List of Therapeutic Companies in Virginia - 31

Acumen is forging a new path towards safe and effective treatments for Alzheimer’s disease and other neurodegenerative diseases through our focus on the biology of toxic soluble amyloid-beta oligomers. Our founders pioneered seminal discoveries and methods to understand the role of toxic amyloid-beta oligomers (Aβo) in synaptic dysfunction and neurodegeneration. These early insights have fostered decades of research on the biology of Aβo at Acumen and throughout the field. We are now on the on cusp of realizing the therapeutic potential of Aβo targeted drugs.

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in the Company’s landmark ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes, which are to be identified using the Company’s proprietary companion diagnostic genetic test.

Aditxt is a social innovation platform. Every year, billions of individuals face health challenges such as autoimmune diseases, misdiagnosis, infectious diseases, organ failure, reproductive health issues, malnutrition, cancer, as well as barriers to accessing healthcare. Innovations with immense potential to address critical healthcare challenges are all around us. Untapped innovations hold the key to transformative solutions. Socially owned and capitalized as  a Nasdaq listed company with a mission of discovering, developing and deploying promising health innovations. Now is the time to inspire and mobilize the social capital inherent in a global community of stakeholders to actively participate in the discovery, development, and implementation of health solutions that could benefit humanity.

Adovate develops novel drugs that target adenosine receptors involved in major diseases. These drug candidates have been created using our next-generation adenosine drug development platform, which enable design of patented compounds with favorable physiochemical characteristics and distribution kinetics that historically limited drugs acting against the adenosine receptors.

The mission of Amerimmune is to innovate in diagnoses and therapies of immune and allergic disorders.

Biopep Solutions Inc. is a privately owned, late pre-clinical stage biotechnology company that discovers and develops innovative therapeutic products for the treatment of cancers and other diseases. The Company’s lead product, BPS-001, is a heterogeneous biologic extract containing a known composition of multiple peptide and protein components. BPS-001 has the potential to treat a wide variety of cancers and diseases.

BioTherapeutics Inc (BTI) synergistically combines the power of advanced computational modeling, data analytics and artificial intelligence with translational experimentations to accelerate the development of innovative products for precision medicine and health. Our computational platform assembles biomedical and healthcare data from the molecular, cellular, tissue and population levels and leverages the latest innovations in technology to turn those data into answers to complex biological questions and solutions to healthcare's problems.

Biovista is a biotechnology company located in Charlottesville, Virginia, founded in 2005 by CEO Andreas Persidis. The company specializes in AI-driven drug repositioning and development services, aiming to enhance the efficiency of bringing new treatments to market. Biovista offers services that include drug repositioning, which identifies new therapeutic uses for existing drugs, and drug de-risking, which assesses and mitigates potential risks in drug development. The company also conducts disease cohort analysis to better understand specific patient populations and treatment strategies. Biovista develops its own drug repositioning programs across various therapeutic areas, including central nervous system disorders, diabetes and obesity, eye disorders, and oncology. The company employs advanced AI technologies to analyze large datasets, facilitating the discovery of novel applications for existing drugs. Biovista is actively involved in R&D projects, reflecting its commitment to advancing drug discovery through innovative approaches.

Cary Pharmaceuticals is a pharmaceutical development company. The Company is advancing the development of QuitPak®, a patented treatment for smoking cessation, and a novel catheter lock solution to prevent clot formation in catheters. The Company is led by an experienced management team and Board of Directors, including Douglas Cary (President) a former Abbott Laboratories executing; Carl Schwan (CFO) a former CFO for two successful initial public offerings that raised $80 million; and Lester Crawford (Director), Former Commissioner of the U.S. Food and Drug Admininstration (FDA).

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. In the completed Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine administered first, before they received the standard of care, which involved surgery followed by either radiation or chemoradiation. The Phase 3 study enrolled 928 patients. Our approach is unique because most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. After analyzing data from the Phase 3 study, we have better defined the target population for Multikine, which is locally advanced primary head and neck cancer patients with no lymph node involvement and with low PD-L1 tumor expression. In the Phase 3 study, we observed statistically significant survival in this target population, showing that Multikine cut the risk of death in half at five years vs control. Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine is the trademark we have registered for this investigational therapy, and this proprietary name is subject to review by the FDA in connection with our future anticipated regulatory submission for approval.

