RISK
FACTORS
An
investment in our securities involves a high degree of risk. You should carefully consider the risks described below before making an
investment decision. Our business, prospects, financial condition or operating results could be harmed by any of these risks, as well
as other risks not currently known to us or that we currently consider immaterial. The trading price of our securities could decline
due to any of these risks, and, as a result, you may lose all or part of your investment. Certain statements in “Risk Factors”
are forward-looking statements. See “Cautionary Statement Regarding Forward-Looking Statements.”
Risks
Related to Our Business, Financial Position and Need for Capital
Our
current and future product candidates may never be approved or achieve commercial market acceptance.
Our
success depends on the market’s confidence that we can develop product candidates for patients with high unmet medical needs, optimize
health outcomes and improve patients’ quality of life. Failure of our current and future product candidates, or those jointly developed
with our collaborators, to develop or perform as expected could significantly impair our business. We and our collaborators may not succeed
in achieving commercial market acceptance for our current or future product candidates due to a number of factors, including:
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the
impact of our investments in product innovation and commercial growth; |
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our
ability to demonstrate the utility of our platform and their potential advantages over existing technologies to academic institutions,
biopharmaceutical companies and the medical community; |
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our
ability, and that of our collaborators, to comply with FDA and other regulatory requirements; and |
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the
rate of development of our product candidates and reputation among academic institutions, key opinion leaders and advocacy groups. |
Additionally,
our business could be negatively impacted due to changes in our research and development plans, financial constraints, the regulatory
environment, negative publicity about our product candidates or competing products both of which are circumstances outside of our control.
We may not be successful in addressing these or other factors that might affect the market acceptance of our product candidates and technologies.
Failure to develop, obtain approval or achieve commercial market acceptance of our product candidates could materially harm our business,
financial condition and results of operations.
We
are a development stage company with a limited operating history and no revenues, and there are a number of factors that may affect our
prospects.
We
are a development stage pharmaceutical company with a limited operating history and no revenues. The likelihood of success of our business
plan must be considered in light of the problems, substantial expenses, difficulties, complications and delays frequently encountered
in connection with developing and expanding early-stage businesses and the regulatory and competitive environment in which we operate.
Pharmaceutical and biopharmaceutical product development is a highly speculative undertaking, involves a substantial degree of risk and
is a capital-intensive business. Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties
frequently encountered by development stage pharmaceutical companies such as our Company, and note that we cannot assure you that we
will be able to successfully address these risks.
Our
operations to date have been primarily limited to our organizational and capital-raising activities, negotiating our license agreements,
and conducting development activities for VAR 200 and IC 100. We have not demonstrated our ability to successfully complete large-scale,
pivotal clinical trials, obtain regulatory approvals, manufacture a commercial scale product or arrange for a third party to do so on
our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Because of our limited operating
history, we have limited insight into trends that may emerge and affect our business, and errors may be made in developing an approach
to address those trends and the other challenges faced by development stage pharmaceutical companies such as our Company. Failure to
adequately respond to such trends and challenges could cause our business, results of operations and financial condition to suffer or
fail. Further, our limited operating history may make it difficult for our stockholders to make any predictions about our likelihood
of future success or viability.
Factors
relating to our business that may affect our prospects may include other such as:
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our
ability to obtain additional funding to develop and commercialize our product candidates; |
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any
delays in regulatory review and approval for implementation of our development plans; |
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delays
in the commencement, enrollment and timing of clinical trials; |
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the
success of our preclinical and clinical trials through all phases of preclinical and clinical development; |
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any
delays in regulatory review and approval of our product candidates; |
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our
ability to obtain and maintain regulatory approval for our product candidates that we seek to develop in the United States and foreign
jurisdictions; |
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potential
side effects of our product candidates that could delay or prevent commercialization, limit the indications for our product candidates,
if approved, require the establishment of Risk Evaluation and Mitigation Strategies (“REMS”), cause an approved drug to
be taken off the market or subject us to fines and penalties and third-party claims; |
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market
acceptance of our product candidates, if approved for marketing; |
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our
dependence on third parties to manufacture and supply our product candidates; |
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our
dependence on clinical research organizations (“CROs”) to conduct our clinical trials; |
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our
dependence on contract manufacturing organizations (“CMOs”) to produce our products for clinical purposes and commercialization; |
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our
ability to establish or maintain collaborations, licensing or other arrangements; |
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our
ability to identify, acquire and incorporate other businesses, products and/or technologies; |
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our
ability to establish and maintain an effective sales and marketing infrastructure, either through the creation of a commercial infrastructure
or through strategic collaborations; |
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competition
from existing products or new products that may emerge; |
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the
ability of patients or healthcare providers to obtain coverage of or sufficient reimbursement for our product candidates; |
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our
ability and our licensors’ abilities to successfully obtain, maintain, defend and enforce intellectual property rights important
to our business; |
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our
ability to leverage our partners’ proprietary technology platform to discover and develop additional product candidates; |
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our
ability to attract and retain key personnel to manage our business effectively; |
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our
ability to build our finance infrastructure and improve our accounting systems and controls; |
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potential
product liability claims; |
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potential
liabilities associated with hazardous materials; and |
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our
ability to obtain and maintain adequate insurance policies. |
We
have never been profitable. To date, we do not have data to support regulatory approval of any of our drug products, we have no products
approved for commercial sale in any jurisdiction, and we have not generated any revenue from product sales. As a result, our ability
to curtail our losses and reach profitability is unproven, and we may never achieve or sustain profitability.
We
have never been profitable and do not expect to be profitable for the foreseeable future. As of December 31, 2021, our accumulated net
loss was approximately ($52,896,817) million. We have devoted most of our financial resources to our organizational and capital-raising
activities and negotiating our license agreements, and other strategic partnerships and collaborations. We have not completed development
of any product candidate through the receipt of marketing approval, and we have therefore not generated any revenues from product sales.
Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict
the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. We expect to incur increased
expenses as we continue the clinical development of VAR 200 and preclinical development of IC 100 and other product candidates that we
may seek to develop and for which we may seek marketing approval in the United States and elsewhere. We also expect an increase in our
expenses associated with creating additional infrastructure (including hiring additional personnel) to commence clinical trials and continue
the development and commercialization of VAR 200 and IC 100 and other product candidates that we may seek to develop. As a result, we
expect to continue to incur net losses and negative cash flows for the foreseeable future. These net losses and negative cash flows have
had, and will continue to have, an adverse effect on our stockholders’ equity and working capital.
To
date, we have financed our operations through the sale of our equity securities. The amount of our future net losses will depend, in
part, on the rate of future growth of our expenses and our ability to generate revenues. If we are unable to develop and commercialize
VAR 200, IC 100, or any other product candidates that we may seek to develop, either alone or with collaborators, or if revenues from
any product candidate that receives marketing approval are insufficient, we will not achieve profitability. Even if we do achieve profitability,
we may not be able to sustain or increase profitability.
We
may be unable to continue as a going concern.
We
are a development stage pharmaceutical company with no commercial products. Our primary product candidates are in the process of being
developed, and will require significant additional preclinical and clinical development and investment before they could potentially
be commercialized. As a result, we have not generated any revenue from operations since inception, and we have incurred substantial
net losses to date. Moreover, our cash position is vastly inadequate to support our business plans and substantial additional funding
will be needed in order to pursue those plans, which include research and development of our primary product candidates, seeking regulatory
approval for those product candidates, and pursuing their commercialization in the United States and other markets. Those circumstances
raise substantial doubt about our ability to continue as a going concern. In particular, we believe that our current cash and cash equivalents
on hand will only be sufficient to meet our anticipated cash requirements through the second quarter of 2023. If we are unable to continue
as a going concern, we might have to liquidate our assets and the values we receive for our assets in liquidation or dissolution could
be significantly lower than the values reflected in our financial statements. In addition, our lack of cash resources and our potential
inability to continue as a going concern may materially adversely affect the value of our capital stock and our ability to raise new
capital or to enter into critical contractual relations with third parties.
We
will need additional capital to develop and commercialize our product candidates. If we are unable to raise sufficient capital, we would
be forced to delay, reduce or eliminate our product development programs.
Developing
pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive. We expect our research and development
expenses to increase in connection with our ongoing activities, particularly as we start clinical trials for VAR 200 and conduct preclinical
development of IC 100. We have no commitments or arrangements for any additional financing to fund our development and commercialization
efforts for VAR 200, IC 100, or any other product candidate that we may seek to develop. We will need to raise substantial additional
capital to develop and commercialize VAR 200, IC 100, and any other product candidate that we may seek to develop. Because successful
development of VAR 200 or IC 100 is uncertain, we are unable to estimate the actual funds required to complete their development and
commercialization.
Until
we can generate a sufficient amount of revenue from VAR 200, IC 100, or any other product candidate that we may seek to develop,
if ever, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaborations
and licensing arrangements. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If
adequate funds are not available, we may be required to delay, reduce the scope of, or curtail, our operations. To the extent that we
raise additional funds by issuing equity securities, or securities convertible into equity securities, the ownership of our then existing
stockholders may be diluted, which dilution could be significant depending on the price at which we may be able to sell our securities.
Also, if we raise additional capital through the incurrence of indebtedness, we may become subject to additional covenants restricting
our business activities, the holders of debt instruments may have rights and privileges senior to those of our equity investors, and
servicing the interest and principal repayment obligations under such debt instruments could divert funds that would otherwise be available
to support research and development, clinical or commercialization activities. Corresponding, we may not be able to enter into collaborations
that we seek to establish. To the extent that we raise additional funds through collaborations and licensing arrangements, it may be
necessary to relinquish some rights to our technologies or our product candidates or grant licenses on terms that may not be favorable
to us. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate
need for additional capital at that time.
Our
future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:
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the
initiation, progress, timing, costs and results of preclinical and clinical trials for our product candidates; |
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whether
the FDA requires that we perform additional studies for our product candidates that we seek to develop beyond those that we anticipate; |
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the
terms and timing of any future collaboration, licensing or other arrangements that we may establish; |
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the
outcome, timing and cost of regulatory approvals; |
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the
effect of competing technological and market developments; |
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the
cost and timing of establishing commercial-scale outsourced manufacturing capabilities; |
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market
acceptance of our product candidates, if we receive regulatory approval; |
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the
cost of establishing sales, marketing and distribution capabilities for our product candidates, if we receive regulatory approval;
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the
extent to which we acquire, license or invest in businesses, products or technologies. |
We
are subject to various U.S. anti-corruption laws and other anti-bribery and anti-kickback laws and regulations.
We
are subject to the U.S. Foreign Corrupt Practices Act of 1977, as amended (the “FCPA”), and other anticorruption,
anti-bribery, and anti-money laundering laws in the jurisdictions in which it does business. These laws generally prohibit us and
our employees from improperly influencing government officials or commercial parties in order to obtain or retain business, direct
business to any person or gain any improper advantage. The FCPA and other applicable anti-bribery and anti-corruption laws also may
hold us liable for acts of corruption and bribery committed by our third-party business partners, representatives and agents who are
acting on our behalf. We and our third-party business partners, representatives and agents may have direct or indirect interactions
with officials and employees of government agencies or state-owned or affiliated entities and it may be held liable for the corrupt
or other illegal activities of these third-party business partners and intermediaries and its employees, representatives,
contractors and agents, even if it does not explicitly authorize such activities. These laws also require that we keep accurate
books and records and maintain internal controls and compliance procedures designed to prevent any such actions. While we have
policies and procedures to address compliance with such laws, it cannot assure that its employees and agents will not take actions
in violation of its policies or applicable law, for which it may be ultimately held responsible and its exposure for violating these
laws increases as its international presence expands and as it increases sales and operations in foreign jurisdictions. Any
violation of the FCPA or other applicable anti-bribery, anti-corruption and anti-money laundering laws could result in whistleblower
complaints, adverse media coverage, investigations, imposition of significant legal fees, loss of export privileges, severe criminal
or civil sanctions or suspension or debarment from U.S. government contracts, substantial diversion of management’s attention,
a drop in our stock price or overall adverse consequences to our business, all of which may have an adverse effect on our
reputation, business, financial condition and operating results.
Our
financial condition and results of operations may be adversely impacted by the COVID-19 pandemic.
Occurrences
of epidemics or pandemics, depending on their scale, may cause different degrees of disruption to the regional, state and local economies
in which we operate our business and develop our product candidates. The current COVID-19 pandemic has had and could continue to have
a material adverse effect on the value, operating results and financial condition of our business. Extraordinary actions taken by international,
federal, state, and local public health and governmental authorities to contain and combat the outbreak and spread of COVID-19 in regions
throughout the world, including travel bans, quarantines, “stay-at-home” orders, suspension of interest accrual and collections
on certain federally-backed student loans and similar mandates for many individuals and businesses to substantially restrict daily activities
have led to a decrease in consumer activity generally. While the extent and duration of the economic slowdown and high unemployment rates
attributable to the COVID-19 pandemic remain uncertain at this time, particularly as new strains of the virus emerge and create potential
challenges to vaccination efforts, a continued significant economic slowdown could have a substantial adverse effect on our financial
condition, liquidity and results of operations.
Risks
Related to Development, Regulatory Approval and Commercialization
A
pandemic, epidemic, or outbreak of an infectious disease, such as COVID-19 could cause a disruption to the development of our product
candidates.
Public
health crises such as pandemics or similar outbreaks could adversely impact our business. In December 2019, a novel strain of a virus
named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), or coronavirus, which causes COVID-19, surfaced in Wuhan, China and
has since spread worldwide. The coronavirus pandemic is evolving, and to date has led to the implementation of various responses, including
government-imposed quarantines, travel restrictions and other public health safety measures. The extent to which the coronavirus impacts
our operations or those of our third-party partners, including our preclinical studies or clinical trial operations, will also depend
on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak, new
information that will emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact,
among others. The continued spread of COVID-19 globally could adversely impact our preclinical or clinical trial operations in the U.S.
and abroad, including our ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers,
may have heightened exposure to COVID-19. For example, similar to other biopharmaceutical companies, we may experience delays in enrolling
our current and/or planned clinical trials. COVID-19 may also affect employees of third-party CROs located in affected geographies that
we rely upon to carry out our clinical trials. In addition, the patient populations that our lead and other core product candidates target
may be particularly susceptible to COVID-19, which may make it more difficult for us to identify patients able to enroll in our future
clinical trials and may impact the ability of enrolled patients to complete any such trials. Any negative impact COVID-19 has to patient
enrollment or treatment or the execution of our product candidates could cause costly delays to clinical trial activities, which could
adversely affect our ability to obtain regulatory approval for and to commercialize our product candidates, increase our operating expenses,
and have a material adverse effect on our financial results.
Additionally,
timely enrollment in planned clinical trials is dependent upon clinical trial sites which could be adversely affected by global health
matters, such as pandemics. We plan to conduct clinical trials for our product candidates in geographies which are currently being affected
by the coronavirus. Some factors from the coronavirus outbreak that will delay or otherwise adversely affect enrollment in the clinical
trials of our product candidates, as well as our business generally, include:
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the
potential diversion of healthcare resources away from the conduct of clinical trials to focus on pandemic concerns, including the attention
of physicians serving as our clinical trial investigators, hospitals serving as our clinical trial sites and hospital staff supporting
the conduct of our prospective clinical trials; |
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limitations
on travel that could interrupt key trial and business activities, such as clinical trial site initiations and monitoring, domestic
and international travel by employees, contractors or patients to clinical trial sites, including any government-imposed travel restrictions
or quarantines that will impact the ability or willingness of patients, employees or contractors to travel to our clinical trial sites
or secure visas or entry permissions, a loss of face-to-face meetings and other interactions with potential partners, any of which
could delay or adversely impact the conduct or progress of our prospective clinical trials; |
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the
potential negative effect on the operations of our third-party manufacturers; |
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interruption
in global shipping, affecting the transport of raw materials for our products, clinical trial materials, such as patient samples, investigational
drug product and conditioning drugs and other supplies used in our prospective clinical trials; and |
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business
disruptions caused by potential workplace, laboratory and office closures and an increased reliance on employees working from home,
disruptions to or delays in ongoing laboratory experiments and operations, staffing shortages, travel limitations or mass transit disruptions,
any of which could adversely impact our business operations or delay necessary interactions with local regulators, ethics committees
and other important agencies and contractors. |
We
have taken temporary precautionary measures intended to help minimize the risk of the virus to our employees, including having all of
our employees to work remotely, suspending all non-essential travel worldwide for our employees and discouraging employee attendance
at industry events and in-person work-related meetings, which could negatively affect our business. We cannot presently predict the scope
and severity of the planned and potential shutdowns or disruptions of businesses and government agencies, such as the SEC or FDA.
Our
business is dependent on the successful development, regulatory approval and commercialization of our product candidates, in particular
VAR 200 and IC 100.
The
success of our business, including our ability to finance our company and generate any revenue in the future, will primarily depend
on the successful development, regulatory approval and commercialization or partnering of our product candidates. In the future, we may
also become dependent on just one of our product candidates or any future product candidates that we may in-license, acquire or develop.
The preclinical and clinical and commercial success of our product candidates will depend on a number of factors, including the following:
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the
ability to raise additional capital on acceptable terms, or at all; |
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timely
completion of our clinical trials, which may be significantly slower or cost more than we currently anticipate and will depend substantially
upon the performance of third-party contractors; |
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whether
we are required by the FDA, or similar foreign regulatory agencies to conduct additional preclinical or clinical trials beyond those
planned to support the approval and commercialization of our product candidates or any future product candidates; |
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acceptance
of our proposed indications and primary endpoint assessments relating to the proposed indications of our product candidates by the
FDA and similar foreign regulatory authorities; |
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our
ability to demonstrate to the satisfaction of the FDA and similar foreign regulatory authorities, the safety and efficacy of our product
candidates or any future product candidates; |
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our
ability to identify an active compound within the drug product that can be detected in a pharmacokinetics study; |
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the
prevalence, duration and severity of potential side effects experienced in connection with our product candidates or future approved
products, if any; |
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the
timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities; |
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achieving
and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual
obligations and with all regulatory requirements applicable to our product candidates or any future product candidates or approved
products, if any; |
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the
ability of third parties with whom we contract to manufacture clinical trial and commercial supplies of our product candidates or any
future product candidates, remain in good standing with regulatory agencies and develop, validate and maintain commercially viable
manufacturing processes that are compliant with current good manufacturing practices, or cGMP, or good agricultural and collection
practices, or GACP; |
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a
continued acceptable safety profile during preclinical and clinical development and following approval of our product candidates or
any future product candidates; |
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our
ability to successfully commercialize our product candidates or any future product candidates in the United States and internationally,
if approved for marketing, sale and distribution in such countries and territories, whether alone or in collaboration with others; |
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acceptance
by physicians, patients and payors of the benefits, safety and efficacy of our product candidates or any future product candidates,
if approved, including relative to alternative and competing treatments; |
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our
ability to comply with numerous post-approval regulatory requirements; |
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our
and our partners’ ability to establish and enforce intellectual property rights in and to our product candidates or any future
product candidates; |
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our
and our partners’ ability to avoid third-party patent interference or intellectual property infringement claims; and |
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our
ability to in-license or acquire additional product candidates or commercial-stage products that we believe we can successfully develop
and commercialize. |
VAR
200 may not obtain an FDA designation as an Orphan Drug for FSGS. The FDA received our submission for Orphan Drug Designation on September
17, 2018. Orphan Drug Designation was unable to be granted because (1) the FSGS preclinical model used to support the request reflected
prevention rather than treatment of FSGS, which was the proposed indication for VAR 200, and (2) the FDA felt that the prevalence estimate
provided was underestimated based on the assumptions and calculations used. We plan to reapply for Orphan Drug Designation when clinical
data are available for VAR 200, using additional information to support the prevalence rate of FSGS.
