Lucy Scientific Discovery Inc. (NASDAQ: LSDI)

The QualityStocks Daily Newsletter would like to spotlight Lucy Scientific Discovery Inc. (NASDAQ: LSDI).

A recent study on methamphetamines and MDMA has produced interesting findings on the two drugs and their potential association with human connection. Researchers found that both MDMA and methamphetamines can enhance feelings of closeness and connectedness, but methamphetamines seemed to deliver stronger long-term benefits on social bonding compared to the psychedelic. While both methamphetamines and MDMA are psychoactive in nature, they affect people in wildly different ways. MDMA (also known as molly or ecstasy) is a hallucinogenic with prosocial and empathogenic properties. MDMA users often report increased feelings of emotional closeness and trust, which has led to increased MDMA use in recreational settings. A recent wave of psychedelic-related research has also found that MDMA can aid in the treatment of mental-health conditions, including anxiety, depression and severe post-traumatic stress disorder (PTSD), resulting in an increase in therapeutic use as well. Such research insights vindicate the view of research and drug-development companies such as Lucy Scientific Discovery Inc. (NASDAQ: LSDI) that wish to undertake thorough research and come up with the right formulation for a given mental-health indication instead of users self-prescribing psychedelics without sufficient data on the compounds' efficacy for the condition for which they are taking those substances.

Lucy Scientific Discovery Inc. (NASDAQ: LSDI) is an early-stage psychotropics manufacturing company focused on becoming the premier contract research, development and manufacturing organization for the emerging psychotropics-based medicines industry.

The company holds a Controlled Drugs and Substances Dealer’s License granted by Health Canada’s Office of Controlled Substances. This specialized license authorizes LSDI to develop, sell, deliver and manufacture pharmaceutical-grade active pharmaceutical ingredients (APIs) used in controlled substances and their raw material precursors. Lucy Scientific Discovery and its wholly owned subsidiary, LSDI Manufacturing Inc., operate under Part J of the Food and Drug Regulations promulgated under the Food and Drugs Act (Canada).

The company’s mission is to make its products and research services available for the development of medicines and experimental therapies to address certain psychiatric health disorders and other medical needs, including various mental health and addiction disorders. LSDI targets customers that include an increasing number of the leading universities, hospitals and other public, private and government institutions throughout the world that have launched research programs aimed at understanding the therapeutic potential of a range of psychedelic substances.

The company is headquartered in Victoria, British Columbia, Canada.

Products

LSDI produces a variety of high-quality natural, synthetic and biosynthetic products to meet the needs of the rapidly growing psychotropics-based medicines market. The company believes the emerging psychotropics industry will pave the way to a brighter future in mental health and overall wellness. LSDI is dedicated to advancing the frontiers of mind science and facilitating the development of psychotropic and psychedelic treatment therapies.

In Canada, the psychedelic compounds that LSDI is approved to produce under its Dealer’s License are regulated under the Controlled Drugs and Substances Act, or CDSA. Those compounds include:

• Psilocybin
• Psilocin
• Lysergic acid diethylamide, or LSD
• N,N-Dimethyltryptamine, or N,N-DMT
• 3,4-Methylenedioxymethamphetamine, or MDMA
• 4-Bromo-2,5-Dimethoxybenzeneethanamine, or 2C-B

The company also sells its consumer psychotropic products directly online and through retailers. Those products, described as microdose mushroom formulations, include a sleep aid, Twilight, and a mindfulness enhancer, Mindful.

Market Opportunity

According to a report from Global Market Insights, the psychotropics drug market had an estimated value of $20.2 billion in 2022 and is projected to reach a value of nearly $37.6 billion by 2032. That represents a CAGR of 6.4% for the forecast period. Factors driving market growth include the increasing prevalence of mental disorders, technological advancements in drug development, a rising geriatric population and increasing healthcare expenditures, the report states.

A growing awareness of mental health issues and an effort to reduce the stigma surrounding psychiatric disorders have encouraged more individuals to seek help, which in turn boosts the market. In addition, advancements in neuroscience, pharmacology and drug development have led to the discovery of new and more effective central nervous system therapeutics.

Innovative treatments offering better outcomes with fewer side effects attract patients and healthcare providers, also driving market growth.

Management Team

LSDI’s executive team brings deep experience in the development and commercialization of products featuring controlled substances, as well as the navigation of regulatory structures applicable to these products.

Richard Nanula is Chairman and CEO of LSDI. He has more than 35 years of leadership experience at several of the largest companies in the world, having been a senior executive at The Walt Disney Company, Amgen, Colony Capital and Starwood Hotels and Resorts. He has also served as a board member for Boeing Corporation and Starwood Capital, where he provided corporate guidance and oversight. He holds an MBA from Harvard Business School.

Assad J. Kazeminy, Ph.D., is Chief Scientific Officer at LSDI. He previously served as CEO of Irvine Pharmaceutical Services Inc. and Avrio Biopharmaceutical LLC, and he has founded several drug development companies. He has over 30 years of research and development experience in the biopharmaceutical industry. He received his Ph.D. in Pharmaceutical Science and Biochemistry from Esfahan University in Iran. He completed a Post Doctorate course of study at the University of Southern California Medical School, Department of Pharmacology.

Brian Zasitko, CPA, CA, is the company’s CFO. He is a Director of Invictus Accounting Group LLP, a professional services firm providing finance, advisory and accounting services. He also serves as CFO of Lobe Sciences Ltd., a company developing psychedelic compounds as therapeutics for the treatment of mild traumatic brain injuries and post-traumatic stress disorder. He has an undergraduate degree from Simon Fraser University and a CPA (CA) from Certified Professional Accountants, British Columbia.

Lucy Scientific Discovery Inc. (NASDAQ: LSDI), closed Monday's trading session at $0.2878, up 0.278746%, on 72,742 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.2599/$4.00.

Recent News

• Lucy Scientific Discovery Inc. (NASDAQ: LSDI) - Study Suggests Methamphetamine More Helpful for Social Bonding Compared to MDMA
• InvestorNewsBreaks - Lucy Scientific Discovery Inc. (NASDAQ: LSDI) Strengthen Position in Alternative Mental-Health Treatments Sector
• Lucy Scientific Discovery (NASDAQ: LSDI) Acquisitions Create 'Golden Opportunity' for Growth, Success

First Tellurium Corp. (CSE: FTEL) (OTCQB: FSTTF)

The QualityStocks Daily Newsletter would like to spotlight First Tellurium Corp. (CSE: FTEL) (OTCQB: FSTTF) .

First Tellurium Corp. (CSE:FTEL ) ( OTC:FSTTF) (the " Company " or " First Tellurium ") announces it has closed the first tranche (the "First Tranche") of a non-brokered private placement (the "Offering") previously announced on September 11, 2023. The Company has issued 1,690,000 flow-through shares (the "Flow-through Shares") at a price of $0.12 per share for gross proceeds of $202,800 and 1,890,000 units (the "Units") at a price of $0.10 per unit for gross proceeds of $189,000. Each Unit consists of one common share and one common share purchase warrant exercisable at $0.15 for a period of two years following the close of the Offering. Proceeds arising from the sale of the flow-through shares will help fund drilling and other exploration at First Tellurium's Deer Horn Project in 2024. Proceeds arising from the sale of the units will be utilized for exploration and maintenance on the Colorado Klondike property and for unallocated working capital.

First Tellurium Corp. (CSE: FTEL) (OTCQB: FSTTF) is committed to exploring for and providing essential and critical metals, including tellurium, gold, silver, copper and tungsten, for North American markets. This objective is anchored by the company’s Deer Horn tellurium-gold-silver-copper project in British Columbia, Canada, and further enhanced by its property option on the Klondike tellurium-gold prospect located in Colorado, USA.

First Tellurium’s unique business model is to generate revenue and value through mineral discovery, project development, project generation and cooperative access to untapped mineral regions in indigenous territory with sustainable exploration potential.

The company is headquartered in Vancouver, British Columbia.

Tellurium and the Green Energy Revolution

Tellurium has a key role to play in the ongoing green energy revolution. It is widely used in the manufacturing of photovoltaic cells for solar panels.

Despite this utility, ongoing trade tensions between China and the U.S. create implications for both tellurium and the production of cadmium-tellurium solar cells. Earlier this year, China announced plans to restrict exports of critical metals gallium and germanium, both essential for the production of semiconductors. For reference, China produces around 80% of the world’s gallium and approximately 60% of the world’s germanium.

China’s recent trade restrictions amplify the fragility of the North American tellurium supply, as the Asian nation currently produces about 60% of the world’s tellurium. This sustained supply vulnerability is why First Solar, the United States’ largest solar panel producer, set up a worldwide search for tellurium deposits in the mid-2000s.

“In North America alone, our understanding is that First Solar looked at over a hundred tellurium properties,” First Tellurium CEO Tyrone Docherty stated in a news release. “Their number one property by far, which they acquired, was the Colorado Klondike which we now control.”

The U.S. is now looking to secure safe, domestic sources of tellurium and many other critical metals to pre-empt potential shortages. The Biden administration has instituted a stream of policies, particularly the U.S. Inflation Reduction Act, to source solar components from North America and other “friendly” jurisdictions.

