TinyGems

Tiny Gems - September 2023

TinyGems
Monthly Picks

Arizona Metals Corp. (TSX: AMC) (OTCQX: AZMCF)

Arizona Metals Corp. (TSX: AMC) (OTCQX: AZMCF) is a mineral exploration company engaged in advancing precious and base metal deposits in the state of Arizona. Its flagship copper-gold-zinc-silver asset is the Kay Mine Project, located in Yavapai County. The company also owns Sugarloaf Peak gold project in La Paz County.

The company in October 2022 received permit approval from the Bureau of Land Management (BLM) for two new drill pads, located approximately 1,200 meters west of the Kay Mine Deposit. These new pads will allow for testing of the company's Western Target, while also allowing for drilling of additional coincident anomalies located between the Central and Western Targets. Construction of the drill road for the Central Target (located 500 meters west of the Kay Mine Deposit) is currently underway, with drilling expected to begin in November 2022. Road construction for the Western Target will begin upon confirmation of BLM acceptance of the company's posted bond, with drilling expected to commence in Q1 2023.

The company is fully funded, with $60 million in cash as of June 30, 2022, to complete the remaining 18,000 meters planned for the Phase 2 program at Kay, as well as an additional 76,000 meters in the Phase 3 program (budgeted at $27 million), which will be used to test the numerous parallel targets heading west of the Kay Deposit, as well as the northern and southern extensions of the Kay Deposit.

Arizona Metals Corp. is based in Toronto, Canada.

Projects

Arizona Metals Corp. owns 100% of the Kay Mine property in Yavapai County, which is located on a combination of patented and BLM claims totaling 1,300 acres that are not subject to any royalties. An historic estimate by Exxon Minerals in 1982 reported a "proven and probable reserve of 6.4 million short tons at a grade of 2.2% copper, 2.8 grams per ton gold, 3.03% zinc, and 55 grams per ton silver." The historic estimate has not been verified as a current mineral resource. None of the key assumptions, parameters, and methods used to prepare the historic estimate were reported by Exxon, and no resource categories were used. Significant data compilation, re-drilling and data verification may be required by a "qualified person" (as defined in National Instrument 43-101 – Standards of Disclosure for Mineral Projects) before the historic estimate can be verified and upgraded to be a current mineral resource. A qualified person has not done sufficient work to classify it as a current mineral resource, and Arizona Metals is not treating the historic estimate as a current mineral resource.

The company also owns 100% of the Sugarloaf Peak Property in La Paz County, which is located on 4,400 acres of BLM claims. Sugarloaf is a heap-leach, open-pit target and has a historic estimate of "100 million tons containing 1.5 million ounces (of) gold" at a grade of 0.5 grams per ton. The historic estimate at the Sugarloaf Peak Property was reported by Westworld Resources in 1983. The historic estimate has not been verified as a current mineral resource. None of the key assumptions, parameters, and methods used to prepare the historic estimate were reported, and no resource categories were used. Significant data compilation, re-drilling and data verification may be required by a qualified person before the historic estimate can be verified and upgraded to a current mineral resource. A qualified person has not done sufficient work to classify it as a current mineral resource, and Arizona Metals is not treating the historic estimate as a current mineral resource.

Market Opportunity

The World Gold Council, an industry association representing gold producers with hundreds of mining operations in nearly 50 countries around the world, reports that global demand for gold during the first six months of 2022 was 2,189 tons, a 12% increase in demand over the same period in 2021. Demand came primarily from gold bar and coin investors, jewelry consumers, central bank purchases to bolster currency reserves and technology manufacturing.

The average price per ounce for the period was $1,871, marking a 1% year-over-year increase. The council reported gold mine production for the period was up 3% over 2021 at 1,764 tons. For the remainder of 2022 and into 2023, the council projects flat gold demand with possible slight increases in gold mine production. The council notes that unpredictable geopolitical factors, the Ukraine war for example, and likelihood of global economic slowdown could have significant near-term impact on gold demand and prices.

Management Team

Marc Pais is President and CEO of Arizona Metals. He previously founded and served as President of Telegraph Gold (listed as Castle Mountain Mining), which was acquired by Equinox Gold, a TSX-listed mining company. He has seven years of experience as a Mining Analyst, with a focus on precious metals development companies. He holds a B.Sc. in Geological Engineering (Mineral Exploration) from Queen's University in Canada.

David Smith is the Vice President, Exploration of Arizona Metals. He has 30 years of global precious metals exploration experience, including codiscovery of the Solidaridad/La Sabila deposit in Mexico with deposits estimated at 1 million ounces of gold. His core areas of expertise are managing mineral projects from acquisition to exploration, resource modeling and mineral project development. He holds an M.Sc. from the University of Oregon and an MBA from Pinchot University/Presidio Graduate School.

Paul Reid is the Executive Chairman of Arizona Metals. He previously founded and served as Executive Chairman of Telegraph Gold (listed as Castle Mountain Mining), which was acquired by Equinox Gold, a TSX-listed mining company. Paul has extensive experience as an Investment Banking professional, involved in raising capital, go-public transactions, and advisory services.

Eloro Resources Ltd. (TSX: ELO) (OTCQX: ELRRF)

Eloro Resources Ltd. (TSX: ELO) (OTCQX: ELRRF) is a publicly traded exploration and mine development company focused on the Iska Iska Property in Bolivia. The company has an option to earn a 99% interest in the highly prospective property.

A recent NI 43-101 Technical Report on Iska Iska, completed by Micon International Limited, is available on Eloro's website and under its filings on SEDAR.

The company also has legacy holdings in Peru and Northern Quebec. It is led by a strong management and technical team working diligently to uncover the value of its portfolio.

Eloro is based in Toronto, Canada.

Iska Iska Project

Iska Iska silver-tin polymetallic project is a road accessible, royalty-free property that's wholly controlled by title holder Empresa Minera Villegas S.R.L. It is located 48 km north of Tupiza city, in the Sud Chichas Province of the Department of Potosi in southern Bolivia.

Iska Iska is a major silver-tin polymetallic porphyry-epithermal complex associated with a Miocene possibly collapsed/resurgent caldera roughly 1.6 km by 1.8 km in dimension with a vertical extent of at least 1 km. Its mineralization age is similar to Cerro Rico de Potosi and other major deposits, such as San Vicente, Chorolque, Tasna and Tatasi, located in the same geological trend.

Eloro began underground diamond drilling from the Huayra Kasa underground workings at Iska Iska on September 13, 2020. On November 18, 2020, Eloro announced the discovery of a significant breccia pipe with extensive silver polymetallic mineralization just east of the Huayra Kasa underground workings and a high-grade gold-bismuth zone in the underground workings. On November 24, 2020, Eloro announced the discovery of the SBBP approximately 150 m southwest of the Huayra Kasa underground workings.

Since the initial discovery hole, Eloro has released a number of significant drill results in the SBBP and the surrounding mineralized envelope, which, along with geophysical data, has defined an extensive target zone. In its September 20, 2022, press release, the company reported that new downhole geophysical data has significantly extended the strike length of the high-grade feeder zone at Santa Barbara a further 250 m along strike to the south-southeast from existing drilling.

The 3D inverse magnetic model, which correlates very strongly with the conductive zone, suggests that the high-grade feeder zone may extend across the entire caldera for as much as a further 1 km along strike for a total potential strike length of at least 2 km. As a result, the estimated completion date for the maiden NI 43-101 mineral resource has been pushed back to the end of Q1 2023.

