AMERICAN CRYOSTEM CORPORATION Forward-looking Statements
We and our representatives may from time to time make written or oral statements
that are "forward-looking," including statements contained in this quarterly
report and other filings with the
· Inadequate capital and barriers to raising the additional capital or to
obtaining the financing needed to implement our business plans;
· Our failure to earn revenues or profits;
· Inadequate capital to continue business;
· Volatility or decline of our stock price;
· Potential fluctuation in quarterly results;
· Rapid and significant changes in markets;
· Litigation with or legal claims and allegations by outside parties; and
· Insufficient revenues to cover operating costs.
The following discussion should be read in conjunction with the financial statements and the notes thereto which are included in this quarterly report. This discussion contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ substantially from those anticipated in any forward-looking statements included in this discussion as a result of various factors.
16 Background
Overview
Due to the effects of the Corona pandemic, we have focused our efforts to
advance clinical studies for our autologous therapeutic cellular product, ATCell
(autologous adipose derived mesenchymal stem cells), patented technologies and
business methods. Our focus on advancing ATCELL into clinical study has resulted
in the Company's approved Investigational New Drug Application (IND) with the
Significant to this FDA approval was the review of our Chemistry Manufacturing and Control (CMC) modules of our IND filing (our ATCell manufacturing platform) and acceptance of the platform to manufacture the clinical trial samples for IV infusion delivery to the trial participants.
The Company has refined its IND strategy to advance its application approval
process and development efforts to focus on low-risk treatments in the short
term. The Company will leverage its validated ATCell manufacturing platform
(CMC) to produce cellular samples for direct injection into joints for the
treatment of osteoarthritis and for topical use in the treatment of non-healing
wounds such as diabetic ulcers and bed sores. The Company believes that based
upon
The Company's long-term goals include completion of its approved Post-Concussion
Syndrome study and, further development of ATCell as a treatment regimen for
incurable and untreatable systemic diseases such as Duchene Muscular Dystrophy,
and a currently planned study treatment of the post infection symptoms
associated with COVID-19 or Long COVID. The Company is currently working with
clinical partners to complete development of the study protocols and expects to
file these additional IND applications in Fiscal 2022. The Company believes that
its long term focus on systemic diseases with significant untreated neurologic
conditions will provide future opportunities for clinical studies of ATCell for
Alzheimer's Disease, Parkinson's Disease, Amyotrophic Lateral Sclerosis (ALS or
The Company believes the reproducibility of scientific studies is a substantial
issue in life science research from drug discovery and development through
clinical trials as researchers throughout the world continue to use different
materials and protocols for processes associated with sample preparation,
cryopreservation and cold chain management. We believe our validated and
standardized handling, processing, storage, and transportation protocols (CMC
platform) has substantially improved the quality and reproducibility of our
preclinical data already submitted to the
Simultaneously with the development and validation of its platform technologies
for the collection processing and storage of tissue and cellular samples, the
Company has built a strong, strategic portfolio of intellectual property, patent
applications, and proprietary operating processes that form its core
standardized cellular platform which we believe supports and promotes a growing
pipeline of biologic products and processes, services, and international
licensing opportunities. Our FDA registered laboratory for human tissue
processing, cryo-storage and cell culture and differentiation media development
is located in
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The Company has successfully negotiated a
The Company also markets a proprietary, patent pending processing platform for the collection, preparation, and cryo-preservation of adipose tissue without manipulation, bio-generation, animal-derived products or other chemical materials. The platform is used by plastic and cosmetic surgeons for the storage of adipose tissue for future tissue transfer procedures and is compliant with Section 361 of the US Food, Drug and Cosmetic Act and Title 21 part 1271 of the US Code of Federal Regulations for use as a homologous filler. Management believes this core process makes each adipose tissue sample suitable for use in cosmetic grafting procedures or for further processing to adult stem cells for other types of stem cell therapies.
