As filed with the Securities and Exchange Commission on March
28, 2022
Registration No. 333-262614
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
AMENDMENT NO. 1 TO
FORM S-1
REGISTRATION
STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Titan
Pharmaceuticals, Inc.
(Exact
name of Registrant as specified in its charter)
| Delaware |
2836 |
94-3171940 |
| (State or other jurisdiction
of |
(Primary Standard
Industrial |
(I.R.S. Employer |
| incorporation or
organization) |
Classification Code
Number) |
Identification Number) |
400
Oyster Point Blvd., Suite 505
South San Francisco, California 94080
(650) 244-4990
(Address,
including zip code, and telephone number, including area code, of
Registrant’s principal executive offices)
Kate
Beebe DeVarney, Ph.D., President and Chief Operating Officer
Titan Pharmaceuticals, Inc.
400 Oyster Point Blvd., Suite 505
South San Francisco, California 94080
(650) 244-4990
(Name,
address, including zip code, and telephone number, including area
code, of agent for service)
Copies
to:
Fran
Stoller
Loeb & Loeb LLP
345 Park Avenue
New York, New York 10154
Telephone: (212) 407-4000
Approximate
date of commencement of proposed sale to the public: As
soon as practicable after the effective date of this registration
statement.
If
any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to Rule 415
under the Securities Act of 1933, check the following box.
x
If
this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act
of 1933, check the following box and list the Securities Act
registration statement number of the earlier effective registration
statement for the same offering.¨
If
this Form is a post-effective amendment filed pursuant to
Rule 462(c) under the Securities Act of 1933, check the
following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same
offering.¨
If
this Form is a post-effective amendment filed pursuant to
Rule 462(d) under the Securities Act of 1933, check the
following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same
offering.¨
Indicate by check mark whether the Registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,” “accelerated filer”,
“smaller reporting company” and “emerging growth company” in
Rule 12b-2 of the Exchange Act of 1934.
| Large
accelerated filer |
¨ |
Accelerated
filer |
¨ |
| Non-accelerated
filer |
x |
Smaller
reporting company |
x |
|
|
Emerging
growth company |
¨ |
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 7(a)(2)(B) of the Securities
Act. ¨
The Registrant hereby amends this Registration Statement on such
date or dates as may be necessary to delay its effective date until
the Registrant shall file a further amendment which specifically
states that this Registration Statement shall thereafter become
effective in accordance with Section 8(a) of the Securities Act or
until the Registration Statement shall become effective on such
date as the Securities and Exchange Commission, acting pursuant to
Section 8(a), may determine.
The information in this preliminary prospectus is not complete and
may be changed. These securities may not be sold until the
registration statement filed with the Securities and Exchange
Commission is effective. This preliminary prospectus is not an
offer to sell these securities, nor does it seek an offer to buy
these securities in any jurisdiction where the offer or sale is not
permitted.
PRELIMINARY PROSPECTUS, SUBJECT TO COMPLETION, DATED MARCH 28,
2022
6,004,855 shares of common stock
This prospectus of relates to the resale from time to time of up to
6,004,855 shares of our common stock, $0.001 par value per share,
including 5,953,834 issuable upon the exercise of outstanding
warrants held by the selling stockholders named herein (the
“Selling Stockholders”).
The Selling Stockholders may offer the shares of common stock from
time to time directly or through underwriters, broker or dealers
and in one or more public or private transactions at market prices
prevailing at the time of sale, at fixed prices, at negotiated
prices, at various prices determined at the time of sale or at
prices related to prevailing market prices, as further described
herein. If the shares of common stock are sold through
underwriters, broker-dealers or agents, the Selling Stockholders or
purchasers of the shares will be responsible for underwriting
discounts or commissions or agents’ commissions. The timing and
amount of any sale is within the sole discretion of the Selling
Stockholders.
We will not receive any proceeds from the sale of these shares by
the Selling Stockholders.
Our
common stock is listed on The NASDAQ Capital Market under the
symbol “TTNP.” On _____ __, 2022, the last reported sale price of
our common stock on The Nasdaq Capital Market was $__ per
share.
Investing in our common stock involves a high degree of risk.
Before buying any of our securities, you should carefully read
“Risk Factors” on page 4 of this prospectus, and under similar
headings in the other documents that are incorporated by reference
into this prospectus.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
The date of this prospectus is ___________, 2022
TABLE OF CONTENTS
You should rely only on the information contained in or
incorporated by reference into this prospectus. Neither we nor the
Selling Stockholders have authorized, and no underwriter is
expected to authorize, anyone to provide you with information that
is different. This prospectus is not an offer to sell or
solicitation of an offer to buy these securities in any
circumstances under which the offer or solicitation is unlawful.
The Selling Stockholders are offering to sell, and seeking offers
to buy, our securities only in jurisdictions where offers and sales
are permitted. You should not assume that the information we have
included in this prospectus is accurate as of any date other than
the date of this prospectus, or that any information we have
incorporated by reference is accurate as of any date other than the
date of the document incorporated by reference, regardless of the
time of delivery of this prospectus or of any of our securities.
Our business, financial condition, results of operations, and
prospects may have changed since that date.
We further note that the representations, warranties and covenants
made by us in any agreement that is filed as an exhibit to the
registration statement of which this prospectus is a part 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
thereto, 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.
The Titan design logo and the marks “Titan,” “Titan
Pharmaceuticals,” “Probuphine®” and “ProNeura®” are the property of
Titan. This prospectus supplement contains additional trade names,
trademarks and service marks of ours and of other companies. We do
not intend our use or display of other companies’ trade names,
trademarks or service marks to imply a relationship with, or
endorsement or sponsorship of us by, these other companies.
SUMMARY
This summary provides an overview of selected information
contained elsewhere or incorporated by reference in this prospectus
and does not contain all of the information you should consider
before investing in our securities. You should carefully read this
prospectus and the registration statement of which this prospectus
is a part in their entirety before investing in our securities,
including the information discussed under “Risk Factors” and our
financial statements and notes thereto that are incorporated by
reference in this prospectus. Unless otherwise indicated herein,
the terms “Titan,” “we,” “our,” “us,” or “the Company” refer to
Titan Pharmaceuticals, Inc.
Our Company
We are a pharmaceutical company developing therapeutics utilizing
our proprietary long-term drug delivery platform, ProNeura®, for
the treatment of select chronic diseases for which steady state
delivery of a drug has the potential to provide an efficacy and/or
safety benefit. ProNeura consists of a small, solid implant made
from a mixture of ethylene-vinyl acetate, or EVA, and a drug
substance. The resulting product is a solid matrix that is designed
to be administered subdermally in a brief, outpatient procedure and
is removed in a similar manner at the end of the treatment period.
These procedures may be performed by trained health care providers,
or HCPs, including licensed and surgically qualified physicians,
nurse practitioners, and physician’s assistants in a HCP’s office
or other clinical setting.
Our first product based on our ProNeura technology was Probuphine®
(buprenorphine implant), which is approved in the United States,
Canada and the European Union, or EU, for the maintenance treatment
of opioid use disorder in clinically stable patients taking 8 mg or
less a day of oral buprenorphine. While Probuphine continues to be
commercialized in Canada and in the EU (as Sixmo™) by other
companies that have either licensed or acquired the rights from
Titan, we discontinued commercialization of the product in the U.S.
during the fourth quarter of 2020. Discontinuation of our
commercial operations has allowed us to focus our limited resources
on important product development programs and transition back to a
product development company.
ProNeura Continuous Drug Delivery Platform
Our ProNeura continuous drug delivery system consists of a small,
solid rod-shaped implant made from a mixture of EVA and a given
drug substance. The resulting product is a solid matrix that is
placed subdermally, normally in the inside part of the upper arm in
a short physician office-based procedure using a local anesthetic
and is removed in a similar manner at the end of the treatment
period. The drug substance is released continuously through the
process of dissolution-controlled diffusion. This results in a
continuous, steady rate of release generally similar to intravenous
administration. We believe that such long-term, near linear release
characteristics are desirable as they avoid the fluctuating peak
and trough drug levels seen with oral dosing that often poses
treatment problems in a range of diseases.
The ProNeura platform was developed to address the need for a
simple, practical method to achieve continuous long-term drug
delivery, and, depending on the characteristics of the compound to
be delivered, can potentially provide treatment on an outpatient
basis over extended periods of up to 12 months. We believe that the
benefits of this technology have been demonstrated by the clinical
results seen to date with Probuphine, and, in addition, that the
development and regulatory process have been affirmed by the U.S.
Food and Drug Administration, or FDA, the European Medicines
Agency, or EMA, and Health Canada approvals of this product. We
have further demonstrated the feasibility of the ProNeura platform
with small molecules, hormones, and bio-active peptides. The
delivery system works with both hydrophobic and hydrophilic
molecules. We have also shown the flexibility of the platform by
experimenting with the release characteristics of the EVA implants,
layering the implants with varying concentrations of drug, and
generating implants of different sizes and porosity to achieve a
desired delivery profile. We have recently received a grant from
the Bill and Melinda Gates Foundation to undertake preliminary work
on a long-acting implant capable of delivering dual compounds- a
human immunodeficiency virus, or HIV, preventative therapeutic and
a contraceptive for women and girls in developing countries.