If
we are unable to achieve one or more of the above factors, many of which are beyond our control, in a timely manner or at all, we could
experience significant delays and increased costs or an inability to obtain regulatory approvals or commercialize our product candidates.
Even if regulatory approvals are obtained, we may never be able to successfully commercialize any of our product candidates. Accordingly,
we cannot assure you that we will be able to generate sufficient revenue through the sale of our product candidates or any future
product candidates to continue operations.
Preclinical
drug development for our product candidate IC 100 is very expensive, time-consuming and uncertain. Our preclinical trials may fail to
adequately demonstrate pharmacologic activity in therapeutic areas of interest; cause unintended short- or long-term effects in other
bodily systems; or produce unexpected toxicity that may alter or risk benefit assessment. The class of compounds reflective of IC 100
has not entered into clinical trials, and the effects of the pharmacologic class are unknown. These and other factors could prevent or
delay further development.
The
scientific discoveries that form the basis for our efforts to generate and develop its product candidates are relatively recent. The
scientific evidence to support the feasibility of developing agents based on our approach is both preliminary and limited. IC 100 represents
a novel therapeutic modality and the successful development may require additional studies and efforts to optimize its therapeutic potential.
IC 100 may not demonstrate in patients the therapeutic properties ascribed to it in the laboratory or preclinical studies, and may interact
with human biological systems in unforeseen, ineffective or even harmful ways. If we are unable to successfully develop and commercialize
IC 100 it may never become profitable and the value of its capital stock may decline.
IC
100 is a relatively novel technology, which makes it difficult to predict the time and cost of development and of subsequently obtaining
regulatory approval, if at all.
We
have concentrated its research and development efforts on a limited number of initial targeted disease indications. There can be no assurance
that we will not experience problems or delays in developing its current or future indications and that such problems or delays will
not cause unanticipated costs, or that any such development problems can be solved. Preclinical data generated on IC 100 along with a
proposed clinical development plan requires review and allowance by the FDA under an Investigational New Drug Application. We have not
generated the data to support such an application, and the results of preclinical studies will require FDA review prior to the initiation
of clinical studies which may not be granted.
We
may not be successful in its efforts to use and expand its development platform to build a pipeline of product candidates.
A
key element of our strategy for IC 100 is to use its experienced management and scientific team to evaluate IC 100 in broad range of
human disease in order to build a pipeline of product candidates. Although our research and development efforts to date have resulted
in potential product candidates, we may not be able to continue to identify and develop additional product candidates. Even if we are
successful in continuing to build its pipeline, the potential product candidates that we identify may not be suitable for clinical development.
For example, these potential product candidates may be shown to have harmful side effects or other characteristics that indicate that
they are unlikely to receive marketing approval and achieve market acceptance. If we do not successfully develop and commercialize product
candidates based upon our approach, we will not be able to obtain product revenue in future periods, which likely would result
in significant harm to its financial position. There is no assurance that we will be successful in its preclinical and clinical development,
and the process of obtaining regulatory approvals will, in any event, require the expenditure of substantial time and financial resources.
Clinical
drug development for our product candidates is very expensive, time-consuming and uncertain. Our clinical trials may fail to adequately
demonstrate the safety and efficacy of our product candidates, which could prevent or delay regulatory approval and commercialization.
Clinical
drug development for our product candidates is very expensive, time-consuming, difficult to design and implement and its outcome is inherently
uncertain. Before obtaining regulatory approval for the commercial sale of a product candidate, we must demonstrate through clinical
trials that a product candidate is both safe and effective for use in the target indication, which is impossible to predict. Most product
candidates that commence clinical trials are never approved by regulatory authorities for commercialization. Our product candidates are
in various stages of development and a failure of one more clinical trial can occur at any stage of testing or at any time during the
trial process. We expect that clinical trials for these product candidates will continue for several years but may take significantly
longer than expected to complete. Not all of our product candidates have been tested in humans and the first use in humans may reveal
unexpected effects. We have not completed all clinical trials for the approval of any of our product candidates.
We
may experience delays in ongoing and future clinical trials for our product candidates and do not know if future clinical trials, if
any, will begin on time, need to be redesigned, enroll adequate number of patients on time or be completed on schedule, if at all. In
addition, we, any partner with which we currently or may in the future collaborate, the FDA, an Institutional Review Board (an “IRB”)
or other regulatory authorities, including state and local agencies and counterpart agencies in foreign countries, may suspend, delay,
require modifications to or terminate our clinical trials at any time, for various reasons, including:
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discovery
of safety or tolerability concerns, such as serious or unexpected toxicities or side effects or exposure to otherwise unacceptable
health risks, experienced by study participants or other safety issues; |
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lack
of effectiveness of any product candidate during clinical trials or the failure of our product candidates to meet specified endpoints; |
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slower
than expected rates of subject recruitment and enrollment rates or inability to enroll a sufficient number of patients in clinical
trials resulting from numerous factors, including the prevalence of other companies’ clinical trials for their product candidates
for the same indication, or clinical trials for indications for which patients do not as commonly seek treatment; |
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delays
or difficulties in our clinical trials due to quarantines or other restrictions resulting from the COVID-19 pandemic; |
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difficulty
in retaining subjects who have initiated a clinical trial but may withdraw at any time due to adverse side effects from the therapy,
insufficient efficacy, fatigue with the clinical trial process or for any other reason; |
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difficulty
in obtaining IRB approval for studies to be conducted at each clinical trial site; |
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delays
in manufacturing or obtaining, or inability to manufacture or obtain, sufficient quantities of materials for use in clinical trials; |
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inadequacy
of or changes in our manufacturing process or the product formulation or method of delivery; |
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changes
in applicable laws, regulations and regulatory policies; |
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delays
or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective contract research
organizations (“CRO”), clinical trial sites and other third-party contractors; |
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inability
to add a sufficient number of clinical trial sites; |
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uncertainty
regarding proper formulation and dosing; |
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failure
by us, our employees, our CROs or their employees or other third-party contractors to comply with contractual and applicable regulatory
requirements or to perform their services in a timely or acceptable manner; |
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failure
by us, our employees, our CROs or their employees or any partner with which we may collaborate or their employees to comply with applicable
FDA or other regulatory requirements relating to the conduct of clinical trials or the handling, storage, security and recordkeeping
for drug and biologic products; |
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scheduling
conflicts with participating clinicians and clinical institutions; |
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failure
to design appropriate clinical trial protocols; |
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insufficient
data to support regulatory approval; |
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inability
or unwillingness of medical investigators to follow our clinical protocols; or |
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difficulty
in maintaining contact with subjects during or after treatment, which may result in incomplete data. |
We
or any partner with which we may collaborate may suffer significant setbacks in our clinical trials similar to the experience of a number
of other companies in the pharmaceutical and biotechnology industries, even after receiving promising results in earlier trials. In the
event that we or our potential partners abandon or are delayed in the clinical development efforts related to our product candidates,
we may not be able to execute on our business plan effectively and our business, financial condition, operating results and prospects
would be harmed.
Changes
in methods of product candidate manufacturing or formulation may result in additional costs or delay.
As
product candidates proceed through preclinical studies to late-stage clinical trials towards potential approval and commercialization,
it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way
in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives. Any
of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other
future clinical trials conducted with the altered materials. Such changes may also require additional testing, FDA notification or FDA
approval. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or
more clinical trials.
We
may be unable to obtain regulatory approval for VAR 200 or IC 100, our early-stage product candidates under applicable regulatory requirements.
The FDA and foreign regulatory bodies have substantial discretion in the approval process, including the ability to delay, limit or deny
approval of product candidates. The delay, limitation or denial of any regulatory approval would adversely impact commercialization,
our potential to generate revenue, our business and our operating results.
We
currently have no products approved for sale, and we may never obtain regulatory approval to commercialize any of our current or future
product candidates. The research, testing, manufacturing, safety surveillance, efficacy, quality control, recordkeeping, labeling, packaging,
storage, approval, sale, marketing, distribution, import, export and reporting of safety and other post-market information related to
our drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States and in foreign
countries, and such regulations differ from country to country. We are not permitted to market any of our current product candidates
in the United States until we receive approval of a NDA, BLA or other applicable regulatory filing from the FDA. We are also not permitted
to market any of our current product candidates in any foreign countries until we or our partners receive the requisite approval from
the applicable regulatory authorities of such countries. To gain approval to market a new drug such as VAR 200 or IC 100, the FDA and/or
foreign regulatory authorities must receive, among other things, preclinical and clinical data that adequately demonstrate the safety,
purity, potency, efficacy and compliant manufacturing of the drug product for the intended indication applied for in a NDA, BLA or other
applicable regulatory filing. The development and approval of new drug products involves a long, expensive and uncertain process, and
delay or failure can occur at any stage. A number of companies in the pharmaceutical and biopharmaceutical industry have suffered significant
setbacks in nonclinical development, clinical trials, including in Phase 3 clinical development, even after promising results in earlier
preclinical studies or clinical trials. These setbacks have been caused by, among other things, findings made while clinical trials were
underway and safety or efficacy observations made in clinical trials, including previously unreported adverse events. Success in clinical
trials does not ensure that later clinical trials will be successful, or that nonclinical studies will be successful. The results of
clinical trials by other parties may not be indicative of the results in trials we or our partners may conduct.
The
FDA and foreign regulatory bodies have substantial discretion in the drug development and approval process, including the ability to
delay, limit drug development or limit or deny approval of product candidates for many reasons. The FDA or the applicable foreign regulatory
body may:
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disagree
with the design or implementation of one or more clinical trials; |
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not
deem a product candidate safe and effective for its proposed indication, or may deem a product candidate’s safety or other perceived
risks to outweigh its clinical or other benefits; |
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not
find the data from preclinical studies and clinical trials sufficient to support approval, or the results of clinical trials may not
meet the level of statistical or clinical significance required by the FDA or the applicable foreign regulatory body for approval; |
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disagree
with our interpretation of data from preclinical studies or clinical trials performed by us or third parties, or with the interpretation
of any partner with which we may collaborate; |
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determine
the data collected from preclinical or clinical trials may not be sufficient to support the submission of an IND or NDA, or other applicable
regulatory filing; |
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require
additional preclinical studies or clinical trials; |
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identify
deficiencies in the formulation, quality control, labeling or specifications of our current or future product candidates; |
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require
clinical trials in pediatric patients in order to establish pharmacokinetics or safety for this more drug-sensitive population; |
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grant
approval contingent on the performance of costly additional post-approval clinical trials; |
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approve
our current or any future product candidates for a more limited indication or a narrower patient population than we originally requested
or with strong warnings that may affect marketability; |
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not
approve the labeling that we believe is necessary or desirable for the successful commercialization of our product candidates; |
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not
approve of the manufacturing processes, controls or facilities of third-party manufacturers or testing labs with which we contract; |
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consider
our products a device instead of a drug requiring a different approval process and manufacturing needs; |
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consider
one of our products a combination product instead of a singular drug requiring additional clinical trials or increased number of patients
per study; or |
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change
its approval policies or adopt new regulations in a manner rendering our clinical data or regulatory filings insufficient for approval. |
Any
delay, limitation or denial in any applicable regulatory approval for any of our product candidates would delay or adversely impact commercialization
of our product candidates and would harm our business, financial condition, operating results and prospects.
Even
if our current product candidates or any future product candidates obtain regulatory approval, they may fail to achieve the broad degree
of physician and patient adoption and use necessary for commercial success.
The
commercial success of any of our current or future product candidates, if approved, will depend significantly on the broad adoption and
use of the resulting product by physicians, patients and payors for approved indications, and may not be commercially successful. The
degree and rate of adoption of our current or future product candidates, if approved, will depend on a number of factors, including:
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the
clinical indications for which the product is approved and patient demand for approved products that treat those indications; |
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the
effectiveness of our product as compared to other available therapies; |
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the
availability of coverage and adequate reimbursement from managed care plans and other healthcare payors for any of our product candidates
that may be approved; |
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the
cost of treatment with our product candidates in relation to alternative treatments and willingness to pay for the product, if approved,
on the part of patients; |
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acceptance
by physicians, major operators of clinics and patients of the product as a safe and effective treatment; |
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physician
and patient willingness to adopt a new therapy over other available therapies to treat approved indications; |
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overcoming
any biases physicians or patients may have toward particular therapies for the treatment of approved indications; |
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proper
training and administration of our product candidates by physicians and medical staff; |
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patient
satisfaction with the results and administration of our product candidates and overall treatment experience; |
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the
revenue and profitability that our product candidate may offer a physician as compared to alternative therapies; |
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the
prevalence and severity of side effects; |
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limitations
or warnings contained in the FDA-approved labeling for our product candidates; |
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any
FDA requirement to undertake a risk evaluation and mitigation strategy, or REMS; |
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the
effectiveness of our sales, marketing and distribution efforts; |
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our
ability to maintain sufficient quantities of supply to meet demand; |
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adverse
publicity about our product candidates or favorable publicity about competitive products; and |
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potential
product liability claims. |
If
any of our current or future product candidates are approved for use but fail to achieve the broad degree of physician and patient adoption
necessary for commercial success, our operating results and financial condition will be adversely affected, which may delay, prevent
or limit our ability to generate revenue and continue our business.
Our
product candidates, if approved, will face significant competition and our failure to effectively compete may prevent us from achieving
significant market penetration.
The
pharmaceutical industry is characterized by rapidly advancing technologies, intense competition, and a strong emphasis on developing
proprietary therapeutics. Numerous pharmaceutical companies, generic drug companies, biotechnology companies, and academic and research
institutions are engaged in the development, patenting, manufacturing, and marketing of health care products competitive with those that
we are developing, including Travere, Pfizer, Goldfinch Bio, Boehringer Ingelheim, Astra Zeneca, Sanofi, Novartis, Roche and others.
Many of our competitors have greater financial resources, marketing capabilities, sales forces, manufacturing capabilities, research
and development capabilities, clinical trial expertise, intellectual property portfolios, experience in obtaining patents and regulatory
approvals for product candidates and other resources than us. Some of the companies that offer competing products also have a broad range
of other product offerings, large direct sales forces and long-term customer relationships with our target physicians, which could inhibit
our market penetration efforts. In addition, certain of our product candidates, if approved, may compete with a share of some patients’
discretionary budgets and for physicians’ attention within their clinical practices.
We
anticipate that, if we obtain regulatory approval of our product candidates, we will face significant competition from other approved
therapies. If approved, our product candidates may also compete with unregulated, unapproved, off-label, and over the counter treatments.
Certain of our product candidates, if approved, will present novel therapeutic approaches for the approved indications and will have
to compete with existing therapies, some of which are widely known and accepted by physicians and patients. To compete successfully in
this market, we will have to demonstrate that the relative cost, safety and efficacy of our approved products, if any, provide an attractive
alternative to existing and other new therapies. Such competition could lead to reduced market share for our product candidates and contribute
to downward pressure on the pricing of our product candidates, which could harm our business, financial condition, operating results
and prospects.
We
expect to face generic or similar type of product competition for our product candidates, which could adversely affect our business,
financial condition, operating results and prospects.
Upon
the expiration or loss of any patent protection for any of our product candidates that are approved, or upon the “at-risk”
launch, despite pending patent infringement litigation against the generic product or its equivalent, by a generic competitor of a generic
version of any of our product candidates that are approved, which may be sold at significantly lower prices than our approved product
candidates, we could lose a significant portion of sales of that product in a short period of time, which would adversely affect our
business, financial condition, operating results and prospects.
Any
product candidates that we commercialize, or that any partner with which we may collaborate commercializes, will be subject to ongoing
and continued regulatory review.
Even
after we or our partners achieve U.S. regulatory approval for a product candidate, if any, we or our partners will be subject to continued
regulatory review and compliance obligations. For example, with respect to our product candidates, the FDA may impose significant restrictions
on the approved indicated uses for which the product may be marketed or on the conditions of approval. A product candidate’s approval
may contain requirements for potentially costly post-approval studies and surveillance, including Phase 4 clinical trials or a REMS,
to monitor the safety and efficacy of the product. We will also be subject to ongoing FDA obligations and continued regulatory review
with respect to, among other things, the manufacturing, processing, labeling, packaging, distribution, adverse event reporting, storage,
advertising, promotion and recordkeeping for our product candidates. These requirements include submissions of safety and other post-marketing
information and reports, registration, as well as continued compliance with cGMP requirements, with the FDA’s good clinical practice,
or GCP, or good agricultural and collections practices, or GACP, requirements and good laboratory practice, or GLP, requirements, which
are regulations and guidelines enforced by the FDA for all of our product candidates in clinical and preclinical development, and for
any clinical trials that we conduct post-approval. To the extent that a product candidate is approved for sale in other countries, we
may be subject to similar restrictions and requirements imposed by laws and government regulators in those countries.
If
we, our partners, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory
requirements, a regulatory agency may:
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impose
restrictions on the marketing or manufacturing of the product, suspend or withdraw product approvals or revoke necessary licenses; |
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mandate
modifications to promotional materials or require us to provide corrective information to healthcare practitioners; |
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require
us or our partners to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs,
required due dates for specific actions and penalties for noncompliance; |
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issue
warning letters, show cause notices or untitled letters describing alleged violations, which may be publicly available; |
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commence
criminal investigations and prosecutions; |
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impose
injunctions, suspensions or revocations of necessary approvals or other licenses; |
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impose
other civil or criminal penalties; |
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suspend
any ongoing clinical trials; |
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delay
or refuse to approve pending applications or supplements to approved applications filed by us or our potential partners; |
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refuse
to permit drugs or precursor chemicals to be imported or exported to or from the United States; |
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suspend
or impose restrictions on operations, including costly new manufacturing requirements; or |
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seize
or detain products or require us or our partners to initiate a product recall. |
The
regulations, policies or guidance of the FDA and other applicable government agencies may change, and new or additional statutes
or government regulations may be enacted that could prevent or delay regulatory approval of our product candidates or further restrict
or regulate post-approval activities. We cannot predict the likelihood, nature or extent of adverse government regulation that may arise
from future legislation or administrative action, either in the United States or abroad. If we are not able to achieve and maintain regulatory
compliance, we may not be permitted to market our product candidates, which would adversely affect our ability to generate revenue
and achieve or maintain profitability.
