The life sciences sector is set to experience a year of innovation, collaboration, and breakthrough discoveries with the announcement of DGE’s 2025 Life Sciences Conference Calendar. Industry professionals, researchers and key stakeholders will have the opportunity to attend a series of events designed to foster knowledge exchange, showcase cutting-edge research, and facilitate networking among peers. View the full calendar now.

5th Risk-Based Quality Management Summit: The 5th RBQM Summit in Philadelphia, PA will bring together RBQM, clinical operations, and risk management colleagues to discuss the latest risk planning strategies. Attendees can expect interactive panel discussions and unparalleled networking opportunities.

Chief Patient Officer Summit West: From the creators of the highly attended Chief Patient Officer Summit. Patient engagement, patient advocacy, and patient communications colleagues will unite in San Diego, CA. Co-Create with patient communities, and take action to implement their feedback. Emerge from the meeting ready for leadership and next steps to ensure the patient voice is head and reflected in R&D, clinical and post approval.

9th Digital Strategy & Innovation for Medical Affairs Summit: Medical affairs, MSLs, and digital strategy professionals will discover ways to optimize digital innovation, work with regulatory and legal review partners, and explore data mining and knowledge retrieval using AI. This conference will provide detailed and insightful discussions on AI’s impact on patient outreach, innovative digital strategies for medical and legal review processes, and how to stay ahead of an ever-evolving technological future.

14th Advancing Women’s Leadership in Pharma & Healthcare Conference: Women have made tremendous progress to overcome challenges and rise to senior executive levels of life sciences and healthcare organizations. Many obstacles remain. The 14th Women’s Leadership Conferences provides a community for women to connect, share experiences, and problem solve using the existing roadblocks to advancement in life sciences and healthcare.

Clinical Trial Payments Summit: Learn the most up-to-date solutions to your trial complexity, software section, and international payment transparency decisions. The Inaugural Summit will unite in Philadelphia, PA in April 2025.

5th PRC Performance Optimization Summit: Build your strategy for cross-disciplinary teamwork, knowledge retention, maintaining compliance, and hitting deadlines on every project across every media format. PRC, Marketing, and Regulatory Promotions colleagues will unite in Philadelphia, PA in May 2025.

2nd Artificial Intelligence for Life Sciences Compliance Congress: Compliance and privacy peers will exchange perspectives on the challenges and opportunities involved in managing expanding responsibilities and priorities in the era of AI. Join the indispensable opportunities to strategize tactics to modernize compliance programs, risk identification and predictive analytics.

4th Transparency & Aggregate Spend Summit: Discover the latest information needed to meet Open Payments, State, and Global transparency reporting requirements. Gain strategies for managing high risk HCP interactions and data integrity amid ever evolving layers of complexity . Through collaborative learning and discussions that enhance your way of thinking and problem solving, you will gain a sharper focus on how others are navigating the waters and return to work with a network of next-level connections. This is the place where industry leaders put the most challenging issues at the center of the conversation.

These conferences represent a comprehensive array of opportunities for life sciences professionals to stay at the forefront of their fields, gain new insight, and build valuable connections. Mark your calendars and prepare to be inspired in 2025!

For sponsorship opportunities, contact Amy at achapman@dgeconfs.com

To register, contact Marcie at mcruz@dgeconfs.com

Dynamic Global Events (“DGE”) is the Life Sciences Leader in providing B2B conferences. Our name is derived from our Goal – to serve the dynamic informational and networking needs of the Pharmaceutical, Biotechnology, Healthcare, Medical Device and allied industries.

• ECGI Holdings is making strategic moves to capitalize on the projected growth in various markets, including the global equestrian apparel market, equestrian equipment and tack market, and the greater overall equestrian market
• The company recently announced the planned launch of a new line of equestrian apparel under Pacific Saddlery’s Allon brand
• This new collection is intended to elevate the standard of equestrian apparel and will feature innovative designs that embody luxury, quality, and an unmatched level of craftsmanship
• ECGI holds that its targeted markets present huge opportunities for generating consistent revenue and supporting continued growth, its status as a relatively small player in the markets notwithstanding

ECGI Holdings (OTC: ECGI), a diversified holding company focusing on viticulture, luxury fashion, and equestrian markets, made its initial investment last year in Pacific Saddlery Inc., a premier manufacturer and retailer of equestrian apparel, tack, equipment, and accessories. The company intended to carve out an operating niche in the luxury brands space, ensuring its products and services are synonymous with quality, elegance, and an unrivaled value proposition for end users (https://ibn.fm/TCS1n).

