The H.C. Wainwright 27th Annual Global Investment Conference. My name is Kyle Meury, and I'm an analyst on the corporate access team. H.C. Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory, and related services to public and private companies across multiple sectors and regions. We have a total of 18 publishing senior analysts and over 650 companies covered across all sectors. If you'd like more information, please check out our website, hcwco.com. From a logistics standpoint, please make sure to reference your conference portal that provides you your meetings and presentations, as well as the conference agenda. With that said, have a productive and enjoyable day. I'd like to introduce Michael Woudenberg, Chief Operating Officer of InMed Pharmaceuticals. Thank you.
Thank you, Kyle. Good day. My name is Michael Woudenberg. I'm the Chief Operating Officer at InMed, as mentioned. I'd like to thank everyone for joining today, and I hope the conference is going well. Before we begin, a quick note: as a Nasdaq-listed company, it's important that I point out that today's presentation contains forward-looking statements. Please see disclaimer for additional information and reference. InMed is a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates targeting the CB1/CB2 receptors. Our R&D pipeline is robust, with three pharmaceutical candidates. First, our Alzheimer's program takes a multifactorial approach and reduces neural inflammation, a key driver of disease progression, and is our lead program. Second, in ophthalmology, our dry AMD candidate has demonstrated both functional and pathological improvements, positioning it as a differentiated therapy.
Third, in dermatology, we've completed a phase II trial in EB and are now seeking strategic partnerships to advance development in chronic anti-itch. Beyond these lead programs, we maintain a broad library of proprietary candidates targeting diverse pharmaceutical applications, supported by strong IP that spans molecules, manufacturing, and methods of use. Complementing our R&D engine, we also operate a profitable subsidiary that sells rare, non-intoxicating cannabinoids into the health and wellness industry, providing near-term revenue while we advance our pharmaceutical pipeline. This slide provides an overview of our company structure. InMed, the parent company, located in Vancouver, British Columbia, Canada, is the hub of the pharmaceutical drug discovery, R&D, and manufacturing technology of the company. BayMedica, located in South San Francisco, California, operates a commercial B2B supply of rare, bioidentical, non-intoxicating cannabinoids to the health and wellness industry.
Leveraging our strong pharmaceutical foundation, our company has collaborated with BayMedica's commercial team to support and strategically scale the supply of their products. This model gives us near-term, near-term revenue opportunities, while advancing a robust pharmaceutical pipeline for long-term growth. Let's turn now to our drug development programs. Our pipeline of proprietary small molecules is focused on Alzheimer's, with INM-901, and dry AMD with INM-089, where the need for disease-modifying therapies remains urgent. Both INM-901 and INM-089 are in preclinical stage, moving towards IND-enabling studies. INM-755 has completed a phase II trial in EB patients, and we are currently pursuing partnerships for potential further development in chronic itch. As everyone's aware, Alzheimer's disease affects millions of people worldwide, robbing patients of their memory and independence, and placing an enormous burden on families and healthcare systems. For decades, progress has been incremental at best.
At InMed, we're developing a new therapy designed to potentially address the underlying biology of this disease. Let's take a deeper look at INM-901 and how our approach could potentially reshape the future of Alzheimer's treatment. This snapshot provides a summary of the current landscape in R&D for Alzheimer's disease. Historically, development has been focused on anti-amyloid betas, but more recently, the thought process has switched to a multifactorial approach similar to cancer. There is no silver bullet, and what is needed may, excuse me, may be a combination of treatments to tackle this devastating disease. The highlighted targets above in yellow, neuroinflammation, neuroprotection, and neurogenesis, illustrate where INM-901 can potentially achieve meaningful therapeutic effect versus single-target approaches. INM-901 provides a multifactorial approach to treating Alzheimer's disease, targeting several key mechanisms of pathology.
It acts as a preferential agonist at CB1 and CB2 receptors, and impacts PPAR signaling pathways. In preclinical studies, it has shown increased neurite outgrowth and neuroprotective effects, both of which are important indicators of enhanced neuronal function. Importantly, INM-901 is formulated for oral delivery and has been shown to effectively cross the blood-brain barrier, a critical hurdle in CNS drug development. In long-term preclinical models, we observed statistically significant reductions in neuroinflammation, along with improvements in cognition and behavior. Taken together, these findings highlight INM-901's differentiated ability to act across multiple pathways, giving it strong potential as a novel disease-modifying therapy in Alzheimer's disease. Let's take a closer look at what this illustration shows us about our compound's mechanism of action. At the center is the Alzheimer's brain, burdened by amyloid plaques, a hallmark of disease progression. From here, two distinct pathways emerge.
