CNS Pharmaceuticals Inc. (NASDAQ: CNSP)

The QualityStocks Daily Newsletter would like to spotlight CNS Pharmaceuticals Inc. (NASDAQ: CNSP).

CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, is spotlighted in a recent article focused on glioblastoma, the most aggressive type of brain cancer. Noting that glioblastoma has an average survival of only 14 to 16 months after diagnosis, the article points out that currently, glioblastoma has no cure and, because it is a highly invasive tumor, complete surgical removal is difficult. “Even with aggressive treatment, the cancer tends to recur, leading to a grim prognosis,” the article states. “The high mortality rate of glioblastoma is also due to its resistance to chemotherapy and radiation treatments, which can damage healthy brain tissue. Glioblastoma affects 12,000 to 15,000 people in the U.S. each year.” The article points out that one biopharmaceutical company working in the space is CNS Pharmaceuticals, which is focused on developing innovative therapies to treat diseases of the central nervous system (“CNS”). The article reports that CNS Pharmaceuticals' lead product candidate is Berubicin, a chemotherapy drug being investigated for the treatment of glioblastoma that has received FDA Orphan Drug Designation.

“The innovation of Berubicin lies in its ability to overcome challenges specific to CNS tumor treatment,” the article states. “Traditionally, chemotherapy drugs struggle to reach the tumor cells in the brain due to the blood-brain barrier. Berubicin was specifically designed to solve this problem, and CNS Pharmaceuticals reports that it has demonstrated Berubicin’s ability to penetrate this barrier, enabling it to directly target cancer cells in the brain, an ability shared by very few chemotherapy drugs. This breakthrough feature enables the potential effectiveness of the treatment. . . . CNS Pharmaceuticals is actively conducting a potentially pivotal phase 2 clinical trial to evaluate the safety and effectiveness of Berubicin, with over 229 patients currently enrolled. This trial aims to assess the drug’s ability to improve outcomes for patients with glioblastoma.”

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

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

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

Organ Targeted Therapeutics

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

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

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

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

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

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

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

Global Brain Tumor Therapeutics Market

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

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

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

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

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

Management Team

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

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

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

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

CNS Pharmaceuticals Inc. (NASDAQ: CNSP), closed Monday's trading session at $1.62, up 20%, on 396,099 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.6105/$6.597.

Recent News

• CNS Pharmaceuticals Inc. (NASDAQ: CNSP) - InvestorNewsBreaks - CNS Pharmaceuticals Inc.'s (NASDAQ: CNSP) Innovative Glioblastoma Treatment 'Could Offer Hope'
• Researchers Look for Novel Immunomodulating Targets with Potential to Transform Glioblastoma Treatment
• InvestorNewsBreaks - CNS Pharmaceuticals Inc. (NASDAQ: CNSP) Reports Rapid Pace of Enrollment in Potentially Pivotal Berubicin Study

Lexaria Bioscience Corp. (NASDAQ: LEXX)

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

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, just announced its intention to launch new human and animal studies that will explore its patented DehydraTECH(TM) technology on glucagon-like peptide-1 (“GLP-1”) drugs for improved bioavailability, cost-effectiveness, tolerability, weight loss potential, management of diabetes and other health conditions. Regarded as a significant expansion for Lexaria, these studies will build on what the company has achieved so far with its DehydraTECH-processed CBD while examining the technology’s impact on GLP-1 drugs (https://cnw.fm/Np3FA).

• Lexaria recently announced its intention to launch new human and animal studies exploring its patented DehydraTECH(TM) technology on GLP-1 drugs for the potential treatment of diabetes
• The studies will build on what Lexaria has achieved so far since it started its diabetes-related studies in 2022
• Its DehydraTECH-CBD demonstrated an almost three-fold improvement in drug delivery into the blood in its DIAB-A22-1 diabetes study compared to the DehydraTECH-CBD formulation used in its HYPER-H21-4 hypertension study
• These studies follow Lexaria’s announcement of its intention to study weight loss and diabetes control in a human population using DehydraTECH

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 $0.937, up 2.3933%, on 62,006 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) - Lexaria Bioscience Corp. (NASDAQ: LEXX) Expands Ongoing Diabetes Study Program to Examine its Patented DehydraTECH(TM) Technology with Launch of Human and Animal Studies for Oral GLP-1 Drugs
• InvestorNewsBreaks - Lexaria Bioscience Corp. (NASDAQ: LEXX) Inks Global Collaboration, License Agreement with SulfoSyn
• InvestorNewsBreaks - Lexaria Bioscience Corp. (NASDAQ: LEXX) Announces Portfolio Expansion to 37 Granted Patents

Clene Inc. (NASDAQ: CLNN)