ECGI in June buttressed the plans to realize this objective by signing a binding Letter of Intent (“LOI”) to acquire all outstanding shares of Pacific Saddlery. This move, the company noted, aligned with its objectives of expanding its presence in the luxury brands sector (https://ibn.fm/suMgU). Not long after, ECGI announced plans to launch a new line of ready-to-wear equestrian apparel under Pacific Saddlery’s celebrated Allon brand (https://ibn.fm/NKmnc).

According to Nick Collins, President of Pacific Saddlery, this new collection is intended to elevate the standard of equestrian apparel. The new line will feature innovative designs that not only embody luxury and quality but also continue to capture the unmatched craftsmanship and style that have become synonymous with Pacific Saddlery’s equestrian products.

The launch comes at a time when the global equestrian apparel market, equestrian equipment and tack market, and the larger equestrian market are poised for significant growth. A report by Global Market Insights projects the global equestrian apparel market, valued at about $6.5 billion in 2023, will grow at a CAGR of 4%, reaching $9.7 billion by 2032. This growth is expected to be driven by the increasing popularity of equestrian events and sports, growing disposable incomes in urban populations, and rising awareness of how equestrian apparel promotes safety, comfort, and performance during leisure riding and equestrian sports (https://ibn.fm/c2zZK).

Additionally, the luxury equestrian apparel market, a subset of the overall luxury apparel market, is expected to witness robust growth, especially given that the overall luxury apparel market is projected to expand to $321.6 billion by 2032 from $218.2 billion in 2024. Key drivers for this growth, a Market Research Future report notes, include North America’s strong affinity for luxury apparel as well as the heightened demand for luxury apparel in emerging markets due to rising disposable income, urbanization, and an aspirational middle class (https://ibn.fm/ybrvy).

ECGI’s other target, the global equestrian equipment market, is forecasted to grow at a CAGR of 4.3% from 2024 to 2032, reaching $17 billion by the end of the forecast period (https://ibn.fm/oqR95). To tap into this growing market, Pacific Saddlery manufactures and sells a variety of tacks under the Allon brand, including bridles.

The company believes these burgeoning markets present vast opportunities for generating consistent revenue and enabling it to post continued growth even as a relatively small player in the market. This is a sharp contrast to small markets, which often have a few well-established top players whose first-mover advantage/incumbency and unrivaled stronghold limit the chances of smaller players succeeding.

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

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

• Clene’s mission is to transform the treatment of neurodegenerative diseases with a new class of drugs, potentially impacting the lives of millions
• The company’s uniquely structured gold nanocrystals have the remarkable ability to convert critical energetic metabolites in living cells for the production of ATP, the essential energy currency for cellular functions, offering disease combatting capabilities
• Clene is currently preparing for Phase 3 clinical trials of CNM-Au8for ALS and MS, following successful early studies

Xtalks Life Science Podcast recently featured Karen S. Ho, PhD, Vice President of Translational Medicine for Clene (NASDAQ: CLNN), a late-stage biopharmaceutical company focused on protecting mitochondrial health and neuronal function to treat neurodegenerative diseases. In the episode, host Ayesha Rashid, PhD, discussed Clene’s innovative gold nanocrystal technology and how Dr. Ho is leading the company’s development in diseases like ALS (Amyotrophic Lateral Sclerosis), MS (Multiple Sclerosis), and PD (Parkinson’s Disease).

Clene’s mission is to transform the treatment of neurodegenerative diseases with a unique approach, potentially impacting the lives of millions. They are pioneering a new class of drugs that integrates principles from chemistry, physics, and material science, and applying these to biological systems.

