Item
1. Business
PolarityTE
- Welcome to the SHIFT
PolarityTE
Inc., headquartered in Salt Lake City, Utah, is a young and growing commercial-stage, biotechnology company founded in 2016 -
and we believe the first of its kind. We are focused on the design and development of novel technology platforms that promote
the regeneration of complex, cellular-derived tissue substrates and the propagation of self-organizing composite systems. We have
developed, and will continue to evolve these technologies and platforms through uniquely targeted and yet comprehensive approaches
to the interactome. The interactome is the complete set of physical interactions between molecules within a cell that underlies
most genotype-to-phenotype relationships and modulates nearly all complex biological pathways and cellular networks seen in living
systems. Understanding this, we believe that to effectively deliver our advanced technologies to patients we must not simply deliver
products, but rather robust platform systems and evolving technology foundations that are intelligent, multi-functional, and able
to adapt and evolve. Over the last year we have established and advanced three of our pipeline programs consisting of our core
“TE” program, (which includes our first commercial product, SkinTE), our Related Technology Derivative program (“RTD”),
and our Advanced Research Center program (“ARC”).
A
glossary is provided at the end of this Item 1, which you may find helpful in reading this report.
Vision
We
aspire to be a global biotechnology company that delivers superior, tangible, and pragmatic platform technologies that provide
superior results to patients, while reducing costs and promoting improved health economics for patients, providers, and payors.
We accomplish this mission through our pursuit of complex simplicity, which embodies the development of robust cell/tissue-derived
therapies that can be efficiently produced and deployed. PolarityTE is committed to delivering transformative technology that
positively impacts humanity.
PolarityTE
was founded by a dedicated group of doctors and scientists from The Johns Hopkins University School of Medicine, who left to become
part of something bigger. Something that could transform the future of medicine. We believe that living systems require more than
a simple singular input (for example a growth factor, stem cell, or nano-particle), to produce a complex output. Therefore, we
took a different direction and developed multi-tiered platform technologies that propagate the necessary complex substrate required
for regenerating fully-functional tissue, such as skin, bone, cartilage, muscle, blood vessels, and neural elements, as well as
solid and hollow organ composite tissue systems. We have engineered and developed our regenerative materials and core tissue substrate
technology platforms to allow us to induce, maintain, and promote the integrated polarity, organized assembly, and interface development
of cells and tissues, so that they replicate regenerative healing in the body and are not seen as foreign by the immune system.
The
core technology of TE products is minimally polarized functional units (“MPFUs”) consisting of self-complexing intelligent
regenerative materials (“SCIRM”). SCIRM within an MPFU form polarizing, multi-cellular aggregates that act as an intrinsic,
regenerative bio-reactor capable of expanding, proliferating, and synthesizing cells, materials, factors, or systems necessary
for regenerating full-thickness, three-dimensional tissue. The TE products we develop begin with the patient’s own tissue
to produce SCIRM that address the specific tissue or system needed for the patient’s care. Our product pipeline focuses
on the development of regenerative products for a variety of tissue types and organ systems that are commonly altered, injured,
or destroyed by a variety of diseases, pathologies, traumatic events, and medical interventions.
SkinTE,
our first tissue product, was registered with the United States Food and Drug Administration (FDA) in August 2017, and is now
commercially available for the repair, reconstruction, replacement, and regeneration of skin in patients who have a need for treatment
of acute or chronic wounds, burns, surgical reconstruction events, scar revision, or removal of dysfunctional skin grafts. We
are pursuing a regional plan for commercial rollout that began in late October 2018, and we now have 22 sales representatives
in the field marketing SkinTE.
OsteoTE
is designed to utilize the patient’s bone to repair, reconstruct, replace, supplement, or regenerate bone damage or defects.
We registered OsteoTE with the FDA in December 2018. We are preparing for the first application of the product in a clinical setting,
which we are endeavoring to achieve in the first half of 2019.
Human
cells, tissues and cellular and tissue-based products (“HCT/Ps”) are governed by specific FDA regulations that provide
for a registration pathway different than the pathway for traditional drug candidates. SkinTE and OsteoTE are both registered
as HCT/Ps under Section 361 of the Public Health Service Act.
We
have a number of additional TE products under development. The following table illustrates the status of our TE product pipeline.
RTD
and ARC represent research and development of new science and product opportunities based on what we learned while developing
the TE platform. RTD is focused on altered state analytes for the generation of composite materials that can be utilized for the
augmentation, modulation, and regulation of cell and tissue-derived systems. ARC is focused on the design and development of gene
transfer, small molecule synthesis, composite therapeutics, and alteration of self-propagating cell/tissue-derived bioreactors.
The
following table shows the research projects we are pursuing through RTD and ARC programs.
We
have significant research facilities and a well-educated and skilled team of scientists and researchers. These resources are highly
beneficial to the work we are doing on our TE products and in RTD and ARC. We also offer research services to unrelated third
parties on a contract basis, which we offer under the trademark POLARITYRD. Contract research services help us defray the costs
of maintaining a first-rate research facility and allow us to meet companies pursuing new technologies that may be opportunities
for collaborative or strategic relationships going forward.
Limitations
to Clinical Standards of Care, Regenerative Technologies and Tissue Substitutes
Clinical
Standards of Care for Tissue Replacement
While
both the literature and current practice indicate that the clinical standard of care remains the replacement of “like with
like” (i.e. skin for skin, bone for bone, cartilage for cartilage), to date, many regenerative technologies, tissue engineered
products and wound care products, have focused on “large scale manufacturable materials” and “off the shelf”
designs, as opposed to employing a more patient-specific approach. Many of these types of products are xenografts, allografts,
or alloplasts in part to allow for abundant sources of raw materials for the products. We believe these products merely act as
synthetic cell/tissue substitutes, which are incapable of delivering true regeneration or regenerative potential of complex tissue
systems and, therefore, why such products continue to fail to deliver results that are comparable to an autologous tissue graft
(i.e. skin graft, bone graft, cartilage grafts etc.).
We
believe that historically the fields of regenerative medicine, tissue engineering, and, to some extent, cell-therapy have remained
characterized by tremendous potential and promise for the future yet continue to remain limited by the pursuit of “artificial
and/or synthetic” approaches that are overly reductionist, and thus fail to deliver “complete systems.” Some
current regenerative medicine approaches try to isolate a single cellular population to regenerate a tissue, such as adipose-derived
stem cells. Others try to deliver a molecule to manipulate cell function, such as driving cell growth and expansion, or coax one
cell type to become another. Another approach tries to create some form of a scaffold that resembles the target tissue with specific
properties designed to mimic that tissue. We believe these approaches incorrectly focus on the synthesis or engineering of singularities
(i.e., a type of cell, a type of molecule, or type of matrix) in an attempt to build a complex tissue from the ground up, which
we believe creates an incomplete system without interactions, diverse cells and molecules, or a natural environment to direct
organization.
Real
Limitations: Using Skin as an Example
Current
clinical standards and practice adhere to the concept that skin should be replaced with skin whenever possible in settings where
patients have suffered the loss of such tissue. Understanding this, medical professionals are left with a decision to attempt
to temporize a wound bed with an allograft, use the patient’s own skin in a skin graft, or apply a variety of skin substitutes
to provide a skin-like barrier while the margin of the wound heals through secondary intention and contraction. Presently, harvest
and placement of autologous full-thickness skin results in the best outcome within wound beds because it most closely resembles
the full-thickness skin that was lost. However, full-thickness harvest of skin inherently also results in a full-thickness skin
defect at the donor site, which requires primary closure (skin edge approximation and suturing) so as not to leave a gaping wound
behind. Because of this absolute limit on how much autologous full-thickness donor skin can be harvested without leaving behind
a non-closable wound, medical professionals can only harvest small elliptically-shaped pieces of such skin from areas of redundancy
which is termed full-thickness skin graft (FTSG).
It
is because there remains only a finite supply of FTSG donor material and sites that medical professionals often rely on the harvest
of split-thickness skin grafts (STSG) for coverage of voids of the integument to get better coverage and more skin. STSGs, however,
do not represent the true anatomy or function of native skin because such graft harvest procedures only take the top 1/10,000th
of an inch of the patient’s own skin and therefore do not capture all the necessary cellular and tissue elements and structures
required for the regeneration of normal skin (Figure I).
Figure
I. Common Site Locations for Skin Graft Harvesting. The left figure depicts the process and common location of where a split-thickness
skin graft (STSG) is harvested from with a vibrating razor that shaves off the very top 1/10,000th of an inch of skin as depicted
in the skin cross section. STSGs are often then meshed (pocked with holes like a screen door) to allow for improved stretch over
surfaces and to permit fluid drainage to pass through the graft and avoid build up under the graft like a bubble. The right figure
depicts the common sites where full-thickness skin grafts are harvested from patients. Note that these areas are often hidden
in anatomic locations where there are creases or folds to place the resulting scar from primary linear closure in aesthetically
considerate places.
After
the failure to harvest all the necessary structures, cellular elements and tissue interfaces from the STSG donor site, the patient
is left with an incomplete top layer of skin covering the initial defect (recipient site) and a remaining bottom layer at the
donor site. In this setting, both donor and recipient sites contain incomplete skin, which results in dysfunctional, painful scar
tissues and lifelong morbidities.
Because
of the limits of STSG and FTSG and the type of procedures required for such harvests, the industry has continued to investigate
skin substitutes and skin alternatives that can be used in place of native cutaneous substrate. Among these alternatives or options
are a culture form of manipulated autograft, allograft, xenograft, and alloplast. None of these substitutes have been able to
replicate the appearance of native skin or regenerate full-thickness skin or the cutaneous appendages (hair follicle, sweat gland,
sebaceous glands, etc.), which are necessary for the development of full-thickness, functionally polarized, hierarchically organized
skin.
The
forgoing skin example shows that the traditional approach to regenerative medicine that competitors employ is anchored within
tissue engineering algorithms that - while cost-effective because of mass production and scalability - are incongruent with living
cells, dynamic tissues, and reactive systems, and, therefore, fail to produce outcomes that effectively heal and alleviate suffering.
Our
Solution
We
believe that our bio-generative SCIRM technology platforms are fundamentally new and inherently promote a drastically different
approach to current conventional cell therapy efforts, regenerative technologies, and current products. Therapeutic singularities
such as a single stem cell, a single growth factor, a single scaffold, or a combination of such singularities are unable to engineer
a complex tissue in vitro for subsequent deployment into living systems. Recognizing the complexity of tissue regeneration as
absolutely requiring cell-to-cell and cell-to-tissue polarity, interfaces, gradients, modulation, and multiplex system interactivity
and real-time integration, we embrace a substantially more complete form of tissue regeneration that is biologically sound and
evolutionarily cohesive with the dynamics of living systems.
We
have designed and developed an entirely new form of regenerative cell/tissue therapy platform based on SCIRMs organized in complex
MPFUs that when deployed into a wound or tissue defect undergo integrative regenerative healing within the system in which it
was deployed by effectively acting as its own bioreactor and thus expanding, proliferating, and synthesizing those cells, materials,
factors, and systems necessary for full-thickness generation and regeneration across a spectrum of tissue substrates and organ
systems.
Our
technology platform is based on complex living tissue systems and the interfaces that drive cell-tissue-matrix polarization events.
We recognize there is something powerful, reactive, and dynamic controlling tissue generation, which is the interactome; the whole
set of interactions a cell is impacted by, both intra and extra-cellularly. Cells rarely act on their own to create functional
repair or regeneration, but rather tissues have functionally-organized cellular aggregates called appendages (almost like small
organs), which run, and even regenerate, the composite tissues they are a part of when altered, stimulated, and processed in certain
ways.
We
believe each person’s cells and tissues have vastly different and dynamic profiles (genes, RNA, proteins, metabolites, etc.)
and, therefore, different requirements when it comes to the regenerative potential or healing capacity of tissue-based systems.
With this in mind, we designed our core “TE” platform technology to focus not on singularities, but on regenerating
complete tissue systems.
Our
core “TE” platform and self-complexing intelligent regenerative materials technologies are based on our ability to
create MPFUs, which contain polarizing multi-cellular aggregates capable of expanding, proliferating, and synthesizing those cells,
materials, factors or systems we believe are necessary for integrative full-thickness three-dimensional tissue regeneration, not
simply two-dimensional cell sheets. Instead of starting with artificial materials, synthetic factors, or altered cell suspensions,
our platform begins with the patient’s own (autologous) tissue and those components, appendages and substrates we believe
are necessary for the development of an expandable and self-propagating complete system. The key attributes of our platform technology
include the following:
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Patient-Generated
Cell Source:
The human body often identifies and rejects foreign cells, creating the potential for tissue rejection, additional
surgery, and foreign or allogeneic body reactions like residual scarring. We address this by using healthy autologous tissue
taken from the patient to regenerate cells and tissues that the body identifies as “self” rather than foreign.
Our goal is to allow a recipient to receive our product and generate new tissue without triggering an allogeneic, or foreign
tissue, rejection.
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Stem
Cell Niche Utilization for Self-Propagating and Self-Organizing Functional Tissues:
We utilize techniques for capturing
the “stem cell niche,” the microenvironment within a tissue that interacts with stem cells to signal cell growth,
development, renewal, and differentiation. While the stem cell niche historically has often been left behind by the commonly
used split-thickness autograft methodology, we believe that it is necessary for the regeneration of functional tissue. Without
the stem cell niche, we believe new tissue will form a scar and lose the functionality of the original tissue from which it
was regenerated. By including the stem cell niche within the autologous tissue that is harvested, we believe the natural function
of the small piece of tissue is preserved as it regenerates into a larger piece that can fill the patient’s targeted
tissue. This is designed to minimize painful scarring, lesions, and other growth anomalies that often accompany autologous
regeneration without the stem cell niche. This design approach also allows regeneration of the tissue’s normal layers
and appendages and provides full-tissue coverage without relying on secondary surgery or in-growth of the surrounding tissue.
We believe inclusion of the stem cell niche allows us to regenerate tissue with its naturally complex layers intact.
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Polarity
Maintenance and Enhancement to Harness Stem Cell Niche Regeneration:
A cell’s polarity refers to its interactive
communication with neighboring cells, including the direction in which a cell should grow. This enables cells and tissues
to carry out specialized functions. Our platform carefully maintains and enhances the polarity of the stem cell niche to harness
its regenerative capacity by mirroring the way tissue develops in the human body. By maintaining and enhancing the polarity
of regenerating tissue, our platform is designed to preserve the natural cell and three-dimensional tissue structure, and
thereby the functionality of regenerated tissues and appendages.
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The
Person as the Bioreactor
: Instead of using a manufactured or engineered environment to support the regenerative process,
our platform uses the human body as a bioreactor by applying our product to the patient and allowing regeneration to occur
there. We believe this allows the patient’s own body to provide the ideal nutrients and extracellular environment for
controlled healing of the regenerative tissue. This approach also reduces turnaround time for delivering product to the patient,
as our manufacturing process does not involve growing cells in an industrial, synthetic bioreactor. In addition, utilization
of the patient as the bioreactor during cellular tissue propagation further reduces relative costs, which are passed onto
patients, providers, and payor systems.
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Reducing
Barriers - Arming More Healthcare Providers with Tangible and Pragmatic Technologies:
We believe that novel technologies
must thrive in the trenches of medicine and be easily utilized by a full spectrum of providers to truly deliver value and
make an impact in patients’ lives. We recognize that a technology that is limited by who can administer it or setting
of care where it can be used creates barriers and limits access to those who need it. Our goal is to design and develop therapies,
technologies and products that overcome these limits by delivering new standards of care, which are easily utilized by ALL
providers, across ALL settings of care.
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Our
Competitive Strengths
We
believe that our key competitive strengths include the following:
Pursuing
the Development of a Complete System that Rivals the Clinical Standard of Care:
We believe that we have designed and developed
a technology platform that may displace the current clinical standard of care in complex tissue regeneration, reconstruction or
replacement efforts. Currently, the clinical standard of care for the reconstruction of complex tissue voids relies on autologous
tissue transplantation. For example, critical defects of the skin, bone, cartilage and other tissues are most appropriately treated
through the autologous graft or flap coverage. While these efforts remain the clinical standard of care in most settings, such
processes result simply in the transplantation of tissue from one area of the body to another region. Such movement of autologous
tissue materials often provides “coverage” but does not result in significant expansion of the cellular entities or
tissue substrates. After the limited ability to expand beyond 1:1 – 1:4 ratios, donor site size and morbidity must be taken
into consideration when harvesting autologous tissues. Understanding these limitations that exist within the clinical standard
of care, we have sought to design and develop an autologous tissue that requires a relatively small tissue contribution from the
donor harvest site that can be significantly expanded on the donor’s treatment site.
Novel
Platform Technology
. Our technology platform deploys activated MPFUs into a wound or other tissue defect with the goal of
regenerating fully-functional, polarized tissues and hierarchically organized tissue structures. We design the MPFUs to facilitate
the expansion, proliferation, and synthesis of the cells, materials, factors, and systems that we believe are necessary for complete,
full-thickness generation and regeneration across a spectrum of tissue substrates and organ systems. Rather than relying on a
single stem cell, growth factor, or scaffold, we believe that complex tissue regeneration requires a dynamic composite cellular
interface to engineer a complex tissue that is expected to integrate into living systems. We design our core tissue substrate
materials to create complex functional living tissue systems in a way that mirrors natural healing in the body and is not seen
as foreign by the immune system. We believe our platform technology will produce superior outcomes for providers and patients.
Deep
Pipeline of Additional Potential Applications
. We believe our platform’s capabilities can be extended across many indications,
including skin, bone, cartilage, muscle, blood vessels, and neural elements, as well as solid and hollow organ composite tissue
systems. For example, we believe there are currently unmet medical needs that can be addressed by the regeneration of cartilage
for the treatment of osteoarthritis and facial reconstruction, the regeneration of fat-for-fat transfers during plastic surgery
procedures, the regeneration of nerves following traumatic loss, the regeneration of blood vessels for vascular grafts, the regeneration
of the urogenital epithelium and submucosa for urethral strictures and bladder reconstruction following tumor removal, the regeneration
of liver tissue for liver fibrosis or failure, and the regeneration of bowel tissue to prevent leaking where the bowel is reconnected
or replaced due to excessive loss from trauma, surgery, or congenital defects. We believe the significant number of product opportunities
afforded by our platform will generate sustainable growth opportunity.
Shortened
Product Development Timelines
. Since our core TE product candidates all stem from a common platform technology, we believe
we can accelerate research and development, pre-clinical model prototyping, and product development in a manner that is efficient
and optimized across tissue substrates.
Scalable
Manufacturing and Distribution Capability
. Because we believe our technology can be applied across a variety of tissue substrates,
we believe we are able to prototype, model, and develop products for commercialization relatively quickly. We have developed flexible
manufacturing processes, systems, and facilities that we believe can allow us to quickly respond to increases in demand and market
forces. Because we believe we can apply our technology to many types of tissue and organ systems, we believe we can effectively
scale and reproduce the manufacturing and distribution of multiple pipeline products at the same time. In addition, we believe
we can leverage our platform technology to create a variety of substrate sub-platforms and related technology derivative arms,
which can act either as additive technologies to core TE products, or as stand-alone products. We believe we may also be able
to integrate our technology with other off-the-shelf products (e.g., to cellularize an acellular scaffold or function with existing
dressings).
Our
Growth Strategy
Complete
the full commercial launch of SkinTE and establish SkinTE as an improvement over the standard of care for skin tissue injuries,
including wounds, burns, and scars
. We believe that SkinTE has the potential to supplant prevailing methods of wound and burn
care because, unlike existing treatment options, it is designed to regenerate full-thickness skin using small samples of the patient’s
own tissue. Rather than being limited by dimensions of the tissue received, SkinTE is designed to regenerate significantly beyond
the sample size. Our regional commercial rollout of SkinTE commenced in late October 2018, and is focused on severe wounds and
burn patients at key regional centers as, in our experience, these patients are often in critical need of large areas of skin
regrowth and may have limited available healthy skin to use for skin grafts. Along with the treatment of severe wounds and burns,
we intend to market SkinTE for chronic wounds, surgical reconstruction events, including cosmetic and elective surgeries, and
for scar revision or the removal of dysfunctional events.
Based
on our internal analysis of annual patient volumes and relative wound sizes, we estimate the annual addressable markets within
the United States for burn wounds, surgical reconstruction and traumatic wounds, and chronic wounds are $3 billion, $23 billion,
and $24 billion, respectively. These markets are largely contained within the approximately 127 burn centers, 600 level I-III
trauma centers, and greater than 2,000 wound care centers and clinics within the United States.
Capitalize
on our scalable manufacturing capabilities and the 361 HCT/P regulatory pathway to commercialize additional pipeline products
quickly and efficiently
. In addition to SkinTE, we are actively preparing and advancing two additional TE core products, OsteoTE
and CartTE, for FDA registration using the 361 HCT/P pathway that does not require FDA approval prior to market entry. Our current
expectation is to rely on the versatility of our platform technology, the 361 HCT/P regulatory pathway, and our scalable manufacturing
capability to develop and launch these two new products over the next two years.
Explore
partnership or collaboration opportunities for pipeline candidates, as well as potential acquisitions or in-licenses of complementary
product candidates.
We are actively exploring the possibility of partnership or collaboration opportunities with third parties,
which we believe could be used to facilitate the commercial adoption of our pipeline candidates worldwide or in certain territories.
We are selectively evaluating the formation of collaborative alliances, product licensure and distribution agreements, and integrated
product offerings, as well as opportunities to accelerate the commercialization and development of our products. In the future,
we also expect to consider the acquisition or in-license of complementary product candidates.
SkinTE
General
Our
first product, SkinTE, is registered with the FDA and is now commercially available for treatment of defects of the skin. SkinTE
is created from a small piece of the patient’s own tissue, which is extracted and then manufactured using our proprietary
technology platform to expand and regenerate full-thickness, fully functional skin with what we believe to be the critical layers,
including epidermis, dermis and hypodermis, and appendages including hair follicles and glands. Each application of SkinTE is
patient-specific and designed for a single deployment. We believe SkinTE offers a compelling alternative to current standards
of care for skin regeneration.
PolarityTE
designed SkinTE for use by physicians and other healthcare professionals in the treatment of patients who have suffered from an
event, disease, or process, or who have an acquired defect that has resulted in the functional loss or absence of the skin. Specifically,
SkinTE is designed for the treatment of chronic wounds such as diabetic foot ulcers, acute wounds, chronic burn wounds or scars,
acute burn wounds, scars of the integument, and defects from medical or surgical resection or reconstruction events that require
skin coverage. According to a 2015 report from MedMarket Diligence, LLC, more than 250 million wounds are expected globally by
2020. And according to Statistics MRC’s 2016 Global Regenerative Medicine Market Outlook, the global market for regenerative
medicine and tissue engineering is expected to grow to $101.3 billion by 2020.
During
the calendar year 2018, we established the product logistics, interactions with hospitals, and our clinical operations and market
access teams, so that we can handle all aspects of manufacturing and commercializing an autologous skin product. We have no reported
adverse reactions from any of the applications of SkinTE. We hired our first sales force and have been building out our first
regional release since October 2018. The full national release of SkinTE is planned for 2019.
SkinTE
is registered as a 361 HCT/P with the FDA pursuant to Section 361 of the Public Health Service Act and 21 CFR 1271. An HCT/P is
defined as an article containing or consisting of human cells or tissues that are intended for implantation, transplantation,
infusion, or transfer into a human recipient. Products that qualify as 361 HCT/Ps are not subject to the FDA’s pre-market
clearance or approval requirements, but rather can be immediately listed for commercial use with the FDA and are then subject
to post-market regulatory requirements such as compliance with current good tissue practices (cGTP), adverse event and deviation
reporting, and post-market inspections by the FDA. For more information on the 361 HCT/P regulatory pathway, please see the discussion
below under “Government Regulation” and “Risk Factors – Risks Related to Registration or Regulatory Approval
of Our Product Candidates and Other Government Regulations.”
Our
Wound, Burn and Skin Reconstruction Treatment Solution – SkinTE
We
described in detail above the real limitations of the standard of care in tissue regeneration as applied to skin. We designed
SkinTE to address the limitations from which current wound and burn treatment methods suffer. We designed SkinTE to combine the
advantages of autologous STSGs with those of FTSGs. Notably, SkinTE is designed to provide not only the large surface area treatment
capability of STSGs, but also the restoration and smaller, less morbid donor site associated with FTSGs. In essence, we believe
our minimally manipulated SkinTE product can provide an expandable form of a FTSG.
To
our knowledge, SkinTE is the only fully autologous, homologous skin regeneration product available for the treatment of wounds
and functional losses of the skin of human patients. We face competition from providers of FTSGs and STSGs, as well as other companies
developing and selling skin substitutes. We are aware of several companies focused on the wound market, including Avita Medical,
Integra LifeSciences, Wright Medical Group, MiMedx, Osiris, Organogenesis, Allosource, MTF Biologics and Vericel. Any advances
in regenerative medicine by a competitor may be used to develop therapies competing against SkinTE. However, to our knowledge
SkinTE is the only fully autologous homologous skin regeneration product available for the treatment of wounds and functional
losses of skin that enables the patient to regenerate his or her own skin with all the functions of full thickness skin, including
hair, sweat glands, sebaceous glands, capillary beds, and all layers of skin, including epidermis, dermis, hypodermis, and subdermal
fat. We believe SkinTE produces a superior result for patients that challenges the current standard of care and the therapies
offered by other companies in the wound care market.
SkinTE
is composed of small viable cellular and tissue-based units, which we call MPFUs, that retain all the components of skin that
we believe are required to regenerate full-thickness skin. The initial processes underlying the function of SkinTE are analogous
to those responsible for the healing of an autologous skin graft, namely imbibition, inosculation, and neo-vascularization. During
imbibition, SkinTE, and the small cellular and tissue based units that comprise it, survive through the direct application of
the SkinTE “paste” on the wound bed, exchanging nutrients and waste within the fluid of the wound bed. Inosculation
is the stage in which the capillaries and blood vessels already present within the wound bed begin to align and connect with those
present within the graft. Neovascularization marks the ingrowth of new blood vessels into the wound bed and out of the graft,
with vasculogenesis describing the formation of new vessels from cellular precursors present within the wound and graft, and angiogenesis
referring to the sprouting of new vessels from pre-existing ones. Due to their size and composition, we design the small cellular
and tissue based units within SkinTE to have reduced metabolic demand and to be capable of surviving through diffusion, and to
readily excrete metabolic waste, resulting in what we believe can be less ischemic damage when compared to FTSGs. Reduction in
ischemic damage has the potential to decrease scar formation and provide a more functional result. Following completion of the
initial stages of integrating and healing within the wound bed, the SkinTE product is designed to begin forming and organizing
discrete areas of full-thickness skin. We have observed in preclinical animal testing that these regenerative centers of full-thickness
skin then expand out radially across the wound, eventually coalescing with each other and the margins of the wound.
Unlike
the currently marketed skin substitutes of which we are aware, each SkinTE tissue-product is derived entirely from the patient’s
own skin and is not combined with any other tissue-engineered substitutes. We believe these differences allow SkinTE to regenerate
all the important layers of the skin as well as the necessary cutaneous appendages for the development of functionally-polarized,
hierarchically organized autologous, homologous skin.
The
SkinTE Process
SkinTE
is designed as an all-in-one system to make the process as simple and efficient as possible for the user—whether that individual
is a surgeon, medical doctor, physician assistant or nurse in an operating room, wound clinic, emergency department, doctor’s
office or forward operating military base. When a new clinical center or practice is activated to begin using our SkinTE product,
we ship a supply of all-inclusive harvest boxes (see the image furthest to the left above) to the facility for convenient on-site,
off-the-shelf storage for that user and facility. Each harvest box contains all the materials and instruments needed to perform
the relatively standard skin excision procedure to obtain the tissue sample, and all the pre-paid/pre-completed shipping labels,
and a one-touch, cool pack shipping box that maintains the temperature within the harvest box as it is delivered to a PolarityTE
biomedical manufacturing facility.
At
our manufacturing facility, we use proprietary techniques to create a paste-like product from the small piece of healthy patient
tissue that preserves the original tissue’s microenvironment and allows new cells to integrate into existing, healthy cells,
with similarly organized assembly and interface development. Following manufacturing at our facility, the SkinTE product is shipped
back to the provider at a time that best suits the patient and provider’s scheduling and location needs (i.e., operating
room, procedure clinic, in-patient bedside, out-patient doctor’s office). Our goal is to be able to return the ready-to-use
SkinTE product to physicians as early as the same day. We have observed, however, that most physician requests have been for return
within 24-72 hours from tissue harvest. At application time, once the patient wound bed is prepared per clinical guidelines, SkinTE
is dispensed onto the surface of the wound bed (see the image in the middle above). The wound is dressed using a non-adherent,
occlusive, non-absorbent dressing placed directly over the SkinTE product (see the image furthest to the right above), with recommended
dressings that we include in the deployment box.
To
assist physicians and other medical providers in using SkinTE, we developed a web application called the PolarityTE 24-Hour Real-Time
Assistant, or the RTA, which permits experienced and medically trained PolarityTE physicians and staff to provide real-time support
through a customer’s computer or smart phone. The RTA permits HIPAA-compliant direct calling, video chat, text, emails,
and data sharing. Through the RTA, our customers can also track their packages and submit forms. We also use the RTA to gain advanced
visibility into daily manufacturing requirements and product flow.
Selling
SkinTE
In
2018, we completed the first two stages of our SkinTE commercial roll-out strategy. The first was the limited market release phase,
which focused on generating trial/ utilization with the goal of securing real-world clinical data and experience to prepare the
organization and product for a broader commercial release. The second stage was the regional market release that began in late
October 2018 with the additional build out of our commercial organization to establish SkinTE with major burn and trauma centers
across the United States. Each hospital targeted requires an assessment by their Value Analysis Committee (VAC) prior to commencing
commercial SkinTE deployment. This is a formal process and our experience to date shows the process was completed with a few organizations
relatively quickly, in several months, with a few organizations in a much longer period, over nine months, and most organizations
falling between those two extremes. After VAC approval, terms of the SkinTE purchase agreement are finalized and patient identification
and treatment initiates, which can take several months.
Once
purchase agreements are in place, our sales team and clinical operations staff maintain close contact with the facility to support
the initial therapeutic applications of SkinTE. Due to the transformational nature of the product, this relationship helps to
ensure the facility’s ability to effectively incorporate SkinTE into their existing burn or wound management protocols.
The
regional market release began in late October 2018, and we have not found a predictable pattern for the length of the sales process
from VAC submission to first paid deployment of SkinTE. We have observed that the sales process is affected by several factors,
including the incidence and nature of burn and wound care cases at target accounts and the receptiveness of the health care providers
to adopt a new therapeutic approach.
We
have observed with a number of organizations there is a delay between the first and follow-on deployments of SkinTE. We suspect
one reason for this may be that the physician waits to evaluate the clinical outcome of the first application before considering
a second application. To help decrease the time between the first and second deployment, we are actively pursuing multiple randomized
controlled clinical trials to further illustrate SkinTE clinical outcomes and overall value proposition. Furthermore, as SkinTE
gains in utilization and acceptance by health care providers, we believe the lead time to first sale may decrease as information
on SkinTE and clinical results are more broadly disseminated in the medical community.
SkinTE
is billed by the square centimeter size of the skin defect to be treated, as is standard for skin wound treatments. Because SkinTE
is created from the patient’s own tissue, we can price below other treatment options like skin substitutes. Unlike other
treatment options, SkinTE can deliver permanent, functional full-thickness skin replacement with only one application, compared
to the multiple procedure regimens common for split-thickness skin grafts, full-thickness skin grafts, autograft, allograft, and
alloplast therapies.
For
the unaudited quarters ended March 31, June 30, September 30, and December 31, 2018, our revenue from the sale of SkinTE was $0.003
million, $0.189 million, $0.197 million, and $0.498 million, respectively. Revenue for the two-month period ended December 31,
2018 was $0.673 million.
Payment
and Reimbursement
Inpatient
Setting
. In the inpatient setting, facility reimbursement is dictated by the associated bundled Medicare Severity-Diagnosis
Related Group (MS-DRG) payment for the entire episode of care under the Medicare Inpatient Prospective Payment System (IPPS).
The bundled DRG facility payment is determined by the DRG code applied, which factors in the primary diagnosis and patient characteristics,
such as co-morbidities present on admission. In this scenario, all products and supplies utilized during the episode of care are
paid for with the bundled DRG facility payment, including products like SkinTE. In addition, physician services are billed and
reimbursed outside of the bundled DRG facility payment, including any procedures performed during that admission, which are billed
for and reimbursed utilizing Current Procedural Terminology (CPT) codes associated with the respective procedures. SkinTE has
been used within the inpatient setting and reimbursed underneath the applicable DRG bundled facility payments, and to our knowledge
all associated procedures billed for outside the DRG as physician services with CPT codes have been reimbursed, as well.
Hospital
Outpatient Department (HOPD) and Ambulatory Surgical Center (ASC) Setting
. Like the inpatient setting, bundled Ambulatory
Classification Payment (APC) facility payments are received under the Medicare Outpatient Prospective Payment System (OPPS) for
services and supplies utilized during episodes of care within Hospital Outpatient Departments (HOPDs) and Ambulatory Surgical
Centers (ASCs). In these settings, bundled APC facility payments are dictated by the procedures performed and billed for through
the appropriate CPT codes. SkinTE has been used in these settings and covered with the associated bundled APC facility payments
and physician services have been paid for outside of the APC payment utilizing CPT codes to bill for the associated procedures.
In addition, we are working towards applying for pass-through status, which would allow SkinTE to be billed for outside of the
bundled APC facility payment.
Office
or Clinic Setting
. In contrast to the inpatient, HOPD, and ASC settings, care provided in a physician office or clinic is
reimbursed based on individual Healthcare Common Procedure Coding System (HCPCS) and CPT codes, facilitating reimbursement for
the specific products utilized and procedures performed during the clinic visit. The CPT codes used in the setting are the same
or similar to the CPT codes used to bill for physician services in the other settings of care. In 2018, providers utilized HCPCS
Q code 4100 (skin substitute not otherwise specified) to bill for the use of SkinTE in the office. Of the providers that used
SkinTE in the office or clinic setting throughout 2018, to our knowledge all were reimbursed utilizing Q4100. Early in 2018 we
filed an application with The Centers for Medicare and Medicaid Services (“CMS”) for a unique HCPCS SkinTE Q code.
We were successful and received Q code 4200, which was effective January 1, 2019. Therefore, beginning January 1, 2019, providers
using SkinTE in the office or clinic setting can use Q4200, the unique SkinTE specific Q code, when billing for the product. Reimbursement
rates in the Medicare Hospital Outpatient Payment System (HOPPS) vary based on whether the product is designated a low-cost product
or high cost product. Assignment is based on average selling Price (ASP) as reported to CMS. New Q codes with limited ASP on file
with CMS are automatically assigned to the low-cost product category. We reported our first ASP in October 2018, so SkinTE’s
Q code will initially be designated a low-cost product limiting the reimbursement to $483 for a single application in a clinic
setting. We will continue to report ASP and work with CMS on this process because we believe that SkinTE can qualify as a high-cost
product reimbursable at $1,548 for a single application in a clinic setting.
Clinical
Studies
We
initiated a head-to-head trial comparing SkinTE to the split-thickness skin graft, the clinical standard of care, in the first
quarter of 2018. Enrollment is in progress and we expect it will be completed in 2019. In parallel with this clinical trial, we
have been accumulating clinical results on non-trial patients from our market release for application of SkinTE for various indications,
including acute burn, burn reconstruction, surgical reconstruction, scar revision, and chronic wounds, such as diabetic foot ulcers
and venous stasis ulcers. Some of these cases have been presented independently by, or in collaboration with, providers at national
conferences including the 2018 American Professional Wound Care Association Conference, the 2018 Diabetic Foot Global Conference;
2018 American Society of Plastic Surgery - The Meeting; 2018 Symposium on Advanced Wound Care; and, the 2018 Innovations in Wound
Healing. We believe peer-reviewed publication of these results will occur in 2019. Following very encouraging pilot results, we
prepared and submitted two separate randomized controlled trials in diabetic foot ulcers and venous stasis ulcers, which constitute
the most common causes of chronic lower extremity wounds that affect over a million Americans. These trials will each treat over
100 patients each, compare SkinTE to the standard of care, and evaluate the efficacy and cost benefit of a single application
of SkinTE providing important reimbursement information for the Centers for Medicare & Medicaid Services and outpatient applications.
We have institutional review board approval for each study, listing of each on clinicaltrials.gov is pending, and we expect the
first enrollments shortly after listing. These will be multi-center trials that will enroll throughout 2019.
OsteoTE
We
applied our platform technology to develop OsteoTE, our autologous, homologous bone regeneration product. OsteoTE is designed
to utilize the patient’s own bone to target applications for bone repair, reconstruction, replacement, supplementation,
and regeneration, including in the long bone (hard, dense bones that provide structure, strength and mobility such as the femur
or humerus), craniomaxillofacial, spine, dental, hand, and foot/ankle markets. As with skin, we believe existing treatments for
the repair of bone with autologous grafts suffer from significant limitations that we can address with OsteoTE. We have conducted
several preclinical large animal studies using established bone treatment models, including critical-sized cranial bone defects
and spinal fusion models. The preclinical results for OsteoTE are very encouraging and parallel the results seen with SkinTE –
the ability to regenerate complex tissues recapitulating the structure and function of the native tissue from which it was created.
Below are preliminary images of OsteoTE bone regeneration in a preclinical model of a cranial defect.
Comparative
Imaging of OsteoTE in Critical Sized Cranial Defect Model System
. (a.) Three-dimensional (3-D) micro computed tomography (micro-CT)
native cranial bone displaying pre-defect left parietal and right parietal bones of
in vivo
model system at timepoint T
PDN
.
