List of Small Molecule Pharmaceuticals Companies in Virginia - 24

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.

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.

BIO-CAT provides the very latest enzyme technology and custom formulations. Founded in 1988, our extensive range of products, from single-to-multi-enzyme blends, service various industrial, food, agriculture and other commercial markets. BIO-CAT is an FSSC 22000 certified facility in Virginia featuring state-of-the-art laboratories for scientific research, product development and on-site quality testing to better serve customers. BIO-CAT Microbials is an innovator in the field of biological solutions for a broad range of emerging and existing markets and industries. BIO-CAT Microbials is a GMP certified facility and a division of BIO-CAT, utilizing the latest enzyme technology in combination with microbes to produce products that are pioneering, more effective and of the highest quality for our customers’ applications.

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.

BrightSpec is an innovative life science tools company with a range of instruments that tap the power of molecular rotational resonance (MRR) spectroscopy. MRR enables the rapid, unambiguous molecular ID and quantitative analysis of mixtures, without separation, no chemometrics, and with no reference sample required. Not only can BrightSpec MRR complement other techniques such as Mass Spectrometry or NMR, in many cases MRR can solve problems not possible by these methods. For instance, MRR can easily distinguish between isomers (compounds with the same atoms but a different arrangement) or identify the exact site of deuteration of a molecule as well as quantify the number of each in the sample. BrightSpec is in the process of working with leading pharma, biotech, and academic players to develop breakthrough methods that will enable important advances in discovery. The company is also working with major chemical, oil & gas, consumer products, security, and environmental players to bring innovative solutions to these applied markets. The work is supported by research from a growing number of academic institutions as evidenced by a rising number of publications using BrightSpec instruments. BrightSpec builds on decades of federal and academic work in more than 110 research groups around the world. The technique was developed foremost in astrochemistry research. Using breakthrough technology developed by Brooks Pate at the University of Virginia, BrightSpec made this powerful technique of practical use by making the instrument significantly faster, cheaper, and easier to use. MRR spectra capture the unique set of rotational resonances, a fingerprint specific to a given molecular structure. These can be calculated theoretically based on quantum mechanics and are highly resolved. Isomers, isotopologues, diastereomers and enantiomers can be distinctly identified.

Capra Biosciences is developing a new technology that will make the manufacturing of chemicals using biology cost-competitive with petroleum-based products. Significant advances in synthetic biology have been made over the past 20 years, enabling a multitude of products with lower environmental impact and potentially better performance than their petrochemical counterparts. However, cost-competitive large-scale manufacturing of these products remains a significant bottleneck to their adaptation. Our technology tackles this bottleneck through an innovative bioreactor design that promises to significantly reduce end-to-end manufacturing costs.

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).

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

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.

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

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).

SoBran, Inc. is a provider of specialized services in bioscience, engineering, logistics, security, and mail screening solutions. Founded in 1987 by Amos-Leon' Otis, the company has grown from a small startup in Virginia to a recognized enterprise known for its innovation and service delivery. SoBran offers a variety of services tailored for government agencies, corporations, and universities. Their bioscience support includes laboratory operations and health monitoring. In engineering, they provide systems engineering management to enhance performance and meet industry standards. Their logistics services ensure efficient supply chain management, while their security services protect critical infrastructure. The SafeMail® solution is a key offering that focuses on secure mail handling to mitigate potential threats. With a strong client base that includes the National Institutes of Health and the Department of Homeland Security, SoBran has earned recognition for its quality and service. The company is ISO 9001:2008 certified and has been named a Black Enterprise Top 100 Company multiple times, reflecting its commitment to excellence.

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.