As
filed with the Securities and Exchange Commission on November 5, 2020
Registration
Statement No. 333-______
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-3
REGISTRATION
STATEMENT UNDER
THE SECURITIES ACT OF 1933
CORMEDIX
INC.
(Exact
name of registrant as specified in its charter)
Delaware
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20-5894890
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(State
or other jurisdiction of
incorporation or organization)
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|
(I.R.S.
Employer
Identification No.)
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400
Connell Drive, Suite 5000
Berkeley Heights, New Jersey 07922
Telephone: (908) 517-9500
(Address,
including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Khoso
Baluch
Chief Executive Officer
CorMedix Inc.
400 Connell Drive, Suite 5000
Berkeley Heights, New Jersey 07922
Telephone: (908) 517-9500
(Name,
address, including zip code, and telephone number, including area code, of agent for service)
Copies
to:
Steven A. Navarro
Morgan, Lewis & Bockius LLP
101 Park Avenue
New York, New York 10178
Telephone: (212) 309-6000
Fax: (212) 309-6001
Approximate
date of commencement of 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 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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|
Emerging
growth company
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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
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Amount to be registered(1)
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Proposed maximum aggregate
offering price per unit (2)
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Proposed maximum aggregate offering price
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Amount of registration fee
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Common stock, $0.001 par value per share
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|
|
–
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$
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–
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|
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$
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–
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|
|
$
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–
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|
Preferred stock, $0.001 par value per share
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
–
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|
Warrants
|
|
|
–
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|
|
|
–
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|
|
|
–
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|
|
|
–
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|
Debt Securities
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|
|
–
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|
|
|
–
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|
|
|
–
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|
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–
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Units(4)
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–
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|
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–
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–
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–
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Total
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$
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100,000,000
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$
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10,910
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(3)
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(1)
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The
Registrant is registering such indeterminate number of shares of common stock and preferred stock, such indeterminate principal
amount of debt securities, such indeterminate number of warrants to purchase common stock, preferred stock or debt securities,
and such indeterminate number of units as shall have an aggregate initial offering price not to exceed $100,000,000, less
the aggregate dollar amount of all securities previously issued hereunder. If any debt securities are issued at an original
issue discount, then the offering price of such debt securities shall be in such greater principal amount as shall result
in an aggregate offering price not to exceed $100,000,000, less the aggregate dollar amount of all securities previously issued
hereunder. Any securities registered hereunder may be sold separately or as units with the other securities registered hereunder.
The proposed maximum offering price per unit will be determined, from time to time, by the Registrant in connection with the
issuance by the Registrant of the securities registered hereunder. The securities registered hereunder also include such indeterminate
number of shares of common stock and preferred stock and amount of debt securities as may be issued upon conversion of or
exchange for preferred stock or debt securities that provide for conversion or exchange, upon exercise of warrants or pursuant
to the anti-dilution provisions of any of such securities. In addition, pursuant to Rule 416 under the Securities Act, the
shares being registered hereunder include such indeterminate number of shares of common stock and preferred stock as may be
issuable with respect to the shares being registered hereunder as a result of stock splits, stock dividends or similar transaction.
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(2)
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The
proposed maximum offering price per unit will be determined from time to time by the Registrant in connection with, and at
the time of, the issuance of the securities and is not specified as to each class of security pursuant to General Instruction
II.D. of Form S-3, as amended.
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(3)
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The
registration fee has been calculated pursuant to Rule 457(o) under the Securities Act of 1933, as amended, based on the proposed
maximum aggregate offering price of all securities listed.
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(4)
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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 the 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 these securities or accept an offer to buy
these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus
is not an offer to sell these securities, and we are not soliciting an offer to buy these securities in any state where the offer
or sale is not permitted.
Subject
to completion, dated November 5, 2020
Prospectus
$100,000,000
of
Common Stock,
Preferred Stock,
Warrants,
Debt Securities and/or
Units
From
time to time, we may offer and sell up to $100,000,000 in the aggregate of any combination of the securities described in this
prospectus, either individually or in units, in one or more offerings in amounts, at prices and on the terms that we will determine
at the time of offering. We may also offer common stock or preferred stock upon conversion of debt securities, common stock upon
conversion of preferred stock, or common stock, preferred stock or debt securities upon the exercise of warrants.
Each
time we sell securities, we will provide specific terms of the securities offered in a supplement to this prospectus. The prospectus
supplement may also add, update or change information contained in this prospectus. We will specify in any accompanying prospectus
supplement the terms of any offering. You should read this prospectus and the applicable prospectus supplement, as well as any
documents incorporated by reference in this prospectus and any prospectus supplement, carefully before you invest in any securities.
This prospectus may not be used by us to consummate a sale of securities unless accompanied by the applicable prospectus supplement
describing the method and terms of such offering.
We
will sell these securities directly to our stockholders or to other purchasers or through agents on our behalf or through underwriters
or dealers, or a combination of these methods, as designated from time to time. If any agents or underwriters are involved in
the sale of any of these securities, the applicable prospectus supplement will provide the names of the agents or underwriters
and any applicable fees, commissions or discounts.
Our
common stock trades on the NYSE American under the trading symbol “CRMD.” On November 4, 2020, the closing
price of our common stock was $5.28 per share. We recommend that you obtain current market quotations for our common stock prior
to making an investment decision.
You
should carefully read this prospectus, the applicable prospectus supplement relating to any specific offering of securities and
all information incorporated by reference herein and therein.
Investing
in our securities involves a high degree of risk. These risks are described under the caption “Risk Factors” beginning
on page 9 of this prospectus and the reports we file with the Securities and Exchange Commission pursuant to the Securities
Exchange Act of 1934, as amended, and in an applicable prospectus supplement and in other documents that are incorporated by reference
into this prospectus and any applicable prospectus supplement concerning factors you should consider before investing in our securities.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities
or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The
date of this prospectus is ______, 2020
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,
using a “shelf” registration process. Under this shelf registration process, we may offer and sell shares of our common
stock and preferred stock, various series of debt securities and/or warrants to purchase any of such securities, either individually
or in units, in one or more offerings, of an indeterminate amount for total gross proceeds of up to $100,000,000. This prospectus
provides you with a general description of the securities we may offer. Each time we offer a type or series of securities under
this prospectus, we will provide a prospectus supplement that will contain 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 a particular offering.
This
prospectus does not contain all of the information included in the registration statement. For a more complete understanding of
the offering of the securities, you should refer to the registration statement, including its exhibits. Prospectus supplements
may also add, update or change information contained or incorporated by reference in this prospectus or in the documents that
we have incorporated by reference into this prospectus. However, no prospectus supplement will fundamentally change the terms
that are set forth in this prospectus or offer a security that is not registered and described in this prospectus at the time
of its effectiveness. This prospectus, together with the applicable prospectus supplements and the documents incorporated by reference
into this prospectus, includes all material information relating to this offering. You should carefully read this prospectus,
the applicable prospectus supplement, the information and documents incorporated herein by reference and the additional information
under the heading “Where You Can Find More Information” before making an investment decision.
We
further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any
document that is incorporated by reference into this prospectus or any accompanying prospectus supplement were made solely for
the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties to
such agreement, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations,
warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants
should not be relied on as accurately representing the current state of our affairs.
It
is important for you to read and consider all of the information contained in this prospectus and any accompanying prospectus
in making your investment decision. We include cross-references in this prospectus and any accompanying prospectus to captions
in these materials where you can find additional related discussions. The table of contents in this prospectus provides the pages
on which these captions are located.
You
should rely only on the information we have provided or incorporated by reference in this prospectus or any prospectus supplement.
We have not authorized anyone to provide you with information different from that contained or incorporated by reference in this
prospectus. No dealer, salesperson or other person is authorized to give any information or to represent anything not contained
or incorporated by reference in this prospectus. You should not rely on any unauthorized information or representation. 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. You should not assume that the information contained in this prospectus, the accompanying prospectus supplement or any
free writing prospectus, or incorporated by reference herein, is accurate as of any date other than as of the date of this prospectus
or any prospectus supplement or any free writing prospectus, as the case may be, or in the case of the documents incorporated
by reference, the date of such documents regardless of the time of delivery of this prospectus and any prospectus supplement or
any sale of our securities. Our business, financial condition, liquidity, results of operations and prospects may have changed
since those dates.
To
the extent there are inconsistencies between any prospectus supplement, this prospectus and any documents incorporated by reference,
the document with the most recent date will control.
This
prospectus may not be used to consummate sales of our securities, unless it is accompanied by a prospectus supplement.
This
prospectus, any prospectus supplement, and any free writing prospectus, and the information incorporated herein and therein by
reference, include trademarks, service marks and trade names owned by us or other companies. All trademarks, service marks and
trade names included or incorporated by reference into this prospectus supplement or the accompanying prospectus are the property
of their respective owners.
Unless
the context otherwise requires, “CorMedix,” the “company,” “we,” “us,” “our”
and similar names refer to CorMedix Inc.
No
action is being taken in any jurisdiction outside the United States to permit a public offering of the securities or possession
or distribution of this prospectus or any accompanying prospectus supplement in that jurisdiction. Persons who come into possession
of this prospectus or any accompanying prospectus supplement in jurisdictions outside the United States are required to inform
themselves about and to observe any restrictions as to this offering and the distribution of this prospectus or any accompanying
prospectus supplement applicable to that jurisdiction.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
The
SEC encourages companies to disclose forward-looking information so that investors can better understand a company’s future
prospects and make informed investment decisions. This prospectus, any accompanying prospectus supplement and the documents we
have filed with the SEC that are incorporated herein and therein by reference contain such “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act of 1995.
