Table of Contents
Filed Pursuant to Rule 424(b)(5)
Registration No. 333-233774
PROSPECTUS SUPPLEMENT
(To Prospectus dated October 28, 2019)
GENPREX, INC.
3,167,986
Shares of Common Stock
We are offering 3,167,986 shares of our common stock, par value
$0.001 per share, pursuant to this prospectus supplement and the
accompanying prospectus and a securities purchase agreement at a
price of $0.40 per share. In a concurrent private placement, we are
also selling to investors, for no additional consideration, a
warrant to purchase one share of common stock for each share
purchased in the offering (the “Warrants”).
Each Warrant will have an exercise price of $0.46, will be
exercisable beginning on the six-month anniversary of the date of
issuance (the “Initial Exercise Date”) and will expire five years
from the date of issuance. The Warrants and the shares of common
stock issuable upon the exercise of the Warrants (the "Warrant
Shares") are not being registered under the Securities Act of 1933,
as amended (the "Securities Act") pursuant to the registration
statement of which this prospectus supplement and the accompanying
base prospectus form a part and are not being offered pursuant to
this prospectus supplement and the accompanying base prospectus.
The Warrants are being offered pursuant to an exemption from the
registration requirements of the Securities Act provided in Section
4(a)(2) of the Securities Act and/or Regulation D. The Warrants are
not and will not be listed for trading on any national securities
exchange.
Our common stock is listed on The Nasdaq Capital Market under the
symbol “GNPX”. On November 19, 2019, the last reported sale price
of our common stock on The Nasdaq Capital Market was $0.62 per
share.
We have retained Joseph Gunnar & Company, LLC to act as
exclusive placement agent in connection with this offering. The
placement agent has agreed to use its reasonable best efforts to
sell the securities offered by this prospectus supplement and the
accompanying prospectus. The placement agent is not purchasing or
selling any shares offered by this prospectus supplement and the
accompanying base prospectus. See "Plan of Distribution" beginning
on page S-15 of this prospectus supplement for more information
regarding these arrangements.
As of November 19, 2019, the aggregate market value of our
outstanding common stock held by non-affiliates was approximately
$12,260,828 based on 15,847,855 outstanding shares of common stock,
of which approximately 13,623,142 shares are held by
non-affiliates, and a per share price of $0.90, based upon the
closing sale price of our common stock on The Nasdaq Capital Market
on September 23, 2019. During the 12 calendar month period that
ends on, and includes, the date of this prospectus supplement, we
have not offered and sold any of our securities pursuant to General
Instruction I.B.6 of Form S-3.
Investing in our securities involves a high degree of risk. See
“Risk Factors” beginning on page S-9 of this
prospectus for a discussion of information that should be
considered in connection with an investment 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.
|
|
|
Per Share
|
|
|
Total(1)
|
|
|
Public offering price
|
|
$ |
0.40 |
|
|
$ |
1,267,194 |
|
|
Placement agent's fees
|
|
$ |
0.028 |
|
|
$ |
88,703 |
|
|
Proceeds to us, before expenses
|
|
$ |
0.372 |
|
|
$ |
1,178,491 |
|
|
(1)
|
We have agreed to pay the placement agent an aggregate cash
placement fee equal to 7% of the gross proceeds in this offering
and the concurrent private placement. We have also agreed to
reimburse the placement agent for certain expenses incurred in
connection with this offering. For additional information on the
placement agent's fees and expense reimbursement, see "Plan of
Distribution" beginning on page S-15 of this prospectus
supplement.
|
Delivery of the shares of common stock to investors is expected
on or about November 22, 2019.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus supplement is truthful
or complete. Any representation to the contrary is a criminal
offense.
________________________
Joseph Gunnar & Co.
The date of this prospectus supplement is November
20, 2019.
TABLE OF
CONTENTS
ABOUT
THIS PROSPECTUS SUPPLEMENT
This document is in two parts. The first part is this prospectus
supplement, which describes the specific terms of this offering and
also adds to and updates information contained in the accompanying
prospectus and the documents incorporated by reference herein. The
second part, the accompanying prospectus, provides more general
information. Generally, when we refer to this prospectus, we are
referring to both parts of this document combined. To the extent
there is a conflict between the information contained in this
prospectus supplement and the information contained in the
accompanying prospectus or any document incorporated by reference
therein filed prior to the date of this prospectus supplement, you
should rely on the information in this prospectus supplement;
provided that if any statement in one of these documents is
inconsistent with a statement in another document having a later
date—for example, a document incorporated by reference in the
accompanying prospectus—the statement in the document having the
later date modifies or supersedes the earlier statement.
We further note that the representations, warranties and covenants
made by us in any agreement that is filed as an exhibit to any
document that is incorporated by reference herein were made solely
for the benefit of the parties to such agreement, including, in
some cases, for the purpose of allocating risk among the parties to
such agreements, and should not be deemed to be a representation,
warranty or covenant to you. Moreover, such representations,
warranties or covenants were accurate only as of the date when
made. Accordingly, such representations, warranties and covenants
should not be relied on as accurately representing the current
state of our affairs.
You should rely only on the information contained in this
prospectus supplement or the accompanying prospectus, or
incorporated by reference herein. We have not authorized, and the
placement agent has not authorized, anyone to provide you with
information that is different. The information contained in this
prospectus supplement or the accompanying prospectus, or
incorporated by reference herein, is accurate only as of the
respective dates thereof, regardless of the time of delivery of
this prospectus supplement and the accompanying prospectus or of
any sale of our securities. It is important for you to read and
consider all information contained in this prospectus supplement
and the accompanying prospectus, including the documents
incorporated by reference herein, in making your investment
decision. You should also read and consider the information in the
documents to which we have referred you in the sections entitled
“Where You Can Find More Information” and “Incorporation by
Reference” in this prospectus supplement and in the accompanying
prospectus.
We are offering to sell, and seeking offers to buy, our securities
only in jurisdictions where offers and sales are permitted. The
distribution of this prospectus supplement and the accompanying
prospectus and the offering of our securities in certain
jurisdictions may be restricted by law. Persons outside the United
States who come into possession of this prospectus supplement and
the accompanying prospectus must inform themselves about, and
observe any restrictions relating to, the offering of our
securities and the distribution of this prospectus supplement and
the accompanying prospectus outside the United States. This
prospectus supplement and the accompanying prospectus do not
constitute, and may not be used in connection with, an offer to
sell, or a solicitation of an offer to buy, any securities offered
by this prospectus supplement and the accompanying prospectus by
any person in any jurisdiction in which it is unlawful for such
person to make such an offer or solicitation.
Unless otherwise mentioned or unless the context requires
otherwise, all references in this prospectus supplement to the
“Company,” “we,” “us,” “our” and “Genprex” refer to Genprex, Inc.,
a Delaware corporation, and its subsidiaries.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING
STATEMENTS AND INDUSTRY DATA
This prospectus supplement, the accompanying prospectus and the
documents we incorporate by reference herein and therein include
forward-looking statements within the meaning of Section 27A
of the Securities Act of 1933, as amended and Section 21E of the
Securities Exchange Act of 1934, as amended. Any statement
contained in this prospectus supplement, the accompanying
prospectus or in the documents we incorporate by reference herein
and therein other than a statement of historical fact, may be a
forward-looking statement, including statements regarding our
future discovery, development and commercialization efforts,
strategy, future operations, future financial position, future
revenue, projected costs, prospects, plans and objectives of
management. In some cases, you can identify forward-looking
statements by such terms as “anticipate,” “believe,” “could,”
“estimate,” “expect,” “forecast,” “intend,” “might,” “may,” “plan,”
“project,” “should,” “target,” “will,” “would” or other words that
convey uncertainty of future events or outcomes to identify these
forward-looking statements. Forward-looking statements may include,
but are not limited to, statements about:
| |
●
|
our ability to obtain additional funding to develop our current and
potential product candidates;
|
| |
●
|
the need to obtain regulatory approval of our current and potential
product candidates;
|
| |
●
|
the success of our clinical trials through all phases of clinical
development;
|
| |
●
|
compliance with obligations under intellectual property licenses
with third parties;
|
| |
●
|
any delays in regulatory review and approval of product candidates
in clinical development;
|
| |
●
|
our ability to commercialize our current and potential product
candidates;
|
| |
●
|
market acceptance of our current and potential product
candidates;
|
| |
●
|
competition from existing products or new products that may
emerge;
|
| |
●
|
potential product liability claims;
|
| |
●
|
our dependence on third-party manufacturers to supply or
manufacture our products;
|
| |
●
|
our ability to establish or maintain collaborations, licensing or
other arrangements;
|
| |
●
|
our ability and third parties’ ability to protect intellectual
property rights;
|
| |
●
|
our ability to adequately support future growth;
|
| |
●
|
our ability to attract and retain key personnel to manage our
business effectively; and
|
| |
●
|
our intended use of proceeds of this offering.
|
If one or more of these factors materialize, or if any underlying
assumptions prove incorrect, our actual results, performance or
achievements may vary materially from any future results,
performance or achievements expressed or implied by these
forward-looking statements.
You should consider these factors and the other cautionary
statements made in this prospectus supplement, the accompanying
prospectus and the documents we incorporate by reference herein and
therein as being applicable to all related forward-looking
statements wherever they appear in this prospectus supplement, the
accompanying prospectus, or the documents incorporated by
reference. While we may elect to update forward-looking statements
wherever they appear in this prospectus supplement, the
accompanying prospectus, or the documents incorporated by reference
herein and therein, we do not assume, and specifically disclaim,
any obligation to do so, whether as a result of new information,
future events or otherwise, unless required by law.
This prospectus summary also includes statistical and other
industry and market data that we obtained from industry
publications and research, surveys and studies conducted by third
parties. All of the market data used in this report involves a
number of assumptions and limitations, and you are cautioned not to
give undue weight to such data. We believe that the information
from these industry publications, surveys and studies is reliable.
The industry in which we operate is subject to a high degree of
uncertainty and risk due to a variety of important factors,
including those risks discussed (i) under the heading “Risk
Factors” on page S-9 of this prospectus supplement,
(ii) in the section titled “Risk Factors” in our Annual Report
on Form 10-K for the year ended December 31, 2018,
as filed with the SEC on April 1, 2019, as amended on October 16,
2019 (the “Annual Report”), and (iii) in other filings we make
with the SEC from time to time. These and other factors could cause
results to differ materially from those expressed in the estimates
made by the independent parties and by us.
PROSPECTUS SUPPLEMENT SUMMARY
This summary does not contain all of the information that you
should consider before investing in our securities. You should read
this entire prospectus supplement and the accompanying prospectus
carefully, including the financial statements and other information
incorporated by reference in this prospectus supplement and the
accompanying prospectus, before making an investment decision. In
addition, please read the “Risk Factors” section of this prospectus
supplement beginning on page S-9 and the
risk factors contained in our Annual Report.
Company Overview
Genprex™ is a clinical stage gene therapy company developing a new
approach to treating cancer, based upon our novel proprietary
technology platform, including our initial product candidate,
Oncoprex™ immunogene therapy, or Oncoprex. Our platform
technologies are designed to administer cancer fighting genes by
encapsulating them into nanoscale hollow spheres called
nanovesicles, which are then administered intravenously and taken
up by tumor cells where they express proteins that are missing or
found in low quantities. Oncoprex has a multimodal mechanism of
action whereby it interrupts cell signaling pathways that cause
replication and proliferation of cancer cells, re-establishes
pathways for apoptosis, or programmed cell death, in cancer cells,
and modulates the immune response against cancer cells. Oncoprex
has also been shown to block mechanisms that create drug
resistance.
We hold an exclusive worldwide license from The University of Texas
MD Anderson Cancer Center, or MD Anderson, to patents covering the
therapeutic use of a series of genes that have been shown in
preclinical and clinical research to have cancer fighting
properties.
With Oncoprex, we are initially targeting non-small cell lung
cancer, or NSCLC. Researchers at MD Anderson have conducted two
Phase I clinical trials and are currently conducting an ongoing
Phase II clinical trial of Oncoprex plus erlotinib in NSCLC.
According to the World Health Organization, lung cancer is the
leading cause of cancer deaths worldwide, killing more people than
breast, colon, kidney, liver, prostate and skin cancers, and is the
second most common type of cancer. Each year, there are over 1.8
million new lung cancer cases and 1.6 million deaths from lung
cancer worldwide, and in the United States there are over 225,000
new cases and more than 150,000 deaths from lung cancer per year.
NSCLC represents 80% of all lung cancers. According to a 2016
American Cancer Society report, the five-year survival rate for
Stage IV (metastatic) NSCLC is about 1%, and overall survival for
lung cancer has not improved appreciably in the last 25 years. We
believe that there is a significant unmet medical need for new
treatments for NSCLC in the United States and globally, and we
believe that Oncoprex may be suitable for a majority of NSCLC
patients.
We believe that our platform technologies could allow delivery of a
number of cancer fighting genes, alone or in combination with other
cancer therapies, to combat multiple types of cancer. Our research
and development pipeline, discussed in “Our Pipeline” below,
demonstrates our clinical and preclinical progress to date.
Cancer results from genetic mutations. Mutations that lead to
cancer are usually present in two major classes of genes:
oncogenes, which are involved in functions such as signal
transduction and transcription; and tumor suppressor genes, which
play a role in governing cell proliferation by regulating
transcription. Transduction is the process by which chemical and
physical signals are transmitted through cells. Transcription is
the process by which a cell’s DNA sequence is copied to make RNA
molecules, which then play a role in protein expression. In normal
cells, mutations in oncogenes are discovered and targeted for
elimination by tumor suppressor genes. In cancer cells, the
oncogene mutations may overwhelm the natural tumor suppression
processes, or those tumor suppression processes may be impaired or
absent. Functional alterations due to mutations in oncogenes or
tumor suppressor genes may result in the abnormal and uncontrolled
growth patterns characteristic of cancer. These genetic alterations
facilitate such malignant growth by affecting signal transduction
pathways and transcription, thus inhibiting normal growth signaling
in the cell, circumventing the natural process of apoptosis,
evading the immune system’s response to cancer, and inducing
angiogenesis, which is the formation of new blood vessels that
supply cancer cells.
The most common genetic alterations present in NSCLC are in tumor
suppressor genes, against which few targeted small molecule drugs
have been developed. Each of the two sets of chromosomes in the
cell nucleus includes two copies of each gene, called alleles,
which may be identical or may show differences. In most situations,
tumor suppressor genes require both alleles of a gene to be deleted
or inactivated to impair tumor suppression activity and lead to
tumor growth. The replacement of just one functional allele may
therefore be enough to restore the normal cellular functions of
growth regulation and apoptosis.
Among the genetic conditions associated with lung cancer are the
overexpression of epidermal growth factor receptors, or EGFRs, and
mutations of kinases. Kinases are enzymes that play an important
role in signal transduction through the modification of proteins by
adding or taking away phosphate groups, a process called
(de-)phosphorylation, to change the proteins’ function. When two
EGFR transmembrane proteins are brought to proximity on the cell
membrane surface, or dimerize, either through a ligand, or binding
molecule, that binds to the extracellular receptor, or through some
other process, the intracellular protein-kinase domains can
autophosphorylate, and activate downstream processes, including
cell signaling pathways that can lead to either cell cycle arrest
or cell growth and proliferation. EGFRs and kinases can act
similarly to a switch that turns “on” and “off” when phosphate
groups are either added or taken away. Mutated kinases can have a
malfunctioning on/off switch, causing the switch to be stuck in the
“on” position or failing to turn the switch “off,” leading to the
loss of cell control.
A subset of NSCLC patients (approximately 10% of NSCLC patients of
North American and European descent and approximately 30% to 50% of
NSCLC patients of Asian descent) carry an EGFR mutation that makes
their tumors sensitive to tyrosine kinase inhibitors, or TKIs, such
as erlotinib. However, even for these patients, tumor resistance to
TKIs frequently develops within two years, resulting in eventual
disease progression. Erlotinib generally does not benefit NSCLC
patients who do not have this activating EGFR mutation. However,
our clinical and preclinical data have shown that the combination
of Oncoprex and erlotinib can increase anti-tumor activity even in
cancers without the EGFR mutations, as well as in cancers that have
become resistant to erlotinib. For this reason, we believe Oncoprex
may be suitable for the majority of NSCLC patients.
Cancer can spread when cells’ natural cancer suppression functions
are impaired. The tumor suppressor gene called Tumor Suppressor
Candidate 2, or TUSC2 (which was formerly known as FUS1) has been
shown to affect both cell proliferation and apoptosis. TUSC2 is a
pan-kinase inhibitor, which means that it has the ability to
inhibit multiple kinase receptors, such as EGFR and
platelet-derived growth factor receptor, or PDGFR. TUSC2 is
frequently inactivated early in the development of lung cancer, and
loss of TUSC2 expression in NSCLC is associated with significantly
worse overall survival compared to patients with normal TUSC2
expression. Many types of cancer cells, including approximately 85%
of NSCLC cells, lack expression of TUSC2.
Cancer can also spread when the body’s natural immune functions are
impaired, including by the cancer cells themselves. PD-1, or
Programmed Death-1, is a receptor expressed on the surface of
activated T cells, which are part of the body’s immune system.
PD-L1, or Programmed Death Ligand-1, is a protein/receptor
expressed on the surface of cancer and other cells. The binding of
PD-1 to PD-L1 has been speculated to contribute to cancer cells’
ability to evade the body’s immune response. PD-1 and molecules
like it are called immune checkpoints, because they can impede the
normal immune response, for example by blocking the T cells from
attacking the cancer cells. In many cancers, PD-L1 receptors are
up-regulated, and substantial research is now being performed in
the emerging field of immuno-oncology to discover drugs or
antibodies that could block PD-L1 and similar receptors. It is
believed that blocking the PD-1/PD-L1 interaction pathway and other
similar checkpoints, such as cytotoxic T-lymphocyte-associated
protein 4, or CTLA-4, with drugs called checkpoint inhibitors can
prevent cancer cells from inactivating T cells.
Our Oncoprex immunogene therapy is designed to interrupt cell
signaling pathways that cause replication and proliferation of
cancer cells, and to target and kill cancer cells via receptor
pathways, and also to stimulate the natural immune responses
against cancer. Oncoprex combines features of gene therapy and
immunotherapy in that it up-regulates TUSC2 expression in the cell,
and also increases the anti-tumor immune cell population and
down-regulates PD-L1 receptors, thereby boosting the immune
response to cancer.
Oncoprex consists of a TUSC2 gene encapsulated in a nanovesicle
made from lipid molecules with a positive electrical charge.
Oncoprex is injected intravenously and can specifically target
cancer cells, which generally have a negative electrical charge.
Once Oncoprex is taken up into a cancer cell, the TUSC2 gene is
expressed into a protein that is capable of restoring certain
defective functions arising in the cancer cell. Oncoprex
nanovesicles are designed to deliver the functioning TUSC2 gene to
cancer cells while minimizing their uptake by normal tissue. Tumor
biopsy studies conducted at MD Anderson show that the uptake of
TUSC2 in tumor cells after Oncoprex treatment is 10 to 25 times the
uptake in normal cells. We believe that Oncoprex, unlike other gene
therapies, which either need to be delivered directly into tumors
or require cells to be removed from the body, re-engineered and
then reinserted into the body, is the first systemic gene therapy
to be used for cancer in humans.
