Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI)

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 BiondVax, 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.

Mullen Automotive Inc. (NASDAQ: MULN)

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. Capable of 0-60 in 3.2 seconds with a max speed of 155 mph, the FIVE comes with an estimated range of 325 miles.

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 Zero Emission Vehicle Awards (ZEVAs) “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. Additionally, the FIVE will be on display at the Consumer Electronics Show (CES) in Las Vegas in January 2022. 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 Sports Car, the 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

Mullen is led by an executive team with extensive EV, OEM and, high-growth startup experience. 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.

Investment Considerations

• Mullen Automotive 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.
• The company commenced trading on the Nasdaq Capital Market on November 5, 2021, following a stock-for-stock merger with Net Element Inc.
• The Mullen FIVE EV Crossover, debuting at the Los Angeles International Auto Show (LAIAS) on November 17, 2021, is currently open for reservations.
• The global EV market is forecast to grow at a CAGR of 22.6% through 2027.
• Mullen is led by CEO and Founder David Michery, a seasoned executive with more than 25 years of management, marketing, distressed assets, and business restructuring experience.

McEwen Mining Inc. (NYSE: MUX) (TSX: MUX)

McEwen Mining Inc. (NYSE: MUX) (TSX: MUX) is an asset rich diversified gold and silver producer in the Americas with a large exposure to copper through its subsidiary, McEwen Copper, owner of the Los Azules copper deposit in Argentina, believed to be the 8^th  largest undeveloped copper resource in the world.

Led by a management team with a track record of success, MUX owns and operates mines in some of the most prolific gold producing regions of the Americas. The company proactively took cost-saving measures months ago to lower expenses and increase production across its portfolio of gold assets, driving some production costs below industry averages. Gold and copper prices, already in an upswing, are forecast to enter an explosive uptrend over the next couple years. Drawing from its experience, McEwen Mining planned, prepared and laid the groundwork to capitalize on this emerging opportunity.

The company currently holds a Zacks Rank #1 (Strong Buy), placing it in the top 5% of over 4,000 stocks ranked by Zacks, based on trends in earnings estimate revisions and EPS surprises. Seldom is management so aligned with investors’ interests and committed to the company’s success. With a combined investment of over $220 million, CEO Rob McEwen holds a 17% ownership stake in McEwen Mining and a 13% ownership in McEwen Copper. Acclaimed in the mining industry, McEwen founded Goldcorp, where he increased the company’s market capitalization 160 times – from $50 million to over $8 billion. That same vision and tenacity led MUX in creating McEwen Copper.

For McEwen Mining shareholders, beyond the company’s exposure to gold upsurges, its 47.7% stake in McEwen Copper is expected to be a blockbuster, turbocharging MUX  by creating the world’s next prolific copper unicorn.

McEwen Copper

With continuous industrial need, new critical demand for copper is rapidly emerging, increasingly driven by the green energy transition. The price of copper rose from a low of about $2 per pound in 2020 to over $4.60 per pound in May 2024, and strong demand is expected to intensify. A study by S&P Global, titled The Future of Copper: Will the Looming Supply Gap Short-circuit the Energy Transition?, projects global copper demand to nearly double over the next decade, from 25 million metric tons today to about 50 million metric tons by 2035. Based on current trends, S&P Global forecasts annual supply shortfalls to reach nearly 10 million metric tons in 2035.

McEwen Mining owns a 47.7% equity stake in McEwen Copper, the holder of a 100% interest in the Los Azules copper project in San Juan, Argentina, which is ranked the 8^th largest undeveloped copper deposit in the world. Current copper resources at Los Azules are estimated at 10.9 billion pounds at a grade of 0.40% Cu (Indicated category) and an additional 26.7 billion pounds at a grade of 0.31% Cu (Inferred category). McEwen Copper also owns a copper exploration project in Nevada, USA, called Elder Creek.

In a 2023 Preliminary Economic Assessment (PEA), Los Azules was estimated to have a 27-year life, producing an average of 321 million lbs. of copper cathode annually, at a cash cost of $1.07 per lb. of copper, in the lowest quartile of the copper cost curve. The project could ultimately become an even larger mine with a longer life, with less than 40% being mined.