At the forefront of their research is the development of catalytically active drugs, with their lead asset being CNM-Au8. This innovative compound employs gold nanocrystals, which are unique because gold, typically known for its inert properties, becomes highly catalytically active in its nanocrystal form if manufactured to be clean-surfaced and highly faceted. A single Clene gold nanocrystal has a structure similar to a faceted diamond, and is much smaller than a red blood cell in size. . Through special processing these nanocrystals can act as catalysts, aiding in the conversion of critical energetic metabolites in living cells into ATP, the essential energy currency for cellular functions. When suspended in water and consumed by patients, these nanocrystals can enter the bloodstream and also cross the blood-brain barrier to reach diseased brain cells. This is crucial for neurons afflicted by neurodegenerative diseases, which face a variety of stressors, including oxidative stress and mitochondrial dysfunction. These cells require additional energy input from ATP to combat these issues. By facilitating ATP production, these nanocrystals help neurons rebuild, protect themselves, and function optimally.

The gold nanocrystals act as catalysts for this energy production process, meaning they open pathways for energy production without themselves being consumed and used up. This remarkable property, requiring nanocrystals that are specially manufactured to avoid organic contamination, is vital in supporting many cellular functions, and shows strong potential for the treatment of various neurodegenerative diseases. Despite differing symptoms, these diseases share the common issue of dealing with energetically demanding neurons that suffer when mitochondrial function and energy production are compromised.

Traditional methods of producing gold nanocrystals involve organic chemicals that can adhere to the crystals’ surfaces, impeding their catalytic activity and potentially introducing biological toxicity. Clene has developed a superior method, using an electrocrystal chemistry to produce stable gold nanocrystal particles with clean, highly faceted surfaces, enhancing their catalytic activity.

In addition, recent research showed that these gold nanocrystals successfully attract a coating of apolipoproteins from human plasma that aids their passage through the blood-brain barrier. Therefore, when the gold nanocrystals are taken in by mouth, they travel through the gastrointestinal system and enter the bloodstream, where they attract apolipoproteins to aid their crossing of the blood brain barrier and get into the brain. Once in the brain the gold nanocrystals help protect neurons from death and repair damaged neurons by catalyzing energy production.

Clene is currently preparing for Phase 3 clinical trials of CNM-Au8 for ALS and MS. Phase 2 studies have already demonstrated that CNM-Au8 can significantly reduce the risk of death in ALS patients, who typically have a prognosis of 2-5 years. Additionally, Phase 2 studies on MS have shown notable improvements in cognition and vision, suggesting remyelination capabilities.

Clene’s ultimate goal is to obtain FDA approval for CNM-Au8, marking a significant milestone in their journey to introduce this groundbreaking treatment approach for neurodegenerative and other diseases, a huge market with significant unmet needs.

The podcast episode can be found at https://ibn.fm/v5bnE.

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

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

• Nightfood made its name in the sleep-friendly snack market, but has made two acquisitions diversifying operations recently to capitalize on an emerging market and a reemerging company
• Nightfood signed an LOI to acquire SWC Group, d/b/a Carryoutsupplies.com
• Carryoutsupplies.com has serviced over 7,000 wholesale accounts since inception in 2004, but faced extreme challenges in the face of the global covid pandemic
• Business is returning, presenting an opportunity for Nightfood to grow sales that reached $2 million in 2023

Nightfood Holdings (OTCQB: NGTF) is at it again. The Tarrytown, NY-based company built its name with sleep-friendly snacks and is now starting to stack its portfolio with opportunistic acquisitions. On July 17, Nightfood announced a letter of intent to acquire SWC Group Inc., doing business as Carryoutsupplies.com, or CarryOut for short.

This move signals Nightfood’s ambition to continue expansion beyond the nighttime snack category and capitalize on a growing segment of the food service industry. The acquisition will be completed through Future Hospitality Ventures Holdings, Inc., a wholly owned subsidiary that Nightfood recently acquired. Future Hospitality is revolutionizing the hospitality industry with plug-and-play robotics and automation solutions designed to enhance service efficiency and consistency. Service robots in hospitality are one of the highest growth industries today.

CarryOut: A Reemerging Leader in Takeout Packaging

CarryOut (www.CarryOutSupplies.com), established in 2004, specializes in custom-printed food packaging offering both traditional and environmentally friendly selections for restaurants, cafes, and other foodservice businesses. Their offerings include containers for hot food, snacks, sushi, beverages,  ice cream, and more. Since inception, the company boasts over 7,000 wholesale accounts and is known for its innovative approach to eco-friendly packaging solutions.

