• About 125 million people worldwide have psoriasis, a chronic disease where the immune system becomes overactive, causing skin cells to multiply too quickly
• The psoriasis treatment market is expected to reach $48.33 billion by 2030, driven by an increase in diagnosed patients and the prevalence of skin disorders in developed nations
• Scinai’s NanoAbs targeting the IL-17 family of cytokines, which have shown promise in treating psoriasis, may offer significant advantages over Apogee Therapeutics, whose recent IPO has resulted in a $1 billion market cap
• Scinai’s NanoAbs offer additional routes of administration, a higher affinity and binding to the target, and stability at room temperature – key differentiators to currently available treatments on the market today

Psoriasis is a chronic disease in which the immune system becomes overactive, causing skin cells to multiply too quickly. According to the National Psoriasis Foundation, 125 million people worldwide have psoriasis. Nearly 50% of people with psoriasis experience moderate to severe symptoms (https://ibn.fm/jgqwh). The psoriasis treatment market was valued at $16.45 billion in 2022 and is expected to grow at a CAGR of 7.8%, reaching $48.33 billion by 2030. The market’s growth is attributed to the number of patients diagnosed with psoriasis and an increasing prevalence of skin disorders in developed nations (https://ibn.fm/0rr6U).

Antibodies and nanobodies against the IL-17 (Interleukin-17) cytokine and other family cytokines are showing success in the treatment of psoriasis and associated immune diseases. Scinai Immunotherapeutics (NASDAQ: SCNI), a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative inflammation and immunology (I&I) biological products primarily for the treatment of autoimmune and infectious diseases, in collaboration with Max Planck Society and the University Medical Center Gottingen, has signed an exclusive worldwide license agreement to develop and commercialize VHH antibodies (NanoAbs) targeting IL-17 as treatments for all potential indications, starting with psoriasis and psoriatic arthritis.

In addition to Scinai, Apogee Therapeutics (NASDAQ: APGE), a biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunological indications, is also targeting IL-17 for psoriasis treatment. Apogee went public in July 2023 at $500 million pre-money, raising $300 million in an upsized deal, and now exceeds a $1 billion market cap.

Both companies are currently in the pre-clinical stage of development – but Scinai believes that its NanoAbs exhibit multiple advantages over Apogee’s product, including:

• Being amenable to new routes of administration – including inhalation and intradermal injection, neither of which work with regular antibodies. Scinai’s NanoAbs potentially create a new market opportunity that does not directly compete with other companies with existing antibody treatments by targeting the large, underserved population of patients with mild to moderate psoriasis.
• Higher affinity and better binding suggest that Scinai’s NanoAbs may permit lower dosages with fewer side effects by providing a higher affinity and better binding to the target, lowering the costs associated with treatment.
• Stability at room temperature – Regular antibodies require complex cold chain logistics until administered to the patient. These treatments are more expensive and limit where and when treatment can be administered, leading to high spoilage. Scinai’s NanoAbs are stable at room temperature, expanding the opportunity for administration and reducing spoilage.

Scinai’s alpaca-derived NanoAbs offer a significant advantage to the underserved population, especially those with mild to moderate psoriasis. Its product potentially offers advantages that Apogee’s product cannot and significantly enhances the route of administration, binding to the target, and an increased window of administration.

The company’s leadership team includes former senior executives from Novartis, GSK, and Bristol-Myers Squibb. It has built, owns, and operates a 20,000-square-foot state-of-the-art GMP biologics manufacturing facility that houses laboratories, production facilities, and offices, giving the company a unique advantage in the industry.