The project’s 2023 PEA presents a distinctly different development strategy from a prior PEA published in 2017. By proposing a heap leach project using solvent extraction-electrowinning instead of the previously detailed mine with a conventional mill and flotation concentrator, McEwen Copper aims to decrease its environmental footprint and reduce permitting risk, albeit with a lower overall copper recovery, slightly higher unit costs and a delay in immediate cashflow due to extended leach cycles.

Rob McEwen led with a $10 million order, and after securing a $25 million investment from mining giant Rio Tinto’s technology arm, Nuton LLC, McEwen Copper closed its non-brokered, private placement offering of $82 million in August 2022. Shortly after, in February 2023, Nuton agreed to invest an additional $30 million into McEwen Copper, and in October 2023, Nuton once again expanded its stake, investing an additional $10 million to bring its ownership position in McEwen Copper to 14.5%.

“We are extremely pleased to have Nuton’s strong continued participation in McEwen Copper,” Rob McEwen stated in a news release. “Together we are exploring new technologies that save energy, water, time and capital in the pursuit of delivering green copper to Argentina and the world, a product that will contribute to the electrification of transportation and the protection of our atmosphere.”

Also in February 2023, FCA Argentina S.A., a subsidiary of Stellantis N.V., one of the world’s leading automakers, invested ARS $30 billion in McEwen Copper. In October 2023, Stellantis invested an additional ARS $42 billion, bringing its current stake in McEwen Copper to 19.4%.

“We are delighted to have Stellantis as a partner in the future development of our Los Azules copper project,” Rob McEwen said of the investment. “Together, we share a vision to build a mine for the future based on regenerative principles that can achieve net-zero carbon emissions by 2038.”

Following the capital raise, McEwen Copper is well-funded to advance its Los Azules Project, with a Feasibility Study planned for Q1 2025. MUX strategically reduced its interest to increase its treasury, in order to reduce debt and fund the further development of its gold and silver assets.

Gold & Silver Projects

The Fox Complex

McEwen Mining owns a 100% stake in the Fox Complex in the heart of a prolific gold district in Timmins, Canada.

“When MUX bought the Fox Complex, in late 2017, it was a distressed asset with a history of high operating cost/oz. While it has taken longer than I expected, the cost to produce an ounce of gold is significantly lower,” CEO Rob McEwen stated in a news release.

McEwen Mining issued 2024 guidance for its cash cost/oz at the Fox Complex of $1,225-1,325 on annual production of 40,000-42,000 GEOs. Fox Complex produced 44,450 GEOs in 2023, which was within the company’s guidance range for production but not cost/oz guidance.

Located in one of the most prolific gold production areas in the world, along the Destor-Porcupine Fault Zone within the Abitibi Greenstone Belt, the Fox Complex includes the Black Fox mine and Froome mine which together have yielded over 1,000,000 ounces of gold to date. Also, the complex includes the Grey Fox and Stock deposits that have over 1,800,000 ounces in  gold resources. The 2.7-billion-year-old Abitibi Greenstone Belt, formed by ancient volcanic activity, has proved to be one of the world’s richest and most abundant gold regions, with a total gold content currently estimated at over 300 million ounces.

In May 2024, MUX will commence development of underground ramp access to the Stock orebodies at the Fox Complex. This development will become the primary source of feed following the completion of mining the Froome deposit in 2026. As part of the future mining sequence initiative, the company has already reported a 31% year-over-year increase of gold resources at Stock West and Stock Main (historical Stock Mine), with confirmation of good grading structures plunging to depth. It has also identified Stock East as a potential new near-term source of future revenue.

The Gold Bar Mine

McEwen Mining owns a 100% stake in the Gold Bar mine, located in an area well known for gold production, the southern Roberts Mountains of the Battle Mountain-Eureka-Cortez gold trend in Eureka County, Central Nevada. The Gold Bar mine is on the same geological structure, 25 miles south of Nevada Gold Mines, a Barrick-Newmont joint venture, part of the Cortez-Goldrush complex. This complex contains estimated reserves and resources of over 50 million gold ounces, with an annual production of 1,000,000 gold ounces.