On November 22, 2022, Eloro announced the acquisition of the Mina Casiterita and Mina Hoyada properties covering 14.75 km2 southwest and west of Iska Iska. Following the acquisition, the total land package in the Iska Iska area to be controlled by Eloro will total 483.75 km2.

Recently completed magnetic surveys by Eloro have outlined an extensive, near surface, magnetic intrusive body on the Mina Casiterita property, immediately southwest of Iska Iska. This intrusive hosts the previously mined high-grade tin veins and is very likely the continuation of the porphyry tin intrusion projected to be below the epithermal Ag-Sn-Zn-Pb mineralization at Iska Iska.

Drilling is planned on Mina Casiterita in Q1 2023, with geological mapping, sampling and geophysical surveys now in progress on the full land package across the Iska Iska region.

Market Outlook

According to industry association The Silver Institute, the outlook for silver demand is exceptionally promising, with global demand forecast to rise to a record high of 1.112 billion ounces in 2022. The increase will be driven by record silver industrial fabrication, which is forecast to improve by 5%, as silver's use expands primarily in solar energy and electric vehicle (EV) manufacturing. The institute states that government commitments to carbon neutrality have resulted in a rapid expansion of green energy projects, driving record photovoltaic panel installations which are expected to lift silver demand in this segment to an all-time high in 2022.

Rising demand in the electronics industry is also boosting the demand for tin, which is primarily used in solder. The electronics and electrical industries use solders containing 40-70% tin, which provide strong and reliable joints under a variety of environmental conditions. At present, the majority of the assemblers are using patented tin-and-copper-based solders. Mordor Intelligence estimated tin demand at 387 kilotons in 2021 and forecasts demand growth of 2.5% annually through 2027. Over the medium term, surging demand from the EV market and increasing applications in the electrical and electronics industry is expected to drive the market.

Management Team

Thomas G. Larsen is CEO of Eloro. He has more than 40 years of experience in the investment industry, specializing in corporate finance and management of junior resource companies, raising in excess of C$200 million. He previously held the position of President and Chief Executive Officer of Champion Iron Limited.

Dr. Bill Pearson is Executive VP of Exploration for Eloro. He has more than 40 years of direct experience in the exploration and production of minerals worldwide. He played an integral role in the acquisitions of Desert Sun Mining Corp. by Yamana Gold in 2006 and Central Sun Mining by B2 Gold in 2009. He was formerly VP Exploration at Desert Sun Mining and Senior VP at Central Sun Mining.

Miles Nagamatsu, CPA, is CFO at Eloro. He has over 30 years of experience in accounting, management, lending, restructurings and turnarounds. Since 1993, he has acted as a CFO of public and private companies primarily in the mineral exploration and investment management sectors. He holds a Bachelor of Commerce degree from McMaster University.

Osvaldo Arce Burgoa is General Manager at Eloro. He is a geological and mineral processing engineer with 26 years of experience in Bolivia. He is a former President of the Bolivian Geological Society, Main Technical Advisor of the National Mining Corporation (COMIBOL) and has served as exploration manager and chief geologist at various mining and exploration companies. He has authored two books on Bolivian geology and holds a doctorate in mining engineering from Tohoku University in Sendai, Japan.

FingerMotion Inc. (NASDAQ: FNGR)

FingerMotion Inc. (NASDAQ: FNGR) is an evolving technological company with core competencies in mobile payment and recharge platform solutions in China. FingerMotion is in the process of developing additional value-added technologies to market to users.

Founded in 2016, FingerMotion's goal is to serve over a billion users in the Chinese market and expand its model to other regional markets. The company has offices in Hong Kong, Shanghai and New York City.

Current Offerings

FingerMotion is analyzing and transforming mobile data to improve the lifestyle of the public through technology and innovation. The company's current offerings include:

  • Telecommunications Products and Services – FingerMotion's proprietary universal exchange platform, 'PigeonHole Integration System (PIS)', offers seamless integration between telecom operators and online stores. The service platform's offerings include top up and recharge, data plan, mobile phone, loyalty points redemption and subscription plans. The platform offers reliable and secure transactions, real-time reconciliation, simple integration for partners and efficient settlements.
  • SMS and MMS Services – The integrated platform is registered as FingerMotion's IP in China and provides a robust back-end control panel for corporate partners to manage their own messaging settings. FingerMotion's clients range from insurance to financial industries, ecommerce firms, airlines and more. The platform offers competitive pricing for partners and provides quick and efficient review to meet timely marketing initiatives.
  • Big Data Insights – FingerMotion brings Big Data-enabled insurance solutions through its Big Data Insights arm, Sapientus. The company's strategic partnerships with the largest Chinese telecommunications giants allow access to uncover behavior insights through geolocation and mobile data usage. Its Big Data offerings include risk scoring, precise marketing, simplified underwriting and customized products.
  • Rich Communication Services (RCS) – FingerMotion's RCS platform will be a proprietary business messaging solution that enables businesses and brands to communicate their services to customers via 5G infrastructure. The company expects its RCS platform to offer a better user experience, more efficiency and cost-effectiveness when compared to other solutions.

Telecommunications and Insurtech Markets

The global telecommunications market was valued at $1.74 trillion in 2019 and is expected to grow at a CAGR of 5% from 2020 to 2027. The steady increase is expected to be driven by the adoption of 5G and the increased popularity of Internet of Things (IoT) applications.

The Chinese telecom market was valued at $254.1 billion in 2017 and is also constantly expanding. The current Chinese telecom market is dominated by three mobile operators – China Mobile, China Unicom and China Telecom, which together are responsible for around 1.6 billion active subscribers (https://ibn.fm/zfwy9).

In addition, the insurtech (insurance technology) market was valued at $2.72 billion globally in 2020 and is expected to grow at a CAGR of 48.8% from 2021 to 2028. The large increase is attributed to the rising use of technology solutions for everyday activities like acquiring insurance coverage (https://ibn.fm/TGo7D).

Through its proprietary platforms and technologies, FingerMotion is uniquely positioned to capitalize on the telecom and insurtech markets' growth and opportunities.

Management Team

Martin J. Shen is the Chief Executive Officer of FingerMotion Inc. He has over 15 years of experience in senior management roles within entrepreneurial startups and large multinational corporations. He has acquired a wide range of corporate management, financial oversight and operation administration expertise through these roles. In his most recent role, he founded Imperial Distributors (formerly known as AP Martin Pharmaceutical Supplies Ltd.), establishing the company as the preferred choice for distributional support to regional pharmacies throughout Western Canada. Before founding Imperial, Mr. Shen served as the Chief Operating Officer and Chief Financial Officer at Wales and Son Industrial (formerly Weir Minerals), a firm specializing in global delivery and support for mining slurry equipment. He began his career at PricewaterhouseCoopers in Vancouver, with work tours in the tax department in Singapore and the tax audit and advisory group in Hong Kong. Mr. Shen is a U.S. Certified Public Accountant and holds a Bachelor of Science from the University of British Columbia.