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

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

• Lexaria Bioscience has completed several studies that confirm and support the superiority and advantages of its patented DehydraTECH(TM) technology over traditional oral delivery methods
• The company recently announced results from its human oral nicotine study NIC-H22-1 comparing its DehydraTECH-nicotine pouch to world-leading brands, Zyn(R) and on!(R)
• Results from the study demonstrated that DehydraTECH-nicotine was statistically significantly faster in reaching Tmax than both brands
• Lexaria has also undertaken other investigational research programs, including the analysis and execution of hypertension, diabetes, hormone therapy, and dementia studies, which could birth excellent partnership opportunities, supporting further growth
• A report by Zacks Investment Research discussed the nicotine study alongside Lexaria’s other recent milestones, maintaining a $12.00 price target

Lexaria Bioscience (NASDAQ: LEXX), a global innovator seeking to enhance the bioavailability of multiple active pharmaceutical ingredients using its patented DehydraTECH(TM) drug delivery technology platform, continues to devote an increasing proportion of its resources and focus toward research and development (“R&D”) as part of its overall goal to establish areas of investigation for commercial pursuits and reduce risks of the unknown for both commercial and regulatory goals.

In the three months ended May 31, 2023 (“Q3 2023”), for example, the company increased its R&D expenses 118% year over year to $1.64 million in Q3 2023 from $752,095 in Q3 2022, with a recent Zacks Investment Research report attributing this expenditure to Lexaria’s multiple DehydraTECH investigational research programs then underway, including analysis and execution of hypertension, nicotine, and diabetes studies (https://ibn.fm/vy8qj). The report also lauded the company’s efficient use of capital, which allowed its R&D activities to expand into new preclinical work, including hormone therapy and dementia.

“While still at an early stage, these programs could be excellent partnership opportunities that will support further growth and potentially provide growth capital,” reads the report (https://ibn.fm/0L40v). “Research efforts around these indications help further characterize DehydraTECH-CBD and its advantages compared with traditional delivery methods.”

The company has completed several studies confirming and supporting DehydraTECH’s superiority and advantages over traditional oral delivery methods. One such study, the human nicotine study NIC-H22-1, compared its DehydraTECH-processed nicotine tobacco-free pouch to two oral nicotine pouch brands, Zyn(R) (from Swedish Match) and on!(R) (from Helix Innovations LLC, a subsidiary of Altria Group Inc.) The randomized, double-blinded, crossover study involved 36 subjects, each dosed three times over several weeks. In May, the company announced that the dosing of the 36 patients was completed and, in early August, issued a press release announcing topline results.

Results from the study demonstrated a statistically significant difference between the time taken to achieve maximum blood saturation levels (“Tmax”) for DehydraTECH-nicotine and both Zyn and on! “Time to Tmax of 15.37 minutes was 2.3 minutes faster than what was produced in the on! arm and 3.1 minutes faster than the time measured in the Zyn arm. In percentage terms, this represented a 15% and 20% faster response to achieve maximum blood saturation levels,” summarizes the report.

Lexaria also used as a benchmark the Tmax to be reached with a combustible cigarette, citing a pharmacokinetic study that put the figure at 8 minutes. “Relative to this benchmark, the company put together a comparison of other nicotine delivery methods, including the data generated from the NIC-H22-1 study. Of the eight comparable vehicles, DehydraTECH oral pouch was the fastest to Tmax relative to combustible cigarettes,” the report continues.

The study also evaluated qualitative aspects of DehydraTECH-nicotine, reporting its superiority across six different categories that examined the desirable and undesirable attributes of nicotine consumption. The categories included euphoria and head rush, tolerability, pleasure, mouth and throat burn, nausea, and hiccups. With these positive results in hand, Zacks expects that partner work with global tobacco juggernauts will expand.

“Within just five short years of R&D and product development, Lexaria has been able to develop an oral nicotine product that meets or exceeds the performance of the world’s leading existing brands,” commented Lexaria CEO Chris Bunka in an August 9 press release (https://ibn.fm/NS89s). “This is a remarkable achievement that speaks to the capabilities of the DehydraTECH technology and also to the Lexaria R&D team, working ardently with scarce resources relative to global multi-billion-dollar behemoths.”

