Except for statements of historical fact, certain information described in this
Form 10-Q report contains "forward-looking statements" that involve substantial
risks and uncertainties. You can identify these statements by forward-looking
words such as "anticipate," "believe," "could," "estimate," "expect," "intend,"
"may," "should," "will," "would" or similar words. The statements that contain
these or similar words should be read carefully because these statements discuss
the Company's future expectations, including its expectations of its future
results of operations or financial position, or state other "forward-looking"
information. Vivos Inc. believes that it is important to communicate its future
expectations to its investors. However, there may be events in the future that
the Company is not able to accurately predict or to control. Further, the
Company urges you to be cautious of the forward-looking statements which are
contained in this Form 10-Q report because they involve risks, uncertainties and
other factors affecting its operations, market growth, service, products and
licenses. The risk factors in the section captioned "Risk Factors" in Item 1A of
the Company's previously filed Form 10-K, as well as other cautionary language
in this Form 10-Q report, describe such risks, uncertainties and events that may
cause the Company's actual results and achievements, whether expressed or
implied, to differ materially from the expectations the Company describes in its
forward-looking statements. The occurrence of any of the events described as
risk factors could have a material adverse effect on the Company's business,
results of operations and financial position.
Vivos Inc. is a radiation oncology medical device company engaged in the
development of its yttrium-90 ("Y-90") based brachytherapy device, RadioGel™,
for the treatment of non-resectable tumors. A prominent team of radiochemists,
scientists and engineers, collaborating with strategic partners, including
national laboratories, universities and private corporations, lead the Company's
development efforts. The Company's overall vision is to globally empower
physicians, medical researchers and patients by providing them with new isotope
technologies that offer safe and effective treatments for cancer.
In 2013 the FDA issued the determination that RadioGel™ is a device for human
therapy for non-resectable cancers in humans. This should result in a faster
path than a drug for final approval.
In January 2018, the Center for Veterinary Medicine Product Classification Group
ruled that RadioGelTM should be classified as a device for animal therapy of
feline sarcomas and canine soft tissue sarcomas. Additionally, after a legal
review, the Company believes that the device classification obtained from the
Food and Drug Administration ("FDA") Center for Veterinary Medicine is not
limited to canine and feline sarcomas, but rather may be extended to a much
broader population of veterinary cancers, including all or most solid tumors in
animals. We expect the result of such classification and label review will be
that no additional regulatory approvals are necessary for the use of IsoPet® for
the treatment of solid tumors in animals. The FDA does not have premarket
authority over devices with a veterinary classification, and the manufacturers
are responsible for assuring that the product is safe, effective, properly
labeled, and otherwise in compliance with all applicable laws and regulations.
Based on the FDA's recommendation, RadioGelTM will be marketed as "IsoPet®" for
use by veterinarians to avoid any confusion between animal and human therapy.
The Company already has trademark protection for the "IsoPet®" name. IsoPet® and
RadioGelTM are used synonymously throughout this document. The only distinction
between IsoPet® and RadioGelTM is the FDA's recommendation that we use "IsoPet®"
for veterinarian usage, and reserve "RadioGelTM" for human therapy. Based on
these developments, the Company has shifted its primary focus to the development
and marketing of Isopet® for animal therapy, through the Company's IsoPet®
Solutions division.
The Company's IsoPet Solutions division was established in May 2016 to focus on
the veterinary oncology market, namely engagement of university veterinarian
hospital to develop the detailed therapy procedures to treat animal tumors and
ultimately use of the technology in private clinics. The Company has worked with
three different university veterinarian hospitals on IsoPet® testing and
therapy. Washington State University treated five cats for feline sarcoma and
served to develop the procedures which are incorporated in our label. They
concluded that the product was safe and effective in killing cancer cells.
Colorado State University demonstrated the CT and PET-CT imaging of IsoPet®. A
contract was signed with University of Missouri to treat canine sarcomas and
equine sarcoids starting in November 2017.
22
The dogs were treated for canine soft tissue sarcoma. Response evaluation
criteria in solid tumors ("RECIST") is a set of published rules that define when
tumors in cancer patients improve (respond), stay the same (stabilize), or
worsen (progress) during treatment. The criteria were published by an
international collaboration including the European Organisation for Research and
Treatment of Cancer ("EORTC"), National Cancer Institute of the United States,
and the National Cancer Institute of Canada Clinical Trials Group.
The testing at the University of Missouri met its objective to demonstrate the
safety of IsoPet®. Using its advanced CT and PET equipment it was able to
demonstrate that the dose calculations were accurate and that the injections
perfused into the cell interstices and did not stay concentrated in a bolus.
This results in a more homogeneous dose distribution. There was insignificant
spread of Y-90 outside the points of injection demonstrating the effectiveness
of the particles and the gel to localize the radiation with no spreading to the
blood or other organs nor to urine or fecal material. This confirms that IsoPet®
is safe for same day therapy.
The effectiveness of IsoPet® for life extension was not the prime objective, but
it resulted in valuable insights. Of the cases one is still cancer-free but the
others eventually recurred since there was not a strong focus on treating the
margins. The University of Missouri has agreed to become a regional center to
administer IsoPet® therapy and will incorporate the improvements suggested by
the testing program.
The Company anticipates that future profits, if any, will be derived from direct
sales of RadioGel™ (under the name IsoPet®) and related services, and from
licensing to private medical and veterinary clinics in the U.S. and
internationally. The Company intends to report the results from the IsoPet®
Solutions division as a separate operating segment in accordance with GAAP.
Commencing in July 2019, the Company recognized its first commercial sale of
IsoPet®. A veterinarian from Alaska brought his cat with a re-occurrent spindle
cell sarcoma tumor on his face. The cat had previously received external beam
therapy, but now the tumor was growing rapidly. He was given a high dose of
400Gy with heavy therapy at the margins. This sale met the revenue recognition
requirements under ASC 606 as the performance obligation was satisfied. The
Company completed sales for an additional four animals that received the IsoPet®
during 2019.