Clinical data from the evaluation of 25 patients in our Phase I/II
clinical trial, as well as our preclinical data, indicate that
Oncoprex can be combined with the widely used anti-cancer drug
erlotinib (marketed as Tarceva® by Genentech, Inc.) in humans.
Erlotinib is a tyrosine kinase inhibitor, or TKI, which uses a
mechanism of action similar to that of pan-kinase inhibitors to
block the action of tyrosine kinases, which are a type of kinase
involved in many cell functions, including cell signaling, growth
and division. In addition, MD Anderson researchers have conducted
preclinical studies combining Oncoprex with:
| |
●
|
the TKI gefitinib (marketed as Iressa® by AstraZeneca
Pharmaceuticals) in animals and in human NSCLC cells;
|
| |
●
|
MK2206 in animals (MK2206 is an inhibitor of AKT kinases, which
affect cell signaling pathways downstream from tyrosine
kinases);
|
| |
●
|
an anti-PD-1 antibody equivalent to the checkpoint inhibitor
pembrolizumab (marketed as Keytruda® by Merck & Co. ) in
animals;
|
| |
●
|
an anti-PD-1 antibody equivalent to the checkpoint inhibitor
nivolumab (marketed as Opdivo® by Bristol-Myers Squibb Company) in
animals; and
|
| |
●
|
an anti-CTLA4 antibody equivalent to ipilimumab (marketed as
Yervoy® by Bristol-Myers Squibb Company) in animals.
|
The manufacturers of the marketed drugs were not involved in any of
our clinical or preclinical studies. In studies involving marketed
drugs, the drugs were administered concurrently with Oncoprex
without being modified in any way, and the antibodies used in our
preclinical studies that did not use the marketed drugs were the
non-humanized equivalent to marketed drugs.
Data from these clinical and preclinical studies indicate that
combining Oncoprex with these other therapies yields results more
favorable than either these therapies or Oncoprex alone, with
minimal side effects relative to other lung cancer drugs, thereby
potentially making Oncoprex a therapy complementary to these cancer
treatments. In addition, based on our clinical and preclinical
studies and on preclinical studies conducted by others, we believe
that Oncoprex could be combined with other lung cancer drugs that
have similar mechanisms of action to the drugs mentioned above,
such as nivolumab (marketed as Opdivo® by Bristol-Myers Squibb
Company) and atezolizumab (marketed as Tecentriq® by
Genentech/Roche). We have not conducted any preclinical or clinical
studies combining Oncoprex with atezolizumab.
Researchers at MD Anderson have collaborated with other researchers
to identify other genes, such as those in the 3p21.3 chromosomal
region, that may act as tumor suppressors or have other cancer
fighting functions. We hold rights to certain of these genes under
license agreements with MD Anderson. Data from preclinical studies
performed by others suggest that product candidates that could be
derived from our technology platform could be effective against
other types of cancer, including glioblastoma, head and neck,
breast, renal cell (kidney), and soft tissue sarcoma, as well as
NSCLC. Therefore, our platform technologies may allow delivery of a
number of cancer fighting genes, alone or in combination with other
cancer therapies, to combat multiple types of cancer.
In 2012, MD Anderson researchers completed a Phase I clinical trial
of Oncoprex as a monotherapy. The primary objective of this Phase I
trial was to assess the toxicity of Oncoprex administered
intravenously and to determine the MTD and recommended Phase II
dose of Oncoprex alone. Secondary objectives were to assess the
expression of TUSC2 following intravenous delivery of Oncoprex in
tumor biopsies and also to assess the anticancer activity of
Oncoprex. This trial demonstrated that Oncoprex was well tolerated
and established the MTD and the therapeutic dosage for Oncoprex at
0.06 mg/kg administered every 21 days. Although this trial was not
designed to show changes in outcomes, a halt in cancer growth was
observed in a number of patients, and tumor regressions occurred in
primary lung tumors and metastatic cancers in the liver, pancreas,
and lymph nodes. In addition, pre- and post-treatment patient
biopsies demonstrated that intravenous Oncoprex selectively and
preferentially targeted patients’ cancer cells, and suggested that
clinical anti-cancer activity was mediated by TUSC2.
We believe that Oncoprex’ combination of pan-kinase inhibition,
direct induction of apoptosis, anti-cancer immune modulation and
complementary action with targeted drugs and immunotherapies is
unique, and positions Oncoprex to provide treatment for patients
with NSCLC and possibly other cancers, who are not benefitting from
currently offered therapies.
MD Anderson researchers have completed the first phase of a Phase
I/II clinical trial of Oncoprex in combination with erlotinib in
patients with Stage IV (metastatic) or recurrent NSCLC that is not
potentially curable by radiotherapy or surgery, whether or not they
have received prior chemotherapy, and whether or not they have an
activating EGFR mutation. The Phase I portion of the trial was a
dose-escalating study with primary endpoints of establishing the
safety and tolerability of the combination of Oncoprex and
erlotinib, and establishing the Maximum Tolerated Dose, or MTD. The
secondary endpoint of the Phase I portion of the trial was to
assess the toxicity of the combination of Oncoprex with erlotinib.
In the Phase I portion of the trial, which began in 2014, 18
subjects were treated, and the MTD was determined to be the highest
tested dose: 0.6 mg/kg of Oncoprex administered every 21 days and
150 mg of erlotinib per day. Toxicities were found to compare
favorably with those of other lung cancer drugs.
The Phase II portion of the trial is designed to include subjects
treated with the combination of Oncoprex and erlotinib at the MTD
with the primary goal of measuring the response rate, and secondary
endpoints of stable disease, time to progression and overall
survival. The response rate for cancer therapies is defined under
the Response Evaluation Criteria in Solid Tumors, or RECIST, as
Complete Response (CR) + Partial Response (PR); disease control
rate is defined under the RECIST criteria as Complete Response (CR)
+ Partial Response (PR) + Stable Disease (SD)>8weeks.
Enrollment criteria for the second phase of the Phase I/II clinical
trial are identical to those in the first phase. The Phase II
portion of the trial began in June 2015 and is ongoing at MD
Anderson. Of the 39 patients allowed in the protocol for the Phase
II portion of the trial, 10 have been enrolled and nine are
evaluable for response under the trial protocol, because they have
received two or more cycles of treatment. Interim results show that
four of the patients had tumor regression and one patient had a
Complete Response, or CR under the RECIST criteria. The patient
with the CR had disappearance of the lung primary tumor, as well as
lung, liver, and lymph node metastases. The median response
duration for all patients, which is defined as the median time
between when response is first noted to the time when cancer
progression is observed, was three months. The response rate for
the nine patients evaluated to date was 11% and the disease control
rate for the nine patients was 78%.
The response rate and disease control rate to date in the Phase II
portion of our Phase I/II clinical trial substantially exceeds the
response rate of 7% (with no CRs) and disease control rate of 58%
reported for a clinical trial of the TKI afatinib (marketed as
Gilotrif® by Boehringer Ingelheim Pharmaceuticals, Inc.) in a study
referred to as the LUX-Lung 1 clinical trial. A total of 585
patients were enrolled in that Phase IIB/III clinical trial, whose
primary endpoint was overall survival and whose secondary endpoints
were progression-free survival, RECIST response, quality of life
and safety. The LUX-Lung 1 clinical trial was a randomized, double
blinded Phase IIB/III clinical trial treating subjects with Stage
IIIB or IV adenocarcinoma, a type of NSCLC. The Phase II portion of
our Phase I/II trial is not blinded, and is designed to treat NSCLC
subjects regardless of EGFR status.
Preliminary analysis of the early data from the Phase II portion of
our Phase I/II trial supports our belief that Oncoprex may provide
medical benefit in several subpopulations of NSCLC patients for
which there is an unmet medical need, and may provide pathways for
accelerated approval by the US Food and Drug Administration, or
FDA. As a result of these initial findings, in April 2016, we
suspended enrollment of new patients in the Phase II portion of the
trial to collect additional trial data and have it analyzed in
order to seek FDA guidance as to whether the protocol for this
clinical trial could be modified to expand enrollment and also to
divide the patients into cohorts with a view toward seeking
accelerated approval in one or more of these cohort populations. We
subsequently decided not to modify the trial, but to continue it as
originally designed. Although this clinical trial is currently
closed to new patient enrollment, it is not terminated, and is
considered “ongoing” because activities such as patient follow-up
and further data collection and analysis continue.
We now plan to reopen enrollment in the current version of the
Phase II portion of the trial. We have encountered delays in
reopening this trial at MD Anderson; and will likely reopen the
trial at one or more other clinical trial sites. We intend to use a
portion of our available funds to add additional clinical trial
sites.
Our Oncoprex immunogene therapy technology was discovered through a
lung cancer research consortium from MD Anderson and The University
of Texas Southwestern Medical Center, or UTSWMC, along with the
National Cancer Institute, or NCI. The TUSC2 discovery teams
included Jack A. Roth, MD, FACS, chairman of our Scientific and
Medical Advisory Board. We have assembled a team of experts in
clinical and translational research, including laboratory
scientists, medical oncologists and biostatisticians, to pursue the
development and commercialization of Oncoprex and other potential
product candidates.
Our technology discoveries and research and development programs
have been the subjects of numerous peer-reviewed publications and
have been supported by Small Business Innovation Research, or SBIR,
grants and grants from the National Institutes of Health, the
United States Department of Treasury, and the State of Texas. We
hold a worldwide, exclusive license from MD Anderson to patents
covering the therapeutic use of TUSC2 and other genes that have
been shown to have cancer fighting properties, as well as a number
of related technologies, including 30 issued patents, and two
pending patent applications.
Our Pipeline
We are developing Oncoprex, our lead product candidate, to be
administered with erlotinib for NSCLC. We are also conducting
preclinical research with the goal of developing Oncoprex to be
administered with immunotherapies in NSCLC. In addition, we have
conducted research into other tumor suppressor genes associated
with chromosome 3p21.3. Our research and development pipeline is
shown below:
Our Strategy
We intend to develop and commercialize treatments for cancer based
on our proprietary gene therapy platform, alone or in combination
with other cancer therapies. Key elements of our strategy
include:
| |
●
|
Conduct Ongoing and New Clinical Trials. We plan to
continue clinical trials of Oncoprex immunogene therapy in
combination with EGFR TKIs, such as erlotinib, and/or in
combination with immunotherapies, such as anti-PD-1 immunotherapy,
for treatment of NSCLC, while exploring pathways to accelerated
Food and Drug Administration, or FDA, approval of this combination
in NSCLC patients. We also may pursue clinical trials using
multi-drug combinations of Oncoprex with additional targeted
therapies and immunotherapies.
|
| |
●
|
Investigate the Effectiveness of Oncoprex in Other
Cancers. We may also explore the combination of Oncoprex
and other therapies in other cancers such as soft tissue, kidney,
head and neck, and/or breast cancer. We may also pursue development
of additional proprietary genes, alone or in combination with EGFR
TKIs such as erlotinib and/or with immunotherapies.
|
| |
●
|
Prepare to Commercialize Oncoprex. We plan to continue
to develop the manufacturing, process development and other
capabilities needed to commercialize Oncoprex.
|
| |
●
|
Pursue Strategic Partnerships. As we gather additional
clinical data, we plan to pursue strategic partnerships with other
developers and providers of anti-cancer drugs to investigate
possible therapeutic combinations of Oncoprex with drugs
manufactured by others, to accelerate the development of our
current and potential product candidates through co-development and
to increase the commercial opportunities for our current and
potential product candidates.
|
| |
●
|
Develop Our Platform Technology. We plan to investigate
the applicability of our platform technology with additional
anti-cancer drugs.
|
Corporate Information
We were incorporated in Delaware in April 2009. Our principal
executive offices are located at 1601 Trinity Street, Bldg. B,
Suite 3.322, Austin, TX 78712, and our telephone number is (512)
537-7997. Our corporate website address is www.genprex.com. The
information contained on our website is not incorporated by
reference into this prospectus, and you should not consider any
information contained on, or that can be accessed through, our
website as part of this prospectus or in deciding whether to
purchase our securities.
THE
OFFERING
|
Common stock offered by us
|
|
3,167,986 shares.
|
|
|
|
|
|
Common stock to be outstanding immediately after this
offering
|
|
19,015,841 shares.
|
| |
|
|
|
Public offering price
|
|
$0.40 per share.
|
|
|
|
|
|
Use of proceeds
|
|
We estimate the net proceeds from this offering and the concurrent
private placement will be approximately $1.1 million, after
deducting the placement agent's fees and estimated offering
expenses payable by us. We intend to use the net proceeds from this
offering for working capital and other general corporate purposes.
See "Use of Proceeds" beginning on page S-12 of this prospectus
supplement for additional detail.
|
|
|
|
|
|
Concurrent private placement
|
|
In a concurrent private placement, we are selling to purchasers of
our common stock in this offering, for no additional consideration,
a Warrant to purchase one share of common stock for each share
purchased in this offering. The warrants will be exercisable
beginning on the date that is six months after the date of issuance
at an exercise price of $0.46 per share and will expire on the five
year anniversary of the date the warrants become exercisable.
The Warrants and the shares of our common stock issuable upon the
exercise of the Warrants are not being registered under the
Securities Act pursuant to the registration statement of which this
prospectus supplement and the accompanying base prospectus form a
part and are not being offered pursuant to this prospectus
supplement and the accompanying base prospectus. The Warrants are
being offered pursuant to an exemption from the registration
requirements of the Securities Act provided in Section 4(a)(2) of
the Securities Act and/or Regulation D. See "Private Placement
Transaction and Warrants" on page S-14 of this prospectus
supplement.
|
| |
|
|
|
Risk factors
|
|
Investing in our securities is highly speculative and involves a
high degree of risk. You should carefully consider the information
set forth in the “Risk Factors” section beginning on page S-9 this
prospectus supplement and other information included or
incorporated by reference into this prospectus supplement before
deciding to invest in our securities.
|
|
|
|
|
|
Trading symbol
|
|
Our common stock is listed on The Nasdaq Capital Market under the
symbol "GNPX.” There is no established public trading market for
the Warrants, and we do not expect a market to develop. We do not
intend to list the Warrants on The Nasdaq Capital Market, any other
national securities exchange or any other nationally recognized
trading system. Without an active trading market, the liquidity of
the Warrants will be limited.
|
The number of shares of common stock to be outstanding immediately
after this offering is based on 15,847,855 shares of common stock
outstanding as of November 19, 2019, and excludes the shares of
common stock issuable upon exercise of the Warrants being offered
by us in the concurrent private placement and also excludes:
| |
●
|
5,905,583 shares of common stock issuable upon exercise of
outstanding options as of November 19, 2019 under our 2009 Equity
Incentive Plan and 2018 Equity Incentive Plan at a weighted average
price of $2.94 per share; and
|
| |
●
|
3,864,552 shares of common stock issuable upon the exercise of
warrants outstanding as of November 19, 2019 at a weighted average
price of $4.60 per share.
|
RISK
FACTORS
An investment in our securities involves a high degree of risk.
Before deciding whether to invest in our securities, you should
consider carefully the risks described below and the risk factors
contained in our Annual Report, together with other information in
this prospectus supplement, and the accompanying prospectus, and
the information and documents incorporated by reference in this
prospectus supplement and the accompanying prospectus, and in any
free writing prospectus that we have authorized for use in
connection with this offering. If any of these risks actually
occurs, our business, financial condition, results of operations or
cash flow could be seriously harmed. This could cause the trading
price of our common stock to decline, resulting in a loss of all or
part of your investment.
Risks Related to This Offering
We have broad discretion in the use of the net proceeds from
this offering and may not use them effectively.
Our management will have broad discretion in the application of the
net proceeds from this offering and could spend the proceeds in
ways that do not improve our results of operations or enhance the
value of our common stock. The failure by our management to apply
these funds effectively could result in financial losses, and these
financial losses could have a material adverse effect on our
business, cause the price of our common stock to decline and delay
the development of our product candidates. We may invest the net
proceeds from this offering, pending their use, in a manner that
does not produce income or that loses value.
If you purchase securities in this offering, you will suffer
immediate dilution of your investment.
The public offering price of our common stock is substantially
higher than the net tangible book value per share of our common
stock. Therefore, if you purchase securities in this offering, you
will pay an effective price per share of common stock that
substantially exceeds our net tangible book value per share after
giving effect to this offering. Based on a public offering price of
$0.40 per share of common stock, if you purchase securities in this
offering, you will experience immediate dilution of $0.18 per
share, representing the difference between the public offering
price of the securities and our pro forma as adjusted net
tangible book value per share after giving effect to this offering.
Furthermore, if any of our outstanding options or warrants are
exercised at prices below the public offering price, we grant
additional options or other awards under our equity incentive plans
or issue additional warrants, you may experience further dilution
of your investment. See the section entitled “Dilution” below for a
more detailed illustration of the dilution you would incur if you
participate in this offering.
If you purchase securities in this offering, you may also
experience future dilution as a result of future equity
offerings.
To raise additional capital, we may in the future offer additional
shares of our common stock or other securities convertible into or
exchangeable for our common stock at prices that may not be the
same as the price paid by investors in this offering. We may sell
shares or other securities in any other offering at a price per
share that is less than the price paid by investors in this
offering, and investors purchasing shares or other securities in
the future could have rights superior to existing stockholders. The
price per share at which we sell additional shares of our common
stock, or securities convertible or exchangeable into common stock,
in future transactions may be higher or lower than the price paid
by investors in this offering.
Because we do not anticipate paying any cash dividends on our
capital stock in the foreseeable future, capital appreciation, if
any, will be your sole source of gain.
We have never declared or paid cash dividends on our capital stock.
We currently intend to retain all of our future earnings, if any,
to finance the growth and development of our business. In addition,
the terms of any future debt agreements may preclude, us from
paying dividends. As a result, capital appreciation, if any, of our
common stock will be your sole source of gain for the foreseeable
future.
Our inability to comply with the listing requirements
of The Nasdaq
Capital Market could result in our common stock being
delisted, which could affect our common stock’s market price and
liquidity and reduce our ability to raise capital.
We are required to meet certain corporate governance and
qualitative and financial tests to maintain the listing of our
common stock on The Nasdaq Capital Market. On June 30, 2019, we
notified The Nasdaq Stock Market that we were not in compliance
with Nasdaq Listing Rule 5605(c)(2)(A) which requires that our
audit committee be composed of at least three independent members.
Under Nasdaq Listing Rule 5605(c)(4), we have until the earlier of
our next annual meeting of stockholders or one year from the
occurrence of the event that caused the failure to comply with
Nasdaq Listing Rule 5605(c)(2)(A); provided, however, that if our
next annual meeting of stockholders occurs no later than 180 days
following the event that caused the vacancy, we shall instead have
180 days from such event to regain compliance.
In addition, on September 10, 2019, we received a letter from the
Listing Qualifications Department of the Nasdaq Stock Market
notifying us that, for the last 30 consecutive business days, the
closing bid price for our common stock was below the minimum $1.00
per share requirement for continued listing on The Nasdaq Capital
Market as set forth in Nasdaq Listing Rule 5550(a)(2). The Nasdaq
letter has no immediate effect on the listing of our common stock
on The Nasdaq Capital Market.
We are evaluating various courses of actions to regain compliance
with Nasdaq Listing Rules 5605(c)(2)(A) and 5550(a)(2), and we
intend to timely submit to Nasdaq a plan to regain compliance with
respect to Nasdaq Listing Rule 5550(a)(2). However, there can be no
assurance that our plan will be accepted by Nasdaq or that if it
is, we will be able to regain compliance with either Nasdaq Listing
Rule 5605(c)(2)(A) or 5550(a)(2).
