDA, as a precursor to the U.S. pivotal trial, we are conducting a small first-in-man study for the VenoValve in Colombia.
The first phase of the first-in-man Colombian trial included 10 patients. In addition to providing safety
and efficacy data, the purpose of the first-in-man study is to provide proof of concept, and to provide valuable feedback
to make any necessary product modifications or adjustments to our surgical implantation procedures for the VenoValve prior
to conducting the U.S. pivotal trial. In December of 2018, we received regulatory approval from Instituto Nacional de Vigilancia
de Medicamentos y Alimentos (“INVIMA”), the Colombian equivalent of the FDA. On February 19, 2019, we announced that
the first VenoValve was successfully implanted in a patient in Bogota. Between April of 2019 and December of 2019, we successfully
implanted VenoValves in 9 additional patients, completing the implantations for the first phase of the Colombian first-in-man
study. Endpoints for the VenoValve first-in-man study include reflux, measured by doppler, a VCSS score used by the clinician
to measure disease severity, and a VAS score used by the patient to measure pain.
On March 4, 2020, Dr.
Jorge Hernando Ulloa, the Primary Investigator for the Company’s first-in-man VenoValve study in Colombia, presented updated
VenoValve data at the 32nd Annual American Venous Forum meeting on Amelia Island, Florida. Dr. Ulloa’s presentation included
data on eight VenoValve patients that are six months post VenoValve surgery (including one patient that is one year post surgery),
two patients that are 90 days post-surgery, and one patient that is 60 days post-surgery. For the first patient to receive the
VenoValve who is now one year post surgery, Reflux has improved 73% and is now normal, the severity of her CVI has improved 94%,
and her pain has improved 75%. This patient showed continued improvement between her six month and one year visits. Because proper
directional blood flow in the leg has been restored on a long term basis, the venous system has normalized and there are barely
any manifestations of the disease for that patient. Overall, VenoValves have been implanted in 11 patients in Colombia. Across
all 11 patients and when comparing pre-operative levels to data recorded at their most recent office visits, Reflux, VCSS Scores,
and VAS scores have improved 51%, 61%, and 65% respectively. That includes one patient who is currently occluded, and whose VenoValve
is currently not functioning as intended. VenoValve safety incidences have been unchanged since last reported, and include one
(1) fluid pocket (which was as aspirated), intolerance from Coumadin anticoagulation therapy, and two (2) minor wound infections
(treated with antibiotics).
HJLI has begun preparing
for Pre-Investigational Device Exemption (“IDE”) discussions with the FDA and to file its IDE application seeking
approval for the U.S. pivotal trial.
CoreoGraft
Background
Heart disease is the
leading cause of death among men and women in the U.S. accounting for about 1 in every 4 deaths. Coronary heart disease is the
most common type of heart disease, killing over 370,000 people each year. Coronary heart disease occurs when arteries around the
heart become blocked or occluded, in most cases by plaque. Although balloon angioplasty with or without cardiac stents have become
the norm if one or two arteries are blocked, coronary artery bypass surgery remains the treatment of choice for patients with
multiple blocked arteries. Approximately 200,000 coronary artery bypass graft (“CABG”) surgeries take place each year
in the U.S. In the U.S., CABG surgeries are the most commonly performed cardiac procedure. CABG surgeries alone account for 55%
of all cardiac surgeries, and CABG surgeries when combined with valve replacement surgeries account for approximately 62% of all
cardiac surgeries. The next largest category accounts for 10% of cardiac surgeries. The number of CABG surgeries are expected
to increase as the population continues to age. On average, three grafts are used for each CABG surgery.
Although CABG surgeries
are invasive, improved surgical techniques over the years have lowered the fatality rate from CABG surgeries to between 1% and
3% prior to discharge from the hospital. Arteries around heart are accessed via an incision along the sternum known as a sternotomy.
Once the incision is made, the sternum (chest) is divided (“cracked”) to access the heart and its surrounding arteries.
CABG surgery is relatively
safe and effective. In most instances, doctors prefer to use the left internal memory artery (“LIMA”), an artery running
inside the ribcage and close to the sternum, to re-vascularize the left side of the heart. Use of the LIMA to revascularize the
left descending coronary artery (known as the “widow maker”) has become the gold standard for revascularizing the
left side of the heart during CABG surgeries. For the right side of the heart, and where additional grafts are needed on the left
side, the current standard of care is to harvest the saphenous vein from the patient’s leg to be dissected into pieces and
used as bypass grafts around the heart. Unfortunately, saphenous vein grafts (“SVGs”) are not nearly as effective
as the LIMA for revascularizing the heart. In fact, SVGs continue to be the weak link for CABG surgeries.
The saphenous vein
harvest procedure is itself invasive. Either a long incision is made along the inner leg of the patient to harvest the vein, or
the saphenous vein is extracted endoscopically. Regardless of the type of bypass procedure, bypass graft harvest remains an invasive
and complication prone aspect of the CABG procedure. Present standard-of-care complications are described in recent published
reports in major medical journals. The percentage of complications from the harvest procedure can be as high as 24%. This is mainly
due to non-healing of the saphenous wound or development of infection in the area of the saphenous vein harvest site.
While the LIMA is known
for excellent short term and long term patency rates, studies indicate that between 10% and 40% percent of SVGs that are used
as conduits for CABG surgeries fail within the first year after the CABG surgery. A significant percentage fail within the first
30 days. At 10 years, the SVGs failure rate can be as high as 75%. When a graft fails, it becomes blocked or occluded, depriving
the heart of blood flow. Mortality during the first year after bypass graft failure is very high, between 5% and 9%. For purposes
of comparison, a 3% threshold is considered to be a high cardiac risk. In fact, a relatively recent study in Denmark has reported
that mortality rates at 8 to 10 years after CABG surgery are as high as 60% to 80%. While a life expectancy of 8 to 10 years following
CABG surgery may have been acceptable in the past, expectations have changed and with people now generally living longer, additional
focus is now being placed on extending life expectancies following CABG surgeries.
Researchers have determined
that there are two main causes of SVGs failure: size mismatch, and a thickening of the interior of the SVGs that begins immediately
following the harvest procedure. Size mismatch occurs because the diameter of SVGs is often significantly larger than the diameter
of the coronary arteries around the heart. This size mismatch causes flow disturbances, leading to graft thromboses and graft
failure. The thickening of the cell walls of SVGs occur when a layer of endothelial cells on the inner surface of the SVGs are
disturbed beginning at the harvesting procedure, starting a chain reaction which causes the cells to thicken and the inside of
the graft to narrow, resulting in blood clots and graft failure.
The
Opportunity
The
CoreoGraft is a bovine based off the shelf conduit that could potentially be used to revascularize the heart during CABG surgery,
instead of harvesting the saphenous vein from the patient’s leg. In addition to avoiding the invasive and painful SVGs
harvest process, HJLI’s CoreoGraft more closely matches the size of the coronary arteries around the heart,
eliminating graft failures that occur due to size mismatch. In addition, with no graft harvest needed, the CoreoGraft could
also reduce or eliminate the inner thickening that burdens and leads to failure of the SVGs. It has been reported that
SVGs have failure rates as high as 10% to 40% within one year of implantation when used as grafts for CABG surgery.
In
addition to providing a potential alternative to SVGs, the CoreoGraft could be used when making grafts from the patients’
own arteries and veins is not an option. For example, patients with systemic arterial and vascular disease often do not
have suitable vessels to be used as grafts. For other patients, such as women who have undergone radiation treatment for breast
cancer and have a higher incidence of heart disease, using the LIMA may not be an option if the LIMA was damaged by radiation
during breast cancer treatment. Another example are patients undergoing a second CABG surgery. Due in large part to early SVGs
failures, patients may need a second CABG surgery. If the SVGs were used for the first CABG surgery, the patient may
have insufficient veins to harvest. While the CoreoGraft may start out as a product for patients with no other options, if the
CoreoGraft establishes good short term and long term patency rates, it could become the graft of first choice for all CABG patients
in addition to the LIMA.
Approximately 200,000
CABG surgeries are performed each year in the U.S., representing more than 55% of all cardiac surgeries and accounting for between
$15 Billion and $25 Billion in annual expenditures. With an average of three grafts used per surgery, we believe the potential
U.S. addressable market for the CoreoGraft to be more than $2 Billion per year. There are currently no FDA approved prosthetic
grafts for CABG surgeries.
Clinical Status
In January of 2020,
we announced the results of a six month, nine sheep, animal feasibility study for the CoreoGraft. Bypasses were accomplished by
attaching the CoreoGrafts from the ascending aorta to the left anterior descending artery, and surgeries were preformed both on-pump
and off-pump. Partners for the feasibility study included the Texas Heart Institute, and American Preclinical Services.