On the right, we see unchecked disease state, rising inflammation, and ongoing neural injury, and escalating amyloid load, all reinforcing a vicious cycle of neurodegeneration. On the left side, we see the therapeutic effects of our compound, which crosses the blood-brain barrier and initiates a broad neuroprotective response. Green arrows down represent reductions in toxic processes like cytotoxicity inflammation. The green arrows up indicate gains in neuronal health, indicating neuroprotection, enhanced function, improved cognition, and restored motor performance. Importantly, we're not just preserving neurons, we're potentially supporting neurogenesis and neuritogenesis. New neurons are generated and integrated into neural cell circuits, which may allow for structural recovery, not just symptom control. We also see synaptic stabilization and axonal support, which help maintain network integrity, even in the presence of disease stressors. This is possible because of our compound's unique pharmacology.
It is orally bioavailable, crosses the blood-brain barrier, and engages CB1, CB2, and PPAR pathways, enabling it to suppress harmful cascades while activating regenerative processes. In short, on the left, we may promote neurogenesis, connectivity, and protection. On the right, we interrupt the cycle of inflammation and plaque accumulation. This multi-action profile positions our candidate as a potentially differentiated, multimodal therapeutic, and a compelling approach to tackling neurodegenerative disease at its core. This illustration outlines a completed long-term study using the 5XFAD mouse model for Alzheimer's disease. This model is recognized for its rapid accumulation of amyloid plaques, robust neuroinflammation, and associated cognitive and behavioral deficits in order to study potential therapies. Following encouraging results from our short-term studies, we extended this work into this seven-month long-term study.
This allowed us to evaluate INM-901 at a later and more advanced stage of disease progression, which is critical for translational relevance. We used multiple treatment arms, including three placebo arms and two different doses of INM-901. At the conclusion of the study, the animals underwent a comprehensive battery of behavioral tests. These included assessments of cognition and memory, as well as tests for anxiety and sensory responsiveness. This broad behavioral evaluation ensured we captured both cognitive and neuropsychiatric domains affected in Alzheimer's. In addition, we collected both brain tissue and plasma samples at study endpoint to enable extensive molecular analysis. Downstream assays included RNA sequencing, multiplex ELISA, Western blotting, and histological analysis. By combining behavioral outcomes with molecular and cellular readouts, we can directly connect functional improvements with mechanistic insights into how INM may be exerting its effects.
This rigorous and comprehensive design positions us to validate earlier findings while expanding our understanding of INM-901's potential as a therapy for Alzheimer's. The results of the long-term study continue to show promise across multiple key areas relevant to neurodegenerative disease. Cognitive and behavioral benefits. We're observing strong positive trends in cognitive function, as well as improvements in anxiety-related behaviors and sensory responsiveness. Neuroinflammation modulation. INM-901 demonstrates robust anti-inflammatory activity with an Alzheimer's disease pathology, an increasingly critical therapeutic target. Reduction of amyloid beta. Importantly, INM-901 effectively reduces amyloid beta accumulation in the brain, aligning with key disease-modifying strategy in Alzheimer's treatment. Mechanistic validation via mRNA data. Gene expression data reinforces these findings and provides supporting improvements in cognition, memory, and neurogenesis at the molecular level.... Together, this multi-pronged activity positions INM-901 as a potentially differentiated candidate in Alzheimer's disease. On the R&D front, our work continues in multiple areas.
We're expanding our data set with additional mRNA, protein, and histological measurements, while closely assessing markers of neural differentiation, function, and survival. We're also evaluating cellular stress responses, growth, and survival pathways. In parallel, CMC activities for both drug product and drug substance are moving ahead for planned future increased supply. Mechanistic studies are ongoing to deepen our understanding of receptor interactions and pharmacokinetics. Looking ahead, dose-ranging studies in a pre-IND meeting will set the stage for GLP studies, which are planned to follow. On the business side, we are actively engaging with potential co-development partners and strategic investors to help accelerate the path forward to maximize the impact of this program. Moving on to our next program for the treatment of Dry AMD with our product, INM-089.
This disease causes a loss of central vision, leading to loss of vision, and affects nearly 20 million people in the U.S. and almost 200 million people worldwide. Importantly, about 90% of AMD cases are of the dry form, where there are limited approved treatments. This represents a significant unmet medical need and a major market for opportunity for innovation. Dry AMD occurs when the macula, the part of the retina responsible for sharp central vision, becomes damaged. In a healthy retina, photoreceptor cells and the retinal pigment epithelium work together to maintain vision. But in dry AMD, these cells are progressively lost, often due to inflammation and the buildup of deposits called drusen. Over time, this damage can advance into what's known as geographic atrophy, where the retina wastes away and central vision is permanently lost.
