This Month's Tiny Gems - December 2020

CNS Pharmaceuticals Inc. (NASDAQ: CNSP)

CNS Pharmaceuticals Inc. (NASDAQ: CNSP) is a clinical stage biotechnology company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system.

The company was founded in 2017 and is headquartered in Houston, Texas.

Organ Targeted Therapeutics

The company's lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme ("GBM"), an aggressive and incurable form of brain cancer. Berubicin also has potential to treat other central nervous system malignancies. Based on limited clinical data, Berubicin appears to be the first anthracycline to cross the blood brain barrier in the adult brain, and it was the subject of a successful Phase 1 study which found the MDT and produced efficacy data as well.

CNS holds a worldwide exclusive license to the Berubicin chemical compound. The company has acquired all requisite data and know-how from Reata Pharmaceuticals Inc. related to a completed Phase I clinical trial of Berubicin in malignant brain tumors. In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. In 2017, CNS entered into a collaboration and asset purchase agreement with Reata.

CNS intends to explore the potential of Berubicin to treat other diseases, including pancreatic and ovarian cancers and lymphoma. The company is also examining plans to develop combination therapies that include Berubicin.

CNS estimates that more than $25 million in private capital and grants were invested in Berubicin prior to the company's $9.8 million IPO in November 2019.

CNS intends to submit an IND for Berubicin during the fourth quarter of 2020 and expects to commence a Phase II clinical trial of Berubicin for the treatment of GBM in the U.S. in Q1 2021. A sub-licensee partner was awarded a $6 million EU/Polish National Center for Research and Development grant to undertake a Phase II trial of Berubicin in adults and a first-ever Phase I trial in pediatric GBM patients in Poland in 2021.

The company's second drug candidate, WP1244, is a novel DNA binding agent licensed from the MD Anderson Cancer Center. In preclinical studies, WP1244 proved to be 500-times more potent than the chemotherapeutic agent, daunorubicin, in inhibiting tumor cell proliferation. The company has entered into a sponsored research agreement with the MD Anderson Cancer Center to further the development of WP1244.

CNS Pharmaceuticals recently engaged U.S.-based Pharmaceutics International Inc. and Italian BSP Pharmaceuticals SpA for the production of the Berubicin drug product. The company has implemented a dual-track manufacturing strategy to mitigate COVID-19-related risks, diversify its supply chain and provide for localized availability of Berubicin. CNS has already completed synthesis of Berubicin's active pharmaceutical ingredient (API) and has shipped the API to both manufacturers in order to prepare an injectable form of Berubicin for clinical use.

Global Brain Tumor Therapeutics Market

The high recurrence rate of malignant brain tumors is due to reappearance of focal masses, indicating that a sub-population of tumor cells in these cancers may be insensitive to current therapies and may be responsible for reinitiating tumor growth. This necessitates the development of newer drugs in the market that demonstrate greater efficacy in treating such aggressive cancers.

A global increase in neurological disorders has placed increased attention on cancers of the brain over the past decade. Neurological disorders are becoming one of the most prevalent types of disorders, due to longer life expectancy, greater exposure to infection and an increasingly sedentary lifestyle. Because few treatments for primary and metastatic cancers of the brain exist, costs are high and have acted as a restraint for the brain tumor therapeutics market.

Despite progress in surgery, radiotherapy and chemotherapeutic strategies, effective treatments for brain cancer are limited by a lack of specific therapies for the brain and the difficulty in transporting therapeutic compounds across the blood brain barrier. Therefore, there is a significant need for novel and effective therapeutic drugs and strategies that prolong survival and improve quality of life for brain tumor patients.

Several companies are making significant investments into R&D, which is expected to bring more treatment options to the market in the near future. Industry reports consistently project continued growth in the market.

One report estimates that the global brain tumor therapeutics market will reach a valuation of $2.74 billion in 2023, with the market expected to register a CAGR of 11% during the forecast period from 2018 to 2023. Another report projects that the global brain tumor therapeutics market will reach $3.4 billion by 2025, up from $2.25 billion in 2019 (http://nnw.fm/eDUjp).

Management Team

John M. Climaco is the CEO of CNS Pharmaceuticals. For 15 years, Climaco has served in leadership roles for a variety of health care companies. Recently, Climaco served as the Executive Vice President of Perma-Fix Medical S.A, where he managed the development of a novel method to produce Technitium-99. Climaco also served as President and CEO of Axial Biotech Inc., a DNA diagnostics company. In the process of taking Axial from inception to product development to commercialization, Climaco forged strategic partnerships with Medtronic, Johnson & Johnson and Smith & Nephew.

Christopher Downs, CPA, is the company's Chief Financial Officer. Downs previously served as Interim Chief Financial Officer and Executive Vice President of InfuSystem Holdings Inc. (NYSE: INFU), a supplier of infusion services to oncologists in the United States. Downs holds a Bachelor of Science from the United States Military Academy at West Point, an MBA from Columbia Business School and a Master of Science in Accounting from the University of Houston-Clear Lake.

Dr. Donald Picker is the Chief Scientific Officer of CNS. Picker has over 35 years of drug development experience. Prior to joining CNS, Picker worked at Johnson Matthey, where he was responsible for the development of Carboplatin, one of the world's leading cancer drugs, which was acquired by Bristol-Myers Squibb with annual sales of over $500 million. In addition, he oversaw the development of Satraplatin and Picoplatin, third-generation platinum drugs currently in late-stage clinical development.