Our plan is to incorporate the data assembled from our work with Isopet® in
animal therapy to support the Company's efforts in the development of our
RadioGel™ device candidate, including obtaining approval from the FDA to market
and sell RadioGel™ as a Class II medical device. RadioGel™ is an injectable
particle-gel for brachytherapy radiation treatment of cancerous tumors in people
and animals. RadioGel™ is comprised of a hydrogel, or a substance that is liquid
at room temperature and then gels when reaching body temperature after injection
into a tumor. In the gel are small, less than two microns, Y-90 phosphate
particles. Once injected, these inert particles are locked in place inside the
tumor by the gel, delivering a very high local radiation dose. The radiation is
beta, consisting of high-speed electrons. These electrons only travel a short
distance so the device can deliver high radiation to the tumor with minimal dose
to the surrounding tissue. Optimally, patients can go home immediately following
treatment without the risk of radiation exposure to family members. Since Y-90
has a half-life of 2.7 days, the radioactivity drops to 5% of its original value
after ten days.
Recently, the Company modified its Indication for Use from skin cancel to
cancerous tissue or solid tumors pathologically associated with locoregional
papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having
discernable tumors associated with metastatic lymph nodes or extranodal disease
in patients who are not surgical candidates or who have declined surgery, or
patients who require post-surgical remnant ablation (for example, after prior
incomplete radioiodine therapy). Papillary thyroid carcinoma belongs to the
general class of head and neck tumors for which tumors are accessible by
intraoperative direct needle injection. The Company's Medical Advisory Board
felt that demonstrating efficacy in clinical trials was much easier with this
new indication.
The Company's lead brachytherapy products, including RadioGel™, incorporate
patented technology developed for Battelle Memorial Institute ("Battelle") at
Pacific Northwest National Laboratory, a leading research institute for
government and commercial customers. Battelle has granted the Company an
exclusive license to patents covering the manufacturing, processing and
applications of RadioGel™ (the "Battelle License"). This exclusive license is to
terminate upon the expiration of the last patent included in this agreement (May
2022). Other intellectual property protection includes proprietary production
processes and trademark protection in 17 countries.
23
Intellectual Property
Our original license with Battelle National Laboratory is reaching its end of
life in 2023. During the past several years, in anticipation of this we have
expanded our proprietary knowledge and our trademark and patent protection.
We have expanded our trademark protection from RadioGel to now include IsoPet.
We obtained the International Certificate of Registration for ISOPET, which is
the first step to file in several countries.
The Company received the Patent Cooperation Treaty ("PCT") International Search
Report on our patent application (No.1811.191). Seven of our claims were
immediately ruled as having novelty, inventive step and industrial
applicability. This gives us the basis to extend for many years the patent
protection for our proprietary Yttrium-90 phosphate particles utilized in
Isopet® and Radiogel™. Vivos, Inc. filed its particle patent in several
countries and in parallel is pursuing amendments to increase the number of
claims.
In addition to the United States of America, our new patent team filed in
Canada, the European Union, Japan, Australia, Brazil, China, India, South Korea,
and the Russian Eurasian (Russia, Armenia, Azerbaijan, Belarus, Kazakhstan,
Kyrgyzstan, Tajikistan, and Turkmenistan).
We have just filed a new provisional patent to protect our current and planned
developments. It includes a summary of our improved hydrogel formulation and
production process, the use of other particles incorporating other isotopes
beyond Y-90, and the anti-circumvention techniques we discovered that would make
it more difficult for competitors to engineer around our proprietary hydrogel
with other hydrogels from our defensive effort we call our "knock-off red team
exercise".
Following the provisional patent, we will file for utility patents on our
polymer/hydrogel improvements. These include reducing the polymer production
time and increasing the output by a factor of three. We have also further
reduced the level of trace contaminants to be well below the FDA guidelines.
We currently are developing a micro-injection system for small tumor therapy.
This will provide more precise controls for treating cancerous thyroid lymph
nodes. It will also be valuable if the company pursues other future indications
for use that will require precise micro-injections, e.g. ocular melanoma, spinal
tumors and brain cancers.
Vista Veterinary Hospital
Vista Veterinary Hospital ("Vista") was selected as the pilot private clinic to
initiate commercial sales of IsoPet®. It is good management practice to
implement and learn from a pilot program before spreading to regional clinics
across the country. Vista is located in the Tri-Cities Washington area which is
convenient for interactions with key personnel of the Company. The pilot is
being used to
? Refine the Memorandum of Understanding to define all the germane interfaces,
roles and liabilities between Vista Inc and the private clinics, including the
pilot responsivity to document and share the key aspects of all therapies with
the Company;
? Create and implement proprietary certification training packages;
? Amend the production center radioactive material license at IsoTherapeutics,
the Company's IsoPet® production center, to allow distribution for commercial
applications;
? Work with the pilot program to obtain a radioactive material licensing in an
NRC agreement state;
? Create equipment and supplies list;
? Create and post regulatory signage;
? Explore different IsoPet® pricing options;
? Evaluate different approaches to obtain patients;
? Optimize patient scheduling practices to reduce cost to the pet owners;
? Develop communication material and a liability document for the pet owners;
and
? Further refine the therapy techniques for advanced cancers.
24
Vista Veterinary Hospital has done well on two audits by the Washington State
Department of Health. The Company is working closely with the Washington State
Department of Health to refine and improve the radioactive material license. The
Company has added several detailed procedures, which will benefit future
regional clinics. In addition, a second veterinarian has completed all the
preliminary requirements to become certified. All that remains is to demonstrate
proficiency in three therapies.
The testing at the universities and at Vista Veterinary Hospital have
demonstrated that IsoPet® is effective on killing cancer tissue in close
proximity to the injections. It is most effective in early cases before the
cancer has begun to spread. Later stage cancers are more difficult to treat
since the tendrils from the primary cancer site are not well defined and
therefore can lead to recurrence.
