Investors, policymakers, enthusiasts, technologists, decision-makers, and business owners are invited to attend the New Orleans Investment Conference to be held in New Orleans, Louisiana, November 1-4, 2023. The 2023 edition of this iconic event is committed to paving the way to real investment insights and financial wisdom in a fast-changing economic landscape. Having a rich history of successful investment symposiums, the New Orleans Investment Conference has consistently brought together some of the brightest minds in finance, politics, and economics. The conference will feature a lineup of world-renowned speakers who will share valuable investment strategies to unlock the secrets of financial success. Sharing a Legacy of Financial Success Amidst the growing economic uncertainties, the New Orleans Investment Conference serves as a beacon of unmatched investment opportunities. The visionaries will cover a wide range of topics, from real estate, geopolitics, precious metals, and commodities to cryptocurrency, and more. The diverse lineup of eminent thought leaders includes:

• Lyn Alden – one of today’s most insightful macro-economic analysts.
• Peter Boockvar – a respected market analyst known as the ‘resident contrarian’ on CNBC.
• Danielle DiMartino Booth – CEO and Chief Strategist at QI Research, and notably, a former Fed insider who served as an advisor to the Dallas Fed for a decade.
• Dominic Frisby – a financial writer and celebrated comedian, renowned for his YouTube presence and authorship of multiple books, including “Bitcoin: The Future of Money?”
• George Gammon – a highly successful American real estate investor, renowned for his show, “The Rebel Capitalist Show.”
• Jim Iuorio – a renowned trader and outspoken market analyst featured on CNBC and Fox News.
• Brent Johnson – CEO of Santiago Capital, famed for his dollar-milkshake theory.
• Konstantin Kisin – a popular political and lifestyle commentator with a massive global following.
• James Rickards – Editor of “Strategic Intelligence,” a financial newsletter, and author of seven best-selling books.
• Matt Taibbi – author of four New York Times bestsellers and an award-winning columnist for Rolling Stone.
• Peter Schiff – widely recognized as an economic and financial analyst who accurately forecasted the real estate bubble and the 2008 financial crisis, and the author of several best-selling books.
• Rick Rule – a global thought leader in the commodities sector, renowned as perhaps the most successful resource speculator.
• Robert Prechter – author of the classic “Elliott Wave Principle” and founder of Elliott Wave International.

From in-depth keynote presentations to interactive sessions, the New Orleans Investment Conference offers insightful financial information that spans the whole investment spectrum. Attendees will get an opportunity to connect with industry experts, like-minded investors, and visionary entrepreneurs. They can forge lasting relationships, explore economic trends, and dissect policy changes to make truly informed investment decisions. To learn more, please visit https://ibn.fm/ISvQC

• Freight Technologies (“Fr8Tech”) is a North American transportation logistic technology company
• The company is keen on simplifying cross-border shipping in the U.S.-Canada-Mexico Agreement (“USCMA”) region by capitalizing on the advanced capabilities of its Fr8App platform
• Fr8App seamlessly connects shippers in the U.S., Canada, and Mexico with an extensive network of reliable carriers and drivers
• Through Fr8App, Fr8Tech is participating in the trucking and freight market’s ongoing paradigm shift, which has seen more and more shippers opt for brokerage services instead of dealing directly with carriers
• Freight brokers are handling over 20% of all trucking freight, up from 6% in 2000

Freight brokers are changing the face of the trucking industry, upending decades-old preferences that previously forced them to operate on the fringes. Brokers now handle over 20% of all trucking freight, up from 6% in 2000. This growth is attributed partly to brokerages’ investments in customer service and technology, which enabled them to offer a “more compelling product” than asset-based carriers and take on a “greater role in routing guides,” according to a recent article (https://ibn.fm/zdexO). As a result, brokers now handle higher quality cargo than in 2000 and are often assigned highly desirable, carrier-friendly freight.

The growth is also due to a number of other factors, chief among them being the fact that brokerages have built extensive databases of reliable carriers and frequent shippers. This means that shippers can lean on brokers for reliable carriers who will ensure their loads are shipped and delivered on time. On the other hand, carriers look to brokerages for a continual supply of business.

On top of providing reliable leads, the role of brokers has also expanded. Freight brokers manage traffic for shippers and act as sales agents for carriers. They also take on sales and customer service roles that are too expensive for small carriers – which make up about 97% of the roughly 531,000 carriers in the U.S. – to afford.

