{"url_path":"/sec/okyo/10-k/2026/item-4","section_key":"item-4","section_title":"Item 4 INFORMATION ON THE COMPANY**","topic":"sec","document":{"doc_type":"20-F","doc_date":"2026-07-20","source_url":"https://www.sec.gov/Archives/edgar/data/1849296/0001493152-26-033847-index.html","accession_number":"0001493152-26-033847","cik":"0001849296","ticker":"OKYO","issuer_name":"OKYO Pharma Ltd","edgar_url":"https://www.sec.gov/Archives/edgar/data/1849296/0001493152-26-033847-index.html","primary_entity_key":"0001849296","primary_entity_name":"OKYO Pharma Ltd"},"word_count":12499,"has_tables":true,"body_markdown":"**ITEM\n4: INFORMATION ON THE COMPANY**\n\n \n\n**A.\nHistory and Development of the Company**\n\n \n\nWe\nwere originally incorporated in the British Virgin Islands as a British Virgin Islands Business Company on July 4, 2007 under the BVI\nBusiness Companies Act 2004 with company number 1415559 under the name Jellon Enterprises, Inc. Our legal and commercial name was changed\nto Minor Metals & Mining, Inc. on October 24, 2007, to Emerging Metals Limited on November 28, 2007, to West African Minerals Corporation\non December 9, 2011, and to OKYO Pharma Corporation on January 10, 2018. On March 9, 2018, shareholders approved the cancellation of\nour AIM listing and migration to Guernsey. On July 3, 2018, following the approval of the Guernsey Companies Registry, we were registered\nunder the Guernsey Companies Law under the name OKYO Pharma Limited, as a Guernsey company with limited liability, an indefinite life\nand company number 65220. We are domiciled in Guernsey. On July 17, 2018, our Ordinary Shares were admitted to listing on the standard\nsegment of the Official List of the FCA and admitted to trading on the standard listing of the Main Market of the London Stock Exchange,\nuntil May 22, 2023. From May 22, 2023, the principal trading market for our ordinary shares has been the NASDAQ Capital Market.\n\n \n\nOur\nregistered office is located at Martello Court, Admiral Park, St. Peter Port, Guernsey GY1 3HB and our telephone number is +44 (0) 20\n7495 2379. Our website address is www.okyopharma.com. The reference to our website is an inactive textual reference only and the information\ncontained in, or that can be accessed through, our website is not a part of this annual report. Our agent for service of process in the\nUnited States is OKYO Pharma US, Inc.\n\n \n\nThe\nSEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers, such\nas us, that file electronically, with the SEC at www.sec.gov.\n\n \n\n34\n\n \n\n \n\n**B.\nBusiness Overview**\n\n \n\nWe\nare a clinical-stage ophthalmology company focused on developing differentiated therapies for corneal and anterior segment diseases.\nThe Company is committed to addressing significant unmet medical needs in corneal and anterior segment diseases through innovative science,\ntargeted therapeutic approaches, and a disciplined clinical and regulatory development strategy.\n\n \n\nLeveraging\nextensive ophthalmology expertise across research, clinical development, regulatory affairs, and commercialization, we are advancing\na pipeline designed to improve outcomes for patients suffering from debilitating ocular diseases that impact vision, ocular comfort,\nand quality of life.\n\n \n\nOur\nlead program, urcosimod, is being developed as a potential first-in-class treatment for neuropathic corneal pain, a severe condition\nfor which there are currently no FDA-approved therapies.\n\n \n\nOur\nresearch program focuses on a novel G Protein-Coupled Receptor, or GPCR, which we believe plays a key role in the pathology of\nspecific ocular eye diseases of high unmet medical need. Our therapeutic approach involves targeting a specific member of this class\nof GPCR receptors called CMKLR1 (or ChemR23) that is involved in the inflammatory and pain modulation pathways that drive these\nconditions. Our lead clinical product candidate, urcosimod (formerly called OK-101), is a lipidated chemerin peptide (See Figure 1)\ndesigned to specifically bind to ChemR23 and block its role in producing ocular pain and inflammation.\n\n \n\n**FIGURE\n1:**\n\n \n\n \n\nOn\nFebruary 21, 2018, we announced that we successfully obtained (via assignment from Biovitas Limited, a related party) a license from\nOTT to patents owned or controlled by On Target Therapeutics (OTT) and a sub-license from OTT to certain patents licensed by OTT from\nTufts Medical Center (TMC) to support our ophthalmic disease drug programs. These licenses gave us the right to exploit the IP estate\ncovering urcosimod (formerly called OK-101) which is directed to compositions-of-matter plus methodologies for treating ocular pain and\ninflammation, utilizing lipid-linked chemerin analogues such as urcosimod.\n\n \n\n**URCOSIMOD\nCLINICAL STUDIES**\n\n** **\n\nInitial\nStudies with Urcosimod to Treat Dry Eye Disease (DED)\n\n \n\nUrcosimod,\nour lead clinical product candidate, was initially focused on keratoconjunctivitis sicca, commonly referred to as DED, which is a multifactorial\ndisease caused by an underlying inflammation resulting in the lack of lubrication and moisture in the surface of the eye. Because the\ndrug was designed to be administered topically, and the pre-IND data package which we prepared was supported by FDA for taking the drug\ninto subjects with DED, we were able to skip the standard Phase 1 studies typically expected with orally delivered or injectable drug\ncandidates in non-life-threatening conditions. Consequently, we opened the first trial with urcosimod as a Phase 2b clinical trial in\nDED patients.\n\n \n\n35\n\n \n\n \n\nOn\nMay 2, 2023, we announced that the first patient with DED was screened for a Phase 2b, multi-center, randomized, double-blinded, placebo-controlled\ntrial of urcosimod (formerly called OK-101) in DED. The double-masked, randomized, placebo-controlled Phase 2 trial was conducted at\nsix sites in the U.S. and enrolled 240 subjects with DED dosed twice-daily (BID). Patients were randomly divided into 3 cohorts, with\none of the cohorts dosed with 0.05% urcosimod (n=81), a second with 0.1% urcosimod (n=80), and the third cohort with vehicle (n=79).\nThe duration of a patient’s treatment was 14 weeks, including a 2-week run-in period on placebo, to exclude placebo responders\nfrom the study, followed by 12 weeks in the randomized portion of the study.\n\n \n\nOn\nJanuary 8, 2024, we announced the results of the urcosimod Phase 2b trial. Urcosimod showed statistically significant improvement in\na number of secondary endpoints in the trial, as well as an excellent safety profile in patients with DED. However, what was particularly\nnotable was the observation that ocular pain, as measured by a visual analog scale (VAS score), showed statistically significant reduction\nthat was durable throughout the trial, with p values = 0.03, 0.04 and 0.01 at Days 29, 57 and 85, respectively.\n\n \n\nOn\nMarch 22, 2024, we announced additional key findings from analyses of the clinical data set from the 240 patient Phase 2, randomized,\ndouble-masked, placebo-controlled trial evaluating the safety and efficacy of urcosimod ophthalmic solution in patients with DED.\n\n \n\nIn\nmid-2024, we made the final decision to switch all further clinical development of urcosimod to the treatment of Neuropathic Cornea Pain\n(NCP), due not only to the considerable preclinical data indicating the drug’s potential to treat this disease, but also due to\nthe positive clinical data observed in reducing ocular pain in the DED trial, as well as the key realization that there is no FDA-approved\ndrug to treat NCP, as compared to seven approved drugs presently available on the market to treat DED.\n\n \n\n**Urcosimod\nto Treat Neuropathic Corneal Pain**\n\n** **\n\nNeuropathic\ncorneal pain is a debilitating condition characterized by persistent, severe eye pain caused by nerve damage, impacting a\nsignificant number of patients worldwide. NCP has remained a challenging condition to treat since there are no FDA approved topical\ndrugs available to treat this condition. Current treatments for neuropathic corneal pain are limited to short term topical\nmedications such as NSAIDs, steroids, gabapentin, and opioids in severe cases. Neuropathic pain occurs through changes in both\nperipheral and central neurons leading to allodynia and hyperalgesia. Peripheral sensitization from the inflammatory cytokines\nduring and after ocular surface injury alters responsiveness of peripheral sensory neurons, which initiates complex\nneuroinflammatory and electrophysiological signaling in the central nervous system that amplifies the pain signaling. Urcosimod aims\nto address this urgent medical need with its innovative approach.\n\n \n\nUrcosimod,\nour novel, non-opioid therapeutic candidate, is designed to target and alleviate the debilitating pain associated with corneal nerve\ndamage, a condition for which there are currently no FDA approved treatments. Neuropathic corneal pain, often resulting from conditions\nlike dry eye disease, surgery, or infections, can severely impact a patient’s quality of life, with current management options\nlimited to pain relief strategies that offer only partial or temporary respite.