Test subjects were
evaluated via angiograms and flow monitors during the study, and a full pathology examination of the CoreoGrafts and the surrounding
tissue was performed post necropsy.
The results from the
feasibility study demonstrated that the CoreoGrafts remained patent (open) and fully functional at 30, 90, and 180 day intervals
after implantation. In addition, pathology examinations of the grafts and surrounding tissue at the conclusion of the study showed
no signs of thrombosis, infection, aneurysmal degeneration, changes in the lumen, or other problems that are known to plague and
lead to failure of SVGs.
In addition to exceptional
patency, pathology examinations indicated full endothelialization for grafts implanted for 180 days both throughout the CoreoGrafts
and into the left anterior descending arteries. Endothelium is a layer of endothelial cells that naturally exist throughout healthy
veins and arteries that acts as a barrier between blood and the surrounding tissue, which helps promote the smooth passage of
blood. Endothelium are known to produce a variety anti-clotting and other positive characteristics that are essential to healthy
veins and arteries. The presence of full endothelialization within the longer term CoreoGrafts indicates that the graft is being
accepted and assimilated in a manner similar to natural healthy veins and arteries that exist throughout the vascular system and
is an indication of long-term biocompatibility.
Since we believe the
results of the CoreoGraft feasibility study were positive, HJLI will now explore the possibility of conducting a first-in-man
study outside of the U.S., where the CoreoGrafts would be implanted and tested in humans.
Our
Competitive Strengths
We
believe we will offer the cardiovascular device market a compelling value proposition with the launch of our two product
candidates, if approved, for the following reasons:
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We
have extensive experience of proprietary processing and manufacturing methodology specifically applicable to the design, processing,
manufacturing and sterilization of our biologic tissue devices. We believe that our patents, which cover certain aspects of
our devices and the processing methods of biologic valvular tissue as a “bioprosthetic” device, may provide an
advantage over potential competitors.
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We
operate a 14,507 square foot manufacturing facility in Irvine, California. Our facility is designed expressly for the manufacture
of Class III tissue based implantable medical devices and is equipped for research and development, prototype fabrication,
current good manufacturing practices, or cGMP, and manufacturing and shipping for Class III medical devices, including biologic
cardiovascular devices.
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We
have attracted senior executives who are experienced in research and development and who have worked on over 50 medical
devices that have received FDA approval or CE marking. We also have the advantage of an experienced board of directors and
scientific advisory board who will provide guidance as we move towards market launch.
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Intellectual
Property
We
possess an extensive proprietary processing and manufacturing methodology specifically applicable to the design, processing, manufacturing
and sterilization of biologic devices. This includes FDA compliant quality control and assurance programs, proprietary tissue
processing technologies demonstrated to eliminate recipient immune responses, trusted relationship with abattoir suppliers, and
a combination of tissue preservation and gamma irradiation that enhances device functions and guarantees sterility. We have
filed patent applications for our VenoValve product and Implantable Vein Frame Two product with the U.S. Patent
and Trademark Office though there is no assurance that patents will be issued. We also are working on new developments for
our CoreoGraft product and expect to be filing for patent protection on that product as well.
Risks
Associated with Our Business
Our
business is subject to many significant risks, as more fully described in the section entitled “Risk Factors” immediately
following this prospectus summary. You should read and carefully consider these risks, together with the risks set forth under
the section entitled “Risk Factors” and all of the other information in this prospectus, including the financial statements
and the related notes included elsewhere in this prospectus, before deciding whether to invest in our common stock. If any of
the risks discussed in this prospectus actually occur, our business, financial condition or operating results could be materially
and adversely affected. In particular, our risks include, but are not limited to, the following:
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failure
to obtain FDA approval to commercially sell our product candidates in a timely manner or at all;
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whether
surgeons and patients in our target markets accept our product candidates, if approved;
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our
ability to retain and recruit key personnel;
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reliance
on third party suppliers for certain components of our product candidates;
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unanticipated
working capital or other cash requirements;
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changes
in FDA regulations, including testing procedures, of medical devices;
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our
estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for, or ability to obtain, additional
financing;
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our
ability to obtain and maintain intellectual property protection for our product candidates;
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changes
in our business strategy or an inability to execute our strategy due to unanticipated changes in the medical device industry;
and
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adverse impact of the coronavirus
pandemic.
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Implications
of Being an Emerging Growth Company
We
qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS
Act. For as long as we remain an emerging growth company, we may take advantage of certain exemptions from various reporting requirements
that are applicable to other public companies. These provisions include, but are not limited to:
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being
permitted to have only two years of audited financial statements and only two years of related selected financial data and
management’s discussion and analysis of financial condition and results of operations disclosure;
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an
exemption from compliance with the auditor attestation requirement in the assessment of our internal control over financial
reporting pursuant to the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act;
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reduced
disclosure about executive compensation arrangements in our periodic reports, registration statements and proxy statements;
and
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exemptions
from the requirements to seek non-binding advisory votes on executive compensation or golden parachute arrangements.
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In
addition, the JOBS Act permits emerging growth companies to take advantage of an extended transition period to comply with new
or revised accounting standards applicable to public companies. We chose to “opt out” of this provision. We will remain
an emerging growth company until the earliest of (i) the end of the fiscal year following the fifth anniversary of the completion
of our initial public offering, (ii) the first fiscal year after our annual gross revenues exceed $1.07 billion, (iii) the date
on which we have, during the immediately preceding three-year period, issued more than $1.0 billion in non-convertible debt securities
or (iv) the end of any fiscal year in which the market value of our common stock held by non-affiliates exceeds $700 million as
of the end of the second quarter of that fiscal year.
Corporate
Information
We
were incorporated in Delaware on December 22, 1999. Our principal executive offices are located at 70 Doppler, Irvine, California,
92618, and our telephone number is (949) 261-2900. Our corporate website address is www.hancockjaffe.com. The information contained
on or accessible through our website is not a part of this prospectus, and the inclusion of our website address in this prospectus
is an inactive textual reference only.
RISK
FACTORS
Investing
in our securities involves a high degree of risk. Before deciding whether to invest in our securities, you should carefully
consider the following risk factors, together with the other risk factors we describe in any prospectus supplement
and in any related free writing prospectus for a specific offering of securities, as well as those incorporated by reference into
this prospectus or such prospectus supplement. You should also carefully consider other information contained and incorporated
by reference in this prospectus and any applicable prospectus supplement, including our financial statements and the related notes
thereto incorporated by reference in this prospectus. The risks and uncertainties described in the applicable prospectus supplement
and our other filings with the SEC incorporated by reference herein are not the only ones we face. Additional risks and uncertainties
not presently known to us or that we currently consider immaterial may also adversely affect us. If any of the described risks
occur, our business, financial condition or results of operations could be materially harmed. In such case, the value of our securities
could decline and you may lose all or part of your investment.
Risks
Related to the Coronavirus
The
coronavirus pandemic has significantly negatively impacted our business.
The
coronavirus pandemic has disrupted the global economy and has negatively impacted large populations including people and businesses
that may be directly or indirectly involved with the operation of our company and the manufacturing, development, and testing
of our product candidates. The full scope and economic impact of the coronavirus is still unknown and there are many risks from
the coronavirus that could generally and negatively impact economies and healthcare providers in the countries where we do business,
the medical device industry as a whole, and development stage, pre-revenue companies such as HJLI. At this time, we have identified
the following coronavirus related risks that we believe have a greater likelihood of negatively impacting our company specific,
including, but not limited to:
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Federal,
State and local shelter-in-place directives which limit our employees from accessing our facility to manufacture, develop
and test our product candidates.
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Travel
restrictions and quarantine requirements which prevent us from initiating and continuing animal studies and patient trial
both inside and outside of the United States.
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The
burden on hospitals and medical personnel resulting in the cancellation of non-essential medical procedures such as surgical
procedures needed to implant our product candidates for pre-clinical and clinical trials.
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Delays
in the procurement of certain supplies and equipment that are needed to develop and test our product candidates.
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Erosion
of the capital markets which make it more difficult to obtain the financing that we need to fund and continue our operations.
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Potential
back-log at regulatory agencies such as the FDA which may result in delays in obtaining regulatory approvals.
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Travel
restrictions which prevent patients from participating and continuing the participation in clinical trials.
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USE
OF PROCEEDS
Unless
otherwise indicated in a prospectus supplement, we intend to use the net proceeds from these sales for general corporate purposes,
which includes, without limitation, the continued development of our two lead products, VenoValve and the CoreoGraft, and working
capital. The amounts and timing of these expenditures will depend on numerous factors, including the development of our current
business initiatives.