Products and Services
ATCELL™ Adipose Derived Stem Cells (ADSCs) Processed and characterized adipose
derived regenerative cells (ADRCs), mesenchymal stem cells (MSCs) are cultured
utilizing the Company's proprietary Standard Operating Procedures (SOPs),
ACSelerate™ patented cell culture and differentiation media and processing
methodology. Cell lines are custom created and stored for patients that can be
delivered "On Demand" for their personal use in future Regenerative Medicine
procedures when approved for use by FDA or for use under the
The Company's ATCELL™ cell lines are processed and cultured in our patented ACSelerate™ cell culture media. All tissue, cells, and research materials made available for sale to research institutions are tested for sterility, disease, lifespan, and population doubling rate (PDL). Cell morphology is confirmed by (i) flow cytometry and (ii) differentiation analysis using ACSelerate™ differentiation media. Each ATCELL™ line can be further cultured and differentiated allowing the Company to provide genetically matched cell types. We believe this research methodology may provide opportunities for the Company's ATCELL™and ACSelerate™ products to become the building blocks of final developed commercial applications.
CELLECT® Validated Collection, Transportation, and Storage System - The Company
developed and implemented an unbreakable "chain of custody" clinical solution to
collect and deliver tissue samples utilizing proprietary and patented methods
and materials. The CELLECT® service successfully eliminated the high cost and
logistical complications associated with utilizing liquid nitrogen DEWARS or dry
ice during shipments of adipose tissue. The service is monitored in real-time
and assures the highest cell viability upon laboratory receipt. The CELLECT®
system incorporates our proprietary ACSelerate-TR™ transport medium into all
collection bags which supports the health of the tissue during transport at
ambient temperature. The CELLECT® kit is an integral part of our validated
ATGRAFT™ and ATCELL™ technology platform to be used by our domestic physician
network and licensees of our platform technologies. The CELLECT®service is
included in our granted patent "Business Method for Collection, Processing,
Cryogenic Storage and Distribution of a Biologic Sample Material" US Patent
Number 10,014,079, issued
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During the development of the CELLECT® service the Company incorporated the
International Blood Banking identification and labeling and product
identification coding system. The coding system was developed in conjunction
with the
ATGRAFT™ Adipose Tissue Storage Service
The Company developed this clinical fat processing and storage (ATGRAFT™) as a
solution for physicians to provide their patients with multiple tissue and cell
storage options. Through one liposuction procedure, the ATGRAFT™ service, allows
individuals to prepare for future cosmetic or regenerative procedures by storing
multiple samples of their own adipose tissue to be returned in the future as a
natural biocompatible filler, or to be further processed to create cellular
therapy applications without the trauma of further liposuctions. ATGRAFT™
procedures may include breast reconstruction, layered augmentation, buttocks
enhancement or volume corrections of the hands, feet, face and neck areas that
experience significant adipose tissue (fat) volume reduction as we age. ATGRAFT™
is processed and stored utilizing our validated standard operating procedures so
that stored fat tissue sample(s) may be retrieved in the future and delivered to
the physician on demand or for re-processing to create stem cells "ATCELL™" for
use in Regenerative medicine applications. The Company charges fees for the
reprocessing of a 25ml stored ATGRAFT™ sample and may charge additional fee's if
expansion of the newly created ATCELL™ sample is also requested. The ATGRAFT™
service is included in our granted patent "Business Method for Collection,
Processing, Cryogenic Storage and Distribution of a Biologic Sample Material" US
Patent Number 10,014,079, issued
The Company charges standardized fees for ATGRAFT™ tissue processing based upon the volume of tissue stored. These processing fees may be paid to the Company by the collecting/treating physician or the consumer. The Company earns additional fees, for storage, thawing, packaging and shipment of the stored samples back to the physician or clinic for immediate use upon receipt. The ATGRAFT™ service lowers physician/patient overall costs by eliminating additional liposuction procedures for each scheduled fat transfer or therapy procedure. Physician cost savings may include: materials, supplies, equipment, and the expenses of utilizing a surgical center, hospital operating room or an in-office aseptic procedure room. The ATGRAFT™ service is designed to operate under the minimally manipulated regulations contained in both 21 CFR 1271.10 and PHS 361.