Lee Yew Hon is the company's Chief Financial Officer. From 2006 until November 2020, he was the Chief Financial Officer of Cubinet Interactive Group of Companies, and he also took on the Chief Operating Officer role in 2011. During his tenure, he was instrumental in leading Cubinet and building teams across the Southeast Asia region, setting up financial processes within a short time. Mr. Lee spearheaded the growth of Cubinet to other regions, including Europe, the Middle East and Russia. He received his diploma from Tunku Abdul Rahman College in 1996. He is a Chartered Accountant, a member of the Malaysia Institute of Accountants (MIA) and an Associate Member of the Chartered Institute of Management Accountants, UK (ACMA).

Li Li is the Senior Vice President of FingerMotion. She recently served as Advisor to Shenzhen WuYiKa Technology Co. Ltd., a comprehensive service platform dedicated to online service distribution and payment. The company has become a fast and efficient provider of new media marketing solutions for the mobile internet. She has held high-level management positions with multiple industry names, including Hangzhou JiuYue Information Technology Co. Ltd. and Hangzhou LingXuan Information Technology. Ms. Li started her career in 2004, founding Shanghai ChuangYeZZ Network Technology Co. Ltd. and serving as its Vice President. With the close cooperation of local operators, the company launched SMS, MMS, WAP, mobile JAVA games, Hunan Satellite TV e-magazine and other wireless internet services to meet the rapid development of wireless internet and application requirements. She received her degree from Nanjing Academy of Engineering.

Fintech Ecosystem Development Corp. (NASDAQ: FEXD)

Fintech Ecosystem Development Corp. (NASDAQ: FEXD) is a special purpose acquisition company (SPAC) formed for the purpose of effecting one or more business combinations with an intent to focus on the financial technology sector.

The company's mission is to create and grow a global financial services ecosystem to address unmet mobile money needs in developing and industrialized countries and markets. FEXD plans to achieve this by acquiring and merging with financial technology pioneers that have the potential to help establish its global fintech ecosystem, and by continuing the development of proprietary technologies and applications to keep the company at the forefront of the cashless society market.

Digital money is replacing physical cash. Consumers can buy products and services from anywhere in the world and make payments across borders. Parents can send money to students studying in other countries. Migrant workers are sending money to families in developing nations. Rural villagers without banks can send and receive money using their smartphones. FEXD is developing mobile transaction platforms, applications and services that are helping to implement these changes.

The company plans to offer a diverse portfolio of products and services to consumers and businesses in the United States, South Asia, East Asia, Africa, Europe and Latin America. Its growth strategy includes acquisition, innovation and market development.

FEXD is a Delaware corporation based in Collegeville, Pennsylvania. The company was launched in May 2021 by a management team led by Dr. Saiful Khandaker that has extensive experience in developing and managing financial service platforms and applications, primarily in the mobile money sector. FEXD is sponsored by Revofast LLC.

Acquisition Targets

In September 2022, FEXD announced definitive agreements for business combinations with Rana Financial Inc., a Georgia corporation, and Mobitech International LLC (dba Afinoz), a limited liability company organized in the United Arab Emirates. The agreements call for Rana and Afinoz to become wholly owned subsidiaries of FEXD, with the combined company expected to continue trading on the Nasdaq under existing ticker symbol 'FEXD'. The mergers are expected to close in Q2 2023.

Rana Financial

Rana Financial is a licensed money transfer company founded in 2009. Rana provides fast and affordable online and mobile transfer of funds between the U.S. and Latin America. Rana has been providing money transfer services in the U.S. market for 13 years and has 30,000 active users. Rana's money transfer business grew to 200,000 transactions in 2021. The merger agreement values Rana at an implied $78 million enterprise value.

Mobitech International LLC

Mobitech International LLC (dba Afinoz) is an artificial intelligence-enabled digital lending platform used by India's leading banks, non-banking financial companies and fintech loan providers. Afinoz's fintech platform supports enterprises making loans primarily to middle- and working-class borrowers via its website or through its mobile phone application. Afinoz's platform makes loans available and affordable to millions of Indian workers and unbanked users by providing access at a low cost. Afinoz's platform has more than 50 lending partners, and its database of registered users in India includes more than two million individuals. The merger agreement values Afinoz at an implied $120 million enterprise value.

Market Opportunity

According to analysis by global market research firm Mordor Intelligence, the worldwide financial technology market is valued at approximately $194 billion in 2023 and is projected to grow to nearly $500 billion by 2028, representing a CAGR of 18.97% for the forecast period. According to the report, various financial crises and the COVID-19 pandemic have fueled consumer adoption of, and investor interest in, fintech over the past several years.

Management Team

Dr. Saiful Khandaker is Founder, CEO and President of FEXD. He is Group CEO and founder of FAMA Holdings Inc., a global developer of fintech platforms, applications and services based in the U.S. with offices in the U.K., India, Bangladesh and Zambia. He is currently leading the development of the FAMACASH™ network, a global fintech ecosystem to provide fast, affordable mobile money services in underserved countries such as Bangladesh. Before founding FAMA, Dr. Khandaker spent more than two decades leading the development of software solutions for Fortune 100 companies and startups. He also helped numerous clients modernize their fintech services as Chief Technology Officer at Mi3. He holds a Doctor of Management in Organizational Leadership, a Master of Science in Technology Management, and a Bachelor of Science in Computer Information Systems.

Jenny Junkeer is CFO at FEXD. She is a Chartered Accountant with over 17 years of experience. As CEO of Junkeer New Era Consulting, she leads a team specializing in helping companies launch and optimize business operations in fast-changing industries. She has extensive experience helping organizations scale operations to maximize value. She is an Adjunct Association Professor at Deakin University in Australia, a board member of the Global Health Initiative Foundation, and Director of Implementation at ConnectCV. She holds a Bachelor of Commerce Degree (Honors) from Monash University.

HeartBeam Inc. (NASDAQ: BEAT)

HeartBeam Inc. (NASDAQ: BEAT) is a cardiac technology company that has developed the first and only 3D-vector 12-lead electrocardiogram (ECG) platform for heart attack detection anytime, anywhere. The company's proprietary ECG telehealth technology aims to redefine the way high risk cardiovascular patients are diagnosed in ambulatory and acute care settings. HeartBeam's initial focus is on providing diagnostic data to help physicians with care management of patients with cardiovascular disease.

In August 2022, HeartBeam announced that it submitted its HeartBeam AIMI™ software for approval from the U.S. Food and Drug Administration (FDA). HeartBeam AIMI is a platform technology to improve the speed and accuracy of heart attack detection in acute care settings. The company is in discussions with the FDA and plans to meet with the agency in an effort to have HeartBeam AIMI cleared in line with its Q1 2023 timeframe, as detailed in a corporate update issued in December 2022.

HeartBeam sees submission of its first product based on its platform technology as an important milestone toward commercialization, which underscores the company's continued progress toward making the HeartBeam AIMI platform widely available to help emergency department physicians quickly and accurately identify a heart attack.

While the FDA conducts its regulatory review, HeartBeam will focus on executing key components of its commercialization plan and subscription revenue model. It will also continue to engage in discussions with strategic institutions, including academic centers, regional healthcare systems and regional community hospital systems that can utilize HeartBeam products.

The company is based in Santa Clara, California.

Products

HeartBeam's development portfolio includes two products:

  • HeartBeam AIMI is software that provides a 3D comparison of baseline and symptomatic 12-lead ECG to more accurately identify a heart attack in acute care settings and, as noted above, has been submitted for FDA approval; and
  • HeartBeam AIMIGo™, the first and only credit card-sized 12-lead output ECG device coupled with a smartphone app and cloud-based diagnostic software system for remote heart attack detection.