Development Programs
Several years ago, we began limited non-clinical laboratory
experiments in collaboration with JT Pharmaceuticals, Inc., or
JT Pharma, to assess the feasibility of delivering JT Pharma’s
kappa opioid agonist peptide, or TP-2021, utilizing our ProNeura
system. We successfully manufactured a prototype implant containing
TP-2021 (TP-2021- ProNeura) to be used in appropriate small animal
models. While our initial work focused on TP-2021’s ability to
activate peripheral kappa opioid receptors, potentially providing a
non-addictive treatment for certain types of pain, in
January 2021, our research pivoted to explore the feasibility
of using TP-2021 in the treatment of chronic pruritus, a severe and
debilitating condition defined as itching of the skin lasting
longer than six weeks. According to a 2015 review by Mollanazar,
N., et al., an estimated 23 – 44 million Americans suffer from
chronic pruritus in the setting of both cutaneous and systemic
conditions. Current treatments include antihistamines,
corticosteroids, and over-the-counter lotions, all of which are
relatively ineffective and/or have undesirable side-effect
profiles. The antipruritic effect of kappa opioid agonists is
thought to be related to their binding to kappa opioid receptors on
keratinocytes, immune cells, and peripheral itch neurons.
In February 2021, we announced that early non-clinical studies
of TP-2021 showed very high affinity and specificity for the human
kappa opioid receptor and demonstrated potent antipruritic activity
when injected subcutaneously in a mouse model for moderate to
severe pruritus. TP-2021 ProNeura implants were then formulated and
tested in this model. In November 2021, data presented at the
annual meeting of the Society for Neuroscience demonstrated that
significant reduction in scratching behavior in this proven animal
model for pruritus was maintained in mice who received the
TP-2021ProNeura implant through Day 56 post-implantation, when
compared with control untreated mice, with no safety issues
observed for the implanted animals over the three-month duration of
treatment. Subsequently, efficacy in this pruritus model has been
extended through Day 84 post-implantation. In addition, the TP-2021
ProNeura implant provided sustained supra-therapeutic plasma levels
of the peptide through Day 84 post-implantation in a separate
pharmacokinetic study in mice. We believe that subdermal
implantation of TP-2021- ProNeura could potentially deliver
therapeutic concentrations of TP-2021 in human subjects for up to
six months or longer following a single in-office procedure. We
will need to conduct Investigational New Drug, or IND, enabling
non-clinical safety and pharmacology studies in preparation for
regulatory approval to enter human clinical studies.
Pursuant to a research and option license agreement with the
Medical University of South Caroline Foundation for Research
Development, we are also synthesizing a limited number of new
peptides designed, like TP-2021, to bind to peripheral kappa opioid
receptors. We will consider further development of any of these
newly synthesized compounds that meet the criteria for
high-affinity receptor bonding and antipruritic activity to enhance
our intellectual property position. We are also assessing the
feasibility of non-implant biodegradable depot formulations of
these kappa opioid receptor agonist peptides to provide
antipruritic activity for shorter (e.g., 1 – 3 months) sustained
periods. We have allocated a substantial portion of the proceeds of
this offering to fund our kappa opioid agonist peptide program
through the IND submission, which we estimate can be accomplished
within 18 to 24 months.
Nalmefene Development Program
In September 2019, the National Institute for Drug Addiction,
or NIDA, awarded us an approximately $8.7 million grant over two
years for our nalmefene implant development program for the
prevention of opioid relapse following detoxification of patients
suffering opioid use disorder, or OUD. An injectable formulation of
nalmefene was approved by the FDA in 1995 for the management and
reversal of opioid overdose, including respiratory depression, but
this is no longer marketed in the U.S. Oral nalmefene was approved
by the EMA in 2013 for treating alcohol dependence. A nasal
formulation of nalmefene is currently in clinical development by
another company for the treatment of opioid overdose.
The NIDA grant provides funds for the completion of implant
formulation development, cGMP manufacturing and non-clinical
studies required for filing an Investigational New Drug
application, or IND. In early 2020, following a meeting with the
FDA to review our non-clinical development plans and obtain
guidance regarding filing an IND, the FDA provided clear guidance
on the type of development plan that we should follow.
Specifically, that this product development should follow the more
expansive 505(b)(1) regulatory pathway rather than the
shorter, more streamlined 505(b)(2) regulatory pathway we had
been pursuing. Based on this input, we determined that collection
of all the requisite non-clinical chronic toxicology data would
require an additional six-month rodent chronic toxicity study and a
three month increase in the duration of an ongoing six-month
non-rodent chronic toxicity study, resulting in a delay of the IND
filing. We discussed the change in development plan with NIDA and
they accepted our plan to reallocate previously approved funds for
conduct of such studies and extended the existing grant term
through August 2022. In September 2021, the FDA advised
that it was reconsidering the regulatory pathway for the nalmefene
implant and could ultimately determine that the
505(b)(2) process is potentially appropriate. We expect to
submit the IND for this program in the second quarter of 2022. If
accepted, we would be eligible for the third through fifth year
grant funding from NIDA. However, this funding availability is
dependent on a progress review at NIDA. Additional funding from
external sources for progression of the clinical program will be
separately sought but will be dependent on finding a suitable
partner.
Other programs
In October 2021, we received an approximately $500,000 grant
from the Bill and Melinda Gates Foundation to demonstrate the
ability to deliver a combination HIV preventative therapeutic and a
contraceptive from a single ProNeura implant for women and
adolescent girls in low- and middle-income countries.
In October 2021, we entered into a research and option license
agreement, or MUSC Agreement, with the MUSC Foundation for Research
Development, or MUSC FRD. Under the terms of the MUSC Agreement, we
will conduct certain research, evaluation, proof of concept
development and testing of at least three tetrapeptide kappa-opioid
receptor agonist compounds related to the provisional U.S. patent
application previously assigned to FRD by the Medical University of
South Carolina (“MUSC”) and entitled “Opioid Agonists and Methods
of Use Thereof.” In exchange, FRD has granted Titan the option to
acquire an exclusive worldwide, commercial license to the
inventions related to MUSC’s compounds.
Corporate Information
We were incorporated under the laws of the State of Delaware in
February 1992. Our principal executive offices are located at
400 Oyster Point Blvd., Suite 505, South San Francisco, CA
94080. Our telephone number is (650) 244-4990.We make our SEC
filings available on the Investor Relations page of our
website, http://titanpharm.com/. Information contained on our
website is not part of this prospectus.
RISK FACTORS
Investing in our securities involves a high degree of risk. You
should carefully consider the risks described below and all of the
information contained or incorporated by reference in this
prospectus. Our business, financial condition, results of
operations and prospects could be materially and adversely affected
by these risks.
Risks Related to This Offering
You may experience future dilution as a result of future equity
offerings and other issuances of our common stock or other
securities. In addition, this offering and future equity offerings
and other issuances of our common stock or other securities may
adversely affect our common stock
price.
In order 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 per share in this offering.
We may not be able to sell shares or other securities in any other
offering at a price per share that is equal to or greater than the
price per share paid by the investor 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 into common stock in future transactions may
be higher or lower than the price per share in this offering. You
will incur dilution upon exercise of any outstanding stock options,
warrants or upon the issuance of shares of common stock under our
stock incentive programs. In addition, the sale of shares in this
offering and any future sales of a substantial number of shares of
our common stock in the public market, or the perception that such
sales may occur, could adversely affect the price of our common
stock. We cannot predict the effect, if any, that market sales of
those shares of common stock or the availability of those shares
for sale will have on the market price of our common stock.
Our share price may be volatile, which could prevent you from
being able to sell your shares at or above your purchase
price.
The market price of shares of our common stock has been and may
continue to be subject to wide fluctuations in response to many
risk factors listed in this section, and others beyond our control,
including:
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results
of our product development efforts; |
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regulatory
actions with respect to our products under development or our
competitors’ products; |
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actual
or anticipated fluctuations in our financial condition and
operating results; |
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actual
or anticipated fluctuations in our competitors’ operating results
or growth rate; |
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announcements
by us, our potential future collaborators or our competitors of
significant acquisitions, strategic collaborations, joint ventures,
or capital commitments; |
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issuance
of new or updated research or reports by securities
analysts; |
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fluctuations
in the valuation of companies perceived by investors to be
comparable to us; |
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inconsistent
trading volume levels of our shares; |
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additions
or departures of key personnel; |
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disputes
or other developments related to proprietary rights, including
patents, litigation matters and our ability to obtain patent
protection for our technologies; |
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announcement
or expectation of additional financing efforts; |
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sales
of our common stock by us, our insiders or our other
stockholders; |
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market
conditions for biopharmaceutical stocks in general; and |
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general
economic and market conditions. |
The stock markets have experienced extreme price and volume
fluctuations that have affected and continue to affect the market
prices of equity securities of many companies. These fluctuations
often have been unrelated or disproportionate to the operating
performance of those companies. These broad market and industry
fluctuations, as well as general economic, political and market
conditions such as recessions, interest rate changes or
international currency fluctuations, may negatively impact the
market price of shares of our common stock and could subject us to
securities class action litigation.
If securities or industry analysts do not publish research or
publish inaccurate or unfavorable research about our business, our
share price and trading volume could decline.
The trading market for our common stock will depend on the research
and reports that securities or industry analysts publish about us
or our business. We do not have any control over these analysts.
There can be no assurance that analysts will cover us or provide
favorable coverage. If one or more of the analysts who cover us
downgrade our stock or change their opinion of our stock, our share
price would likely decline. If one or more of these analysts cease
coverage of our company or fail to regularly publish reports on us,
we could lose visibility in the financial markets, which could
cause our share price or trading volume to decline.
Provisions in our corporate charter documents and under
Delaware law could make an acquisition of our company, which may be
beneficial to our stockholders, more difficult and may prevent
attempts by our stockholders to replace or remove our current
management.
