SMSbiotech has discovered and named a new type of stem cell called the Small Mobile Stem cell, which is the core of its patented and proprietary technology.
SMSbiotech Brief Introduction
SMSbiotech, a C-Corp founded in 2015, is a San Diego-based biotech company utilizing a novel human stem cell to advance the field of regenerative medicine. SMSbiotech has developed a new, powerful proprietary technology based on its discovery of Small Mobile Stem (SMS) cells. Our discovery of SMS cells offers a fundamental solution that addresses the lack of ability of many patients to restore cells and tissues damaged by disease, trauma, and/or aging. As such, it offers a new platform technology that provides practical and efficient solutions in the field of regenerative medicine to unmet needs targeting cures rather than symptoms of the disease.
Introduction to Our Technology
SMSbiotech provides a regenerative solution to lung tissue degeneration. SMS cells that can be bio-manufactured on a large scale provide an off-the-shelf allogenic cell therapy solution. These cells were originally obtained from healthy human adult blood. The cells are not genetically modified and are grown while maintaining potency. SMS cells have been shown, in the lab and in animal models, to stimulate lung cells and restore lung air sacs that are damaged. The mechanisms of SMS cells have been studied to a great extent and are unique to these cells. Furthermore, SMS cells are the only cells that can be administered, non-invasively, directly to the lung that is, by inhalation using a nebulizer.
What sets SMSbiotech apart from other biotech companies?
The discovery, development, patenting, and commercialization of the SMS cells set SMSbiotech apart from other biotech companies. SMS cells present unique characteristics that provide unique advantages over other attempted or past therapies.
What is the Main Targeted Disease?
Chronic Obstructive Pulmonary Disease (COPD), which encompasses emphysema and chronic bronchitis, is a deadly progressive lung disease for which there is currently no cure. Patient’s lungs gradually deteriorate, as does their quality of life until death. It is the 3rd leading cause of death. More than 16 million U.S. citizens have COPD (400 million worldwide), affecting at least one of every four families. Given that current treatments only address symptoms, experts believe a mere 10% improvement in lung functions would be a great achievement in medicine.
What are the Future Verticals?
SMSbiotech proprietary stem cell technology is a platform that targets multiple other chronic diseases, as shown in animal studies.
What is the Therapeutic Pipeline?
What is Your Pathway to Revenue?
The earliest revenues will be generated upon executing compassionate use treatments which could be as early as the phase 1 COPD clinical trial.
What is Your Regulatory Path?
Cell therapy is governed by the FDA office CBER. Human trials that involve regenerative medicine include quite fewer human subjects than regular drugs, keeping overall clinical trial costs down. SMSbiotech intends to request a fast-track designation during the IND submission, given the therapy addresses a serious disease. Based on the 21st Century Act passed by Congress, SMSbiotech regenerative therapy qualifies for RMAT (Regenerative Medicine Advanced Therapy) designation. This, however, requires completing some human testing. RMAT includes all breakthrough therapy designation features, including early interactions with FDA, and it supports accelerated approval. Furthermore, based on the severity of the disease and the absence of solutions, FDA will grant expanded access (compassionate use). This will allow for a revenue-generating implementation of the therapy during the early trial period as well as the targeting of other indications.
Adoption of COPD Therapy:
SMS cells are likely to be easily adopted by the medical community and the patients :
- SMS cells are adult stem cells; these cells are known to be safe, contrary to embryonic or iPSCs. This will reassure patients, physicians, and regulators.
- The clear mechanism of action that was demonstrated in vitro will help create an understanding and acceptance of these cells by the scientific and medical community.
- The therapy intends to address the actual disease, that is, the damaged lung tissue, not merely the symptoms of the damage.
- The therapy can be reasonably priced given the mentioned advantages related to the central mode of production.
- The cells will be applied non-invasively through inhalation to the lung directly, that is, the location of the damaged tissue.
- The cells are not genetically manipulated; such cells are potentially unsafe and may harbor dangerous mutations. SMS cells do not require genetic manipulations, their actions follow a naturally optimized process of stimulating regeneration.
- The therapy addresses an indication that is a deadly disease causing a long-term worsening of suffering that could extend for decades. This suffering includes not only patients but also family members and loved ones who are related to the patient.
- The effects of the SMS cell therapy should be observable by analyzing lung function and detecting the lung structural changes, a clear, non-subjective manifestation of the efficacy of the drug.
What Are Current Relevant Markets?
In 2020 COPD caused a $50 Billion economic burden in the US. The global COPD treatment market was valued at US $19.8 Bn in 2021. The global COPD therapeutic market is expected to grow at a 5% CAGR from 2019 to 2027. Considering the size of the market, acquiring a 2.5% US market share would generate $500 million in sales and $ 350 million in EBITDA for SMSbiotech. The company would then be worth $ 3.5 billion.Current treatments target COPD’s detrimental symptoms but not the fundamental cause of the disease. They may slow progress but do not reverse or cure the disease. Current treatments include short-acting and long-acting Bronchodilator Inhalers (albuterol, levalbuterol, and ipratropium) and Corticosteroids. Non-drug treatments include supplemental oxygen and surgery such as lung volume reduction and lung transplantation. Examples of companies that provide bronchodilator inhalers: GlaxoSmithKline, Merck, AstraZeneca, Boehringer- Ingelheim.
What is the Goal of SMSbiotech as an Innovative Company?
SMSbiotech technology will lead to the development of more efficient, disease-changing, and relevant medicines, serving a broad spectrum of patients and reducing the burden on healthcare. This will create a platform technology that will allow for multiple exists to investors through licensing, royalty deals, and partnerships with major players in the industry.
Who are your Board Members?
Who can currently invest in SMSbiotech?
SMSbiotech is a privately held company, and only accredited investors can invest. One of the following items must apply:
- Is a natural person and has a net worth, either alone or with the Purchaser’s spouse, of more than $1,000,000, excluding the value of the primary residence of such natural person and excluding the amount of debt secured by such primary residence, up to the estimated fair market value of the property.
- Is a natural person and had income in excess of $200,000 ($300,000 including income of spouse) during each of the previous two years and expects to have income in excess of such amounts during the current year.
- The entity/the Investor is a corporation, LLC, partnership, business trust, or tax-exempt 501(c)(3) organization that has greater than $5,000,000 in total assets and was not formed for the specific purpose of investing in SMSbiotech, Inc.
- The entity/the Investor is any trust that has greater than $5,000,000 in total assets, and is directed by a person with such knowledge and experience in financial and business matters that such person is capable of evaluating the risks and merits of an investment in SMSbiotech, Inc., and that was not formed for the specific purpose of investing in SMSbiotech, Inc.
- The entity/the Investor is a private business development company as defined in Section 202(a)(22) of the Investment Advisors Act.
- The entity’s/the Investor’s equity owners are all accredited investors. This category may apply even if the entity was formed for the specific purpose of investing in SMSbiotech, Inc.
- The entity/the Investor is a bank, savings and loan association, registered broker or dealer, insurance company, or registered investment company.