\n\n \n\nThe\nchemerin receptor (ChemR23) that urcosimod targets to produce its anti-inflammatory activity is not only expressed on select populations\nof immune cells, but has now been shown to be expressed, as well, on neurons and glial cells in the dorsal root ganglion, spinal cord,\nand retina.\n\n \n\nIn\na separate set of animal model experiments, we evaluated the pain-reducing activity of urcosimod in a ciliary nerve ligation mouse model\nof corneal neuropathic pain. In collaboration with Pedram Hamrah, MD, Professor of Ophthalmology, an internationally recognized cornea\nspecialist and clinician-scientist, who at the time of the collaboration was at Tufts Medical Center, Boston, we demonstrated that urcosimod\nsuppresses corneal neuropathic pain in a mouse model of ciliary nerve ligation developed in Dr. Hamrah’s laboratory. Notably, urcosimod\nwas topically administered to mice in contrast to gabapentin which was used as a positive control and was administered *via* intraperitoneal\ninjection. Pain relief was evaluated by an eye-wipe count, and urcosimod was shown to reduce corneal pain similar to that of gabapentin,\na commonly used anticonvulsant oral drug typically used to treat neuropathic pain for conditions such as shingles and other systemic\nnerve pain disorders. Notably, the drug concentration of urcosimod used in this study was identical to that used in mouse models of DED\nthat demonstrated ocular anti-inflammatory activity. Urcosimod had no neurotoxic effect and did not affect the corneal epithelial integrity.\n\n \n\n36\n\n \n\n \n\nBased\non the success of the animal model experiments, we concluded that urcosimod has the potential to address both the increased inflammatory\ncytokines resulting from tear film imbalance as well as heightened neurosensory abnormalities through peripheral corneal nerve damage.\nConsequently, we believe that urcosimod has the potential to treat neuropathic corneal pain.\n\n \n\nOn\nOctober 9, 2023, we announced the filing of the IND with the FDA for the development of urcosimod to treat NCP. The NCP trial, designed\nas a single-center trial, was planned to be conducted at Tufts Medical Center with Professor Pedram Hamrah, MD, a leading expert in NCP,\nserving as Principal Investigator of the study. The trial, once started, was anticipated to take 6-9 months to conduct, and was anticipated\nto have a minor budgetary impact, with a total cost for the trial, including cost of drug manufacture and formulation, amounting to under\n$2 million.\n\n \n\nOn\nFebruary 9, 2024, we announced that the U.S. Food and Drug Administration (FDA) had cleared urcosimod as its first Investigational\nNew Drug (IND) application for the treatment of NCP. Notably, our initial IND submission to FDA proposed an open-label design for\nthe clinical trial. Based on positive feedback from FDA, the Phase 2 study was altered to be a single-center, double-masked,\nrandomized, 12-week placebo-controlled trial comparing urcosimod to placebo in NCP patients. A total of 48 patients were planned for\nthe study, with NCP disease confirmed *via* confocal microscopy. The primary endpoint was set as the measure corneal pain\nrelief in subjects with NCP as measured using a visual analog scale (VAS) to quantify pain relief. These protocol changes\nwould thus enable a statistically valid demonstration of a true drug effect of urcosimod on NCP symptoms.\n\n \n\nOn\nOctober 23, 2024, we announced that the first patient had been dosed in the Phase 2 trial of topical ocular urcosimod to treat NCP. The\nPhase 2 study was designed as a double-masked, randomized, 12-week placebo-controlled trial in NCP patients and was conducted at Tufts\nMedical Center, Boston, as the single clinical site for the study. A total of 48 patients were planned to be enrolled in the study, with\nNCP disease confirmed *via* confocal microscopy. Pedram Hamrah, M.D., one of the world’s foremost experts on NCP, served as\nPrincipal Investigator of the study.\n\n \n\nOn\nFebruary 12, 2025, we announced that our lead drug candidate, OK-101, was officially assigned the United States Adopted Name (USAN) “urcosimod”.\nThe USAN suffix “-mod” in urcosimod denotes its classification as a modulator of key inflammatory and neuropathic pathways,\ncritical to addressing ocular conditions such as neuropathic corneal pain (NCP). Importantly, we also made clear that all press releases\nafter the date of February 12, 2025 would contain the new drug name “urcosimod” instead of OK-101 in the body of the text,\nwith the alert to the reader of this change by inserting the wording “urcosimod (formerly called OK-101)” in the beginning\nparagraph of press released during 2025.\n\n \n\nOn\nMarch 31, 2025, we announced successfully establishing that urcosimod was shown to be stable for over two and a half years in single-use\nampoules used for administration of the drug to patients. Commercial marketing of ophthalmic drugs for ocular conditions which typically\nutilizes small plastic bottles has seen an increasing utilization of single-use ampoules by patients for ocular conditions such as DED,\nfor ease of use, and for minimizing concerns regarding potential loss of sterility with use of plastic bottles for daily administration\nof drug over extended periods of weeks and months.\n\n \n\nOn\nApril 30, 2025, we announced plans to close the trial with just 17 patients having completed the study out of a strong desire to\nimmediately interrogate the currently masked data by unmasking the data set. The trial was designed as a single-center,\ndouble-masked, randomized, 12-week placebo-controlled trial comparing urcosimod to placebo in NCP patients. The primary endpoint was\nset as the measure corneal pain relief in subjects with NCP as measured using a visual analog scale (VAS) to quantify pain relief. Due to compelling VAS pain relief data observed in these first 18 patients, we stopped the trial. We\nannounced that analysis of the data from these patients, with the closing of this trial, should take no longer than 6 weeks. This\ndecision to close the trial would also enable us to significantly cut the time to our requesting a meeting with FDA, should the\nresults be positive. This would enable us to cover plans for the drug’s further clinical development with FDA. Notably, a\nnumber of patients who completed the trial requested compassionate use of urcosimod which would need to be implemented by Tufts\nMedical Center and the Principal Investigator of the trial, subject to the necessary FDA consents.\n\n \n\n37\n\n \n\n \n\nOn\nMay 1, 2025, we announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation to urcosimod for the treatment\nof NCP. Fast Track designation by the FDA is granted to facilitate the development and expedite the review of therapies that aim to treat\nserious conditions and fulfill unmet medical needs. This designation is intended to accelerate the availability of new treatments to\npatients, providing earlier access to potentially beneficial therapies. The Fast Track designation provides several key benefits, including\nmore frequent meetings with the FDA to discuss the drug’s development plan, eligibility for Accelerated Approval and Priority Review\nif relevant criteria are met, and a potential Rolling Review of the New Drug Application (NDA).\n\n \n\nOn\nJuly 16, 2025, we announced results from the 18-patient Phase 2 trial of urcosimod to treat NCP patients. This randomized,\ndouble-masked, placebo-controlled, Phase 2 Proof-of-Concept trial of urcosimod to treat NCP was conducted at a single trial site at\nTufts Medical Center in Boston, MA, with Pedram Hamrah, M.D., a leading expert in NCP, as Principal Investigator. An important point\nto remember regarding analysis of the data from the trial was that the trial was designed as a randomized, placebo-controlled,\ndouble-masked Phase 2 study, with 48 patients needed to power the trial for statistically significant p values in the study. With\nOKYO announcing in April (see April 30, 2025 paragraph above) the decision to stop the trial after just 18 patients had completed\nthe 3-month dosing regimen, the Company moved from a focus on statistically significant p values in the trial to immediately\nunmasking the database to establish whether the considerable reduction in VAS scores being observed in the trial were attributable\nto patients on drug. This trial was thus an effort to quickly demonstrate a drug effect for urcosimod to treat NCP. The advantage of this strategy was to save the roughly 6-8 months needed to enroll the remaining 30 patients in order to get to the\nmajor purpose of the trial – demonstrating urcosimod’s potential to benefit patients with NCP.\n\n \n\nWhat\nfollows is a description of the results from this Phase2 trial:\n\n \n\nThe\nPrimary Objective of this Phase 2 trial was assessing the efficacy of the two doses of urcosimod (0.05% and 0.1%) in comparison to\nplacebo in reducing symptoms of neuropathic corneal pain, as measured by the mean change from baseline in the VAS scores from Visit\n1 (Day 0) through the end of treatment at Visit 4 (Week 12). The VAS scale used in the trial is a scale from 0 to 10, where 0 = no\npain and 10 = worst imaginable pain.