There have been 84 expressions of interest in IsoPet® therapy from across the
United States, but only about 10% of these were treated and they were very
advanced cases. The reasons are instructive. Most of the cases were for so
advanced that the pet parents found out about IsoPet® on the Internet as a last
hope. Several others were internal cancers that could not be reached, for
example deep in the throat. Several cases were treatable, but the pets weighed
more than 20 pounds and the pet parents were not willing to fly them in the
"Safe Cargo" holds. Those patients would have been treated by regional clinics
once we implement that strategy. Several cases were mast cell cancers. The
Company is confident that those tumors could have been treated, but once killed
they release mast cells in a process called granulation. This could cause a
shock to the animal's system. The Company will focus one of our clinical studies
on the optimum approach for those therapies.
Vista Veterinary Hospital accepted advanced cancer cases and has gained
experience to extend the animal's lives. The first cat was terminally ill and
had previously had external beam, surgery and chemotherapy. The facial tumor was
treated with 400 Gy and the biopsy confirmed that the cancer was killed. In
about seven months the cancer returned in the throat and could not be treated so
the cat had to be put down. Dr. Bauder, the veterinarian pet parent, was still
elated about the life extension and is asking us to use him as a reference. The
other cases were also very advanced with multiple tumors and they recurred since
they had already spread before therapy. One animal, Yukon had a large tumor on
his leg that was recommended for amputation. The tumor size decreased 50% after
the first treatment, but then stopped decreasing. For the first time a second
therapy was administered and the tumor has continued to decrease in size.
Yukon's life was extended for more than a year until she finally succumbed to
metastatic cancer in another location.
Since IsoPet® has shown to be effective in killing cancer at the site of
injection the current focus is in optimizing the techniques to help the pet
resorb the necrotic tissue rapidly. In addition, IsoPet® was used to treat a
mast cell tumor. When these cancers are destroyed, they release their mast cell.
The animal was treated with a steroid to counter this effect and to date is
doing well.
The Company's efforts are now to obtain more early-stage cancer patients. The
biggest obstacle is to convince the veterinarians of the pet parents to agree
with IsoPet® therapy rather than using a more traditional method such as
surgery. This is a slow process due to the conservative nature of the
veterinarian professions. This is the prime motivation to continue with
additional clinical trials and to publish the results.
The Company worked closely with FX Masse to develop nine certification training
modules for use in potential regional clinics. These modules are necessary to
satisfy the radioactive material handling licenses. This approach is very cost
effective.
Johns Hopkins University VCTN, Veterinary Clinical Trials Network, is now an
Isopet® regional clinic. Additionally, Johns Hopkins will also perform new
Isopet® animal studies on various specific cancers. They have the required
radioactive material license and have completed their training certification for
Isopet®. This important relationship will also help meet our objective of
obtaining high quality data on a range of cancers that can be published in
leading journals. These publications are the optimal way to increase awareness
of Isopet® and to gain broader acceptance from the veterinarian/oncology
community.
We currently are working with the NY Surgical Center on Long Island to become a
new IsoPet Regional Center. They have completed their certification training and
have submitted their Radioactive Material Handling License application to the NY
regulators. Aside from the normal solid tumor therapy they are interested in
treating the margins for resected tumors and to use their surgical techniques to
treat tumors deep within the body, such as bladder cancers.
25
Regulatory History
Human Therapy
RadioGel™ has a long regulatory history with the Food and Drug Administration
("FDA"). Initially, the Company submitted a presubmission (Q130140) to obtain
FDA feedback about the proposed product. The FDA requested that the Company file
a request for designation with the Office of Combination Products (RFD130051),
which led to the determination that RadioGel™ is a device for human therapy for
non-resectable cancers, which must be reviewed and ultimately regulated by the
Center for Devices and Radiological Health ("CDRH"). The Company then submitted
a 510(k) notice for RadioGel™ (K133368), which was found Not Substantially
Equivalent due to the lack of a suitable predicate, and RadioGel™ was assigned
to the Class III product code NAW (microspheres). Class III products or devices
are generally the highest risk devices and are therefore subject to the highest
level of regulatory review, control and oversight. Class III products or devices
must typically be approved by FDA before they are marketed. Class II devices
represent lower risk products or devices than Class III and require fewer
regulatory controls to provide reasonable assurance of the product's or device's
safety and effectiveness. In contrast, Class I products and devices are deemed
to be lower risk than Class I or II, and are therefore subject to the least
regulatory controls.
A pre-submission meeting (Q140496) was held with the FDA on June 17, 2014,
during which the FDA maintained that RadioGel™ should be considered a Class III
device and therefore subject to pre-market approval. On December 29, 2014, the
Company submitted a de novo petition for RadioGel™ (DEN140043). The de novo
petition was denied by the FDA on June 1, 2015, with the FDA providing numerous
comments and questions. On September 29, 2015, the Company submitted a follow-up
pre-submission informational meeting request with the FDA (Q151569). This
meeting took place on November 9, 2015, at which time the FDA indicated
acceptance of the Company's applied dosimetry methods and clarified the FDA's
outstanding questions regarding RadioGel™. Following the November 2015
pre-submission meeting, the Company prepared a new pre-submission package to
obtain FDA feedback on the proposed testing methods, intended to address the
concerns raised by the FDA staff and to address the suitability of RadioGel™ for
de novo reclassification. This pre-submission package was presented to the FDA
in a meeting on August 29, 2017. During the August 2017 meeting, the FDA
clarified their position on the remaining pre-clinical testing needed for
RadioGel™. Specifically, the FDA addressed proposed dosimetry calculating
techniques, dosimetry distribution between injections, hydrogel viscoelastic
properties, and the details of the Company's proposed animal testing.