But perhaps more importantly, freight brokerages provide a regular flow of freight for many of these small carriers. In fact, freight brokers have been able to maintain load volumes even when the trucking market has softened in what has altered the typical freight cycle. Combined, these factors are increasingly making freight brokers indispensable, effectively turning the tide.

Participating in the trucking and freight market’s paradigm shift is Freight Technologies (NASDAQ: FRGT), often abbreviated as Fr8Tech, a North American transportation logistics technology company. Through its primary operating subsidiary, Fr8App, a cutting-edge digital broker, Fr8Tech is simplifying cross-border shipping in the U.S.-Canada-Mexico Agreement (“USCMA”) region.

Fr8App utilizes one of the most connected and intelligent freight-matching platforms, eponymously named Fr8App. The platform seamlessly connects shippers in the U.S., Canada, and Mexico, with an extensive network of reliable carriers and drivers, ensuring reliable and efficient freight transportation. It promises competitive and transparent prices – charging fixed rates with no hidden fees – and prescreens each carrier on multiple criteria to make sure they meet the desired standards and safety checks.

With live 24/7 GPS tracking on desktop or mobile, Fr8App provides complete visibility of shipments as they traverse country and state borders. But that’s not all. The platform’s chat feature facilitates real-time, direct, and constant communication between shippers and carriers, enhancing coordination. Fr8App offers other features, including route optimization, payment management, and advanced data analytics.

As freight brokers continue to revolutionize the trucking industry, playing the increasingly indispensable role of matching shippers with reliable carriers, Fr8Tech’s Fr8App is staking a claim by harnessing the power of its advanced technology, real-time capabilities, and an extensive suite of features.

For more information, visit the company’s website at www.Fr8Technologies.com and its freight matching platform information site at www.Fr8.App.

NOTE TO INVESTORS: The latest news and updates relating to FRGT are available in the company’s newsroom at https://ibn.fm/FRGT

Corporate Communications
IBN (InvestorBrandNetwork)
Los Angeles, California
www.InvestorBrandNetwork.com
310.299.1717 Office
Editor@InvestorBrandNetwork.com

• Lexaria, a global innovator in drug delivery platforms, just announced an exclusive license to SulfoSyn Limited to use its patented DehydraTECH(TM) technology
• Lexaria will also perform specific DehydraTECH-related manufacturing operations on SulfoSyn’s behalf for an initial term of 2 years
• The license agreement adds to Lexaria’s growing list, which, as of the last two years, includes BevNology LLC, Premier Wellness Science Co. Ltd., and Dehydr8, LLC, among others
• It highlights the superiority of Lexaria’s technology, as further compounded by the 37 patents granted so far

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, just announced its latest global, exclusive license to SulfoSyn Limited to use its patented DehydraTECH(TM) technology. This license will allow SulfoSyn to use Lexaria’s technology in non-pharmaceutical uses of sulforaphane worldwide, with the ability to sub-license its rights to other companies (https://ibn.fm/E48bP).

This agreement is the product of months of research for the two entities. In late 2022, both Lexaria and SulfoSyn started exploring the applicability of DehydraTECH upon sulforaphane. This Sulphur-rich composite molecule is commonly found in vegetables such as broccoli, kale, and cabbage. The testing established that DehydraTECH did have certain superior qualities on the sulforaphane molecule, a result that showed the technology’s commercial viability, specifically for SulfoSyn.

As a result, SulfoSyn will be at liberty to use the DehydraTECH technology for various non-pharmaceutical uses, including supplements, foods, additives, dietary ingredients, and more. In addition, Lexaria has also been contracted by the company to perform specific DehydraTECH-related manufacturing operations on behalf of SulfoSyn for an initial term of 2 years, an engagement that will see Lexaria increase its revenue.

An up-front cash payment has since been paid by SulfoSyn, with minimum future payments already agreed to. In addition, the licensing agreement will see an ongoing royalty payment generated once the minimum payments are exceeded.

This license agreement with SulfoSyn adds to Lexaria’s growing list, which, in the last two years, includes BevNology LLC, Premier Wellness Science Co. Ltd., and Dehydr8, LLC, among others. Given the company’s focus on licensing its technology to companies worldwide, this latest addition marks a significant milestone while highlighting its current growth trajectory, particularly as it continues to create value for its shareholders.

