OUR NEW PROFILE IS: (NASDAQ: OKYO)
OKYO REVERSED OFF OF THE 52 WEEK LOWS AND HAS CLOSED GREEN 8 OF THE LAST 9 ON LIGHT INTEREST
OKYO HAS JUST 8.55 MILLION SHARES IN THE ENTIRE FLOAT
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Hello Everyone,
We have one last profile for you to watch as we head into the weekend. It certainly has been a busy week for us here but we were able to watch some significant movers in the market.
We have another profile that we have never before profiled on this newsletter before.
Pull up OKYO Immediately.
Take a look at the chart below. This one bounced off of the 52 week lows and has been moving up on light interest which is a very bullish sign for this one.
OKYO Pharma Limited is a life sciences company focused on the discovery and development of novel molecules to treat inflammatory dry eye diseases and ocular pain. The Company’s lead candidate to treat dry eye disease, OK-101, is currently in Phase II clinical trials in the US.
A range of ocular diseases, like glaucoma, uveitis and retinal diseases are most prevalent in the geriatric population, and rates of disease are increasing as the population ages. One of the most common ocular diseases is dry eye disease (DED). It affects almost 50 million people in the US, and the global market for DED was worth $4.5 billion in 2022. It is predicted to reach $6.3 billion by 2028, at a compound annual growth rate (CAGR) of 5.67% during the forecast period.
OKYO Pharma Ltd. (NASDAQ: OKYO) is a biopharma leading the way when it comes to developing novel treatments for DED and ocular pain. Founded in 2018, the company was able to bypass phase 1 safety trials and has begun screening patients for its phase 2 efficacy trials.
The trial includes 240 patients, and OKYO anticipates having topline data on its drug, OK-101, in Quarter 4 of 2023. OK-101 uses a novel chemerin receptor that both acts as an anti-inflammatory agent and reduces corneal neuropathic pain in the patient. As the treatment is administered topically as eye drops, there is almost no risk of systemic exposure or risk of the treatment getting into the bloodstream.
If the trial meets its pre-specified endpoints, this could contribute data toward registration trials, and speed up OK-101’s timeline for approval from the Food and Drug Administration (FDA).
The company is laser-focused on bringing its treatment to market, as it believes the treatment has significant potential in the sector. With recent acquisitions indicating a commitment from big biopharmaceuticals to the ophthalmology market, there may be many eyes watching the progress of OKYO’s phase 2 trials.
In 2018, OKYO successfully obtained (via assignment from Panetta Partners Limited, a related party) an exclusive license from On Target Therapeutics (OTTx) to patents owned or controlled by OTTx and a sub-license from OTTx to certain patents licensed by OTTx from Tufts Medical Center (TMC) to support its ophthalmic disease drug programs. These licenses gave OKYO the right to exploit the IP estate which is directed to compositions-of-matter and methodologies for treating ocular inflammation such as DED with lipid-linked chemerin analogues. OKYO also has a license from TMC to a separate IP estate for treating symptoms of ocular neuropathic pain, uveitis and associated pain. The scope of the TMC IP granted use through the sublicense with OTT is commensurate with the scope of use of the IP granted to OTT from TMC. This intellectual property, which includes 3 patents related to OK-101 including technology, dry eye, and neuropathic pain, forms the basis of OKYO’s OK-101 program.
CHEMERIN RECEPTOR
- Chemerin, the endogenous agonist of chemerin receptor ChemR23, a specific member of the G protein coupled receptor (GPCR) class, activates immune cells at the inflammation site.
- Chemerin activates ChemR23 on circulating monocytes and macrophages, recruiting these cells to the inflammation site.
- Chemerin is also physiologically cleaved into smaller potent anti-inflammatory peptides that reprogram macrophages to repress inflammation inducing anti-inflammatory cytokines at the inflammatory site, thus restoring normal tissue structure and function.
- OK-101, OKYO’s lead drug candidate contains a stable chemerin-derived 10-mer peptide as the active anti-inflammatory component of the drug, along with a conjugated lipid component, producing both enhanced agonist potency along with wash resistance.
OK-101 DRUG CANDIDATE
- One of the major challenges with topical administration of any drug designed for treating OED is drug wash-out through natural processes of tearing and blinking, minimizing drug ‘residence’ time at the ocular site needed to provide a pharmacologic benefit.