Gold Bar had been mined between 1991 and 1994, producing 134,000 gold ounces. A new facility was built by MUX in 2019. Gold Bar accounted for 42,700 GEOs in 2023, within the company’s guidance for the year. For 2024, McEwen Mining issued guidance of 40,000-43,000 at a cash cost of $1,450-1,550. The first half of the year is expected to deliver higher production relative to the second half, due to a scheduled waste stripping phase in the Pick pit, in preparation for the 2025 mining program.

Notably, in April 2024, McEwen Mining announced its entry into a definitive agreement and plan of merger with Timberline Resources Corporation (TSX.V: TBR) (OTCQB: TLRS) in a transaction valued at roughly $18.8 million. The merger with Timberline is expected to augment McEwen’s existing portfolio of production and exploration projects in Nevada, leveraging synergies between Timberline’s projects and the Company’s Gold Bar mine.

El Gallo/Fenix

Project Fenix is the proposed redevelopment plan for McEwen Mining’s El Gallo Complex in Mexico. There is a long history of mining in this region. MUX began operating it as an open pit, heap leach mine in 2013, which produced 281,000 gold equivalent ounces at average cash cost of $655 per ounce. Due to the transition to deeper sulfide mineralization that is not amenable to heap leaching, mining activities ceased in the second quarter of 2018 and residual heap leaching followed until mid-2023. The redevelopment plan envisions constructing a mill at the existing mine site that will initially reprocess the existing heap leach material, then transition to open pit mining and processing of the sulphide gold and silver mineralization. The company recently acquired a complete process plant on very advantageous terms that has considerably reduced the projected capital requirements for the project.

CEO Rob McEwen stated in a news release, “This acquisition has made Fenix more attractive to build and could provide a new long life mine for McEwen Mining.”

The initial development approach is to build a mill to reprocess the material on the heap leach pad and produce in the range of 18,000 – 26,000 oz of gold annually for eight years. Construction of the Fenix project is expected to begin in the second half of 2024.

San José Mine

McEwen Mining is a 49% owner and non-operator of the San José gold and silver mine, located in Santa Cruz province, Argentina, encircling Newmont’s prolific Cerro Negro (approx. 300,000 gold ounces produced in 2023). This high-grade underground mine has been operating since 2007 and currently has an expected life of six years with a reserve grade of 296 gpt silver and 5.4 gpt gold.

Exploration is continuing to extend high-grade veins and discover new veins at the complex. San José’s drilling programs to define additional resources and reserves have a long history of success due to a high vein density, aided by good geophysical response from hidden veins.

Production guidance for 2024 for MUX’s 49% interest is 50,000-60,000 GEOs. As a minority shareholder in the mine, MUX equity accounts for its investment in San José, and receives 49% of the dividends from the mine’s free cash flow.

Market Outlook

Mining stocks suffered significant losses in the wake of the COVID-19 pandemic. However, this has turned, and many analysts now forecast a gold bull market in 2024 and beyond.

“The operating challenges we faced in recent years have severely damaged our credibility with our shareholders and the market. As a result, few investors have taken a close look recently at our assets,” Rob McEwen said in a news release. “If they did, I believe some would see the potential value that I see today… I believe there is considerable potential value in MUX, and that is a big reason why I have a personal financial commitment of $220 million in MUX and McEwen Copper.”

Management Team

Robert R. McEwen is Chairman, CEO and Chief Owner of McEwen Mining. He has been associated with the gold industry all his career, with his first 18 years in the investment industry and, since 1990, as CEO of several gold mining companies. He founded Goldcorp and took that company from a $50 million market capitalization to more than $8 billion. He owns 17% of McEwen Mining and is in complete alignment with investors – his investment in MUX and McEwen Copper is $220 million and he takes an annual salary of only $1. He was awarded the Order of Canada and the Queen Elizabeth’s Diamond Jubilee Award, was inducted into the Mining Hall of Fame, was named an Ernst and Young Entrepreneur of the Year and has Honorary Doctor of Law degrees from York University and Western University.