In addition, this milestone highlights the superiority of Lexaria’s DehydraTECH technology, as further compounded by the patents received so far and the pending patents worldwide. On August 29 and September 26, the company received its latest new patents in Canada, bringing the total number of granted patents to 37. Even so, Lexaria continues to invest heavily in its research and development (“R&D”), exploring the potential usage of its technology in various areas of application, including nicotine replacement, antivirals, cardiovascular drugs, human hormone delivery, CBD, PDE5 inhibitors and more.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://ibn.fm/LEXX

• Brian J. Esposito, founder and CEO of Esposito Intellectual Enterprises, LLC., boasts 20 years of experience and a proven track record of driving growth and innovation
• Increase in Strong Advisory Board: Agnes Budzyn, Anthony Scaramucci, Larry Namer, Michael J. Malik Sr., Andrew Fromm, Brandon Fugal, and Raul Leal
• Newest board additions bring the company closer to its ultimate vision and further strengthen its competitive advantages, including innovative technology, a diverse portfolio, and highly experienced leadership

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

Digital assets offer an important new opportunity for investors. However, learning to navigate it can be complicated for many of those who are interested. For those looking to invest in the digital assets, blockchain, and security token industry, Diamond Lake Minerals offers an opportunity that makes it easy to invest without needing to learn all of the ins and outs. It’s an offering that requires a thoughtful mix of technical, managerial, and marketing prowess. 

The company’s new CEO, Brian J. Esposito, has been ranked among the world’s top 10 CEOs for 2020, 2021, and 2022 in The World’s CEO Rankings Awards by Adria Management, LLC. He is a renowned entrepreneur and business leader with a proven track record of driving growth and innovation. Mr. Esposito is the founder and CEO of Esposito Intellectual Enterprises, LLC (EIE), a holding company with over 20 years of experience with business startups and investments. He has been featured in The Corporate Investment Times, in the Top 100 in Real Estate in 2021, and the Top 100 Innovators and Entrepreneurs in 2022. Diamond Lake Minerals benefits from Mr. Esposito’s wealth of knowledge and experience, which are fueled by his drive, ethics, and passion, giving impressive growth opportunities to the company.

“My goal at Diamond Lake Minerals is to build a company with strong earnings, provide real shareholder value with sustainable, healthy growth, and have in the public markets one of the most highly coveted securities that has ever been created,” he said (https://ibn.fm/juECd). “With my history, experience, reach, strong relationships, and strategies, as well as building out a tremendous team here at Diamond Lake Minerals, I believe we can truly accomplish just that.”

Michael Reynolds, President and Director of Diamond Lake Minerals, said he had been searching for the right CEO for seven years. “It is a rarity to find, in this day and age, a seasoned executive and leader who has not only overcome and accomplished what Mr. Esposito has but also someone who respects and values old-school business principles and philosophies,” Mr. Reynolds added. “He is someone who understands how to truly build shareholder value and can handle himself extremely well in any situation. I have all the confidence in the world that Diamond Lake Minerals is in the right hands and expect to see great things for this wonderful company and all its current and future shareholders.”

In addition to Mr. Esposito, Diamond Lake Minerals welcomed new advisors, developing a talented and diversely experienced board.

• Agnes Budzyn, the Managing Partner of Bluedge Ventures, is a distinguished entrepreneur and board member with a wealth of experience in blockchain, digital assets, and traditional finance. Ms. Budzyn holds prestigious positions on the Board of Directors at the Biden Institute, the FTSE Russell Digital Asset Advisory Committee, and the Yale Club Audit Committee.
• Anthony Scaramucci, the founder and managing partner of SkyBridge, has unparalleled expertise in finance, technology, and business strategy. His skill and experience will be instrumental in shaping Diamond Lake Minerals’ strategic direction to redefine the future of traditional and digital securities.
• Larry Namer, the founder of E! Entertainment TV and President of Metan Global, is an esteemed entertainment industry veteran renowned for his influential contributions to cable television, live events, music, and new media. His innovative vision and experience make him a welcomed addition to Diamond Lake Minerals’ ambitious vision.
• Michael J. Malik Sr., a prominent entrepreneur and leader in casino development, has spearheaded projects in California, Michigan, New York, and more. His contributions during his career have been instrumental in bringing gaming and entertainment opportunities to numerous communities. 
• Andrew Fromm, founder of Fromm Consulting, is a seasoned CEO and consultant with a focus on music publishing. He is known for his expertise in asset sales, songwriting, and artist development. His experience and network showcase his versatility and authority in the field.
• Brandon Fugal, Chairman of Colliers International in Utah, is a co-founder of multiple ventures including Coldwell Banker Commercial Advisors, Cypher, Axcend, and Texas Growth Fund, and is recognized for his authority in real estate and entrepreneurship. 
• Raul Leal, CEO of SH Hotels & Resorts, is an experienced CEO in the hospitality sector known for his visionary leadership of SH Hotels & Resorts, and his former role at Virgin Hotels. He is known for securing over $500 million in funding and revolutionizing guest experiences.

