List of NanoMedicine/Nanotechnology Companies with Phase 2 Active Clinical Trial - 17

Aadi Bioscience, Inc. is a commercial-stage biopharmaceutical company developing precision therapies for genetically-defined cancers.

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed Kostaive®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (over 400 patents and patent applications in the U.S., Europe, Japan, China, and other countries).

ARTIDIS AG is a clinical stage medical technology company developing the first nanotechnology platform for tissue analysis combined with a digital data platform, intended for broad use in drug discovery, tissue engineering as well as for rapid diagnostics and personalized treatment optimization.

Ashvattha Therapeutics is developing a new class of drugs that identify and treat diseased cells with unprecedented precision. Our proprietary hydroxyl dendrimer (HD) platform, exclusively licensed from Johns Hopkins University, allows for the creation of hydroxyl dendrimer therapeutics (HDTs), which link known small molecule drugs to HDs for selective delivery with sustained effect in diseased tissues. We believe this approach to precision medicine has the potential to change the standard of care across neurology, ophthalmology, hyperinflammatory diseases and neuro-oncology.

Developing seamless neural interfaces.

Developing new drugs under FDA regulation for hypoxia brain and heart ischemia and viral infection like coronavirus and influenza.

Clene Inc., a clinical-stage biopharmaceutical company, focuses on the development of various therapeutics for neurodegenerative diseases. The company has a nanotechnology drug platform for the development of orally administered neurotherapeutic drugs. Its lead drug is CNM-Au8, which is being studied in various clinical trials, including a Phase 2 study for the treatment of stable multiple sclerosis; a Phase 2 biomarker study in Parkinson’s; and Phase 2 and Phase 3 trials to investigate the potential for disease modification for neurodegenerative diseases. The company’s products also include CNM-AgZn17, a topical gel polymer suspension of silver and zinc ions that is being developed for the treatment of infectious diseases and to accelerate wound healing; and NM-PtAu7, a gold-platinum CSN therapeutic. Clene Inc. is based in Salt Lake City, Utah.

We are a group of dedicated scientific, medical, and business professionals who are driven to find treatments and cures to a variety of diseases. By attacking the disease directly with our novel nanoparticle-based technologies and working strategically with our medical and scientific partners we seek to provide treatments and cures previously unavailable to doctors and their patients.

Advancing regenerative medicine through the development of a natural biomaterial that restores mother nature’s template to treat disease and injury. ECM scaffolds, in solid form, have been successfully used in more than 10 million human patients to repair a variety of body systems such as musculoskeletal tissues, cardiovascular structures, and non-healing skin wounds, among others. These products have all received FDA clearance. ECM Therapeutics'​ patented ECM hydrogel technology allows for expanded, less invasive applications in multiple disease areas. The first clinical product, EsophaGel, treats Barrett’s esophagus, a precancerous condition that currently has no effective therapy.

Entos Pharmaceuticals Inc. is a clinical-stage genetic medicines company. A new reality in genetic medicine lies ahead, one that will be ushered in with the advent of safe, effective, and redosable nucleic acid delivery technologies. At Entos, we develop next generation genetic medicines using our proprietary Fusogenix proteolipid vehicle (PLV) drug delivery system. Fusogenix PLVs are formulated with FAST proteins to enable the delivery of nucleic acid into target cells through direct fusion.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is then taken up by tumor cells that express tumor suppressor proteins that are deficient in the body. The Company’s lead product candidate, REQORSA® (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Both NSCLC clinical programs received a Fast Track Designation from the Food and Drug Administration. Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells.

InnoUp is a clinical-stage nanotechnology company focused on developing safer and more effective treatments for Food Allergies, Oncology, and Vaccines. We have developed a new drug encapsulation platform currently being tested in different clinical and pre-clinical programs. INP20 - Oral Peanut Allergy Vaccine: Phase I INP12 - Low-toxicity Paclitaxel oral chemotherapy for Breast Cancer: Phase I INP30 - Oral Vaccine Infectious Diseases: pre-clinical Our encapsulation platform is based on biocompatible nanoparticles that allow all types of payloads (drugs, proteins, RNA, and DNA). These nanoparticles have been engineered to increase bio-adhesion capacity to the mucosa, which translates into a need for lower and safer drug doses to achieve a therapeutic effect. Therefore, drugs encapsulated using our platform become more effective and safer. The technology is protected worldwide, including USA and Europe, until 2035. Our short-term business strategy includes starting operations in the US beginning 2022 with the opening of an affiliate in Boston, MA. From there, we will manage the movement to the next phases of our clinical programs (Phase II) in the US. We are already working with the FDA for the pre-IND meeting preparation. We plan to increase our value in the mid-term by building a clinical-stage multi-asset pipeline with expected significant efficacy and safety milestones by 2025. Besides, we plan to build our GMP manufacturing facility to control our manufacturing process fully. We expect it to be fully operative by 2025. We are actively working on raising money to cover the following steps and, we are open to considering all types of investment. In parallel, we are also actively seeking licensing partners interested in our products.

NexImmune, Inc., a clinical-stage biotechnology company, engages in developing therapies with curative potential for patients with cancer and other life-threatening immune-mediated diseases. It develops approaches to T cell immunotherapies based on its proprietary Artificial Immune Modulation (AIM) technology. The company has two product candidates in human trials, including NEXI-001 in acute myeloid leukemia, or AML; and NEXI-002 in multiple myeloma, or MM. NexImmune, Inc. was founded in 2011 and is headquartered in Gaithersburg, Maryland.

Radiopharm Theranostics is developing a world-class platform of radiopharmaceutical and nuclear medicine products for both diagnostic and therapeutic applications. The company is focused on innovating the way we see and treat cancer, with a particular emphasis on HER-2 cancers. Radiopharm Theranostics has a strong team of executives and board members, and is actively engaged in investor relations and corporate governance. The company has also launched a joint venture with MD Anderson to focus on novel radiopharmaceuticals.

Revalesio is a clinical-stage pharmaceutical company committed to creating treatments for neurological diseases and conditions that lack adequate therapeutic options. Our therapies address cellular imbalances related to mitochondrial dysfunction and thereby modulate the immune response. They have been shown to protect neurons in models of chronic neurological diseases and improve recovery in acute neurological injury. We are partnering with internationally renowned scientists in biomedical research in a concerted effort to improve the lives of millions.

Shaperon is a clinical stage biotech company developing novel inflammasome inhibitors(small molecule). Its unique mechanism of action of GPCR-regulated P2X7 inhibition suppresses a broad spectrum of inflammatory cytokines including IL-1β, IL-18, IL-6, and TNF-α, etc. by controlling both priming and activation phase of inflammasome, whereas conventional approaches are designed to suppress only the activation phase. With this unique and novel modality which is best suited to address complex immune-mediated inflammatory disorders, we are currently developing multiple clinical programs in atopic dermatitis, cytokine release syndrome, Alzheimer’s disease, ulcerative colitis, NASH, etc. In addition to inflammasome R&D programs, Shaperon has anti-viral, anti-cancer nanobody therapeutics. Shaperon’s proprietary immunized nanobody libraries combined with high throughput screening and in vitro/in vivo system enable us to fast forward the realization of advantages of Nanobodies over conventional antibody-based medicines. We currently developing multi-valent, multi-specific Nanobodies in multiple delivery forms in oncology and viral infection diseases.