PLAN
OF DISTRIBUTION
We
may sell the securities from time to time to or through underwriters or dealers, through agents, or directly to one or more purchasers.
A distribution of the securities offered by this prospectus may also be effected through the issuance of derivative securities,
including without limitation, warrants, rights to purchase and subscriptions. In addition, the manner in which we may sell some
or all of the securities covered by this prospectus includes, without limitation, through:
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a
block trade in which a broker-dealer will attempt to sell as agent, but may position or resell a portion of the block, as
principal, in order to facilitate the transaction;
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purchases
by a broker-dealer, as principal, and resale by the broker-dealer for its account; or
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ordinary
brokerage transactions and transactions in which a broker solicits purchasers.
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A
prospectus supplement or supplements with respect to each series of securities will describe the terms of the offering, including,
to the extent applicable:
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the
terms of the offering;
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the
name or names of the underwriters or agents and the amounts of securities underwritten or purchased by each of them, if any;
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the
public offering price or purchase price of the securities or other consideration therefor, and the proceeds to be received
by us from the sale;
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any
delayed delivery requirements;
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any
over-allotment options under which underwriters may purchase additional securities from us;
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any
underwriting discounts or agency fees and other items constituting underwriters’ or agents’ compensation;
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any
discounts or concessions allowed or re-allowed or paid to dealers; and
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any
securities exchange or market on which the securities may be listed.
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The
offer and sale of the securities described in this prospectus by us, the underwriters or the third parties described above may
be effected from time to time in one or more transactions, including privately negotiated transactions, either:
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at
a fixed price or prices, which may be changed;
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in
an “at the market” offering within the meaning of Rule 415(a)(4) of the Securities Act;
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at
prices related to such prevailing market prices; or
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at
negotiated prices.
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Only
underwriters named in the prospectus supplement will be underwriters of the securities offered by the prospectus supplement.
Underwriters
and Agents; Direct Sales
If
underwriters are used in a sale, they will acquire the offered securities for their own account and may resell the offered securities
from time to time in one or more transactions, including negotiated transactions, at a fixed public offering price or at varying
prices determined at the time of sale. We may offer the securities to the public through underwriting syndicates represented by
managing underwriters or by underwriters without a syndicate.
Unless
the prospectus supplement states otherwise, the obligations of the underwriters to purchase the securities will be subject to
the conditions set forth in the applicable underwriting agreement. Subject to certain conditions, the underwriters will be obligated
to purchase all of the securities offered by the prospectus supplement, other than securities covered by any over-allotment option.
Any public offering price and any discounts or concessions allowed or re-allowed or paid to dealers may change from time to time.
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 sell securities directly or through agents we designate from time to time. We will name any agent involved in the offering
and sale of securities, and we will describe any commissions we will pay the agent in the prospectus supplement. Unless the prospectus
supplement states otherwise, our agent will act on a best-efforts basis for the period of its appointment.
We
may authorize agents or underwriters to solicit offers by certain types of institutional investors to purchase 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. We will describe the conditions to these contracts and the commissions we must
pay for solicitation of these contracts in the prospectus supplement.
Dealers
We
may sell the offered securities to dealers as principals. The dealer may then resell such securities to the public either at varying
prices to be determined by the dealer or at a fixed offering price agreed to with us at the time of resale.
Institutional
Purchasers
We
may authorize agents, dealers or underwriters to solicit certain institutional investors to purchase offered securities on a delayed
delivery basis pursuant to delayed delivery contracts providing for payment and delivery on a specified future date. The applicable
prospectus supplement or other offering materials, as the case may be, will provide the details of any such arrangement, including
the offering price and commissions payable on the solicitations.
We
will enter into such delayed contracts only with institutional purchasers that we approve. These institutions may include commercial
and savings banks, insurance companies, pension funds, investment companies and educational and charitable institutions.
Indemnification;
Other Relationships
We
may provide agents, underwriters, dealers and remarketing firms with indemnification against certain civil liabilities, including
liabilities under the Securities Act, or contribution with respect to payments that the agents or underwriters may make with respect
to these liabilities. Agents, underwriters, dealers and remarketing firms, and their affiliates, may engage in transactions with,
or perform services for, us in the ordinary course of business. This includes commercial banking and investment banking transactions.
Market-Making;
Stabilization and Other Transactions
There
is currently no market for any of the offered securities, other than our common stock, which is quoted on The NASDAQ Capital Market.
If the offered securities are traded after their initial issuance, they may trade at a discount from their initial offering price,
depending upon prevailing interest rates, the market for similar securities and other factors. While it is possible that an underwriter
could inform us that it intends to make a market in the offered securities, such underwriter would not be obligated to do so,
and any such market-making could be discontinued at any time without notice. Therefore, no assurance can be given as to whether
an active trading market will develop for the offered securities. We have no current plans for listing of the debt securities,
preferred stock, warrants or subscription rights on any securities exchange or quotation system; any such listing with respect
to any particular debt securities, preferred stock, warrants or subscription rights will be described in the applicable prospectus
supplement or other offering materials, as the case may be.
Any
underwriter may engage in over-allotment, stabilizing transactions, short-covering transactions and penalty bids in accordance
with Regulation M under the Securities Exchange Act of 1934, as amended, or 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 price. Syndicate-covering or other short-covering transactions
involve purchases of the securities, either through exercise of the over-allotment option or 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 stabilizing or 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.
Any
underwriters or agents that are qualified market makers on The NASDAQ Capital Market may engage in passive market making transactions
in our common stock on The NASDAQ Capital Market in accordance with Regulation M under the Exchange Act, during the business day
prior to the pricing of the offering, before the commencement of offers or sales of our common stock. Passive market makers must
comply with applicable volume and price limitations and must be identified as passive market makers. In general, a passive market
maker must display its bid at a price not in excess of the highest independent bid for such security; if all independent bids
are lowered below the passive market maker’s bid, however, the passive market maker’s bid must then be lowered when
certain purchase limits are exceeded. Passive market making may stabilize the market price of the securities at a level above
that which might otherwise prevail in the open market and, if commenced, may be discontinued at any time.
Fees
and Commissions
If
5% or more of the net proceeds of any offering of securities made under this prospectus will be received by a FINRA member participating
in the offering or affiliates or associated persons of such FINRA member, the offering will be conducted in accordance with FINRA
Rule 5121.
DESCRIPTION
OF SECURITIES WE MAY OFFER
General
This
prospectus describes the general terms of our capital stock. The following description is not complete and may not contain all
the information you should consider before investing in our capital stock. For a more detailed description of these securities,
you should read the applicable provisions of Delaware law and our certificate of incorporation and our bylaws. When we offer to
sell a particular series of these securities, we will describe the specific terms of the series in a supplement to this prospectus.
Accordingly, for a description of the terms of any series of securities, you must refer to both the prospectus supplement relating
to that series and the description of the securities described in this prospectus. To the extent the information contained in
the prospectus supplement differs from this summary description, you should rely on the information in the prospectus supplement.
The
total number of shares of capital stock we are authorized to issue is 60,000,000 shares, of which (a) 50,000,000 are common stock
and (b) 10,000,000 are preferred stock.
We,
directly or through agents, dealers or underwriters designated from time to time, may offer, issue and sell, together or separately,
up to $75,000,000 in the aggregate of:
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common
stock;
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preferred
stock;
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warrants
to purchase our securities;
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subscription
rights to purchase our securities;
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secured
or unsecured debt securities consisting of notes, debentures or other evidences of indebtedness which may be senior debt securities,
senior subordinated debt securities or subordinated debt securities, each of which may be convertible into equity securities;
or
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units
comprised of, or other combinations of, the foregoing securities.
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We
may issue the debt securities as exchangeable for or convertible into shares of common stock, preferred stock or other securities
that may be sold by us pursuant to this prospectus or any combination of the foregoing. The preferred stock may also be exchangeable
for and/or convertible into shares of common stock, another series of preferred stock or other securities that may be sold by
us pursuant to this prospectus or any combination of the foregoing. When a particular series of securities is offered, a supplement
to this prospectus will be delivered with this prospectus, which will set forth the terms of the offering and sale of the offered
securities.