Words
such as “may,” “might,” “should,” “anticipate,” “estimate,” “expect,”
“projects,” “intends,” “plans,” “believes” and words and terms of similar substance
used in connection with any discussion of future operating or financial performance, identify forward-looking statements. Forward-looking
statements represent management’s current judgment regarding future events and are subject to a number of risks and uncertainties
that could cause actual results to differ materially from those described in the forward-looking statements. These risks include,
but are not limited to: the results of CorMedix’s discussions with the FDA regarding the Defencath™ development path,
including whether a second Phase 3 clinical trial will be required for approval of Defencath’s marketing approval; CorMedix’s
ability to obtain the resources needed to secure approval of the new drug application for Defencath from the FDA; the risks and
uncertainties associated with CorMedix’s ability to manage its limited cash resources; CorMedix’s ability to obtain
additional financing to support CorMedix’s research and development and clinical activities and operations; that preclinical
results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; CorMedix’s
ability to obtain approval of the New Drug Application (NDA) for Defencath, which is required to commercialize the product in
the U.S.; CorMedix’s ability to secure reimbursement under favorable terms for Defencath when regulatory approval is obtained;
obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix’s product candidates; the outcome
of clinical trials of CorMedix’s product candidates and whether they demonstrate these candidates’ safety and effectiveness;
the risks associated with the launch of Defencath and Neutrolin® in new markets; CorMedix’s ability to enter into, execute
upon and maintain collaborations with third parties for its development and marketing programs; CorMedix’s dependence on
its collaborations and its license relationships; CorMedix’s ability to conduct planned or future research, including the
continued development of Defencath and Neutrolin and of additional uses for taurolidine; and the ability to retain and hire necessary
personnel to staff our operations appropriately; CorMedix’s ability to maintain its listing on the NYSE American; achieving
milestones under CorMedix’s collaborations; CorMedix’s dependence on preclinical and clinical investigators, preclinical
and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual
property developed by or licensed to CorMedix. At this time, we are unable to assess whether, and to what extent, the uncertainty
surrounding the Coronavirus pandemic may impact our business and operations. Please also see the discussion of risks and uncertainties
under “Risk Factors” below, and contained in the accompanying prospectus and otherwise incorporated by reference herein,
and in our most recent annual report on Form 10-K as well as any amendments thereto, as revised or supplemented by our subsequent
quarterly reports on Form 10-Q, as filed with the SEC and which are incorporated herein by reference.
In
light of these assumptions, risks and uncertainties, the results and events discussed in the forward-looking statements contained
in this prospectus, any accompanying prospectus supplement or in any document incorporated herein or therein by reference might
not occur. Investors are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the respective
dates of this prospectus, any accompanying prospectus supplement or the date of the document incorporated by reference in this
prospectus or any accompanying prospectus supplement. We expressly disclaim any obligation to update or alter any forward-looking
statements, whether as a result of new information, future events or otherwise, except as required by federal securities laws.
PROSPECTUS
SUMMARY
This
summary highlights certain information about us, the securities offered hereby and selected information contained elsewhere in
or incorporated by reference into this prospectus. This summary is not complete and does not contain all of the information that
you should consider before deciding whether to invest in our securities. For a more complete understanding of our company and
the securities offered hereby, we encourage you to read and consider carefully the more detailed information in this prospectus,
including the information incorporated by reference into this prospectus, and the information referred to under the heading “Risk
Factors” in this prospectus beginning on page 9, and in the documents incorporated by reference into this prospectus.
OUR
COMPANY
Overview
We
are a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment
of infectious and inflammatory diseases.
Our
primary focus is on the development of our lead product candidate, Defencath™, for potential commercialization in the United
States, or the U.S., and other key markets as a catheter lock solution, or CLS. The CLS is regulated as a medical device in the
European Union, or EU, where it is CE-marked and commercialized as Neutrolin®. We have in-licensed the worldwide rights to
develop and commercialize Defencath and Neutrolin. The CLS is a formulation of taurolidine 1.35%, citrate 3.5% and heparin 1000
u/ml and is regulated by the U.S. Food and Drug Administration, or the FDA, as an investigational new drug, where it is being
developed to prevent catheter-related blood stream infections, (CRBSIs) and thrombosis in patients using central venous catheters,
or CVCs, for hemodialysis. FDA has granted conditional approval for the proprietary name Defencath in the U.S. CRBSIs and thrombosis
represent key complications among hemodialysis, intensive care, cancer and total parenteral nutrition, or TPN, patients with CVCs.
These complications can lead to treatment delays and increased costs to the healthcare system when they occur due to hospitalizations,
need for intravenous, or IV, antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the CVC, related
treatment costs and increased mortality. The total annual cost for treating CRBSI episodes and their related complications in
the U.S. is up to $2.7 billion, with approximately 250,000 CRBSI episodes per year.1 We initially expect to sell Defencath
directly to dialysis centers and hospitals, but also plan to expand its usage into intensive care, oncology and total parenteral
nutrition patients needing catheters. We estimate that by 2025 the U.S. market for catheter-lock solutions for hemodialysis patients
will be approximately 80 million catheter lumen locks per year, for oncology patients will be approximately 136 million catheter
lumen locks per year, and for TPN patients will be approximately 13 million catheter lumen locks per year. We believe Defencath
addresses a significant unmet medical need and a potential large market opportunity in the U.S.
In late 2013, we met with the FDA to
determine the regulatory pathway for U.S. marketing approval of Defencath and began discussions on the clinical development program.
In January 2015, the FDA granted Fast Track designation to Defencath, which is a program designed to facilitate development of
drugs that are intended to treat serious and life-threatening conditions and to address an unmet medical need. Fast Track designation
provides eligibility to request Priority Review of the marketing application.
Also, in January 2015, the FDA designated
Defencath as a Qualified Infectious Disease Product, or QIDP, which provides for an extension of five years of marketing exclusivity
to be added to any exclusivity for which the application qualifies upon approval. For example, an additional five years of marketing
exclusivity will be added to the five years granted to a New Chemical Entity, or NCE, upon approval of the New Drug Application,
or NDA. QIDP designation also confers eligibility for Priority Review of the NDA.
1 Becker’s Hospital Review
We
launched the Phase 3 Prospective, Multicenter, Double-blind, Randomized, Active Control Study to Demonstrate Safety & Effectiveness
of Defencath/Neutrolin in Preventing Catheter related Bloodstream Infection in Subjects on Hemodialysis for End Stage Renal Disease
(LOCK-IT-100) in patients with hemodialysis catheters in the U.S. in December 2015. The clinical trial was designed to demonstrate
the safety and effectiveness of Defencath compared to the standard of care CLS, Heparin, in preventing CRBSIs. The primary endpoint
for the trial assessed the incidence of CRBSI and time to CRBSI for each study subject. Secondary endpoints were catheter patency,
which was defined as required use of tissue plasminogen activating factor, or tPA, or removal of catheter due to dysfunction,
and removal of catheter for any reason.
In
July 2018, 28 potential cases of CRBSI were identified in LOCK-IT-100 that occurred through early December 2017. As previously
agreed with the FDA, an interim efficacy analysis was performed based on the first 28 cases. There was a highly statistically
significant 72% reduction in CRBSI by Defencath relative to the active control of Heparin (p=0.0034). Because the pre-specified
level of statistical significance was reached for the primary endpoint and efficacy had been demonstrated with no safety concerns,
the independent Data Safety Monitoring Board (DSMB) recommended early termination.
Following
discussions with the FDA, we proceeded with an orderly termination of LOCK-IT-100. The study had continued enrolling and treating
subjects until study termination, and the final analysis was based on a total of 795 subjects.
We remained blinded until the topline
results of the full data set of LOCK-IT-100 were announced in late January 2019. In a total of 41 cases, there was a 71% reduction
in CRBSI by Defencath relative to Heparin, which was highly statistically significant (p=0.0006), with a good safety profile.
During 2019, we had a series of meetings with the FDA to discuss the analyses of data from LOCK-IT-100, including an end of Phase
3 meeting, a pre-NDA meeting and a CMC meeting, in preparation for submission of the NDA.
The FDA granted our request for a rolling
submission and review of the NDA, which is designed to expedite the approval process for products being developed to address an
unmet medical need. Although the FDA usually requires two pivotal clinical trials to provide substantial evidence of safety and
effectiveness for approval of an NDA, the FDA will in some cases accept one adequate and well-controlled trial, where it is a
large multicenter trial with a broad range of subjects and study sites that has demonstrated a clinically meaningful and statistically
very persuasive effect on a disease with potentially serious outcome. In March 2020, we began the modular submission process for
the NDA for Defencath for the prevention of CRBSI in hemodialysis patients, and recently announced on July 8, 2020, that submission
of all modules for the NDA was completed. In August 2020, the FDA accepted for filing the Defencath NDA and also granted our request
for Priority Review. Priority Review provides for six-month review period instead of the standard ten-month review period, and
February 28, 2021 has been set as the Prescription Drug User Fee Act, or PDUFA, date for the completion of the review for approval
of the NDA. The FDA noted that it is planning to hold an advisory committee meeting to discuss the application and that it
had not identified any potential review issues at this time. The meeting of the Antimicrobial Drugs Advisory Committee to discuss
the Defencath NDA has tentatively been scheduled for January 14, 2021. We have not been informed of any delays by the FDA in the
review of the NDA, but the FDA has limited international and domestic travel due to COVID-19, and pre-approval inspections are
required for manufacturing sites.