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

October 2023 has turned into a month for the celebration of nanotechnology. On Wednesday, Oct. 4, 2023, three U.S.-based scientists, Moungi Bawendi, Louis Brus, and Aleksey Ekimov, were awarded the 2023 Nobel Prize in Chemistry for their discovery and synthesis of tiny clusters of atoms known as quantum dots, which are widely used today in applications as diverse as digital flat screens to surgery. On Friday, Oct. 6, the White House Office of Science and Technology Policy tweeted, “Happy #NationalNanoDay! #Nanotechnology is at the heart of many recent and emerging technologies, such as #NobelPrize winning #QuantumDots, higher energy density #batteries, hardware for #AI, and #QuantumComputers. What will nanotechnology enable in the future?”  Clene Nanomedicine believes that its lead asset, CNM-Au8(R), holds one such key to the future: the future of medicines to treat neurodegenerative disease. Clene (NASDAQ: CLNN) is a biopharmaceutical company that aims to revolutionize the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”), Parkinson’s Disease, and multiple sclerosis (“MS”). CNM-Au8 is manufactured by Clene using patented nanotechnology that results in an investigational drug with catalytic activity that targets mitochondrial health to improve neuronal function and survival. By increasing energy production and utilization inside cells, CNM-Au8 has been shown to enable neuroprotection and remyelination in multiple independent preclinical studies.

• In line with recent emphasis on the growing importance of nanotechnology in the US, Clene Nanomedicine innovated its investigational drug, CNM-Au8(R), using nanotechnology for the treatment of neurodegenerative disease
• Clene’s nanotechnological approach was recently recognized by the NINDS of NIH with a substantial grant to conduct an Expanded Access Protocol in ALS with CNM-Au8(R)
• Clene aims to file a New Drug Application for CNM-Au8(R) for ALS indications in the first half of 2024

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 $0.52, up 2.1611%, on 398,107 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.414/$1.99.

Recent News

• Clene Inc. (NASDAQ: CLNN) - InvestorNewsBreaks - Clene Inc. (NASDAQ: CLNN) CEO Featured in Latest Episode of The Bell2Bell Podcast
• InvestorNewsBreaks - Clene Inc. (NASDAQ: CLNN) Announces $45.1M NINDS Grant to Support Expanded Access Protocol for CNM-Au8(R) in ALS
• Unveiling the Neuroprotective Power of CNMAu8 A Promising Breakthrough in Neurodegenerative Disease Treatment

Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF)

The QualityStocks Daily Newsletter would like to spotlight Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF).

Appia Rare Earths & Uranium (CSE: API) (OTCQX: APAAF) (FSE: A0I0), a Canadian company in the rare earth element and uranium sectors, is reporting on results from the first 17 drill holes completed from the reverse circulation (“RC”) drilling campaign at its PCH Ionic Clay Project in Goiás State, Brazil. According to the report, the first 17 RC drill holes represent a significant doubling in average depth of mineralized zones to 13 meters with overall weighted average grades of 1,566 parts per million total rare earth oxides (“TREO”), which is comparable to or surpasses other well-known international deposits. The report notes that all of the first 17 RC drill holes of the phase 1 drill program are rare earth element (“REE”) mineralized, with the average depth of RC drilling being more than 13 meters from the surface, a significant doubling in average depth of the mineralized zones. “It's very exciting to witness the PCH Ionic Clay project's potential increasing through this phase 1 drilling campaign with the average depth of mineralized zones increasing to 13 meters while consistently delivering extraordinary overall assay values which, in many cases, are from top to bottom of the hole,” said Appia Rare Earths & Uranium CEO Ton Drivas in the press release. “Ionic clay rare earths deposits are usually found within the top 10 to 20m from surface; they are easier to mine; more environmentally friendly because they contain low or no radioactivity; exhibit simpler metallurgy therefore easier and cheaper to process; and contain good amounts of both the very valuable heavy and light magnet rare earths that are in high demand for cleaner electrification and use in a large number of high-tech applications.”

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

• Appia recently entered into a definitive agreement to acquire up to a 70% interest in the 17,551.07-hectare PCH Project located in the State of Goiás, Brazil
• The company completed a due diligence program, with the initial results confirming widespread REE enrichment across the property
• Total rare earth element (“REE”) grades in numerous auger holes drilled at Target 4 ranged from 274 parts per million (“ppm”) to 16,648 ppm (1.66%), with an average of 1,291 ppm total REE, the results showed
• The PCH Project has a relatively higher content of heavy REE (“HREE”) in the deposit than Serra Verde, a large ionic-clay REE deposit and mine currently under construction in northern Goiás State
• Appia has since embarked on comprehensive exploration activities to uncover the potential of its highly promising deposit

Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF) is a mineral exploration company focused on exploration activities at its newly acquired Cachoeirinha rare earths project (“PCH Project”) in Brazil, as well as delineating high-grade critical rare earth elements (REE) and gallium at its Alces Lake property in Saskatchewan. Other properties in Appia’s portfolio include its Elliot Lake Property in Ontario’s historic mining camp, with a large NI 43-101 uranium and rare earths resource. Fully funded with over $5 million (CDN) in cash, no debt, aggressive exploration currently underway, and experienced management, Appia is progressing rapidly on multiple fronts in highly desired market sectors.

The company is headquartered in Toronto, Canada.

Projects

PCH Project-Brazil

The PCH project hosts REE mineralization in both ionic clays developed from the weathering of alkaline granites and in-situ rare earth mineralization associated with the underlying granite and a carbonatite intrusion to depths greater than 100 meters. Sampling data shows enrichment in rare earth minerals to depths of between eight meters and +30 meters.