Engineered BioPharmaceuticals, Inc. is a state-of-the-art biotechnology company focused on advancing dry powder pharmaceutical manufacturing and delivery through Atmospheric Spray Freeze Drying (ASFD) technology. Manufacturing dry powder pharmaceuticals using the ASFD process offers many possibilities including increased stability and shelf life of drug formulations, ability to store at room temperature, reduced weight and bulk, and the ability to facilitate the development of novel self-administration methods of delivery, such as nasal and pulmonary. A significant advantage of the ASFD process compared to its competitors is that it allows pharmaceutical powders to be "engineered" for a wide variety of final use applications. A specific final particle size is easily achieved by adjusting the droplet diameter via the spray nozzle. In addition, the density, and thereby the aerodynamic size, can be adjusted independent of the geometric diameter by altering the starting solute concentration. With our population demanding sophisticated therapeutics to extend life expectancy and improve quality of life, contrasted with the dire need to reduce spiraling healthcare costs, there is enormous pressure and opportunity for the pharmaceutical industry to embrace new technologies that answer the call. We are excited about the innovative work taking place at eBio to advance the field and look forward to the opportunity to use ASFD technology to impact the future of medicine.

G3 leverages molecular profiles of human health and disease to develop life changing diagnostics and therapeutics.

GlycoMantra is a biologics company developing novel therapeutics for unmet medical needs in metastatic castration-resistant prostate cancer, NASH liver disease, and other diseases.

Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat substance use disorder and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of addiction. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid dependence treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of addiction, including alcohol use disorder. Headquartered in the United States in Richmond, VA, Indivior employs more than 800 individuals globally and its portfolio of products is available in 37 countries worldwide. Our guiding principles foster a corporate culture of trust, innovation, and a pioneering spirit: • Focus on patient needs to drive decisions • Seek the wisdom of the team • Believe that people’s actions are well intended • Care enough to coach • See it, own it, make it happen • Demonstrate honesty and integrity at all times

KeifeRx is an emerging clinical-stage biopharmaceutical company developing novel and optimized, low dose, orally delivered tyrosine kinase inhibitors (TKIs) for the treatment of multiple, high-need neurodegenerative and immune diseases.

KeViRx, Inc. is a preclinical stage pharmaceutical company headquartered in Charlottesville, VA. We are developing small molecules drugs that treat microvascular leakage and inflammation, pathologies that are the basis for many diseases, including cancer and respiratory disease. We are now entering IND-enabling studies for pulmonary microvascular leakage and inflammation during acute lung injury. Our lead asset, KVX-053 has potent anti-inflammatory and immunomodulatory effects. In preclinical models, KVX-053 reduces lung injury scoring & the biomarkers of lung injury, inflammation & proinflammatory cytokine release, & immune cell infiltration into the lung. KVX-053 also improves lung function after lung injury.

Mallinckrodt is a global specialty biopharmaceutical and medical imaging business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology and pulmonology along with analgesics and central nervous system drugs for prescribing by office- and hospital-based physicians. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Global Medical Imaging segment includes contrast media and nuclear imaging agents. The company's fiscal 2014 revenue totaled $2.54 billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com. Mission: Managing Complexity. Improving Lives. Values: Quality, Integrity, Service Principal Executive Office: Mallinckrodt plc Damastown Industrial Estate Mulhuddart, Dublin 15 Ireland U.S. Headquarters: 675 McDonnell Blvd. St. Louis, MO 63042 USA Website: www.mallinckrodt.com Stock Ticker: MNK Corporate Blog: http://blog.mallinckrodt.com/ Careers Website: www.mallinckrodt.com/careers Investor Relations: http://www.mallinckrodt.com/investors

Nexilico is an early-stage biotechnology startup that employs the power of computational biology and AI to address challenging problems in medicine and biotechnology. As a pioneer in the next generation in silico microbiome technologies, Nexilico advances scientific understanding about the role of microbiomes in health and disease and leverages that information to develop novel microbiome-based technologies

NImmune is a late-stage precision immunology biopharmaceutical company that develops best-in-class biomarker-driven immunoregulatory therapeutics. Underpinned by advanced computational modeling and bioinformatics coupled with biomedical research capabilities to pioneer innovation in immunoregulatory drug development, NImmune’s business model enables the rapid and capital-efficient clinical development of high conviction drug candidates into New Drug Application (NDA) filing and commercialization. NImmune’s clinical development pipeline includes omilancor, a Phase 3-ready lead clinical candidate targeting LANCL2, an oral, once-daily, gut-restricted, first-in-class therapeutic for Ulcerative Colitis and Crohn’s disease with registration-directed pivotal clinical trials planned for 2023.