- Membrane Anchored Peptide (MAP) technology enabled the development of a long acting and stable OK-101 drug candidate.
- OKYO’s lead drug candidate OK-101 consists of a 10-mer C-terminal chemerin peptide sequence, a linker component, and an anchoring lipid domain.
- Unique MAP technology enabled the development of a drug with enhanced potency and the expectation of increased drug residence time on the ocular surface.
DRY EYE DISEASE
- Approximately 5 million people suffer from ocular pain every year.
- Neuropathic corneal pain, a severe, chronic, and debilitating disease for which there are no approved commercial treatments currently available.
- Current treatments are limited to short term NSAIDs, steroids, and opioids in severe cases. Side effects and the risk of addiction to opioids is a serious concern.
- The Global ocular pain market is expected to reach $0.5 Billion by 2030.
- Topical administration of OKYO’s lead drug candidate OK-101 was effective in suppressing corneal pain in a ciliary nerve ligation mouse model of neuropathic corneal pain; exhibiting a potency similar to that of gabapentin, a commonly used oral drug for neuropathic pain that was conversely given by intraperitoneal injection.
- The pain-relieving potential of a dry eye drug would provide an important benefit to the considerable number of dry eye patients suffering from ocular pain in addition to the existing inflammatory effects of the condition.
ALLERGIC CONJUNCTIVITIS
- Allergic conjunctivitis, often called ‘pink eye’ is an inflammation of conjunctiva, caused by an allergic reaction to pollen, mold, smoke, dust etc.
- Up to 40% of the global population suffers from allergic conjunctivitis, which is mostly treated with antihistamines and corticosteroids (2018 annual revenue in US was > $1 Billion). Notably, a significant number of patients do not respond to antihistamines which typically leads to overuse of corticosteroids in these patients.
- In an animal model, OKYO’s lead drug candidate OK-101 was effective in suppressing ocular inflammation by downregulating key inflammatory CD4+ T cells.
- Uveitis is the third leading cause of blindness worldwide. The most common type of uveitis is an inflammation of the iris called iritis (anterior uveitis). Uveitis can damage vital eye tissue, leading to permanent vision loss.
- Uveitis is currently treated with corticosteroid eyedrops and injections that reduce inflammation, (2018 annual revenue in US was > $500M). However, the long-term use of corticosteroids causes risk of cataract and glaucoma, requiring close monitoring for their potential side effects.
- In an animal model, our lead drug candidate OK-101 was effective in suppressing ocular inflammation by downregulating key inflammatory biomarkers CD4+ T cells.
- Our focus is to suppress the inflammation and pain associated with the uveitis using our lead drug candidate OK-101.
OCULAR PAIN
- Worldwide, ~700 million patients suffer from dry eye disease. In US, ~30 million patients suffer from dry eye disease.
- Dry Eye affects over 35% of the population aged 50+, with women representing approximately two-thirds of those affected.
- Prevalence of dry eye is expected to increase substantially due to an aging population and increased use of contact lenses and digital screen time.
- Several side effects and modest efficacy of currently available drugs demand new therapies to treat dry eye disease.
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NEWS
PUBLISHED
JUN 6, 2023
OKYO PHARMA ANNOUNCES RANDOMIZED SEGMENT NOW UNDERWAY IN PHASE 2 CLINICAL TRIAL OF TOPICAL OCULAR OK-101 FOR DRY EYE DISEASE
PUBLISHED
JUN 6, 2023
OKYO PHARMA ANNOUNCES RANDOMIZED SEGMENT NOW UNDERWAY IN PHASE 2 CLINICAL TRIAL OF TOPICAL OCULAR OK-101 FOR DRY EYE DISEASE
PUBLISHED
JUN 1, 2023
EYE CARE SECTOR SEES SEVERAL LARGE ACQUISITIONS – COULD THIS TICKER BE ON ROUTE FOR THE NEXT BIG ACQUISITION?