Zacks’ report also covered Lexaria’s other recent milestones, including the move to incorporate a new wholly owned subsidiary called Lexaria Nutraceutical Corp. The move is intended to optimize the company’s strategy, helping maximize the potential for its DehydraTECH technology in multiple markets worldwide. Moreover, the report discussed Lexaria’s recent publications, patents, and capital raise, as well as details from its hypertension and diabetes studies.

With the recently released nicotine data preparing Lexaria to enter into discussions with prospective partners and its hypertension program on course to result in an Investigational New Drug (“IND”) application, Zacks maintains a price target of $12.00 per share.

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

Shoals Technologies Group (NYSE: SHLS) is a leading provider of electrical balance of systems (“EBOS”) solutions for solar, storage, and electric vehicle charging infrastructure. Since its founding in 1996, the company has introduced innovative technologies and systems solutions that allow its customers to substantially increase installation efficiency and safety while improving system performance and reliability. Shoals Technologies Group, Inc. is a recognized leader in the renewable energy industry whose solutions are deployed on over 62 GW of solar systems globally. For more information, visit the company’s website at www.Shoals.com.

To schedule a one-on-one meeting, please contact your ROTH MKM representative.

To view IBN’s coverage of the conference, visit https://ibn.fm/RothSolar2023

About IBN’s Coverage

IBN, a multifaceted financial news and publishing company, is providing the online investment community with a custom-built portal that includes summaries on each of the companies participating at 10th Annual Solar & Storage Symposium. In addition to enabling proficient evaluation of each company via one-click access to market research tools and helpful website links, IBN is using social media and syndicated articles to maximize the visibility of the event.

For more than a decade, IBN has provided real-time coverage for numerous global events and conferences through its various brands, social media accounts and investment newsletters. To further expand visibility of participating companies at these events, and to ensure another successful year for its event collaborations, IBN’s syndication partners have extended digital coverage to include individual broadcasts on financial websites and platforms visited by millions of investors daily.

For more information, please visit https://www.InvestorBrandNetwork.com

Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: http://IBN.fm/Disclaimer

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• SuperCom has introduced the all-in-one PureOne monitoring device with three unique tech modules, offering advanced technology for the cost-effective electronic home and civil monitoring of offenders
• The electronic offender monitoring market in Europe and the Americas is expected to reach $2.1 billion in 2026 and is seeking new technologies to meet a rapidly growing demand
• SuperCom’s innovative solutions promise a critical technological and social impact – improving public safety worldwide and reducing governmental costs in the process
• The company’s growth strategy includes potential acquisitions and expansion into new regions with limited electronic monitoring capabilities

SuperCom (NASDAQ: SPCB), a leading global provider of traditional and digital identity security solutions offering advanced safety, identification, and security products and solutions to governments, introduces its all-in-one PureOne monitoring device. This device features three built-in modules – the BLE module allows the device to communicate with the Pure Beacon (home unit) Bluetooth device, the GNSS module for location positioning, and the LTE cellular module for communication with the company’s Pure Monitor. The device has a portable charger, and both components feature an LED interface for easier system navigation.

Since 1988, SuperCom has been a trusted global provider of traditional and digital identity offerings with a mission to revolutionize the public safety sector through proprietary electronic monitoring technology, data intelligence, and complementary services. The company’s largest focus is on the electronic monitoring of offenders and domestic violence prevention.

In alignment with its mission, the company offers an all-in-one PureSecurity offender monitoring suite, accompanied by GPS monitoring, home detention, domestic violence prevention, and more. These services are specifically catered to serve each client’s needs. The competitive advantages of SuperCom’s technology include:

• Long Battery Life (No Tag Charging Required)
• Ultra Lightweight Form Factor
• Next-Gen Location Tech
• Protection of Domestic Violence Victims

According to Berg Insight, the global electronic offender monitoring market in Europe and the Americas is expected to reach $2.1 billion in 2026. These electronic monitoring devices aim to increase offender accountability, reduce recidivism rates, and enhance public safety by providing an additional tool over traditional methods of community supervision (https://ibn.fm/DuCI5).