William Shaver is interim COO and a Director of McEwen Mining. He has decades of management and executive experience in mine design, construction and operations. He was a founder of Dynatec Corporation, which became one of the leading contracting and mine operating groups in North America. In 2013, he was recognized as Ernst and Young Entrepreneur of the Year. Most recently, he served as COO of INV Metals. He is a Professional Engineer with a B.Sc. in Mining Engineering from Queens University.

Perry Ing is interim CFO at McEwen Mining. He has 25 years of experience in the Canadian mining industry. Over the past 15 years, he has held positions as CFO of Mountain Province Diamonds, Kirkland Lake Gold and McEwen Mining. Prior to that, he worked at Barrick Gold and Goldcorp and started his career in the mining practice at PwC. He has a Bachelor of Commerce from the University of Toronto and is a Chartered Professional Accountant in Canada and Certified Professional Accountant in the U.S.

Adrian Blanco S. is the company’s Director of Operations for America and Mexico. He has extensive international experience in several industrial sectors and has held executive positions in Mexico, the United States, Peru and Argentina. He joined the McEwen Mining team in 2015 and has led a successful business transformation toward operational discipline, best business practices and financial profitability at subsidiaries Compañia Minera Pangea and McEwen Mining Nevada. He graduated from an Executive Management Program at IPADE and Harvard Business School.

Michael Meding is Vice President and General Manager of McEwen Copper. He has over 20 years of international experience, primarily with major mining companies such as Barrick Gold and Trafigura, including extensive experience with project development and operations in Argentina. While at Barrick Gold’s Veladero mine in Argentina, Mr. Meding played a key role in the turnaround, extension of the mine life and subsequent strategic partnering with Shandong Gold. He holds an MBA from Indiana University in Pennsylvania and an MBA from the Leipzig Graduate School of Management in Germany.

Lexaria Bioscience Corp. (NASDAQ: LEXX)

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

DehydraTECH is covered by 19 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.

Investment Considerations

• Lexaria Bioscience Corp. has disruptive proprietary technology protected by a broad international patent portfolio.
• The company has been issued 19 patents in the U.S., European Union and other countries, with more than 50 patents pending around the world.
• Lexaria’s DehydraTECH technology has a vast worldwide, multi-billion-dollar total addressable market, including multiple rapid-growth segments like cannabinoid and noncombustible nicotine delivery.
• The company has licensed its fat-soluble active molecule delivery technology to multiple established companies for use in their products.v
• Lexaria completed an uplisting to Nasdaq Capital Markets and an $11 million financing in January 2021.

Freight Technologies Inc. (NASDAQ: FRGT)

Freight Technologies Inc. (NASDAQ: FRGT) (“Fr8Tech”) is a technology company developing solutions to optimize and automate the supply chain process, providing a platform for B2B cross-border shipping in the NAFTA region. The company’s mission is to revolutionize cross-border shipping by providing carriers with increased growth opportunities and shippers with flexibility, visibility and simplicity for the once-complex process of international over-the-road shipping.

Freight Technologies, formerly known as Hudson Capital Inc., assumed its current name and ticker symbol on May 27, 2022. Its primary operating subsidiary and its marketplace are known as Fr8App, and it conducts operations throughout North America under the names of Fr8App and/or Freight App. The company is headquartered in Houston, Texas, with multiple locations across the U.S. and Mexico.