We
may in the future conduct clinical trials for our product candidates outside the United States and the FDA and applicable foreign regulatory
authorities may not accept data from such trials.
We
may in the future choose to conduct one or more of our clinical trials outside the United States, including in Canada, Europe and South
America. Although the FDA or applicable foreign regulatory authority may accept data from clinical trials conducted outside the United
States or the applicable jurisdiction, acceptance of such study data by the FDA or applicable foreign regulatory authority may be subject
to certain conditions. Where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United
States, the FDA will not approve the application on the basis of foreign data alone unless those data are applicable to the U.S. population
and U.S. medical practice; the studies were performed by clinical investigators of recognized competence; and the data are considered
valid without the need for an on-site inspection by the FDA or, if the FDA considers such an inspection to be necessary, the FDA is able
to validate the data through an on-site inspection or other appropriate means. Many foreign regulatory bodies have similar requirements.
In addition, such foreign studies would be subject to the applicable local laws of the foreign jurisdictions where the studies are conducted.
There can be no assurance the FDA or applicable foreign regulatory authority will accept data from trials conducted outside of the United
States or the applicable jurisdiction. If the FDA or applicable foreign regulatory authority does not accept such data, it would likely
result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan.
Our
product candidates may cause undesirable side effects or have other unexpected properties that could delay or prevent their regulatory
approval, limit the commercial profile of an approved label or result in post-approval regulatory action.
Unforeseen
side effects from any of our product candidates could arise either during clinical development or, if approved, after the approved product
has been marketed. Undesirable side effects caused by product candidates could cause us, any partners with which we may collaborate or
regulatory authorities to interrupt, modify, delay or halt clinical trials and could result in a more restrictive label or the delay
or denial of regulatory approval by the FDA or comparable foreign authorities. Results of clinical trials could reveal a high and unacceptable
severity and prevalence of side effects. In such an event, trials could be suspended or terminated, and the FDA or comparable
foreign regulatory authorities could order us, or our potential partners, to cease further development of or deny approval of product
candidates for any or all targeted indications. The drug-related side effects could affect patient recruitment or the ability of enrolled
patients to complete the trial or result in product liability claims. Any of these occurrences may harm our business, financial condition,
operating results and prospects.
Additionally,
if we or others identify undesirable side effects, or other previously unknown problems, caused by our product candidates after obtaining
U.S. or foreign regulatory approval or other products with the same or related active ingredients, a number of potentially negative consequences
could result, including:
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regulatory
authorities may withdraw their approval of the product; |
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regulatory
authorities may require a recall of the product or we or our potential partners may voluntarily recall a product; |
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regulatory
authorities may require the addition of warnings or contraindications in the product labeling, narrowing of the indication in the product
label or field alerts to physicians and pharmacies; |
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we
may be required to create a medication guide outlining the risks of such side effects for distribution to patients or institute a REMS; |
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we
may have limitations on how we promote the product; |
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we
may be required to change the way the product is administered or modify the product in some other way; the FDA or applicable foreign
regulatory authority may require additional clinical trials or costly post-marketing testing and surveillance to monitor the safety
or efficacy of the product; |
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the
FDA or applicable foreign regulatory authority may require additional clinical trials or costly post-marketing testing and surveillance
to monitor the safety or efficacy of the product |
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sales
of the product may decrease significantly; |
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we
could be sued and held liable for harm caused to patients; and |
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our
brand and reputation may suffer. |
Any
of the above events resulting from undesirable side effects or other previously unknown problems could prevent us or our potential partners
from achieving or maintaining market acceptance of the affected product candidate and could substantially increase the costs of commercializing
our product candidates.
We
may face product liability exposure, and if successful claims are brought against us, we may incur substantial liability if our insurance
coverage for those claims is inadequate.
We
face an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an even greater
risk if we commercialize any products. This risk exists even if a product is approved for commercial sale by the FDA and manufactured
in facilities licensed and regulated by the FDA or an applicable foreign regulatory authority. Our products and product candidates are
designed to affect important bodily functions and processes. Any side effects, manufacturing defects, misuse or abuse associated with
our product candidates could result in injury to a patient or even death. We cannot offer any assurance that we will not face product
liability suits in the future, nor can we assure you that our insurance coverage will be sufficient to cover our liability under any
such cases.
In
addition, a liability claim may be brought against us even if our product candidates merely appear to have caused an injury. Product
liability claims may be brought against us by consumers, health care providers, pharmaceutical companies or others selling or otherwise
coming into contact with our product candidates, among others. If we cannot successfully defend ourselves against product liability claims
we will incur substantial liabilities and reputational harm. In addition, regardless of merit or eventual outcome, product liability
claims may result in:
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withdrawal
of clinical trial participants; |
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termination
of clinical trial sites or entire trial programs; |
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inability
to gain regulatory approval of our product candidates; |
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the
inability to commercialize our product candidates; |
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decreased
demand for our product candidates; |
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impairment
of our business reputation; |
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product
recall or withdrawal from the market or labeling, marketing or promotional restrictions; |
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substantial
costs of any related litigation or similar disputes; |
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distraction
of management’s attention and other resources from our primary business; |
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substantial
monetary awards to patients or other claimants against us that may not be covered by insurance; or |
We
currently maintain product liability insurance coverage, which may not be sufficient to cover all of our product liability related expenses
or losses and may not cover us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive,
and, in the future, we may not be able to maintain insurance coverage at a reasonable cost, in sufficient amounts or upon adequate terms
to protect us against losses due to product liability. We will need to increase our product liability coverage if any of our product
candidates receive regulatory approval, which will be costly, and we may be unable to obtain this increased product liability insurance
on commercially reasonable terms, or at all. A successful product liability claim or series of claims brought against us could
cause our stock price to decline and, if judgments exceed our insurance coverage, could decrease our cash and could harm our business,
financial condition, operating results and prospects.
If
any of our product candidates are approved for marketing and we are found to have improperly promoted off-label uses, or if physicians
misuse our products or use our products off-label, we may become subject to prohibitions on the sale or marketing of our products, product
liability claims and significant fines, penalties and sanctions, and our brand and reputation could be harmed.
The
FDA and other regulatory agencies strictly regulate the marketing and promotional claims that are made about drug and biologic products.
In particular, a product may not be promoted for uses or indications that are not approved by the FDA or such other regulatory agencies
as reflected in the product’s approved labeling and comparative safety or efficacy claims cannot be made without direct comparative
clinical data. If we are found to have promoted off-label uses of any of our product candidates, we may receive warning or untitled letters
and become subject to significant liability, which would materially harm our business. Both federal and state governments have levied
large civil and criminal fines against companies for alleged improper promotion and have enjoined several companies from engaging in
off-label promotion. If we become the target of such an investigation or prosecution based on our marketing and promotional practices,
we could face similar sanctions, which would materially harm our business. In addition, management’s attention could be diverted
from our business operations, significant legal expenses could be incurred and our brand and reputation could be damaged. The FDA has
also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed
or curtailed. If we are deemed by the FDA to have engaged in the promotion of our products for off-label use, we could be subject to
FDA regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine
or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider
our business activities constitute promotion of an off-label use, which could result in significant penalties, including criminal, civil
or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs and the curtailment
or restructuring of our operations.
We
cannot, however, prevent a physician from using our product candidates outside of those indications for use when in the physician’s
independent professional medical judgment he or she deems appropriate. Physicians may also misuse our product candidates or use improper
techniques, potentially leading to adverse results, side effects or injury, which may lead to product liability claims. If our product
candidates are misused or used with improper technique, we may become subject to costly litigation by physicians or their patients. Furthermore,
the use of our product candidates for indications other than those cleared by the FDA may not effectively treat such conditions, which
could harm our reputation among physicians and patients.
We
may choose not to continue developing or commercializing any of our product candidates at any time during development or after approval,
which would reduce or eliminate our potential return on investment for those product candidates.
At
any time, we may decide to discontinue the development of any of our product candidates or not to continue commercializing one or more
of our approved product candidates for a variety of reasons, including the appearance of new technologies that make our product obsolete,
competition from a competing product or changes in or failure to comply with applicable regulatory requirements. If we terminate a program
in which we have invested significant resources, we will not receive any return on our investment and we will have missed the opportunity
to have allocated those resources to potentially more productive uses.
We
or our current and prospective partners may be subject to product recalls in the future that could harm our brand and reputation and
could negatively affect our business.
We
or our current and prospective partners may be subject to product recalls, withdrawals or seizures if any of our product candidates,
if approved for marketing, fail to meet specifications or are believed to cause injury or illness or if we are alleged to have violated
governmental regulations including those related to the manufacture, labeling, promotion, sale or distribution. Any recall, withdrawal
or seizure in the future could materially and adversely affect consumer confidence in our brands and lead to decreased demand for our
approved products. In addition, a recall, withdrawal or seizure of any of our approved products would require significant management
attention, would likely result in substantial and unexpected expenditures and would harm our business, financial condition and operating
results.
If
we or any partners with which we may collaborate are unable to achieve and maintain coverage and adequate levels of reimbursement for
any of our product candidates for which we receive regulatory approval, or any future products we may seek to commercialize, their commercial
success may be severely hindered.
For
any of our product candidates that become available only by prescription, successful sales by us or by any partners with which we may
collaborate depend on the availability of coverage and adequate reimbursement from third-party payors. Patients who are prescribed medicine
for the treatment of their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their
prescription drugs. The availability of coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and
Medicaid, and private third-party payors is critical to new product acceptance. Coverage decisions may depend upon clinical and economic
standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already available or subsequently
become available. If any of our product candidates do not demonstrate attractive efficacy profiles, they may not qualify for coverage
and reimbursement. Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate or
may require co-payments that patients find unacceptably high. Patients are unlikely to use our products unless coverage is provided and
reimbursement is adequate to cover a significant portion of the cost of our products.
In
addition, the market for our product candidates will depend significantly on access to third-party payors’ drug formularies or
lists of medications for which third-party payors provide coverage and reimbursement. The industry competition to be included in such
formularies often leads to downward pricing pressures on pharmaceutical companies. Also, third-party payors may refuse to include a particular
branded drug in their formularies or otherwise restrict patient access to a branded drug when a less costly generic equivalent or another
alternative is available.
Further,
third-party payors, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of
controlling healthcare costs. In addition, in the United States, although private third-party payors tend to follow Medicare, no uniform
policy of coverage and reimbursement for drug products exists among third-party payors. Therefore, coverage and reimbursement for drug
products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and
costly process that will require us to provide scientific and clinical support for the use of our product candidates to each payor separately,
with no assurance that coverage and adequate reimbursement will be obtained.
Further,
we believe that future coverage and reimbursement will likely be subject to increased restrictions both in the United States and in international
markets. Third-party coverage and reimbursement for any of our product candidates for which we may receive regulatory approval may not
be available or adequate in either the United States or international markets, which could harm our business, financial condition, operating
results and prospects.
Healthcare
legislative or regulatory reform measures, including government restrictions on pricing and reimbursement, may have a negative impact
on our business and results of operations.
In
the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and
proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate
post approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval.
Among
policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems
with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical
industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. For example,
in the United States, the Patient Protection and Affordable Care Act of 2010 (the “ACA”), substantially changed the
way health care is financed by both governmental and private insurers and significantly affects the pharmaceutical industry. Many provisions
of the ACA impact the biopharmaceutical industry, including that in order for a biopharmaceutical product to receive federal reimbursement
under the Medicare Part B and Medicaid programs or to be sold directly to U.S. government agencies, the manufacturer must extend discounts
to entities eligible to participate in the drug pricing program under the Public Health Services Act (the “ PHS”).
Since its enactment, there have been judicial and Congressional challenges and amendments to certain aspects of the ACA. There is continued
uncertainty about the implementation of the ACA, including the potential for further amendments to the ACA and legal challenges to or
efforts to repeal the ACA.
Additionally,
there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost
of prescription drugs and biologics. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal
and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing
and manufacturer patient programs, and reform government program reimbursement methodologies for products. At the federal level, the
now-departed Trump administration proposed numerous prescription drug cost control measures. Similarly, the new Biden administration
has made lowering prescription drug prices one of its priorities. The Biden administration has not yet proposed any specific plans, but
we expect that these will be forthcoming in the near term. At the state level, legislatures are increasingly passing legislation and
implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement
constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some
cases, designed to encourage importation from other countries and bulk purchasing.
Other
examples of proposed changes include, but are not limited to, expanding post-approval requirements, changing the Orphan Drug Act, and
restricting sales and promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will
be enacted, or whether government regulations, guidance or interpretations will be changed, or what the impact of such changes would
be on the marketing approvals, sales, pricing, or reimbursement of our drug candidates or products, if any, may be. We expect that these
and other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional
downward pressure on the price that we receive for any approved drug. Any reduction in reimbursement from Medicare or other government
programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other
healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our drugs.
In
addition, FDA regulations and guidance may be revised or reinterpreted by the FDA in ways that may significantly affect our business
and our products. Any new regulations or guidance, or revisions or reinterpretations of existing regulations or guidance, may impose
additional costs or lengthen FDA review times for DMT310 or any future product candidates. We cannot determine how changes in regulations,
statutes, policies, or interpretations when and if issued, enacted or adopted, may affect our business in the future. Such changes could,
among other things, require:
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additional
clinical trials to be conducted prior to obtaining approval; |
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changes
to manufacturing methods; |
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recalls,
replacements, or discontinuance of one or more of our products; and |
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recordkeeping. |
Such
changes would likely require substantial time and impose significant costs, or could reduce the potential commercial value of our product
candidates. In addition, delays in receipt of or failure to receive regulatory clearances or approvals for any other products would harm
our business, financial condition, and results of operations.
We
may also be subject to healthcare laws, regulation and enforcement and our failure to comply with those laws could adversely affect our
business, operations and financial condition.
Certain
federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable
to our business. We are subject to regulation by both the federal government and the states in which we or our partners conduct our business.
The laws and regulations that may affect our ability to operate include:
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the
federal Anti-Kickback Statute, which prohibits, among other things, any person or entity from knowingly and willfully offering, soliciting,
receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in
cash or in kind, to induce either the referral of an individual or in return for the purchase, lease, or order of any good, facility
item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as the Medicare and Medicaid
programs; |
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federal
civil and criminal false claims laws and civil monetary penalty laws, including, for example, the federal civil False Claims Act, which
impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for, among other
things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs,
claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money
to the federal government; |
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the
federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created new federal criminal
statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program
or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under
the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private), knowingly and willfully
embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense
and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false
statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters; |
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HIPAA,
as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose
obligations on covered entities, including healthcare providers, health plans, and healthcare clearinghouses, as well as their respective
business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered
entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; |
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the
federal physician sunshine requirements under the Affordable Care Act, which require manufacturers of drugs, devices, biologics and
medical supplies to report annually to the Centers for Medicare & Medicaid Services information related to payments and other transfers
of value provided to physicians and teaching hospitals, and ownership and investment interests held by physicians and their immediate
family members; and |
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state
law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services
reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with
the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal
government, or otherwise restrict payments that may be provided to healthcare providers and other potential referral sources; state
laws that require drug manufacturers to report information related to payments and other transfers of value to healthcare providers
or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of
which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. |
Because
of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our
business activities could be subject to challenge under one or more of such laws. In addition, recent health care reform legislation
has strengthened these laws. For example, the Affordable Care Act, among other things, amended the intent requirement
of the federal Anti-Kickback Statute and certain criminal healthcare fraud statutes. A person or entity no longer needs to have actual
knowledge of the statute or specific intent to violate it. In addition, the Affordable Care Act provided that the government may assert
that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent
claim for purposes of the federal civil False Claims Act.
Achieving
and sustaining compliance with these laws may prove costly. In addition, any action against us for violation of these laws, even if we
successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the
operation of our business. If our operations are found to be in violation of any of the laws described above or any other governmental
laws or regulations that apply to us, we may be subject to penalties, including administrative, civil and criminal penalties, damages,
fines, disgorgement, the exclusion from participation in federal and state healthcare programs, individual imprisonment or the curtailment
or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.
Our
business involves the use of hazardous materials and we and our third-party suppliers and manufacturers must comply with environmental
laws and regulations, which can be expensive and restrict how we do business.
The
manufacturing activities of our third-party suppliers and manufacturers involve the controlled storage, use and disposal of hazardous
materials owned by us, including the components of our product candidates and other hazardous compounds. We and our manufacturers and
suppliers are subject to laws and regulations governing the use, manufacture, storage, handling, and disposal of these hazardous materials.
In some cases, these hazardous materials and various wastes resulting from their use are stored at our suppliers’ or manufacturers’
facilities pending use and disposal. We and our suppliers and manufacturers cannot completely eliminate the risk of contamination, which
could cause an interruption of our commercialization efforts, research and development efforts and business operations, injury to our
service providers and others and environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations
governing the use, storage, handling and disposal of these materials and specified waste products. Although we believe that the safety
procedures utilized by our third-party suppliers and manufacturers for handling and disposing of these materials generally comply with
the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental
contamination or injury from these materials. In such an event, we may be held liable for any resulting damages and such liability could
exceed our resources. We do not currently carry biological or hazardous waste insurance coverage.
Our
employees, independent contractors, principal investigators, consultants, vendors, CROs and any partners with which we may collaborate
may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
We
are exposed to the risk that our employees, independent contractors, principal investigators, consultants, vendors, CROs and any partners
with which we may collaborate may engage in fraudulent or other illegal activity. Misconduct by these persons could include intentional,
reckless or negligent conduct or unauthorized activity that violates: laws or regulations, including those laws requiring the reporting
of true, complete and accurate information to the FDA or foreign regulatory authorities; manufacturing standards; federal, state and
foreign healthcare fraud and abuse laws and data privacy; or laws that require the true, complete and accurate reporting of financial
information or data. In particular, sales, marketing and other business arrangements in the healthcare industry are subject to extensive
laws intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws may restrict or prohibit a wide range
of business activities, including research, manufacturing, distribution, pricing, discounting, marketing and promotion, sales commission,
customer incentive programs and other business arrangements. Activities subject to these laws also involve the improper use of information
obtained in the course of clinical trials, or illegal misappropriation of drug product, which could result in regulatory sanctions or
other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations, and serious harm to our reputation.