The Company believes that its submissions to the FDA to date have addressed all
the FDA staff's feedback over the past four years. Of particular importance, the
Company has provided corresponding supporting data for proposed future testing
of RadioGel™ to address any remaining questions raised by the FDA. We believe,
although no assurances can be given, that the clinical testing modifications
presented to the FDA in August 2017 will result in a de novo reclassification
for RadioGel™ by the FDA. In addition, in previous FDA submittals, the Company
proposed applying RadioGel™ for a very broad range of cancer therapies, referred
to as Indication for Use. The FDA requested that the Company reduce its
Indications for Use. To comply with that request, the Company expanded its
Medical Advisory Board ("MAB") and engaged doctors from respected hospitals who
have evaluated the candidate cancer therapies based on three criteria: (1)
potential for FDA approval and successful therapy? (2) notable advantage over
current therapies? and (3) probability of wide-spread acceptance by the medical
community.
In November 2020 the Company submitted a request for a Breakthrough Device
Designation. Ultimately, this was denied, but the FDA acknowledged, "The FDA
does believe that RadioGel™ meets criterion #2a: Device represents breakthrough
technology. Your device does meet this criterion because it is a novel
application of a brachytherapy device outside of the liver." More importantly
the process resulted in a rapid review of our existing data and approach. It led
to a redirection of our efforts on writing the IDE and saved the Company much
time in the review of that future application.
26
Based on advice from the FDA the Company has scheduled a Pre-Submission meeting
on November 30, 2021 to discuss a draft of an Investigational Device Exemptions
(IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain
First in Human (FIH) Studies. Using this process results in more rapid feedback
to prepare the final IDE.
The FDA was very supportive and had suggested this Q-Submission path for rapid
turnaround and dialog. The Mayo Clinic physicians did an excellent job
presenting the need for Radiogel™ to treat recurrent thyroid cancer and to
answer a range of questions from the new FDA review team. The FDA provided many
helpful suggestions on a range of subjects from labeling to dosimetry to the
Mayo protocol for clinical testing, and the need for some additional specific
testing. They suggested having another Q-Sub Review and conference call
dedicated to the details of the dosimetry calculations.
In parallel the Company working with the Mayo Clinic's principal investigators
to improve the clinical trial protocol for their Institutional Review Board.
The MAB selected eighteen applications for RadioGel™, each of which meet the
criteria described above. This large number confirms the wide applicability of
the device and defines the path for future business growth. The Company's
application establishes a single Indication for Use - treatment of cancerous
tissue or solid tumors pathologically associated with locoregional papillary
thyroid carcinoma and recurrent papillary thyroid carcinoma. We anticipate that
this initial application will facilitate each subsequent application for
additional Indications for Use, and the testing for many of the subsequent
applications could be conducted in parallel, depending on available resources.
Financing and Strategy
The Company's stock offering under Regulation A+ was qualified by the Securities
and Exchange Commission ("SEC") on June 3, 2020. A second Regulation A+ was
qualified by the SEC on September 15, 2021 to raise capital for 50,000,000
shares at a price of $0.10 for a maximum of $5,000,000.
The Company's initial Regulation A+ raised approximately $4,000,000 from the
sale of shares under Regulation A+, and intends to use the proceeds generated as
follows:
For the animal therapy market:
? Fund the effort to communicate the benefits of IsoPet® to the veterinary
community and the pet parents.
? Conduct additional clinical studies to generate more data for the veterinary
community
? Subsidize some IsoPet® therapies, if necessary, to ensure that all viable
candidates are treated.
? Assist a new regional clinic with their license and certification training.
For the human market:
? Enhance the pedigree of the Quality Management System.
? Complete the previously defined pre-clinical testing and additional testing on
an animal model closely aligned with our revised indication for use. Report
the results to the FDA in a pre-submission meeting.
? Use the feedback from that meeting to write the IDE (Investigational Device
Exemption), which is required to initiate clinical trials.
Research and development of the Company's brachytherapy product line has been
funded with proceeds from the sale of equity and debt securities. The Company
may require additional funding of approximately $2 million annually to maintain
current operating activities. Over the next 12 to 24 months, the Company
believes it will cost approximately $9 million to: (1) fund the FDA approval
process to conduct human clinical trials, (2) conduct Phase I, pilot, clinical
trials, (3) activate several regional clinics to administer IsoPet® across the
county, (4) create an independent production center within the current
production site to create a template for future international manufacturing, and
(5) initiate regulatory approval processes outside of the United States. The
proceeds to be raised from the recent qualified Regulation A+ will be used to
continue to fund this development.
27
The continued deployment of the brachytherapy products and a worldwide
regulatory approval effort will require additional resources and personnel. The
principal variables in the timing and amount of spending for the brachytherapy
products in the next 12 to 24 months will be the FDA's classification of the
Company's brachytherapy products as Class II or Class III devices (or otherwise)
and any requirements for additional studies which may possibly include clinical
studies. Thereafter, the principal variables in the amount of the Company's
spending and its financing requirements would be the timing of any approvals and
the nature of the Company's arrangements with third parties for manufacturing,
sales, distribution and licensing of those products and the products' success in
the U.S. and elsewhere. The Company intends to fund its activities through
strategic transactions such as licensing and partnership agreements or from
proceeds to be raised from the recent qualified Regulation A+.
Following receipt of required regulatory approvals and financing, in the U.S.,
the Company intends to outsource material aspects of manufacturing,
distribution, sales and marketing. Outside of the U.S., the Company intends to
pursue licensing arrangements and/or partnerships to facilitate its global
commercialization strategy.
In the longer-term, subject to the Company receiving adequate funding,
regulatory approval for RadioGel™ and other brachytherapy products, and
thereafter being able to successfully commercialize its brachytherapy products,
the Company intends to consider resuming research efforts with respect to other
products and technologies intended to help improve the diagnosis and treatment
of cancer and other illnesses.
Based on the Company's financial history since inception, the Company's
independent registered public accounting firm has expressed substantial doubt as
to the Company's ability to continue as a going concern. The Company has limited
revenue, nominal cash, and has accumulated deficits since inception. If the
Company cannot obtain sufficient additional capital, the Company will be
required to delay the implementation of its business strategy and may not be
able to continue operations.