In early 2023, Appia announced a definitive agreement to acquire a 70% interest in the PCH Project, which is 17,551 hectares in size and located in the Tocantins Structural Province of the Brasília Fold Belt, Goiás State, Brazil. It is classified as an alkaline intrusive rock occurrence with the potential for highly anomalous REE and Niobium mineralization.

The region around Iporá, a city located roughly 30 km from the PCH Project, has significant mineral exploration and mining activity and well-developed infrastructure.

In July 2023, Appia commenced an aggressive auger and reverse circulation (RC) drill campaign to delineate a potential resource estimate at the PCH project. Initial results at the site revealed significant exploration potential with impressive values that often surpass known ionic clay deposits in Brazil, particularly for the highly valuable heavy rare earths Terbium and Dysprosium.

The auger holes drilled at Target 4 have exhibited a range of total REE grades, ranging from 274 ppm to 16,648 ppm (1.66%), with an average of 1,291 ppm total REE. The valuable rare earths used in magnet applications – praseodymium, neodymium, terbium and dysprosium (Pr, Nd, Tb, and Dy) plus yttrium (Y) accounted for approximately 14% of total rare earths, reaching a maximum of 28.4%. Notably, the deposit also contains anomalous values of niobium and scandium, with average values of 736 ppm for Nb and 62 ppm for scandium in a composite sample from Target 4.

Heavy rare earths (HREEs) show maximum values of 1,624 ppm and average values of 1,291 ppm, primarily as terbium and dysprosium. Light rare earths (LREEs) show maximum values of 14,024 ppm (1.54%) with an average of 1,145 ppm. Neodymium and praseodymium, the main magnetic light rare earths, show respective maximum values of 3,131 ppm (Nd) and 885 ppm (Pr) and average values of 216 ppm (Nd) and 61.7 ppm (Pr). The overall HRRE/LREE ratio has a maximum of 39.5% and an average value of 16.67%.

“Appia is thrilled with the progress made and the promising results thus far,” CEO Tom Drivas stated in a news release. “The company remains committed to advancing its exploration plans, aiming to promptly gather significant data throughout the year, and to work towards estimating a maiden mineral resource in the coming months.”

Alces Lake Project – Saskatchewan

Appia’s Alces Lake project, located in northern Saskatchewan, encompasses some of the highest-grade total and critical REEs and gallium mineralization in the world, hosted within several surface and near-surface monazite occurrences that remain open at depth and along strike.

Following the company’s acquisition of additional new mineral claims in the area in February 2023, Appia’s Alces Lake claim block now totals 38,522 contiguous hectares (95,191 acres) – 100% owned by the Company.

Appia announced the completion of a NI43-101 technical report on the property in June 2023, providing an update on exploration previously reported in March 2021.The report is available on SEDAR under the company’s profile.

Extensive diamond drilling and geophysics surveys are underway to explore a more than 25-kilometer structural corridor. In July 2023, the company issued an update on its diamond drill program having completed the first phase of drilling at the project’s Magnet Ridge Zone to further test the extent of the mineralization to the south south-east (SSE). President Stephen Burega noted the presence of “continued mineralization at significantly thicker intercepts.”

As part of its 2023 exploration program at Alces Lake, Appia plans to target priority areas that extend SSE from the Wilson, Richard, Charles, Bell, Ivan, Dylan, Dante and AMP zones through the Magnet Ridge Zone and beyond, covering an area extending approximately 20 kilometers in length and 5 to 7 km in width. Appia will also undertake reconnaissance drilling on priority regional geological and geophysical targets in the Western Anomaly area.

Other Projects

• Appia holds a total of 75,314 hectares (186,106 acres) of land on four uranium claim blocks in the prolific Athabasca Basin (Loranger, North Wollaston, Eastside and Otherside). Exploration plans for these properties are expected to be announced once permits are in hand.
• Appia also has a 100% interest in 12,545 hectares (31,000 acres), with rare earth element and uranium deposits over five mineralized zones, in the Elliot Lake Camp, Ontario.

Market Opportunity

A report from Mordor Intelligence forecasts the global REE market is expected to grow from 168 million tons in 2023 to 206.25 million tons by 2028, marking a CAGR of 4.19% during the forecast period. The market is gradually improving following the economic and production restrictions of the COVID-19 pandemic.

Factors driving the market’s growth include high demand from emerging economies and the dependency of environmentally friendly technologies on rare earth elements.

According to UxC, one of the nuclear industry’s leading market research and analysis companies, the uranium market is rapidly becoming production-driven, where spot and long-term prices more closely correlate to the marginal cost of uranium production.

Although global reactor requirements are projected to be flat through 2024, UxC forecasts that significant demand growth from 2025 to 2040 will necessitate new production as resources are exhausted at several uranium projects. In addition, a large percentage of production exists in regions of the world with high geopolitical risk, which makes the market vulnerable to future disruptions and price volatility.

Management Team

Tom Drivas is CEO of Appia Rare Earths & Uranium Corp. He is an entrepreneur with over 30 years of experience in various industries, including over 20 years in the mineral resource industry. He is also currently a director of Romios Gold Resources Inc., a publicly traded company he founded in 1995.