Like so many other businesses, the COVID-19 pandemic nearly wiped-out CarryOut. However, the resilient business model is now recovering with over $2 million in revenue for 2023, a formidable figure, but still well below pre-pandemic revenue records. Management at Nightfood believes CarryOut is well-positioned to surpass its pre-pandemic success.

Growth Through Eco-Friendly Packaging Solutions

CarryOut caters to the increasing demand for sustainable food packaging by offering a range of traditional and eco-friendly options. This aligns with Nightfood’s commitment to innovation and future-focused solutions. The acquisition presents an opportunity for Nightfood to leverage CarryOut’s expertise and expand its footprint in the eco-friendly packaging market.

“We are thrilled at the opportunity to acquire rapidly growing CarryOut Supplies and for the opportunity to restore it to its pre-COVID scale and beyond,” said Sonny Wang, CEO of Nightfood in a press release. “CarryOut is an exciting stand-alone business, and the strategic value of this acquisition is greatly enhanced by synergies with our existing subsidiaries and those we anticipate acquiring in the future.”

The prospect of future acquisitions could be well received by investors. Nightfood sees significant growth potential in securing partnerships with regional and national foodservice chains through CarryOut’s unique and environmentally friendly offerings. Additionally, the acquisition creates synergies with Nightfood’s existing and future subsidiaries, suggesting further diversification plans.

This acquisition marks a significant step for Nightfood, demonstrating its ambition to be a leading force in the broader foodservice industry. While Nightfood will continue to develop its core sleep-focused products, the CarryOut acquisition highlights its commitment to identifying and capitalizing on emerging trends within the foodservice sector.

For more information, visit the company’s website at https://ir.nightfood.com/.

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

• PaxMedica is preparing to submit a New Drug Application to the U.S. Food and Drug Administration for suramin to treat Human African Trypanosomiasis
• On June 27th, PaxMedica will have a Type C meeting with the FDA, pivotal for the progress of PAX-101, their leading drug candidate for autism treatment, within the regulatory framework
• The outcomes of this FDA meeting are crucial, representing a key moment for PaxMedica to demonstrate the therapeutic potential and public health benefits of PAX-101
• The global ASD therapeutics market is projected to grow from $2.01 billion in 2023 to $3.42 billion by 2030, driven by increasing prevalence, rising awareness, and investment in R&D

PaxMedica (NASDAQ: PXMD), a biopharmaceutical company specializing in neurological disorder treatments, is preparing to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for suramin to treat Human African Trypanosomiasis, a century-old treatment in East Africa. In April 2024, PaxMedica underscored its commitment to global health by responding to an urgent request from Malawi for an emergency release of suramin, demonstrating its dedication to advancing healthcare solutions.

On June 27th, PaxMedica will have a crucial Type C meeting with the FDA, pivotal for the progress of PAX-101, their leading drug candidate for autism treatment, within the regulatory framework. Type C meetings with the FDA address specific drug development issues like clinical trial design and data requirements, not covered by Type A or Type B meetings. This meeting will be a strategic opportunity for PaxMedica to discuss PAX-101’s development steps and ensure compliance with regulatory standards.

This upcoming meeting is a significant event for PaxMedica, as it aims to align with the FDA on PAX-101, an intravenous formulation of suramin that could potentially treat conditions like Human African Trypanosomiasis and Autism Spectrum Disorder (“ASD”). By engaging with the FDA, PaxMedica seeks to clarify regulatory pathways and address potential clinical trial hurdles, moving PAX-101 closer to market approval.

The outcomes of this FDA meeting are crucial, representing a key moment for PaxMedica to demonstrate the therapeutic potential and public health benefits of PAX-101. Successfully navigating this meeting could advance clinical trials and the approval process, crucial for addressing HAT, a neglected tropical disease, and ASD, affecting millions worldwide. PaxMedica’s recent efforts, like providing suramin for HAT treatment in Malawi, highlight the company’s commitment to global health and the potential positive impact of PAX-101 on healthcare.

PaxMedica’s primary mission is to address the unmet medical needs in ASD. The company is developing PAX-101 for ASD, with a completed Phase 2B study showing promising results. Additionally, PAX-102, an intranasal formulation of suramin, is under evaluation for ASD and other neurodevelopmental conditions. The company’s commitment extends to exploring selective APTs that target specific purinergic receptors, potentially offering enhanced therapeutic benefits.

