AMERICAN CRYOSTEM CORP MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND PLAN OF OPERATIONS (form 10-Q) – Marketscreener.com
Posted: May 24, 2022 at 1:45 am
Forward-looking Statements
Inadequate capital and barriers to raising the additional capital or to
Litigation with or legal claims and allegations by outside parties; and
Insufficient revenues to cover operating costs.
The Company is expanding its efforts to attract and cultivate collaborativepartners to accelerate its product development efforts, harnessing itsmanufacturing platform and tissue processing platforms. The R&D collaborationsare to discover, develop, and commercialize cellular therapies, laboratoryproducts and combinations thereof with synergistic technologies to createregenerative medicine applications and develop new intellectual property.
1. The Company filed its first Investigational New Drug Application (IND) with
the US Food and Drug Administration (FDA) for the ATCELL cellular therapy
product. The IND filing is titled "ATCell Expanded Autologous Adipose Derived
Mesenchymal Stem Cells deployed via Intravenous Infusion for the Treatment of
Post-Concussion Syndrome (PCS) in Retired Athletes and Military Personnel",
File number 19089, which was approved by the FDA on September 17, 2020. The
Company intends to invite additional developers of cellular therapies to
initiate additional arms of the clinical study focused on the use of ATCELL
for use in systemic inflammatory response relief for patient suffering from
systemic diseases. A number of these additional study targets have been
identified and ongoing discussions support the Company's belief that clinical
investigations can be developed and rapidly added upon completion of the new
2. DMD - The Company has completed the protocol for the treatment of Duchene
Muscular Dystrophy and is in final discussions with its Collaborative partner,
to select the principal investigator (PI) and clinical trial site selection.
3. Long COVID - The Company has completed the protocol for treatment of Long
COVID and is currently finalizing its FDA filings. We have completed, along
with a government partner the clinical protocol for a new Investigational New
Drug (IND) application to be filed with FDA within the next 90 days for Long
COVID. According to the Centers for Disease Control and Prevention,
"post-COVID conditions can be considered a lack of return to a usual state of
health following acute COVID-19 illness." In the US, following COVID recovery,
it is reported that up to 30% of those afflicted, diagnosed, or treated for
COVID-19 have continuing symptoms and medical complications following recovery
4. Wound Healing - the creation of topical applications and ingredients used by
physicians in the wound care and cosmetic industries as well as therapeutic
cellular applications and bio-materials development. An initial pilot study
involving a minimum of 10 participants for the assessment of its autologous
tissue products for the wound healing market is underway. The Company is
combining its tissue products, which do not require FDA approval, with current
standard-of-care methods to accelerate and improve the healing of diabetic and
5. ATGRAFT - products include adipose tissue and cell sample processing and
storage as a form of personal "bio-insurance", and adipose tissue (fat)
storage for cosmetic fat engraftment procedures. High demand for pure and
natural aesthetics in fast growing cosmetic industry with non-FDA required
Tissue Processing and Storage Services:
Laboratory Products; Culture Medium, and Manufacturing Services
The Company has created several versions of its ACSelerate cell culture mediaincluding:
ACSelerate-MAX - xeno serum free cell culture media,
ACSelerate-SFM - animal serum free cell culture media,
ACSelerate-LSM - low FBS (0.05%) cell culture media,
ACSelerate-CY- for differentiation of ATCELLinto chondrocytes (ATCELL-CY),
ACSelerate-OB- for differentiation of ATCELLinto osteoblasts (ATCELL-OB)
ACSelerate-AD - for differentiation of ATCELLinto adipocytes (ATCELL-AD)
ACSelerate-MY- for differentiation of ATCELL into myocytes (ATCELL-MY)
ACSelerate-CP- non-DMSO (Dimethyl Sulfoxide) cellular cryopreservation media
ACSelerate-TR- sterile transportation medium designed to maintain the
viability of the tissue during the shipment of adipose tissue to our processing
International Licensing Program - COVID RISK FACTOR
(https://www.transparencymarketresearch.com/pressrelease/stem-cells-market.htm)
China
Thailand
Japan
Collaborations / Partnering Opportunities / Acquisitions
WRNMMC
WRNMMC is part of The Military Health System (MHS) which is the enterprisewithin the United States Department of Defense that provides health care toactive duty, Reserve component and retired U.S. Military personnel and theirdependents.
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
Intellectual Property
Systems and Methods for the Adipose Tissue Digestion U.S. Serial No.Digestion of Adipose Tissue Laboratory Processing 13/646,647 filed OctoberSamples Obtained From a Client Methods
Additionally, the Company has in-licensed the following IP:
Wound healing compositions and Protein Genomics andmethods using tropoelastin and American CryoStem USPTO: #6,808,707lysyl oxidase
Market Size and Opportunities
Regenerative Medicine Market
Development of Regional U.S. Markets
Physician Network
Development of International Markets
Corporate Information
Available Information
Results of Operations - Three Months
The Company's revenue for the quarter ended March 31, 2022, increased to $31,935versus $1,935 in the same period of Fiscal 2021.
Liquidity and Capital Resources
Accounts Receivable decreased to $65,680 at March 31, 2022 from $78,782 atSeptember 30, 2021.
There was no significant impact on the Company's operations as a result ofinflation for the six months ended March 31, 2022.
The Company leases Equipment at its laboratory from NFS Leasing, Inc. Leasepayments are $2,993.62 per month for eighteen (18) months. The final leasepayment is scheduled for January 1, 2023. When the final payment is made, theCompany will own the equipment. See Note 11 . Leases in the FinancialStatements.
The Company was not party to any litigation against it and is not aware of anylitigation contemplated against it as of March 31, 2022. See also LegalProceedings below.
From time to time the Company takes advances makes principal payments on thenote. During the six months ended March 31, 2022, the Company was advanced$1,729 and made payments of $18,000 on the note.
The principal balance of the Note is $131,505 at March 31, 2022 and 147,775 atSeptember 30, 2021.
Terms of the Series A Voting Convertible Preferred Shares are as follows:
1. Each Series A Share is convertible into 20 shares of American CryoStem common
stock $0.001 par value, subject to any recapitalization event.
2. Stated annual dividend of $0.20 per share payable quarterly in cash or stock
at the discretion of the Company's Board of directors.
The rest is here:
AMERICAN CRYOSTEM CORP MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND PLAN OF OPERATIONS (form 10-Q) - Marketscreener.com
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