The FDA also previously agreed that we
could request consideration of Defencath for approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs,
or LPAD. LPAD, passed as part of the 21st Century Cures Act, is a new program intended to expedite the development and approval
of certain antibacterial and antifungal drugs to treat serious or life-threatening infections in limited populations of patients
with unmet medical needs. Given that the LPAD pathway provides for a streamlined clinical development program for a limited population
that may involve smaller, shorter, or fewer clinical trials, we believe that LPAD will provide additional flexibility for the
FDA to approve Defencath to prevent CRBSIs in the limited population of adult patients with end stage renal disease receiving
hemodialysis through a CVC.
We were granted a deferral by the FDA
under the Pediatric Research Equity Act, or PREA that requires sponsors to conduct pediatric studies for NDAs for a new active
ingredient, such as taurolidine in Defencath, unless a waiver or deferral is obtained from the FDA. A deferral acknowledges that
a pediatric assessment is required but permits the applicant to submit the pediatric assessment after the submission of an NDA.
We have made a commitment to conduct the pediatric study after approval of the NDA for use in adult hemodialysis patients. Pediatric
studies for an approved product conducted under PREA may qualify for pediatric exclusivity, which if granted would provide an
additional six months of marketing exclusivity. Defencath would then have the potential to receive a total marketing exclusivity
period of 10.5 years, including exclusivity pursuant to NCE and QIDP.
We anticipate that Medicare reimbursement
could be available for Defencath in hemodialysis and other catheter indications in intensive care, oncology and TPN through relevant
hospital inpatient diagnosis-related groups, or DRGs, or outpatient ambulatory payment classifications, or APCs, the EndStage
Renal Disease Prospective Payment System, or ESRD PPS, base payment, or under the Durable Medical Equipment, Prosthetics, Orthotics,
and Supplies, or DMEPOS, Fee Schedule, depending on the setting of care. We also plan to seek separate reimbursement as a drug,
where available under Medicare, through mechanisms such as pass-through status under the Hospital Outpatient Prospective Payment
System, the transitional drug add-on payment adjustment, or TDAPA, under the ESRD PPS, or reimbursement as a drug used with a
DMEPOS infusion pump. We have engaged U.S. Centers for Medicare & Medicaid Services, or CMS, in preliminary discussions concerning
the reimbursement for Defencath under TDAPA; however, qualifications cannot be determined until after FDA approval and CMS evaluates
the request for coverage in a quarterly review. If approved under TDAPA, reimbursement of Defencath would be calculated based
on its average selling price.
Although
we cannot fully anticipate changes in reimbursement requirements and mechanisms in the coming years, we expect Defencath would
be eligible for and would obtain TDAPA. To be eligible for TDAPA, an innovative new renal drug or biologic must be, among other
things, identified as having an end action effect that treats or manages a condition or conditions associated with ESRD and as
not fitting into an established ESRD PPS functional category. We believe that in addition to the Fast Track and QIDP designations
granted by FDA, Defencath meets the criterion of being a new renal dialysis product used to treat or manage a condition associated
with ESRD, since infections are the second leading cause of death in patients with ESRD and CVCs are a significant risk factor
for infection-associated mortality.
International
In the European Union, or EU, Neutrolin
is regulated as a Class 3 medical device. In July 2013, we received CE Mark approval for Neutrolin. In December 2013, we started
commercial sales of Neutrolin in Germany for the prevention of CRBSI and maintenance of catheter patency in hemodialysis patients
using a tunneled, cuffed CVC for vascular access. To date, Neutrolin is registered and may be sold in certain European Union and
Middle Eastern countries for such treatment.
In September 2014, the TUV-SUD and The Medicines Evaluation
Board of the Netherlands, or MEB, granted a label expansion for Neutrolin, to include use in oncology patients receiving chemotherapy,
IV hydration and IV medications via CVC for the EU and in December 2014, we received approval from the Hessian District President
in Germany to expand the label for these same expanded indications. The expansion also adds patients receiving medication and IV
fluids via CVC in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent
care centers). An indication for use in total parenteral nutrition was also approved.
Additional
Development Possibilities
We
intend to pursue additional indications for Defencath use as a CLS in populations with an unmet medical need that also represent
a significant market opportunity. For example, we intend to pursue marketing authorization in the U.S. for use as a CLS to reduce
CRBSIs in oncology and total parenteral nutrition patients using a CVC.
In addition to the CLS, we are sponsoring
a pre-clinical research collaboration for the use of taurolidine as a possible treatment for pediatric tumors. In February 2018,
the FDA granted orphan drug designation to taurolidine for the treatment of neuroblastoma in children. We may seek one or more
strategic partners or other sources of capital to help with the development and commercialization of taurolidine for the treatment
of neuroblastoma in children. We are also evaluating opportunities for the possible expansion of taurolidine as a platform compound
for use in certain medical devices. Patent applications have been filed in several indications, including wound closure, surgical
meshes, and wound management. Based on initial feasibility work, we are advancing pre-clinical studies for taurolidine-infused
surgical meshes, suture materials and hydrogels. We will seek to establish development/commercial partnerships as these programs
advance.
The FDA regards taurolidine as an NCE
and therefore it is currently an unapproved new drug. We might in the future pursue product candidates that would involve devices
impregnated with taurolidine, and we believe that at the current time such products would be combination products subject to device
premarket submission requirements, while subject also, under review by FDA, to the standards for drug approvability. Consequently,
given that there is no appropriate predicate medical device currently marketed in the U.S. on which a 510(k) approval process
could be based and that taurolidine is not yet approved in any application, we anticipate that we would be required to submit
a premarket approval application, or PMA, for marketing authorization for any medical device indications that we may pursue for
devices containing taurolidine. In the event that an NDA for Defencath is approved by the FDA, the regulatory pathway for these
medical device product candidates may be revisited with the FDA. Although there may be no appropriate predicate, de novo Class
II designation can be proposed, based on a risk assessment and a reasonable assurance of safety and effectiveness.
In
December 2019, the novel coronavirus disease, COVID-19, was identified in Wuhan, China. This virus has been declared a pandemic
and has spread to multiple global regions. The outbreak and government measures taken in response have also had a significant
impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted;
facilities and production have been suspended; and demand for certain goods and services, such as medical services and supplies,
has spiked, while demand for other goods and services, such as travel, has fallen. In response to the COVID-19 outbreak, “shelter
in place” orders and other public health guidance measures have been implemented across much of the United States, Europe
and Asia, including in the locations of our offices, clinical trial sites, key vendors and partners. Our program timelines may
be negatively affected by COVID-19, which could materially and adversely affect business, financial conditions and results of
operations.
Corporate
History and Information
We were organized as a Delaware corporation on July 28, 2006
under the name “Picton Holding Company, Inc.” and we changed our corporate name to “CorMedix Inc.” on January
18, 2007. Our operations to date have been primarily limited to conducting clinical trials and establishing manufacturing for our
product candidates, licensing product candidates, business and financial planning, research and development, seeking regulatory
approval for our products, initial commercialization activities for Defencath in the U.S. and Neutrolin in the EU and other foreign
markets, and maintaining and improving our patent portfolio.
Our
executive offices are located at 400 Connell Drive, Suite 5000, Berkeley Heights, NJ 07922. Our telephone number is (908) 517-9500.
Our website address is www.cormedix.com. Information contained in, or accessible through, our website does not constitute part
of this prospectus.
Offerings
Under This Prospectus
We
may offer shares of our common stock and preferred stock, various series of debt securities and/or warrants to purchase any of
such securities, either individually or in units, up to an indeterminate amount from time to time under this prospectus at prices
and on terms to be determined by market conditions at the time of any offering. This prospectus provides you with a general description
of the securities we may offer. Each time we offer a type or series of securities under this prospectus, we will provide a prospectus
supplement that will describe the specific amounts, prices and other important terms of the securities.
The
prospectus supplement also may add, update or change information contained in this prospectus or in documents we have incorporated
by reference into this prospectus. However, no prospectus supplement will fundamentally change the terms that are set forth in
this prospectus or offer a security that is not registered and described in this prospectus at the time of its effectiveness.
This
prospectus may not be used to consummate a sale of any securities unless it is accompanied by a prospectus supplement.
We
may sell the securities directly to investors or to or through agents, underwriters or dealers. We, and our agents or underwriters,
reserve the right to accept or reject all or part of any proposed purchase of securities. If we offer securities through agents
or underwriters, we will include in the applicable prospectus supplement:
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the
names of those agents or underwriters;
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applicable
fees, discounts and commissions to be paid to them;
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details
regarding over-allotment options, if any; and
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the
net proceeds to us.
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Common
Stock
We
may issue shares of our common stock from time to time. The holders of common stock are entitled to one vote per share on all
matters to be voted upon by stockholders. Subject to preferences that may be applicable to any outstanding preferred stock, the
holders of common stock are entitled to receive ratably any dividends that may be declared from time to time by our board of directors
out of funds legally available for that purpose. In the event of our liquidation, dissolution or winding up, the holders of common
stock are entitled to share ratably in all assets remaining after payment of liabilities, subject to prior distribution rights
of any preferred stock then outstanding.
Preferred
Stock
We
may issue shares of our preferred stock from time to time, in one or more series. Our board of directors will determine the rights,
preferences, privileges and restrictions of the preferred stock, including dividend rights, conversion rights, voting rights,
terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation
of such series, without any further vote or action by stockholders. Convertible preferred stock will be convertible into our common
stock or exchangeable for our other securities. Conversion may be mandatory or at your option or both and would be at prescribed
conversion rates.
If
we sell any series of preferred stock under this prospectus and applicable prospectus supplements, we will fix the rights, preferences,
privileges and restrictions of the preferred stock of such 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
reports 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. We urge you to read the applicable prospectus
supplement related to the series of preferred stock being offered, as well as the complete certificate of designation that contains
the terms of the applicable series of preferred stock.