Common
Stock
As
of April 6, 2020, there were 19,132,138 shares of common stock issued and outstanding, held of record by approximately
109 stockholders. Subject to preferential rights with respect to any outstanding preferred stock, all outstanding
shares of common stock are of the same class and have equal rights and attributes. Under the terms of certificate of incorporation,
holders of our common stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders, including
the election of directors, and do not have cumulative voting rights. The holders of outstanding shares of common stock are entitled
to receive dividends out of assets or funds legally available for the payment of dividends of such times and in such amounts as
our board of directors from time to time may determine. Our common stock is not entitled to pre-emptive rights and is not subject
to conversion or redemption. Upon liquidation, dissolution or winding up of our company, the assets legally available for distribution
to stockholders are distributable ratably among the holders of our common stock after payment of liquidation preferences, if any,
on any outstanding payment of other claims of creditors. The rights, preferences and privileges of holders of common stock are
subject to and may be adversely affected by the rights of the holders of shares of any series of preferred stock that we may designate
and issue in the future.
Preferred
Stock
Our
certificate of incorporation empowers our board of directors, without action by our shareholders, to issue up to 10,00,000 shares
of preferred stock from time to time in one or more series, which preferred stock may be offered by this prospectus and supplements
thereto. As of April 6, 2020, there were no shares of preferred stock designated, issued or outstanding. Our board may
fix the rights, preferences, privileges, and restrictions of our authorized but undesignated preferred shares, including:
We
will fix the rights, preferences, privileges and restrictions of the preferred stock of each series in the certificate of designation
relating to that series. We will file as an exhibit to the registration statement of which this prospectus is a part, or will
incorporate by reference from a current report on Form 8-K that we file with the SEC, the form of any certificate of designation
that describes the terms of the series of preferred stock we are offering before the issuance of the related series of preferred
stock. This description will include any or all of the following, as required:
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the
title and stated value;
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the
number of shares we are offering;
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the
liquidation preference per share;
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the
purchase price;
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the
dividend rate, period and payment date and method of calculation for dividends;
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whether
dividends will be cumulative or non-cumulative and, if cumulative, the date from which dividends will accumulate;
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any
contractual limitations on our ability to declare, set aside or pay any dividends;
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the
procedures for any auction and remarketing, if any;
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the
provisions for a sinking fund, if any;
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the
provisions for redemption or repurchase, if applicable, and any restrictions on our ability to exercise those redemption and
repurchase rights;
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any
listing of the preferred stock on any securities exchange or market;
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whether
the preferred stock will be convertible into our common stock, and, if applicable, the conversion price, or how it will be
calculated, and the conversion period;
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whether
the preferred stock will be exchangeable into debt securities, and, if applicable, the exchange price, or how it will be calculated,
and the exchange period;
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voting
rights, if any, of the preferred stock;
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preemptive
rights, if any;
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restrictions
on transfer, sale or other assignment, if any;
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a
discussion of any material or special United States federal income tax considerations applicable to the preferred stock;
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the
relative ranking and preferences of the preferred stock as to dividend rights and rights if we liquidate, dissolve or wind
up our affairs;
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any
limitations on issuance of any class or series of preferred stock ranking senior to or on a parity with the series of preferred
stock as to dividend rights and rights if we liquidate, dissolve or wind up our affairs; and
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any
other specific terms, preferences, rights or limitations of, or restrictions on, the preferred stock.
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If
we issue shares of preferred stock under this prospectus, after receipt of payment therefor, the shares will be fully paid and
non-assessable.
The
DGCL provides that the holders of preferred stock will have the right to vote separately as a class on any proposal involving
fundamental changes in the rights of holders of that preferred stock. This right is in addition to any voting rights provided
for in the applicable certificate of designation.
Our
board of directors may authorize the issuance of preferred stock with voting or conversion rights that could adversely affect
the voting power or other rights of the holders of our common stock. Preferred stock could be issued quickly with terms designed
to delay or prevent a change in control of our Company or make removal of management more difficult. Additionally, the issuance
of preferred stock could have the effect of decreasing the market price of our common stock.
Warrants
We
may issue warrants to purchase our securities or other rights, including rights to receive payment in cash or securities based
on the value, rate or price of one or more specified commodities, currencies, securities or indices, or any combination of the
foregoing. Warrants may be issued independently or together with any other securities that may be sold by us pursuant to this
prospectus or any combination of the foregoing and may be attached to, or separate from, such securities. To the extent warrants
that we issue are to be publicly-traded, each series of such warrants will be issued under a separate warrant agreement to be
entered into between us and a warrant agent.
We
will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from
a current report on Form 8-K that we file with the SEC, forms of the warrant and warrant agreement, if any. The prospectus supplement
relating to any warrants that we may offer will contain the specific terms of the warrants and a description of the material provisions
of the applicable warrant agreement, if any. These terms may include the following:
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the
title of the warrants;
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the
price or prices at which the warrants will be issued;
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the
designation, amount and terms of the securities or other rights for which the warrants are exercisable;
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the
designation and terms of the other securities, if any, with which the warrants are to be issued and the number of warrants
issued with each other security;
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the
aggregate number of warrants;
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any
provisions for adjustment of the number or amount of securities receivable upon exercise of the warrants or the exercise price
of the warrants;
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the
price or prices at which the securities or other rights purchasable upon exercise of the warrants may be purchased;
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if
applicable, the date on and after which the warrants and the securities or other rights purchasable upon exercise of the warrants
will be separately transferable;
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a
discussion of any material U.S. federal income tax considerations applicable to the exercise of the warrants;
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the
date on which the right to exercise the warrants will commence, and the date on which the right will expire;
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the
maximum or minimum number of warrants that may be exercised at any time;
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information
with respect to book-entry procedures, if any; 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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Exercise
of Warrants. Each warrant will entitle the holder of warrants to purchase the amount of securities or other rights, at the
exercise price stated or determinable in the prospectus supplement for the warrants. Warrants may be exercised at any time up
to the close of business on the expiration date shown in the applicable prospectus supplement, unless otherwise specified in such
prospectus supplement. After the close of business on the expiration date, if applicable, unexercised warrants will become void.
Warrants may be exercised in the manner described in the applicable prospectus supplement. When the warrant holder makes the payment
and properly completes and signs the warrant certificate at the corporate trust office of the warrant agent, if any, or any other
office indicated in the prospectus supplement, we will, as soon as possible, forward the securities or other rights that the warrant
holder has purchased. If the warrant holder exercises less than all of the warrants represented by the warrant certificate, we
will issue a new warrant certificate for the remaining warrants.
Subscription
Rights
We
may issue rights to purchase our securities. The rights may or may not be transferable by the persons purchasing or receiving
the rights. In connection with any rights offering, we may enter into a standby underwriting or other arrangement with one or
more underwriters or other persons pursuant to which such underwriters or other persons would purchase any offered securities
remaining unsubscribed for after such rights offering. In connection with a rights offering to holders of our capital stock a
prospectus supplement will be distributed to such holders on the record date for receiving rights in the rights offering set by
us.
We
will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from
a current report on Form 8-K that we file with the SEC, forms of the subscription rights, standby underwriting agreement or other
agreements, if any. The prospectus supplement relating to any rights that we offer will include specific terms relating to the
offering, including, among other matters:
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the
date of determining the security holders entitled to the rights distribution;
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the
aggregate number of rights issued and the aggregate amount of securities purchasable upon exercise of the rights;
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the
exercise price;
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the
conditions to completion of the rights offering;
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the
date on which the right to exercise the rights will commence and the date on which the rights will expire; and
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any
applicable federal income tax considerations.
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Each
right would entitle the holder of the rights to purchase the principal amount of securities at the exercise price set forth in
the applicable prospectus supplement. Rights may be exercised at any time up to the close of business on the expiration date for
the rights provided in the applicable prospectus supplement. After the close of business on the expiration date, all unexercised
rights will become void.
Holders
may exercise rights as described in the applicable prospectus supplement. Upon receipt of payment and the rights certificate properly
completed and duly executed at the corporate trust office of the rights agent, if any, or any other office indicated in the prospectus
supplement, we will, as soon as practicable, forward the securities purchasable upon exercise of the rights. If less than all
of the rights issued in any rights offering are exercised, we may offer any unsubscribed securities directly to persons other
than stockholders, to or through agents, underwriters or dealers or through a combination of such methods, including pursuant
to standby underwriting arrangements, as described in the applicable prospectus supplement.
Debt
Securities
As
used in this prospectus, the term “debt securities” means the debentures, notes, bonds and other evidences of indebtedness
that we may issue from time to time. The debt securities will either be senior debt securities, senior subordinated debt or subordinated
debt securities. We may also issue convertible debt securities. Debt securities may be issued under an indenture (which we refer
to herein as an Indenture), which are contracts entered into between us and a trustee to be named therein. The Indenture has been
filed as an exhibit to the registration statement of which this prospectus forms a part. We may issue debt securities and incur
additional indebtedness other than through the offering of debt securities pursuant to this prospectus. It is likely that convertible
debt securities will not be issued under an Indenture.