HeartBeam is developing HeartBeam AIMIGo, a medical-grade detection and monitoring technology for use in remote heart attack detection thereby allowing physicians to diagnose a patient's heart attack as it occurs even if the patient is not at a medical facility. The company's system, once approved by the FDA, can be used by patients at home or almost anywhere and anytime to help their physicians assess whether chest pain is the result of a heart attack or another cause. While approximately 82% of chest pain ED visits are unnecessary, patients delay approximately 3 to 4 hours after symptoms begin, increasing mortality rates by 40%. The company's goal is to shorten the time to treatment outside of the medical facility to improve patients' well-being.

HeartBeam AIMIGo is a powerful, portable and easy-to-use prescription-based product. It comprises a smartphone app, a credit card-sized ECG device placed on a patient's chest, the HeartBeam cloud platform, and a digital portal for the physician to view ECG results and direct patient action. For the first time outside of a medical setting, HeartBeam AIMIGo enables patients and their clinicians to determine if symptoms are due to a heart attack, quickly and easily, so care can be expedited, if needed.

Pending FDA clearance, HeartBeam AIMIGo is initially intended to be available by prescription, and is reimbursable under existing remote patient monitoring codes (RPM codes). This provides a new revenue stream to physicians who before did not have a way to monitor these high-risk patients. The RPM codes provide a monthly reoccurring revenue stream to the company, as well. On average, at current reimbursement rates, the practice will receive $1,300+ per year per patient they monitor, and the company will receive $600 per year per patient from this RPM reimbursement.

Market Overview

Adoption rates of telehealth services increased dramatically in recent years, with the COVID-19 pandemic serving as a major driver of growth. Among the areas seeing the greatest expansion are cardiology, radiology, behavioral health and online consultation.

Encouraging this growth, governments are actively developing new policies and reimbursement guidelines to promote the use of digital health platforms. The U.S. Centers for Medicare & Medicaid Services (CMS), for example, has recently expanded reimbursement for telehealth services. U.S. market growth is also being driven by the rising prevalence of chronic conditions and the growing geriatric population.

Remote heart attack detection is a previously unsolved problem with a massive and underserved market that is several times larger than the $2 billion total addressable market (TAM) in the U.S. for ECG cardiac arrhythmia monitoring.

Approximately 8 million Americans have suffered at least one heart attack, and a total of 18 million have been diagnosed with coronary artery disease (CAD). Based on these figures, HeartBeam projects a total addressable U.S. market TAM valued at $10 billion annually for its HeartBeam AIMIGo solution for remote heart attack monitoring of CAD.

Management Team

Branislav Vajdic, Ph.D., Chief Executive Officer and Founder of HeartBeam, Inc, combines over 30 years of experience in technology development and senior management positions. Dr. Vajdic has been deeply involved with the development of HeartBeam's technology to fit his vision for the company. Prior to HeartBeam, from 2007 to 2010, Dr. Vajdic was CEO and Founder of NewCardio, a publicly traded company in the cardiovascular devices space. From 1984 to 2007, Dr. Vajdic was at Intel, where he held various senior management position. At Intel, Dr. Vajdic was the designer of first Flash memory and two key inventions that enabled Flash as a product and led engineering groups responsible for Pentium 1 through Pentium 4 designs. Dr. Vajdic was awarded two Intel Achievement Awards, the highest level of award for outstanding contributions to Intel. Dr. Vajdic is author of numerous patents and publications in the fields of cardiovascular devices, as well as chip design. Dr. Vajdic holds a Ph.D. in Electrical Engineering from the University of Minnesota.

Robert P. Eno, President of HeartBeam, brings over 28 years of experience with a proven track record of developing markets and commercializing disruptive medical technologies. He has created go-to-market strategies for multiple breakthrough products, including noninvasive FFRCT diagnostic for coronary artery disease, laser cataract surgery, scanning laser photocoagulation and intravascular brachytherapy. Before joining HeartBeam, Mr. Eno was Chief Executive Officer of Preview Medical Inc., a diagnostic equipment company creating a new category of real-time, in vivo tissue classification for solid tumor cancers using machine learning and proprietary optical signals. Previously, he served as Senior Vice President of Marketing for HeartFlow Inc., leading all aspects of the marketing and product functions for a new category of personalized, noninvasive testing for heart disease, including its initial product, HeartFlow FFRCT. He has also held senior marketing and sales leadership roles at OptiMedica (acquired by Abbott), NeoGuide Systems (acquired by Intuitive) and Avantec Vacular (acquired by Goodman Co. Ltd). Mr. Eno began his career at Guidant, where he held a series of marketing and strategic planning roles in the Vascular Intervention business. He holds an MBA from the Stanford Graduate School of Business and a BA, with Honors and Distinction, from Stanford University, where he was Phi Beta Kappa.

Peter J. Fitzgerald, MD, Ph.D., HeartBeam's Chief Medical Officer, is the Director of the Center for Cardiovascular Technology and Director of the Cardiovascular Core Analysis Laboratory at Stanford University Medical School. He is an interventional cardiologist and holds a Ph.D. in electrical engineering. Dr. Fitzgerald is Professor Emeritus in the Departments of Medicine (Cardiology) at Stanford University and has led or participated in over 175 clinical trials and published over 650 manuscripts/chapters and lectures worldwide. Over the past two decades, he has trained over 150 post-doctoral candidates in engineering and medicine. Dr. Fitzgerald has been principle and founder of 24 medical device companies in the San Francisco Bay area, transitioning 18 of these start-ups to medium/large-cap life science companies. In 2009, he co-founded TriVentures, an Israeli-based incubator/venture fund for early-stage medical technology and digital health. He has also been a consultant to the U.S. Food and Drug Administration for the past 20 years, focused on medical technology and data driven health analytics.

Jon Hunt, Ph.D., HeartBeam's Executive Vice President and Chief Business Officer, has over 35 years' experience in the medical/medical device industry with extensive domestic and international experience in general management, clinical/regulatory, sales and marketing. He also has diverse experience in Fortune 500 companies, as well as start-up environments. Dr. Hunt was the Vice President of Clinical Science and Technology, Medical Device Innovation Consortium, from July 2019 to July 2021, and Vice President of Clinical and Regulatory Affairs, Cryterion Medical from January 2018 to June 2019 (acquired by Boston Scientific Corporation in July 2018 for $202M). Dr. Hunt was the Founding President and CEO of Bardy Diagnostics, Inc. from October 2013 to November 2017 (acquired by Hill-Rom Holdings, Inc.). Prior to joining Bardy Diagnostics, Dr. Hunt spent the previous 11 years as the Vice President of Clinical & Regulatory Affairs with Cameron Health, Inc. (acquired by Boston Scientific Corporation). Dr. Hunt spent the previous 10 years with Cardiac Pacemakers, Inc., St. Jude Medical and Cardiac Pathways Corporation. Dr. Hunt began his career with Cardiac Pacemakers, Inc. (now Boston Scientific Corporation) as the Director of Clinical Programs. He subsequently held positions at St. Jude Medical in Clinical Affairs and as the Business Unit Director for the Cardiac Rhythm Management division for Europe, the Middle East and Africa. At Cardiac Pathways Corporation, Dr. Hunt held various executive positions as Vice President of International Sales and Marketing and Vice President of Worldwide Sales and Marketing (acquired by Boston Scientific Corporation). Dr. Hunt received his Ph.D. in Motor Control from The Pennsylvania State University, his Master's from California State University, Long Beach and his undergraduate degree from Keele University in the United Kingdom.