The world’s criminal justice systems face challenges that SuperCom can help solve. Countries are seeing high recidivism rates, prison overcrowding, excessive costs, and unsafe communities. SuperCom’s solutions help negate these challenges and offer a superior alternative for a growing social problem.

SuperCom’s solutions create a positive social impact – improving public safety worldwide. The company’s solutions help save lives and eradicate domestic violence, increase overall public safety and well-being, offer meaningful rehabilitation and proper reentry to society, and facilitate reducing incarcerated population sizes and associated governmental expenditures.

The company’s solutions are a versatile alternative to traditional methods. It offers capabilities allowing governments to provide a wide array of at-home programs, including house arrest, GPS monitoring, domestic violence support, inmate monitoring, alcohol monitoring, and other rehabilitation services. SuperCom has already won over 50 new multi-year governmental projects since 2018.

SuperCom’s growth strategy includes potential acquisitions and expansion into countries and states with limited electronic monitoring. In a press release about the company’s project with the government of Finland, SuperCom President and CEO Ordan Trabelsi said there was a growing number of countries opting for advanced electronic monitoring solutions, which highlights the increasing need for exceptional technology in this industry. “We take pride in the fact that our innovative and proven technology is chosen repeatedly, allowing us to continue revolutionizing the electronic monitoring industry as we enter new European countries,” Trabelsi added (https://ibn.fm/LSdhh).

SuperCom continues solidifying its position as a leading electronic monitoring market and a trusted partner to governments worldwide – providing innovative and proven technology and services to help governments improve public safety, reduce recidivism, and lower overall costs.

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

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

• RVL Pharmaceuticals’ CEO Brian Markison and COO JD Schaub will participate in a fireside chat and 1-on-1 investor meetings on Tuesday, September 12, 2023, during this year’s H.C. Wainwright Annual Global Investment Conference in New York City
• The company will discuss UPNEEQ(R) and its use as the first non-surgical treatment option approved by the FDA for acquired blepharoptosis
• RVL Pharmaceuticals plans to continue marketing to medical aesthetics providers and will launch a direct-to-consumer campaign later this year
• The medical aesthetics market was valued at $13.9 billion in 2022 and is expected to reach $23.4 billion by 2027

RVL Pharmaceuticals (NASDAQ: RVLP), a specialty pharmaceutical company, recently announced that its CEO Brian Markison will be participating in a fireside chat and hosting 1-on-1 investor meetings during the H.C. Wainwright 25th Annual Global Investment Conference in New York City on Tuesday, September 12, 2023. Mr. Markison will be discussing the company and its commercialization of UPNEEQ(R) (oxymetazoline hydrochloride ophthalmic solution), 0.1%, which is available by prescription for the treatment of acquired blepharoptosis, also known as ptosis or low-lying eyelid(s), in adults (https://ibn.fm/097y6).

UPNEEQ(R) is the first non-surgical treatment option approved by the U.S. Food and Drug Administration (“FDA”) for acquired blepharoptosis. The company obtained the necessary FDA approvals in July 2020 – launching UPNEEQ(R) in September 2020 to a limited number of eye care professionals. The company began expanding its commercial operations in 2021 to include ophthalmology, optometry, and oculoplastic specialties. In 2022, UPNEEQ(R) was launched into the U.S. medical aesthetics market.

In 2022, the global medical aesthetics market had an estimated value of $13.9 billion. By 2027, the estimated value is expected to reach $23.4 billion, representing a compound annual growth rate (“CAGR”) of 11%. The market’s projected growth is attributed to the rising preference for minimally invasive aesthetic procedures over traditional surgical options (https://ibn.fm/Ny5DV).

UPNEEQ(R), the first and only FDA-approved eye drop for low-lying eyelids, fits into the non-invasive medical aesthetics category. With a single drop per day, clinical trials showed an average of one-millimeter lift to the upper eyelid, improving appearance and the superior visual field in patients with a functional deficit. Testing also showed that UPNEEQ(R) was well tolerated by participants and is safe; side effects were similar to those experienced in the placebo group.

