What was once thought science-fiction is now becoming reality with AgeX Therapeutics novel approach to treating age-related diseases and degradation.
AgeX Therapeutics, Inc. (NYSEAMERICAN: $AGE) is an early stage biotechnology company focused on the development and commercialization of novel therapeutics targeting biological aging. Based on the “clockwork mechanism” of human aging. The firm’s mission is to promote longevity and lead medical breakthroughs.
The firm’s promising stem cell therapies will be a disruption to the conventional medical treatment model.
What are Stem Cells?
A stem cell is a type of cell which has the unique capability of developing and differentiating into a specialized cell, such as a red blood cell.
Akin to a block of clay, certain stem cells are able to specialize into any cell type given the right conditions. Stem cells have been noted for their ability to rejuvenate cells and tissues that have been damaged or lost to diseases, and are found in the following forms:
Somatic stem cells
Somatic stem cells are found within the adult body. These stem cells are considered multipotent, in that they can not be specialized into any cell type.
For example, somatic blood stem cells, extracted from bone marrow, can only specialize into blood cell type lineages.
Furthermore, somatic stem cells are limited in quantity which poses challenges in harvesting adequate amounts for repeated therapeutic use. When researchers tried scaling these cells, multiple errors occurred within the cells’ DNA rendering them useless.
Additionally, certain somatic cell types are difficult to source which challenges their ability in therapeutic use.
Somatic stem cells have been noted for their shorter lifespan compared to Embryonic stem cells and induced Pluripotent stem cells.
Embryonic stem (ES) cells
Embryonic stem cells are harvested from the inner cell mass of the blastocyst, three to five days after egg fertilization.
Embryonic stem cells are pluripotent, in that they have the ability to specialize into any cell type, other than the umbilical cord and placenta, when subjected to the right conditions.
These stem cells are unique in their ability of being highly scalable in the lab, providing an abundant source for therapeutic use.
These cells are typically harvested from blastocysts that were produced from in-vitro fertilization (IVF), for assisted reproduction which were no longer of use.
induced Pluripotent stem cells (iPS)
Induced Pluripotent stem cells are an engineered form of somatic stem cells that behave similar to embryonic stem cells. Though some behavioural differences between the two stem cell types have been observed.
The pluripotent nature of these stem cells, provide it with a wide array of therapeutic potential and may allow patients to receive their own stem cells reducing the risk of immune rejection.
Revolutionary Technologies Offered by AgeX Therapeutics
Purestem is AgeX Therapeutics’ Pluripotent stem cell (PSC) line which includes Embryonic stem (ES) cells and induced Pluripotent stem cells (iPSC).
The firm has been licensed by Lineage Cell Therapeutics to utilize the technology for applications other than orthopedics, medical aesthetics, and certain ophthalmological applications.
AgeX Therapeutics plans to utilize their PureStem line to produce vascular endothelial progenitor cells for the treatment of age-related ischemic diseases and Brown Adipose Tissue (BAT) cells for the treatment of Type II diabetes.
Induced Tissue Regeneration (iTR)
Diseases attributed to old age are a result of loss in the regenerative capacity of cells. This is due to the shortening of telomere length, the portion of DNA which dictates the lifespan of a cell, due to cell replication.
Scientists discovered that when cells lose their regenerative ability certain genes were expressed and others were not. A gene of interest was marked COX7A1.
The proprietary formulation AGEX-iTR1547, which incorporates the iTR technology reduced expression of COX7A1, allows cells to regain their regenerative potential.
Essentially, the iTR technology reprograms cells to extend their lifespan, regressing their biological clocks.
The iTR technology is expected to induce tissue regeneration and in combination of telomerase, may result in cell immortality and regenerative biology.
Renelon, a formulation from Lineage Cell Therapeutics which incorporates AgeX Therapeutics iTR technology, is a topical that may have the capability for scarless tissue repair, but will not return cells to a regenerative state.
An issue with stem cell therapy is the potential for the body’s immune system to reject the treatment. This results in the immune system attacking the introduced stem cells, resulting in more harm than rejuvenation.
One way to combat this is, is to match patients with their respective stem cell types. Though, this can pose many challenges and may deter patients from pursuing stem cell therapy.
AgeX Therapeutics’ vision is to create a universal stem cell type which they hope to accomplish utilizing their UniverCyte technology.
UniverCyte is a proprietary technology that incorporates the molecule HLA-G, which functions to protect an infant from immune rejection of the mother.
The firm will implement UniverCyte to modify their Purestem cell line to incorporate HLA-G, preventing treatment rejection by the recipient’s immune system. In essence, creating an “off-the-shelf” stem cell treatment.
HyStem Delivery Technology
HyStem is an unique hydrogel which mimics the outer protective layer of a cell (Extracellular matrix). This increases the bioavailability of the transplanted PureStem cells and allows them to thrive and function in the recipient’s body.