Provisions in our certificate of incorporation and our bylaws may
discourage, delay or prevent a merger, acquisition or other change
in control of our company that stockholders may consider favorable,
including transactions in which you might otherwise receive a
premium for your shares. These provisions could also limit the
price that investors might be willing to pay in the future for
shares of our common stock, thereby depressing the market price of
our common stock. In addition, because our board of directors is
responsible for appointing the members of our management team,
these provisions may frustrate or prevent any attempts by our
stockholders to replace or remove our current management by making
it more difficult for stockholders to replace members of our board
of directors. Among other things, these provisions provide
that:
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the
authorized number of directors can be changed only by resolution of
our board of directors; |
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our
bylaws may be amended or repealed by our board of directors or our
stockholders; |
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stockholders
may not call special meetings of the stockholders or fill vacancies
on the board of directors; |
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our
board of directors is authorized to issue, without stockholder
approval, preferred stock, the rights of which will be determined
at the discretion of the board of directors and that, if issued,
could operate as a “poison pill” to dilute the stock ownership of a
potential hostile acquirer to prevent an acquisition that our board
of directors does not approve; |
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· |
our
stockholders do not have cumulative voting rights, and therefore
our stockholders holding a majority of the shares of common stock
outstanding will be able to elect all of our directors;
and |
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our
stockholders must comply with advance notice provisions to bring
business before or nominate directors for election at a stockholder
meeting. |
Our failure to meet the continued listing requirements of Nasdaq
could result in a de-listing of our common stock.
During 2020, we received several notices from the Listing
Qualifications Department the Nasdaq Stock Market, or Nasdaq,
regarding the fact that the market price of our common stock was
below the $1.00 minimum bid price requirement for continued
listing. As a result of the reverse stock split we effected on
November 30, 2020, we were able to regain compliance with the
minimum bid requirement and remain listed on Nasdaq. We have also
previously received notices of noncompliance due to our failure to
maintain the $2,500,000 minimum stockholders’ equity requirement
for continued listing. We were able to regain compliance with that
requirement through capital raises and our discontinuation of the
expenses associated with Probuphine commercial operations. There
can be no assurance that we will continue to meet all of the
criteria necessary for Nasdaq to allow us to remain listed. For
example, our share price has recently fallen below the $1.00
minimum bid price requirement for continued listing.
If our common stock is delisted from Nasdaq, our common stock would
likely then trade only in the over-the- counter market. If our
common stock were to trade on the over-the-counter market, selling
our common stock could be more difficult because smaller quantities
of shares would likely be bought and sold, transactions could be
delayed, and we could face significant material adverse
consequences, including: a limited availability of market
quotations for our securities; reduced liquidity with respect to
our securities; a determination that our shares are a “penny
stock,” which will require brokers trading in our securities to
adhere to more stringent rules, possibly resulting in a reduced
level of trading activity in the secondary trading market for our
securities; a reduced amount of news and analyst coverage for our
Company; and a decreased ability to issue additional securities or
obtain additional financing in the future. These factors could
result in lower prices and larger spreads in the bid and ask prices
for our common stock and would substantially impair our ability to
raise additional funds and could result in a loss of institutional
investor interest and fewer development opportunities for us.
In addition to the foregoing, if our common stock is delisted from
Nasdaq and it trades on the over-the- counter market, the
application of the “penny stock” rules could adversely affect
the market price of our common stock and increase the transaction
costs to sell those shares. The Securities and Exchange Commission,
or SEC, has adopted regulations which generally define a “penny
stock” as an equity security that has a market price of less than
$5.00 per share, subject to specific exemptions. If our common
stock is delisted from Nasdaq and it trades on the over-the-
counter market at a price of less than $5.00 per share, our common
stock would be considered a penny stock. The SEC’s penny stock
rules require a broker-dealer, before a transaction in a penny
stock not otherwise exempt from the rules, to deliver a
standardized risk disclosure document that provides information
about penny stocks and the risks in the penny stock market. The
broker-dealer must also provide the customer with current bid and
offer quotations for the penny stock, the compensation of the
broker-dealer and the salesperson in the transaction, and monthly
account statements showing the market value of each penny stock
held in the customer’s account. In addition, the penny stock
rules generally require that before a transaction in a penny
stock occurs, the broker-dealer must make a special written
determination that the penny stock is a suitable investment for the
purchaser and receive the purchaser’s agreement to the transaction.
If applicable in the future, these rules may restrict the
ability of brokers-dealers to sell our common stock and may affect
the ability of investors to sell their shares, until our common
stock no longer is considered a penny stock.
Risks Related to Our Business and Industry
Our ProNeura development programs are at very early stages
and will require substantial additional resources that may not be
available to us.
To date, other than our work on Probuphine in OUD, and our work on
nalmefene, we have conducted only limited research and development
activities assessing our ProNeura delivery system’s applicability
in other potential indications. While the nalmefene program is
being funded in large part by NIDA, there is no assurance that NIDA
will continue to provide the necessary funding to complete the
regulatory approval process for this product candidate. We will
also require substantial additional funds to advance our
kappa opioid agonist program beyond the proof-of-concept stage and
to support further research and
development activities, including the anticipated costs of
nonclinical studies and clinical trials, regulatory approvals, and
eventual commercialization of any therapeutic based on our ProNeura
platform technology. If we are unable to obtain substantial
government grants or enter into third party collaborations to fund
our ProNeura programs, we will need to seek additional sources of
financing, which may not be available on favorable terms, if at
all. If we are unsuccessful in obtaining the requisite funding for
our ProNeura programs, we could be forced to discontinue product
development. Furthermore, funding arrangements with collaborative
partners or others may require us to relinquish rights to
technologies, product candidates or products that we would
otherwise seek to develop or commercialize ourselves or license
rights to technologies, product candidates or products on terms
that are less favorable to us than might otherwise be
available.
Our ability to successfully develop any future product candidates
based on our ProNeura drug delivery technology is subject to the
risks of failure and delay inherent in the development of new
pharmaceutical products, including: delays in product development,
clinical testing, or manufacturing; unplanned expenditures in
product development, clinical testing, or manufacturing; failure to
receive regulatory approvals; emergence of superior or equivalent
products; inability to manufacture on our own, or through any
others, product candidates on a commercial scale; and failure to
achieve market acceptance. Because of these risks, our research and
development efforts may not result in any commercially viable
products and our business, financial condition, and results of
operations could be materially harmed.
Clinical trials required for new product candidates are expensive
and time-consuming, and their outcome is
uncertain.
Conducting clinical trials is a lengthy, time-consuming, and
expensive process. The length of time may vary substantially
according to the type, complexity, novelty, and intended use of the
product candidate, and often can be several years or more per
trial. Delays associated with products for which we are directly
conducting clinical trials may cause us to incur additional
operating expenses. The commencement and rate of completion of
clinical trials may be delayed by many factors, including, for
example:
| |
• |
inability
to manufacture sufficient quantities of qualified materials under
cGMP for use in clinical trials; |
| |
• |
slower
than expected rates of patient recruitment; |
| |
• |
failure
to recruit a sufficient number of patients; modification of
clinical trial protocols; |
| |
• |
changes
in regulatory requirements for clinical trials; |
| |
• |
the
lack of effectiveness during clinical trials; |
| |
• |
the
emergence of unforeseen safety issues; |
|
• |
delays,
suspension, or termination of the clinical trials due to the
institutional review board responsible for overseeing the study at
a particular study site; and |
| |
• |
government
or regulatory delays or “clinical holds” requiring suspension or
termination of the trials. |
The results from early clinical trials are not necessarily
predictive of results obtained in later clinical trials.
Accordingly, even if we obtain positive results from early clinical
trials, we may not achieve the same success in future clinical
trials. Clinical trials may not demonstrate statistically
significant safety and effectiveness to obtain the requisite
regulatory approvals for product candidates. The failure of
clinical trials to demonstrate safety and effectiveness for the
desired indications could cause us to abandon a product candidate
and could delay development of other product candidates. Any delay
in, or termination of, our clinical trials could materially harm
our business, financial condition, and results of operations.
We face risks associated with third parties conducting preclinical
studies and clinical trials of our
products.
We depend on third-party laboratories and medical institutions to
conduct preclinical studies and clinical trials for our products
and other third-party organizations to perform data collection and
analysis, all of which must maintain both good laboratory and good
clinical practices. We also depend upon third party manufacturers
for the production of any products we may successfully develop to
comply with cGMP of the FDA, which are similarly outside our direct
control. If third party laboratories and medical institutions
conducting studies of our products fail to maintain both good
laboratory and clinical practices, the studies could be delayed or
have to be repeated.
We face risks associated with product liability lawsuits that could
be brought against us.
The testing, manufacturing, marketing and sale of human therapeutic
products entail an inherent risk of product liability claims. We
currently have a limited amount of product liability insurance,
which may not be sufficient to cover claims that may be made
against us in the event that the use or misuse of our product
candidates causes, or merely appears to have caused, personal
injury or death. In the event we are forced to expend significant
funds on defending product liability actions, and in the event
those funds come from operating capital, we will be required to
reduce our business activities, which could lead to significant
losses. Adequate insurance coverage may not be available in the
future on acceptable terms, if at all. If available, we may not be
able to maintain any such insurance at sufficient levels of
coverage and any such insurance may not provide adequate protection
against potential liabilities. Whether or not a product liability
insurance policy is obtained or maintained in the future, any
claims against us, regardless of their merit, could severely harm
our financial condition, strain our management and other resources
or destroy the prospects for commercialization of the product which
is the subject of any such claim.
We may be unable to protect our patents and proprietary
rights.
Our future success will depend to a significant extent on our
ability to:
| |
• |
obtain
and keep patent protection for our products, methods and
technologies on a domestic and international basis; |
| |
• |
enforce
our patents to prevent others from using our
inventions; |
| |
• |
maintain
and prevent others from using our trade secrets; and |
| |
• |
operate
and commercialize products without infringing on the patents or
proprietary rights of others. |
We cannot assure you that our patent rights will afford any
competitive advantages, and these rights may be challenged or
circumvented by third parties. Further, patents may not be issued
on any of our pending patent applications in the U.S. or abroad.