The strategic advisors added to Diamond Lake Minerals are all highly motivated to work alongside Mr. Esposito to bring the company closer to its ultimate vision and further strengthen its competitive advantages: innovative technology, experienced leadership, a diverse portfolio, and regulatory compliance.

For more information, visit the company’s website at www.DiamondLakeMinerals.com or on LinkedIn at www.linkedin.com/company/diamond-lake-minerals/.

NOTE TO INVESTORS: The latest news and updates relating to DLMI are available in the company’s newsroom at https://ibn.fm/DLMI

• Sekur Private Data has reported increasing new subscriber signups for SekurVPN, the world’s first non-big-tech-powered, Swiss-hosted privacy-focused VPN solution launched in April
• So far, SekurVPN’s sales have surpassed its projections, and the company is now expecting solid growth for SekurVPN for the foreseeable future
• The company recently announced plans to increase its prices for SekurVPN by 30%, following careful considerations and consultations with the digital marketing team
• Even with the new prices, SekurVPN is still the most affordable privacy VPN in the market, according to CEO Alain Ghiai
• Sekur Private Data recently announced plans to launch its Swiss-hosted communications suite, Sekur, in the German language and launch a digital marketing campaign in the DACH region

Sekur Private Data (CSE: SKUR) (OTCQB: SWISF) (FRA: GTD0), a global leader in Swiss-hosted secure data management and communication solutions, has consistently endeavored to prioritize requests from its existing and would-be customers, launching products and solutions that cater to customers’ professed needs. Earlier this year, the company launched SekurVPN, the world’s first non-big-tech-powered, Swiss-hosted privacy-focused VPN solution (https://ibn.fm/vbLx6).

“We are excited to announce the launch of SekurVPN. The idea got prioritized as we received numerous requests from our existing and would-be customers through our support platform, and our efforts have culminated in this timely launch,” Sekur Private Data CEO Alain Ghiai said at the time. “This is an opportunity for our users and shareholders and anyone wishing to have true privacy on the internet, at a very affordable pricing model, and we have already seen subscriptions signed up.”

Since the April launch, Sekur Private Data has reported increasing new subscriber signups, with September signups for SekurVPN increasing by over 100% month over month, according to the company (https://ibn.fm/cdfo7). The company attributed this uptick to the proliferation of cyberattacks and digital identity theft. By early October, new signups for the SekurVPN service represented 60% of all new signups for Sekur Private Data’s suite of services, according to an October 10 news release.

According to Ghiai, Sekur Private Data’s sales have so far surpassed its projections, and the company is now expecting solid growth for SekurVPN in the foreseeable future. To move the company even closer to realizing this expected growth, the company decided to increase the prices for SekurVPN by 30%, following consultations with its digital marketing team and careful consideration (https://ibn.fm/2Npew).

As a result of the price increase, the company expects to increase the average revenue per user (“ARPU”) over time by 25-30%. Coupled with single VPN signups, the ARPU is expected to rise from under US$9 to just below US$12. Moreover, the new SekurVPN pricing model increases the minimum bundle price from US$12 to US$14 and the full bundle signup from US$15 to US$17 for individual customers. Under the new pricing dispensation, the prices for business packages, which come with additional features, are 20-25% higher than consumer packages.

“We are very pleased with the progress we are making with SekurVPN signups in the last couple of months, and we have decided to adjust our pricing upward after careful planning with our marketing team,” said Ghiai of the price increase. “SekurVPN is still the most affordable privacy VPN in the market, offering added benefits of being a true Swiss hosted privacy VPN without third party big tech hosting and without traffic mining.”

Meanwhile, Sekur Private Data recently announced plans to launch its Swiss-hosted communications suite, Sekur, in the German language, in line with its commitment to prioritizing customer requests. The company also intends to launch a digital marketing campaign in the DACH region, which covers Germany, Austria, and Switzerland, by the end of Q4 2023 (https://ibn.fm/hSDsK).

