List of Small Molecule Pharmaceuticals Companies in Israel - 33

Azura Ophthalmics is utilizing our deep understanding of ocular surface diseases and drug development to deliver a new therapeutic class of Ophthalmic Keratolytics to treat underserved ophthalmic conditions. Our differentiated approach combines ophthalmologic and dermatologic solutions to harness the unique properties of keratolytics to treat the root cause of numerous underserved ocular indications. Our internally discovered pipeline of new chemical entities allows us to develop a portfolio of first-in-class ophthalmic therapeutics for significant unmet needs.

Biokine Therapeutics is a private biopharmaceutical company founded in 2000. Biokine lead product BKT140/BL8040, is a high affinity, long-acting CXCR4 receptor inhibitor that already passed successful Phase III for Stem Cell Mobilization and Phase I/II for Immunotherapy for cancer together with immune check point inhibitor Pembrolizumab (Keytruda, Merck) and Atezolizumab (Tecentriq, Genentech/Roche). BL8040 was licensed to BiolineRx and is being developed in the clinic together with BiolineRx Ltd. (NASDAQ:BLRX). Biokine has also developed a suite of unique technologies, MigHit™ – which is a phenotypic screen that allows identification of small molecules targeting migration and survival pathways in cancer and ImmunHit™ which is platform technology enables identification of small molecules targeting IFN-g mediated immune response in cancer and inflammation.

BioLineRx Ltd., a clinical-stage biopharmaceutical development company, focuses on oncology. Its development pipeline consists of clinical-stage therapeutic candidates, which include BL-8040, a peptide for the treatment of solid tumors, hematological malignancies, and stem cell mobilization; AGI-134, an immuno-oncology agent in the development for solid tumors; and BL-5010, a customized, proprietary, pen-like applicator for the non-surgical removal of skin lesions. The company has collaboration agreement with MSD for the cancer immunotherapy field; MD Anderson Cancer Center to investigate the combination of BL-8040 with KEYTRUDA (pembrolizumab) in pancreatic cancer; and Genentech Inc. to investigate the combination of BL-8040 for solid tumors. BioLineRx Ltd. was founded in 2003 and is headquartered in Hevel Modi'in, Israel.

Biomica is an emerging biopharmaceutical company developing innovative microbiome-based therapeutics utilizing Evogene's Computational Predictive Biology (CPB) platform.

Bsense Bio Therapeutics is developing small molecules for the treatment of sensory hyperexcitability related disorders. Bsense is pioneering a novel approach targeting multiple hyperexcitability related mechanisms using a single compound, to achieve greater efficacy and safety. Sensory neuron Hyperexcitability refers to a multitude of indications such as Pain, Pruritus, Tinnitus and seizure, in which sensory neurons are excessively active leading to dire clinical and quality of life ramifications for patients. These indications are considered as significant unmet medical needs representing a major healthcare burden. Bsense Bio's approach is based on the targeting of two cation channels, a ligand-gated cation channel and a voltage-gated potassium channel, respectively, TRPV1 and Kv7.2/3, which are co-localized on sensory nociceptive neurons and are widely recognized as prominent players in the modulation of neuronal excitability. The company has generated preclinical proof-of-concept in chronic pain and has recently been generating data in additional hyperexcitability indications in the space of Pruritis and Tinnitus (some of which with Orphan disease designation). The company is financed by Takeda Ventures Inc., OrbiMed Israel Partners, and Johnson & Johnson Innovation (JJDC), RMGP and the Israel Innovation Authority (IIA). Bsense was founded in September 2018 at the FutuRx biotech incubator based on technology that originated from Prof. Bernard Attali and Dr. Asher Peretz work from the Tel Aviv University.

Can-Fite BioPharma Ltd. is an Israeli biopharmaceutical company with fully integrated pharmaceutical discovery and clinical development capabilities. The Company develops small molecule therapeutic products for the treatment of cancer, liver and inflammatory diseases. Can-Fite develops its products by harnessing its technology platform which is based on the Gi protein associated A3 adenosine receptor (A3AR).

Can-Fite is an Israel-based biopharmaceutical company that researches and develops small-molecule therapeutics for the treatment of inflammatory, liver, and metabolic diseases.