Because of the extensive time required for development, testing and
regulatory review of a potential product, it is possible that
before a potential product can be commercialized, any related
patent may expire or remain in existence for only a short period
following commercialization, reducing or eliminating any advantage
of the patent. If we sue others for infringing our patents, a court
may determine that such patents are invalid or unenforceable. Even
if the validity of our patent rights is upheld by a court, a court
may not prevent the alleged infringement of our patent rights on
the grounds that such activity is not covered by our patent
claims.
In addition, third parties may sue us for infringing their patents.
In the event of a successful claim of infringement against us, we
may be required to:
| |
• |
pay
substantial damages; |
| |
• |
stop
using our technologies and methods; |
| |
• |
stop
certain research and development efforts; |
| |
• |
develop
non-infringing products or methods; and |
| |
• |
obtain
one or more licenses from third parties. |
If required, we cannot assure you that we will be able to obtain
such licenses on acceptable terms, or at all. If we are sued for
infringement, we could encounter substantial delays in development,
manufacture and commercialization of our product candidates. Any
litigation, whether to enforce our patent rights or to defend
against allegations that we infringe third party rights, will be
costly, time consuming, and may distract management from other
important tasks.
We also rely in our business on trade secrets, know-how and other
proprietary information. We seek to protect this information, in
part, through the use of confidentiality agreements with employees,
consultants, advisors and others. Nonetheless, we cannot assure you
that those agreements will provide adequate protection for our
trade secrets, know-how or other proprietary information and
prevent their unauthorized use or disclosure. To the extent that
consultants, key employees or other third parties apply
technological information independently developed by them or by
others to our proposed products, disputes may arise as to the
proprietary rights to such information, which may not be resolved
in our favor.
We must comply with extensive government
regulations.
The research, development, manufacture, labeling, storage,
record-keeping, advertising, promotion, import, export, marketing
and distribution of pharmaceutical products are subject to an
extensive regulatory approval process by the FDA in the U.S. and
comparable health authorities in foreign markets. The process of
obtaining required regulatory approvals for drugs is lengthy,
expensive and uncertain. Approval policies or regulations may
change, and the FDA and foreign authorities have substantial
discretion in the pharmaceutical approval process, including the
ability to delay, limit or deny approval of a product candidate for
many reasons. Despite the time and expense invested in clinical
development of product candidates, regulatory approval is never
guaranteed. Regulatory approval may entail limitations on the
indicated usage of a drug, which may reduce the drug’s market
potential. Even if regulatory clearance is obtained, post-market
evaluation of the products, if required, could result in
restrictions on a product’s marketing or withdrawal of the product
from the market, as well as possible civil and criminal sanctions.
Of the large number of drugs in development, only a small
percentage successfully complete the regulatory approval process
and are commercialized.
We face intense competition.
With respect to our product development programs, we face
competition from numerous companies that currently market, or are
developing, products for the treatment of the diseases and
disorders we have targeted, many of which have significantly
greater research and development capabilities, experience in
obtaining regulatory approvals and manufacturing, marketing,
financial and managerial resources than we have. We also compete
with universities and other research institutions in the
development of products, technologies and processes, as well as the
recruitment of highly qualified personnel. Our competitors may
succeed in developing technologies or products that are more
effective than the ones we have under development or that render
our proposed products or technologies noncompetitive or obsolete.
In addition, our competitors may achieve product commercialization
or patent protection earlier than we will.
We depend on a small number of employees and
consultants.
We are highly dependent on the services of a limited number of
personnel and the loss of one or more of such individuals could
substantially impair our ongoing commercialization efforts. We
compete in our hiring efforts with other pharmaceutical and
biotechnology companies, and it may be difficult and could take an
extended period of time because of the limited number of
individuals in our industry with the range of skills and experience
required and because of our limited resources.
In addition, we retain scientific and clinical advisors and
consultants to assist us in all aspects of our business.
Competition to hire and retain consultants from a limited pool is
intense. Further, because these advisors are not our employees,
they may have commitments to, or consulting or advisory contracts
with, other entities that may limit their availability to us, and
typically they will not enter into non-compete agreements with us.
If a conflict of interest arises between their work for us and
their work for another entity, we may lose their services. In
addition, our advisors may have arrangements with other companies
to assist those companies in developing products or technologies
that may compete with ours.
We face potential liability related to the privacy of health
information we obtain from clinical trials sponsored by us or our
collaborators, from research institutions and our collaborators,
and directly from individuals.
Numerous federal and state laws, including state security breach
notification laws, state health information privacy laws, and
federal and state consumer protection laws, govern the collection,
use, and disclosure of personal information. In addition, most
health care providers, including research institutions from which
we or our collaborators obtain patient health information, are
subject to privacy and security regulations promulgated under the
Health Insurance Portability and Accountability Act of 1996, or
HIPAA, as amended by the Health Information Technology for Economic
and Clinical Health Act. Although we are not directly subject to
HIPAA, we could potentially be subject to criminal penalties if we,
our affiliates, or our agents knowingly obtain or disclose
individually identifiable health information maintained by a
HIPAA-covered entity in a manner that is not authorized or
permitted by HIPAA.
We face risks related to health epidemics, such as the current
COVID-19 global pandemic, that could adversely affect our
operations or financial results.
The spread of COVID-19, the novel coronavirus, including
restrictions on travel, “shelter in place” orders, and quarantine
policies put into place by businesses and state and local
governments to mitigate its transmission, may have a material
adverse effect on our business. While the duration of the pandemic
and its potential economic impact are difficult to predict, it
already has caused significant disruption in the healthcare
industry and is likely to have continuing impacts as it continues.
The travel restrictions, “shelter in place” orders, quarantine
policies, and general concerns about the spread of COVID-19 was a
significant factor in our decision to wind down our commercial
operations because of the resulting disruptions in the delivery of
healthcare to patients, our sales and marketing efforts and REMS
training activities, as well as the operations of the various parts
of our supply and distribution chain. The ultimate impact of the
COVID-19 pandemic, or any other health epidemic, is highly
uncertain and subject to change. We do not yet know the full extent
of potential impacts on our business, healthcare systems or the
global economy as a whole. As the pandemic continues, it may result
in a sustained economic downturn that could affect our ability to
access capital on reasonable terms, or at all.
We are increasingly dependent on information technology
systems, infrastructure and data. Cybersecurity breaches could
expose us to liability, damage our reputation, compromise our
confidential information or otherwise adversely affect our
business.
We are increasingly dependent upon information technology systems,
infrastructure and data. Our computer systems may be vulnerable to
service interruption or destruction, malicious intrusion and random
attack. Security breaches pose a risk that sensitive data,
including intellectual property, trade secrets or personal
information may be exposed to unauthorized persons or to the
public. Cyber-attacks are increasing in their frequency,
sophistication and intensity, and have become increasingly
difficult to detect. Cyber-attacks could include the deployment of
harmful malware, denial-of service, social engineering and other
means to affect service reliability and threaten data
confidentiality, integrity and availability. Our key business
partners face similar risks, and a security breach of their systems
could adversely affect our security posture. While we continue to
invest in data protection and information technology, there can be
no assurance that our efforts will prevent service interruptions,
or identify breaches in our systems, that could adversely affect
our business and operations and/or result in the loss of critical
or sensitive information, which could result in financial, legal,
business or reputational harm.
Risks Related to Our Financial Condition and Need for Additional
Capital
We have incurred net losses in almost every year since our
inception, which losses will continue for the foreseeable
future.
We have incurred net losses in almost every year since our
inception. Our financial statements have been prepared assuming
that we will continue as a going concern. For the years ended
December 31, 2021 and 2020, we had net losses of approximately $8.8
million and $18.2 million, respectively, and had net cash used in
operating activities of approximately $7.9 million and $17.2
million, respectively. These net losses and negative cash flows
have had, and will continue to have, an adverse effect on our
stockholders’ equity and working capital. We expect to continue to
incur net losses and negative operating cash flow for the
foreseeable future as we focus on development of ProNeura based
products. The amount of future net losses will depend, in part, on
the rate of future growth of our expenses and our ability to obtain
government or third-party funding for our development programs.
We will require additional proceeds to fund our product
development programs and working capital requirements.
We currently estimate that our available cash and cash equivalents
will be sufficient to fund our working capital needs and product
development efforts only to the end of the third quarter of 2022.
We will require additional funds to advance our kappa opioid
agonist program beyond the proof-of-concept stage, and to fund any
of our ProNeura development programs, including nalmefene, into the
clinic and to complete the regulatory approval process necessary to
commercialize any products we might develop. While we are currently
evaluating the alternatives available to us, including government
grants, third-party collaborations for one or more of our ProNeura
programs and potential merger opportunities, our efforts to address
our liquidity requirements may not be successful. Furthermore,
there can be no assurance that any source of capital will be
available to us on acceptable terms. or will not involve
substantial dilution to our stockholders. Our failure to obtain
substantial funds in the next several months would likely result in
the cessation of one or more of our development programs or the
wind-down of our business.
Our net operating losses and research and development tax
credits may not be available to reduce future federal and state
income tax payments.
At December 31, 2021, we had federal net operating loss and tax
credit carryforwards of approximately $258.9 million and
approximately $7.5 million, respectively, and state net operating
loss and tax credit carryforwards of approximately $110.6 million
and approximately $9.2 million, respectively, available to offset
future taxable income, if any. Current federal and state tax laws
include substantial restrictions on the utilization of net
operating loss and tax credits in the event of an ownership change
and we cannot assure you that our net operating loss and tax
carryforwards will continue to be available.