Stephen Burega is President of Appia. He brings 16 years of management and operations experience in the mining and natural resources sectors. His extensive emerging markets background, along with a deep understanding of stakeholder management, social development and structured community engagement, position him well to lead Appia’s First Nations community engagements. He is also President and CEO of Romios Gold Resources which is focused on base and precious metal exploration in North America.

Frank van de Water is the company’s CFO. He holds CPA and CA designations and has been involved with international mining, metals and resource companies in North America, Latin America, Europe and Africa for more than 40 years.

Dr. Irvine R. Annesley, Ph.D., is VP Exploration at Appia. He is a licensed geoscientist (P.GEO.) and Professor in Economic (Mining and Mineral Exploration) Geology at École Nationale Supérieure de Géologie in France and an Adjunct Professor in Geology at the University of Saskatchewan. He has over 35 years of global exploration and applied research experience in uranium, gold and base metals exploration, most recently with Athabasca uranium explorer JNR Resources Inc.

Don Hains, P.Geo., is the company’s Consulting Geologist and Qualified Person Consulting Industrial Minerals Expert.

Antonio Vitor is Appia’s Country Manager, Brazil. He has a track record as a portfolio manager and board member. He has held multiple significant positions, including Territory Manager at Shell, as well as Senior Project Planning and Consulting roles at PwC and Petrobras.

Jack Lifton is the company’s Senior Technical Advisor and Consultant. He is an author and lecturer on the market fundamentals of technology metals.

Appia Rare Earths & Uranium Corp. (OTCQX: APAAF), closed Monday's trading session at $0.15, up 14.0684%, on 312,220 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.075/$0.3781.

Recent News

• Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF) - Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF) Makes Significant Steps in Cementing Its Position among Top Critical Mineral Explorers with PCH Project
• InvestorNewsBreaks - Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF) (FSE: A0I0) Releases Drilling Results from Brazil-Based PCH Ionic Clay Project
• InvestorNewsBreaks - Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF) (FSE: A0I0) Shares Update Regarding Appia Rare Earths, Uranium Trading

RJD Green Inc. (OTC: RJDG)

The QualityStocks Daily Newsletter would like to spotlight RJD Green Inc. (OTC: RJDG) .

RJD Green (OTC: RJDG), a holding company with a focus on acquiring and managing assets and companies, through its Silex Holdings Inc. division, has entered a definitive purchase agreement with a premier Midwest regional sales and installation company that offers fireplace and wood stove products and accessories. According to the announcement, the Midwest company is a leading regional provider of popular fireplace models including direct vent, zero clearance and electric. Specifically, the company has maintained 24.5% EBITDA over the past three years, and when combined with Silex Interiors, an operation of Silex Holdings, projected revenues will be more than $7.9 million and more than $1.2 million EBITDA prior to the immediate revenue growth opportunities available. The agreement is scheduled to close in November.

“This acquisition, the first of three add-on acquisitions in progress, will solidify our construction products and services division by combining two excellent profit centers with symmetrical regional markets,” said RJD Green CEO Ron Brewer in the press release. “Post-closing, we will initiate offering of all products from the three 4,000-square-foot showrooms within our regional markets and incorporate our ongoing sales and marketing programs in the additional markets. As well, we will fully explore the synergistic operational and administrative opportunities available that create substantial efficiencies and greater customer outreach. Growth will occur through the planned introduction of new products and services by both operations along with maintaining the existing customer base. If all three add-on opportunities are completed, the consolidated revenues will create over $13,000,000 in annual revenue prior to growth. RJG Green is continuing outreach to possible acquisitions in the healthcare sector and green-environmental products and services as well as the Silex efforts.”

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

RJD Green Inc. (OTC: RJDG) is a holding company focused on managing portfolio assets while actively exploring potential acquisitions and opportunities in diversified industries. The company currently operates in three divisions: RJD Green Healthcare Division, Earthlinc Environmental Solutions and Silex Holdings Inc.

The company’s corporate management team has a history of success in both public and private arenas, with diverse enterprise experience that includes RJD Green’s three current market sectors of focus. Corporate overhead is maintained at minimal operating cost, with each officer and team member maintaining daily management responsibility for specific operating divisions and entities.

Each acquisition and asset is operated as a separate profit center, with the recognition that, in small business operations, proficiency and frugal budgeting are required to maximize profitability. The RJD Green team excels in working collaboratively with the company’s business partners, creating common efforts for reaching mutual reward from its relationships.

The company is headquartered in Tulsa, Oklahoma.

Business Divisions

RJD Green Healthcare Division

Through this division, the company has developed a business model that utilizes the healthcare industry experience and extensive industry relationships of its management team. RJD Green’s leadership has long-term relationships with many key providers within the service sectors of the healthcare industry.

The first RJD Green Healthcare Division services acquisition was IoSoft Inc., a company that provides discrete payment technologies, services and software that can be integrated into targeted offerings for healthcare provider networks, hospitals, healthcare payers and individual providers. The IoSoft team has years of experience and relationships within the more than a million providers in the healthcare market.

Earthlinc Environmental Solutions

This division was formed to promote green applied technologies and offer environmental services in North America. Its focus is on performance-driven solutions for environmental-based issues.