Warrants
We
may issue warrants for the purchase of common stock, preferred stock and/or debt securities in one or more series. We may issue
warrants independently or together with common stock, preferred stock and/or debt securities, and the warrants may be attached
to or separate from these securities. We will evidence each series of warrants by warrant certificates that we will issue under
a separate agreement. We may enter into warrant agreements with a bank or trust company that we select to be our warrant agent.
We will indicate the name and address of the warrant agent in the applicable prospectus supplement relating to a particular series
of warrants.
In
this prospectus, we have summarized certain general features of the warrants. We urge you, however, to read the applicable prospectus
supplement related to the particular series of warrants being offered, as well as the warrant agreements and warrant certificates
that contain the terms of the warrants. We will file as exhibits to the registration statement of which this prospectus is a part,
or will incorporate by reference from reports that we file with the SEC, the form of warrant agreement or warrant certificate
containing the terms of the warrants we are offering before the issuance of the warrants.
Debt
Securities
We
may offer debt securities from time to time, in one or more series, as either senior or subordinated debt or as senior or subordinated
convertible debt. The senior debt securities will rank equally with any other unsecured and unsubordinated debt. The subordinated
debt securities will be subordinate and junior in right of payment, to the extent and in the manner described in the instrument
governing the debt, to all of our senior indebtedness. Convertible debt securities will be convertible into or exchangeable for
our common stock or our other securities. Conversion may be mandatory or at your option or both and would be at prescribed conversion
rates.
With
respect to any debt securities that we issue, we will issue such debt securities under an indenture, which we would enter into
with the trustee named in the indenture. The form of indenture was filed as an exhibit to the registration statement of which
this prospectus is a part and is incorporated herein by reference. Any indenture would be qualified under the Trust Indenture
Act of 1939.
Units
We
may issue units consisting of common stock, preferred stock, debt securities and/or warrants for the purchase of common stock,
preferred stock and/or debt securities in one or more series. In this prospectus, we have summarized certain general features
of the units. We urge you, however, to read the applicable prospectus supplement related to the series of units being offered,
as well as the unit agreements that contain the terms of the units. We will file as exhibits to the registration statement of
which this prospectus is a part, or will incorporate by reference reports that we file with the SEC, the form of unit agreement
and any supplemental agreements that describe the terms of the series of units we are offering before the issuance of the related
series of units.
RISK
FACTORS
An investment in our securities involves a high degree of
risk. You should carefully consider the risks, uncertainties and assumptions discussed under the heading “risk factors”
included in our most recent annual report on Form 10-K, as revised or supplemented by our subsequent quarterly reports on Form
10-Q on file with the SEC and are incorporated herein by reference, and which may be amended, supplemented or superseded from
time to time by other reports we file with the SEC in the future. You should also consider the risks referred to above and all
of the other information contained in this prospectus and any accompanying prospectus supplement, and incorporated by reference
into this prospectus and any accompanying prospectus supplement, including our financial statements and related notes, before
investing in our securities. If any of the possible events described in those sections actually occur, our business, business
prospects, cash flow, results of operations or financial condition could be harmed. In this case, the trading price of our securities
could decline, and you might lose all or part of your investment in our securities.
USE
OF PROCEEDS
We
cannot assure you that we will receive any proceeds in connection with securities offered by us pursuant to this prospectus. Unless
otherwise provided in the applicable prospectus supplement, we intend to use the net proceeds from the sale of our securities
by us under this prospectus for general corporate purposes, including obtaining regulatory approval and commercialization of Defencath™
in the U.S., research and development, and working capital and general expenditures. We will set forth in the applicable prospectus
supplement our intended use for the net proceeds received from the sale of any securities by us. Pending the application of the
net proceeds, we intend to invest a portion of the net proceeds generally in short-term, investment grade, interest-bearing securities.
PLAN
OF DISTRIBUTION
We
may sell the securities from time to time by a variety of methods, including:
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on
the NYSE American or any other national securities exchange or U.S. inter-dealer system of a registered national securities association
on which our common stock or other securities may be listed or quoted at the time of sale;
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in
privately negotiated transactions;
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in
an exchange distribution in accordance with the rules of the applicable exchange;
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as
settlement of short sales entered into after the date of the prospectus;
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through
the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;
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through
broker-dealers, who may act as agents or principals;
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through
sales “at the market” to or through a market-maker;
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in
a block trade, in which a broker-dealer will attempt to sell a block as agent but may position and resell a portion of the block
as principal to facilitate the transaction;
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through
one or more underwriters on a firm commitment or best-efforts basis;
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directly
to one or more purchasers;
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through
agents;
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in
options transactions;
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over
the Internet;
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any
other method permitted pursuant to applicable law; or
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in
any combination of the above.
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In
effecting sales, brokers or dealers engaged by us may arrange for other brokers or dealers to participate. Broker-dealer transactions
may include:
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purchases of the securities by a broker-dealer as principal and resales of the securities by the broker-dealer for its account pursuant to this prospectus;
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ordinary brokerage transactions; or
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transactions in which the broker-dealer solicits purchasers.
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We
may sell the securities to or through underwriters or dealers, through agents, or directly to one or more purchasers. We may distribute
securities from time to time in one or more transactions:
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at
a fixed price or prices, which may be changed;
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at
market prices prevailing at the time of sale;
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at
prices related to such prevailing market prices; or
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Each
prospectus supplement will describe the method of distribution of the securities and any applicable restrictions.
A
prospectus supplement or supplements (and any related free writing prospectus that we may authorize to be provided to you) will
describe the terms of the offering of the securities, including, to the extent applicable:
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the
name or names of the underwriters, if any;
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the
purchase price of the securities or other consideration therefor, and the proceeds, if any, we will receive from the sale;
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any
over-allotment options under which underwriters may purchase additional securities from us;
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any
agency fees or underwriting discounts and other items constituting agents’ or underwriters’ compensation;
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any
public offering price;
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any
discounts or concessions allowed or reallowed 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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Only
underwriters named in the prospectus supplement will be underwriters of the securities offered by the prospectus supplement.
If
underwriters are used in the sale, they will acquire the securities for their own account and may resell the securities from time
to time in one or more transactions at a fixed public offering price or at varying prices determined at the time of sale. The
obligations of the underwriters to purchase the securities will be subject to the conditions set forth in the applicable underwriting
agreement. We may offer the securities to the public through underwriting syndicates represented by managing underwriters or by
underwriters without a syndicate. 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 reallowed 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.
We
may provide agents and underwriters with indemnification against 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
and underwriters may engage in transactions with, or perform services for, us in the ordinary course of business.
All
securities we may offer, other than common stock, will be new issues of securities with no established trading market. Any underwriters
may make a market in these securities, but will not be obligated to do so and may discontinue any market making at any time without
notice. We cannot guarantee the liquidity of the trading markets for any securities.
Any
underwriter may engage in over-allotment, stabilizing transactions, short-covering transactions and penalty bids in accordance
with Regulation M under the Exchange Act. Over-allotment involves sales in excess of the offering size, which create a short
position. Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed
a specified maximum 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 that are qualified market makers on the NYSE American may engage in passive market making transactions in the common
stock on the NYSE American 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 the 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.
DESCRIPTION
OF OUR CAPITAL STOCK
Common
Stock
The
following is a summary of certain provisions of our capital stock. Such summary does not purport to be complete. You should refer
to our Amended and Restated Certificate of Incorporation, as amended, and our Second Amended and Restated Bylaws and each Certificate
of Designation for our Series C-3, E and G preferred stock, in each case, incorporated by reference as an exhibit to our most
recent Form 10-K. The summary below is also qualified by provisions of such documents and applicable law.
Pursuant
to our Amended and Restated Certificate of Incorporation, as amended, we are authorized to issue 160,000,000 shares of common
stock, $0.001 par value per share. As of November 4, 2020, we had 32,132,492 shares of common stock outstanding.
The
holders of our common stock are entitled to one vote per share on all matters to be voted on by the stockholders, and there are
no cumulative voting rights. Generally, all matters to be voted on by stockholders must be approved by a majority (or, in the
case of election of directors, by a plurality) of the votes entitled to be cast by all shares of common stock present in person
or represented by proxy, subject to any voting rights granted to holders of any preferred stock.
The
holders of common stock are entitled to receive ratable dividends, if any, payable in cash, in stock or otherwise if, as and when
declared from time to time by our Board of Directors out of funds legally available for the payment of dividends, subject to any
preferential rights that may be applicable to any outstanding preferred stock. In the event of a liquidation, dissolution, or
winding up of our Company, after payment in full of all outstanding debts and other liabilities, the holders of common stock are
entitled to share ratably in all remaining assets, subject to prior distribution rights of preferred stock, if any, then outstanding.
No shares of common stock have preemptive rights or other subscription rights to purchase additional shares of common stock. There
are no redemption or sinking fund provisions applicable to the common stock. All outstanding shares of common stock are fully
paid and nonassessable. The rights, preferences and privileges of holders of our common stock will be subject to, and might be
adversely affected by, the rights of holders of any preferred stock that we may issue in the future. All shares of common stock
that are acquired by us shall be available for reissuance by us at any time.
Issued
and Outstanding Preferred Stock
Under
the terms of our Amended and Restated Certificate of Incorporation, as amended, our Board of Directors is authorized to issue
up to 2,000,000 shares of preferred stock in one or more series without stockholder approval. Our Board of Directors has the discretion
to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights,
redemption privileges and liquidation preferences, of each series of preferred stock. As of November 4, 2020, of the 2,000,000
shares of preferred stock authorized, our Board of Directors has designated (all with par value of $0.001 per share): 200,000
shares as Series C-3 Non-Voting Convertible Preferred Stock; 89,623 shares as Series E Convertible Preferred Stock and 100,000
as Series G Convertible Preferred Stock. At November 4, 2020, we had outstanding: 52,000 shares of Series C-3 Non-Voting Convertible
Preferred Stock; 89,623 shares of Series E Convertible Preferred Stock and 100,000 shares of Series G Convertible Preferred Stock.