The Fr8Tech Solutions Suite

Fr8Tech leverages artificial intelligence to provide cloud-based platforms aimed at automating the over-the-road transportation process, effectively reducing human touch points and expediting load booking times. The company’s suite of solutions includes:

• Fr8app – A B2B marketplace powered by AI and Machine Learning offering a real-time broker portal to connect shippers with qualified carriers
• Fr8Radar – A tracking solution providing shippers and carriers real-time locational data via Fr8app’s mobile solution or through integration with third-party GPS alternatives
• Fr8TMS – A transportation management system designed to help shippers manage their freight and all of the documents involved in shipping transactions, including invoices, customs documents, confirmation rates and proof of deliveries
• Fr8FMS – A fleet management system allowing transportation companies to better manage their fleets, reduce operational costs and provide better service to their customers
• Fr8Data – A data solution offering real-time dashboards and reports to shippers and carriers in an effort to increase visibility and control while supporting better business decisions
• Fr8Fleet – A platform that provides private fleet management, enabling large corporate shippers to purchase dedicated capacity secured by Fr8app in exchange for a fixed fee

Commitment to the Environment

Through its core focus on technology, Fr8Tech seeks to reduce the carbon footprint of the logistics industry. Its solutions aim to minimize empty miles for transportation firms and reduce overall paper consumption.

Fr8University

Fr8University is an educational program offering classroom and on-the-job training for Fr8Tech team members. Through the program, employees learn in-depth business fundamentals and applications along the truckload freight industry value chain.

Led by corporate educator Mario Mena, Fr8University is designed as an investment in the company’s human capital, providing an opportunity to communicate Fr8Tech’s corporate culture while accelerating operational growth.

Market Outlook

Fr8Tech’s established foothold in Mexico is key to its current efforts to promote sustainable growth in the cross-border shipping industry. Ongoing disruption in U.S.-Chinese trade relations have strengthened Mexico’s status as the largest trading partner of the U.S., with cross-border annual freight spending estimated at $385 billion according to data from the U.S. Department of Transportation. Annual domestic shipping in Mexico is estimated at $34 billion, while annual domestic shipping in the U.S. is estimated to total $732 billion.

Despite the size of this industry, fragmentation and inefficiencies prevail in the space. Thousands of legacy brokers, tens of thousands of shippers and hundreds of thousands of carriers still rely on outdated systems to arrange transport, spending hours on the phone negotiating pricing, waiting days to find trucks and drivers, preparing and printing forms, and operating without tracking or visibility. Add in cross-border complexity relating to customs and additional paperwork, and you have an industry ripe for technological disruption.

Fr8Tech’s recent revenue growth trends have highlighted the company’s efforts to capitalize on this opportunity. In 2021, Fr8Tech achieved revenues of $21.5 million, marking a year-over-year increase of 134%. The company issued revenue guidance for fiscal 2022 of $40 million in a February 9, 2022, press release, which would account for a further 86% year-over-year increase.

Management Team

Javier Selgas is CEO and a Director of Freight Technologies Inc. and Freight App Inc. He brings to the company over 15 years of experience developing technology and digital marketing strategies, including serving as Country Manager for Osigu, Spain, and as head of AJEgroup’s IT division for the Asia-Pacific region. Prior to joining Fr8Tech, Mr. Selgas founded digital marketing agency Lanzadera Online. He has also served as an IT consultant to major corporations, including Endesa and Ibermatica.

Mike Flinker is President of Fr8Tech. He has over four decades of experience in the transportation industry, with 30+ years focused on cross-border logistics. Prior to joining Fr8Tech, Mr. Flinker founded FLS Transportation, the largest cross-border logistics company in Canada. He also previously held positions with Clarke Transport Inc., Canadian Pacific and Reimer Express Inc. (a division of Roadway Express).

Paul Freudenthaler is the company’s CFO and Secretary to the company Board. He has over 30 years of financial expertise, having previously served as CFO for several leading companies across multiple countries, including Macquarie in Mexico, Old Mutual in Latin America and Ascentium Capital in the U.S. Mr. Freudenthaler’s experience include leadership roles from which he guided IPOs and M&A transactions.

Luisa Lopez is COO of Fr8Tech. She brings to the company 25+ years of management experience in logistics, supply chain, operations and customer service. Ms. Lopez previously served as a Director of Landstar, where she was responsible for commercial and client development strategies in the Mexican market. Additionally, she managed more than 2,000 transport units specialized in staff and school mobility while with Traxion in Mexico.