The DACH countries have plenty in common, not least of which is their shared use of the German language. The region is home to more than 100 million inhabitants and had a gross domestic product of about US$5.35 trillion in 2022.

“We are excited to offer all our Sekur solutions in German language and launch in the DACH region soon, as we have received requests from our user base for more exposure in Germany in particular,” commented Ghiai. “There is a real need in Germany for protecting small and larger businesses from the cyberattacks they are experiencing at a much higher rate this year. Offering the solutions in German language is opening a whole new market of over 100 million people to Sekur, previously out of our reach mostly due to the language barrier.”

Sekur Private Data prides itself on providing private and secure communications for everyone. And given that it does not rely on any Big Tech service or platform, the company offers proprietary technology and hosts its services on secure servers based in Switzerland. This infrastructure enables the company to offer a truly independent, private, and secure means of communication without any data mining. Looking ahead, the company intends to continue to offer true data privacy to individual users and businesses, as well as to protect the intellectual property they have entrusted the company with.

For more information, visit the company’s website at www.SekurPrivateData.com.

NOTE TO INVESTORS: The latest news and updates relating to SWISF are available in the company’s newsroom at https://ibn.fm/SWISF

• Mountain Top Properties has issued 250,108,363 shares of common stock as of August 2023
• The company will consider selling securities to fund future operations
• Mountain Top Capital Fund I has a target to raise $75 million to fund its Hamptons projects
• The company targets minimum ROI of 20% to 30% per transaction

Mountain Top Properties (OTC: MTPP) is a diversified real estate holding company that acquires, sells and operates assets through its wholly owned subsidiaries and limited partnerships. The company specializes in property management, property technology (“PropTech”) and real estate redevelopment.

Mountain Top Properties was incorporated in 1990 and is based in Liverpool, New York, with offices in Sag Harbor, New York.

Organization

The company’s flagship subsidiary is Mountain Top Realty Inc., the managing partner of its first real estate fund focused on residential redevelopment in the prestigious and storied Hamptons, New York, beachfront communities.

Mountain Top Properties is also the lead investor in blockchain-enabled industrial and warehouse flex space HQXpress, which services the warehousing, reverse logistics and liquidation markets.

The company is in negotiations for the addition of AI-powered technologies that promise to simplify real estate services, including purchasing and sales.

Mountain Top Capital Fund I LLC

Mountain Top Capital Fund I LLC is a New York limited liability company recently organized by affiliates of Mountain Top Realty, manager of the fund. Through this fund, Mountain Top Realty will leverage the company’s experience, market conditions and industry relationships to capitalize on real estate projects as they arise.

This partnership will be focused on waterfront or water view properties in the Hamptons. The Hamptons market has historically remained strong and continues to set new highs year over year.

The fund has partnered with On Site Builder Construction Co. Inc., which is managed by Joseph Kelley, who, for over 40 years, has continued to build the highest quality architecturally designed custom houses, varying in style from classic to ultra-modern, in the Hamptons. Several houses he has built are showcased in books and magazines and featured across various forms of digital and social media. His assembled team of skilled subcontractors are among the finest skilled craftsmen in their various fields of expertise.

Mr. Kelley has built over 60 custom homes in this market and has the unique distinction of building the most expensive house sold in Sag Harbor in 2014, which sold for $31,750,000; the most expensive house in the Hamptons in 2019, which first sold for $27,500,000 in 2017 and later was renovated and re-traded for $39,250,000; and the most expensive house sold in the Hamptons in 2022, which sold with the neighboring house for $118,500,000. Mr. Kelley’s portfolio of projects is valued at over $400,000,000. Although he has historically worked as a custom home builder, he would like to shift from providing a service to now providing a finished product in this market.

Market Opportunity

Mountain Top Capital Fund I has a target to raise $75 million to acquire, renovate and remarket Hamptons waterfront or water view properties. The fund has secured debt capital commitments for 70% of the acquisition costs and 100% of the construction costs and will use $10 million to leverage strategic waterfront opportunities in and around the Hamptons.

Profits from each project will be distributed upon the sale of the project, which is anticipated every 15 to 18 months, with a target of a minimum return on investment of 20% to 30% per transaction.