The Company has been impacted from the effects of COVID-19. The Company's
headquarters are in Northeast Washington however there focus of the animal
therapy market has been the Northwestern sector of the United States. The
Company continues their marketing to the animal therapy market and attempt to
increase the exposure to their product and generate revenue accordingly.
As of March 31, 2022, the Company has $1,221,825 cash on hand. There are
currently commitments to vendors for products and services purchased. To
continue the development of the Company's products, the current level of cash
may not be enough to cover the fixed and variable obligations of the Company.
There is no guarantee that the Company will be able to raise additional funds or
to do so at an advantageous price.
Product Features
The Company's RadioGel™ device has the following product features:
? Beta particles only travel a short distance so the device can deliver high
radiation to the tumor with minimal dose to the nearby normal tissues. In
medical terms Y-90 beta emitter has a high efficacy rate;
? Benefitting from the short penetration distance, the patient can go home
immediately with no fear of exposure to family members, and there is a greatly
reduced radiation risk to the doctor. A simple plastic tube around the
syringe, gloves and safety glasses are all that is required. Other gamma
emitting products require much more protection;
? A 2.7-day half-life means that only 5% of the radiation remains after ten
days. This is in contrast to the industry-standard gamma irradiation product,
which has a half-life of 17 days;
28
? The short half-life also means that any medical waste can be stored for thirty
days then disposed as normal hospital waste;
? RadioGel™ can be administered with small diameter needles (27-gauge) so there
is minimal damage to the normal tissue. This is in contrast to the injection
of metal seeds, which does considerable damage; and
? After about 120 days the gel resorbs by a normal biological cycle, called the
Krebs Cycle. The only remaining evidence of the treatment are phosphate
particles so small in diameter that it requires a high-resolution microscope
to find them. This is in contrast to permanent presence of metal seeds.
Steps from Production to Therapy
Device Production
During the next two years, the Company intends to outsource material aspects of
manufacturing and distribution. As future product volume increases, the Company
will reassess its make-buy decision on manufacturing and will analyze the
cost/benefit of a centrally located facility.
Production of the Hydrogel
RadioGel™ is manufactured with a proprietary process under ventilated sterile
hood by following strict Good Laboratory Practices ("GLP") procedures. It is
made in large batches that are frozen for up to three months. When the product
is ready to ship, a small quantity of the gel is dissolved in a sterile saline
solution. It is then passed through an ultra-fine filter to ensure sterility.
Production of the Yttrium-90 Phosphate Particles
The Y-90 particles are produced with simple ingredients via a proprietary
process, again following strict GLP procedures. They are then mixed into a
phosphate-buffered saline solution. They can be produced in large batches for
several shipments. The number of particles per shipment is determined by the
dose prescribed by the doctor.
Shipment
RadioGel™ is shipped in two containers, one with a solution of the gel and the
other with a solution of the particles. Before shipment they are subjected to
sterility testing, again by strict procedures. The vial with the Y-90 is put
through a special radiation calibrator, which measures beta particles. The vials
can be shipped via FedEx or UPS by following the proper protocols.
At the User
The user receives the two vials. The solution containing the RadioGel™ is mixed
with the solution containing the Y-90 particles. This is then shaken to ensure
homogeneity and withdrawn into a syringe. The quantities that are mixed are
calculated from the information on the product label.
The specific injection technique depends on the Indication for Use. For small
tumors, one centimeter in diameter or less, the cancer is treated with a single
injection. For larger tumors, the cancer is treated with a series of small
injections from the same syringe or multiple syringes.
Principal Markets
The Company is currently pursuing two synergistic business sectors, medical and
veterinary, each of which are summarized below.
29
Medical Sector
RadioGel™ is currently fully developed, requiring only FDA approval before
commercialization. The Company has been seeking FDA approval of RadioGel™ for
almost five years. Recent progress has been delayed due to a lack of adequate
funding. The principal issue preventing approval is that the Company attempted
to obtain regulatory approval for a broad range of Indications for Use,
including all non-resectable cancers, without sufficient supporting data.
Building on the FDA's ruling of RadioGel™ as a device, the Company is currently
developing test plans to address issues raised in the Company's prior FDA
submittal regarding RadioGel™. The Company intends to request FDA approval to
submit RadioGel™ for de novo classification, which would reclassify the device
from a Class III device to a Class II device and accelerate the regulatory
approval path.
After analyzing the Company's data and the last five years of communication from
the FDA, the Company has taken the following steps:
1. Under new leadership, the Company is implementing all past recommendations
from the FDA. The Company intends to narrow the Indications for Use, will
provide test plans for FDA review to respond to answer all previous FDA
questions, and will request a pre-submission meeting;
2. Prepare a pre-submission request document and FDA meeting request to obtain
feedback on the test plans in order to initiate testing, to present the
proposed content for the final application and to request permission to
submit a de novo;
3. Submit an Investigational Device Exemption ("IDE") to obtain permission to
conduct human clinical studies; and
4. File a de novo or Pre-Market Approval application.
The critical path is the required testing - in vitro, animal testing, human
clinical studies - all of which is resource dependent.
In previous submittals, the Company proposed applying a very broad range of
cancer therapies, referred to as Indications for Use, to RadioGel™. The FDA has
strongly advised the Company to reduce its Indications for Use. To comply with
that request, the Company has expanded its MAB, consisting of Drs. Barry D.
Pressman (Chairman), Albert DeNittis, and Howard Sandler.
The MAB evaluated the candidate cancer therapies based on three criteria: (i)
the potential for FDA approval and successful therapy; (ii) notable advantages
of RadioGel™ over current therapies; and (iii) the likelihood that RadioGel™ can
be widely accepted by the medical community and profitably commercialized.
