• Longeveron management will present at the 25th Annual H.C. Wainwright Global Investment Conference scheduled for September 11-13, 2023, in New York
• Wa’el Hashad, the company’s CEO, will discuss Longeveron’s cellular therapy programs in a pre-recorded presentation. Both he and Lisa Locklear, EVP & Chief Financial Officer, will be at the conference to discuss the company’s investment strategies and clinical trial progress
• The company aims to create awareness among scientists and investors of its clinical trial progress, positive clinical results, and cellular therapy programs
• Longeveron is evaluating its lead investigational product candidate, a cellular product named Lomecel-B(TM), in ongoing clinical trials
• The product candidate is being advanced as a potential treatment for hypoplastic left heart syndrome (“HLHS”), Aging-related Frailty, and Alzheimer’s disease

Longeveron (NASDAQ: LGVN), a clinical-stage company, is focused on developing cellular therapy primarily for conditions with a clear unmet medical need. The company is guided by the mission to advance cell-based product candidates into pivotal Phase 3 trials, with the goal of attaining regulatory approvals and subsequently commercializing the product.

Longeveron has so far made significant strides in line with this mission, progress that the company’s management will share during the 25th Annual H.C. Wainwright Global Investment Conference scheduled for September 11-13, 2023, in New York. On his part, Wa’el Hashad, the company’s CEO, will discuss Longeveron’s cellular therapy programs in a pre-recorded presentation. Both he and Lisa Locklear, Longeveron’s EVP & Chief Financial Officer, will attend the conference in person to discuss the company’s investment strategies and clinical trial progress (https://ibn.fm/99cEG).

The programs and clinical trials are currently anchored in the company’s lead investigational therapeutic candidate, a cellular therapy called Lomecel-B(TM). Lomecel-B is derived from culture-expanded medicinal signaling cells (“MSCs”) isolated from the bone marrow of healthy young adult donors (https://ibn.fm/sYprw). The drug candidate is undergoing evaluation – as part of three separate Phase 2 clinical trials – as a potential treatment for three indications: hypoplastic left heart syndrome (“HLHS”), Aging-related Frailty, and Alzheimer’s disease.

HLHS is a rare congenital heart condition that affects about 1,000 newborns every year in the United States. HLHS patients are born with a severely underdeveloped left ventricle, which is normally responsible for pumping oxygenated blood to the body. The condition is fatal shortly after birth if left untreated. Thus, to avert certain death, the babies undergo three heart surgeries (Stage I, Stage II, and Stage III), staggered over several years, which convert the heart into a functioning 3-chamber heart (instead of a normal 4-chamber heart).  In the reconstructed heart, and after the Stage III surgery, the right ventricle entirely takes over the role of pumping oxygenated blood to the body.

Unfortunately, despite these efforts, HLHS babies still have high mortality and morbidity and often still require a heart transplant, mainly due to heart failure. The mortality risk for children with hypoplastic left heart syndrome is highest in the first year of life. For this reason, Longeveron is evaluating Lomecel-B’s potential to improve cardiac function when administered directly to the myocardium (heart muscles) at the time of Stage II surgery. The company completed its safety-focused open-label Phase 1 (“ELPIS I”) study evaluating Lomecel-B(TM) for the treatment of HLHS, reporting positive clinical results.

When cardiac surgeons injected the product directly into the babies’ hearts, the MSCs were well tolerated, with no significant adverse cardiac events and no infections related to the investigational treatment reported. Moreover, the study results showed a 100% survival rate up to 5 years after treatment, with no need for heart transplant, for the ten infants enrolled in the study. By comparison, historical data indicates an approximate 20% mortality rate over the same period of time (see “Other References” below).

The positive Phase 1 data led to the  U.S. Food and Drug Administration (“FDA”) granting  Rare Pediatric Disease Designation (“RPDD”) (https://ibn.fm/RVvzm), Orphan Drug Designation (“ODD”) (https://ibn.fm/W6ebo), and Fast Track Designation (“FTD”) (https://ibn.fm/uAPT7) for Lomecel-B(TM) for the treatment of HLHS.

