AMERICAN CRYOSTEM CORP MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND PLAN OF OPERATIONS (form 10-Q) | MarketScreener

2022-08-26 20:47:18 By : Mr. Yang Lao

· 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 collaborative partners to accelerate its product development efforts, harnessing its manufacturing platform and tissue processing platforms. The R&D collaborations are to discover, develop, and commercialize cellular therapies, laboratory products and combinations thereof with synergistic technologies to create regenerative 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 its FDA filings. We have completed, along with a government partner

the clinical protocol for a new Investigational New Drug (IND) application

that was filed on July 7, 2022, and we were approved to proceed with the study

on August 5, 2022 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

6. Osteoarthritis - The Company completed its study protocol for ATCell for

osteoarthritis and has completed the filing with the Cayman Island Ministry of

Health. This new study is currently pending approval. The study is designed

for 100 participants as a "patient pay model", an acceptable model in the

Cayman Islands. Upon approval the study will be marketed to patients in the

Caribbean and the US and will generate revenue to the Company for each

patient's processing and delivery of their treatment samples to the clinic n

Tissue Processing and Storage Services:

Laboratory Products; Culture Medium, and Manufacturing Services

The Company has created several versions of its ACSelerate™ cell culture media including:

· 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 ATCELL™into chondrocytes (ATCELL-CY™),

· ACSelerate-OB™- for differentiation of ATCELL™into osteoblasts (ATCELL-OB™)

· ACSelerate-AD™ - for differentiation of ATCELL™into 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)

WRNMMC is part of The Military Health System (MHS) which is the enterprise within the United States Department of Defense that provides health care to active duty, Reserve component and retired U.S. Military personnel and their dependents.

· 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

· To provide a medical benefit commensurate with the service and sacrifice of

more than 9.5 million active-duty personnel, military retirees, and their

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,

· Medal of Honor recipients and their families

· Some former spouses, and

· Others identified as eligible in the Defense Enrollment Eligibility Reporting

Systems and Methods for the Adipose Tissue Digestion U.S. Serial No. Digestion of Adipose Tissue Laboratory Processing 13/646,647 filed October Samples Obtained From a Client Methods

Additionally, the Company has in-licensed the following IP:

Wound healing compositions and Protein Genomics and USPTO: #6,808,707 methods using tropoelastin and American CryoStem lysyl oxidase

Development of Regional U.S. Markets

See Note 3 , Note 13 and Note 14 for additional information.

Results of Operations - Three Months

The Company's revenue for the quarter ended June 30, 2022, decreased to $42,599 versus $132,119 for the same period of Fiscal 2021.

Accounts Receivable decreased to $14,859 at June 30, 2022 from $78,782 at September 30, 2021.

There was no significant impact on the Company's operations as a result of inflation for the nine months ended June 30, 2022.

The Company leases Equipment at its laboratory from NFS Leasing, Inc. Lease payments are $2,993.62 per month for eighteen (18) months. The final lease payment is scheduled for January 1, 2023. When the final payment is made, the Company will own the equipment. See Note 11 . Leases in the Financial Statements.

The Company was not party to any litigation against it and is not aware of any litigation contemplated against it as of June 30, 2022. See also Legal Proceedings below.

From time to time the Company takes advances and makes principal payments on the note. During the nine months ended June 30, 2022, the Company was advanced $2,120 and made payments of $24,805 on the note.

The principal balance of the Note is $125,090 at June 30, 2022 and $147,775 at September 30, 2021.

The Company exchanged 1,000,000 newly created Series A Voting Convertible Preferred Shares for 20,000,000 common shares held by ACS Global, Inc.

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.

3. Each preferred share shall have 20 votes on all matters subject to a Company

4. Convertible after one year at the discretion of the ACS Global board of

During the nine months ended June 30, 2022, the company was advanced $14,900 by a company 100% owned by the Chief Executive Officer of American CryoStem Corporation. At June 30, 2022, American CryoStem has a balance due of $14,900.

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.

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