Clene Inc. (NASDAQ: CLNN)

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.

Cepton Inc. (NASDAQ: CPTN)

Cepton Inc.  (NASDAQ: CPTN) is a provider of state-of-the-art, intelligent, lidar-based solutions serving a range of markets, including automotive (ADAS/AV), smart cities, smart spaces and smart industrial applications.  General Motors (NYSE:GM) has granted a series production award for Cepton’s lidar, the biggest such award to date in the automotive space. Cepton’s is the lidar component of GM’s Ultra Cruise autonomous driving platform. By leveraging its patented Micro Motion Technology (MMT®) lidar platform, the company develops reliable, scalable and cost-effective solutions that deliver long-range, high-resolution 3D perception for smart applications.

Cepton was established in 2016 by co-founders Dr. Jun Pei and Dr. Mark McCord. The company is headquartered in San Jose, California, and serves a fast-growing customer base through an international presence spanning North America, Germany, Japan, India and China.

Micro Motion Technology (MMT®)

Cepton was built from the ground up to meet key lidar industry challenges for mass market adoption. This company’s portfolio of proprietary technology is uniquely aimed at facilitating this industry growth through a combination of performance, reliability, affordability and design integration.

Key among its innovations is MMT®, a mirrorless, frictionless, rotation-free 3D imaging platform designed specifically for lidars. Its benefits for OEMs and system integrators include:

• Reliability – The durable design uses common, easily attainable materials.
• Versatility – The platform is capable of achieving near- to ultra-long range with a wide field of view.
• Efficiency – MMT® features a compact form factor, low power usage and inexpensive components.
• Scalability – Its simple design means that scale-up to high manufacturing volumes is easily attainable.

Because of their compact form factor, Cepton lidars are embeddable and ideally suited for advanced driver-assistance system (ADAS) integration, whether behind windshield, in headlamp or in fascia.

Agreement with KOITO

KOITO Manufacturing Co. Ltd., the world’s premier Tier 1 auto lighting supplier, originally started an evaluation of Cepton’s MMT® based lidars in 2018. In 2020, KOITO made an investment in Cepton aimed at accelerating the company’s development and enabling KOITO’s industrialization of high-performance and high reliability lidar sensors for ADAS and autonomous vehicle (AV) applications.

Through this collaboration, Cepton was able to secure the largest ADAS lidar series production award^[1] with General Motors as a sole source in the automotive space. The award covers GM vehicles for the initial period of 2023-2027.

On August 5, 2021, the two companies deepened their relationship when KOITO committed to invest a further $50 million in Cepton’s business through its participation in a Private Investment in Public Equity (PIPE) offering of shares of common stock of Growth Capital Acquisition Corp. in connection with Cepton’s recent merger.

Collaboration with GM

On July 13, 2021, Cepton announced that it had secured an ADAS lidar series production award from a leading, Detroit-based global automotive OEM – the biggest lidar production award by any OEM to any lidar company. It was later clarified that the OEM was General Motors, and Cepton’s lidar is part of GM’s ADAS Ultra Cruise system.

GM is “expected to deploy Cepton lidars in its next generation of advanced driver assistance systems (ADAS) across multiple vehicle classes and models – not just luxury cars.” As such, the agreement marks the potential for “an industry-first, mass-market adoption of lidar technology for automotive ADAS, with an anticipated deployment in consumer vehicles starting in 2023.”

On July 28, 2021, Ford Motor Company (NYSE: F) distributed an article on Medium noting, “Ford has been engaged with Cepton almost since their inception in 2016, both for R&D collaboration and small-scale deployments. Cepton LiDAR are deployed in some of [Ford’s] smart city projects. Based on Ford’s guidance, Cepton delivered a custom version of their LiDAR to enable R&D on advanced ADAS features.”

Market Outlook

Driven by increasing development and adoption in automobile safety applications, environmental mapping and 3D-modeling, the global lidar market is forecast to experience considerable growth over the coming years. A research report published by MarketsAndMarkets suggests that the sector will grow to an estimated $3.4 billion by 2026, achieving a CAGR of 21.6% over the next five years.