Lomecel-B(TM) is currently being evaluated in a Phase 2 clinical trial (“ELPIS II”). A multicenter, randomized, double-blind, controlled clinical trial, ELPIS II is designed to evaluate Lomecel-B(TM) as an adjunct therapy to the standard-of-care Stage II HLHS heart reconstructive surgery. The primary endpoint is to assess whether the treatment improves heart function and improves survival compared to standard-of-care surgery alone. The trial has enrolled more than 50% of the 38 targeted subjects.

Longeveron is also conducting a Phase 2a trial (“CLEAR MIND”) to evaluate multiple doses of Lomecel-B(TM) in patients with mild Alzheimer’s disease. The primary objective of the trial is the safety and tolerability of single and multiple doses of Lomecel-B in patients with mild AD. The study will also evaluate the efficacy of single and multiple doses of Lomecel-B on disease progression in patients with mild Alzheimer’s disease. Longeveron expects the topline data results in October 2023.

Moreover, Longeveron has completed two studies (Phase 2b and a Phase 1/2a trial) in the United States. for the treatment of Aging-related Frailty. The company has also received regulatory approval in Japan, permitting an investigator-sponsored Phase 2 clinical trial for Aging-related Frailty. The Japan clinical trial is ongoing. Aging-related Frailty is a life-threatening geriatric condition that increases the risk of poor clinical outcomes from injury and disease. It does not have an approved treatment, representing an untapped opportunity for Longeveron. The company aims to work with regulatory agencies to advance Lomecel-B(TM) as potentially the first approved drug for Aging-related Frailty.

Looking ahead, Longeveron is looking to create awareness of these cellular therapy programs, the progress made with its clinical trials, and accompanying positive clinical data at conferences and scientific sessions. The upcoming investment conference provides an ideal setting as it brings together investors from all over the world.

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

Other References:

1. Newburger et al. Circulation (2018) 137:2246-2253
2. Newburger et al. Circulation (2014) 129:2013-2020
3. Ohye et al. N Engl J Med (2010) 362:1980-1992

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

• U.S.-based generic drug developer SOHM recently announced the addition of two leading officers — Dr. David Aguilar (Ph.D) as Chief Operating Officer and Dr. Krishna Bhat (MD, Ph.D, FACC) as Chief Medical Advisor
• The new officers are expected to help direct SOHM’s global growth strategy as the company continues to develop and diversify its product offerings, which include a variety of mediums for administering antibiotics, analgesics, anti-inflammatory and anti-cold therapies, as well as vitamins
• SOHM also recently announced an LOI to acquire a stem cell disruptive technology and related patents, which include the potential for someday treating damaged hearts via gene editing
• The company’s global operation is primarily focused on emerging markets in Africa, Latin America, and Southeast Asia

Generic drug manufacturing and distributing innovator SOHM (OTC: SHMN) is strengthening its governing team with the addition of two experienced visionaries committed to helping the company’s growth in the pharmaceutical, nutraceutical, and cosmeceutical marketplace.

Dr. Krishna Bhat (MD, Ph.D, FACC), an experienced bioscientist and cardiologist, will bring his leadership skills to the company’s advisory board as its new Chief Medical Advisor, increasing his commitment beyond his involvement as a longtime shareholder, according to an announcement Aug. 24.

“Dr. Bhat brings valuable experience and expertise in the field of cardiology, which will support our planned acquisition of ABBIE Technology and its innovative patents, clinical trials, diagnostic kits and cardiac treatments,” SOHM president and CEO Baron Night stated in the news release (https://ibn.fm/ZNXX2). “Dr. Bhat is a renowned Clinical and Interventional Cardiologist who has authored over 16 medical scientific publications. We look forward to benefiting from his insights and guidance for our current and future pipelines.”

Earlier in August, SOHM signed a letter of intent to acquire “ABBIE” (A Binding Based Integrating Enzyme) stem cell disruptive technology and patents from CGA Intellectual Holdings Inc. to create novel products and solutions in the regenerative medicine and cosmeceutical industries, with initial development focused on “optimization of targeting and understanding limitations of the ‘payload’ size that can be utilized to deliver the gene(s) of interest” (https://ibn.fm/25YWT).

The ABBIE platform is still in early stages of research and development, but it has already shown promising results through gene editing in animal and human cells in vitro and is expected to provide significant solutions for cardiac patients by offering cell therapies to repair damaged hearts (https://ibn.fm/2cR9S).