If we do not regain compliance with the continued listing
requirements for The Nasdaq Capital Market within specified periods
and subject to permitted extensions (if any), our common stock may
be recommended for delisting (subject to any appeal we would file).
If our common stock is delisted, it could be more difficult to buy
or sell our common stock and to obtain accurate quotations, and the
price of our common stock could suffer a material decline.
Delisting would also impair our ability to raise capital.
Our executive officers, directors and principal stockholders,
if they choose to act together, have the ability to control all
matters submitted to stockholders for approval.
Upon the closing of this offering, the number of shares of our
common stock beneficially owned by our executive officers,
directors and principal stockholders and their respective
affiliates who owned more than 5% of our outstanding shares of
common stock before this offering, will, in the aggregate,
represent approximately 48.81% of our outstanding common stock. As
a result, if these stockholders were to choose to act together,
they would be able to control all matters submitted to our
stockholders for approval, as well as our management and affairs.
For example, these persons, if they choose to act together, would
control the election of directors and approval of any merger,
consolidation or sale of all or substantially all of our
assets.
This concentration of voting power may:
| |
●
|
delay, defer or prevent a change in control;
|
| |
●
|
entrench our management and the board of directors; or
|
| |
●
|
delay or prevent a merger, consolidation, takeover or other
business combination involving us on terms that other stockholders
may desire.
|
Future sales of our common stock in the public market could
cause our stock price to fall.
Sales of a substantial number of shares of our common stock in the
public market, or the perception that these sales might occur,
could depress the market price of our common stock and could impair
our ability to raise capital through the sale of additional equity
securities. As of November 19, 2019, we had 15,847,855 shares of
common stock outstanding, all of which shares were, and continue to
be, eligible for sale in the public market, subject in some cases
to compliance with the requirements of Rule 144, including the
volume limitations and manner of sale requirements. In addition,
all of the shares offered under this prospectus supplement and the
accompanying prospectus will be freely tradable without restriction
or further registration upon issuance.
USE OF
PROCEEDS
We estimate that the net proceeds from the sale of the common stock
in this offering and the Warrants in the concurrent private
placement will be approximately $1.1 million, excluding the
proceeds, if any, from the exercise of the Warrants, after
deducting the placement agent's fees and estimated offering
expenses payable by us.
We currently intend to use the net proceeds from this offering for
working capital and other general corporate purposes.
This expected use of net proceeds from this offering represents our
intentions based upon our current plans and business conditions,
which could change in the future as our plans and business
conditions evolve. The amounts and timing of our actual
expenditures may vary significantly depending on numerous factors,
including the progress of our development, the status of and
results from our clinical trials of our product candidates, as well
as any additional collaborations that we may enter into with third
parties for our product candidates, and any unforeseen cash needs.
As a result, our management will retain broad discretion over the
allocation of the net proceeds from this offering. We intend to
invest the proceeds, pending their use as described above, in
short-term, interest-bearing, investment-grade securities.
DIVIDEND POLICY
To date, we have paid no cash dividends to our stockholders, and we
do not intend to pay cash dividends in the foreseeable future.
CAPITALIZATION
The following table sets forth our consolidated cash and cash
equivalents, equity and total capitalization as of September 30,
2019:
| |
●
|
on an actual basis; and
|
| |
●
|
on an as adjusted basis to give effect to the sale of 3,167,986
shares of our common stock in this offering and Warrants to
purchase an aggregate of 3,167,986 shares of our common stock in
the concurrent private placement and the application of the
estimated net proceeds as described under "Use of Proceeds.”
|
You should read the data set forth in the table below in
conjunction with the section of this prospectus supplement under
the caption "Use of Proceeds" as well as our "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" and our financial statements and notes and other
financial information included or incorporated by reference in this
prospectus supplement.
|
|
|
At September 30, 2019
|
|
|
|
|
Actual
|
|
|
As Adjusted
|
|
|
Cash and cash equivalents
|
|
$ |
2,548,434 |
|
|
$ |
3,726,925 |
|
|
Preferred stock $0.001 par value: 10,000,000 shares authorized; no
shares issued and outstanding
|
|
|
— |
|
|
|
— |
|
|
Common stock $0.001 par value: 200,000,000 shares authorized;
15,842,855 and 19,010,841 shares issued and outstanding,
respectively
|
|
|
15,843 |
|
|
|
19,011 |
|
|
Additional paid-in capital
|
|
|
41,569,745 |
|
|
|
42,745,068 |
|
|
Accumulated deficit
|
|
|
(38,054,490 |
) |
|
|
(38,054,490 |
) |
|
Total stockholders' equity
|
|
|
3,531,098 |
|
|
|
4,709,589 |
|
|
Total capitalization
|
|
$ |
3,531,098 |
|
|
$ |
4,709,589 |
|
The above table excludes the shares of common stock issuable upon
exercise of the Warrants being offered by us in the concurrent
private placement and also excludes:
| |
●
|
5,905,583 shares of common stock issuable upon exercise of
outstanding options as of September 30, 2019 under our 2009 Equity
Incentive Plan and 2018 Equity Incentive Plan at a weighted average
price of $2.94 per share; and
|
| |
●
|
3,864,552 shares of common stock issuable upon the exercise of
warrants outstanding as of September 30, 2019 at a weighted average
price of $4.60 per share.
|
DILUTION
Purchasers of common stock in this offering will experience
immediate dilution to the extent of the difference between the
public offering price per share of common stock and the net
tangible book value per share of common stock immediately after
this offering and the concurrent private placement.
Our net tangible book value as of September 30, 2019 was
approximately $3.1 million, or $0.20 per share of common stock. Net
tangible book value per share is determined by dividing the net of
total tangible assets less total liabilities, by the aggregate
number of shares of common stock outstanding as of September 30,
2019. After giving effect to the sale by us of 3,167,986 shares of
common stock at the public offering price of $0.40 per share of
common stock, and after deducting the placement agent's fees and
estimated offering expenses, our net tangible book value as of
September 30, 2019 would have been approximately $4.3 million, or
$0.22 per share of common stock. This represents an immediate
increase in net tangible book value of $0.02 per share to our
existing stockholders and an immediate dilution of $0.18 per share
of common stock issued to the investors participating in this
offering.
The following table illustrates this per share dilution:
|
|
|
|
|
|
|
Amount
|
|
|
Public offering price per share
|
|
|
|
|
|
$ |
0.40 |
|
|
Net tangible book value per share at September 30, 2019
|
|
$ |
0.20 |
|
|
|
|
|
|
Increase in net tangible book value per share to the existing
stockholders attributable to this offering
|
|
$ |
0.02 |
|
|
|
|
|
|
Net tangible book value per share attributable to this offering
|
|
|
|
|
|
$ |
0.22 |
|
|
Dilution per share to investors participating in this offering
|
|
|
|
|
|
$ |
0.18 |
|
The above table is based on 15,842,855 shares of common stock
outstanding as of September 30, 2019 and excludes the shares of
common stock issuable upon exercise of the Warrants being offered
by us in the concurrent private placement and also excludes:
| |
●
|
5,905,583 shares of common stock issuable upon exercise of
outstanding options as of September 30, 2019 under our 2009 Equity
Incentive Plan and 2018 Equity Incentive Plan at a weighted average
price of $2.94 per share; and
|
| |
●
|
3,864,552 shares of common stock issuable upon the exercise of
warrants outstanding as of September 30, 2019 at a weighted average
price of $4.60 per share.
|
DESCRIPTION OF COMMON STOCK
Our authorized capital stock consists of 200,000,000 shares of
common stock, $0.001 par value per share, and 10,000,000 shares of
preferred stock, $0.001 par value per share. Our board of directors
may establish the rights and preferences of the preferred stock
from time to time. As of November 19, 2019, there were 15,847,855
shares of our common stock issued and outstanding and no shares of
preferred stock issued and outstanding.
Our common stock is traded on The Nasdaq Capital Market under the
symbol "GNPX". On November 19, 2019, the last reported sale price
of our common stock on The Nasdaq Capital Market was $0.62 per
share.
The material terms of our common stock are described under the
heading "Description of Capital Stock" in the accompanying
prospectus beginning on page 17.
PRIVATE PLACEMENT TRANSACTION AND
WARRANTS
In a concurrent private placement, we are selling to each of the
investors in this offering, for no additional consideration,
Warrants to purchase 3,167,986 shares of common stock for each
share purchased in this offering.
Each Warrant will be exercisable beginning on the six-month
anniversary of the date of issuance (the "Initial Exercise Date")
at an exercise price of $0.46 per share, subject to adjustment, and
will remain exercisable for five years from the Initial Exercise
Date, but not thereafter. Subject to limited exceptions, a holder
of Warrants will not have the right to exercise any portion of its
Warrants if the holder, together with its affiliates, would
beneficially own in excess of 4.99% (or at the election of a holder
prior to the date of issuance, 9.99%) of the number of shares of
our common stock outstanding immediately after giving effect to
such exercise (the "Beneficial Ownership Limitation"); provided,
however, that upon 61 days' prior notice to the Company, the holder
may increase the Beneficial Ownership Limitation, but not to above
9.99%.
The exercise price and number of shares of common stock issuable
upon the exercise of the Warrants will be subject to adjustment in
the event of any stock dividend and split, reverse stock split,
certain subsequent rights offerings, recapitalization,
reorganization or similar transaction, as described in the
Warrants.
The Warrants and the Warrant Shares are not being registered under
the Securities Act pursuant to the registration statement of which
this prospectus supplement and the accompanying base prospectus
form a part and are not being offered pursuant to this prospectus
supplement and the accompanying base prospectus. The Warrants and
the Warrant Shares are being offered pursuant to an exemption from
the registration requirement of the Securities Act provided in
Section 4(a)(2) of the Securities Act and/or Regulation D Rule
506(c).
After the Initial Exercise Date, if and only if there is no
effective registration statement registering, or no current
prospectus available for, the issuance of the shares of common
stock issuable upon exercise of the Warrants, the purchasers may
exercise the Warrants by means of a "cashless exercise." In
addition, in the event: (i) we, directly or indirectly, in one or
more related transactions effect any merger or consolidation with
or into another person, (ii) we, directly or indirectly, sell,
lease, license, assign, transfer, convey or otherwise dispose of
all or substantially all of our assets in one or a series of
related transactions, (iii) any, direct or indirect, purchase
offer, tender offer or exchange offer is completed pursuant to
which the holders of our common stock are permitted to sell, tender
or exchange their shares for other securities, cash or other
property and has been accepted by the holders of 50% or more of our
outstanding common stock, (iv) we, directly or indirectly, in one
or more related transactions effect any reclassification,
reorganization or recapitalization of our common stock or any
compulsory share exchange pursuant to which our common stock is
effectively converted into or exchange for other securities, cash
or property, or (v) we, directly or indirectly, in one or more
related transactions consummate a stock or share purchase agreement
or other business combination (including, without limitation, a
reorganization, recapitalization, spin-off, merger or scheme of
arrangement) with another person or group of persons whereby such
other person or group acquires more than 50% of our outstanding
shares of common stock (each, a "Fundamental Transaction"), then
following such event, the holders of the Warrants will be entitled
to receive upon exercise of the Warrants the same kind and
amount of securities, cash or property receivable as a result of
such Fundamental Transaction which the holders would have received
had they exercised their Warrants immediately prior to such
Fundamental Transaction. Any successor entity in a Fundamental
Transaction in which we are not the surviving entity shall assume
the obligations under the Warrants. Additionally, in the event of a
Fundamental Transaction that is within our control or approved by
our board of directors, the holders of the Warrants will have the
right to require us or a successor entity to repurchase the
unexercised portion of each Warrant at the Black Scholes value of
the unexercised portion of each Warrant on the date of consummation
of such transaction as determined in accordance with the Black
Scholes option pricing model. If the Fundamental Transaction is not
within our control, including a Fundamental Transaction not
approved by our board of directors, the holders of the Warrants
shall have the right to require us or a successor entity to
purchase the unexercised portion of each Warrant for the same type
or form of consideration that is being offered and paid to the
holders of our common stock in connection with the Fundamental
Transaction at the Black Scholes value of the unexercised portion
of each Warrant on the date of the consummation of such Fundamental
Transaction.
We will be required to file a registration statement on Form S-3
(or other appropriate form if we are not then S-3 eligible) by
January 6, 2020 to provide for the resale of the shares of common
stock issuable upon the exercise of the Warrants, and will be
obligated to use our commercially reasonable efforts to keep such
registration statement effective from the date the Warrants
initially become exercisable until the date on which no purchaser
owns any Warrants or shares issuable upon exercise of the
Warrants.
PLAN OF
DISTRIBUTION
Joseph Gunnar & Company, LLC, which we refer to as the
placement agent, has agreed to act as our exclusive placement agent
in connection with this offering. The placement agent is not
purchasing or selling any of the shares of our common stock offered
by this prospectus supplement, but will use its reasonable best
efforts to arrange for the sale of the securities offered by this
prospectus supplement. We have entered into a securities purchase
agreement directly with investors in connection with this offering.
We will make offers only to a limited number of accredited
investors. Joseph Gunnar & Company, LLC is also acting as
placement agent for the private placement transaction. The offering
is expected to close on or about November 22, 2019, subject to
customary closing conditions, without further notice to you.
Fees and Expenses
We have agreed to pay the placement agent a placement agent's fee
equal to 7.0% of the aggregate purchase price of the shares of our
common stock sold in this offering. The following table shows the
per share and total cash placement agent's fees we will pay to the
placement agent in connection with the sale of the shares of our
common stock offered pursuant to this prospectus supplement and the
accompanying prospectus.
|
|
|
Per Share
|
|
|
Total
|
|
|
Public offering price
|
|
$ |
0.40 |
|
|
$ |
1,267,194 |
|
|
Placement agent's fees(1)
|
|
$ |
0.028 |
|
|
$ |
88,703 |
|
|
Proceeds to us before expenses
|
|
$ |
0.372 |
|
|
$ |
1,178,491 |
|
(1) We have also agreed to reimburse the placement
agent for certain expenses. See below.
In addition, we have agreed to reimburse the placement agent's
expenses up to $45,000 upon closing the offering. We estimate that
the total expenses of the offering payable by us, excluding the
placement agent fees and expenses, will be approximately
$55,000.
Placement Agent Warrants
We have agreed to issue to the placement agent warrants to purchase
443,518 shares of our common stock, which equals 7.0% of the shares
of common stock (including shares of common stock issuable upon
exercise of the Warrants) sold in this offering. The warrants will
have an exercise price of $0.575 per share, which equals 125% of
the public offering price of the shares of common stock sold in
this offering and may be exercised on a cashless basis. The
warrants will expire on November 20, 2024. Pursuant to FINRA Rule
5110(g), the placement agent warrants and any shares issued upon
exercise of the placement agent warrants shall not be sold,
transferred, assigned, pledged, or hypothecated, or be the subject
of any hedging, short sale, derivative, put, or call transaction
that would result in the effective economic disposition of the
securities by any person for a period of 180 days immediately
following the date of effectiveness or commencement of sales of
this offering, except the transfer of any security:
| |
●
|
by operation of law or by reason of our reorganization;
|
| |
●
|
to any FINRA member firm participating in the offering and the
officers or partners thereof, if all securities so transferred
remain subject to the lock-up restriction set forth above for the
remainder of the time period;
|
| |
●
|
if the aggregate amount of our securities held by the placement
agent or related persons do not exceed 1% of the securities being
offered; or
|
| |
●
|
that is beneficially owned on a pro rata basis by all equity owners
of an investment fund, provided that no participating member
manages or otherwise directs investments by the fund and the
participating members in the aggregate do not own more than 10% of
the equity in the fund; and
|
the exercise or conversion of any security, if all securities
remain subject to the lock-up restriction set forth above for the
remainder of the time period.
Regulation M
The placement agent may be deemed to be an underwriter within the
meaning of Section 2(a)(11) of the Securities Act, and any
commissions received by it and any profit realized on the resale of
the shares sold by it while acting as principal might be deemed to
be underwriting discounts or commissions under the Securities Act.
As an underwriter, the placement agent would be required to comply
with the requirements of the Securities Act and the Exchange Act,
including, without limitation, Rule 415(a)(4) under the Securities
Act and Rule 10b-5 and Regulation M under the Exchange Act. These
rules and regulations may limit the timing of purchases and sales
of shares by the placement agent acting as principal. Under these
rules and regulations, the placement agent:
| |
●
|
may not engage in any stabilization activity in connection with our
securities; and
|
| |
●
|
may not bid for or purchase any of our securities or attempt to
induce any person to purchase any of our securities, other than as
permitted under the Exchange Act, until it has completed its
participation in the distribution.
|
Nasdaq Listing
Our common stock is listed on The Nasdaq Capital Market under the
symbol "GNPX." On November 19, 2019, the last reported sale
price of our common stock on the Nasdaq Capital Market was $0.62
per share. We do not intend to list the warrants on The Nasdaq
Capital Market, any other national securities exchange or any other
nationally recognized trading system.
Other Relationships
The placement agent or its affiliates may in the future engage in
transactions with, and may perform, from time to time, investment
banking and advisory services for us in the ordinary course of
their business and for which they would receive customary fees and
expenses. In addition, in the ordinary course of their business
activities, the placement agent and its affiliates may make or hold
a broad array of investments and actively trade debt and equity
securities (or related derivative securities) and financial
instruments (including bank loans) for its own account and for the
accounts of its customers. Such investments and securities
activities may involve securities and/or instruments of ours or our
affiliates.
We have granted the placement agent a right of first refusal for a
six month period from the closing of this offering to act as the
underwriter or placement agent for future public offerings by us,
under certain circumstances.
LEGAL MATTERS
The validity of the shares of common stock offered hereby will be
passed upon for us by Sheppard, Mullin, Richter & Hampton
LLP, New York, New York. Ellenoff Grossman & Schole LLP,
New York, New York, has acted as counsel for the placement agent in
connection with certain matters relating to this offering.
EXPERTS
Daszkal Bolton LLP, an independent registered public accounting
firm, has audited our financial statements included in our Annual
Report on Form 10-K for the year ended December 31, 2018, as set
forth in its report, which is incorporated by reference in this
prospectus supplement and elsewhere in the registration statement.
Our financial statements are incorporated by reference in reliance
on Daszkal Bolton LLP’s report, given on their authority as experts
in accounting and auditing.
WHERE YOU
CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements and
other information with the SEC. Our SEC filings are available to
the public over the Internet at the SEC’s website at
http://www.sec.gov. Copies of certain information filed by us with
the SEC are also available on our website at
https://www.genprex.com. Our website is not a part of this
prospectus supplement and is not incorporated by reference in this
prospectus.
This prospectus supplement is part of a registration statement we
filed with the SEC. This prospectus supplement and the accompanying
prospectus omit some information contained in the registration
statement in accordance with SEC rules and regulations. You should
review the information and exhibits in the registration statement
for further information about us and our consolidated subsidiaries
and the securities we are offering. Statements in this prospectus
supplement and in the accompanying prospectus concerning any
document we filed as an exhibit to the registration statement or
that we otherwise filed with the SEC are not intended to be
comprehensive and are qualified by reference to these filings. You
should review the complete document to evaluate these
statements.