(b.) Gross image of surgically-created, complete, bi-parietal critical sized defects of both the left and right parietal bones
within the
in vivo
model system at timepoint T
0
. (c.) 3-D micro-CT of surgically-created, complete (full-thickness),
bi-parietal critical sized defects of both the left and right parietal bones within the
in vivo
model system. ① Indicates
the right parietal bone region with 8 mm diameter defect at timepoint T
0
which was un-treated and maintained as the
defect control throughout study. ② Indicates the left parietal bone region with 8 mm defect which was treated with OsteoTE
and maintained as the defect-treated control throughout the study. (d.) 3-D micro-CT of surgically-created, complete, bi-parietal
critical sized defects of both the left and right parietal bones within the
in vivo
model system at 4 weeks post-procedure
and intervention (timepoint T
PPI-4WK
).
Indicates the un-treated right parietal bone region (defect control) at 4 weeks.
Indicates the treated left parietal bone region (OsteoTE) at 4 weeks. (e.) Depicts the relative
margins of the primary bi-parietal defects (dotted circles) at time point T
0
; ROI (broken line box) indicates zoomed
comparison of 4 weeks post-treatment defects of 3-D micro-CT and correlative 3-D thermal spectrum colored surface plot indicating
relative surface depth and volumetric contour. Abbreviations: Pre-defect Native Timepoint (T
PDN
): timepoint at which
native skull was imaged prior to creation of defect; Defect Native Timepoint (T
0
): timepoint at which complete (full-thickness)
8 mm critically sized defects were created in parietal skull regions; Post-procedure and intervention at 4 weeks timepoint (T
PPI-4WK
):
timepoint at which 4 weeks have passed since the defects were created +/- treated with intervention.
Based
on our internal analysis of the Truven Health Analytics Market Scan Research Database, there were approximately 1.9 million addressable
orthopedic cases in the United States, including patients suffering from pathology of the femur, radius, ulna, tibia, fibula,
or humerus. We believe OsteoTE can be deployed in numerous indications in the craniomaxillofacial, foot and ankle, hand and wrist,
hip and pelvis, spine, long bone and dental markets. Each of these markets presents a potential multi-billion-dollar market opportunity
for OsteoTE. According to a report issued by the research firm MarketsandMarkets, the global spinal fusion and implant market
is expected to reach $17.3 billion by 2021, the global craniomaxillofacial implants market is expected to reach $2.5 billion by
2021, and the dental market is expected to reach $35.4 billion by 2021. We registered OsteoTE with the FDA as a 361 HCT/P tissue-based
product in December 2018, and our goal is to commercialize OsteoTE through a phased release starting in early 2019.
CartTE
With
our CartTE product candidate, we are aiming to deliver on a long-imagined product—one that can tackle the highly prevalent
and debilitating process of osteoarthritis to delay or prevent the need for more invasive procedures, such as prosthetic joint
replacement and reconstruction. Furthermore, we believe the autologous cartilage construct delivered with CartTE can be utilized
in a variety of other applications, including facial reconstruction, facial aesthetics, hand reconstruction, as well as wrist
reconstruction. We have initiated the preclinical studies needed to evaluate cartilage replacement in critical-sized defects and
will continue to evaluate CartTE’s potential in various cartilage replacement indications.
Osteoarthritis
of the hip or knee is estimated to affect 9% of the US population greater than 30 years of age, with costs of treatment totaling
$28.6 billion in 2013, according to a review by Grande et al. Market projections by Krutz et al. in 2007 predict that the demand
for primary (first-time) total hip and knee replacements will grow to 572,000 and 3.48 million procedures per year by 2030 in
the US, respectively. In contrast to the staggering number of patients suffering from osteoarthritis and those pursuing joint
replacement, the cartilage repair and regeneration market is only estimated to reach $6.7 billion by 2025, according to a Cartilage
Repair/Regeneration Market Analysis report by Grand View Research. This lopsided market, in which cartilage repair and regeneration
only captures a small fraction of the patient population that could benefit from articular cartilage regeneration, demonstrates
a significant opportunity for our autologous cartilage regeneration product, CartTE, to displace the current trends and standards
of care, delivering the regenerative medicine product that has remained elusive until now.
Additional
Core TE Product Candidates
In
addition, we intend to continue developing:
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AdipoTE
to optimize the delivery of autologous fat beyond the capabilities of current fat transfer techniques utilized in procedures
on, among others, the breast, buttocks, and face. In 2016, according to the American Society for Aesthetic Plastic Surgery,
approximately 100,000 fat transfer procedures were performed when combining the breast, buttocks, and face, including a 41%
increase in fat transfers to the breast (American Society for Aesthetic Plastic Surgery).
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AngioTE
to address vascular regeneration including microscopic capillary networks all the way up to great vessel replacement. Approximately
400,000 coronary bypass grafts are performed per year in the US according to the CDC. In addition, 650,000 patients per year
in the US and 2 million patients per year worldwide are affected by end stage renal disease, who may benefit from placement
of hemodialysis access, including arteriovenous fistula creation.
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NeuralTE
for peripheral nerve injuries of the extremities, as well as for patients with neuromas or chronic compression due to joint
replacements, migraines, craniofacial injuries, carpal tunnel syndrome, and those who have undergone hernia or abdominal-based
procedures;
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UroTE
targeting the delivery of autologous urogenital epithelium and submucosa across a spectrum of diseases and processes, including
urethral strictures, urethral creation, bladder reconstruction, and ureter reconstruction;
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LiverTE
to address numerous causes of liver failure, including NASH, fibrosis/cirrhosis, surgical resection of the liver. According
to the CDC, 1.6% of US adults are diagnosed with liver disease, which fails to recognize the portion that are at risk of liver
disease, or those with distant metastases within their liver that may undergo resection of a significant portion of the organ.
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BowelTE
to deliver an optimized autologous construct to aid in the regeneration of bowel tissue. According to the CDC, approximately
10 million outpatient procedures and 6 million inpatient procedures were performed on the digestive system in 2010. Anyone
undergoing surgical repair or anastomosis of the bowel could potentially benefit from a product delivering bowel regeneration.
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We
believe a number of the product candidates described above will be suitable for marketing via the 361 HCT/P regulatory pathway.
If we successfully register and list a product with the FDA using the 361 HCT/P pathway, we plan to deploy a commercialization
strategy that is like that for SkinTE. Any products not suitable for the 361 HCT/P regulatory pathway will need to go through
the FDA pre-market approval process, which usually involves the filing, as applicable, of an Investigational New Drug Application
or Biologics License Application that will require further preclinical and clinical testing and substantially extend the time
of bringing the product to market.
Manufacturing
We
do not separately engineer individual manufacturing processes around each individual tissue product. Rather, we design, develop,
and adapt our core “TE” products and product candidates to a common manufacturing process that allows us to establish
fast, effective, and cost-efficient systems. Adopting a common manufacturing process enhances our production capacity and expansion
strategy, and at the same time potentially reduces our cost of goods sold.
We
have designed and developed manufacturing processes and quality systems that allow us to receive a specimen, qualify the incoming
tissue, process and manufacture the cell/tissue product, and perform outgoing quality control and quality assurance work prior
to shipping. We believe that our ultra-clean dual-barrier system, which involves clean room structures containing fully-isolated
and air-locked internal ISO 4 containment systems, allows us to move specimen and product in an efficient manner, while maintaining
protective quality systems.
We
have designed our scalable manufacturing process to allow us to be flexible and agile in real-time, while allowing us to shift
resources daily to meet acute production needs as well as respond to larger factors, including market forces, multi-facility buildouts,
and changes in rapidly evolving technology platforms. In designing our products and systems, we focused both on being able to
meet market demand and to scale manufacturing. We believe that we have designed our manufacturing clean dual-barrier system to
be efficient in flow processes, column production, and scalability. In compliance with ISO standards and cGTP, our repeating clean
manufacturing column systems and fully-isolated and air-locked internal ISO 4 containment units are engineered and designed with
scalable production in mind.
We
currently operate a facility in Salt Lake City, Utah, consisting of approximately 178,528 square feet. We use this facility for
product manufacturing and research and development work. We intend to establish over time remote manufacturing facilities we call
“nodes” at locations close to health care providers we believe will be significant purchasers of our products. One
of the significant benefits of nodes is the creation of manufacturing redundancy, so that production can be sustained if one of
our manufacturing facilities is unable to produce due to natural disaster or other cause. We also believe nodes have the potential
to lower shipping costs, which would improve our gross margin on products sold in the areas where the nodes are located.
Suppliers
As
part of our strategy of ensuring timely delivery of our products, we have avoided relying on any third-party supplier as a sole
source vendor for any element of our production process. In the past year, we have signed agreements with primary suppliers to
reduce costs, ensure faster fulfillment, and increase our bulk purchasing capability. We have identified alternate suppliers and,
where appropriate, supply alternatives for any sourcing challenges.
Intellectual
Property
As
we advance our platform technology, our RTA, and our RTDs, we seek to apply a multilayered approach for protecting intellectual
property relating to our innovation – with patents (utility and design), copyrights, trademarks, as well as know-how and
trade secret protection.
We
do not currently own any granted patents, but have a number of patent applications pending in the U.S. and around the world. We
have four pending U.S. non-provisional utility patent applications relating to MPFUs – U.S. Serial Nos. 14/954,335; 15/650,656;
15/650,659; and 16/165,169. Each of these applications claims priority to a U.S. provisional application filed on December 2,
2014. We have one Patent Cooperation Treaty (PCT) International Patent Application (PCT International Publication No. WO 2016/089825)
and national phase applications have been entered in OAIP, ARIPO, Australia, Brazil, Canada, China, Colombia, Costa Rica, Eurasia,
Europe, Great Britain, Hong Kong, Israel, India, Indonesia, Japan, South Korea, Mexico, Malaysia, New Zealand, Philippines, Singapore,
South Africa, Thailand, United Arab Emirates, Ukraine, Vietnam. These applications, as well as our pending non-public applications
(which will only be identified after publication), are proceeding along the normal timeline of patent office examination in each
respective country. The receipt of office actions from patent offices is part of the examination process, as is our response to
such office actions. To date, no patent application has been abandoned or lapsed. Nor has any application been rejected in a manner
that forecloses the possibility of receiving a granted patent from that same application. All our patent applications are currently
alive and actively being pursued. We cannot predict when or where the first set of patent claims might be granted, nor can we
speculate on the scope of claims in such a future patent.
We
seek to complement the protection of our innovation with a portfolio of trademarks and service marks in the United States and
around the world. The POLARITYTE trademark has been registered in the United States, Australia, Brazil, China, the European Union,
Iceland, India, Israel, Japan, South Korea, Malaysia, Mexico, Norway, the Russian Federation, Singapore, Switzerland, Taiwan,
and Turkey. Additional registered trademarks in the United States include our logo, WELCOME TO THE SHIFT, and WHERE SELF REGENERATES
SELF.
In
striving to protect and enhance proprietary technology, inventions, and improvements that are commercially important to the development
of our business, we also rely heavily on trade secrets relating to our proprietary technology and on know-how. We enter into confidentiality
agreements with our employees, consultants, scientific advisors, and contractors. We also seek to preserve the integrity and confidentiality
of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information
technology systems.
Competition
The
regenerative medicine industry is characterized by rapidly advancing technologies, intense competition, and a strong emphasis
on intellectual property. We face substantial competition from companies developing and selling regenerative medicine products,
as well as academic research institutions and governmental agencies and public and private research institutions.
Many
of our current or potential competitors, either alone or with their collaboration partners, have significantly greater financial
resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, and marketing
approved products than we do. Smaller or early-stage companies may also prove to be significant competitors, particularly through
collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining
qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials,
as well as in acquiring technologies complementary to, or necessary for, our programs.
Our
commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more
effective, have fewer or less severe side effects, are more convenient, or are less expensive than any products that we may develop.
Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for
ours (if required), which could result in our competitors establishing a strong market position before we are able to enter the
market. The key competitive factors affecting the success of our programs are likely to be their efficacy, safety, convenience,
price, and the availability of reimbursement from government and other third-party payers.
RTD
and ARC
We
believe our TE platform technology is a revolutionary approach to regenerative medicine in and of itself, but we also find that
it suggests new areas of inquiry and potential innovation. To this end, we have active research we are pursuing through our Related
Technology Derivatives (RTD) and Advanced Research Center (ARC) programs. RTDs can be designed to augment the application and
regenerative outcomes of our pipeline products or be used as stand-alone products. ARC programs focus on the improvement of RTDs
as well as augmentation of our pipeline products. We are excited about the recent advancements in the field of gene therapy and
are interested in the possibility of genetically altering our products, including SkinTE, to better treat and possibly cure rare
diseases, such as Epidermolysis Bullosa, a genetic condition that causes the skin to be very fragile and to blister easily.
Contract
Research Services
In
May 2018, we purchased the assets of a preclinical research sciences business and related real estate from Ibex Group, L.L.C.,
a Utah limited liability company, and Ibex Preclinical Research, Inc., a Utah corporation. We acquired these assets to accelerate
research and development of our TE product candidates, and now operate the business as IBEX to advance our product development
and deliver preclinical research services to third parties. The business consists of a “good laboratory practices”
(GLP) compliant preclinical research facility that is USDA registered and includes vivarium, operating rooms, preparation rooms,
storage facilities, and surgical and imaging equipment. The real property includes two parcels in Logan, Utah, consisting of approximately
1.75 combined gross acres of land, together with the buildings, structures, fixtures, and personal property located on the real
property.
PolarityTE
RD offers a complimentary array of research services to those offered through IBEX, providing access to experimental planning,
histology, and in vivo and in vitro imaging, including micro-ct. The PolarityTE RD arm is well equipped with state of the art
equipment and sophisticated research staff that provide a range of services including veterinary and preclinical services, advanced
imaging, biomedical engineering and validation, molecular biology assays and proteomics analyses.
Government
Regulation
Government
authorities or laws and regulations in the United States and other countries regulate the manufacturing, approval, labeling, packaging,
storage, record-keeping, and promotion of products such as those we have developed and are developing. Any product we are developing
must comply with the standards required for the product category under which the product is classified by such government authorities
or laws.
FDA
Regulation of Tissue-Based Products
The
FDA has specific regulations governing human cells, tissues and cellular and tissue-based products, or HCT/Ps. An HCT/P is a product
containing or consisting of human cells or tissue intended for transplantation into a human patient. In the United States, HCT/Ps
are subject to varying degrees of regulation by the FDA, depending on if they fall solely within the scope of Section 361 of the
Public Health Service Act (the “PHS Act”) (42 U.S.C. § 264) or if they are regulated as drugs, devices, or biological
products under Section 351 of the PHS Act (42 U.S.C. § 262) or the FD&C Act.
If
an HCT/P meets the criteria for regulation solely under Section 361 of the Public Health Service Act (so-called “361 HCT/Ps”),
no premarket FDA review for safety and effectiveness under a drug, device, or biological product marketing application is required.
However, the processor of the tissue is required to register and list its products with the FDA, comply with regulations regarding
labeling, record keeping, donor eligibility and screening and testing, process the tissue in accordance with established current
Good Tissue Practices (cGTP), and investigate and, in certain circumstances, report adverse events or deviations.
To
be a 361 HCT/P, a product generally must meet all four of the following criteria:
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must be minimally manipulated;
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must be intended for homologous use;
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Its
manufacture must not involve combination with another article, except for water, crystalloids or a sterilizing, preserving
or storage agent, provided the addition of such article does not raise new clinical safety concerns; and
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It
must not have a systemic effect and must not be dependent upon the metabolic activity of living cells for its primary function
(unless the product is intended for reproductive use, autologous use, or use in a first- or second-degree blood relative).
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We
believe that SkinTE and OsteoTE qualify as 361 HCT/P tissue based products, and believe that our core “TE” products
in development (e.g., CartTE) will qualify as 361 HCT/Ps. Other products we are developing are being evaluated with respect to
regulatory classification, and we will prepare for any pathway of manufacturing or regulation that is required.
All establishments that manufacture 361 HCT/Ps must register and list their HCT/Ps with the FDA’s Center
for Biologics Evaluation and Research (“CBER”) within five days after commencing operations. In addition, establishments
are required to update their registration annually in December or within 30 days of certain changes, and submit changes in HCT/P
listing at the time of or within six months of such change. Establishments that manufacture 361 HCT/Ps will know that they are
registered in compliance with 21 C.F.R. § 1271.10(a) when they receive a validated form with the registration number (“FEI#”)
after submitting the Form FDA 3356 (registration form). Current Good Tissue Practice (“cGTP”) requirements govern,
as may be applicable, the facilities, controls, and methods used in the manufacture of HCT/Ps, including without limitation, recovery,
donor screening, donor testing, processing, storage, labeling, packaging, and distribution of 361 HCT/Ps. FDA inspection and enforcement
with respect to establishments described in 21 C.F.R. § 1271 includes inspections conducted, as deemed necessary, to determine
compliance with the applicable provisions and may include, but is not limited to, an assessment of the establishment’s facilities,
equipment, finished and unfinished materials, containers, processes, HCT/Ps, procedures, labeling, records, files, papers, and
controls required to be maintained under 21 C.F.R. § 1271. Such inspections can occur at any time with or without written
notice at such frequency as is determined by the FDA in its sole discretion. Our Salt Lake City manufacturing site was inspected
in July 2018 and we received certain inspectional observations on Form FDA 483 following that inspection. We responded to those
observations and engaged in a productive dialog with the FDA. Following our responses, in or around February 2019, FDA classified
the July 2018 inspection of our Salt Lake City Manufacturing site as “Voluntary Action Initiated,” or “VAI.”
A VAI classification indicates that, although FDA found and documented objectionable conditions during its inspection, FDA will
not take or recommend regulatory or enforcement action with respect to such inspectional observations at this time.
If
we fail to comply with the FDA regulations and laws applicable to our operation or tissue products, the FDA could take enforcement
action, including, without limitation, pursuing any of the following sanctions, among others:
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Untitled
letters, warning letters, fines, injunctions, product seizures, and civil penalties;
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Orders
for product retention, recall, or destruction;
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Operating
restrictions, partial suspension or total shutdown of operations;
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Refusing
any requests for product clearance or approval;
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Withdrawing
or suspending any applications for approval or approvals already granted; or
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Criminal
prosecution.
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For
more information on this regulatory risk, please see the discussion below, “Risk Factors,” including but not limited
to the information under the heading, “Risks Related to Registration or Regulatory Approval of Our Product Candidates and
Other Government Regulations.”
Fraud,
Abuse and False Claims
We
are directly and indirectly subject to various federal and state laws governing relationships with healthcare providers and other
potential referral sources for our products pertaining to healthcare fraud and abuse, including anti-kickback, false claims, and
similar laws. In addition, federal and state laws are also sometimes open to interpretation. The Company could potentially face
legal risks if our interpretation differs from those of enforcement authorities. Further, from time to time the Company may find
itself at a competitive disadvantage if the Company’s interpretation differs from that of its competitors.
In
particular, the federal healthcare program Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, offering,
receiving or providing remuneration (in cash or in kind), directly or indirectly, in exchange for or to induce either the referral
of an individual, or the furnishing, arranging for, or recommending of, a good or service for which payment may be made in whole
or part under federal healthcare programs, such as the Medicare and Medicaid programs. Penalties for violations include criminal
penalties and civil sanctions such as fines, imprisonment and possible exclusion from Medicare, Medicaid and other federal healthcare
programs. The Anti-Kickback Statute is broad and prohibits many arrangements and practices that are lawful in businesses outside
of the healthcare industry. In implementing the statute, the Office of Inspector General of the U.S. Department of Health and
Human Services (“OIG”) has issued a series of regulations, known as the “safe harbors.” These safe harbors
set forth provisions that, if all their applicable requirements are met, except certain remuneration and remunerative arrangements
from violating the Anti-Kickback Statute. The failure of a transaction or arrangement to fit precisely within one or more safe
harbors does not necessarily mean that it is illegal or that prosecution will be pursued. However, conduct and business arrangements
that do not fully satisfy each applicable element of a safe harbor may result in increased scrutiny by Government enforcement
authorities, such as the OIG. Many states have laws similar to the federal law.
Also,
the federal civil False Claims Act (“FCA”) imposes civil liability on any person or entity that submits, or causes
the submission of, a false or fraudulent claim to the U.S. government. Damages under the FCA can be significant, and consist of
the imposition of fines and penalties. The FCA also allows a private individual or entity (i.e., a whistleblower) with knowledge
of past or present fraud against the federal government to sue on behalf of the government and to be paid a portion of the government’s
recovery, which can include both civil penalties and up to three times the amount of the government’s damages (usually the
amount reimbursed by federal healthcare programs). The U.S. Department of Justice takes the position that the marketing and promotional
practices of life sciences product manufacturers, including the off-label promotion of products, the provision of inaccurate or
misleading reimbursement guidance, or the payment of prohibited kickbacks, may cause the submission of improper claims to federal
and state healthcare entitlement programs such as Medicare and Medicaid by health care providers that use the manufacturer’s
products, which results in a violation of the FCA. In certain cases, manufacturers have entered into criminal and civil settlements
with the federal government under which they entered into plea agreements, paid substantial monetary amounts and entered into
corporate integrity agreements (“CIAs”) that require, among other things, substantial government oversight, as well
as reporting and remedial actions going forward
If
we fail to comply with these laws, we could be subject to enforcement actions, including but not limited to:
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Multi-year
investigations by federal and state governments;
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Criminal
and civil fines and penalties;
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Obligations
under settlement agreements, such as CIAs or Deferred Prosecution Agreements; or
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Exclusion
from participation in federal and state healthcare programs.
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For
more information on this fraud, abuse, and false claim risk, please see the discussion below, “Risk Factors,” including
but not limited to the information under the heading, “We are subject to numerous federal and state healthcare laws and
regulations, and a failure to comply with such laws and regulations could have an adverse effect on our business and our ability
to compete in the marketplace.”
Environmental
Matters
Our
research, development and tissue preservation activities generate some chemical and biomedical wastes, consisting primarily of
diluted alcohols and acids, and human and animal pathological and biological wastes, including human and animal tissue and body
fluids removed during laboratory procedures. The chemical and biomedical wastes generated by our research, development and tissue
processing operations are placed in appropriately constructed and labeled containers and are segregated from other wastes. We
contract with third parties for transport, treatment, and disposal of waste. We strive to remain compliant with applicable laws
and regulations promulgated by the Resource Conservation and Recovery Act, the U.S. Environmental Protection Agency and similar
state agencies.
Reimbursement
In
the United States, demand for access to any medical product will depend in large part on both the availability and the amount
of reimbursement from third-party payers, including government healthcare programs (including Medicare and Medicaid), and commercial
healthcare insurers, including managed care organizations and other private health plans. Third-party payers have complex rules
and requirements for coverage and reimbursement of healthcare products and services. Even the applications to such third-party
payers to be eligible for reimbursement for product or services are complex and can be lengthy and time consuming. For new technologies
coming to market, these payers are increasingly examining the clinical evidence supporting medical necessity and cost effectiveness
decisions in addition to safety and efficacy, which can result in barriers to early coverage reimbursement, or denial of coverage
and reimbursement altogether. Accordingly, significant uncertainty exists as to the availability of coverage and reimbursement
status for new medical products. If third-party payer reimbursement is unavailable to our customer hospitals, physicians, and
providers, our sales may be limited and we may not be able to realize an appropriate return on our investment in research and
product development.
Payers
often set payment rates depending on the site of service and many use the Medicare program as a benchmark for their own payment
methodologies. In the hospital inpatient setting, Medicare payment generally is set at pre-determined rates for all products and
services provided during a patient stay, and is based on such factors as the patient diagnosis, procedures performed, patient
age, and complications. In the physician office or clinic setting, Medicare payment generally is based on a fee schedule, with
payment rates set for each procedure performed and product used, although the schedule may in some instance bundle the product
into the payment for the procedure. In some outpatient settings, such as in the case of the hospital outpatient clinic setting,
Medicare payment rates generally are premised on classifications of services that have similar clinical characteristics and similar
costs. To better track utilization, we filed an application with CMS for a unique HCPCS SkinTE Q code. We were successful and
received Q code 4200, which was effective January 1, 2019.
Reimbursement
policies depend in part on legislation designed to regulate the healthcare industry and federal and state governments continue
to propose and pass new healthcare legislation and government agencies revise or change their regulations and policies from time
to time. We cannot predict whether or how such reform measures and policy changes would affect reimbursement rates and demand
for our products.
Patient
Privacy
HIPAA,
as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their implementing regulations,
including the final omnibus rule published on January 25, 2013, mandates, among other things, the adoption of uniform standards
for the electronic exchange of information in common healthcare transactions, as well as standards relating to the privacy and
security of individually identifiable health information, which require the adoption of administrative, physical and technical
safeguards to protect such information. Among other things, HITECH makes HIPAA’s security standards directly applicable
to business associates, defined as independent contractors or agents of covered entities that create, receive or obtain protected
health information in connection with providing a service for or on behalf of a covered entity. Because our products use autologous
tissue sources that are tracked and reapplied to the same individual patient from which the tissue was harvested, our business
maintains substantial amounts of patient identifiable health information. HITECH also increased the civil and criminal penalties
that may be imposed against covered entities and business associates, and gave state attorneys general new authority to file civil
actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs
associated with pursuing federal civil actions. In addition, certain state laws govern the privacy and security of health information
in certain circumstances, some of which are more stringent than HIPAA and many of which differ from each other in significant
ways and may not have the same effect, thus complicating compliance efforts. Failure to comply with these laws, where applicable,
can result in the imposition of significant civil or criminal penalties. Since we do not submit claims electronically to payers,
we do not believe we are a covered entity under HIPAA.
Transparency
Laws
The
Patient Protection and Affordable Care Act imposes, among other things, annual reporting requirements for covered manufacturers
for certain payments and other transfers of value provided to physicians and teaching hospitals, as well as certain ownership
and investment interests held by physicians and their immediate family members. We do not believe that we are a covered manufacturer
under the Sunshine Act because our products are neither regulated as pharmaceuticals, biologics, nor medical devices by the FDA,
and 361 HCT/P autologous tissue sources are not expressly addressed by this law.
USDA
The
Company and its subsidiaries conduct preclinical research and development, which is regulated by the United States Department
of Agriculture (USDA) Animal and Plant Health and Inspection Service (APHIS) and must be performed in compliance with the Animal
Welfare Act, Animal Welfare Regulations, and Animal Care Policies. The Company and each of its subsidiaries that conduct preclinical
research have in place Institutional Animal Care and Use Committees to oversee compliance with the animal care and use program
and report accordingly to the USDA on an at least a semi-annual basis. All performance sites that maintain USDA-covered species
are actively registered as USDA research facilities.
Employees
We
had approximately 156 full-time employees as of December 31, 2018, all of whom are in the United States. None of our employees
are represented by a labor union or covered by a collective bargaining agreement. We consider our relationship with our employees
to be good.
Corporate
History
On
December 1, 2016, Majesco Acquisition Corp., a Nevada corporation and wholly-owned subsidiary of Majesco Entertainment Company,
a Delaware corporation (“Majesco DE”) entered into an Agreement and Plan of Reorganization with PolarityTE, Inc.,
a Nevada corporation (“PolarityTE NV”) and Dr. Denver Lough, the owner of 100% of the issued and outstanding shares
of capital stock of PolarityTE NV. The asset acquisition was subject to shareholder approval, which was received on March 10,
2017, and the transaction closed on April 7, 2017. In January 2017, Majesco DE changed its name to “PolarityTE, Inc.”
(“PolarityTE”). Majesco Acquisition Corp. was then merged with PolarityTE NV, which remains a subsidiary of PolarityTE.
Majesco Acquisition Corp. II, formed in November 2016 under Majesco Entertainment Company, changed its name to “PolarityTE
MD, Inc.,” and remains a wholly-owned subsidiary of PolarityTE.
Prior
to the acquisition of PolarityTE NV, Majesco DE developed and published a wide range of video games on digital networks through
its Midnight City label. On May 2, 2017, Majesco Entertainment Company, a Nevada corporation and wholly owned subsidiary of PolarityTE
(“Majesco NV Sub”), was formed, into which all the assets and liabilities of this gaming business were placed. On
June 23, 2017, PolarityTE sold the Majesco NV Sub to Zift Interactive LLC, a Nevada limited liability company, pursuant to a purchase
agreement. Pursuant to the terms of the agreement, PolarityTE sold 100% of the issued and outstanding shares of common stock of
Majesco NV Sub to Zift, including all the right, title, and interest in and to Majesco NV Sub’s business of developing,
publishing, and distributing video game products.
In
May 2018 we acquired assets of a preclinical research and veterinary sciences business and related real estate, which we now operate
through our subsidiary, Ibex Preclinical Research, Inc. The aggregate purchase price was $3.8 million, of which $2.3 million was
paid at closing and the balance satisfied by a promissory note payable to the Seller with an initial fair value of $1.22 million
and contingent consideration with an initial fair value of approximately $0.3 million. As a result, we have significant research
facilities and a well-educated and skilled team of scientists and researchers that comprise the contract research segment of our
business. These resources are highly beneficial to the work we are doing on our TE products and in RTD and ARC. We also offer
research services to unrelated third parties on a contract basis, which we offer under the trademark POLARITYRD. Contract research
services help us defray the costs of maintaining a first-rate research facility and allow us to meet companies pursuing new technologies
that may be opportunities for collaborative or strategic relationships going forward.
Contact
and Available Information
Our
principal executive offices are located at 123 Wright Brothers Drive, Salt Lake City, UT 84116 and our telephone number is (385)
237-2279. Our website address is www.polarityte.com.
We
file annual, quarterly, and current reports, as well as proxy statements and other information with the Securities and Exchange
Commission, which is available to the public free of charge over the Internet at our website at
http://www.polarityte.com
.
In addition, any materials we file with the Securities and Exchange Commission (“SEC”) are available on the SEC’s
website as www.sec.gov free of charge.
Glossary–
for ease of reference, the following provides simplified explanations for some of the terms used herein. This Glossary is not
intended to define these terms as they may be used in other documents, authored by PolarityTE or otherwise
Allogeneic
– relating to tissues or cells that are genetically dissimilar and hence immunologically incompatible, although from individuals
of the same species.
Allogeneic
tissue rejection – the rejection of foreign tissue after the body develops an immune response to it.
Allografts
– tissue grafts derived from a donor of the same species as the recipient but not genetically identical, e.g. tissue grafts
derived from cadavers.
Alloplast
– an allogeneic material used to construct, reconstruct, or augment tissue.
Autologous
tissue – tissue originating from one’s own body.
Bioreactor
- a vessel in which a biological process is carried out that involves organisms or biochemically active substances derived from
organisms.
Compartment
Syndrome - a condition caused by pressure build up from internal bleeding or tissue swelling.
Dermis
– the middle layer of skin, that contains connective tissue, hair follicles, and sweat glands.
Epidermis
– the outermost layer of skin, responsible for providing a waterproof barrier and creating skin tone.
Epithelium
- the tissue that covers a free surface or lines a tube or cavity of an animal body, such as the alimentary canal.
Fibroblasts
- cells in connective tissue that produce collagen and other fibers.
Full-thickness
skin graft (FTSG) - a skin graft that contains both the epidermis and the entire dermis.
Growth
factor – a substance that is required for the stimulation of growth in living cells.
HCT/Ps
- human cells, tissues and cellular and tissue-based products regulated by the FDA under 21 C.F.R. Parts 1270 and 1271.
HIPPA
- the Health Insurance Portability and Accountability Act.
Homologous
– when used in relation to tissue, skin, or tissue product means it is similar in position, structure, function, or characteristics
to the corresponding patient tissue.
Hypodermis
– the deep subcutaneous layer of skin, below the dermis, that is made of fat and connective tissue.
Inosculate
- to connect or join to become continuous.
Integument
– the enveloping membrane of the body, including the epidermis, dermis, and all derivatives of the epidermis (hair, sebaceous
glands, etc.).
Interface
- a region of contact between living and/or organic material and other biomaterial or organic/inorganic material.
Interactome
– the complete set of physical interactions between molecules within a cell that underlies most genotype-to-phenotype relationships
and modulates nearly all complex biological pathways and cellular networks seen in living systems.
In
Vitro - outside a living organism, for example laboratory vessel (e.g., a test tube) and under laboratory conditions.
In
Vivo - in a living organism.
Ischemic
damage - damage that causes a restriction in blood supply, thus causing diminished delivery of oxygen to the affected tissue.
MPFU
- a minimally polarized functional unit.
Neovascularization
- the formation of new vessels from pre-existing ones (angiogenesis) or from cellular precursors (vasculogenesis).
Osteoarthritis
- a disease that occurs when the protective cartilage on the ends of bones wears down over time.
Parietal
bone - a bone forming the central side and upper back part of each side of the skull.
Polarity
– the asymmetric organization of cellular elements, which allows development of specialized tissue and downstream function.
Scaffold
– a three-dimensional material that has been engineered to cause desirable cellular interactions to contribute to the formation
of new functional tissues.
Scar
revision – minimizing a scar so that it is less conspicuous and blends in with the surrounding skin tone and texture.
SCIRM
- self-complexing intelligent regenerative material.
Sebaceous
glands – small glands in the skin that secrete lubricating oily matter (sebum) into the hair follicles to lubricate the
skin and hair.
Skin
graft - the transplantation of skin onto a damaged area of the body.
Split-thickness
skin graft (STSG) – a skin graft that contains the epidermis and only part of the dermis.
Stem
cell – an undifferentiated cell capable of renewing itself, and from which certain other kinds of cells arise by differentiation.
Stem
cell niche - the microenvironment within a tissue that interacts with stem cells to signal cell growth, development, renewal,
and differentiation.
Tissue
engineering triad – the three components of tissue engineering, as historically taught, requiring the use of a scaffold,
a signal such as a growth factor, and a cell component such as a stem cell.
Urethral
stricture - the narrowing of the urethra caused by injury, infection etc.
Xenografts
– a tissue graft or organ transplant from a donor of a different species from the recipient.
Item
1A. Risk Factors.
Our
business and operations are subject to many risks and uncertainties as described below. However, the risks and uncertainties described
below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we may currently deem
immaterial, may become important factors that could harm our business, financial condition or results of operations. If any of
the following risks occur, our financial condition or results of operations could suffer.
Risks
Related to Our Business
If
the clinical development and commercialization of our lead product candidate, SkinTE, is not successful, our ability to finance
our operations may be adversely affected.
Our
near-term prospects depend upon our ability to effectively market our lead product candidate, SkinTE, and to demonstrate its safety
and effectiveness in humans, as well as its superiority over existing therapies and standards of care. Our ability to finance
our company and to generate revenues will depend in part on our ability to obtain favorable results in the planned clinical evaluations
of SkinTE and to successfully develop and commercialize SkinTE.
SkinTE
could be unsuccessful if it:
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does
not demonstrate acceptable safety and efficacy in humans, or otherwise does not meet applicable regulatory standards;
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does
not offer sufficient, clinically meaningful therapeutic or other improvements over existing or future therapies used to treat
burns or other defects of skin tissues/integument for which it is being tested and evaluated;
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is
not capable of being produced in commercial quantities at acceptable costs or acceptable timelines; or
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is
not accepted as safe, efficacious, cost-effective, less costly, and preferable to current therapies in the medical community
and by third-party payers.
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If
we are not successful in developing and commercializing SkinTE or are significantly delayed in doing so, our financial condition
and prospects may be adversely affected and we may experience difficulties in raising the substantial additional capital required
to fund our business.
We
are an early stage company. Our limited operating history makes it difficult to evaluate our current business and prospects, and
our profitability in the future is uncertain.
Our
limited operating history hinders an evaluation of our prospects, which should be considered in light of the risks, expenses,
and difficulties frequently encountered in the establishment of a new business in an industry with many market participants and
intense competition, and in the shift from development to commercialization of new product candidates based on innovative technologies.
We
have a history of operating losses and may never achieve or sustain profitability.
We
have incurred significant operating losses, and may continue to incur significant operating losses over the next several years.
We incurred a net loss of $18.4 million for the two-month period ended December 31, 2018, and $65.4 million for the year ended
October 31, 2018. Our ability to achieve profitable operations in the future will depend in large part upon the successful development
and commercialization of our product candidates and technologies. Factors impacting our ability to successfully develop and commercialize
our product candidates include:
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approvals
by or registrations with the FDA and other US and foreign government agencies;
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our
ability to educate and train physicians and hospitals on the benefits of our product candidates;
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the
rate at which providers adopt our technology and product candidates;
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our
ability to scale up our commercialization, including our selling and manufacturing activities;
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our
ability to complete the development of our product candidates in a timely manner;
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our
ability to obtain adequate reimbursement from third parties for our products and product candidates; and
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other
activities generally necessary to introduce and bring new products and medical technologies to market.
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The
likelihood of the long-term success of our company must be considered in light of the expenses, difficulties, and delays frequently
encountered in the development and commercialization of new and innovative medical techniques and technologies, unknown and uncertain
regulatory hurdles for a new and novel technology or technique, competitive factors and competition, as well as the uncertain
nature of new business development and ongoing capital requirements.
We
may have inadequate resources to complete the development and commercialization of our product candidates or to continue our development
programs.
We
are a development stage company, and thus we expect to continue to spend a significant amount of cash on research and development
of our product candidates. Until we can successfully commercialize our product candidates and achieve significant revenue, if
any, we will be required to raise additional capital to fund our ongoing operations. We may not be able to raise capital on acceptable
terms, or at all.
The
cost and timing of completion of our preclinical and clinical development programs is uncertain.
We
expect that a large percentage of our future research and development expenses will be incurred in support of current and future
preclinical and clinical development programs. These expenditures are subject to numerous uncertainties in timing and cost of
completion. We evaluate our objectives in preclinical models based upon our own development goals, but such evaluation may differ
from requirements of regulatory authorities. We may conduct early stage clinical trials, which may differ for each of our targeted
markets or markets we may target in the future (i.e., presently, skin, bone, muscle, cartilage, fat, blood vessels, and nerves).
As we obtain results from investigations, preclinical studies, or clinical trials, we may elect to discontinue or delay further
evaluations for certain product candidates or programs to focus resources on more promising product candidates or programs. Completion
of clinical trials may take several years and the length of time generally varies according to the type, complexity, novelty,
and intended use of a product candidate. The cost of clinical trials is uncertain and may vary significantly over the life of
a product or development project because of unanticipated differences, regulatory requirements, or other obligations, or challenges
arising during clinical development.
Our
product development programs are based on novel technologies. As a result, our product candidates are inherently risky.
We
cannot guarantee that the results we see in clinical applications will be comparable to the preclinical results we have observed
in animals for all our product candidates. We also cannot at this stage be certain of the safety of all product candidates that
may be developed from our platform technology in humans.