The global ASD therapeutics market is projected to grow from $2.01 billion in 2023 to $3.42 billion by 2030, driven by increasing prevalence, rising awareness, and investment in R&D. PaxMedica believes that the addressable market for PAX-101, if approved, could significantly exceed these forecasts, given the current lack of treatments targeting the core symptoms of autism (https://ibn.fm/EVpYW).

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

• New York City has received lots of backlash, mainly from People for the Ethical Treatment of Animals (“PETA”), for its approach to addressing its rat problem
• Its approach, so far, has been characterized by the use of traps, poisons, and its “Trash Revolution” program, all of which have been unsustainable
• SenesTech, a rodent fertility control product provider, through its flagship Evolve(TM) product, offers an alternative that could potentially eliminate the entire rodent population in 12 to 18 months
• This solution avoids the adverse effects of the use of poisons, both to humans and other animals, and offers a sustainable, more proactive alternative to tackling the problem

Following New York City’s recent hard stance in the fight against rodents in the city, its leadership has been under backlash, mainly from People for the Ethical Treatment of Animals (“PETA”). The organization blamed the rat problem on the city’s lack of proper systems and infrastructure to manage garbage, which ultimately attracts rats in the first place. But it has also raised concerns about the inhumane approach the city has taken to fight the rodent problem, such as poisons and traps, a move that has been termed as “villainizing rats for problems created by humans” (https://ibn.fm/lsmj1). New York has mainly dealt with the rat problem by poisoning them and controlling trash. Although the approach has helped, it is seen as inadequate, with real dangers for non-rodent populations, and, unsurprisingly, poisons (and traps when used) are viewed as inhumane for the rodents. SenesTech (NASDAQ: SNES), a rodent fertility control product provider and the inventor of the only EPA-registered contraceptive for male and female rats, offers what many are calling a clearly superior option, and one that could potentially eliminate the entire rodent population in 12 to 18 months (https://ibn.fm/i9oU9). SenesTech’s flagship product, Evolve(TM), has been repeatedly demonstrated as an effective rat control alternative to the mainstream offerings currently in the market. The active ingredient in the product has been scientifically proven to reduce rodent fertility, ultimately offering a more proactive approach to addressing the growing rat problem, as opposed to a more reactive approach, as is the case with poisons and traps. The obvious argument is that it’s better to control reproduction than to kill rats after they are born. The company’s offering also addresses the potential secondary impact of using poisons to control rat populations, given the harm this approach can cause, not only to humans but also to other animals. One of many examples is an escaped zoo owl that was found dead, killed by raised levels of rodenticide in his system, caused by the consumption of poisoned rats for sustenance. “Rat birth control is a promising non-toxic solution to remediating heavily infested areas without dumping lethal poisons all over our city’s streetscape,” noted Shaun Abrew, an Upper West Side City Council Member. SenesTech’s offering would help deal with the rat problem but also help win PETA’s and other public goodwill in the fight against the problem for the city of New York. The city’s population acknowledges the problem and has fallen victim in one way or another, be it dealing with disease or an overall degradation in the quality of life. Adopting rat birth control through SenesTech’s Evolve(TM) would help remedy the situation while allowing all parties, PETA included, to join the fight against the rodents. For more information, visit the company’s website at www.SenesTech.com. NOTE TO INVESTORS: The latest news and updates relating to SNES are available in the company’s newsroom at https://ibn.fm/SNES

• Age-related macular degeneration is a disease significantly impacting the quality of life, making it difficult for individuals to perform everyday activities such as reading, driving, and recognizing faces
• InMed is currently developing a pipeline of drugs, like INM-089, to treat diseases with a high unmet medical need
• Delivers improved retinal pigment epithelium integrity, neuroprotection and photoreceptor improvement in in vivo preclinical disease model

Age-related macular degeneration (“AMD”) is a prevalent eye condition that primarily affects older adults, leading to vision loss in the central part of the retina, known as the macula. This disease significantly impacts the quality of life, making it difficult for individuals to perform everyday activities such as reading, driving, and recognizing faces. InMed Pharmaceuticals (NASDAQ: INM), a clinical stage company developing a pipeline of pharmaceutical drug candidates to treat several diseases with a high unmet medical need, is at the forefront of developing innovative treatments for this debilitating condition, with their flagship product INM-089 showing great promise.

