Filed Pursuant to Rule 424(b)(2)
Registration Statement No. 333-262614
PROSPECTUS
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 April 4, 2022, the last reported sale price
of our common stock on The Nasdaq Capital Market was $.895 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 April 4, 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:
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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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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. |
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:
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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. |
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. |
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.
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