As the only junior mining company in the world focused on tellurium exploration, First Tellurium is ahead of the curve in capitalizing on these initiatives to establish strategic, domestic supplies of key resources for solar panel manufacturers.

First Tellurium’s ESG Initiatives

Through its exploration and partnerships with Fenix Advanced Materials, Cheona Metals and IRMA, First Tellurium strives to generate a measurable, beneficial social or environmental impact alongside a financial return. The company conducts a diversified search for metals, working in alliance with indigenous peoples, NGOs, governments and leading metals buyers. First Tellurium believes this is the future of mineral exploration — generating revenue by exploring responsibly and leveraging diverse partnerships.

First Tellurium proudly adheres to, and supports, the principles and rights set out in the United Nations Declaration on the Rights of Indigenous Peoples and, in particular, the fundamental proposition of free, prior and informed consent.

 

Projects

Deer Horn Tellurium-Gold-Silver-Copper Project

Deer Horn is located on 51.33 square kilometers (km) in west-central British Columbia, 36 km south of the prolific Huckleberry copper-molybdenum mine and 135 km southwest of the community of Burns Lake. It is one of few significant tellurium discoveries outside Asia and includes a 2.4 km-long vein system of high-grade gold, silver and tellurium, as well as broader zones of bulk-tonnage gold, silver and tellurium mineralization. The company completed a positive Preliminary Economic Estimate and has begun permitting for a 10,000-tonne bulk sample program to advance the project toward mine feasibility. It is North America’s only silver-gold-tellurium property with an NI 43-101 compliant tellurium resource, and it hosts a number of other mineralized targets and zone containing critical metals such as copper, tungsten and zinc.

First Tellurium owns 50% of the property, with an option to acquire up to a 75% interest. The company has engaged Dias Geophysical of Saskatoon, Saskatchewan, to conduct induced polarization (IP) geophysics on the Deer Horn Project in summer 2023. The program is designed to help develop drill targets for a subsequent drilling program.

Klondike Gold-Tellurium Project

The Klondike property is located in Saguache County, Colorado, southwest of Buena Vista in the state’s historical mining district. The company reports it has engaged Burgex Mining Consultants of Sandy, Utah, to stake additional claims around the Klondike property. The claims have been filed with the Bureau of Land Management.

Klondike demonstrates exceptional tellurium grades. Tellurium, used in high-efficiency cadmium telluride (Cd-Te) solar panels, next-generation lithium-ion batteries and thermoelectric devices to change heat into energy, is an essential element for the world’s transition to green energy.

The Klondike property was a top tellurium prospect owned previously by First Solar Inc., one of the world’s largest solar panel producers. First Solar terminated its worldwide raw materials exploration program in 2012 and sold the property to Colorado Klondike LLC, which optioned the project to First Tellurium. Colorado Klondike, led by First Solar’s former Exploration Manager in North America, is managing the upcoming exploration program.

The Colorado Geological Survey (CGS), in partnership with the Colorado School of Mines, reported on First Solar’s exploration at Klondike in 2015, noting: “Surface sampling by First Solar, Inc. in 2006 found very high tellurium grades of up to 3.3% (33,000 ppm), along with locally high gold grades. Tellurium grades at Klondike were the highest encountered in the company’s nationwide exploration program.”

Market Outlook

First Tellurium in spring 2023 referenced recent forecasts by the International Energy Agency (IEA) pointing to rapid growth in solar photovoltaic (solar PV) deployment worldwide. According to the agency, solar PV installations will generate more power by 2027 than any other energy source, including coal, natural gas and hydro. To meet this demand, consumption of both silver and tellurium, key components of solar panels, is expected to surge in coming years.

Chen Lin, founder of Lin Asset Management, has written in his investment newsletter for clients that solar PV is now the largest industrial usage of silver. He said that in 2022 solar PV production used about 12% of total silver demand, or about 120 million ounces of silver. Lin expects this number to rise dramatically in the coming years, and that is likely to lead to silver supply deficits for decades to come.

Lin points out that solar power is now the cheapest source of energy in many parts of the world and that all forecasts point to dramatic expansion of solar PV in the coming two decades. Conservative estimates forecast 300 gigawatts of solar PV production by 2027, up from the current level of about 200 gigawatts.

Management Team

Tyrone Docherty is President, Director and CEO of First Tellurium Corp. He previously served as President and CEO of Quinto Mining Inc., taking over when it had a market cap of $4 million. With limited resources in a difficult market environment, he raised more than $30 million and advanced Quinto’s Quebec iron ore property to a viable project. Quinto later sold for $175 million, with Quinto management taking shares of the purchaser, Consolidated Thompson Iron Mines, amounting to approximately 20-21% of that company. Consolidated Thompson Iron Mines sold two years later for $4.9 billion, giving the former Quinto team an enterprise value of approximately $1 billion. From 2012 to 2018, Mr. Docherty was Director and Chairman of Mason Graphite Inc. He has worked in the financial and minerals markets for more than 30 years.

Tony Fogarassy, M.Sc. LL.M., is Chairman of First Tellurium Corp. He is a lawyer and a geologist. His extensive legal and technical expertise includes minerals, oil and gas, coal and renewable energy projects and environmental and aboriginal/indigenous law in North America, Africa and Asia. He graduated as gold medalist in geological sciences from the University of British Columbia and in law from the London School of Economics.

First Tellurium Corp. (OTCQB: FSTTF), closed Monday's trading session at $0.0655, up 6.1588%, on 16,679 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.053/$0.1765.

Recent News

• First Tellurium Corp. (CSE: FTEL) (OTCQB: FSTTF) - First Tellurium Closes First Tranche of Private Placement
• MiningNewsBreaks - First Tellurium Corp. (CSE: FTEL) (OTC: FSTTF) Eyes Significant Potential at Deer Horn Property
• First Tellurium Reports Completion of New Thermoelectric Generator Prototype

Longeveron Inc. (NASDAQ: LGVN)

The QualityStocks Daily Newsletter would like to spotlight Longeveron Inc. (NASDAQ: LGVN) .

Longeveron, a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions, reported positive top-line results from its CLEAR MIND Phase 2a human clinical trial

The study, which explored Lomecel-B(TM)'s effects on mild Alzheimer's disease, met the primary endpoint of safety on statistical and medical assessment

Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions, just announced positive top-line results from its CLEAR MIND Phase 2a clinical trial for treating mild Alzheimer's disease. Most notably, the primary endpoint of safety was met based on statistical and medical assessment, with only one Serious Adverse Event ("SAE") reported on each Lomecel-B(TM) group in what Dr. Jeffrey Cummings, MD, Vice Chair of Research, UNLV Department of Brain Health, described as "Encouraging results" (https://ibn.fm/BNOjU).

Longeveron Inc. (NASDAQ: LGVN) is a clinical-stage biotechnology company developing regenerative medicines to address unmet medical needs for specific aging-related and life-threatening conditions. The Company’s research and therapies are aimed at improving the outcome of infants born with a life-threatening heart condition, as well as improving the healthspan for the aging population – the number of years a person is expected to live in relatively good health, free of chronic disease and disabilities of aging, with function and ability to perform activities of daily living.

Longeveron is involved in clinical trials in the following indications: Hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty.

The Company’s philosophy revolves around the idea that regenerative medicine may hold the potential to improve certain rare medical conditions and contribute to healthy aging. While there has been a remarkable rise in life expectancy over the last century due to medical and public health advancements, this increase in longevity has not been paralleled by the number of years a person is expected to live in relatively good health, free of chronic disease and disabilities of aging.

Longeveron’s lead investigational product is Lomecel-B™, an allogeneic Medicinal Signaling Cell therapy product isolated from the bone marrow of young, healthy adult donors. As humans age, they experience a decrease in immune system function, a decline in blood vessel functioning, chronic inflammation, and other issues. Clinical data has suggested that Lomecel-B™ may address these conditions through multiple mechanisms of action (MOA) that simultaneously target key aging-related processes.

The Company is headquartered in Miami, Florida.

Lomecel-B™

Lomecel-B™ is being evaluated in multiple clinical trials for aging-related chronic diseases and other life-threatening conditions under U.S. FDA-approved Investigational New Drug applications. Lomecel-B™ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas.

The drug is made from special living cells called Medicinal Signaling Cells (MSCs) that are isolated from fresh bone marrow tissue that has been donated by adult donors aged 18 to 45. Once the MSCs have been isolated from the fresh bone marrow through a careful selection process, the cells are culture-expanded (allowed to replicate under controlled laboratory conditions) into the billions using specialized techniques and processes. After a specific number of expansion cycles, called “passages,” the cells are harvested, separated into specific doses (e.g., 50 million cells), and cryopreserved until future use.

These cells have been shown to have characteristics that allow them to be transplanted from a donor to host without triggering a harmful immune response in the recipient, and they can be administered on an outpatient basis in as little as 40 minutes after thawing. Because of these characteristics, Lomecel-B™ is considered an “off-the-shelf” product.

In some trials, such as for Alzheimer’s disease and Aging-related Frailty, Lomecel-B™ is administered via peripheral intravenous infusion, while, in the Company’s HLHS trial, Lomecel-B™ is administered via direct injection into the heart tissue.