The report further highlights increasing investments in lidar startups by automotive giants as a driver of growth opportunities in the sector, particularly in North America.

In 2020, ground-based lidar accounted for the lion’s share of the overall lidar market, and this trend is expected to continue as the automotive sector continues to rapidly advance adoption across the full spectrum of vehicle classes. One factor not to be underestimated is the high barrier of entry and the exceptionally long time required for automotive OEMs to vet and award a production win to a lidar company. It is a commonly held view that the over 50 lidar companies will inevitably coalesce into a handful serving all OEMs.

Cepton, having a head start through its established partnership with leading global OEM GM, is uniquely positioned to capitalize on this market growth in the years to come.

Management Team

Cepton’s founder-led team is made up of lidar industry pioneers with decades of collective experience across advanced lidar and imaging technologies.

Jun Pei, Ph.D., is the company’s CEO and Co-Founder. He is a technology specialist with a focus in optics and electronics. Prior to founding Cepton, Dr. Pei founded AEP Technology, a firm focused on developing advanced 3D optical instruments. He received his Ph.D. in electrical engineering from Stanford University.

Mark McCord, Ph.D., is Cepton’s CTO and Co-Founder. Prior to founding Cepton, he led advanced development at KLA-Tencor. Dr. McCord also formerly served as an associate professor at Stanford University, where he earned his Ph.D. in electrical engineering.

Winston Fu, Ph.D., is the company’s CFO. Dr. Fu is the founder of Silicon Valley venture capital firm LDV Partners. Prior to joining Cepton, he served as CFO and Chairman of Active-Semi before its acquisition. Dr. Fu has also helped to build many technology companies as an entrepreneur and/or board member. He received his Ph.D. in applied physics from Stanford University, as well as an MBA from the Kellogg School of Management at Northwestern University.

[1] Largest known ADAS lidar series production award based on number of vehicle models awarded

Investment Considerations

• Cepton Inc. provides highly competitive price-for-performance lidar solutions based on its proprietary Micro Motion Technology (MMT®).
• The company was awarded by General Motors the industry’s largest automotive OEM program, with an anticipated start of production set for 2023.
• Cepton has partnered with KOITO, the world’s premier Tier 1 auto lighting supplier, to accelerate product development and enable economies of scale.
• The company boasts a compelling financial profile supported by a capital efficient model leveraging Tier 1 and system integrator relationships, as well as contract manufacturing.
• Cepton is founder-led and guided by management team with a proven track record in advanced lidar and imaging technology.

Annovis Bio Inc. (NYSE: ANVS)

Annovis Bio Inc. (NYSE: ANVS) is a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer’s Disease (AD) and Parkinson’s Disease (PD). Annovis Bio stands out by developing a drug that targets multiple neurotoxic proteins simultaneously, aiming to restore axonal and synaptic activity. This innovative approach aims to treat memory loss and dementia associated with AD and body and brain dysfunction associated with PD, making Annovis a unique player in the neurodegeneration space.

Lead Drug Candidate: Buntanetap

Buntanetap (formerly Posiphen) targets neurodegeneration by inhibiting the formation of multiple neurotoxic proteins, including amyloid beta, tau, alpha-synuclein, and TDP43. This multifaceted inhibition improves synaptic transmission and axonal transport, reduces neuroinflammation, and protects nerve cells from dying. Unlike monoclonal antibody therapies, Buntanetap is an orally available small molecule capable of inhibiting multiple neurotoxic proteins at once, positioning it as a comprehensive solution for neurodegenerative diseases.

In a recent Phase II/III Alzheimer’s study, Buntanetap demonstrated statistically significant efficacy. Patients with early AD showed a significantly higher rate of improvement in ADAS-Cog 11 scores across all treatment doses compared to placebo, with a -3.3 point improvement compared to -0.3 for placebo (p < 0.01). Plasma Tau protein levels also reduced, consistent with previous Phase II biomarker data, further validating Buntanetap’s mechanism of action.