Rick Brounstein, HeartBeam's Chief Financial Officer, combines over 30 years of experience in health technology senior management. Since 2017, Mr. Brounstein has been and is currently a partner of Hardesty, LLC, a financial services firm, and Mr. Brounstein is currently a managing director of CTRLCFO, LLC, a firm Mr. Brounstein founded in 2016 to support funded start-ups in life science and technology. From 2008 to 2011, Mr. Brounstein was Chief Financial Officer of NewCardio, Inc., a microcap public company in the cardiology space, and, over his career, he has been with nine other companies in life science or technology, holding positions including Chief Financial Officer, Chief Operating Officer, Treasurer and Accounting Manager. From June 2001 through November 2007, Mr. Brounstein held several positions at Calypte Biomedical Corporation, a publicly traded medical device company, including Chief Financial Officer and Executive Vice President. In January 2007, Mr. Brounstein was appointed as the National Member Representative for the 2007 COSO Monitoring Project, which published new guidelines for monitoring internal financial controls in February 2009; Mr. Brounstein subsequently was a member of the FEI task force that issued the updated COSO Internal Control Framework in 2013. In March 2005, Mr. Brounstein was appointed to the SEC Advisory Committee on Smaller Public Companies. Mr. Brounstein earned his Certified Public Accountant (CPA) certification while working at Arthur Andersen LLP, formerly a public accounting firm. Mr. Brounstein holds a B.A. in accounting and an M.B.A. in finance, both from Michigan State University.

Ken Persen, HeartBeam's Chief Technology Officer, combines over 28 years of experience in the medical device and digital health industries in engineering and senior management positions. Mr. Persen has been involved in several companies in Cardiac Rhythm Management, holding positions including Chief Executive Officer, Chief Technology Officer, Executive Vice President and Director of Engineering. Since 2016 and prior to joining HeartBeam, Mr. Persen was the Chief Technology Officer at LIVMOR, Inc., a digital health company. In addition, from 2016 through November 2021, he was also Chief Executive Officer of LIVMOR. Prior roles included Director of Engineering at Cameron Health (acquired by Boston Scientific), a late-stage medical device start up, and engineering and management positions at Guidant Corp. (acquired by Boston Scientific), a large medical device manufacturer. He has an undergraduate degree from University of Minnesota, Duluth, with a BA in Computer Science.

Knightscope, Inc. (NASDAQ: KSCP)

Knightscope, Inc. (NASDAQ: KSCP), founded in 2013 and based in Mountain View, California, is a leader in the development of autonomous security capabilities targeting to disrupt the $500 billion security industry. Knightscope's technology uniquely combines self-driving technology, robotics, artificial intelligence and electric vehicles.

Knightscope designs and builds Autonomous Security Robots (ASRs) that provide 24/7/365 security to the places you live, work, visit and study. The company's client list covers public institutions and commercial business operations, including multiple Fortune 1000 companies to date. These ASRs have been proven to enhance safety at hospitals, logistics facilities, manufacturing plants, schools and corporations. ASRs act as highly cost-effective complementary systems to traditional security and law enforcement officials, providing an additional advantage by continuing to offer uninterrupted patrolling capabilities across the country.

The company's ASRs have assisted in the arrest of suspects involved in crimes ranging from armed robbery to hit-and-runs. Their machine-embedded thermal scanning capability even aided in preventing the breakout of a major fire.

The company has achieved several milestones since its creation in 2013, including:

  • Operating for more than 1 million hours in the field and securing contracts across multiple time zones, winters and summers holding contracts from Hawaii, through Texas, to Rhode Island.
  • Generated numerous crime-fighting wins validating the technology and the market opportunity (see www.knightscope.com/crime).
  • Raising over $100 million since inception to build its technology from scratch and successfully listed on NASDAQ under ticker symbol 'KSCP' during January 2022.

Company Mission – Reimagining Public Safety

Knightscope's long-term vision has an eye on the greater good. The company's mission is to make the United States of America the safest nation in the world while supporting the 2+ million law enforcement and security professionals across the country.

Crime has an estimated negative economic impact in excess of $2 trillion annually. As crime is reduced, positive impacts will likely be realized across several aspects of society, including housing, financial markets, insurance, municipal budgets, local business and safety in general.

Knightscope CEO William Santana Li was interviewed by Kevin O'Leary, more commonly known as Shark Tank's Mr. Wonderful. When asked to explain how the benefits provided by the ASRs outrank a human doing the same job, Li said, "First, just the simple presence of a physical deterrent causes criminal behavior to change. Second, the machines are self-driving cars that patrol all around and recharge themselves. They also generate 90 terabytes of data per year. No human would ever be able to process that. The robots are intended to be eyes and ears for the humans, not a one-to-one replacement."

The Knightscope solution to reduce crime combines the physical presence of ASRs, sometimes referred to as proprietary Autonomous Data Machines, with real-time onsite data collection and analysis. The ASRs are fitted with eye-level 360° cameras, thermal scanning, public address announcements and various other features that work in tandem with humans to provide law enforcement officers and security guards unprecedented situational awareness.

Those 90 terabytes of data are then formatted in a useable way, so law enforcement can leverage that information and execute their responsibilities more effectively.

Public Safety Innovation

The company's recurring revenue business model is set up to mimic the recurring societal problem of crime, and it takes into consideration the fact that innovation in the security and public safety industry has been stagnant for decades. Because the traditional practices of the sector have remained unchanged for years, automation has potential to drive substantial cost savings – and significant improvement in capabilities.

Human security guards are one of both the largest expenses and the largest liabilities for companies. Knightscope's robots are offered at an effective price of $3 to $9 per hour, compared with approximately $85 for an armed off-duty law enforcement officer and $15 to $35 for an unarmed security guard.

This innovation has the potential to drive considerable cost savings. Based on these estimates, manufacturing costs can be recovered as soon as the first year of operation.

Product Offerings

The company has nine patents and a framework of unique intellectual property. Knightscope currently offers a K1 stationary machine, a K3 indoor machine and a K5 outdoor machine. A K7 multi-terrain four-wheel version is in development.

The ASRs autonomously patrol client sites without the need for remote control, providing a visible, force multiplying, physical security presence to help protect assets, monitor changes in the area and deter crime. The data is accessible through the Knightscope Security Operations Center (KSOC), an intuitive, browser-based interface that enables security professionals to review events generated by the ASRs providing effectively 'mobile smart eyes and ears'. Learn more at www.knightscope.com/ksoc

The ASRs and the related technologies were developed ground up by the company and are Made in the USA.

The Robot Roadshow

Knightscope has created the ultimate hybrid physical and virtual event, bringing its Autonomous Security Robot technologies to cities across the country for interactive and in-person demonstrations.

Each roadshow landing is hosted virtually by a Knightscope expert, and visitors can interact directly with each of the company's ASRs and see the Knightscope Security Operations Center (KSOC) user interface in action. Learn more at www.knightscope.com/roadshow

Management Team

Chief Executive Officer William Santana Li is a veteran entrepreneur, a former executive at Ford Motor Company and the founder of GreenLeaf, a company that grew to be the world's second-largest automotive recycler and is now part of LKQ Corporation (NASDAQ: LKQ).