RVL Pharmaceuticals believes that the growth in the medical aesthetics and eye care markets will be driven by an aging population and an increased life expectancy, resulting in more consumers who desire improved appearance and well-being over a longer period. The company also anticipates other contributing factors that include the growing awareness, utilization, and improved accessibility of treatments due to an increase in physicians offering eye care and medical aesthetics services.

Low-lying lids can affect adults of all ages. A survey conducted by eye care providers and medical aesthetics specialists revealed they believe that approximately half of the adult patients visiting their practices are affected by drooping or low-lying eyelids. RVL Pharmaceuticals estimates that approximately 60% of adult women self-identify as having some degree of ptosis, indicating that they are bothered by the position of their eyelids.

UPNEEQ(R) customers include optometrists, ophthalmologists, oculoplastic surgeons, facial plastic surgeons, dermatologists, and a broad range of practitioners qualified to diagnose and treat acquired blepharoptosis in adults. Patients can purchase UPNEEQ(R) directly from eye care, medical aesthetic professionals, or RVL Pharmaceuticals’ wholly owned pharmacy, RVL Pharmacy LLC. To support patients, RVL Pharmaceuticals launched the Elevate platform this year, which enables UPNEEQ(R) orders and subscription refills across HCP practices and RVL Pharmacy patients.

RVL Pharmaceuticals’ near-term focus is to continue the rollout of UPNEEQ(R) into the medical aesthetics market through its dedicated sales force. RVL is focused on raising patient and provider awareness of acquired ptosis through medical conferences, HCP and direct-to-consumer advertising, social media, and marketing partnerships.

The company’s fireside chat at the H.C. Wainwright 25th Annual Global Investment Conference will be webcast and available live and via replay from the RVL Pharmaceuticals website under the Investors & News section. The playback will be accessible for up to 90 days after the conference’s conclusion.

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

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

• XESP continues to affirm its commitment to optimizing companies’ growth, mainly through its managed service that offers digital activation and engagement solutions
• Its proprietary technology, the Digital Engagement Engine(TM), which utilizes automation, unique data management, and a modern workflow, has proven to offer what no other competitor offers in the market
• This product is founded on critical principles integral to building customer loyalty, among them the importance of meeting customers’ demands for the modern digital experience
• Through this proprietary technology, XESP offers a solution that makes addressing the changing consumer demands a lot easier, faster, and more efficient

Electronic Servitor Publication Network (OTCQB: XESP), is a digital engagement company and a market disruptor offering cutting-edge data analysis and intelligent technology to help enterprises reach their target markets. Through its managed service, which offers digital activation and engagement solutions, the company looks to provide superior intelligent interaction management, dynamic content provisioning, and a logic-driven workflow, all tested avenues for elevating customer experiences and response.

XESP is focused on the use of evolving technologies to increase customer reach and spur organizational growth. The company’s proprietary technology, the Digital Engagement Engine(TM), is an example of the company’s focus on solutions that directly address clients’ digital engagement needs.

By utilizing a combination of automation, unique data management, and a modern workflow built on a microservices architecture, XESP can offer what no competitor offers in the market. The company has differentiated itself through this technology, offering a unique value proposition.

“The Digital Engagement Engine(TM) isn’t just another marketing or technology tool; it’s a way to develop real connections with target markets.”

A recent Destination CRM article written by Trey Simonton of MadCap Software points to 4 ways for building customer loyalty (https://ibn.fm/VvNRK):

1. Meet customers’ demands for modern digital experiences
2. Leverage online guides to upsell related offerings
3. Use online tutorials and guides to attract new customers
4. Support growing customer calls for sustainability

XESP’s offering is founded on such basic principles, serving as the building blocks for the managed services the company provides and how it tailors its Digital Engagement Engine specifically to the needs of the intended customer.