Cell Culture Media Products- On
The Company developed and patented cell culture media products for growing human stromal cells (including all cells found in human skin, fat and other connective tissue). ACSelerate™ MAX cell culture media is manufactured animal serum free, which is suitable for human clinical and therapeutic uses. Additional versions have been developed and patented for application development and research purposes. The ACSelerate™ cell culture media product line was specifically developed to address increasing industry demands for animal serum-free cell culture products and for the acceleration of products from the laboratory to the patient.
On
19
On
We have generated minimal culture media revenue from
Contract Manufacturing, Autokine-CM® Anti-Aging, Autologous Skin Care Product
Line - Under agreement with
Our Company's contract manufacturing services can be extended to develop custom and/or white label products and services for both local and global cosmetic and regenerative medicine companies, physicians, wellness clinics and medical spas. The Company intends to expand its relationships and contract manufacturing services domestically.
International Licensing Program -Many jurisdictions outside the US currently
permit use of cellular therapies and regenerative medicine applications. The
Company receives international inquiries concerning the sale or licensing of our
SOPs, products and services into the Regenerative Medicine and Medical Tourism
Markets. The Company believes that the inquiries to date are a result of the
global boom in Regenerative Medicine, Medical Tourism and, the pace of approval
of cellular therapies and regenerative medicine applications in the US. To
address the Company's sales, marketing and branding opportunities globally, the
Company has created its international licensing program. To date we have
licensed our technologies in
The Company believes it can take advantage of the significant growth of the
global cellular therapy market through its international licensing and marketing
efforts. A recently published study by
(https://www.transparencymarketresearch.com/pressrelease/stem-cells-market.htm)
On
20Hong Kong
On
In 2017 as part of the Company's transaction with Baoxin, HIT and the Company
agreed to transfer certain product and distribution rights granted to HIT under
its 2014 agreement to Baoxin. The Company was paid a fee of US
On
The Company assisted CRYOVIVA with the development of their branding and
marketing campaign for
Product Development
Our strategic approach to product development is to design, develop and launch new products and services that utilize our existing products and services, i.e. the use of the CELLECT® collection materials in providing ATCell and ATGRAFT™ processing and storage services. This approach allows progress with our co-developed clinical studies to build our application pipeline with cellular therapies. We can rely upon the production and validation data to support our FDA application and Biologic License Application filings. Management believes that this approach may also provide the Company with opportunities to attract strong international licensing and collaborative partners and accumulate complementary scientific data.
21
To leverage the Company's development efforts, the Company incorporates its proprietary and patented patent pending laboratory products, such as our ACSelerate™ cell culture media, into our processing and product production services. The Company requires licensees of our tissue and cell processing technologies to purchase the consumable products required in the collection, processing, and storage of tissue/stem cells as part of the licensing agreement including our CELLECT® Collection, Transportation, and Storage System and ACSelerate™ Cell Culture Media Products. Strategically, the incorporation of proprietary products into our current clinical studies generates the uniform and consistent data necessary to support product approval applications with FDA.
Our product development efforts have resulted in completing and validating the
Company's platform technologies for the collection, processing and storage of
adipose tissue and stem cells evidences the Company's ability to provide uniform
cell samples and quantities from any adipose tissue sample. The consistency of
the platform to produce autologous cellular therapy samples allows for the
collection of reproduceable manufacturing results and additional clinical study
data which is required by the
The Company's validated its platform technologies for the Chemistry Manufacturing and Control (CMC) sections of its submitted and approved IND application for Post-Concussion Syndrome. The Company will incorporate and rely on the approved CMC as the manufacturing platform for all future IND applications with the FDA which management believes will help to accelerate the approval of its planed studies for orthopedic, wound healing and Duchene Muscular Dystrophy clinical study applications.
We intend to expand our product and services pipelines based upon our intellectual property portfolio, FDA clinical study applications, collaborative development relationships, and international licensing and partnering opportunities. Our plans include supporting collaborations by providing our products and services with the expectation that they become the basis for new adipose tissue and stem cell based Regenerative Medicine therapies, FDA clinical study applications approved biologic license approvals.
