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. All information regarding share numbers, market prices and exercise prices
gives effect to a 1-for-30 reverse stock split effected on November 30, 2020. Share amounts have been approximated in light of
the rounding up of fractional interests.
Company Overview
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 provides an efficacy and/or safety benefit. ProNeura consists of a small, solid implant made from a mixture
of EVA (ethylene-vinyl acetate) and a drug substance. The resulting product is a solid matrix that is administered subdermally,
normally in the inner upper arm, 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.
Probuphine® is the first product
based on our ProNeura technology approved in the U.S., 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. On October 15, 2020, we
issued a press release announcing our decision to discontinue selling Probuphine® (buprenorphine) implant in the United
States and wind down our commercialization activities, and to pursue a plan that will enable us to focus on our
ProNeura-based product development programs. We based this decision on several factors, most notably that commercializing
Probuphine with the requirements of the current product label and the Risk Evaluation and Mitigation Strategy, or REMS,
program has proven to be onerous, leading to minimal utilization despite our significant efforts to overcome these obstacles.
Other factors that have negatively impacted Titan’s ability to effectively commercialize Probuphine include the
financial constraints that have limited our sales and marketing capabilities; suboptimal reimbursement rates; and the
complexity of the distribution channel. The continually changing environment due to the COVID-19 pandemic has further
exacerbated these issues. As a result, sales of Probuphine were, and would likely continue for the foreseeable future to be,
extremely limited. After careful review of the recent sales and marketing results, the hurdles that Titan has and would
continue to face, and the substantial additional expenditures and resources that would be required, our board of directors
made a determination to advise the U.S. Food and Drug Administration (“FDA”) of its decision to cease
commercialization of Probuphine. A wind-down plan taking into considerations FDA and state regulatory requirements, as well
as business considerations is underway.
Development Programs
Kappa Opioid Agonist Peptide Program
On October 27, 2020, we entered into an Asset Purchase Agreement
with JT Pharmaceuticals, Inc., or JT Pharma, for the acquisition and development of JT Pharma’s kappa opioid agonist peptide,
or JT- 09, for use in combination with our ProNeura technology. James McNab, a member of our board of directors, is a principal
of JT Pharma. Several years ago, we began limited laboratory work in in collaboration with JT Pharma to assess the feasibility
of delivering JT-1 09 through peptide-infused ProNeura rods in animal models. Our initial work focused on JT-109’s ability
to activate peripheral kappa opioid receptors, with the JT ProNeura rods potentially providing a non-addictive treatment for certain
types of pain. Recently, our collaboration with JT has pivoted to explore the feasibility of also using JT Proneura rods in the
treatment of chronic pruritus, a debilitating condition defined as itching of the skin lasting longer than six weeks. In 2015,
an estimated 23 – 44 million Americans suffered from chronic pruritus in the setting of both cutaneous and systemic conditions.
Current treatments include anti-histamines, corticosteroids, and over-the- counter lotions, all of which are relatively ineffective
and may 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. We believe, based on our early animal
data, that subcutaneous implantation of the JT ProNeura rods could potentially deliver therapeutic concentrations of JT- 09 for
up to six months or longer following a single in-office procedure. We are conducting the initial non-clinical studies designed
to establish proof of concept in an animal model. If successful, we will need to conduct Investigational New Drug, or IND, enabling
safety and pharmacology studies.
RISK
FACTORS
Any investment in our securities
involves a high degree of risk. Investors should carefully consider the risks described below and all of the information contained
or incorporated by reference in this prospectus before deciding whether to purchase our common stock. Our business, financial condition
or results of operations could be materially adversely affected by these risks if any of them actually occur. This prospectus also
contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those
anticipated in these forward-looking statements as a result of certain factors, including the risks we face as described below
and elsewhere in this prospectus.