Hystem is compatible with multiple cell types within the body (brain, bone, skin, cartilage, vascular system and heart). The hydrogel can be applied locally or by injection and can be administered in a strategic controlled-release fashion, providing superior therapeutic use.
“AgeX’s cell therapy technologies may help transform regenerative medicine by potentially overcoming important challenges that the sector faces. AgeX’s UniverCyte platform may help therapeutic cells from a donor be administered or transplanted in a patient without the need for potent immunosuppressive medications. In addition, AgeX’s Purestem platform may deliver cell therapy products that are industrially scalable with lower manufacturing costs. Also, AgeX can provide to companies and academic institutions, as source material for deriving their different cell therapy candidates, proprietary lines of NIH-registered pluripotent stem cells produced under Good Manufacturing Practices. AgeX is actively seeking collaboration and licensing opportunities around its technologies as our recent deals with industry and academia highlight.” –Nafees Malik, MD, COO
What’s wrong with the pharmaceutical industry?
According to Edelman’s Trust Barometer: Healthcare report, trust in the pharmaceutical industry remains neutral with a median trust of 55 out of 100 reported over the previous five years. Lack of trust in the pharmaceutical industry is nevertheless well warranted.
The pharmaceutical industry is no longer in the business of innovating
According to research conducted by Robin Feldman, and co-author Connie Wang, a minimum of 74% of patents filed for novel therapies between 2005-2015 were for drugs already available on the market.
This suggests patients are receiving a rehashed treatment for their ailments year over year with no real improvement in their conditions.
AgeX Therapeutics is pushing for innovation with its breakthrough stem cell technologies and induced tissue repair therapies. Which aim to cure patients with biology instead of pharmaceuticals.
Price-gouging is commonplace
Price-gouging is the process of inflating the price of a good, service or commodity beyond what a consumer believes is fair. This is especially sinister for goods such as pharmaceuticals, a necessity for consumers.
For example: Marathon Pharmaceuticals had taken a generic drug approved in Europe and Canada for Duchenne muscular dystrophy, introduced it into the US market under Emflaza and charged a 6000% premium.
Oftentimes patients choose not to take medication because of the high costs associated with them. In the case of Emflaza patients in the US were charged $89,000 annually for treatment compared to $1000 to $2000 annually in Canada and Europe.
Stem cell and induced tissue repair therapy will require less frequent maintenance and provide greater efficacy to traditional pharmaceuticals, which will prove to be cost effective in the long run.
Efficacy of common medications is being questioned
A meta-analysis of the 20 most common medical therapies (including Metformin and Aspirin) concluded that efficacy was lower than what physicians or pharmaceutical companies stated.
This may prove fatal in the long term if patients are not being treated adequately for their conditions.
Stem cell and induced tissue repair therapy is expected to have greater efficacy compared to traditional pharmaceuticals by working with the body’s natural biology to promote cell rejuvenation, thus repairing the root cause of the ailment versus only alleviating the symptoms.
How Can AgeX Therapeutics’ Pipeline Solve Degenerative Diseases?
Cardiac ischemia is the narrowing or blocking of the arteries which restricts the amount of oxygen-rich blood delivered to the heart.
This can lead to myocardial infraction (heart attack) and heart tissue death. Chest pain may prelude cardiac ischemia referred to as, angina.
Cardiac ischemia is noted to be the leading cause of death in countries across all income groups. Treatment of Cardiac ischemia requires an extensive regiment of pharmaceuticals and as the condition progresses patients may need to undergo invasive medical therapies which are associated with a plethora of risks.
AgeX Therapeutics’ AGEX-VASC1 is a non-invasive PureStem cell-based therapy made of specialized vascular endothelial progenitor cells for the treatment of cardiac ischemia.
The aim of the therapy is to rejuvenate vascular endothelial progenitor cells to restore proper function of the arteries and repair damaged tissue.
Type II Diabetes
Type II diabetes entails the accumulation of glucose in the blood resulting in dangerously high concentrations.
This is the result of improper functioning of Insulin, a hormone which regulates glucose levels by moving the compound from the blood into the cells. This provides the cell with the necessary energy to carry out its functions.
In Type II diabetes insulin is impaired which causes cells to become energy deficient. The body then begins to breakdown tissues, muscles and organs for energy. This results in vast symptoms associated with fatigue, such as blurry vision and frequent urination.
Treatment includes radical lifestyle changes, which can be challenging for some people, a combination of prescription medication (including Metformin) and may require insulin therapy.
Patients are condemned to a life of constantly monitoring their glucose levels to ensure they don’t experience any negative symptoms.