CAUTIONARY NOTE REGARDING
FORWARD-LOOKING STATEMENTS
This prospectus contains “forward-looking statements” that involve
substantial risks and uncertainties. All statements other than
statements of historical facts contained in this prospectus,
including statements regarding our future results of operations and
financial position, strategy and plans, and our expectations for
future operations, are 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.
We have attempted to identify forward-looking statements by
terminology including “anticipates,” “believes,” “can,” “continue,”
“could,” “estimates,” “expects,” “intends,” “may,” “plans,”
“potential,” “predicts,” “should,” or “will” or the negative of
these terms or other comparable terminology. Although we do not
make forward looking statements unless we believe we have a
reasonable basis for doing so, we cannot guarantee their accuracy.
Forward-looking statements included or incorporated by reference in
this prospectus or our other filings with the Securities and
Exchange Commission, or the SEC, include, but are not necessarily
limited to, those relating to uncertainties relating to:
|
· |
our ability to raise capital when
needed; |
|
· |
difficulties or delays in the product
development process, including the results of preclinical studies
or clinical trials; |
|
· |
financing and strategic agreements and
relationships; |
|
· |
difficulties or delays in the
regulatory approval process; |
|
· |
adverse side effects or inadequate
therapeutic efficacy of our drug candidates that could slow or
prevent product development or commercialization; |
|
· |
dependence on third party
suppliers; |
|
· |
uncertainties relating to
manufacturing, sales, marketing and distribution of our drug
candidates that may be successfully developed and approved for
commercialization; |
|
· |
the uncertainty of protection for our
patents and other intellectual property or trade secrets; and |
|
· |
competition. |
These statements are only predictions and involve known and unknown
risks, uncertainties and other factors, including the risks
outlined under “Risk Factors” or elsewhere in this prospectus,
which may cause our or our industry’s actual results, levels of
activity, performance or achievements expressed or implied by these
forward-looking statements.
Forward-looking statements should not be read as a guarantee of
future performance or results, and will not necessarily be accurate
indications of the times at, or by which, that performance or those
results will be achieved. Forward-looking statements are based on
information available at the time they are made and/or management’s
good faith belief as of that time with respect to future events,
and are subject to risks and uncertainties that could cause actual
performance or results to differ materially from what is expressed
in or suggested by the forward-looking statements.
Forward-looking statements speak only as of the date they are made.
You should not put undue reliance on any forward-looking
statements. We assume no obligation to update forward-looking
statements to reflect actual results, changes in assumptions or
changes in other factors affecting forward-looking information,
except to the extent required by applicable securities laws. If we
do update one or more forward-looking statements, no inference
should be drawn that we will make additional updates with respect
to those or other forward-looking statements. We caution you not to
give undue weight to such projections, assumptions and
estimates.
USE OF PROCEEDS
We will not receive any of the proceeds from the sale of shares of
common stock by the Selling Stockholders. However, to the extent
that the Private Warrants (as defined herein under “Selling
Stockholders”) are exercised for cash, we will receive proceeds up
to an aggregate of $5,317,000. We intend to use any cash proceeds
received from exercise of the Private Warrants for working capital
and other general corporate purposes.
DIVIDEND POLICY
We have never declared or paid cash dividends on our common stock.
We currently intend to retain all available funds and any future
earnings for use in the operation of our business and do not
anticipate paying any cash dividends in the foreseeable future. Any
future determination to declare cash dividends will be made at the
discretion of our board of directors and will depend on our
financial condition, results of operations, capital requirements,
general business conditions and other factors that our board of
directors may deem relevant.
SELLING
STOCKHOLDERS
On February 2, 2022, we entered into a Securities Purchase
Agreement with a single institutional investor (the “Purchaser”)
pursuant to which we issued pre-funded warrants to purchase an
aggregate of 1,289,796 shares of common stock at an exercise price
of $0.001 per share (the “Private Pre-Funded Warrants”) and
warrants to purchase an aggregate of 4,664,038 shares of common
stock at an exercise price of $1.14 (the “Private Warrants” and
together with the Private Pre-Funded Warrants, the “Placement
Warrants””). The Private Warrants are exercisable until
August 4, 2027.
In February 2022, we issued shares to JT Pharma pursuant to
the asset purchase agreement upon the achievement of a clinical
milestone.
We agreed to register the shares of common stock issued to JT
Pharma and the shares of common stock issuable upon exercise of the
Placement Warrants to permit the Selling Stockholders and their
respective pledgees, donees, transferees and other
successors-in-interest that receive their shares from the Selling
Stockholders as a gift, partnership distribution or other non-sale
related transfer after the date of this prospectus to resell the
shares when and as they deem appropriate in the manner described in
the “Plan of Distribution.”
The information set forth in the following table regarding the
beneficial ownership after resale of shares of common stock is
based upon information provided by the Selling Stockholders and the
assumption that the Purchaser will exercise the Placement Warrants
in full and sell all of the underlying shares of common stock
covered by this prospectus.
|
Name of Selling Stockholder |
|
Shares of
common stock
beneficially
owned prior to
offering |
|
|
Maximum
number of
shares of
common
stock to be
sold |
|
|
Number of
shares of
common
stock owned
after offering |
|
|
Percentage
ownership
after
offering |
| Armistice
Capital Master Fund Ltd.(1) |
|
|
8,430,736 |
(2) |
|
|
5,953,834 |
|
|
|
2,476,902 |
|
|
(2) |
| JT
Pharmaceuticals, Inc. |
|
|
51,021 |
(3) |
|
|
51,021 |
|
|
|
— |
|
|
* |
* Less than 1%
|
(1) |
The securities are directly held by Armistice Capital Master
Fund Ltd. (the “Master Fund”), a Cayman Islands exempted company,
and may be deemed to be indirectly beneficially owned by Armistice
Capital, LLC (“Armistice”), as the investment manager of the Master
Fund; and (ii) Steven Boyd, as the Managing Member of Armistice
Capital. Armistice and Steven Boyd disclaim beneficial ownership of
the reported securities except to the extent of their respective
pecuniary interest therein. The address of the Master Fund is c/o
Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY
10022. |
| |
|
|
| |
(2) |
Includes 1,300,000 shares underlying registered pre-funded
warrants, the shares underlying the Placement Warrants being
registered for resale hereby and 50,000 shares underlying other
warrants. The warrants are each subject to certain beneficial
ownership limitations that prohibit the Master Fund from exercising
any portion thereof if, following the exercise, the Master Fund’s
ownership of our common stock would exceed the relevant warrant’s
ownership limitation of either 4.99% or 9.99%. |
|
(3) |
Does not include shares held by James McNab, a member of our
board. Mr. McNab is a principal of JT Pharma and has voting
and dispositive power with respect to these shares. |
PLAN OF
DISTRIBUTION
The Selling Stockholders will act independently of our company in
making their decisions with respect to the timing, manner and size
of any sales. The Selling Stockholders and any of their respective
pledgees, donees, transferees or other successors-in-interest may,
from time to time, sell any or all of the shares of common stock
beneficially owned by them and offered hereby directly or through
one or more broker-dealers or agents. The Selling Stockholders will
be responsible for commissions charged by such broker-dealers or
agents. Such shares of common stock may be sold in one or more
transactions at fixed prices, at prevailing market prices at the
time of the sale, at varying prices determined at the time of sale,
or at negotiated prices.
Each Selling Stockholder may use any one or more of the following
methods when selling shares:
• through underwriters, brokers or
dealers (who may act as agent or principal and who may receive
compensation in the form of discounts, concessions or commissions
from the Selling Stockholder, the purchaser or such other persons
who may be effecting such sales) for resale to the public or to
institutional investors at various times;
• through negotiated transactions,
including, but not limited to, block trades in which the broker or
dealer so engaged will attempt to sell the shares as agent but may
position and resell a portion of the block as principal to
facilitate the transaction;
• through purchases by a broker or
dealer as principal and resale by that broker or dealer for its
account;
• on any national securities exchange
or quotation service on which the shares may be listed or quoted at
the time of sale at market prices prevailing at the time of sale,
at prices related to such prevailing market prices, or at
negotiated prices;
• in private transactions other than
exchange or quotation service transactions;
• short sales, purchases or sales of
put, call or other types of options, forward delivery contracts,
swaps, offerings of structured equity-linked securities or other
derivative transactions or securities;
• transactions with a broker-dealer
or its affiliate, whereby the broker-dealer or its affiliate will
engage in short sales of shares and may use shares to close out its
short position;
• options or other types of
transactions that require the delivery of shares to a broker-dealer
or an affiliate thereof, who will then resell or transfer the
shares;
• loans or pledges of shares to a
broker-dealer or an affiliate, who may sell the loaned shares or,
in an event of default in the case of a pledge, sell the pledged
shares;
• through offerings of securities
exercisable, convertible or exchangeable for shares, including,
without limitation, securities issued by trusts, investment
companies or other entities;
• offerings directly to one or more
purchasers, including institutional investors;
• through ordinary brokerage
transactions and transactions in which a broker solicits
purchasers;
• through distribution to the
security holders of the Selling Stockholder;
• through a combination of any such
methods of sale; or
• through any other method permitted
under applicable law.
Additionally, the Selling Stockholders may resell all or a portion
of its shares in open market transactions in reliance upon
Rule 144 under the Securities Act, provided that it meets the
criteria and conforms to the requirements of Rule 144.