Market Opportunity

Longeveron estimates the potential market size for Lomecel-B™ in the treatment of HLHS to be up to $1 billion annually, globally.

U.S. patients suffering from Aging-related Frailty are estimated using U.S. Census Bureau statistics to be approximately 8.1 million. That population potentially represents a market for Lomecel-B™ of between $4 billion and $8 billion globally per year, according to Company estimates.

Additionally, the Alzheimer’s Association puts the number of Americans with that disease at 5.1 million, highlighting another potentially addressable market for Lomecel-B™, that’s worth $5 billion to $10 billion annually.

Management Team

Wa’el Hashad is CEO of Longeveron. He has more than 35 years of experience in the pharmaceutical and biotech industries. He has launched several successful brands in the U.S. and worldwide markets. Prior to joining Longeveron, he was president and CEO of Avanir Pharmaceuticals. Before Avanir, he was the chief commercial officer of Seres Therapeutics. He also has held senior leadership positions at Amgen, Boehringer Ingelheim, and Eli Lilly and Company. He holds a bachelor’s degree in pharmacy from Cairo University and an MBA from the University of Akron.

Joshua M. Hare, M.D., FACC, FAHA, is Co-Founder, Chief Science Officer and Chairman of Longeveron. He is a double board-certified cardiologist and is the founding director of the Interdisciplinary Stem Cell Institute at the University of Miami’s Miller School of Medicine. He is a recipient of the Paul Beeson Physician Faculty Scholar in Aging Research Award and is an elected member of the American Association of Physicians and The American Society for Clinical Investigation. He is also an elected Fellow of the American Heart Association. He received a bachelor’s degree from the University of Pennsylvania and his M.D. from The Johns Hopkins University School of Medicine.

Lisa Locklear is CFO at Longeveron. She previously served as the senior vice president and CFO for Avanir Pharmaceuticals. Prior to Avanir, she held senior financial roles at GSN Games, CoreLogic, Ingram Micro, the Walt Disney Company, and Price Waterhouse, with assignments in Paris and London. She holds a bachelor’s degree in plant science from the University of California, Davis, and an MBA from the University of California, Irvine. She is a licensed CPA (inactive) and is a member of the American Institute of Certified Public Accountants, the California Society of CPAs, and Financial Executives International.

Dr. Nataliya Agafonova, M.D., is the Chief Medical Officer at Longeveron. She previously served as clinical development lead, senior medical director, and product development chair at Otsuka Pharmaceuticals. Before that, she was the clinical development lead and senior medical director at Bristol-Myers Squibb. She previously held senior leadership positions at Ardea Bioscience, Biogen, Amgen, and Genzyme Corporation. She earned an M.D. from the Ukrainian National Medical University and completed her internal medicine residency at Kharkov State University Hospital in Ukraine.

Certain statements in this corporate profile that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, statements regarding the offer and sale of securities, the terms of the offering, about the ability of Longeveron’s clinical trials to demonstrate safety and efficacy of the Company’s product candidates, and other positive results; the timing and focus of the Company’s ongoing and future preclinical studies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity for the Company’s product candidates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the Company’s product candidates; the Company’s ability to obtain and maintain regulatory approval of its product candidates in the U.S., Japan and other jurisdictions; the Company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; the Company’s plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and the Company’s ability to attract and retain such personnel; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s need to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive impact it may have on its investors; the Company’s financial performance and ability to continue as a going concern, and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditure requirements. Additionally, Longeveron makes no assurance that any public offering of its securities as described herein will occur on the timelines, in the manner or on the terms anticipated due to numerous factors. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 14, 2023 and its Quarterly Report on Form 10-Q for the second quarter of 2023 filed with the SEC on August 11, 2023. The forward-looking statements contained in this corporate profile are made as of the date of this corporate profile, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor Contact
Mike Moyer
LifeSci Advisors
Tel: 617-308-4306
Email: mmoyer@lifesciadvisors.com

Date prepared: August 31, 2023

Longeveron Inc. (NASDAQ: LGVN), closed Monday's trading session at $1.93, up 3.7634%, on 69,218 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $1.50/$4.5793.

Recent News

• Longeveron Inc. (NASDAQ: LGVN) - Longeveron Inc. (NASDAQ: LGVN) Validates Safety and Therapeutic Potential of its Lomecel-B(TM) Lead Investigational Product in its CLEAR MIND Phase 2a Clinical Trial
• InvestorNewsBreaks - Longeveron Inc. (NASDAQ: LGVN; LGVNR) Top-Line Results from Phase 2a Trial Spotlighted in Latest NNA Release
• InvestorNewsBreaks - Longeveron Inc. (NASDAQ: LGVN; LGVNR) Closes on $4M Registered Direct Offering

Lexaria Bioscience Corp. (NASDAQ: LEXX)

The QualityStocks Daily Newsletter would like to spotlight Lexaria Bioscience Corp. (NASDAQ: LEXX).

Lexaria's DehydraTECH is easily integrated into oral product manufacturing processes to better deliver API payloads to improve bioavailability, reduce side effects and more

Lexaria is evaluating the impact of DehydraTECH on oral performance of GLP-1 drugs for diabetes and weight loss, a market forecast to reach up to an astonishing $200 billion per year

DehydraTECH is a scalable technology for a multitude of applications that has separately been licensed by Altria for oral nicotine products

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

NetworkNewsWire Editorial Coverage: The prestigious New England Journal of Medicine recently published results of a large study of 2,539 adults wherein weight loss of 49 to 52 pounds was a common outcome. With more than 37 million Americans suffering from diabetes, and with obesity at epidemic levels, it's little wonder that millions of people are singing their praises of the new class of drugs responsible for these outrageously positive outcomes. GLP-1 agonists are a class of medications that mainly help manage blood sugar (glucose) levels in people with type 2 diabetes but are also helping treat obesity. Seems everyone is excited about controlling blood sugar and easily losing weight. But there may be an even better avenue to increased effectiveness and better outcomes. Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile), a global innovator in drug-delivery platforms, began diabetes-related formal studies last year with its DehydraTECH(TM) platform, which showed reduced blood-sugar levels and lowered body weight. With such encouraging early results, Lexaria is planning to launch new human and animal studies to examine whether DehydraTECH processing can make GLP-1 drugs such as semaglutide even better. Lexaria's heavily-patented DehydraTECH drug delivery technology might improve bioavailability, lower costs, and enhance tolerability, weight-loss potential and management of diabetes and other health conditions. DehydraTECH may become a game changer in the multibillion-dollar GLP-1 drug market and could potentially lead to a collaboration with a dominant player in the space, such as Novo Nordisk (NYSE: NVO), Pfizer Inc. (NYSE: PFE), Merck & Company Inc. (NYSE: MRK), or AstraZeneca PLC (NASDAQ: AZN).

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 21 issued and more than 50 pending patents in over 40 countries around the world. 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, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs) and nicotine.

Market Outlook

Lexaria’s ongoing research and development efforts are mainly focused on development of product candidates across several key segments:

• Oral Cannabinoids – a market estimated to be worth $18.4 billion in 2021 and expected to reach $46.2 billion by 2025.
• Antivirals – an estimated $52.1 billion market in 2021 that’s expected to grow to $66.7 billion by 2025.
• Oral Mucosal Nicotine – smokeless tobacco products, a $13.6 billion market in 2018, is forecast to grow at 7.2 percent annually through 2025.
• Human Hormones – estrogen and testosterone replacement therapies represented a $21.9 billion market in 2019, with a forecast CAGR of 7.7 percent through 2027.
• Ibuprofen and Naproxen – NSAID sales totaled $15.6 billion globally in 2019 and are projected to reach $24.4 billion by 2027.
• Vitamin D3 – the global market size was $1.1 billion in 2021, growing at 7 percent per year and expected to reach $1.7 billion in 2026.

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.

Greg Downey is Lexaria’s CFO. He has more than 35 years of diverse financial experience in the mining, oil and gas, manufacturing, and construction industries, and in the public sector. He served for eight years as CFO for several public companies and has provided business advisory and financial accounting services to many large organizations.

Gregg Smith is a strategic advisor to Lexaria. He is a founder and private investor with Evolution VC Partners. He is a member of the Sand Hill Angels and held previous investment banking roles with Cowen and Company and Bank of America Merrill Lynch.

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.

Lexaria Bioscience Corp. (LEXX), closed Monday's trading session at $1.33, up 14.6552%, on 123,903 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.6488/$3.5953.

Recent News

• Lexaria Bioscience Corp. (NASDAQ: LEXX) - Can Diabetes, Weight-Loss Drugs Get Even Better?
• Lexaria Bioscience Corp. (NASDAQ: LEXX) Receives Two New Canadian Patents Amid Continued Efforts to Safeguard the Applicability of Its DehydraTECH(TM) Technology in Multiple Jurisdictions and Sectors
• TinyGemsBreaks - Lexaria Bioscience Corp. (NASDAQ: LEXX) Committed to Research and Development, Eyeing Excellent Opportunities

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI)

The QualityStocks Daily Newsletter would like to spotlight Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI).