Investigational New Drug (IND)
The Company filed its first Investigational New Drug Application (IND) with the
On
A
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The Company maintains the rights to commercialize all technology developed under this CRADA Agreement. The technology is centered on creating in vitro (test tube) assays to standardize and commercialize new treatment protocols; optimizing quality control measures; and developing standardized protocol potency assays for precise therapy dosing.
Management believes that these new assays can be commercialized to generate substantial sales and licensing revenues and create value for the Company's stakeholders.
Through the Collaboration entitled "Stem Cells for Regeneration and Medical
Innovation, a multi-faceted and multi-staged research project with
WRNMMC is part of
The missions of the MHS are complex and interrelated: To ensure America's 1.4 million active duty and 331,000 reserve-component personnel are healthy so they can complete their national security missions.
· To ensure that all active and reserve medical personnel in uniform are trained
and ready to provide medical care in support of operational forces around the
world.
· To provide a medical benefit commensurate with the service and sacrifice of
more than 9.5 million active-duty personnel, military retirees, and their
families.
The MHS also provides health care, through the TRICARE health plan, to:
· Active-duty service members and their families,
· Retired service members and their families,
· Reserve component members and their families,
· Surviving family members,
· Medal of Honor recipients and their families
· Some former spouses, and
· Others identified as eligible in the Defense Enrollment Eligibility Reporting
System
The MHS has a $50+ billion budget and serves approximately 9.5 million beneficiaries. The MHS employs more than 144,217 in 51 hospitals, 424 clinics, 248 dental clinics and 251 veterinary facilities across the nation and around the world, as well as in contingency and combat-theater operations worldwide.
The Company's long term research is focused on further developing standardized cellular processing models to support FDA, IND treatment protocol approvals by further identifying, and validating certain mechanisms and characteristics of mesenchymal stem cells related to regulating modulation of immune response(s) and promoting tissue regeneration and stability (homeostasis) for the treatment of traumatic injuries, inflammation, auto-immune diseases, and brain and organ damage associated with viruses such as SARS-CoV-2 (COVID-19), including, the expanding group of people dealing with the chronic and debilitating symptoms of what is commonly termed "Long Haul COVID" or "Long COVID."
23PeproTech, Inc.
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Cells on Ice:
In August of 2015 the Company entered into an Agreement with
On
Additional Collaborations
The Company is developing collaborations with industry and university partners. These developing relationships in their earliest stages are covered by Confidential Disclosure Agreements (CDA) and those that are more advanced may also include Material Transfer Agreements (MTA) under which the Company supplies either ATCELL™ or ACSelerate™ medium products for evaluation, testing, and the development of new cellular therapy applications. No assurance can be given that these relationships will progress to full collaborative agreements or ultimately result in new technology for future commercialization.
Intellectual Property
From the Company's formation, our strategy has been to invest time and capital
in intellectual property protection. This strategy is intended to strengthen our
Company's foundation in any defensive or offensive legal challenge. In addition,
we are developing our IP portfolio to ensure and enhance our business
flexibility and allow us to gain favorable terms in potential future
collaborative partnerships with third parties. Our intellectual property
portfolio currently includes four issued
24
Title Technology Patent / Application
Number
ACS cell culture media
Cell culture media, Kits, and line US Patent No. 7,989,205
Methods of Use Covers 12 types of Issued August 2, 2011
Medium
ACS cell culture media US Patent No. 9,487,755
Cell culture media, Kits, and line Issued November 8, 2016
Methods of Use Additional claim Granted Continuation of US
for all 12 medium types Patent No. 7,989,205
ACS cell culture media US Patent Application
Cell culture media, Kits, and line No. 15/344,805
Methods of Use Continuation of Granted Continuation of US
Patent covering Patent No. 7,989,205
additional improvements
PCT/US15/68350
30 month National Phase
A cell culture medium entry date of June 31,
Human serum for cell culture for growth of human 2017, additional
medium for growth of human adipose stromal cells International Filings
adipose stromal cells for human and for China, India, the
therapeutic applications European Union, Saudi
Arabia, Israel, Brazil,
Mexico, Australia and
New Zealand.