Chief Client Officer Stacy Dean Stephens brings his experience as a former Dallas law enforcement officer, as well as his skills as a seasoned entrepreneur, to assist on the client acquisition side.

Chief Intelligence Officer Mercedes Soria is an award-winning technologist and former Deloitte.

Chief Design Officer Aaron Lehnhardt brings over two decades of two- and three-dimensional product and industrial design in modeling and VR to the table, on top of his experience as a senior designer at Ford Motor Company.

Chief Financial Officer Mallorie Burke is a seasoned financial executive and strategic advisor for both private and publicly traded technology companies with a successful track record of mergers & acquisitions, corporate growth and exit strategies, including public listings.

General Counsel Peter Weinberg leverages 30 years of diverse corporate counsel experience, spanning from startups to well-established companies, private and public. He has significant experience training personnel at all levels in critical areas to improve corporate compliance and productivity.

Lexaria Bioscience Corp. (NASDAQ: LEXX)

Lexaria Bioscience Corp. (NASDAQ: LEXX) is a global innovator in drug delivery platforms. The company's patented technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting healthier oral ingestion methods and increasing the effectiveness of fat-soluble active molecules. DehydraTECH promotes fast-acting, less expensive and more effective oral drug delivery and has been thoroughly evaluated through in vivo, in vitro and human clinical testing.

DehydraTECH is covered by 35 granted patents and many patents pending worldwide. Lexaria's first patent was issued by the U.S. Patent and Trademark Office in October 2016 (US 9,474,725 B1), providing 20 years of patent protection expiring June 2034. Multiple patents have been awarded since then and are expected in the future.

Lexaria has also collaborated with the National Research Council (NRC), the Canadian government's premier research and technology organization. The company has been granted patent protection for specific delivery of nicotine, vitamins, NSAIDs, antiviral drugs, cannabinoids and more.

Lexaria began developing DehydraTECH in 2014 and has since continued to strengthen and broaden the technology. The company has no plans to create or sell Lexaria-branded products containing controlled substances. Instead, Lexaria licenses its technology to other companies around the world to offer consumers the best possible performance across an array of ingestible product formats.

The company's technology is best thought of as an additional layer that providers of consumer supplements, prescription and non-prescription drugs, nicotine and CBD products can utilize to improve the effectiveness of their own existing or planned new offerings. Lexaria has licensed DehydraTECH to multiple companies, including a world-leading tobacco producer for the research and development of smokeless, oral-based nicotine products, and for use in industries that produce cannabinoid beverages, edibles and oral products.

DehydraTECH is suitable for use with a wide range of product formats including pharmaceuticals, nutraceuticals, consumer packaged goods and over-the-counter capsules, pills, tablets and oral suspensions.

DehydraTECH Technology

Lexaria's DehydraTECH is designed specifically for formulating and delivering lipophilic (fat-soluble) drugs and active ingredients. DehydraTECH increases their effectiveness and improves the way active pharmaceutical ingredients enter the bloodstream. The major benefits to a subject ingesting a DehydraTECH-enabled drug or consumer product can be summarized by the following:

  • Speeds up delivery – the effects of the product are felt by the subject in just minutes.
  • Increases bioavailability – the technology is much more effective at delivering a drug or product into the bloodstream.
  • Increases brain absorption – animal testing suggests significant improvement in the quantity of drug delivered across the blood-brain barrier.
  • Improves drug potency – more of the ingested product is made available to the body, so lower doses are required to achieve the desired effect.
  • Reduces drug administration cost – lower doses mean lower overall drug costs.
  • Masks unwanted taste – the technology eliminates or reduces the need for sweeteners.

Lexaria has demonstrated in animal studies a propensity for DehydraTECH technology to elevate the quantity of drug delivered across the blood-brain barrier by as much as 1,900 percent, initiating additional new patent applications and opening possibilities for improved drug delivery.

Since 2016, DehydraTECH has repeatedly demonstrated, with cannabinoids and nicotine, the ability to increase bio-absorption by up to five to 10 times, reduce time of onset from one to two hours to just minutes, and mask unwanted tastes. The technology is to be further evaluated for additional orally administered bioactive molecules, including antivirals, cannabinoids and nicotine.

Market Considerations

Lexaria is focusing ongoing research and development efforts on the advancement of product candidates across several key segments:

  • Tobacco [1] – Valued at $786.1 billion in 2022, this market is forecast to reach $908.3 billion by 2026
  • Nicotine Replacement [2] – Valued at $59.8 billion in 2022, this market is forecast to reach $147.9 billion by 2028
  • CBD [3] – Valued at $4.1 billion in 2022, this market is forecast to reach $111.8 billion by 2030
  • Cardiovascular Drugs [4] – Valued at $96.1 billion in 2022, this market is forecast to reach $107.8 billion by 2025
  • Antivirals [5] – Valued at $55.6 billion in 2022, this market is forecast to reach $66.7 billion by 2025
  • Epilepsy [6] – Valued at $10.6 billion in 2021, this market is forecast to reach $16.6 billion by 2031
  • Human Hormones [7] – Valued at $5.4 billion in 2022, this market is forecast to reach $13 billion by 2026
  • PDE5 Inhibitors [8] – Valued at $4.9 billion in 2022, this market is forecast to reach $6 billion by 2025

Management Team

Chris Bunka is Chairman and CEO of Lexaria Bioscience Corp. He is a serial entrepreneur who has been involved in several private and public companies since the late 1980s. He has extensive experience in the capital markets, corporate governance, mergers and acquisitions, as well as corporate finance. He is named as an inventor on multiple patent innovations.

John Docherty, M.Sc., is the President of Lexaria. He is a pharmacologist and toxicologist, and a specialist in the development of drug delivery technologies. He is the former president and COO of Helix BioPharma Corp. (TSX: HBP). He is named as an inventor on multiple issued and pending patents.

Julian Gangolli is a strategic advisor to Lexaria and is a proven and respected senior executive with a visible and successful track record at highly regarded publicly traded companies. He joined Allergan in 1998 and was North American President when it was sold in 2015, after becoming one of the leading specialty pharmaceutical companies in the United States. Mr. Gangolli joined GW Pharmaceuticals in 2015 as U.S. President. As President, he oversaw the approval of the first CBD drug by the FDA and the subsequent successful commercialization of Epidiolex® in the US. Epidiolex® is indicated for the treatment of refractory epilepsies and seizures in children. The commercial success of Epidiolex® in the U.S. led to the acquisition of GW Pharmaceuticals by Jazz Pharmaceuticals in 2021 for over $7 billion.

Dr. Philip Ainslie serves as a scientific and medical advisor to Lexaria. He is co-director for the Centre for Heart, Lung and Vascular Health, Canada. He is also Research Chair in Cerebrovascular Physiology and Professor at the School of Health and Exercise Sciences, Faculty of Health and Social Development at the University of British Columbia.

NextPlat Corp. (NASDAQ: NXPL) (NASDAQ: NXPLW)

NextPlat Corp. (NASDAQ: NXPL) (NASDAQ: NXPLW), a next generation e-commerce platform, was created with vision and purpose to capitalize on high growth sectors and global markets. The company collaborates with businesses – large and small – to simplify and accelerate online commerce and uniquely enables customers and partners to optimize their e-commerce reach, presence and revenue. NextPlat recently launched a new e-commerce development program to provide American businesses with easy access to the massive Chinese consumer market.