We
are subject to the risks of failure inherent in the development of product candidates based on new technologies. The novel nature
of our products creates significant challenges regarding product development and optimization, manufacturing, government regulation,
third-party reimbursement, and market acceptance. For example, if regulatory agencies have limited experience or concerns in approving
cellular and tissue-based therapies for commercialization, the development and commercialization pathway for our therapies may
be subject to increased uncertainty, as compared to the pathway for new conventional drugs.
Further,
when manufacturing autologous cell and tissue-based therapies, the number and the composition of the cell population varies from
patient to patient, in part due to the age of the patient, since the therapy is dependent on patient-specific physiology. Such
variability in the number and composition of these cells could adversely affect our ability to manufacture autologous cell and
tissue-based therapies in a cost-effective manner and meet acceptable product release specifications for use in a clinical trial
or, if approved or registered, for commercial sale. Consequently, the development and regulatory approval or registration process
for autologous cell and tissue-based product candidates could be delayed or may never be completed.
Our
product candidates represent new classes of therapy that the marketplace may not understand or accept. Furthermore, the success
of our product candidates is dependent on wider acceptance by the medical community.
The
market may not understand or accept our product candidates. Our product candidates represent new treatments or therapies and compete
with a number of more conventional products and therapies manufactured and marketed by others. The new nature of our product candidates
creates significant challenges regarding product development and optimization, manufacturing, government regulation, and third-party
reimbursement. As a result, the development pathway for our product candidates and the commercialization of our potential products
may be subject to increased scrutiny, as compared to the pathways for more conventional products.
The
degree of market acceptance of any of our potential products will depend on a number of factors, including:
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The
clinical safety and effectiveness of our products and their perceived advantage over alternative treatment methods;
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Our
ability to convince healthcare providers that the use of our products in a procedure is more beneficial than the standard
of care or other available methods;
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Our
ability to explain clearly and educate others on the autologous use of patient-specific human cells and tissue-based products,
and to avoid potential confusion with and differentiate ourselves from the ethical controversies associated with human fetal
tissue and engineered human tissue;
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Adverse
reactions involving our products or the products or product candidates of others that are cell- or tissue-based; and
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The
cost of our products and the reimbursement policies of government and other third-party payers, including the amounts of reimbursement
made for our products and the conditions for such reimbursement.
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If
patients or the medical community do not accept our potential products as safe and effective for any of the foregoing reasons,
or for any other reason, it could affect our sales, having a material adverse effect on our business, financial condition and
results of operations.
Our
revenues from our regenerative medicine business will depend upon adequate reimbursement from public and private insurers and
health systems.
Our
success will depend on the extent to which reimbursement for the costs of our treatments will be available from third-party payers,
such as public and private insurers and health systems, as well as the amounts that they will agree to reimburse. Government and
other third-party payers attempt to contain healthcare costs by limiting both coverage and the level of reimbursement, and the
amount of reimbursement for new treatments. Therefore, significant uncertainty usually exists as to the reimbursement status of
new healthcare treatments. If we are not successful in obtaining adequate reimbursement for our treatments from these third-party
payers, the market’s acceptance of our treatments could be adversely affected. Inadequate reimbursement levels also likely
would create downward price pressure on our treatments. Even if we succeed in obtaining widespread reimbursement for our treatments
at adequate pricing, future changes in reimbursement policies could have a negative impact on our business, financial condition
and results of operations.
Commercial
third-party payers and government payers are increasingly attempting to contain healthcare costs by demanding price discounts,
including by limiting coverage on which products they will pay for and the amounts that they will pay for new products, and by
creating conditions to reimbursement, such as coverage eligibility requirements based upon clinical evidence development involving
research studies and the collection of physician decision impact and patient outcomes data. Because of these cost-containment
trends, commercial third-party payers and government payers that currently provide or in the future may provide reimbursement
for one or more of our product candidates may reduce, suspend, revoke, or discontinue payments or coverage at any time, including
those payers that designate one or more of our product candidates as experimental and investigational. Payers may also create
conditions to coverage or contract with third-party vendors to manage laboratory benefit coverage, in both cases creating burdens
for ordering by physicians and patients that may make our product candidates more difficult to sell. The percentage of submitted
claims that are ultimately paid, the length of time to receive payment on claims, and the average reimbursement of those paid
claims, is likely to vary from period to period. Finally, payers may demand discounts or offer reimbursement that minimizes our
ability to sell our products profitably, or simply choose to not cover or reimburse our products at all.
As
a result, there is significant uncertainty surrounding whether the use of products that incorporate new technology, such as our
product candidates, will be eligible for coverage by commercial third-party payers and government payers or, if eligible for coverage,
what the reimbursement rates will be for these product candidates. The fact that a product has been approved for reimbursement
in the past for any particular indication or in any particular jurisdiction, does not guarantee that such product will remain
approved for reimbursement or that similar or additional products will be approved in the future. Reimbursement of our existing
and future products by commercial third-party payers and government payers may depend on a number of factors, including a payer’s
determination that our existing and future products are:
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not
experimental or investigational;
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medically
reasonable and necessary;
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appropriate
for the specific patient;
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cost
effective;
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supported
by peer-reviewed publications;
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included
in clinical practice guidelines and pathways; and
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supported
by clinical utility and health economic studies demonstrating improved outcomes and cost effectiveness.
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Market
acceptance, sales of products based upon our platform technology, and our profitability may depend on reimbursement policies and
healthcare reform measures. Several entities conduct technology assessments and provide the results of their assessments for informational
purposes to other parties. These assessments may be used by third-party payers and healthcare providers as grounds to deny coverage
for a product. The levels at which government authorities and third-party payers, such as private health insurers and health maintenance
organizations, may reimburse the price patients pay for such products could affect whether we are able to successfully commercialize
our product candidates. Our product candidates may receive negative assessments that may impact our ability to receive reimbursement
for the product. We cannot be sure that reimbursement in the United States or elsewhere will be available for any of our product
candidates in the future. If reimbursement is not available or is limited, our ability to commercialize our product candidates
would be substantially impaired adversely affecting the viability of our commercial operations.
The
United States and foreign governments continue to propose and pass legislation designed to reduce the cost of healthcare. We expect
that there will continue to be federal and state proposals to implement governmental controls or impose healthcare requirements.
In addition, the Medicare program and increasing emphasis on managed or accountable care in the United States will continue to
put pressure on product utilization and pricing. Utilization and cost control initiatives could decrease the volume of orders
and payment that we would receive for any products in the future, which would limit our revenue and profitability. If we are unable
to obtain reimbursement approval from commercial third-party payers and Medicare and Medicaid programs for our product candidates,
or if the amount reimbursed is inadequate, our ability to generate revenues could be limited.
We
are subject to numerous federal and state healthcare laws and regulations, and a failure to comply with such laws and regulations
could have an adverse effect on our business and our ability to compete in the marketplace.
There
are numerous laws and regulations that govern the means by which companies in the healthcare industry may market their treatments
to healthcare professionals and may compete by discounting the prices of their treatments, including for example, the federal
Anti-Kickback Statute, the federal False Claims Act (“FCA”), and state law equivalents to these federal laws that
are meant to protect against fraud and abuse, and there are analogous laws in foreign countries. Violations of these laws are
punishable by criminal and civil sanctions, including, but not limited to, in some instances civil and criminal penalties, damages,
fines, and exclusion from participation in federal and state healthcare programs, including Medicare and Medicaid. In addition,
federal and state laws are also sometimes open to interpretation. Accordingly, we could potentially face legal risks if our interpretation
differs from those of enforcement authorities. Further, from time to time we may find ourselves at a competitive disadvantage
if our interpretation differs from that of our competitors.
Specifically,
anti-kickback laws and regulations prohibit any knowing and willful offer, payment, solicitation or receipt of any form of remuneration
(direct or indirect, in cash or in kind) in return for the referral, use, ordering, or recommending of the use of a product or
service for which payment may be made by Medicare, Medicaid or other Government-sponsored healthcare programs. We have entered
into consulting agreements, research agreements and product development agreements with physicians, including some who may order
our products or make decisions to use them. In addition, some of these physicians own our stock, which they purchased in arm’s
length transactions on terms identical to those offered to non-physicians, or received stock awards from us as consideration for
services performed by them. While these transactions were structured with the intention of complying with all applicable laws,
including state anti-referral laws and other applicable anti-kickback laws, it is possible that regulatory or enforcement agencies
or courts may in the future view these transactions as prohibited arrangements that must be restructured or for which we would
be subject to other significant civil or criminal penalties. There can be no assurance that regulatory or enforcement authorities
will view these arrangements as following applicable laws or that one or more of our employees or agents will not disregard the
rules we have established. Because our strategy relies on the involvement of physicians who consult with us on the design of our
potential products, perform clinical research on our behalf, or educate the market about the efficacy and uses of our potential
products, we could be materially impacted if regulatory or enforcement agencies or courts interpret our financial relationships
with physicians who refer or order our potential products to be in violation of applicable laws and determine that we would be
unable to achieve compliance with such applicable laws. This could harm our reputation and the reputations of the physicians we
engage to provide services on our behalf. In addition, the cost of noncompliance with these laws could be substantial since we
could be subject to monetary fines and civil or criminal penalties, and we could also be excluded from federally-funded healthcare
programs, including Medicare and Medicaid, for non-compliance. Further, even the costs of defending investigations of noncompliance
could be substantial.
Also,
the FCA imposes civil liability on any person or entity that submits, or causes the submission of, a false or fraudulent claim
to the federal government. Damages under the FCA can be significant and consist of the imposition of fines and penalties. The
FCA also allows a private individual or entity (i.e., a whistleblower) with knowledge of past or present fraud against the federal
government to sue on behalf of the government and to be paid a portion of the government’s recovery, which can include both
civil penalties and up to three times the amount of the government’s damages (usually the amount reimbursed by federal healthcare
programs). The U.S. Department of Justice on behalf of the government takes the position that the marketing and promotional practices
of life sciences product manufacturers, including the off-label promotion of products, the provision of inaccurate or misleading
reimbursement guidance, or the payment of prohibited kickbacks to doctors or other referral sources may cause the submission of
improper claims to federal and state healthcare entitlement programs, such as Medicare and Medicaid, by health care providers
that use the manufacturer’s products, which results in a violation of the FCA. In certain cases, manufacturers have entered
into criminal and civil settlements with the federal government under which they entered into plea agreements, paid substantial
monetary amounts, and entered into corporate integrity agreements that require, among other things, substantial reporting and
remedial actions going forward.
In
addition, there has been a recent trend of increased federal and state regulation of payments made to physicians and other health
care providers. In addition to federal laws, some states, such as California, Massachusetts, and Vermont, mandate implementation
of commercial compliance programs, along with the tracking and reporting of gifts, compensation, and other remuneration to physicians.
The shifting commercial compliance environment and the need to build and maintain robust and expandable systems to comply with
different compliance or reporting requirements in multiple jurisdictions increase the possibility that a healthcare company may
run afoul of one or more of the requirements.
The
scope and enforcement of all these laws is uncertain and subject to rapid change, especially considering the lack of applicable
precedent and regulations. There can be no assurance that federal or state regulatory or enforcement authorities will not investigate
or challenge our current or future activities under these laws. Any investigation or challenge could have a material adverse effect
on our business, financial condition, and results of operations. Any state or federal regulatory or enforcement review of us,
regardless of the outcome, would be costly and time consuming. Additionally, we cannot predict the impact of any changes in these
laws, whether these changes are retroactive or will have effect on a going-forward basis only.
We
operate in a highly competitive and evolving field and face competition from regenerative medicine, biotech, and pharmaceutical
companies, tissue engineering entities, tissue processors and medical device manufacturers, as well as new market entrants.
We
operate in a very competitive and continually evolving field. Competition from other regenerative medicine, biotech, and pharmaceutical
companies, tissue engineering entities, tissue processors, medical device companies and from research and academic institutions
is intense, expected to increase, subject to rapid change, and could be significantly affected by new product introductions. Our
failure to compete effectively would have a material and adverse effect on our business, results of operations, and financial
condition.
Specifically,
we face significant competition in both the regenerative medicine and wound care space from multiple products, including ReCell,
Integra Bilayer Wound Matrix, EpiFix, Apligraf, Dermagraft, Grafix, Epicel, and others. The availability and price of our competitors’
products could limit the demand and the price we are able to charge for our product candidates. We may not be able to implement
our business plan if the acceptance of our product candidates is inhibited by price competition or the reluctance of physicians
to switch from existing methods of treatment to our product candidates, or if physicians switch to other new drug or biologic
products, or choose to reserve our product candidates for use in limited circumstances.
Our
access to sensitive patient information is subject to complex regulations at multiple levels and we would be adversely affected
if we fail to adequately protect this information.
We
receive, maintain and utilize personal health and other confidential and sensitive data as part of the treatments we provide.
We have developed a web and mobile application through which our customers can communicate with physicians and others, which may
involve sharing patient identifiable health information. The use and disclosure of such information is regulated at the federal,
state and international levels, and these laws, rules and regulations are subject to change and increased enforcement activity,
such as the audit program implemented by the U.S. Department of Health and Human Services under HIPAA. International laws, rules
and regulations governing the use and disclosure of such information are generally more stringent than in the United States, and
they vary from jurisdiction to jurisdiction. Noncompliance with any privacy or security laws or regulations, or any security breach,
cyber-attack or cybersecurity breach, and any incident involving the theft, misappropriation, loss, or other unauthorized disclosure
of, or access to, sensitive or confidential information, whether by us or by a third party, could require us to expend significant
resources to remediate any damage, interrupt our operations, and damage our brand and reputation, and could also result in investigations,
regulatory enforcement actions, material fines and penalties, loss of customers, litigation, or other actions that could have
a material adverse effect on our business, brand, reputation, cash flows, and operating results.
Our
business depends on provider and patient willingness to entrust us with health related and other sensitive personal information.
Events that negatively affect that trust, including incorrect or incomplete disclosure of our uses of their information, or failing
to keep our information technology systems and sensitive information secure from significant attack, theft, damage, loss, or unauthorized
disclosure or access, whether as a result of our action or inaction or that of third parties, could adversely affect our brand,
reputation, and revenues, and also expose us to mandatory disclosure to the media, litigation (including class action litigation),
and other enforcement proceedings, material fines, penalties or remediation costs, and compensatory, special, punitive, and statutory
damages, consent orders, or injunctive relief, any of which could adversely affect our business, cash flows, operating results,
or financial position. There can be no assurance that any such failure will not occur, or if any does occur, that we will detect
it or that it can be sufficiently remediated.
Many
of our competitors have substantially greater resources than we do, and we expect that all our product candidates will face intense
competition from existing or future products.
All
our product candidates face intense competition from existing and future products marketed by large, well-established companies
(including but not limited to Avita Medical, Integra LifeSciences, Wright Medical Group, MiMedx, Osiris, Organogenesis, Allosource,
MTF Biologics and Vericel). These competitors may successfully market products that compete with our product candidates, successfully
identify product candidates or develop products earlier than we do, or develop products that are more effective or cost less than
our products. These competitive factors could require us to conduct additional new research and development activities to establish
new competitive product targets, which would be costly and time consuming. These activities would adversely affect our ability
to effectively commercialize products and achieve revenue and profits.
We
depend heavily on our senior management and we may be unable to replace key executives if they leave.
The
loss of the services of one or more members of our senior management team or our inability to attract, retain and maintain additional
senior management personnel could harm our business, financial condition, results of operations, and prospects. Our operations
and prospects depend in large part on the performance of our senior management team, particularly Dr. Denver Lough, our Chief
Executive Officer and Chief R&D Officer. In addition, we may not be able to find qualified replacements if his services are
no longer available. We do not presently maintain “key-man” life insurance on any of our executives or key employees.
Many
executive officers and employees in the regenerative medicine business are subject to strict non-compete or confidentiality agreements
with their employers, which would limit our ability to recruit them to join our company. In addition, some of our existing and
future employees are or may be subject to confidentiality agreements with previous employers. Our competitors may allege breaches
of and seek to enforce such non-compete agreements or initiate litigation based on such confidentiality agreements. Such litigation,
whether or not meritorious, may impede our ability to hire executive officers and other key employees who have been employed by
our competitors and may result in intellectual property claims against us.
If
serious adverse or inappropriate side effects are identified during the development or use of our product candidates or with any
procedures with which our product candidates are used, we may need to abandon or limit our development of those product candidates.
If
our product candidates are associated with undesirable side effects or have characteristics that are unexpected, we may need to
abandon their use or development or limit them to certain uses or subpopulations in which the undesirable side effects or other
characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. In addition, if any of the
procedures with which our product candidates are used is determined to be unsafe, we may be required to delay, alter, or abandon
our product development or commercialization.
We
intend to, but may not be successful in, establishing and maintaining strategic partnerships.
We
intend to pursue strategic partnership opportunities in the future to enhance and accelerate the development and commercialization
of our proposed products. We may rely on such partnerships to assist in launching, marketing, and developing our product candidates.
However, we may face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming
and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements
for any future proposed products and programs because our research and development pipeline may be insufficient, our proposed
products and programs may be deemed to be at too early of a stage of development for collaborative effort, or third parties may
not view our product candidates and programs as having the requisite potential to demonstrate safety and efficacy or other requirements
or goals that potential strategic partners may seek. Even if we are successful in our efforts to establish strategic partnerships,
the terms that we agree upon may not be favorable to us, and we may not be able to maintain such strategic partnerships if, for
example, development or approval of a product candidate is delayed or sales of an approved or registered product are disappointing.
Rapid
technological change could cause our business to become obsolete.
The
technologies underlying our product candidates are subject to rapid and profound technological change. Competition intensifies
as technical advances in each field are made and become more widely known. There is no assurance that others will not develop
services, products, or processes with significant advantages over the products, services, and processes that we offer or are seeking
to develop. Any such occurrence could have a material and adverse effect on our business, results of operations, and financial
condition.
The
success of any of our product candidates or enhancements to an existing product will depend on numerous factors, including our
ability to:
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properly
identify and anticipate physician and patient needs;
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develop
and introduce enhancements in a timely manner;
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adequately
protect our intellectual property and avoid infringing upon the intellectual property rights of third parties;
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demonstrate
safety and efficacy in humans; and
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obtain
the necessary regulatory clearances, registrations, or approvals.
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If
we do not develop and, when necessary, obtain regulatory clearance, registration, or approval for product candidates or product
enhancements in time to meet market demand, or if there is insufficient demand for these products or enhancements, our results
of operations will suffer. Our research and development efforts may require a substantial investment of time and resources before
we are able to determine the commercial viability of a new product, technology, material, or other innovation. In addition, even
if we can successfully develop enhancements or new generations of our product candidates, these enhancements or new generations
of product candidates may not produce sales more than the costs of development, and they may be quickly rendered obsolete by changing
customer preferences or the introduction by our competitors of product candidates embodying new technologies or features.
To
be commercially successful, we must convince physicians that our treatments are safe and effective alternatives to existing treatments
and that our treatments should be accepted and used.
We
believe physicians will only adopt our treatment if they determine, based on experience, clinical data and published peer reviewed
journal articles, that the use of our treatment is a favorable alternative to existing and conventional methods, such as adopting
the use of SkinTE as a substitute for skin grafting. Physicians may be slow to change their medical treatment practices for the
following reasons, among others:
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lack
of evidence supporting additional patient benefits from our treatments over existing and conventional methods;
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perceived
liability risks generally associated with the use of new procedures and general resistance to change; or
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limited
availability or amounts of reimbursement from third-party payers.
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In
addition, while acceptance by the medical community may be fostered by broad evaluation via peer-reviewed literature, we may not
have the resources to facilitate sufficient publication. We also believe that recommendations for, and support of our treatments
by, influential physicians are essential for market acceptance and adoption. If we do not obtain this support or are unable to
demonstrate favorable long-term clinical data, physicians and hospitals may not use our treatments, which would have a material
and adverse effect on our result of operations and prospects.
If
we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our
product candidates, we may not be successful in commercializing them.
We
recently formed a sales and marketing team for SkinTE, which we intend to further develop. Nevertheless, our experience in the
sale and marketing of SkinTE and other potential products is very limited, and we cannot predict whether or to what extent our
internal sales effort may be successful. To achieve commercial success for any product candidate, we must either develop an effective
internal sales and marketing team or outsource these functions to third parties.
There
are risks involved both with establishing our own sales and marketing capabilities and entering into arrangements with third parties
to perform these services. For example, recruiting and training a sales force is expensive and time consuming and could delay
any product launch. If the commercial launch of SkinTE, OsteoTE, or another product candidate for which we recruit a sales force
and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred
these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales
and marketing personnel.
If
we enter into arrangements with third parties to perform sales, marketing and distribution services, our product revenues or the
profitability of these product revenues to us are likely to be lower than if we were to market and sell any products ourselves.
In addition, we may not be successful in entering into arrangements with third parties to sell and market our potential products
or may be unable to do so on terms that are favorable to us. We likely will have limited control over such third parties, and
any of them may fail to devote the necessary resources and attention to sell and market our potential products effectively and
in compliance with applicable laws.
Significant
disruptions of information technology systems or breaches of information security could adversely affect our business.
We
rely to a large extent upon information technology systems to protect our intellectual property and to operate our business. In
the ordinary course of business, we collect, store, and transmit large amounts of confidential information, including, but not
limited to, our trade secrets and data, personal information, and intellectual property. The size and complexity of our information
technology and information security systems make such systems potentially vulnerable to service interruptions or to security breaches
from inadvertent or intentional actions by our employees or vendors, or from malicious attacks by third parties. Such attacks
are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of motives (including,
but not limited to, industrial espionage and market manipulation) and expertise. There can be no assurance that our efforts to
protect our data and related information technology and intellectual property will prevent service interruptions or security breaches.
Any interruption or breach in our systems could adversely affect our business operations or result in the loss of critical or
sensitive confidential information or intellectual property, and could result in financial, legal, business, and reputational
harm to us or allow third parties to gain material, inside information that they use to trade in our securities.
We
face the risk of product liability claims and may not be able to obtain or maintain adequate product liability insurance.
Our
business exposes us to the risk of product liability claims that are inherent in the manufacturing, processing, and marketing
of human cellular and tissue-based products. We may be subject to such claims if our product candidates cause, or appear to have
caused, an injury during clinical trials or after commercialization. Claims may be made by patients, healthcare providers, or
others selling our product candidates. Defending a lawsuit, regardless of merit, could be costly, divert management attention,
and result in adverse publicity, which could result in the withdrawal of, or reduced acceptance of, our product candidates in
the market.
Although
we have obtained product liability insurance, such insurance is subject to deductibles and coverage limitations and we may not
be able to maintain this insurance. Also, it is possible that claims could exceed the limits of our coverage. If we are unable
to obtain or maintain product liability insurance at an acceptable cost or on acceptable terms with adequate coverage, or otherwise
protect ourselves against potential product liability claims or we underestimate the amount of insurance we need, we could be
exposed to significant liabilities, which may harm our business. A product liability or other claim with respect to uninsured
liabilities or for amounts in excess of insured liabilities could result in significant costs and significant harm to our business.
We
may implement a product recall or voluntary market withdrawal, which could significantly increase our costs, damage our reputation
and disrupt our business.
The
manufacturing, marketing, and processing of our product candidates involves an inherent risk that our tissue products or processes
do not meet applicable quality standards and requirements. In that event, we may voluntarily implement a recall or market withdrawal
or may be required to do so by a regulatory authority. A recall or market withdrawal of one of our product candidates would be
costly and would divert management resources. A recall or withdrawal of one of our product candidates, or a similar product processed
by another entity, also could impair sales of our product candidates because of confusion concerning the scope of the recall or
withdrawal, or because of the damage to our reputation for quality and safety.
We
may not be able to effectively control and manage our growth.
Our
strategy envisions a period of rapid growth. Our expected growth may impose a significant burden on our future planned administrative
and operational resources. The growth of our business may require significant investments of capital and increased demands on
our management, workforce, and facilities. We will be required to substantially expand our administrative and operational resources
and attract, train, manage, and retain qualified management and other personnel. Failure to do so or to satisfy such increased
demands would interrupt or would have a material adverse effect on our business and results of operations.
We
may increasingly become a target for public scrutiny, including complaints to regulatory agencies, negative media coverage, including
social media and malicious reports, all of which could severely damage our reputation and materially and adversely affect our
business and prospects.
We
focus on the research and development (including through preclinical, animal testing) of therapies used in the regenerative medicine
and wound care space, and such therapies may be the subject of regulatory, watchdog, and media scrutiny and coverage, which also
raise the possibility of heightened attention from the public, the media and other stakeholders. From time to time, these objections
or allegations, regardless of their veracity, may result in public protests or negative publicity, which could result in government
inquiry or harm our reputation. Corporate transactions we or related parties undertake may also subject us to increased media
exposure and public scrutiny. There is no assurance that we would not become a target for public scrutiny in the future or such
scrutiny and public exposure would not severely damage our reputation as well as our business and prospects.
Risks
Related to Our Intellectual Property
We
do not currently own any issued patents and our ability to protect our intellectual property and proprietary technology through
patents and other means is uncertain and may be inadequate, which could have a material and adverse effect on us.
Our
success depends significantly on our ability to protect our proprietary rights in technologies that presently consist of trade
secrets and patent applications. We currently have no issued patents relating to any of our product candidates. We intend to expand
our patenting activities and rely on patent protection, as well as a combination of copyright, trade secret, and trademark laws
and nondisclosure, confidentiality, and other contractual restrictions to protect our proprietary technology, and there can be
no assurance these methods of protection will be effective. These legal means afford only limited protection and may not adequately
protect our rights or permit us to gain or keep any competitive advantage. In addition, our presently pending patent applications
include claims to material aspects of our activities that are not currently protected by issued patents. The patent application
process can be time consuming and expensive. We cannot ensure that any of the pending patent applications we acquire, have acquired,
or may file will result in issued patents. Competitors may be able to design around our patents or develop procedures that provide
outcomes that are comparable or even superior to ours. There is no assurance that the inventors of the patents and applications
that we expect to own or license were the first-to-invent or the first-inventor-to-file on the inventions, or that a third party
will not claim ownership in one of our patents or patent applications. We cannot assure you that a third party does not have or
will not obtain patents that could preclude us from practicing the patents we own or license now or in the future.
The
failure to obtain and maintain patents or protect our intellectual property rights could have a material and adverse effect on
our business, results of operations, and financial condition. We cannot be certain that, if challenged, any patents we ultimately
obtain would be upheld because a determination of the validity and enforceability of a patent involves complex issues of fact
and law. If one or more of any patents we obtain is invalidated or held unenforceable, such an outcome could reduce or eliminate
any competitive advantage we might otherwise have had.
In
the event a competitor infringes upon any patent we obtain, or a third party including but not limited to a university or other
research institution, makes a claim of ownership over our patents or other intellectual property rights, confirming, defending,
or enforcing those rights may be costly, uncertain, difficult, and time consuming.
There
can be no assurance that a third party, including, but not limited to, a university or other research institution that our founders
were associated with in the past, will not make claims to ownership or other claims related to our technology.
There
can be no assurance that a third party, including but not limited to, a university or other research institution that our founders
were associated with in the past, will not make claims to ownership or other claims related to our technology. We believe we have
developed our technology outside of any institutions, but we cannot guarantee such institutions would not assert a claim to the
contrary. Even if successful, litigation to enforce or defend our intellectual property rights could be expensive and time consuming,
and could divert our management’s attention. Further, bringing litigation to enforce our future patent(s) subjects us to
the potential for counterclaims. If one or more of our future patents is challenged in U.S. or foreign courts or the United States
Patent and Trademark Office (“USPTO”) or foreign patent offices, the patent(s) may be found invalid or unenforceable,
which could harm our competitive position. If any court or any patent office ultimately cancels or narrows the claims in any of
our future patents through any pre- or post-grant patent proceedings, such an outcome could prevent or hinder us from being able
to enforce the patent against competitors. Such adverse decisions could negatively affect our future revenue and results of operations.
We
may be subject to claims that our employees have wrongfully appropriated, used, or disclosed intellectual property of their former
employers.
We
employ individuals who were previously employed by other companies, universities, or academic institutions. We may be subject
to claims that we or our employees have inadvertently or otherwise used or disclosed intellectual property, including trade secrets
or other proprietary information, of a prior employer. Litigation may be necessary to defend against these claims. If we fail
in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel,
which could adversely impact our business. Even if we are successful in defending against such claims, litigation could result
in substantial costs and be a distraction to management and other employees. Any of the foregoing could have an adverse impact
on our business, financial condition, results of operations, and cash flows.
We
may be subject to claims that former or current employees, collaborators, or other third parties have an interest in our patents
or other intellectual property as an inventor or co-inventor. Litigation may be necessary to defend against any claims challenging
inventorship. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual
property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a
material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in
substantial costs and be a distraction to management and other employees.
If
we are unable to protect the confidentiality of our proprietary information and know-how related to any of our product candidates,
our competitive position would be impaired and our business, financial condition, and results of operations could be adversely
affected.
Some
of our technology, including our knowledge regarding the processing of our product candidates, is unpatented and is maintained
by us as trade secrets. To protect these trade secrets, the information is restricted to our employees, consultants, collaborators,
and advisors on a need-to-know basis. In addition, we require our employees, consultants, collaborators and advisors to execute
confidentiality agreements upon the commencement of their relationships with us. These agreements require that all confidential
information developed by the individual or made known to the individual by us during the individual’s relationship with
us be kept confidential and not disclosed to third parties. These agreements, however, do not ensure protection against improper
use or disclosure of confidential information, and these agreements may be breached. A breach of confidentiality could affect
our competitive position. In addition, in some situations, these agreements and other obligations of our employees to assign intellectual
property to the Company may conflict with, or be subject to, the rights of third parties with whom our employees, consultants,
collaborators, or advisors have previous employment or consulting relationships. Also, others may independently develop substantially
equivalent proprietary information and techniques or otherwise gain access to our trade secrets.
Adequate
remedies may not exist in the event of unauthorized use or disclosure of our confidential information. The disclosure of our trade
secrets could impair our competitive position and have a material adverse effect on our business, financial condition, and results
of operations.
We
may become subject to claims of infringement of the intellectual property rights of others, which could prohibit us from developing
our treatment, require us to obtain licenses from third parties, or to develop non-infringing alternatives, and subject us to
substantial monetary damages. We have not obtained and do not intend to obtain any legal opinion regarding our freedom to practice
our technology.
Third
parties could assert that our processes, product candidates, or technology infringe their patents or other intellectual property
rights. Whether a process, product, or technology infringes a patent or other intellectual property involves complex legal and
factual issues, the determination of which is often uncertain. We cannot be certain that we will not be found to have infringed
the intellectual property rights of others. Because patent applications may remain unpublished for certain periods of time and
may take years to be issued as patents, there may be applications now pending of which we are unaware or that do not currently
contain claims of concern that may later result in issued patents that our product candidates, procedures, or processes will infringe.
There may be existing patents that our product candidates, procedures, or processes infringe, of which infringement we are not
aware. Third parties could also assert ownership over our intellectual property. Such an ownership claim could cause us to incur
significant costs to litigate the ownership issues. If an ownership claim by a third party were upheld as valid, we may be unable
to obtain a license from the third party on acceptable terms, to continue to make, use, or sell technology free from claims by
that third party of infringement of the third party’s intellectual property. We have not obtained, and do not have a present
intention to obtain, any legal opinion regarding our freedom to practice our technology.
If
we are unsuccessful in actions we bring against the patents of other parties, and it is determined that we infringe upon the patents
of third parties, we may be subject to injunctions, or otherwise prevented from commercializing potential products or services
in the relevant jurisdiction, or may be required to obtain licenses to those patents or develop or obtain alternative technologies,
any of which could harm our business. Furthermore, if such challenges to our patent rights are not resolved in our favor, we could
be delayed or prevented from entering into new collaborations or from commercializing certain product candidates or services,
which could adversely affect our business and results of operations.
If
we are successful in obtaining patent protection, we may not be able to enforce those patent rights against third parties.
Successful
challenge of any future patents such as through opposition, reexamination,
inter partes
review, interference, or derivation
proceedings could result in a loss of patent rights in the relevant jurisdiction. Furthermore, because of the substantial amount
of discovery required relating to intellectual property litigation, there is a risk that some of our confidential or sensitive
information could be compromised by disclosure in the event of litigation. In addition, during litigation there could be public
announcements of the results of hearings, motions, or other interim proceedings or developments. If securities analysts or investors
perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.
We
may not be able to protect our intellectual property in countries outside of the United States.
Intellectual
property law outside the United States is uncertain and, in many countries, is currently undergoing review and revisions. The
laws of some countries do not protect patent and other intellectual property rights to the same extent as United States laws.
Third parties may challenge our patents in foreign countries by initiating pre- and post-grant oppositions or invalidation proceedings.
Developments during opposition or invalidation proceedings in one country may directly or indirectly affect a corresponding patent
or patent application in another country in an adverse manner. It may be necessary or useful for us to participate in proceedings
to determine the validity of our patents or our competitors’ patents that have been issued in countries other than the United
States. This could result in substantial costs, divert our efforts and attention from other aspects of our business, and could
have a material adverse effect on our results of operations and financial condition.
Risks
Related to Registration or Regulatory Approval of Our Product Candidates and Other Government Regulations
Our
business is subject to continuing regulatory oversight by the FDA and other authorities, whose requirements are costly to comply
with, and our failure to comply could result in negative effects on our business.
The
FDA has specific regulations governing human cell, tissue, and cellular and tissue-based products, commonly known as “HCT/Ps”.
The FDA has broad post-market and regulatory and enforcement powers. The FDA’s regulation of HCT/Ps includes requirements
for registration and listing of products, donor screening and testing, processing and distribution (“Current Good Tissue
Practices”), labeling, record keeping, adverse-reaction reporting, inspection, and enforcement.
We
believe SkinTE and OsteoTE are appropriately regulated under Section 361 of the Public Health Service Act (so-called “361
HCT/Ps”) and that, as a result, no premarket review or approval by the FDA is required. If the FDA does not agree that one
or more of our HCT/P products meet its regulatory criteria for regulation solely as 361 HCT/Ps, our product candidates will be
regulated as drugs, devices, or biological products, and we could be required to withdraw those products from the market until
the required clinical trials are complete and the applicable premarket regulatory clearances or approvals are obtained.
Other
products we develop may not be 361 HCT/Ps. As result, those product candidates would be subject to additional regulatory requirements,
including premarket approval or clearance. Even if pre-market clearance or approval is obtained, the approval or clearance may
place substantial restrictions on the indications for which the products may be marketed or to whom the products may be marketed,
and may require warnings to accompany the product or impose additional restrictions on the sale or use of the product. In addition,
regulatory approval is subject to continuing compliance with regulatory standards, including the FDA’s current good manufacturing
practice (cGMP) or quality system regulations and adverse event reporting regulations.
If
we fail to comply with the FDA regulations regarding our products and manufacturing processes, the FDA could take enforcement
action, including, without limitation, any of the following sanctions:
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letters, warning letters, fines, injunctions, consent decrees, product seizures, or civil penalties;
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Operating
restrictions, partial suspension or total shutdown of clinical studies, manufacturing, marketing, or distribution;
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Refusing
requests for clearance or approval of new products, processes, or procedures, or for certificates or approval to enable export
of the same;
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Withdrawing
or suspending current applications for approval or clearance, or any approvals or clearances already granted; and
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Civil
or criminal prosecution.
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It
is likely that the FDA’s regulation of 361 HCT/Ps and other types of products (e.g., drugs, devices, or biologics) will
continue to evolve in the future. Complying with any such new regulatory requirements, guidance or statutes may entail significant
time delays and expense, which could have a material adverse effect on our business. While the FDA may issue new or revised guidance
or regulations for 361 HCT/Ps, we do not know whether or when such revised draft or final guidance or regulations (if any) will
be issued, the scope of such guidance, any new rules or regulations, whether they will apply to our technologies or products,
or whether they will be advantageous or disadvantageous to us. In addition, even if it does not issue new regulations or guidance,
the FDA could in the future adopt more restrictive interpretations of existing regulations or increase its enforcement activity,
which may adversely affect our business.
We
believe our FDA-registered SkinTE and OsteoTE products satisfy applicable criteria for regulation as a 361 HCT/P and are therefore
exempt from FDA requirements for premarket approval or clinical studies. If the FDA disagrees with our interpretation of the relevant
laws and regulations as they apply to these product candidates, and requires an Investigational New Drug application (“IND”)
or Investigational Device Exemption application (“IDE”) for any of our product candidates, we may need to delay, abandon,
or revise our current development plans, discontinue ongoing marketing, or recall products. The submission of an IND, Biologics
License Applications (“BLA”), New Drug Application (“NDA”), or other medical device clearance or approval
application would require us to compile significant amounts of data related to that regulatory process, as well as data from preclinical
or clinical testing. We cannot guarantee that we will ever be able to secure such approvals, if required. Even if such approvals
are obtained, regulation as a drug, biologic, or medical device would subject us to additional FDA post marketing requirements
that are complex and involve substantial expense, such as compliance with drug, biologic, or medical device current Good Manufacturing
Practice or quality system requirements.
The
FDA regulates HCT/Ps under a two-tiered framework. Certain higher risk HCT/Ps are regulated as new drugs, biologics, or medical
devices. Manufacturers of new drugs, biologics, and some medical devices must complete extensive clinical trials, which must be
conducted pursuant to an effective IND or IDE. In addition, the FDA must review and approve a BLA or NDA before a new drug or
biologic may be marketed. For most medical devices, including novel or high-risk medical devices, the FDA must approve a premarket
approval application (“PMA”) or grant clearance to a premarket notification (“510(k)”) application prior
to marketing of the device.