AMD is the leading cause of vision loss among people aged 50 and older. It comes in two forms: dry AMD, which is more common and less severe, and wet AMD, which is rarer but more severe. The exact cause of AMD is not fully understood, but it is believed to involve a combination of genetic and environmental factors.

Results from several in vitro and in vivo studies demonstrated several pharmacological effects in the potential treatment of dry AMD. These include:

• providing neuroprotection of photoreceptors and improving photoreceptor function
• preserving retinal function in the back of the eye
• improving integrity of the retinal pigment epithelium (“RPE”)
• improve the thickness of “outer nuclear layer” (“ONL”) of the retina where photoreceptors are located (Based on widely accepted ocular research, the thickness of the outer nuclear layer is strongly correlated with photoreceptor preservation and visual acuity.)

INM-089 is also a proprietary small molecule compound acting as a preferential signaling ligand of cannabinoid receptor 1 (“CB1”) and cannabinoid receptor 2 (“CB2”). CB1 and CB2 receptors are both part of the endocannabinoid system that is found throughout the human body and is responsible for many homeostatic functions. CB1 receptors are primarily located in the brain and central nervous system, while CB2 receptors are involved in modulating neuroinflammation and immune responses.

InMed’s commitment to scientific excellence is reflected in its robust pipeline of cannabinoid-based treatments. In addition to INM-089 for AMD, the company is developing therapies for other serious conditions, including dermatological and Alzheimer’s diseases. Their research and development efforts are supported by a team of experienced scientists and industry professionals dedicated to bringing new treatments to market.

As InMed continues to advance INM-089 through pre-clinical studies, the company’s commitment to innovation and patient care remains steadfast. The future looks promising for those affected by AMD, thanks to the pioneering efforts of InMed Pharmaceuticals and their dedication to developing life-changing therapies.

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

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

• The new executive team includes Mark White, Alexander Morin, Hilda Maibach, and Blake Jensen
• These additions are pivotal as the company makes strides toward bringing flagship drug candidate buntanetap closer to New Drug Application (“NDA”) status and to market

Annovis Bio (NYSE: ANVS), a pioneering late-stage clinical drug platform company focusing on transformative therapies for neurodegenerative disorders such as Alzheimer’s Disease (“AD”) and Parkinson’s Disease (“PD”), is thrilled to welcome four seasoned professionals to its executive team.

Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio, said the company was delighted to have this strong group of individuals join the Annovis team. “Their expertise and leadership are critical in this pivotal moment in our company, as we continue making strides towards bringing buntanetap closer to NDA and to market for Alzheimer’s and Parkinson’s diseases,” Maccecchini added (https://ibn.fm/Co9Hy).

Mark White, who is currently serving on the Annovis Board of Directors, has been appointed as Chief Business Officer. He brings extensive experience in global pharmaceutical marketing, business development, and sales. His career includes significant roles at Pfizer, Bracco, Abbott, and Bayer. At Pfizer, he served as Vice President of Worldwide Marketing, where he was responsible for global new product development, business development, and in-line marketing for the Inflammation Therapeutic Area. Mark holds both bachelor’s and master’s degrees from the University of Missouri, as well as an MBA from the University of Chicago Booth School of Business.

Dr. Alexander Morin joins as the Director of Strategic Communications, bringing a rich background in the biopharmaceutical industry’s science and communications sectors. Previously, he was an Account Executive at a boutique public relations firm, where he enhanced corporate communications strategies and visibility for a variety of clients, including biotech companies, non-profits, and large pharmaceutical firms. Before his PR role, Dr. Morin was a consultant scientist at a CRO, designing studies for drug candidates. He holds a Ph.D. in Neuroscience from the Open University (“UK”), with a research focus on drug development for chronic traumatic brain injury.

With over 30 years of experience, Hilda Maibach steps in as Senior Vice President of Statistics. She has extensive expertise in clinical and observational studies across Oncology, Infectious Disease, Metabolic disorders, and Central Nervous System Disorders. Her work has supported industry, NIH, and DOD-funded clinical trials, emphasizing improving measurement sensitivity and innovating clinical trial design, data acquisition, and management. Ms. Maibach has also incorporated real-world evidence and bioinformatics tools into clinical study design to reduce costs and enhance outcome reliability. Her academic background includes research faculty positions at Emory and Stanford Universities, as well as a role as a statistician at the Centers for Disease Control (“CDC”) for CLIA. She holds an MSc in Statistics from Stanford University.