\n\n \n\nThe\nstudy enrolled 18 patients at a single site (Tufts Medical Center in Boston, MA) with 17 patients completing the study. One patient was\nwithdrawn due to a medical reason not related to drug. Subjects were randomized in a 1:1:1 ratio to receive topical delivery to the eye\nof 0.05% urcosimod, or 0.1% urcosimod, or placebo, four times daily for 12 weeks.\n\n \n\nTop\nLine Data\n\n \n\nFor\nthe per-protocol population, the change in mean pain score was 5.5 in the 0.05% urcosimod group (n = 4) and 2.75 in the placebo group\n(n =4), reflecting a 2.75 delta difference between drug and placebo following the 12-week treatment period. Notably, 75% of patients\ntreated with 0.05% urcosimod in this group achieved greater than 80% improvement in pain severity based on VAS scores. Urcosimod (0.05%)\ndemonstrated a marked reduction in pain scores as early as Week 4, with a mean change of 5.25 compared to 3.0 in placebo group. Moreover,\nfor the 0.05% urcosimod group a statistically significant reduction in mean pain scores was observed from Visit 1 to the end of treatment\nVisit 4 (p-value = 0.025). The placebo group also showed a statistically significant improvement from baseline (Visit 1) to the final\nvisit (Visit 4), with a p-value = 0.035. However, mean improvement seen in the placebo group was only half what was seen for the 0.05%\nurcosimod group (2.75 vs 5.5). Moreover, for the placebo group’s reduction from Visit 1 to the end of treatment Visit 4, 75% of\nthose patients had only mild to borderline moderate NCP pain scores (0-4 on the scale of 0-10) at baseline. In contrast, all the patients\nin the 0.05% urcosimod group had moderate to severe NCP pain scores (5-9 on the scale of 0-10), indicating a more challenging baseline\ncondition. While the between-group difference in the per-protocol population did not reach statistical significance (p = 0.07), the 0.05%\nurcosimod group demonstrated a consistent numerical advantage over placebo. These results, alongside consistent trends observed across\ntime points, strongly support continued evaluation of urcosimod for treatment of the NCP indication.\n\n \n\n38\n\n \n\n \n\nIn\nthe intent-to-treat population, 67% of patients in the 0.05% urcosimod group (n =6) demonstrated greater than 50% improvement in\npain, as measured by VAS scores, compared to 33% in the placebo group (n = 6). The mean reduction in pain severity from baseline (Visit\n1) to end of treatment (Visit 4), measured by VAS, was 4.2 in the 0.05% urcosimod group and 2.5 in the placebo group. The comparison\nbetween groups in this population yielded a p-value of 0.2 and therefore did not meet the threshold for statistical significance.\n\n \n\nThe\ndrug-effect size of 0.05% urcosimod when compared to placebo at week 12, using Cohen-d demonstrated a strong treatment effect (Cohen-d\nvalue > 1.2). Cohen-d is a standard statistical measure used to assess and compare the effect size of the trial drug relative to the\nplacebo.\n\n \n\nIn\nline with earlier findings from a previously conducted Phase 2 trial to evaluate urcosimod to treat dry eye disease, results from the\n0.1% drug treatment group in this trial showed virtually no efficacy in the 0.10% drug treatment group.\n\n \n\nOn\nDecember 11, 2025, we announced new analyses of corneal images from the recently completed placebo-controlled, randomized, double-masked,\nPhase 2 clinical trial of urcosimod in NCP. Patients treated with 0.05% urcosimod demonstrated not only a positive reduction in neuropathic\ncorneal pain, but also favorable changes in corneal nerve structure which were not observed in the placebo group. Patients treated with\n0.05% urcosimod demonstrated directionally favorable improvements in nerve fiber count and fiber length, trends not observed in the placebo\ngroup. These findings suggest that urcosimod may have a positive impact on corneal nerve health in patients with neuropathic corneal\npain. Corneal nerve imaging data from the Phase 2 NCP trial were analyzed using in vivo confocal microscopy.\n\n \n\nData\ncompiled from nerve growth analyses which were an exploratory endpoint in the recently completed 18-patient trial of urcosimod\ndemonstrated a favorable impact on corneal nerve health. Patients treated with 0.05% urcosimod showed median increases in total\nnerve fiber count (+2.0, n/0.16 mm², IQR 0.54 to 3.63) and total nerve fiber length (+2.6 mm/mm², IQR 1.55 to 5.67; p =\n0.057 vs placebo). In contrast, the placebo group exhibited median decreases in total nerve fiber count (–1.92, n/0.16\nmm², IQR –2.79 to –0.04) and total nerve fiber length (–1.63 mm/mm², IQR –3.76 to 0.63). This\nexploratory dataset, exhibiting consistent and meaningful directional improvements for 0.05% patients on urcosimod across key\nanatomical endpoints, highlights urcosimod’s potential to support corneal nerve restoration and reinforces its promise as a\nfirst-in-class therapeutic approach for neuropathic corneal pain that warrants further investigations. All values represent median\n(n = 4). * IQR = (Inter Quartile Range).\n\n \n\nOn\nJanuary 28, 2026, we announced that we had held a successful Type C meeting with the Food & Drug Administration (FDA) regarding the\nPhase 2b/3 human clinical trial of urcosimod for the treatment of neuropathic corneal pain (NCP).\n\n \n\nKey\nhighlights from the Type C FDA meeting included:\n\n \n\n●FDA\nconfirmed the approach that the proposed primary endpoint of the Visual Analogue Scale (VAS)\npain reduction at Week 12 is clinically meaningful, including explicit acknowledgment that\na ≥2-point improvement on the VAS scale represents a meaningful treatment effect\n\n●The\nAgency provided statistical guidance to enhance robustness, noting that if the statistical\nanalysis plan (SAP) is finalized prior to unmasking and results are strong, the data could\nprovide substantial evidence of effectiveness at a future End-of-Phase 2b/3 meeting\n\n \n\n39\n\n \n\n \n\n●FDA\nendorsed the proposed study design, sample size, and powering assumptions, and agreed that\nthe Ocular Pain Assessment Survey (OPAS) is appropriate as supportive quality-of-life evidence\n\n●FDA\nalignment on the Chemistry, Manufacturing and Controls (CMC) strategy and key clinical elements,\nwith no material issues raised, derisking the pathway to a pivotal trial and supports potential\nregistration if study results are robust\n\n \n\nOn\nMarch 18, 2026, we announced new positive findings from an exploratory analysis of patient-reported outcomes in its recently completed\nPhase 2a trial of urcosimod (0.05%) for the treatment of NCP. After 12 weeks of treatment, patients receiving urcosimod demonstrated\ngreater improvements across key aspects of emotional well-being and quality of life compared to placebo. These measures were assessed\non a 0–10 scale. These new quality-of-life (QoL) data was presented at the Association for Research in Vision and Ophthalmology\n(ARVO) 2026 Annual Meeting. The presentation, titled: “First-in-Human Study of Urcosimod to Treat Neuropathic Corneal Pain (NCP)\nShowed Clinically Meaningful Pain Reduction and Quality-of-Life Improvement in NCP Patients” detailed the Phase 2a clinical trial\nresults, including reductions in pain as measured by the VAS, improvements in patient-reported QoL measures, as well as signals suggesting\npotential restoration of corneal nerve structure in NCP patients. Notable improvements included:\n\n \n\n●Enjoying\nlife/relationships with other people: mean change from baseline of −4.5 (IQR −6.00\nto −0.75) for urcosimod vs. 0 (IQR −4.75 to 1.25) for placebo.\n\n●Mood:\nmean change of −1.5 (IQR −5.25 to 0.25) for urcosimod vs. −0.5 (IQR −4.75\nto 2.25) for placebo.\n\n●Time\nspent thinking about eye pain: mean change of −3.0 (IQR −5.00 to 0.00) for urcosimod\nvs. −1.5 (IQR −4.00 to 0.00) for placebo.\n\n \n\nOn\nJuly 8, 2026, we announced that we had held a successful Type D meeting with the Food & Drug Administration (FDA). This meeting\nconfirmed that the next human clinical trial of urcosimod for the treatment of neuropathic corneal pain (NCP) would be a Phase 3 trial, with approximately 111 subjects enrolled in 2 arms in a 2:1\nrandomization of 0.05% urcosimod versus placebo. The trial is also expected to be a global trial, with additional trial sites in Europe, as well as the USA.\n\n \n\nKey\nhighlights from the Type D FDA meeting included:\n\n \n\n●FDA\nalignment on a single-dose Phase 3 study design and potential single-trial\nregistration pathway further strengthening the Company’s clinical development program for urcosimod.\n\n●Study design finalized to enroll approximately 111 subjects in a 2:1 randomization\nof 0.05% urcosimod versus placebo\n\n●The\nCompany unveils NEPTUNE (Neuropathic Eye Pain Treatment with Urcosimod & Nerve Evaluation), as the name for the global trial to\nbe held in the United States and Europe\n\n \n\nOther\nBusiness Updates:\n\n \n\nOn\nJanuary 5, 2026, we announced that effective immediately Robert J. Dempsey was appointed Chief Executive Officer of OKYO Pharma and an\nexecutive Board member of the Board of Directors. Mr. Dempsey brings more than two decades of global ophthalmology experience, including\ndrug development, commercialization, and value-creating strategic transactions to OKYO. He previously served as Group Vice President\nand Head of Global Ophthalmology at Shire, prior to its acquisition by Takeda, where he led the divestiture of Xiidra®\n(lifitegrast ophthalmic solution) 5%, which was one of only three ophthalmology deals in the past twenty years with more than $1 billion\nupfront. Mr. Dempsey architected and led the successful launch of Xiidra® and brings deep strategic and commercial expertise\nacross ocular surface disease indications, including direct management responsibility and commercial oversight for Restasis®\n(cyclosporine ophthalmic emulsion) 0.05%. His professional network in the eye care community is broad and well-established, reflecting\nhis service as a CEO and independent director across multiple ophthalmic companies. Gary S. Jacob, Ph.D., former CEO, transitioned to\nChief Development Officer and continue to serve on the Board of Directors.