Risks Related to Our Business
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,
we expect that the proceeds of this offering will only be sufficient to complete the proof of concept work on JT-09 and we will
require substantial additional funds 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 do not succeed 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. Importantly, if the JT-09 initial proof of concept efforts are unsuccessful and
we discontinue this program, our future prospects could be materially adversely impacted. 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:
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inability to manufacture sufficient quantities of qualified materials under cGMP, for use in clinical
trials;
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slower than expected rates of patient recruitment;
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failure to recruit a sufficient number of patients; modification of clinical trial protocols;
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changes in regulatory requirements for clinical trials;
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the lack of effectiveness during clinical trials;
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the emergence of unforeseen safety issues;
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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
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government or regulatory delays or “clinical holds” requiring suspension or termination
of the trials.
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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.
The
winding down of our commercial operations may be more costly and time-consuming than we anticipate.
The cessation of our Probuphine related
commercial activities requires us to comply with FDA and state regulatory requirements, including those related to notifications
to various stakeholders and the continuation of adverse event reporting, as well as to address a number of business considerations,
such as termination of third-party agreements and transfer of manufacturing equipment. The costs and timing associated with the
wind down of our commercial operations may exceed our current estimates, requiring a reallocation of proceeds that may limit what
we can accomplish in our product development programs unless additional financing is procured sooner than we currently anticipate.
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:
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obtain and keep patent protection for our products, methods and technologies on a domestic and
international basis;
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enforce our patents to prevent others from using our inventions;
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maintain and prevent others from using our trade secrets; and
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operate and commercialize products without infringing on the patents or proprietary rights of others.
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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:
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pay substantial damages;
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stop using our technologies and methods;
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stop certain research and development efforts;
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develop non-infringing products or methods; and
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obtain one or more licenses from third parties.
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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.
Risks Related to Our Financial Condition
and Need for Additional Capital
We
have incurred net losses in almost every year since our inception and we may never achieve or sustain profitability.
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, 2019 and 2018, we had net losses of approximately $16.5 million and $9.3 million, respectively, and had
net cash used in operating activities of approximately $15.4 million and $8.4 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 wind down our commercial activities
and 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. There can be no
assurance that we will ever achieve profitability.
We
will require additional proceeds to fund our product development programs.
We currently estimate that our available
cash and cash equivalents is sufficient to fund our planned operations into the third quarter of 2021. We will require additional
funds to advance JT-09 beyond the proof of concept stage, if successful, and to fund any of our ProNeura development programs 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 and third-party collaborations for one or more
of our ProNeura programs, our efforts to address our liquidity requirements may not be successful. There can be no assurance that
any source of capital will be available to us on acceptable terms.
We received a loan under the Paycheck
Protection Program of the CARES Act, and all or a portion of the loan may not be forgivable.
On April 20, 2020, we received an approximately
$0.7 million PPP Loan pursuant to the Paycheck Protection Program of the CARES Act. The PPP Loan matures in April 2022 with an
annual interest rate of 1.0%. The PPP Loan has a six month deferral of payments period and may be prepaid at any time without penalty.
The proceeds of the PPP Loan are to be used to retain workers and maintain payroll and make mortgage interest, lease and utility
payments. Under the CARES Act, we will be eligible to apply for forgiveness of all loan proceeds used to pay payroll costs, rent,
utilities and other qualifying expenses during the 24-week period following receipt of the loan, provided that we maintain our
number of employees and compensation within certain parameters during such period. Not more than 40% of the forgiven amount may
be for non-payroll costs. If the conditions outlined in the PPP loan program are adhered to by us, all or part of such loan could
be forgiven. However, we cannot provide any assurance that we will be eligible for loan forgiveness or that any amount of the PPP
loan will ultimately be forgiven by the SBA. Any forgiven amounts will not be included in our taxable income.
Risks Related to our Common Stock
Our failure to meet the continued listing
requirements of Nasdaq could result in a delisting of our common stock.