INCORPORATION BY REFERENCE
The SEC allows us to incorporate by reference into this prospectus
supplement much of the information we file with the SEC, which
means that we can disclose important information to you by
referring you to those publicly available documents. The
information that we incorporate by reference is considered to be
part of this prospectus supplement and the accompanying prospectus.
Because we are incorporating by reference future filings with the
SEC, this prospectus supplement and the accompanying prospectus are
continually updated and those future filings may modify or
supersede some of the information included or incorporated in this
prospectus supplement and the accompanying prospectus. This means
that you must look at all of the SEC filings that we incorporate by
reference to determine if any of the statements in this prospectus
supplement or the accompanying prospectus or in any document
previously incorporated by reference have been modified or
superseded. This prospectus supplement and the accompanying
prospectus incorporate by reference the documents listed below and
any future filings we make with the SEC under Sections 13(a),
13(c), 14 or 15(d) of the Exchange Act (in each case, other than
those documents or the portions of those documents not deemed to be
filed) until the offering of the securities under the registration
statement is terminated or completed:
| |
●
|
our Annual Report on Form 10-K for the fiscal year ended
December 31, 2018 filed with the SEC on April 1, 2019, as
amended on October 16, 2019;
|
| |
●
|
our Quarterly Report on Form 10-Q for the quarter ended March 31,
2019 filed with the SEC on May 15, 2019, as amended on May 20, 2019
and October 16, 2019, our Quarterly Report on Form 10-Q for the
quarter ended June 30, 2019 filed with the SEC on August 13, 2019,
as amended on October 16, 2019 and our Quarterly Report on Form
10-Q for the quarter ended September 30, 2019 as filed with the SEC
on November 14, 2019 ;
|
| |
●
|
our Current Reports on Form 8-K filed with the SEC on January 31,
2019, February 19, 2019, June 11, 2019 and September 13, 2019;
|
| |
●
|
our definitive proxy statement on Schedule 14A for our 2019 Annual
Meeting of Stockholders filed with the SEC on April 30, 2019;
and
|
| |
●
|
the description of our capital stock contained in our Registration
Statement on Form 8-A filed with the SEC on October 13, 2017.
|
You may request a copy of these filings, at no cost, by writing or
telephoning us at the following address or telephone number:
Genprex, Inc.
1601 Trinity Street, Bldg. B, Suite 3.322
Austin, Texas 78712
Attention: Investor Relations
Telephone: (512) 537-7997
The information in this preliminary
prospectus is not complete and may be changed. We may not
offer these securities or accept an offer to buy these
securities until the registration statement filed
with the Securities and Exchange Commission is effective. This
preliminary prospectus is not an offer to sell these
securities and it is not soliciting an offer to buy these
securities in any jurisdiction where the offer or sale is not
permitted.
Subject to Completion Dated OCTOBER 4, 2019
PROSPECTUS
$25,000,000
Common Stock
Preferred Stock
Debt Securities
Warrants
Units
From time to time, we may offer up to $25,000,000 of any
combination of the securities described in this prospectus in one
or more offerings. We may also offer securities as may be issuable
upon conversion, redemption, repurchase, exchange or exercise of
any securities registered hereunder, including any applicable
anti-dilution provisions.
This prospectus provides a general description of the
securities we may offer. Each time we offer securities, we will
provide specific terms of the securities offered in a supplement to
this prospectus. We may also authorize one or more free writing
prospectuses to be provided to you in connection with these
offerings. The prospectus supplement and any related free writing
prospectus may also add, update or change information contained in
this prospectus. You should carefully read this prospectus, the
applicable prospectus supplement and any related free writing
prospectus, as well as any documents incorporated by reference,
before you invest in any of the securities being offered.
This prospectus may not be used to consummate a sale of
any securities unless accompanied by a prospectus
supplement.
Our common stock is traded on the Nasdaq Capital Market under
the symbol “GNPX.” On September 30, 2019, the last reported sales
price of our common stock was $0.80 per share. The applicable
prospectus supplement will contain information, where applicable,
as to any other listing on the Nasdaq Capital Market or any
securities market or other exchange of the securities, if any,
covered by the prospectus supplement.
We will sell these securities directly to investors, through
agents designated from time to time or to or through underwriters
or dealers, on a continuous or delayed basis. For additional
information on the methods of sale, you should refer to the section
entitled “Plan of Distribution” in this prospectus. If any agents
or underwriters are involved in the sale of any securities with
respect to which this prospectus is being delivered, the names of
such agents or underwriters and any applicable fees, commissions,
discounts or over-allotment options will be set forth in a
prospectus supplement. The price to the public of such securities
and the net proceeds we expect to receive from such sale will also
be set forth in a prospectus supplement.
The aggregate market value of our outstanding common stock held by
non-affiliates was approximately $9,859,715, which was
calculated based on 10,601,844 shares of outstanding common
stock held by non-affiliates as of October 2, 2019, and a price per
share of $0.93, the closing price of our common stock on September
16, 2019. Pursuant to General Instruction I.B.6 of Form S-3, in no
event will we sell securities pursuant to this registration
statement with a value more than one-third of the aggregate market
value of our common stock held by non-affiliates in any 12-month
period, so long as the aggregate market value of our common stock
held by non-affiliates is less than $75.0 million. In the event
that subsequent to the effective date of this registration
statement, the aggregate market value of our outstanding common
stock held by non-affiliates equals or exceeds $75.0 million, then
the one-third limitation on sales shall not apply to additional
sales made pursuant to this registration statement. We have sold no
securities pursuant to General Instruction I.B.6 of Form S-3 during
the 12 calendar months prior to, and including, the date of this
registration statement.
Investing in our securities involves a high degree of
risk. You should review carefully the risks and uncertainties
described under the heading “Risk Factors” contained in the
applicable prospectus supplement and any related free writing
prospectus, and under similar headings in the other documents that
are incorporated by reference into this prospectus.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY
STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE
SECURITIES OR DETERMINED IF THIS PROSPECTUS IS TRUTHFUL OR
COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL
OFFENSE.
The date of this prospectus is
,
2019.
TABLE OF CONTENTS
No dealer, salesperson or other person is authorized to give any
information or to represent anything not contained in this
prospectus. You must not rely on any unauthorized information or
representations. This prospectus is an offer to sell only the
shares offered hereby, but only under circumstances and in
jurisdictions where it is lawful to do so. The information
contained in this prospectus is current only as of its date.
For investors outside the United States: Neither we nor any of the
underwriters have taken any action that would permit this offering
or possession or distribution of this prospectus in any
jurisdiction where action for that purpose is required, other than
in the United States. You are required to inform yourselves about
and to observe any restrictions relating to this offering and the
distribution of this prospectus.
Market data and certain industry data and forecasts used throughout
this prospectus were obtained from internal company surveys, market
research, consultant surveys, publicly available information,
reports of governmental agencies and industry publications and
surveys. Industry surveys, publications, consultant surveys and
forecasts generally state that the information contained therein
has been obtained from sources believed to be reliable, but that
the accuracy and completeness of such information is not
guaranteed. While we are not aware of any misstatements regarding
the industry data presented in this prospectus, our estimates
involve risks and uncertainties and are subject to change based on
various factors, including those discussed under the heading “Risk
Factors” in this prospectus.
The terms “Genprex,” the “Company,” “our,” or “we” refer to
Genprex, Inc. and, unless the context otherwise requires, its
predecessors.
ABOUT
THIS PROSPECTUS
This prospectus is a part of a registration statement on Form S-3
that we filed with the Securities and Exchange Commission, or SEC,
utilizing a “shelf” registration process. Under this shelf
registration process, we may sell any combination of the securities
described in this prospectus in one or more offerings up to a total
aggregate offering price of $25,000,000. This prospectus provides
you with a general description of the securities we may offer.
Each time we sell 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 these offerings. The prospectus
supplement and any related free writing prospectus that we may
authorize to be provided to you may also add, update or change
information contained in this prospectus or in any documents that
we have incorporated by reference into this prospectus. You should
read this prospectus, any applicable prospectus supplement and any
related free writing prospectus, together with the information
incorporated herein by reference as described under the heading
“Incorporation of Certain Information by Reference,” before
investing in any of the securities offered.
THIS PROSPECTUS MAY NOT BE USED TO CONSUMMATE A SALE OF
SECURITIES UNLESS IT IS ACCOMPANIED BY A PROSPECTUS
SUPPLEMENT.
Neither we, nor any agent, underwriter or dealer has authorized any
person to give any information or to make any representation other
than those contained or incorporated by reference in this
prospectus, any applicable prospectus supplement or any related
free writing prospectus prepared by or on behalf of us or to which
we have referred you. This prospectus, any applicable supplement to
this prospectus or any related free writing prospectus do not
constitute an offer to sell or the solicitation of an offer to buy
any securities other than the registered securities to which they
relate, nor do this prospectus, any applicable supplement to this
prospectus or any related free writing prospectus constitute an
offer to sell or the solicitation of an offer to buy securities in
any jurisdiction to any person to whom it is unlawful to make such
offer or solicitation in such jurisdiction.
You should not assume that the information contained in this
prospectus, any applicable prospectus supplement or any related
free writing prospectus is accurate on any date subsequent to the
date set forth on the front of the document or that any information
we have incorporated by reference is correct on any date subsequent
to the date of the document incorporated by reference, even though
this prospectus, any applicable prospectus supplement or any
related free writing prospectus is delivered, or securities are
sold, on a later date.
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 in this prospectus were
made solely for the benefit of the parties to such agreement,
including, in some cases, for the purpose of allocating risk among
the parties to such agreements, and should not be deemed to be a
representation, warranty or covenant to you. Moreover, such
representations, warranties or covenants were accurate only as of
the date when made. Accordingly, such representations, warranties
and covenants should not be relied on as accurately representing
the current state of our affairs.
This prospectus contains summaries of certain provisions contained
in some of the documents described herein, but reference is made to
the actual documents for complete information. All of the summaries
are qualified in their entirety by the actual documents. Copies of
some of the documents referred to herein have been filed, will be
filed or will be incorporated by reference as exhibits to the
registration statement of which this prospectus is a part, and you
may obtain copies of those documents as described below under the
heading “Where You Can Find More Information.”
SUMMARY
This summary highlights selected information from this prospectus
and does not contain all of the information that you need to
consider in making your investment decision. You should carefully
read the entire prospectus, the applicable prospectus supplement
and any related free writing prospectus, including the risks of
investing in our securities discussed under the heading “Risk
Factors” contained in the applicable prospectus supplement and any
related free writing prospectus, and under similar headings in the
other documents that are incorporated by reference into this
prospectus. You should also carefully read the information
incorporated by reference into this prospectus, including our
financial statements, and the exhibits to the registration
statement of which this prospectus is a part.
Company Overview
Genprex™ is a clinical stage gene therapy company developing a new
approach to treating cancer, based upon our novel proprietary
technology platform, including our initial product candidate,
Oncoprex™ immunogene therapy, or Oncoprex. Our platform
technologies are designed to administer cancer fighting genes by
encapsulating them into nanoscale hollow spheres called
nanovesicles, which are then administered intravenously and taken
up by tumor cells where they express proteins that are missing or
found in low quantities. Oncoprex has a multimodal mechanism of
action whereby it interrupts cell signaling pathways that cause
replication and proliferation of cancer cells, re-establishes
pathways for apoptosis, or programmed cell death, in cancer cells,
and modulates the immune response against cancer cells. Oncoprex
has also been shown to block mechanisms that create drug
resistance.
We hold an exclusive worldwide license from The University of Texas
MD Anderson Cancer Center, or MD Anderson, to patents covering the
therapeutic use of a series of genes that have been shown in
preclinical and clinical research to have cancer fighting
properties.
With Oncoprex, we are initially targeting non-small cell lung
cancer, or NSCLC. Researchers at MD Anderson have conducted two
Phase I clinical trials and are currently conducting an ongoing
Phase II clinical trial of Oncoprex plus erlotinib in NSCLC.
According to the World Health Organization, lung cancer is the
leading cause of cancer deaths worldwide, killing more people than
breast, colon, kidney, liver, prostate and skin cancers, and is the
second most common type of cancer. Each year, there are over 1.8
million new lung cancer cases and 1.6 million deaths from lung
cancer worldwide, and in the United States there are over 225,000
new cases and more than 150,000 deaths from lung cancer per year.
NSCLC represents 80% of all lung cancers. According to a 2016
American Cancer Society report, the five-year survival rate for
Stage IV (metastatic) NSCLC is about 1%, and overall survival for
lung cancer has not improved appreciably in the last 25 years. We
believe that there is a significant unmet medical need for new
treatments for NSCLC in the United States and globally, and we
believe that Oncoprex may be suitable for a majority of NSCLC
patients.
We believe that our platform technologies could allow delivery of a
number of cancer fighting genes, alone or in combination with other
cancer therapies, to combat multiple types of cancer. Our research
and development pipeline, discussed in “Our Pipeline” below,
demonstrates our clinical and preclinical progress to date.
Cancer results from genetic mutations. Mutations that lead to
cancer are usually present in two major classes of genes:
oncogenes, which are involved in functions such as signal
transduction and transcription; and tumor suppressor genes, which
play a role in governing cell proliferation by regulating
transcription. Transduction is the process by which chemical and
physical signals are transmitted through cells. Transcription is
the process by which a cell’s DNA sequence is copied to make RNA
molecules, which then play a role in protein expression. In normal
cells, mutations in oncogenes are discovered and targeted for
elimination by tumor suppressor genes. In cancer cells, the
oncogene mutations may overwhelm the natural tumor suppression
processes, or those tumor suppression processes may be impaired or
absent. Functional alterations due to mutations in oncogenes or
tumor suppressor genes may result in the abnormal and uncontrolled
growth patterns characteristic of cancer. These genetic alterations
facilitate such malignant growth by affecting signal transduction
pathways and transcription, thus inhibiting normal growth signaling
in the cell, circumventing the natural process of apoptosis,
evading the immune system’s response to cancer, and inducing
angiogenesis, which is the formation of new blood vessels that
supply cancer cells.
The most common genetic alterations present in NSCLC are in tumor
suppressor genes, against which few targeted small molecule drugs
have been developed. Each of the two sets of chromosomes in the
cell nucleus includes two copies of each gene, called alleles,
which may be identical or may show differences. In most situations,
tumor suppressor genes require both alleles of a gene to be deleted
or inactivated to impair tumor suppression activity and lead to
tumor growth. The replacement of just one functional allele may
therefore be enough to restore the normal cellular functions of
growth regulation and apoptosis.
Among the genetic conditions associated with lung cancer are the
overexpression of epidermal growth factor receptors, or EGFRs, and
mutations of kinases. Kinases are enzymes that play an important
role in signal transduction through the modification of proteins by
adding or taking away phosphate groups, a process called
(de-)phosphorylation, to change the proteins’ function. When two
EGFR transmembrane proteins are brought to proximity on the cell
membrane surface, or dimerize, either through a ligand, or binding
molecule, that binds to the extracellular receptor, or through some
other process, the intracellular protein-kinase domains can
autophosphorylate, and activate downstream processes, including
cell signaling pathways that can lead to either cell cycle arrest
or cell growth and proliferation. EGFRs and kinases can act
similarly to a switch that turns “on” and “off” when phosphate
groups are either added or taken away. Mutated kinases can have a
malfunctioning on/off switch, causing the switch to be stuck in the
“on” position or failing to turn the switch “off,” leading to the
loss of cell control.
A subset of NSCLC patients (approximately 10% of NSCLC patients of
North American and European descent and approximately 30% to 50% of
NSCLC patients of Asian descent) carry an EGFR mutation that makes
their tumors sensitive to tyrosine kinase inhibitors, or TKIs, such
as erlotinib. However, even for these patients, tumor resistance to
TKIs frequently develops within two years, resulting in eventual
disease progression. Erlotinib generally does not benefit NSCLC
patients who do not have this activating EGFR mutation. However,
our clinical and preclinical data have shown that the combination
of Oncoprex and erlotinib can increase anti-tumor activity even in
cancers without the EGFR mutations, as well as in cancers that have
become resistant to erlotinib. For this reason, we believe Oncoprex
may be suitable for the majority of NSCLC patients.
Cancer can spread when cells’ natural cancer suppression functions
are impaired. The tumor suppressor gene called Tumor Suppressor
Candidate 2, or TUSC2 (which was formerly known as FUS1) has been
shown to affect both cell proliferation and apoptosis. TUSC2 is a
pan-kinase inhibitor, which means that it has the ability to
inhibit multiple kinase receptors, such as EGFR and
platelet-derived growth factor receptor, or PDGFR. TUSC2 is
frequently inactivated early in the development of lung cancer, and
loss of TUSC2 expression in NSCLC is associated with significantly
worse overall survival compared to patients with normal TUSC2
expression. Many types of cancer cells, including approximately 85%
of NSCLC cells, lack expression of TUSC2.
Cancer can also spread when the body’s natural immune functions are
impaired, including by the cancer cells themselves. PD-1, or
Programmed Death-1, is a receptor expressed on the surface of
activated T cells, which are part of the body’s immune system.
PD-L1, or Programmed Death Ligand-1, is a protein/receptor
expressed on the surface of cancer and other cells. The binding of
PD-1 to PD-L1 has been speculated to contribute to cancer cells’
ability to evade the body’s immune response. PD-1 and molecules
like it are called immune checkpoints, because they can impede the
normal immune response, for example by blocking the T cells from
attacking the cancer cells. In many cancers, PD-L1 receptors are
up-regulated, and substantial research is now being performed in
the emerging field of immuno-oncology to discover drugs or
antibodies that could block PD-L1 and similar receptors. It is
believed that blocking the PD-1/PD-L1 interaction pathway and other
similar checkpoints, such as cytotoxic T-lymphocyte-associated
protein 4, or CTLA-4, with drugs called checkpoint inhibitors can
prevent cancer cells from inactivating T cells.
Our Oncoprex immunogene therapy is designed to interrupt cell
signaling pathways that cause replication and proliferation of
cancer cells, and to target and kill cancer cells via receptor
pathways, and also to stimulate the natural immune responses
against cancer. Oncoprex combines features of gene therapy and
immunotherapy in that it up-regulates TUSC2 expression in the cell,
and also increases the anti-tumor immune cell population and
down-regulates PD-L1 receptors, thereby boosting the immune
response to cancer.
Oncoprex consists of a TUSC2 gene encapsulated in a nanovesicle
made from lipid molecules with a positive electrical charge.
Oncoprex is injected intravenously and can specifically target
cancer cells, which generally have a negative electrical charge.
Once Oncoprex is taken up into a cancer cell, the TUSC2 gene is
expressed into a protein that is capable of restoring certain
defective functions arising in the cancer cell. Oncoprex
nanovesicles are designed to deliver the functioning TUSC2 gene to
cancer cells while minimizing their uptake by normal tissue. Tumor
biopsy studies conducted at MD Anderson show that the uptake of
TUSC2 in tumor cells after Oncoprex treatment is 10 to 25 times the
uptake in normal cells. We believe that Oncoprex, unlike other gene
therapies, which either need to be delivered directly into tumors
or require cells to be removed from the body, re-engineered and
then reinserted into the body, is the first systemic gene therapy
to be used for cancer in humans.
Clinical data from the evaluation of 25 patients in our Phase I/II
clinical trial, as well as our preclinical data, indicate that
Oncoprex can be combined with the widely used anti-cancer drug
erlotinib (marketed as Tarceva® by Genentech, Inc.) in humans.