Sandra L. Silberman, M.D., Ph.D., is the Chief Medical Officer of CNS Pharmaceuticals. Silberman is a hematologist/oncologist who earned her B.A., Sc.M. and Ph.D. from the Johns Hopkins University School of Arts and Sciences, School of Public Health and School of Medicine, respectively, and her M.D. from Cornell University Medical College. She then completed both a clinical fellowship in hematology/oncology and a research fellowship in tumor immunology at the Brigham & Women's Hospital and the Dana Farber Cancer Institute in Boston, Massachusetts. Silberman has played key roles in the development of many drugs, including Gleevec(TM), for which she led the global clinical development at Novartis. Silberman advanced several original, proprietary compounds into Phases I through III during her work with leading biopharmaceutical companies, including Bristol-Myers Squibb, AstraZeneca, Imclone and Roche.

DarioHealth Corp. (NASDAQ: DRIO)

New York and Israel-based DarioHealth Corp. (NASDAQ: DRIO) leads global digital therapeutics (DTx) with its popular, smartphone-centered personalized chronic illness management software-as-a-service (SaaS). The company's strategic advantages include:

• AI-powered digital solutions that drive durable behavior change in chronic disease patients, and
• Personalized user experience at scale to make behavior change the path of least resistance.

Approximately $3 trillion in annual U.S. costs associated with chronic illnesses like diabetes, hypertension and obesity are largely preventable with behavioral therapies. Formerly limited to periodic office visits, these therapies can now scale to millions with tech-enabled, continual and remote health monitoring, as well as AI-driven digital and live coaching. This is all possible while still maintaining the personalization required for success in reducing illness and its related effects and costs.

Roughly 51,000 active, paying users manage their health with Dario's platform that combines smartphone-connected vitals measurement, remote patient monitoring (RPM), lifestyle management tools, and AI-driven and human coaching to deliver improved clinical outcomes.

Among the most downloaded medical apps, the Dario platform is rated at 4.9 stars on the Apple App Store and features 11,000 reviews, along with a Net Promoter Score (a measurement of consumers' willingness to recommend the product to others) that's the highest in its field.

Company Strategy

Clinical studies demonstrate Dario's direct improvement on users' health measures like H1AC scores (diabetes) and blood pressure (hypertension).

Patient engagement in therapies leads to health success. Dario's platform centers on continual maximization of patient engagement through personalization, including 'nudges' and live, AI-generated responses to health measures provided by Dario's smartphone-connected medical devices.

Proprietary data analysis provides valuable insights that not only improve health care providers' medical capabilities but, through artificial intelligence, encourage patients to take evidence-based and highly personalized preventative measures that reduce risk, emergency room visits and preventable hospitalization.

Dario is now deploying its successful B2C platform in B2B2C, targeting employers and health plans with competitive advantages in cost, software and hardware.

The company estimates an annual addressable U.S. market of $72 billion, only 1% of which has been penetrated with digital therapeutics.

The strategic transition to B2B2C (from exclusively B2B) is intended to accelerate revenue growth by reducing Dario's cost per acquisition per user and expanding margins.

Dario's commitment to aggressive growth is also shown by its appointment of a new president, chief medical officer and head of sales for North America, all from a highflyer behavioral health company.

Key growth drivers planned include expansion of the company's paying B2C subscriber base; lateral expansion into other chronic conditions that overlap with its core diabetes populations, such as hypertension, obesity and depression; and increased B2B2C penetration.

Financial Highlights

The company plans to leverage a massive opportunity for growth, with a global addressable market for digital therapeutics of roughly $108 billion. In the U.S. alone, that number is estimated at $72 billion, and only about 1% of that market has been penetrated.

Dario's strategic transition to an SaaS membership business model increased gross profit by 87% in Q1 2020, as compared to the prior year. Membership revenue increased from 27.1% to 46.7% in the same period. The company is seeing improved operating efficiencies as it shifts focus to the B2B2C business model, and it expects average revenue per user per month (ARPU), which was $6 and $25 in 2019 and 2020, respectively, to reach $70.

Value to Consumers and Businesses

Dario continually evaluates and optimizes the value and return its platform delivers to consumers and businesses.

Consumers seeking to understand how their everyday behavior impacts their personal health and chronic conditions benefit from actionable feedback on how to improve health and better collaborate with health care providers.

Businesses looking to increase employee satisfaction, loyalty and productivity with fewer health-related absences take advantage of Dario's services for employers.

Health care providers improve patient compliance using the platform's interactive services that allow for greater monitoring, which improve engagement with patients at the right times and with the right treatments.

Health plans can leverage DarioHealth's solutions to improve patient outcomes and lower costs.

Recent Studies

The company recently presented the results of two new studies at the American Diabetes Association's 80th Scientific Sessions, which showed sustained improvements in blood glucose levels and blood pressure among users of its digital therapeutic platform for chronic diseases. The results of these two studies demonstrate that the use of Dario's therapeutic platform promotes behavioral modification, enhanced individual engagement and improved clinical outcomes.

Remote Patient Monitoring (RPM) Agreements

The Centers for Medicare & Medicaid Services recently approved RPM codes for Medicare patients, which enables physicians to bill for between-visit patient care.

This simplifies implementation of the company's open and scalable AI-driven platform and further supports transition to the company's high-margin, recurring SaaS model targeting B2B2C revenue channels.

Emergency COVID-19 FDA Guidelines Allow Self-Test Blood Glucose Meters

In an effort to preserve personal protective equipment (PPE) and reduce contact between health care providers and patients in hospital settings due to COVID-19, the U.S. Food and Drug Administration (FDA) has recognized that home-use blood glucose meters, including Dario's smartphone-connected metering device, may be used by patients with diabetes who are hospitalized due to COVID-19 to check their own blood glucose levels and provide the readings to the health care personnel caring for them.

As a result, hospitals can now allow patients to self-test using their Dario blood glucose testing strips and smartphone-connected devices, or hospitals can issue patients Dario devices upon admission for COVID-19-related conditions.