On September 19, 2019, we received a letter
from Nasdaq notifying us that the market price of our common stock has been below the $1.00 minimum bid price requirement for continued
listing and requiring us to regain compliance with the minimum bid price requirement within 180 days. On April 17, 2020, Nasdaq
notified us that the 180-day period to regain compliance with the minimum bid price requirement had been extended due to the global
market impact caused by COVID-19. More specifically, Nasdaq has stated that the compliance periods for any company previously notified
about non-compliance are suspended effective April 16, 2020, until June 30, 2020. On July 1, 2020, companies received the balance
of any pending compliance period exception to regain compliance as a result of which we were given until November 30, 2020 to regain
compliance with the minimum bid price rule We effected a reverse stock split on November 30, 2020, which has had the result of
increasing the closing bid price of our common stock to above $1.00; however, we were not be able to regain compliance with the
minimum bid price requirement within the time frame set by Nasdaq and, accordingly, on December 1, 2020, we received a notice from
Nasdaq’s Listing Qualifications Department stating that Nasdaq has determined to initiate procedures to delist our from Nasdaq.
The notice provided us until December 8, 2020 to request an appeal of Nasdaq’s determination to delist and we have submitted
our request, which will stay the suspension of our securities pending a decision by the hearing panel. There can be no assurance
that Nasdaq will allow us to remain listed.
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 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.
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:
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our Current Reports on Form 8-K filed with the SEC on April
24, 2020, June
25, 2020, June
29, 2020, July
16, 2020, August
5, 2020, August
12, 2020, August
13, 2020, August
20, 2020, September
1, 2020, September
14, 2020, September
18, 2020, September
24, 2020; October
15, 2020, October
26, 2020, October
28, 2020, November
2, 2020, December
1, 2020 and December 3, 2020.
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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 supplement 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 issuance described in this registration statement will be as set forth below. We will pay all of the expenses with respect
to issuance, and such amounts, with the exception of the SEC registration fee, are estimates.
SEC registration fee
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$
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544
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Legal fees and expenses
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25,000
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Accounting fees and expenses
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|
8,000
|
|
Printing expenses
|
|
|
5,000
|
|
Other (including transfer agent and registrar fees)
|
|
|
1,456
|
|
Total
|
|
$
|
40,000
|
|
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;
|
|
|
|
|
·
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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.
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
Exhibit
|
|
|
No.
|
|
Description
|
1.1
|
|
Underwriting Agreement
dated October 28, 2020 between Titan Pharmaceuticals, Inc. and Maxim Group LLC(26)
|
3.1.1
|
|
Amended and Restated
Certificate of Incorporation of the Registrant, as amended(4)
|
3.1.2
|
|
Certificate of Amendment
to the Restated Certificate of Incorporation dated September 24, 2015(6)
|
3.1.3
|
|
Certificate of Amendment
to the Restated Certificate of Incorporation dated January 23, 2019(16)
|
3.1.4
|
|
Certificate of Amendment
to the Restated Certificate of Incorporation dated September 24, 2020(16)
|
3.2
|
|
By-laws of the Registrant(1)
|
4.1
|
|
Form of Lender Warrant(8)
|
4.2
|
|