The
debt securities may be fully and unconditionally guaranteed on a secured or unsecured senior or subordinated basis by one or more
guarantors, if any. The obligations of any guarantor under its guarantee will be limited as necessary to prevent that guarantee
from constituting a fraudulent conveyance under applicable law. In the event that any series of debt securities will be subordinated
to other indebtedness that we have outstanding or may incur, the terms of the subordination will be set forth in the prospectus
supplement relating to the subordinated debt securities.
We
may issue debt securities from time to time in one or more series, in each case with the same or various maturities, at par or
at a discount. Unless indicated in a prospectus supplement, we may issue additional debt securities of a particular series without
the consent of the holders of the debt securities of such series outstanding at the time of the issuance. Any such additional
debt securities, together with all other outstanding debt securities of that series, will constitute a single series of debt securities
under the applicable Indenture and will be equal in ranking.
Should
an Indenture relate to unsecured indebtedness, in the event of a bankruptcy or other liquidation event involving a distribution
of assets to satisfy our outstanding indebtedness or an event of default under a loan agreement relating to secured indebtedness
of our company or its subsidiaries, the holders of such secured indebtedness, if any, would be entitled to receive payment of
principal and interest prior to payments on the unsecured indebtedness issued under an Indenture.
Each
prospectus supplement will describe the terms relating to the specific series of debt securities. These terms will include some
or all of the following:
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the
title of debt securities and whether the debt securities are senior or subordinated;
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any
limit on the aggregate principal amount of debt securities of such series;
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the
percentage of the principal amount at which the debt securities of any series will be issued;
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the
ability to issue additional debt securities of the same series;
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the
purchase price for the debt securities and the denominations of the debt securities;
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the
specific designation of the series of debt securities being offered;
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the
maturity date or dates of the debt securities and the date or dates upon which the debt securities are payable and the rate
or rates at which the debt securities of the series shall bear interest, if any, which may be fixed or variable, or the method
by which such rate shall be determined;
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the
basis for calculating interest;
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the
date or dates from which any interest will accrue or the method by which such date or dates will be determined;
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the
duration of any deferral period, including the period during which interest payment periods may be extended;
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whether
the amount of payments of principal of (and premium, if any) or interest on the debt securities may be determined with reference
to any index, formula or other method, such as one or more currencies, commodities, equity indices or other indices, and the
manner of determining the amount of such payments;
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the
dates on which we will pay interest on the debt securities and the regular record date for determining who is entitled to
the interest payable on any interest payment date;
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the
place or places where the principal of (and premium, if any) and interest on the debt securities will be payable, where any
securities may be surrendered for registration of transfer, exchange or conversion, as applicable, and notices and demands
may be delivered to or upon us pursuant to the applicable Indenture;
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the
rate or rates of amortization of the debt securities;
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any
terms for the attachment to the debt securities of warrants, options or other rights to purchase or sell our securities;
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if
the debt securities will be secured by any collateral and, if so, a general description of the collateral and the terms and
provisions of such collateral security, pledge or other agreements;
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if
we possess the option to do so, the periods within which and the prices at which we may redeem the debt securities, in whole
or in part, pursuant to optional redemption provisions, and the other terms and conditions of any such provisions;
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our
obligation or discretion, if any, to redeem, repay or purchase debt securities by making periodic payments to a sinking fund
or through an analogous provision or at the option of holders of the debt securities, and the period or periods within which
and the price or prices at which we will redeem, repay or purchase the debt securities, in whole or in part, pursuant to such
obligation, and the other terms and conditions of such obligation;
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the
terms and conditions, if any, regarding the option or mandatory conversion or exchange of debt securities;
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the
period or periods within which, the price or prices at which and the terms and conditions upon which any debt securities of
the series may be redeemed, in whole or in part at our option and, if other than by a board resolution, the manner in which
any election by us to redeem the debt securities shall be evidenced;
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any
restriction or condition on the transferability of the debt securities of a particular series;
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the
portion, or methods of determining the portion, of the principal amount of the debt securities which we must pay upon the
acceleration of the maturity of the debt securities in connection with any event of default;
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the
currency or currencies in which the debt securities will be denominated and in which principal, any premium and any interest
will or may be payable or a description of any units based on or relating to a currency or currencies in which the debt securities
will be denominated;
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provisions,
if any, granting special rights to holders of the debt securities upon the occurrence of specified events;
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any
deletions from, modifications of or additions to the events of default or our covenants with respect to the applicable series
of debt securities, and whether or not such events of default or covenants are consistent with those contained in the applicable
Indenture;
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any
limitation on our ability to incur debt, redeem stock, sell our assets or other restrictions;
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the
application, if any, of the terms of the applicable Indenture relating to defeasance and covenant defeasance (which terms
are described below) to the debt securities;
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what
subordination provisions will apply to the debt securities
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the
terms, if any, upon which the holders may convert or exchange the debt securities into or for our securities or property;
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whether
we are issuing the debt securities in whole or in part in global form;
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any
change in the right of the trustee or the requisite holders of debt securities to declare the principal amount thereof due
and payable because of an event of default;
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the
depositary for global or certificated debt securities, if any;
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any
material federal income tax consequences applicable to the debt securities, including any debt securities denominated and
made payable, as described in the prospectus supplements, in foreign currencies, or units based on or related to foreign currencies;
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any
right we may have to satisfy, discharge and defease our obligations under the debt securities, or terminate or eliminate restrictive
covenants or events of default in the Indentures, by depositing money or U.S. government obligations with the trustee of the
Indentures;
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the
names of any trustees, depositories, authenticating or paying agents, transfer agents or registrars or other agents with respect
to the debt securities;
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to
whom any interest on any debt security shall be payable, if other than the person in whose name the security is registered,
on the record date for such interest, the extent to which, or the manner in which, any interest payable on a temporary global
debt security will be paid;
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if
the principal of or any premium or interest on any debt securities is to be payable in one or more currencies or currency
units other than as stated, the currency, currencies or currency units in which it shall be paid and the periods within and
terms and conditions upon which such election is to be made and the amounts payable (or the manner in which such amount shall
be determined);
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the
portion of the principal amount of any debt securities which shall be payable upon declaration of acceleration of the maturity
of the debt securities pursuant to the applicable Indenture;
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if
the principal amount payable at the stated maturity of any debt security of the series will not be determinable as of any
one or more dates prior to the stated maturity, the amount which shall be deemed to be the principal amount of such debt securities
as of any such date for any purpose, including the principal amount thereof which shall be due and payable upon any maturity
other than the stated maturity or which shall be deemed to be outstanding as of any date prior to the stated maturity (or,
in any such case, the manner in which such amount deemed to be the principal amount shall be determined); and
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any
other specific terms of the debt securities, including any modifications to the events of default under the debt securities
and any other terms which may be required by or advisable under applicable laws or regulations.
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Unless
otherwise specified in the applicable prospectus supplement, we do not anticipate the debt securities will be listed on any securities
exchange. Holders of the debt securities may present registered debt securities for exchange or transfer in the manner described
in the applicable prospectus supplement. Except as limited by the applicable Indenture, we will provide these services without
charge, other than any tax or other governmental charge payable in connection with the exchange or transfer.
Debt
securities may bear interest at a fixed rate or a variable rate as specified in the prospectus supplement. In addition, if specified
in the prospectus supplement, we may sell debt securities bearing no interest or interest a t a rate that at the time of issuance
is below the prevailing market rate, or at a discount below their stated principal amount. We will describe in the applicable
prospectus supplement any special federal income tax considerations applicable to these discounted debt securities.
We
may issue debt securities with the principal amount payable on any principal payment date, or the amount of interest payable on
any interest payment date, to be determined by referring to one or more currency exchange rates, commodity prices, equity indices
or other factors. Holders of such debt securities may receive a principal amount on any principal payment date, or interest payments
on any interest payment date, that are greater or less than the amount of principal or interest otherwise payable on such dates,
depending upon the value on such dates of applicable currency, commodity, equity index or other factors. The applicable prospectus
supplement will contain information as to how we will determine the amount of principal or interest payable on any date, as well
as the currencies, commodities, equity indices or other factors to which the amount payable on that date relates and certain additional
tax considerations.
Units
We
may issue units consisting of any combination of the other types of securities offered under this prospectus in one or more series.
We may evidence each series of units by unit certificates that we may issue under a separate agreement. We may enter into unit
agreements with a unit agent. Each unit agent, if any, may be a bank or trust company that we select. We will indicate the name
and address of the unit agent, if any, in the applicable prospectus supplement relating to a particular series of units. Specific
unit agreements, if any, will contain additional important terms and provisions. We will file as an exhibit to the registration
statement of which this prospectus is a part, or will incorporate by reference from a current report that we file with the SEC,
the form of unit and the form of each unit agreement, if any, relating to units offered under this prospectus.