The company anticipates the fund’s Hamptons projects will be followed up by several other funds targeting additional high-end markets.

Management Team

Beau Kelley is CEO, President, CFO and Director of Mountain Top Properties.

For more information, visit the company’s website at www.Mountain-Top-Properties.com.

NOTE TO INVESTORS: The latest news and updates relating to MTPP are available in the company’s newsroom a https://ibn.fm/MTPP

• SenesTech, a rodent fertility control expert, just announced the launch of its Evolve(TM) Soft Bait, representing an innovative, patent pending, minimum risk alternative treatment to reduce fertility in rats
• This product adds to the company’s growing line of pest control solutions, such as ContraPest(R), a highly palatable liquid contraceptive bait
• SenesTech’s management has lauded this milestone, noting how the product, with its non-liquid form, will dramatically increase its addressable market
• The company plans to market it to professionals as well as directly to consumers through e-commerce and big-box stores

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

Evolve(TM) adds to SenesTech’s growing line of pest control solutions, such as ContraPest(R), a highly palatable liquid rat contraceptive bait. Like the company’s other products, Evolve(TM) promises to offer a long-term solution to pest problems, effective fertility control, and a user-friendly format perfect for professionals and consumers. The product also seamlessly integrates with pest management programs while addressing infestation at its source, all made possible by its high palatability.

“Evolve(TM) was developed to offer customers a soft bait product that has similar efficacy to ContraPest(R), but in a format that is easier to deploy and predominantly used in the rodenticide market,” noted Joel Fruendt, President and CEO of SenesTech.

SenesTech’s management has lauded this milestone, noting how the product will geometrically increase its addressable market, all while also creating value for its shareholders.

“The addition of Evolve(TM) to our portfolio of fertility control products will increase our obtainable  market at a price point that is very attractive to the end user,” noted Fruendt.

The company plans to target professionals and consumers through e-commerce and big-box stores. Its management is confident that this approach will bring its products closer to residential users while expanding the company’s reach to a broader array of consumers.

For more information, visit the company’s website at www.SenesTech.com.

NOTE TO INVESTORS: The latest news and updates relating to SNES are available in the company’s newsroom at https://ibn.fm/SNES

• Clene is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases like ALS
• In 2019, Clene’s drug candidate, CNM-Au8(R), was selected for the HEALEY ALS Platform Trial, with enrollment commencing in the summer of 2020
• Over the years since, Clene has consistently released additional data from the Trial, most recently reporting significant long-term survival improvement among patients treated with CNM-Au8 compared to PRO-ACT historical controls
• The company also announced the publication of a peer-reviewed study in the nanotechnology-focused journal Small; the study describes CNM-Au8’s mechanism of action
• Clene received a $45.1 million NINDS grant to support an Expanded Access Protocol (“EAP”) program and study for CNM-Au8 in ALS

Amyotrophic lateral sclerosis (“ALS”), or Lou Gehrig’s disease, is a progressive and degenerative neuromuscular disease that destroys nerve cells known as motor neurons, which control voluntary muscle movement (https://ibn.fm/bgJGu). A fatal neurological disorder, ALS lowers the life expectancy of patients to two to five years post-diagnosis, although some patients may live longer, as was the case with the late Stephen Hawking, who lived with ALS for more than five decades (https://ibn.fm/v6LIz).

The Centers for Disease Control and Prevention (“CDC”) estimated that more than 31,000 patients were living with ALS in 2017 (https://ibn.fm/Vdee8), with a subsequent study calculating the 2017 prevalence of ALS in the adult U.S. population arriving at an age-adjusted prevalence of between 5.5 and 9.9 per 100,000 U.S. population. The study based its calculations on estimates of adult persons who met the National ALS Registry definition of ALS (https://ibn.fm/YhM3C).

Unfortunately, no cure has yet been identified, although the U.S. Food and Drug Administration (“FDA”) has approved several treatments that slow disease progression in certain patients. Driven by the need to find a cure or treatment for all patients, the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital launched a platform trial for ALS (“the HEALEY ALS Platform Trial” or “the Trial”) in 2019. The Trial sought to evaluate several “promising” candidate treatments from different developers, among them CNM-Au8(R), the lead drug candidate for Clene Nanomedicine, Inc., a wholly owned subsidiary of Clene (NASDAQ: CLNN) (https://ibn.fm/E4bma). The CNM-Au8 arm of the Trial, dubbed Regimen C, initiated patient enrollment in the summer of 2020.