Series
C-3 Non-Voting Convertible Preferred Stock
The
Series C-3 Preferred Stock has the rights, privileges and terms described below.
Rank.
The Series C-3 Preferred Stock will rank:
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senior
to our common stock;
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senior
to any class or series of capital stock created after the issuance of the Series C-3 Preferred Stock; and
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junior
to the Series E Non-Voting Convertible Preferred Stock, in
each case, as to dividends or distributions of assets upon our liquidation, dissolution or winding up whether voluntarily or involuntarily.
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Conversion.
Each share of Series C-3 Preferred Stock is convertible into 10 shares of our common stock (subject to adjustment in the event
of stock dividends and distributions, stock splits, stock combinations, or reclassifications affecting our common stock) at a
per share price of $1.00 at any time at the option of the holder, except that a holder will be prohibited from converting shares
of Series C-3 Preferred Stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates,
would beneficially own more than 9.99% of the total number of shares of our common stock then issued and outstanding.
Liquidation
Preference. In the event of our liquidation, dissolution or winding up, holders of Series C-3 Preferred Stock will receive
a payment equal to $10.00 per share of Series C-3 Preferred Stock before any proceeds are distributed to the holders of our common
stock. After the payment of this preferential amount, and subject to the rights of holders of any class or series of our capital
stock hereafter created specifically ranking by its terms senior to the Series C-3 Preferred Stock, holders of Series C-3 Preferred
Stock will participate ratably in the distribution of any remaining assets with the common stock and any other class or series
of our capital stock hereafter created that participates with the common stock in such distributions.
Voting
Rights. Shares of Series C-3 Preferred Stock will generally have no voting rights, except as required by law and except that
the consent of holders of two thirds of the outstanding Series C-3 Preferred Stock will be required to amend the terms of the
Series C-3 Preferred Stock or the certificate of designation for the Series C-3 Preferred Stock or increase the number of authorized
shares of Series C-3 Preferred Stock.
Dividends.
Holders of Series C-3 Preferred Stock are entitled to receive, and we are required to pay, dividends on shares of the Series C-3
Preferred Stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends
in the form of common stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends
in the form of common stock) are paid on shares of the common stock.
Redemption.
We are not obligated to redeem or repurchase any shares of Series C-3 Preferred Stock. Shares of Series C-3 Preferred Stock are
not otherwise entitled to any redemption rights, or mandatory sinking fund or analogous fund provisions.
Listing.
There is no established public trading market for the Series C-3 Preferred Stock, and we do not expect a market to develop. In
addition, we do not intend to apply for listing of the Series C-3 Preferred Stock on any national securities exchange or trading
system.
Fundamental
Transactions. If, at any time that shares of Series C-3 Preferred Stock are outstanding, we effect a merger or other change
of control transaction, as described in the certificate of designation and referred to as a fundamental transaction, then a holder
will have the right to receive, upon any subsequent conversion of a share of Series C-3 Preferred Stock (in lieu of conversion
shares) for each issuable conversion share, the same kind and amount of securities, cash or property as such holder would have
been entitled to receive upon the occurrence of such fundamental transaction if such holder had been, immediately prior to such
fundamental transaction, the holder of a share of common stock.
Series
E Convertible Preferred Stock
Rank.
The Series E Preferred Stock will rank:
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senior
to our common stock;
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senior
to the Series C-3 Non-Voting Convertible Preferred Stock;
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on
parity with the Series G Convertible Preferred Stock; and
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senior
to any class or series of capital stock created after the issuance of the Series E Preferred Stock,
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each case, as to dividends or distributions of assets upon our liquidation, dissolution or winding up whether voluntarily or involuntarily.
Conversion.
Each share of Series E Preferred Stock is convertible into 4.3733 shares of our common stock (subject to adjustment as provided
in the certificates of designation for the Series E Preferred Stock) at a per share price of $3.75 at any time at the option of
the holder, except that a holder will be prohibited from converting shares of Series E Preferred Stock into shares of common stock
if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 4.99% of the total
number of shares of our common stock then issued and outstanding.
Liquidation
Preference. In the event of our liquidation, dissolution or winding up, holders of Series E Preferred Stock will receive a
payment equal to $49.20 per share of Series E Preferred Stock on parity with the payment of the liquidation preference due the
Series G Preferred Stock, but before any proceeds are distributed to the holders of common stock, and the Series C-3 Non-Voting
Convertible Preferred Stock. After the payment of this preferential amount, holders of Series E Preferred Stock will participate
ratably in the distribution of any remaining assets with the common stock and any other class or series of our capital stock that
participates with the common stock in such distributions.
Voting
Rights. Shares of Series E Preferred Stock are entitled to vote on an as-converted basis, based upon an assumed conversion
price of $7.93.
Dividends.
Holders of Series E Preferred Stock are entitled to receive, and we are required to pay, dividends on shares of the Series E Preferred
Stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form
of common stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form
of common stock) are paid on shares of the common stock.
Redemption.
We are not obligated to redeem or repurchase any shares of Series E Preferred Stock. Shares of Series E Preferred Stock are not
otherwise entitled to any redemption rights, or mandatory sinking fund or analogous fund provisions.
Listing.
There is no established public trading market for the Series E Preferred Stock, and we do not expect a market to develop. In addition,
we do not intend to apply for listing of the Series E Preferred Stock on any national securities exchange or trading system.
Fundamental
Transactions. If, at any time that shares of Series E Preferred Stock are outstanding, we effect a merger or other change
of control transaction, as described in the certificate of designation and referred to as a fundamental transaction, then a holder
will have the right to receive, upon any subsequent conversion of a share of Series E Preferred Stock (in lieu of conversion shares)
for each issuable conversion share, the same kind and amount of securities, cash or property as such holder would have been entitled
to receive upon the occurrence of such fundamental transaction if such holder had been, immediately prior to such fundamental
transaction, the holder of a share of common stock.
Debt
Restriction. As long as any of the Series E Preferred Stock is outstanding, we cannot create, incur, guarantee, assume or
suffer to exist any indebtedness, other than (i) trade payables incurred in the ordinary course of business consistent with past
practice, and (ii) up to $10 million aggregate principal amount of indebtedness with a maturity less than twelve months outstanding
at any time, which amount may include up to $5 million of letters of credit outstanding at any time.
Other
Covenants. In addition to the debt restrictions above, as long as any the Series E Preferred Stock is outstanding , we cannot,
among others things: create, incur, assume or suffer to exist any encumbrances on any of our assets or property; redeem, repurchase
or pay any cash dividend or distribution on any of our capital stock (other than as permitted, which includes the dividends on
the Series E Preferred Stock and Series G Preferred Stock); redeem, repurchase or prepay any indebtedness (other than as permitted);
or engage in any material line of business substantially different from our current lines of business.
Purchase
Rights. In the event we issue any options, convertible securities or rights to purchase stock or other securities pro rata
to the holders of common stock, then a holder of Series E Preferred Stock will be entitled to acquire, upon the same terms a pro
rata amount of such stock or securities as if the Series E Preferred Stock had been converted to common stock.
Series
G Convertible Preferred Stock
Rank.
The Series G Preferred Stock will rank:
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senior
to our common stock;
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senior
to any class or series of capital stock created after the issuance of the Series G Preferred Stock;
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junior
to the Series C-3 Non-Voting Convertible Preferred Stock, pending the consent of the holders of such series to the subordination
thereof; and
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on
parity with the Series E Convertible Preferred Stock,
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in
each case, as to dividends or distributions of assets upon our liquidation, dissolution or winding up whether voluntarily or involuntarily.
Conversion.
Each share of Series G Preferred Stock is convertible into approximately 55.5978 shares of our common stock (subject to adjustment
as provided in the certificate of designation for the Series G Preferred Stock) at a per share price of $3.37 at any time at the
option of the holder, except that a holder will be prohibited from converting shares of Series G Preferred Stock into shares of
common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 4.99%
of the total number of shares of our common stock then issued and outstanding.
Liquidation
Preference. In the event of our liquidation, dissolution or winding up, holders of Series E Preferred Stock will receive a
payment equal to $187.36452 per share of Series G Preferred Stock on parity with the payment of the liquidation preference due
the Series E Preferred Stock, but before any proceeds are distributed to the holders of Series C-3 Preferred Stock (pending the
consent of the holders of such series to the subordination thereof) and after any proceeds are distributed to the holders of common
stock. After the payment of this preferential amount, holders of Series G Preferred Stock will participate ratably in the distribution
of any remaining assets with the common stock and any other class or series of our capital stock that participates with the common
stock in such distributions.
Voting
Rights. Shares of Series G Preferred Stock are entitled to vote on an as-converted basis, based upon an assumed conversion
price of $7.93.
Dividends.
Holders of Series G Preferred Stock are entitled to receive, and we are required to pay, dividends on shares of the Series G Preferred
Stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form
of common stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form
of common stock) are paid on shares of the common stock.
Redemption.
We are not obligated to redeem or repurchase any shares of Series G Preferred Stock. Shares of Series G Preferred Stock are not
otherwise entitled to any redemption rights, or mandatory sinking fund or analogous fund provisions.
Listing.
There is no established public trading market for the Series G Preferred Stock, and we do not expect a market to develop. In addition,
we do not intend to apply for listing of the Series G Preferred Stock on any national securities exchange or trading system.