Irregularities in blood glucose levels are suspected as a factor in the increased severity of potentially deadly COVID-19 complications. As such, a high priority is being placed on stabilization of patients' blood glucose levels.

Awards and Recognition

DarioHealth's Blood Glucose Monitoring System was voted as the 'Best Glucometer for Data Management' by Top Ten Reviews. Jeph Preece, senior editor at Top Ten Reviews, said, "The Dario app is the best data management system that I've seen. Compared to apps by popular brands, Dario's system looks and feels like it's years ahead of the curve."

'The Global Digital Health 100', an annual award sponsored by the reputable Journal of Health, recognized DarioHealth as a leader among health technology companies demonstrating the greatest potential to change the way that health care is delivered.

Energy Fuels Inc. (NYSE American: UUUU) (TSX: EFR)

Energy Fuels Inc. (NYSE American: UUUU) (TSX: EFR), based in Lakewood, Colorado, is the country's largest producer of uranium and the leading conventional producer of vanadium, both designated by the U.S. government as critical minerals. Energy Fuels is also making progress entering the rare earth element production business.

As the leading U.S. diversified uranium miner, Energy Fuels' uranium production portfolio stands apart in the world. Energy Fuels has more uranium production facilities, more production capacity, and more in-ground resources than any other company in the United States. In fact, the company's assets have produced over one-third of all U.S. uranium over the past 15 years and is uniquely positioned to increase production to meet new demand.

Energy Fuels utilizes both conventional and in-situ recovery ("ISR") technology to produce uranium from three strategic facilities:

• White Mesa Mill in Utah (conventional) has a licensed capacity of over 8 million pounds of U3O8 per year. The highly strategic White Mesa Mill is the only conventional uranium mill in the country and is proximate to some of the largest and highest-grade uranium mines and projects in the U.S., including the Company's Canyon mine, La Sal Complex, Henry Mountains Complex and Roca Honda Project. White Mesa Mill provides Energy Fuels with significant production scalability as uranium demand increases. The White Mesa Mill also has other diverse businesses, including vanadium, rare earth elements (REE's), alternate feed materials recycling and land cleanup, all described below.
• Nichols Ranch Plant (ISR) is located in the productive Powder River Basin district of Wyoming and has a total licensed capacity of 2 million pounds of U3O8 per year. Nichols Ranch has produced 1.2 million pounds of U3O8 since commissioning in 2014, and it has significant future expansion potential from 34 fully licensed wellfields containing significant in-ground uranium resources.
• Alta Mesa Plant (ISR) is located on over 200,000 acres of private land in Texas. The fully licensed and constructed ISR project has a total operating capacity of 1.5 million pounds of uranium per year and produced nearly 5 million pounds of U3O8 between 2005 and 2013. This low-cost production facility is currently on standby, maintained in a state of readiness to respond to expected increases in demand.

In addition to being the largest uranium miner in the U.S., Energy Fuels' overall portfolio also includes a pipeline of high-quality, large-scale exploration and development projects that are permitted or are in advanced stages of permitting, as well as an industry-leading U.S. NI 43-101 Mineral Resource portfolio.

FACTOID: Energy Fuels has led industry efforts over the past two-plus years to get the U.S. government to recognize the importance of domestically produced uranium, including the 2018 – 2019 Uranium Section 232, the ongoing Nuclear Fuel Working Group and the recently announced creation of the U.S. strategic uranium reserve. The U.S. is by far the largest consumer of uranium in the world, yet we import almost all of our requirements; Energy Fuels aims to change that.

Nuclear Market Potential

Multiple studies in top scientific journals have shown that nuclear power is cleanest and most economical way to produce reliable electricity as worldwide demand continues to soar. Nuclear power is presently the only available and affordable low-carbon power source that can meet both current and future baseload electricity demands while simultaneously reducing air pollution and mitigating climate change. U.S. nuclear power plants currently generate nearly 20% of the nation's electricity overall and 55% of its carbon‐free electricity and even a modest increase in electricity demand would require significant new nuclear capacity by 2025. According to the World Nuclear Association (WNA), there are currently 441 operable reactors, with another 54 units under construction and 439 in various stages of planning; in addition, the WNA has identified a potentially massive supply/demand gap through 2040 of 1 billion pounds. These factors among others are expected to significantly drive increased demand for uranium.

Reasons Nuclear is Gaining Traction

• Nuclear reactors emit no greenhouse gases during operation. Over their full lifetimes, they result in comparable emissions to renewable forms of energy such as wind and solar.
• Unlike any other form of energy, the waste from nuclear energy is contained and managed securely. Used fuel is currently being safely stored for ultimate disposal or future reprocessing, and 96% of this waste can potentially be recycled.
• Greater demand for clean electricity to power everything from homes to automobiles, reducing dependence on fossil fuels.

No. 1 U.S. Producer of Vanadium in 2019

Energy Fuels also produces vanadium as a byproduct of uranium production. Vanadium is designated a critical mineral, essential to the economic and national security of the United States. Energy Fuels was the largest producer of vanadium in the U.S. in 2019, and has significant high-grade, in-ground vanadium resources, as well as a separate high-purity vanadium production circuit at their White Mesa Mill, which is also the only conventional vanadium mill in the country. Crucial for use in the steel, aerospace, and chemical industries, vanadium plays a critical role in the production of high-strength and light-weight metallic alloys and demand is expected to increase across the globe.

Energy Fuels has several fully permitted and developed standby mines containing large quantities of high-grade vanadium, along with uranium, including:

• La Sal Complex (Utah)
• Whirlwind Mine (Colorado/Utah)
• Rim Mine (Colorado)

Vanadium has also gained increased attention as a catalyst in next-generation high-capacity, "community-scale" batteries used for energy storage generated from renewable sources. Demand is only expected to grow as this market expands. With recent upgrades in its vanadium production operations, in 2019 Energy Fuels produced commercial levels of the highest purity (99.7%) vanadium in the mill's history and can rapidly adjust production to meet volatile market conditions. Energy Fuels is one of the very few known avenues that provides investors access the vanadium market.