The first acquisition, Animal Waste Management, is a patented technology that is fully developed and entering the market for waste processing on commercial chicken and hog farms. Development was supported by the University of Arkansas and the Missouri Department of Natural Resources.

The acquired technology controls the liquid, solid and gas waste generated, creating an odorless, clean, bacteria-free by-product that can be used for animal feed filler, while allowing the water to be reused as ground water on the farm.

Silex Holdings Inc.

This division was formed for the purpose of acquiring and managing high growth assets and business enterprises. Its operations are focused on acquisitions in specialty industrial contracting, building material products and construction services.

Acquisitions are modeled to offer immediate growth, such as a unique geographical or proprietary market niche or other differentiating quality, and are synergistic in corporate management and administration, as well as sales and marketing.

The company’s first acquisition through this division, Silex Interiors, is a manufacturer, distributor and installer of countertops, cabinets and related kitchen and bath products. Silex is modeled for expansion into major markets nationally through internal expansion, acquisition and franchising.

Market Opportunity

According to a report from Reportlinker.com, the global healthcare services market is expected to grow from $6.8 billion in 2021 to $10.4 billion in 2026 at a CAGR of 8.6%. The report attributed the forecast growth primarily to healthcare companies restructuring their operations as a result of lasting challenges presented by the COVID-19 pandemic.

Research firm Verdantix reported the environmental services market was worth an estimated $35.2 billion in 2022 and is expected to reach a value of $50.6 billion by 2029, marking a CAGR of 6.3% for the forecast period. Verdantix identified factors driving growth to include changing environmental compliance regulations, rising demand for infrastructure projects and increased ESG reporting scrutiny.

In 2021, Icon Market Research estimated the global specialty trade contractors market at $3.9 billion, forecasting that it will reach $5.7 billion by 2028 at an expected CAGR of 9.2% through the identified period.

Management Team

Ron Brewer is CEO of RJD Green. He has served as a corporate officer in both public and private companies, including as president of Mid-Continent Companies. He has experience in all three industries represented by the company’s divisions. He has provided management and guidance to five environmental services and technology companies, as well as guiding business development services in healthcare for hospitals, practice assistance and various service providers in the sector. He has also developed three separate companies in the same construction products sector.

Jerry Niblett is COO at RJD Green. He has over 19 years of management success in oil and gas operations at both corporate and small-cap enterprises. His corporate employment history includes Dominion Energy, Texaco, Shell and Sunoco Pipeline LP. He has worked in multiple energy sectors, including petro-chemical refining, natural gas compression, crude oil pipeline and storage, oil and gas exploration, and oil and gas products and services business development. He holds a bachelor’s degree in Total Quality Management, graduating with honors.

John Rabbitt is CFO at RJD Green. He has worked at Fortune 500 firms including Pillsbury, PepsiCo and CPA firm Ernst and Ernst. He played a key role in the growth of MEI Corp. from $20 million annual revenue to $850 million annually in nine years, at which time it was acquired by PepsiCo. He has a proven track record in both fast-growth and turnaround environments, serving in CEO/COO and CFO positions for firms ranging from $5 million to $300 million annual revenue. His education includes degrees in accounting and business from Drake University and PepsiCo’s Management Institute.

RJD Green Inc. (OTC: RJDG), closed Monday's trading session at $0.006, up 20%, on 603,191 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.0041/$0.01315.

Recent News

• RJD Green Inc. (OTC: RJDG) - InvestorNewsBreaks - RJD Green Inc. (RJDG) Division Inks Definitive Purchase Agreement with Midwest Fireplace, Wood Stove Company
• RJD Green Inc.'s (RJDG) Management Team Positioning Company for Stable, Long-Term Returns
• InvestorNewsBreaks - RJD Green Inc.'s (RJDG) Silex Holdings Seeking to Fill Niche in Growing Home Improvement Market

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) (OTCQB: FSTTF), a Delta, Canada-based company that is currently developing next-generation battery technologies, may play a significant role in the global green-energy transition thanks to a mineral called tellurium. The mineral has applications in everything from solid-state battery designs to thermoelectric devices and solar panels that can transform energy from the sun into relatively low-carbon energy.

While conventional batteries use a polymer gel or liquid electrolyte to move lithium ions from the anode and cathode, solid-state batteries rely on solid electrolytes to carry ions between the electrodes.

Lithium-tellurium batteries outclass conventional lithium-ion batteries in terms of energy density and have zero risk of fire, which frees up the space needed for safety components, making them more energy dense as well as safer and lighter than conventional batteries. This is just one of the potentially revolutionary technologies that partly rely on tellurium for their functionality.

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 $0.075, even for the day, on 12,748 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.0676/$0.1765.