If
we offer any units, certain terms of that series of units will be described in the applicable prospectus supplement, including,
without limitation, the following, as applicable:
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the
title of the series of units;
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identification
and description of the separate constituent securities comprising the units;
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the
price or prices at which the units will be issued;
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the
date, if any, on and after which the constituent securities comprising the units will be separately transferable;
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a
discussion of certain United States federal income tax considerations applicable to the units; and
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any
other material terms of the units and their constituent securities.
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Delaware
Anti-Takeover Law and Provisions of Our Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws
Some
provisions of Delaware law, our certificate of incorporation and our bylaws contain provisions that could make the following transactions
more difficult: an acquisition of us by means of a tender offer; an acquisition of us by means of a proxy contest or otherwise;
or the removal of our incumbent officers and directors. It is possible that these provisions could make it more difficult to accomplish
or could deter transactions that stockholders may otherwise consider to be in their best interest or in our best interests, including
transactions which provide for payment of a premium over the market price for our shares.
These
provisions, summarized below, are intended to discourage coercive takeover practices and inadequate takeover bids. These provisions
are also designed to encourage persons seeking to acquire control of us to first negotiate with our board of directors. We believe
that the benefits of the increased protection of our potential ability to negotiate with the proponent of an unfriendly or unsolicited
proposal to acquire or restructure us outweigh the disadvantages of discouraging these proposals because negotiation of these
proposals could result in an improvement of their terms.
Delaware
Anti-Takeover Law
We
are subject to Section 203 of the DGCL. Section 203 generally prohibits a publicly traded corporation from engaging in a “business
combination” with an “interested stockholder” for a period of three years after the date of the transaction
in which the person became an interested stockholder, unless:
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prior
to the date of the transaction, the board of directors of the corporation approved either the business combination or the
transaction which resulted in the stockholder becoming an interested stockholder;
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upon
consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder
owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding specified
shares; or
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at
or subsequent to the date of the transaction, the business combination is approved by the board of directors and authorized
at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2/3 %
of the outstanding voting stock which is not owned by the interested stockholder.
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Section
203 defines a “business combination” to include:
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any
merger or consolidation involving the corporation and the interested stockholder;
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any
sale, lease, exchange, mortgage, pledge, transfer or other disposition of 10% or more of the assets of the corporation to
or with the interested stockholder;
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subject
to exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation
to the interested stockholder;
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subject
to exceptions, any transaction involving the corporation that has the effect of increasing the proportionate share of the
stock of any class or series of the corporation beneficially owned by the interested stockholder; or
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the
receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits
provided by or through the corporation.
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In
general, Section 203 defines an “interested stockholder” as any person that is:
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the
owner of 15% or more of the outstanding voting stock of the corporation;
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an
affiliate or associate of the corporation who was the owner of 15% or more of the outstanding voting stock of the corporation
at any time within three years immediately prior to the relevant date; or
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the
affiliates and associates of the above.
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Under
specific circumstances, Section 203 makes it more difficult for an “interested stockholder” to effect various business
combinations with a corporation for a three-year period, although the stockholders may, by adopting an amendment to the corporation’s
certificate of incorporation or bylaws, elect not to be governed by this section, effective 12 months after adoption.
Our
certificate of incorporation and bylaws do not exclude us from the restrictions of Section 203. We anticipate that the provisions
of Section 203 might encourage companies interested in acquiring us to negotiate in advance with our board of directors since
the stockholder approval requirement would be avoided if a majority of the directors then in office approve either the business
combination or the transaction that resulted in the stockholder becoming an interested stockholder.
Undesignated
Preferred Stock
The
ability of our board of directors, without action by the stockholders, to issue up to 10,000,000 shares of undesignated preferred
stock with voting or other rights or preferences as designated by our board of directors could impede the success of any attempt
to change control of us. These and other provisions may have the effect of deferring hostile takeovers or delaying changes in
control or management of our company.
Stockholder
Meetings
Our
certificate of incorporation and bylaws provide that a special meeting of stockholders may be called only by our chairman of the
board, chief executive officer or president, or by a resolution adopted by a majority of our board of directors.
Requirements
for Advance Notification of Stockholder Nominations and Proposals
Our
bylaws establish advance notice procedures with respect to stockholder proposals to be brought before a stockholder meeting and
the nomination of candidates for election as directors, other than nominations made by or at the direction of the board of directors
or a committee of the board of directors.
Elimination
of Stockholder Action by Written Consent
Our
certificate of incorporation and bylaws eliminate the right of stockholders to act by written consent without a meeting.
Removal
of Directors
Our
certificate of incorporation provides that no member of our board of directors may be removed from office by our stockholders
except for cause and, in addition to any other vote required by law, upon the approval of not less than two-thirds of the total
voting power of all of our outstanding voting stock then entitled to vote in the election of directors.
Stockholders
Not Entitled to Cumulative Voting
Our
certificate of incorporation does not permit stockholders to cumulate their votes in the election of directors. Accordingly, the
holders of a majority of the outstanding shares of our common stock entitled to vote in any election of directors can elect all
of the directors standing for election, if they choose, other than any directors that holders of our preferred stock may be entitled
to elect.
Choice
of Forum
Our
certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for any
derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a
claim against us arising pursuant to the DGCL, our certificate of incorporation or our bylaws; any action to interpret, apply,
enforce, or determine the validity of our certificate of incorporation or bylaws; or any action asserting a claim against us that
is governed by the internal affairs doctrine. The enforceability of similar choice of forum provisions in other companies’
certificates of incorporation has been challenged in legal proceedings, and it is possible that a court could find these types
of provisions to be inapplicable or unenforceable.
Amendment
Provisions
The
amendment of any of the above provisions, except for the provision making it possible for our board of directors to issue preferred
stock, would require approval by holders of at least two thirds of the total voting power of all of our outstanding voting stock.
The
provisions of the DGCL, our amended and restated certificate of incorporation and our amended and restated bylaws could have the
effect of discouraging others from attempting hostile takeovers and, as a consequence, they may also inhibit temporary fluctuations
in the market price of our common stock that often result from actual or rumored hostile takeover attempts. These provisions may
also have the effect of preventing changes in the composition of our board and management. It is possible that these provisions
could make it more difficult to accomplish transactions that stockholders may otherwise deem to be in their best interests.
FORMS
OF SECURITIES
Each
security may be represented either by a certificate issued in definitive form to a particular investor or by one or more global
securities representing the entire issuance of securities. Certificated securities in definitive form and global securities will
be issued in registered form. Definitive securities name you or your nominee as the owner of the security, and in order to transfer
or exchange these securities or to receive payments other than interest or other interim payments, you or your nominee must physically
deliver the securities to the trustee, registrar, paying agent or other agent, as applicable. Global securities name a depositary
or its nominee as the owner of the debt securities, warrants or units represented by these global securities. The depositary maintains
a computerized system that will reflect each investor’s beneficial ownership of the securities through an account maintained
by the investor with its broker/dealer, bank, trust company or other representative, as we explain more fully below.
Registered
Global Securities
We
may issue the securities in the form of one or more fully registered global securities that will be deposited with a depositary
or its nominee identified in the applicable prospectus supplement and registered in the name of that depositary or nominee. In
those cases, one or more registered global securities will be issued in a denomination or aggregate denominations equal to the
portion of the aggregate principal or face amount of the securities to be represented by registered global securities. Unless
and until it is exchanged in whole for securities in definitive registered form, a registered global security may not be transferred
except as a whole by and among the depositary for the registered global security, the nominees of the depositary or any successors
of the depositary or those nominees.
The
specific terms of the depositary arrangement with respect to any securities to be represented by a registered global security
will be described in the prospectus supplement relating to those securities. We anticipate that the following provisions will
apply to all depositary arrangements.
Ownership
of beneficial interests in a registered global security will be limited to persons, called participants, that have accounts with
the depositary or persons that may hold interests through participants. Upon the issuance of a registered global security, the
depositary will credit, on its book-entry registration and transfer system, the participants’ accounts with the respective
principal or face amounts of the securities beneficially owned by the participants. Any dealers, underwriters or agents participating
in the distribution of the securities will designate the accounts to be credited. Ownership of beneficial interests in a registered
global security will be shown on, and the transfer of ownership interests will be effected only through, records maintained by
the depositary, with respect to interests of participants, and on the records of participants, with respect to interests of persons
holding through participants. The laws of some states may require that some purchasers of securities take physical delivery of
these securities in definitive form. These laws may impair your ability to own, transfer or pledge beneficial interests in registered
global securities.