This progression makes dry AMD the most common and devastating form of AMD, underscoring the urgent need for effective treatments. INM-089 represents a differentiated approach to treating a dry AMD. It acts as a preferential signaling ligand for both CB1 and CB2 receptors. In preclinical disease models, it has demonstrated promise in preserving retinal function, protecting retinal ganglion cells, and improving the thickness of the outer nuclear layer, where the photoreceptors critical for vision reside. Importantly, it is also deliverable through the standard intravitreal injection route, the preferred method for retinal therapies, ensuring alignment with current clinical practices. Together, these features highlight INM-089 as a novel therapeutic candidate with the potential to address the significant need in dry AMD by protecting vision at multiple points of vulnerability in the retina.
Our next steps focus on advancing INM-089 through key R&D milestones, including additional mechanistic studies and preparation for a pre-IND meeting leading into GLP studies. In parallel, we are progressing CMC activities to support continued preclinical and future clinical readiness. On the business side, we're pursuing partnerships and strategic investors to accelerate development. Together, these efforts set a clear path towards the clinic and long-term value creation. Our dermatology candidate, INM-755, completed a phase II study in patients with EB, a severe genetic dermatological disease with chronic itch as one of the primary symptoms. In this study, two-thirds of patients experienced a clinically meaningful reduction in itch, with nearly 30% showing clear benefit beyond control. These results confirm meaningful anti-itch, anti-itch activity and provide a strong foundation for further development. We are now pursuing strategic partnerships to advance INM-755 in broad chronic itch indications.
Alongside our R&D programs, we have our commercial subsidiary, BayMedica, that provides a complementary revenue stream and strategic presence in the market it serves. BayMedica specializes in producing rare, non-intoxicating cannabinoids at high purity, consistent quality, and bioidentical to those found in nature for sales to the health and wellness markets. What differentiates BayMedica is the ability to deliver consistency and quality at scale, a challenge few have overcome. Its production methods are cost-effective, leveraging multiple manufacturing approaches to ensure efficiency, while our team brings deep expertise in cannabinoid biosynthesis and chemistry. The business provides not only commercial revenue today, but also strategic value in establishing manufacturing know-how and market presence as we advance our broader pipeline.... Turning to financial performance, BayMedica continues to deliver steady growth.
Over the past 12 months, BayMedica generated $4.8 million in revenue, with kilograms sold more than doubling in the last 18 months, and despite pricing pressure, it has remained profitable. Importantly, the business is operating as cash flow positive, providing support for the company while we advance our pharmaceutical pipeline. Overall, this is a scalable business that not only delivers near-term revenue, but also supports InMed's pharmaceutical development. At the corporate level, we combine the right people and the right financial discipline to drive growth and value. For a relatively small R&D organization, the InMed team has decades of experience guiding biopharma companies from early discovery through clinical development and commercialization. On the R&D side, we have deep capabilities spanning preclinical research, chemistry, synthetic biology, and translational science. This is complemented by proven operational strength in GMP manufacturing, scale-up, and regulatory strategy.
Taken together, this is a seasoned team with the skills required to advance programs efficiently, build value, and position the company for long-term success. Turning to our financials, we are well-positioned to support the next phase of development. We maintain a solid cash position, providing the resources needed to advance our R&D programs through calendar year 2026. Including all shares in our recent financings, we now have approximately 4.2 million issued and outstanding, which would be considered a very low-float company. However, for such a low float, we maintain good liquidity with a high average daily volume. We believe that our current market cap, we are undervalued, as we have three pharma development programs, a profitable commercial business, and a significant cash position. Overall, we believe our financial position gives us the flexibility to execute on strategy.
We continue to explore partnerships and investment opportunities to accelerate our growth. InMed's strategy is built around four core drivers that position us for long-term value creation. First, we're advancing our lead program, INM-901 in Alzheimer's disease, towards IND filing and subsequent human clinical trials. In parallel, our second program, INM-089 in dry AMD, is progressing towards IND filing. Beyond these lead assets, we continue to target proprietary drug candidates to further strengthen and diversify our R&D platform, and finally, we are committed to executing strategic initiatives that not only accelerate development, but build sustained shareholder value. Together, we have a clear path forward, advancing our pharma programs, expanding our portfolio, ensuring disciplined execution to deliver impact for both patients and investors. Thank you for your attention today. If anyone has any questions, please reach out to our VP of IR, Colin Clancy.
His details are included here in this final slide. Thanks.
Thank you, Michael, for leading a very productive and informative presentation. We're very grateful for your presence at our conference this year. Thank you again to everyone joining our conference. We hope you have an enjoyable time, and thank you.
Thanks, Kyle.