PUBLISHED
MAY 11, 2023
OKYO PHARMA NOW PARTICIPATING ON THE WEBULL CORPORATE COMMUNICATIONS SERVICE PLATFORM
PUBLISHED
MAY 11, 2023
OKYO PHARMA NOW PARTICIPATING ON THE WEBULL CORPORATE COMMUNICATIONS SERVICE PLATFORM
PUBLISHED
MAY 9, 2023
GOLDMAN SMALL CAP RESEARCH PUBLISHES NEW RESEARCH REPORT ON OKYO PHARMA LIMITED
PUBLISHED
MAY 4, 2023
OKYO PHARMA REACHES MILESTONE WITH FIRST PATIENT SCREENING FOR DRY EYE DISEASE TRIAL
PUBLISHED
MAY 3, 2023
OKYO PHARMA ANNOUNCES PRESENTATIONS AT THE AMERICAN SOCIETY OF CATARACT AND REFRACTIVE SURGERY (ASCRS 2023) IN SAN DIEGO, CA, MAY 5-8, 2023
PUBLISHED
MAY 3, 2023
OKYO PHARMA ANNOUNCES PRESENTATIONS AT THE AMERICAN SOCIETY OF CATARACT AND REFRACTIVE SURGERY (ASCRS 2023) IN SAN DIEGO, CA, MAY 5-8, 2023
PUBLISHED
MAY 2, 2023
OKYO PHARMA ANNOUNCES FIRST-PATIENT FIRST-VISIT FOR PHASE 2 TRIAL EVALUATING EFFICACY AND SAFETY OF OK-101 IN PATIENTS WITH DRY EYE DISEASE
PUBLISHED
MAY 2, 2023
OKYO PHARMA ANNOUNCES FIRST-PATIENT FIRST-VISIT FOR PHASE 2 TRIAL EVALUATING EFFICACY AND SAFETY OF OK-101 IN PATIENTS WITH DRY EYE DISEASE
PUBLISHED
APR 25, 2023
OKYO PHARMA ANNOUNCES ACTIVATION OF FIRST CLINICAL TRIAL SITE IN THE U.S. FOR THE PHASE 2 TRIAL EVALUATING OK-101 FOR THE TREATMENT OF DRY EYE DISEASE
PUBLISHED
APR 18, 2023
OKYO PHARMA MANAGEMENT TAKES COMPANY STOCK IN PRIVATE PLACEMENT INSTEAD OF DEFERRED PAY
PUBLISHED
APR 5, 2023
NOTICE OF GENERAL MEETING AND PUBLICATION OF CIRCULAR
MANAGEMENT TEAM
GARY JACOB, PHD
CHIEF EXECUTIVE OFFICER/DIRECTOR
Dr. Jacob has over 35 years of extensive experience in the pharmaceutical and biotechnology industries across multiple disciplines, including research and development, operations, business development, capital financing activities and senior management expertise. He has developed broad and influential contacts throughout the biopharmaceutical, financial, banking and investor communities. Dr. Jacob is the Co-Founder and former CEO and Chairman of Synergy Pharmaceuticals. During his time at Synergy, he served as Chairman, Chief Executive Officer and Executive Chairman, and is the co-inventor of Synergy’s FDA-approved drug Trulance® which is currently marketed in the U.S. by Bausch Health, Inc. to treat functional GI disorders. Dr. Jacob is also the former CEO and Managing Director of Immuron Inc., an Australian biotechnology company dual-listed on the Australian ASX exchange and on NASDAQ. Dr. Jacob currently is Chairman of the Board of Hepion Pharmaceuticals, Inc., a public NASDAQ listed company with a drug in clinical development to treat nonalcoholic steatohepatitis (NASH), and is also on the Board of Directors of Cardiff Oncology, Inc., a NASDAQ listed public oncology company. He served as Chief Executive Officer and Director of Callisto Pharmaceuticals, Inc. from May 2003 until January 2013.
Prior to his involvement with Callisto and Synergy, Dr. Jacob was at Monsanto/G.D. Searle, where he was Director of Glycobiology and a Monsanto Science Fellow, specializing in the field of Glycobiology and drug discovery. Dr. Jacob holds over 30 patents and is the co-inventor of two pharmaceutical drugs which are FDA approved. Dr. Jacob earned a B.S. cum laude in Chemistry from the University of Missouri, St. Louis and holds a Ph.D. in Biochemistry from the University of Wisconsin, Madison.
RAJ PATIL, PHD
CHIEF SCIENTIFIC OFFICER
Dr. Patil brings 30 years of ophthalmic experience and a powerful combination of academic scholarship and pharmaceutical R&D excellence.