Fundamental
Transactions. If, at any time that shares of Series G Preferred Stock are outstanding, we effect a merger or other change
of control transaction, as described in the certificate of designation and referred to as a fundamental transaction, then a holder
will have the right to receive, upon any subsequent conversion of a share of Series G Preferred Stock (in lieu of conversion shares)
for each issuable conversion share, the same kind and amount of securities, cash or property as such holder would have been entitled
to receive upon the occurrence of such fundamental transaction if such holder had been, immediately prior to such fundamental
transaction, the holder of a share of common stock.
Debt
Restriction. As long as any of the Series G Preferred Stock is outstanding, we cannot create, incur, guarantee, assume or
suffer to exist any indebtedness, other than (i) trade payables incurred in the ordinary course of business consistent with past
practice, and (ii) up to $10 million aggregate principal amount of indebtedness with a maturity less than twelve months outstanding
at any time, which amount may include up to $5 million of letters of credit outstanding at any time.
Other
Covenants. In addition to the debt restrictions above, as long as any the Series G Preferred Stock is outstanding, we cannot,
among others things: create, incur, assume or suffer to exist any encumbrances on any of our assets or property; redeem, repurchase
or pay any cash dividend or distribution on any of our capital stock (other than as permitted, which includes the dividends on
the Series E Preferred Stock and the Series G Preferred Stock); redeem, repurchase or prepay any indebtedness (other than as permitted);
or engage in any material line of business substantially different from our current lines of business.
Purchase
Rights. In the event we issue any options, convertible securities or rights to purchase stock or other securities pro rata
to the holders of common stock, then the a holder of Series G Preferred Stock will be entitled to acquire, upon the same terms
a pro rata amount of such stock or securities as if the Series G Preferred Stock had been converted to common stock.
Transfer
Agent and Registrar
We
act as our own transfer agent and registrar for the Series C-3, E and G Preferred Stock.
Description
of Preferred Stock That May Be Offered
Our
board of directors has the authority, without further action by the stockholders, to issue up to 2,000,000 shares of preferred
stock in one or more series and to fix the rights, preferences, privileges and restrictions thereof, including dividend rights,
conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting
any series or the designation of such series, without any further vote or action by our stockholders. The shares of preferred
stock outstanding are described above. The issuance of new or additional preferred stock could adversely affect the voting power
of holders of common stock and the likelihood that such holders will receive dividend payments and payments upon liquidation and
could have the effect of delaying, deferring or preventing a change in control of our company.
We
will fix the rights, preferences, privileges and restrictions of any new series of preferred stock 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 reports 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
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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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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whether
interests in the preferred stock will be represented by depositary shares;
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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, the shares will be fully paid and non-assessable.
The
General Corporation Law of the State of Delaware, the state of our incorporation, 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 that may be 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 may have the effect of decreasing the market price of our common stock.
Certain
Anti-Takeover Provisions of Delaware Law and of Our Amended and Restated Certificate of Incorporation and Second Amended and Restated
Bylaws
Certain
provisions of the Delaware General Corporation Law (the “DGCL”) and our Amended and Restated Certificate of Incorporation,
as amended, and our Second Amended and Restated Bylaws discussed below may have the effect of making more difficult or discouraging
a tender offer, proxy contest or other takeover attempt. These provisions are expected to encourage persons seeking to acquire
control of our Company to first negotiate with our Board of Directors. We believe that the benefits of increasing our ability
to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure our Company 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, an anti-takeover law. In general, Section 203 prohibits a publicly held Delaware corporation
from engaging in a “business combination” with an “interested stockholder” for a period of three years
following the date the person became an interested stockholder, unless:
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the
Board of Directors approves the transaction in which the stockholder became an interested stockholder prior to the date the
interested stockholder attained that status;
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when
the stockholder became an interested stockholder, he or she owned at least 85% of the voting stock of the corporation outstanding
at the time the transaction commenced, excluding shares owned by persons who are directors and also officers and certain shares
owned by employee benefits plans; or
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on
or subsequent to the date the business combination is approved by the Board of Directors, the business combination is authorized
by the affirmative vote of at least 66 2/3% of the voting stock of the corporation at an annual or special meeting of stockholders.
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Generally,
a “business combination” includes a merger, asset or stock sale, or other transaction resulting in a financial benefit
to the interested stockholder. Generally, an “interested stockholder” is a person who, together with affiliates and
associates, owns, or is an affiliate or associate of the corporation and within three years prior to the determination of interested
stockholder status did own, 15% or more of a corporation’s voting stock.
The
existence of Section 203 of the DGCL would be expected to have an anti-takeover effect with respect to transactions not approved
in advance by our Board of Directors, including discouraging attempts that might result in a premium over the market price for
the shares of our common stock.
Charter
Documents
Our
Amended and Restated Certificate of Incorporation, as amended, and Second Amended and Restated Bylaws include a number of provisions
that may have the effect of deterring hostile takeovers or delaying or preventing changes in control or management of our Company.
First, our Second Amended and Restated Bylaws limit who may call special meetings of the stockholders, such meetings may only
be called by the chairman of the Board of Directors, the chief executive officer, the Board of Directors or holders of an aggregate
of at least 15% of our outstanding entitled to vote. Second, our Amended and Restated Certificate of Incorporation does not include
a provision for cumulative voting for directors. Under cumulative voting, a minority stockholder holding a sufficient percentage
of a class of shares may be able to ensure the election of one or more directors. Third, our Second Amended and Restated Bylaws
provide that the number of directors on our Board of Directors, which may range from five to nine directors, shall be exclusively
fixed by our Board of Directors, which has set the number of directors at seven. Fourth, newly created directorships resulting
from any increase in our authorized number of directors and any vacancies in our Board of Directors resulting from death, resignation,
retirement, disqualification or other cause (including removal from office by a vote of the shareholders) will be filled by a
majority of our Board of Directors then in office. Finally, our Second Amended and Restated Bylaws establish procedures, including
90-day advance notice requirement, with regard to the nomination of candidates for election as directors and stockholder proposals.
These and other provisions of our Amended and Restated Certificate of Incorporation and Second Amended and Restated Bylaws and
Delaware law could discourage potential acquisition proposals and could delay or prevent a change in control or management of
our Company.
DESCRIPTION
OF DEBT SECURITIES
The
following description, together with the additional information we include in any applicable prospectus supplement, summarizes
the material terms and provisions of any debt securities that we may offer under this prospectus. While the terms we have summarized
below will apply generally to any future debt securities we may offer, we will describe the particular terms of any debt securities
that we may offer in more detail in the applicable prospectus supplement. The terms of any debt securities we may offer under
a prospectus supplement may differ from the terms described below. For any debt securities that we may offer, an indenture (and
any relevant supplemental indenture), if required, will contain additional important terms and provisions, the form of which we
filed as an exhibit to the registration statement of which this prospectus is a part and is incorporated therein by reference.
We will file any definitive indenture as an exhibit to reports that we file with the SEC and incorporate by reference in this
prospectus and the applicable prospectus supplement. Any indenture would be qualified under the Trust Indenture Act of 1939.
With
respect to any debt securities that we issue, we will describe in each prospectus supplement the following terms relating to a
series of debt securities:
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the
principal amount being offered, and if a series, the total amount authorized and the total amount outstanding;
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any
limit on the amount that may be issued;
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whether
or not we will issue the series of debt securities in global form, and if so, the terms and who the depository will be;
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the
principal amount due at maturity;
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whether
and under what circumstances, if any, we will pay additional amounts on any debt securities held by a person who is not a
United States person for tax purposes, and whether we can redeem the debt securities if we have to pay such additional amounts;
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the
annual interest rate, which may be fixed or variable, or the method for determining the rate and the date interest will begin
to accrue, the dates interest will be payable and the regular record dates for interest payment dates or the method for determining
such dates;
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whether
or not the debt securities will be convertible into shares of our common stock or our preferred stock and, if so, the terms
of such conversion;
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whether
or not the debt securities will be secured or unsecured by some or all of our assets, and the terms of any secured debt;
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the
terms of the subordination of any series of subordinated debt;
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the
place where payments will be payable;
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restrictions
on transfer, sale or other assignment, if any;
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our
right, if any, to defer payment or interest and the maximum length of any such deferral period;
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the
date, if any, after which and the conditions upon which, and the price at which, we may, at our option, redeem the series
of debt securities pursuant to any optional or provisional redemption provisions and the terms of those redemptions provisions;
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the
date, if any, on which, and the price at which we are obligated, pursuant to any mandatory sinking fund or analogous fund
provisions or otherwise, to redeem, or at the holder’s option to purchase, the series of debt securities and the currency
or currency unit in which the debt securities are payable;
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whether
the indenture will restrict our ability to pay dividends, or will require us to maintain any asset ratios or reserves;
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whether
we will be restricted from incurring any additional indebtedness, issuing additional securities, or entering into a merger,
consolidation or sale of our business;
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a
discussion of any material or special United States federal income tax considerations applicable to the debt securities;
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information
describing any book-entry features;
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any
provisions for payment of additional amounts for taxes;
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whether
the debt securities are to be offered at a price such that they will be deemed to be offered at an “original issue discount”
as defined in paragraph (a) of Section 1273 of the Internal Revenue Code of 1986, as amended;
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the
denominations in which we will issue the series of debt securities, if other than denominations of $1,000 and any integral
multiple thereof;
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whether
we and/or the indenture trustee may change an indenture without the consent of any holders;
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the
form of debt security and how it may be exchanged and transferred;
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description
of the indenture trustee and paying agent, and the method of payments; and
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any
other specified terms, preferences, rights or limitations of, or restrictions on, the debt securities and any terms that may
be required by us or advisable under applicable laws or regulations.