In addition, federal procurement laws impose substantial penalties for misconduct in connection with government contracts and require
certain contractors to maintain a code of business ethics and conduct. If any such actions are instituted against us, and we are not
successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the
imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare,
Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment
of our operations, any of which could adversely affect our ability to operate our business and our operating results.
Actual
or alleged non-compliance with applicable employment laws and regulation may require operational changes and undermine our competitive
positioning or have other material adverse effects on our business.
Our
business is subject to a variety of employment laws and regulations and may become subject to additional such requirements in the future.
Although we believe we are in in material compliance with applicable employment laws and regulations, in the event of a change in requirements,
we may be required to modify our operations or to utilize resources to maintain compliance with such laws and regulations. Moreover,
we may be subject to various employment-related claims including individual actions, class actions, and government enforcement actions
relating to alleged employment discrimination, employee classification and related withholding, wage-hour disputes, labor standards or
healthcare and benefit issues in the future. Such claims, regardless of validity, may have a material adverse effect on our business,
financial condition, cash flows or other results of operations.
Our
future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens
and other risks and uncertainties.
Our
future profitability will depend, in part, on our ability to commercialize our product candidates in foreign markets for which we intend
to rely on collaborations with third parties. If we commercialize VAR 200 or IC 100 or our other product candidates in foreign markets,
we would be subject to additional risks and uncertainties, including:
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our
customers’ ability to obtain market access and appropriate reimbursement for our product candidates in foreign markets; |
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our
inability to directly control commercial activities because we are relying on third parties; |
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the
burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements; |
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different
medical practices and customs in foreign countries affecting acceptance in the marketplace |
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import
or export licensing requirements; |
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longer
accounts receivable collection times; |
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longer
lead times for shipping; |
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language
barriers for technical training; |
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reduced
protection of intellectual property rights in some foreign countries; |
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foreign
currency exchange rate fluctuations; and |
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the
interpretation of contractual provisions governed by foreign laws in the event of a contract dispute. |
Foreign
sales of our product candidates could also be adversely affected by the imposition of governmental controls, political and economic instability,
trade restrictions and changes in tariffs, any of which may adversely affect our results of operations.
As
a result of Business Combination with a special purpose acquisition company, regulatory obligations may impact us differently than other
publicly traded companies.
We
became a publicly traded company by completing the Business Combination with Larkspur, a special purpose acquisition company (a “SPAC”).
As a result of the Business Combination, and the transactions contemplated thereby, our regulatory obligations have, and may continue,
to impact us differently than other publicly traded companies. For instance, the SEC and other regulatory agencies may issue additional
guidance or apply further regulatory scrutiny to companies like us that have completed a business combination with a SPAC. Managing this
regulatory environment, which has and may continue to evolve, could divert management’s attention from the operation of our business,
negatively impact our ability to raise additional capital when needed or have an adverse effect on the price of our common stock.
Risks
Related to Our Dependence on Third Parties
We
have in the past relied and expect to continue to rely on third-party CROs and other third parties to conduct and oversee our clinical
trials and other aspects of product development. If these third parties do not meet our requirements or otherwise conduct the trials
as required, we may not be able to satisfy our contractual obligations or obtain regulatory approval for, or commercialize, our product
candidates when expected or at all.
We
have in the past relied and expect to continue to rely on third-party CROs to conduct and oversee our clinical trials and other aspects
of product development. We also rely upon various medical institutions, clinical investigators and contract laboratories to conduct our
trials in accordance with our clinical protocols and all applicable regulatory requirements, including the FDA’s regulations and
GCPs, which are an international standard meant to protect the rights and health of patients and to define the roles of clinical trial
sponsors, administrators and monitors, and state regulations governing the handling, storage, security and recordkeeping for drug and
biologic products. These CROs and other third parties play a significant role in the conduct of these trials and the subsequent collection
and analysis of data from the clinical trials. We rely heavily on these parties for the execution of our clinical trials and preclinical
studies, and control only certain aspects of their activities. We and our CROs and other third-party contractors are required to comply
with GCP, GLP, and GACP requirements, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities
for products in clinical development. Regulatory authorities enforce these GCP, GLP and GACP requirements through periodic inspections
of trial sponsors, principal investigators and trial sites. If we or any of these third parties fail to comply with applicable GCP, GLP
and GACP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or other regulatory authority
may require us to perform additional clinical trials before approving our or our partners’ marketing applications. We cannot assure
you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical or preclinical
trials complies with applicable GCP and GLP requirements. In addition, our clinical trials must generally be conducted with product produced
under cGMP regulations. Our failure to comply with these regulations and policies may require us to repeat clinical trials, which would
delay the regulatory approval process.
Our
CROs are not our employees, and we do not control whether or not they devote sufficient time and resources to our clinical trials. Our
CROs may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical
trials, or other drug development activities, which could harm our competitive position. We face the risk of potential unauthorized disclosure
or misappropriation of our intellectual property by CROs, which may reduce our trade secret protection and allow our potential competitors
to access and exploit our proprietary technology. If our CROs do not successfully carry out their contractual duties or obligations,
fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to
adhere to our clinical protocols or regulatory requirements or for any other reason, our clinical trials may be extended, delayed or
terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize any product candidate that we develop.
As a result, our financial results and the commercial prospects for any product candidate that we develop would be harmed, our costs
could increase, and our ability to generate revenue could be delayed.
If
any of our CROs or clinical trial sites terminate their involvement in one of our clinical trials for any reason, we may not be able
to enter into arrangements with alternative CROs or clinical trial sites, or do so on commercially reasonable terms. In addition, if
our relationship with clinical trial sites is terminated, we may experience the loss of follow-up information on patients enrolled in
our ongoing clinical trials unless we are able to transfer the care of those patients to another qualified clinical trial site. In addition,
principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and could receive
cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived
or actual conflicts of interest, the integrity of the data generated at the applicable clinical trial site may be questioned by the FDA.
We
rely completely on third-party contractors to supply, manufacture and distribute clinical drug supplies for our product candidates, including
certain sole-source suppliers and manufacturers, we intend to rely on third parties for commercial supply, manufacturing and distribution
if any of our product candidates receive regulatory approval and we expect to rely on third parties for supply, manufacturing and distribution
of preclinical, clinical and commercial supplies of any future product candidates.
We
do not currently have, nor do we plan to acquire, the infrastructure or capability to supply, manufacture or distribute preclinical,
clinical or commercial quantities of drug substances or products. Our ability to develop our product candidates depends and our ability
to commercially supply our products will depend, in part, on our ability to successfully obtain the raw materials and APIs and other
substances and materials used in our product candidates from third parties and to have finished products manufactured by third parties
in accordance with regulatory requirements and in sufficient quantities for preclinical and clinical testing and commercialization. If
we fail to develop and maintain supply relationships with these third parties, we may be unable to continue to develop or commercialize
our product candidates.
We
rely and will continue to rely on certain third parties as the sole source of the materials they supply or the finished products they
manufacture. Any of our existing suppliers or manufacturers may:
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to supply us with product on a timely basis or in the requested amount due to unexpected damage to or destruction of facilities or
equipment or otherwise; |
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fail
to increase manufacturing capacity and produce drug product and components in larger quantities and at higher yields in a timely
or cost-effective manner, or at all, to sufficiently meet our commercial needs; |
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be
unable to meet our production demands due to issues related to their reliance on sole-source suppliers and manufacturers; |
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supply
us with product that fails to meet regulatory requirements; |
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become
unavailable through business interruption or financial insolvency; |
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regulatory status as an approved source; |
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be
unable or unwilling to renew current supply agreements when such agreements expire on a timely basis, on acceptable terms or at all;
or |
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production or manufacturing of necessary drug substances or products. |
In
the event of any of the foregoing, if we do not have an alternative supplier or manufacturer in place, we would be required to expend
substantial management time and expense to identify, qualify and transfer processes to alternative suppliers or manufacturers. Transferring
technology to other sites may require additional processes, technologies and validation studies, which are costly, may take considerable
amounts of time, may not be successful and, in most cases, require review and approval by the FDA. Any need to find and qualify new suppliers
or manufacturers could significantly delay production of our product candidates, adversely impact our ability to market our product candidates
and adversely affect our business. Replacements may not be available to us on a timely basis, on acceptable terms or at all. Additionally,
we and our manufacturers do not currently maintain significant inventory of drug substances and other materials. Any interruption in
the supply of a drug substance or other material or in the manufacture of our product candidates could have a material adverse effect
on our business, financial condition, operating results and prospects.
We
do not have direct control over the ability of our contract suppliers and manufacturers to maintain adequate capacity and capabilities
to serve our needs, including quality control, quality assurance and qualified personnel. Although we are ultimately responsible for
ensuring compliance with regulatory requirements such as cGMPs and GACP, we are dependent on our contract suppliers and manufacturers
for day-to-day compliance with cGMPs or GACP for production of raw materials, APIs and finished products. Facilities used by our contract
suppliers and manufacturers to produce the APIs and other substances and materials or finished products for commercial sale must pass
inspection and be approved by the FDA and other relevant regulatory authorities. Our contract suppliers and manufacturers must comply
with cGMP and GACP requirements enforced by the FDA through its facilities inspection program and review of submitted technical information.
If the safety of any product or product candidate or component is compromised due to a failure to adhere to applicable laws or for other
reasons, we may not be able to successfully commercialize or obtain regulatory approval for the affected product or product candidate,
and we may be held liable for injuries sustained as a result. Any of these factors could cause a delay or termination of preclinical
studies, clinical trials or regulatory submissions or approvals of our product candidates, and could entail higher costs or result in
our being unable to effectively commercialize our approved products on a timely basis, or at all.
In
addition, these contract manufacturers are engaged with other companies to supply and manufacture materials or products for such companies,
which also exposes our suppliers and manufacturers to regulatory risks for the production of such materials and products. As a result,
failure to meet the regulatory requirements for the production of those materials and products may also affect the regulatory clearance
of a contract supplier’s or manufacturer’s facility. If the FDA or a comparable foreign regulatory agency does not approve
these facilities for the supply or manufacture of our product candidates, or if it withdraws its approval in the future, we may need
to find alternative supply or manufacturing facilities, which would negatively impact our ability to develop, obtain regulatory approval
of or market our product candidates, if approved.
Our
reliance on contract manufacturers and suppliers further exposes us to the possibility that they, or third parties with access to their
facilities, will have access to and may misappropriate our trade secrets or other proprietary information.
If
we are not able to establish and maintain collaborations, we may have to alter our development and commercialization plans.
The
development and potential commercialization of our product candidates will require substantial additional cash to fund expenses. In order
to fund further development of our product candidates, we may collaborate with pharmaceutical and biotechnology companies for the development
and potential commercialization of those product candidates. We face significant competition in seeking appropriate partners. Whether
we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the partner’s resources
and experience, the terms and conditions of the proposed collaboration and the proposed partner’s evaluation of a number of factors.
Those factors may include the design or results of clinical trials; the likelihood of approval by the FDA or other regulatory authorities;
the potential market for the subject product candidate; the costs and complexities of manufacturing and delivering such product candidate
to patients; the potential of competing products; any uncertainty with respect to our ownership of our intellectual property; and industry
and market conditions generally. The partner may also consider alternative product candidates or technologies for similar indications
that may be available for collaboration and whether such a collaboration could be more attractive than the one with us for our product
candidate. We may also be restricted under future license agreements from entering into agreements on certain terms with potential partners.
Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of recent
business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future partners.
Future
collaborations we may enter into may involve the following risks:
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collaborators
may have significant discretion in determining the efforts and resources that they will apply to these collaborations; |
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collaborators
may not perform their obligations as expected; |
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changes
in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, may divert resources
or create competing priorities; |
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collaborators
may delay discovery and preclinical development, provide insufficient funding for product development of targets selected by us,
stop or abandon discovery and preclinical development for a product candidate, repeat or conduct new discovery and preclinical development
for a product candidate; |
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collaborators
could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product
candidates if the collaborators believe that competitive products are more likely to be successfully developed than ours; |
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product
candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates
or products, which may cause collaborators to cease to devote resources to the development of our product candidates; |
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disagreements
with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development,
might cause delays or termination of the discovery, preclinical development or commercialization of product candidates, might lead
to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which
would be time-consuming and expensive; |
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collaborators
may not properly maintain or defend our intellectual property rights or intellectual property rights licensed to us or may use our
proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary
information or expose us to potential litigation; |
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collaborators
may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; and |
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collaborations
may be terminated for the convenience of the collaborator and, if terminated, we could be required to raise additional capital to
pursue further development or commercialization of the applicable product candidates. |
Collaborations
typically impose detailed obligations on each party. If we were to breach our obligations, we may face substantial consequences, including
potential termination of the collaboration, and our rights to our partners’ product candidates, in which we have invested substantial
time and money, would be lost.
We
may not be able to negotiate collaborations on a timely basis, on acceptable terms or at all. If we are unable to do so, we may have
to curtail the development of a product candidate, reduce or delay its development program or one or more of our other development programs,
delay its potential commercialization or increase our expenditures and undertake development or commercialization activities at our own
expense. If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain
additional capital, which may not be available to us on acceptable terms or at all. If we do not have sufficient funds, we may not be
able to further develop our product candidates or bring them to market and generate product revenue.
Risks
Related to Managing Our Growth, Our Employees and Our Operations
We
will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in executing
our growth strategy and managing any growth.
Our
management, personnel, systems and facilities currently in place are not adequate to support our business plan and near-term future growth.
We will need to further expand our chemistry and manufacturing team, clinical team, managerial, operational, financial, and other resources
to support our planned research, development and commercialization activities.
To
manage our operations, growth and various projects effectively requires that we:
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to improve our operational, financial, management and regulatory compliance controls and reporting systems and procedures; |
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attract
and retain sufficient numbers of talented employees; |
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develop
a marketing, sales and distribution capability; |
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manage
our commercialization activities for our product candidates effectively and in a cost-effective manner; |
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establish
and maintain relationships with development and commercialization partners; |
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manage
our preclinical and clinical trials effectively; |
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manage
our third-party supply and manufacturing operations effectively and in a cost-effective manner, while increasing production capabilities
for our current product candidates to commercial levels; and |
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manage
our development efforts effectively while carrying out our contractual obligations to partners and other third parties. |
In
addition, historically, we have utilized and continue to utilize the services of part-time outside consultants to perform a number of
tasks for us, including tasks related to preclinical and clinical testing. Our growth strategy may also entail expanding our use of consultants
to implement these and other tasks going forward. We rely on consultants for certain functions of our business and will need to effectively
manage these consultants to ensure that they successfully carry out their contractual obligations and meet expected deadlines. There
can be no assurance that we will be able to manage our existing consultants or find other competent outside consultants, as needed, on
economically reasonable terms, or at all. If we are not able to effectively manage our growth and expand our organization by hiring new
employees and expanding our use of consultants, we might be unable to successfully implement the tasks necessary to execute effectively
on our planned research, development and commercialization activities and, accordingly, might not achieve our research, development and
commercialization goals.
If
we fail to attract and retain management and other key personnel, we may be unable to continue to successfully develop or commercialize
our product candidates or otherwise implement our business plan.
Our
ability to compete in the highly competitive pharmaceuticals industry depends upon our ability to attract and retain highly qualified
managerial, scientific, medical, sales and marketing and other personnel. We are highly dependent on our management, including: Stephen
C. Glover, Peter Wolfe, Nicholas A. LaBella, Jr. and Karen A. Cashmere. The loss of the services of any of these individuals could
impede, delay or prevent the successful development of our product pipeline, completion of our planned clinical trials, commercialization
of our product candidates or in-licensing or acquisition of new assets and could negatively impact our ability to successfully implement
our business plan. If we lose the services of any of these individuals, we might not be able to find suitable replacements on a timely
basis or at all, and our business could be harmed as a result. We do not maintain “key man” insurance policies on the lives
of these individuals or the lives of any of our other employees. In order to retain valuable employees at our company, in addition to
salary and cash incentives, we provide stock options that vest over time. The value to employees of stock options that vest over time
will be significantly affected by movements in our stock price that are beyond our control, and may at any time be insufficient to counteract
offers from other companies.
We
might not be able to attract or retain qualified management and other key personnel in the future due to the intense competition for
qualified personnel among biotechnology, pharmaceutical and other businesses, particularly in the Weston, FL area where we are headquartered.
We could have difficulty attracting experienced personnel to our company and may be required to expend significant financial resources
in our employee recruitment and retention efforts. Many of the other pharmaceutical companies with whom we compete for qualified personnel
have greater financial and other resources, different risk profiles and longer histories in the industry than we do. They also may provide
more diverse opportunities and better chances for career advancement. If we are not able to attract and retain the necessary personnel
to accomplish our business objectives, we may experience constraints that will harm our ability to implement our business strategy and
achieve our business objectives.
In
addition, we have scientific and clinical advisors who assist us in formulating our development and clinical strategies. These advisors
are not our employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability
to us. In addition, our advisors may have arrangements with other companies to assist those companies in developing products or technologies
that may compete with ours.
The
competitive job market creates a challenge and potential risk as we grow and strive to attract and retain a highly skilled workforce.
Competition
for our employees, including highly skilled technology and product professionals, is extremely intense reflecting a tight labor market.
This can present a risk as we compete for experienced candidates, especially if the competition is able to offer more attractive financial
terms of employment. This risk extends to our current employee population. In addition, we have been impacted and could be further impacted
by the ongoing COVID-19 pandemic, which could cause talented employees to change locations, and may make it more challenging to attract
and retain skilled professionals. We may also invest significant time and expense in engaging and developing our employees as we grow
our business, which also increases their value to other companies that may seek to recruit them. Turnover can result in significant replacement
costs and lost productivity. Additionally, U.S. immigration policy may make it more difficult for qualified foreign nationals to obtain
or maintain work visas under the H-1B classification. These H-1B visa limitations may make it more difficult and/or more expensive for
us to hire the skilled professionals we need to execute our growth strategy and may adversely impact our business.
We
currently have limited marketing capabilities and no sales organization. If we are unable to establish sales and marketing capabilities
on our own or through third parties, we will be unable to successfully commercialize our product candidates, if approved, or generate
product revenue.