AGEX-BAT1 is a PureStem cell based therapy which provides specialized brown adipocyte cells for the treatment of Type II diabetes. The firm believes this will promote the rejuvenation of Brown Adipose Tissue (BAT) providing patients with sustaining glucose regulation and insulin sensitivity effectively curing them of Type II diabetes.
Degradation and Aging
The firm’s AGEX-iTR1547 is their drug-based proprietary formulation with the potential to restore the regenerative potential in a plethora of aged tissue affected by degenerative diseases.
The therapy is currently in pre-clinical trials for the treatment of Chronic Heart Failure, a progressive disease which entails weakening of the heart muscles. It is estimated that 6.5 million Americans suffer from heart failure.
It Takes Money to Make Money, Financials
Since AgeX is an early stage biotechnology company, it is expected to burn thought a lot of cash over the course of developing their products.
Current products offered by AgeX are: ESI BIO brand embryonic stem cells, PureStem progenitor cells, Cytiva stem-cell derived human heart cells and their GeneCards database suite.
According to the firm’s most recent quarterly report, year to year revenue has increased by 32.73%. This increase is driven by grants and other revenues.
As a result, gross profit has increased by 48% year over year.
The firm’s quick ratio is 0.15 and its debt-to-equity ratio is -14.58. Primary drivers of the small quick ratio and negative debt-to-equity include:
- a loan acquired from primary shareholder Juvenescence Ltd.,
- a 38.05% increase in accounts payable and accrued liabilities,
- a 182.81% increase in related party payables, and
- a 43.82% increase in deferred revenues.
As the firm grows and has success with clinical trials these ratios are expected to increase.
As of 2019, the stem cell market is worth $9.6B USD and is forecasted to have a Compound Annual Growth Rate (CAGR) of 8.2% from 2020-2027.
The success of AgeX’s product line will position the firm competitively in a growing market and very promising industry, providing shareholders with great upside.
According to AgeX Therapeutics’ most recent annual report, major risks facing the firm include:
- The commercial success of their pipeline depends on the degree of acceptance by physicians, patients, third-party payors and others within the medical community.
- Inherent risks associated with clinical trials, such as failing to meet safety and efficacy outlined by regulating bodies.
- In the case of the success of AgeX Therapeutics pipeline they may have to become dependant on third parties to ensure the commercial success of their products.
May 29th – Share price moved from a previous close of $0.76 to $1.42, a 87.417% increase. A large volume order of 10M shares was filled, signalling investors confidence.
June 2nd – AgeX Therapeutics and ImStem Biotechnology signed a non-binding letter of intent regarding investigational MSC candidate IMS001 for COVID-19 and other causes of ARDS
“With ageing populations in many countries across the world, it is imperative that science and medicine help people age in a healthy manner and minimize chronic and degenerative conditions associated with old age. This in turn will help maintain elderly people’s quality of life as well as protect healthcare systems and preserve economic growth. Regenerative medicine is expected to play a key role in achieving this outcome.”
-Nafees Malik, MD, COO.
It is important to evaluate management before making an investment decision, a bad captain makes for a disastrous journey. AgeX Therapeutics’ management have proven themselves in their respective fields. Key management figures include:
Michael D. West, CEO
- Received PhD. from Baylor College of Medicine in 1989 with a focus on the biology of cellular aging and degenerative diseases
- Founder and first CEO of Geron Corporation (NASDAQ: GERN) from 1992 to 1998
- Held positions as, CEO, President & Chief Scientific Officer at Advanced Cell Technology Inc. (ACT), acquired by Astellas Pharma, Inc. from 1998 to 2007
- Served as CEO/Co-CEO for BioTime Inc. (NYSE American: BTX) from 2007 to 2019
- Watch Michael D. West talk about AgeX Therapeutics
Nafees Malik, MD, COO
- 15 year career has included roles in: clinical medicine, investment banking, biopharmaceutical companies, research and academic institutions and strategy consulting
- Dedicated to the strategic and commercial analysis of cell and gene therapies and regenerative medicine
- Head of Cell and Gene Therapy at Juvenescence Ltd.
Hal Sternberg, PhD, VP of Research
- BioTime Inc.’s VP of research for over 25 years and one of the company’s co founders
- Prior to BioTime held various positions at UC Berkeley, from 1982 to 1988, where his focus was Alzheimer’s diseases
- Key player in bringing the medical product Hextend to the market
Aubrey de Grey, PhD., VP of New Scientific Discovery,
- Has been very vocal in the media about the benefits and future potential potential of stem cell therapies
- PhD in biology with an emphasis on the biological mechanisms of aging
- Watch Aubrey de Grey provide a discourse on aging and rejuvenation
Considering AgeX Therapeutics novel approach to age related diseases, revolutionary technology, future potential of its pipeline, and very strong management, shares of AgeX would seem poised for significant appreciation. Look for $2.50 in the coming year.