Current Initiatives

NextPlat provides cutting edge technology in an advanced e-commerce ecosystem. The company is actively expanding its global network of online storefronts serving thousands of consumers, enterprises and governments. The company also has developed a next generation platform built for Web3 that enables the creation and sale of digital assets, as well as optimizing e-commerce transactions and business building activities. The company's current initiatives include:

  • E-Commerce Development Program – In April 2023, NextPlat announced it had entered into a merchant sourcing agreement with Alibaba.com Singapore E-Commerce Private Limited ("Alibaba") and its Tmall Global e-commerce platform whereby the two companies will collaborate to increase the sale of products produced and sold by American companies to the multi-trillion-dollar Chinese consumer market. Alibaba's Tmall Global e-commerce platform will provide NextPlat customers a turn-key solution through which products can be sold to the Chinese consumer market. The launch of the Florida E-Commerce Development Program is the first in a series of new NextPlat programs designed to assist U.S. businesses in expanding their online sales capabilities to reach new international customers in the Chinese market. NextPlat intends to rapidly expand this unique e-commerce development opportunity to businesses throughout the United States and all of North America, as well as Central and South America. The new development program features NextPlat's turnkey global e-commerce solution for customers and leverages NextPlat's relationships with key partners, including Tmall Global, China's largest cross-border B2C online marketplace.
  • Progressive Care Inc. – In August 2022, NextPlat completed a strategic $7 million investment in Progressive Care Inc. (OTCQB: RXMD), a personalized health care services and technology company. In a news release announcing the investment, NextPlat CEO Charles M. Fernandez noted that the company is "committed to harnessing the power of digital technologies to capitalize on the ongoing digital transformation of Progressive Care and the entire health care industry." NextPlat intends to accelerate Progressive Care's digital health care transformation with the launch of a new e-commerce platform for health care products later this year.
  • NextPlat NFT Platform – Building on its existing e-commerce initiatives, NextPlat is working to bridge the gap between tangible and digital e-commerce marketplaces by incorporating burgeoning Web3 technologies. The company intends to launch a fully integrated NFT platform in the coming months that will enable brands to create, manage and authenticate digital assets while serving as a new source of revenue for NextPlat. Through this model, the company will receive a portion of the revenue generated from branded NFT drops, as well as subsequent secondary market transactions.
  • Global Telesat Communications and Orbital SatCom Corp. – Targeting both domestic and international markets, NextPlat's subsidiaries leverage partnerships with major e-commerce platforms such as Amazon, Alibaba, eBay and Walmart to serve a growing base that includes more than 50,000 corporate, governmental and individual customers. In total, the brands market more than 10,000 individual products, with a focus on satellite-based connectivity solutions. In addition to exploring accretive M&A opportunities, NextPlat aims to diversify its range of products and broaden its geographic footprint moving forward in an effort to better capitalize on the tremendous growth potential in the United States, Europe and Asia.

"Our goal for 2023 and beyond is to leverage our improved operational capabilities and enhanced leadership team as we expand our offerings in communications and connectivity into the high-growth health care market where we intend to launch an array of innovative new offerings," Fernandez said in a March 2023 news release detailing the company's record top-line performance. "Although there remain supply chain headwinds and the challenge of global inflation, we are confident that we have the right combination of market-tested expertise, technology and partnerships that will enable us to bring the power of e-commerce to more customers, brands and industries in the United States and abroad."

Market Opportunity

The rapid growth of e-commerce over the last decade is expected to continue for the foreseeable future. According to data published by Forbes, roughly 20.8% of all retail purchases are expected to take place online in 2023, accounting for total sales of $6.31 trillion worldwide. It total, e-commerce sales are expected to grow by 10.4% YoY in 2023, accounting for a whopping 24% of all retail purchases by 2026.

For NextPlat, existing partnerships in the industry could be key to capitalizing on this growth. The Forbes report indicates that Amazon accounts for roughly 38.7% of e-commerce sales, while sites like Walmart, eBay and Alibaba round out the list of most visited e-commerce websites. Alibaba is especially interesting due to NextPlat's recent strategic merchant sourcing agreement with Tmall Global. The Chinese market is "mammoth," as a recent Alizila report noted. The country's annual online retail sales of physical goods have nearly doubled in the last five years, reaching approximately 13.8 trillion yuan in 2022, which is nearly $2 trillion USD.

The health care portion of the e-commerce market is generating particularly bullish forecasts, bolstered by the continued adoption of the 340B Drug Pricing Program in the U.S., which requires most drug manufacturers to provide outpatient drugs to covered entities at significantly reduced prices. Industry reports suggest that the global health care e-commerce market will expand at a compound annual growth rate of 16.8% from 2022 to 2030, climbing to a value of more than $1.37 trillion by the end of the forecast period.

Management Team

Charles M. Fernandez, CEO, Executive Chairman and Director of NextPlat, has over three decades of experience in identifying profitable start-up and dislocation opportunities, building significant value and executing exit strategies as an entrepreneur and global investor. Successful across multiple sectors, Fortune Magazine actually labeled Fernandez 'a restructuring whiz'. As President of Fairholme Capital Management, which he joined in 2008, Mr. Fernandez co-managed all three Fairholme funds and brought in a $2 billion gain for shareholders. Throughout his impressive career, he has participated in more than 100 significant mergers, acquisitions and product development projects across multiple industries. Mr. Fernandez was the founder, Chairman and CEO of eApeiron Solutions LLC, a brand protection and e-commerce company in partnership with Alibaba (NYSE: BABA) and Eastman Kodak (NYSE: KODK), which was successfully sold to Smartrac, a unit of Avery Dennison Corp. (NYSE: AVY).

Rodney Barreto is Chairman and CEO of the Barreto Group and Director of Nextplat. Mr. Barreto's business career spans over 35 years, including his role at the Barreto Group and, earlier, as the founding partner of Floridian Partners LLC, a corporate and public affairs consulting firm recognized by policy makers as one of the top in its industry in Florida. He chaired the Super Bowl Host Committee in 2007, 2010 and 2020, helping to raise more than $100 million for the success of Miami Super Bowls. As a philanthropist and conservationist, Mr. Barreto is also a three-time appointee to the Florida Fish and Wildlife Conservation Commission, where he has served for over 10 years including holding the title of Chairman eight times. He has twice chaired the Annual U.S. Conference of Mayors, was Chairman of the 1999 Breeder's Cup Championship held in South Florida and was the Chairman of the 1999 Sister Cities International Convention in Miami. Currently, Mr. Barreto is the Membership Chairman of the Florida Council of 100, and a member of the Boards of Fairchild Tropical Botanic Garden, the Baptist Health South Florida Giving Society, the Bonefish and Tarpon Trust, the Guy Harvey Ocean Foundation, and a member of Miami Dade County Schools Superintendent Carvalho's Business Advisory Council. Prior to his career in public affairs and real estate, Mr. Barreto was a City of Miami police officer and is a member of the Florida Highway Patrol Advisory Council.

Renovaro BioSciences Inc. (NASDAQ: RENB)

Renovaro BioSciences Inc. (NASDAQ: RENB), formerly Enochian BioSciences Inc., is an advanced, pre-clinical biotechnology firm in cell, gene and immunotherapy focused on solid tumors with short life expectancy. The company aims to unlock potentially long-term or life-long cancer remission in some of the deadliest cancers, and to potentially treat or cure serious infectious diseases such as Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) infection.