SOHM also recently announced the appointment of Dr. David Aguilar (Ph.D) as Chief Operating Officer to direct the company’s sustainability, stability, growth and new developments at its uppermost level, drawing on his 22 years of experience in the pharmaceutical industry working with clinical and regulatory needs for preclinical and IND filings of allogeneic cell-based therapies.

“We are delighted and fortunate to have someone with Dr. David Aguilar’s talent, business acumen and deep institutional knowledge of SOHM, Inc. oversee these functions and manage our global businesses,” Night stated in the Aug. 8 announcement (https://ibn.fm/cCzUz).

SOHM is headquartered in California and exports its products around the world, focusing on emerging markets in Africa, Latin America and Southeast Asia. The company uses manufacturing alliances in India and strategic alliances with U.S. manufacturing facilities to develop its product line, which includes antibiotics, analgesics, anti-inflammatory and anti-cold therapies, and vitamins.

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

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

• PaxMedica recently announced positive top line results from its PAX-101 Phase 3 African Sleeping Sickness Study, paving the way for an expected New Drug Application filing in 2024
• The company granted exclusive pharmacy distribution for PAX-101 to Vox Nova LLC, the first purpose-built limited distribution specialty pharmacy benefit manager for people with ASD
• PaxMedica submitted PAX-101 Clinical Trial Request to the South African Health Products Regulatory Authority, requesting approval for a double-blind, placebo-controlled study in ASD
• The company entered a Research Collaboration Agreement with PoloMar Health and The BRAIN Foundation for a Phase II proof-of-concept trial in ASD

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

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

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

The company is headquartered in Tarrytown, New York.

Product Pipeline

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

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

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

Market Opportunity

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

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

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

Management Team

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

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

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

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

• RJDG acquires and manages assets in three diverse markets: construction, digital healthcare services, and environmental solutions
• Asset portfolio includes Silex Interiors, ioSoft Inc., and Earthlinc Environmental Solutions
• Silex Interiors manufactures, distributes, and installs bathroom and kitchen furniture, countertops, and related products; awarded contract that is expected to generate $850,000+ revenue in 2023
• ioSoft Inc. provides secure payment technologies, cloud-based software, and professional services to healthcare industry; recently procured software development and IT support contract to customize ioSoft Suites for the RailPro Group
• Earthlinc Environmental Solutions offers patented waste processing technology for commercial chicken and hog farms; transforms waste into animal feed while recycling the water for reuse on the farm

Diversification is critical to investment success for many reasons: stable returns, risk reduction, and protection against market volatility. With these principles in mind, RJD Green (OTC: RJDG) a holding company, manages assets in three diverse, high-growth industries in separate “recession-resistant” markets, including construction, digital healthcare services, and environmental solutions.

RJDG formed its specialty construction division to focus on industrial contracting, building material products, and construction services. The company’s first acquisition, Silex Interiors, is a manufacturer, distributor, and installer of countertops, cabinets, and related bathroom and kitchen products with a large target market comprising commercial contractors, residential builders, new and renovation contractors, and retail customers. With the aim of filling a market niche between “big box” stores and smaller retail distributors, RJDG plans to launch Silex into major national markets through internal expansion, franchising, and supplementary acquisitions.

Silex was awarded a large contract for natural stone countertops and cabinets in May 2023 that is expected to generate over $850,000 in revenue (https://ibn.fm/olu6H). “This significant commercial contract awarded to Silex continues the revenue progression in our commercial business segment and reflects geographic expansion,” said RJD Green CEO Ron Brewer. “The commercial contracts have helped offset the traditional seasonal revenue downturn that occurs in our home building sector and will contribute to revenue growth for the remainder of the year. These results reflect our continued implementation of our growth plan for Silex Holdings to expand market segments and broaden our customer base.”

ioSoft Inc., a software company under RJDG’s software division, provides secure payment technologies, cloud-based software, and professional services to healthcare payers and providers. The company’s SaaS offerings integrate seamlessly with legacy or existing systems, offering clients a flexible, scalable, cloud-based solution for managing medical billing, healthcare claims adjudication, and electronic payments.