Scinai Immunotherapeutics (NASDAQ: SCNI), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative inflammation and immunology ("I&I") biological products primarily for the treatment of autoimmune and infectious diseases, will be attending and participating in BIO-Europe, one of Europe's premier pharmaceutical industry partnering events. The event is slated for Nov. 6–8, 2023, in Munich, Germany. According to the announcement, Scinai will showcase both its CDMO services, marketed under the brand Scinai Bioservices, and its in-house nanosized VHH antibody-based therapeutics pipeline. In addition, management will be available to meet with potential partners and clients. Scinai offers a state-of-the-art manufacturing facility for biopharmaceutical products as well as biologic drugs process development and scale-up for protein-based drugs; the company also provides analytical method development for QC testing and cGMP manufacturing. In addition, the company's in-house R&D program specializes in developing, manufacturing and commercializing I&I biological products targeting the treatment of autoimmune and infectious diseases. To view the full press release, visit https://ibn.fm/5Dj2I

Researchers from the University of Southampton, United Kingdom and La Jolla Institute for Immunology (LJI) have identified a group of immune cells that may be responsible for severe asthma. Identified as  cytotoxic CD4+ tissue-resident memory T cells, these cells congregate in the lungs and seem to have the ability to cause the harm associated with later development of asthma.

Researchers say these immune cells are especially prevalent in men and note that men who are diagnosed with asthma after age 40 often have high counts of this specific T cell in their lungs, which increases their odds of developing severe asthma. The study used information from the WATCH study, an NHS-clinic-based study that follows hundreds of patients with asthma over several years. This program has allowed researchers to study asthma patients of all ages and sexes at various stages of the disease and analyze their immune cell populations. The efforts by enterprises such as Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) to develop immunotherapies against autoimmune conditions could help to address issues such as adult-onset asthma.

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious diseases and autoimmune diseases.

In collaboration with the prestigious Max Planck Institute for Multidisciplinary Sciences (MPG) and the University Medical Center Göttingen (UMG), both in Germany, Scinai is developing a pipeline of innovative nanosized antibody (NanoAb) therapies addressing diseases underserved by current treatments and with large and growing markets, such as COVID-19, asthma and psoriasis.

NanoAbs, also known as VHH-antibodies or Nanobodies, are alpaca-derived nanosized antibodies that exhibit multiple significant competitive advantages over existing antibody therapies, including stability at high temperatures, superior binding affinity, more effective and convenient routes of administration and efficient production. Scinai is uniquely positioned to advance nanosized antibody innovation from R&D through commercialization.

The company’s highly experienced and successful pharmaceutical industry leadership team includes former senior executives from Novartis, GSK and Bristol-Myers Squibb.

Since its founding, Scinai has executed eight clinical trials, including a seven-country, 12,400-participant Phase 3 trial of a prior influenza vaccine candidate, and it built, owns and operates a 20,000 sq. ft. state-of-the-art GMP biologics manufacturing facility housing its laboratories, production facilities and offices.

Lead Candidate: Inhaled COVID-19 NanoAb

In December 2021, Scinai signed definitive agreements with the Max Planck Society – parent organization of the Max Planck Institute for Multidisciplinary Sciences– and the UMG to enter a strategic collaboration for the development and commercialization of innovative COVID-19 NanoAbs.

The company is planning a rapid development path that leverages its expertise and capabilities in biological drug development and manufacturing. Scinai anticipates preclinical proof-of-concept results for an inhaled COVID-19 NanoAb by the end of 2022, with initial Phase 1/2a human clinical trial results expected in 2023.

The intended inhaled mechanism of delivery of Scinai’s COVID-19 NanoAb formulation may serve as a significant differentiator when compared to approved monoclonal antibodies, which are injected. Inhaled delivery has shown to be cheaper, more convenient and likely safer for patients and providers.

NanoAb Pipeline: Psoriasis, Asthma and More

The COVID-19 NanoAb development agreement is part of a broader five-year research collaboration agreement signed in March 2022 covering discovery, development and commercialization of NanoAbs for several other disease indications with large market medical needs, including asthma, psoriasis, macular degeneration and psoriatic arthritis.

Scinai has an exclusive worldwide license for development and commercialization of COVID-19 NanoAbs and exclusive options for similar worldwide licenses for NanoAbs for the above mentioned additional large market disorders currently underserved by approved therapeutic antibodies.

Academic research teams from MPG and UMG have verified strong affinity by the new NanoAbs to their biological target molecules and high thermostability. They have also demonstrated strong neutralization by several NanoAb candidates of their respective target molecules. Neutralization studies of the other NanoAbs are expected to begin later in 2022.

Based on the promising results, Scinai will focus development efforts beginning with the following NanoAbs:

• NanoAbs targeting IL-17 as drug candidates for the potential treatment of psoriasis and psoriatic arthritis
• NanoAbs targeting IL-13 and NanoAbs targeting TSLP as drug candidates for the potential treatment of asthma

These are conditions for which the antibody target is validated by existing treatments and the mechanism of action is well understood. Both represent large medical needs and growing markets. Scinai anticipates preclinical proof-of-concept for at least one of these NanoAbs in 2023. This is in addition to the aforementioned human clinical Phase 1/2a for the inhaled COVID-19 NanoAb therapy, which is also anticipated in 2023.

CDMO Services

While NanoAb pipeline development is Scinai’s core focus, the company also offers its cGMP manufacturing facility, aseptic fill and finish suite, laboratories and experienced professionals for contract development and manufacturing organization (CDMO) services. This offering is designed to keep the Scinai team abreast of the latest industry developments and trends while building experience and generating revenue to support the company’s NanoAb pipeline development.

Market Opportunity

COVID-19 treatment, target of the company’s lead NanoAb therapy candidate, had an estimated market size of $22 billion in 2021.

Future Scinai drug candidates will target conditions with large markets growing at attractive CAGRs.

The global asthma treatment market was valued at $18.08 billion in 2019 and is projected to reach $26.01 billion by 2027, exhibiting a CAGR of 4.5% during the forecast period, according to Fortune Business Insights. The research firm predicts that the global psoriasis treatment market will grow from $26.37 billion in 2022 to $47.24 billion by 2029, exhibiting a CAGR of 8.7% over the forecast period.

Management Team

Amir Reichman is Scinai’s CEO. He previously was Head of Global Vaccines Engineering Core Technologies at GSK Vaccines in Belgium. Prior to that, he held leadership roles at Novartis Vaccines’ Global Vaccines Supply Chain Management organization. He was the first employee of NeuroDerm Ltd., a company focused on transdermal drug delivery, and served as Senior Scientist until his departure in 2009. He earned a M.Sc. in Biotechnology Engineering from Ben-Gurion University and an MBA in Finance and Health Care Management from the University of Pennsylvania’s Wharton School.

Tamar Ben-Yedidia, Ph.D., is Chief Science Officer at Scinai. She has more than 30 years of experience in immunology, with specific expertise in the development of vaccines. She began her career with Biotechnology General Ltd., working on development of a recombinant Hepatitis-B vaccine. She later joined the Weizmann Institute of Science, working on the design of a peptide-based vaccine against several pathogens. She is widely published, with numerous refereed articles and invited reviews in various scientific journals. She received her Ph.D. from the Weizmann Institute.

Elad Mark is COO at Scinai. He has over 15 years of biotechnology industry experience encompassing diverse project stages including feasibility studies, conceptual and detailed design, commissioning, qualification and process validation. Prior to joining Scinai, he led Novartis’s $800 million investment in a biologics facility in Singapore. With Biopharmax and Antero, both global pharmaceutical engineering companies, he successfully led projects in Israel, China and Singapore. He holds a BSc. in Engineering from the Afeka Tel Aviv Academic College of Engineering and an MBA from the Open University of Israel.

Uri Ben-Or is CFO at Scinai. He has served as CFO with public life science companies traded on the TASE, OTC and Nasdaq. Ben-Or provides his services to Scinai through CFO Direct, a company he founded and for which he serves as CEO. He served as the VP of Finance of Glycominds, a leading biotechnology company, and as CFO of a spin-off from Telrad Networks. He also served as a Corporate Controller at Menorah Capital Markets and as an Auditor at PWC. He holds a B.A. in Business from the College of Administration, an MBA from Bar-Ilan University, and is a CPA.

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI), closed Monday's trading session at $0.637, up 2.7254%, on 2,460 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.6194/$11.49.

Recent News

• Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) - Study Identifies Immune Cells Responsible for Severe Asthma
• InvestorNewsBreaks - Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Announces Participation at BIO-Europe Munich 2023
• Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) to Showcase Its Boutique End-to-End CDMO Services at the Premier CPHI Barcelona Event

Diamond Lake Minerals Inc. (OTC: DLMI)

The QualityStocks Daily Newsletter would like to spotlight Diamond Lake Minerals Inc. (OTC: DLMI).