Develop DNA nanostructures

Founded in 2018, Quoin is an emerging specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities, and care teams. Quoin’s innovative pipeline comprises three products that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Epidermolysis Bullosa and others. The company plans to establish a sales infrastructure to commercialize its products in both U.S. and Europe and seeks to enter into strategic licensing partnerships for all other territories. We are dedicated to finding unique solutions for rare and orphan indications and will continue to expand our pipeline of products to address the unmet needs of underserved patient populations. To learn more about Quoin Pharmaceuticals please visit our website: www.quoinpharma.com

ReAlta Life Sciences is a biotech company that focuses on rebalancing the inflammatory response to address life-threatening acute inflammatory and rare diseases with their EPICC peptides based on the human astrovirus research.

RECKITT BENCKISER GROUP PLC is a Consumer Goods company that offers a wide range of household, healthcare, and hygiene products.

Response Pharmaceuticals, Inc, is a clinical-stage therapeutic development company focused on developing treatments for weight management and metabolic disease. Our initial clinical focus is to help people taking antipsychotic medications for disabling mental illness combat weight gain and metabolic dysregulation that is endemic with these treatments.

Retension Pharmaceuticals is developing RTN-001, a differentiated, tissue-targeted PDE5 inhibitor that has been optimized for the treatment of uncontrolled hypertension. RTN-001 has been evaluated in over 265 subjects across 9 clinical trials. In these studies, RTN-001 was well tolerated and demonstrated a sustained and clinically significant impact on central and brachial blood pressure in patients with uncontrolled hypertension. RTN-001 is a second generation PDE5i that preferentially distributes to cardiovascular tissues, where it acts to mediate a sustained and clinically significant impact on central and brachial blood pressure in patients with uncontrolled hypertension.

Rivus Pharmaceuticals, Inc., is dedicated to transforming the treatment of cardio-metabolic disease by advancing a new class of oral, once daily, small molecule therapeutics called Controlled Metabolic Accelerators (CMAs). Rivus’ CMAs are designed to improve cellular metabolism and treat the underlying cause of highly prevalent metabolic and cardiovascular diseases including type 2 diabetes, severe hypertriglyceridemia (SHTG), non-alcoholic steatohepatitis (NASH), as well as cardiovascular diseases such as heart failure with reduced ejection fraction (HFpEF).

Serpin Pharma is a biotech company that develops targeted therapeutics to enhance the body's natural immune response, reducing inflammation and restoring immune balance.

Slate Bio is a Virginia-based biopharmaceutical company that develops and commercializes T cell therapies for the treatment of autoimmune and inflammatory diseases.

Our vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (theranostics). With our robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and now, high value radiopharmaceutical intellectual property, we are poised to deliver on the promise of radiopharmaceuticals. www.sofie.com www.twitter.com/sofiebio www.instagram.com/sofiebio

Synthonics, Inc. is a privately-held specialty pharmaceutical company focused on the discovery and development of patentable drugs that incorporate our proprietary metal coordination chemistry. We bind metals to known pharmaceutical agents to create new products that are better absorbed and thus have greater therapeutic benefits than their predecessors. Although our chemistry has broad application, we're preliminarily focused on drugs, such as T3 (liothyronine) and levodopa, whose short half-life limits their clinical utility.

TearSolutions Inc. is a Delaware Corporation based in Charlottesville, VA. The company has successfully completed a well-powered 204 patient Phase II Proof of Concept clinical trial for the treatment of ocular surface disease in primary Sjögren’s Syndrome patients. Statistically significant improvement in both sign and symptom at two weeks was found. The trial compared vehicle and two doses of LacripepTM, a novel 19 AA peptide that is present in normal tears and deficient in all forms of dry eye. The peptide restores homeostasis to the ocular surface, in particular the barrier function of the corneal epithelium and normal function of sensory nerves at the corneal surface in preclinical animal models. Restoration of epithelial barrier function can be measured clinically as a decrease in corneal fluorescein staining while the improvement in sensory nerve function restores normal production of the components of tears: the aqueous via reinnervation of lacrimal glands, the lipid via reinnervation of meibomium glands and the mucin via reinnervation of goblet cells. Improvement in fluorescein staining and tear production (Schirmer tear test) are clinical ‘signs’ of ocular suface disease that have been used in the FDA approval of Xiidra and Restasis, respectively. Lacripep was discovered at the University of Virginia with NIH National Eye Institute funding as a naturally occurring fragment of the larger 119 AA protein, lacritin, in an unbiased screen for novel factors capable of addressing dry eye.