We
currently have limited marketing capabilities and no sales organization. To commercialize our product candidates, if approved, in the
United States, Canada, the European Union and other jurisdictions we seek to enter, we must build our marketing, sales, distribution,
managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and we may not be
successful in doing so. Although our management team has experience in the marketing, sale and distribution of pharmaceutical products
from prior employment at other companies, we as a company have no prior experience in the marketing, sale and distribution of pharmaceutical
products and there are significant risks involved in building and managing a sales organization, including our ability to hire, retain
and incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel and
effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales,
marketing and distribution capabilities would adversely impact the commercialization of these products. We may choose to collaborate
with additional third parties that have direct sales forces and established distribution systems, either to augment our own sales force
and distribution systems or in lieu of our own sales force and distribution systems. If we are unable to enter into such arrangements
on acceptable terms or at all, we may not be able to successfully commercialize our product candidates. If we are unable to successfully
commercialize our product candidates, either on our own or through collaborations with one or more third parties, our business, financial
condition, operating results and prospects would suffer.
Our
failure to successfully in-license, acquire, develop and market additional product candidates or approved products would impair our
ability to grow our business.
We
intend to in-license, acquire, develop and market additional products and product candidates and we may in-license or acquire commercial-stage
products or engage in other strategic transactions. Because our internal research and development capabilities are limited, we may be
dependent upon pharmaceutical companies, academic scientists and other researchers to sell or license products or technology to us. The
success of this strategy depends partly upon our ability to identify and select promising pharmaceutical product candidates and products,
negotiate licensing or acquisition agreements with their current owners and finance these arrangements.
The
process of proposing, negotiating and implementing a license or acquisition of a product candidate or approved product is lengthy and
complex. Other companies, including some with substantially greater financial, marketing, sales and other resources, may compete with
us for the license or acquisition of product candidates and approved products. We have limited resources to identify and execute the
acquisition or in-licensing of third-party products, businesses and technologies and integrate them into our current infrastructure.
Moreover, we may devote resources to potential acquisitions or licensing opportunities that are never completed, or we may fail to realize
the anticipated benefits of such efforts. We may not be able to acquire the rights to additional product candidates on terms that we
find acceptable, or at all.
Further,
any product candidate that we acquire may require additional development efforts prior to commercial sale, including preclinical or clinical
testing and approval by the FDA and applicable foreign regulatory authorities. All product candidates are prone to risks of failure typical
of pharmaceutical product development, including the possibility that a product candidate will not be shown to be sufficiently safe and
effective for approval by regulatory authorities. In addition, we cannot provide assurance that any approved products that we acquire
will be manufactured or sold profitably or achieve market acceptance.
Additional
potential transactions that we may consider include a variety of different business arrangements, including spin-offs, strategic partnerships,
joint ventures, restructurings, divestitures, business combinations and investments. Any such transaction may require us to incur non-recurring
or other charges, may increase our near- and long-term expenditures and may pose significant integration challenges or disrupt our management
or business, which could adversely affect our operations and financial results. For example, these transactions entail numerous potential
operational and financial risks, including:
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exposure
to unknown liabilities; |
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disruption
of our business and diversion of our management’s time and attention in order to develop acquired products, product candidates
or technologies; |
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incurrence
of substantial debt or dilutive issuances of equity securities to pay for acquisitions; |
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substantial
acquisition and integration costs; |
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write-downs
of assets or impairment charges; |
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increased
amortization expenses; |
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difficulty
and cost in combining the operations and personnel of any acquired businesses with our operations and personnel; |
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impairment
of relationships with key suppliers, partners or customers of any acquired businesses due to changes in management and ownership;
and |
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inability
to retain our key employees or those of any acquired businesses. |
Accordingly,
there can be no assurance that we will undertake or successfully complete any transactions of the nature described above, and any transaction
that we do complete could harm our business, financial condition, operating results and prospects.
Manufacturing
and supply of the APIs and other substances and materials used in our product candidates is a complex and technically challenging undertaking,
and there is potential for failure at many points in the manufacturing, testing, quality assurance and distribution supply chain, as
well as the potential for latent defects after products have been manufactured and distributed.
Manufacturing
and supply of APIs, other substances and materials and finished drug products is technically challenging. Changes beyond our direct control
can impact the quality, volume, price and successful delivery of our product candidates and can impede, delay, limit or prevent the successful
development and commercialization of our product candidates. Mistakes and mishandling are not uncommon and can affect successful production
and supply. Some of these risks include:
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failure
of our manufacturers to follow cGMP or GACP requirements or mishandling of product while in production or in preparation for transit; |
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inability
of our contract suppliers and manufacturers to efficiently and cost-effectively increase and maintain high yields and batch quality,
consistency and stability; |
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our
inability to develop an FDA approved bioassay for release of any future product; |
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difficulty
in establishing optimal drug delivery substances and techniques, production and storage methods and packaging and shipment processes; |
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transportation
and import/export risk, particularly given the global nature of our supply chain; |
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delays
in analytical results or failure of analytical techniques that we depend on for quality control and release of any future product; |
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natural
disasters, pandemics, labor disputes, financial distress, lack of raw material supply, issues with facilities and equipment or other
forms of disruption to business operations of our contract manufacturers and suppliers; and |
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latent
defects that may become apparent after the product has been released and which may result in recall and destruction of product. |
Any
of these factors could result in delays or higher costs in connection with our clinical trials, regulatory submissions, required approvals
or commercialization of our product candidates, which could harm our business, financial condition, operating results and prospects.
Our
operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating
results to fall below expectations.
Our
operations to date have been primarily limited to researching and developing our product candidates and undertaking preclinical studies
and clinical trials of our product candidates. We have not yet obtained regulatory approvals for any of our product candidates. Consequently,
any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history
or approved products on the market. Furthermore, our operating results may fluctuate due to a variety of other factors, many of which
are outside of our control and may be difficult to predict, including the following:
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delays
in the commencement, enrollment and the timing of clinical testing for our product candidates; |
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the
timing and success or failure of clinical trials for our product candidates or competing product candidates, or any other change
in the competitive landscape of our industry, including consolidation among our competitors or partners; |
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any
delays in regulatory review and approval of product candidates in clinical development; |
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the
timing and cost of, and level of investment in, research and development activities relating to our product candidates, which may
change from time to time; |
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the
cost of manufacturing our product candidates, which may vary depending on FDA guidelines and requirements, and the quantity of production; |
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our
ability to obtain additional funding to develop our product candidates; |
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expenditures
that we will or may incur to acquire or develop additional product candidates and technologies; |
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the
level of demand for our product candidates, should they receive approval, which may vary significantly; |
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potential
side effects of our product candidates that could delay or prevent commercialization or cause an approved drug to be taken off the
market; |
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the
ability of patients or healthcare providers to obtain coverage of or sufficient reimbursement for our product candidates, if approved; |
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our
dependency on third-party manufacturers to supply or manufacture our product candidates; |
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our
ability to establish an effective sales, marketing and distribution infrastructure in a timely manner; |
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market
acceptance of our product candidates, if approved, and our ability to forecast demand for those product candidates; |
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our
ability to receive approval and commercialize our product candidates outside of the United States; |
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our
ability to establish and maintain collaborations, licensing or other arrangements; |
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our
ability and third parties’ abilities to protect intellectual property rights; |
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costs
related to and outcomes of potential litigation or other disputes; |
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our
ability to adequately support future growth; |
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our
ability to attract and retain key personnel to manage our business effectively; |
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potential
liabilities associated with hazardous materials; |
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our
ability to maintain adequate insurance policies; and |
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future
accounting pronouncements or changes in our accounting policies. |
Our
operating results and liquidity needs could be negatively affected by market fluctuations and economic downturn.
Our
operating results and liquidity could be negatively affected by economic conditions generally, both in the United States and elsewhere
around the world. The market for discretionary medical products and procedures may be particularly vulnerable to unfavorable economic
conditions. Some patients may consider certain of our product candidates to be discretionary, and if full reimbursement for such products
is not available, demand for these products may be tied to the discretionary spending levels of our targeted patient populations. Domestic
and international equity and debt markets have experienced and may continue to experience heightened volatility and turmoil based on
domestic and international economic conditions and concerns. In the event these economic conditions and concerns continue or worsen and
the markets continue to remain volatile, our operating results and liquidity could be adversely affected by those factors in many ways,
including weakening demand for certain of our products and making it more difficult for us to raise funds if necessary, and our stock
price may decline. Additionally, although we plan to market our products primarily in the United States, we could in the future have
partners with extensive global operations, indirectly exposing us to risk.
Our
business and operations would suffer in the event of failures in our internal computer systems.
Despite
the implementation of security measures, our computer systems and those of our current and any future partners, contractors and consultants
are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical
failures. While we have not experienced any such material system failure, accident or security breach to date, if such an event were
to occur and cause interruptions in our operations, it could result in a material disruption of our manufacturing activities, development
programs and our business operations. For example, the loss of manufacturing records or clinical trial data from completed or future
clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce
the data. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or
inappropriate disclosure of confidential or proprietary information, we could incur liability and the further commercialization and development
of our products and product candidates could be delayed.
We
are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity
and data leakage risks.
Significant
disruptions to our information technology systems or breaches of information security could adversely affect our business. In the ordinary
course of business, we collect, store and transmit large amounts of confidential information, and it is critical that we do so in a secure
manner to maintain the confidentiality and integrity of such confidential information. The size and complexity of our information technology
systems, and those of our third-party vendors with whom we contract, make such systems potentially vulnerable to service interruptions
and security breaches from inadvertent or intentional actions by our employees, partners or vendors, from attacks by malicious third
parties, or from intentional or accidental physical damage to our systems infrastructure maintained by us or by third parties. Maintaining
the secrecy of this confidential, proprietary, or trade secret information is important to our competitive business position. While we
have taken steps to protect such information and invested in information technology, there can be no assurance that our efforts will
prevent service interruptions or security breaches in our systems or the unauthorized or inadvertent wrongful use or disclosure of confidential
information that could adversely affect our business operations or result in the loss, dissemination, or misuse of critical or sensitive
information. A breach of our security measures or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation
or misuse of trade secrets, proprietary information, or other confidential information, whether as a result of theft, hacking, fraud,
trickery or other forms of deception, or for any other reason, could enable others to produce competing products, use our proprietary
technology or information, or adversely affect our business or financial condition. Further, any such interruption, security breach,
loss or disclosure of confidential information, could result in financial, legal, business, and reputational harm to us and could have
a material adverse effect on our business, financial position, results of operations or cash flow.
Due
to our primarily remote workforce, we may face increased business continuity and cyber risks that could significantly harm our business
and operations.
The
COVID-19 pandemic has caused us to modify our business practices by migrating to a primarily remote workforce where our employees are
accessing our servers remotely through home or other networks to perform their job responsibilities. While most of our operations can
be performed remotely and are operating effectively at present, there is no guarantee that this will continue or that we will continue
to be as effective while working remotely because our team is dispersed, many employees may have additional personal needs to attend
to (such as looking after children as a result of school closures or a family member who becomes sick), and employees may become sick
themselves and be unable to work. As conditions improve and restrictions are lifted, similar uncertainties exist with the return-to-work
process. Additionally, while we put in place additional safeguards to protect data security and privacy, a remote workforce places
additional pressure on our user infrastructure and third parties that are not easily mitigated. These risks include home internet availability
affecting work continuity and efficiency, and additional dependencies on third-party communication tools, such as instant messaging and
online meeting platforms.
Risks
Related to Our Intellectual Property
Failure
to adequately protect our intellectual property could adversely affect our business, financial condition, and operating results.
Our
business depends on its intellectual property and proprietary technology, the protection of which is crucial to the success of its business.
We rely on a combination of trademark, copyright, and trade secret laws, license agreements, intellectual property assignment agreements,
and confidentiality procedures to protect its intellectual property. Additionally, we rely on proprietary information (such as trade
secrets, know-how and confidential information) to protect intellectual property that may not be patentable, or that we believe is best
protected by means that do not require public disclosure. We generally attempt to protect our intellectual property, technology, and
confidential information by requiring our employees and consultants who develop intellectual property on our behalf to enter into confidentiality
and invention assignment agreements and third parties we share information with to enter into nondisclosure agreements. These agreements
may not effectively prevent unauthorized use or disclosure of our confidential information, intellectual property, or technology and
may not provide an adequate remedy in the event of unauthorized use or disclosure of our confidential information or technology, or infringement
of our intellectual property. For example, we may fail to enter into the necessary agreements, and even if entered into, these agreements
may be willfully breached or may otherwise fail to prevent disclosure, third-party infringement or misappropriation of our proprietary
information, may be limited as to their term and may not provide an adequate remedy in the event of unauthorized disclosure or use of
proprietary information. In addition, our proprietary information may otherwise become known or be independently developed by our competitors
or other third parties. To the extent that our employees, consultants, contractors, and other third parties use intellectual property
owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. Costly and
time-consuming litigation could be necessary to enforce and determine the scope of our intellectual property rights and other proprietary
rights, and failure to obtain or maintain protection for our proprietary information could adversely affect our competitive business
position.
Despite
our efforts to protect our proprietary rights, other parties may unintentionally or willfully disclose, obtain or use our technologies
or systems, which may allow unauthorized parties to copy aspects of our platform or other software, technology, and functionality or
obtain and use information that we consider proprietary. In addition, unauthorized parties may also attempt, or successfully endeavor,
to obtain our intellectual property, confidential information and trade secrets through various methods, including through scraping of
public data or other content from our website or mobile applications, cybersecurity attacks, and legal or other methods of protecting
this data may be inadequate. Monitoring unauthorized use and disclosures of our intellectual property, proprietary technology, or confidential
information can be difficult and expensive and we cannot be sure that the steps we have taken will prevent misappropriation or infringement
of our intellectual property or proprietary rights.
We
have registered domain names for websites that we use in our business, such as www.zyversa.com and other variations. The inclusion
of the website address in this prospectus does not include or incorporate by reference the information on our website into this
prospectus.
Competitors
have and may continue to adopt service names similar to ours, thereby harming our ability to build brand identity and possibly leading
to user confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other trademarks
that are similar to our trademarks. Further, litigation or proceedings before the U.S. Patent and Trademark Office or other governmental
authorities and administrative bodies in the United States and abroad may be necessary in the future to enforce our intellectual property
rights and to determine the validity and scope of the proprietary rights of others. Any litigation we initiate concerning the violation
by third parties of our intellectual property rights is likely to be expensive and time-consuming and could lead to the invalidation
of, or render unenforceable, its intellectual property, or could otherwise have negative consequences for us. Even if we sue other parties
for such infringement, such suits may have adverse consequences for our business. In addition, we may not timely or successfully apply
for a patent or register its trademarks or otherwise secure its intellectual property, which could result in negative effects to our
market share, financial condition and results of operations. Our efforts to protect, maintain, or enforce our proprietary rights may
not be respected in the future or may be invalidated, circumvented or challenged, and could result in substantial costs and diversion
of resources, which could adversely affect our business, financial condition, and operating results.
We
may be unable to continue to use the domain names that we use in our business or prevent third parties from acquiring and using domain
names that infringe on, are similar to, or otherwise decrease the value of our brand, trademarks, or service marks.
We
have registered domain names that we use in, or are related to, its business. If we lose the ability to use a domain name, whether due
to trademark claims, failure to renew the applicable registration, or any other cause, we may be forced to market our offerings under
a new domain name, which could cause us substantial harm, or to incur significant expense in order to purchase rights to the domain name
in question. We may not be able to obtain preferred domain names outside the United States due to a variety of reasons, including because
they are already held by others. In addition, our competitors and others could attempt to capitalize on our brand recognition by using
domain names similar to our domain names. We may be unable to prevent third parties from acquiring and using domain names that infringe
on, are similar to, or otherwise decrease the value of our brand or our trademarks or service marks. Protecting, maintaining, and enforcing
our rights in our domain names may require litigation, which could result in substantial costs and diversion of resources, which could
in turn adversely affect our business, financial condition, and operating results.
Recent
patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement
or defense of our future patents.
Our
ability to obtain patents is highly uncertain because, to date, some legal principles remain unresolved, there has not been a consistent
policy regarding the breadth or interpretation of claims allowed in patents in the United States and the specific content of patents
and patent applications that are necessary to support and interpret patent claims is highly uncertain due to the complex nature of the
relevant legal, scientific, and factual issues. Changes in either patent laws or interpretations of patent laws in the United States
and other countries may diminish the value of our intellectual property or narrow the scope of our patent protection.
For
example, on September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act
includes a number of significant changes to United States patent law. These include provisions that affect the way patent applications
will be prosecuted and may also affect patent litigation. The United States Patent and Trademark Office (the “USPTO”),
has developed new and untested regulations and procedures to govern the full implementation of the Leahy-Smith Act, and many of the
substantive changes to patent law associated with the Leahy-Smith Act, and in particular, the first to file provisions, became effective
in March 2013. The Leahy-Smith Act has also introduced procedures making it easier for third parties to challenge issued patents, as
well as to intervene in the prosecution of patent applications. Finally, the Leahy-Smith Act contains new statutory provisions that require
the USPTO to issue new regulations for their implementation, and it may take the courts years to interpret the provisions of the new
statute. It is too early to tell what, if any, impact the Leahy-Smith Act will have on the operation of our business and the protection
and enforcement of our intellectual property. However, the Leahy-Smith Act and its implementation could increase the uncertainties and
costs surrounding the prosecution of our patent applications and the enforcement or defense of our future patents. Further, the U.S.
Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain
circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our
ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once
obtained. Depending on actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could
change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we have owned or licensed
or that we might obtain in the future. An inability to obtain, enforce, and defend patents covering our proprietary technologies would
materially and adversely affect our business prospects and financial condition.
Similarly,
changes in patent laws and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or
changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or
to enforce patents that we may obtain in the future. Further, the laws of some foreign countries do not protect proprietary rights to
the same extent or in the same manner as the laws of the United States. As a result, we may encounter significant problems in protecting
and defending our intellectual property both in the United States and abroad. For example, if the issuance to us, in a given country,
of a patent covering an invention is not followed by the issuance, in other countries, of patents covering the same invention, or if
any judicial interpretation of the validity, enforceability, or scope of the claims, or the written description or enablement, in a patent
issued in one country is not similar to the interpretation given to the corresponding patent issued in another country, our ability to
protect our intellectual property in those countries may be limited. Changes in either patent laws or in interpretations of patent laws
in the United States and other countries may materially diminish the value of our intellectual property or narrow the scope of our patent
protection.
We
may not be able to protect our intellectual property rights throughout the world.