Erlotinib is a tyrosine kinase inhibitor, or TKI, which uses a
mechanism of action similar to that of pan-kinase inhibitors to
block the action of tyrosine kinases, which are a type of kinase
involved in many cell functions, including cell signaling, growth
and division. In addition, MD Anderson researchers have conducted
preclinical studies combining Oncoprex with:
| |
●
|
the TKI gefitinib (marketed as Iressa® by AstraZeneca
Pharmaceuticals) in animals and in human NSCLC cells;
|
| |
●
|
MK2206 in animals (MK2206 is an inhibitor of AKT kinases, which
affect cell signaling pathways downstream from tyrosine
kinases);
|
| |
●
|
an anti-PD-1 antibody equivalent to the checkpoint inhibitor
pembrolizumab (marketed as Keytruda® by Merck & Co. ) in
animals;
|
| |
●
|
an anti-PD-1 antibody equivalent to the checkpoint inhibitor
nivolumab (marketed as Opdivo® by Bristol-Myers Squibb Company) in
animals; and
|
| |
●
|
an anti-CTLA4 antibody equivalent to ipilimumab (marketed as
Yervoy® by Bristol-Myers Squibb Company) in animals.
|
The manufacturers of the marketed drugs were not involved in any of
our clinical or preclinical studies. In studies involving marketed
drugs, the drugs were administered concurrently with Oncoprex
without being modified in any way, and the antibodies used in our
preclinical studies that did not use the marketed drugs were the
non-humanized equivalent to marketed drugs.
Data from these clinical and preclinical studies indicate that
combining Oncoprex with these other therapies yields results more
favorable than either these therapies or Oncoprex alone, with
minimal side effects relative to other lung cancer drugs, thereby
potentially making Oncoprex a therapy complementary to these cancer
treatments. In addition, based on our clinical and preclinical
studies and on preclinical studies conducted by others, we believe
that Oncoprex could be combined with other lung cancer drugs that
have similar mechanisms of action to the drugs mentioned above,
such as nivolumab (marketed as Opdivo® by Bristol-Myers Squibb
Company) and atezolizumab (marketed as Tecentriq® by
Genentech/Roche). We have not conducted any preclinical or clinical
studies combining Oncoprex with atezolizumab.
Researchers at MD Anderson have collaborated with other researchers
to identify other genes, such as those in the 3p21.3 chromosomal
region, that may act as tumor suppressors or have other cancer
fighting functions. We hold rights to certain of these genes under
license agreements with MD Anderson. Data from preclinical studies
performed by others suggest that product candidates that could be
derived from our technology platform could be effective against
other types of cancer, including glioblastoma, head and neck,
breast, renal cell (kidney), and soft tissue sarcoma, as well as
NSCLC. Therefore, our platform technologies may allow delivery of a
number of cancer fighting genes, alone or in combination with other
cancer therapies, to combat multiple types of cancer.
In 2012, MD Anderson researchers completed a Phase I clinical trial
of Oncoprex as a monotherapy. The primary objective of this Phase I
trial was to assess the toxicity of Oncoprex administered
intravenously and to determine the MTD and recommended Phase II
dose of Oncoprex alone. Secondary objectives were to assess the
expression of TUSC2 following intravenous delivery of Oncoprex in
tumor biopsies and also to assess the anticancer activity of
Oncoprex. This trial demonstrated that Oncoprex was well tolerated
and established the MTD and the therapeutic dosage for Oncoprex at
0.06 mg/kg administered every 21 days. Although this trial was not
designed to show changes in outcomes, a halt in cancer growth was
observed in a number of patients, and tumor regressions occurred in
primary lung tumors and metastatic cancers in the liver, pancreas,
and lymph nodes. In addition, pre- and post-treatment patient
biopsies demonstrated that intravenous Oncoprex selectively and
preferentially targeted patients’ cancer cells, and suggested that
clinical anti-cancer activity was mediated by TUSC2.
We believe that Oncoprex’ combination of pan-kinase inhibition,
direct induction of apoptosis, anti-cancer immune modulation and
complementary action with targeted drugs and immunotherapies is
unique, and positions Oncoprex to provide treatment for patients
with NSCLC and possibly other cancers, who are not benefitting from
currently offered therapies.
MD Anderson researchers have completed the first phase of a Phase
I/II clinical trial of Oncoprex in combination with erlotinib in
patients with Stage IV (metastatic) or recurrent NSCLC that is not
potentially curable by radiotherapy or surgery, whether or not they
have received prior chemotherapy, and whether or not they have an
activating EGFR mutation. The Phase I portion of the trial was a
dose-escalating study with primary endpoints of establishing the
safety and tolerability of the combination of Oncoprex and
erlotinib, and establishing the Maximum Tolerated Dose, or MTD. The
secondary endpoint of the Phase I portion of the trial was to
assess the toxicity of the combination of Oncoprex with erlotinib.
In the Phase I portion of the trial, which began in 2014, 18
subjects were treated, and the MTD was determined to be the highest
tested dose: 0.6 mg/kg of Oncoprex administered every 21 days and
150 mg of erlotinib per day. Toxicities were found to compare
favorably with those of other lung cancer drugs.
The Phase II portion of the trial is designed to include subjects
treated with the combination of Oncoprex and erlotinib at the MTD
with the primary goal of measuring the response rate, and secondary
endpoints of stable disease, time to progression and overall
survival. The response rate for cancer therapies is defined under
the Response Evaluation Criteria in Solid Tumors, or RECIST, as
Complete Response (CR) + Partial Response (PR); disease control
rate is defined under the RECIST criteria as Complete Response (CR)
+ Partial Response (PR) + Stable Disease (SD)>8weeks.
Enrollment criteria for the second phase of the Phase I/II clinical
trial are identical to those in the first phase. The Phase II
portion of the trial began in June 2015 and is ongoing at MD
Anderson. Of the 39 patients allowed in the protocol for the Phase
II portion of the trial, 10 have been enrolled and nine are
evaluable for response under the trial protocol, because they have
received two or more cycles of treatment. Interim results show that
four of the patients had tumor regression and one patient had a
Complete Response, or CR under the RECIST criteria. The patient
with the CR had disappearance of the lung primary tumor, as well as
lung, liver, and lymph node metastases. The median response
duration for all patients, which is defined as the median time
between when response is first noted to the time when cancer
progression is observed, was three months. The response rate for
the nine patients evaluated to date was 11% and the disease control
rate for the nine patients was 78%.
The response rate and disease control rate to date in the Phase II
portion of our Phase I/II clinical trial substantially exceeds the
response rate of 7% (with no CRs) and disease control rate of 58%
reported for a clinical trial of the TKI afatinib (marketed as
Gilotrif® by Boehringer Ingelheim Pharmaceuticals, Inc.) in a study
referred to as the LUX-Lung 1 clinical trial. A total of 585
patients were enrolled in that Phase IIB/III clinical trial, whose
primary endpoint was overall survival and whose secondary endpoints
were progression-free survival, RECIST response, quality of life
and safety. The LUX-Lung 1 clinical trial was a randomized, double
blinded Phase IIB/III clinical trial treating subjects with Stage
IIIB or IV adenocarcinoma, a type of NSCLC. The Phase II portion of
our Phase I/II trial is not blinded, and is designed to treat NSCLC
subjects regardless of EGFR status.
Preliminary analysis of the early data from the Phase II portion of
our Phase I/II trial supports our belief that Oncoprex may provide
medical benefit in several subpopulations of NSCLC patients for
which there is an unmet medical need, and may provide pathways for
accelerated approval by the US Food and Drug Administration, or
FDA. As a result of these initial findings, in April 2016, we
suspended enrollment of new patients in the Phase II portion of the
trial to collect additional trial data and have it analyzed in
order to seek FDA guidance as to whether the protocol for this
clinical trial could be modified to expand enrollment and also to
divide the patients into cohorts with a view toward seeking
accelerated approval in one or more of these cohort populations. We
subsequently decided not to modify the trial, but to continue it as
originally designed. Although this clinical trial is currently
closed to new patient enrollment, it is not terminated, and is
considered “ongoing” because activities such as patient follow-up
and further data collection and analysis continue.
We now plan to reopen enrollment in the current version of the
Phase II portion of the trial. We have encountered delays in
reopening this trial at MD Anderson; and will likely reopen the
trial at one or more other clinical trial sites. We intend to use a
portion of our available funds to add additional clinical trial
sites.
Our Oncoprex immunogene therapy technology was discovered through a
lung cancer research consortium from MD Anderson and The University
of Texas Southwestern Medical Center, or UTSWMC, along with the
National Cancer Institute, or NCI. The TUSC2 discovery teams
included Jack A. Roth, MD, FACS, chairman of our Scientific and
Medical Advisory Board. We have assembled a team of experts in
clinical and translational research, including laboratory
scientists, medical oncologists and biostatisticians, to pursue the
development and commercialization of Oncoprex and other potential
product candidates.
Our technology discoveries and research and development programs
have been the subjects of numerous peer-reviewed publications and
have been supported by Small Business Innovation Research, or SBIR,
grants and grants from the National Institutes of Health, the
United States Department of Treasury, and the State of Texas. We
hold a worldwide, exclusive license from MD Anderson to patents
covering the therapeutic use of TUSC2 and other genes that have
been shown to have cancer fighting properties, as well as a number
of related technologies, including 30 issued patents, and two
pending patent applications.
Our Pipeline
We are developing Oncoprex, our lead product candidate, to be
administered with erlotinib for NSCLC. We are also conducting
preclinical research with the goal of developing Oncoprex to be
administered with immunotherapies in NSCLC. In addition, we have
conducted research into other tumor suppressor genes associated
with chromosome 3p21.3. Our research and development pipeline is
shown below:
Our Strategy
We intend to develop and commercialize treatments for cancer based
on our proprietary gene therapy platform, alone or in combination
with other cancer therapies. Key elements of our strategy
include:
| |
●
|
Conduct Ongoing and New Clinical Trials. We plan to continue
clinical trials of Oncoprex immunogene therapy in combination with
EGFR TKIs, such as erlotinib, and/or in combination with
immunotherapies, such as anti-PD-1 immunotherapy, for treatment of
NSCLC, while exploring pathways to accelerated Food and Drug
Administration, or FDA, approval of this combination in NSCLC
patients. We also may pursue clinical trials using multi-drug
combinations of Oncoprex with additional targeted therapies and
immunotherapies.
|
| |
●
|
Investigate the Effectiveness of Oncoprex in Other Cancers.
We may also explore the combination of Oncoprex and other therapies
in other cancers such as soft tissue, kidney, head and neck, and/or
breast cancer. We may also pursue development of additional
proprietary genes, alone or in combination with EGFR TKIs such as
erlotinib and/or with immunotherapies.
|
| |
●
|
Prepare to Commercialize Oncoprex. We plan to continue to
develop the manufacturing, process development and other
capabilities needed to commercialize Oncoprex.
|
| |
●
|
Pursue Strategic Partnerships. As we gather additional
clinical data, we plan to pursue strategic partnerships with other
developers and providers of anti-cancer drugs to investigate
possible therapeutic combinations of Oncoprex with drugs
manufactured by others, to accelerate the development of our
current and potential product candidates through co-development and
to increase the commercial opportunities for our current and
potential product candidates.
|
| |
●
|
Develop Our Platform Technology. We plan to investigate the
applicability of our platform technology with additional
anti-cancer drugs.
|
Corporate Information
We were incorporated in Delaware in April 2009. Our principal
executive offices are located at 1601 Trinity Street, Bldg. B,
Suite 3.322, Austin, TX 78712, and our telephone number is (512)
537-7997. Our corporate website address is www.genprex.com. The
information contained on our website is not incorporated by
reference into this prospectus, and you should not consider any
information contained on, or that can be accessed through, our
website as part of this prospectus or in deciding whether to
purchase our common stock.
The Securities We May Offer
We may offer shares of our common stock and preferred stock,
various series of debt securities and warrants to purchase any of
such securities, up to a total aggregate offering price of
$100,000,000 from time to time in one or more offerings under this
prospectus, together with any applicable prospectus supplement and
any related free writing prospectus, at prices and on terms to be
determined by market conditions at the time of the relevant
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, including, to the extent
applicable:
| |
•
|
designation or classification;
|
| |
•
|
aggregate principal amount or aggregate offering price;
|
| |
•
|
maturity, if applicable;
|
| |
•
|
original issue discount, if any;
|
| |
•
|
rates and times of payment of interest or dividends, if any;
|
| |
•
|
redemption, conversion, exchange or sinking fund terms, if any;
|
| |
•
|
conversion or exchange prices or rates, if any, and, if applicable,
any provisions for changes to or adjustments in the conversion or
exchange prices or rates and in the securities or other property
receivable upon conversion or exchange;
|
| |
•
|
ranking, if applicable;
|
| |
•
|
restrictive covenants, if any;
|
| |
•
|
voting or other rights, if any; and
|
| |
•
|
important U.S. federal income tax considerations.
|
The prospectus supplement and any related free writing prospectus
that we may authorize to be provided to you may also add, update or
change information contained in this prospectus or in documents we
have incorporated by reference. However, no prospectus supplement
or free writing prospectus will offer a security that is not
registered and described in this prospectus at the time of the
effectiveness of the registration statement of which this
prospectus is a part.
This prospectus may not be used to consummate a sale of
securities unless it is accompanied by a prospectus
supplement.
We may sell the securities directly to investors or through
underwriters, dealers or agents. We, and our underwriters or
agents, reserve the right to accept or reject all or part of any
proposed purchase of securities. If we do offer securities through
underwriters or agents, we will include in the applicable
prospectus supplement:
| |
•
|
the names of those underwriters or agents;
|
| |
•
|
applicable fees, discounts and commissions to be paid to them;
|
| |
•
|
details regarding over-allotment options, if any; and
|
| |
•
|
the estimated net proceeds to us.
|
Common Stock. We may issue shares of our common stock
from time to time. Holders of our common stock are entitled to one
vote per share for the election of directors and on all other
matters that require stockholder approval. Subject to any
preferential rights of any then outstanding preferred stock, in the
event of our liquidation, dissolution or winding up, holders of our
common stock are entitled to share ratably in the assets remaining
after payment of liabilities and the liquidation preferences of any
then outstanding preferred stock. Our common stock does not carry
any preemptive rights enabling a holder to subscribe for, or
receive shares of, any class of our common stock or any other
securities convertible into shares of any class of our common
stock, or any redemption rights.
Preferred Stock. We may issue shares of our preferred
stock from time to time, in one or more series. Under our amended
and restated certificate of incorporation, our board of directors
has the authority, without further action by stockholders, to
designate up to 10,000,000 shares of preferred stock in one or more
series and to fix the rights, preferences, privileges,
qualifications and restrictions granted to or imposed upon the
preferred stock, including dividend rights, conversion rights,
voting rights, rights and terms of redemption, liquidation
preference and sinking fund terms, any or all of which may be
greater than the rights of the common stock. To date, none of the
10,000,000 authorized shares of preferred stock have been
designated by our board of directors. Convertible preferred stock
will be convertible into our common stock or exchangeable for our
other securities. Conversion may be mandatory or at the option of
the holders of our preferred stock and would be at prescribed
conversion rates.
We will fix the rights, preferences, privileges, qualifications and
restrictions of the preferred stock of each series that we sell
under this prospectus and applicable prospectus supplements in the
certificate of designation relating to that series. We will
incorporate by reference into the registration statement of which
this prospectus is a part 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, however, to read the
applicable prospectus supplement (and any related free writing
prospectus that we may authorize to be provided to you) 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.
Debt Securities. We may issue 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 our common stock or preferred stock. Conversion
may be mandatory or at the holder’s option and would be at
prescribed conversion rates.
The debt securities will be issued under one or more documents
called indentures, which are contracts between us and a national
banking association or other eligible party, as trustee. In this
prospectus, we have summarized certain general features of the debt
securities. We urge you, however, to read the applicable prospectus
supplement (and any free writing prospectus that we may authorize
to be provided to you) related to the series of debt securities
being offered, as well as the complete indentures that contain the
terms of the debt securities. A form of indenture has been filed as
an exhibit to the registration statement of which this prospectus
is a part, and supplemental indentures and forms of debt securities
containing the terms of the debt securities being offered will be
filed as exhibits to the registration statement of which this
prospectus is a part or will be incorporated by reference from
reports that we file with the SEC.
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. Any
warrants issued under this prospectus may be evidenced by warrant
certificates. Warrants may be issued under a separate warrant
agreement to be entered into between us and the investors or a
warrant agent. We will indicate the name and address of the warrant
agent, if applicable, in the prospectus supplement relating to the
particular series of warrants being offered. Our Board of Directors
will determine the terms of the warrants. In this prospectus, we
have summarized certain general features of the warrants. We urge
you, however, to read the applicable prospectus supplement (and any
free writing prospectus that we may authorize to be provided to
you) related to the particular series of warrants being offered, as
well as the complete warrant agreements and warrant certificates
that contain the terms of the warrants. Forms of the warrant
agreements and forms of warrant certificates containing the terms
of the warrants being offered, and supplemental warrant agreements
and forms of warrant certificates will be filed as exhibits to the
registration statement of which this prospectus is a part or will
be incorporated by reference from reports that we file with the
SEC.
Units. We may offer units consisting of our
common stock or preferred stock, debt securities and/or warrants to
purchase any of these securities in one or more series. We may
evidence each series of units by unit certificates that we will
issue under a separate agreement. We may enter into unit agreements
with a unit agent. Each unit agent will be a bank or trust company
that we select. We will indicate the name and address of the unit
agent in the applicable prospectus supplement relating to a
particular series of units. This prospectus contains only a summary
of certain general features of the units. The applicable prospectus
supplement will describe the particular features of the units being
offered thereby. You should read any prospectus supplement and any
free writing prospectus that we may authorize to be provided to you
related to the series of units being offered, as well as the
complete unit agreements that contain the terms of the units.
Specific unit agreements will contain additional important terms
and provisions and will be incorporated by reference into the
registration statement of which this prospectus is a part from
reports we file with the SEC.
RISK FACTORS
Investing in our securities involves a high degree of risk. You
should carefully review the risks and uncertainties described under
the heading “Risk Factors” contained in the applicable prospectus
supplement and any related free writing prospectus, and under
similar headings in our Annual Report on Form 10-K for the year
ended December 31, 2018, as updated by our annual, quarterly and
other reports and documents that are incorporated by reference into
this prospectus, before deciding whether to purchase any of the
securities being registered pursuant to the registration statement
of which this prospectus is a part. Each of the risk factors could
adversely affect our business, operating results and financial
condition, as well as adversely affect the value of an investment
in our securities, and the occurrence of any of these risks might
cause you to lose all or part of your investment. Additional risks
not presently known to us or that we currently believe are
immaterial may also significantly impair our business
operations.
Our common stock could be subject to delisting from
Nasdaq.
On September 10, 2019, Genprex, Inc. (the “Company”) received a
letter from the Listing Qualifications Department (the “Staff”) of
the Nasdaq Stock Market (“Nasdaq”) notifying the Company that, for
the last 30 consecutive business days, the closing bid price for
the Company’s common stock was below the minimum $1.00 per share
requirement for continued listing on The Nasdaq Capital Market as
set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price
Requirement”). The Nasdaq letter had no immediate effect on the
listing of the Company’s common stock on the Nasdaq Capital
Market.