Rare Earth Element (REE) Production, Alternate Feed Material Recycling, and Land Cleanup

The White Mesa Mill also provides the company with diverse cashflow generating opportunities. Security of supply for Rare Earth Elements (REEs) supporting U.S. military and defense requirements is a major issue today. Energy Fuels has been approached by a number of entities, including the U.S. government, inquiring about the potential to process certain REEs at the mill. The White Mesa Mill is currently licensed to process certain REEs, including tantalum and niobium. And, early indications are that the mill can be utilized to produce several other REEs. The White Mesa Mill is also the only facility in North America licensed and capable of recycling alternate feed materials (AFMs). AFMs are essentially low-level waste materials that contain recoverable quantities of natural (or unenriched) uranium. The Company typically generates between $5 and $15 million per year from AFM recycling. Finally, Energy Fuels is seeking to become involved in the cleanup of legacy Cold War era uranium mines in the Four Corners region of the U.S., including on the Navajo Nation. The U.S. Environmental Protection Agency (EPA) has access to over $1.5 billion for the cleanup of just a fraction of the sites on the Navajo Nation. The White Mesa Mill is fully licensed to receive much of this material, we are one of the government's lowest cost options, and we have the ability to recycle the material and produce usable uranium from it.

Management Team

Mark S. Chalmers, President and CEO
Mark S. Chalmers is the president and chief executive officer of Energy Fuels, a position he has held since Feb. 1, 2018, following his role as chief operating officer of Energy Fuels from July 1, 2016 – Jan. 31, 2018. From 2011 to 2015, Chalmers served as executive general manager of Production for Paladin Energy Ltd., a uranium producer with assets in Australia and Africa, including the Langer Heinrich and Kayelekera mines where, as head of operations, he oversaw sustained, significant increases in production while reducing operating costs. He also possesses extensive experience in in situ recovery ("ISR") uranium production, including management of the Beverley Uranium Mine owned by General Atomics (Australia), and the Highland mine owned by Cameco Corporation (USA). Chalmers has also consulted to several of the largest players in the uranium supply sector, including BHP Billiton, Rio Tinto, and Marubeni, and until recently served as the chair of the Australian Uranium Council, a position he held for 10 years. Chalmers is a registered professional engineer and holds a Bachelor of Science in Mining Engineering from the University of Arizona.

W. Paul Goranson, COO
W. Paul Goranson is the chief operating officer for Energy Fuels. Goranson has 30 years of mining, processing and regulatory experience in the uranium extraction industry that includes both conventional and in-situ recovery ("ISR") mining, and he is a registered professional engineer. Prior to the acquisition by Energy Fuels of Uranerz Energy Corporation, Goranson served as president, chief operating officer and director for Uranerz, where he was responsible for operations of the Nichols Ranch ISR Uranium Project. In addition to those duties, he also managed uranium marketing, regulatory and government affairs, exploration and land. Prior to joining Uranerz, Goranson served as president of Cameco Resources, where he led the operations at the Smith Ranch-Highland, Crow Butte and North Butte ISR uranium recovery facilities. Goranson also served as vice president of Mesteña Uranium LLC, and he has served in senior positions with Rio Algom Mining, (a subsidiary of BHP Billiton), and Uranium Resource Inc. Goranson has a Bachelor of Science in Natural Gas Engineering from Texas A&I University, and a Master of Science in Environmental Engineering from Texas A&M University-Kingsville.

David C. Frydenlund, CFO, General Counsel, Corporate Secretary
David C. Frydenlund is chief financial officer, general counsel, and corporate secretary of Energy Fuels. His responsibilities include oversight of all legal matters relating to the company's activities. His expertise extends to NRC, EPA, state and federal regulatory and environmental laws and regulations. From 1997 to 2012, Frydenlund was vice president of regulatory affairs, general counsel and corporate secretary of Denison Mines Corp., and its predecessor International Uranium Corporation ("IUC"). He also served as a director of IUC from 1997 to 2006 and CFO of IUC from 2000 to 2005. From 1996 to 1997, Frydenlund was vice president of the Lundin Group of international public mining and oil and gas companies, and prior thereto was a partner with the Vancouver law firm of Ladner Downs (now Borden Ladner Gervais) where his practice focused on corporate, securities and international mining transactions law. Frydenlund holds a bachelor's degree in business and economics from Simon Fraser University, a master's degree in economics and finance from the University of Chicago and a law degree from the University of Toronto.

Curtis H. Moore, Vice President of Marketing and Corporate Development
Curtis H. Moore is the vice president of Marketing and Corporate Development for Energy Fuels. He oversees product marketing for Energy Fuels, and is closely involved in mergers & acquisitions, investor relations, public relations, and corporate legal. He has been with Energy Fuels for over 12 years, holding various roles of increasing responsibility. Prior to joining Energy Fuels, Moore worked in multi-family real estate development, government relations and public affairs, production homebuilding, and private law practice. Moore is a licensed attorney in the State of Colorado. He holds Juris Doctor and MBA degrees from the University of Colorado at Boulder, and a Bachelor of Arts dual degree in Economics-Government from Claremont McKenna College in Claremont, California.