Similarly, in the Phase III study of Buntanetap in patients with early Parkinson’s disease, significant advancements were observed. Topline data results are anticipated in June 2024. Preliminary findings indicate promising results in improving cognitive and motor function, underscoring Buntanetap’s potential as a transformative therapy for Parkinson’s disease.

Market Opportunity

The aging population presents a significant market opportunity, with nearly 7 million Americans currently suffering from Alzheimer’s Disease (AD), a figure projected to rise to almost 13 million by 2050​ (Alzheimer’s Association)​​ (Republican Policy Committee)​. Additionally, approximately 1.2 million people in the U.S. have Parkinson’s Disease​ (SingleCare)​.

The economic burden of Alzheimer’s is immense, with care costs expected to reach $360 billion in 2024 and escalate to nearly $1 trillion annually by 2050​​. The need for effective, comprehensive treatments like Buntanetap is more critical than ever.

Company Highlights

• Innovative Therapeutic Approach: Annovis Bio uniquely targets multiple neurotoxic proteins, aiming to restore nerve cell health and improve cognitive and motor function in AD and PD patients.
• Robust Clinical Data: Phase II/III studies show significant improvements in cognitive function and biomarker levels in early AD patients.
• Groundbreaking Clinical Insights: Preliminary results from Phase II studies indicate significant improvements in motor functions and speed in patients with Parkinson’s Disease (PD).
• Upcoming Phase III Trials: Plans are underway for an 18-month Phase III trial focusing on biomarker-positive early AD patients, designed to further validate Buntanetap’s disease-modifying potential.
• Capital Efficiency: Annovis Bio is capital-efficient, with zero debt and multiple global patents extending into the 2040s.

Management Team

Maria L. Maccecchini, Ph.D., Founder, President, CEO, and Executive Board Member, founded Annovis Bio in May 2008 with the mission to develop better therapeutics for Alzheimer’s, Parkinson’s, and other neurodegenerative diseases. She has previously been a partner and director at two angel groups, Robin Hood Ventures and MidAtlantic Angel Group, and founded Symphony Pharmaceuticals/Annovis, which was sold to Transgenomic in 2001. Her extensive experience includes roles such as General Manager at Bachem Bioscience and Head of Molecular Biology at Mallinckrodt. Dr. Maccecchini holds a Ph.D. in biochemistry from the Biocenter of Basel, with postdoctoral work at Caltech and the Roche Institute of Immunology.

Cheng Fang, Ph.D., Senior VP of Research and Development, is an accomplished neuroscientist with two decades of experience in neurodegenerative diseases. She has a successful track record of scientific publications and contributions, coupled with extensive pre-clinical and clinical development experience. Dr. Fang has been instrumental in advancing the understanding of neurodegenerative disease mechanisms and developing therapeutic strategies.

Michael Christie, Ph.D., VP of Process Chemistry, has over 40 years of experience in the pharmaceutical industry, focusing on process chemistry R&D, pilot plant production, and GMP operations. He has held senior management positions at companies such as SmithKline, Rhodia, Teva, and Cephalon, and founded a contract process R&D service company, which was later acquired by ChiRex. Dr. Christie is co-author or co-inventor on several publications and patents. He earned his BS in chemistry from the University of Michigan and his doctorate from MIT.

Melissa Gaines, Senior VP of Clinical Operations, is an accomplished clinical research professional with over 20 years of experience across academia, contract research organizations, and pharmaceutical companies. She has proven abilities in monitoring and managing Phase I to IV clinical trials, specializing in CNS disorders and extending to a broad range of therapeutic indications. Her CNS experience spans from small Phase I and II studies to large global Phase III trials in Alzheimer’s disease, Parkinson’s disease, sleep disorders, and various psychiatric diseases in both adult and pediatric populations. In her current role, she oversees and supports all clinical project activities, driving operational success and ensuring high-quality clinical outcomes.

Learn more about the Annovis Bio team on LinkedIn.