The MAB selected eighteen Indications for Use for RadioGel™, each of which meets
the above-mentioned criteria. These eighteen Indications for Use are listed
below. This large number confirms the wide applicability of the device and
defines the path for future growth. The Company intends to apply to the FDA for
a single Indication for Use, followed by subsequent applications for additional
Indications for Use. The initial application should facilitate each subsequent
application, and the testing for many of the subsequent applications could be
conducted in parallel, depending on available resources.
? Skin cancer ? Non-dendritic brain
? Involved lymph nodes ? Pediatric cancers - several
types
? Bladder ? Rectal
? Liver ? Gynecological
? Localized prostate ? Spinal
? Pancreas ? Recurrent esophageal
? Head and neck (including sino-nasal and ? Breast cancer resection cavity
oropharyngeal)
? Ocular melanoma ? Anaplastic thyroid
30
Veterinary Sector
There are approximately 150 million pet dogs and cats in the United States.
Nearly one-half of dogs and one-third of cats are diagnosed with cancer at some
point in their lifetime. The Veterinary Oncology & Hematology Center in Norwalk,
Connecticut, reports that cancer is the number one natural cause of death in
older cats and dogs, accounting for nearly 50 percent of pet deaths each year.
The American Veterinary Medical Association reports that half of the dogs ten
years or older will die because of cancer. The National Cancer Institute reports
that about six million dogs are diagnosed with cancer each year, translating to
more than 16,000 a day.
The Company's IsoPet® operating division focuses on the veterinary oncology
market. Dr. Alice Villalobos, a founding member of the Veterinary Cancer Society
and the Chair of our Veterinary Medicine Advisory Board, has been providing
guidance to management regarding this market. The Veterinary Medicine Advisory
Board gives us recommendations regarding the overall strategy for our animal
business sector. Specially, they recommended the university veterinary hospitals
for demonstration therapies, the specific cancers to be treated, and have
provided business contact information to the private clinics.
Development of the product and application techniques and animal testing is
allowed under FDA regulation. Commercial sales of RadioGelTM for animals
requires confirmation by the FDA Center for Veterinary Medicine ("CVM"). In
January 2018, the Center for Veterinary Medicine Product Classification Group,
the entity within the CVM that is responsible for determining the classification
of a product, ruled that RadioGelTM should be classified as a device for animal
therapy of feline sarcomas and canine soft tissue sarcomas.
Additionally, after a legal review, the Company believes that the device
classification obtained from the FDA Center for Veterinary Medicine is not
limited to canine and feline sarcomas, but rather may be extended to a much
broader population of veterinary cancers, including all or most all solid tumors
in animals. We expect the result of such classification and label approval will
be that no additional regulatory approvals are necessary for the use of
RadioGelTM for the treatment of solid tumors in animals. The FDA does not have
premarket authority over devices with a veterinary classification, and the
manufacturers are responsible for assuring that the product is safe, effective,
properly labeled, and otherwise in compliance with all applicable laws and
regulations.
The Company currently intends to utilize university veterinary hospitals for
therapy development, given that veterinary hospitals offer superior and
plentiful veterinarians and students, a large number of animal patients,
radioactive material handling licenses, and are respected by private veterinary
centers and hospitals.
Competitors
The Company competes in a market characterized by technological innovation,
extensive research efforts, and significant competition.
The pharmaceutical and biotechnology industries are intensely competitive and
subject to rapid and significant technological changes. A number of companies
are pursuing the development of pharmaceuticals and products that target the
same diseases and conditions that our products target. We cannot predict with
accuracy the timing or impact of the introduction of potentially competitive
products or their possible effect on our sales. Certain potentially competitive
products to our products may be in various stages of development. Also, there
may be many ongoing studies with currently marketed products and other
developmental products, which may yield new data that could adversely impact the
use of our products in their current and potential future Indications for Use.
The introduction of competitive products could significantly reduce our sales,
which, in turn would adversely impact our financial and operating results.
There are a wide variety of cancer treatments approved and marketed in the U.S.
and globally. General categories of treatment include surgery, chemotherapy,
radiation therapy and immunotherapy. These products have a diverse set of
success rates and side effects. The Company's products, including RadioGel™,
fall into the brachytherapy treatment category. There are a number of
brachytherapy devices currently marketed in the U.S. and globally. The
traditional iodine-125 (I-125) and palladium-103 (Pd-103) technologies for
brachytherapy are well entrenched with powerful market players controlling the
market. The industry-standard I-125-based therapy was developed by Oncura, which
is a unit of General Electric Company. Additionally, C.R. Bard, a major industry
player competes in the I-125 brachytherapy marketplace. These market competitors
are also involved in the distribution of Pd-103 based products. Cs-131
brachytherapy products are sold by IsoRay. Several Y-90 therapies have been FDA
approved including SIR-Spheres by Sirtex, TheraSphere by Biocompatibles UK and
Zevalin by Spectrum Pharmaceuticals.
31
Raw Materials
The Company currently subcontracts the manufacturing of RadioGelTM at
IsoTherapeutics. Prior to 2021, Eckert and Ziegler was the only supplier of Y-90
in the United States, and was the sole supplier of the Y-90 used by
IsoTherapeutics to manufacture the Company's RadioGel™. The Company obtains
supplies, hardware, handling equipment and packaging from several different U.S.
suppliers.
During 2021, utilized Akina, Inc. as an alternate supplier of its hydrogel
polymer component.
Customers
The Company anticipates that potential customers for our potential brachytherapy
products likely would include those institutions and individuals that currently
purchase brachytherapy products or other oncology treatment products.
Government Regulation
The Company's present and future intended activities in the development,
manufacturing and sale of cancer therapy products, including RadioGel™, are
subject to extensive laws, regulations, regulatory approvals and guidelines.
Within the United States, the Company's therapeutic radiological devices must
comply with the U.S. Federal Food, Drug and Cosmetic Act, which is enforced by
FDA. The Company is also required to adhere to applicable FDA Quality System
Regulations, also known as the Good Manufacturing Practices, which include
extensive record keeping and periodic inspections of manufacturing facilities.