Filing,
prosecuting and defending patents on our product candidates in all countries throughout the world would be prohibitively expensive. The
requirements for patentability may differ in certain countries, particularly developing countries. In addition, the laws of some foreign
countries do not protect intellectual property rights to the same extent as laws in the United States. Consequently, we may not be able
to prevent third parties from practicing our inventions in all countries outside the United States. Competitors may use our technologies
in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing
products to territories where we have patent protection, but enforcement on infringing activities is inadequate. These products may compete
with our products, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
Many
companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The
legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual
property protection, particularly those relating to pharmaceuticals, which could make it difficult for us to stop the infringement of
our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights
in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could
put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, and could provoke
third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded,
if any, may not be commercially meaningful. In addition, certain countries in Europe and certain developing countries have compulsory
licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those countries, we may have limited
remedies if our patents are infringed or if we are compelled to grant a license to our patents to a third party, which could materially
diminish the value of those patents. This could limit our potential revenue opportunities. Accordingly, our efforts to enforce
our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual
property that we own or license. Finally, our ability to protect and enforce our intellectual property rights may be adversely affected
by unforeseen changes in foreign intellectual property laws.
Obtaining
and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements
imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Periodic
maintenance and annuity fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over
the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural,
documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases
be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance
can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the
relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure
to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal
documents. If we or our licensors fail to maintain the patents and patent applications covering our product candidates, our competitors
might be able to enter the market, which would have an adverse effect on our business.
If
we fail to comply with our obligations under our intellectual property license agreements, we could lose license rights that are important
to our business.
We
are a party to certain license agreements that impose various diligence, milestone, royalty, insurance and other obligations on us. If
we fail to comply with these obligations, the respective licensors may have the right to terminate the license, in which event we may
not be able to develop or market the affected product candidate. The loss of such rights could materially adversely affect our business,
financial condition, operating results and prospects. For more information about these license arrangements, see “Business
– Strategic Alliances and Arrangements.”
If
we are sued for infringing intellectual property rights of third parties, it will be costly and time-consuming, and an unfavorable outcome
in that litigation could have a material adverse effect on our business.
Our
commercial success depends upon our ability to develop, manufacture, market and sell our product candidates and use our proprietary technologies
without infringing the proprietary rights of third parties. We cannot guarantee that marketing and selling such candidates and using
such technologies will not infringe existing or future patents. Numerous U.S. and foreign issued patents and pending patent applications
owned by third parties exist in the fields relating to our product candidates. As the biotechnology and pharmaceutical industries expand
and more patents are issued, the risk increases that others may assert that our product candidates, technologies or methods of delivery
or use infringe their patent rights. Moreover, it is not always clear to industry participants, including us, which patents cover various
drugs, biologics, drug delivery systems or their methods of use, and which of these patents may be valid and enforceable. Thus, because
of the large number of patents issued and patent applications filed in our fields, there may be a risk that third parties may allege
they have patent rights encompassing our product candidates, technologies or methods.
In
addition, there may be issued patents of third parties that are infringed or are alleged to be infringed by our product candidates or
proprietary technologies. Because some patent applications in the United States may be maintained in secrecy until the patents are issued,
because patent applications in the United States and many foreign jurisdictions are typically not published until eighteen months after
filing and because publications in the scientific literature often lag behind actual discoveries, we cannot be certain that others have
not filed patent applications for technology covered by our own and in-licensed issued patents or our pending applications. Our competitors
may have filed, and may in the future file, patent applications covering our product candidates or technology similar to ours. Any such
patent application may have priority over our own and in-licensed patent applications or patents, which could further require us to obtain
rights to issued patents covering such technologies. If another party has filed a U.S. patent application on inventions similar to those
owned or in-licensed to us, we or, in the case of in-licensed technology, the licensor may have to participate, in the United States,
in an interference proceeding to determine priority of invention.
We
may be exposed to, or threatened with, future litigation by third parties having patent or other intellectual property rights alleging
that our product candidates or proprietary technologies infringe such third parties’ intellectual property rights, including litigation
resulting from filing under Paragraph IV of the Hatch-Waxman Act. These lawsuits could claim that there are existing patent rights for
such drug and this type of litigation can be costly and could adversely affect our operating results and divert the attention of managerial
and technical personnel, even if we do not infringe such patents or the patents asserted against us are ultimately established as invalid.
There is a risk that a court would decide that we are infringing the third party’s patents and would order us to stop the activities
covered by the patents. In addition, there is a risk that a court will order us to pay the other party damages for having violated the
other party’s patents.
As
a result of patent infringement claims, or to avoid potential claims, we may choose or be required to seek licenses from third parties.
These licenses may not be available on commercially acceptable terms, or at all. Even if we are able to obtain a license, the license
would likely obligate us to pay license fees or royalties or both, and the rights granted to us might be nonexclusive, which could result
in our competitors gaining access to the same intellectual property, or such rights might be restrictive and limit our present and future
activities. Ultimately, we or a licensee could be prevented from commercializing a product, or forced to cease some aspect of our business
operations, if, as a result of actual or threatened patent infringement claims, we are unable to enter into licenses on acceptable terms.
In
addition to possible infringement claims against us, we may become a party to other patent litigation and other proceedings, including
interference, derivation, re-examination or other post-grant proceedings declared or granted by the USPTO, and similar proceedings in
foreign countries, regarding intellectual property rights with respect to our current or of our other products.
There
is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology and pharmaceutical
industries generally. To date, no litigation asserting infringement claims has ever been brought against us. If a third-party claims
that we infringe its intellectual property rights, we may face a number of issues, including:
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infringement
and other intellectual property claims which, regardless of merit, may be expensive and time-consuming to litigate and may divert
our management’s attention from our core business; |
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substantial
damages for infringement, which we may have to pay if a court decides that the product or technology at issue infringes or violates
the third party’s rights, and if the court finds that the infringement was willful, we could be ordered to pay treble damages
and the patent owner’s attorneys’ fees; |
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a
court prohibiting us from selling or licensing the product or using the technology unless the third party licenses its intellectual
property rights to us, which it is not required to do; |
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if
a license is available from a third party, we may have to pay substantial royalties or upfront fees or grant cross-licenses to intellectual
property rights for our products or technologies; and |
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redesigning
our products or processes so they do not infringe, which may not be possible or may require substantial monetary expenditures and
time. |
Some
of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially
greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could harm our ability
to raise additional funds or otherwise adversely affect our business, financial condition, operating results and prospects.
Because
we rely on certain third-party licensors and partners, and will continue to do so in the future, if one of our licensors or partners
is sued for infringing a third party’s intellectual property rights, our business, financial condition, operating results and prospects
could suffer in the same manner as if we were sued directly. In addition to facing litigation risks, we have agreed to indemnify certain
third-party licensors and partners against claims of infringement caused by our proprietary technologies, and we have entered or may
enter into cost-sharing agreements with some our licensors and partners that could require us to pay some of the costs of patent litigation
brought against those third parties whether or not the alleged infringement is caused by our proprietary technologies. In certain instances,
these cost-sharing agreements could also require us to assume greater responsibility for infringement damages than would be assumed just
on the basis of our technology.
The
occurrence of any of the foregoing could adversely affect our business, financial condition or operating results.
We
may become involved in lawsuits to protect or enforce our patents or other intellectual property or the patents of our licensors, which
could be expensive and time-consuming.
Competitors
may infringe our intellectual property, including our patents or the patents of our licensors. As a result, we may be required to file
infringement claims to stop third-party infringement or unauthorized use. This can be expensive and time-consuming, particularly for
a company of our size. In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable,
or may refuse to stop the other party from using the technology at issue on the grounds that our patent claims do not cover its technology
or that the factors necessary to grant an injunction against an infringer are not satisfied. An adverse determination of any litigation
or other proceedings could put one or more of our patents at risk of being invalidated, interpreted narrowly or amended such that they
do not cover our product candidates. Moreover, such adverse determinations could put our patent applications at risk of not issuing,
or issuing with limited and potentially inadequate scope to cover our product candidates or to prevent others from marketing similar
products.
Interference,
derivation or other proceedings brought at the USPTO may be necessary to determine the priority or patentability of inventions with respect
to our patent applications or those of our licensors or potential partners. Litigation or USPTO proceedings brought by us may fail or
may be invoked against us by third parties. Even if we are successful, domestic or foreign litigation or USPTO or foreign patent office
proceedings may result in substantial costs and distraction to our management. We may not be able, alone or with our licensors or potential
partners, to prevent misappropriation of our proprietary rights, particularly in countries where the laws may not protect such rights
as fully as in the United States.
Furthermore,
because of the substantial amount of discovery required in connection with intellectual property litigation or other proceedings, there
is a risk that some of our confidential information could be compromised by disclosure during this type of litigation or other proceedings.
In addition, during the course of this kind of litigation or proceedings, there could be public announcements of the results of hearings,
motions or other interim proceedings or developments or public access to related documents. If investors perceive these results to be
negative, the market price for our common stock or warrants could be significantly harmed.
Our
reliance on third parties requires us to share our trade secrets, which increases the possibility that our trade secrets will be misappropriated
or disclosed, and confidentiality agreements with employees and third parties may not adequately prevent disclosure of trade secrets
and protect other proprietary information.
We
consider proprietary trade secrets or confidential know-how and unpatented know-how to be important to our business. We may rely on trade
secrets or confidential know-how to protect our technology, especially where patent protection is believed by us to be of limited value.
To
protect this type of information against disclosure or appropriation by competitors, our policy is to require our employees, consultants,
collaborators, contractors and advisors to enter into confidentiality agreements and, if applicable, material transfer agreements, consulting
agreements or other similar agreements with us prior to beginning research or disclosing proprietary information. These agreements typically
limit the rights of the third parties to use or disclose our confidential information, including our trade secrets. However, current
or former employees, consultants, collaborators, contractors and advisors may unintentionally or willfully disclose our confidential
information to competitors, and confidentiality agreements may not provide an adequate remedy in the event of unauthorized disclosure
of confidential information. The need to share trade secrets and other confidential information increases the risk that such trade secrets
become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation
of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery
of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have an adverse effect on
our business and results of operations. Enforcing a claim that a third party obtained illegally and is using trade secrets or confidential
know-how is expensive, time consuming and unpredictable. The enforceability of confidentiality agreements may vary from jurisdiction
to jurisdiction.
In
addition, these agreements typically restrict the ability of our employees, consultants, collaborators, contractors and advisors to publish
data potentially relating to our trade secrets, although our agreements may contain certain limited publication rights. Despite our efforts
to protect our trade secrets, our competitors may discover our trade secrets, either through breach of our agreements with third parties,
independent development or publication of information by any of our third-party collaborators. A competitor’s discovery of our
trade secrets would impair our competitive position and have an adverse impact on our business.
We
may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed to us alleged trade
secrets of their former employers or their former or current customers.
As
is common in the biotechnology and pharmaceutical industries, certain of our employees were formerly employed by other biotechnology
or pharmaceutical companies, including our competitors or potential competitors. Moreover, we engage the services of consultants to assist
us in the development of our products and product candidates, many of whom were previously employed at or may have previously been or
are currently providing consulting services to, other biotechnology or pharmaceutical companies, including our competitors or potential
competitors. We may be subject to claims that these employees and consultants or we have inadvertently or otherwise used or disclosed
trade secrets or other proprietary information of their former employers or their former or current customers. Although we have no knowledge
of any such claims being alleged to date, if such claims were to arise, litigation may be necessary to defend against any such claims.
Even if we are successful in defending against any such claims, any such litigation could be protracted, expensive, a distraction to
our management team, not viewed favorably by investors and other third parties and may potentially result in an unfavorable outcome.
If
our patent term expires before or soon after our products are approved, or if manufacturers of generic or biosimilar drugs successfully
challenge our patents, our business may be materially harmed.
Patents
have a limited duration. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally
twenty (20) years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent,
and the protection it affords, is limited. Even if patents covering our product candidates, their manufacture, or use are obtained, once
the patent life has expired, we may be open to competition from competitive medications, including generic or biosimilar medications.
Depending
upon the timing, duration and conditions of FDA marketing approval of our product candidates, one or more of our United States patents
may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred
to as the Hatch-Waxman Act, and similar legislation in the European Union. The Hatch-Waxman Act permits a patent term extension of up
to five years for a patent covering an approved product as compensation for effective patent term lost during product development and
the FDA regulatory review process. The patent term extension cannot extend the remaining term of a patent beyond a total of 14 years
from the date of product approval, and only one patent applicable to an approved drug may be extended. However, we may not receive an
extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to
satisfy applicable requirements. Moreover, the length of the extension could be less than we request. If we are unable to obtain patent
term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for
that product will be shortened and our competitors may obtain approval to market competing products sooner than we expect. Also, the
scope of our right to exclude during any patent term extension period may be limited or may not cover a competitor’s product or
product use. As a result, our revenue from applicable products could be reduced, possibly materially.
Given
the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting such drug candidates
might expire before or shortly after such drug candidates are commercialized. As a result, our patents and patent applications may not
provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Any of the foregoing
could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.
Manufacturers
of generic or biosimilar drugs may challenge the scope, validity, or enforceability of our patents in court or before a patent office,
and we may not be successful in enforcing or defending those intellectual property rights and, as a result, may not be able to develop
or market the relevant product exclusively, which would have a material adverse effect on any potential sales of that product. Upon the
expiration of our issued patents or patents that may issue from our pending patent applications, we will not be able to assert such patent
rights against potential competitors and our business and results of operations may be adversely affected.
If
our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest
and our business may be adversely affected.
Our
unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing
on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition
among potential collaborators or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar
to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential
trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations
of our unregistered trademarks or trade names. Over the long term, if we are unable to successfully register our trademarks and trade
names and establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our
business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain
names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources
and could adversely impact our financial condition or results of operations.
Our
proprietary information may be lost, or we may suffer security breaches.
In
the ordinary course of our business, we collect and store sensitive data, including intellectual property, clinical trial data, proprietary
business information, personal data and personally identifiable information of our clinical trial subjects and employees, in our data
centers and on our networks. The secure processing, maintenance and transmission of this information is critical to our operations. Despite
our security measures, our information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee
error, malfeasance or other disruptions. Although, to our knowledge, we have not experienced any such material security breach to date,
any such breach could compromise our networks and the information stored there could be accessed, publicly disclosed, lost or stolen.
Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect
the privacy of personal information, significant regulatory penalties, disrupt our operations, damage our reputation and cause a loss
of confidence in us and our ability to conduct clinical trials, which could adversely affect our reputation and delay our clinical development
of our product candidates.
Risks
Related to Being a Public Company
Our
management team has limited experience managing a public company and may not successfully manage our transition to public company status.
Most
members of our management team have limited experience managing a publicly traded company, interacting with public company investors
and complying with the increasingly complex laws pertaining to public companies. Our management team may not successfully or
efficiently manage the transition to being a public company that is subject to significant regulatory oversight and reporting
obligations under the federal securities laws and the continuous scrutiny of securities analysts and investors. These new
obligations and constituents will require significant attention from our senior management and could divert their attention away
from the day-to-day management of our business, which could harm our business, results of operations and financial
condition.
We incur significant increased expenses and administrative burdens as a public company, which could have an adverse effect on its business,
financial condition and operating results.
As
a public company, we face increased legal, accounting, administrative and other costs and expenses that we did not incur as a private
company, and these expenses may increase even more after we are no longer an “emerging growth company.” The Sarbanes-Oxley
Act, including the requirements of Section 404, as well as rules and regulations subsequently implemented by the SEC, the Dodd-Frank
Wall Street Reform and Consumer Protection Act of 2010 and the rules and regulations promulgated and to be promulgated thereunder, the
PCAOB and the securities exchanges and the listing standards of the Nasdaq, impose additional reporting and other obligations on public
companies.
Compliance
with public company requirements will increase costs and make certain activities more time-consuming. A number of those requirements
will require us to carry out activities that we had not done previously. For example, we have created new board committees, entered into
new insurance policies, and adopted new internal controls and disclosure controls and procedures. In addition, expenses associated with
SEC reporting requirements will be incurred. Furthermore, if any issues in complying with those requirements are identified (for example,
if management or our independent registered public accounting firm identifies material weaknesses in the internal control over financial
reporting), we could incur additional costs rectifying those issues, the existence of those issues could adversely affect our reputation
or investor perceptions of it and it may be more expensive to obtain director and officer liability insurance. Risks associated with
our status as a public company may make it more difficult to attract and retain qualified persons to serve on our Board or as executive
officers. In addition, as a public company, we may be subject to stockholder activism, which can lead to substantial costs, distract
management, and impact the manner in which we operate our business in ways we do not currently anticipate. As a result of disclosure
of information in this prospectus and in filings required of a public company, our business and financial condition will become more
visible, which may result in threatened or actual litigation, including by competitors and other third parties. If such claims are successful,
our business and results of operations could be materially adversely affected and even if the claims do not result in litigation or are
resolved in our favor, these claims and the time and resources necessary to resolve them, could divert the resources of our management
and adversely affect our business and results of operations. The additional reporting and other obligations imposed by these rules and
regulations will increase legal and financial compliance costs and the costs of related legal, accounting, and administrative activities.
These increased costs will require us to divert a significant amount of money that could otherwise be used to expand the business and
achieve strategic objectives. Advocacy efforts by stockholders and third parties may also prompt additional changes in governance and
reporting requirements, which could further increase costs.
The
requirements of being a public company may strain our resources, divert management’s attention and affect its ability to attract
and retain qualified board members.
We
are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the Sarbanes-Oxley
Act and any rules promulgated thereunder, as well as the rules of Nasdaq. The requirements of these rules and regulations increase our
legal and financial compliance costs, make some activities more difficult, time-consuming or costly, and increase demand on our systems
and resources. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and
internal controls for financial reporting. In order to maintain and, if required, improve our disclosure controls and procedures and
internal control over financial reporting to meet this standard, significant resources and management oversight will be required and,
as a result, management’s attention may be diverted from other business concerns. These rules and regulations can also make it
more difficult for us to attract and retain qualified independent members of our board of directors. Additionally, these rules and regulations
make it more difficult and more expensive for us to obtain director and officer liability insurance. We may be required to accept reduced
coverage or incur substantially higher costs to obtain coverage. The increased costs of compliance with public company reporting requirements
and our potential failure to satisfy these requirements can have a material adverse effect on our operations, business, financial condition
or results of operations.
In
order to satisfy our obligations as a public company, we will need to hire qualified accounting and financial personnel with appropriate
public company experience.
As
a newly public company, we will need to establish and maintain effective disclosure and financial controls and make changes in our corporate
governance practices. We may need to hire additional accounting and financial personnel with appropriate public company experience and
technical accounting knowledge, and it may be difficult to recruit and retain such personnel. Even if we are able to hire appropriate
personnel, our existing operating expenses and operations will be impacted by the direct costs of their employment and the indirect consequences
related to the diversion of management resources from research and development efforts.