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We
summarize below the material terms of the form of indenture, if required, or indicate which material terms will be described in
the applicable prospectus supplement. The indenture:
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does
not limit the amount of debt securities that we may issue;
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allows
us to issue debt securities in one or more series;
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does
not require us to issue all of the debt securities of a series at the same time;
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allows
us to reopen a series to issue additional debt securities without the consent of the holders of the debt securities of such
series; and
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provides
that the debt securities will be unsecured, except as may be set forth in the applicable prospectus supplement.
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DESCRIPTION
OF WARRANTS
The
following description, together with the additional information we may include in any applicable prospectus supplement, summarizes
the material terms and provisions of any warrants that we may offer under this prospectus and the related warrant agreements and
warrant certificates. While the terms summarized below will apply generally to any warrants that we may offer, we will describe
the particular terms of any series of warrants in more detail in the applicable prospectus supplement. The terms of any warrants
offered under a prospectus supplement may differ from the terms described below. With respect to any warrants that we offer, specific
warrant agreements will contain additional important terms and provisions and will be incorporated by reference as an exhibit
to the registration statement that includes this prospectus or as an exhibit to reports that we file with the SEC and incorporated
by reference in this prospectus:
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the
specific designation and aggregate number of, and the price at which we will issue, the warrants;
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the
currency or currency units in which the offering price, if any, and the exercise price are payable;
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if
applicable, the exercise price for shares of our common stock or preferred stock and the number of shares of common stock
or preferred stock to be received upon exercise of the warrants;
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in
the case of warrants to purchase debt securities, the principal amount of debt securities purchasable upon exercise of one
warrant and the price at, and currency in which, this principal amount of debt securities may be purchased upon such exercise;
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the
date on which the right to exercise the warrants will begin and the date on which that right will expire or, if you may not
continuously exercise the warrants throughout that period, the specific date or dates on which you may exercise the warrants;
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whether
the warrants will be issued in fully registered form or bearer form, in definitive or global form or in any combination of
these forms, although, in any case, the form of a warrant included in a unit will correspond to the form of the unit and of
any security included in that unit;
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any
applicable material U.S. federal income tax consequences;
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the
identity of the warrant agent for the warrants and of any other depositaries, execution or paying agents, transfer agents,
registrars or other agents;
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the
proposed listing, if any, of the warrants or the common stock issuable upon exercise of the warrants on any securities exchange;
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if
applicable, the date from and after which the warrants and the common stock will be separately transferable;
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if
applicable, the minimum or maximum amount of the warrants that may be exercised at any one time;
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information
with respect to book-entry procedures, if any;
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the
anti-dilution provisions of the warrants, if any;
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any
redemption or call provisions;
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whether
the warrants are to be sold separately or with other securities as parts of units; and
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any
additional terms of the warrants, including terms, procedures and limitations relating to the exchange and exercise of the
warrants.
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Before
exercising their warrants, holders of warrants will not have any of the rights of holders of the securities purchasable upon such
exercise, including:
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in
the case of warrants to purchase debt securities, the right to receive payments of principal of, or premium, if any, or interest
on, the debt securities purchasable upon exercise or to enforce covenants in the applicable indenture; or
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in
the case of warrants to purchase common stock or preferred stock, the right to receive dividends, if any, or, payments upon
our liquidation, dissolution or winding up or to exercise voting rights, if any.
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Transfer
Agent and Registrar
The
transfer agent and registrar for any warrants will be set forth in the applicable prospectus supplement.
DESCRIPTION
OF UNITS
We
might issue units composed of one or more debt securities, shares of common stock, shares of preferred stock and warrants in any
combination. Each unit will be issued so that the holder of the unit is also the holder of each security included in the unit.
Thus, the holder of a unit will have the rights and obligations of a holder of each included security. The unit agreement under
which a unit is issued may provide that the securities included in the unit may not be held or transferred separately, at any
time or at any time before a specified date. We will file as exhibits to the registration statement of which this prospectus is
a part, or will incorporate by reference from reports that we file with the SEC, the form of unit agreement, warrant and any supplemental
agreements that describe the terms of the series of units we are offering before the issuance of the related series of units.
We
may choose to evidence each series of units by unit certificates that we would issue under a separate agreement. If we choose
to evidence the units by unit certificates, we will enter into the unit agreements with a unit agent and will indicate the name
and address of the unit agent in the applicable prospectus supplement relating to the particular series of units.
LEGAL
MATTERS
Certain
legal matters with respect to the securities offered hereby have been passed upon by Morgan, Lewis & Bockius LLP, New York,
New York.
EXPERTS
The
consolidated balance sheets of CorMedix Inc. as of December 31, 2019 and 2018 and the related consolidated statements of operations
and comprehensive income (loss), stockholders’ equity, and cash flows for each of the years in the two-year period ended
December 31, 2019, and management’s assessment of the effectiveness of internal control over financial reporting as of December
31, 2019 (which is included in management’s report on internal control over financial reporting in the annual report on
Form 10-K for the year ended December 31, 2019), have been incorporated herein by reference in reliance on the report of Friedman
LLP, independent registered public accounting firm, given upon their authority as experts in accounting and auditing.
WHERE
YOU CAN FIND ADDITIONAL INFORMATION
We
are required to file annual and quarterly reports, current reports, proxy statements, and other information with the SEC. We make
these documents publicly available, free of charge, on our website at www.cormedix.com as soon as reasonably practicable after
filing such documents with the SEC. Any requests for this information should be made by calling or sending a letter to the Secretary
of the Company, c/o CorMedix Inc., at our office located at 400 Connell Drive, Suite 5000, Berkeley Heights, NJ 07922.
SEC
filings are also available at the SEC’s web site at http://www.sec.gov. Our common stock is listed on the NYSE American,
and you can read and inspect our filings at the offices of the NYSE American at 20 Broad Street, New York, NY 10005.
INCORPORATION
OF DOCUMENTS BY REFERENCE
The
SEC allows us to “incorporate by reference” information that we file with them. Incorporation by reference allows
us to disclose important information to you by referring you to those other documents. The information incorporated by reference
is an important part of this prospectus and any applicable accompanying prospectus supplement, and information that we file later
with the SEC will automatically update and supersede this information. We filed a registration statement on Form S-3 under
the Securities Act of 1933, as amended, with the SEC with respect to the securities being offered pursuant to this prospectus
and any applicable accompanying prospectus supplement. This prospectus omits certain information contained in the registration
statement, as permitted by the SEC. You should refer to the registration statement, including the exhibits, for further information
about us and the securities being offered pursuant to this prospectus and any applicable accompanying prospectus supplement. Statements
in this prospectus and any applicable accompanying prospectus supplement regarding the provisions of certain documents filed with,
or incorporated by reference in, the registration statement are not necessarily complete and each statement is qualified in all
respects by that reference. Copies of all or any part of the registration statement, including the documents incorporated by reference
or the exhibits, may be obtained as described above in “Where You Can Find More Information.” The documents we are
incorporating by reference into this prospectus are:
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our
Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed with the SEC pursuant to Section 13
of the Exchange Act on March 16, 2020;
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our
Quarterly Reports on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 5, 2020, for the quarter
ended June 30, 2020, filed with the SEC on August 10, 2020 and for the quarter ended March 31, 2020, filed with the SEC on
May 11, 2020;
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our
Current Reports on Form 8-K, filed with the SEC pursuant to Section 13 of the Exchange Act on February 3, 2020, February 4, 2020, February 6, 2020, April 8, 2020, April 22, 2020, April 23, 2020, May 11, 2020 July 8, 2020, July 29, 2020, August 31, 2020, September 17, 2020, October 14, 2020 and November 2, 2020;
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the
description of our capital stock contained in Exhibit 4.5 to our Annual Report on Form 10-K filed with the SEC on March 16, 2010, including any amendment or report filed for the purpose of updating such description; and
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all
of the filings pursuant to the Exchange Act after the date of the filing of the registration statement and prior to the effectiveness
of the registration statement.
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In
addition, all documents subsequently filed by us after the date of the initial registration statement pursuant to Section 13(a),
13(c), 14 or 15(d) of the Exchange Act before the date our offering is terminated or completed are deemed to be incorporated by
reference into, and to be a part of, this prospectus.
Any
statement contained in this prospectus and any applicable prospectus supplement or in a document incorporated or deemed to be
incorporated by reference into this prospectus and any applicable prospectus supplement will be deemed to be modified or superseded
for purposes of this prospectus and any prospectus supplement to the extent that a statement contained in this prospectus and
any applicable prospectus supplement or any other subsequently filed document that is deemed to be incorporated by reference into
this prospectus and any applicable prospectus supplement modifies or supersedes the statement. Any statement so modified or superseded
will not be deemed, except as so modified or superseded, to constitute a part of this prospectus and any applicable prospectus
supplement.
We
will furnish without charge to you, on written or oral request, a copy of any or all of the documents incorporated by reference,
including exhibits to these documents. You should direct any requests for documents to CorMedix, Inc., Attention: Secretary, 400
Connell Drive, Suite 5000, Berkeley Heights, New Jersey 07922, (908) 517-9500.
You
should rely only on information contained in, or incorporated by reference into, this prospectus and any applicable prospectus
supplement. We have not authorized anyone to provide you with information different from that contained in this prospectus and
any applicable prospectus supplement or incorporated by reference in this prospectus and any applicable prospectus supplement.
We are not making offers to sell the securities in any jurisdiction in which such an offer or solicitation is not authorized or
in which the person making such offer or solicitation is not qualified to do so or to anyone to whom it is unlawful to make such
offer or solicitation.
PART
II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14.
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Other
Expenses of Issuance and Distribution.
