List of Repurposed/505(b)(2) Drugs Companies in California - 13

Afecta Pharmaceuticals is an early clinical stage small molecule therapeutics company focused on developing precision medicines to treat chronic disorders and cancers more effectively. Afecta has a validated, proprietary Artificial Intelligence disease/drug targeting platform, PharmetRx®, to discover and optimize Multi-Target drug compounds and formulate them in NanoRx®, our tissue-specific drug delivery technology. Backed by an experienced management team, Afecta is currently advancing AFX-220, our clinically proven lead candidate that effectively treats the disruptive behaviors that occur in children and adolescents with several neurodevelopmental disorders such as Autism, AD/HD, and others. Please visit our website to learn more, register to access our Executive Summary, and receive our latest updates.

Developing innovative therapeutics to materially improve the lives of patients. We strive to be transparent and open in our goals, plans, and progress.

CURE Pharmaceutical is an innovative drug delivery and development company committed to improving drug efficacy, safety and the patient experience through its proprietary drug dosage forms and delivery systems. CURE has an industry leading full-service cGMP manufacturing facility and is a preeminent developer and manufacturer of a patented and proprietary delivery system (CureFilm™), the most advanced oral thin film on the market today. CURE has developed an array of products in cutting-edge delivery platforms and partners with leading pharmaceutical companies. CURE has positioned itself to advance numerous therapeutic categories, including the pharmaceutical cannabis sector with partnerships in the U.S., Canada, Israel and Germany, among other markets. Our mission is to improve people's lives by redefining how medicines are delivered and experienced.

DelNova, Inc. is an innovative drug development company targeting unmet medical needs, including complications arising from the use of botulinum toxin (e.g., Botox®, Dysport®, Xeomin®, Jeuveau®). Our first product under development, ReViVox™ (U.S. patent allowed), is based on a clinically validated drug and will address the impacts of unintended localized paralysis from therapeutic and aesthetic botulinum toxin [BoNT] injections. There is currently no reversal agent to safely resolve these side effects; patients can wait weeks or months for drug-induced paralysis to subside. Business Summary: DelNova is developing innovative therapeutics based on an in-depth knowledge of drug delivery. Many unmet patient needs are addressable by modifying the use of known drugs to target delivery for a more efficacious, yet safer outcome. The first product under development is based on a known drug, currently approved for use in other medical conditions and with a different route of administration. The novel formulation will be used for the reversal of undesirable side effects resulting from neurotoxin injections [eg. BOTOX (TM] in both medical and cosmetic uses. Problem: Botox™ (or other BoNT) injections may result in temporary, but undesirable side effects. Transient adverse effects are due to neurotoxin infiltrating into nearby tissue, causing unintended localized paralysis. This could be attributed to either poor injection technique and/or toxin spread. There is no reversal agent to safely mitigate unintended adverse effects; the only option is to wait until the effect of the drug paralysis subsides (weeks to months). For cosmetic procedures, side effects may include droopy eyes or brows, arched eyebrows, or misalignment . In some medical procedures adverse effects may include weakened neck muscles (for migraine ) or difficulty urinating ( for overactive bladder) . Solution: ReViVox(TM); a reversal / rescue product for muscle recovery post BoNT treatment.

Evoke Pharma is a biotechnology company that focuses on pharmaceutical product development.

Handa Pharma is a specialty pharmaceutical company that focuses on developing and commercializing high-quality prescription medications in proprietary therapeutics.

KARE Biosciences is a biotechnology company looking to license products and partner with other companies to develop drugs for a wide range of indications. KARE Biosciences is currently focused on repurposing ramatroban for the treatment of acute COVID-19 and long COVID. Ramatroban has great potential in many other indications including sickle cell disease, cardiovascular disease, rhabdomyolysis induced acute kidney injury, community acquired pneumonia, dengue fever, pulmonary fibrosis, Alzheimer's disease and more. Please visit our website for more information about our products.

MatriSys Bio is a clinical stage Specialty Biopharmaceutical Company focused on the $142 Billion WW dermatology and skin care market. We are developing therapies for the top 5 dermatology & skin care conditions - Atopic Dermatitis, Rosacea, Psoriasis, Acne, and Skin Infections, which have a huge impact on quality of life. More than 230 million patients suffer from these 5 skin diseases, which represent a $12.9 Billion Rx market and a $121 Billion skin care market.

Perlara is a the first biotech PBC on a mission to codevelop drugs with highly motivated families racing to cure the long tail of genetic diseases.

Satsuma Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, developing novel therapeutic products for the acute treatment of migraines. Its lead product candidate is STS101, a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate, which is in ASCEND Phase III clinical trials and can be self-administered with proprietary pre-filled, single-use, and nasal delivery device. The company was incorporated in 2016 and is headquartered in South San Francisco, California.

Sollievo Pharmaceuticals, Inc. Based in San Juan Capistrano, CA, Sollievo Pharmaceuticals, Inc. is a development-stage pharmaceutical company that is positioned to disrupt the $1.2 Billion global injectable treatment of acute agitation and aggression market. Sollievo Pharmaceuticals is uniquely working to overcome the limitations of the current 30-year-old sedating medications by creating a new, consistent, fast-acting intramuscular product, Sollievo's mission is to improve the safety of the healthcare environment by finding solutions to the rising incidence of patient-generated abuse of doctors, nurses, and staff.

Surface Ophthalmics, Inc. is a pharmaceutical company focused on development and commercialization of innovative therapeutics for ocular diseases. We are striving to solve key patient needs in eye care through leveraging deep expertise, a bold approach, an eye toward efficiency, and a clear, differentiated clinical advantages. Our current drug pipeline consists of three proprietary drug candidates, all utilizing Klarity®, a patented delivery vehicle. We are led by an experienced and proven management team and board of directors with over 80 years of ophthalmology related professional experience.

Ventoux Biosciences is working to transform treatment for Dupuytren's and related, under-served, immuno-fibrotic diseases. Founded by a Dupuytren's patient and propelled by a team with Dupuytren's and fibrosis expertise from bench to bedside – we seek to revolutionize current treatment options via development of novel, first-line, disease-modifying, non-surgical options for patients. Dupuytren's is a chronic, progressive, debilitating and often painful fibrosis of the hands and is >3x more prevalent than Rheumatoid Arthritis. However; no cure and no approved disease slowing agents exist. Unlike RA, surgery remains as the standard of care for Dupuytren's patients. Following positive anti-fibrotic data in an established scleroderma / dermal fibrosis model, we are working to advance our lead candidate VEN-201 to human studies. Our business strategy is to expedite treatment for patients by leveraging expedited FDA clinical & regulatory pathways. Dupuytren's impacts ~265m patients across 7 major markets and upwards of 10 million patients in the U.S. alone. VEN-201 represents a potential novel, differentiated, first-line treatment to slow disease progression and help patients maintain hand function and delay potential progression to surgery or surgical interventions.