RJD Green recently announced that ioSoft procured a software development and IT support contract for the RailPro Group, a consulting and marketing team focused on retail marketing and energy-related companies (https://ibn.fm/j7bNy). Under the agreement, ioSoft will customize the ioSoft Suite’s platform, including its ioSoft Unified Payment System(TM) and ioSoft LinkUp(TM) – a robust communication interface enabling users to view claim information, update enrollment, and access ID cards 24/7 from any connected device.

Earthlinc Environmental Solutions, part of RJDG’s environmental services division, provides North American companies with green solutions to ecological challenges. The company’s first acquisition, Animal Waste Management, offers patented waste processing technology for commercial chicken and hog farms. Developed with support from the University of Arkansas and the Missouri Department of Natural Resources, the technology transforms liquid, solid, and gas waste into clean, odorless, bacteria-free animal feed while recycling the water to be reused on the farm.

Based in Tulsa, Oklahoma, RJD Green Inc.’s management team leverages a successful track record in the public and private sectors, with extensive experience in each area of focus under its diverse divisions. The team expertly matches investments with projects to optimize growth, profitability, and shareholder returns.

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

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

• D-Wave’s quantum solutions help businesses solve computationally complex optimization problems, including logistics, employee scheduling, factory processes, and more
• Advantage(TM) is D-Wave’s fifth-generation quantum computer featuring industry-leading 5,000+ qubits and 15-way qubit connectivity
• D-Wave’s commercial customers include blue-chip industry leaders like Mastercard, Deloitte, Siemens Healthineers, Unisys, NEC Corporation, Pattison Food Group Ltd., and Lockheed Martin

Business leaders today are faced with a myriad of solutions to consider for integration into their organization’s IT infrastructure, many of which are critical in achieving meaningful operational efficiency and business advantage. One of the most promising yet perplexing solutions is quantum computing. Most businesses are faced with a vast array of optimization problems, but solving those challenges efficiently can be incredibly challenging. D-Wave Quantum (NYSE: QBTS), a leader in quantum computing systems, software, and services, focuses on solving such challenges by delivering value to customers through practical quantum solutions for problems such as logistics, artificial intelligence, drug discovery, scheduling, and financial modeling.

As a leader in quantum computing, D-Wave has delivered the world’s first commercial quantum computer, the first real-time quantum cloud service, countless highly proprietary hardware and software products, and numerous scientific milestones. These innovations serve to help organizations harness the power of quantum technology to address their most computationally complex problems and to help business leaders recognize when to consider quantum over classical computing to tackle their biggest challenges.

Classical computers offer limited computation – using bits represented by 0s and 1s to store information. Quantum computers use quantum bits (qubits) to encode information as 0s and 1s with the ability to use them simultaneously. This superposition, along with other quantum mechanical phenomena and tunneling, enables quantum computers to manipulate enormous combinations all at once.

When using classical computers, business leaders are faced with the inability to search multiple avenues for solutions to complex problems – the solutions are often time-consuming and may never come to fruition. D-Wave’s quantum computer uses quantum annealing to search for solutions to these problems, with the goal of ultimately finding the best solutions without waiting weeks or months for an answer.

D-Wave’s current commercial quantum product offerings include:

• Advantage – a fifth-generation quantum computer featuring 15-way qubit connections and processor architecture with more than 5,000 qubits.
• Leap(TM) – the company’s quantum cloud service that allows developers proficient in Python to begin building and running quantum applications. Leap delivers immediate, real-time access to D-Wave’s Advantage quantum computer and hybrid solver services, with enterprise-class performance and scalability.
• Ocean(TM) – a suite of open-source Python tools that empower developers to experiment, rapidly develop, and harness the power of Advantage to solve complex problems.
• Launch(TM) – an onboarding solution that helps businesses get started on the quantum journey. Launch was designed to guide enterprises from problem discovery through in-production application deployment.

D-Wave’s commercial customers include blue-chip industry leaders like Volkswagen, Mastercard, Deloitte, ArcelorMittal, Siemens Healthineers, Unisys, Accenture, BBVA, NEC Corporation, Pattison Food Group Ltd., DENSO and Lockheed Martin. D-Wave features a diverse and robust collection of use cases on its Customer Success Stories page, showing how quantum computing has provided value in the real world (https://ibn.fm/ecL2y).

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

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

• 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

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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.

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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