Company Core Tissue US Serial No 13/194,900
Collection Processing Filed June 6, 2010
A Business Method for and Storage Methodology Patent Application
Collection, Cryogenic Storage Covers CELLECT Kit, Published
and Distribution of a Transport and December 5, 2013 Claims
Biological Sample Material Cryopreservation Medium Granted US Patent No.
for ATGRAFT and ATCELL 10,014,079. Continuation
Products filed upon issuance.
Developed Improvement
Company Core Tissue established; Divisional,
A Business Method for Collection Processing Continuation-In-Part
Collection, Cryogenic Storage and Storage Methodology claiming priority to US
and Distribution of a Continuation covering Serial No. 13/194,900
Biological Sample Material Improvements imminent (PCT
Application filing
planned)
Systems and Methods for the Adipose Tissue Digestion
filed October 6, 2011 ,
For Cryopreservation Claims Granted US Patent
No.10,154,664 December
18,2018 . Continuation
filed upon issuance.Systems and Methods for the Adipose Tissue Digestion Developed Improvement Digestion of Adipose Tissue Laboratory Processing established; Divisional, Samples Obtained From a Client Methods
Continuation-In-Part
For Cryopreservation claiming priority to US
Serial No. 13/646,900
imminent (PCT
Application filing
planned)
Compositions and Methods for Company Adipose Tissue U.S. Serial No.
collecting, Washing, Storage Platform for 14/406,203 National
Cryoprocessing, Recovering and Cosmetic Procedures Phase entry date of
Return of Lipoaspirate to Covers the core December 5, 2014 based
Physicians for Autologous processing adipose on PCT/US2013/044621
Adipose Transfer Procedures" tissue for ATGRAFT
adipose tissue dermal European Union
filler product Application No.
EPI3800847.9
China Application No.
2013800391988
Compositions and Methods for Company Adipose Tissue Developed Improvement
"Collecting, Washing, Storage Platform for established; Divisional,
Cryoprocessing, Recovering and Cosmetic Procedures Continuation-In-Part
Return of Lipoaspirate to Covers additional claims claiming priority to US
Physicians for Autologous related to ATGRAFT Serial No. 14/406,203
Adipose Transfer Procedures" process not included in imminent (PCT
original application Application filing
planned)
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The Company in-licenses the following IP:
Patent Title Use of Patent Application #
Cosmetic compositions including Protein Genomics and
tropoelastin isomorphs American CryoStem USPTO #5,726,040
(wound healing) (Autogenesis)
collaboration
Protein Genomics and
Cosmetic compositions American CryoStem USPTO #6,451,326
(wound healing) (Autogenesis)
collaboration
Recombinant hair treatment Protein Genomics and
compositions American CryoStem USPTO #6,572,845
(wound healing) (Autogenesis)
collaboration
Wound healing compositions and Protein Genomics and
methods using tropoelastin and
(Autogenesis)
(wound healing) collaboration
Business methods, processes and
systems for collection,
cryogenic storage and Personal Cell Sciences
distribution of cosmetic and American CryoStem USPTO application #61/588,841
formulations from an obtained collaboration
stem cell based a biological
(PCS)
Trademarks
In addition to patents, the Company has registered the following trademarks with
the
The Company has also secured a number of online domain names relevant to its business, including www.americancryostem.com, www.acslaboratories.com and ATGRAFT.com.
Marketing and Distribution
The key objective of our marketing strategy is to position
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We plan to continue marketing programs focused on reaching plastic and cosmetic surgeons to join the initial group of providers that began to offer our services to their patients. This marketing initiative has been implemented using a traditional sales approach common to the pharmaceutical and biotechnology industries. This fundamental sales approach at the core of our marketing activities is being strategically and tactically expanded using a combination of in-house sales personnel and outside independent channels.
Our plan, capital permitting, provides for a comprehensive integrated marketing approach using various traditional and new media, such as the Internet, social media/blogging, video, print, TV, radio and trade shows to reach targeted potential consumers and promote awareness of our Company and our branded products and services. The essence of this targeted strategy is to reach the end-users as quickly as possible and to accelerate the adoption curve of our products and services. We also plan to utilize outside marketing resources and trade groups to increase the number of surgeons willing to offer our products and services to their patients.