\n\n** **\n\nOn\nFebruary 10, 2026, we announced the appointment of Flavio Mantelli, MD, PhD as Chief Medical Officer. Dr. Mantelli brings unparalleled\nexperience in ocular surface drug development, having led the clinical development, regulatory approval, and global launch of Oxervate®\n(cenegermin-bkbj) at Dompé farmaceutici S.p.A., which achieved blockbuster status with sales topping $1 billion in 2024, and is\nwidely considered as one of the most successful orphan drug launches in ophthalmology. Dr. Mantelli is a highly regarded ophthalmologist\nwith an extensive background in cornea and ocular surface diseases, neurotrophic keratopathy, and inflammatory eye conditions. He brings\ncritical knowledge and experience to OKYO in developing therapeutics from first-in-human studies through to global regulatory approval.\nDr. Mantelli will oversee clinical strategy and advancement of urcosimod in neuropathic corneal pain (NCP) building on urcosimod’s\nFDA fast-track designation.\n\n \n\nThis\nappointment, following the recent CEO appointment, further strengthened OKYO’s world-class ophthalmology leadership team.\n\n \n\nOn\nFebruary 26, 2026, we announced the successful pricing of an underwritten public offering of 10,815,000 ordinary shares at an offering\nprice of $1.85 per ordinary share. The Company has granted the underwriter a 30-day option to purchase up to an additional 1,622,250\nordinary shares at the public offering price, less underwriting discounts and commissions. The gross proceeds to the Company from the\nOffering, before deducting offering expenses payable by the Company and discounts, is approximately $20 million. Assuming full exercise\nby the underwriter of its option to purchase additional ordinary shares, the gross proceeds to the Company from the Offering would be\napproximately $23 million, before deducting offering expenses payable by the Company and discounts. The Company intends to use the net\nproceeds from this Offering primarily for the upcoming Phase 3 trial as well as for working capital.\n\n \n\n40\n\n \n\n \n\n**OK201**\n\n \n\nOn\nAugust 6, 2019, we signed a collaborative agreement with Tufts Medical Center, Boston and Pedram Hamrah, MD, Professor of Ophthalmology\nat Tufts University School of Medicine, Boston, MA to evaluate OKYO’s BAM8-22 analogues, including OK-201, as non-opioid analgesics\nto suppress corneal neuropathic pain using a mouse ocular pain model developed in Dr. Hamrah’s laboratory.\n\n \n\nOn\nApril 28, 2021, we announced positive results of OK-201, a non-opioid analgesic drug candidate delivered topically in Dr. Hamrah’s\nmouse neuropathic corneal pain model, as a potential drug to treat acute and chronic ocular pain. Importantly, OK-201 demonstrated a\nreduced corneal pain response equivalent to that of gabapentin, a commonly used oral drug for neuropathic pain. These observations demonstrated\npreclinical ‘proof-of-concept’ for the topical administration of OK-201 as a potential non-opioid analgesic for ocular pain.\nCurrent treatments for corneal pain are limited to short term NSAIDs, steroids and oral gabapentin and opioids in severe cases.\n\n \n\nAlthough\nthe results with OK-201 were encouraging, due to subsequent success obtained with urcosimod in follow-on animal model studies\nutilizing the same mouse neuropathic corneal pain model as for OK-201, we have decided to maintain OK-201 at the exploratory level\nwhile we are focusing our primary energy on the urcosimod program to treat NCP, based on urcosimod’s combination of\nanti-inflammatory and ocular pain-reducing activities in animal models of these conditions.\n\n \n\n**Intellectual\nProperty**\n\n \n\nWe\nconsider the protection of our proprietary technologies and products, as well as our ability to maintain patent protection that covers\nthe composition of matter of our product candidates, their methods of use, and other related technologies and inventions, to be a critical\nelement in the success of our business. As of June 30, 2025, our owned and licensed intellectual property included 8 issued patents and\n15 pending patent applications in the U.S. and abroad.\n\n \n\nIssued\nUnited States patent directed to lipidated chemerin fragments or analogs has a statutory expiration date of March 13, 2034, with potential\npatent term extension available until 2039, following the grant of marketing authorization. Issued United States patent directed to methods\nof using lipidated chemerin fragments or analogs for treating neuropathic pain has a statutory expiration date of March 13, 2034 (plus\n187 days of patent term adjustment, or PTA), with potential patent term extension available until 2039, following the grant of marketing\nauthorization. Issued United States patent directed to methods of using lipidated chemerin fragments or analogs for treating DED has\na statutory expiration date of January 23, 2037, with potential patent term extension available until 2041, following the grant of marketing\nauthorization. We have pending patent applications for lipidated chemerin fragments or analogs and methods of use thereof that, if issued,\nwould be expected to expire in the United States and in countries outside of the United States between 2034 and 2043, excluding any patent\nterm adjustment that might be available following the grant of the patent and any patent term extensions that might be available following\nthe grant of marketing authorizations.\n\n \n\nIssued\nUnited States patent directed to lipidated BAM8-22 peptides or analogs and methods of use thereof has a statutory expiration date of\nNovember 9, 2036 (plus 70 days of PTA), with potential patent term extension available until 2042, following the grant of marketing authorization.\nWe have pending patent applications for lipidated BAM8-22 peptides or analogs and methods of use thereof that, if issued, would be expected\nto expire in the United States and in countries outside of the United States between 2036 and 2040, excluding any patent term adjustment\nthat might be available following the grant of the patent and any patent term extensions that might be available following the grant\nof marketing authorizations.\n\n \n\n41\n\n \n\n \n\nWe\nplan to protect our intellectual property position by, among other things, licensing or filing our own U.S. and foreign patent applications\nrelated to our proprietary technologies and products, and any inventions or improvements that are important to the development and implementation\nof our business. We also may seek patent protection, if available, with respect to biomarkers and diagnostic methods that may be used\nto determine optimal patient populations for use of our product candidates.\n\n \n\nWherever\npossible, we seek to protect our inventions by filing U.S. patent applications as well as foreign counterpart applications in select\ncountries. Because patent applications in the U.S. are maintained in secrecy for at least 18 months after the applications are filed,\nand since publication of discoveries in the scientific or patent literature often lags behind actual discoveries, we cannot be certain\nthat we were the first to make the inventions covered by each of our issued or pending patent applications, or that we were the first\nto file for protection of inventions set forth in such patent applications. Our planned or potential products may be covered by third-party\npatents or other intellectual property rights, in which case continued development and marketing of our products would require a license.\nRequired licenses may not be available to us on commercially acceptable terms, if at all. If we do not obtain these licenses, we could\nencounter delays in product introductions while we attempt to design around the patents, or we could find that the development, manufacture\nor sale of products requiring such licenses are not possible.\n\n \n\nIn\naddition to patent protection, we also rely on know-how, trade secrets and the careful monitoring of proprietary information, all of\nwhich can be difficult to protect. We seek to protect some of our proprietary technologies and processes by entering into confidentiality\nagreements with our employees, consultants, and contractors. These agreements may be breached, we may not have adequate remedies for\nany breach and our trade secrets may otherwise become known or be independently discovered by competitors. To the extent that our employees\nor our consultants or contractors use intellectual property owned by others in their work for us, disputes may also arise as to the rights\nin related or resulting know-how and inventions.