Form of Rights Agreement
Warrant(10)
|
4.3
|
|
Warrant Agency Agreement
between Titan Pharmaceuticals, Inc. and Continental Stock Transfer & Trust Company and Form of Offering Warrant(15)
|
4.4
|
|
Representative’s
Purchase Warrant(15)
|
4.5
|
|
Form of August 2019
Private Placement Warrant(17)
|
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(18)
|
4.7
|
|
Form of January
2020 Private Placement Warrant(19)
|
4.8
|
|
Form of March 3,
2020 Warrant Amendment Agreement(23)
|
4.9
|
|
Description of the
Registrant’s Common Stock(22)
|
4.10
|
|
Warrant Agency Agreement
between Titan Pharmaceuticals, Inc. and Continental Stock Transfer & Trust Company and Form of Warrant(25)
|
4.11
|
|
Form of Lock-Up
and Voting Agreement(25)
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5.1
|
|
Opinion of Loeb & Loeb LLP
|
10.1
|
|
2001 Non-Qualified
Employee Stock Option Plan(2)
|
10.2
|
|
2002 Stock Option
Plan(3)
|
10.3
|
|
Titan Pharmaceuticals,
Inc. 2014 Incentive Plan(5)
|
10.4
|
|
Titan Pharmaceuticals,
Inc. Third Amended and Restated 2015 Omnibus Equity Incentive Plan(16)
|
10.5
|
|
Employment Agreement
between Titan Pharmaceuticals, Inc. and Sunil Bhonsle(7)
|
10.6
|
|
Employment Agreement
between Titan Pharmaceuticals, Inc. and Marc Rubin(7)
|
10.7
|
|
Venture Loan and
Security Agreement, dated July 27, 2017, by and between Titan Pharmaceuticals, Inc. and Horizon Technology Finance Corporation(8)
|
10.8
|
|
Amendment of Venture
Loan and Security Agreement, dated February 2, 2018, by and between Titan Pharmaceuticals, Inc. and Horizon Technology Finance
Corporation(9)
|
10.9
|
|
Amended and Restated
Venture Loan and Security Agreement, dated March 21, 2018, by and between Titan Pharmaceuticals, Inc., Horizon Technology
Finance Corporation and L. Molteni & C. Dei Frattelli Alitti Società Di Esercizio S.P.A.(10)
|
10.10
±
|
|
Asset Purchase,
Supply and Support Agreement dated March 21, 2018, by and between Titan Pharmaceuticals, Inc. and L. Molteni & C. Dei
Frattelli Alitti Società Di Esercizio S.P.A.(10)
|
10.11
|
|
Rights Agreement
dated March 21, 2018, by and between Titan Pharmaceuticals, Inc. and L. Molteni & C. Dei Frattelli Alitti Società
Di Esercizio S.P.A.(10)
|
10.12
±
|
|
Termination and
Transition Services Agreement dated May 25, 2018 by and between Titan Pharmaceuticals, Inc. and Braeburn Pharmaceuticals,
Inc.(11)
|
10.13
±
|
|
Amendment to Asset
Purchase, Supply and Support Agreement dated August 3, 2018, by and between Titan Pharmaceuticals, Inc. and L. Molteni &
C. Dei Frattelli Alitti Società Di Esercizio S.P.A(12)
|
10.14
±
|
|
Distribution and
Sublicense Agreement dated February 1, 2016 as amended by agreement dated August 2, 2018 between Titan Pharmaceuticals, Inc.
and Knight Therapeutics Inc.(13)
|
10.15
|
|
Amendment to lease
for Registrant’s facility dated March 21, 2016(13)
|
10.16
|
|
Unsecured Convertible
Loan Agreement dated September 18, 2018(14)
|
10.17
|
|
Employment Agreement
between the Registrant and Katherine Beebe DeVarney(20)
|
10.18
|
|
Employment Agreement
between the Registrant and Dane Hallberg(20)
|
10.19
|
|
Securities Purchase
Agreement, dated August 7, 2019, by and between Titan Pharmaceuticals, Inc. and the investors named therein(17)
|
10.20
|
|
Securities Purchase
Agreement, dated January 7, 2020, by and between Titan Pharmaceuticals, Inc. and the investors named therein(19)
|
10.21
|
|
Placement Agency
Agreement, dated August 7, 2019, by and between Titan Pharmaceuticals, Inc. and Maxim Group LLC(17)
|
10.22
|
|
Placement Agency
Agreement, dated January 7, 2020, by and between Titan Pharmaceuticals, Inc. and Maxim Group LLC(19)
|
10.23
|
|
Amendment dated
September 10, 2019 to Amended and Restated Venture Loan and Security Agreement, dated March 21, 2018, by and between Titan
Pharmaceuticals, Inc., Horizon Technology Finance Corporation and L. Molteni & C. Dei Frattelli Alitti Società
Di Esercizio S.P.A.(21)
|
10.24
±
|
|
Amendment No. 2
dated September 10, 2019 to Asset Purchase, Supply and Support Agreement by and between Titan Pharmaceuticals, Inc. and L.