Processa Pharmaceuticals Inc. (NASDAQ: PCSA)

Processa Pharmaceuticals Inc. (NASDAQ: PCSA) aims to develop products where existing clinical evidence of efficacy already exists in unmet medical need conditions. In support of this goal, the company has assembled an unparalleled management team, board of directors and product development team featuring experts in developing drug products, from IND-enabling studies to NDA submission. In total, the team's combined scientific, development and regulatory experience has resulted in more than 30 drug approvals by the U.S. Food and Drug Administration (FDA) and more than 100 meetings with the FDA while working on more than 50 drug development programs, including drug products targeted to orphan disease and unmet medical need conditions.

Headquartered in Hanover, Maryland, Processa has built a pipeline of drugs which already have some proof-of-concept clinical data supporting clinical use in their selected indications.

Development Pipeline

The Processa process focuses on the advancement of drugs that are ready for clinical development or have minimal pre-IND enabling studies to complete. More specifically, Processa:

1. Acquires drugs that already have some clinical data to support the targeted treatment – whether it be the drug itself, an analog of the drug or a drug with similar pharmacological targets;
2. Navigates through the FDA, collaborating with the reviewers to define a complete development program; and
3. Develops each drug over the course of 2-5 years, out-licensing the drug either just prior to pivotal study after Phase 2b or after the completion of the pivotal study.

Processa's current development pipeline features multiple drug candidates, including PCS499 and PCS100. The company has also announced three additional licensing agreements since June 2020, further bolstering its clinical efforts. Each drug is briefly described below.

PCS6422

On August 27, 2020, Processa announced its entry into a contingent precedent exclusive licensing agreement with Elion Oncology Inc. to develop, manufacture and commercialize eniluracil (PCS6422) globally. PCS6422 is an oral drug to be administered with fluoropyrimidine cancer drugs (e.g., capecitabine, 5-FU) to decrease the breakdown of the cancer drug to inactive metabolites or metabolites that are known to cause unwanted side effects and to increase the anti-cancer related metabolites.

An IND for a Phase 1B study was cleared by the FDA in May 2020. The study will evaluate the safety and tolerability of several dose combinations of PCS6422 and capecitabine in advanced GI tumor patients. Processa intends to enroll the first patient in 1H2021, obtain interim results, and have a final report completed in 2H2022.

"Having worked on 5-FU and other cancer agents in the past, adding PCS6422 to our pipeline and expanding our involvement in oncology was an easy decision given the significant impact that PCS6422 may have on improving the efficacy and safety of capecitabine or other fluoropyrimidines," CEO Dr. David Young said of the agreement.

PCS499

PCS499 as a potential treatment for necrobiosis lipoidica ("NL") was first presented to the FDA in a pre-IND meeting in 2018. In 2019, it was the subject of an IND submission and a promising Phase 2 safety study. On March 30, 2020, Processa announced a successful meeting with the FDA regarding the design and execution of the next clinical study to evaluate the ability of PCS499 to completely close ulcers in patients with NL.

"We are pleased with the outcome of the FDA meeting and the feedback we received from the FDA. We believe that the results from our completed Phase 2 trial in NL patients, especially those with more severe ulcerated forms of NL, are encouraging and we appreciate the guidance provided by the FDA regarding our next clinical trial and the requirements to support our NDA submission," Dr. David Young, CEO of Processa, stated in the news release.

NL is a chronic, disfiguring condition affecting the skin and tissue under the skin, typically on the lower extremities, with no currently FDA-approved treatments. More severe complications can occur, such as deep tissue infections and osteonecrosis, threatening the life of the limb. Approximately 22,500 – 55,500 people in the United States and more than 150,000 – 400,000 people worldwide are affected by the ulcerated form of NL.

YH12852

On August 20, 2020, Processa announced its entry into an agreement with Yuhan Corporation, a South Korean firm, to license YH12852, a small molecule drug in development for the treatment of functional gastrointestinal (GI) disorders. Under the terms of the agreement, Processa will acquire the rights to a portfolio of patents with an exclusive license to develop, manufacture and commercialize YH12852 globally, excluding South Korea.

YH12852 is a novel, potent and highly selective 5-hydroxytryptamine 4 (5-HT4) receptor agonist. Other 5-HT receptor agonists with less 5-HT4 selectivity have been shown to successfully treat GI mobility disorders such as chronic constipation, constipation-predominant irritable bowel syndrome, functional dyspepsia and gastroparesis. The less selective 5-HT4 agonists, such as cisapride, have been removed from the market because of the cardiovascular side effects associated with the drugs binding to other receptors, especially 5-HT receptors other than 5-HT4.

CEO Dr. David Young called the agreement "further evidence of Processa's commitment to seek out novel treatments for unmet medical conditions." Processa intends to meet with the FDA in early 2021 to further define the clinical development program. In 2021, Processa expects to initiate a Phase 2 trial in a functional GI motility-related disorder that that needs better therapeutic options, such as postoperative ileus and opioid-induced constipation.

ATT-11T

On June 1, 2020, Processa announced its entry into a licensing agreement with Aposense Ltd. for the patent rights and know-how to develop and commercialize ATT-11T, a next generation irinotecan cancer drug. In the release, CEO Dr. David Young noted that the licensing deal fit with Processa's strategy to "continue to bring innovative products to patients with an unmet medical need condition."

ATT-11T is a novel lipophilic anti-cancer pro-drug that is being developed for the treatment of the same solid tumors as prescribed for irinotecan. This pro-drug is a conjugate of a specific proprietary Aposense molecule connected to SN-38, the active metabolite of irinotecan. The proprietary Aposense molecule on ATT-11T allows ATT-11T to bind to cell membranes to form an inactive pro-drug depot on the cell, with SN-38 preferentially accumulating in the membrane of tumors cells and the tumor core. This unique characteristic is expected to make the therapeutic window of ATT-11T wider than irinotecan, such that the anti-tumor effect of ATT-11T will occur at a much lower dose than irinotecan with a milder adverse effect profile than irinotecan. The wider therapeutic window will likely lead to more patients responding with less side effects when on ATT-11T compared to irinotecan.