Brian J. Esposito, founder and CEO of Esposito Intellectual Enterprises, LLC., boasts 20 years of experience and a proven track record of driving growth and innovation

Increase in Strong Advisory Board: Agnes Budzyn, Anthony Scaramucci, Larry Namer, Michael J. Malik Sr., Andrew Fromm, Brandon Fugal, and Raul Leal

Newest board additions bring the company closer to its ultimate vision and further strengthen its competitive advantages, including innovative technology, a diverse portfolio, and highly experienced leadership

Diamond Lake Minerals (OTC: DLMI), a company positioning itself as a rapidly developing leader in the digital asset and security token space, recently announced the appointment of a new CEO and several advisors, alongside its strategic rebranding. The addition of Brian J. Esposito as new CEO, plus board members Agnes Budzyn, Anthony Scaramucci, Larry Namer, Michael J. Malik Sr., Andrew Fromm, Brandon Fugal, and Raul Leal, promotes and bolsters the company's strategic growth plan, strengthening its corporate advantages in developing and supporting SEC-registered security tokens.

Diamond Lake Minerals Inc. (OTC: DLMI) is a multi-strategy operating company offering traditional investors an entry point to the future of digital securities. The company’s goal, through its established M&A roadmap, is to responsibly innovate and develop promising businesses that are likely to benefit from the ongoing shift toward digital assets. Through this approach, Diamond Lake Minerals provides traditional investors an opportunity to gain exposure to the emergence of regulated digital securities through a more familiar investment vehicle – the purchase of stock.

Founded in 1954 and headquartered in Salt Lake City, Diamond Lake Minerals is positioning itself as a leader in the digital asset and security token space. The company’s mission is to bring back to the public markets timeless business principles focused on healthy, sustainable growth and strong earnings with a goal of creating value for stakeholders in the modern digital world.

Diamond Lake Minerals believes the future of financial markets is set to be revolutionized by tokenization. Tokenization refers to the use of digital assets that can be traded via protocols with instantaneous settlement and reduced fees, eliminating the need for traditional clearing or settlement processes. Beyond efficiency, the emerging landscape emphasizes transparency, liquidity and security in asset management and investment.

With the backing of Esposito Intellectual Enterprises and its 20+ years of experience, Diamond Lake Minerals has access to the expertise of 110+ companies and 200+ joint ventures, along with knowledge spanning 25+ industries. The company is creating a vertically integrated ecosystem that encompasses various high-growth sectors. This integration aims to maximize operational efficiencies and profitability across all business units.

Products & Services Portfolio

Diamond Lake Minerals, guided by its strategic partnerships and future roadmap, envisions a diverse portfolio across multiple industries, as shown in the overview below. The company is poised to redefine the conglomerate model for the 21st century, with a focus on vertical integration, digital securities and sustainable growth.

Its target market segments include:

• Fashion: DLMI seeks stakes in brands blending timeless aesthetics with tech influences.
• Beauty: DLMI eyes partnerships with innovators elevating beauty through sustainable practices.
• Real Estate: DLMI aims for interests in ventures modernizing property transactions via blockchain.
• Hospitality: DLMI’s vision includes associations with enterprises enhancing guest experiences via tech integration.
• Liquor: DLMI aspires to collaborate with unique distillers merging tradition and innovation.
• IoT: DLMI intends to invest in solutions seamlessly connecting the digital and physical worlds.
• Wireless: DLMI envisions stakes in wireless tech optimizing global communication.
• Technology: DLMI plans to back pioneers driving the next tech revolution.
• Maritime: DLMI seeks partnerships in maritime solutions emphasizing green initiatives.
• Aviation: DLMI’s strategy includes holdings in aviation innovators focusing on efficiency.
• Aerospace: DLMI aims to support ventures pushing boundaries in space exploration.
• Education: DLMI collaborates with platforms revolutionizing learning through tech.
• Charity: DLMI eyes alliances with charitable entities leveraging transparency via blockchain.
• Healthcare: DLMI foresees investments in healthcare tech personalizing patient care.
• TV: DLMI intends stakes in TV platforms innovating content delivery.
• Film: DLMI aspires to support filmmakers merging storytelling with immersive tech.
• Music: DLMI plans interests in music ventures amplifying artists through digital platforms.
• Entertainment: DLMI targets stakes in platforms redefining entertainment paradigms.
• IP: DLMI envisions collaborations safeguarding intellectual properties via tech solutions.
• Data Management: DLMI seeks ventures optimizing data utilization and insights.
• Data Storage: DLMI’s roadmap includes alliances with secure data storage solutions.
• Streaming: DLMI intends to back streaming platforms prioritizing user experience.
• Real World Assets: DLMI eyes investments translating tangible assets into digital value.
• Gold & Silver: DLMI aims for stakes in platforms digitizing precious metal trading.
• Sports: DLMI envisions collaborations enhancing sports experiences via tech integration.
• Sports Technology: DLMI seeks ventures revolutionizing athlete performance and fan engagement.
• Water: DLMI plans to back solutions ensuring water sustainability and accessibility.
• Water Treatment: DLMI targets investments in eco-friendly water purification technologies.
• Animation: DLMI eyes stakes in animation houses blending art with cutting-edge tech.
• Studio Production: DLMI’s vision includes support for studios transforming content creation.
• Consumer Products: DLMI seeks partnerships with brands prioritizing consumer-centric innovations.
• Collectables: DLMI envisions collaborations with platforms digitizing unique collectibles.
• Digital Assets: DLMI aims to invest in ventures maximizing the potential of digital ownership.
• Web3: DLMI aspires to back pioneers ushering in the decentralized web era.
• Identity Management: DLMI eyes solutions prioritizing user identity security in the digital space.
• Media & Journalists: DLMI seeks alliances promoting unbiased reporting and content democratization.
• Metaverse: DLMI envisions stakes in ventures crafting immersive virtual universes.
• Space Economy: DLMI targets investments in ventures monetizing space exploration.
• Modular Homes: DLMI plans interests in solutions revolutionizing home construction.
• Financial Technology: DLMI seeks partnerships modernizing financial transactions.
• Gaming: DLMI aims to back game developers enhancing user immersion.
• Travel: DLMI eyes collaborations transforming travel experiences through tech.
• Health & Wellness: DLMI’s strategy includes investments in holistic health tech solutions.
• Augmented Reality: DLMI envisions stakes in AR platforms blurring reality and digital.
• AI: DLMI seeks to support AI innovations humanizing tech interactions.
• Esports: DLMI targets investments in platforms amplifying esports experiences.
• Construction: DLMI plans to back ventures modernizing construction practices.
• Virtual Reality: DLMI intends stakes in VR platforms offering alternate realities.
• Retail Tech: DLMI envisions collaborations digitizing retail experiences.
• Biotechnology: DLMI seeks ventures pushing boundaries in biotech innovations.

Market Opportunity

According to Diamond Lake Minerals’ business plan executive summary, the market for digital securities is projected to grow from $10 billion in 2022 to $1 trillion by 2028, a CAGR of 45% for the forecast period.

The global blockchain market value is expected to grow from an estimated $3 billion in 2020 to $39.7 billion by 2025, marking a CAGR of 67.3% for the period. Valued at $2.28 billion in 2021, the Security Token Offerings market is projected to grow at a CAGR of 19%. This growth is expected to be driven by the rising adoption of tokenization and the increasing prominence of STOs, especially in North America.

In addition, the global investment management market is projected to grow from a value of $100 trillion in 2020 to $178 trillion by 2025, recording a CAGR of 7.2% over the period.

Management Team

Brian J. Esposito is CEO of Diamond Lake Minerals. As founder and CEO of Esposito Intellectual Enterprises LLC, he brings over 20 years of diverse experience in sectors like manufacturing, technology, music and real estate, and is known for his global executive networking and balance sheet optimization skills.

Michael Reynolds is President and Director of Diamond Lake Minerals. With 35 years in private finance and M&A, he has been instrumental in growing companies like Herbalife through reverse acquisition, as well as elevating JB Oxford to $120 million in revenue. His expertise in operational management and business development ensures professional solutions for clients’ business interests.

Jon Karas is DLMI’s senior transaction and investment executive. As the CEO and co-founder of Akon Legacy Ventures, he structured, negotiated and closed numerous transactions focused on innovation and social impact in smart cities, blockchain, agriculture, mining and technology. He co-founded and led multiple companies in media and entertainment and was the driving force behind the development, financing and production of a broad range of film and television content.

Advisory Board

Anthony Scaramucci, Founder and Managing Partner of SkyBridge Capital and Chairman of SALT, brings to Diamond Lake Minerals unparalleled expertise in finance, technology and business strategy. He is expected to be instrumental in shaping DLMI’s strategic direction as the company continues to redefine the future of traditional and digital securities.

Larry Namer, Founder of E! Entertainment TV and President of Metan Global, boasts a remarkable career spanning more than half a century. He is an esteemed veteran of the entertainment industry, renowned for his influential contributions to cable television, live events, music and new media. He also leads LJN Media, a consulting firm known for its cross-industry expertise in technology, business and finance.

Andrew Fromm is a seasoned CEO and consultant with a focus on music publishing. He is known for his expertise in asset sales, songwriting and artist development. His extensive network extends beyond the music industry, showcasing his versatility and authority in the field.