By contrast, the FDA exempts 361 HCT/Ps from these requirements if they meet certain specified criteria. We
believe that SkinTE and OsteoTE, meet the criteria for regulation as a 361 HCT/P rather than as a new drug or biologic or medical
device and, therefore, we do not currently expect that these products will be subject to the requirement for an IND or IDE or FDA
premarket review and approval. Thus, our financial and business plans assume that we will not need to seek or obtain premarket
FDA approval or clearance for SkinTE or OsteoTE. Rather, we will have to comply with the requirements for 361 HCT/Ps set forth
in FDA regulations and develop adequate substantiation to support marketing claims we plan to make. The FDA could disagree with
our belief that our product candidates, including but not limited to SkinTE and OsteoTE, are 361 HCT/Ps. The FDA conducted an inspection
of our Salt Lake City, UT manufacturing facility in July 2018, and issued certain inspectional observations on Form FDA 483. We
responded to those observations and engaged in a productive dialog with the FDA. Following our responses, in or around February
2019, FDA classified the July 2018 inspection of our Salt Lake City Manufacturing site as “Voluntary Action Initiated,”
or “VAI.” A VAI classification indicates that, although FDA found and documented objectionable conditions during its
inspection, FDA will not take or recommend regulatory or enforcement action with respect to such inspectional observations at this
time.
The
Tissue Reference Group (“TRG”) is a body within the FDA designed to provide recommendations regarding whether a product
candidate will be regulated as a 361 HCT/P. The Office of Combination Products (“OCP”) at FDA provides informal and
formal opinions regarding the classification of products as 361 HCT/Ps or drugs, biologics, or medical devices. Product manufacturers
are not required to consult with the TRG or OCP and instead can market their products based on their own conclusion that the product
meets the 361 HCT/P criteria. We have not consulted the TRG or sought a formal opinion from the OCP.
The
regulatory pathway for cell and tissue-based products is subject to significant uncertainty. The FDA’s criteria for regulation
as a 361 HCT/P are complex, and the FDA has provided limited guidance on the meaning of certain terms used in the criteria, such
as “minimal manipulation,” “homologous,” or “combination of the cells and tissues with another article.”
In addition, SkinTE and OsteoTE, use new technology that may present a matter of first impression for the FDA in determining whether
to require premarket authorization. Further, our product candidates may receive a high degree of scrutiny from the FDA. The FDA
or Congress could change the relevant criteria or interpretations for determining which products qualify as 361 HCT/Ps or the
regulatory requirements for HCT/Ps.
Additionally,
it may be difficult to convince the courts to overturn any adverse decisions made against us by the FDA. Courts have recognized
the longstanding principle that the FDA’s decisions on scientific matters, including the agency’s conclusion that
a tissue processing procedure involves more than minimal manipulation, are entitled to substantial deference. This means that
if the FDA disagrees with our conclusion that any of our product candidates should be regulated as a 361 HCT/P, and not as a new
biologic, drug, or medical device, it may be very difficult to challenge the agency’s position in court.
Even
if the FDA regulates our product candidates, including SkinTE or OsteoTE, as 361 HCT/Ps, we must still generate adequate substantiation
for any claims we will make in our marketing. Failure to establish such adequate substantiation in the opinion of federal or state
authorities could substantially impair our ability to generate revenue.
Although
as 361 HCT/Ps, we may not need to submit certain products to the FDA for premarket approval or be subject to FDA requirements
for labeling or promotion of new drugs, biologics, or medical devices, we still must generate adequate substantiation for claims
we make in our marketing materials. Both the Federal Trade Commission (“FTC”) and the states retain jurisdiction over
the marketing of 361 HCT/Ps (and other) products in commerce and require a reasonable basis for claims made in marketing materials.
Through our planned preclinical and clinical studies, as well as other endeavors, we intend to generate such adequate substantiation
for any claims we make about our products. If, however, after we commence marketing of any of our product candidates, including
SkinTE or OsteoTE, the FTC or one or more states conclude that we lack adequate substantiation for our claims, we may be subject
to significant penalties, or may be forced to alter our marketing of our product candidates in one or more jurisdictions. Any
of this could materially harm our business. In addition, if our promotion of any of our product candidates suggests that the HCT/P
is not intended for homologous use, the FDA might consider the product to be a new drug, biologic, or medical device. We will
therefore be limited in the promotional claims that we can make about our product candidates.
Any
changes in the governmental regulatory classifications of our product candidates could prevent, limit, or delay our ability to
market or develop our product candidates.
The
FDA establishes regulatory requirements based on the classification of a product. An HCT/P is a product containing or consisting
of human cells or tissue intended for transplantation into a human patient. 361 HCT/Ps are not subject to any premarket clearance
or approval requirements and are subject to less extensive post-market regulatory requirements. Because Several of our products
are, or will be, designed to satisfy the standards applicable to 361 HCT/Ps, any change in the regulatory classification or designation
of our products would affect our ability to obtain FDA approval or clearance for, and marketing of, those products.
If
one of our products is deemed not to be a 361 HCT/P, FDA regulations will require premarket clearance or approval requirements
that will involve significant time and cost investments by us. Further, there can be no assurance that the FDA will not, at some
future point, change its position on current or future products’ 361 HCT/P status, and any regulatory reclassification could
have adverse consequences for us and make it substantially more difficult or expensive for us to conduct our business by requiring
extensive clinical trials, premarket clearance, or approval, and compliance with additional post-market regulatory requirements
with respect to those products. Moreover, increased regulatory scrutiny within the industry in which we operate could lead to
increased regulation of HCT/Ps, including 361 HCT/Ps. We also cannot assure you that the FDA will not impose more stringent interpretations,
restrictions, or requirements with respect to products that qualify as 361 HCT/Ps.
Even
if we successfully launch any product candidate, it will be subject to ongoing regulation. We could be subject to significant
penalties if we fail to comply with these requirements, and we may be unable to commercialize our product candidates.
Even
if the FDA does not object to the marketing of any of our product candidates as a 361 HCT/P and, therefore, without an NDA, BLA,
PMA, or 510(k), we will still be subject to numerous post-market requirements, including those related to registration and listing,
record keeping, labeling, current good tissue practices (“cGTPs”), donor eligibility, deviation and adverse event
reporting, and other activities. HCT/Ps that do not meet the definition of a 361 HCT/P and, therefore, are required to be approved
or cleared via an NDA, BLA, PMA, or 510(k) are also subject to these or additional obligations. If we fail to comply with these
requirements, we could be subject to, without limitation, warning letters, product seizures, injunctions, or civil and criminal
penalties. We have established our own processing facility, which we believe is cGTP compliant. Any failure by us to maintain
cGTP compliance would require remedial actions, which could potentially include actions such as product recalls or delays in distribution
and sales of our products, as well as enforcement actions.
We
face significant uncertainty in the industry due to government healthcare reform.
There
have been and continue to be proposals by the federal government, state governments, regulators and third-party payers to control
healthcare costs (including but not limited to capitation – the generalized cap on annual fees for a type of service or
procedure such as burn or wound care or rehabilitation), and generally, to reform the healthcare system in the United States.
There are many programs and requirements for which the details have not yet been fully established or the consequences are not
fully understood. These proposals may affect aspects of our business. We also cannot predict what further reform proposals, if
any, will be adopted, when they will be adopted, or what impact they may have on us.
Risks
Related to Our Manufacturing
Our
failure to comply with the regulatory guidelines set forth by the FDA with respect to our product candidates could delay or prevent
the completion of market entry, clinical trials, the approval or registration of any product candidates, or the commercialization
of our product candidates.
We
are subject to regulation and inspection by the FDA for cGTP, with respect to our 361 HCT/P products, and current Good Manufacturing
Practice (“cGMP”), with respect to our product candidates that are not 361 HCT/Ps. Complying with cGTP or cGMP and
will require that we expend time, money, and effort in production, recordkeeping, and quality control to assure that the product
meets applicable specifications and other requirements. For any products for which we are required to obtain FDA pre-market approval,
we, or our contracted manufacturing facility, must also pass a pre-approval inspection prior to FDA approval. Failure to pass
a pre-approval inspection may significantly delay FDA approval of our product candidates. If we fail to comply with these requirements,
we would be subject to possible regulatory action and may be limited in the jurisdictions in which we are permitted to sell our
product candidates. As a result, our business, financial condition, and results of operations may be materially harmed.
We
have limited experience in manufacturing products for commercial purposes and we cannot assure you that we will be able to successfully
and efficiently manage the manufacturing of our product candidates, either ourselves or through third-party contractors with whom
we may enter strategic relationships.
The
manufacture of cell and tissue-based therapy products, such as our product candidates, is highly complex and is characterized
by inherent risks and challenges such as autologous raw material inconsistencies, logistical challenges, significant quality control
and assurance requirements, manufacturing complexity, and significant manual processing. Unlike products that rely on chemicals
for efficacy, such as most pharmaceuticals, cell and tissue-based therapy products are difficult to characterize due to the inherent
variability of biological input materials.
Additionally,
we have limited experience in manufacturing products for commercial purposes and could experience difficulties in the continued
manufacturing of our product candidates. Because our experience in manufacturing, sales, marketing, and distribution is limited,
we may encounter unforeseen difficulties in our efforts to efficiently manage the manufacturing, sale, and distribution of our
product candidates, or have to rely on third-party contractors, over which we may not have sole control, to manufacture our product
candidates. Moreover, there can be no assurance that we or any third-party contractors with whom we enter strategic relationships
will be successful in streamlining manufacturing operations and implementing efficient, low-cost manufacturing capabilities and
processes that will enable us to meet the quality, price, and production standards or production volumes to achieve profitability.
Our failure to develop these manufacturing processes and capabilities in a timely manner could prevent us from achieving positive
results of operations and cash flows.
Our
manufacturing operations in the U.S. depend primarily on one facility. If this facility is destroyed or we experience any manufacturing
difficulties, disruptions, or delays, this could limit supply of our product or adversely affect our ability to sell products
or conduct our clinical trials, and our business would be adversely impacted.
All
the manufacturing of our product candidates takes place at our single U.S. facility. If regulatory, manufacturing, or other problems
require us to discontinue production at this facility, we will not be able to supply our product candidates to patients or have
supplies for any clinical trials, which would adversely impact our business. If this facility or the equipment in it is significantly
damaged or destroyed by fire, flood, power loss, or similar events, we may not be able to quickly or inexpensively replace our
manufacturing capacity or replace the facility at all. In the event of a temporary or protracted loss of this facility or equipment,
we might not be able to transfer manufacturing to another third party. Even if we could transfer manufacturing from one facility
to another, the shift would likely be expensive and time-consuming, particularly since an alternative facility would need to comply
with the cGTP or cGMP (if applicable) regulatory and quality standard requirements and, if applicable, FDA approval would be required
before any products manufactured at that facility could be made commercially available.
Our
financial condition may impair our ability to obtain credit terms with our suppliers
.
Our
revenues may be dependent and our reimbursement arrangement may provide us with extended payment terms. However, our financial
condition may make it difficult for us to continue to receive payment terms from our suppliers or vendors making demand for adequate
assurance, which could include a demand for payment-in-advance. If we are unable to obtain reasonable payment terms or if any
of our material vendors or suppliers were to successfully demand payment-in-advance, it could have a material adverse effect on
our liquidity.
Risks
Related to Our Common Stock
An
active trading market for our common stock may not continue to develop or be sustained.
Although
our common stock is listed on the NASDAQ Capital Market, or NASDAQ, we cannot assure you that an active, liquid trading market
for our shares will continue to develop or be sustained. If an active market for our common stock does not continue to develop
or is not sustained, it may be difficult for you to sell shares quickly or without depressing the market price for the shares
or to sell your shares at all.
The
trading price of the shares of our common stock has been and may continue to be volatile, and you may not be able to resell some
or all your shares at a desired price.
Our
stock price has been highly volatile during the 12-month period ended December 31, 2018, with closing stock prices ranging from
a high of $38.97 per share to a low of $12.11 per share. The stock market in general, and the market for biotech companies in
particular, have experienced extreme volatility that has often been unrelated to the operating performance of particular companies.
Because of this volatility, investors in our stock may not be able to sell their common stock at or above the price paid for the
shares. The market price for our common stock may be influenced by many factors, including:
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actual
or anticipated variations in our operating results;
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changes
in financial estimates by us or by any securities analysts who might cover our stock;
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the
timing and results of our product development plans
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failure
or discontinuation of any of our development programs;
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conditions
or trends in our industry;
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stock
market price and volume fluctuations of comparable companies and, in particular, those that operate in the biotech industry;
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announcements
by us or our competitors of significant acquisitions, strategic partnerships, or divestitures;
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developments
or disputes concerning patent applications, issued patents, or other proprietary rights;
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announcements
of investigations or regulatory scrutiny of our operations or lawsuits filed against us;
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capital
commitments;
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investors’
general perception of our company and our business;
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recruitment
or departure of key personnel;
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announcements
and expectations of additional financing efforts; and
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sales
of our common stock, including sales by our directors and officers or specific stockholders.
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In
addition, in the past, stockholders have initiated class action lawsuits against biotechnology companies following periods of
volatility in the market prices of these companies’ stock. We are currently a party to such litigation and may be in the
future due to price volatility. Such litigation could cause us to incur substantial costs and divert management’s attention
and resources from the operation of our business.
If
equity research analysts do not continue to publish research or reports or publish unfavorable research or reports about us, our
business or our industry, our stock price and trading volume could decline.
The
trading market for our common stock is influenced by the research and reports that equity research analysts publish about us and
our business. Presently we have only limited research coverage by equity research analysts. Equity research analysts may elect
not to initiate or continue to provide research coverage of our common stock, and such lack of research coverage may adversely
affect the market price of our common stock. We have no control over the analysts or the content and opinions included in their
reports. The price of our stock could decline if one or more equity research analysts downgrade our stock or issue other unfavorable
commentary or research. If one or more equity research analysts ceases coverage of our company or fails to publish reports on
us regularly, demand for our stock could decrease, which in turn could cause our stock price or trading volume to decline.
Sales
of a substantial number of shares of our common stock 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 our common stock in the public market could occur at any time. If our stockholders sell,
or the market perceives that our stockholders intend to sell, substantial amounts of our common stock in the public market, the
market price of our common stock could decline significantly.
In
addition, we have filed registration statements on Form S-8 registering the issuance of shares of common stock subject to options
or other equity awards issued or reserved for future issuance under our equity incentive plans. Shares registered under these
registration statements on Form S-8 are available for sale in the public market subject to vesting arrangements and exercise of
existing options, the grant of new options in the future, and the restrictions of Rule 144 in the case of our affiliates.
We
are the subject of an SEC investigation, which could result in litigation, government investigations and enforcement actions
that could have a material adverse impact on our operations and financial condition.
We
have been the target of what we believe to be manipulative short seller attacks and coordinated “short and distort”
campaigns, including, but not limited to, Citron Research, led by Andrew Left, Sharesleuth and Capital Forum, as well as anonymous
persons and entities who post and/or publish what we believe to be coordinated, deliberately and purposefully false materials
on or within internet-based platforms, including, but not limited to, blogs, chat rooms, forums and social media. We believe these
materials, communications and “short and distort” efforts to be highly coordinated with purposefully manipulative
trading activities of our securities and have therefore monitored closely these events, which we do not tolerate.
In
June and October 2018, Citron published reports with what we believe to be false and misleading information about PolarityTE,
including a narrative about Barry Honig and Michael Brauser, the former co-chairmen of the board of directors (Mr. Honig is also
the former Chief Executive Officer) of Majesco Entertainment Company, our corporate predecessor prior to its acquisition of PolarityTE
NV and our current regenerative medicine business in April 2017. Despite what we believe to be clear inaccuracies in each Citron
report and the Capital Forum report, our stock price was significantly negatively affected following the release of each report.
After a third-party vendor we retained identified highly unusual trading activity in the Company’s stock took place around
the time of release of the Citron and Capitol Forum reports, we reported apparent intentional market manipulation by third parties
to FINRA, Nasdaq and the SEC in October 2018.
On
September 7, 2018, the SEC filed a complaint in the U.S. District Court for the Southern District of New York (SEC v. Honig et
al., No. 1:18-cv-01875 (S.D.N.Y. 2018)) alleging that certain persons, including John Stetson, our former Chief Financial Officer
and Chief Investment Officer, Barry Honig, who is also a current 5% shareholder of the Company, and Michael Brauser, who is also
a current 5% shareholder of the Company, manipulated the price of securities of three public companies (none of which is PolarityTE).
This complaint, which was amended on March 8, 2019 (as amended, the “Complaint”), alleges that the defendants violated
the anti-fraud and other provisions of the Securities Act, the Exchange Act and SEC rules promulgated thereunder by writing, or
causing to be written, false or misleading promotional articles, engaging in a variety of other manipulative trading practices
as well as filing false reports of their beneficial ownership or failure to file reports of their beneficial ownership when required
to do so.
In October 2018, we received
a document request and inquiries from the SEC relating to subjects addressed in the short seller reports and cooperated fully
by providing the SEC with all information relevant to their requests. On March 1, 2019, we received a subpoena from the SEC requesting
additional documents related to, among other things, (i) communications and agreements between us and, among others, John Stetson,
Barry Honig and Michael Brauser, (ii) the transaction pursuant to which Majesco Entertainment Company acquired PolarityTE NV and
our current regenerative medicine business, (iii) the performance of and communications with regulators regarding SkinTE, our
lead product, and (iv) any promotion of the Company or its securities. On March 4, 2019, we obtained from the SEC a copy of the
formal order of investigation of the Company and its affiliates with respect to possible violations of the federal securities
laws, including, among other things, the anti-fraud provisions of the Securities Act and the Exchange Act with respect to the
Company’s public disclosures, the beneficial ownership reporting provisions of the Exchange Act and the anti-price manipulation
provisions of the Exchange Act. We intend to fully cooperate with the SEC regarding their March 2019 subpoena and this ongoing
investigation.
As
a result of the SEC investigation or additional attacks by “short and distort” market participants and others, we
could be subject to additional stockholder litigation, government inquiries or enforcement actions that could name us, our affiliates,
or others. While we will not tolerate stock manipulation and will continue to report suspected wrongdoing to authorities, we cannot
predict whether any of these will arise or, if they do, the possible outcomes. Stockholder litigation, government inquiries or
enforcement actions could adversely affect our reputation, result in significant expenditures, including legal expenses, and potentially
result in significant fines, penalties or other remedies against us, which could have a material adverse effect on our results
of operations and financial condition. Although we maintain insurance that may provide coverage for some of these expenses and
costs, and we have given notice to our insurers of the claims, there is risk that the insurers will rescind or otherwise not renew
the policies, that some or all of the claims will not be covered by such policies, or that, even if covered, our ultimate liability
will exceed the available insurance.
Our
stock price may also be negatively affected by “short and distort” schemes, any public report of stock manipulation,
the SEC investigation, any negative press or other coverage we receive as a result thereof and the uncertainty surrounding the
result of any of these developments, which could adversely affect our ability to raise capital to fund future operations, result
in the loss of potential business opportunities, be exploited by our competitors, undermine the confidence that hospitals and
doctors, key potential adopters of our products, have in us and our technology, cause concern to our current or potential customers,
and make it more difficult to attract and retain qualified personnel and business partners, any of which would materially harm
our financial condition, results of operations and prospects. We expect management will continue to devote significant time, attention
and resources to these matters and any additional matters that may arise, which could have a material adverse impact on our commercial
development, results of operations and financial condition.
The
trading price of our common stock may be volatile as a result of short-seller activity and false information.
As
previously stated, we have been the target of what we believe to be manipulative short seller attacks and coordinated “short
and distort” campaigns, including, but not limited to, Citron Research, led by Andrew Left, Sharesleuth and Capital Forum,
as well as anonymous persons and entities who post and/or publish what we believe to be coordinated, deliberately and purposefully
false materials on or within internet-based platforms, including, but not limited to, blogs, chat rooms, forums and social media.
We believe these materials, communications and “short and distort” efforts to be highly coordinated with purposefully
manipulative trading activities of our securities and have therefore monitored closely these events, which we do not tolerate.
Despite
being what we believe to be false, misleading and purposeful inaccuracies in these reports, our stock price was significantly
and negatively affected following their release. After a third-party vendor we retained identified highly unusual trading activity
in the Company’s stock, we reported apparent intentional market manipulation by third parties to FINRA, Nasdaq and the SEC.
While we intend to continue to vigorously defend ourselves against what we believe to be the manipulation of our stock by interested
short sellers and activists, we cannot assure you that we will not continue to be a target of future reports from these or other
entities. Even if such future reports continue to contain what we believe to be inaccuracies, our stock price is likely to be
negatively affected by the publication of additional reports. In addition, such reports may disrupt our business and divert the
attention of our management and employees, and any allegations contained in any such reports could result in the loss of potential
business opportunities, be exploited by our competitors, undermine the confidence that hospitals and doctors, key potential adopters
of our products, have in us and our technology, cause concern to our current or potential customers, and make it more difficult
to attract and retain qualified personnel and business partners, which would materially harm our financial condition, results
of operations and prospects.
Moreover,
we believe a large proportion of our common stock has been and may continue to be traded by short sellers, which may put pressure
on the supply and demand for our common stock, further influencing volatility in its market price. Actions of short sellers may
cause significant fluctuations in our stock price based on temporary or speculative market perceptions or other factors that do
not necessarily reflect the underlying fundamentals and prospects of our business.
In
addition, following periods of volatility in the overall market and the market price of a company’s securities, securities
class action litigation has often been instituted against such companies, including the pending class action shareholder litigation
filed against us described further below under “Item 3. Legal Proceedings.” While we are continuing to defend such
actions vigorously, any judgment against us or any future stockholder litigation could result in substantial costs and a diversion
of our management’s attention and resources.
The
issuance of additional stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise
will dilute all other stockholders.
Our
amended and restated certificate of incorporation authorizes us to issue up to 250,000,000 shares of common stock and up to 25,000,000
shares of preferred stock with such rights and preferences as may be determined by our board of directors (the “Board”).
Subject to compliance with applicable rules and regulations, we may issue our shares of common stock or securities convertible
into our common stock from time to time in connection with a financing, acquisition, investment, our stock incentive plans or
otherwise. Any such issuance could result in substantial dilution to our existing stockholders and cause the trading price of
our common stock to decline.
Our
executive officers and directors and their affiliates own a significant percentage of our issued and outstanding common stock
and can exercise significant influence over matters submitted to stockholders for approval.
As
of March 7, 2019, our executive officers and directors and their affiliates exercised voting control over approximately 37.28%
of our outstanding common stock. As a result, if these stockholders were to choose to act together, they could exert a significant
degree of influence over matters submitted to our stockholders for approval, as well as our management and affairs. For example,
these persons, if they choose to act together, could have significant influence on the election of directors and approval of any
merger, consolidation, or sale of all or substantially all our assets, including a transaction on terms that other stockholders
may desire.
Our
Restated Certificate of Incorporation, our Restated Bylaws, and Delaware law could deter a change of our management, which could
discourage or delay offers to acquire us.
Certain
provisions of Delaware law and of our Restated Certificate of Incorporation, as amended, and by-laws, could discourage or make
it more difficult to accomplish a proxy contest or other change in our management or the acquisition of control by a holder of
a substantial amount of our voting stock. It is possible that these provisions could make it more difficult to accomplish, or
could deter, transactions that stockholders may otherwise consider to be in their best interests or in our best interests. These
provisions include:
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we
have a classified Board requiring that members of the Board be elected in different years, which lengthens the time needed
to elect a new majority of the Board;
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our
Board is authorized to issue up to 25,000,000 shares of preferred stock without stockholder approval, which could be issued
by our Board to increase the number of outstanding shares or change the balance of voting control and thwart a takeover attempt;
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stockholders
are not entitled to remove directors other than by a two-thirds vote and only for cause;
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stockholders
cannot call a special meeting of stockholders;
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we
require all stockholder actions be taken at a meeting of our stockholders, and not by written consent; and
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stockholders
must give advance notice to nominate directors or submit proposals for consideration at stockholder meetings.
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In
addition, we are subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law, which regulates
corporate acquisitions by prohibiting Delaware corporations from engaging in specified business combinations with particular stockholders
of those companies. These provisions could discourage potential acquisition proposals and could delay or prevent a change in control
transaction. They could also have the effect of discouraging others from making tender offers for our common stock, including
transactions that may be in your best interests. These provisions may also prevent changes in our management or limit the price
that investors are willing to pay for our stock.
A
material weakness in internal control over financial reporting could have a material adverse effect on our business, results of
operations, financial condition and liquidity.
As
discussed in Item 9A -
Controls and Procedures
, we have identified material weaknesses in internal control over financial
reporting through our evaluation of our controls at October 31, 2018. Our material weaknesses consist of:
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insufficient
internal controls related to information technology general controls in the areas of user access, user provisioning, and change
management over certain systems that support the financial reporting process; and
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ineffective
controls related to the documentation and completeness of the Company’s stock-based compensation expense.
|
A
material weakness could result in a material misstatement of our annual or interim financial statements requiring a restatement
of the affected financial statements. A material misstatement and resulting restatement entail numerous risks, including the following:
|
|
|
|
|
|
●
|
We
could be subject to civil litigation, including class action shareholder actions arising out of or relating to a restatement,
which litigation, if decided against us, could require us to pay substantial judgments, settlements or other penalties;
|
|
|
●
|
Negative
publicity relating to a restatement may adversely affect our business and the market price of our common stock;
|
|
|
●
|
Management’s
focus on achieving our business objectives may be diverted to addressing (i) the restatement (ii) customers’, employees’,
investors’ and regulators’ questions and concerns regarding the restatement (iii) any negative impact on the Company’s
public image with our customers and in the financial market caused by the restatement, and (iv) any subsequent litigation
that may result from the restatement;
|
|
|
●
|
The
SEC may review a restatement and require further amendment of our public filings; and
|
|
|
●
|
We
may incur significant expenses associated with preparing and filing a restatement.
|
Each
of these risks described above could have a material adverse effect on our business, results of operations, financial condition,
and liquidity.
Because
we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will
be your sole source of gains and you may never receive a return on your investment.
You
should not rely on an investment in our common stock to provide dividend income. We have not declared or paid cash dividends on
our common stock to date and have no plans to pay cash dividends in the foreseeable future. We currently intend to retain our
future earnings, if any, to fund the development and growth of our business. As a result, capital appreciation, if any, of our
common stock will be your sole source of gain for the foreseeable future. Investors seeking cash dividends should not purchase
our common stock.
We
incur costs and demands upon management because of being a public company.
As
a public company listed in the United States, we are incurring, and will continue to incur, significant legal, accounting and
other costs. These costs could negatively affect our financial results. In addition, changing laws, regulations and standards
relating to corporate governance and public disclosure, including regulations implemented by the SEC and stock exchanges, may
increase legal and financial compliance costs and make some activities more time consuming. These laws, regulations and standards
are subject to varying interpretations and, as a result, their application in practice may evolve over time as new guidance is
provided by regulatory and governing bodies. We intend to invest resources to comply with evolving laws, regulations and standards,
and this investment may result in increased general and administrative expenses and a diversion of management’s time and
attention from revenue-generating activities to compliance activities. If, notwithstanding our efforts to comply with new laws,
regulations and standards, we fail to comply, regulatory authorities may initiate legal proceedings against us and our business
may be harmed.
Failure
to comply with these rules also might make it more difficult for us to obtain some types of insurance, including directors’
and officers’ liability insurance, and we might be forced to accept reduced policy limits and coverage or incur substantially
higher costs to obtain the same or similar coverage. The impact of these events could also make it more difficult for us to attract
and retain qualified persons to serve on our board of directors, on committees of our board of directors or as members of senior
management
Item
1B. Unresolved Staff Comments.
None.
Item
2. Properties.
Effective
July 15, 2018, we entered into a commercial lease agreement with Salt Lake City Corporation, pursuant to which we leased approximately
44,695 rentable square feet of office space at 123 Wright Brothers Drive in Salt Lake City, Utah. The initial term of the lease
is two years, and may be extended for an additional term of five years by agreement of the parties. The base rent plus maintenance
fees over the two-year term of the lease is $469,288 per year, or $39,108 per month.
On
December 27, 2017, we entered into a commercial lease agreement with Adcomp LLC, a Utah limited liability company, pursuant to
which we leased approximately 178,528 rentable square feet of warehouse, manufacturing, office, and lab space at 1960 S. 4250
West, Salt Lake City, UT. The initial term of the lease is five years and it expires on November 30, 2022. We have a one-time
option to renew for an additional five years. The initial base rent under this lease is $98,190 per month ($0.55 per sq. ft.)
for the first year of the initial lease term and increases 3.0% per annum thereafter.
In
May 2018, we purchased two parcels of real property in Cache County, Utah, consisting of approximately 1.75 combined gross acres
of land, together with the buildings, structures, fixtures, and personal property located at 1072 West RSI Drive, Logan, Utah.
This facility is used for the operation of our pre-clinical contract services business.
On
October 19, 2018, we entered into an office lease with Lefrak SBN Limited Partnership, a Georgia limited partnership, covering
approximately 7,250 square feet of space in the building located at 40 West 57
th
Street, New York, New York City. The
lease is for a term of three years. The annual lease rate is $60 per square foot. Initially we will occupy and pay for only 3,275
square feet of space, and we are not obligated under the lease to pay for the remaining 3,975 square feet covered by the lease
unless we elect to occupy that additional space. We have a sublease with the affiliate of one of our directors pursuant to which
said affiliate will sublease 1,220 square feet at the same lease rate we pay to the landlord, and an option to expand the space
occupied to an additional 2,753 square feet, which means we would be leasing 6,028 square feet from the landlord and subleasing
3,972 square feet to the affiliate of our director.
We
lease office space in Hazlet, New Jersey at a cost of approximately $1,100 per month under a month to month lease agreement.
We
expect that we will require additional facilities to continue our research and development program and commercialization efforts
and are actively seeking suitable locations.
Item
3. Legal Proceedings.
Shareholder
Litigation
On
June 26, 2018, a class action complaint alleging violations of the Federal securities laws was filed in the United States District
Court, District of Utah, by Jose Moreno against the Company and two directors of the Company, Case No. 2:18-cv-00510-JNP (the
“Moreno Complaint”). On July 6, 2018, a similar complaint was filed in the same court against the same defendants
by Yedid Lawi, Case No. 2:18-cv-00541-PMW (the “Lawi Complaint”). Both the Moreno Complaint and Lawi Complaint allege
that the defendants made or were responsible for, disseminating information to the public through reports filed with the Securities
and Exchange Commission and other channels that contained material misstatements or omissions in violation of Sections 10 and
20(a) of the Exchange Act and Rule 10b-5 adopted thereunder. Specifically, both complaints allege that the defendants misrepresented
the status of one of the Company’s patent applications while touting the unique nature of the Company’s technology
and its effectiveness. Plaintiffs are seeking damages suffered by them and the class consisting of the persons who acquired the
publicly-traded securities of the Company between March 31, 2017, and June 22, 2018. Plaintiffs have filed motions to consolidate
and for appointment as lead plaintiff. On November 28, 2018, the Court consolidated the
Moreno
and
Lawi
cases under
the caption
In re PolarityTE, Inc. Securities Litigation
(the “Consolidated Securities Litigation”), and requested
the appointment of the plaintiff in
Lawi
as the lead plaintiff. On January 16, 2019, the Court granted the motion of Yedid
Lawi for appointment as lead plaintiff, and on February 1, 2019, the Court granted the lead plaintiff’s motion for approval
of lead counsel and liaison counsel. The Court ordered that the lead plaintiff file and serve a consolidated complaint no later
than 60 days after February 1, 2019, the defendants shall have 60 days after filing and service of the consolidated complaint
to answer or otherwise respond, and the lead plaintiff must file a motion for class certification within 90 days of service of
the consolidated complaint. The Company believes the allegations in the Moreno Complaint and Lawi Complaint are without merit,
and intends to defend the litigation, vigorously. The Company expects its first response will be to file a motion to dismiss after
the lead plaintiff files and serves the consolidated complaint. At this early stage of the proceedings the Company is unable to
make any prediction regarding the outcome of the litigation.
In
November 2018, a shareholder derivative lawsuit was filed in the United States District Court, District of Utah, with the caption
Monther v. Lough, et al
., case no. 2:18-cv-00791-TC, alleging violations of the Exchange Act, breach of fiduciary duty,
and unjust enrichment on the part of certain officers and directors based on the facts and circumstances recited in the Consolidated
Securities Litigation. On November 26, 2018, the court issued an order staying all proceedings until after the disposition of
motions to dismiss the Consolidated Securities Litigation.
SEC
Investigation
We
have been the target of what we believe to be manipulative short seller attacks and coordinated “short and distort”
campaigns, including, but not limited to, Citron Research, led by Andrew Left, Sharesleuth and Capital Forum, as well as anonymous
persons and entities who post and/or publish what we believe to be coordinated, deliberately and purposefully false materials
on or within internet-based platforms, including, but not limited to, blogs, chat rooms, forums and social media. We believe these
materials, communications and “short and distort” efforts to be highly coordinated with purposefully manipulative
trading activities of our securities and have therefore monitored closely these events, which we do not tolerate.
In
June and October 2018, Citron published reports with what we believe to be false and misleading information about PolarityTE,
including a narrative about Barry Honig and Michael Brauser, the former co-chairmen of the board of directors (Mr. Honig is also
the former Chief Executive Officer) of Majesco Entertainment Company, our corporate predecessor prior to its acquisition of PolarityTE
NV and our current regenerative medicine business in April 2017. Despite what we believe to be clear inaccuracies in each Citron
report and the Capital Forum report, our stock price was significantly negatively affected following the release of each report.
After a third-party vendor we retained identified highly unusual trading activity in the Company’s stock took place around
the time of release of the Citron and Capitol Forum reports, we reported apparent intentional market manipulation by third parties
to FINRA, Nasdaq and the SEC in October 2018.
On
September 7, 2018, the SEC filed a complaint in the U.S. District Court for the Southern District of New York (SEC v. Honig et
al., No. 1:18-cv-01875 (S.D.N.Y. 2018)) alleging that certain persons, including John Stetson, our former Chief Financial Officer
and Chief Investment Officer, Barry Honig, who is also a current 5% shareholder of the Company, and Michael Brauser, who is also
a current 5% shareholder of the Company, manipulated the price of securities of three public companies (none of which is PolarityTE).
This complaint, which was amended on March 8, 2019 (as amended, the “Complaint”), alleges that the defendants violated
the anti-fraud and other provisions of the Securities Act, the Exchange Act and SEC rules promulgated thereunder by writing, or
causing to be written, false or misleading promotional articles, engaging in a variety of other manipulative trading practices
as well as filing false reports of their beneficial ownership or failure to file reports of their beneficial ownership when required
to do so.
In October 2018, we received a document request and inquiries from the SEC relating
to subjects addressed in the short seller reports and cooperated fully by providing the SEC with all information relevant to their
requests. On March 1, 2019, we received a subpoena from the SEC requesting additional documents related to, among other things,
(i) communications and agreements between us and, among others, John Stetson, Barry Honig and Michael Brauser, (ii) the transaction
pursuant to which Majesco Entertainment Company acquired PolarityTE NV and our current regenerative medicine business, (iii) the
performance of and communications with regulators regarding SkinTE, our lead product, and (iv) any promotion of the Company or
its securities. On March 4, 2019, we obtained from the SEC a copy of the formal order of investigation of the Company and its
affiliates with respect to possible violations of the federal securities laws, including, among other things, the anti-fraud provisions
of the Securities Act and the Exchange Act with respect to the Company’s public disclosures, the beneficial ownership reporting
provisions of the Exchange Act and the anti-price manipulation provisions of the Exchange Act. We intend to fully cooperate with
the SEC regarding their March 2019 subpoena and this ongoing investigation.
Patent
Litigation
On
February 26, 2015, a complaint for patent infringement was filed in the United States District Court for the Eastern District
of Texas by Richard Baker, an individual residing in Australia, against Microsoft, Nintendo, a former subsidiary of the Company,
and a number of other game publisher defendants. The complaint alleged that the Zumba Fitness Kinect game infringed plaintiff’s
patents in motion tracking technology. The plaintiff represented himself pro se in the litigation and sought monetary damages
in the amount of $1.3 million. The case was subsequently transferred to the Western District of Washington. On June 16, 2017,
final judgment was entered in favor of the defendants finding that the accused products did not literally infringe the asserted
patent and that plaintiff was barred from pursing infringement under the doctrine of equivalents due to prosecution history estoppel.
The plaintiff appealed that decision to the Court of Appeals for the Federal Circuit. On April 9, 2018, the Court of Appeals for
the Federal Circuit affirmed the judgment of the District Court for the Western District of Washington. On May 7, 2018, the plaintiff
filed a petition for panel rehearing and rehearing en banc by the Court of Appeals. The petition for rehearing was denied on June
8, 2018. The plaintiff subsequently filed a petition for a writ of certiorari with the Supreme Court of the United States, which
was denied in November 2018. Consequently, this matter has been resolved without liability to the Company.
Other
Matters
In
the ordinary course of business, we may become involved in lawsuits, claims, investigations, proceedings, and threats of litigation
relating to intellectual property, commercial arrangements, regulatory compliance, and other matters. Except as noted above, at
December 31, 2018, we were not party to any legal or arbitration proceedings that may have significant effects on our financial
position or results of operations. No governmental proceedings are pending or, to our knowledge, contemplated against us. We are
not a party to any material proceedings in which any director, member of senior management or affiliate of ours is either a party
adverse to us or our subsidiaries or has a material interest adverse to us or our subsidiaries.
Item
4. Mine Safety Disclosures.
Not
applicable.
PART
III
Item
10 - Directors, Executive Officers and Corporate Governance.
The
following table sets forth the names and ages of all our directors.
|
Denver
Lough
|
|
36
|
|
Class
III Director
|
|
Steve
Gorlin
|
|
80
|
|
Class
II Director
|
|
Jeff
Dyer
|
|
59
|
|
Class
I Director
|
|
Jon
Mogford
|
|
50
|
|
Class
I Director
|
|
Willie
C. Bogan
|
|
69
|
|
Class
II Director
|
|
Peter
A. Cohen
|
|
71
|
|
Class
III Director
|
|
Rainer
Erdtmann
|
|
54
|
|
Class
III Director
|
|
David
Seaburg
|
|
49
|
|
Class
II Director
|
|
Minnie
Baylor-Henry
|
|
71
|
|
Class
I Director
|
The
following is a summary of the background and qualifications of each of our directors.
Dr.