The Selling Stockholders may be deemed to be statutory underwriters
under the Securities Act. In addition, any other broker-dealers who
act in connection with the sale of the shares hereunder may be
deemed to be “underwriters” within the meaning of
Section 2(11) of the Securities Act, and any commissions
received by them and profit on any resale of the shares as
principal may be deemed to be underwriting discounts and
commissions under the Securities Act. Any other broker-dealers
engaged by the Selling Stockholders may arrange for other
brokers-dealers to participate in sales. Such broker-dealers and
any other participating broker-dealers may, in connection with such
sales, be deemed to be underwriters within the meaning of the
Securities Act. If the Selling Stockholders effect such
transactions through underwriters, broker-dealers or agents, such
underwriters, broker-dealers or agents may receive commissions in
the form of discounts, concessions or commissions from such Selling
Stockholders or commissions from purchasers of the shares of common
stock for whom they may act as agent or to whom they may sell as
principal, or both (which discounts, concessions or commissions as
to particular underwriters, broker-dealers or agents may be less
than or in excess of those customary in the types of transactions
involved). Any discounts or commissions received by any such
broker-dealers may be deemed to be underwriting discounts and
commissions under the Securities Act.
There can be no assurance that the Selling Stockholders will sell
any or all of the shares of common stock registered pursuant to the
registration statement of which this prospectus forms a part.
We are not aware of any plans, arrangements or understandings
between the Selling Stockholders and any other underwriter,
broker-dealer or agent regarding the sale of shares of common stock
by the Selling Stockholders.
We will pay all expenses incident to the filing of this
registration statement. These expenses include accounting and legal
fees in connection with the preparation of the registration
statement of which this prospectus form a part, legal and other
fees in connection with the qualification of the sale of the shares
under the laws of certain states (if any), registration and filing
fees and other expenses.
LEGAL MATTERS
The validity of the shares of common stock offered hereby will be
passed upon for us by Loeb & Loeb LLP, New York, New
York.
EXPERTS
The financial statements as of and for the years ended
December 31, 2021 and 2020 incorporated by reference in this
prospectus constituting a part of the registration statement on
Form S-1 have been so incorporated in reliance on the report
of WithumSmith+Brown, formerly OUM & Co. LLP, an
independent registered public accounting firm, incorporated herein
by reference, given on the authority of said firm as experts in
auditing and accounting.
WHERE YOU CAN FIND ADDITIONAL
INFORMATION
We have filed with the Securities and Exchange Commission a
registration statement on Form S-1 under the Securities Act
with respect to the securities offered by this prospectus. This
prospectus, which is part of the registration statement, omits
certain information, exhibits, schedules and undertakings set forth
in the registration statement. For further information pertaining
to us and the securities offered hereby, reference is made to the
registration statement and the exhibits and schedules to the
registration statement. Statements contained in this prospectus as
to the contents or provisions of any documents referred to in this
prospectus are not necessarily complete, and in each instance where
a copy of the document has been filed as an exhibit to the
registration statement, reference is made to the exhibit for a more
complete description of the matters involved.
You may read and copy all or any portion of the registration
statement without charge at the public reference room of the
Securities and Exchange Commission at 100 F Street, N.E.,
Washington, D.C. 20549. Copies of the registration statement may be
obtained from the Securities and Exchange Commission at prescribed
rates from the public reference room of the Securities and Exchange
Commission at such address. You may obtain information regarding
the operation of the public reference room by calling
1-800-SEC-0330. In addition, registration statements and certain
other filings made with the Securities and Exchange Commission
electronically are publicly available through the Securities and
Exchange Commission’s website at www.sec.gov. The registration
statement, including all exhibits and amendments to the
registration statement, has been filed electronically with the
Securities and Exchange Commission. You may also read all or any
portion of the registration statement and certain other filings
made with the Securities and Exchange Commission on our website at
www.heatbio.com. The information contained in, and that can be
accessed through, our website is not incorporated into and is not
part of this prospectus.
We are subject to the information and periodic reporting
requirements of the Exchange Act and, accordingly, are required to
file annual reports containing financial statements audited by an
independent public accounting firm, quarterly reports containing
unaudited financial data, current reports, proxy statements and
other information with the Securities and Exchange Commission. You
will be able to inspect and copy such periodic reports, proxy
statements and other information at the Securities and Exchange
Commission’s public reference room, the website of the Securities
and Exchange Commission referred to above, and our website at
www.titanpharm.com. Except for the specific incorporated reports
and documents listed above, no information available on or through
our website shall be deemed to be incorporated in this prospectus
or the registration statement of which it forms a part.
INCORPORATION OF CERTAIN
DOCUMENTS BY REFERENCE
The SEC allows us to “incorporate by reference” into this
prospectus 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, and later information that we
file with the SEC will automatically update and supersede some of
this information. We incorporate by reference the documents listed
below and any future filings we make with the SEC under
Section 13(a), 13(c), 14 or 15(d) of the Exchange Act,
including filings made after the date of the initial registration
statement, until we sell all of the shares covered by this
prospectus or the sale of shares by us pursuant to this prospectus
is terminated. In no event, however, will any of the information
that we furnish to, pursuant to Item 2.02 or Item 7.01 of any
Current Report on Form 8-K (including exhibits related
thereto) or other applicable SEC rules, rather than file with, the
SEC be incorporated by reference or otherwise be included herein,
unless such information is expressly incorporated herein by a
reference in such furnished Current Report on Form 8-K or
other furnished document. The documents we incorporate by reference
are:
Any statement contained in a document incorporated or deemed to be
incorporated by reference into this prospectus will be deemed to be
modified or superseded for purposes of this prospectus to the
extent that a statement contained in this prospectus or any other
subsequently filed document that is deemed to be incorporated by
reference into this prospectus modifies or supersedes the
statement. Any statement so modified or superseded will not be
deemed, except as so modified or superseded, to constitute a part
of this prospectus.
We will provide each person to whom a prospectus is delivered a
copy of all of the information that has been incorporated by
reference in this prospectus but not delivered with the prospectus.
You may obtain copies of these filings, at no cost, through the
“Investor Relations” section of our website (www.titanpharm.com)
and you may request a copy of these filings (other than an exhibit
to any filing unless we have specifically incorporated that exhibit
by reference into the filing), at no cost, by writing or
telephoning us at the following address:
400 Oyster Point Boulevard, Suite 505
South San Francisco, CA 94080
(650) 244-4990
Information on, or that can be accessed through, our website is not
incorporated into this prospectus or other securities filings and
is not a part of these filings.
PART II - INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution
We estimate that expenses in connection with the distribution
described in this registration statement (other than fees and
commissions charged by the underwriters) will be as set forth
below. We will pay all of the expenses with respect to the
distribution, and such amounts, with the exception of the SEC
registration fee and the Financial Industry Regulatory
Authority, Inc., or FINRA, filing fee, are estimates.
|
SEC registration fee |
|
$ |
685 |
|
| Legal
fees and expenses |
|
|
25,000 |
|
|
Accounting fees and expenses |
|
|
12,000 |
|
|
Printing expenses |
|
|
10,000 |
|
|
Other (including transfer agent and registrar fees) |
|
|
2,315 |
|
|
Total |
|
$ |
50,000 |
|
Item 14. Indemnification of Directors and Officers
Subsection (a) of Section 145 of the General Corporation
Law of the State of Delaware, or DGCL, empowers a corporation to
indemnify any person who was or is a party or who is threatened to
be made a party to any threatened, pending or completed action,
suit or proceeding, whether civil, criminal, administrative or
investigative (other than an action by or in the right of the
corporation) by reason of the fact that the person is or was a
director, officer, employee or agent of the corporation, or is or
was serving at the request of the corporation as a director,
officer, employee or agent of another corporation, partnership,
joint venture, trust or other enterprise, against expenses
(including attorneys’ fees), judgments, fines and amounts paid in
settlement actually and reasonably incurred by the person in
connection with such action, suit or proceeding if the person acted
in good faith and in a manner the person reasonably believed to be
in or not opposed to the best interests of the corporation, and,
with respect to any criminal action or proceeding, had no
reasonable cause to believe the person’s conduct was unlawful.
Subsection (b) of Section 145 empowers a corporation to
indemnify any person who was or is a party or is threatened to be
made a party to any threatened, pending or completed action or suit
by or in the right of the corporation to procure a judgment in its
favor by reason of the fact that the person acted in any of the
capacities set forth above, against expenses (including attorneys’
fees) actually and reasonably incurred by the person in connection
with the defense or settlement of such action or suit if the person
acted in good faith and in a manner the person reasonably believed
to be in or not opposed to the best interests of the corporation,
except that no indemnification shall be made in respect of any
claim, issue or matter as to which such person shall have been
adjudged to be liable to the corporation unless and only to the
extent that the Court of Chancery or the court in which such action
or suit was brought shall determine upon application that, despite
the adjudication of liability but in view of all the circumstances
of the case, such person is fairly and reasonably entitled to
indemnity for such expenses which the Court of Chancery or such
other court shall deem proper.
Section 145 further provides that to the extent a director or
officer of a corporation has been successful on the merits or
otherwise in the defense of any action, suit or proceeding referred
to in subsections (a) and (b) of Section 145, or in
defense of any claim, issue or matter therein, such person shall be
indemnified against expenses (including attorneys’ fees) actually
and reasonably incurred by such person in connection therewith;
that indemnification provided for by Section 145 shall not be
deemed exclusive of any other rights to which the indemnified party
may be entitled; and the indemnification provided for by
Section 145 shall, unless otherwise provided when authorized
or ratified, continue as to a person who has ceased to be a
director, officer, employee or agent and shall inure to the benefit
of such person’s heirs, executors and administrators.
Section 145 also empowers the corporation to purchase and
maintain insurance on behalf of any person who is or was a
director, officer, employee or agent of the corporation, or is or
was serving at the request of the corporation as a director,
officer, employee or agent of another corporation, partnership,
joint venture, trust or other enterprise against any liability
asserted against such person and incurred by such person in any
such capacity, or arising out of his status as such, whether or not
the corporation would have the power to indemnify such person
against such liabilities under Section 145.
