Exousia Pro (OTCPINK: MAJI) is developing a next-generation drug delivery platform using plant-based exosomes and a proprietary manufacturing process that could potentially address the biggest challenges in the therapeutic exosome sector—scalability, precision targeting, and efficient transport of complex genetic material.
“Exosomes offer significant advantages over traditional drug delivery systems. They’re nearly invisible to the immune system, cross biological barriers, and naturally fuse with cell membranes—making them powerful vehicles for targeted therapy,” Mike Sheikh, CEO of Exousia, says in an interview with BioTuesdays.
He adds, “And, because exosomes are 1/100th the size of a human cell, they can cross the blood-brain barrier—whereas only .2% of monoclonal antibodies (mAbs) can achieve this.”
All plant and animal cells naturally produce exosomes, Mr. Sheikh explains. These nanoscale sacs of cellular fluid, typically 30 to 100 nanometers wide, are secreted into the extracellular space and play a central role in intercellular communication. They are involved in various physiological and pathological processes. Their ability to travel through bodily fluids—blood, saliva, urine—and deliver cargo to specific targets highlights their potential as efficient biological couriers.
“Unlike mAbs, which largely act as targeting agents and don’t protect their cargo, exosomes can shield what’s inside and be engineered to deliver it where it matters,” he says. “That flexibility lets us consider intranasal, subcutaneous, or even topical administration when appropriate.”
Across the industry, most exosome production still follows a two-step routine: isolate vesicles from producer cells then load them with cargo in a separate manipulation. Each handling step invites yield loss, shifts particle characteristics, and adds batch variability.
Mr. Sheikh explains that this approach becomes especially inefficient as payloads grow larger or more delicate. “Standard post-isolation tricks like electroporation and sonication are notorious for damaging vesicles and causing clumping,” he says. “They’re blunt tools for a delicate job.”
Exousia’s patented in-producer approach enables DNA to be incorporated as cells are naturally forming exosomes, preserving vesicle integrity and improving encapsulation efficiency. This integrated process not only ensures consistent particle characteristics and functional potency but also reduces post-processing and labor intensity—making the platform scalable and commercially viable.
“This isn’t just a nicer factory flow,” Mr. Sheikh says. “It makes DNA a practical payload. You unlock gene modulation and durable expression that proteins alone can’t deliver—and you do it without sacrificing yield.”
By controlling critical quality attributes early—such as particle size distribution, cargo copy number, and functional potency—Exousia’s platform is designed for regulatory comparability and consistency as it scales.
Highlighting that biology gives exosomes an edge over synthetic carriers, Mr. Sheikh notes that nanoparticle drug delivery systems and liposomes require elaborate surface chemistries to escape immune surveillance and still, often struggle to reach the right tissues. Liposomes, though proven in some applications, may provoke inflammation, show nonspecific uptake, and demand extensive engineering to achieve the desired biodistribution.
“Nature already designed exosomes for cell-to-cell communication,” Mr. Sheikh says. “We tune what’s already there, resulting in fewer compromises between targeting, safety, and manufacturability.”
He acknowledges that the exosome space has seen both validation and friction. While early leaders advanced sophisticated targeting and payload concepts, many programs stalled on familiar pain points: scaling to GMP volumes without losing potency, keeping heterogeneity tightly controlled, and aligning with regulatory expectations for novel biologics.
“Fixing problems after the vesicles are made is the wrong place to start,” Mr. Sheikh points out. “Our philosophy is to set quality up front—integrating targeting and, uniquely for DNA, efficient loading during natural formation.”
Exousia’s lead therapeutic candidate is aimed at glioblastoma (GBM), a deadly brain cancer with high recurrence and resistance to standard treatments. The therapy combines gene silencing of a therapy-resistant pathway with Temozolomide chemotherapy, delivered via exosomes engineered to cross the blood-brain barrier and target cancer stem cells—the key drivers of tumor regrowth.
“Cancer stem cells are the generals of the tumor,” Mr. Sheikh says. “If you don’t neutralize them, they regroup and bring the cancer back.”
In preclinical models using humanized mice implanted with patient-derived GBM stem cells, Exousia’s therapy produced marked tumor reduction in just seven days—with exosomes alone showing significant therapeutic impact.
“That told us the delivery vehicle isn’t just a passive shuttle—it’s contributing to the therapeutic effect,” Mr. Sheikh asserts.
The company plans to seek orphan drug designation and pursue compassionate-use INDs in high-need areas. Mr. Sheikh emphasizes that compassionate use isn’t a shortcut but a strategic way to generate early clinical insights in a controlled, patient-first context. To compress timelines and streamline regulatory submissions, Exousia is also leveraging AI-assisted preparation and human-on-a-chip platforms aligned with FDA guidance.
Beyond GMB, Mr. Sheikh says that Exousia’s modular platform is being applied to programs in pancreatic, breast, lung, and colorectal cancers, as well as infectious diseases, where DNA payloads offer uniquely powerful interventions.
In tandem with its clinical programs, Exousia is commercializing plant-derived exosomes in the regenerative wellness space—specifically from nutrient-rich mushroom species—for dermatology, dentistry, and nutraceutical markets. Early formulations aim to promote hair growth, skin regeneration, and anti-inflammatory benefits.
“The consumer market is asking for biologically authentic solutions,” Mr. Sheikh contends. “We can bring scientific rigor to that space without distracting from our clinical mission.”
According to industry forecasts, the exosome skincare market is expected to grow from $310 million in 2025 to $633 million by 2033, with demand surging across North America, Europe, and Asia Pacific.
“We’re pragmatic about capital,” he adds. “A thoughtful consumer line can help fund the long game in oncology.”
Exousia operates a Biosafety Level 2 research facility in Orlando, Florida, and plans to upgrade to a GMP-compliant facility to support clinical manufacturing and commercial-scale production.
Mr. Sheikh emphasizes that investors have taken note of the platform’s potential and Exousia’s lean structure. “We have a market cap of $5 million, with 42 million shares outstanding, and a concentrated shareholder base.”
He concludes, “We’re still early, but we’ve solved a fundamental problem—DNA delivery at scale in a way that aligns biology with manufacturability. Our job is to turn elegant biology into dependable solutions.”
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