Denver Lough
was appointed our Chairman and Chief Executive Officer and Chief Scientific Officer on December 1, 2016 and
has continued to serve in this capacity throughout 2018. He also served as Chief Scientific Officer from December 2016 to May
2018, when he became Chief R&D Officer. Prior to December 2016, Dr. Lough served both clinical and research roles at multiple
institutions. From 2012 until 2016 Dr. Lough was a Plastic & Reconstructive Surgery House Staff Officer at Johns Hopkins University
School of Medicine, Department of Plastic & Reconstructive Surgery. Dr. Lough has received numerous accolades and awards by
national societies related to basic and translational science applications in tissue engineering, regenerative medicine, and immunology
as well as within solid organ and reconstructive transplantation. We believe that Dr. Lough is qualified to serve as a member
of our Board because of his experience in clinical medicine, surgery, research as well as the development and innovation of technologies
related to regenerative medicine and related patent applications and intellectual property which the Company has reviewed for
potential development. Dr. Lough holds an M.D. and PhD in Biochemistry, Molecular and Cell Biology from Georgetown University,
which he earned in 2012. Dr. Lough has served within the Department of Surgery and Institute for Plastic Surgery Southern Illinois
University School of Medicine and Translational Research Director at Laboratory for Regenerative Medicine and Applied Sciences.
He has served within the Laboratories for Craniomaxillofacial Regenerative Medicine at the Johns Hopkins Hospital Department of
Plastic and Reconstructive Surgery. In addition, Dr. Lough was a lead research associate in the Vascularized Composite Allotransplantation
Laboratory at the Johns Hopkins Hospital Department of Plastic and Reconstructive Surgery and has been a research consultant to
the Johns Hopkins Hendrix Burn Research Center. He has also served within the Brady Urological Institute at the Johns Hopkins
School of Medicine. Dr. Lough was assembled as a member among other burn experts as a Taiwanese presidential disaster response
team following the largest civilian burn disaster in 2015.
Steve
Gorlin
joined the Board in February 2017. Mr. Gorlin helped found several biotechnology and pharmaceutical companies over
the past 40 years, including Hycor Biomedical, Inc. (acquired by Agilent), Theragenics Corporation (NYSE: TGX), CytRx Corporation
(NASDAQ: CYTR), Medicis Pharmaceutical Corporation (acquired by Valeant), EntreMed, Inc. (NASDAQ: ENMD), MRI Interventions, DARA
BioSciences, Inc. (NASDAQ: DARA), MiMedx Group, Inc. (NASDAQ: MDXG), and Medivation, Inc. (NASDAQ: MDVN). Since December 2014,
Mr. Gorlin has served as a director of Catasys, Inc. and Co-Chairman of the board of directors of Medovex, Inc., and since May
2011 he has served on the board of directors of NTC China, Inc. In addition, since 2011, Mr. Gorlin has served as a member of
the board of directors of DemeRX, Inc. (“DemeRX”) and from 2011 until 2012 he served as Chairman of the board of DemeRX.
Since July 2015, he has also served as Vice Chairman of the board of NantKwest, Inc. and from July 2013 until May 2015 he served
on various executive committees and the board of directors of Conkwest, Inc., a private company, which is now NantKwest, Inc.
From November 2006 until June 2013, Mr. Gorlin served as a member of the board of directors of MiMedx Group, Inc. From 2010 until
2014 Mr. Gorlin served on the Business Advisory Council to the Johns Hopkins School of Medicine, from 2011 until 2013 he served
on The Johns Hopkins BioMedical Engineering Advisory Board and from 2007 until 2011 he served on the Board of the Andrews Institute.
He is presently a member of the Research Institute Advisory Committee (RIAC) of Massachusetts General Hospital. Mr. Gorlin founded
several non-medical related companies, including Perma-Fix, Inc., Pretty Good Privacy, Inc. (sold to Network Associates), Judicial
Correction Services, Inc. (sold to Correctional Healthcare) and NTC China, Inc. He started The Touch Foundation, a nonprofit organization
for the blind and was a principal financial contributor to the founding of Camp Kudzu for diabetic children. Mr. Gorlin is qualified
to serve as a member of the Company’s Board because of his experience in regenerative medicine and pharmaceutical drug and
medical device research and development.
Jeff
Dyer
was appointed to our Board of Directors on March 2, 2017. Mr. Dyer has served as the Horace Beesley Professor of Strategy
at Brigham Young University since September 1999. From August 1993 until September 1999 he served as an Assistant Professor at
Wharton School, University of Pennsylvania, and from July 1984 until September 1988 he served as Management Consultant and Manager
of Bain & Company. Mr. Dyer received his Bachelor of Science degree in psychology and MBA from Brigham Young University and
his PhD in management from University of California, Los Angeles. Mr. Dyer is qualified to serve as a member of the Company’s
Board because of his extensive business and management expertise and knowledge of capital markets.
Dr.
Jon Mogford
was appointed to our Board of Directors on February 8, 2017. Dr. Mogford has served in various capacities for
the Texas A&M University System (“Texas A&M”). Since May 2013, Dr. Mogford has served as the Vice Chancellor
for Research, from August 2012 until April 2013 he served as the Chief Research Officer and from November 2011 until August 2012
he served as Associate Vice Chancellor for Strategic Initiatives at Texas A&M. Prior to joining Texas A&M in 2011, from
February 2010 until October 2011, Dr. Mogford served as Deputy Director of the Defense Sciences Office (DSO) of the Defense Advanced
Research Projects Agency (DARPA) in the U.S. Department of Defense. From July 2005 until January 2009, Dr. Mogford served as Program
Manager of DSO of DARPA. In addition, since November 2016, Dr. Mogford has served as a member of the board of directors of Medovex
Corp. Dr. Mogford is the recipient of the Secretary of Defense Medal for Outstanding Public Service. Dr. Mogford obtained his
bachelor’s degree in Zoology from Texas A&M University and doctorate in Medical Physiology from the Texas A&M University
Health Science Center, College Station, Texas. His research in vascular physiology continued at the University of Chicago as a
Postdoctoral fellow from 1997 until 1998. Dr. Mogford transitioned his research focus to the field of wound healing at Northwestern
University, both as a Research Associate and as a Research Assistant Professor from 1998 until 2003. He then served as a Life
Sciences Consultant to DARPA on the Revolutionizing Prosthetics program from December 2003 until June 2005. Dr. Mogford is qualified
to serve as a member of the Company’s Board because of his experience and research in regenerative medicine.
Willie
C. Bogan
joined the Board in April 2018. Mr. Bogan served as Associate General Counsel and Corporate Secretary of McKesson
Corporation (“McKesson”), a San Francisco-based healthcare services and information technology company (relocating
to Las Colinas, TX in 2019) currently ranked 6th on the Fortune 500, from July 2009 until his retirement from McKesson in November
2015. He joined McKesson in November 2006 as Associate General Counsel and Assistant Secretary. Before joining McKesson, Mr. Bogan
held senior advisory positions at the following public companies in the San Francisco Bay Area: Bank of America; Safeway; Charles
Schwab; and Catellus Development Corporation, a real estate development company. Prior to becoming in-house counsel, he was a
partner at Steinberg Miller Bogan & Goldstein in Manhattan Beach, California. He started his law career as a law firm associate
in Los Angeles, California. Mr. Bogan graduated Phi Beta Kappa and Summa Cum Laude from Dartmouth College where he majored in
Spanish. He received an M.A. degree in Politics and Economics from Oxford University where he studied as a Rhodes Scholar. He
earned his J.D. degree from Stanford Law School. Mr. Bogan is qualified to serve as a member of the Board because of his knowledge
of the healthcare industry and his experience as an advisor to public companies and their boards of directors on securities law
and corporate governance matters.
Peter
A. Cohen
joined the Board in June 2018. Mr. Cohen has served as Vice Chairman of the Board of Scientific Games Corporation
since September 2004. Mr. Cohen was Chairman of Cowen Inc. (formerly known as Cowen Group, Inc.), a diversified financial services
company, from November 2009 through June 2018, and served as Chief Executive Officer from November 2009 through December 2017.
Mr. Cohen was a founding partner and principal of Ramius LLC, a private investment management firm formed in 1994 that was combined
with Cowen in late 2009. Mr. Cohen served as a member of the board of directors of Chart Acquisition Corp. (which, because of
a business combination, is now known as Tempus Applied Solutions Holdings, Inc.) from September 2011 to November 2016. From November
1992 to May 1994, Mr. Cohen was Vice Chairman of the Board and a director of Republic New York Corporation, as well as a member
of its executive management committee. Mr. Cohen was Chairman and Chief Executive Officer of Shearson Lehman Brothers from 1983
to 1990. Mr. Cohen is currently a Trustee of Mount Sinai Medical Center and has served on its board for approximately thirty years.
Mr. Cohen is qualified to serve as a member of the Board because of his knowledge of the capital markets and corporate finance,
and his experience as a public company director.
Rainer
Erdtmann
joined the Board in August 2018. He has 26 years of experience in finance and investment banking. For the past three
years Mr. Erdtmann has been a portfolio manager and general partner of Point Sur Investors LLC, specializing in identifying innovative
biotech companies. Prior to Point Sur Investors, from February 2009 until September 2015, Mr. Erdtmann was with Pharmacyclics,
Inc., a Nasdaq-listed company. He began as Vice President, Finance & Administration, Corporate Secretary and acted as the
Principal Financial and Accounting Officer. In that capacity he was responsible for accounting, SEC reporting, audits, and investor
relations. He built and had operational responsibility for Finance, IT, HR, Legal, Facilities, and Events. He later served as
Executive Vice President of Corporate Affairs including Corporate Communications. Additionally, he structured and administered
the international revenue for Pharmacyclics into a swiss-based subsidiary. Mr. Erdtmann began his career at Commerzbank, Germany,
where he was an investment banker and portfolio manager for institutional international accounts. Mr. Erdtmann earned the Diplom
Kaufmann degree, with honors, in Finance and Banking from the Westfaelische Wilhelms Universitaet, Muenster, Germany. Mr. Erdtmann
is qualified to serve as a member of the Board because of his knowledge of the biotech industry, his deep experience in capital
markets and finance, and his knowledge of commercial and business practices in Europe and North America.
David
Seaburg
has served as a Director of the Company since August 2018, and served as a consultant until his appointment as
President of Corporate Development for the Company effective March 11, 2019. Prior to March 11, 2019, he served as the Managing
Director and Head of Sales Trading at Cowen & Company, a diversified financial services company. Over the course of his 20+
year career at Cowen in both Equity Sales Trading and Trading, Mr. Seaburg advanced to increasingly senior level roles at the
firm. In 2006, Mr. Seaburg was named Head of Sales Trading and appointed to the firm’s Equity Operating Committee. Mr. Seaburg
was a CNBC Fast Money Contributor and provided regular on-air commentary for the network. Mr. Seaburg holds a Bachelor of Arts
degree in Business Finance and Economics from Northeastern University. Mr. Seaburg is qualified to serve as a member of the Board
because of his knowledge of financial management, marketing, investor relations, acquisition transactions, and capital markets.
Minnie
Baylor-Henry
joined the Board in December 2018. She is a regulatory affairs leader who provides regulatory strategic support
services to life sciences companies through her consulting firm, B-Henry & Associates. Before starting her consulting company,
Ms. Baylor-Henry was employed by Johnson & Johnson (“J&J”) and members of the J&J health care group in
a number of positions, including: Worldwide Vice President Regulatory Affairs - Medical Devises for J&J from January 2011
to March 2015; Vice President - Medical & Regulatory Affairs – Specialty Pharmaceuticals, and Vice President-Regulatory
Affairs – Over-the-Counter Products for McNeil Consumer Health Care from August 2003 to October 2008; and, Senior Director,
Regulatory Affairs for RW Johnson Pharmaceutical Research & Development Corporation from July 1999 to August 2003. From October
2008 to October 2010, Ms. Baylor-Henry served as the National Director Regulatory Affairs Life Sciences for Deloitte. For eight
years prior to August 1999, Ms. Baylor-Henry served in several positions with the U.S. Food & Drug Administration, including
Director/Branch Chief – Division of Drug Marketing, Advertising and Communications, National Health Fraud Coordinator –
Office of Regulatory Affairs/ Federal/ State Relations, and Regulatory Review Officer. From July 2018, to the present Ms. Baylor-Henry
has served as a director of scPharmaceuticals, Inc., a publicly-held company engaged in the business of developing technologies
that enable the subcutaneous administration of therapies that have previously been limited to intravenous delivery. Ms. Baylor-Henry
received her pharmacy degree from Howard University’s College of Pharmacy and a law degree from Catholic University’s
Columbus School of Law. Ms. Baylor-Henry is qualified to serve as a member of the Board because of her knowledge of the healthcare
industry and experience with the regulatory regimen applicable to biologic and pharmaceutical products.
The
following table sets forth the names, and positions of our executive officers.
|
Name
|
|
Position(s)
|
|
Denver
Lough
|
|
Chief
Executive Officer, Chief R&D Officer, Chairman and Class III Director
|
|
David
Seaburg
|
|
President
of Corporate Development and Class II Director
|
|
Edward
Swanson
|
|
Chief
Operating Officer
|
|
Paul
E. Mann
|
|
Chief
Financial Officer
|
|
Cameron
Hoyler
|
|
General
Counsel, Secretary, EVP Corporate Development & Strategy
|
The
following is a summary of the background of each of our executive officers, except for Dr. Lough and Mr. Seaburg, whose backgrounds
are presented above with our director information.
Dr.
Edward Swanson
,
33,
was appointed as Chief Operating Officer and Director of the Company on December 1, 2016. Following
completion of his undergraduate degree in Applied Sciences in Biomedical Sciences at the School of Engineering and Applied Sciences
at the University of Pennsylvania, Dr. Swanson received his medical degree from Harvard Medical School, where he attended as a
student from August 2008 to May 2012, graduating with honors for his thesis researching surgical outcomes within craniofacial
and plastic surgery. From July 2012 until December 2016, Dr. Swanson was a Surgical Resident in Plastic & Reconstructive Surgery
in the Department of Plastic and Reconstructive Surgery at The Johns Hopkins University School of Medicine. During his time at
Johns Hopkins, he served in a leadership role within the residency, sitting on the Program Evaluation Committee from July 2015
to December 2016, and The Johns Hopkins Hospital House staff Patient Safety and Quality Council from July 2014 to June 2015. Dr.
Swanson has extensive experience in basic and translational biomedical research, including as a research associate in Wound Healing
in the Division of Plastic Surgery at the Brigham and Women’s Hospital and Harvard Medical School from May 2004 to August
2004, thesis student in Traumatic Brain Injury at the University of Pennsylvania from August 2006 to May 2007, research fellow
in Pancreatic Cancer Cellular Biology at the Brigham and Women’s Hospital and Harvard Medical School from July 2007 to July
2008, research fellow in Nanomedicine at Harvard Medical School and MIT from May 2008 to August 2008, and research fellow in Vascularized
Composite Allotransplantation at the Massachusetts General Hospital and Harvard Medical School during his final year of medical
school. In addition, Dr. Swanson directed large animal translational research as a lead research associate in the Vascularized
Composite Allotransplantation Laboratory in the Department of Plastic and Reconstructive Surgery at The Johns Hopkins University
School of Medicine from July 2014 to June 2015, overseeing experimental projects funded by multimillion dollar grants. Furthermore,
Dr. Swanson has demonstrated national and international leadership throughout the field of plastic and reconstructive surgery
at a young age, with greater than 40 peer-reviewed publications, five book chapters, and 30 national/international conference
presentations. We believe that Dr. Swanson is qualified to serve as a member of our Board because of his experience in technology
related to regenerative medicine and related technologies and their clinical applications, which the Company has reviewed for
potential development.
Paul
E. Mann, age 42
, served as the Healthcare Portfolio Manager for Highbridge Capital Management from August 2016 until he
joined the Company as Chief Financial Officer in June 2018. From August 2013 to March 2016, Mr. Mann served as an analyst with
Soros Fund Management. Prior to joining Soros Fund Management, Mr. Mann was an analyst and portfolio manager with Lodestone Natural
Resources and UBS from September 2011 to March 2013. Prior to moving to the buy-side, Mr. Mann spent 11 years as a sell-side analyst
at Morgan Stanley and Deutsche Bank. He started his career as a research scientist at Proctor and Gamble and he has an MA (Cantab)
and an MEng in Chemical Engineering from Cambridge University. Mr. Mann is a CFA charter holder.
Cameron
Hoyler, 35
, was appointed General Counsel in April 2017, EVP Corporate Development & Strategy in May 2018, and Secretary
in September 2018. Prior to joining the Company, Mr. Hoyler was an attorney at King & Spalding LLP, where he practiced in
the Life Sciences and Product Liability groups from September 2012 to April 2017. Mr. Hoyler represented and counseled clients
involved in disputes and transactions in a variety of settings, including product liability, employment, commercial, trademark,
real estate, and insurance coverage. While at King & Spalding LLP, Mr. Hoyler devoted the vast majority of his practice to
representing clients in the pharmaceutical and medical device industries, including Bristol-Myers Squibb Company, AstraZeneca
Pharmaceuticals LP, and McKesson Corporation, in addition to working for clients in other highly-regulated industries, such as
Chevron U.S.A. Inc. and Monsanto Company. From September 2010 to September 2012, Mr. Hoyler practiced at the law firm of Filice,
Brown, Eassa & McLeod, where his practice included product liability, premises liability, employment, and insurance-related
matters. He earned his Bachelor of Arts from the University of Pennsylvania, and his Juris Doctor from the University of San Francisco
School of Law.
Section
16(a) Beneficial Ownership Reporting Compliance
Section
16(a) of the Exchange Act requires the Company’s directors, executive officers, and stockholders who own more than 10% of
the Company’s stock to file forms with the SEC to report their ownership of the Company’s stock and any changes in
ownership. The Company assists its directors and executives by identifying reportable transactions of which it is aware and preparing
and filing the forms on their behalf. All persons required to file forms with the SEC must also send copies of the forms to the
Company. We have reviewed all forms provided to us. Based on that review and on written information given to us by our executive
officers and directors, we believe that all Section 16(a) filings during the past fiscal year were filed on a timely basis and
that all directors, executive officers and 10% beneficial owners have fully complied with such requirements during the past fiscal
year, except that Paul Mann did not report on a timely basis the transfer of shares to the Company to satisfy a tax obligation
arising from the vesting of restricted stock units.
Code
of Ethics
We
have adopted Code of Business Ethics and Practices that applies to every employee, officer, and director. Our Code of Business
Ethics and Practices is publicly available, and can be found on our website at http://www.polarityte.com/ by clicking on the link
to “Investor Relations” and the link to “Corporate Governance.”
Procedure
for Recommending Directors
There
has not been a material change to the procedures by which security holders may recommend nominees for election to our board of
directors since August 17, 2018, the date we filed our Proxy Statement for the annual meeting of stockholders held on September
20, 2018.
Audit
Committee
Our
board of directors has a standing Audit Committee. The board of directors has affirmatively determined the Audit Committee is
composed of independent directors, as independence is defined for members of an audit committee in the rules of The NASDAQ Stock
Market and Rule 10A-3(b)(1) adopted under the exchange Act. The members of the Audit Committee are Rainer Erdtmann, Peter A. Cohen,
and Jeff Dyer. The Board has determined that Rainer Erdtmann meets the qualification requirements of an audit committee financial
expert as defined in Item 407 of Regulation S-K.
Item
11 - Executive Compensation.
Summary
Compensation Table
The
following Summary Compensation Table sets forth summary information as to compensation paid or accrued to our named executive
officers during the last two fiscal years ended October 31, 2018 and 2017. Our named executive officers include our principal
executive officer and the two most highly compensated executive officers other than the principal executive officer who were serving
as executive officers at the end of the last completed fiscal year. There is no individual who was not serving as an executive
officer at the end of the last completed fiscal year who served as an executive officer during the last completed fiscal year
and would have been one of the two most highly compensated executive officers had the individual been serving at the end of the
fiscal year.
|
Name
and
Principal
Position
|
|
Year
|
|
|
Salary
($)
|
|
|
Bonus
($)
|
|
|
Stock
Awards
($)(1)
|
|
|
Option
Awards
($)(1)
|
|
|
Total
($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denver
Lough
|
|
|
2018
|
|
|
|
448,462
|
|
|
|
1,010,000
|
|
|
|
2,395,050
|
(2)
|
|
|
9,860,825
|
(5)
|
|
|
13,714,337
|
|
|
Chairman of the
Board,
|
|
|
2017
|
|
|
|
315,000
|
|
|
|
100,000
|
|
|
|
-0-
|
|
|
|
2,121,250
|
(6)
|
|
|
2,536,250
|
|
|
Chief Executive
Officer, Chief R&D Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Edward Swanson
|
|
|
2018
|
|
|
|
338,462
|
|
|
|
650,000
|
|
|
|
798,350
|
(3)
|
|
|
2,738,775
|
(7)
|
|
|
4,525,587
|
|
|
Chief Operating
Officer
|
|
|
2017
|
|
|
|
270,000
|
|
|
|
100,000
|
|
|
|
-0-
|
|
|
|
1,794,578
|
(8)
|
|
|
2,164,578
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Paul E. Mann
|
|
|
2018
|
|
|
|
133,846
|
|
|
|
75,666
|
|
|
|
3,971,124
|
(4)
|
|
|
9,682,330
|
(9)
|
|
|
13,862,967
|
|
|
Chief Financial
Officer
|
|
|
2017
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
(1)
The figures in these columns represent the aggregate grant date fair value for restricted stock and option awards, respectively,
granted during fiscal years 2018 and 2017 computed in accordance with FASB ASC Topic 718. See Note 12 to our consolidated financial
statements presented in this Annual Report for details as to the assumptions used to determine the grant date fair value of the
restricted stock and option awards.
(2)
Represents 105,000 shares at a grant date fair value of $22.81 per common share.
(3)
Represents 35,000 shares at a grant date fair value of $22.81 per common share.
(4)
Represents 100,000 shares at a grant date fair value of $37.05 per common share and 11,667 shares at a grant date fair value of
$22.81 per common share.
(5)
Represents stock options to purchase 400,000 common shares at an exercise price of $24.59 per common share and 195,000
common shares at an exercise price of $20.12.
(6)
Represents stock options to purchase 1,000,000 common shares at an exercise price of $3.15 per common share.
(7)
Represents stock options to purchase 100,000 common shares at an exercise price of $24.59 and 65,000 common shares at an
exercise price of $20.12.
(8)
Represents stock options to purchase 846,000 common shares at an exercise price of $3.15 per common share.
(9)
Represents stock options to purchase 350,000 common shares at an exercise price of $31.88 per common share and 21,666 common shares
at an exercise price of $20.12.
The
following Summary Compensation Table sets forth summary information as to compensation paid or accrued to our named executive
officers during the two-month period ended December 31, 2018.
|
Name
and
Principal
Position
|
|
Salary
($)
|
|
|
Bonus
($)
|
|
|
Stock
Awards
($)
|
|
|
Option
Awards
($)
|
|
|
Total
($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denver
Lough
|
|
|
88,333
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
88,333
|
|
|
Chairman of the
Board,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chief Executive
Officer, Chief R&D Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Edward Swanson
|
|
|
66,667
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
66,667
|
|
|
Chief Operating
Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Paul E. Mann
|
|
|
66,667
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
66,667
|
|
|
Chief Financial
Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Narrative
Disclosure to Summary Compensation Table
Denver
Lough’s Employment Agreement
We
have a written employment agreement with Dr. Lough dated November 10, 2017. We paid Dr. Lough a bonus of $150,000 when we signed
the agreement. The agreement has an initial term of three years and automatically renews for successive one-year periods unless
either party provides the other party with written notice of his or its intention not to renew at least three months prior to
the expiration of the current term.
Dr.
Lough’s base salary is $530,000 per year. He is eligible to receive a bonus in the amount of 100% of annual salary, as may
be determined from time to time by the Board of Directors in its discretion, and is eligible to participate in any equity- based
incentive compensation plan or program we adopt. During 2018, Dr. Lough was awarded:
|
|
●
|
cash
bonuses totaling $1,010,000,
|
|
|
●
|
restricted
stock units representing the right to receive a total of 105,000 shares of common stock that vest in four equal installments
every six months beginning six months following the grant date, and
|
|
|
●
|
options
to purchase 400,000 common shares at an exercise price of $24.59 and 195,000 common shares at an exercise price of
$20.12, both exercisable for a term of 10 years that vest in 24 equal monthly installments beginning one month after the grant
date.
|
Dr.
Lough, if terminated while not in material breach of the agreement, shall also have the right to participation payments paid to
the Company (or any affiliate) from commercial transactions associated with U.S. Patent Application No. 14/954,335 and PCT International
Patent Application No. PCT/US2015/063114, and any and all patents and patent applications, whether domestic or foreign, claiming
priority thereto or arising therefrom, and intellectual property rights associated with the patents (sales or licenses to third
parties).
Edward
Swanson’s Employment Agreement
We
have a written employment agreement with Dr. Swanson dated November 10, 2017. We paid Dr. Swanson a bonus of $100,000 when we
signed the agreement. The agreement has an initial term of two years and automatically renews for successive one-year periods
unless either party provides the other party with written notice of his or its intention not to renew at least three months prior
to the expiration of the current term.
Dr.
Swanson’s base salary is $400,000 per year. He is eligible to receive a bonus in the amount of 100% of annual salary, as
may be determined from time to time by the Board of Directors in its discretion, and is eligible to participate in any equity-
based incentive compensation plan or program we adopt. During 2018, Dr. Swanson was awarded:
|
|
●
|
cash
bonuses totaling $650,000,
|
|
|
●
|
restricted
stock units representing the right to receive a total of 35,000 shares of common stock that vest in four equal installments
every six months beginning six months following the grant date, and
|
|
|
●
|
options
to purchase 100,000 common shares at an exercise price of $24.59 and 65,000 common shares at an exercise price of $20.12,
both exercisable for a term of 10 years that vest in 24 equal monthly installments beginning one month after the grant date.
|
Paul
E. Mann’s Employment Agreement
Mr.
Mann’s employment agreement (the “Mann Agreement”) provides for an annual base salary of $400,000 and a discretionary
annual bonus up to 100% of his base salary as determined at the discretion of the board of directors. Mr. Mann was granted options
under the Company’s 2017 Equity Incentive Plan to purchase 350,000 and 21,666 shares of the Company common stock at a price
equal to fair value as determined under the Plan exercisable over a period of 10 years, which vests subject to continued employment
in 24 equal monthly installments beginning one month after the effective date of his engagement, and restricted stock awards equivalent
to 100,000 and 11,667 shares of Company common stock that vests, subject to continued employment, in four installments every six
months beginning on the date six months following the effective date of his engagement. At the discretion of the Board, Mr. Mann
may be granted additional equity compensation awards. Mr. Mann is also entitled to certain payments and benefits if the Company
terminates his employment without “cause” or he terminates his employment for “good reason”. Benefits
are also provided if Mr. Mann is terminated because of a change in control. The benefit levels under the employment agreements
generally include continued payment of base salary, a bonus for the year of termination, accelerated vesting of equity awards
and continued welfare benefits, and are described in more detail under the “Potential Payments Upon Termination or Change-In-Control”
below. Mr. Mann is entitled to participate in the Company’s insurance and benefit plans on the same basis as other employees
of the Company.
Potential
Payments Upon Termination or Change-In-Control
Under
our employment agreements with Dr. Lough, Dr. Swanson, and Mr. Mann, we are obligated to make payments or provide benefits to
them in the event of a termination of employment or a change of control. If employment of one of these officer is terminated for
any reason, then the officer is entitled to receive:
|
|
●
|
the
sum of his then base salary from the date of termination,
|
|
|
●
|
reasonable
expenses incurred by the officer relating to the performance of his duties,
|
|
|
●
|
accrued
but unused vacation time through the date of termination,
|
|
|
●
|
the
sum of his then annual bonus, and
|
|
|
●
|
all
equity awards earned and vested prior to the date of termination.
|
Furthermore,
if the officer is terminated for any reason other than “cause,” by the officer for “good reason,” or because
of a change in control, then the officer is entitled to receive the greater of:
|
|
●
|
a
cash amount equal to the sum of the officer’s base salary, annual bonus, and equity awards earned during the year immediately
preceding the date of termination, or
|
|
|
●
|
the
amount payable (including base salary, annual bonus, and equity awards) for the remainder of the term of the employment agreement;
|
subject
to the officer delivering to us a written release agreement.
Under
the agreements, “cause” means: the willful and continued failure of the officer to perform substantially his duties
and responsibilities (other than due to death or disability) and such failure is not cured within 30 days following a written
demand for performance; conviction of, or plea of guilty or
nolo contendere
to, a felony; or fraud, dishonesty, or gross
misconduct that is materially and demonstratively injurious to the Company. “Good reason” means the occurrence of
any of the following events without the officer’s consent: the assignment to the officer of duties that are significantly
different from, or that result in a substantial diminution of, the duties that he assumed on at the beginning of the employment
agreement; the assignment to the officer of a title that is different from and subordinate to the title at the beginning of the
employment agreement; or material breach of the employment agreement by the Company. Should the officer be required to serve in
a diminished capacity in a division or unit of another entity (including the acquiring entity), after a change in control, such
event constitutes good reason regardless of the title of the officer.
Dr.
Lough, if terminated while not in material breach of his employment agreement, is entitled to receive participation payments on
amounts paid to us from commercial transactions associated with U.S. Patent Application No. 14/954,335, and PCT International
Patent Application No. PCT/US2015/063114, and any and all patents and patent applications, whether domestic or foreign, claiming
priority thereto or arising therefrom, and intellectual property rights associated with the patents, such as sales or licenses
to third parties.
Outstanding
Equity Awards at Fiscal Year-End
The
following table shows grants of stock options and grants of unvested stock awards outstanding on the last day of the fiscal year
ended October 31, 2018, to each of the executive officers named in the Summary Compensation Table.
|
|
|
Option
Awards
|
|
Stock
Awards
|
|
|
Name
|
|
Option
Grant
Date
|
|
Number
of Securities Underlying Unexercised Options Exercisable (#)(1)
|
|
|
Number
of Securities Underlying Unexercised Options Unexercisable (#)(1)
|
|
|
Option
Exercise Price
($)
|
|
|
Option
Expiration
Date
|
|
Number
of
Shares or
Units
of Stock
That
Have
Not
Vested
(#)
|
|
|
Market
Value of Shares or Units of Stock That Have Not Vested
($)(2)
|
|
|
Denver
|
|
11-30-2016
|
|
|
958,333
|
|
|
|
41,667
|
|
|
$
|
3.15
|
|
|
11-30-2026
|
|
|
105,000
|
|
|
$
|
1,600,200
|
|
|
Lough
|
|
11-10-2017
|
|
|
183,333
|
|
|
|
216,667
|
|
|
$
|
24.59
|
|
|
11-10-2027
|
|
|
-
|
|
|
|
-
|
|
|
|
|
9-20-2018
|
|
|
8,125
|
|
|
|
186,875
|
|
|
$
|
20.12
|
|
|
9-20-2028
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Edward
|
|
11-30-2016
|
|
|
810,750
|
|
|
|
35,250
|
|
|
$
|
3.15
|
|
|
11-30-2026
|
|
|
35,000
|
|
|
$
|
533,400
|
|
|
Swanson
|
|
11-10-2017
|
|
|
45,833
|
|
|
|
54,167
|
|
|
$
|
24.59
|
|
|
11-10-2027
|
|
|
-
|
|
|
|
-
|
|
|
|
|
9-20-2018
|
|
|
2,708
|
|
|
|
62,292
|
|
|
$
|
20.12
|
|
|
9-20-2028
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Paul
E.
|
|
6-20-2018
|
|
|
58,333
|
|
|
|
291,667
|
|
|
$
|
31.88
|
|
|
6-20-2028
|
|
|
100,000
|
|
|
$
|
1,524,000
|
|
|
Mann
|
|
9-20-2018
|
|
|
903
|
|
|
|
20,763
|
|
|
$
|
20.12
|
|
|
9-20-2028
|
|
|
11,667
|
|
|
$
|
177,805
|
|
|
(1)
|
All
stock option listed vest in 24 monthly installments beginning one month following the grant date.
|
|
(2)
|
Market
value based on closing stock price of $15.24 on October 31, 2018
|
The
following table shows grants of stock options and grants of unvested stock awards outstanding on the last day of the two-month
period ended December 31, 2018, to each of the executive officers named in the Summary Compensation Table.
|
|
|
Option
Awards
|
|
Stock
Awards
|
|
|
Name
|
|
Option
Grant Date
|
|
Number
of Securities Underlying Unexercised Options Exercisable (#)(1)
|
|
|
Number
of Securities Underlying Unexercised Options Unexercisable (#)(1)
|
|
|
Option
Exercise Price
($)
|
|
|
Option
Expiration
Date
|
|
Number
of
Shares or
Units
of Stock
That
Have
Not
Vested
(#)
|
|
|
Market
Value of Shares or Units of Stock That Have Not Vested
($)(2)
|
|
|
Denver
|
|
11-30-2016
|
|
|
1,000,000
|
|
|
|
-
|
|
|
$
|
3.15
|
|
|
11-30-2026
|
|
|
105,000
|
|
|
$
|
1,416,450
|
|
|
Lough
|
|
11-10-2017
|
|
|
216,667
|
|
|
|
183,333
|
|
|
$
|
24.59
|
|
|
11-10-2027
|
|
|
-
|
|
|
|
-
|
|
|
|
|
9-20-2018
|
|
|
24,375
|
|
|
|
170,625
|
|
|
$
|
20.12
|
|
|
9-20-2028
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Edward
|
|
11-30-2016
|
|
|
846,000
|
|
|
|
-
|
|
|
$
|
3.15
|
|
|
11-30-2026
|
|
|
35,000
|
|
|
$
|
472,150
|
|
|
Swanson
|
|
11-10-2017
|
|
|
54,167
|
|
|
|
45,833
|
|
|
$
|
24.59
|
|
|
11-10-2027
|
|
|
-
|
|
|
|
-
|
|
|
|
|
9-20-2018
|
|
|
8,125
|
|
|
|
56,875
|
|
|
$
|
20.12
|
|
|
9-20-2028
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Paul
E.
|
|
6-20-2018
|
|
|
87,500
|
|
|
|
262,500
|
|
|
$
|
31.88
|
|
|
6-20-2028
|
|
|
75,000
|
|
|
$
|
1,011,750
|
|
|
Mann
|
|
9-20-2018
|
|
|
2,708
|
|
|
|
18,958
|
|
|
$
|
20.12
|
|
|
9-20-2028
|
|
|
11,667
|
|
|
$
|
157,388
|
|
|
(1)
|
All
stock option listed vest in 24 monthly installments beginning one month following the grant date.
|
|
(2)
|
Market
value based on closing stock price of $13.49 on December 31, 2018
|
Director
Compensation
The
following table shows the total compensation paid or accrued during the fiscal year ended October 31, 2018, to each of our directors,
current and former.
|
Name
|
|
Fees
Earned
or
Paid
in Cash
($)
|
|
|
Stock
Awards
($)(1)
|
|
|
Option
Awards
($)(1)
|
|
|
All
Other
Compensation
($)
|
|
|
Total
($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steve Gorlin
|
|
|
38,000
|
|
|
|
119,500
|
(2)
|
|
|
82,225
|
(6)
|
|
|
-0-
|
|
|
|
239,775
|
|
|
Jeff Dyer
|
|
|
45,000
|
|
|
|
119,500
|
(2)
|
|
|
82,225
|
(6)
|
|
|
-0-
|
|
|
|
246,775
|
|
|
Jon Mogford
|
|
|
40,000
|
|
|
|
119,500
|
(2)
|
|
|
82,225
|
(6)
|
|
|
-0-
|
|
|
|
241,775
|
|
|
Willie C. Bogan
|
|
|
20,000
|
|
|
|
777,300
|
(3)
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
797,300
|
|
|
Peter A. Cohen
|
|
|
10,000
|
|
|
|
706,200
|
(4)
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
716,200
|
|
|
Rainer Erdtmann
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
800,542
|
(7)
|
|
|
-0-
|
|
|
|
800,542
|
|
|
David Seaburg
|
|
|
-0-
|
|
|
|
1,347,600
|
(5)
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
1,347,600
|
|
|
Minnie Baylor-Henry(8)
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
-0-
|
|
(1)
The figures in these columns represent the aggregate grant date fair value for restricted stock and option awards, respectively,
granted during fiscal years 2018 and 2017 computed in accordance with FASB ASC Topic 718. See Note 12 to our consolidated financial
statements presented in this Annual Report for details as to the assumptions used to determine the grant date fair value of the
restricted stock and option awards.
(2)
Represents 5,000 shares at a grant date fair value of $23.91 per common share.
(3)
Represents 30,000 shares at a grant date fair value of $25.91 per common share.
(4)
Represents 30,000 shares at a grant date fair value of $23.54 per common share.
(5)
Represents 60,000 shares at a grant date fair value of $22.46 per common share.
(6)
Represents stock options to purchase 5,000 common shares at an exercise price of $24.59 per common share.
(7)
Represents stock options to purchase 50,000 common shares at an exercise price of $20.47 per common share.
(8)
Minnie Baylor-Henry became a director in December 2018. At that time, she received the initial director compensation previously
approved by resolution of the Board in September 2018 for all new directors. The compensation included a grant to her of 8,975
restricted stock units for an equal number of common shares that vest in three annual installments commencing December 10, 2019,
subject to continued service as a director, and an option to purchase 19,329 shares of the Company’s common stock exercisable
over a term of 10 years that vest in three annual installments commencing December 10, 2019, subject to continued service as a
director. The restricted stock units and option were issued under the Company’s 2019 Equity Incentive Plan, and the option
exercise price is $13.65 per share, which is fair value determined under the Plan. The fair value of the compensation determined
in accordance with FASB ASC Topic 718 is $350,000. Ms. Baylor-Henry will also be entitled to participate in the annual compensation
package the Company provides to its non-employee directors.