Recent News

• First Tellurium Corp. (CSE: FTEL) (OTCQB: FSTTF) - Tellurium Could Accelerate Transition to Green Energy
• First Tellurium Reports on Exploration Progress at Deer Horn
• First Tellurium Increases Private Placement Financing

Horizon Fintex | Upstream

The QualityStocks Daily Newsletter would like to spotlight Horizon Fintex | Upstream

Upstream, the revolutionary retail trading app for stocks and NFTs powered by Horizon Fintex and MERJ Exchange Limited, has released the latest episode of its “Upstream Up Close” interview series. In this episode, Vanessa, Upstream’s head of marketing, is joined by client success manager Amanda and digital marketing specialists Anastasia and Fernanda to discuss a recent dappGambl report indicating that 95% of NFTs have been labeled nearly worthless. During the episode, the group acknowledges that, as a speculative investment vehicle, NFTs are “dead,” but the group noted that when looking at NFTs through the lens of fan engagement and utility non-fungible tokens are far from obsolete.

The group discussed a handful of ways that NFTs can add value to loyalty and rewards programs across businesses of all sizes and included several examples, including Starbucks, which embraced NFTs to redefine customer interaction through its Starbucks Odyssey rewards program; Dutch fashion brand Scotch & Soda, which offers users exclusive experiences and events through its program; and Soapy Joe’s Car Wash, which launched an NFT campaign allowing customers to collect Ethereum-based NFTs. “Traditional loyalty programs, with their points, discounts and generic freebies, are ripe for innovation,” stated the Upstream blog reporting the episode. “Modern consumers demand more. They want personalization, community, authenticity, and true digital ownership. NFT-based loyalty programs provide precisely that.”

To view the full blog, visit https://ibn.fm/8NY5K

Horizon Fintex is a software business specializing in compliant securities solutions. The company aims to facilitate the future of capital markets by leveraging the regulatory experience of Wall Street bankers and the proven track record of technology veterans to bring focus to compliance, efficiency, security and transparency.

Horizon’s flagship product is the revolutionary trading app ‘Upstream’, a MERJ Exchange Market, and the first regulated market powered by a blockchain to offer both digital securities and NFT trading. Upstream traders experience T+0 settlement, best bids and offers displayed on a transparent public orderbook that prevents predatory market practices – all from a user-friendly trading app.

Products

Horizon Fintex offers a full suite of end-to-end blockchain-enhanced software solutions to create a seamless experience for both issuers and investors. Its product suite includes:

• Securitization & Issuance – ETSware is an end-to-end Electronic Trading System streamlining capital raising from primary issuance through compliant secondary trading.
• KYC Compliance Onboarding – KYCware is a white label Know Your Customer (KYC) and Anti-Money Laundering (AML) compliance software solution offering best-in-class cryptographic security to compliantly onboard and verify user identity through a smartphone application.
• AML Screening Software – AMLCop offers advanced Anti-Money Laundering (AML) software to streamline the verification of user details against a proprietary database of global sanctions, politically exposed persons (PEPs) and watchlists.
• Cap. Table Management Tools – CustodyWare equips registered U.S. transfer agents with next-generation cap. table management software to manage securities on behalf of their clients pursuant to an SEC-registered or exempt securities offering.
• Exchange & Trading App Technology – Open Order Book offers Ethereum blockchain securities exchange software to power the next generation of trading venues for digital assets.

Upstream – The Horizon-Powered Trading App

Upstream is a joint venture with MERJ Exchange (merj.exchange), an affiliate of the World Federation of Exchanges.

Upstream aims to be the premiere global trading hub offering issuers around the world exposure to a digital-first investor base that can trade using USDC digital currency along with credit, debit, PayPal, and USD (fiat) to increase liquidity and enhance price discovery; while also offering investors access to dual-listed companies, IPOs, crowdfunded companies, U.S. & Int’l. equities, digital coupons and NFTs directly from a user-friendly trading app.

Upstream aims to unlock liquidity for investors of all levels while offering industry-leading levels of transparency, accessibility and investor protections enforced using Ethereum blockchain technology.

Management Team

Brian Collins is the CEO of Horizon Fintex. He founded the company in 2010. From 1999-2010, Mr. Collins was CEO of Abbey Technology in Switzerland, specializing in the design of trading software for Swiss banks. Prior to this, he worked for Credit Suisse in Zürich, designing and building proprietary equity trading solutions. Mr. Collins graduated in 1990 with a BS in Computer Systems from the University of Limerick, Ireland.

Mark Elenowitz is the company’s President. He is a Wall Street veteran with over 29 years of experience. Mr. Elenowitz was the co-founder of a U.S. broker dealer and is Managing Director of two U.S. broker dealers, responsible for advising clients on compliance, capital structure and capital market navigation. He was responsible for leading the first successful Reg A+ IPO of a company to list on the NYSE and others which listed directly onto Nasdaq. He is a noted speaker at Small Cap and Reg A events, including the SEC Small Business Forum, and has been profiled in BusinessWeek and CNBC, as well as several other publications. Mr. Elenowitz is a graduate of the University of Maryland School of Business and Management with a BS in Finance and holds Series 24, 62, 63, 79, 82 and 99 licenses.

Dr. Andrew Le Gear is the CTO of Horizon Fintex. Prior to joining the company in 2013, he worked as a software engineer with Dell Inc. (2012-2013) and Lehman Brothers and Nomura Plc. (2007-2012). Dr. Le Gear was a co-founder of Juneberi Ltd., a research-driven software tech start-up (2004-2007). He graduated in 2006 with a Ph.D. in Computer Science from the University of Limerick, Ireland.