Blake Jensen, with over 20 years of experience in Quality, joins Annovis Bio as the Head of Quality. His background spans work within contract service providers and emerging biopharma companies, along with his prior role as an investigator for the U.S. FDA. Mr. Jensen has developed and implemented quality systems for start-up companies as a solo QA department and has led Quality teams of up to 90 people. He has considerable experience with regulatory inspections, hosting inspections from various health authorities, conducting inspection readiness activities, mock inspections, and delivering inspection training. During his time with the FDA, he conducted BIMO and GMP inspections. In the CRO space, he has managed teams across quality risk management, global audits, vendor management, CAPA, audit and inspection defense, policy and procedure management, billable audits, and quality analytics.

Annovis Bio is excited about the new additions to its executive team and confident that these highly experienced professionals will significantly contribute to the company’s mission of developing transformative therapies for neurodegenerative diseases. The combined expertise of Mark White, Alexander Morin, Hilda Maibach, and Blake Jensen will enhance strategic initiatives, strengthen communications, refine statistical approaches, and ensure the highest standards of quality. The company looks forward to their invaluable contributions as it continues to advance its clinical programs and strive to make a meaningful impact on the lives of patients with Alzheimer’s and Parkinson’s diseases.

For more information, visit the company’s website at www.AnnovisBio.com, and social channels
LinkedIn, X and YouTube.

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

• CNM-Au8(R) works by improving cellular energy production and utilization, which is crucial for maintaining neuronal health
• Clene has conducted several clinical trials to evaluate the safety and efficacy of CNM-Au8 in neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”)
• The global ALS treatment market is expected to grow significantly, driven by the increasing prevalence of the disease among the aging population
• Clene has submitted a briefing book to the FDA to seek feedback on a potential pathway for accelerated approval for CNM-Au8 to treat ALS

Clene (NASDAQ: CLNN), a biopharmaceutical company, is at the forefront of transforming the treatment of neurodegenerative disorders like ALS (amyotrophic lateral sclerosis) and multiple sclerosis (“MS”). In a recent Emerging Growth Conference 73 – Biotech Feature, Clene presented new findings and information pertinent to current and potential investors.

Under the leadership of CEO Rob Etherington, the company focuses on improving mitochondrial health, which is crucial for neurological functions. Mitochondria play a vital role in cellular metabolism and energy production. In neurodegenerative diseases, impaired mitochondrial function is a significant issue. Clene’s lead agent, CNM-Au8, targets the nicotinamide adenine dinucleotide (NAD+) pathway to restore and protect neurological function.

CNM-Au8 works by improving cellular energy production and utilization, which is crucial for maintaining neuronal health. Mitochondrial dysfunction is a common pathway leading to neuronal death in neurodegenerative diseases. By targeting this dysfunction, CNM-Au8 aims to provide neuroprotection and promote remyelination, potentially altering the course of these debilitating conditions.

Clene has conducted extensive clinical trials to evaluate the safety and efficacy of CNM-Au8. In Phase 2 trials for ALS, the treatment has been associated with improved survival rates and delayed clinical worsening. The drug has demonstrated a a favorable safety profile, with over 650 years of cumulative patient exposure without any serious adverse events attributed to it. These trials have also demonstrated significant improvements in biomarkers and in measures of clinical function.

Key studies include:

HEALEY ALS Platform Trial with Harvard’s Massachusetts General Hospital: Focused on ALS, this study showed statistically significant survival benefits in the double-blind phase.

RESCUE-ALS Study: A nine-month double-blind study that continues to follow patients for over three years through an open-label long-term extension, demonstrating promising survival and functional preservation outcomes.

VISIONARY Multiple Sclerosis Study: Despite being half-enrolled due to the COVID pandemic, CNM-Au8 treatment on top of standard-of-care MS drugs showed significant improvements in vision and cognitive function, which are critical unmet needs in MS treatment.

The global ALS treatment market is expected to grow significantly, driven by the increasing prevalence of the disease among the aging population. CNM-Au8 holds promise not only for ALS but also for other neurodegenerative diseases like MS and Parkinson’s, where current treatment options are limited. Its ability to penetrate the blood-brain barrier and its neuroprotective properties make it a strong candidate for addressing the high unmet needs in these markets​.