Molteni & C. Dei Frattelli Alitti Società Di Esercizio S.P.A.(21)
|
10.25
|
|
Amendment No. 2
dated March 12, 2020 to Amended and Restated Venture Loan and Security Agreement, dated March 21, 2018, by and between Titan
Pharmaceuticals, Inc., Horizon Technology Finance Corporation and L. Molteni & C. Dei Frattelli Alitti Società
Di Esercizio S.P.A.(22)
|
10.26
±±
|
|
Agreement for Co-Promotion
Partnership, dated June 23, 2020, by and between Titan Pharmaceuticals, Inc. and Indegene, Inc.(23)
|
10.27
|
|
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.(24)
|
10.28±±
|
|
Asset Purchase Agreement
dated October 27, 2020 between Titan Pharmaceuticals, Inc. and JT Pharmaceuticals, Inc.(27)
|
14.1
|
|
Code of Business
Conduct and Ethics(5)
|
23.1
|
|
Consent of OUM & Co,, LLP, Independent Registered Public Accounting Firm
|
23.2
|
|
Consent of Loeb & Loeb LLP (contained in Exhibit 5.1)
|
24.1
|
|
Power of Attorney (included on the signature page of this Registration Statement
|
±
|
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 Annual Report on Form 10-K for the year ended December 31, 2001.
|
(3)
|
Incorporated by reference from the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2002.
|
(4)
|
Incorporated by reference from the Registrant’s Registration Statement on Form 10 filed on January 14, 2010.
|
(5)
|
Incorporated by reference from the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2013.
|
(6)
|
Incorporated by reference from the Registrant’s Current Report on Form 8-K filed on September 28, 2015.
|
(7)
|
Incorporated by reference from the Registrant’s Current Report on Form 8-K filed on April 3, 2019.
|
(8)
|
Incorporated by reference from the Registrant’s Current Report on Form 8-K filed on July 27, 2017.
|
(9)
|
Incorporated by reference from the Registrant’s Current Report on Form 8-K filed on February 7, 2018.
|
(10)
|
Incorporated by reference from the Registrant’s Current Report on Form 8-K filed on March 26, 2018.
|
(11)
|
Incorporated by reference from the Registrant’s Current Report on Form 8-K filed on May 30, 2018.
|
(12)
|
Incorporated by reference from the Registrant’s Current Report on Form 8-K filed on August 3, 2018.
|
(13)
|
Incorporated by reference from the Registrant’s Quarterly Report on Form 10-Q for the period ended June 30, 2018.
|
(14)
|
Incorporated by reference from the Registrant’s Current Report on Form 8-K dated September 20, 2018.
|
(15)
|
Incorporated by reference from the Registrant’s Current Report on Form 8-K dated September 25, 2018.
|
(16)
|
Incorporated by reference from the Registrant’s Current Report on Form 8-K dated January 25, 2019.
|
(17)
|
Incorporated by reference from the Registrant’s Current Report on Form 8-K dated August 8, 2019.
|
(18)
|
Incorporated by reference from the Registrant’s Current Report on Form 8-K dated October 18, 2019.
|
(19)
|
Incorporated by reference from the Registrant’s Current Report on Form 8-K dated January 7, 2020.
|
(20)
|
Incorporated by reference from the Registrant’s Annual Report on Form 10-K dated April 1, 2019.
|
(21)
|
Incorporated by reference from the Registrant’s Registration Statement on Form S-1 dated September 12, 2019.
|
(22)
|
Incorporated by reference from the Registrant’s Annual Report on Form 10-K dated March 30, 2020.
|
(23)
|
Incorporated by reference from the Registrant’s Quarterly Report on Form 10-Q for the period ended June 30, 2020.
|
(24)
|
Incorporated by reference from the Registrant’s Current Report on Form 8-K dated October 26, 2020.
|
(25)
|
Incorporated by reference from the Registrant’s Registration Statement on Form S-1/A dated October 27, 2020.
|
(26)
|
Incorporated by reference from the Registrant’s Current Report on Form 8-K dated November 2, 2020.
|
(27)
|
Incorporated by reference from the Registrant’s Quarterly Report on Form 10-Q for the period ended September 30, 2020.
|
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.