In accordance with Nasdaq listing rules, the Company has been
provided an initial period of 180 calendar days, or until March 9,
2020 (the “Compliance Date”), to regain compliance with the Minimum
Bid Price Requirement. If, at any time during this 180-day period,
the closing bid price of the Company’s common stock is at least
$1.00 for a minimum of 10 consecutive business days, unless the
Staff exercises its discretion to extend such 10-day period, the
Staff will provide the Company written confirmation of compliance
with the Minimum Bid Price Requirement and the matter will be
closed. If the Company does not regain compliance by the Compliance
Date, the Company may be eligible for an additional 180 calendar
day compliance period. To qualify for such additional compliance
period, the Company would have to meet the continued listing
requirements of the Nasdaq Capital Market, except for the Minimum
Bid Price Requirement, and the Company would need to provide
written notice of its intention to cure the deficiency during the
additional compliance period. If the Company is not eligible for
the additional compliance period or it appears to the Staff that
the Company will not be able to cure the deficiency or if the Staff
exercises its discretion to not provide such additional compliance
period, the Staff will provide written notice to the Company that
its common stock will be subject to delisting. At that time, the
Company may appeal the Staff’s delisting determination to a Nasdaq
Hearings Panel.
SPECIAL NOTE
REGARDING FORWARD-LOOKING STATEMENTS
Investing in our securities involves a high degree of risk This
prospectus, each prospectus supplement and the information
incorporated by reference in this prospectus and each prospectus
supplement contain forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, or the
Securities Act, and Section 21E of the Securities Exchange Act of
1934, as amended, or the Exchange Act, that involve a number of
risks and uncertainties. Although our forward-looking statements
reflect the good faith judgment of our management, these statements
can only be based on facts and factors currently known by us.
Consequently, these forward-looking statements are inherently
subject to risks and uncertainties, and actual results and outcomes
may differ materially from results and outcomes discussed in the
forward-looking statements.
Forward-looking statements can be identified by the use of
forward-looking words such as “believes,” “expects,” “hopes,”
“may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,”
“would,” “continue,” “seeks,” “pro forma,” or “anticipates,” or
other similar words (including their use in the negative), or by
discussions of future matters such as the development of new
products, technology enhancements, possible collaborations and
other statements that are not historical. These statements include
but are not limited to statements under the captions “Business,”
“Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” and in other
sections incorporated by reference from our Annual Report on Form
10-K and Quarterly Reports on Form 10-Q, as applicable, as well as
our other filings with the SEC. You should be aware that the
occurrence of any of the events discussed under the heading “Risk
Factors” in any applicable prospectus supplement and any documents
incorporated by reference herein or therein could substantially
harm our business, operating results and financial condition and
that if any of these events occurs, it could adversely affect the
value of an investment in our securities.
The cautionary statements made in this prospectus are intended to
be applicable to all related forward-looking statements wherever
they may appear in this prospectus or in any prospectus supplement
or any documents incorporated by reference herein or therein. We
urge you not to place undue reliance on these forward-looking
statements, which speak only as of the date they are made. Except
as required by law, we assume no obligation to update our
forward-looking statements, even if new information becomes
available in the future
USE OF
PROCEEDS
We will retain broad discretion over the use of the net proceeds
from the sale of the securities offered hereby. Except as described
in any prospectus supplement or any related free writing prospectus
that we may authorize to be provided to you, we currently intend to
use the net proceeds from the sale of the securities offered hereby
for general corporate purposes, which may include research and
development, capital expenditures, working capital and general and
administrative expenses. We may also use a portion of the net
proceeds to repay any debts and/or acquire or invest in businesses,
products and technologies that are complementary to our own,
although we have no current plans, commitments or agreements with
respect to any acquisitions as of the date of this prospectus. We
have not determined the amount of net proceeds to be used
specifically for any of the foregoing purposes. We will set forth
in the applicable prospectus supplement or free writing prospectus
our intended use for the net proceeds received from the sale of any
securities sold pursuant to the prospectus supplement or free
writing prospectus. Pending these uses, we intend to invest the net
proceeds in short- and intermediate-term, investment-grade,
interest-bearing securities.
Each time we offer securities under this prospectus, we will
describe the intended use of the net proceeds from that offering in
the applicable prospectus supplement. The actual amount of net
proceeds we spend on a particular use will depend on many factors,
including, our future capital expenditures, the amount of cash
required by our operations, and our future revenue growth, if
any.
DESCRIPTION OF CAPITAL STOCK
Our authorized capital stock consists of 200,000,000 shares of
common stock, par value $0.001 per share, and 10,000,000 shares of
preferred stock, par value $0.001 per share. All of our authorized
preferred stock is undesignated. The following description of our
capital stock, together with any additional information we include
in any applicable prospectus supplement or any related free writing
prospectus, summarizes the material terms and provisions of our
common stock and the preferred stock that we may offer under this
prospectus. While the terms we have summarized below will apply
generally to any future common stock or preferred stock that we may
offer, we will describe the particular terms of any class or series
of these securities in more detail in the applicable prospectus
supplement. This summary of the rights of our common and
preferred stockholders and some of the provisions of our amended
and restated certificate of incorporation and amended and restated
bylaws and of the Delaware General Corporation Law is not complete.
For more detailed information, please see our amended and restated
certificate of incorporation and amended and restated bylaws, which
are filed as exhibits to the registration statement of which this
prospectus is a part, as well as the relevant provisions of the
Delaware General Corporation Law.
Common Stock
Outstanding Shares.
As of October 2, 2019, there were 15,842,855 shares of voting
common stock issued and outstanding held of record by 221
stockholders.
As of October 2, 2019, there were an aggregate of 5,905,583 shares
of common stock subject to outstanding options under our 2009
Equity Incentive Plan and our 2018 Equity Incentive Plan. In
addition, as of August 30, 2019, there were 3,864,552 shares of
common stock issuable upon the exercise of outstanding
warrants.
Voting
Our voting common stock is entitled to one vote for each share held
of record on all matters submitted to a vote of the stockholders,
including the election of directors, and does not have cumulative
voting rights. Accordingly, the holders of a majority of the shares
of our voting common stock entitled to vote in any election of
directors can elect all of the directors standing for election.
Dividends
Subject to preferences that may be applicable to any
then-outstanding preferred stock, the holders of common stock are
entitled to receive dividends, if any, as may be declared from time
to time by our board of directors out of legally available
funds.
Liquidation
In the event of our liquidation, dissolution or winding-up, holders
of our common stock will be entitled to share ratably in the net
assets legally available for distribution to stockholders after the
payment of all of our debts and other liabilities, subject to the
satisfaction of any liquidation preference granted to the holders
of any outstanding shares of preferred stock.
Rights and Preferences
Holders of our common stock have no preemptive, conversion or
subscription rights, and there are no redemption or sinking fund
provisions applicable to our common stock. The rights, preferences
and privileges of the holders of our common stock are subject to,
and may be adversely affected by, the rights of the holders of
shares of any series of our preferred stock that we may designate
and issue in the future.
Fully Paid and Nonassessable
All of our outstanding shares of common stock are, and the shares
of common stock to be issued in this offering will be, fully paid
and nonassessable.
Preferred Stock
Under our amended and restated certificate of incorporation, our
board of directors will have the authority, without further action
by the stockholders, to issue up to 10,000,000 shares of
convertible preferred stock in one or more series, to establish
from time to time the number of shares to be included in each such
series, to fix the rights, preferences and privileges of the shares
of each wholly unissued series and any qualifications, limitations
or restrictions thereon and to increase or decrease the number of
shares of any such series, but not below the number of shares of
such series then outstanding.
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 the common
stock. The issuance of preferred stock, while providing flexibility
in connection with possible acquisitions and other corporate
purposes, could, among other things, have the effect of delaying,
deferring or preventing a change in our control that may otherwise
benefit holders of our common stock and may adversely affect the
market price of the common stock and the voting and other rights of
the holders of common stock. We have no current plans to issue any
shares of preferred stock.
Anti-Takeover Effects of Provisions of Our Amended and Restated
Certificate of Incorporation, Our Amended and Restated
Bylaws and Delaware Law
Delaware Anti-Takeover Law
We are subject to Section 203 of the Delaware General Corporation
Law, or Section 203. Section 203 generally prohibits a public
Delaware corporation from engaging in a “business combination” with
an “interested stockholder” for a period of three years following
the time that such stockholder became an interested stockholder,
unless:
| |
●
|
prior to such time the board of directors of the corporation
approved either the business combination or the transaction which
resulted in the stockholder becoming an interested stockholder;
|
| |
●
|
upon consummation of the transaction which resulted in the
stockholder becoming an interested stockholder, the interested
stockholder owned at least 85% of the voting stock of the
corporation outstanding at the time the transaction commenced,
excluding for purposes of determining the voting stock outstanding
(but not the outstanding voting stock owned by the interested
stockholder) those shares owned (1) by persons who are directors
and also officers and (2) employee stock plans in which employee
participants do not have the right to determine confidentially
whether shares held subject to the plan will be tendered in a
tender or exchange offer; or
|
| |
●
|
at or subsequent to such time, the business combination is approved
by the board of directors and authorized at an annual or special
meeting of stockholders, and not by written consent, by the
affirmative vote of at least 66-2/3% of the outstanding voting
stock which is not owned by the interested stockholder.
|
Section 203 defines a business combination to include:
| |
●
|
any merger or consolidation involving the corporation and the
interested stockholder;
|
| |
●
|
any sale, transfer, pledge or other disposition involving the
interested stockholder of 10% or more of the assets of the
corporation;
|
| |
●
|
subject to exceptions, any transaction that results in the issuance
or transfer by the corporation of any stock of the corporation to
the interested stockholder;
|
| |
●
|
subject to exceptions, any transaction involving the corporation
that has the effect of increasing the proportionate share of the
stock of any class or series of the corporation beneficially owned
by the interested stockholder; and
|
| |
●
|
the receipt by the interested stockholder of the benefit of any
loans, advances, guarantees, pledges or other financial benefits
provided by or through the corporation.
|
In general, Section 203 defines an interested stockholder as any
entity or person beneficially owning 15% or more of the outstanding
voting stock of the corporation and any entity or person affiliated
with or controlling or controlled by the entity or person.
Amended and Restated Certificate of Incorporation and Amended
and Restated Bylaws
Provisions of our amended and restated certificate of incorporation
and amended and restated bylaws may delay or discourage
transactions involving an actual or potential change in our control
or change in our management, including transactions in which
stockholders might otherwise receive a premium for their shares or
transactions that our stockholders might otherwise deem to be in
their best interests. Therefore, these provisions could adversely
affect the price of our common stock. Among other things, our
amended and restated certificate of incorporation and amended and
restated bylaws:
| |
●
|
permit our board of directors to issue up to 10,000,000 shares of
preferred stock, with any rights, preferences and privileges as
they may designate (including the right to approve an acquisition
or other change in our control);
|
| |
●
|
provide that the authorized number of directors may be changed only
by resolution of the board of directors;
|
| |
●
|
provide that the board of directors or any individual director may
only be removed with cause and the affirmative vote of the holders
of at least 66-2/3% of the voting power of all of our then
outstanding common stock;
|
| |
●
|
provide that all vacancies, including newly created directorships,
may, except as otherwise required by law, be filled by the
affirmative vote of a majority of directors then in office, even if
less than a quorum;
|
| |
●
|
divide our board of directors into three classes;
|
| |
●
|
require that any action to be taken by our stockholders must be
effected at a duly called annual or special meeting of stockholders
and not be taken by written consent;
|
| |
●
|
provide that stockholders seeking to present proposals before a
meeting of stockholders or to nominate candidates for election as
directors at a meeting of stockholders must provide notice in
writing in a timely manner and also specify requirements as to the
form and content of a stockholder’s notice;
|
| |
●
|
do not provide for cumulative voting rights (therefore allowing the
holders of a majority of the shares of common stock entitled to
vote in any election of directors to elect all of the directors
standing for election, if they should so choose);
|
| |
●
|
provide that special meetings of our stockholders may be called
only by the chairman of the board, our Chief Executive Officer or
by the board of directors pursuant to a resolution adopted by a
majority of the total number of authorized directors; and
|
| |
●
|
provide that the Court of Chancery of the State of Delaware will be
the sole and exclusive forum for (i) any derivative action or
proceeding brought on our behalf, (ii) any action asserting a claim
of breach of a fiduciary duty owed by any of our directors or
officers to us or our stockholders, (iii) any action asserting a
claim against us arising pursuant to any provision of the Delaware
General Corporation Law or our certificate of incorporation or
bylaws, or (iv) any action asserting a claim against us governed by
the internal affairs doctrine. This exclusive forum provision would
not apply to actions brought to enforce any liability or duty
created by the Securities Act or the Exchange Act or any other
claim over which the federal courts have exclusive jurisdiction. To
the extent that any such claims may be based upon federal law
claims, Section 27 of the Exchange Act creates exclusive federal
jurisdiction over all suits brought to enforce any duty or
liability created by the Exchange Act or the rules and regulations
thereunder, and Section 22 of the Securities Act creates concurrent
jurisdiction for federal and state courts over all suits brought to
enforce any duty or liability created by the Securities Act or the
rules and regulations thereunder. Although our amended and restated
certificate of incorporation contains the choice of forum provision
described above, it is possible that a court could rule that such a
provision is inapplicable for a particular claim or action or that
such provision is unenforceable.
|
The amendment of any of these provisions, with the exception of the
ability of our board of directors to issue shares of preferred
stock and designate any rights, preferences and privileges thereto,
would require approval by the holders of at least 66-2/3% of our
then-outstanding common stock.
Limitations on Liability and Indemnification of Officers and
Directors
Our certificate of incorporation and bylaws limit the liability of
our officers and directors and provide that we will indemnify our
officers and directors, in each case, to the fullest extent
permitted by the Delaware General Corporation Law. We have obtained
directors’ and officers’ liability insurance coverage.
Nasdaq Capital Market Listing
Our common stock is listed on the Nasdaq Capital Market under the
symbol “GNPX”.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is V Stock
Transfer, LLC. The transfer agent and registrar’s address is 18
Lafayette Place, Woodmere, New York 11598.
DESCRIPTION
OF DEBT SECURITIES
We may issue debt securities from time to time, in one or more
series, as either senior or subordinated debt or as senior or
subordinated convertible debt. While the terms we have summarized
below will apply generally to any debt securities that we may offer
under this prospectus, 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 offered
under a prospectus supplement may differ from the terms described
below. Unless the context requires otherwise, whenever we refer to
the indenture, we also are referring to any supplemental indentures
that specify the terms of a particular series of debt
securities.
We will issue the debt securities under the indenture that we will
enter into with the trustee named in the indenture. The indenture
will be qualified under the Trust Indenture Act of 1939, as
amended, or the Trust Indenture Act. We have filed the form of
indenture as an exhibit to the registration statement of which this
prospectus is a part, and supplemental indentures and forms of debt
securities containing the terms of the debt securities being
offered will be filed as exhibits to the registration statement of
which this prospectus is a part or will be incorporated by
reference from reports that we file with the SEC.
The following summary of material provisions of the debt securities
and the indenture is subject to, and qualified in its entirety by
reference to, all of the provisions of the indenture applicable to
a particular series of debt securities. We urge you to read the
applicable prospectus supplements and any related free writing
prospectuses related to the debt securities that we may offer under
this prospectus, as well as the complete indenture that contains
the terms of the debt securities.
General
The indenture does not limit the amount of debt securities that we
may issue. It provides that we may issue debt securities up to the
principal amount that we may authorize and may be in any currency
or currency unit that we may designate. Except for the limitations
on consolidation, merger and sale of all or substantially all of
our assets contained in the indenture, the terms of the indenture
do not contain any covenants or other provisions designed to give
holders of any debt securities protection against changes in our
operations, financial condition or transactions involving us.
We may issue the debt securities issued under the indenture as
“discount securities,” which means they may be sold at a discount
below their stated principal amount. These debt securities, as well
as other debt securities that are not issued at a discount, may be
issued with “original issue discount,” or OID, for U.S. federal
income tax purposes because of interest payment and other
characteristics or terms of the debt securities. Material U.S.
federal income tax considerations applicable to debt securities
issued with OID will be described in more detail in any applicable
prospectus supplement.
We will describe in the applicable prospectus supplement the terms
of the series of debt securities being offered, including:
| |
•
|
the title of the series of debt securities;
|
| |
•
|
any limit upon the aggregate principal amount that may be
issued;
|
| |
•
|
the maturity date or dates;
|
| |
•
|
the form of the debt securities of the series;
|
| |
•
|
the applicability of any guarantees;
|
| |
•
|
whether or not the debt securities will be secured or unsecured,
and the terms of any secured debt;
|
| |
•
|
whether the debt securities rank as senior debt, senior
subordinated debt, subordinated debt or any combination thereof,
and the terms of any subordination;
|
| |
•
|
if the price (expressed as a percentage of the aggregate principal
amount thereof) at which such debt securities will be issued is a
price other than the principal amount thereof, the portion of the
principal amount thereof payable upon declaration of acceleration
of the maturity thereof, or if applicable, the portion of the
principal amount of such debt securities that is convertible into
another security or the method by which any such portion shall be
determined;
|
| |
•
|
the interest rate or rates, 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;
|
| |
•
|
our right, if any, to defer payment of interest and the maximum
length of any such deferral period;
|
| |
•
|
if applicable, the date or dates after which, or the period or
periods during which, and the price or prices 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 redemption provisions;
|
| |
•
|
the date or dates, if any, on which, and the price or prices 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;
|
| |
•
|
the denominations in which we will issue the series of debt
securities, if other than denominations of $1,000 and any integral
multiple thereof;
|
| |
•
|
any and all terms, if applicable, relating to any auction or
remarketing of the debt securities of that series and any security
for our obligations with respect to such debt securities and any
other terms which may be advisable in connection with the marketing
of debt securities of that series;
|
| |
•
|
whether the debt securities of the series shall be issued in whole
or in part in the form of a global security or securities; the
terms and conditions, if any, upon which such global security or
securities may be exchanged in whole or in part for other
individual securities; and the depositary for such global security
or securities;
|
| |
•
|
if applicable, the provisions relating to conversion or exchange of
any debt securities of the series and the terms and conditions upon
which such debt securities will be so convertible or exchangeable,
including the conversion or exchange price, as applicable, or how
it will be calculated and may be adjusted, any mandatory or
optional (at our option or the holders’ option) conversion or
exchange features, the applicable conversion or exchange period and
the manner of settlement for any conversion or exchange;
|
| |
•
|
if other than the full principal amount thereof, the portion of the
principal amount of debt securities of the series which shall be
payable upon declaration of acceleration of the maturity
thereof;
|
| |
•
|
additions to or changes in the covenants applicable to the
particular debt securities being issued, including, among others,
the consolidation, merger or sale covenant;
|
| |
•
|
additions to or changes in the events of default with respect to
the securities and any change in the right of the trustee or the
holders to declare the principal, premium, if any, and interest, if
any, with respect to such securities to be due and payable;
|
| |
•
|
additions to or changes in or deletions of the provisions relating
to covenant defeasance and legal defeasance;
|
| |
•
|
additions to or changes in the provisions relating to satisfaction
and discharge of the indenture;
|
| |
•
|
additions to or changes in the provisions relating to the
modification of the indenture both with and without the consent of
holders of debt securities issued under the indenture;
|
| |
•
|
the currency of payment of debt securities if other than U.S.
dollars and the manner of determining the equivalent amount in U.S.
dollars;
|
| |
•
|
whether interest will be payable in cash or additional debt
securities at our or the holders’ option and the terms and
conditions upon which the election may be made;
|
| |
•
|
the terms and conditions, if any, upon which we will pay amounts in
addition to the stated interest, premium, if any, and principal
amounts of the debt securities of the series to any holder that is
not a “United States person” for federal tax purposes;
|
| |
•
|
any restrictions on transfer, sale or assignment of the debt
securities of the series; and
|
| |
•
|
any other specific terms, preferences, rights or limitations of, or
restrictions on, the debt securities, any other additions or
changes in the provisions of the indenture, and any terms that may
be required by us or advisable under applicable laws or
regulations.
|
Conversion or Exchange Rights
We will set forth in the applicable prospectus supplement the terms
on which a series of debt securities may be convertible into or
exchangeable for our common stock or our other securities
(including securities of a third party). We will include provisions
as to settlement upon conversion or exchange and whether conversion
or exchange is mandatory, at the option of the holder or at our
option. We may include provisions pursuant to which the number of
shares of our common stock or our other securities that the holders
of the series of debt securities receive would be subject to
adjustment.