\n\n \n\n*License\nAgreement for Urcosimod*\n\n \n\nOn\nTarget Therapeutics (OTT) and Tufts Medical Centre (TMC) entered into a license agreement on April 3, 2017, or the Master License, pursuant\nto which OTT licensed exclusive rights to certain patent applications that describe and claim lipidated chemerin peptides and their uses\nin DED, or Chemerin. The Master License remains in effect until the royalty term has expired with respect to all licensed products in\nall countries. The Master License may be terminated by either party in the event of a material breach and in addition, OTT may terminate\nthe Master License at any time upon 90 days’ notice.\n\n \n\nOn\nMay 22, 2017, OTT entered into a license and sublicense agreement with Panetta Partners Limited, one of our principal stockholders, relating\nto Chemerin, or the Chemerin License Agreement, which was licensed from OTT and sublicensed from TMC. On May 1, 2018, we entered into\nan assignment of the Sublicense with Panetta Partners Limited. Under the terms of the Chemerin License Agreement, we have exclusive rights\nto Chemerin. Specifically, we have the benefit of the exclusive worldwide rights to a U.S. patent application (which if issued would\nexpire in 2036). In addition, we have exclusive worldwide rights to a Patent Cooperation Treaty, or PCT, patent which has been nationalized\nin the U.S., Europe, Japan, Australia and Canada and if issued it would expire in 2037. The Chemerin License Agreement provides for the\npayment by us of up to $4.9 million in development milestone payments and up to $37 million in sales milestones as follows:\n\n \n\nDevelopment\nmilestone payments being:\n\n \n\n \n●\n$300,000\nupon first patient enrolled in a Phase I clinical trial;\n\n \n \n \n\n \n●\n$600,000\nupon first patient enrolled on a Phase II clinical trial;\n\n \n \n \n\n \n●\n$1,500,000\nupon first patient enrolled in a Phase III clinical trial; and\n\n \n \n \n\n \n●\n$2,500,000\nupon first commercial sale of a licensed product.\n\n \n\n42\n\n \n\n \n\nSales\nmilestones payments as follows:\n\n \n\n \n●\n$2,000,000\non first achievement of annual net sales of $50,000,000;\n\n \n \n \n\n \n●\n$4,000,000\non first achievement of annual net sales of $100,000,000;\n\n \n \n \n\n \n●\n$6,000,000\non first achievement of annual net sales of $250,000,000;\n\n \n \n \n\n \n●\n$10,000,000\non first achievement of annual net sales of $500,000,000; and\n\n \n \n \n\n \n●\n$15,000,000\non first achievement of annual net sales of $1,000,000,000.\n\n \n\n \n\nThe\nabove payments equate to low and declining single digit percentage royalties on net sales.\n\n \n\nWe\nbelieve that we have novel composition-of-matter coverage on the lipidated chemerin peptide lead analogues and novel method-of-use claims\nin treating DED and other ophthalmic diseases. Each patent office has different patentability requirements, but we believe that the license\npatent applications 16/070,467 (U.S. patent application entitled “Compounds and methods for treating inflammation”; applicant:\nTufts Medical Center / Trustees of Tufts College) and PCT/US2017/014605 (U.S. patent application entitled “Compounds and methods\nfor treating inflammation”; applicant Tufts Medical Center / Trustees of Tufts College) contain patentable subject matter. The\nprocess for issuance of a patent involves a correspondence with each local patent office in the jurisdictions in which the patent application\nis filed. That process, patent prosecution, involves a discussion of any relevant prior art and typically a discussion of the scope of\nthe claims. The patent prosecution process can take several years depending on the jurisdiction and is not in the control of the patent\nowner, but in the control of the local patent office.\n\n \n\nThe\nsubject matter of the licensed IP may have been developed with government financial assistance and are subject to certain federal regulations\nunder the Bayh-Dole Act of 1980. In particular, the federal government retains a “nonexclusive, nontransferable, irrevocable, paid-up\nlicense” for its own benefit to inventions produced with its financial assistance. The Bayh-Dole Act also provides federal agencies\nwith “march-in rights” and allows the government certain rights to require products to be manufactured in the United States.\nMarch-in rights allow the government, in specified circumstances, to require the contractor or successors in title to the patent to grant\na “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants.” If the\npatent owner refuses to do so, the government may grant the license itself.\n\n \n\n*OK-201*\n\n \n\nWe\nentered into a license agreement with TMC on May 1, 2018, relating to intellectual property and proprietary technology for the use of\ncertain lipidated BAM peptides in the treatment of neuropathic pain. Under the terms of the license agreement, we have acquired an exclusive\nlicense to certain patents (pending and issued), inventions (including future patent filings on lipidated BAM molecules related to the\nlicensed patents). The license agreement requires an upfront license fee of $15,000 (£11,000), which has been paid by us and annual\nmaintenance fees of $15,000 (£11,000) commencing on the first anniversary of the license agreement. The maintenance fees decrease\nto $10,000 after the three-year anniversary until the first commercial sale. The license agreement also provides for further development\nand sales milestone payments and royalties.\n\n \n\nOn\nFebruary 23, 2021, we announced that patent No. 10,899,796 entitled “Compounds and Methods for Treating Pain” was issued\nby the United States Patent and Trademark Office. The patent is directed to a class of BAM peptides linked to specific lipids that demonstrate\npotential for treating symptoms of neuropathic pain, ocular pain, ocular inflammation and/or DED. The work recited in this patent lays\nout the potential of this class of lipidated BAM analogues as non-opioid analgesics for ocular pain management without the side effects\nand potential abuse associated with opioid medications and is the foundation of our OK-201 program. In addition to the license from TMC\nwe have a collaboration agreement with TMC pursuant to which TMC has agreed to make available the services of Dr Pedram Hamrah M.D. as\nprincipal investigator and nominated reach associate to carry out investigative and research studies in furtherance of our OK-201 neuropathic\npain program. The patent will expire in early 2036.\n\n \n\n43\n\n \n\n \n\n**Government\nRegulation**\n\n \n\n**Overview**\n\n \n\nGovernment\nauthorities in most jurisdictions extensively regulate the research, development, clinical testing, manufacture, distribution and marketing\nof pharmaceutical products such as those that the Company is developing. Obtaining regulatory approvals and ensuring subsequent compliance\nwith applicable laws and regulations requires the expenditure of substantial time and financial and managerial resources. Regulatory\nrequirements in different jurisdictions vary, and the timing and success of efforts to obtain regulatory approvals can be highly uncertain.\nDevelopment of a successful drug candidate, from identification of a candidate drug compound, through preclinical and clinical testing,\nto filing of a marketing approval application, to registration, typically takes more than ten years.\n\n \n\nDrug\ndevelopment is a highly structured process divided into two major stages, preclinical and clinical. In the preclinical stage, the toxicology\nand mode of action of an active compound is evaluated. The clinical stage is designed to prove the safety of any new pharmaceutical,\ndetermine dosage requirements and, predominantly in the later phases, prove its therapeutic utility. This stage is carried out in three\nphases, which, as a developer moves through the phases, require increasingly large, complex, expensive and time-consuming clinical studies.\nDuring Phase 1, the product candidate is initially given to a small number of healthy human subjects or patients and tested for safety,\ntolerance, absorption, metabolism, distribution and excretion. During Phase 2, additional trials are conducted in a larger, but still\nrelatively limited, patient population to verify that the product candidate has the desired effect and to identify optimal dosage levels.\nFurthermore, possible adverse effects and safety risks are identified. The therapeutic utility of the product candidate for specific\ntargeted diseases is also studied in more depth. During Phase 3, trials are undertaken to further evaluate dosage, to provide statistically\nsignificant evidence of clinical effectiveness and to further study the safety in an expanded patient population at multiple clinical\ntrial sites. Phase 3 trials may require several hundreds or thousands of patients and are therefore the most expensive and time-consuming\nto conduct. At any time during one of the phases, a trial may produce a negative result, in which case the developer may choose to end\nthe development project, or a regulator could force clinical trials to terminate.