In the United States, the FDA regulates, among other things, new product
clearances and approvals to establish the safety and efficacy of these products.
We are also subject to other federal and state laws and regulations, including
the Occupational Safety and Health Act and the Environmental Protection Act.
The Federal Food, Drug, and Cosmetic Act and other federal statutes and
regulations govern or influence the research, testing, manufacture, safety,
labeling, storage, record keeping, approval, distribution, use, reporting,
advertising and promotion of such products. Noncompliance with applicable
requirements can result in civil penalties, recall, injunction or seizure of
products, refusal of the government to approve or clear product approval
applications, disqualification from sponsoring or conducting clinical
investigations, preventing us from entering into government supply contracts,
withdrawal of previously approved applications, and criminal prosecution.
In the United States, medical devices are classified into three different
categories over which the FDA applies increasing levels of regulation: Class I,
Class II, and Class III. Most Class I devices are exempt from premarket
notification 510(k); most Class II devices require premarket notification
510(k); and most Class III devices require premarket approval. RadioGel™ is
currently classified as a Class III device.
Approval of new Class III medical devices is a lengthy procedure and can take a
number of years and require the expenditure of significant resources. There is a
shorter FDA review and clearance process for Class II medical devices, the
premarket notification or 510(k) process, whereby a company can market certain
Class II medical devices that can be shown to be substantially equivalent to
other legally marketed devices.
The Company intends to apply for a de novo with an anticipated expenditure of
$10.0 million over the next four years. This expenditure estimate includes
anticipated costs associated with in vitro and in vivo pre-clinical testing, our
application for an Investigational Device Exemption, Phase I and Phase II
clinical trials and our application for a de novo.
32
As a registered medical device manufacturer with the FDA, we are subject to
inspection to ensure compliance with FDA's current Good Manufacturing Practices,
or cGMP. These regulations require that we and any of our contract manufacturers
design, manufacture and service products, and maintain documents in a prescribed
manner with respect to manufacturing, testing, distribution, storage, design
control, and service activities. Modifications or enhancements that could
significantly affect the safety or effectiveness of a device or that constitute
a major change to the intended use of the device require a new 510(k) premarket
notification for any significant product modification.
The Medical Device Reporting regulation requires that we provide information to
the FDA on deaths or serious injuries alleged to be associated with the use of
our devices, as well as product malfunctions that are likely to cause or
contribute to death or serious injury if the malfunction were to recur. Labeling
and promotional activities are regulated by the FDA and, in some circumstances,
by the Federal Trade Commission.
As a medical device manufacturer, we are also subject to laws and regulations
administered by governmental entities at the federal, state and local levels.
For example, our facility is licensed as a medical device manufacturing facility
in the State of Washington and is subject to periodic state regulatory
inspections. Our customers are also subject to a wide variety of laws and
regulations that could affect the nature and scope of their relationships with
us.
In the United States, as a manufacturer of medical devices and devices utilizing
radioactive byproduct material, we are subject to extensive regulation by not
only federal governmental authorities, such as the FDA and FAA, but also by
state and local governmental authorities, such as the Washington State
Department of Health, to ensure such devices are safe and effective. In
Washington State, the Department of Health, by agreement with the federal
Nuclear Regulatory Commission ("NRC"), regulates the possession, use, and
disposal of radioactive byproduct material as well as the manufacture of
radioactive sealed sources to ensure compliance with state and federal laws and
regulations. RadioGel™ constitutes both medical devices and radioactive sealed
sources and are subject to these regulations.
Moreover, our use, management, and disposal of certain radioactive substances
and wastes are subject to regulation by several federal and state agencies
depending on the nature of the substance or waste material. We believe that we
are in compliance with all federal and state regulations for this purpose.
Environmental Regulation
Our business does not require us to comply with any extraordinary environmental
regulations. Our RadioGel™ product is manufactured in an independently owned and
operated facility. Any environmental effects or contamination event that could
result would be from the shipping company during shipment and misuse by the
treatment facility upon arrival.
Human Capital
As of March 31, 2022, the Company had one full-time personnel. The Company
utilizes several independent contractors to assist with its operations. The
Company does not have a collective bargaining agreement with any of its
personnel and believes its relations with its personnel are good.
Results of Operations
Comparison of the Three Months Ended March 31, 2022 and 2021
The following table sets forth information from our statements of operations for
the three months ended March 31, 2022 and 2021:
Three Months Ended Three Months Ended
March 31, 2022 March 31, 2021
Revenues $ 13,000 $ -
Cost of goods sold (3,000 ) -
Gross profit 10,000 -
Operating expenses (757,493 ) (235,090 )
Operating loss (747,493 ) (235,090 )
Non-operating income (expense) 47,588 (53,099 )
Net loss $ (699,905 ) $ (288,189 )
33
Revenues and Cost of Goods Sold
Revenue was $13,000 and $0 for the three months ended March 31, 2022 and 2021,
respectively. All revenue recognized in the three months ended March 31, 2022
and 2021 relate to consulting income with respect to the IsoPet® therapies.
Management does not anticipate that the Company will generate sufficient revenue
to sustain operations until such time as the Company secures multiple
revenue-generating arrangements with respect to RadioGel™ and/or any of our
other brachytherapy technologies.