So
long as the depositary, or its nominee, is the registered owner of a registered global security, that depositary or its nominee,
as the case may be, will be considered the sole owner or holder of the securities represented by the registered global security
for all purposes under the applicable indenture, warrant agreement or unit agreement.
Except
as described below, owners of beneficial interests in a registered global security will not be entitled to have the securities
represented by the registered global security registered in their names, will not receive or be entitled to receive physical delivery
of the securities in definitive form and will not be considered the owners or holders of the securities under the applicable indenture,
warrant agreement or unit agreement. Accordingly, each person owning a beneficial interest in a registered global security must
rely on the procedures of the depositary for that registered global security and, if that person is not a participant, on the
procedures of the participant through which the person owns its interest, to exercise any rights of a holder under the applicable
indenture, warrant agreement or unit agreement. We understand that under existing industry practices, if we request any action
of holders or if an owner of a beneficial interest in a registered global security desires to give or take any action that a holder
is entitled to give or take under the applicable indenture, warrant agreement or unit agreement, the depositary for the registered
global security would authorize the participants holding the relevant beneficial interests to give or take that action, and the
participants would authorize beneficial owners owning through them to give or take that action or would otherwise act upon the
instructions of beneficial owners holding through them.
Payments
to holders with respect to securities represented by a registered global security registered in the name of a depositary or its
nominee will be made to the depositary or its nominee, as the case may be, as the registered owner of the registered global security.
None of the Company, the trustees, the warrant agents, the unit agents or any other agent of the Company, agent of the trustees,
the warrant agents or unit agents will have any responsibility or liability for any aspect of the records relating to payments
made on account of beneficial ownership interests in the registered global security or for maintaining, supervising or reviewing
any records relating to those beneficial ownership interests.
We
expect that the depositary for any of the securities represented by a registered global security, upon receipt of any payment
of principal, premium, interest or other payment or distribution to holders of that registered global security, will immediately
credit participants’ accounts in amounts proportionate to their respective beneficial interests in that registered global
security as shown on the records of the depositary. We also expect that payments by participants to owners of beneficial interests
in a registered global security held through participants will be governed by standing customer instructions and customary practices,
as is now the case with the securities held for the accounts of customers or registered in “street name,” and will
be the responsibility of those participants.
If
the depositary for any of these securities represented by a registered global security is at any time unwilling or unable to continue
as depositary or ceases to be a clearing agency registered under the Exchange Act and a successor depositary registered as a clearing
agency under the Exchange Act is not appointed by us within 90 days, we will issue securities in definitive form in exchange for
the registered global security that had been held by the depositary. Any securities issued in definitive form in exchange for
a registered global security will be registered in the name or names that the depositary gives to the relevant trustee, warrant
agent, unit agent or other relevant agent of ours or theirs. It is expected that the depositary’s instructions will be based
upon directions received by the depositary from participants with respect to ownership of beneficial interests in the registered
global security that had been held by the depositary.
LEGAL
MATTERS
Unless
otherwise indicated in the applicable prospectus supplement, the validity of the securities offered by this prospectus will be
passed upon for us by Ellenoff Grossman & Schole LLP, New York, New York. If legal matters in connection with offerings made
by this prospectus are passed on by counsel for the underwriters, dealers or agents, if any, that counsel will be named in the
applicable prospectus supplement.
EXPERTS
The financial statements
of Hancock Jaffe Laboratories, Inc. as of December 31, 2019 and 2018 and for each of the years ended December 31, 2019
and 2018 have been audited by Marcum LLP, an independent registered public accounting firm, as stated in their report
appearing herein. Such financial statements are included in this prospectus and registration statement in reliance upon
the report (which report includes an explanatory paragraph relating to our ability to continue as a going concern) of Marcum LLP,
appearing elsewhere herein, and upon the authority of such firm as experts in accounting and auditing.
WHERE
YOU CAN FIND ADDITIONAL INFORMATION
We
file annual, quarter and periodic reports, proxy statements and other information with the Securities and Exchange Commission
using the Commission’s EDGAR system. The Commission maintains a web site that contains reports, proxy and information statements
and other information regarding registrants that file electronically with the Commission. The address of such site is http//www.sec.gov.
INCORPORATION
OF DOCUMENTS BY REFERENCE
We
are “incorporating by reference” in this prospectus certain documents we file with the SEC, which means that we can
disclose important information to you by referring you to those documents. The information in the documents incorporated by reference
is considered to be part of this prospectus. Statements contained in documents that we file with the SEC and that are incorporated
by reference in this prospectus will automatically update and supersede information contained in this prospectus, including information
in previously filed documents or reports that have been incorporated by reference in this prospectus, to the extent the new information
differs from or is inconsistent with the old information. We have filed or may file the following documents with the SEC and they
are incorporated herein by reference as of their respective dates of filing.
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1.
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Our
Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 18, 2020;
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|
2.
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Our
Current Reports on Form 8-K filed with the SEC on March 2, 2020, March 25, 2020 and April 3, 2020; and
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3.
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The description of our common stock contained in our Registration
Statement on Form 8-A, filed on May 25, 2018 pursuant to Section 12(b) of the Exchange Act, which incorporates by reference the
description of the shares of our common stock contained in the section entitled “Description of Securities” in our
Registration Statement on Form S-1 (File No. 333-220372), as initially filed with the SEC on September 7, 2017, as amended, and
any amendment or report filed with the SEC for purposes of updating such description.
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All
documents that we filed with the SEC pursuant to Sections 13(a), 13(c), 14, and 15(d) of the Exchange Act subsequent to the date
of this registration statement and prior to the filing of a post-effective amendment to this registration statement that indicates
that all securities offered under this prospectus have been sold, or that deregisters all securities then remaining unsold, will
be deemed to be incorporated in this registration statement by reference and to be a part hereof from the date of filing of such
documents.
Any
statement contained in a document incorporated or deemed to be incorporated by reference in this prospectus shall be deemed modified,
superseded or replaced for purposes of this prospectus to the extent that a statement contained in this prospectus, or in any
subsequently filed document that also is deemed to be incorporated by reference in this prospectus, modifies, supersedes or replaces
such statement. Any statement so modified, superseded or replaced shall not be deemed, except as so modified, superseded or replaced,
to constitute a part of this prospectus. None of the information that we disclose under Items 2.02 or 7.01 of any Current Report
on Form 8-K or any corresponding information, either furnished under Item 9.01 or included as an exhibit therein, that we may
from time to time furnish to the SEC will be incorporated by reference into, or otherwise included in, this prospectus, except
as otherwise expressly set forth in the relevant document. Subject to the foregoing, all information appearing in this prospectus
is qualified in its entirety by the information appearing in the documents incorporated by reference.
You
may requests, orally or in writing, a copy of these documents, which will be provided to you at no cost (other than exhibits,
unless such exhibits are specifically incorporate by reference), by contacting the Company at Hancock Jaffe
Laboratories, Inc., at 70 Doppler, Irvine, California 92618, attention: Corporate Secretary. Our telephone number is
(949) 261-2900. Information about us is also available at our website at http://www.hancockjaffe.com/. However, the
information in our website is not a part of this prospectus and is not incorporated by reference.
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
14. Other Expenses of Issuance and Distribution.
The
Company is paying all expenses of the offering. The following table sets forth all expenses to be paid by the registrant. All
amounts shown are estimates except for the registration fee.
SEC registration fee
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$
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9,735
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Legal fees and expenses
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$
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15,000
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Accounting fees and expenses
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$
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8,500
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Trustees’ Fees and Expenses
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*
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Warrant Agent Fees and Expenses
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*
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Miscellaneous
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*
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Total
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$
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33,235
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*
These fees are calculated based on the securities offered and the number of issuances and accordingly cannot be estimated at this
time. The applicable prospectus supplement will set forth the estimated amount of expenses of any offering of securities.
Item
15. Indemnification of Directors and Officers.
Section
102 of the General Corporation Law of the State of Delaware permits a corporation to eliminate the personal liability of directors
of a corporation to the corporation or its stockholders for monetary damages for a breach of fiduciary duty as a director, except
for breaches of the director’s duty of loyalty to the corporation or its stockholders, acts or omissions not in good faith
or which involve intentional misconduct or a knowing violation of a law, authorizations of the payments of a dividend or approval
of a stock repurchase or redemption in violation of Delaware corporate law or for any transactions from which the director derived
an improper personal benefit. Our amended and restated certificate of incorporation provides that no director will be liable to
us or our stockholders for monetary damages for breach of fiduciary duties as a director, subject to the same exceptions as described
above. We have entered into indemnification agreements with each of our directors which may, in some cases, be broader than the
specific indemnification provisions contained under Delaware law. We also expect to maintain standard insurance policies that
provide coverage (1) to our directors and officers against loss arising from claims made by reason of breach of duty or other
wrongful act and (2) to us with respect to indemnification payments we may make to such officers and directors.