For starters, for a business to build customer loyalty, it must more effectively meet customer demands, specifically for the modern digital experience that defines the industry today. With more sales being conducted online, digital experiences can no longer be ignored. In 2022, over 21% of global retail sales were all conducted online. This amounted to $5.7 trillion, with 2.14 billion people shopping online in 2020 (https://ibn.fm/n71pq). Meeting these people’s demands for the modern digital experience makes a massive difference between a successful and failed business today.

Another principle is leveraging online guides to upsell related offerings. With more customers today preferring self-service over calling a support center, more businesses are moving toward enabling this functionality, although live personal interactions can be kept as one of the options. XESP, through its technology, is helping to refine the process, offering innovative solutions that present offers for related products tailored to specific customers, their purchase history, and overall preferences.

This of course also complements the growing customer calls for sustainability, with 79% of consumers pushing for brands to focus on developing working practices that consider the environment.

As consumer demands continue to evolve, especially in this digital age, more businesses are learning the importance of the internet and are being forced to cater to the changing consumer demands. XESP, through its proprietary technology, offers a solution that makes the entire process easier, faster, and more efficient, with a guarantee of elevating customer experiences. By offering meaningful customer interactions, businesses can realize growth, higher customer retention, and customer satisfaction in the long run.

“That meaningful interaction drives a greater relationship with your audience and trust,” noted Peter Hager, XESP’s CEO. “Ultimately, it drives greater growth in your organization and, very simply put, replicates what you do face-to-face. And if we can do that online, which the Digital Engagement Engine helps you do, you’re going to produce better results,” he added (https://ibn.fm/1501i).

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

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

• In July 2023, LSDI launched Twilight, a new sleep aid product
• The company in July 2023 announced its acquisition of SANA-013 from Wesana Health; SANA-013 is being developed for the treatment of several mental health and central nervous system conditions
• LSDI in May 2023 launched its new Mindful product line designed to enhance well-being and promote a mindful approach to life
• Also in May 2023, the company announced a partnership with non-profit TheraPsil to advance medical psilocybin access and research
• LSDI announced in April 2023 that its board had approved the repurchase of up to 500,000 shares of its Class A common stock

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

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

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

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

Products

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

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

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

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

Market Opportunity

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

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

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

Management Team

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

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

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

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

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

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

• CNS Pharmaceuticals recently announced updated results from its pivotal clinical study on GBM treatment through its lead drug candidate, Berubicin
• The novel anthracycline demonstrated its capability to be an innovative potential treatment option for GBM
• 151 patients have been enrolled in the study, marking the data cutoff point and a significant milestone toward reporting topline results before the end of the year
• Based on the results seen preclinically, the company remains optimistic that Berubicin may provide a much-needed clinical benefit for GBM patients

CNS Pharmaceuticals (NASDAQ: CNSP), a clinical-stage biotechnology company specializing in the development of novel treatments with a focus on brain cancer, glioblastoma (“GBM”), and neuro-oncology, recently announced the presentation of updated safety results from its potentially pivotal clinical study on GBM treatment through its lead drug candidate, Berubicin. Most notably, this novel anthracycline demonstrated its capability to be a safe and innovative potential treatment option for GBM, having shown aspects integral to effective therapy for the disease (https://ibn.fm/yp5AC).

“Berubicin has demonstrated its capability to be an innovative treatment in GBM that is safe and well tolerated, which has the potential to be a novel and effective therapy for this disease,” noted Sandra Silberman, MD, PhD, Chief Medical Officer of CNS Pharmaceuticals.

So far, 151 patients have been enrolled in the clinical study, with 105 set on Berubicin while the remaining 46 will be on Lomustine. This marks the data cutoff point for CNS Pharmaceuticals, a significant milestone toward reporting topline results before the end of the year.

“We are approaching the most important milestone to date since we launched CNS Pharma,” noted John Climaco, CNS Pharmaceuticals’ CEO.