The platform trial was designed to accelerate the development of breakthrough treatments for patients with ALS by testing multiple drugs using a shared placebo group and infrastructure. This, according to Sean M. Healey & AMG Center for ALS, reduced the cost of research by 30%, lowered the trial time by 50%, and increased patient participation by 67% (https://ibn.fm/d2dau).

Since the commencement of the HEALEY ALS Platform Trial, Clene has regularly updated the scientific community and its shareholders by releasing new insights uncovered from the Trial. Most recently, the company announced long-term follow-up data following an analysis in which 59 participants who were originally randomized and treated with CNM-Au8 30mg for up to 133 weeks in the HEALEY ALS Platform Trial were compared to matched placebo participants derived from the largest U.S. clinical database of previous ALS trials, known simply as PRO-ACT (https://ibn.fm/RghZL).

The data revealed that the 59 participants demonstrated a statistically significant (p=0.046) 49% decreased risk of death compared to matched placebo participants drawn from the PRO-ACT dataset. In its analysis, Clene also pooled data from the HEALEY ALS Platform Trial and the RESCUE-ALS Trial, a Phase 2 multicenter, randomized, double-blind, parallel-group, placebo-controlled group, investigating the efficacy, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in patients with early ALS. The combined data showed that 82 participants originally randomized to CNM-Au8 demonstrated a statistically significant (p=0.004) 59% decreased risk of death compared to PRO-ACT matched placebo patients. (Improved survival status is an important measure of drug effect.) Moreover, Clene reported no serious adverse events associated with CNM-Au8.

“To show such profound survival improvement using the HEALEY ALS Platform Trial dataset alone and a pooled HEALEY and RESCUE dataset is remarkable, and helps confirm the survival benefit seen in the prespecified secondary endpoint,” commented Benjamin Greenberg, M.D., Head of Medical at Clene. “Clene is extremely gratified to see this consistent long-term survival data from the HEALEY ALS Platform Trial OLE, with a continued clean safety profile, adding to the totality of the survival evidence.”

CNM-Au8 is an orally-dosed, investigational drug that improves mitochondrial function by targeting the NAD+ metabolic pathway, leading to increased neuronal survival and function. The robust neuroprotective properties of the drug candidate can be attributed to its therapeutic catalytic activity, according to a peer-reviewed scientific paper describing CNM-Au8’s mechanism of action (https://ibn.fm/wSgRu).

When neurons were exposed to toxins (excitotoxic stressors or toxic peptides) that induce neuronal death, the study observes, CNM-Au8 treatment promoted the survival of cells and preservation of the neurite network. The study, titled “A Mechanism Underpinning the Bioenergetic Metabolism-Regulating Function of Gold Nanocatalysts,” is published in the nanotechnology-focused journal Small. It is co-authored by lead investigators at the University of South Carolina and Clene, among them Professor Hui Wang, Ph.D., from the Department of Chemistry and Biochemistry at the Columbia, South Carolina-based institution. The publication is available through Open Access at (https://ibn.fm/m5kc0).

“The insights gained from this research provide, for the first time, important guiding principles for the rational design of a new class of gold-based catalytic therapeutic agents with energy metabolism-regulating and neuroprotective function,” said Professor Wang.

Meanwhile, Clene’s efforts to improve mitochondrial health and protect neuronal function to treat neurodegenerative diseases received a significant boost following a recently awarded grant. The National Institute of Neurological Disorder and Stroke (“NINDS”), a division of the National Institutes of Health (“NIH”), awarded a four-year grant totaling $45.1 million to Clene, through its subsidiary in collaboration with Columbia University and Synapticure, to support an Expanded Access Protocol (“EAP”) program and study for CNM-Au8 in ALS. Through the EAP program, the study will enable ALS patients who do not meet the criteria to enroll in a clinical trial to try the drug candidate as a novel investigational therapy (https://ibn.fm/ciWbQ).

For more information, visit the company’s website at www.Clene.com.

NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN

• Longeveron, a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions, reported positive top-line results from its CLEAR MIND Phase 2a human clinical trial
• The study, which explored Lomecel-B(TM)’s effects on mild Alzheimer’s disease, met the primary endpoint of safety on statistical and medical assessment

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

This study was designed to explore Lomecel-B(TM)’s effects on mild Alzheimer’s disease. Dubbed the CLEAR MIND trial, this randomized, double-blinded, placebo-controlled Phase 2a trial included 50 patients aged between 60 and 85 years diagnosed with mild Alzheimer’s disease. The study was conducted at ten centers in the United States, testing three different dosing regimens of Lomecel-BT(TM) vs. placebo, with patients randomized in a 1:1:1:1 ratio.