\n\n \n\nFollowing\ncompletion of the Phase 3 trials, the developer submits all the preclinical and clinical trial documentation as well as extensive data\ncharacterizing the manufacturing process to the regulator to seek regulatory approval to market the formulation as a pharmaceutical product.\nThe regulator reviews all the information related to the safety of the active compound, and whether the pharmacological effect claimed\nby the developer on the proposed label can be substantiated by the results of the clinical trials. The regulator has the option to decide\nto approve the application as requested, ask for changes to the claims made by the developer, ask for more information, require that\nfurther clinical trials are undertaken, or refuse to approve the formulation for sale.\n\n \n\nEven\nafter initial regulatory approval has been obtained, further studies, including Phase 4 post-approval safety studies, may be required\nto provide additional data on safety and will be required to gain approval for the use of a product as a treatment for clinical indications\nother than those for which the product was initially tested. There are also continuing, annual user fee requirements for any marketed\nproducts and the establishments at which such products are manufactured, as well as new application fees for supplemental applications\nwith clinical data. In addition, regulatory authorities require post-marketing reporting to monitor the adverse effects of the product.\nResults of post-approval programs may limit or expand the further marketing of the products. Further, if there are any modifications\nto the product, including changes in indication, manufacturing process or labelling, or a change in the manufacturing facility, an application\nseeking approval of such changes or, as the case may be, notification, must be submitted to the relevant regulatory authorities before\nthe modified product can be commercialized. Moreover, an approved drug product may be subject to a REMS, which could impose a number\nof post-approval obligations, including (among other things) a communication plan for physicians regarding safe use of the drug, distribution\nand use restrictions, and/or periodic assessments of the effectiveness of the REMS. Finally, studies may be required as a contingency\nof regulatory approval (post-approval commitments), and completion of these studies within a regulator mandated time frame may be required.\n\n \n\n**European\nUnion**\n\n \n\nThe\ndevelopment, marketing and sale of medicinal products in the EU is subject to extensive pre- and post- marketing regulation by regulatory\nauthorities at both the EU and national levels. The requirements, regulatory approvals and processes governing the conduct of clinical\ntrials, product licensing, pricing and reimbursement vary from country to country, although there is some degree of EU wide harmonization.\n\n \n\n44\n\n \n\n \n\n*Clinical\nTrials*\n\n \n\nClinical\ntrials of medicinal products in the EU must be conducted in accordance with EU and national regulations, focusing, in particular on traceability,\napply to clinical trials of advanced therapy medicinal products. If the sponsor of the clinical trial is not established within the EU,\nit must appoint an entity within the EU to act as its legal representative. The sponsor must take out a clinical trial insurance policy\nand, in most EU countries, the sponsor is liable to provide ‘no fault’ compensation to any study subject injured in the clinical\ntrial.\n\n \n\nPrior\nto commencing a clinical trial, the sponsor must obtain a clinical trial authorization from the relevant regulatory authority, and a\npositive opinion from an independent ethics committee. The application for a clinical trial authorization must include, among other things,\na copy of the trial protocol and an investigational medicinal product dossier containing information about the manufacture and quality\nof the medicinal product under investigation. Currently, clinical trial authorization applications must be submitted to the regulatory\nauthority in each Member State in which the trial will be conducted. Under the new Regulation on Clinical Trials, which is currently\nexpected to take effect in 2019, there will be a centralized application procedure where one national authority takes the lead in reviewing\nthe application and the other national authorities have only a limited involvement. Any substantial changes to the trial protocol or\nother information submitted with the clinical trial applications must be notified to or approved by the relevant competent authorities\nand ethics committees. Medicines used in clinical trials must be manufactured in accordance with cGMP.\n\n \n\n*Marketing\nApproval*\n\n \n\nIn\nthe EU medicinal products can only be commercialized after obtaining marketing authorization, or MA. There are three procedures for obtaining\nmarketing approvals: the centralized procedure, the decentralized procedure and the mutual recognition procedure/national procedure.\n\n \n\nThe\nCommunity marketing authorization, which is issued by the European Commission through the centralized procedure, based on the opinion\nof the Committee for Medicinal Products for Human Use (CHMP) of the EMA, is valid throughout the entire territory of the EU. The centralized\nprocedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, and medicinal\nproducts containing a new active substance indicated for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, autoimmune\nand viral diseases. The centralized procedure is optional for products containing a new active substance not yet authorized in the EU,\nor for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public\nhealth in the EU.\n\n \n\nMarketing\napprovals obtained using the decentralized procedure are available for products not falling within the mandatory scope of the Centralized\nProcedure. An identical dossier is submitted to the regulatory authorities of each of the Member States in which the marketing approval\nis sought, one of which is selected by the applicant as the Reference Member State, or RMS. The competent authority of the RMS prepares\na draft assessment report, a draft summary of the product characteristics and a draft of the labelling and package leaflet, which are\nsent to the other the concerned Member States, or CMSs, for their approval. A CMS can raise an objection, based on the assessment report,\nthe summary of product characteristics, the labelling and the package leaflet on the grounds of potential serious risk to public health.\nIf no such objections are raised the product will be granted a national marketing authorization in the RMS and all of the selected CMSs.\nWhere a product has already been authorized for marketing in a Member State, this decentralized procedure approval can be recognized\nin other Member States through the mutual recognition procedure.\n\n \n\nMarketing\napprovals obtained using the national procedure are issued by a single regulatory authority of one of the Member States and only apply\nto the territory covered by the relevant regulatory authority. They are available for products not falling within the mandatory scope\nof the centralized procedure. Once a product has been authorized for marketing in a Member State through the national procedure, any\napplication in another Member State must be by the mutual recognition procedure whereby the marketing approval can also be recognized\nin other Member States through the mutual recognition procedure.\n\n \n\n45\n\n \n\n \n\nUnder\nthe procedures described above, before granting the MA, the EMA or the relevant regulatory authority of the Member States of the EU makes\nan assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and therapeutic\nutility.\n\n \n\nThe\nholder of a marketing authorization in any Member State of the EU is subject to various obligations under applicable EU regulations,\nsuch as pharmacovigilance obligations, requiring it to, among other things, report and maintain detailed records of adverse reactions,\nand to submit periodic safety update reports to the regulatory authorities. The holder must also ensure that the manufacturing and batch\nrelease of its product is in compliance with the applicable requirements. The marketing approval holder is further obligated to ensure\nthat the advertising and promotion of its products complies with applicable laws, which can differ from Member State to Member State\nof the EU.\n\n \n\n*Data\nExclusivity*\n\n \n\nMAAs\nfor generic medicinal products in the EU do not need to include the results of preclinical and clinical trials, but instead can refer\nto the data included in the marketing approval of a reference product for which regulatory data exclusivity has expired. If a marketing\napproval is granted for a medicinal product containing a new active substance, that product benefits from eight years of data exclusivity,\nduring which generic MAAs referring to the data of that product may not be accepted by the regulatory authorities, and a further two\nyears of market exclusivity, during which such generic products may not be placed on the market. The two-year period may be extended\nto three years if during the first eight years a new therapeutic indication with significant clinical benefit over existing therapies\nis approved.