Consolidation, Merger or Sale
Unless we provide otherwise in the prospectus supplement applicable
to a particular series of debt securities, the indenture will not
contain any covenant that restricts our ability to merge or
consolidate, or sell, convey, transfer or otherwise dispose of our
assets as an entirety or substantially as an entirety. However, any
successor to or acquirer of such assets (other than a subsidiary of
ours) must assume all of our obligations under the indenture or the
debt securities, as appropriate. If the debt securities are
convertible into or exchangeable for our other securities or
securities of other entities, the person with whom we consolidate
or merge or to whom we sell all of our property must make
provisions for the conversion of the debt securities into
securities that the holders of the debt securities would have
received if they had converted the debt securities before the
consolidation, merger or sale.
Events of Default under the Indenture
Unless we provide otherwise in the prospectus supplement applicable
to a particular series of debt securities, the following are events
of default under the indenture with respect to any series of debt
securities that we may issue:
| |
•
|
if we fail to pay any installment of interest on any series of debt
securities, as and when the same shall become due and payable, and
such default continues for a period of 90 days; provided, however,
that a valid extension of an interest payment period by us in
accordance with the terms of any indenture supplemental thereto
shall not constitute a default in the payment of interest for this
purpose;
|
| |
•
|
if we fail to pay the principal of, or premium, if any, on any
series of debt securities as and when the same shall become due and
payable whether at maturity, upon redemption, by declaration or
otherwise, or in any payment required by any sinking or analogous
fund established with respect to such series; provided, however,
that a valid extension of the maturity of such debt securities in
accordance with the terms of any indenture supplemental thereto
shall not constitute a default in the payment of principal or
premium, if any;
|
| |
•
|
if we fail to observe or perform any other covenant or agreement
contained in the debt securities or the indenture, other than a
covenant specifically relating to another series of debt
securities, and our failure continues for 90 days after we receive
written notice of such failure, requiring the same to be remedied
and stating that such is a notice of default thereunder, from the
trustee or holders of at least 25% in aggregate principal amount of
the outstanding debt securities of the applicable series; and
|
| |
•
|
if specified events of bankruptcy, insolvency or reorganization
occur.
|
If an event of default with respect to debt securities of any
series occurs and is continuing, other than an event of default
specified in the last bullet point above, the trustee or the
holders of at least 25% in aggregate principal amount of the
outstanding debt securities of that series, by notice to us in
writing, and to the trustee if notice is given by such holders, may
declare the unpaid principal of, premium, if any, and accrued
interest, if any, due and payable immediately. If an event of
default specified in the last bullet point above occurs with
respect to us, the principal amount of and accrued interest, if
any, of each issue of debt securities then outstanding shall be due
and payable without any notice or other action on the part of the
trustee or any holder.
The holders of a majority in principal amount of the outstanding
debt securities of an affected series may waive any default or
event of default with respect to the series and its consequences,
except defaults or events of default regarding payment of
principal, premium, if any, or interest, unless we have cured the
default or event of default in accordance with the indenture. Any
waiver shall cure the default or event of default.
Subject to the terms of the indenture, if an event of default under
an indenture shall occur and be continuing, the trustee will be
under no obligation to exercise any of its rights or powers under
such indenture at the request or direction of any of the holders of
the applicable series of debt securities, unless such holders have
offered the trustee reasonable indemnity. The holders of a majority
in principal amount of the outstanding debt securities of any
series will have the right to direct the time, method and place of
conducting any proceeding for any remedy available to the trustee,
or exercising any trust or power conferred on the trustee, with
respect to the debt securities of that series, provided that:
| |
•
|
the direction so given by the holder is not in conflict with any
law or the applicable indenture; and
|
| |
•
|
subject to its duties under the Trust Indenture Act, the trustee
need not take any action that might involve it in personal
liability or might be unduly prejudicial to the holders not
involved in the proceeding.
|
A holder of the debt securities of any series will have the right
to institute a proceeding under the indenture or to appoint a
receiver or trustee, or to seek other remedies only if:
| |
•
|
the holder has given written notice to the trustee of a continuing
event of default with respect to that series;
|
| |
•
|
the holders of at least 25% in aggregate principal amount of the
outstanding debt securities of that series have made written
request;
|
| |
•
|
such holders have offered to the trustee indemnity satisfactory to
it against the costs, expenses and liabilities to be incurred by
the trustee in compliance with the request; and
|
| |
•
|
the trustee does not institute the proceeding, and does not receive
from the holders of a majority in aggregate principal amount of the
outstanding debt securities of that series other conflicting
directions within 90 days after the notice, request and offer.
|
These limitations do not apply to a suit instituted by a holder of
debt securities if we default in the payment of the principal,
premium, if any, or interest on, the debt securities.
We will periodically file statements with the trustee regarding our
compliance with specified covenants in the indenture.
Modification of Indenture; Waiver
We and the trustee may change an indenture without the consent of
any holders with respect to specific matters:
| |
•
|
to cure any ambiguity, defect or inconsistency in the indenture or
in the debt securities of any series;
|
| |
•
|
to comply with the provisions described above under “Description of
Debt Securities–Consolidation, Merger or Sale;”
|
| |
•
|
to provide for uncertificated debt securities in addition to or in
place of certificated debt securities;
|
| |
•
|
to add to our covenants, restrictions, conditions or provisions
such new covenants, restrictions, conditions or provisions for the
benefit of the holders of all or any series of debt securities, to
make the occurrence, or the occurrence and the continuance, of a
default in any such additional covenants, restrictions, conditions
or provisions an event of default or to surrender any right or
power conferred upon us in the indenture;
|
| |
•
|
to add to, delete from or revise the conditions, limitations, and
restrictions on the authorized amount, terms, or purposes of issue,
authentication and delivery of debt securities, as set forth in the
indenture;
|
| |
•
|
to make any change that does not adversely affect the interests of
any holder of debt securities of any series in any material
respect;
|
| |
•
|
to provide for the issuance of and establish the form and terms and
conditions of the debt securities of any series as provided above
under “Description of Debt Securities–General” to establish the
form of any certifications required to be furnished pursuant to the
terms of the indenture or any series of debt securities, or to add
to the rights of the holders of any series of debt securities;
|
| |
•
|
to evidence and provide for the acceptance of appointment under any
indenture by a successor trustee; or
|
| |
•
|
to comply with any requirements of the SEC in connection with the
qualification of any indenture under the Trust Indenture Act.
|
In addition, under the indenture, the rights of holders of a series
of debt securities may be changed by us and the trustee with the
written consent of the holders of at least a majority in aggregate
principal amount of the outstanding debt securities of each series
that is affected. However, unless we provide otherwise in the
prospectus supplement applicable to a particular series of debt
securities, we and the trustee may make the following changes only
with the consent of each holder of any outstanding debt securities
affected:
| |
•
|
extending the fixed maturity of any debt securities of any
series;
|
| |
•
|
reducing the principal amount, reducing the rate of or extending
the time of payment of interest, or reducing any premium payable
upon the redemption of any series of any debt securities; or
|
| |
•
|
reducing the percentage of debt securities, the holders of which
are required to consent to any amendment, supplement, modification
or waiver.
|
Discharge
The indenture provides that we can elect to be discharged from our
obligations with respect to one or more series of debt securities,
except for specified obligations, including obligations to:
| |
•
|
register the transfer or exchange of debt securities of the
series;
|
| |
•
|
replace stolen, lost or mutilated debt securities of the
series;
|
| |
•
|
pay principal of and premium and interest on any debt securities of
the series;
|
| |
•
|
maintain paying agencies;
|
| |
•
|
hold monies for payment in trust;
|
| |
•
|
recover excess money held by the trustee;
|
| |
•
|
compensate and indemnify the trustee; and
|
| |
•
|
appoint any successor trustee.
|
In order to exercise our rights to be discharged, we must deposit
with the trustee money or government obligations sufficient to pay
all the principal of, any premium, if any, and interest on, the
debt securities of the series on the dates payments are due.
Form, Exchange and Transfer
We will issue the debt securities of each series only in fully
registered form without coupons and, unless we provide otherwise in
the applicable prospectus supplement, in denominations of $1,000
and any integral multiple thereof. The indenture provides that we
may issue debt securities of a series in temporary or permanent
global form and as book-entry securities that will be deposited
with, or on behalf of, The Depository Trust Company, or DTC, or
another depositary named by us and identified in the
applicable prospectus supplement with respect to that series. To
the extent the debt securities of a series are issued in global
form and as book-entry, a description of terms relating to any
book-entry securities will be set forth in the applicable
prospectus supplement.
At the option of the holder, subject to the terms of the indenture
and the limitations applicable to global securities described in
the applicable prospectus supplement, the holder of the debt
securities of any series can exchange the debt securities for other
debt securities of the same series, in any authorized denomination
and of like tenor and aggregate principal amount.
Subject to the terms of the indenture and the limitations
applicable to global securities set forth in the applicable
prospectus supplement, holders of the debt securities may present
the debt securities for exchange or for registration of transfer,
duly endorsed or with the form of transfer endorsed thereon duly
executed if so required by us or the security registrar, at the
office of the security registrar or at the office of any transfer
agent designated by us for this purpose. Unless otherwise provided
in the debt securities that the holder presents for transfer or
exchange, we will impose no service charge for any registration of
transfer or exchange, but we may require payment of any taxes or
other governmental charges.
We will name in the applicable prospectus supplement the security
registrar, and any transfer agent in addition to the security
registrar, that we initially designate for any debt securities. We
may at any time designate additional transfer agents or rescind the
designation of any transfer agent or approve a change in the office
through which any transfer agent acts, except that we will be
required to maintain a transfer agent in each place of payment for
the debt securities of each series.
If we elect to redeem the debt securities of any series, we will
not be required to:
| |
•
|
issue, register the transfer of, or exchange any debt securities of
that series during a period beginning at the opening of business 15
days before the day of mailing of a notice of redemption of any
debt securities that may be selected for redemption and ending at
the close of business on the day of the mailing; or
|
| |
•
|
register the transfer of or exchange any debt securities so
selected for redemption, in whole or in part, except the unredeemed
portion of any debt securities we are redeeming in part.
|
Information Concerning the Trustee
The trustee, other than during the occurrence and continuance of an
event of default under an indenture, undertakes to perform only
those duties as are specifically set forth in the applicable
indenture. Upon an event of default under an indenture, the trustee
must use the same degree of care as a prudent person would exercise
or use in the conduct of his or her own affairs. Subject to this
provision, the trustee is under no obligation to exercise any of
the powers given it by the indenture at the request of any holder
of debt securities unless it is offered reasonable security and
indemnity against the costs, expenses and liabilities that it might
incur.
Payment and Paying Agents
Unless we otherwise indicate in the applicable prospectus
supplement, we will make payment of the interest on any debt
securities on any interest payment date to the person in whose name
the debt securities, or one or more predecessor securities, are
registered at the close of business on the regular record date for
the interest.
We will pay principal of and any premium and interest on the debt
securities of a particular series at the office of the paying
agents designated by us, except that unless we otherwise indicate
in the applicable prospectus supplement, we will make interest
payments by check that we will mail to the holder or by wire
transfer to certain holders. Unless we otherwise indicate in the
applicable prospectus supplement, we will designate the corporate
trust office of the trustee as our sole paying agent for payments
with respect to debt securities of each series. We will name in the
applicable prospectus supplement any other paying agents that we
initially designate for the debt securities of a particular series.
We will maintain a paying agent in each place of payment for the
debt securities of a particular series.
All money we pay to a paying agent or the trustee for the payment
of the principal of or any premium or interest on any debt
securities that remains unclaimed at the end of two years after
such principal, premium or interest has become due and payable will
be repaid to us, and the holder of the debt security thereafter may
look only to us for payment thereof.
Governing Law
The indenture and the debt securities will be governed by and
construed in accordance with the internal laws of the State of New
York, except to the extent that the Trust Indenture Act of 1939 is
applicable.
DESCRIPTION OF WARRANTS
The following description, together with the additional information
we may include in any applicable prospectus supplements and free
writing prospectuses, summarizes the material terms and provisions
of the warrants that we may offer under this prospectus, which may
consist of warrants to purchase common stock, preferred stock or
debt securities and may be issued in one or more series. Warrants
may be issued independently or together with common stock,
preferred stock or debt securities offered by any prospectus
supplement, and may be attached to or separate from those
securities. While the terms we have summarized below will apply
generally to any warrants that we may offer under this prospectus,
we will describe the particular terms of any series of warrants
that we may offer in more detail in the applicable prospectus
supplement and any applicable free writing prospectus. The terms of
any warrants offered under a prospectus supplement may differ from
the terms described below. However, no prospectus supplement will
fundamentally change the terms that are set forth in this
prospectus or offer a security that is not registered and described
in this prospectus at the time of its effectiveness.
If applicable, 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, if any, including a form of warrant certificate,
that describes the terms of the particular series of warrants we
are offering before the issuance of the related series of warrants.
The following summaries of material provisions of the warrants and
the warrant agreements are subject to, and qualified in their
entirety by reference to, all the provisions of the warrant
agreement and warrant certificate applicable to the particular
series of warrants that we may offer under this prospectus. We urge
you to read the applicable prospectus supplements related to the
particular series of warrants that we may offer under this
prospectus, as well as any related free writing prospectuses, and
the complete warrant agreements and warrant certificates that
contain the terms of the warrants.
General
We will describe in the applicable prospectus supplement the terms
relating to a series of warrants being offered, including:
| |
•
|
the title of such securities;
|
| |
•
|
the offering price or prices and aggregate number of warrants
offered;
|
| |
•
|
the currency or currencies for which the warrants may be
purchased;
|
| |
•
|
if applicable, the designation and terms of the securities with
which the warrants are issued and the number of warrants issued
with each such security or each principal amount of such
security;
|
| |
•
|
if applicable, the date on and after which the warrants and the
related securities will be separately transferable;
|
| |
•
|
if applicable, the minimum or maximum amount of such warrants which
may be exercised at any one time;
|
| |
•
|
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 which, and currency in which, this principal
amount of debt securities may be purchased upon such exercise;
|
| |
•
|
in the case of warrants to purchase common stock or preferred
stock, the number of shares of common stock or preferred stock, as
the case may be, purchasable upon the exercise of one warrant and
the price at which, and the currency in which, these shares may be
purchased upon such exercise;
|
| |
•
|
the effect of any merger, consolidation, sale or other disposition
of our business on the warrant agreements and the warrants;
|
| |
•
|
the terms of any rights to redeem or call the warrants;
|
| |
•
|
the terms of any rights to force the exercise of the warrants;
|
| |
•
|
any provisions for changes to or adjustments in the exercise price
or number of securities issuable upon exercise of the warrants;
|
| |
•
|
the dates on which the right to exercise the warrants will commence
and expire;
|
| |
•
|
the manner in which the warrant agreements and warrants may be
modified;
|
| |
•
|
a discussion of any material or special U.S. federal income tax
consequences of holding or exercising the warrants;
|
| |
•
|
the terms of the securities issuable upon exercise of the warrants;
and
|
| |
•
|
any other specific terms, preferences, rights or limitations of or
restrictions on the warrants.
|
Before exercising their warrants, holders of warrants will not have
any of the rights of holders of the securities purchasable upon
such exercise, including:
| |
•
|
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
|
| |
•
|
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.
|
Exercise of Warrants
Each warrant will entitle the holder to purchase the securities
that we specify in the applicable prospectus supplement at the
exercise price that we describe in the applicable prospectus
supplement. Unless we otherwise specify in the applicable
prospectus supplement, holders of the warrants may exercise the
warrants at any time up to the specified time on the expiration
date that we set forth in the applicable prospectus supplement.
After the close of business on the expiration date, unexercised
warrants will become void.
Unless we otherwise specify in the applicable prospectus
supplement, holders of the warrants may exercise the warrants by
delivering the warrant certificate representing the warrants to be
exercised together with specified information, and paying the
required amount to the warrant agent in immediately available
funds, as provided in the applicable prospectus supplement. We will
set forth on the reverse side of the warrant certificate and in the
applicable prospectus supplement the information that the holder of
the warrant will be required to deliver to the warrant agent in
connection with the exercise of the warrant.
Upon receipt of the required payment and the warrant certificate
properly completed and duly executed at the corporate trust office
of the warrant agent or any other office indicated in the
applicable prospectus supplement, we will issue and deliver the
securities purchasable upon such exercise. If fewer than all of the
warrants represented by the warrant certificate are exercised, then
we will issue a new warrant certificate for the remaining amount of
warrants. If we so indicate in the applicable prospectus
supplement, holders of the warrants may surrender securities as all
or part of the exercise price for warrants.
Governing Law
Unless we provide otherwise in the applicable prospectus
supplement, the warrants and warrant agreements, and any claim,
controversy or dispute arising under or related to the warrants or
warrant agreements, will be governed by and construed in accordance
with the laws of the State of New York.
Enforceability of Rights by Holders of Warrants
If selected, each warrant agent will act solely as our agent under
the applicable warrant agreement and will not assume any obligation
or relationship of agency or trust with any holder of any warrant.
A single bank or trust company may act as warrant agent for more
than one issue of warrants. A warrant agent will have no duty or
responsibility in case of any default by us under the applicable
warrant agreement or warrant, including any duty or responsibility
to initiate any proceedings at law or otherwise, or to make any
demand upon us. Any holder of a warrant may, without the consent of
the related warrant agent or the holder of any other warrant,
enforce by appropriate legal action its right to exercise, and
receive the securities purchasable upon exercise of, its
warrants.
DESCRIPTION OF UNITS
The following description, together with the additional information
we may include in any applicable prospectus supplements and free
writing prospectuses, summarizes the material terms and provisions
of the units that we may offer under this prospectus.
While the terms we have summarized below will apply generally to
any units that we may offer under this prospectus, we will describe
the particular terms of any series of units in more detail in the
applicable prospectus supplement. The terms of any units offered
under a prospectus supplement may differ from the terms described
below. However, no prospectus supplement will fundamentally change
the terms that are set forth in this prospectus or offer a security
that is not registered and described in this prospectus at the time
of its effectiveness.