Peter Hall is the company’s CIO. Prior to joining Horizon Fintex in 2011, he worked at Microsoft (2008-2011), Atos Origin (2004-2008) and AIT Group Plc. (1998-2002). Mr. Hall has held CISSP certification since 2010. He graduated from the University of Sheffield, UK in 1995 and earned an MS from the University College London in 2006.

Mike Boswell is the CFO of Horizon Fintex. A Wall Street veteran, he co-founded a U.S. broker dealer and served as Chief Compliance Officer. Mr. Boswell was also Managing Director of TriPoint Capital Advisors, a merchant banking and financial consulting company, and CFO of Mission Solutions Group, a privately held defense sector firm. He earned an MBA from John Hopkins University and a BS in Mechanical Engineering from the University of Maryland. Mr. Boswell holds Series 24, 62, 63, 79, 82 and 99 licenses.

Recent News

• Horizon Fintex | Upstream - InvestorNewsBreaks – Upstream Experts Talk NFTs as Effective Ways to Add Value to Loyalty, Rewards Programs
• InvestorNewsBreaks – Upstream Suggests Ways to Boost Customer Engagement in Coming Months with Holiday-Themed NFT
• InvestorNewsBreaks – Upstream Discusses Value of Speculative vs. Utility-Based NFTs

Renovaro BioSciences Inc. (NASDAQ: RENB)

The QualityStocks Daily Newsletter would like to spotlight Renovaro BioSciences Inc. (NASDAQ: RENB) .

An estimated 1.2 million people in the United States. and 350 million globally are infected with hepatitis B, a type of viral infection that attacks the liver. The condition is often characterized by symptoms such as dark urine, fever, appetite loss, abdominal pain, fatigue and weakness, jaundice and joint pain. Around 1% of hepatitis patients will develop fulminant hepatitis, a dangerous condition that can lead to liver failure and death while 5% of patients who develop hepatitis B in adulthood will develop chronic hepatitis B. However, the majority of hepatitis B patients can manage the condition through pharmaceuticals, eating a healthy diet and drinking fluids to remain hydrated. Early diagnosis through testing is key to addressing the condition before symptoms can snowball and become more severe. Physicians typically test for the condition using a hepatitis B surface antibody test (HBsAB) to check for blood antibodies and determine if an individual has developed immunity to the hepatitis B virus (HBV). Taking a BBsAb test will allow you to detect whether you have HBV immunity and if you currently have antibodies that can stave off infections in the future. This test can also help physicians determine if you were recently exposed to HBV and how recently the exposure occurred. Entities such as Renovaro BioSciences Inc. (NASDAQ: RENB) are actively developing treatments that they hope will be able to cure hepatitis B as well as other serious infectious diseases that are threatening populations around the globe.

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

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

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

Renovaro is headquartered in Los Angeles, California.

RENB-DC11

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

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

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

Other Development Candidates

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

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

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

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

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

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

Market Opportunity

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

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

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

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

Management Team

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

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

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

Renovaro BioSciences Inc. (NASDAQ: RENB), closed Monday's trading session at $4.51, off by 4.0426%, on 104,600 volume. The average volume for the last 3 months is 845,577 and the stock's 52-week low/high is $0.3928/$5.25.

Recent News

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Mullen Automotive Inc. (NASDAQ: MULN)

The QualityStocks Daily Newsletter would like to spotlight Mullen Automotive Inc. (MULN).

Mullen Automotive (NASDAQ: MULN), an emerging electric vehicle (“EV”) manufacturer, has released a commercial vehicle production update for its Class 3 EV cab chassis trucks and Class 1 EV cargo vans. According to the report, the company is on track to produce 150 Class 3 EV trucks through December 2023 and to begin production and delivery of its Class 1 EV cargo van in Q4 2023. Specifically, the report noted that the company’s Class 3 production plans for the remainder of 2023 include an estimated 150 vehicles to be produced and delivered to Randy Marion Automotive Group (“RMA”), noting that the first 10 Class 3 vehicles were delivered to RMA last month. In addition, Mullen expects to deliver the balance of the 1,000 Class 3 vehicle purchase order in calendar year 2024. Mullen’s Class 1 EV cargo van production is on track to begin in Q4 2023, with the production of an estimated 300 vehicles initially planned and increasing numbers projected when the facility is in full production.

In summary, the report noted that total planned commercial vehicle production for calendar years 2023 and 2024 includes 150 Class 3 EV cab chassis trucks and 300 Class 1 EV cargo vans in 2023, with 850 Class 3 EV cab chassis trucks and 6,000 Class 1 EV cargo vans planned for 2024. “I am proud to say both our Class 3 production acceleration and our Class 1 manufacturing preparations are on track at our Tunica assembly plant,” said Mullen Automotive CEO and chair David Michery in the press release. “We have firmed up our production schedules for 2024, which align with our existing customer orders and provide ample room for additional customer demand.”

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

Mullen Automotive Inc. (NASDAQ: MULN) is a Southern California-based automotive company that owns and partners with several synergistic businesses working toward the unified goal of creating clean and scalable energy solutions. Mullen has evolved over the past decade in sync with consumers and technology trends. Today, the company is working diligently to provide exciting EV options built entirely in the United States and made to fit perfectly into the American consumer’s life. Mullen strives to make EVs more accessible than ever by building an end-to-end ecosystem that takes care of all aspects of EV ownership.