Section 102(b)(7) of the DGCL provides that a
corporation’s certificate of incorporation may contain a provision
eliminating or limiting the personal liability of a director to the
corporation or its stockholders for monetary damages for breach of
fiduciary duty as a director, provided that such provision shall
not eliminate or limit the liability of a director (i) for any
breach of the director’s duty of loyalty to the corporation or its
stockholders, (ii) for acts or omissions not in good faith or
which involve intentional misconduct or a knowing violation of law,
(iii) under Section 174 of the DGCL, or (iv) for any
transaction from which the director derived an improper personal
benefit.
Our certificate of incorporation and our bylaws provide that we
will indemnify our directors and officers to the fullest extent
permitted by the DGCL, which prohibits our certificate of
incorporation from limiting the liability of our directors for the
following:
|
· |
any breach of the director’s duty of
loyalty to us or our stockholders; |
|
· |
acts or omissions not in good faith or
that involve intentional misconduct or a knowing violation of
law; |
|
· |
unlawful payment of dividends or
unlawful stock repurchases or redemptions; or |
|
· |
any transaction from which the
director derived an improper benefit. |
Our certificate of incorporation provides for indemnification of
our directors and executive officers to the maximum extent
permitted by the DGCL, and our bylaws provide for indemnification
of our directors and executive officers to the maximum extent
permitted by the DGCL.
We have entered into indemnification agreements with each of our
current directors. These agreements will require us to indemnify
these individuals to the fullest extent permitted under Delaware
law against liabilities that may arise by reason of their service
to us and to advance expenses incurred as a result of any
proceeding against them as to which they could be indemnified. We
also intend to enter into indemnification agreements with our
future directors and executive officers.
In any underwriting agreement we enter into in connection with the
sale of common stock and pre-funded warrants being registered
hereby, the underwriters will agree to indemnify, under certain
conditions, us, our directors, our officers and persons who control
us, within the meaning of the Securities Act, against certain
liabilities.
Item 15. Recent Sales of Unregistered Securities
The following information sets forth certain information with
respect to all unregistered securities which we have sold during
the last three years:
In June 2019, we issued 14,943 shares of our common stock to
L. Molteni & C. Dei Frattelli Alitti Società Di Esercizio
S.P.A. upon the conversion of a convertible loan at conversion
price of $45.00 per share.
In August 2019, in connection with a concurrent registered
direct offering to a single institutional investor, we issued
warrants to purchase 95,078 shares of common stock at an exercise
price of $32.10 per share, which warrants are exercisable for a
period of five years commencing February 9, 2020. Maxim Group
LLC acted as the placement agent in connection with the offering
and received a cash fee of 7.0% of the gross proceeds paid to us
and reimbursement of certain out-of-pocket expenses.
In January 2020, in connection with a concurrent registered
direct offering to a few institutional investors, we issued
warrants to purchase 290,000 shares of common stock at an exercise
price of $7.50 per share, which warrants are exercisable for a
period of five years commencing September 18, 2020. Maxim
Group LLC acted as the placement agent in connection with the
offering and received a cash fee of 7.0% of the gross proceeds paid
to us and reimbursement of certain out-of-pocket expenses.
In January 2021, in connection with a concurrent registered
direct offering to a few institutional investors, we issued
warrants to purchase 2,725,000 shares of common stock at an
exercise price of $3.55 per share, which warrants are exercisable
for a period of five and one-half years commencing January 20,
2021. Maxim Group LLC acted as the placement agent in connection
with the offering and received a cash fee of 7.0% of the gross
proceeds paid to us and reimbursement of certain out-of-pocket
expenses.
In February 2022, in connection with a concurrent registered
direct offering to a single institutional investor, we
(i) sold 1,289,796 pre-funded warrants at a price of $1.179,
each exercisable to purchase one share of common stock at an
exercise price of $0.001 per share and (ii) issued warrants to
purchase 4,664,038 shares of common stock at an exercise price of
$1.14 per share, which warrants are exercisable for a period of
five and one-half years commencing February 4, 2022. Maxim
Group LLC acted as the placement agent in connection with the
offering and received a cash fee of 7.0% of the gross proceeds paid
to us and reimbursement of certain out-of-pocket expenses.
In January 2022, we issued 51,021 shares of our common stock to JT
Pharma pursuant to an asset purchase agreement as part of a
milestone payment.
The offers, sales and issuances of the securities described above
were exempt from registration under the Securities Act by virtue of
Section 4(a)(2) of the Securities Act.
Item 16. Exhibits
|
No. |
|
Description |
| 3.1.1 |
|
Amended
and Restated Certificate of Incorporation of the Registrant, as
amended(2) |
| 3.1.2 |
|
Certificate
of Amendment to the Restated Certificate of Incorporation dated
September 24, 2015(4) |
| 3.1.3 |
|
Certificate
of Amendment to the Restated Certificate of Incorporation dated
January 23, 2019(10) |
| 3.1.4 |
|
Certificate
of Amendment to the Restated Certificate of Incorporation dated
November 30, 2020(20) |
| 3.2 |
|
By-laws
of the Registrant(1) |
| 3.3 |
|
Amendment
to the By-laws of the Registrant dated December 29, 2021
(23) |
| 4.1 |
|
Form of
Lender Warrant(6) |
| 4.2 |
|
Form of
Rights Agreement Warrant(7) |
| 4.3 |
|
Warrant
Agency Agreement between Titan Pharmaceuticals, Inc. and
Continental Stock Transfer & Trust Company and
Form of Offering Warrant(9) |
| 4.4 |
|
Representative’s
Purchase Warrant(9) |
| 4.5 |
|
Form of
August 2019 Private Placement
Warrant(11) |
| 4.6 |
|
Class B
Warrant Agency Agreement dated October 16, 2019 between Titan
Pharmaceuticals, Inc. and Maxim Group LLC Form of
January 2020 Private Placement
Warrant(12) |
| 4.7 |
|
Form of
January 2020 Private Placement
Warrant(13) |
| 4.8 |
|
Form of
March 3, 2020 Warrant Amendment
Agreement(16) |
| 4.9 |
|
Description
of the Registrant’s Common Stock(15) |
| 4.10 |
|
Warrant
Agency Agreement between Titan Pharmaceuticals, Inc. and
Continental Stock Transfer & Trust Company and
Form of Warrant(18) |
| 4.11 |
|
Form of
January 2021 Private Placement
Warrant(21) |
| 4.12 |
|
Form of
February 2022 Registered Pre-Funded
Warrant(24) |
| 4.13 |
|
Form of
February 2022 Private Pre-Funded
Warrant(24) |
| 4.14 |
|
Form of
February 2022 Placement Warrant(24) |
| 5.1 |
|
Opinion
of Loeb & Loeb LLP* |
| 10.1 |
|
Titan
Pharmaceuticals, Inc. Third Amended and Restated 2015 Omnibus
Equity Incentive Plan(10) |
| 10.2 |
|
Employment
Agreement between the Registrant and Marc
Rubin(5) |
| 10.3
± |
|
Distribution
and Sublicense Agreement dated February 1, 2016 as amended by
agreement dated August 2, 2018 between Titan
Pharmaceuticals, Inc. and Knight
Therapeutics Inc.(8) |
| 10.4 |
|
Amendment
to lease for Registrant’s facility dated March 21,
2016(8) |
| 10.6 |
|
Debt
Settlement and Release Agreement by and between Titan
Pharmaceuticals, Inc., Horizon Technology Finance Corporation
and L. Molteni & C. Dei Frattelli Alitti Società Di
Esercizio S.P.A.(17) |
| 10.7±± |
|
Asset
Purchase Agreement dated October 27, 2020 between Titan
Pharmaceuticals, Inc. and JT
Pharmaceuticals, Inc.(19) |
| 10.8 |
|
Placement
Agency Agreement dated January 15, 2021, by and between Titan
Pharmaceuticals, Inc. and Maxim Group
LLC(21) |
| 10.9 |
|
Amendment
to Employment Agreement between the Registrant and Marc
Rubin(22) |
| 10.10 |
|
Form of
February 2022 Securities Purchase
Agreement(24) |
| 10.11 |
|
Placement
Agency Agreement dated February 2, 2022, by and between Titan
Pharmaceuticals, Inc. and Maxim Group
LLC(24) |
| 14.1 |
|
Code
of Business Conduct and Ethics(3) |
| 23.1 |
|
Consent of WithumSmith+Brown, PC,
Independent Registered Public Accounting Firm |
| 23.2 |
|
Consent
of OUM & Co., LLP, Independent Registered Public
Accounting Firm |
| 23.3 |
|
Consent
of Loeb & Loeb LLP (contained in
Exhibit 5.1)* |
| 24.1 |
|
Power
of Attorney (included on the signature page of this
Registration Statement) |
| 107 |
|
Filing
Fee Table |
|
* |
To be filed by amendment. |
|
± |
Confidential treatment has been granted as to certain portions
of this exhibit. |
|
±± |
Certain information has been omitted from this exhibit in
reliance upon Item 601(b)(10) of Regulation S-K. |
|
(1) |
Incorporated by reference from the Registrant’s Registration
Statement on Form S-3 (File No. 333-221126). |
|
(2) |
Incorporated by reference from the Registrant’s Registration
Statement on Form 10 filed on January 14, 2010. |
|
(3) |
Incorporated by reference from the Registrant’s Annual Report
on Form 10-K for the year ended December 31, 2013. |
|
(4) |
Incorporated by reference from the Registrant’s Current Report
on Form 8-K filed on September 28, 2015. |
|
(5) |
Incorporated by reference from the Registrant’s Current Report
on Form 8-K filed on April 3, 2019. |
|
(6) |
Incorporated by reference from the Registrant’s Current Report
on Form 8-K filed on July 27, 2017. |
|
(7) |
Incorporated by reference from the Registrant’s Current Report
on Form 8-K filed on March 26, 2018. |
|
(8) |
Incorporated by reference from the Registrant’s Quarterly
Report on Form 10-Q for the period ended June 30,
2018. |
|
(9) |
Incorporated by reference from the Registrant’s Current Report
on Form 8-K dated September 25, 2018. |
|
(10) |
Incorporated by reference from the Registrant’s Current Report
on Form 8-K dated January 25, 2019. |
|
(11) |
Incorporated by reference from the Registrant’s Current Report
on Form 8-K dated August 8, 2019. |
|
(12) |
Incorporated by reference from the Registrant’s Current Report
on Form 8-K dated October 18, 2019. |
|
(13) |