Market Size and Opportunities
By leveraging and capitalizing on our proprietary Adipose Tissue Processing Platform, we are working to address multiple high growths, multi-billion-dollar market opportunities, including those prevailing within the Regenerative Medicine, Cosmeceuticals, Medical Tourism and Cell Culture Media markets. The Company regularly reviews independent market research to gauge the market dynamics of its intended domestic and international markets and to identify additional areas within these markets where the Company's cell culture medium, laboratory products, and tissue and cellular processing services, can be marketed, sold and/or licensed.
Global Stem Cells Market
A report from
A report published by
Regenerative Medicine Market
The Global Translational Regenerative Medicine market is expected to grow
significantly over the forecast period. The Global Translational Regenerative
Medicine market was valued at
27 Cell Culture Market
Cell Culture Market Global Forecast to 2023, according to "marketsandmarkets"
the cell culture market is expected to reach USD
Development of Regional
The Company continues to develop relationships to leverage our products and services through existing cosmetic surgery and regenerative medicine practices The Company continues its efforts to develop and expand its network of individual physicians and surgeons seeking to adopt the Company's products and services focusing on surgeons performing liposuction, tissue transfer and regenerative procedures involving the use of adipose tissue. The Company intends to expand its efforts to medical professionals interested in Regenerative Medicine applications utilizing ADSCs to establish itself as a primary source of collection, processing and preparation of cellular therapies as they are developed and approved for patient use by the FDA.
Development of International Markets
International Licensing Program - Globally, many jurisdictions outside the US permit the use of adipose tissue based cellular therapies and regenerative medicine applications. The Company has received numerous inquiries concerning the sale or licensing of our products and services in these jurisdictions. The Company believes that the inquiries to date are a result of the global boom in Medical Tourism and the slow pace of approval of cellular therapies and regenerative medicine applications in the US. To address these inquiries and to expand the Company's sales, marketing and branding opportunities the Company has designed and is offering an International Licensing Program.
The program is designed to permit the licensing of the Company's products and services to organizations that meet the Company's financial and technical criteria. The licensing program allows for a variety of business relationship including franchising, partnering and joint venturing. Marketing efforts to date have been to clinics, physician and hospitals in foreign jurisdictions capable of rapidly building or committing the appropriate facilities and personnel to create the required laboratory facilities to operate the CELLECT®, ATGRAFT™ and ATCELL™ services in their local market. Strategically, the Company's international licensees will maintain the branding of the Company's services along the lines of the "Intel Inside" branding program.
Qualified Licensees can quickly take advantage of the rapidly expanding
opportunity to collect, process, store and culture individual regenerative cell
samples for their clients with the comfort and confidence that they are
providing services that have been developed to conform to
Licensing programs may be initiated through a letter of intent (LOI) agreement between the Company and the prospective licensee. This LOI agreement is designed for due diligence and facility qualifications purposes. The Company may receive an initial fee under the agreement which may or may not be credited toward future royalty payments. Following evaluation of the prospective licensee the Company will enter into a final Agreement which outlines all upfront fees, minimum royalties, consumable purchase obligations of the Licensee and may contain a minimum annual license fee.
Significant to our international development activities is the global expansion
of the
On
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The Company has been assisting CRYOVIVA with the development of their branding
and marketing campaign for
Due to the continuing global impact from COVID-19, CRYOVIVA has greatly reduced
their and operations and put their marketing plans on hold in 2021 and the
Company has generated minimal revenues. The Company cannot at this time estimate
the timing for
On
We have been informed by the Baoxin's Chairman and CEO that they completed their
new facility located in
In the second quarter of 2015 the Company entered into negotiations with
On
29 Corporate Information
Our principal executive offices are located at
Available Information
We file electronically with the
Going Concern
As of the date of this report, there is substantial doubt regarding our ability to continue as a going concern as we have not generated sufficient cash flow to fund our proposed business.