\n\n \n\nThere\nis a special regime for biosimilars, or biological medicinal products that are similar to a reference medicinal product but that do not\nmeet the definition of a generic medicinal product, for example, because of differences in raw materials or manufacturing processes.\nFor such products, the results of appropriate preclinical or clinical trials must be provided, and guidelines from the EMA detail the\ntype of quantity of supplementary data to be provided for different types of biological product. There are no such guidelines for complex\nbiological products, such as gene or cell therapy medicinal products, and so it is unlikely that biosimilars of those products will currently\nbe approved in the EU. However, guidance from the EMA states that they will be considered in the future in light of the scientific knowledge\nand regulatory experience gained at the time.\n\n \n\n*Orphan\nMedicinal Products*\n\n \n\nThe\nEMA’s Committee for Orphan Medicinal Products, or COMP, may recommend orphan medicinal product designation to promote the development\nof products that are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting\nnot more than five in 10,000 persons in the EU. Additionally, designation is granted for products intended for the diagnosis, prevention\nor treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is unlikely\nthat sales of the product in the EU would be sufficient to justify the necessary investment in developing the medicinal product. The\nCOMP may only recommend orphan medicinal product designation when the product in question offers a significant clinical benefit over\nexisting approved products for the relevant indication. Following a positive opinion by the COMP, the European Commission adopts a decision\ngranting orphan status. The COMP will reassess orphan status in parallel with EMA review of a marketing authorization application and\norphan status may be withdrawn at that stage if it no longer fulfills the orphan criteria (for instance because in the meantime a new\nproduct was approved for the indication and no convincing data are available to demonstrate a significant benefit over that product).\nOrphan medicinal product designation entitles a party to financial incentives such as reduction of fees or fee waivers and ten years\nof market exclusivity is granted following marketing authorization. During this period, the competent authorities may not accept or approve\nany similar medicinal product, unless it offers a significant clinical benefit. This period may be redacted to six years if the orphan\nmedicinal product designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not\nto justify maintenance of market exclusivity.\n\n \n\n46\n\n \n\n \n\n**United\nStates**\n\n \n\n*Standard\nProcedure*\n\n \n\nIn\nthe United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act of 1938 and its implementing regulations. The\nprocess of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and\nregulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements\nat any time during the product development process, approval process or after approval, may subject an applicant to a variety of administrative\nor judicial sanctions, such as the FDA’s refusal to approve pending NDAs or BLAs, withdrawal of an approval, imposition of a clinical\nhold, issuance of warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions,\nfines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.\n\n \n\nThe\nprocess required by the FDA before a drug may be marketed in the United States generally involves the following:\n\n \n\n \n●\ncompletion\nof preclinical laboratory studies, animal studies and formulation studies in compliance with the FDA’s good laboratory practice\nregulations;\n\n \n \n \n\n \n●\nsubmission\nto the FDA of an IND, which the FDA must approve before human clinical trials may begin;\n\n \n \n \n\n \n●\napproval\nof the human clinical trial by the institutional review board, or IRB, at each clinical site before each trial may be initiated;\n\n \n \n \n\n \n●\nperformance\nof adequate and well-controlled human clinical trials in accordance with applicable IND and other clinical trial-related regulations,\nsometimes referred to as GCPs to establish the safety and clinical utility of the proposed product candidate for its proposed indication;\n\n \n \n \n\n \n●\nsubmission\nto the FDA of a BLA or NDA;\n\n \n \n \n\n \n●\nsatisfactory\ncompletion of an FDA pre-approval inspection of the production facility or facilities where the product is produced to assess compliance\nwith the FDA’s cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the product’s\nidentity, strength, quality, purity and potency;\n\n \n \n \n\n \n●\npotential\nFDA audit of the preclinical and/or clinical trial sites that generated the data in support of the NDA; and\n\n \n \n \n\n \n●\nFDA\nreview and approval of the BLA or NDA prior to any commercial marketing or sale of the product in the United States.\n\n \n\nOnce\nan approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained\nor if problems occur after the product reaches the market. Other potential consequences include, among other things:\n\n \n\n \n●\nrestrictions\non the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;\n\n \n \n \n\n \n●\nfines,\nwarning letters or holds on post-approval clinical trials;\n\n \n \n \n\n \n●\nrefusal\nof the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product approvals;\n\n \n \n \n\n \n●\nproduct\nseizure or detention, or refusal to permit the import or export of products; or\n\n \n \n \n\n \n●\ninjunctions\nor the imposition of civil or criminal penalties.\n\n \n\n47\n\n \n\n \n\n*Clinical\nTrials*\n\n \n\nClinical\ntrials involve the administration of the IND to human patients under the supervision of qualified investigators in accordance with GCP\nrequirements, which include the requirement that all research patients provide their informed consent in writing for their participation\nin any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the\nparameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any\nsubsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, an IRB at each institution participating\nin the clinical trial must review and approve the plan for any clinical trial before it commences at that institution. Information about\ncertain clinical trials must be submitted within specific timeframes to the National Institutes of Health for public dissemination on\ntheir website. Regulatory authorities, IRBs or the sponsor may suspend or terminate a clinical trial at any time on various grounds,\nincluding a finding that the research patients are being exposed to an unacceptable health risk.\n\n \n\n*Marketing\nApproval*\n\n \n\nAssuming\nsuccessful completion of the required clinical testing, the results of the preclinical studies and clinical trials, together with detailed\ninformation relating to the product’s chemistry, manufacture, controls, or CMC, and proposed labelling, among other things, are\nsubmitted to the FDA as part of an NDA or BLA requesting approval to market the product for one or more indications. In most cases, the\nsubmission of an NDA or BLA is subject to a substantial application user fee. Under the Prescription Drug User Fee Act guidelines that\nare currently in effect, the FDA has a goal of 10 months from the date of filing of a standard NDA for a new molecular entity to review\nand act on the submission. This review typically takes 12 months from the date the NDA is submitted to the FDA because the FDA has approximately\ntwo months to make a filing decision.\n\n \n\nIn\naddition, under the Pediatric Research Equity Act of 2003**,**certain NDAs or supplements to an NDA must contain data that\nare adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations,\nand to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may, on\nits own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval\nof the product for use in adults, or full or partial waivers from the pediatric data requirements.\n\n \n\nThe\nFDA conducts a preliminary review of all NDAs within the first 60 days after submission, before accepting them for filing, to determine\nwhether they are sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an\nNDA for filing. In this event, the application must be resubmitted with the additional information. The resubmitted application is also\nsubject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive\nreview. The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether the facility in which\nit is manufactured, processed, packaged or held meets standards designed to assure the product’s continued safety, quality and\npurity.\n\n \n\nThe\nFDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including\nclinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be\napproved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations\ncarefully when making decisions.\n\n \n\nBefore\napproving a BLA or NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not\napprove an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements\nand adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the\nFDA may inspect one or more clinical trial sites to assure compliance with GCP requirements.