We
are an emerging growth company and any decision to comply only with certain reduced reporting and disclosure requirements applicable
to emerging growth companies could make our common stock less attractive to investors.
We
are an “emerging growth company,” as defined in the JOBS Act. For as long as it continues to be an emerging growth company,
we may choose to take advantage of exemptions from various reporting requirements applicable to other public companies but not to “emerging
growth companies,” including:
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not
being required to have independent registered public accounting firm audit our internal control over financial reporting under Section
404 of the Sarbanes-Oxley Act; |
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reduced
disclosure obligations regarding executive compensation in our periodic reports and annual report on Form 10-K; and |
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exemptions
from the requirements of holding non-binding advisory votes on executive compensation and stockholder approval of any golden parachute
payments not previously approved. |
As
a result, the stockholders may not have access to certain information that they may deem important. Our status as an emerging growth
company will end as soon as any of the following takes place:
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the
last day of the fiscal year in which we have at least $1.07 billion in annual revenue; |
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the
date we qualify as a “large accelerated filer,” with at least $700.0 million of equity securities held by non-affiliates; |
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the
date on which we haves issued, in any three-year period, more than $1.0 billion in non-convertible debt securities; or |
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the
last day of the fiscal year ending after the fifth anniversary of the Larkspur IPO. |
Under
the JOBS Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as those standards
apply to private companies. We may elect to take advantage of this extended transition period and as a result, its financial statements
may not be comparable with similarly situated public companies.
We
cannot predict if investors will find our common stock less attractive if it chooses to rely on any of the exemptions afforded emerging
growth companies. If some investors find our Common Stock less attractive because we rely on any of these exemptions, there
may be a less active trading market for our Common Stock and the market price of our Common Stock may be more volatile
and may decline.
If
we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce
timely and accurate financial statements or comply with applicable regulations could be impaired, which may adversely affect investor
confidence in us and, as a result, the market price of our common stock.
As
a public company, we will be required to comply with the requirements of the Sarbanes-Oxley Act including,
among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting. We continue
to develop and refine our disclosure controls and other procedures that are designed to ensure that information we are required to disclose
in the reports that we will file with the SEC is recorded, processed, summarized, and reported within the time periods specified in SEC
rules and forms and that information required to be disclosed in reports under the Exchange Act is accumulated and communicated to our management, including our principal executive and financial officers.
We
must continue to improve our internal control over financial reporting. We will be required to make a formal assessment of the effectiveness
of its internal control over financial reporting and once we cease to be an emerging growth company, we will be required to include an
attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve
compliance with these requirements within the prescribed time period, we will be engaging in a process to document and evaluate our internal
control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal
resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of our internal
control over financial reporting, validate through testing that controls are functioning as documented and implement a continuous reporting
and improvement process for internal control over financial reporting. There is a risk that we will not be able to conclude, within the
prescribed time period or at all, that our internal control over financial reporting is effective as required by Section 404 of the Sarbanes-Oxley
Act. Moreover, our testing, or the subsequent testing by our independent registered public accounting firm, may reveal additional deficiencies
in our internal control over financial reporting that are deemed to be material weaknesses.
Any
failure to implement and maintain effective disclosure controls and procedures and internal control over financial reporting, including
the identification of one or more material weaknesses, could cause investors to lose confidence in the accuracy and completeness of our
financial statements and reports, which would likely adversely affect the market price of our common stock. In addition, we could be
subject to sanctions or investigations by the stock exchange on which our common stock is listed, the SEC and other regulatory authorities.
We
may be subject to securities litigation, which is expensive and could divert management attention.
The
per share price of our common stock may be volatile and, in the past, companies that have experienced volatility in the market price
of their stock have been subject to securities litigation, including class action litigation. Litigation of this type could result in
substantial costs and diversion of management’s attention and resources, which could have a material adverse effect on our business,
financial condition, and results of operations. Any adverse determination in litigation could also subject us to significant liabilities.
Because
we became a publicly traded company by means other than a traditional underwritten initial public offering, our stockholders may face
additional risks and uncertainties.
Because
we became a publicly traded company by means of consummating the Business Combination rather than by means of a traditional underwritten
initial public offering, there is no independent third-party underwriter selling the shares of our common stock, and, accordingly, our
stockholders will not have the benefit of an independent review and investigation of the type normally performed by an unaffiliated,
independent underwriter in a public securities offering. Due diligence reviews typically include an independent investigation of the
background of the company, any advisors and their respective affiliates, review of the offering documents and independent analysis of
the plan of business and any underlying financial assumptions.
Although
we performed a due diligence review and investigation of Old ZyVersa in connection with the Business Combination, the lack of
an independent due diligence review and investigation increases the risk of investment in our securities because our due
diligence review and investigation may not have uncovered facts that would be important to a potential investor.
In addition, because we did not
become a publicly traded company by means of a traditional underwritten initial public offering, security or industry analysts may not
provide, or be less likely to provide, coverage of us. Investment banks may also be less likely to agree to underwrite secondary
offerings on behalf of us than they might otherwise be if we became a publicly traded company by means of a traditional underwritten
initial public offering because they may be less familiar with us as a result of more limited coverage by analysts and the media.
The failure to receive research coverage or support in the market for our Common Stock could have an adverse effect on our ability
to develop a liquid market for our Common Stock.
Risks Related to this Offering and Ownership of
Our Securities
An
active trading market for our Common Stock may never develop or be sustained.
Although
our Common Stock is listed on Nasdaq, the market for our shares has demonstrated varying levels of trading activity. If an active trading
market does not develop, or develops but is not maintained, you may have difficulty selling any of our Common Stock due to the limited
public float. We cannot predict the prices at which our Common Stock will trade. It is possible that in one or more future periods our
results of operations and progression of our product pipeline may not meet the expectations of public market analysts and investors,
and, as a result of these and other factors, the price of our Common Stock may fall. Accordingly, we cannot assure you of your ability
to sell your shares of our Common Stock when desired or at prices at or above the price you paid for your shares or at all.
The
market price of our Common Stock may be volatile, which could result in substantial losses for investors.
The
trading price of our Common Stock has been and may continue to be highly volatile and could be subject to wide fluctuations in response
to various factors, some of which are beyond our control.
The
market price of our Common Stock may fluctuate due to a variety of factors, including:
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development and approval of our product candidates; |
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the
timing of the launch and commercialization of our product candidates, if they are approved, and the degree to which such launch and
commercialization meets the expectations of securities analysts and investors; |
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actual
or anticipated fluctuations in our operating results, including fluctuations in our quarterly and annual results; |
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operating
expenses being more than anticipated; |
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the
failure or discontinuation of any of our product development and research programs; |
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changes
in the structure or funding of research at academic and research laboratories and institutions, including changes that would affect
their ability to purchase our instruments or consumables; |
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the
success of existing or new competitive businesses or technologies; |
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announcements
about new research programs or products of our competitors; |
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developments
or disputes concerning patent applications, issued patents or other proprietary rights; |
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the
recruitment or departure of key personnel; |
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litigation
and governmental investigations involving us, our industry or both; |
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regulatory
or legal developments in the United States and other countries; |
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volatility
and variations in market conditions in the life sciences technology sector generally, or the proteomics or genomics sectors specifically; |
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investor
perceptions of us or our industry; |
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the
level of expenses related to any of our research and development programs or products; |
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actual
or anticipated changes in our estimates as to our financial results or development timelines, variations in our financial results
or those of companies that are perceived to be similar to us or changes in estimates or recommendations by securities analysts, if
any, that cover our Common Stock or companies that are perceived to be similar to us; |
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whether
our financial results meet the expectations of securities analysts or investors; |
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the
announcement or expectation of additional financing efforts; |
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sales
of our Common Stock by us or by our insiders or other stockholders; |
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the
expiration of market standoff or lock-up agreements; |
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general
economic, industry and market conditions; and |
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the
COVID-19 pandemic, natural disasters or major catastrophic events. |
These
market and industry factors may materially reduce the market price of our Common Stock regardless of our operating performance.
Recently,
stock markets in general, and the market for life sciences technology companies in particular, have experienced significant price and
volume fluctuations that have often been unrelated or disproportionate to changes in the operating performance of the companies whose
stock is experiencing those price and volume fluctuations, particularly in light of the current COVID-19 pandemic. Broad market and industry
factors may seriously affect the market price of our Common Stock, regardless of our actual operating performance. These fluctuations
may be even more pronounced in the trading market for our Common Stock and warrants. Following periods of such volatility in the market
price of a company’s securities, securities class action litigation has often been brought against that company.
Because
of the potential volatility of the price of our Common Stock, we may become the target of securities litigation in the future.
Securities litigation could result in substantial costs and divert management’s attention and resources from our business.
Our
issuance of additional capital stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise
will dilute all other stockholders.
Our
issuance of additional capital stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise
will dilute our stockholders. We expect to issue additional capital stock in the future that will result in dilution to all other stockholders.
We expect to grant equity awards to employees, directors, and consultants under our stock incentive plans. We may also raise capital
through equity financings in the future. As part of our business strategy, we may acquire or make investments in complementary companies,
products, or technologies and issue equity securities to pay for any such acquisition or investment. Any such issuances of additional
capital stock may cause stockholders to experience significant dilution of their ownership interests and the per share value of our common
stock to decline.
Further,
we may incur additional dilution as a result of the re-setting the conversion price of the PIPE Shares or the Series B Shares if we issue
equity at a price below the applicable conversion prices. The conversion price of the PIPE Shares and the Series B Shares will be reset
to the price our shares are sold in this offering, but not below a price of $2.00 for the PIPE Shares and $7.00 for the Series B Shares.
Additionally, the exercise price of the PIPE Warrants will be reset to the price our shares are sold in this offering, but not below
a price of $2.00. The number of shares of Common Stock issuable upon the exercise of the PIPE Warrants will be adjusted to equal 100%
of the shares of Common Stock issuable upon conversion of the PIPE Shares. The possible issuance of additional shares of Common Stock
upon exercise or conversion, as applicable, of the PIPE Shares, Series B Shares and PIPE Warrants may cause stockholders to experience
significant dilution.
Consummation
of this offering may have an adverse effect on our ability to raise additional capital on terms favorable to us or that are not substantially
dilutive to existing shareholders. If we are unable to raise additional capital by issuing equity or equity-linked securities on terms
favorable to us, we may not have sufficient liquidity to execute on our business strategy. In addition, consummation of this offering
could have an adverse effect on the market price of our Common Stock because the additional shares that will be sold in this offering
represent a significant portion of the issued and outstanding shares of our Common Stock and the price of the shares of Common Stock
sold in this offering may be below the current market price of our Common Stock.
There
can be no assurance that we will be able to comply with the continued listing standards of Nasdaq.
If
Nasdaq delists our shares of Common Stock from trading on its exchange for failure to meet Nasdaq’s listing standards, we and our
stockholders could face significant material adverse consequences including:
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limited availability of market quotations for our securities; |
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reduced
liquidity for our securities; |
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a
determination that our Common Stock is a “penny stock” which will require brokers trading in our Common Stock to adhere
to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities; |
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a
limited amount of new and analyst coverage; and |
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a
decreased ability to issue additional securities or obtain additional financing in the future. |
We
may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative
effect on our financial condition and the share price of our Common Stock, which could cause you to lose some or all of your investment.
We
may be forced to later write-down or write-off assets, restructure operations, or incur impairment or other charges that could result
in reporting losses. Unexpected risks may arise and known risks may materialize in a manner not previously anticipated. Even though these
charges may be non-cash items that would not have an immediate impact on our liquidity, the fact that we report charges of this nature
could contribute to negative market perceptions about us or our securities. In addition, charges of this nature may cause us to violate
leverage or other covenants to which we may be subject. Accordingly, our stockholders could suffer a reduction in the value of their
shares from any such write-down or write-downs.
A
portion of our total outstanding shares are restricted from immediate resale but may be sold into the market in the near future. This
could cause the market price of our Common Stock to drop significantly, even if our business is doing well.
Sales
of a substantial number of shares of the Common Stock in the public market could occur at any time. These sales, or the perception
in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of the Common Stock.
While the Sponsor has agreed, and will continue to be subject, to certain restrictions regarding the transfer of the Common Stock,
these shares may be sold after the expiration of the applicable restrictions. We have filed a registration statement that
provides for the resale of such shares from time to time. As restrictions on resale end and the registration statements are available
for use, the market price of the Common Stock could decline if the holders of currently restricted shares sell them or are perceived
by the market as intending to sell them.
The
unaudited pro forma condensed combined financial information included in this Prospectus is for illustrative purposes only and
the actual financial condition and results of operations may differ materially than those prior to the Business Combination.
The
unaudited pro forma financial information included herein is presented for illustrative purposes only and is not necessarily indicative
of what our actual financial position or results of operations will be in the future. The preparation of the pro forma financial information
is based upon available information and certain assumptions and estimates that we currently believe are reasonable. The unaudited pro
forma condensed combined financial information for us in this Registration Statement is presented for illustrative purposes only and
is not necessarily indicative of what our actual financial position or results of operations will be in the future. See “Unaudited
Pro Forma Condensed Combined Financial Information” for more information.
In
addition, the assumptions used in preparing the pro forma financial information may not prove to be accurate and other factors may affect our financial condition or results of operations in the future. Any potential decline in our financial condition or
results of operations may cause significant variations in our stock price.
On
January 27, 2023, we filed an amendment (the “Amendment”) to our current report on Form 8-K/A filed on December 16, 2023
(the “Original 8-K/A”); the Amendment was filed solely to replace entirely the unaudited pro forma condensed combined financial
information included on the Original 8-K/A and which was included in our registration statement on Form S-4 relating to the Business
combination. The unaudited pro forma condensed combined financial information previously reflected management’s estimates based
on information available at the consummation of the Business Combination and was subject to change as additional information became available
and analysis was performed. We updated the unaudited pro forma condensed combined financial information upon completion of our analysis
to now reflect the Business Combination as a forward merger of ZyVersa Therapeutics, Inc. (“Old Zyversa”) as it was determined
that Old ZyVersa is a variable interest entity. The unaudited pro forma condensed combined financial information and related notes thereto
reflects fair value adjustments to the net assets of Old ZyVersa acquired by the Company, which primarily consist of in-process research
and development intangible assets which are indefinite-lived. The revised unaudited pro forma condensed combined financial information
is included in this prospectus. As a result of the changes to the unaudited pro forma condensed combined financial information, we may
face potential litigation or other disputes which may include, among other things, litigation involving our shareholders, claims invoking
the federal and state securities laws, contractual claims or other claims arising from such changes. As of the date of this prospectus,
we have no knowledge of any such claims, litigation or disputes. However, we can provide no assurance that such, claims, litigation or
disputes will not arise in the future. Any such claims, litigation or disputes, whether successful or not, could have a material adverse
effect on our business, results of operations and financial condition.
We are
subject to business uncertainties
that could affect the market price of our Common Stock.
Uncertainty
about our business or operations may affect the relationship between us and our respective suppliers, users, distributors,
licensors, and licensees. Any such impact may have an adverse effect on us and the market price of our Common Stock. These
uncertainties may cause parties that deal with us to seek to change existing business relationships with them and to delay or
defer decisions concerning us. Changes to existing business relationships, including termination or modification, could negatively
affect each of our revenue, earnings and cash flow, as well as the market price of our shares of Common Stock.
Additionally, matters may
require commitments of time and resources that could otherwise have been devoted to other opportunities that might have been
beneficial to us. Further, the Business Combination may give rise to potential liabilities, including as a result of pending and
future stockholder lawsuits relating to the Business Combination. Any of these matters could adversely affect our business,
financial condition or results of operations.
Insiders
own a significant percentage of our Common Stock and will be able to exercise significant influence over matters subject to stockholder
approval.
As
of January 24, 2023, our directors, executive officers, holders of more than 5% of our outstanding shares of Common Stock and their respective
affiliates beneficially owned, collectively, approximately 97% of the outstanding shares of Common Stock. As a result, these stockholders,
if they act together, may significantly influence all matters requiring stockholder approval, including the election of directors and
approval of significant corporate transactions. This concentration of ownership may have the effect of delaying or preventing a change
in control of our company that our other stockholders may believe is in their best interests. This in turn could have a material adverse
effect on our stock price and may prevent attempts by our stockholders to replace or remove the board of directors or management.
Third
parties may terminate or alter existing contracts or relationships with us.
Contracts with distributors,
affiliates, landlords, licensors, and other business partners and third parties with which we currently has relationships may
have the ability to terminate, reduce the scope of, or otherwise materially adversely alter their relationships with us. The pursuit
of such rights may result in us suffering a loss of potential future revenue or incurring liabilities in connection with a breach
of such agreements and losing rights that are material to our business. Any such disruptions could limit our ability to
achieve the anticipated benefits of the Business Combination. The adverse effect of such disruptions could also impact our business
and operations or the market price of our Common Stock.
We
incurred substantial transaction fees
and costs in connection with completing the Business Combination and the integrating the businesses of Larkspur and
Old ZyVersa.
We incurred material non-recurring
expenses in connection with the Business Combination and the completion of the transactions contemplated by the Business Combination
Agreement and related transaction agreements. While we have assumed that a certain level of expenses would be incurred in connection
with the Business Combination, there are many factors beyond our control that have affected and could continue to
affect the total amount of, or the timing of, such expenses with respect to our combined business. Additional unanticipated
costs may continue to be incurred in the course of conducting our business following the Business Combination.
Our business and operations
could be negatively affected if it becomes subject to any securities litigation or stockholder activism, which could cause us
to incur significant expense, hinder execution of our business and growth strategy and impact our stock price.
In the past, following periods
of volatility in the market price of a company’s securities, securities class action litigation has often been brought against
that company. Stockholder activism, which could take many forms or arise in a variety of situations, has been increasing recently. Volatility
in the stock price of our common stock or other reasons may in the future cause it to become the target of securities litigation
or stockholder activism. Securities litigation and stockholder activism, including potential proxy contests, could result in substantial
costs and divert management’s and the board of directors’ attention and resources from our business. Additionally,
such securities litigation and stockholder activism could give rise to perceived uncertainties as to our future, adversely affect
its relationships with service providers and make it more difficult to attract and retain qualified personnel. We may also
be required to incur significant legal fees and other expenses related to any securities litigation and activist stockholder matters.
Further, our stock price could be subject to significant fluctuation or otherwise be adversely affected by the events, risks and
uncertainties of any securities litigation and stockholder activism.
The
grant of registration rights to certain holders, including pursuant to the PIPE Subscription Agreement, and the future exercise of such
rights may adversely affect the market price of our Common Stock.