Brandon Fugal is the Chairman of Colliers International in Utah and a former EY Entrepreneur of the Year. He has co-founded multiple ventures, including Coldwell Banker Commercial Advisors, Cypher, Axcend and Texas Growth Fund, and he is a recognized authority in real estate and entrepreneurship.

Michael Malik Sr. is a Detroit-based entrepreneur with a $750 million net worth, known for his pivotal role in legalizing gambling and developing major casino projects across the U.S., including Detroit’s MotorCity Casino and various Native American gaming ventures. He brings to Diamond Lake Minerals a wealth of experience and a proven track record in the gaming, sporting and entertainment industries spanning over five decades.

Raul Leal is an experienced CEO in the hospitality sector, known for his visionary leadership at SH Hotels & Resorts and former role at Virgin Hotels, where he secured over $500 million in funding and revolutionized guest experiences.

Agnes Budzyn, an accomplished entrepreneur and CEO of Bluedge Ventures, brings to the company a rich history in traditional finance and blockchain technology, serving on various global boards and committees. She has been recognized by the World Economic Forum and numerous institutions for her expertise and contributions to bridging legacy finance with emerging digital asset infrastructure.

Diamond Lake Minerals Inc. (OTC: DLMI), closed Monday's trading session at $3, even for the day, on 100 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.35/$3.50.

Recent News

• Diamond Lake Minerals Inc. (OTC: DLMI) - Diamond Lake Minerals Inc. (DLMI) Welcomes Brian J. Esposito As Company CEO In Addition To Seven New Strategic Advisors
• InvestorNewsBreaks - Diamond Lake Minerals Inc. (DLMI) Expands Leadership Team, Eyes Bright Future
• InvestorNewsBreaks - Diamond Lake Minerals Inc. (DLMI) Announces E! TV Founder as Newest Strategic Advisor, Becomes IBN Client Partner

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

The QualityStocks Daily Newsletter would like to spotlight Eloro Resources Ltd. (TSX.V: ELO) (OTCQX: ELRRF).

The junior mining segment has had a rough couple of years, experiencing two years straight of lackluster returns and a losing streak that rivals the segment's historic gold bear market in from 2011 to 2015. This year has been just as difficult for junior miners as most players in the sector have seen another year of poor performance amid record underinvestment. Investment in the mining sector has been declining for the past decade, and the junior mining sector has felt it the most. Smaller companies typically have less access to capital and have few funding options once traditional capital runs out. Furthermore, massive investment in the green-energy transition has reduced the incentive for investors to invest in the next generation of mineral commodities as future demand may not be enough to consume all the supply. With conditions for junior mining companies deteriorating by the day, some pundits have compared the ongoing situation to the historic lows of 2016 when the mining industry hit a significant cyclical bottom. That year was characterized by limited capital in the junior mining sector and stocks trading at multiyear lows, factors that are also affecting the industry today. Exploration companies such as Eloro Resources Ltd. (TSX: ELO) (OTCQX: ELRRF) can now take advantage of the current push for green energy to woo more investors and accelerate their mine-development projects.

Eloro Resources Ltd. (TSX.V: ELO) (OTCQX: ELRRF) is a publicly traded exploration and mine development company with a portfolio of gold and base-metal properties in Bolivia, Peru and Quebec.

The company has an option to acquire a 99% interest in the highly prospective Iska Iska Property, classified as a silver-tin polymetallic epithermal-porphyry complex, a significant mineral deposit type in the Potosi Department of southern Bolivia. Iska Iska is a road-accessible, royalty-free property.

Eloro also owns an 82% interest in the La Victoria Gold/Silver Project, located in the North-Central Mineral Belt of Peru, some 50 kilometers south of Barrick’s Lagunas Norte Gold Mine and Pan American Silver’s La Arena Gold Mine. La Victoria consists of eight mining concessions and eight mining claims encompassing approximately 89 square kilometers. La Victoria has good infrastructure, with access to road, water and electricity, and is located at an altitude that ranges from 3,150 meters to 4,400 meters above sea level.

The company has a strong management and technical team working diligently to uncover the value of both Iska Iska and La Victoria. Eloro is based in Toronto, Canada.

Projects

Iska Iska – Potosi, Bolivia

Iska Iska is associated with a Miocene possibly collapsed/resurgent caldera, emplaced on Ordovician age rocks with major breccia pipes, dacitic domes and hydrothermal breccias. The property is wholly controlled by the title holder, Empresa Minera Villegas S.R.L. It is located 48 kilometers north of Tupiza city, in the Sud Chichas Province of the Department of Potosi. This is an important mineral deposit type in the prolific South Mineral Belt of Bolivia. Eloro commissioned a NI 43-101 Technical Report on Iska Iska, which was completed by Micon International Limited and is available on Eloro’s website and under its filings on SEDAR.

A fully financed drill program is currently underway on the property, situated near world-class deposits including Silver Sand, San Bartolomé, Pulacayo, San Cristobal, San Vicente, Chorolque, Tasna, Choroma and Siete Suyos. Iska Iska is in the southwest part of the Eastern Cordillera, which hosts a number of major polymetallic mines and mineral deposits. Drilling and continuous channel sampling results have demonstrated some very high metal values, especially silver and tin, within an immense system, where mineralization has been encountered in every drill hole to date. The company believes there is excellent potential for world-class bulk mineable deposits.

La Victoria – Ancash, Peru

The La Victoria project, targeting gold and silver production, is situated near world-class, low-cost gold producers Pan American Silver and Barrick Gold Corporation. Located in Ancash Department, La Victoria sits on the western slopes of the Peruvian Andes. The property is located 12 hours from Lima, with a travel distance of 600 kilometers. The nearest road accessible population centers from La Victoria are Huandoval, Pallasca and Cabana. The project includes four principal mineralized zones in Peru’s prolific North-Central Mineral Belt – San Markito, Victoria, Victoria South and Ccori Orcco – with excellent potential for gold discovery. Operations at La Victoria are planned to proceed with a 2,000-meter diamond drilling program to test targets to outline potential resources at San Markito. Trenching and sampling confirmed high silver values and veins at San Markito in 2020.

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. Prior to that, he was President and Chief Executive Officer of Champion Iron Mines 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.

Eloro Resources Ltd. (OTCQX: ELRRF), closed Monday's trading session at $1.17, off by 2.3372%, on 9,512 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $1.17/$3.135.

Recent News

• Eloro Resources Ltd. (TSX.V: ELO) (OTCQX: ELRRF) - How Junior Mining Firms Can Leverage Current Market Conditions
• InvestorNewsBreaks - Eloro Resources Ltd. (TSX.V: ELO) (OTCQX: ELRRF) (FSE: P2QM) Files NI 43-101 Iska Iska Technical Report
• Hawkish Fed Keeps Pressure on Gold Though Prices Halt Their Slide

Clene Inc. (NASDAQ: CLNN)

The QualityStocks Daily Newsletter would like to spotlight Clene Inc. (NASDAQ: CLNN).

Clene is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases like ALS

In 2019, Clene's drug candidate, CNM-Au8(R), was selected for the HEALEY ALS Platform Trial, with enrollment commencing in the summer of 2020

Over the years since, Clene has consistently released additional data from the Trial, most recently reporting significant long-term survival improvement among patients treated with CNM-Au8 compared to PRO-ACT historical controls

The company also announced the publication of a peer-reviewed study in the nanotechnology-focused journal Small; the study describes CNM-Au8's mechanism of action

Clene received a $45.1 million NINDS grant to support an Expanded Access Protocol ("EAP") program and study for CNM-Au8 in ALS

Amyotrophic lateral sclerosis ("ALS"), or Lou Gehrig's disease, is a progressive and degenerative neuromuscular disease that destroys nerve cells known as motor neurons, which control voluntary muscle movement (https://ibn.fm/bgJGu). A fatal neurological disorder, ALS lowers the life expectancy of patients to two to five years post-diagnosis, although some patients may live longer, as was the case with the late Stephen Hawking, who lived with ALS for more than five decades (https://ibn.fm/v6LIz). Unfortunately, no cure has yet been identified, although the U.S. Food and Drug Administration ("FDA") has approved several treatments that slow disease progression in certain patients. Driven by the need to find a cure or treatment for all patients, the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital launched a platform trial for ALS ("the HEALEY ALS Platform Trial" or "the Trial") in 2019. The Trial sought to evaluate several "promising" candidate treatments from different developers, among them CNM-Au8(R), the lead drug candidate for Clene Nanomedicine, Inc., a wholly owned subsidiary of Clene (NASDAQ: CLNN) (https://ibn.fm/E4bma). The CNM-Au8 arm of the Trial, dubbed Regimen C, initiated patient enrollment in the summer of 2020.

Clene Inc. (NASDAQ: CLNN) is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple sclerosis (MS).

Its lead drug candidate is CNM-Au8®, an oral suspension developed to restore neuronal health and function by increasing energy production and utilization by driving critical cellular energy producing reactions that enable neuroprotection and remyelination to increase neuronal and glial resilience to disease-relevant stressors. CNM-Au8 is being studied in various clinical trials, including the Harvard/MGH Healey ALS Platform clinical trial for patients with ALS; RESCUE-ALS, a completed proof-of-concept clinical trial in patients with early symptomatic ALS; the REPAIR trials, completed target engagement clinical trials showing brain energy metabolite change with CNM-Au8; and a completed MS clinical trial for the treatment of visual pathway deficits in chronic optic neuropathy for remyelination in stable relapsing MS. The company also has a nanotherapeutic platform of drug discovery.