We will file as exhibits to the registration statement of which
this prospectus is a part, or will incorporate by reference from a
Current Report on Form 8-K that we file with the SEC, the form of
unit agreement that describes the terms of the series of units we
are offering, and any supplemental agreements, before the issuance
of the related series of units. The following summaries of material
terms and provisions of the units are subject to, and qualified in
their entirety by reference to, all the provisions of the unit
agreement and any supplemental agreements applicable to a
particular series of units. We urge you to read the applicable
prospectus supplements related to the particular series of units
that we sell under this prospectus, as well as the complete unit
agreement and any supplemental agreements that contain the terms of
the units.
General
We may issue units comprised 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 describe in the applicable prospectus supplement the terms
of the series of units, including:
| |
•
|
the designation and terms of the units and of the securities
comprising the units, including whether and under what
circumstances those securities may be held or transferred
separately;
|
| |
•
|
any provisions of the governing unit agreement that differ from
those described below; and
|
| |
•
|
any provisions for the issuance, payment, settlement, transfer or
exchange of the units or of the securities comprising the
units.
|
The provisions described in this section, as well as those
described under “Description of Capital Stock,” “Description of
Debt Securities” and “Description of Warrants” will apply to each
unit and to any common stock, preferred stock, debt security or
warrant included in each unit, respectively.
Unit Agent
The name and address of the unit agent, if any, for any units we
offer will be set forth in the applicable prospectus
supplement.
Issuance in Series
We may issue units in such amounts and in numerous distinct series
as we determine.
Enforceability of Rights by Holders of Units
Each unit agent will act solely as our agent under the applicable
unit agreement and will not assume any obligation or relationship
of agency or trust with any holder of any unit. A single bank or
trust company may act as unit agent for more than one series of
units. A unit agent will have no duty or responsibility in case of
any default by us under the applicable unit agreement or unit,
including any duty or responsibility to initiate any proceedings at
law or otherwise, or to make any demand upon us. Any holder of a
unit may, without the consent of the related unit agent or the
holder of any other unit, enforce by appropriate legal action its
rights as holder under any security included in the unit.
We, the unit agents and any of their agents may treat the
registered holder of any unit certificate as an absolute owner of
the units evidenced by that certificate for any purpose and as the
person entitled to exercise the rights attaching to the units so
requested, despite any notice to the contrary. See “Legal Ownership
of Securities.”
LEGAL OWNERSHIP OF
SECURITIES
We can issue securities in registered form or in the form of one or
more global securities. We describe global securities in greater
detail below. We refer to those persons who have securities
registered in their own names on the books that we or any
applicable trustee or depositary maintain for this purpose as the
“holders” of those securities. These persons are the legal holders
of the securities. We refer to those persons who, indirectly
through others, own beneficial interests in securities that are not
registered in their own names as “indirect holders” of those
securities. As we discuss below, indirect holders are not legal
holders and investors in securities issued in book-entry form or in
street name will be indirect holders.
Book-Entry Holders
We may issue securities in book-entry form only, as we will specify
in the applicable prospectus supplement. This means securities may
be represented by one or more global securities registered in the
name of a financial institution that holds them as depositary on
behalf of other financial institutions that participate in the
depositary’s book-entry system. These participating institutions,
which are referred to as participants, in turn, hold beneficial
interests in the securities on behalf of themselves or their
customers.
Only the person in whose name a security is registered is
recognized as the holder of that security. Global securities
will be registered in the name of the depositary or its
participants. Consequently, for global securities, we will
recognize only the depositary as the holder of the securities, and
we will make all payments on the securities to the depositary. The
depositary passes along the payments it receives to its
participants, which in turn pass the payments along to their
customers who are the beneficial owners. The depositary and its
participants do so under agreements they have made with one another
or with their customers; they are not obligated to do so under the
terms of the securities.
As a result, investors in a global security will not own securities
directly. Instead, they will own beneficial interests in a global
security, through a bank, broker or other financial institution
that participates in the depositary’s book-entry system or holds an
interest through a participant. As long as the securities are
issued in global form, investors will be indirect holders, and not
legal holders, of the securities.
Street Name Holders
A global security may be terminated in certain situations as
described under “-Special Situations When a Global Security Will Be
Terminated,” or issue securities that are not issued in global
form. In these cases, investors may choose to hold their securities
in their own names or in “street name.” Securities held by an
investor in street name would be registered in the name of a bank,
broker or other financial institution that the investor chooses,
and the investor would hold only a beneficial interest in
those securities through an account he or she maintains at that
institution.
For securities held in street name, we or any applicable trustee or
depositary will recognize only the intermediary banks, brokers and
other financial institutions in whose names the securities are
registered as the holders of those securities, and we or any such
trustee or depositary will make all payments on those securities to
them. These institutions pass along the payments they receive to
their customers who are the beneficial owners, but only because
they agree to do so in their customer agreements or because they
are legally required to do so. Investors who hold securities in
street name will be indirect holders, not holders, of those
securities.
Legal Holders
Our obligations, as well as the obligations of any applicable
trustee or third party employed by us or a trustee, run only to the
legal holders of the securities. We do not have obligations to
investors who hold beneficial interests in global securities, in
street name or by any other indirect means. This will be the case
whether an investor chooses to be an indirect holder of a security
or has no choice because we are issuing the securities only in
global form.
For example, once we make a payment or give a notice to the legal
holder, we have no further responsibility for the payment or notice
even if that legal holder is required, under agreements with its
participants or customers or by law, to pass it along to the
indirect holders but does not do so. Similarly, we may want to
obtain the approval of the holders to amend an indenture, to
relieve us of the consequences of a default or of our obligation to
comply with a particular provision of an indenture, or for other
purposes. In such an event, we would seek approval only from the
legal holders, and not the indirect holders, of the securities.
Whether and how the legal holders contact the indirect holders is
up to the legal holders.
Special Considerations for Indirect Holders
If you hold securities through a bank, broker or other financial
institution, either in book-entry form because the securities are
represented by one or more global securities or in street name, you
should check with your own institution to find out:
| |
•
|
how it handles securities payments and notices;
|
| |
•
|
whether it imposes fees or charges;
|
| |
•
|
how it would handle a request for the holders’ consent, if ever
required;
|
| |
•
|
whether and how you can instruct it to send you securities
registered in your own name so you can be a holder, if that is
permitted in the future;
|
| |
•
|
how it would exercise rights under the securities if there were a
default or other event triggering the need for holders to act to
protect their interests; and
|
| |
•
|
if the securities are in book-entry form, how the depositary’s
rules and procedures will affect these matters.
|
Global Securities
A global security is a security that represents one or any other
number of individual securities held by a depositary. Generally,
all securities represented by the same global securities will have
the same terms.
Each security issued in book-entry form will be represented by a
global security that we issue to, deposit with and register in the
name of a financial institution or its nominee that we select. The
financial institution that we select for this purpose is called the
depositary. Unless we specify otherwise in the applicable
prospectus supplement, the DTC will be the depositary for all
securities issued in book-entry form.
A global security may not be transferred to or registered in the
name of anyone other than the depositary, its nominee or a
successor depositary, unless special termination situations arise.
We describe those situations below under “-Special Situations When
a Global Security Will Be Terminated.” As a result of these
arrangements, the depositary, or its nominee, will be the sole
registered owner and legal holder of all securities represented by
a global security, and investors will be permitted to own only
beneficial interests in a global security. Beneficial interests
must be held by means of an account with a broker, bank or other
financial institution that in turn has an account with the
depositary or with another institution that does. Thus, an investor
whose security is represented by a global security will not be a
legal holder of the security, but only an indirect holder of a
beneficial interest in the global security.
If the prospectus supplement for a particular security indicates
that the security will be issued as a global security, then the
security will be represented by a global security at all times
unless and until the global security is terminated. If termination
occurs, we may issue the securities through another book-entry
clearing system or decide that the securities may no longer be held
through any book-entry clearing system.
Special Considerations for Global Securities
As an indirect holder, an investor’s rights relating to a global
security will be governed by the account rules of the investor’s
financial institution and of the depositary, as well as general
laws relating to securities transfers. We do not recognize an
indirect holder as a holder of securities and instead deal only
with the depositary that holds the global security.
If securities are issued only as global securities, an investor
should be aware of the following:
| |
•
|
an investor cannot cause the securities to be registered in his or
her name, and cannot obtain non-global certificates for his or her
interest in the securities, except in the special situations we
describe below;
|
| |
•
|
an investor will be an indirect holder and must look to his or her
own bank or broker for payments on the securities and protection of
his or her legal rights relating to the securities, as we describe
above;
|
| |
•
|
an investor may not be able to sell interests in the securities to
some insurance companies and to other institutions that are
required by law to own their securities in non-book-entry form;
|
| |
•
|
an investor may not be able to pledge his or her interest in the
global security in circumstances where certificates representing
the securities must be delivered to the lender or other beneficiary
of the pledge in order for the pledge to be effective;
|
| |
•
|
the depositary’s policies, which may change from time to time, will
govern payments, transfers, exchanges and other matters relating to
an investor’s interest in the global security;
|
| |
•
|
we and any applicable trustee have no responsibility for any aspect
of the depositary’s actions or for its records of ownership
interests in the global security, nor will we or any applicable
trustee supervise the depositary in any way;
|
| |
•
|
the depositary may, and we understand that DTC will, require that
those who purchase and sell interests in the global security within
its book-entry system use immediately available funds, and your
broker or bank may require you to do so as well; and
|
| |
•
|
financial institutions that participate in the depositary’s
book-entry system, and through which an investor holds its interest
in the global security, may also have their own policies affecting
payments, notices and other matters relating to the securities.
|
There may be more than one financial intermediary in the chain of
ownership for an investor. We do not monitor and are not
responsible for the actions of any of those intermediaries.
Special Situations When a Global Security Will Be
Terminated
In a few special situations described below, a global security will
terminate and interests in it will be exchanged for physical
certificates representing those interests. After that exchange, the
choice of whether to hold securities directly or in street name
will be up to the investor. Investors must consult their own banks
or brokers to find out how to have their interests in securities
transferred to their own names, so that they will be direct
holders. We have described the rights of holders and street name
investors above.
A global security will terminate when the following special
situations occur:
| |
•
|
if the depositary notifies us that it is unwilling, unable or no
longer qualified to continue as depositary for that global security
and we do not appoint another institution to act as depositary
within 90 days;
|
| |
•
|
if we notify any applicable trustee that we wish to terminate that
global security; or
|
| |
•
|
if an event of default has occurred with regard to securities
represented by that global security and has not been cured or
waived.
|
The applicable prospectus supplement may also list additional
situations for terminating a global security that would apply only
to the particular series of securities covered by the prospectus
supplement. When a global security terminates, the depositary, and
neither we nor any applicable trustee, is responsible for deciding
the names of the institutions that will be the initial direct
holders.
PLAN OF
DISTRIBUTION
We may sell the securities from time to time pursuant to
underwritten public offerings, negotiated transactions, block
trades or a combination of these methods. 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:
| |
•
|
at a fixed price or prices, which may be changed;
|
| |
•
|
at market prices prevailing at the time of sale;
|
| |
•
|
at prices related to such prevailing market prices; or
|
We may also sell equity securities covered by this registration
statement in an “at the market offering” as defined in Rule 415
under the Securities Act. Such offering may be made into an
existing trading market for such securities in transactions at
other than a fixed price, either:
| |
•
|
on or through the facilities of the Nasdaq Capital Market or any
other securities exchange or quotation or trading service on which
such securities may be listed, quoted or traded at the time of
sale; and/or
|
| |
•
|
to or through a market maker other than on the Nasdaq Capital
Market or such other securities exchanges or quotation or trading
services.
|
Such at-the-market offerings, if any, may be conducted by
underwriters acting as principal or agent.
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:
| |
•
|
the name or names of any underwriters, dealers or agents, if
any;
|
| |
•
|
the purchase price of the securities and the proceeds we will
receive from the sale;
|
| |
•
|
any over-allotment options under which underwriters may purchase
additional securities from us;
|
| |
•
|
any agency fees or underwriting discounts and other items
constituting agents’ or underwriters’ compensation;
|
| |
•
|
any public offering price;
|
| |
•
|
any discounts or concessions allowed or reallowed or paid to
dealers; and
|
| |
•
|
any securities exchange or market on which the securities may be
listed.
|
Only underwriters named in the prospectus supplement are
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. 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 related to this offering, 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.
Other than common stock, all securities we offer 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.
We may enter into derivative transactions with third parties
(including the writing of options), or sell securities not covered
by this prospectus to third parties in privately negotiated
transactions. If the applicable prospectus supplement indicates, in
connection with such a transaction, the third parties may, pursuant
to this prospectus and the applicable prospectus supplement, sell
securities covered by this prospectus and the applicable prospectus
supplement. If so, the third party may use securities borrowed from
us or others to settle such sales and may use securities received
from us to close out any related short positions. We may also loan
or pledge securities covered by this prospectus and the applicable
prospectus supplement to third parties, who may sell the loaned
securities or, in an event of default in the case of a pledge, sell
the pledged securities pursuant to this prospectus and the
applicable prospectus supplement. The third party in such sale
transactions will be an underwriter and will be identified in the
applicable prospectus supplement or in a post-effective
amendment.
Any underwriter may engage in overallotment, stabilizing
transactions, short covering transactions and penalty bids.
Overallotment involves sales in excess of the offering size, which
create a short position. Stabilizing transactions permit bids to
purchase the underlying security so long as the stabilizing bids do
not exceed a specified maximum. Short covering transactions involve
purchases of the securities in the open market after the
distribution is completed to cover short positions. Penalty bids
permit the underwriters to reclaim a selling concession from a
dealer when the securities originally sold by the dealer are
purchased in a 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.
These transactions may be effected on any exchange or
over-the-counter market or otherwise.
Any underwriters who are qualified market makers on the Nasdaq
Capital Market may engage in passive market making transactions in
the securities on the Nasdaq Capital Market in accordance with Rule
103 of Regulation M, during the business day prior to the pricing
of the offering, before the commencement of offers or sales of the
securities. 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.
LEGAL MATTERS
The validity of the issuance of the securities offered hereby will
be passed upon by Streusand, Landon, Ozburn & Lemmon, LLP,
Austin, Texas. Additional legal matters may be passed upon for us
or any underwriters, dealers or agents, by counsel that we will
name in an appropriate prospectus supplement.
EXPERTS
Daszkal Bolton LLP, an independent registered public accounting
firm, has audited our financial statements included in our Annual
Report on Form 10-K for the year ended December 31, 2018, as set
forth in their report, which is incorporated by reference in this
prospectus and elsewhere in the registration statement. Our
financial statements are incorporated by reference in reliance on
Daszkal Bolton LLP’s report, given on their authority as experts in
accounting and auditing.
WHERE YOU CAN FIND
MORE INFORMATION
This prospectus is part of a registration statement we filed with
the SEC. This prospectus does not contain all of the information
set forth in the registration statement and the exhibits to the
registration statement. For further information with respect to us
and the securities we are offering under this prospectus, we refer
you to the registration statement and the exhibits and schedules
filed as a part of the registration statement. Neither we nor any
agent, underwriter or dealer has authorized any person to provide
you with different information. We are not making an offer of these
securities in any state where the offer is not permitted. You
should not assume that the information in this prospectus is
accurate as of any date other than the date on the front page of
this prospectus, regardless of the time of delivery of this
prospectus or any sale of the securities offered by this
prospectus.
We file annual, quarterly and current reports, proxy statements and
other information with the SEC. You may read and copy the
registration statement, as well as any other document filed by us
with the SEC, at the SEC’s Public Reference Room at 100 F
Street NE, Washington, D.C. 20549. You can also request copies of
these documents by writing to the SEC and paying a fee for the
copying cost. You may obtain information on the operation of the
Public Reference Room by calling the SEC at (800) SEC-0330. The SEC
maintains a website that contains reports, proxy statements and
other information regarding issuers that file electronically with
the SEC, including Genprex. The address of the SEC website is
www.sec.gov.
We maintain a website at www.genprex.com. Information contained in
or accessible through our website does not constitute a part of
this prospectus.
INCORPORATION OF
CERTAIN INFORMATION BY REFERENCE
The SEC allows us to “incorporate by reference” the information we
file with it, which means that we can disclose important
information to you by referring you to those documents. The
information we incorporate by reference is an important part of
this prospectus. Information in this prospectus supersedes
information incorporated by reference that we filed with the SEC
prior to the date of this prospectus. We incorporate by reference
into this prospectus and the registration statement of which this
prospectus is a part the information or documents listed below that
we have filed with the SEC (File No. 001-38244):
| |
●
|
our Annual Report on Form 10-K for the year ended December 31,
2018, filed with the SEC on April 1, 2019;
|
| |
●
|
our Quarterly Report on Form 10-Q/A for the period ended March 31,
2019, filed with the SEC on May 20, 2019;
|
| |
●
|
our Quarterly Report on Form 10-Q for the period ended June 30,
2019, filed with the SEC on August 13, 2019;
|
| |
●
|
our Current Reports on Form 8-K filed with the SEC on January 31,
2019, February 19, 2019, June 11, 2019, August 30, 2019, and
September 13, 2019; and
|
| |
●
|
the description of our capital stock contained in our Registration
Statement on Form 8-A filed with the SEC on October 13, 2017.
|
We also incorporate by reference into this prospectus all documents
(other than Current Reports furnished under Item 2.02 or Item 7.01
of Form 8-K and exhibits filed on such form that are related to
such items) that are filed by us with the SEC pursuant to Sections
13(a), 13(c), 14 or 15(d) of the Exchange Act (i) after the date of
the initial filing of the registration statement of which this
prospectus forms a part and prior to effectiveness of the
registration statement, or (ii) after the date of this prospectus
but prior to the termination of the offering. These documents
include periodic reports, such as Annual Reports on Form 10-K,
Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, as
well as proxy statements.
We will furnish without charge to you, on written or oral request,
a copy of any or all of the documents incorporated by reference in
this prospectus but not delivered with this prospectus, including
exhibits that are specifically incorporated by reference in that
information. You should direct any requests for documents to
Genprex, Inc., Attn: Corporate Secretary, 1701 Trinity Street,
Bldg. B, Suite 3.322, Austin, Texas 78712.
You also may access these filings on our website at
www.genprex.com. We do not incorporate the information on our
website into this prospectus or any supplement to this prospectus
and you should not consider any information on, or that can be
accessed through, our website as part of this prospectus or any
supplement to this prospectus (other than those filings with the
SEC that we specifically incorporate by reference into this
prospectus or any supplement to this prospectus).
Any statement contained herein or in a document incorporated or
deemed to be incorporated by reference into this document will be
deemed to be modified or superseded for purposes of the document to
the extent that a statement contained in this document or any other
subsequently filed document that is deemed to be incorporated by
reference into this document modifies or supersedes the
statement.
Notwithstanding the statements in the preceding paragraphs, no
document, report or exhibit (or portion of any of the foregoing) or
any other information that was furnished and deemed by the rules of
the SEC not to have been filed shall be incorporated by reference
into this prospectus.
GENPREX, INC.
3,167,986 Shares of Common Stock
____________________________
PROSPECTUS SUPPLEMENT
November 20, 2019
____________________________
Joseph Gunnar & Co.
Genprex (NASDAQ:GNPX)
Historical Stock Chart
From Dec 2020 to Jan 2021
Genprex (NASDAQ:GNPX)
Historical Stock Chart
From Jan 2020 to Jan 2021