Section
145 of the General Corporation Law of the State of Delaware provides that a corporation has the power 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 a threatened, pending, or completed action, suit or proceeding to which he or she is
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,
indemnification is limited to expenses (including attorneys’ fees) actually and reasonably incurred by the person in connection
with defense or settlement of such action or suit and 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 indemnity for such expenses which the Court of Chancery or such
other court shall deem proper. In addition, to the extent that a present or former director or officer of a corporation has been
successful on the merits or otherwise in defense of any action, suit, or proceeding described above (or claim, issue, or matter
therein), such person shall be indemnified against expenses (including attorneys’ fees) actually and reasonably incurred
by such person in connection therewith. Expenses (including attorneys’ fees) incurred by an officer or director in defending
any civil, criminal, administrative, or investigative action, suit, or proceeding may be advanced by the corporation upon receipt
of an undertaking by such person to repay such amount if it is ultimately determined that such person is not entitled to indemnification
by the corporation under Section 145 of the General Corporation Law of the State of Delaware. Our amended and restated certificate
of incorporation provides that we will, to the fullest extent permitted by law, indemnify any person made or threatened to be
made a party to an action or proceeding by reason of the fact that he or she (or his or her testators or intestate) is or was
our director or officer or serves or served at any other corporation, partnership, joint venture, trust or other enterprise in
a similar capacity or as an employee or agent at our request, including service with respect to employee benefit plans maintained
or sponsored by us, against expenses (including attorneys’), judgments, fines, penalties and amounts paid in settlement
incurred in connection with the investigation, preparation to defend, or defense of such action, suit, proceeding, or claim. However,
we are not required to indemnify or advance expenses in connection with any action, suit, proceeding, claim, or counterclaim initiated
by us or on behalf of us. Our amended and restated bylaws provides that we will indemnify and hold harmless each person who was
or is a party or threatened to be made a party to any action, suit, or proceeding by reason of the fact that he or she is or was
our director or officer, or is or was serving at our request in a similar capacity of another corporation, partnership, joint
venture, trust or other enterprise, including service with respect to employee benefit plans (whether the basis of such action,
suit, or proceeding is an action in an official capacity as a director or officer or in any other capacity while serving as a
director of officer) to the fullest extent authorized by the Delaware General Corporation Law against all expense, liability and
loss (including attorney’s fees, judgments, fines, ERISA excise taxes, or penalties and amounts paid in settlement) reasonably
incurred or suffered by such person in connection with such action, suit or proceeding, and this indemnification continues after
such person has ceased to be an officer or director and inures to the benefit of such person’s heirs, executors and administrators.
The indemnification rights also include the right generally to be advanced expenses, subject to any undertaking required under
Delaware General Corporation Law, and the right generally to recover expenses to enforce an indemnification claim or to defend
specified suits with respect to advances of indemnification expenses.
Item
16. Exhibits.
The
following exhibits are filed with this Registration Statement.
The
agreements included or incorporated by reference as exhibits to this registration statement contain representations and warranties
by each of the parties to the applicable agreement. These representations and warranties were made solely for the benefit of the
other parties to the applicable agreement and (i) were not intended to be treated as categorical statements of fact, but rather
as a way of allocating the risk to one of the parties if those statements prove to be inaccurate; (ii) may have been qualified
in such agreement by disclosures that were made to the other party in connection with the negotiation of the applicable agreement;
(iii) may apply contract standards of “materiality” that are different from “materiality” under the applicable
securities laws; and (iv) were made only as of the date of the applicable agreement or such other date or dates as may be specified
in the agreement.
The
undersigned registrant acknowledges that, notwithstanding the inclusion of the foregoing cautionary statements, it is responsible
for considering whether additional specific disclosures of material information regarding material contractual provisions are
required to make the statements in this registration statement not misleading.
*
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Filed
herewith.
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|
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**
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If
applicable, to be filed by an amendment or as an exhibit to a report pursuant to section 13(a) or section 15(d) of the Exchange
Act and incorporated by reference
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|
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+
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To be filed pursuant
to Rule 305(b)(2) of the Trust Indenture Act.
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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 of 1933;
(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 prospectus filed with the Commission pursuant to Rule
424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering
price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
(iii)
to include any material information with respect to the plan of distribution not previously disclosed in the registration statement
or any material change to such information in the registration statement;
provided
, however , that paragraphs (1)(i), (1)(ii) and (1)(iii) do not apply if the information required to be included in
a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant
pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 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 of 1933, 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 of 1933 to any purchaser:
(i)
Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as
of the date the filed prospectus was deemed part of and included in the registration statement; and
(ii)
Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance
on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information
required by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement
as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale
of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and
any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement
relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration
statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by
reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with
a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement
or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.
(5)
That, for the purpose of determining liability of the registrant under the Securities Act of 1933 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 of the registrant under the Securities
Act of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities
Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to section
15(d) of the Securities Exchange Act of 1934) 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)
The undersigned registrant hereby undertakes to supplement the prospectus, after the expiration of the subscription period, to
set forth the results of the subscription offer, the transactions by the underwriters during the subscription period, the amount
of unsubscribed securities to be purchased by the underwriters, and the terms of any subsequent reoffering thereof. If any public
offering by the underwriters is to be made on terms differing from those set forth on the cover page of the prospectus, a post-effective
amendment will be filed to set forth the terms of such offering.
(d)
Insofar as indemnification for liabilities arising under the Securities Act of 1933 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 Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities
Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment
by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful
defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the
securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy
as expressed in the Securities Act of 1933 and will be governed by the final adjudication of such issue.
(e)
The undersigned registrant hereby undertakes to file an application for the purpose of determining the eligibility of the trustee
to act under subsection (a) of Section 310 of the Trust Indenture Act in accordance with the rules and regulations prescribed
by the Commission under Section 305(b)(2) of the Trust Indenture Act.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this Registration Statement to be
signed on its behalf by the undersigned, thereunto duly authorized, in the City of Irvine, State of California, on this 7th
day of April, 2020.
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HANCOCK JAFFE LABORATORIES, INC.
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By:
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/s/ Robert A. Berman
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Robert A. Berman
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Chief Executive Officer
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KNOW
ALL PERSONS BY THESE PRESENTS that each individual whose signature appears below hereby constitutes and appoints Robert A. Berman
as his or her true and lawful attorney-in-fact and agent with full power of substitution, 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 post-effective amendments, to this registration
statement, and to sign any registration statement for the same offering covered by this registration statement that is to be effective
upon filing pursuant to Rule 462(b) promulgated under the Securities Act of 1933 increasing the number of shares for which registration
is sought, and all post-effective amendments thereto, and to file the same, with all exhibits thereto and all documents in connection
therewith, making such changes in this registration statement as such attorney-in-fact and agent so acting deem appropriate, with
the SEC, 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 with respect to the offering of securities contemplated by this registration statement, 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, her or their substitute or substitutes, may lawfully do or cause to be done or by virtue hereof.
Pursuant
to the requirements of the Securities Act of 1933, as amended, this Registration Statement has been signed by the following persons
in the capacities and on the dates indicated.
Signature
|
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Title
|
|
Date
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|
|
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/s/
Robert A. Berman
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Chief Executive Officer and Director
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|
April
7, 2020
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Robert A. Berman
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(Principal Executive Officer)
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/s/
Craig Glynn
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Interim
Chief Financial Officer & Interim Treasurer
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April
7, 2020
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Craig Glynn
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(Interim
Principal Financial Officer and Interim Principal
Accounting Officer)
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/s/
Dr. Francis Duhay
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Director
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April 7, 2020
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Dr. Francis Duhay
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/s/
Dr. Sanjay Shrivastava
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Director
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April 7, 2020
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Dr. Sanjay Shrivastava
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/s/
Matthew Jenusaitis
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Director
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April 7, 2020
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Matthew Jenusaitis
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/s/
Robert Gray
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Director
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April 7, 2020
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Robert Gray
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Grafico Azioni Hancock Jaffe Laboratories (NASDAQ:HJLI)
Storico
Da Dic 2024 a Gen 2025
Grafico Azioni Hancock Jaffe Laboratories (NASDAQ:HJLI)
Storico
Da Gen 2024 a Gen 2025