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We
estimate that expenses payable by us in connection with the offering described in this registration statement will be as follows:
SEC registration fee
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$
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10,910
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Legal fees and expenses
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50,000
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*
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Accounting fees and expenses
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20,000
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*
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Printing expenses
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10,000
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*
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Miscellaneous
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34,590
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*
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Total
|
|
|
125,500
|
*
|
|
*
|
Estimated as permitted under Item 511 of Regulation S-K.
|
Item 15.
|
Indemnification
of Directors and Officers.
|
Section
145 of the DGCL permits a corporation, under specified circumstances, to indemnify its directors, officers, employees or agents
against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlements actually and reasonably incurred
by them in connection with any action, suit or proceeding brought by third parties by reason of the fact that they were or are
directors, officers, employees or agents of the corporation, if such directors, officers, employees or agents acted in good faith
and in a manner they reasonably believed to be in or not opposed to the best interests of the corporation and, with respect to
any criminal action or proceeding, had no reason to believe their conduct was unlawful. In a derivative action, that is one by
or in the right of the corporation, indemnification may be made only for expenses actually and reasonably incurred by directors,
officers, employees or agents in connection with the defense or settlement of an action or suit, and only with respect to a matter
as to which they will have acted in good faith and in a manner they reasonably believed to be in or not opposed to the best interests
of the corporation, except that no indemnification will be made if such person will have been adjudged liable to the corporation,
unless and only to the extent that the court in which the action or suit was brought will determine upon application that the
defendant directors, officers, employees or agents are fairly and reasonably entitled to indemnity for such expenses despite such
adjudication of liability.
Pursuant
to the DGCL, our Amended and Restated Certificate of Incorporation, as amended provides that no director will be personally liable
to our company or our stockholders for monetary damages for breach of fiduciary duty as a director, except for liability (i) for
any breach of the director’s duty of loyalty to our company or our stockholders, (ii) for acts or omissions not in good
faith or which involve intentional misconduct or a knowing violation of law, (iii) under Section 174 of the DGCL, or (iv) for
any transaction from which the director derived any improper personal benefit. Our Second Amended and Restated Bylaws provide
that we will generally indemnify our directors, officers, employees or agents to the fullest extent permitted by the law against
all losses, claims, damages or similar events. We have obtained liability insurance for each director and officer for certain
losses arising from claims or charges made against them while acting in their capacities as directors or officers of our Company.
(a)
The following exhibits are filed as part of this Registration Statement:
Exhibit Number
|
|
Description of Document
|
|
Registrant’s Form
|
|
Dated
|
|
Exhibit Number
|
|
Filed Herewith
|
3.1
|
|
Form of Amended and Restated Certificate of Incorporation.
|
|
S-1/A
|
|
3/01/2010
|
|
3.3
|
|
|
3.2
|
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation, dated February 24, 2010.
|
|
S-1/A
|
|
3/19/2010
|
|
3.5
|
|
|
3.3
|
|
Second Amended and Restated Bylaws as amended October 8, 2020.
|
|
8-K
|
|
10/14/2020
|
|
3.1
|
|
|
3.4
|
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation, dated December 3, 2012.
|
|
10-K
|
|
3/27/2013
|
|
3.3
|
|
|
3.5
|
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation, dated August 9, 2017.
|
|
8-K
|
|
8/10/2017
|
|
3.1
|
|
|
3.6
|
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation, dated March 25, 2019
|
|
8-K
|
|
3/25/2019
|
|
3.1
|
|
|
3.7
|
|
Amended and Restated Certificate of Designation of Series C-3 Non-Voting Convertible Preferred Stock of CorMedix Inc., filed with the Delaware Secretary of State on September 15, 2014.
|
|
8-K
|
|
9/16/2014
|
|
3.16
|
|
|
3.8
|
|
Second Amended and Restated Certificate of Designation of Series E Convertible Preferred Stock of CorMedix Inc., filed with the Delaware Secretary of State on September 5, 2019.
|
|
8-K
|
|
9/11/2019
|
|
3.18
|
|
|
3.9
|
|
Certificate of Designation of Series G Convertible Preferred Stock of CorMedix Inc., filed with the Delaware Secretary of State on September 5, 2019.
|
|
8-K
|
|
9/11/2019
|
|
3.18
|
|
|
4.1
|
|
Specimen of Common Stock Certificate.
|
|
S-1/A
|
|
3/19/2010
|
|
4.1
|
|
|
4.2
|
|
Form of Warrant issued on January 8, 2014.
|
|
8-K
|
|
1/09/2014
|
|
4.23
|
|
|
4.3
|
|
Form of Series B Warrant to Purchase Common Stock of CorMedix Inc. issued on May 3, 2017.
|
|
8-K
|
|
5/03/2017
|
|
4.2
|
|
|
4.4
|
|
Form of Underwriter’s Warrant to Purchase Common Stock of CorMedix Inc., issued May 3, 2017.
|
|
8-K
|
|
5/03/2017
|
|
4.3
|
|
|
4.5
|
|
Form of Warrant issued on November 16, 2017.
|
|
8-K
|
|
11/13/2017
|
|
4.15
|
|
|
4.6
|
|
Form of Indenture.
|
|
S-3
|
|
3/09/2018
|
|
4.16
|
|
|
4.7*
|
|
Form of Note.
|
|
|
|
|
|
|
|
|
4.8*
|
|
Form of Common Stock Warrant Agreement and Warrant Certificate.
|
|
|
|
|
|
|
|
|
4.9*
|
|
Form of Preferred Stock Warrant Agreement and Warrant Certificate.
|
|
|
|
|
|
|
|
|
4.10*
|
|
Form of Debt Securities Warrant Agreement and Warrant Certificate.
|
|
|
|
|
|
|
|
|
4.11*
|
|
Form of Unit Agreement.
|
|
|
|
|
|
|
|
|
5.1
|
|
Opinion of Morgan, Lewis & Bockius LLP.
|
|
|
|
|
|
|
|
x
|
23.1
|
|
Consent of Friedman LLP, Independent Registered Accounting Firm
|
|
|
|
|
|
|
|
x
|
23.3
|
|
Consent of Morgan, Lewis & Bockius LLP (included as part of Exhibit 5.1).
|
|
|
|
|
|
|
|
x
|
24.1
|
|
Power of Attorney (included in the signature page hereto).
|
|
|
|
|
|
|
|
x
|
25.1**
|
|
Form T-1 Statement of Eligibility of Trustee
|
|
|
|
|
|
|
|
|
*
|
To
be filed by amendment or as an exhibit to a Current Report on Form 8-K and incorporated herein by reference, if applicable.
|
|
|
**
|
To
be filed in accordance with Section 305(b)(2) of the Trust Indenture Act of 1939, as amended.
|
(b)
Financial statement schedule.
None.
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 SEC 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;
(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) above 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 Registrant pursuant to Section
13 and Section 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 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)
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 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 Act and will be governed by the final adjudication of such
issue.
(d)
The undersigned Registrant hereby undertakes that:
(1)
For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of
prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus
filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be
part of this registration statement as of the time it was declared effective; and
(2)
For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that
contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein,
and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(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 (“Act”) in
accordance with the rules and regulations prescribed by the Commission under section 305(b)(2) of the Act.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the Registrant certifies that it has reasonable grounds to believe that it
meets all of the requirements for filing on Form S-3 and has duly caused this Registration Statement on Form S-3 to be signed
on its behalf by the undersigned, thereunto duly authorized, in the City of Berkeley Heights, State of New Jersey, on November
5, 2020.
|
CORMEDIX
INC.
|
|
|
|
|
By:
|
/s/
Khoso Baluch
|
|
|
Khoso
Baluch
|
|
|
Chief Executive Officer
|
POWER
OF ATTORNEY
We,
the undersigned officers and directors of CorMedix Inc., do hereby constitute and appoint Khoso Baluch and Matthew David, or either
of them, our true and lawful attorneys-in-fact and agents, each with full power of substitution and resubstitution, for him and
in his name, place and stead, in any and all capacities, to sign any and all amendments to this Registration Statement, and any
and all additional registration statements pursuant to Rule 462(b) of the Securities Act of 1933, as amended, and to file the
same, with exhibits thereto, and other documents in connection therewith, with the SEC, granting unto said attorneys-in-fact and
agents, and each of them, full power and authority to do and perform each and every act and thing requisite are necessary to be
done in and about the premises, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying
and confirming all that each of said attorney-in-fact and agents, or his or her substitute or substitutes, may lawfully do or
cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Act, this Registration Statement on Form S-3 has been signed by the following persons in
the capacities and on the dates indicated.
Signature
|
|
Capacity
|
|
Date
|
|
|
|
|
|
/s/ Khoso Baluch
|
|
Director and Chief Executive Officer
|
|
November 5, 2020
|
Khoso Baluch
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/ Matthew David
|
|
Chief Financial Officer
|
|
November 5, 2020
|
Matthew David
|
|
(Principal Financial Officer and Principal Accounting Officer)
|
|
|
|
|
|
|
|
/s/ Janet Dillione
|
|
Director
|
|
November 5, 2020
|
Janet Dillione
|
|
|
|
|
|
|
|
|
|
/s/ Myron Kaplan
|
|
Director
|
|
November 5, 2020
|
Myron Kaplan
|
|
|
|
|
|
|
|
|
|
/s/ Alan W. Dunton
|
|
Director
|
|
November 5, 2020
|
Alan W. Dunton
|
|
|
|
|
|
|
|
|
|
/s/ Steven Lefkowitz
|
|
Director
|
|
November 5, 2020
|
Steven Lefkowitz
|
|
|
|
|
|
|
|
|
|
/s/ Paulo F. Costa
|
|
Director
|
|
November 5, 2020
|
Paulo F. Costa
|
|
|
|
|
|
|
|
|
|
/s/ Greg Duncan
|
|
Director
|
|
November 5, 2020
|
Greg Duncan
|
|
|
|
|
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