The ATT-11T licensing agreement is conditioned upon Processa's closing of a satisfactory financing round and the listing of the company's shares on the Nasdaq or NYSE, among other conditions.

PCS100

On September 3, 2020, Processa announced its entry into an exclusive worldwide license agreement with Akashi Therapeutics to develop and commercialization Akashi's lead drug, HT-100. Rebranded PCS100, the candidate is an anti-fibrotic, anti-inflammatory drug demonstrated to have some clinical anti-fibrotic effect in children. Processa intends to develop PCS100 first in rare adult fibrotic related diseases such as focal segmental glomerulosclerosis (FSGS), idiopathic pulmonary fibrosis (IPF) or Scleroderma, where there are still few therapeutic options.

Management Team

David Young, Pharm.D., Ph.D. is the CEO and founder of Processa. He has over 30 years of pharmaceutical research, drug development and corporate experience. Young has served in leadership roles with a number of pharmaceutical firms throughout his career, including serving as founder and CEO of Promet Therapeutics LLC since 2015 and as Chief Scientific Officer of Questcor Pharmaceuticals from 2009 to 2014. At Questcor, he was responsible for working with the FDA on modernizing the Acthar Gel label and for obtaining FDA approval in infantile spasms. In total, Young has met with the FDA more than 100 times on more than 50 drug products and has been a key team member on more than 30 NDA/supplemental NDA approvals.

Sian Bigora, Pharm.D., is Processa's Chief Development Officer and founder. She has over 20 years of pharmaceutical research, regulatory strategy and drug development experience, working closely with Young. Prior to joining Processa, Bigora served as Co-Founder, Director and Chief Development Officer at Promet Therapeutics LLC and as Vice President of Regulatory Affairs at Questcor Pharmaceuticals from 2009 to 2015, where she led efforts to modernize the Acthar Gel label and obtain FDA approval in infantile spasms – events which were of material importance to Questcor's subsequent success.

Patrick Lin is Chief Business & Strategy Officer and founder of Processa. He has over 20 years of financing and investing experience in the biopharma sector. Prior to joining Processa, Lin served as Co-Founder and Chairman of Promet Therapeutics LLC. He is also founder and managing partner of Primarius Capital, a family office that manages public and private investments focused on small capitalization companies.

James Stanker has served as CFO of Processa since 2018. He has over 30 years of financial and executive leadership experience in the areas of accounting principles and audit standards, regulatory reporting, and fiscal management and strategy. He served in a financial leadership role as an audit partner at Grant Thornton from February 2000 until his retirement in August 2016, where he was responsible for managing audit quality in the Atlantic Coast market territory.

Wendy Guy is the Chief Administrative Officer and founder of Processa. She has more than two decades of experience in business operations, having worked closely with Young over the last 18 years in corporate management and operations, HR and finance. Prior to joining Processa, she was Co-Founder, Director and Chief Administrative Officer of Promet Therapeutics LLC and Senior Manager, Business Operation over the Maryland office for Questcor Pharmaceuticals.

Net Element (NASDAQ: NETE)

On August 5, 2020, Net Element announced the execution of a definitive agreement to merge with privately-held Mullen Technologies Inc., a Southern California-based electric vehicle company, in a stock-for-stock reverse merger in which Mullen's stockholders will receive a majority of the outstanding stock in the post-merger company. The completion of the merger is subject to shareholder and NASDAQ approval, as well as other conditions referenced in the merger agreement.

Net Element Inc. (NASDAQ: (NASDAQ: NETE) is a global financial technology and value-added solutions group that supports electronic payments acceptance in an omni-channel environment spanning across point-of-sale, e-commerce and mobile devices. The company operates a payments-as-a-service transactional model and value-added services platform for small to medium enterprises in the U.S. and selected emerging markets.

Net Element believes the future of global commerce is being revolutionized as consumers quickly migrate toward omni-channel shopping utilizing mobile devices, desktop, and online services. The company's all-in-one payment solutions support and unify a whole range of applications through a single, robust platform, allowing global onboarding and support for multiple payment methods.

Net Element has also launched a blockchain-focused business unit that will develop and deploy blockchain technology-based solutions. Net Element expects the new division to create a decentralized crypto-based ecosystem that will act as a framework for an unlimited number of value-added services, connecting merchants and consumers in a seamless, economically efficient transaction. This new business unit intends to also identify and invest in unique projects that decentralize and disrupt the payment processing industry by combining blockchain technology and real-world applications with talented development teams, strong fundamentals and addressable markets large in size.

"We believe that we're at the dawn of a new evolution where additional digital payment methods are being introduced," Net Element chairman and CEO Oleg Firer, says. "Introduction of our division focused on blockchain as part of the NASDAQ-listed entity will add transparency and compliance assurance to our investors as well as provide access to deploy value-added services to over 20 million electronic commerce clients that are currently part of Net Element's growing network."

Net Element clients are treated to customized solutions that provide the flexibility needed to keep up with customers. Among the services offered are mobile payment apps that accept payments anywhere, anytime; cloud-based solutions built to increase productivity and enhance revenue for clients and partners; marketing solutions that turn lookers into buyers; and business analytics that make it easy for clients to monitor business metrics, engage with customers and compare the competition. Its multi-channel platform combines e-commerce, offline, point-of-sale, comprehensive back office tools, mobile point-of-sale, credit scoring and customer interaction in one powerful platform-as-a-service technology.

Net Element owns and operates a global mobile payments and transactional processing provider, TOT Group, Inc., with the following subsidiaries:

• Unified Payments – An award-winning, customized mobile billing and payments solution, recognized by Inc. Magazine as the No. 1 Fastest Growing Company in America in 2012.
• Aptito – A next-generation, all-in-one, cloud-based restaurant management and point-of-sale payments platform using wireless technology.
• Payonline – A fully integrated, processor agnostic electronic commerce platform.