Commencement of Trading on Nasdaq

On November 5, 2021, Mullen announced its commencement of trading on the Nasdaq Capital Market.

“Today is a monumental day for Mullen Automotive. I am especially proud of our team, investors and all who have believed in Mullen and taken us to this point as a publicly traded company on the Nasdaq Capital Market,” David Michery, CEO and Chairman of Mullen Automotive, stated in the news release. “Trading on Nasdaq now opens us up to new investors, both institutional and retail shareholders, and broadens our awareness and company profile, while increasing awareness of Mullen and our technology platform and opening new opportunities in EV and beyond. The road ahead has never been brighter for Mullen, and I am proud to lead us into the future.”

The milestone came in the wake of the company’s stock-for-stock merger with Net Element Inc.

The Mullen FIVE

The Mullen FIVE EV Crossover, debuting at the Los Angeles International Auto Show (LAIAS) on November 17, 2021, embodies Mullen’s Southern California roots with an inspired design focused on two complementary Golden State themes – California landscape and California urban.

The FIVE is built on an EV Crossover skateboard platform that offers multiple powertrain configurations and trim levels in a svelte design that is Strikingly Different™ and exciting to experience in person.

Prior to the start of LAIAS, the Mullen FIVE was selected as a finalist by the LA Auto Show for Top EV SUV in the ZEVA “People’s Choice” Awards.

LAIAS provides Mullen an opportunity to display multiple variants of the FIVE model while also showcasing its powertrain, battery and charging technology. The company intends to bring the FIVE to market in 2024, and reservations are currently open here.

Mullen’s development portfolio also includes EV Fleet Vans, which it intends to bring to market in Q2 2022, and the pure electric, high performance Mullen DragonFLY.

Expansion of Manufacturing Capacity

On November 2, 2021, Mullen announced plans to expand its facility in Robinsonville, Mississippi.

Mullen’s Advanced Manufacturing and Engineering Facility (AMEC) currently occupies 124,000 square feet of manufacturing space. The total available land on the property is over 100 acres, and Mullen is moving ahead with plans to build out another 1.2 million square feet of manufacturing space to support class 1 and class 2 EV cargo vans and the Mullen FIVE EV Crossover.

On the expanded site, Mullen plans to build a body shop, a fully automated paint shop and a general assembly shop.

EV Market Outlook

The global EV market was reported to consist of 3,269,671 units in 2019, a figure that is expected to grow at a CAGR of 21.1% through 2030 to a total of 26,951,318 units worldwide. This market’s monetary value was estimated at $162.34 billion in 2019 and is expected to grow at a CAGR of 22.6%, resulting in an approximate value of $802.81 billion by 2027. The primary driver for this exponential growth is a worldwide increase in vehicle emissions regulations.

Management Team

David Michery is the CEO and Founder of Mullen and has been leading the company and its divisions since inception in 2014. With over 25 years of executive management, marketing, distressed assets, and business restructuring experience, Mr. Michery brings a wealth of relevant knowledge and expertise to the Mullen brand. He has notably created 12 trademarks so far to develop the company brand and vision.

Mr. Michery is working toward a sustainable future accessible to all by creating a suite of clean-energy electric vehicles at varied price points. With entirely U.S.-based manufacturing and operations, he is also determined to have Mullen Technologies play a role in shaping a self-sustaining local economy by creating more jobs in America.

Mr. Michery manages risks and company expectations as a pathway to success and has personally overseen several businesses that totaled over $1 billion in transactions. His key strength is the ability to be fiscally responsible and lead teams to complete projects on time and within budget. As a seasoned professional in this space, Mr. Michery has demonstrated skill in building businesses from the ground up and into successful entities that subsequently sold for hundreds of millions of dollars.

Mullen Automotive Inc. (MULN), closed Monday's trading session at $0.357, off by 9.0446%, on 35,282,384 volume. The average volume for the last 3 months is 120.957M and the stock's 52-week low/high is $0.353/$137.25.

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PaxMedica Inc. (NASDAQ: PXMD)

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

PaxMedica (NASDAQ: PXMD), a clinical-stage biopharmaceutical company focused 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, recently announced its Gold Sponsorship of The BRAIN Foundation's esteemed Synchrony Symposia 2023. The BRAIN Foundation supports translational research that will lead to the development of FDA-approved treatments and an improved standard of care for co-morbidities in individuals with ASD.

• The BRAIN Foundation’s Synchrony Symposia is the first and only international symposium on translational research for Autism Spectrum Disorder (“ASD”)
• PaxMedica Chairman and CEO Howard Weisman says that participating at the symposium is pivotal in advancing and fostering autism research
• As a Gold Sponsor, PaxMedica will have purview to the symposium’s interdisciplinary discussions, insights, and research presentations, clinical roundtables, mentor-mentee sessions, and more

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 $0.2621, off by 3.7105%, on 338,497 volume. The average volume for the last 3 months is 920,715 and the stock's 52-week low/high is $0.20/$4.07.

Recent News

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