Clexio Biosciences is a CNS-first clinical-stage pharmaceutical company. Our therapies are designed to address patients' unmet needs through scientifically based integration of drugs with innovative technologies. Clexio's growing pipeline is focused on the development of safe and effective treatments with rapid onset of action for a wide range of neurological and psychiatric conditions, including Major Depressive Disorder, Parkinson's Disease, Pain and other conditions involving impairment of the neurological system. Patients, and what they are living with, are at the center of everything we do. Our passion is to find ways to help patients regain a sense of balance, health and a life worth living. Clexio's team is comprised of a multi-disciplinary team with vast experience in drug development. We see our team and our partners as the key ingredients to our success. Join our vision to make lives of millions of patients worth living again.

Concenter BioPharma - a patented, unique, proven, novel platform of drugs with 3 modes of action. We are advancing a pipeline of products that demonstrate vast potential in addressing multi­billion markets for treating a range of diseases (that require common MoA’s – our Platform). We will become a global specialty biopharmaceutical company focused on people and providing innovative therapies for them. Our Platform will enable us to jump quickly from one product to another without having to rediscover and recreate an underlying technology for each product. we are committed to developing and delivering therapies that work harmoniously with the human body and advance the treatment landscape for people living with life-threatening diseases.

Eitan Medical is reimagining drug delivery with reliable innovation that puts patients at the center of care, making infusion easier and safer than ever before. Patient safety and care is only the starting point, as Eitan Medical goes beyond, delivering connected, intuitive infusion solutions that are designed to improve patients' and clinicians' quality of life across the continuum of care, including hospital, ambulatory care, and home care solutions. For over a decade, Eitan Medical and its global partners have provided safe, intuitive, and flexible infusion solutions that meet evolving drug delivery needs.

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab™) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Evogene (Nasdaq: EVGN, TASE: EVGN) is a computational biology company aiming to revolutionize the development of life-science based products by utilizing cutting edge technologies to increase probability of success while reducing development time and cost. Evogene established three unique technological engines – MicroBoost AI, ChemPass AI and GeneRator AI – leveraging Big Data and Artificial Intelligence and incorporating deep multidisciplinary understanding in life sciences. Each technological engine is focused on the discovery and development of products based on one of the following core components: microbes (MicroBoost AI), small molecules (ChemPass AI), and genetic elements (GeneRator AI). Evogene uses its technological engines to develop products through subsidiaries and with strategic partners. Currently, Evogene's main subsidiaries utilize the technological engines to develop human microbiome-based therapeutics by Biomica Ltd., ag-chemicals by AgPlenus Ltd. and ag-biologicals by Lavie Bio Ltd. For more information, please visit: www.evogene.com

Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases. Our lead compound, Aramchol™, a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase 3 registrational study. We are also collaborating with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide. Our corporate headquarters is located in Tel Aviv, Israel. For more information about Galmed, please visit our website at: www.galmedpharma.com

ImPact Biotech is focused on the development and launch of Padeliporfin VTP (Vascular Targeted Photodynamic) therapy for the treatment of solid tumors. The company is headquartered in Israel, with presence in Luxembourg, France and USA, as well as its own GMP-certified (Good Manufacturing Practice) facility and research center in Israel. ImPact Biotech holds exclusive rights from the Weizmann Institute of Science (WIS, Israel) and Memorial Sloan Kettering Cancer Center (MSKCC, New York), to develop and commercialize drugs and related technologies used in VTP.

InnoCan Pharma is a pharmaceutical company specializing in developing novel therapeutics that harness the unique healing properties of Cannabinoids to improve quality of life. OUR ADVANTAGES Led by a highly-experienced team with a proven track record of success, InnoCan will leverage Israel’s worldleading medical cannabis research community to develop powerful, Cannabinoid-combined, patent-pending formulas. Our outstanding products will be clinically validated by undertaking Post Marketing Surveillance (PMS) studies and combine smart delivery systems to enhance the potency and efficacy of current products for better results. EXPECTED EARLY REVENUES: InnoCan expects to generate early revenues ($30 million in 5 years) from the multi-billion dollar Over The Counter (OTC) market by leveraging the rapid FDA OTC drug monograph process or similar regulatory pathways in Europe and Canada. These regulatory pathways enable InnoCan, in a very short time, to bring to market outstanding new products that combine the huge therapeutic potential of Cannabinoid complex/hemp oil added “excipients” to existing approved OTC drugs. TECHNOLOGY: POWERFUL, PATENT PENDING FORMULAS WITH SMART DELIVERY SYSTEMS InnoCan's products will be highly differentiated within the market through the powerful synergistic effect of the Cannabis-complex Hemp Oil with the active ingredients, combined with our on-demand release delivery system providing improved patient efficacy and compliance. FIRST-LINE PRODUCTS: A LEAP-FORWARD IN DERMATOLOGY TREATMENT DESIGN The companies first products will initially target the multi-billion dollars markets of psoriasis and localized pain , where research shows topical cannabinoid-combined treatments are highly effective, followed by oral hygiene, eczema/ itching, skin support after chemotherapy and women's health. To join the investment opportunity with InnoCan, please contact Iris Bincovich at IrisB@InnocanPharma.com.