Net Element is ranked on Deloitte's Technology Fast 500™ list of North America's 500 fastest growing technology, media, telecommunications, life sciences and energy tech companies in both 2017 and 2018, during which the company grew 190 percent and 183 percent, respectively. The company credits its progression to organic growth in its North America Transactions Segment, specifically the success of its Unified Payments brand, which focuses on value-added payment acceptance solutions for small to medium enterprises in the United States.

Net Element was also listed among South Florida Business Journal's 2016 fastest growing technology companies.

Leveraging its suite of application performing interfaces (APIs) and connectors, Net Element powers commerce for businesses of all sizes through multi-channel platforms, all-in-one digital solutions, and end-to-end encryption of cardholder data utilizing tamper resistant hardware that ensures integrity and simplifies security.

Leading this innovation is chairman and CEO Oleg Firer, who is responsible for the overall vision, strategy and execution of the company's mission of powering global commerce. He is joined by CFO Jeffrey Ginsburg, CPA, and Steven Wolberg, the company's chief legal officer and secretary. Each corporate officer brings a unique blend of leadership, vision, experience and creative energy to the company.

From mobile payments and value-added transactional innovations like Aptito to e-commerce and retail payment transaction processing brands like Payonline and Unified Payments, Net Element is transforming the online and mobile experience.

SRAX Inc. (NASDAQ: SRAX)

SRAX Inc. (NASDAQ: SRAX) is a digital marketing and consumer data management technology company. SRAX's technology unlocks data to reveal brands' core consumers and their characteristics across marketing channels.

Through its BIGtoken platform, SRAX has developed a consumer-managed data marketplace where people can own and earn from their data, thereby providing everyone in the internet ecosystem choice, transparency and compensation.

SRAX's tools deliver a digital competitive advantage for brands in the CPG, automotive, investor relations, luxury and lifestyle verticals by integrating all aspects of the advertising experience, including verified consumer participation, into one platform.

SRAX Verticals

• SRAX Core: SRAX Core is a custom digital media management platform that enables brands and agencies to surpass the challenges of omnichannel marketing campaigns. It offers one comprehensive dashboard to manage digital media campaigns, inventory and reporting.
• SRAX Social: SRAX Social is a free social media management tool that makes it easy for brands, agencies and individuals to grow their digital presence. It offers free and unlimited users, Facebook auto boosting, and a custom analytics dashboard. Its managed services team can also build and execute marketing plans for your unique specific needs.
• SRAX IR: SRAX IR unlocks stock buyers' behaviors and trends for issuers of publicly traded companies. The platform provides insights on shareholders and market makers, investor relations management, shareholder outreach tools and data-driven marketing.
• SRAX Auto: SRAX Auto unlocks auto intenders' data to create measurable connected experiences on the road to purchase. It offers proprietary auto intender profiles, multi touchpoint communication and custom location-based ads.
• SRAX Shopper: SRAX Shopper delivers a cross channel, premium digital experience at scale to high value shopper audiences. It offers proprietary shopper profiles, cost per click pricing, and custom text and add to cart ad units.
• SRAX Lux: Launched in June 2019, the SRAX Lux platform targets and reaches luxury consumers at luxury retail stores, high-end art, music, film, fashion and sports events, across all consumer devices.

International Expansion

BIGtoken is formally launching into several international markets and partnering to foster local support. SRAX recently signed a joint venture with the Yash Birla Group to launch BIGtoken in India. Based in Mumbai, the Yash Birla Group, one of India's largest conglomerates, has diversified interests in consumer and industrial products.

The partnership will bring BIGtoken's platform to India, which has a digital population of 627 million. The India digital advertising market is $3.6 billion and is set to grow at a compound annual growth rate of 32%, making it one of the largest growing digital ad markets in the world.

SRAX Mexico is led by Moe Avitia, who has more than 18 years of experience in business development and building high-tech teams. SRAX Mexico includes a team of 90 employees, including 70 engineers.

BIGtoken Europe is currently evaluating data centers in individual countries for privacy laws.

Leadership

Christopher Miglino is CEO and founder of SRAX. He has spent the past 20 years working in the digital advertising space and has successfully launched and sold two internet companies. Both of these companies were sold to publicly traded companies on the NASDAQ. He has a detailed understanding of how technology interacts with brands.

Kristoffer Nelson is COO of SRAX and a founding member of BIGtoken. With over 15 years of technology and creative business experience, Nelson has been a guest speaker for Loyola Marymount University among other academic institutions, the National Association of Broadcasters, the IAB and numerous other professional and media organizations.

Trxade Group Inc. (NASDAQ: MEDS)

Trxade Group Inc. (NASDAQ: MEDS) is an integrated pharmaceutical services company that offers a unique combination of a web-based purchasing platform (www.trxade.com) for transactions between independent pharmacists and drug distributors (B2B); a network of pharmacies with E-Hub software; a mail order pharmacy; and warehouse and drug delivery services. This synergistic combination of product offerings and superior data analytics is poised to benefit all stakeholders and consumers within the pharmaceutical industry.

Trxade will leverage and scale its fully integrated model to execute the following growth strategies:

• Increase share of pharmacist drug purchasing
• Additional SKUs and expand product breath
• Partner with Specialty and International Mfg.
• Expand mail order licenses to all 50 states
• Scale Delivmeds for consumer delivery nationwide
• Integration with telemedicine
• M&A Opportunities within drug value chain

Founded in 2010 and headquartered in Tampa, Florida, Trxade's overarching corporate strategy is to penetrate the existing retail independent pharmacy marketplace and diversify the company's pharmaceutical mix with additional specialty and acute care products. Trxade is advancing on this mission by focusing on three key niches in the health care market.