The oncology platform is now at the forefront of Renovaro's development activities. While Renovaro's current efforts focus primarily on pancreatic cancer, it plans to include other solid tumors with short life-expectancy in the first in human Phase I/IIa studies that are on track to start by mid-2024. The company's Pre-Investigational New Drug (pre-IND) submission included a human study plan covering pancreatic cancer, as well as other cancers that are difficult to treat, potentially including triple-negative breast cancer, head and neck cancers and mesothelioma.

Renovaro's proprietary, novel technology uses cell- and gene-therapy to promote a renewed immune response against solid tumors. Important confirmatory results from two humanized mouse models using the company's novel dendritic cell-based therapy, independently conducted by Dr. Anahid Jewett, a renowned cancer researcher in the field of immunotherapy at UCLA, were presented previously at two scientific conferences and were the foundation supporting a pre-IND submission to the U.S. Food and Drug Administration. Notably, Dr. Jewett's findings from these studies consistently demonstrated 80% to 90% pancreatic tumor reduction in size and weight that was correlated with significant enhancement of key aspects of the immune response.

Renovaro is headquartered in Los Angeles, California.

RENB-DC11

Renovaro's product development strategy is anchored in the use of "non-self" or allogeneic cells that enhance targeted immune response. Its lead candidate, RENB-DC11, is an innovative therapeutic vaccination platform that could potentially be used to induce life-long remissions from some of the deadliest solid tumors.
Treatment with RENB-DC11 has now been shown to significantly reduce the size of human pancreatic tumors in humanized mice in three independent studies. The reduction in tumor size correlated with statistically significant increases in key components of an immune response.

Pre-IND was completed in June 2023, with IND filing forecast for first half of 2024. First in-human Phase I/IIa trials are predicted shortly after in H1 of 2024, including pancreatic and other solid tumors with poor treatment options and life-expectancy.

Renovaro believes that RENB-DC11 could represent the most promising and effective strategy to achieve life-long remission for a number of common and deadly tumors.

Other Development Candidates

In addition to its lead oncology platform, Renovaro's development pipeline includes a platform targeting infectious diseases, including:

  • RENB-HV12 – An engineered allogeneic T-Cell vaccine, this therapeutic HIV vaccine candidate enhances immune infiltration, immune killing and immune surveillance. Potential pre-IND submission is planned for first half of 2024, with IND-submission expected in second half of 2024.
  • RENB-HV21 – Leveraging allogeneic NK plus Gamma Delta T (GDT) cells as potential therapy for HIV, ENOB-HV21 shows promising preliminary results without confounding factors. Renovaro owns an exclusive license and has completed the Pre-IND submission, with a potential IND submission and human trials expected in 2024.
  • RENB-HV01 – Caring Cross, a non-profit corporation, has shown that its proprietary CAR-T cells cure HIV in a mouse model. Studies in humans have begun. Renovaro has entered into a profit-sharing sublicense with Caring Cross and would share in profits if the product is commercialized.
  • RENB-HB01 – This therapeutic approach aims to eliminate all HBV rapidly ("seek and kill") with a two to three dose treatment regimen. It is expected to be applicable for early disease to maximize impact with low risk of toxicity. Pre-IND comments have been received from the FDA for its AAV-delivery system.
    LOI to Merge with GEDi Cube International Ltd.

On August 9, 2023, Renovaro announced its execution of a binding, exclusive letter of intent to merge a subsidiary with cutting-edge health AI company GEDi Cube International Ltd. The combined company is expected to create a potential multiplier effect to accelerate earlier diagnosis, more effective therapy, and precision in silico drug discovery.

GEDi Cube's innovative technology, developed over nearly a decade, has already validated earlier diagnoses of lung cancer in humans at a leading university hospital. GEDi Cube has likewise created the early diagnosis technology for 12 additional cancers, including pancreatic and breast cancer.

"I believe joining forces with GEDi Cube could enhance the efficacy of our upcoming trials and speed up the discovery of novel treatment approaches, thereby extending our life-saving technology to more cancer patients and renewing hope for them and their families," Dr. Mark Dybul, CEO of Renovaro, stated in the news release.

GEDi Cube is led by CEO Craig Rhodes, who brings to that company tremendous industry experience leading life sciences groups at industry leaders Intel, Oracle and NVIDIA.

Market Opportunity

Pancreatic cancer alone is diagnosed globally in approximately 495,000 people each year, including roughly 64,000 in the U.S. Nearly 466,000 of those patients die annually, including approximately 51,000 in the U.S. Because of limited treatment options, life expectancy is very poor – with an approximately 10% patient survival rate at five years after diagnosis.

The global pancreatic cancer treatment market was valued at $2.15 billion in 2021 and is projected to grow from $2.48 billion in 2022 to $6.85 billion by 2029, according to Fortune Business Insights. That growth represents a CAGR of 15.7% for the forecast period.

A separate report from Fortune Business Insights projects that the global HIV drug market will grow from $30.46 billion in 2021 to $45.58 billion in 2028, recording a CAGR of 5.9% over the forecast period.

According to GlobalData, the value of the market for hepatitis B treatment is forecast to experience a significant increase in the coming years, with revenues expected to grow from $1.6 billion in 2022 to $10.5 billion in 2029. That represents a very rapid CAGR of 30% over the period. An estimated 296 million people suffer from the condition worldwide.

Management Team

Dr. Mark Dybul is the CEO of Renovaro. He has served as a tenured professor in the Department of Medicine at Georgetown University Medical Center since June 2017. He also served as Faculty Co-Director of the Center for Global Health and Quality from 2017-2021. Dr. Dybul has worked on HIV and public health for nearly 30 years as a clinician, scientist, teacher and administrator, including as an architect and eventually the Global Ambassador of the U.S. President's Emergency Plan for AIDS Relief and the Executive Director of the Global Fund to Fight AIDS, Tuberculosis and Malaria from 2013 through May of 2017, and as the co-director of the Global Health Law Program at the O'Neill Institute for National and Global Health Law from 2009 through 2012. He is a member of the U.S. National Academy of Medicine.

Luisa Puche is the company's CFO. She has served as a senior accounting and financial advisor and president of Puche Group LLC from 2015-2019. She served in various key executive roles, including Interim Chief Accounting Officer, at Brightstar Corp., a $10 billion global wireless device services provider. Ms. Puche began her career at Ernst & Young, where she served for approximately 10 years. Leveraging her broad global audit, advisory and corporate expertise, she has provided strong cross-functional leadership experience managing small and large projects for both publicly traded and privately held companies in various industries, including a global implementation of the latest revenue recognition accounting standard for Del Monte, as well as the global implementation of their SOX-404 program.

Francois Binette, Ph.D., is the Chief Operating Officer and Executive Vice President of Research & Development at Renovaro. He has over 25 years of product development expertise in Advanced Therapies and Regenerative Medicine. His broad industry experience spans a wide range of serious medical conditions, from orthopedics to ophthalmology, CNS and immuno-oncology. His career includes positions at Genzyme, Biosyntech, the DePuy Franchise of Johnson and Johnson, Medtronic and Lineage Cell Therapeutics. He received his Ph.D. from Laval University in Québec, followed by post-doctoral training at the Sanford-Burnham Institute in La Jolla and Harvard Medical School in Boston.

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