Wa’el Hashad, Longeveron’s CEO, was pleased with the results, noting how they validated the safety and therapeutic potential of Lomecel-B(TM) for treating Alzheimer’s disease.

“We believe these results provide important validation of both the safety and therapeutic potential of Lomecel-B(TM) in the treatment of Alzheimer’s disease and provide a robust foundation for additional clinical trials in this and other indications,” he noted.

Lomecel-B(TM) is Longeveron’s lead investigational product and has shown potential in anti-inflammatory and pro-vascular regenerative responses. This potential has prompted Longeveron to explore its application in aging-related chronic diseases and other life-threatening conditions under the U.S. FDA-approved Investigational New Drug applications. So far, the product has demonstrated multiple potential mechanisms of action that cover pro-regenerative, pro-vascular, anti-inflammatory, and tissue repair and healing effects, ultimately expanding its potential application across multiple disease areas.

With its success in the CLEAR MIND Phase 2a clinical trial, Longeveron hopes to continue the momentum, including announcing plans to announce additional biomarker data from the trial in November.

“We look forward to announcing additional biomarker data from this trial, anticipated in November 2024, which may further characterize the clinical effects of Lomecel-B(TM) in this study population,” noted Mr. Hashad.

In addition, Mr. Hashad shared the company’s plans for the Phase 2b ELPIS II clinical trial in Hypoplastic Left Heart Syndrome (“HLHS”), which is anticipated to be completed in 2024, and the company’s Aging-related Frailty Phase 2 program, which is currently ongoing in Japan. Combined, all these studies reflect Longeveron’s commitment to try to create shareholder value and establish its position as a leader in its segment.

Forward-Looking Statements

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

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

For more information, visit the company’s website at www.Longeveron.com.

NOTE TO INVESTORS: The latest news and updates relating to LGVN are available in the company’s newsroom at http://ibn.fm/LGVN

• PaxMedica Chairman and CEO Howard Weisman participated in a recent Bell2Bell Podcast interview and was joined by Buzz Woods from Corporate Communications
• Weisman discussed the company’s strategy to seek FDA approval for Suramin as a treatment for Human African Trypanosomiasis (“HAT”) and plans for 2024
• If PaxMedica is successful in getting approval in HAT, the company believes that could lead to the receipt of a Priority Review Voucher (“PRV”)
• The company hopes to monetize the PRV to raise funds that will support research and future trials investigating Suramin as a treatment for Autism Spectrum Disorder
• PaxMedica hopes to file an investigational new drug application to use Suramin in a large-scale trial in the U.S. in 2024

PaxMedica (NASDAQ: PXMD), a clinical-stage biopharmaceutical company specializing in innovative treatments for unmet needs in neurodevelopmental disorders, has recently introduced a groundbreaking regulatory strategy that could potentially pave the way for the approval of its lead product candidate, Suramin, in the United States. During a recent episode of the Bell2Bell (“B2B”) Podcast, Chairman and CEO Howard Weisman, along with Buzz Woods from Corporate Communications, delved into this strategy.

To hear the interview, please visit https://ibn.fm/4yGe6.

Suramin, a longstanding treatment for early-stage East African sleeping sickness (Human African Trypanosomiasis or “HAT”), has yet to receive approval for use in the United States for any indication, a gap that PaxMedica aims to bridge. Weisman underscored the crucial link between their regulatory approach for HAT and their overarching mission of addressing Autism Spectrum Disorder (“ASD”), with a specific emphasis on the role of the Investigational New Drug application (“IND”) in facilitating a large-scale study in ASD.

As PaxMedica continues to navigate the complex regulatory landscape, the company remains resolute in its commitment to drive pioneering advancements in neurology and biopharmaceutical research, particularly directed towards addressing the pressing unmet needs in the treatment of neurodevelopmental disorders.

To hear the interview, please visit https://ibn.fm/4yGe6.

For more information, visit the company’s website at www.PaxMedica.com.

NOTE TO INVESTORS: The latest news and updates relating to PXMD are available in the company’s newsroom at https://ibn.fm/PXMD