CNM-Au8

CNM-Au8, Clene’s lead asset, is a highly concentrated aqueous suspension of catalytically active, clean-surfaced, faceted gold nanocrystals. Multiple pathogenic insults contribute to neuronal death. Mitochondrial dysfunction and NAD+ decline is a common final pathway in neurodegeneration, with NAD+ as a critical determinant of cell survival and function. CNM-Au8’s catalytic mechanisms target the energetic deficits, oxidative stress and accumulation of misfolded proteins that are common to many neurodegenerative diseases.

The unique catalytic mechanism of action of CNM-Au8 is hypothesized to act as a neuroprotective and remyelinating therapy in neurodegenerative disease states in order to: (1) drive, support and maintain beneficial metabolic and energetic cellular reactions within diseased, stressed and/or damaged cells, (2) directly catalyze the reduction of harmful, reactive oxygen species (“ROS”) and (3) promote protein homeostasis via activation of the heat shock factor-1 pathway, recognized to dampen the cytotoxicity caused by misfolded and denatured proteins, which are known to occur ubiquitously in neurodegenerative diseases.

CNM-Au8 is used in combination with other agents, has no known drug-drug interactions, and is designed to improve function and survival. The clinical effects of both function and survival were seen in its clinical ALS trials, as earlier announced.

More than 500 estimated years of collective exposure across ALS, MS, and Parkinson’s disease participants in CNM-Au8 clinical trials and Expanded Access Protocol (compassionate use) programs have been recorded without any observed safety signals.

CNM-Au8 is a federally registered trademark of Clene Inc. Clene, based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland, began in 2013.

Market Opportunity

ALS is the most prevalent adult-onset progressive motor neuron disease, affecting approximately 30,000 people in the U.S. and an estimated 500,000 people worldwide, with a life expectancy of typically three to five years. Clene estimates that global ALS treatment sales will be greater than $1 billion annually within the coming few years. Additional treatments affecting daily function and survival remain the market need.

Additionally, there are more than 2 million MS patients globally, and Clene estimates the market size to be worth more than $23 billion annually. While the MS community has been successful at limiting relapses, non-relapsing MS patients continue to clinically deteriorate even while receiving effective immunomodulatory disease-modifying therapies (“DMTs”). A critical unmet medical need remains for therapeutic interventions that protect neuronal function and myelin health independent of immunomodulation to address progression independent of relapse activity.

Management Team

Robert Etherington is President, Director and CEO of Clene. He has more than 30 years of sales, marketing and leadership experience in the pharmaceutical industry. Prior to joining Clene, he worked at Actelion Pharmaceuticals, the largest biopharma company in the European Union prior to its acquisition by Johnson & Johnson in 2017, where he led that company’s U.S. commercial operations. He began his pharmaceutical sales and marketing career at Parke-Davis, a division of Pfizer, where he rose to the position of Team Leader overseeing the drug Lipitor.

Mark Mortenson is Chief Science Officer at Clene. He is co-inventor of the technology platform developed to produce the company’s therapeutics. He is the inventor or co-inventor on 32 other U.S. patents and hundreds of corresponding international patents. He is a former chief patent counsel responsible for 5,500 U.S. and international patents and patent applications. He holds bachelor’s degrees in physics and ceramic engineering from Alfred University, a master’s degree in materials science from Penn State University and a J.D. from George Washington University.

Benjamin Greenberg, M.D., MHS, FAAN, is Head of Medical at Clene. He is an internationally recognized expert in disorders of the central nervous system. He is currently professor of neurology and Vice Chair of Clinical and Translational Research in the department of Neurology at University of Texas Southwestern Medical Center in Dallas. He holds a bachelor’s degree from Johns Hopkins, a master’s degree in molecular microbiology and immunology from the Johns Hopkins School of Public Health and graduated from Baylor College of Medicine. He served residency in neurology at The Johns Hopkins Hospital.

Morgan R. Brown is CFO at Clene. He has more than 30 years of finance and accounting experience, with 23 years at biotech, pharmaceutical and medical device companies. He has served in similar roles at Lipocine Inc., Innovus Pharmaceuticals, World Heart Corp., Lifetree Clinical Research and NPS Pharmaceuticals Inc. He previously worked at accounting firm KPMG. He is a CPA with a bachelor’s degree in accounting from Utah State University and an M.S. in business administration from the University of Utah.

Clene Inc. (NASDAQ: CLNN), closed Monday's trading session at $0.405, off by 2.7611%, on 542,902 volume. The average volume for the last 3 months is 418,939 and the stock's 52-week low/high is $0.3915/$1.99.

Recent News

• Clene Inc. (NASDAQ: CLNN) - Clene Inc. (NASDAQ: CLNN) Reports Improved Survival Status in ALS Patients Treated with CNM-Au8(R) on Follow-Up Analysis; Announces Peer-Reviewed Study
• Clene Inc. (NASDAQ: CLNN) Announces Four-Year Grant to Support Expanded Access Protocol for CNM-Au8 From NINDS
• InvestorNewsBreaks - Clene Inc. (NASDAQ: CLNN) 'Innovates' Investigational Drug with Patented Nanotechnology

SenesTech Inc. (NASDAQ: SNES)

The QualityStocks Daily Newsletter would like to spotlight SenesTech Inc. (NASDAQ: SNES).

SenesTech, a rodent fertility control expert, just announced the launch of its Evolve(TM) Soft Bait, representing an innovative, patent pending, minimum risk alternative treatment to reduce fertility in rats

This product adds to the company's growing line of pest control solutions, such as ContraPest(R), a highly palatable liquid contraceptive bait

SenesTech's management has lauded this milestone, noting how the product, with its non-liquid form, will dramatically increase its addressable market

The company plans to market it to professionals as well as directly to consumers through e-commerce and big-box stores

SenesTech (NASDAQ: SNES), a rodent fertility control expert and the inventor of the only EPA-registered contraceptive for male and female rats, just announced the launch of its Evolve(TM) Soft Bait ("Evolve"), a minimum-risk solution in a new form, designed to reduce fertility in rats. As a potential solution to the root cause of pest problems - rats' ability to rapidly reproduce - Evolve offers an effective product in a format that is familiar to pest control professionals and at a price that is comparable to traditional rodenticides. Results can be seen in as little as four to six weeks (https://ibn.fm/yS388).

SenesTech Inc. (NASDAQ: SNES) is the rodent fertility control expert and the inventor of the only EPA-registered contraceptive for male and female rats. The company’s technology provides an innovative and humane method for managing rat populations.

SenesTech is focused on developing effective solutions that are grounded in science and proven through research, all while providing value to people, communities and the environment. The company’s passion is to create a healthier world by better controlling rat pest populations. This aim is critical, as, if left unchecked, a breeding pair of rats and their descendants can produce up to 15,000 pups after just one year.

The company strives for clean cities, efficient businesses and happy households – with a product that was scientifically designed to be effective without killing rats. SenesTech is committed to the sustainable, humane treatment of animals, improving the quality of all human life and enhancing environmental stewardship through the global application of its effective solution in fertility control technology.

SenesTech is headquartered in Phoenix, Arizona.

ContraPest®

SenesTech’s first product, ContraPest®, applies revolutionary technology to a global challenge that has persisted since the Middle Ages – the proliferation of rats in urban and agricultural settings. ContraPest® targets the reproductive capabilities of Norway and roof rats. As a highly palatable liquid, the formulation promotes sustained consumption, helping to reduce fertility in both male and female rats, bringing populations down and keeping them down.

The company’s flagship offering can be used as part of integrated pest management (IPM) programs – fitting seamlessly into all IPM programs – to help reduce reproduction and magnify the success of these protocols, or as a standalone solution for customers who want to reduce or eliminate the use of lethal rodent control methods.

In multiple, independent field deployments, ContraPest was shown to reduce rat activity over 90% when added to an existing IPM program.

ContraPest® is registered federally as a General Use Product.

Delivery Systems and New Products

In July 2023, SenesTech began to distribute a new delivery system for ContraPest®, the Isolate Bait System™. This new delivery system brings to market a simple design that enables more efficient deployment, incorporates an enhanced formulation of ContraPest® that is expected to provide improved performance of the fertility control bait in the field and is paired with a new bait station that is more space-efficient and economical.

The other delivery systems available for ContraPest include the Ultimate Bait System™, a tank and tray in a larger format for use with more severe infestations, and the Elevate Bait System™, a unique delivery system that targets above ground infestations, as with roof rats.

SenesTech, as of August 2023, is also in the final stages of releasing a soft bait formulation, which provides the unique attributes of proven fertility control in an industry-familiar format demanded by big box retailers, key e-commerce channels and leading industry pest management professionals.

Market Opportunity

According to SenesTech’s figures, rats cause over $27 billion in damage to public and private infrastructure annually in the United States. Rats also destroy 20% of the global stored food supply every year by consuming or contaminating it.