INTEC PHARMA is a pharmaceutical distribution company that specializes in cold chain logistics for healthcare products.

Kamari Pharma was founded in 2018 to develop innovative treatments for unmet needs and rare diseases in dermatology. We are developing proprietary small molecules, selective TRPV3 inhibitors for regulation of skin physiology and pathology. We are aiming to treat conditions of the skin with no current treatments by targeting the root cause of Ca++ dysregulation. TRPV3 was established as a target for drug development and showed involvement in various skin disorders including Olmsted Syndrome, Keratodermas, Pruritus, Ichthyosis, Atopic Dermatitis, and others. The Company is comprised of individuals with vast experience in drug discovery and dermatology pharmaceutical development in the biotech industry, as well as clinical advisors who are world-class key opinion leaders in related scientific areas. Our team includes a strong board of directors with a proven track record of success in advancing therapies to treat both rare diseases and dermatologic diseases and conditions.

Lutris Pharma is a clinical stage biopharmaceutical company focused on improving anti-cancer therapy effectiveness and quality of life for patients who are being treated with EGFR (Epidermal Growth Factor Receptor) inhibitors or with radiation, where dermal toxicity often leads to a reduction of anti-cancer therapy compliance. The company aims to provide novel topical therapies in order to mitigate these side effects. Lutris Pharma’s lead asset, LUT014, a topical B-Raf Inhibitor, is a proprietary, first-in-class, small molecule currently in a phase 2 clinical trial in metastatic colorectal cancer patients with EGFR inhibitor induced acneiform lesions and a phase 1/2 study for the treatment of radiation-induced dermatitis.

MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries. MediWound’s first drug, NexoBrid®, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company’s lead drug under development, EscharEx®. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. MediWound’s pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a recently completed Phase I/II study. For more information visit www.mediwound.com

Neurim Pharmaceuticals is a neuroscience drug discovery and development company creating drugs for brain restoration & reinforcement, focusing on the central nervous system. With a proven track record of drug development and commercialization, Neurim’s first products, Circadin® and Slenyto® , are already in use in more than 40 countries across 5 continents. Constantly expanding into additional therapeutic areas, the R&D pipeline comprises new products that address insomnia, Alzheimer’s dementia and sleep apnea.

NeuroDerm is an agile and entrepreneurial R&D company, driving healthcare innovation and patient-centric solutions through Pharma & MedTech integration. By developing next-generation drug-device combination solutions for central nervous system disorders, we aspire to make a meaningful difference in patients’ lives and drive future healthcare connectivity. Our mission is to address the challenges of the future healthcare and wellbeing ecosystem. We are passionately driven to reduce disease burden and improve the quality of life of patients and their families through innovative drug-device combination therapies and technologies.

Neuromagen Pharma is an early-stage pharmaceutical company developing a new class of innovative small molecules which activate telomerase reverse transcriptase (TERT) – an enzyme which plays a major role in aging-related diseases and in cellular senescence. Neuromagen's pipeline includes drugs for neurodegenerative diseases such as ALS and Alzheimer's, type 1 diabetes, fertility, and cardiovascular diseases.

NurExone Biologic is developing a revolutionary biological exosome based technology drug platform to treat damage in the Central Nerve System. The breakthrough exosome-based technology was proven in preclinical studies to have the potential to treat spinal cord injuries.

PainReform Ltd. is a clinical stage specialty pharmaceutical company focused on the reformulation of established therapeutics. Their first product, PRF-110, is based on the local anesthetic ropivacaine, targeting the post-operative pain relief market. The company is also involved in investor relations, stock performance, and earnings.

Pharma Two B is a clinical-stage pharmaceutical company developing novel, synergistic, combination products based on previously approved drugs. We refined our years of expertise to identify and characterize potential drug combinations that can offer high therapeutic effects with improved safety profiles. Our goal is to develop clinically meaningful and safe added-value combination products to address unmet medical needs. Our lead investigational product, P2B001, successfully completed both Phase IIb and Phase III studies for the treatment for early Parkinson’s Disease (PD).