The
following table shows the total compensation paid or accrued during two-month period ended December 31, 2018, to each of our directors,
current and former.
|
Name
|
|
Fees
Earned
or
Paid
in Cash
($)
|
|
|
Stock
Awards
($)(1)
|
|
|
Option
Awards
($)(1)
|
|
|
All
Other
Compensation
($)
|
|
|
Total
($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steve Gorlin
|
|
|
10,000
|
|
|
|
58,853
|
(2)
|
|
|
90,027
|
(4)
|
|
|
-0-
|
|
|
|
158,880
|
|
|
Jeff Dyer
|
|
|
10,167
|
|
|
|
58,853
|
(2)
|
|
|
90,027
|
(4)
|
|
|
-0-
|
|
|
|
159,047
|
|
|
Jon Mogford
|
|
|
9,500
|
|
|
|
-0-
|
|
|
|
138,507
|
(5)
|
|
|
-0-
|
|
|
|
148,007
|
|
|
Willie C. Bogan
|
|
|
9,167
|
|
|
|
58,853
|
(2)
|
|
|
90,027
|
(4)
|
|
|
-0-
|
|
|
|
158,047
|
|
|
Peter A. Cohen
|
|
|
9,000
|
|
|
|
58,853
|
(2)
|
|
|
90,027
|
(4)
|
|
|
-0-
|
|
|
|
157,880
|
|
|
Rainer Erdtmann
|
|
|
10,833
|
|
|
|
-0-
|
|
|
|
138,507
|
(5)
|
|
|
-0-
|
|
|
|
149,340
|
|
|
David Seaburg
|
|
|
7,500
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
7,500
|
|
|
Minnie Baylor-Henry
|
|
|
2,823
|
|
|
|
127,176
|
(3)
|
|
|
195,996
|
(6)
|
|
|
-0-
|
|
|
|
325,995
|
|
(1)
The figures in these columns represent the aggregate grant date fair value for restricted stock and option awards, respectively,
granted during the two months ended December 31, 2018 computed in accordance with FASB ASC Topic 718. See Note 12 to our consolidated
financial statements presented in this Annual Report for details as to the assumptions used to determine the grant date fair value
of the restricted stock and option awards.
(2)
Represents 4,020 shares at a grant date fair value of $14.64 per common share.
(3)
Represents 8,975 shares at a grant date fair value of $14.17 per common share.
(4)
Represents stock options to purchase 8,624 common shares at an exercise price of $15.24 per common share.
(5)
Represents stock options to purchase 13,268 common shares at an exercise price of $15.24 per common share.
(6)
Represents stock options to purchase 19,329 common shares at an exercise price of $13.65 per common share.
During
the fiscal year ended October 31, 2018, our non-employee directors were compensated in accordance with the following terms.
|
|
●
|
Each
non-employee director receives a quarterly cash retainer of $10,000. The Company’s Audit Committee Chairman receives
a $15,000 annual Service Fee, the Compensation Committee Chairman receives a $10,000 annual service fee, and the Nominating
and Corporate Governance Committee Chairman receives an $8,000 annual service fee.
|
|
|
●
|
Each
non-employee director is entitled to receive 10-year options under the Company equity incentive plan to purchase that number
of shares of the Company’s Common Stock valued at $150,000, calculated by dividing $150,000 by the Black-Scholes value
of the stock options based on the closing stock price the day the stock options are awarded.
|
|
|
●
|
Each
non-employee director is entitled to a fee of $1,500 for each Board of Directors meeting at which the director is present
in person, and each member of our Board committees is entitled to a fee of $800 for each committee meeting at which the director
is present in person. Each non-employee director is entitled to a fee of $500 for each teleconference called by either the
Chairman of the Board of Directors, the President of the Company or the Chairman of a Board of Directors committee.
|
Effective
November 1, 2018, non-employee directors will be compensated as follows:
|
|
●
|
Each
non-employee director receives an annual cash retainer of $45,000 paid quarterly;
|
|
|
●
|
Our
Audit Committee Chairman will receive an annual fee of $20,000, our Compensation Committee Chairman will receive an annual
fee of $15,000, and our Nominating and Governance Committee Chairman will receive an annual fee of $10,000;
|
|
|
●
|
Non-chair
members of our Audit Committee will receive an annual fee of $9,000, of our Compensation Committee will receive an annual
fee of $7,000, and of our Nominating and Governance Committee Chairman will receive an annual fee of $5,000; and
|
|
|
●
|
Each
non-employee director is entitled to receive an annual equity award with a value of $175,000 determined under the Black-Scholes
formula, which may be issued entirely in stock options exercisable over 10 Years that vest, subject to continuing service,
in 12 monthly installments beginning one month after the grant date, or 65% in stock options and 35% restricted stock units
that vest, subject to continuing service, in a lump sum one year after the grant date.
|
David
Seaburg
In
August 2018 David Seaburg was elected by the Board of Directors to serve as a director of the Company. Subsequently the Company
entered into a written consulting agreement with Mr. Seaburg pursuant to which he agreed to provide investor relations and other
services to the Company over a period of two years for a fee consisting of (i) quarter-annual cash payment of $10,000, (ii) 60,000
restricted stock units issued under the Company equity incentive plan that vest in four equal installments every six months during
the term of the agreement subject to continued service, and (iii) an annual award under the Company equity incentive plan of options
exercisable over a term of 10 years to purchase common stock in number equal to the number of shares of common stock with a value
of $150,000 at the time of the award based on a Black-Scholes calculation. The agreement terminated effective March 11, 2019,
when he joined the Company as President of Corporate Development.
The
new employment agreement with Mr. Seaburg effective in March 2019 is for a term of one year beginning, and automatically renews
for successive one-year periods unless either party elects to terminate the agreement by notice to the other party given not less
than three months prior to the end of the then current term. The annual base salary under the agreement is $325,000 and will be
increased (but may not be decreased) on each anniversary of the date during the employment term by a percentage equal to the greater
of (i) a percentage increase determined by the board of directors, or (ii) a percentage increase (if any) of the Consumer Price
Index for All Urban Consumers. Mr. Seaburg is eligible for an annual bonus of up to 40% of his base salary as determined at the
discretion of the board of directors. Mr. Seaburg was also granted under the Company’s 2019 Equity Incentive Plan an option
to purchase 250,000 shares of Company common stock at a price of $16.50 per share, which vests subject to continued employment
in 24 equal monthly installments beginning April 1, 2018, and a restricted stock award representing the right to receive a total
of 40,000 shares of common stock that vests, subject to continued employment, in four installments every six months beginning
on September 1, 2019. Mr. Seaburg is entitled to participate in the Company’s insurance and benefit plans on the same basis
as other employees of the Company.
Item
12 - Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The
following table sets forth information regarding the beneficial ownership of our common stock as of March 7, 2019, by
|
|
●
|
each
person known to us to be the beneficial owner of more than 5% of the common stock,
|
|
|
●
|
each
of our current directors,
|
|
|
●
|
each
officer named in the Summary Compensation Table presented in Item 11, above, and
|
|
|
●
|
all
our directors and executive officers as a group.
|
The
number of shares of common stock beneficially owned by each person is determined under applicable SEC rules. Under such rules,
beneficial ownership includes any shares as to which the person has sole or shared voting power or investment power, and any shares
that the person has the right to acquire within 60 days of the date as of which the beneficial ownership determination is made.
Applicable percentages are based upon 21,688,858 voting shares issued and outstanding as of March 7, 2019 and treating any shares
that the holder has the right to acquire within 60 days as outstanding for purposes of computing their percent ownership. Except
as otherwise indicated, each of the stockholders listed below has sole voting and investment power over the shares beneficially
owned, subject to community property laws where applicable, and addresses are c/o PolarityTE, Inc., 123 Wright Brothers Drive,
Salt Lake City, Utah 84116.
|
|
|
Number
of Shares of Common Stock Beneficially Owned
|
|
|
Percentage
of
Common
Stock
|
|
|
Executive Officers
and Directors (1):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denver Lough (2)
|
|
|
8,936,746
|
|
|
|
38.79
|
|
|
Edward Swanson
|
|
|
942,434
|
|
|
|
4.20
|
|
|
Paul Mann
|
|
|
190,514
|
|
|
|
0.87
|
|
|
Cameron Hoyler
|
|
|
232,708
|
|
|
|
1.10
|
|
|
Steve Gorlin
|
|
|
112,645
|
|
|
|
0.52
|
|
|
Jon Mogford
|
|
|
114,967
|
|
|
|
0.53
|
|
|
Jeff Dyer
|
|
|
161,197
|
|
|
|
0.74
|
|
|
Willie C. Bogan
|
|
|
11,812
|
|
|
|
0.05
|
|
|
Peter A. Cohen
|
|
|
61,812
|
|
|
|
0.28
|
|
|
Rainer Erdtmann (3)
|
|
|
169,564
|
|
|
|
0.78
|
|
|
David Seaburg
|
|
|
45,833
|
|
|
|
0.21
|
|
|
Minnie Baylor-Henry
|
|
|
-0-
|
|
|
|
|
|
|
Executive Officers
and Directors as a Group (12 persons)
|
|
|
10,980,232
|
|
|
|
43.71
|
|
|
|
|
|
|
|
|
|
|
|
|
Greater that 5%
Holders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Barry Honig (2)(4)
555 S. Federal
Hwy, #450, Boca Raton, FL 33432
|
|
|
1,502,609
|
|
|
|
6.93
|
|
|
|
|
|
|
|
|
|
|
|
Michael Brauser (5)
4400 Biscayne
Blvd., Suite 850, Miami, FL 33137
|
|
|
1,448,168
|
|
|
|
6.68
|
|
(1) Includes the following number of shares
of options that were exercisable or restricted share awards expected to vest within 60 days of March 7, 2019: Dr. Lough,
1,349,792; Dr. Swanson 940,375; Mr. Mann, 155,069; Mr. Hoyler, 142,708; Mr. Gorlin, 57,645; Dr. Mogford,
59,967; Mr. Dyer, 133,645; Mr. Bogan, 4,312; Mr. Cohn, 4,312; Mr. Erdtmann, 25,384; and Mr. Seaburg, 20,833.
(2)
Denver Lough was granted an irrevocable proxy to vote 536,954 common shares held by affiliates of Barry Honig pursuant to the
Exchange Agreement dated March 6, 2018, between the Company and certain stockholders, including the affiliates of Barry Honig.
The 536,954 shares over which Dr. Lough holds voting rights are included in the total number of shares of common stock he beneficially
holds, but he disclaims any dispositive power or pecuniary interest with respect to those shares. The 536,954 shares are also
included in the total number of shares of common stock beneficially held by Mr. Honig.
(3)
Includes 94,180 shares owned by Point Sur Investors Fund I. Mr. Erdtmann is Managing Director and General Partner of Point Sur
Investors LLC, the general partner of Point Sur Investors Fund I, and as a result may be deemed to have shared voting and investment
control over the shares held by Point Sur Investors Fund I.
(4)
The stock information for Mr. Honig is based on information contained in an amendment to Schedule 13G filed with the Securities
and Exchange Commission on January 22, 2019.
(5)
The stock information for Mr. Brauser is based on information contained in an amendment to Schedule 13G filed with the Securities
and Exchange Commission on February 21, 2019.
Item
13 - Certain Relationships and Related Transactions and Director Independence.
Director
Independence
Our
Board is currently comprised of nine members. The Board has reviewed the materiality of any relationship that each of our directors
has with the Company, either directly or indirectly. Based upon this review, the Board has determined that Steve Gorlin, Jeff
Dyer, Dr. Jon Mogford, Willie C. Bogan, Peter A. Cohen, Rainer Erdtmann and Minnie Baylor-Henry are “independent directors”
as defined by the rules of The NASDAQ Stock Market.
Certain
Relationships and Related Transactions
In
October 2018, we entered into an office lease covering approximately 7,250 square feet of rental space in the building located
at 40 West 57
th
Street in New York City. The lease is for a term of three years. The annual lease rate is $60 per square
foot. Initially we will occupy and pay for only 3,275 square feet of space, and we are not obligated under the lease to pay for
the remaining 3,975 square feet covered by the lease unless we elect to occupy that additional space. Comparable annual lease
rates for similar office space in the area range between $67 and $110 per square foot. We believe the terms of the lease are very
favorable to us, and we obtained these favorable terms through the efforts of Peter A. Cohen, a director, which he provided so
that the company he owns, Peter A. Cohen, LLC (“Cohen LLC”), could sublease a portion of the office space.
Initially,
we are using three offices and two work stations in the office and share common areas representing approximately 2,055 square
feet. Cohen LLC is using approximately 1,220 square feet. The monthly lease payment for 3,275 square feet is $16,377. Of this
amount $6,103 is allocated pro rata to Cohen LLC based on square footage occupied. Additional lease charges for operating expenses
and taxes are allocated under the sublease based on the ratio of rent paid by us and Cohen LLC to total rent.
Cohen
LLC identified two associated entities that may wish to occupy an additional 2,753 square feet of space in the office. Under the
terms of the sublease Cohen LLC can add this additional space to the 1,220 square feet occupied, which would bring the total space
occupied by us and Cohen LLC to 6,028 square feet. Because a portion of the additional space subleased to Cohen LLC is less private
and attractive, we agreed to reduce the overall annual lease rate for the Cohen LLC space to $58.60 per square foot, which means
we will be paying an annual lease rate for the space we use of $62.70. Assuming Cohen LLC subleases the additional office space,
our annual lease payment to the lessor would be $361,680, and Cohen LLC would pay to us $232,830 under the sublease.
Item
14 - Principal Accountant Fees and Services.
The
following table sets forth the fees billed by EisnerAmper LLP (“EisnerAmper”), for each of our last two fiscal years
and the two-month period ended December 31, 2019, for the categories of services indicated.
|
|
|
Two
Months Ended
12/31/18
($)
|
|
2018
($)
|
|
|
2017
($)
|
|
|
Audit
Fees
|
|
285,200
|
|
|
485,210
|
|
|
|
198,540
|
|
|
Audit
Related Fees
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
Tax
Fees
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
Other
Fees
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
Total
Fees
|
|
285,200
|
|
|
485,210
|
|
|
|
198,540
|
|
Audit
fees consist of fees billed for professional services rendered for the audit of our financial statements and review of interim
consolidated financial statements included in quarterly reports and services that are normally provided by the principal accountants
relating to statutory and regulatory filings or engagements.
Audit
related fees consist of fees billed for assurance and related services that are reasonably related to the performance of the audit
or review of our consolidated financial statements and are not included in audit fees.
Tax
fees consist of fees billed for professional services for tax compliance, tax advice, and tax planning. These services include
preparation of federal and state income tax returns.
Other
fees consist of fees for product and services other than the services reported in the categories described above.
Audit
Committee Pre-Approval Policies and Procedures
Our
Audit Committee assists the Board in overseeing and monitoring the integrity of our financial reporting process, our compliance
with legal and regulatory requirements, and the quality of our internal and external audit processes. The role and responsibilities
of the Audit Committee are set forth in a written charter adopted by the Board, which is available on our website at
www.polarityte.com.
The Audit Committee is responsible for selecting, retaining, and determining the compensation of our independent public accountant,
approving the services they will perform, and reviewing the performance of the independent public accountant. The Audit Committee
reviews with management and our independent public accountant our annual financial statements on Form 10-K and our quarterly financial
statements on Forms 10-Q. The Audit Committee reviews and reassesses the charter annually and recommends any changes to the Board
for approval. The Audit Committee is responsible for overseeing our overall financial reporting process. In fulfilling its responsibilities
for the financial statements for fiscal year 2018, the Audit Committee took the following actions:
|
|
●
|
reviewed
and discussed the audited financial statements for the fiscal year ended October 31, 2018, with management and EisnerAmper;
|
|
|
|
|
|
|
●
|
discussed
with EisnerAmper the matters required to be discussed in accordance with the rules set forth by the Public Company Accounting
Oversight Board (“PCAOB”), relating to the conduct of the audit;
|
|
|
|
|
|
|
●
|
received
written disclosures and the letter from EisnerAmper regarding its independence as required by applicable requirements of the
PCAOB regarding EisnerAmper’s communications with the Audit Committee and the Audit Committee further discussed with
EisnerAmper its independence; and
|
|
|
|
|
|
|
●
|
considered
the status of pending litigation, taxation matters, and other areas of oversight relating to the financial reporting and audit
process that the Audit Committee determined appropriate.
|
Our
Audit Committee approved all services that our independent accountants provided to us in the past two fiscal years.
POLARITYTE,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(in
thousands)
|
|
|
For
the Two Months
Ended
December 31,
|
|
|
For
the Years Ended October 31,
|
|
|
|
|
2018
|
|
|
2018
|
|
|
2017
|
|
|
CASH FLOWS FROM OPERATING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(18,418
|
)
|
|
$
|
(65,441
|
)
|
|
$
|
(130,829
|
)
|
|
Loss from discontinued
operations
|
|
|
–
|
|
|
|
–
|
|
|
|
349
|
|
|
Loss from continuing operations
|
|
|
(18,418
|
)
|
|
|
(65,441
|
)
|
|
|
(130,480
|
)
|
|
Adjustments to reconcile net loss from
continuing operations to net cash used in continuing operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation
expense
|
|
|
8,946
|
|
|
|
38,821
|
|
|
|
16,627
|
|
|
Change in fair value
of derivatives
|
|
|
–
|
|
|
|
(3,814
|
)
|
|
|
(109
|
)
|
|
Depreciation and
amortization
|
|
|
330
|
|
|
|
1,394
|
|
|
|
432
|
|
|
Loss on extinguishment
of warrant liability
|
|
|
–
|
|
|
|
520
|
|
|
|
–
|
|
|
Amortization of
intangible assets
|
|
|
33
|
|
|
|
100
|
|
|
|
–
|
|
|
Amortization of
debt discount
|
|
|
10
|
|
|
|
35
|
|
|
|
–
|
|
|
Change in fair value
of contingent consideration
|
|
|
57
|
|
|
|
20
|
|
|
|
–
|
|
|
Other non-cash adjustments
|
|
|
86
|
|
|
|
–
|
|
|
|
–
|
|
|
Research and development
- intellectual property acquired
|
|
|
–
|
|
|
|
–
|
|
|
|
104,693
|
|
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
228
|
|
|
|
(940
|
)
|
|
|
–
|
|
|
Inventory
|
|
|
(98
|
)
|
|
|
(238
|
)
|
|
|
–
|
|
|
Prepaid expenses
and other current assets
|
|
|
(279
|
)
|
|
|
(911
|
)
|
|
|
(190
|
)
|
|
Other assets
|
|
|
(535
|
)
|
|
|
(378
|
)
|
|
|
–
|
|
|
Accounts payable
and accrued expenses
|
|
|
1,621
|
|
|
|
2,136
|
|
|
|
1,411
|
|
|
Deferred
revenue
|
|
|
20
|
|
|
|
150
|
|
|
|
–
|
|
|
Net cash used in
continuing operating activities
|
|
|
(7,999
|
)
|
|
|
(28,546
|
)
|
|
|
(7,616
|
)
|
|
Net
cash provided by discontinued operating activities
|
|
|
–
|
|
|
|
–
|
|
|
|
33
|
|
|
Net
cash used in operating activities
|
|
|
(7,999
|
)
|
|
|
(28,546
|
)
|
|
|
(7,583
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(834
|
)
|
|
|
(9,221
|
)
|
|
|
(2,544
|
)
|
|
Purchase of available-for-sale
securities
|
|
|
(10,200
|
)
|
|
|
–
|
|
|
|
–
|
|
|
Proceeds from maturities
of available-for-sale securities
|
|
|
4,003
|
|
|
|
–
|
|
|
|
–
|
|
|
Acquisition
of IBEX
|
|
|
–
|
|
|
|
(2,258
|
)
|
|
|
–
|
|
|
Net cash used in
continuing investing activities
|
|
|
(7,031
|
)
|
|
|
(11,479
|
)
|
|
|
(2,544
|
)
|
|
Net
cash provided by discontinued investing activities
|
|
|
10
|
|
|
|
60
|
|
|
|
25
|
|
|
Net
cash used in investing activities
|
|
|
(7,021
|
)
|
|
|
(11,419
|
)
|
|
|
(2,519
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal payments
on note payable
|
|
|
(257
|
)
|
|
|
–
|
|
|
|
–
|
|
|
Proceeds from stock
options exercised
|
|
|
–
|
|
|
|
687
|
|
|
|
1,301
|
|
|
Net proceeds from
the sale of preferred stock and warrants
|
|
|
–
|
|
|
|
–
|
|
|
|
17,667
|
|
|
Net proceeds from
the sale of common stock
|
|
|
–
|
|
|
|
92,676
|
|
|
|
2,278
|
|
|
Payment of contingent
consideration liability
|
|
|
–
|
|
|
|
(30
|
)
|
|
|
–
|
|
|
Payments
on capital leases
|
|
|
(11
|
)
|
|
|
(74
|
)
|
|
|
–
|
|
|
Net
cash (used in)/provided by financing activities
|
|
|
(268
|
)
|
|
|
93,259
|
|
|
|
21,246
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease)/increase in cash and
cash equivalents
|
|
|
(15,288
|
)
|
|
|
53,294
|
|
|
|
11,144
|
|
|
Cash and cash
equivalents - beginning of period
|
|
|
70,961
|
|
|
|
17,667
|
|
|
|
6,523
|
|
|
Cash and cash
equivalents - end of period
|
|
$
|
55,673
|
|
|
$
|
70,961
|
|
|
$
|
17,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental schedule
of non-cash investing and financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of Series
A preferred stock to common stock
|
|
$
|
–
|
|
|
$
|
769
|
|
|
$
|
976
|
|
|
Conversion of Series
B preferred stock to common stock
|
|
$
|
–
|
|
|
$
|
4,020
|
|
|
$
|
549
|
|
|
Conversion of Series
C preferred stock to common stock
|
|
$
|
–
|
|
|
$
|
201
|
|
|
$
|
1,809
|
|
|
Conversion of Series
D preferred stock to common stock
|
|
$
|
–
|
|
|
$
|
312
|
|
|
$
|
1,517
|
|
|
Conversion of Series
E preferred stock to common stock
|
|
$
|
–
|
|
|
$
|
104,693
|
|
|
$
|
–
|
|
|
Exchange of Series
F preferred stock for common stock
|
|
$
|
–
|
|
|
$
|
13,061
|
|
|
$
|
–
|
|
|
Extinguishment of
warrant liability
|
|
$
|
–
|
|
|
$
|
2,525
|
|
|
$
|
–
|
|
|
Unpaid liability
for acquisition of property and equipment
|
|
$
|
600
|
|
|
$
|
300
|
|
|
$
|
54
|
|
|
Warrants exchanged
for common stock shares
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
78
|
|
|
Establishment of
warrant liability in connection with Series F Preferred Stock issuance
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
4,299
|
|
|
Establishment of
derivative liability in connection with Series F Preferred Stock issuance
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
9,319
|
|
|
Deemed dividend
– accretion of discount on Series F preferred stock
|
|
$
|
–
|
|
|
$
|
1,290
|
|
|
$
|
369
|
|
|
Cumulative dividends
on Series F preferred stock
|
|
$
|
–
|
|
|
$
|
373
|
|
|
$
|
124
|
|
|
Series F preferred
stock dividends paid in common stock
|
|
$
|
–
|
|
|
$
|
306
|
|
|
$
|
–
|
|
|
Contingent consideration
for IBEX acquisition
|
|
$
|
–
|
|
|
$
|
278
|
|
|
$
|
–
|
|
|
Contingent consideration
earned and recorded in accounts payable
|
|
$
|
31
|
|
|
$
|
33
|
|
|
$
|
–
|
|
|
Note payable issued
as partial consideration for IBEX acquisition
|
|
$
|
–
|
|
|
$
|
1,220
|
|
|
$
|
–
|
|
|
Property and equipment
additions through capital leases
|
|
$
|
20
|
|
|
$
|
251
|
|
|
$
|
–
|
|
|
Unpaid tax liability
related to net share settlement of restricted stock units
|
|
$
|
155
|
|
|
$
|
–
|
|
|
$
|
–
|
|
|
Unrealized gain
on short-term investments and cash equivalents
|
|
$
|
36
|
|
|
$
|
–
|
|
|
$
|
–
|
|
The
accompanying notes are an integral part of these consolidated financial statements
POLARITYTE,
INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
1.
PRINCIPAL BUSINESS ACTIVITY AND BASIS OF PRESENTATION
PolarityTE,
Inc. and subsidiaries (the “Company”) is a commercial-stage biotechnology and regenerative biomaterials company focused
on transforming the lives of patients by discovering, designing and developing a range of regenerative tissue products and biomaterials
for the fields of medicine, biomedical engineering and material sciences.
Change
in Fiscal Year end.
On January 11, 2019, the Board approved an amendment to the Restated Bylaws of the Company changing the
Company’s fiscal year end from October 31 to December 31. The Company made this change to align its fiscal year end with
other companies within its industry. The change in the Company’s fiscal year end resulted in a two-month transition period
that began on November 1, 2018 and ended on December 31, 2018. Reference to a fiscal year refers to the twelve months ended October
31, which has historically been the end of the Company’s fiscal year.
Asset
Acquisition and Name Change.
On December 1, 2016
,
Majesco Entertainment Company (
n/k/a
PolarityTE, Inc.), a
Delaware corporation entered into an agreement to acquire the assets of Polarity NV, a regenerative medicine company. The asset
acquisition was subject to shareholder approval, which was received on March 10, 2017 and the transaction closed on April 7, 2017,
as more fully described below. In January 2017, the Company changed its name to “PolarityTE, Inc.”
On
April 7, 2017, the Company issued 7,050 shares of its newly authorized Series E Preferred Stock (the “Series E Preferred
Shares”) to Dr. Denver Lough, the developer of the Company’s tissue regeneration technology who became the Company’s
Chief Executive Officer, for the purchase of Polarity NV’s assets. The Series E Preferred Stock was convertible into an
aggregate of 7,050,000 shares of the Company’s common stock with a fair value of approximately $104.7 million based on the
closing price of the Company’s common stock as of April 7, 2017. Since the assets purchased were in-process research and
development assets with no alternative future use, the total purchase price was immediately expensed as research and development
- intellectual property acquired.
The
Company adopted ASU 2017-01,
Business Combinations (Topic 805), Clarifying the Definition of a Business
, during the first
quarter of fiscal 2017. In accordance with ASU 2017-01 the Company analyzed the above transaction noting that substantially all
the fair value of the gross assets acquired were concentrated in a single intellectual property asset and Polarity NV had no employees
on the acquisition date. The Company further considered that Polarity NV’s intellectual property did not generate any revenue
and never had any employees or workforce. In December 2016, the Company established a clinical advisory board and added three
members in December 2016 and three more in January 2017. Establishing the clinical advisory board and hiring a COO are critical
to establishing a workforce that has the knowledge and experience to obtain regulatory approval of the Company’s intellectual
property. Therefore, the acquisition of an intellectual property asset and no employees from Polarity NV on April 7, 2017 did
not represent the acquisition of an organized workforce with the necessary skills and experience to create outputs and, therefore,
did not represent a business combination.
Discontinued
Operations.
On June 23, 2017, the Company sold Majesco Entertainment Company, a Nevada corporation and wholly-owned subsidiary
of the Company (“Majesco Sub”) to Zift Interactive LLC (“Zift”), a Nevada limited liability company pursuant
to a purchase agreement. Pursuant to the terms of the agreement, the Company sold 100% of the issued and outstanding shares of
common stock of Majesco Sub to Zift, including all of the right, title and interest in and to Majesco Sub’s business of
developing, publishing and distributing video game products through mobile and online digital downloading. Pursuant to the terms
of the agreement, the Company will receive total cash consideration of approximately $100,000 ($5,000 upon signing the agreement
and 19 additional monthly payments of $5,000) plus contingent consideration based on net revenues with a fair value of $0. As
of December 31, 2018, the Company has received $95,000 in cash consideration, of which $5,000 remains receivable and is included
in prepaid expenses and other current assets.
In
May 2018, the Company purchased the assets of a preclinical research sciences business and related real estate from Ibex Group,
L.L.C., a Utah limited liability company, and Ibex Preclinical Research, Inc., a Utah corporation (collectively, “IBEX”).
The Company acquired these assets to accelerate research and development of its TE product candidates, and now operates the business
to advance its product development and deliver preclinical research services to third parties (see Note 4).
2.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Principles
of Consolidation.
The accompanying consolidated financial statements include the accounts of the Company and its wholly owned
subsidiaries. Significant intercompany accounts and transactions have been eliminated in consolidation.
Segments.
The Company’s operations are based in the United States and involve products and services which are managed separately.
Accordingly, it operates in two segments: 1) regenerative medicine products and 2) contract services. The Chief Operating Decision
Maker (CODM) is our Chief Executive Officer (CEO). The CODM allocates resources to and assesses the performance of each operating
segment using information about its revenue and operating income (loss). Prior to the acquisition of IBEX, the Company operated
in one segment.
Use
of estimates.
The preparation of financial statements in conformity with accounting principles generally accepted in the United
States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
or the disclosure of gain or loss contingencies at the date of the financial statements and the reported amounts of revenues and
expenses during the reporting periods. Among the more significant estimates included in these financial statements are the valuation
of warrant liability, valuation of derivative liability, extent of progress toward completion of contracts, stock-based compensation,
the valuation allowances for deferred tax benefits, and the valuation of tangible and intangible assets included in acquisitions.
Actual results could differ from those estimates.
Reclassifications.
Certain reclassifications have been made to our prior period financial statements to conform with the current period presentation.
On our consolidated balance sheet, we have combined the Receivable from Zift current and non-current with prepaid expenses and
other current assets and other assets, respectively.
Cash
and cash equivalents.
Cash equivalents consist of highly liquid investments with original maturities of three months or less
from the date of purchase.
Investments
.
Investments in debt securities have been classified as available-for-sale and are carried at fair value, with unrealized
gains and losses reported as a component of accumulated other comprehensive income. Realized gains and losses are included in
other income, net. The cost of securities sold is based on the specific-identification method. Interest on marketable securities
is included in interest income, net. Investments with original maturities of greater than three months from the date of purchase
are classified as current.
Accounts
Receivable.
Accounts receivable consists of amounts due to the Company related to the sale of the Company’s core product
SkinTE and contract services. Accounts that are outstanding longer than the contractual payment terms are considered past due.
The Company determines its allowance for doubtful accounts by considering a number of factors, including the length of time trade
accounts receivable are past due and the customer’s current ability to pay its obligation to the Company. The Company writes
off accounts receivable when they become uncollectible. As of December 31, 2018 and October 31, 2018, an allowance for doubtful
accounts was not considered necessary.
Accounts
Payable and Accrued Expenses.
The carrying amounts of accounts payable and accrued expenses approximate fair value as these
accounts are largely current and short term in nature.
Inventory.
Inventory comprises raw materials, which are valued at the lower of cost or net realizable value, on a first-in, first-out
basis. The Company evaluates the carrying value of its inventory on a regular basis, taking into account anticipated future sales
compared with quantities on hand, and the remaining shelf life of goods on hand.
Property
and Equipment.
Property and equipment is stated at cost. Depreciation is being provided for by the straight-line method over
the estimated useful lives of the assets, generally ranging from three to eight years. Amortization of leasehold improvements
is provided for over the shorter of the term of the lease or the life of the asset.
Capitalized
Software.
We capitalize certain internal and external costs incurred to acquire or create internal use software. Costs to
create internal software are capitalized during the application development period. Capitalized software is included in property
and equipment and is depreciated over three years once development is complete.
Goodwill and Intangible
Assets.
Goodwill represents the excess acquisition cost over the fair value of net tangible and intangible assets acquired.
Goodwill is not amortized and is subject to annual impairment testing or between annual tests if an event or change in circumstance
occurs that would more likely than not reduce the fair value of a reporting unit below its carrying value. In testing for goodwill
impairment, the Company has the option to first assess qualitative factors to determine whether the existence of events or circumstances
lead to a determination that it is more likely than not that the fair value of a reporting unit is less than its carrying amount.
If, after assessing the totality of events and circumstances, the Company concludes that it is not more likely than not that the
fair value of a reporting unit is less than its carrying amount, then no further testing is necessary. If the Company concludes
otherwise, then the Company needs to perform the quantitative goodwill impairment test. The goodwill impairment test is
performed at the reporting unit level by comparing the estimated fair value of a reporting unit with its respective carrying value.
If the estimated fair value exceeds the carrying value, goodwill at the reporting unit level is not impaired and the second step
of the impairment test in unnecessary. If the estimated fair value is less than carrying value, an impairment charge should
be recorded for the amount by which a reporting unit’s carrying amount exceeds its fair value.
The
fair value of reporting units is based on widely accepted valuation techniques that the Company believes market participants would
use, although the valuation process requires significant judgment and often involves the use of significant estimates and assumptions.
We performed a qualitative assessment and concluded that it is more likely than not that the fair value of the reporting unit
is more than its carrying value. Accordingly, there was no indication of impairment, and further quantitative testing was not
required. Adverse market or economic events could result in impairment charges in future periods.
Intangible
assets deemed to have finite lives are amortized on a straight-line basis over their estimated useful lives, which generally range
from one to eleven years. The useful life is the period over which the asset is expected to contribute directly, or indirectly,
to its future cash flows. Intangible assets are reviewed for impairment when certain events or circumstances exist. For amortizable
intangible assets, impairment exists when the undiscounted cash flows exceed its carrying value. At least annually, the remaining
useful life is evaluated.
Impairment
of Long-Lived Assets.
The Company reviews long-lived assets, including property and equipment, for impairment whenever events
or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that
the Company considers in deciding when to perform an impairment review include significant underperformance of the business in
relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the
use of the assets. If an impairment review is performed to evaluate a long-lived asset for recoverability, the Company compares
forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying
value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of
an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired
asset over its fair value, determined based on discounted cash flows. No impairment loss has been recognized.
Income
Taxes.
The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are
recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing
assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and
liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences
are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized
in income in the period that includes the enactment date. The Company evaluates the potential for realization of deferred tax
assets at each balance sheet date and records a valuation allowance for assets for which realization is not more likely than not.
The Company recognizes interest and penalties as a component of income tax expense.
Stock-Based
Compensation.
The Company measures all stock-based compensation to employees using a fair value method and records such expense
in general and administrative and research and development expenses. Compensation expense for stock options with cliff vesting
is recognized on a straight-line basis over the vesting period of the award, based on the fair value of the option on the date
of grant. For stock options with graded vesting, the Company recognizes compensation expense over the service period for each
separately vesting tranche of the award as though the award were in substance, multiple awards.
The
fair value for options issued is estimated at the date of grant using a Black-Scholes option-pricing model. The risk-free rate
is derived from the U.S. Treasury yield curve in effect at the time of the grant. The volatility factor is determined based on
the Company’s historical stock prices. Forfeitures are recognized as they occur.
The
value of restricted stock grants is measured based on the fair market value of the Company’s common stock on the date of
grant and amortized over the vesting period of, generally, six months to three years.
The
accounting for non-employee options and restricted stock is similar to that of employees, however, unlike employee options and
restricted stock, the measurement date is not the grant date. The measurement date is when performance is complete. Until the
options or shares vest, they are re-measured (re-valued) each reporting period and the expense marked up or marked down accordingly.
Loss
Per Share.
Basic loss per share of common stock is computed by dividing net loss attributable to common stockholders by the
weighted average number of shares of common stock outstanding for the period.
Since the
Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share since
the effects of potentially dilutive securities are antidilutive.
Commitments
and Contingencies.
We are subject to claims and litigation in the ordinary course of our business. We record a liability for
contingencies when the amount is both probable and reasonably estimable. We record associated legal fees as incurred.
Accounting
for Warrants
. The Company accounts for the issuance of common stock purchase warrants issued in connection with the equity
offerings in accordance with the provisions of ASC 815, Derivatives and Hedging (“ASC 815”). The Company classifies
as equity any contracts that (i) require physical settlement or net-share settlement or (ii) gives the Company a choice of net-cash
settlement or settlement in its own shares (physical settlement or net-share settlement). The Company classifies as assets or
liabilities any contracts that (i) require net-cash settlement (including a requirement to net-cash settle the contract if an
event occurs and if that event is outside the control of the Company) or (ii) gives the counterparty a choice of net-cash settlement
or settlement in shares (physical settlement or net-share settlement). In addition, under ASC 815, registered common stock warrants
that require the issuance of registered shares upon exercise and do not expressly preclude an implied right to cash settlement
are accounted for as derivative liabilities. The derivative warrant liabilities were settled during the fiscal year ended October
31, 2018.
Change
in Fair Value of Derivatives.
The Company assessed the classification of common stock purchase warrants as of the date of
each offering and determined that certain instruments met the criteria for liability classification. Accordingly, the Company
classified the warrants as a liability at their fair value and adjusts the instruments to fair value at each reporting period.
This liability is subject to re-measurement at each balance sheet date until the warrants are exercised or expired, and any change
in fair value is recognized as “change in fair value of derivatives” in the consolidated statements of operations.
The fair value of the warrants has as well as other derivatives, been estimated using a Monte-Carlo or Black-Scholes valuation
model. The warrants were settled during the fiscal year ended October 31, 2018.
Revenue
Recognition.
The Company adopted Accounting Standards Codification (“ASC”) 606,
Revenue from Contracts with
Customers
, effective November 1, 2018 using the modified retrospective method applied to all contracts as of November 1, 2018.
Results for reporting periods beginning after November 1, 2018 are presented under ASC 606, while prior period amounts are not
adjusted and continue to be reported in accordance with our historic accounting under ASC 605,
Revenue Recognition
. The
adoption of this standard did not have a cumulative effect on opening accumulated deficit as of November 1, 2018, as the timing
and measurement of revenue recognition is materially the same under ASC 606 as it was under the prior relevant guidance.
Under
ASC 605, regenerative medicine revenue is recognized upon the shipment of products or the performance of services when each of
the following four criteria is met: (i) persuasive evidence of an arrangement exists; (ii) products are delivered or services
are performed; (iii) the sales price is fixed or determinable; and (iv) collectability is reasonably assured. In the contract
services segment, revenue is recognized on the proportional performance method over the term of the respective service contract
which requires us to make reasonable estimates of the extent of progress toward completion of the contract. Under this method,
revenue is recognized according to the percentage of cost completed for the study. As a result, unbilled receivables and deferred
revenue are recognized based on payment timing and work completed.
Under
ASC 606, revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration
which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements
that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s)
with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate
the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies
a performance obligation.
In
the regenerative medicine products segment, the Company records product revenues primarily from the sale of its regenerative tissue
products. The Company sells its products to healthcare providers, primarily through direct sales representatives. Product revenues
consists of a single performance obligation that the Company satisfies at a point in time. In general, the Company recognizes
product revenue upon delivery to the customer.