Incorporated by reference from the Registrant’s Current Report
on Form 8-K dated January 7, 2020. |
|
(14) |
Incorporated by reference from the Registrant’s Annual Report
on Form 10-K dated April 1, 2019. |
|
(15) |
Incorporated by reference from the Registrant’s Annual Report
on Form 10-K dated March 30, 2020. |
|
(16) |
Incorporated by reference from the Registrant’s Quarterly
Report on Form 10-Q for the period ended June 30,
2020. |
|
(17) |
Incorporated by reference from the Registrant’s Current Report
on Form 8-K dated October 26, 2020. |
|
(18) |
Incorporated by reference from the Registrant’s Registration
Statement on Form S-1/A dated October 27, 2020. |
|
(19) |
Incorporated by reference from the Registrant’s Quarterly
Report on Form 10-Q for the period ended September 30,
2020. |
|
(20) |
Incorporated by reference from the Registrant’s Current Report
on Form 8-K dated December 1, 2020. |
|
(21) |
Incorporated by reference from the Registrant’s Current Report
on Form 8-K dated January 19, 2021. |
|
(22) |
Incorporated by reference from the Registrant’s Current Report
on Form 8-K dated October 28, 2021. |
|
(23) |
Incorporated by reference from the Registrant’s Current Report
on Form 8-K dated December 29, 2021. |
|
(24) |
Incorporated by reference from the Registrant’s Current Report
on Form 8-K dated February 3, 2022. |
ITEM 17. UNDERTAKINGS
(a) The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are
being made, a post-effective amendment to this registration
statement:
(i) To include any prospectus required by
Section 10(a)(3) of the Securities Act of 1933 (the
“Securities Act”);
(ii) To reflect in the prospectus any facts or events arising
after the effective date of the registration statement (or the most
recent post-effective amendment thereof) which, individually or in
the aggregate, represent a fundamental change in the information
set forth in the registration statement. Notwithstanding the
foregoing, any increase or decrease in volume of securities offered
(if the total dollar value of securities offered would not exceed
that which was registered) and any deviation from the low or high
end of the estimated maximum offering range may be reflected in the
form of prospectus filed with the Commission pursuant to
Rule 424(b) if, in the aggregate, the changes in volume
and price represent no more than 20% change in the maximum
aggregate offering price set forth in the “Calculation of
Registration Fee” table in the effective registration
statement.
(iii) To include any material information with respect to the
plan of distribution not previously disclosed in the registration
statement or any material change to such information in the
registration statement;
Provided, however, that Paragraphs (a)(1)(i), (ii), and
(iii) of this section do not apply if the information required
to be included in a post-effective amendment by those paragraphs is
contained in reports filed with or furnished to the Commission by
the registrant pursuant to section 13 or section 15(d) of the
Securities Exchange Act of 1934 that are incorporated by reference
in the registration statement.
(2) That, for the purpose of determining any liability under
the Securities Act, each such post-effective amendment shall be
deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at
that time shall be deemed to be the initial bona fide offering
thereof.
(3) To remove from registration by means of a post-effective
amendment any of the securities being registered which remain
unsold at the termination of the offering.
(4) That, for the purpose of determining liability under the
Securities Act to any purchaser: If the registrant is subject to
Rule 430C (§230.430C of this chapter), each prospectus filed
pursuant to Rule 424(b) as part of a registration
statement relating to an offering, other than registration
statements relying on Rule 430B or other than prospectuses
filed in reliance on Rule 430A (§230.430A of this chapter),
shall be deemed to be part of and included in the registration
statement as of the date it is first used after effectiveness.
Provided, however, that no statement made in a registration
statement or prospectus that is part of the registration statement
or made in a document incorporated or deemed incorporated by
reference into the registration statement or prospectus that is
part of the registration statement will, as to a purchaser with a
time of contract of sale prior to such first use, supersede or
modify any statement that was made in the registration statement or
prospectus that was part of the registration statement or made in
any such document immediately prior to such date of first use.
(5) That, for the purpose of determining liability under the
Securities Act to any purchaser in the initial distribution of the
securities, the undersigned registrant undertakes that in a primary
offering of securities of the undersigned registrant pursuant to
this registration statement, regardless of the underwriting method
used to sell the securities to the purchaser, if the securities are
offered or sold to such purchaser by means of any of the following
communications, the undersigned registrant will be a seller to the
purchaser and will be considered to offer or sell such securities
to such purchaser:
(i) Any preliminary prospectus or prospectus of the
undersigned registrant relating to the offering required to be
filed pursuant to Rule 424 (§230.424 of this chapter);
(ii) Any free writing prospectus relating to the offering
prepared by or on behalf of the undersigned registrant or used or
referred to by the undersigned registrant;
(iii) The portion of any other free writing prospectus
relating to the offering containing material information about the
undersigned registrant or its securities provided by or on behalf
of the undersigned registrant; and
(iv) Any other communication that is an offer in the offering
made by the undersigned registrant to the purchaser.
(b) The undersigned registrant hereby undertakes that, for
purposes of determining any liability under the Securities Act,
each filing of the registrant’s annual report pursuant to section
13(a) or section 15(d) of the Securities Exchange Act of
1934 (and, where applicable, each filing of an employee benefit
plan’s annual report pursuant to section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference
in the registration statement shall be deemed to be a new
registration statement relating to the securities offered therein,
and the offering of such securities at that time shall be deemed to
be the initial bona fide offering thereof.
(c) The undersigned registrant hereby undertakes to supplement
the prospectus, after the expiration of the subscription period, to
set forth the results of the subscription offer, the transactions
by the underwriters during the subscription period, the amount of
unsubscribed securities to be purchased by the underwriters, and
the terms of any subsequent reoffering thereof. If any public
offering by the underwriters is to be made on terms differing from
those set forth on the cover page of the prospectus, a
post-effective amendment will be filed to set forth the terms of
such offering.
(d) Insofar as indemnification for liabilities arising under
the Securities Act may be permitted to directors, officers and
controlling persons of the Company pursuant to the foregoing
provisions, or otherwise, the registrant has been advised that in
the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable. In the event that
a claim for indemnification against such liabilities (other than
the payment by the registrant of expenses incurred or paid by a
director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted
by such director, officer or controlling person in connection with
the securities being registered, the registrant will, unless in the
opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public
policy as expressed in the Securities Act and will be governed by
the final adjudication of such issue.
(e) For the purpose of determining any liability under the
Securities Act, the registrant will treat the information omitted
from the form of prospectus filed as part of this registration
statement in reliance upon Rule 430A and contained in a form
of prospectus filed by the registrant under Rule 424(b)(1), or
(4), or 497(h) under the Securities Act as part of this
registration statement as of the time the Commission declared it
effective.
(f) For the purpose of determining any liability under the
Securities Act, each post-effective amendment that contains a form
of prospectus shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of
such securities at that time shall be deemed to be the initial bona
fide offering thereof.
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as
amended, the Registrant has duly caused this Registration Statement
on Form S-1 or amendment thereto to be signed on its behalf by
the undersigned, thereunto duly authorized, in the City of South
San Francisco, State of California, this March 28, 2022.
| |
TITAN
PHARMACEUTICALS, INC. |
| |
|
| |
By: |
/s/
Kate Beebe DeVarney, Ph.D. |
| |
Name: |
Kate
Beebe DeVarney, Ph.D. |
| |
Title: |
President
and Chief Operating Officer |
Pursuant to the requirements of the Securities Act 1933, as
amended, this report has been signed by the following persons on
behalf of the Registrant and in the capacities and on the dates
indicated.
|
Signature |
|
Title |
|
Date |
|
/s/
Marc Rubin, M.D. |
|
Executive
Chairman |
|
March
28, 2022 |
| Marc
Rubin, M.D. |
|
(principal
executive officer and principal financial officer) |
|
|
| |
|
|
|
|
|
/s/
Kate Beebe DeVarney, Ph.D. |
|
President,
Chief Operating Officer and Director |
|
March
28, 2022 |
| Kate
Beebe DeVarney, Ph.D. |
|
|
|
|
| |
|
|
|
|
|
* |
|
Director |
|
March
28, 2022 |
| Joseph
A. Akers |
|
|
|
|
| |
|
|
|
|
|
* |
|
Director |
|
March
28, 2022 |
| M.
David MacFarlane, Ph.D. |
|
|
|
|
| |
|
|
|
|
|
* |
|
Director |
|
March
28, 2022 |
| James
R. McNab, Jr. |
|
|
|
|
| |
|
|
|
|
|
/s/
Brian E. Crowley |
|
Vice
President, Finance |
|
March
28, 2022 |
| Brian
E. Crowley |
|
(principal
accounting officer) |
|
|
* By Marc Rubin, attorney-in-fact
Titan Pharmaceuticals (NASDAQ:TTNP)
Historical Stock Chart
From May 2023 to Jun 2023
Titan Pharmaceuticals (NASDAQ:TTNP)
Historical Stock Chart
From Jun 2022 to Jun 2023