We are a global clinical-stage bio-pharmaceutical company focused on developing, manufacturing and commercializing novel, locally administered therapies to improve surgical outcomes. Our PLEX (Polymer-Lipid Encapsulation matriX) technology is a unique platform that is anchored in the surgical site to provide controlled and continuous delivery of medications. Our product candidates are designed to deliver medications in the body over days to several months in a controlled manner. This allows surgeons to deliver medication right to the surgical site to improve patient outcomes in localized medical conditions such as; infection, pain, inflammation and cancer. Our initial infection treatment targets are Surgical Site Infections (SSIs), the second most prevalent type of Healthcare Acquired Infections (HAIs). SSIs have substantial negative impact on patients’ clinical outcomes and also pose a significant healthcare system burden. We strive to reduce overall surgical infection rates, including infections due to antibiotic-resistant bacteria which the FDA defined as being one of the world’s most pressing public health problems.

We are a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Our proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. We are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. We refer to our additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T.

Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance. The Company’s oncology pipeline includes NT219, CM24 and IM1240. *NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. In a Phase 1/2 study of NT219, the Company is currently advancing it as a monotherapy treatment of solid tumors, and in a dose escalation in combination with cetuximab for the treatment of recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN) or colorectal adenocarcinoma (CRC). These studies will be followed by an expansion phase of NT219 at its recommended Phase 2 level in combination with cetuximab in patients with recurrent and metastatic SCCHN. *CM24 is a humanized monoclonal antibody that blocks CEACAM1, an immune checkpoint protein that supports tumor immune evasion and survival through multiple pathways. The Company is advancing CM24 as a combination therapy with anti-PD-1 checkpoint inhibitors in a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma (PDAC). The Company has entered into a clinical collaboration agreement with Bristol Myers Squibb for the Phase 2 clinical trials to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab in addition to chemotherapy. *IM1240 is a preclinical, conditionally-activated tri-specific antibody that engages both T cells and NK cells to mount a strong, localized immune response within the tumor microenvironment. The third arm specifically targets the Tumor Associated Antigen (TAA) 5T4 that is expressed in a variety of solid tumors and is correlated with advanced disease, increased invasiveness and poor clinical outcomes. IM1240 has a cleavable capping technology that confines the compound’s therapeutic activity to the local tumor microenvironment, and thereby potentially increases the anticipated therapeutic window in patients.

Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) is a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative inflammation and immunology (I&I) biological products. Previously known as BiondVax Pharmaceuticals, the company has undergone significant changes, including a shift in focus and a rebranding to reflect a new strategic direction. Scinai Immunotherapeutics is also working on an innovative plaque psoriasis treatment that has shown encouraging preclinical results.

SciSparc Ltd. (NASDAQ: SPRC) is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. Our focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol (CBD): SCI-110 (formerly THX-110) for the treatment of Tourette syndrome and for the treatment of obstructive sleep apnea; SCI-160 (formerly THX-160) for the treatment of pain; and SCI-210 (formerly THX-210) for the treatment of autism spectrum disorder and epilepsy.

Tarsier® Pharma is a clinical late stage company developing novel treatments for ocular inflammatory blinding diseases, beginning with uveitis.

Vidac is a clinical stage innovative biopharmaceutical company dedicated to discovering and developing first-in-class medicines to help people suffering from a range of oncology and dermatology ailments. We at Vidac are passionate about transforming breakthrough science into innovative therapies to address major unmet medical needs. Our breakthrough technology targets the VDAC/HK2 system that is unique to malignant cells. Modulating this target leads to selective apoptosis of cancer cells without affecting the surrounding healthy tissue, thus holds the promise of delivering first-in-class drugs that are both efficacious and well tolerated by patients.

XTL Biopharmaceuticals Ltd. (NASDAQ:XTLB, TASE:XTLB.TA) is a clinical-stage biotech company focused on the development of pharmaceutical products for the treatment of autoimmune diseases including lupus. The Company’s lead drug candidate, hCDR1, is a world-class clinical asset for the treatment of systemic lupus erythematosus (SLE). Treatments currently on the market for SLE are not effective enough for most patients and some have significant side effects. Robust clinical data on hCDR1 has been produced in three clinical trials with 400 patients and over 200 preclinical studies with data published in more than 40 peer reviewed scientific journals.