With over 650 years of cumulative subject exposure, CNM-Au8 has shown a strong safety profile with no serious adverse events linked to the drug. This robust safety data coupled with efficacy and biomarker results from two independent Phase 2 clinical trials in ALS has been instrumental in the company’s engagement with the FDA. Clene has submitted a briefing book to the FDA to seek feedback on a potential pathway for accelerated approval for #CNMAU8.

Clene is gearing up for phase three programs for both ALS and MS. The company’s innovative approach, backed by strong intellectual property with over 150 patents worldwide, positions it as a leader in addressing neurodegenerative diseases. The anticipated FDA interactions and ongoing studies will be crucial steps towards potentially bringing a transformative treatment to patients suffering from these devastating conditions.

Clene’s commitment to improving mitochondrial health offers a beacon of hope for patients with neurodegenerative diseases. With its promising clinical data, strong safety profile, and strategic regulatory engagements, the company is well-positioned to make significant strides in this challenging field.

A replay of the presentation can be found on the Emerging Growth Conference YouTube channel (https://ibn.fm/wCwsg).

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

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

• Lexaria, a global innovator in drug delivery platforms, recently completed dosing of its human pilot study #2, GLP-1-H24-2
• The study is to explore the tolerability, side effects, and blood levels of semaglutide, a glucagon-like peptide-1 (“GLP-1”) drug
• For Lexaria, the results from this study look to validate earlier studies that have demonstrated improvements in the delivery of semaglutide into the bloodstream
• Results from the GLP-1-H24-2 study are set to be announced in late August or early September

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, recently announced the dosing completion of its human pilot study #2, GLP-1-H24-2. Lexaria’s patented DehydraTECH(TM) “drug delivery platform technology” increases bioavailability, improving the way active pharmaceutical ingredients (“APIs”) enter the bloodstream by promoting more effective oral delivery, helping with speed of onset, and brain absorption of APIs. The potential of effective oral delivery of GLP -1 drugs, a class of drugs used to address diabetes and weight loss, represents a vast global market potential for DehydraTECH.

Blood samples collected throughout the study have been transported to the bioanalytical lab for analysis, and the organization looks to complete the analysis and announce the results in late August or early September.

“Lexaria is delighted that our contracted clinical research organization was able to complete the active phase of the study on schedule,” noted Chris Bunka, Lexaria’s CEO. “The results of this Study are expected to validate our earlier work with semaglutide, and also to discover whether it is possible to achieve any absorption of this market-leading GLP-1 drug through the tissues of the mouth,” he added (https://ibn.fm/HIyRm).

This study explored tolerability, side effects, and blood levels of semaglutide, a glucagon-like peptide-1 (“GLP-1”) drug. It also sought to measure blood glucose and insulin levels, highlighting the drug’s potential in treating diabetes and weight loss. The study comprised three primary arms, each of which compared three 7mg semaglutide dose formulations. The first arm was a positive control of Rybelsus(R), the only GLP-1 drug approved by the FDA for oral dosing to treat diabetes and weight loss. The second arm saw the use of Lexaria’s patented DehydraTECH technology in processing semaglutide in swallowed tablets. The last arm was an in-mouth dissolvable DehydraTECH-semaglutide oral tablet, a first in the industry.

This final study arm will be the first to investigate whether DehydraTECH-enhanced semaglutide can be absorbed systemically at any level through the sublingual/buccal tissues of the mouth and throat with fewer side effects than swallowed administration. It takes into account the stomach’s acidic environment, which seriously degrades GLP-1 drugs that are swallowed, resulting in meager blood absorption rates of less than 1% when an absorption technology is not used.

Previous Lexaria studies have demonstrated improvements in the delivery of semaglutide into the bloodstream and in controlling blood sugar. They also demonstrated that DehydraTECH GLP-1 processed semaglutide is generally better tolerated than the Rybelsus(R) tablets themselves, with the latter often resulting in instances of moderate diarrhea and nausea. GLP-1-H24-2 looks to validate these results and more, further pointing to the superiority of its DehydraTECH technology and highlighting its potential in treating diabetes and weight loss.

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

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