“We are just a few months away from reporting topline results from our Berubicin potentially pivotal study interim analysis and, although we do not know what the data looks like at this time, we remain hopeful as we also approach full enrollment of the trial,” he added (https://ibn.fm/0Yy0n).

The primary endpoint of this study is Overall Survival (“OS”), a goal that the United States Food and Drug Administration (“FDA”) has recognized as the basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. Approximately 50% of patients on both arms have completed the study, with each showing comparable demographics, including age, race, gender, KPS, and BSA. Based on the results seen preclinically and in the clinical study thus far, the company remains optimistic that Berubicin may provide a much-needed clinical benefit for GBM patients.

“Based on the results we’ve seen preclinically and in the clinic thus far, including these updated results from our ongoing potentially pivotal study, we remain optimistic that Berubicin may provide a much-needed clinical benefit for GBM patients,” noted Dr. Silberman.

The FDA has already granted CNS Pharmaceuticals Fast Track Designation for Berubicin, allowing it more frequent interactions with the agency, both for guidance and review. In addition, the company has received Orphan Drug Designation from the FDA, affording it seven years of marketing exclusivity upon approval of an NDA. Progress from its ongoing study is inching closer to enjoying these benefits and more, and its management is optimistic that it will offer a more viable treatment option for GBM than what is already in the market.

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

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

• In June 2023, Longeveron filed with the SEC to offer subscription rights worth up to $30 million of shares of Class A common stock to stockholders and holders of warrants. The rights offering, which became effective on August 17, 2023, is being made through a distribution of five tradable subscription rights (listed on The NASDAQ Capital Market under the ticker symbol LGVNR) to purchase shares of Class A common stock for each share of common stock and warrant to purchase common stock owned as of the record date of August 18, 2023, at a $3.00 subscription price per share. The subscription period opened on August 22, 2023, and will continue until September 21, 2023, unless extended at the company’s sole discretion.
• During Q2 2023, the company announced children in its ELPIS I Trial of Lomecel-B(TM) for HLHS had 100% survival up to five years of age after receiving the drug, as compared with an approximate 80% survival rate in historical trials. Lomecel-B(TM) for HLHS has previously received Fast Track Designation, Rare Pediatric Disease Designation, and Orphan Drug Designation from the U.S. Food and Drug Administration (“FDA”).
• In August 2023, the company announced the Phase 2 ELPIS II trial, funded by the National Heart, Lung, and Blood Institute (“NHLBI”) and using the company’s Lomecel-B(TM) asset in Hypoplastic Left Heart Syndrome (“HLHS”), has surpassed the 50% enrollment threshold. Additionally, the trial has activated its eighth clinical site location – one additional site beyond the seven originally planned – in order to try to expedite the completion of the trial enrollment.
• The company expects to share top-line results from its Phase 2a CLEAR MIND trial of Lomecel-B(TM) for the treatment of Alzheimer’s disease in early October 2023.
• Longeveron is conducting a Phase 2 study of Lomecel-B in patients with Aging-related Frailty in conjunction with Japan’s National Center for Geriatrics & Gerontology and Tokyo’s Juntendo University Hospital.

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

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

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

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

The company is headquartered in Miami, Florida.

Lomecel-B(TM)

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

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

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

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

Market Opportunity

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

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

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

Management Team

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

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

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

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

Forward-Looking Statements

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

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

Date prepared: August 31, 2023

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

• A field project review in June 2023 confirmed widespread mineralization at Appia’s Ionic Clay Project in Brazil
• The company’s highly experienced management team has more than 100 years of combined experience in the metals and minerals industry
• Appia’s Alces Lake project contains some of the highest-grade total critical REE mineralization in the world
• As of June 2023, the company had no debt

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

The company is headquartered in Toronto, Canada.

Projects

PCH Project-Brazil

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

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

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

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

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

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

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

Alces Lake Project – Saskatchewan

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

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

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

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

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

Other Projects

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

Market Opportunity

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

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

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

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

Management Team

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

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

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

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

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

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

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

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

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