Raj previously worked with Ora Inc, as Vice President of Research & Development, where he was responsible for driving all anterior and posterior segment research of Ora’s R&D Institute. Earlier in his career, he worked at iVeena Delivery Systems as Vice President of Advanced Ocular Delivery Systems. His tenure at iVeena included a two-year sabbatical in Singapore, where he served as an Associate Professor of Ophthalmology at DUKE/NUS Medical School and Principal Investigator at Singapore Eye Research Institute.
Raj also held a number of leadership roles at Alcon/Novartis Institute of Biomedical Research, including Associate Director of Research and Head of Molecular Pharmacology glaucoma and retina research. Prior to joining the business world, Dr. Patil served as an Associate Professor of Ophthalmology, Cell Biology & Genetics at University of Nebraska Medical Centre in Omaha and as an Assistant Professor of Ophthalmology, Molecular Biology & Pharmacology at Washington University in St. Louis.
Raj received his PhD in Biochemistry from National Chemical Laboratory/University of Pune, India and completed his postdoctoral training in Biochemistry and Molecular Biology at the University of Michigan, Ann Arbor, MI. He is the recipient of Olga Keith Wiess Special Scholar Award from Research to Prevent Blindness Foundation and NIH Director’s New Innovator Award. Dr. Patil has authored over 50 peer-reviewed research articles and serves as reviewer and editorial board member for numerous journals and is frequently invited to lecture at academic and industry events.
KEEREN SHAH
CHIEF FINANCIAL OFFICER
Keeren Shah serves as our Chief Financial Officer. Ms. Shah currently also serves as the Finance Director of Tiziana Life Sciences LTD, Accustem Sciences Limited and Rasna Therapeutics Inc., having previously served as the Group Financial Controller for all businesses from June 2016 to July 2020. Prior to joining the Company, Ms. Shah spent 10 years at Visa, Inc. as a Senior Leader in its finance team where she was responsible for key financial controller activities, financial planning and analysis, and core processes as well as leading and participating in key transformation programmes and Visa Inc.’s initial public offering. Before joining Visa, Ms. Shah also held a variety of finance positions at other leading companies including Arthur Andersen and BBC Worldwide. She holds a Bachelor of Arts with honours in Economics and is a member of the Chartered Institute of Management Accountants.
Willy Simon, Non-Executive Director
Willy Jules Simon is a banker and worked at Kredietbank N.V. and Citibank London before serving as an executive member of the Board of Generale Bank NL from 1997 to 1999 and as the chief executive of Fortis Investment Management from 1999 to 2002. He acted as chairman of Bank Oyens & van Eeghen from 2002 to 2004. Willy Simon has been the chairman of Bever Holdings, a company listed in Amsterdam, since 2006 and Chairman of Ducat Maritime since 2015. He is also a non-executive director of Tiziana Life Sciences plc.
John Brancaccio, Non-Executive Director
Mr. Brancaccio, a retired CPA, is a financial executive with extensive international and domestic experience in pharmaceutical and biotechnology for privately and publicly held companies. From 2000 to 2002, Mr. Brancaccio was the Chief Financial Officer/Chief Operating Officer of Eline Group, an entertainment and media company. From May 2002 until March 2004, Mr. Brancaccio was the Chief Financial Officer of Memory Pharmaceuticals Corp., a biotechnology company. From April 2004 until May 2017, Mr. Brancaccio was the Chief Financial Officer of Accelerated Technologies, Inc., an incubator for medical device companies. Mr. Brancaccio is currently a director of Cardiff Oncology, Inc., Hepion Pharmaceuticals, Inc., Rasna Therapeutics, Inc., and Tiziana Life Sciences plc.