Following completion of the Business
Combination, the Amended and Restated Registration Rights Agreement was entered into by and among us and certain other parties
thereto, replacing Larkspur’s prior registration rights agreement. Pursuant to the Amended and Restated Registration Rights Agreement,
the holders of registrable securities subject thereto, and their permitted transferees and assigns will have customary registration rights
(including demand, shelf and piggy-back rights, subject to cooperation and cut-back provisions) with respect to their shares of common
stock. Pursuant to the registration rights agreement entered into in connection with the consummation of the PIPE Investment,
we filed a registration statement with the SEC following the Business Combination for, in the case of the PIPE Investment,
a secondary offering of the shares of common stock underlying the PIPE Securities. Further, pursuant to such registration rights agreement,
we agreed that we will use commercially reasonable best efforts (i) to cause such registration statement to be declared effective
promptly thereafter and (ii) to maintain the effectiveness of such registration statement until such time as there are no longer
any registrable securities outstanding. In addition, the PIPE Subscription Agreement provides that these holders will have certain “piggy-back”
registration rights to include their securities in other registration statements filed by us. We have also agreed to grant registration
rights to holders of Series B Shares whereby such holders will receive customary registration rights (including
demand, shelf and piggy-back rights, subject to cooperation and cut-back provisions) with respect to the shares of common stock underlying
the Series B Shares.
If
securities or industry analysts either do not publish research about us or publish inaccurate or unfavorable research about us, our business
or our market, or if they adversely change their recommendations regarding our Common Stock, the trading price or trading volume
of our Common Stock could decline.
The
trading market for our common stock will be influenced in part by the research and reports that securities or industry analysts may publish
about us, our business, our market, or our competitors. If one or more securities analysts initiate research with an unfavorable rating
or downgrade our Common Stock, provide a more favorable recommendation about our competitors or publish inaccurate or unfavorable research
about our business, our Common Stock price would likely decline. If few securities analysts commence coverage of us, or if one or more
of these analysts cease coverage of us, or fail to publish reports on us on a regular basis, we could lose visibility
in the financial markets and demand for our securities could decrease, which in turn could cause the price and trading volume of our
common stock to decline.
A
significant portion of our total outstanding shares is restricted from immediate resale but may be sold into the market in the near future,
which could cause the market price of our common stock to decline significantly, even if our business is doing well.
The
market price of our Common Stock could decline as a result of sales of a large number of shares of our Common Stock in the market, or
the perception that these sales could occur. We have a total of 9,081,922 shares of Common Stock outstanding as of January 24,
2023. At any time after the expiration of a lock-up to which such shares are subject, certain stockholders will be entitled, under our
Amended and Restated Registration Rights Agreement, to certain rights with respect to the registration of the offer and sale of those
shares under the Securities Act, including requesting that we file a registration statement to register the offer and sale of their shares.
In
addition, we intend to file a registration statement to register shares reserved for future issuance under our equity compensation plans.
Upon effectiveness of that registration statement, subject to the satisfaction of applicable vesting restrictions and the expiration
or waiver of the market standoff agreements and lock-up agreements referred to above, the shares issued upon exercise of outstanding
stock options, restricted stock unit awards, and warrants or the vesting of other equity awards granted under such plans will be available
for immediate resale in the public market.
Sales
of our Common Stock as restrictions end or pursuant to registration rights may make it more difficult for us to sell equity securities
in the future at a time and at a price that we deem appropriate. These sales also could cause the trading price of our common stock to
fall and make it more difficult for you to sell shares of our Common Stock at a time and price that you deem appropriate.
We
do not intend to pay cash dividends for the foreseeable future.
We
currently intend to retain our future earnings, if any, to finance the further development and expansion of our business and do not intend
to pay cash dividends in the foreseeable future. Any future determination to pay dividends will be at the discretion of our board of
directors and will depend on our financial condition, results of operations, capital requirements, restrictions contained in future agreements
and financing instruments, business prospects and such other factors as our board of directors deems relevant.
Our
stockholders may experience dilution in the future.
The
percentage of shares of our common stock owned by current stockholders may be diluted in the future because of equity issuances for acquisitions,
capital market transactions, or otherwise, including, without limitation, equity awards that we may grant to our directors, officers,
and employees, exercise of our warrants.
Sales of a substantial number of shares of our Common Stock in the public market, including the resale of the shares of Common Stock underlying the PIPE Shares and PIPE Warrants pursuant to an effective resale registration statement or Rule 144, could occur at any time. These sales, or the perception in the market that the holders of a large number of shares of Common Stock intend to sell shares, could reduce the market price of our Common Stock. Pursuant to our obligations under the Amended and Restate Registration Rights Agreement and the registration rights agreements with the holders of the Series A Preferred Stock and the Series B Preferred Stock, we have agreed to register approximately 15 million shares of Common Stock. Such securities represent approximately 167% of the shares of Common Stock outstanding as of the date hereof. The resale, or expected or potential resale, of a substantial number of shares of our Common Stock in the public market could adversely affect the market price for the Common Stock and make it more difficult for our shareholders to sell their holdings at times and prices that they determine are appropriate. Further, the adverse market and price pressures resulting from an offering pursuant to a resale registration statement regarding the registration rights agreements described in this paragraph may continue for an extended period of time.
We intend to use
a substantial portion of the net proceeds from this offering to redeem the PIPE Shares, which may have an adverse effect on our business
and stockholders.
A substantial portion
of the net proceeds from this offering will be used to redeem the PIPE Shares. Although we intend to use the remaining proceeds, if
any, for working capital and other general corporate purposes, the redemption of the PIPE Shares will impact the cash we have
available for other purposes and to execute on our business strategy. There can be no assurance that the Company will receive
proceeds from this offering in an amount in excess of the amount required to redeem the PIPE Shares and, therefore, the Company may
not receive any proceeds from this offering for general corporate purposes. We expect to raise additional capital by issuing equity
or equity-linked securities in subsequent offerings. If we are unable to raise additional capital by issuing equity or equity-linked
securities on terms favorable to us, we may not have sufficient liquidity to execute on our business strategy, which could have an
adverse effect on our business, the value of our common stock, and our stockholders. For additional information, see sections
titled, “Prospectus Summary – Purpose of the Offering,” “Use of Proceeds,”
“Management’s Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital
Resources - Post-Business Combination Capital Needs,” and other risk factors under “Risk
Factors.”
Our
Charter provides, subject to limited exceptions, that the Court of Chancery will be the sole and exclusive forum for certain stockholder
litigation matters, which could limit our stockholders’ ability to obtain a chosen judicial forum for disputes with us or
our directors, officers, employees or stockholders.
Our
Second Amended and Restated Certificate of Incorporation (“Charter”) requires, to the fullest extent permitted by
law, that derivative actions brought in our name, actions against directors, officers and employees for breach of fiduciary duty
and other similar actions may be brought in the Court of Chancery or, if that court lacks subject matter jurisdiction, another federal
or state court situated in the State of Delaware. Any person or entity purchasing or otherwise acquiring any interest in shares of our
capital stock shall be deemed to have notice of and consented to the forum provisions in our Charter. In addition, our Charter and amended
and restated bylaws will provide that the federal district courts of the United States shall be the exclusive forum for the resolution
of any complaint asserting a cause of action under the Securities Act and the Exchange Act. While the exclusive forum provision does
not restrict the ability of shareholders to bring claims under the Securities Act, it may limit shareholders’ ability to bring
a claim in the judicial forum that they find favorable and may increase certain litigation costs on the shareholders, which may discourage
the filing of claims under the Securities Act against us, our directors and officers.
In
March 2020, the Delaware Supreme Court issued a decision in Salzburg et al. v. Sciabacucchi, which found that an exclusive forum
provision providing for claims under the Securities Act to be brought in federal court is facially valid under Delaware law. It is unclear
whether this decision will be appealed, or what the final outcome of this case will be. We intend to enforce this provision, but we do
not know whether courts in other jurisdictions will agree with this decision or enforce it.
This
choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes
with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuits with respect
to such claims. Alternatively, if a court were to find the choice of forum provision contained in the Charter to be inapplicable or unenforceable
in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business,
operating results and financial condition.
Additionally,
it is uncertain whether this choice of forum provision is enforceable. Section 22 of the Securities Act creates concurrent jurisdiction
for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations
thereunder. In light of this uncertainty, investors bringing a claim may face certain additional risks, including increased costs and
uncertainty of litigation outcomes.
Anti-takeover
provisions in our organizational documents could delay or prevent a change of control.
Certain
provisions of our Charter and Bylaws may have an anti-takeover
effect and may delay, defer or prevent a merger, acquisition, tender offer, takeover attempt or other change of control transaction that
a stockholder might consider in its best interest, including those attempts that might result in a premium over the market price for
the shares held by our stockholders.
These
provisions provide for, among other things:
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ability of our board of directors to issue one or more series of preferred stock; |
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classified board; |
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advance
notice for nominations of directors by stockholders and for stockholders to include matters to be considered at our annual meetings; |
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limitations on convening special stockholder meetings; |
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limiting
the persons who may call special meetings of stockholders; |
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limiting
the ability of stockholders to act by written consent; and |
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board of directors have the express authority to make, alter or repeal our Bylaws. |
These
anti-takeover provisions could make it more difficult or frustrate or prevent a third party from acquiring us, even if the third party’s
offer may be considered beneficial by many of our stockholders. Additionally, the provisions may frustrate or prevent any attempts by
our stockholders to replace or remove its current management by making it more difficult for stockholders to replace members of our board
of directors, which is responsible for appointing the members of its management. As a result, our stockholders may be limited in their
ability to obtain a premium for their shares. These provisions could also discourage proxy contests and make it more difficult for you
and other stockholders to elect directors of your choosing and to cause us to take other corporate actions you desire. See “Description
of Securities We Are Offering.”
Claims
for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us
and may reduce the amount of money available to us.
Our
organizational documents provide that we will indemnify our directors and officers, in each case to the fullest extent permitted by Delaware
law.
In
addition, as permitted by Section 145 of the General Corporation Law of the State of Delaware (the “DGCL”), our Bylaws
and indemnifications agreements entered into with our directors and officers provide that:
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we
will indemnify its directors and officers for serving us in those capacities or for serving other business enterprises at
its request, to the fullest extent permitted by Delaware law. Delaware law provides that a corporation may indemnify such person
if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests
of the registrant and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was
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may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law; |
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will be required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except
that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled
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will not be obligated pursuant to our Bylaws to indemnify a person with respect to proceedings initiated by that person against us
or our other indemnitees, except with respect to proceedings authorized by our board of directors or brought to enforce
a right to indemnification; |
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rights conferred in the Bylaws are not exclusive, and we are authorized to enter into indemnification agreements with our directors,
officers, employees and agents and to obtain insurance to indemnify such persons; and |
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may not retroactively amend our Bylaws provisions to reduce its indemnification obligations to directors, officers, employees and
agents. |
Warrants
exercisable for shares of our Common Stock, if exercised, will increase the number of shares eligible for future resale in the public
market and result in dilution to our stockholders.
There
are private placement warrants exercisable for an aggregate of approximately 240,204 shares of our Common Stock that were issued in
connection with Larkspur’s IPO, with a weighted-average exercise price of $11.50 per share. There are Public Warrants
exercisable for an aggregate of approximately 5,825,369 shares of our Common Stock, with a weighted-average exercise price of $11.50
per share. Following the consummation of this offering, there will be PIPE Warrants exercisable for an aggregate of
approximately 4,151,442 shares of our Common Stock (subject to possible adjustment for anti-dilution events), with a
weighted-average exercise price of $2.08 per share. In addition, there are warrants exercisable for 1,818,760 shares of our
Common Stock, that were issued to Old ZyVersa stockholders and assumed by us in connection with the Business Combination. The
exercise price of the PIPE Warrants will be reset to the price of our Common Stock at the initial reset date of the conversion
price of our PIPE Shares, but not below a price of $2.00. The number of shares of Common Stock issuable upon the exercise of the
PIPE Warrants will be adjusted to equal 100% of the shares of Common Stock issuable upon conversion of the PIPE Shares.
To
the extent any such warrants are exercised, additional shares of our Common Stock will be issued, which will result in dilution to the
holders of shares of our Common Stock and increase the number of shares of Common Stock eligible for resale in the public market. Sales
of substantial numbers of such shares of Common Stock in the public market or the fact that such warrants may be exercised could adversely
affect the market price of our Common Stock.
There
can be no assurance that the PIPE Warrants or the Public Warrants will be in the money at the time they become exercisable; they may
expire worthless and therefore we may not receive cash proceeds from the exercise of warrants.
As of the date of this prospectus, we have 5,825,369 outstanding Public Warrants to purchase 5,825,369 shares of our Common Stock, exercisable at an exercise price of $11.50 per share, which expire on the earlier to occur of December 12, 2027 or redemption and (ii) outstanding PIPE Warrants to purchase up to 4,317,500 shares of our Common Stock, exercisable at an initial exercise price of $11.50 per share (subject to adjustment in connection with the consummation of this offering), which expire on December 12, 2027. The exercise of the PIPE Warrants and Public Warrants, and any proceeds we may receive from their exercise, are highly dependent on the price of our Common Stock and the spread between the exercise price of such warrant and the price of our Common Stock at the time of exercise. For example, to the extent that the price of our Common Stock exceeds $11.50 per share, it is more likely that holders of our PIPE Warrants and Public Warrants will exercise their warrants. If the price of our Common Stock is less than $11.50 per share, it is unlikely that such holders will exercise their warrants. As of February 10, 2023, the closing price of our Common Stock was $2.08 per share. There can be no assurance that all of our warrants will be in the money prior to their expiration. Our Public Warrants under certain conditions, as described in the warrant agreement, are redeemable by us at a price of $0.01 per warrant. Our PIPE Warrants are not redeemable and are exercisable on a cashless basis. As such, it is possible that we may never generate any cash proceeds from the exercise of our warrants.
If
you purchase securities in this offering, you will suffer immediate dilution of your investment.
You
will incur immediate and substantial dilution as a result of this offering. The combined public offering price per share of common stock
and accompanying warrant and the combined public offering price per pre-funded warrant and accompanying warrant will be substantially
higher than the pro forma as adjusted net tangible book value per share of our Common Stock after giving effect to this offering. Therefore,
if you purchase securities in this offering, you will pay an effective price per share of Common Stock you acquire that substantially
exceeds our pro forma net tangible book value per share after this offering. Based on an assumed public offering price of $2.08
per share of Common Stock and accompanying warrant (the last reported sale price of our Common Stock on Nasdaq on February
10, 2023), and assuming no sale of any pre-funded warrants in this offering, no exercise of the warrants being offered in this offering,
that no value is attributed to such warrants and that such warrants are classified as and accounted for as equity, you will experience
immediate dilution of $1.21 per share, representing the difference between our as adjusted net tangible book value per share after
giving effect to this offering and the assumed public offering price per share and accompanying warrant.
Our
management will have broad discretion in the use of the net proceeds from this offering and may invest or spend the proceeds in ways
with which you do not agree and in ways that may not yield a return.
Our
management will have broad discretion in the application of the net proceeds from this offering, including for any of the purposes described
in the section titled “Use of Proceeds,” and you will not have the opportunity as part of your investment decision
to assess whether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine
our use of the net proceeds from this offering, their ultimate use may vary from their currently intended use. The failure by our management
to apply these funds effectively could harm our business. Pending their use, we may invest the net proceeds from this offering in investment-grade,
interest-bearing securities. These investments may not yield a favorable return to our securityholders.
There
is no public market for the pre-funded warrants or the warrants offered hereby.
There
is no established public trading market for the pre-funded warrants or the warrants offered hereby, and we do not expect such a market
to develop. In addition, we do not intend to apply to list the pre-funded warrants or the warrants on any national securities exchange
or other nationally recognized trading system. Without an active market, the liquidity of the pre-funded warrants and the warrants will
be limited.
Holders
of the pre-funded warrants or the warrants purchased in this offering will have no rights as common stockholders until such holders exercise
their pre-funded warrants or warrants and acquire our Common Stock.
Until
holders of the pre-funded warrants or the warrants acquire shares of our Common Stock upon exercise thereof, such holders will have no
rights with respect to the shares of our Common Stock underlying the pre-funded warrants or the warrants. Upon exercise of the pre-funded
warrants or the warrants, the holders will be entitled to exercise the rights of a common stockholder only as to matters for which the
record date occurs after the exercise date.
The
warrants are speculative in nature.
The
warrants do not confer any rights of common stock ownership on their holders, such as voting rights or the right to receive dividends,
but rather merely represent the right to acquire shares of common stock at a fixed price for a limited period of time. Moreover, following
this offering, the market value of the warrants, if any, will be uncertain and there can be no assurance that the market value of the
warrants will equal or exceed their imputed offering price. The warrants will not be listed or quoted for trading on any market or exchange.
There can be no assurance that the market price of our Common Stock will ever equal or exceed the exercise price of the warrants, and
consequently, the warrants may expire valueless.
A.G.P./Alliance Global Partners may have a “conflict of interest” under FINRA Rule 5121.
A.G.P./Alliance Global Partners, a placement
agent in this offering, has a “conflict of interest” under Rule 5121 of the Financial Industry Regulatory Authority,
Inc. (“FINRA”) based on its beneficial ownership of our securities. Accordingly, this offering will be made in compliance with the applicable provisions of Rule 5121.
The rule requires that a “qualified independent underwriter” meeting certain standards participate in the preparation of
the registration statement and prospectus and exercise the usual standards of due diligence with respect thereto. Benchmark has agreed
to act as a “qualified independent underwriter” within the meaning of Rule 5121 in connection with this offering. Benchmark
will receive $25,000 for serving as a qualified independent underwriter in connection with this offering. In its role as qualified independent
underwriter, Benchmark has participated in due diligence and the preparation of this prospectus and the registration statement of which
this prospectus forms a part and has exercised the usual standards of due diligence with respect thereto. See the section of this prospectus
captioned “Plan of Distribution (Conflicts of Interest)” for additional information.
This
is a best efforts offering, no minimum amount of securities is required to be sold, and we may not raise the amount of capital we believe
is required for our business plans, including our near-term business plans.
The
placement agents have agreed to use its reasonable best efforts to solicit offers to purchase the securities in this offering.
The placement agents have no obligation to buy any of the securities from us or to arrange for the purchase or sale of any specific
number or dollar amount of the securities. There is no required minimum number of securities that must be sold as a condition to completion
of this offering. Because there is no minimum offering amount required as a condition to the closing of this offering, the actual offering
amount, placement agent fees and proceeds to us are not presently determinable and may be substantially less than the maximum amounts
set forth above. We may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received
by us, and investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to
support our continued operations, including our near-term continued operations. Thus, we may not raise the amount of capital we believe
is required for our operations in the short-term and may need to raise additional funds, which may not be available or available on terms
acceptable to us.