In
the contract services segment, the Company records service revenues from the sale of its contract research services, which includes
delivery of preclinical studies and other research services to unrelated third parties. Service revenues generally consist of
a single performance obligation that the Company satisfies over time using an input method based on costs incurred to date relative
to the total costs expected to be required to satisfy the performance obligation. The Company believes that this method provides
a faithful depiction of the transfer of services over the term of the performance obligation based on the remaining services needed
to satisfy the obligation. This requires the Company to make reasonable estimates of the extent of progress toward completion
of the contract. As a result, unbilled receivables and deferred revenue are recognized based on payment timing and work completed.
Generally, a portion of the payment is due upfront and the remainder upon completion of the study, with most studies completing
in less than a year. As of December 31, 2018, October 31, 2018 and 2017, the Company had unbilled receivables of $157,000, $160,000
and $0 and deferred revenue of $170,000, $150,000 and $0. The unbilled receivables balance is included in consolidated accounts
receivable. Revenue of $83,000 was recognized during the two months ended December 31, 2018 that was included in the deferred
revenue balance as of October 31, 2018.
Costs
to obtain the contract are incurred for product revenue as they are shipped and are expensed as incurred.
The
Company considers a significant customer to be one that comprises more than 10% of net revenues or accounts receivable. Concentration
of revenues were as follows for the two months ended December 31, 2018 and the fiscal year ended October 31, 2018:
|
|
|
|
|
Two
Months Ended
December
31, 2018
|
|
|
Year
Ended
October
31, 2018
|
|
|
|
|
Segment
|
|
%
of Revenue
|
|
|
%
of Revenue
|
|
|
Customer A
|
|
Contract Services
|
|
|
32
|
%
|
|
|
19
|
%
|
|
Customer B
|
|
Regenerative Medicine
|
|
|
17
|
%
|
|
|
*
|
|
|
Customer C
|
|
Contract Services
|
|
|
11
|
%
|
|
|
*
|
|
Concentration
of accounts receivable were as follows as of December 31, 2018:
|
|
|
|
|
As
of December 31, 2018
|
|
|
|
|
|
|
|
Segment
|
|
%
of Accounts
Receivable
|
|
|
|
|
|
Customer A
|
|
Contract services
|
|
|
23
|
%
|
|
|
|
|
|
Customer B
|
|
Regenerative medicine
|
|
|
20
|
%
|
|
|
|
|
|
Customer D
|
|
Regenerative medicine
|
|
|
14
|
%
|
|
|
|
|
*The
amount did not exceed 10%
Recent
Accounting Pronouncements
In
February 2016, FASB issued ASU No. 2016-02,
Leases (Topic 842),
which supersedes FASB ASC Topic 840,
Leases (Topic 840)
and provides principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors.
The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on
the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine
whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease,
respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater
than twelve months regardless of classification. Leases with a term of twelve months or less will be accounted for similar to
existing guidance for operating leases. The standard is effective for annual and interim periods beginning after December 15,
2018, with early adoption permitted.
In
July 2018, the FASB issued ASU No. 2018-11,
Leases (Topic 842): Targeted Improvements
, which provides entities with an
additional transition method. Under ASU 2018-11, entities have the option of initially applying Topic 842 at the adoption date,
rather than at the beginning of the earliest comparative period presented and recognizing the cumulative effect of applying the
new standard as an adjustment to beginning retained earnings in the year of adoption while continuing to present all prior periods
under previous lease accounting guidance. The Company has elected this transition method at the adoption date of January 1, 2019.
The new standard provides a number of optional practical expedients in transition. The Company has elected all of the available
practical expedients except the practical expedient allowing the use of hindsight in determining the lease term and assessing
impairment of right-of-use assets based on all facts and circumstances through the effective date of the new standard.
The
Company expects that this standard will have a material effect on the financial statements upon adoption. The most significant
effects will primarily relate to (a) the recognition of ROU assets and lease liabilities on the balance sheet, which upon adoption
will range from $5.2 million to $5.6 million in relation to its existing operating lease agreements for the office and laboratory
spaces in Salt Lake City, Utah; and (b) providing significant new disclosures about leasing activities.
In
June 2018, the FASB issued ASU 2018-07,
Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-based
Payment Accounting
. The standard expands the scope of Topic 718 to include share-based payments issued to nonemployees for
goods or services, simplifying the accounting for share-based payments to nonemployees by aligning it with the accounting for
share-based payments to employees, with certain exceptions. The standard is effective for fiscal years beginning after December
15, 2018, including interim periods within those fiscal years with early adoption permitted, including adoption in an interim
period. The Company does not believe the adoption of this standard will have a significant impact on its financial statements
given the limited number of nonemployee stock-based awards outstanding.
In
August 2018, the FASB issued ASU 2018-15,
Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40)
. The
ASU aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract
with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements
that include an internal-use software license). The standard is effective for fiscal years beginning after December 15, 2019,
including interim periods within those fiscal years with early adoption permitted, including adoption in an interim period.
The Company is currently evaluating the impact this
standard will have on its financial statements.
In
November 2018, the FASB issued ASU No. 2018-18,
Collaborative Arrangements (Topic 808): Clarifying the Interaction between
Topic 808 and Topic 606
. The ASU clarifies that certain transactions between collaborative arrangement participants should
be accounted for as revenue when the collaborative arrangement participant is a customer in the context of a unit of account and
precludes recognizing as revenue consideration received from a collaborative arrangement participant if the participant is not
a customer. The standard is effective for fiscal years beginning after December 15, 2019, including interim period within those
fiscal years with early adoption permitted.
The
Company is currently evaluating the impact this standard will have on its financial statements.
Recently
Adopted Accounting Pronouncements
In
May 2014, the FASB issued ASU 2014-09,
Revenue from Contracts with Customers (Topic 606)
, a new accounting standard that
requires recognition of revenue to depict the transfer of promised goods or services to customers in an amount that reflects the
consideration to which an entity expects to be entitled in exchange for those goods or services. The FASB has also issued several
updates to ASU 2014-09. The new standard supersedes U.S. GAAP guidance on revenue recognition and requires the use of more estimates
and judgments than the present standards. It also requires additional disclosures regarding the nature, amount, timing and uncertainty
of cash flows arising from contracts with customers. The ASU is effective for annual reporting periods beginning after December
15, 2017, including interim periods and is to be retrospectively applied. The Company adopted this ASU effective November 1, 2018,
using the modified retrospective method. The adoption had no material impact on the financial statements.
In
August 2016, the FASB issued ASU 2016-15,
Statement of Cash Flows - Classification of Certain Cash Receipts and Cash Payments
,
which addresses eight specific cash flow issues with the objective of reducing the existing diversity in practice in how certain
cash receipts and cash payments are presented and classified in the statement of cash flows. The standard is effective for fiscal
years beginning after December 15, 2017, including interim periods within those fiscal years.
The
adoption of this ASU on November 1, 2018 has not had a material impact on the Company’s consolidated financial statements
and related disclosures.
In
May 2017, the FASB issued ASU 2017-09,
Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting.
ASU
2017-09 provides clarity and reduces both (1) diversity in practice and (2) cost and complexity when applying the guidance in
Topic 718, to a change to the terms or conditions of a share-based payment award. The amendments in ASU 2017-09 should be applied
prospectively to an award modified on or after the adoption date. This ASU is effective for fiscal years, and interim periods
within those years, beginning after December 15, 2017.
The adoption of this ASU on November
1, 2018 has not had a material impact on the Company’s consolidated financial statements and related disclosures.
In
January 2017, the FASB issued ASU No. 2017-04,
Intangibles - Goodwill and Other (Topic 350): Simplifying the Accounting for
Goodwill Impairment.
ASU No. 2017-04 removes Step 2 of the goodwill impairment test, which requires a hypothetical purchase
price allocation. A goodwill impairment will now be the amount by which a reporting unit’s carrying value exceeds its fair
value, not to exceed the carrying amount of goodwill. The Company early adopted this standard on November 1, 2018. The adoption
of this ASU
had no impact on the Company’s consolidated financial statements and related
disclosures.
3.
LIQUIDITY
The
Company has experienced recurring losses and cash outflows from operating activities. For the two months ended December 31, 2018,
and the fiscal year ended October 31, 2018, the Company incurred net losses of $18.4 million and $65.4 million, respectively,
with cash used in operating activities of $8.0 million and $28.5 million, respectively. On April 12, 2018, the Company completed
a public offering of 2,335,937 shares of the Company’s common stock, par value $0.001 per share, at an offering price of
$16.00 per share resulting in net proceeds of approximately $34.6 million, after deducting offering expenses payable by the Company
and on June 7, 2018, the Company completed an underwritten offering of 2,455,882 shares of the Company’s common stock, par
value $0.001 per share, at an offering price of $23.65 per share resulting in net proceeds of approximately $58.0 million, after
deducting offering expenses payable by the Company (see Note 11).
Based
upon the current status of our product development and commercialization plans, we believe that our existing cash and cash equivalents
will be adequate to satisfy our capital needs for at least the next 12 months from the date of filing. However, we
anticipate needing substantial additional financing to continue clinical deployment and commercialization of our lead product
SkinTE, development of our other product candidates, and scaling the manufacturing capacity for our products and product candidates,
and prepare for commercial readiness. However, we will continue to pursue fundraising opportunities when available, but such financing
may not be available in the future on terms favorable to us, if at all. If adequate financing is not available, we may be required
to delay, reduce the scope of, or eliminate one or more of our product development programs. We plan to meet our capital requirements
primarily through issuances of equity securities, debt financing, revenue from product sales and future collaborations. Failure
to generate revenue or raise additional capital would adversely affect our ability to achieve our intended business objectives.
4
.
IBEX ACQUISITION
On
March 2, 2018, the Company, along with its wholly owned subsidiary, Utah CRO Services, Inc., a Nevada corporation, entered into
agreements with IBEX for the purchase of the assets and rights to the Seller’s preclinical research and contract services
business and related real estate. The Company acquired this preclinical biomedical research facility in order to accelerate research
and development of PolarityTE pipeline products. The business consists of a GLP compliant preclinical research facility, including
vivarium, operating rooms, preparation rooms, storage facilities, and surgical and imaging equipment. The real property includes
two parcels in Cache County, Utah, consisting of approximately 1.75 combined gross acres of land, together with the buildings,
structures, fixtures, and personal property located on the real property. The above was accounted for as a business combination.
The
acquisition closed on May 3, 2018. The aggregate purchase price was $3.8 million, of which $2.3 million was paid at closing and
the balance satisfied by a promissory note payable to the Seller with an initial fair value of $1.2 million (see Note 10) and
contingent consideration with an initial fair value of approximately $0.3 million. During the year ended October 31, 2018, the
Company recorded approximately $38,000 of direct and incremental costs associated with acquisition-related activities. These costs
were incurred primarily for banking, legal, and professional fees associated with the IBEX acquisition. These costs were recorded
in general and administrative expenses in the consolidated statement of operations.
During
the two months ended December 31, 2018 and the fiscal year ended October 31, 2018, IBEX contributed approximately $437,000 and
$831,000 to net revenues and approximately $250,000 and $331,000 to gross profit, respectively.
Purchase
Price Allocation
The
following table summarizes the purchase price allocation for the IBEX acquisition (in thousands):
|
Equipment
|
|
$
|
430
|
|
|
Land and buildings
|
|
|
2,000
|
|
|
Intangible assets
|
|
|
1,057
|
|
|
Goodwill
|
|
|
278
|
|
|
Accrued property
taxes
|
|
|
(9
|
)
|
|
Aggregate purchase
price
|
|
$
|
3,756
|
|
|
Less: Promissory
note to seller
|
|
|
1,220
|
|
|
Contingent
consideration
|
|
|
278
|
|
|
Cash
paid at closing
|
|
$
|
2,258
|
|
As
part of the acquisition of IBEX, the Company recorded a contingent consideration liability of $0.3 million in current liabilities
in the consolidated balance sheet. The contingent consideration represents the estimated fair value of future payments due to
the Seller of IBEX based on IBEX’s revenue generated from studies quoted prior to but completed after the transaction. Contingent
consideration is initially recognized at fair value as purchase consideration and subsequently remeasured at fair value through
earnings. The initial fair value of the contingent consideration was based on the present value of estimated future cash flows
using a 20% discount rate. The contingent consideration is the payment of 15% of the actual revenues received for work on any
study initiated within 18 months following the closing of the purchase on the basis of certain specific customer prospects that
received service proposals prior to the closing, provided that the total payments will not exceed $650,000. The subsequent increase
in fair value of contingent consideration from acquisition to October 31, 2018 of approximately $20,000 was recognized in general
and administrative expense in the Company’s consolidated statement of operations for the fiscal year ended October 31, 2018.
During the two months ended December 31, 2018, $57,000 was recognized in general and administrative expense in the Company’s
consolidated statement of operations for additional increase in fair value of contingent consideration. The excess of the fair
value of purchase consideration over the fair values of identifiable assets and liabilities acquired is recorded as goodwill,
including the value of the assembled workforce.
Disclosure
of pro-forma revenues and earnings attributable to the acquisition is excluded because it is impracticable to obtain complete
historical financial records for IBEX Preclinical Research, Inc.
The
following table shows the valuation of the individual identifiable intangible assets acquired along with their estimated remaining
useful lives as of the acquisition date (in thousands):
|
|
|
Approximate
Fair
Value
|
|
|
Remaining
Useful
Life
(in
years)
|
|
|
Non-compete agreement
|
|
$
|
410
|
|
|
4
|
|
|
Customer contracts and relationships
|
|
|
534
|
|
|
7 to 8
|
|
|
Trade names and trademarks
|
|
|
101
|
|
|
10 to 11
|
|
|
Backlog
|
|
|
12
|
|
|
Less than 1
|
|
|
Total
intangible assets
|
|
$
|
1,057
|
|
|
|
|
5.
FAIR VALUE
In
accordance with
ASC 820, Fair Value Measurements and Disclosures
, financial instruments were measured at fair value using
a three-level hierarchy which maximizes use of observable inputs and minimizes use of unobservable inputs:
|
|
●
|
Level
1: Observable inputs such as quoted prices in active markets for identical instruments. This methodology applies to our Level
1 investments, which are composed of money market funds.
|
|
|
|
|
|
|
●
|
Level
2: Quoted prices for similar instruments that are directly or indirectly observable in the market. This methodology applies
to our Level 2 investments, which are composed of corporate debt securities, commercial paper, and U.S. government debt securities.
|
|
|
|
|
|
|
●
|
Level
3: Significant unobservable inputs supported by little or no market activity. Financial instruments whose values are determined
using pricing models, discounted cash flow methodologies, or similar techniques, for which determination of fair value requires
significant judgment or estimation. This methodology applies to our Level 3 financial instruments, which are composed of warrant
liability, derivative liability, and contingent consideration.
|
Financial
instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to
the fair value measurement. There were no transfers within the hierarchy for any of the periods presented.
In
connection with the offering of Units in September 2017 (see Note 11), the Company issued warrants to purchase an aggregate of
322,727 shares of common stock. These warrants were exercisable at $30.00 per share and expire in two years. The warrants were
liabilities pursuant to ASC 815. The warrant agreement provided for an adjustment to the number of common shares issuable under
the warrant or adjustment to the exercise price, including but not limited to, if: (a) the Company issues shares of common stock
as a dividend or distribution to holders of its common stock; (b) the Company subdivides or combines its common stock (i.e., stock
split); or (c) the Company issues new securities for consideration less than the exercise price. Under ASC 815, warrants that
provide for down-round exercise price protection are recognized as derivative liabilities.
The
Series F Preferred Shares contained an embedded conversion feature that was not clearly and closely related to the identified
host instrument and, as such, was recognized as a derivative liability measured at fair value. The Company classified these derivatives
on the consolidated balance sheet as a current liability.
As
noted in Note 11, both the warrants and the Series F Preferred Shares were exchanged for common stock on March 6, 2018.
The
fair value of the bifurcated embedded conversion feature was estimated to be approximately $7.2 million and $9.3 million, respectively,
at March 5, 2018 and October 31, 2017 as calculated using the Monte Carlo simulation with the following assumptions:
|
|
|
|
Series
F Conversion Feature
|
|
|
|
|
|
March
5, 2018
|
|
|
|
October
31, 2017
|
|
|
Stock price
|
|
$
|
20.05
|
|
|
$
|
25.87
|
|
|
Exercise price
|
|
$
|
27.50
|
|
|
$
|
27.50
|
|
|
Risk-free rate
|
|
|
2.2
|
%
|
|
|
1.6
|
%
|
|
Volatility
|
|
|
88.2
|
%
|
|
|
96.0
|
%
|
|
Term
|
|
|
1.5
|
|
|
|
1.9
|
|
The
fair value of the warrant liability was estimated to be approximately $2.5 million and $4.3 million, respectively, at March 5,
2018 and October 31, 2017 as calculated using the Monte Carlo simulation with the following assumptions:
|
|
|
|
Warrant
Liability
|
|
|
|
|
|
March
5, 2018
|
|
|
|
October
31, 2017
|
|
|
Stock price
|
|
$
|
20.05
|
|
|
$
|
25.87
|
|
|
Exercise price
|
|
$
|
30.00
|
|
|
$
|
30.00
|
|
|
Risk-free rate
|
|
|
2.2
|
%
|
|
|
1.6
|
%
|
|
Volatility
|
|
|
88.2
|
%
|
|
|
96.0
|
%
|
|
Term
|
|
|
1.5
|
|
|
|
1.9
|
|
The
following table sets forth the fair value of the Company’s financial assets and liabilities measured on a recurring basis
by level within the fair value hierarchy as of December 31, 2018, October 31, 2018 and 2017 (in thousands):
|
|
|
Fair
Value Measurement as of December 31, 2018
|
|
|
|
|
Level
1
|
|
|
Level
2
|
|
|
Level
3
|
|
|
Total
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money
market funds
|
|
$
|
7
|
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
7
|
|
|
Commercial paper
|
|
|
–
|
|
|
|
21,392
|
|
|
|
–
|
|
|
|
21,392
|
|
|
Corporate debt securities
|
|
|
–
|
|
|
|
5,448
|
|
|
|
–
|
|
|
|
5,448
|
|
|
U.S.
government debt securities
|
|
|
–
|
|
|
|
3,226
|
|
|
|
–
|
|
|
|
3,226
|
|
|
Total
|
|
$
|
7
|
|
|
$
|
30,066
|
|
|
$
|
–
|
|
|
$
|
30,073
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent
consideration
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
261
|
|
|
$
|
261
|
|
|
Total
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
261
|
|
|
$
|
261
|
|
|
|
|
Fair
Value Measurement as of October 31, 2018
|
|
|
|
|
Level
1
|
|
|
Level
2
|
|
|
Level
3
|
|
|
Total
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money
market funds
|
|
$
|
69,659
|
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
69,659
|
|
|
Total
|
|
$
|
69,659
|
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
69,659
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent
consideration
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
235
|
|
|
$
|
235
|
|
|
Total
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
235
|
|
|
$
|
235
|
|
|
|
|
Fair
Value Measurement as of October 31, 2017
|
|
|
|
|
Level
1
|
|
|
Level
2
|
|
|
Level
3
|
|
|
Total
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money
market funds
|
|
$
|
17,322
|
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
17,322
|
|
|
Total
|
|
$
|
17,322
|
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
17,322
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liability
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
4,256
|
|
|
$
|
4,256
|
|
|
Derivative
liability
|
|
|
–
|
|
|
|
–
|
|
|
|
9,246
|
|
|
|
9,246
|
|
|
Total
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
13,502
|
|
|
$
|
13,502
|
|
The
following table sets forth the changes in the estimated fair value of our contingent consideration liability (in thousands) which
is included in other current liabilities:
|
|
|
|
Contingent
Consideration
|
|
|
Fair value – October 31, 2017
|
|
$
|
–
|
|
|
IBEX acquisition – May 3, 2018
|
|
|
278
|
|
|
Change in fair value
|
|
|
20
|
|
|
Earned and paid in cash
|
|
|
(30
|
)
|
|
Earned and moved
to accounts payable
|
|
|
(33
|
)
|
|
Fair value - October 31, 2018
|
|
$
|
235
|
|
|
Change in fair value
|
|
|
57
|
|
|
Earned and moved
to accounts payable
|
|
|
(31
|
)
|
|
Fair value – December 31,
2018
|
|
$
|
261
|
|
6.
Cash Equivalents and Available-for-Sale Marketable Securities
Cash
equivalents and available-for-sale marketable securities consisted of the following as of December 31, 2018 (in thousands):
|
|
|
December
31, 2018
|
|
|
|
|
Amortized
Cost
|
|
|
Unrealized
Gains
|
|
|
Unrealized
Losses
|
|
|
Market
Value
|
|
|
Cash
equivalents:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money
market funds
|
|
$
|
7
|
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
7
|
|
|
Commercial paper
|
|
|
20,648
|
|
|
|
30
|
|
|
|
–
|
|
|
|
20,678
|
|
|
U.S.
government debt securities
|
|
|
3,224
|
|
|
|
2
|
|
|
|
–
|
|
|
|
3,226
|
|
|
Total cash equivalents
|
|
|
23,879
|
|
|
|
32
|
|
|
|
–
|
|
|
|
23,911
|
|
|
Short-term
investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial paper
|
|
|
714
|
|
|
|
–
|
|
|
|
–
|
|
|
|
714
|
|
|
Corporate
debt securities
|
|
|
5,444
|
|
|
|
5
|
|
|
|
(1
|
)
|
|
|
5,448
|
|
|
Total short-term
investments
|
|
|
6,158
|
|
|
|
5
|
|
|
|
(1
|
)
|
|
|
6,162
|
|
|
Total
|
|
$
|
30,037
|
|
|
$
|
37
|
|
|
$
|
(1
|
)
|
|
$
|
30,073
|
|
As of October 31, 2018
and 2017, the Company held $69.7 million and $17.3 million in money market funds included in cash equivalents with no unrealized
gains or losses. As of October 31, 2018 and 2017 the Company did not hold any available-for-sale securities. All investments of
debt securities held as of December 31, 2018 had maturities of less than one year. For the two months ended December 31, 2018,
the Company recognized no material realized gains or losses on available-for-sale marketable securities.
7.
PROPERTY AND EQUIPMENT, NET
The
following table presents the components of property and equipment, net (in thousands):
|
|
|
December
31, 2018
|
|
|
October
31, 2018
|
|
|
October
31, 2017
|
|
|
Machinery and equipment
|
|
$
|
8,276
|
|
|
$
|
8,134
|
|
|
$
|
2,418
|
|
|
Land and buildings
|
|
|
2,000
|
|
|
|
2,000
|
|
|
|
–
|
|
|
Computers and software
|
|
|
1,372
|
|
|
|
1,337
|
|
|
|
211
|
|
|
Leasehold improvements
|
|
|
1,230
|
|
|
|
1,137
|
|
|
|
–
|
|
|
Construction in progress
|
|
|
2,402
|
|
|
|
1,587
|
|
|
|
–
|
|
|
Furniture and
equipment
|
|
|
614
|
|
|
|
566
|
|
|
|
30
|
|
|
Total property and
equipment, gross
|
|
|
15,894
|
|
|
|
14,761
|
|
|
|
2,659
|
|
|
Accumulated depreciation
|
|
|
(2,158
|
)
|
|
|
(1,834
|
)
|
|
|
(486
|
)
|
|
Total
property and equipment, net
|
|
$
|
13,736
|
|
|
$
|
12,927
|
|
|
$
|
2,173
|
|
Depreciation
and amortization expense for property and equipment, including assets acquired under capital leases for the two months ended December
31, 2018 and for the fiscal years ended October 31, 2018 and 2017 is as follows (in thousands):
|
|
|
For
the Two Months ended December 31,
|
|
|
For
the Years Ended October 31,
|
|
|
|
|
2018
|
|
|
2018
|
|
|
2017
|
|
|
General and administrative
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
$
|
155
|
|
|
$
|
223
|
|
|
$
|
1
|
|
|
Discontinued
operations
|
|
|
–
|
|
|
|
–
|
|
|
|
11
|
|
|
|
|
|
155
|
|
|
|
223
|
|
|
|
12
|
|
|
Research and development
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
|
175
|
|
|
|
1,171
|
|
|
|
431
|
|
|
Total
depreciation and amortization expense
|
|
$
|
330
|
|
|
$
|
1,394
|
|
|
$
|
443
|
|
8.
INTANGIBLE ASSETS AND GOODWILL
Intangible
assets, net, consist of the following (in thousands):
|
|
|
December
31, 2018
|
|
|
October
31, 2018
|
|
|
October
31, 2017
|
|
|
Non-compete agreement
|
|
$
|
410
|
|
|
$
|
410
|
|
|
$
|
–
|
|
|
Customer contracts and relationships
|
|
|
534
|
|
|
|
534
|
|
|
|
–
|
|
|
Trade names and trademarks
|
|
|
101
|
|
|
|
101
|
|
|
|
–
|
|
|
Backlog
|
|
|
12
|
|
|
|
12
|
|
|
|
–
|
|
|
Total intangible
assets, gross
|
|
|
1,057
|
|
|
|
1,057
|
|
|
|
–
|
|
|
Accumulated amortization
|
|
|
(133
|
)
|
|
|
(100
|
)
|
|
|
–
|
|
|
Total
intangible assets, net
|
|
$
|
924
|
|
|
$
|
957
|
|
|
$
|
–
|
|
Amortization
expense for the two months ended December 31, 2018 and for the fiscal year ended October 31, 2018 was approximately $33,000 and
$100,000, respectively.
The
future amortization of these intangible assets is expected to be as follows (in thousands):
|
Year ended December 31, 2019
|
|
$
|
193
|
|
|
Year ended December 31, 2020
|
|
|
189
|
|
|
Year ended December 31, 2021
|
|
|
189
|
|
|
Year ended December 31, 2022
|
|
|
121
|
|
|
Year ended December 31, 2023
|
|
|
87
|
|
|
Thereafter
|
|
|
145
|
|
|
|
|
$
|
924
|
|
There
were no changes in the carrying amount of goodwill for the two months ended December 31, 2018. The changes in the carrying amount
of goodwill for fiscal year ended October 31, 2018 is as follows (in thousands):
|
|
|
Regenerative
Medicine
|
|
|
Contract
Services
|
|
|
Total
|
|
|
October 31, 2017
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
–
|
|
|
Additions due to acquisitions (1)
|
|
|
–
|
|
|
|
278
|
|
|
|
278
|
|
|
October 31, 2018
|
|
|
–
|
|
|
|
278
|
|
|
|
278
|
|
|
December 31, 2018
|
|
$
|
–
|
|
|
$
|
278
|
|
|
$
|
278
|
|
|
|
(1)
|
On
May 3, 2018, the Company acquired the preclinical research and contract services business and related real estate from IBEX
L.L.C.
|
9.
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
The
following table presents the major components of accounts payable and accrued expenses (in thousands):
|
|
|
December
31, 2018
|
|
|
October
31, 2018
|
|
|
October
31, 2017
|
|
|
Accounts payable
|
|
$
|
2,918
|
|
|
$
|
2,007
|
|
|
$
|
441
|
|
|
Salaries and other compensation
|
|
|
1,280
|
|
|
|
933
|
|
|
|
574
|
|
|
Other accruals
|
|
|
1,670
|
|
|
|
792
|
|
|
|
369
|
|
|
Legal and accounting
|
|
|
640
|
|
|
|
631
|
|
|
|
555
|
|
|
Total
accounts payable and accrued expenses
|
|
$
|
6,508
|
|
|
$
|
4,363
|
|
|
$
|
1,939
|
|
Salaries
and other compensation includes accrued payroll expense, accrued bonus, and estimated employer 401(k) plan contributions.
10.
LONG TERM NOTE PAYABLE
In
connection with the IBEX Acquisition, described in Note 4, the Company issued a promissory note payable to the Seller with an
initial fair value of $1.2 million. The promissory note has a principal balance of $1.3 million and bears interest at a rate of
3.5% interest per annum. Principal and interest are payable in five equal installments that began on November 3, 2018 and continuing
on each six-month anniversary thereafter (“Payment Date”). The promissory note may be prepaid by the Company at any
time and becomes due and payable at the earlier of the maturity date of November 3, 2020 or upon an event of default, which includes
failure to pay any installment on each Payment Date, breach of any negative covenants, insolvency or bankruptcy. Upon the occurrence
of an event of default, the promissory note will bear an accelerated interest rate of 7% per annum from the date of the event
of default.
The
Company initially recognized the promissory note at its fair value, using an estimated market rate of interest for the Company,
which was higher than the promissory note’s stated rate. The result of imputing a market rate of interest resulted in an
initial discount to the principal balance of approximately $113,000, which is being amortized to interest expense over the term
of the promissory note using the effective interest method. The unamortized debt discount was $68,000 and $78,000 at December
31, 2018 and October 31, 2018, respectively. Amortization of debt discount of $10,000 and $35,000 was included in interest expense
for the two months ended December 31, 2018 and the fiscal year ended October 31, 2018, respectively.
11.
PREFERRED SHARES AND COMMON SHARES
Common
Stock Issuance
On
April 12, 2018, the Company completed a public offering of 2,335,937 shares of the Company’s common stock, par value $0.001
per share, at an offering price of $16.00 per share resulting in net proceeds of approximately $34.6 million, after deducting
offering expenses payable by the Company.
On
June 7, 2018, the Company completed an underwritten offering of 2,455,882 shares of the Company’s common stock, par value
$0.001 per share, at an offering price of $23.65 per share resulting in net proceeds of approximately $58.0 million, after deducting
offering expenses payable by the Company.
Exchange
of 100% of Outstanding Series F Preferred Stock Shares and Warrants
On
September 20, 2017, the Company sold an aggregate of $17,750,000 worth of units of the Company’s securities (the “Units”)
to accredited investors at a purchase price of $2,750 per Unit. Each Unit consisted of (i) one share of the Company’s newly
authorized 6% Series F Convertible Preferred Stock, par value $0.001 per share (the “Series F Preferred Shares”),
convertible into one hundred (100) shares of the Company’s common stock, and (ii) a two-year warrant to purchase up to 322,727
shares of the Company’s common stock, at an exercise price of $30.00 per share.
The
Series F Preferred Shares were convertible into shares of the Company’s common stock based on a conversion calculation equal
to the stated value of the Series F Preferred Shares, plus all accrued and unpaid dividends, if any, on such Series F Preferred
Shares, as of such date of determination, divided by the conversion price. The stated value of each Series F Preferred Share was
$2,750 and the initial conversion price was $27.50 per share, each subject to adjustment for stock splits, stock dividends, recapitalizations,
combinations, subdivisions or other similar events.
On
the two-year anniversary of the initial issuance date, any Series F Preferred Shares outstanding and not otherwise already converted,
would, at the option of the holder, either (i) automatically convert into common stock of the Company at the conversion price
then in effect or (ii) be repaid by the Company based on the stated value of such outstanding Series F Preferred Shares.
The
warrants issued in connection with the Series F Preferred Shares were determined to be liabilities pursuant to ASC 815. The warrant
agreement provided for an adjustment to the number of common shares issuable under the warrant or adjustment to the exercise price,
including but not limited to, if: (a) the Company issued shares of common stock as a dividend or distribution to holders of its
common stock; (b) the Company subdivided or combined its common stock (i.e., stock split); or (c) the Company issues new securities
for consideration less than the exercise price. Under ASC 815, warrants that provide for down-round exercise price protection
are recognized as derivative liabilities.
The
conversion feature within the Series F Preferred Shares was determined to not be clearly and closely related to the identified
host instrument and, as such, was recognized as a derivative liability measured at fair value pursuant to ASC 815.
The
initial fair value of the warrants and bifurcated embedded conversion feature, estimated to be approximately $4.3 million and
$9.3 million, respectively, was deducted from the gross proceeds of the Unit offering to arrive at the initial discounted carrying
value of the Series F Preferred Shares. The resulting discount to the aggregate stated value of the Series F Preferred Shares
of approximately $13.6 million was recognized as accretion using the effective interest method similar to preferred stock dividends,
over the two-year period prior to optional redemption by the holders.
On
March 6, 2018, the Company entered into separate exchange agreements (the “Exchange Agreements”) with holders (each
a “Holder”, and collectively the “Holders”) of 100% of the Company’s outstanding Series F Preferred
Shares, and the Company’s warrants to purchase shares of the Company’s common stock issued in connection with the
Series F Preferred Shares (such “Warrants” and Series F Preferred Shares collectively referred to as the “Exchange
Securities”) to exchange the Exchange Securities and unpaid dividends on the Series F Preferred Shares for common stock
(the “Exchange”).
The
Exchange resulted in the following issuances: (A) all outstanding Series F Preferred Shares were converted into 972,070 shares
of restricted common stock at an effective conversion price of $18.26 per share of common stock (the closing price of Common Stock
on the NASDAQ Capital Market on February 26, 2018); (B) the right to receive 6% dividends underlying Series F Preferred Shares
was terminated in exchange for 31,321 shares of restricted common stock; (C) 322,727 Warrants to purchase common stock were exchanged
for 151,871 shares of restricted common stock; and (D) the Holders of the Warrants relinquished any and all other rights pursuant
to the Warrants, including exercise price adjustments.
As
part of the Exchange, the Holders also relinquished all other rights related to the issuance of the Exchange Securities, the respective
governing agreements and certificates of designation, including any related dividends, adjustment of conversion and exercise price,
and repayment option. The existing registration rights agreement with the holders of the Series F Preferred Shares was also terminated
and the holders of the Series F Preferred Shares waived the obligation of the Company to register the common shares issuable upon
conversion of Series F Preferred Shares or upon exercise of the warrants, and waived any damages, penalties and defaults related
to the Company failing to file or have declared effective a registration statement covering those shares.
The
exchange of all outstanding Series F Preferred Shares, and the holders’ right to receive 6% dividends, for common stock
of the Company was recognized as follows:
|
Fair market value of
1,003,393 shares of common stock issued at $20.05 (Company’s closing stock price on March 5, 2018) in exchange for Series
F Preferred Shares and accrued dividends
|
|
$
|
20,117,990
|
|
|
Carrying value of Series F Preferred
Shares at March 5, 2018, including dividends
|
|
|
(5,898,274
|
)
|
|
Carrying value
of bifurcated conversion option at March 5, 2018
|
|
|
(7,162,587
|
)
|
|
Deemed dividend
on Series F Preferred Shares exchange
|
|
$
|
7,057,129
|
|
As
the Warrants were classified as a liability, the exchange of the Warrants for common shares was recognized as a liability extinguishment.
As of March 5, 2018, the fair market value of the 151,871 common shares issued in the Exchange was $3,045,034 and the fair value
of the common stock warrant liability was $2,525,567 resulting in a loss on extinguishment of warrant liability of $519,467 during
the year ended October 31, 2018.
The
Company recognized accretion of the discount to the stated value of the Series F Preferred Shares of approximately $1,290,000
during the year ended October 31, 2018, as a reduction of additional paid-in capital and an increase in the carrying value of
the Series F Preferred Shares. The accretion is presented in the Statement of Operations as a deemed dividend, increasing net
loss to arrive at net loss attributable to common stockholders.
Preferred
Stock Conversion and Elimination
On
February 6, 2018, 15,756 shares of Series B Convertible Preferred Stock (“Series B Preferred Shares”) were converted
into 262,606 shares of common stock.
On
March 6, 2018, the Company received conversion notices (in accordance with original terms) from holders of 100% of the outstanding
shares of Series A Convertible Preferred Stock (the “Series A Preferred Shares”), Series B Preferred Shares and Series
E Convertible Preferred Stock (the “Series E Preferred Shares”) and issued an aggregate of 7,945,250 shares of common
stock to such holders.
The
shares of Series E Preferred Stock were held by Dr. Denver Lough, the Company’s Chief Executive Officer. On March 6, 2018,
the Company entered into a new registration rights agreement (the “Lough Registration Rights Agreement”) with Dr.
Lough, pursuant to which the Company agreed to file a registration statement to register the resale of 7,050,000 shares of Common
Stock issued upon conversion of the Series E Preferred Shares within six months, to cause such registration statement to be declared
effective by the Securities and Exchange Commission as promptly as possible following its filing and, with certain exceptions
set forth in the Lough Registration Rights Agreement, to maintain the effectiveness of the registration statement until all of
such shares have been sold or are otherwise able to be sold pursuant to Rule 144 under the Securities Act without restriction.
Any sales of shares under the registration statement were subject to certain limitations as specified with more particularity
in the Lough Registration Rights Agreement. In April 2018, Dr. Lough entered into a lock up agreement for 180 days, which prohibited
him from selling any shares that may be registered until October 2018. The registration statement was not filed as of December
31, 2018. Dr. Lough has not made a demand for filing a registration statement and the Company does not propose to file a registration
statement at the present time.
On
March 7, 2018, the Company filed a Certificate of Elimination with the Secretary of State of the State of Delaware terminating
the Company’s Series A, Series B, Series C, Series D, Series E and Series F Preferred Stock. As a result, the Company has
25,000,000 shares of authorized and unissued preferred stock as of December 31, 2018 with no designation as to series.