Rats are known to spread at least 35 diseases, globally posing a dangerous risk to public health and safety. Not only does this age-old problem persist despite extensive campaigns to eradicate it, but multiple sources have reported that post-COVID rat populations have boomed.

Poison-based control methods sicken rats, and they typically die slowly. An animal that eats a poisoned rat may also sicken or die. The global rodenticide market is projected to be worth $1.7 billion by 2026.

In one case study, results reported by the customer showed a $5,000 investment in ContraPest® saved more than $500,000 annually in reduced labor, loss and damage.

Management Team

Joel Fruendt is SenesTech’s President and CEO. He has 15 years of executive leadership in the vector and pest control industries as Vice President and General Manager of Clarke Environmental Inc., a leading vector and pest control products and services company. He has extensive expertise in the development and manufacturing of EPA-registered chemical control products, and the commercialization and sale of those products. He received the ‘Smart Leaders’ award from Smart Business Magazine and holds a bachelor’s degree in business from Illinois Wesleyan University.

Tom Chesterman is CFO at SenesTech. He has over 20 years of experience as the CFO of public companies in the life science, tech and telecommunications industries. Most recently, he was the Vice President and Treasurer of GCI, a telecommunications company. Previous to that, he was the CFO of life science companies Bio-Rad Laboratories, Aradigm and Bionovo. He has a bachelor’s degree from Harvard University and an MBA from the University of California at Davis.

Dan Palasky is Chief Technical Officer at SenesTech. Previously he held the title of Vice President of Research & Development at PLZ Corp., a manufacturer of chemical consumer products, serving as the technical expert for its entire product portfolio. He started his career with Camie-Campbell, Inc., as a chemist in the R&D department. Mr. Palasky received his bachelor’s degree in chemical engineering from the Missouri University of Science & Technology and his MBA in Project Management from Aspen University.

SenesTech Inc. (NASDAQ: SNES), closed Monday's trading session at $0.305, off by 1.6129%, on 12,537 volume. The average volume for the last 3 months is 112,112 and the stock's 52-week low/high is $0.2845/$7.718.

Recent News

• SenesTech Inc. (NASDAQ: SNES) - SenesTech Inc. (NASDAQ: SNES) Geometrically Increases its Addressable Market with the Addition of Evolve(TM) Soft Bait to its Portfolio
• InvestorNewsBreaks - SenesTech Inc. (NASDAQ: SNES) Brings Sustainable Solution for Rising Demand in 'Rattiest Cities'
• InvestorNewsBreaks - SenesTech Inc. (NASDAQ: SNES) Featured in Virtual Webcast at Lytham Partners Fall 2023 Investor Conference

PaxMedica Inc. (NASDAQ: PXMD)

The QualityStocks Daily Newsletter would like to spotlight PaxMedica Inc. (NASDAQ: PXMD).

PaxMedica (NASDAQ: PXMD), a clinical-stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies ("APT") for the treatment of autism spectrum disorder ("ASD") and other serious conditions with intractable neurologic symptoms, has released information regarding its 1-for-17 reverse stock split. According to the announcement, as a result of the reverse stock split of PaxMedica's common stock that became effective at 8:03 a.m. ET today, the company's common stock will begin trading on a split-adjusted basis tomorrow, Oct. 31, 2023, when the market opens. The company noted that its common stock will continue to trade under the existing trading symbol PXMD. "As a result of the reverse stock split, each 17 presplit shares of common stock outstanding were automatically combined and converted into one issued and outstanding share of common stock," the company stated in the press release. "No fractional shares of common stock were issued to any stockholders in connection with the reverse stock split. Holders of record who would otherwise have been entitled to receive a fractional share received a number of shares rounded up to the next whole share in lieu of fractional shares."

To view the full press release, visit https://ibn.fm/DJTtP

PaxMedica Inc. (NASDAQ: PXMD) is a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic therapies (APTs) for the treatment of Autism Spectrum Disorder (ASD) and other serious conditions with intractable neurologic symptoms.

The company’s lead programs are focused on ASD, for which there are currently no approved pharmacologic treatments that target its cause and symptoms. Currently used treatments only address the symptoms of the condition, rather than targeting the pathophysiology itself.

PaxMedica is on a promising path to address these unmet medical needs, bringing hope to millions. Anti-purinergic therapies target the excess production of purines in cells. An overexpression of purines can offset homeostasis and result in an overproduction of cellular adenosine triphosphate, the main energy molecule in all living cells.

The company is headquartered in Tarrytown, New York.

Product Pipeline

PaxMedica is building a robust pipeline of products targeting ASD and related neurodevelopmental conditions. The company’s lead product in development may help eliminate, reduce or modulate some of the more troublesome aspects of ASD. That would open the potential for people with autism to integrate their behavior with others more successfully and improve their lives.

PaxMedica’s lead programs, PAX-101 and PAX-102, utilize the company’s proprietary source of suramin sodium, a broadly acting anti-purinergic therapy that has been known for over 100 years. Its current pipeline includes:

• PAX-101 (IV Suramin) for ASD – PAX-101 completed a Phase 2B study for ASD in 2021. Suramin is a broadly acting APT and has reported positive results from a dose range study. The results of PaxMedica’s Phase 2B study, which targeted 52 subjects across six sites in South Africa, were presented to AACAP in October 2021.
• PAX-102 (Intranasal Suramin) – PaxMedica has developed a proprietary intranasal formulation of suramin that is currently being evaluated in ASD and other neurodevelopmental conditions.
• PAX-101 for HAT – Given suramin’s historical use as a treatment for Human African Trypanosomiasis (HAT), or African Sleeping Sickness, the company is also developing PAX-101 as a treatment for HAT. PaxMedica’s most advanced program is the pursuit of PAX-101 for early-stage East African HAT.
• Selective APTs – PaxMedica has conducted several preclinical studies to evaluate other APTs that are more selective to specific purinergic receptors and may offer additional benefits over suramin.

Market Opportunity

According to a report by Fortune Business Insights, a leading global market research company, the global ASD therapeutics market was estimated at $1.93 billion in 2022 and is projected to grow from $2.01 billion in 2023 to $3.42 billion by 2030, a CAGR of 7.9% over the forecast period. As there is no current treatment for the core symptoms of autism, PaxMedica believes the addressable market for PAX-101, if approved, could greatly exceed these forecasts.

Autistic disorder, Asperger’s Syndrome and Pervasive Development Disorder are the three main types of ASD, affecting millions of people globally. A 2020 report by the U.S. Centers for Disease Control & Prevention estimated that one in 36 children in the U.S. have been diagnosed with autism disorder.

Several factors are expected to contribute to market growth prospects. A growing prevalence of the condition globally and rising awareness coupled with available treatment options are key factors expected to drive ASD therapeutics market growth during the forecast period. Growing investment in R&D to find effective treatments is also expected to fuel global market growth.

Management Team

Howard Weisman is Chairman and CEO of PaxMedica. He has been a founder and CEO of several specialty pharma and medical device companies. Most recently, he was executive chairman and co-founder of Sofregen, a biotech company. He also served as CEO and president of Seventh Sense Biosystems, a medical device development company. He also was founder, chairman and CEO of EKR Therapeutics, a specialty pharmaceutical company, and founder and COO of ESP Pharma, a company focused on cardio and neurovascular products. He has a bachelor’s degree in chemistry from Rutgers University.

David Hough, M.D., is Chief Medical Officer at PaxMedica. He is a neuroscience clinical development consultant who previously served as vice president at Janssen Research and Development and in various leadership roles over 17 years. Most recently, he was the compound development team leader for SPRAVATO® for treatment-resistant depression. Prior to that, he was the schizophrenia disease area leader. He played a pivotal role in the development programs for oral INVEGA®, INVEGA SUSTENNA® and XEPLION® for schizophrenia. He is a graduate of West Point and is board certified in psychiatry.

Stephen Sheldon is COO and CFO at PaxMedica. He has served as CEO of Thailand-based specialty healthcare company Indochina Healthcare Co. Ltd. since 2015. Previously, he was a consultant for PricewaterhouseCoopers Healthcare Advisory in the Chicago office. He was responsible for developing specialty pharmacy patient programs, strategy development for specialty products and compliance programs. He has an MBA from Thunderbird School of Global Management and a bachelor’s degree in computer science and visual arts from Bowdoin College.

PaxMedica Inc. (NASDAQ: PXMD), closed Monday's trading session at $0.1658, off by 16.6834%, on 3,260,488 volume. The average volume for the last 3 months is 2.117M and the stock's 52-week low/high is $0.1471/$4.07.

Recent News

• PaxMedica Inc. (NASDAQ: PXMD) - InvestorNewsBreaks - PaxMedica Inc. (NASDAQ: PXMD) Reports on 1-for-17 Reverse Stock Split
• InvestorNewsBreaks - PaxMedica Inc. (NASDAQ: PXMD) Reports on Publication of Low-Dose Suramin for ASD Research
• PaxMedica Inc.'s (NASDAQ: PXMD) CEO and Corporate Communications Chief Discuss Regulatory Strategy for Lead Drug Candidate and Future Plans in Recent Bell2Bell Podcast Interview