Operating Expenses
Operating expenses for the three months ended March 31, 2022 and 2021,
respectively consists of the following:
Three months ended Three months ended
March 31, 2022 March 31, 2021
Professional fees, including stock-based
compensation $ 577,037 $ 78,214
Payroll expenses 70,787 49,341
Research and development 72,569 71,700
General and administrative expenses 37,100 35,835
Total operating expenses $ 757,493 $ 235,090
Operating expenses for the three months ended March 31, 2022 and 2021 was
$757,493 and $235,090, respectively. The increase in operating expenses from
2021 to 2022 can be attributed to the increase in professional fees ($78,214 for
the three months ended March 31, 2021 versus $577,037 for the three months ended
March 31, 2022) as the Company's consultants increased their services as they
were ramping up operations and the increases related to the vesting of the RSUs
of $454,880; the increase in general and administrative expense ($35,835 for the
three months ended March 31, 2021 versus $37,100 for the three months ended
March 31, 2022); the increase in research and development ($71,700 for the three
months ended March 31, 2021 versus $72,569 for the three months ended March 31,
2022) as the Company ramped up the development of their products to include
studies that are required to continue to have their products accepted by the
FDA, and an increase in payroll expenses ($49,341 for the three months ended
March 31, 2021 versus $70,787 for the three months ended March 31, 2022) related
to the CEOs employment contract.
Non-Operating Income (Expense)
Non-operating income (expense) for the three months ended March 31, 2022 and
2021 consists of the following:
Three months ended Three months ended
March 31, 2022 March 31, 2021
Interest expense $ - $ (6,549 )
Forgiveness of debt 47,588 129,745
Loss on debt extinguishment - (176,295
Non-operating income (expense) $ 47,588 $ (53,099 )
34
Non-operating income (expense) for the three months ended March 31, 2022 varied
from the three months ended March 31, 2021 primarily due to a decrease in
interest expense from $6,549 for the three months ended March 31, 2021 to $0 for
the three months ended March 31, 2022 as a result of conversions and repayments
of notes payable. In addition, the Company converted a note in January 2021
which resulted in a loss on conversion and recognized a gain on forgiveness of
debt on old payables as they satisfied agreements with vendors to pay a portion
of the payable with the remaining amount forgiven in both 2021 and 2022.
Net Loss
Our net loss for the three months ended March 31, 2022 and 2021 was $(699,905)
and $(288,189), respectively.
Liquidity and Capital Resources
At March 31, 2022, the Company had working capital of $1,222,358, as compared to
working capital of $1,467,383 at December 31, 2021. During the three months
ended March 31, 2022 and 2021, the Company experienced negative cash flow from
operations of $384,298 and $203,097 and realized $0 and $1,811,238 of cash flows
from financing activities. As of March 31, 2022, the Company did not have any
commitments for capital expenditures.
Cash used in operating activities increased from $203,097 for the three months
ended March 31, 2021 to $384,298 for the three months ended March 31, 2022. Cash
used in operating activities was primarily a result of the Company's non-cash
items, such as loss from operations, stock based compensation, loss conversion
of debt as well as forgiveness of debt as well as the changes in prepaid
expenses and accounts payable. Cash provided from financing activities decreased
from $1,811,238 for the three months ended March 31, 2021 to $0 for the three
months ended March 31, 2022. The decrease in cash provided from financing
activities was primarily a result of increase in proceeds from the Regulation A+
where the Company raised $1,811,238 from common stock and warrant issuances in
2021 versus, $0 in 2022.
The Company has generated material operating losses since inception. The Company
had a net loss of $699,905 for the three months ended March 31, 2022, and a net
loss of $288,189 for the three months ended March 31, 2021. The Company expects
to continue to experience net operating losses for the foreseeable future.
Historically, the Company has relied upon investor funds to maintain its
operations and develop the Company's business. The Company anticipates raising
additional capital within the next twelve months for working capital as well as
business expansion, although the Company can provide no assurance that
additional capital will be available on terms acceptable to the Company, if at
all. If the Company is unable to obtain additional financing to meet its working
capital requirements, it may have to curtail its business or cease all
operations.
The Company requires funding of at least $5 million per year to maintain current
operating activities. Over the next 24 months, the Company believes it will cost
approximately $9 million to fund: (1) fund the FDA approval process to conduct
human clinical trials, (2) conduct Phase I, pilot, clinical trials, (3) activate
several regional clinics to administer IsoPet® across the county, (4) create an
independent production center within the current production site to create a
template for future international manufacturing, and (5) initiate regulatory
approval processes outside of the United States.
The principal variables in the timing and amount of spending for the
brachytherapy products in the next 12 to 24 months will be the FDA's
classification of the Company's brachytherapy products as Class II or Class III
devices (or otherwise) and any requirements for additional studies, which may
possibly include clinical studies. Thereafter, the principal variables in the
amount of the Company's spending and its financing requirements would be the
timing of any approvals and the nature of the Company's arrangements with third
parties for manufacturing, sales, distribution and licensing of those products
and the products' success in the U.S. and elsewhere. The Company intends to fund
its activities through strategic transactions such as licensing and partnership
agreements or additional capital raises.
Although the Company is seeking to raise additional capital and has engaged in
numerous discussions with investment bankers and investors, to date, the Company
has not received firm commitments for the required funding. Based upon its
discussions, the Company anticipates that if the Company is able to obtain the
funding required to retire outstanding debt, pay past due payables and maintain
its current operating activities, that the terms associated with such funding
will result in material dilution to existing shareholders.
Recent geopolitical events, including the inherent instability and volatility in
global capital markets, as well as the lack of liquidity in the capital markets,
could impact the Company's ability to obtain financing and its ability to
execute its business plan.
35
Accounting Policies and Estimates
The preparation of financial statements and related disclosures in conformity
with accounting principles generally accepted in the United States of America
requires management to make estimates and assumptions that affect the amounts
reported in the unaudited condensed financial statements and accompanying notes.
Management bases its estimates on historical experience and on various other
assumptions that are believed to be reasonable under the circumstances. Actual
results could differ from these estimates under different assumptions or
conditions. During the period ended March 31, 2022, we believe there have been
no significant changes to the items disclosed as significant accounting policies
in management's notes to the financial statements in our annual report on Form
10-K for the year ended December 31, 2021, filed on March 7, 2022.
Off-Balance Sheet Arrangements
The Company does not have any off-balance sheet arrangements that are reasonably
likely to have a current or future effect on the Company's financial condition,
revenues, results of operations, liquidity or capital expenditures.
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