Convertible
preferred stock activity for the year ended October 31, 2018 consisted of the following:
|
|
|
Shares
Outstanding
-
October
31, 2017
|
|
|
Preferred
Stock Conversions and Series F Exchange – During the Year Ended October 31, 2018
|
|
|
Common
Stock Shares Issued – During the Year Ended October 31, 2018
|
|
|
Series A
|
|
|
3,146,671
|
|
|
|
(3,146,671
|
)
|
|
|
713,036
|
|
|
Series B
|
|
|
47,689
|
|
|
|
(47,689
|
)
|
|
|
794,820
|
|
|
Series C
|
|
|
2,578
|
|
|
|
(2,578
|
)
|
|
|
59,950
|
|
|
Series D
|
|
|
26,667
|
|
|
|
(26,667
|
)
|
|
|
44,445
|
|
|
Series E
|
|
|
7,050
|
|
|
|
(7,050
|
)
|
|
|
7,050,000
|
|
|
Series F
|
|
|
6,455
|
|
|
|
(6,455
|
)
|
|
|
972,070
|
|
|
Total
|
|
|
3,237,110
|
|
|
|
(3,237,110
|
)
|
|
|
9,634,321
|
|
There
was no convertible preferred stock outstanding as of December 31, 2018 and October 31, 2018. Convertible preferred stock as of
October 31, 2017 consisted of the following (in thousands, except share amounts):
|
|
|
Shares
Authorized
|
|
|
Shares
Issued
and
Outstanding
|
|
|
Net
Carrying
Value
|
|
|
Aggregate
Liquidation
Preference
|
|
|
Common
Shares
Issuable
Upon
Conversion
|
|
|
Series A
|
|
|
8,830,000
|
|
|
|
3,146,671
|
|
|
$
|
769
|
|
|
$
|
2,140
|
|
|
|
713,245
|
|
|
Series B
|
|
|
54,250
|
|
|
|
47,689
|
|
|
|
4,020
|
|
|
|
–
|
|
|
|
794,806
|
|
|
Series C
|
|
|
26,000
|
|
|
|
2,578
|
|
|
|
201
|
|
|
|
–
|
|
|
|
59,953
|
|
|
Series D
|
|
|
170,000
|
|
|
|
26,667
|
|
|
|
312
|
|
|
|
–
|
|
|
|
44,445
|
|
|
Series E
|
|
|
7,050
|
|
|
|
7,050
|
|
|
|
104,693
|
|
|
|
–
|
|
|
|
7,050,000
|
|
|
Series F
|
|
|
6,455
|
|
|
|
6,455
|
|
|
|
4,541
|
|
|
|
17,750
|
|
|
|
645,455
|
|
|
Other authorized,
unissued
|
|
|
15,906,245
|
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
Total
|
|
|
25,000,000
|
|
|
|
3,237,110
|
|
|
$
|
114,536
|
|
|
$
|
19,890
|
|
|
|
9,307,904
|
|
12.
STOCK-BASED COMPENSATION
For
the two months ended December 31, 2018 and the fiscal years ended October 31, 2018 and 2017, the Company recorded stock-based
compensation expense related to restricted stock awards and stock options as follows (in thousands):
|
|
|
For
the Two Months
Ended
December 31,
|
|
|
For
the Years Ended October 31,
|
|
|
|
|
2018
|
|
|
2018
|
|
|
2017
|
|
|
General and administrative
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
$
|
7,505
|
|
|
$
|
31,982
|
|
|
$
|
14,869
|
|
|
Discontinued
operations
|
|
|
–
|
|
|
|
–
|
|
|
|
1,118
|
|
|
|
|
|
7,505
|
|
|
|
31,982
|
|
|
|
15,987
|
|
|
Research and development
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
|
919
|
|
|
|
6,322
|
|
|
|
1,758
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
|
522
|
|
|
|
517
|
|
|
|
–
|
|
|
Total
stock-based compensation expense
|
|
$
|
8,946
|
|
|
$
|
38,821
|
|
|
$
|
17,745
|
|
|
Stock-based
compensation expense classified as a liability
|
|
$
|
38
|
|
|
$
|
–
|
|
|
$
|
–
|
|
|
Stock-based
compensation expense classified to equity
|
|
$
|
8,908
|
|
|
$
|
38,321
|
|
|
$
|
17,745
|
|
Incentive
Compensation Plans
2019
Plan
On
October 5, 2018, the Company’s Board of Directors (the “Board”) approved the Company’s 2019 Equity Incentive
Plan (the “2019 Plan”). The 2019 Plan provides for the grant of incentive stock options, nonqualified stock options,
restricted stock, restricted stock units, stock appreciation rights and other types of stock-based awards to the Company’s
employees, officers, directors and consultants. The Compensation Committee of the Board will administer the 2019 Plan, including
determining which eligible participants will receive awards, the number of shares of common stock subject to the awards and the
terms and conditions of such awards. Up to 3,000,000 shares of common stock are issuable pursuant to awards under the 2019 Plan.
Unless earlier terminated by the Board, the 2019 Plan shall terminate at the close of business on October 5, 2028. As of December
31, 2018, the Company had approximately 2,546,584 shares available for future issuances under the 2019 Plan.
2017
Plan
On
December 1, 2016, the Company’s Board of Directors (the “Board”) approved the Company’s 2017 Equity Incentive
Plan (the “2017 Plan”). The purpose of the 2017 Plan is to promote the success of the Company and to increase stockholder
value by providing an additional means through the grant of awards to attract, motivate, retain and reward selected employees,
consultants and other eligible persons. The 2017 Plan provides for the grant of incentive stock options, nonqualified stock options,
restricted stock, restricted stock units, stock appreciation rights and other types of stock-based awards to the Company’s
employees, officers, directors and consultants. The Compensation Committee of the Board will administer the 2017 Plan, including
determining which eligible participants will receive awards, the number of shares of common stock subject to the awards and the
terms and conditions of such awards. Up to 7,300,000 (increased from 3,450,000 in October 2017) shares of common stock are issuable
pursuant to awards under the 2017 Plan. Unless earlier terminated by the Board, the 2017 Plan shall terminate at the close of
business on December 1, 2026. As of December 31, 2018, the Company had approximately 53,102 shares available for future issuances
under the 2017 Plan.
2014
Plan
In
the fiscal year ended October 31, 2015, the Company adopted the 2014 Plan, an omnibus equity incentive plan administered by the
Company’s board of directors, or by one or more committees of directors appointed by the Board, pursuant to which the Company
may issue up to 2,250,000 shares of the Company’s common stock under equity-linked awards to certain officers, employees,
directors and consultants. The 2014 Plan permits the grant of stock options, including incentive stock options and nonqualified
stock options, stock appreciation rights, restricted shares, restricted share units, cash awards, or other awards, whether at
a fixed or variable price, upon the passage of time, the occurrence of one or more events, or the satisfaction of performance
criteria or other conditions, or any combination thereof. As of December 31, 2018, the Company had approximately 1,927,453 shares
available for future issuances under the 2014 Plan.
Stock
Options
Employee
stock-option activity for the two months ended December 31, 2018 and the fiscal years ended October 31, 2018 and 2017:
|
|
|
Number
of
shares
|
|
|
Weighted-Average
Exercise
Price
|
|
|
Outstanding, October 31, 2016
|
|
|
383,210
|
|
|
$
|
5.74
|
|
|
Granted
|
|
|
3,482,000
|
|
|
$
|
6.29
|
|
|
Exercised
|
|
|
(268,847
|
)
|
|
$
|
4.84
|
|
|
Forfeited
|
|
|
(70,833
|
)
|
|
$
|
6.42
|
|
|
Outstanding - October 31, 2017
|
|
|
3,525,530
|
|
|
$
|
6.34
|
|
|
Granted
|
|
|
2,638,769
|
|
|
$
|
23.55
|
|
|
Exercised
|
|
|
(161,810
|
)
|
|
$
|
4.31
|
|
|
Forfeited
|
|
|
(217,984
|
)
|
|
$
|
21.89
|
|
|
Outstanding - October 31, 2018
|
|
|
5,784,505
|
|
|
$
|
13.68
|
|
|
Granted
|
|
|
396,861
|
|
|
$
|
14.27
|
|
|
Exercised
|
|
|
–
|
|
|
$
|
–
|
|
|
Forfeited
|
|
|
(938
|
)
|
|
$
|
24.20
|
|
|
Outstanding – December 31,
2018
|
|
|
6,180,428
|
|
|
$
|
13.72
|
|
|
Options exercisable, December 31,
2018
|
|
|
3,899,806
|
|
|
$
|
9.23
|
|
|
Weighted-average
grant date fair value of options granted during the two months ended December 31, 2018
|
|
|
|
|
|
$
|
9.95
|
|
Non-employee
stock option activity for the two months ended December 31, 2018 and the fiscal years ended October 31, 2018 and 2017:
|
|
|
Number
of
shares
|
|
|
Weighted-Average
Exercise
Price
|
|
|
Outstanding - October 31, 2016
|
|
|
–
|
|
|
$
|
–
|
|
|
Granted
|
|
|
293,000
|
|
|
$
|
19.61
|
|
|
Forfeited
|
|
|
–
|
|
|
$
|
–
|
|
|
Outstanding - October 31, 2017
|
|
|
293,000
|
|
|
$
|
19.61
|
|
|
Granted
|
|
|
3,000
|
|
|
$
|
18.63
|
|
|
Forfeited
|
|
|
–
|
|
|
$
|
–
|
|
|
Outstanding - October 31, 2018
|
|
|
296,000
|
|
|
$
|
19.60
|
|
|
Granted
|
|
|
23,791
|
|
|
$
|
21.42
|
|
|
Forfeited
|
|
|
(334
|
)
|
|
$
|
6.33
|
|
|
Outstanding – December 31, 2018
|
|
|
319,457
|
|
|
$
|
19.75
|
|
|
Options exercisable - December
31, 2018
|
|
|
199,207
|
|
|
$
|
17.90
|
|
Stock
options are generally granted to employees or non-employees at exercise prices equal to the fair market value of the Company’s
stock of the day prior to the grant. Stock options generally vest over one to three years and have a term of five to ten years.
The total fair value of employee options granted during the two months ended December 31, 2018 was approximately $4.0 million.
The grant date fair value of non-employee options granted during the two months ended December 31, 2018 was approximately $0.4
million. The intrinsic value of options outstanding at December 31, 2018 was $28.5 million. The weighted average remaining contractual
term of outstanding and exercisable options at December 31, 2018 was 8.7 years and 8.2 years, respectively.
The
fair value of each option grant is estimated on the date of grant using the Black-Scholes option-pricing model with the following
range of assumptions for the two months ended December 31, 2018 and the fiscal years ended October 31, 2018 and 2017:
|
|
|
|
December
31,
|
|
|
|
October
31,
|
|
|
|
|
|
2018
|
|
|
|
2018
|
|
|
|
2017
|
|
|
Risk free annual interest
rate
|
|
|
2.6%-3.2
|
%
|
|
|
2.0%-3.2
|
%
|
|
|
1.6%-2.3
|
%
|
|
Expected volatility
|
|
|
80.6%-94.4
|
%
|
|
|
80.9%-96.5
|
%
|
|
|
71.7%-86.5
|
%
|
|
Expected term of options (years)
|
|
|
5.0-6.5
|
|
|
|
5.0-6.0
|
|
|
|
5.0-6.0
|
|
|
Assumed dividends
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
The
fair value of employee and non-employee stock option grants is recognized over the vesting period of, generally, one to three
years. As of December 31, 2018, there was approximately $21.0 million of unrecognized compensation cost related to non-vested
employee and non-employee stock option awards, which is expected to be recognized over a remaining weighted-average vesting period
of 0.8 years.
Restricted-stock
activity for employees and non-employees for the two months ended December 31, 2018 and the fiscal years ended October 31, 2018
and 2017:
|
|
|
Number
of
shares
|
|
|
Weighted-Average
Grant-Date
Fair Value
|
|
|
Unvested, October 31, 2016
|
|
|
274,829
|
|
|
$
|
6.00
|
|
|
Granted
|
|
|
1,057,500
|
|
|
$
|
4.80
|
|
|
Vested
|
|
|
(1,105,197
|
)
|
|
$
|
4.47
|
|
|
Unvested - October 31, 2017
|
|
|
227,132
|
|
|
$
|
7.83
|
|
|
Granted
|
|
|
712,034
|
|
|
$
|
25.27
|
|
|
Vested
|
|
|
(242,819
|
)
|
|
$
|
11.74
|
|
|
Forfeited
|
|
|
(22,387
|
)
|
|
$
|
20.62
|
|
|
Unvested - October 31, 2018
|
|
|
673,960
|
|
|
$
|
24.52
|
|
|
Granted
|
|
|
63,192
|
|
|
$
|
14.17
|
|
|
Vested (1)
|
|
|
(86,042
|
)
|
|
$
|
24.17
|
|
|
Forfeited
|
|
|
–
|
|
|
$
|
–
|
|
|
Unvested – December 31, 2018
|
|
|
651,110
|
|
|
$
|
23.65
|
|
|
|
(1)
|
The
number of vested restricted stock units includes shares that were withheld on behalf of employees to satisfy the minimum statutory
tax withholding requirements.
|
The
total fair value of restricted stock vested during the two months ended December 31, 2018 was approximately $2.1 million.
The
value of restricted stock grants is measured based on the fair market value of the Company’s common stock on the date of
grant and recognized over the vesting period of, generally, six months to three years. As of December 31, 2018, there was approximately
$10.0 million of unrecognized compensation cost related to unvested restricted stock awards, which is expected to be recognized
over a remaining weighted-average vesting period of 0.9 years.
13.
EMPLOYEE BENEFIT PLAN
The
Company’s 401(k) Plan is a deferred salary arrangement under Section 401(k) of the Internal Revenue Code. Under the 401(k)
Plan, participating employees (full-time employees with the company for one year) may defer a portion of their pre-tax earnings,
up to the IRS annual contribution limit ($18,500 for calendar year 2018). The Company contributes 3% of employee’s eligible
earnings. We recorded contribution expense related to our 401(k) Plan of $35,000 for the two months ended December 31, 2018, $120,000
for the fiscal year ended October 31, 2018, and $55,000 for the fiscal year ended October 31, 2017.
14.
INCOME TAXES
The
Company calculates its provision for federal and state income taxes based on current tax law. The Tax Cuts and Jobs Act (tax reform)
was enacted on December 22, 2017 (“Enactment Date”), and has several key provisions impacting accounting for and reporting
of income taxes. The most significant provision reduces the U.S. corporate statutory tax rate from 35% to 21% beginning on January
1, 2018. Although most provisions of tax reform are not effective until 2018, the Company is required to record the effect of
a change in tax law as of the Enactment Date on its deferred tax assets. As the Company maintains a full valuation allowance against
its deferred tax assets, there is no income tax expense recorded related to this change.
In
response to the enactment of the Act in late 2017, the U.S. Securities and Exchange Commission issued Staff Accounting Bulletin
No. 118 (“SAB 118”) to address situations where the accounting is incomplete for certain income tax effects of the
Tax Act upon issuance of an entity’s financial statements for the reporting period in which the Tax Act was enacted. Under
SAB 118, a company may record provisional amounts during a measurement period for specific income tax effects of the Tax Act for
which the accounting is incomplete but a reasonable estimate can be determined, and when unable to determine a reasonable estimate
for any income tax effects, report provisional amounts in the first reporting period in which a reasonable estimate can be determined.
While the Company was able to make reasonable estimates of the impact of the tax effects of the Tax Act, the final impact of the
Tax Act may differ from those estimates, including, but not limited to changes in our interpretations and assumptions, additional
guidance that may be issued by the IRS, return to provision differences and state rate adjustments. As guidance and technical
corrections are issued in the upcoming quarters, the Company will record updates to its original provisional estimates.
The
Company remeasured certain U.S. deferred tax assets and liabilities based on the rates at which they are expected to reverse in
the future, which is generally 21%. The provisional amount recorded related to the remeasurement of the deferred tax balance was
tax expense of $2.6 million which was offset by a reduction in the valuation allowance resulting in no tax expense.
Loss
before income taxes and discontinued operations consisted of (in thousands):
|
|
|
For
the Two Months
Ended
December 31,
|
|
|
For
the Years Ended October 31,
|
|
|
|
|
2018
|
|
|
2018
|
|
|
2017
|
|
|
Net loss from continuing
operations before income taxes
|
|
$
|
(18,418
|
)
|
|
|
(65,743
|
)
|
|
|
(130,480
|
)
|
The
provision (benefit) for income taxes for the years ended December 31, 2018, October 31, 2018, and 2017 consisted of (in thousands):
|
|
|
For the Two Months
Ended December 31,
|
|
|
For the Years Ended October 31,
|
|
|
|
|
2018
|
|
|
2018
|
|
|
2017
|
|
|
Current:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
$
|
–
|
|
|
$
|
(302
|
)
|
|
$
|
–
|
|
|
State
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
Deferred:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
|
(3,734
|
)
|
|
|
(11,561
|
)
|
|
|
(2,679
|
)
|
|
State
|
|
|
(257
|
)
|
|
|
(475
|
)
|
|
|
(304
|
)
|
|
Change in: valuation allowance
|
|
|
3,991
|
|
|
|
12,036
|
|
|
|
2,983
|
|
|
Total provision (benefit) for income taxes
|
|
$
|
-
|
|
|
$
|
(302
|
)
|
|
$
|
–
|
|
The
difference between income taxes computed at the statutory federal rate and the provision for income taxes for the years ended
December 31, 2018, October 31, 2018, and 2017 related to the following (in thousands, except percentages):
|
|
|
For the Two Months
Ended December 31,
|
|
|
For the Years Ended October 31,
|
|
|
|
|
2018
|
|
|
2018
|
|
|
2017
|
|
|
|
|
Amount
|
|
|
Percent of
Pretax Income
|
|
|
Amount
|
|
|
Percent of
Pretax Income
|
|
|
Amount
|
|
|
Percent of
Pretax Income
|
|
|
Tax (benefit) at federal statutory rate
|
|
$
|
(3,867
|
)
|
|
|
21
|
%
|
|
$
|
(22,325
|
)
|
|
|
34
|
%
|
|
$
|
(44,283
|
)
|
|
|
34
|
%
|
|
State income taxes, net of federal income taxes
|
|
|
(254
|
)
|
|
|
1
|
%
|
|
|
(475
|
)
|
|
|
(1
|
)%
|
|
|
(304
|
)
|
|
|
–
|
%
|
|
Effect of warrant liability
|
|
|
–
|
|
|
|
–
|
%
|
|
|
(1,120
|
)
|
|
|
2
|
%
|
|
|
(74
|
)
|
|
|
–
|
%
|
|
Effect of other permanent items
|
|
|
5
|
|
|
|
–
|
%
|
|
|
30
|
|
|
|
–
|
%
|
|
|
(82
|
)
|
|
|
–
|
%
|
|
Effect of Acquisition of intangible assets
|
|
|
–
|
|
|
|
–
|
%
|
|
|
–
|
|
|
|
–
|
%
|
|
|
35,595
|
|
|
|
(27
|
)%
|
|
Effect of stock compensation
|
|
|
27
|
|
|
|
–
|
%
|
|
|
–
|
|
|
|
–
|
%
|
|
|
3,147
|
|
|
|
(3
|
)%
|
|
Change in valuation allowance
|
|
|
3,991
|
|
|
|
(22
|
)%
|
|
|
12,036
|
|
|
|
(18
|
)%
|
|
|
2,983
|
|
|
|
(2
|
)%
|
|
Reduction of NOL’s due to Section 382 Limitations
|
|
|
-
|
|
|
|
–
|
%
|
|
|
11,552
|
|
|
|
(17
|
)%
|
|
|
3,018
|
|
|
|
(2
|
)%
|
|
Other
|
|
|
98
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
$
|
-
|
|
|
|
–
|
%
|
|
$
|
(302
|
)
|
|
|
–
|
%
|
|
$
|
–
|
|
|
|
-
|
%
|
The
components of deferred income tax assets (liabilities) were as follows (in thousands):
|
|
|
For
the Two Months
Ended
December 31,
|
|
|
For
the Years Ended October 31,
|
|
|
|
|
2018
|
|
|
2018
|
|
|
2017
|
|
|
Impairment of development
costs
|
|
$
|
–
|
|
|
$
|
7
|
|
|
$
|
–
|
|
|
Depreciation and amortization
|
|
|
(533
|
)
|
|
|
(546
|
)
|
|
|
95
|
|
|
Compensation expense not deductible
until options are exercised
|
|
|
12,543
|
|
|
|
10,529
|
|
|
|
4,553
|
|
|
All other temporary differences
|
|
|
236
|
|
|
|
382
|
|
|
|
248
|
|
|
Net operating loss carry forward
|
|
|
10,526
|
|
|
|
8,455
|
|
|
|
3,158
|
|
|
Less valuation
allowance
|
|
|
(22,772
|
)
|
|
|
(18,827
|
)
|
|
|
(8,054
|
)
|
|
Deferred tax
asset (liability)
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
–
|
|
Realization
of deferred tax assets, including those related to net operating loss carryforwards, are dependent upon future earnings, if any,
of which the timing and amount are uncertain. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance.
Based upon the Company’s current operating results management cannot conclude that it is more likely than not that such
assets will be realized.
Due
to the Company’s history of losses and uncertainty of future taxable income, a valuation allowance sufficient to fully offset
net operating losses and other deferred tax assets has been established. The valuation allowance will be maintained until sufficient
positive evidence exists to support a conclusion that a valuation allowance is not necessary. The issuance of the Series E Preferred
Stock in connection with its original acquisition of the PolarityTE, Inc., a Nevada corporation in April 2017, will likely result
in limitations on the utilization of the Company’s net operating loss carryforwards under IRS section 382. The effect of
this is being analyzed now.
Utilization
of the net operating loss carryforwards may be subject to a substantial annual limitation due to the “change in ownership”
provisions of the Internal Revenue Code. The annual limitation may result in the expiration of net operating loss carryforwards
before utilization. Due to the change in tax law, all losses post 2018 will have an unlimited carryforward period (but can only
utilize 80% max per year). All prior net operating losses still have the same carryforward limit of 20 years. The net operating
loss carryforwards available for income tax purposes at December 31, 2018 amounts to approximately $47.3 million and expires between
2038 and 2039 for federal income taxes, and approximately $25.5 million for state income taxes, which primarily expires between
2032 and 2033.
The
Company files income tax returns in the U.S. and various states As of December 31, 2018, the Company had no unrecognized tax benefits,
which would impact its tax rate if recognized. As of October 31, 2018, the Company had no accrual for the potential payment of
penalties. As of December 31, 2018, the Company was not subject to any U.S. federal, and state tax examinations. The Company’s
U.S. federal tax returns have been examined for tax years through 2011 with the results of such examinations being reflected in
the Company’s results of operations as of October 31, 2013. The Company does not anticipate any significant changes in its
unrecognized tax benefits over the next 12 months.
15.
LOSS PER SHARE
The
following outstanding potentially dilutive shares have been excluded from the calculation of diluted net loss per share for the
periods presented due to their anti-dilutive effect:
|
|
|
December
31,
|
|
|
October
31,
|
|
|
|
|
2018
|
|
|
2018
|
|
|
2017
|
|
|
Shares issuable upon conversion
of preferred stock
|
|
|
–
|
|
|
|
–
|
|
|
|
9,307,904
|
|
|
Shares issuable upon exercise of warrants
|
|
|
–
|
|
|
|
–
|
|
|
|
322,727
|
|
|
Shares issuable upon exercise of stock options
|
|
|
6,499,885
|
|
|
|
6,080,505
|
|
|
|
3,818,530
|
|
|
Non-vested shares under restricted stock
grants
|
|
|
651,110
|
|
|
|
673,960
|
|
|
|
227,132
|
|
16.
COMMITMENTS AND CONTINGENCIES
Contingencies
On
June 26, 2018, a class action complaint alleging violations of the Federal securities laws was filed in the United States District
Court, District of Utah, by Jose Moreno against the Company and two directors of the Company, Case No. 2:18-cv-00510-JNP (the
“Moreno Complaint”). On July 6, 2018, a similar complaint was filed in the same court against the same defendants
by Yedid Lawi, Case No. 2:18-cv-00541-PMW (the “Lawi Complaint”). Both the Moreno Complaint and Lawi Complaint allege
that the defendants made or were responsible for, disseminating information to the public through reports filed with the Securities
and Exchange Commission and other channels that contained material misstatements or omissions in violation of Sections 10 and
20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 adopted thereunder. Specifically, both complaints allege that the
defendants misrepresented the status of one of the Company’s patent applications while touting the unique nature of the
Company’s technology and its effectiveness. Plaintiffs are seeking damages suffered by them and the class consisting of
the persons who acquired the publicly-traded securities of the Company between March 31, 2017, and June 22, 2018. Plaintiffs have
filed motions to consolidate and for appointment as lead plaintiff. On November 28, 2018, the Court consolidated the
Moreno
and
Lawi
cases under the caption
In re PolarityTE, Inc. Securities Litigation
(the “Consolidated Securities
Litigation”), and requested the appointment of the plaintiff in
Lawi
as the lead plaintiff. On January 16, 2019,
the Court granted the motion of Yedid Lawi for appointment as lead plaintiff, and on February 1, 2019, the Court granted the lead
plaintiff’s motion for approval of lead counsel and liaison counsel. The Court ordered that the lead plaintiff file and
serve a consolidated complaint no later than 60 days after February 1, 2019, the defendants shall have 60 days after filing and
service of the consolidated complaint to answer or otherwise respond, and the lead plaintiff must file a motion for class certification
that within 90 days of service of the consolidated complaint. The Company believes the allegations in the Moreno Complaint and
Lawi Complaint are without merit, and intends to defend the litigation, vigorously. The Company expects its first response will
be to file a motion to dismiss after the lead plaintiff files and serves the consolidated complaint. At this early stage of the
proceedings the Company is unable to make any prediction regarding the outcome of the litigation.
In
November 2018, a shareholder derivative lawsuit was filed in the United States District Court, District of Utah, with the caption
Monther v. Lough, et al
., case no. 2:18-cv-00791-TC, alleging violations of the Securities Exchange Act of 1934, breach
of fiduciary duty, and unjust enrichment on the part of certain officers and directors based on the facts and circumstances recited
in the Consolidated Securities Litigation. On November 26, 2018, the court issued an order staying all proceedings until after
the disposition of motions to dismiss the Consolidated Securities Litigation.
On
February 26, 2015, a complaint for patent infringement was filed in the United States District Court for the Eastern District
of Texas by Richard Baker, an individual residing in Australia, against Microsoft, Nintendo, a former subsidiary of the Company,
and a number of other game publisher defendants. The complaint alleged that the Zumba Fitness Kinect game infringed plaintiff’s
patents in motion tracking technology. The plaintiff represented himself pro se in the litigation and sought monetary damages
in the amount of $1.3 million. The case was subsequently transferred to the Western District of Washington. On June 16, 2017,
final judgment was entered in favor of the defendants finding that the accused products did not literally infringe the asserted
patent and that plaintiff was barred from pursing infringement under the doctrine of equivalents due to prosecution history estoppel.
The plaintiff appealed that decision to the Court of Appeals for the Federal Circuit. On April 9, 2018, the Court of Appeals for
the Federal Circuit affirmed the judgment of the District Court for the Western District of Washington. On May 7, 2018, the plaintiff
filed a petition for panel rehearing and rehearing en banc by the Court of Appeals. The petition for rehearing was denied on June
8, 2018. The plaintiff subsequently filed a petition for a writ of certiorari with the Supreme Court of the United States, which
was denied in November 2018. Consequently, this matter has been finally resolved without liability to the Company.
In
the ordinary course of business, we may become involved in lawsuits, claims, investigations, proceedings, and threats of litigation
relating to intellectual property, commercial arrangements, regulatory compliance, and other matters. Except as noted above, at
December 31, 2018, we were not party to any legal or arbitration proceedings that may have significant effects on our financial
position or results of operations. No governmental proceedings are pending or, to our knowledge, contemplated against us. We are
not a party to any material proceedings in which any director, member of senior management or affiliate of ours is either a party
adverse to us or our subsidiaries or has a material interest adverse to us or our subsidiaries.
Commitments
The
Company leases facilities and certain equipment under noncancelable leases that expire at various dates through November 2022.
Leases are classified as capital leases when the terms of the lease transfer substantially all the risk and rewards of ownership
to the lease. Other leases are classified as operating leases.
Property
and equipment under capital leases are initially recorded at the lower of asset fair value or the present value of the minimum
lease payments on the consolidated balance sheet. The corresponding liability to the lessor is included in the balance sheet as
a capital lease obligation. Lease payments under capital leases are treated as debt-service payments and recognized as a reduction
of the capital lease obligation and an increase in interest expense.
During
November 2018, the Company entered into a capital lease agreement for laboratory equipment. The lease commencement date is January
1, 2019, at which time the Company will gain control of the asset. During the two months ended December 31, 2018, the Company
made payments towards the lease of $535,000. The payments are recorded on the balance sheet in other assets and will be reclassified
as a lease asset to property and equipment at the time the lease commences.
The
following schedule summarizes the future minimum lease payments for operating and capital leases at December 31, 2018 (
in thousands
):
|
|
|
Operating
leases
|
|
|
Capital
leases
|
|
|
Year ended December 31, 2019
|
|
$
|
1,895
|
|
|
$
|
66
|
|
|
Year ended December 31, 2020
|
|
|
1,819
|
|
|
|
58
|
|
|
Year ended December 31, 2021
|
|
|
1,455
|
|
|
|
55
|
|
|
Year ended December 31, 2022
|
|
|
1,216
|
|
|
|
28
|
|
|
|
|
$
|
6,385
|
|
|
$
|
207
|
|
Rent
expense for the two months ended December 31, 2018, and the fiscal years ended October 31, 2018 and 2017 was $357,000, $1.4 million
and $222,000, respectively.
The
Company has entered into employment agreements with key executives that contain severance terms and change of control provisions.
17.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
In
October 2018, the Company entered into an office lease covering approximately 7,250 square feet of rental space in the building
located at 40 West 57
th
Street in New York City. The lease is for a term of three years. The annual lease rate is $60
per square foot. Initially the Company will occupy and pay for only 3,275 square feet of space, and the Company is not obligated
under the lease to pay for the remaining 3,975 square feet covered by the lease unless we elect to occupy that additional space.
Comparable annual lease rates for similar office space in the area range between $67 and $110 per square foot. The Company believes
the terms of the lease are very favorable to us, and the Company obtained these favorable terms through the assistance of Peter
A. Cohen, a director, which he provided so that the company he owns, Peter A. Cohen, LLC (“Cohen LLC”), could sublease
a portion of the office space.
Initially,
the Company is using three offices and two work stations in the office and share common areas representing approximately 2,055
square feet. Cohen LLC is using approximately 1,220 square feet. The monthly lease payment for 3,275 square feet is $16,377. Of
this amount $6,103 is allocated pro rata to Cohen LLC based on square footage occupied. Additional lease charges for operating
expenses and taxes are allocated under the sublease based on the ratio of rent paid by the Company and Cohen LLC to total rent.
Cohen
LLC identified two associated entities that may wish to occupy an additional 2,753 square feet of space in the office. Under the
terms of the sublease Cohen LLC can add this additional space to the 1,220 square feet occupied, which would bring the total space
occupied by us and Cohen LLC to 6,028 square feet. Because a portion of the additional space subleased to Cohen LLC is less private
and attractive, the Company agreed to reduce the overall annual lease rate for the Cohen LLC space to $58.60 per square foot,
which means the Company will be paying an annual lease rate for the space the Company uses of $62.70. Assuming Cohen LLC subleases
the additional office space, our annual lease payment to the lessor would be $361,680, and Cohen LLC would pay to the Company
$232,830 under the sublease. During the two months ended December 31, 2018, the Company recognized $21,000 of sublease income
related to this agreement. As of December 31, 2018, there were no amounts due from the related party.
In
August 2018 David Seaburg was elected by the Board of Directors to serve as a director of the Company. Subsequently the Company
entered into a written consulting agreement with Mr. Seaburg pursuant to which he will provide investor relations and other services
to the Company over a period of two years for a fee consisting of (i) quarter-annual cash payment of $10,000, (ii) 60,000 restricted
stock units issued under the Company equity incentive plan that vest in four equal installments every six months during the term
of the agreement subject to continued service, and (iii) an annual award under the Company equity incentive plan of options exercisable
over a term of 10 years to purchase common stock in number equal to the number of shares of common stock with a value of $150,000
at the time of the award based on a Black-Scholes calculation. During the two months ended December 31, 2018, the Company made
no payments to Mr. Seaburg for consulting services. The total value of Mr. Seaburg’s agreement is approximately $1.7 million,
which will be recognized as expense over the 24-month consulting period. Under this agreement, the Company recognized approximately
$233,000 of expense during the two months ended December 31, 2018 and $324,000 of expense during the fiscal year ended October
31, 2018. The agreement terminated effective March 11, 2019, when he joined the Company as President of Corporate Development.
18.
DISCONTINUED OPERATIONS
On
June 23, 2017, the Company sold Majesco Entertainment Company, a Nevada corporation and wholly-owned subsidiary of the Company
(“Majesco Sub”) to Zift Interactive LLC (“Zift”), a Nevada limited liability company pursuant to a purchase
agreement. The results of operations from the discontinued business for the two months ended December 31, 2018 and the fiscal
years ended October 31, 2018 and 2017 are as follows (in thousands):
|
|
|
For
the Two Months
Ended
December 31,
|
|
|
For
the Years Ended October 31,
|
|
|
|
|
2018
|
|
|
2018
|
|
|
2017
|
|
|
Revenues
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
558
|
|
|
Expenses
|
|
|
–
|
|
|
|
–
|
|
|
|
1,007
|
|
|
Loss from discontinued
operations
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
(449
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of discontinued operations
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
100
|
|
The
cash flows from the discontinued business for the two months ended December 31, 2018 and the fiscal years ended October 31, 2018
and 2017 are as follows (in thousands):
|
|
|
For
the Two Months
Ended
December 31,
|
|
|
For
the Years Ended October 31,
|
|
|
|
|
2018
|
|
|
2018
|
|
|
2017
|
|
|
CASH FLOWS FROM OPERATING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss from discontinued
operations
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
(349
|
)
|
|
Adjustments to reconcile net loss from
discontinued operations to net cash used in discontinued operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
–
|
|
|
|
–
|
|
|
|
11
|
|
|
Stock based compensation
expense
|
|
|
–
|
|
|
|
–
|
|
|
|
1,118
|
|
|
Amortization of
capitalized software development costs and license fees
|
|
|
–
|
|
|
|
–
|
|
|
|
50
|
|
|
Gain on sale of
Majesco Sub
|
|
|
–
|
|
|
|
–
|
|
|
|
(100
|
)
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
–
|
|
|
|
–
|
|
|
|
113
|
|
|
Accounts
payable and accrued expenses
|
|
|
–
|
|
|
|
–
|
|
|
|
(810
|
)
|
|
Net
cash provided by discontinued operating activities
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
33
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash received
from sale of Majesco Sub
|
|
$
|
10
|
|
|
$
|
60
|
|
|
$
|
25
|
|
|
Net
cash provided by discontinued investing activities
|
|
$
|
10
|
|
|
$
|
60
|
|
|
$
|
25
|
|
19.
SEGMENT REPORTING
The
Company’s operations involve products and services which are managed separately. Accordingly, it operates in two segments:
1) regenerative medicine and 2) contract services.
Certain
information concerning our segments for the two months ended December 31, 2018 and the fiscal years ended October 31, 2018 and
2017 is presented in the following table (in thousands):
|
|
|
For
the Two Months
Ended
December 31,
|
|
|
For
the Years Ended October 31,
|
|
|
|
|
2018
|
|
|
2018
|
|
|
2017
|
|
|
Net revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reportable segments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Regenerative
medicine
|
|
$
|
210
|
|
|
$
|
689
|
|
|
$
|
–
|
|
|
Contract
services
|
|
|
463
|
|
|
|
874
|
|
|
|
–
|
|
|
Total
net revenues
|
|
$
|
673
|
|
|
$
|
1,563
|
|
|
$
|
–
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reportable segments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Regenerative medicine
|
|
$
|
(18,352
|
)
|
|
$
|
(65,219
|
)
|
|
$
|
(130,480
|
)
|
|
Contract services
|
|
|
(66
|
)
|
|
|
(222
|
)
|
|
|
–
|
|
|
Discontinued
operations
|
|
|
–
|
|
|
|
–
|
|
|
|
(349
|
)
|
|
Total
net loss
|
|
$
|
(18,418
|
)
|
|
$
|
(65,441
|
)
|
|
$
|
(130,829
|
)
|
|
|
|
As
of
December
31, 2018
|
|
|
As
of
October 31, 2018
|
|
|
As
of
October 31, 2017
|
|
|
Identifiable assets employed:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reportable segments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Regenerative
medicine
|
|
$
|
74,795
|
|
|
$
|
82,512
|
|
|
$
|
20,152
|
|
|
Contract services
|
|
|
5,371
|
|
|
|
5,330
|
|
|
|
–
|
|
|
Discontinued
operations
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
Total
assets
|
|
$
|
80,166
|
|
|
$
|
87,842
|
|
|
$
|
20,152
|
|
20.
TRANSITION PERIOD COMPARATIVE FINANCIALS (UNAUDITED)
Consolidated
statements of operations for the two months ended December 31, 2017 is as follows:
|
|
|
For
the Two Months
Ended
December 31,
|
|
|
|
|
2017
|
|
|
|
|
|
(Unaudited)
|
|
|
Net revenues
|
|
$
|
13
|
|
|
Cost of sales
|
|
|
1
|
|
|
Gross profit
|
|
|
12
|
|
|
|
|
|
|
|
|
Operating costs and
expenses
|
|
|
|
|
|
Product research
and development
|
|
|
4,930
|
|
|
General
and administrative
|
|
|
7,979
|
|
|
Total
operating costs and expenses
|
|
|
12,909
|
|
|
Operating loss
|
|
|
(12,897
|
)
|
|
|
|
|
|
|
|
Other income (expense)
|
|
|
|
|
|
Interest income
|
|
|
18
|
|
|
Change
in fair value of derivatives
|
|
|
1,964
|
|
|
Net loss
|
|
|
(10,915
|
)
|
|
Deemed dividend – accretion of
discount on Series F preferred stock
|
|
|
(593
|
)
|
|
Deemed dividend
– exchange of Series F preferred stock
|
|
|
(182
|
)
|
|
Net
loss attributable to common stockholders
|
|
$
|
(11,690
|
)
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted:
|
|
|
|
|
|
Net loss
|
|
$
|
(1.68
|
)
|
|
Deemed dividend – accretion of
discount on Series F preferred stock
|
|
|
(0.09
|
)
|
|
Deemed dividend
– exchange of Series F preferred stock
|
|
|
(0.03
|
)
|
|
Net
loss attributable to common stockholders
|
|
$
|
(1.80
|
)
|
|
Weighted average
shares outstanding, basic and diluted:
|
|
|
6,496,841
|
|
21.
SUBSEQUENT EVENTS
On
March 1, 2019, the Company was informed it is the subject of an SEC investigation, and it is unable to make any prediction regarding
the outcome of the investigation at this time.
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