Business-to-Business (B2B)

The $330 billion U.S. pharmaceutical industry is comprised of more than 65,000 pharmacy facilities and 1,500 state-licensed suppliers. Roughly 24,000 of these facilities are independent pharmacies, which collectively spend approximately $93 billion a year on branded and generic drugs.

Trxade targets these independent pharmacies, leveraging a robust, "E-Bay/Kayak-like" technology platform with optimum buyer/seller pricing algorithms, product availability, and predictive data analytics features.

Trxade currently serves and transacts with more than one-third (10,250) of these independent pharmacies and facilitates over $10 million of drug purchases a month!

Consumer

Trxade also targets the "consumer side" of the pharmaceutical industry, aiming to lower prescription drug costs by attacking the inefficient value chain; offering drug price transparency and efficient buying; and, delivering drugs DIRECT to independent pharmacists and consumers.

The company operates a full-service mail order pharmacy for U.S. consumers, as well as a mobile app called "Delivmeds" (http://www.delivmeds.com) which enables SAME DAY home delivery of dispensed prescriptions.

Retail

Trxade's Managed Services Organization ("TrxadeMSO") enables its member independent retail pharmacies to get patients, process orders, and deliver or ship prescriptions to patients. TrxadeMSO provides access to encompassing network of pharmacies through the E-Hub software, allowing for timely and comprehensive medication fulfillment.

These offerings ensure the best-suited pharmacy receives the patient's information, thereby ensuring appropriate medication coverage based on the patient's location, payor coverage, and medication access/inventory. This will save the clinicians and their staff time as they benefit from efficiency and enhanced workflow management in script processing and fulfillment.

Health Care Market 

The U.S. health care market currently hovers near $4 trillion and is expected to grow as the general population ages. This growth will have greater impact on consumers as out-of-pocket expenses also rise. Additionally, drug costs are paced to increase faster than the overall health care and well above inflation.

Drug pricing is variable, and reimbursement is squeezing profits. This provides significant opportunity for the Trxade model of price visibility and profit optimization.

Trxade's fair online market platform targets the nation's retail community and independent pharmacies, of which there are approximately 24,000 nationwide. TRxADE has found that independent pharmacies, in order to be cost-effective, often operate with minimal staff and conduct up-to-the minute price checks. The TRxADE S2P platform gives these pharmacists the ability to easily compare the price of drugs offered by various suppliers and select the most favorable deals, saving money by taking advantage of best purchase pricing.

TRxADE's programs include:

• TRxADE Exchange, which opens and widens the distribution channel to the retail, community pharmacy. A purchasing pharmacy can view products from manufacturers, buying groups, and wholesalers on a real-time and continuous basis. This approach significantly enhances the competitive spirit of the exchange where the lowest price exists for each product at any given point in time. TRxADE has become a competitive tool for all progressive entities and is recognized for its easy searching of hard-to-find generic pharmaceuticals at substantially reduced prices.  
• RX Guru™ is an industry-leading price prediction model that integrates product shortage insight into pharmacy acquisition benchmarks ("PAC") to ascertain trends and pricing variances that result in significant purchasing opportunities. RX Guru affords members the opportunity to continuously benefit from real price purchasing opportunities that are concealed from the rest of the industry. 
• Product Shortage Database – TRxADE maintains the most comprehensive retail, specialty and acute care pharmaceutical product shortage database in the country. Other industry competitors mainly restrict their efforts to specialty and acute care product shortages and narrowly research oral generic products. TRxADE's advanced prediction tools help members source those hard-to-find products at affordable costs in a timely and easy-to-search process. 

Management Team 

Trxade's management team is rich in expertise within the pharmaceutical supply chain and is supported by a base of advisors and contractors who are experts in related fields of the pharmaceutical sector.

Suren Ajjarapu – Chairman of the Board, Chief Executive Officer and Secretary
Suren Ajjarapu has served as Trxade's chairman of the board, CEO and secretary since 2014, and as the chairman of the board, chief executive officer and secretary of Trxade Nevada since its inception. Ajjarapu also serves as a chairman of the board for Feeder Creek Group Inc., since March 2018. Ajjarapu formerly was a founder, CEO and chairman of Sansur Renewable Energy Inc., a company involved in developing wind power sites in the Midwest, United States; a founder, president and director of Aemetis Inc., a biofuels company (AMTX.OB); a founder, chairman and CEO of International Biofuels, a subsidiary of Aemetis Inc.; and a co-founder, COO, and director at Global Information Technology Inc., an IT outsourcing and systems design company. Ajjarapu holds an M.S. in environmental engineering from South Dakota State University, Brookings, South Dakota, and an MBA from the University of South Florida, specializing in international finance and management. Ajjarapu is also a graduate of the Venture Capital and Private Equity program at Harvard University.

Prashant Patel – Director, President and Chief Operating Officer
Prashant Patel has served as Trxade's full-time president and COO, and as a director since the company's acquisition of Trxade Nevada in 2014, and as the COO and president and as a director of Trxade Nevada since its inception. He has been a president and member of the board of Trxade since August 2010. Patel is a registered pharmacist and pharmaceutical consultant with over 10 years of experience in retail pharmacy and pharmaceutical logistics. He is the founder of several pharmacies in the Tampa Bay area, in Florida. Since 2008, Patel has been managing member of the APAA LLC pharmacy. Since 2007, Patel has been a vice president of Holiday Pharmacy Inc. Patel graduated from Nottingham University School of Pharmacy and practiced in the United Kingdom before obtaining his masters in Transport, Trade and Finance from Cass Business School, City University, UK.