Bernard Denoyer, Non-Executive Director
Bernard F. Denoyer has 49 years of financial management experience including his service as Senior Vice President, Finance and Secretary of development stage Synergy Pharmaceuticals, Inc, from July 2008 until FDA approval and his retirement in June 2017. Between 2004 and January 2013 Mr. Denoyer concurrently served as Principal Financial Officer of Synergy’s former parent company, Callisto Pharmaceuticals, Inc. From October 2000 to December 2003, Mr. Denoyer was an independent consultant. Prior to this, Mr. Denoyer served as Chief Financial Officer and Senior Vice President of META Group, Inc. Mr. Denoyer earned his CPA with Ernst & Young in 1975. He received a master’s Certificate of Accounting from the Kellogg Graduate School of Management in 1974, an MBA in Finance with honours from Columbia Business School in 1972 and a BA in Economics from Fairfield University in 1969. Mr. Denoyer is fluent in French and studied in Paris at l’Istitut d’Etude Politique et Economique in 1968. He is currently serving on the Board of Trustees for two not-for-profits, St. Edmunds Retreat, Inc. and Midwestern Connecticut Council on Alcoholism, Inc.
SCIENTIFIC ADVISORY BOARD
Napoleone Ferrara, MD, Board Member
Dr. Ferrara is a Professor at the University of California San Diego Medical Center and a member of The National Academy of Sciences and has received numerous prestigious awards, including the Lasker Award and the Breakthrough Prize in Life Sciences. His research on understanding the role of angiogenesis and vascular endothelial growth factor (VEGF) in cancer development, led to the discovery that VEGF is a key mediator of angiogenesis associated with intraocular neovascular syndromes. This pioneering research led to the clinical development of a humanized anti-VEGF Fab (Ranibizumab, Lucentis®), which has also been approved as a therapy for neovascular age-related macular degeneration (AMD), retinal vein occlusion and diabetic macular edema. Ranibizumab and other anti-VEGF agents have had a dramatic impact on the development of therapies for these blinding disorders. When Lucentis® (Ranibizumab) received FDA approval in late June 2006, the new macular degeneration drug was celebrated as a major medical breakthrough. Dr. Ferrara’s research also led to the development and approval of humanized anti-VEGF mAbs (Bevacizumab; Avastin®) for cancer treatment, with Avastin® being one of the bestselling cancer drugs over the last two decades. Lucentis® and Avastin® collectively achieved over $9 billion in sales last year.
Pedram Hamrah, MD, FRCS, FARVO, Board Member
Pedram Hamrah, MD is Co-Director of the Cornea Service and Director of the Center for Translational Ocular Immunology at New England Eye Center at Tufts Medical Center in Boston. Dr Hamrah’s research interests focus on corneal immunology and neuroscience, ocular imaging (immuno-imaging), ocular surface diseases and corneal neuropathic pain. He is currently on faculty at the departments of Ophthalmology and Bioengineering at Tufts University, where he is the director of clinical research and director of the Center for Translational Ocular Immunology. In addition, he is a faculty member at the immunology, neuroscience, and cell, molecular and developmental biology graduate programs at the Sackler School of Graduate Biomedical Sciences at Tufts. Throughout his career, he has focused on discovery, patient care and teaching. Dr. Hamrah currently serves on over a dozen editorial boards, is the associate editor for The Ocular Surface and TVST, section editor for Eye and assistant editor at Ocular Immunology and Inflammation.
Jay S. Pepose, MD, PhD, FARVO
Dr. Pepose, a specialist in refractive surgery and corneal and external diseases, is the founder and Medical Director of the Pepose Vision Institute and held the Bernard Becker Chair in Ophthalmology and Visual Sciences at Washington University School of Medicine in St. Louis. He is a consultant to numerous ophthalmic drug and device companies and serves as a Director and Chief Medical Advisor for Ocuphire Pharma. Dr. Pepose has been involved in over 40 clinical research trials, including registration trials for dry eye drugs, and has been the recipient of R-01 grant support from the National Eye Institute. He has served on the editorial boards of numerous prestigious journals, including the American Journal of Ophthalmology, Investigative Ophthalmology & Visual Science (IOVS), Cornea, and The Journal of Refractive Surgery and has over 200 peer reviewed publications. Dr. Pepose, an ARVO Gold Fellow, is a recipient of the Cogan Award from the Association for Research in Vision and Ophthalmology (ARVO) and the Life Achievement Honor Award from the American Academy of Ophthalmology. Dr. Pepose received an A.B. and M.A. in neurophysiology from Brandeis University and completed the M.D.-Ph.D. program at UCLA School of Medicine. He completed ophthalmology residency at the Wilmer Institute at the Johns Hopkins Medical Center and fellowship training at Georgetown University Medical Center
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