The accompanying consolidated financial statements have been presented in
accordance with generally accepted accounting principles in the
Our plans with regard to these matters encompass the following actions: (i) obtaining funding from new investors to alleviate our working capital deficiency, and (ii) implementing a plan to generate sales of our proposed products. Our continued existence is dependent upon our ability to resolve our liquidity problems and achieve profitability in our current business operations. However, the outcome of management's plans cannot be ascertained with any degree of certainty. Our financial statements do not include any adjustments that might result from the outcome of these risks and uncertainties.
Results of Operations- Three Months
The Company's revenue for the quarter ended
Operating expenses increased to
Administrative expenses decreased to
Interest expense for the quarter ending
Net loss for the third quarter of Fiscal 2021 was
30
Liquidity and Capital Resources
As of
Accounts Receivable increased to
Convertible debt increased to
The Company will continue to focus on its financing and investment activities, but should we be unable to raise sufficient funds, we will be required to curtail our operating plans or cease them entirely. We cannot assure you that we will generate the necessary funding to operate or develop our business. Please see "Cash Requirements" above for our existing plans with respect to raising the capital we believe will be required. In the event that we are able to obtain the necessary financing to move forward with our business plan, we expect that our expenses will increase significantly as we attempt to grow our business. Accordingly, the above estimates for the financing required may not be accurate and must be considered in light these circumstances.
There was no significant impact on the Company's operations as a result of
inflation for the nine months ended
Cash Requirements
We will require additional capital to fund marketing, operational expansion, processing staff training, as well as for working capital. We are attempting to raise sufficient funds that would enable us to satisfy our cash requirements for a period of the next 12 to 24 months. In order to finance further market development with the associated expansion of operational capabilities for the time period, we will need to raise additional working capital. However, we cannot assure you we can attract sufficient capital to enable us to fully fund our anticipated cash requirements during this period. In addition, we cannot assure you that the requisite financing, whether over the short or long term, will be raised within the necessary time frame or on terms acceptable to us, if at all. Should we be unable to raise sufficient funds we may be required to curtail our operating plans if not cease them entirely. As a result, we cannot assure you that we will be able to operate profitably on a consistent basis, or at all, in the future.
In order to move our Company through its next critical growth phase of development and commercialization and to ensure we are in position to support our research collaborations and market penetration strategies, Management continues to seek new investment into the Company from existing and new investors with particular emphasis on identifying the best deal structure to attract and retain meaningful capital sponsorship from both the retail and institutional investing communities, while limiting dilution to our current shareholders. Management also focuses its efforts on increasing sales and licensing revenue and reducing expenses.
Effects of COVID 19
The main effects of the COVID 19 pandemic were with the Company's US domestic
physician network and its international partners.
Commitments
Effective
31 Operating Lease
The Company leases its office facility, in
The Company leases its laboratory facility, in
The Company was not party to any litigation against it and is not aware of any
litigation contemplated against it as of
We anticipate that any further capital commitments that may be incurred will be financed principally through the issuance of our securities. However, we cannot assure you that additional financing will be available to us on a timely basis, on acceptable terms, or at all.
Related Party Transactions
On
Off Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
Critical Accounting Policies
We prepare financial statements in conformity with
Basis of Presentation
Our financial statements are presented on the accrual basis of accounting in accordance with generally accepted accounting principles in the United State of America, whereby revenues are recognized in the period earned and expenses when incurred.
32
Management's Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.
Long-Lived Assets
We review and evaluate our long-lived assets for impairment whenever events or changes in circumstances indicate that their net book value may not be recoverable. When such factors and circumstances exist, we compare the assets' carrying amounts against the estimated undiscounted cash flows to be generated by those assets over their estimated useful lives. If the carrying amounts are greater than the undiscounted cash flows, the fair values of those assets are estimated by discounting the projected cash flows. Any excess of the carrying amounts over the fair values are recorded as impairments in that fiscal period.
Statement of Cash Flows
For purposes of the statement of cash flows, we consider all highly liquid investments (i.e., investments which, when purchased, have original maturities of three months or less) to be cash equivalents.
Recent Accounting Pronouncements
In
In
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