\n\n \n\nAfter\nevaluating the NDA or BLA and all related information, including the advisory committee recommendation, if any, and inspection reports\nregarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete\nresponse letter (which generally contains a statement of specific conditions that must be met in order to secure final approval of the\nNDA and may require additional clinical or preclinical testing in order for the FDA to reconsider the application). Even with submission\nof this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.\nIf and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter. An approval\nletter authorizes commercial marketing of the drug with specific prescribing information for specific indications.\n\n \n\n48\n\n \n\n \n\nEven\nif the FDA approves a product, it may limit the approved indications for use of the product, require that contraindications, warnings\nor precautions be included in the product labelling, require that post-approval studies, including Phase 4 clinical trials, be conducted\nto further assess a drug’s safety after approval, require testing and surveillance programs to monitor the product after commercialization,\nor impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS, which can materially\naffect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the\nresults of post-marketing studies or surveillance programs. After approval, some types of changes to the approved product, such as adding\nnew indications, manufacturing changes, and additional labelling claims, are subject to further testing requirements and FDA review and\napproval.\n\n \n\n*Orphan\nDrug Designation*\n\n \n\nUnder\nthe Orphan Drug Act of 1983, the FDA may designate a biologic product as an “orphan drug” if it is intended to treat a rare\ndisease or condition (generally meaning that it affects fewer than 200,000 individuals in the United States, or more in cases in which\nthere is no reasonable expectation that the cost of developing and making a biologic product available in the United States for treatment\nof the disease or condition will be recovered from sales of the product).\n\n \n\nIf\na product with orphan status receives the first FDA approval for the disease or condition for which it has such designation, the product\nis entitled to orphan product exclusivity, meaning that the FDA may not approve any other applications to market the same drug or biologic\nproduct for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product\nwith orphan exclusivity or if the party holding the exclusivity fails to assure the availability of sufficient quantities of the drug\nto meet the needs of patients with the disease or condition for which the drug was designated. Competitors, however, may receive approval\nof different products for the same indication for which the orphan product has exclusivity or obtain approval for the same product but\nfor a different indication for which the orphan product has exclusivity.\n\n \n\n**Post-Approval\nRequirements for the EU and United States**\n\n \n\nThe\nFDA and the relevant regulatory authorities in the EU strictly regulate marketing, labelling, advertising and promotion of products that\nare placed on the market in their respective territories. Drugs may be promoted only for the approved indications and in accordance with\nthe provisions of the approved label. The regulatory authorities actively enforce the laws and regulations prohibiting the promotion\nof off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.\n\n \n\nIn\naddition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register\ntheir establishments with the relevant regulatory authorities and are subject to periodic unannounced inspections by them to confirm\ncompliance with cGMP requirements. Changes to the manufacturing process are strictly regulated and often require prior approval of the\nrelevant regulatory authorities before being implemented. Regulations laid down by the FDA and the regulatory authorities in the EU also\nrequire investigation and correction of any deviations from the requirements of cGMP and impose reporting and documentation requirements\nupon the marketing approval holder and any third-party manufacturers that the marketing approval holder may decide to use.\n\n \n\n**Other\nHealthcare Laws in the EU and United States**\n\n \n\nThe\nCompany will also be subject to healthcare regulation and enforcement by the U.S. federal government and the state governments in the\nEU and any other countries in which the Company conducts its business, including its research, and the marketing and distribution of\nits product candidates and products once they have obtained marketing approval. Failure to comply with these laws, where applicable,\ncan result in the imposition of significant civil penalties, criminal penalties, exclusion from participating in health care programs,\nadditional reporting requirements and oversight if the Company becomes subject to a corporate integrity agreement or similar agreement\nto resolve allegations of non-compliance with these laws and other sanctions. The healthcare laws and regulations that may affect our\nability to operate in the United States include: the federal fraud and abuse laws, including the federal anti-kickback and false claims\nlaws; federal data privacy and security laws; and federal transparency laws related to payments and/or other transfers of value made\nto physicians and other healthcare professionals and teaching hospitals. Many U.S. states have similar laws and regulations that may\ndiffer from each other and federal law in significant ways. Moreover, several U.S. states have enacted legislation requiring pharmaceutical\nmanufacturers to, among other things, establish marketing compliance programs, file periodic reports with the state, and make periodic\npublic disclosures on sales and marketing activities, and prohibiting certain other sales and marketing practices. Rules and legislation\ncovering more or less the same subject matter as those in the United States apply to in countries in the EU and to other countries. These\ncan differ between jurisdictions and can sometimes result in lower or higher exposure in those countries than in the United States. Where\na product is sold in a number of countries compliance efforts can therefore be complicated.\n\n \n\n49\n\n \n\n \n\n**Coverage\nand Reimbursement in the EU and United States**\n\n \n\nSales\nof products developed from our product candidates, if approved, will depend, in part, on the extent to which such products will be covered\nby third party payors, such as government health care authorities, government health care programs, commercial insurance and managed\nhealthcare organizations. These third-party payors are increasingly limiting coverage or reducing reimbursements for medical products\nand services. In the United States, no uniform policy of coverage and reimbursement for products exists among third party payors. Therefore,\ncoverage and reimbursement for products can differ significantly from payor to payor. In addition, the U.S. government, state legislatures\nand foreign governments have continued implementing cost-containment programs, including price controls, restrictions on reimbursement\nand requirements for substitution of generic products.\n\n \n\nGovernments\ninfluence the price of medicinal products in the EU through their pricing and reimbursement rules and control of national healthcare\nsystems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems\nunder which products may only be marketed once a reimbursement price has been agreed. To obtain reimbursement or pricing approval, some\nof these countries may require the completion of clinical trials that compare the cost-effectiveness of a particular product candidate\nto currently available therapies. Other Member States allow companies to fix their own prices for medicines but monitor and control company\nprofits. The downward pressure on healthcare costs in general in the EU governments influence the price of medicinal products through\ntheir pricing and reimbursement.\n\n \n\nThe\nadoption of price controls and cost-containment measures, and the adoption of more restrictive policies in jurisdictions with existing\ncontrols and measures, could further limit our net revenue and results. Decreases in third party reimbursement for our product candidates\nor a decision by a third-party payor to not cover our product candidates could reduce physician usage of the Company’s product\ncandidates, once approved, and have a material adverse effect on our sales, results of operations and financial condition.\n\n \n\n**Privacy\nand Data Protection Laws in Europe**\n\n \n\nWe\nare subject to European laws relating to our and our suppliers’, partners’ and subcontractors’ collection, control,\nprocessing and other use of personal data (i.e., any data relating to an identifiable living individual, whether that individual can\nbe identified directly or indirectly). We are subject to the supervision of local data protection authorities in those jurisdictions\nwhere we are established, where we offer goods or services to EU residents and where we monitor the behaviour of individuals in the EU\n(i.e., undertaking clinical trials). We and our suppliers, partners and subcontractors process personal data including in relation to\nour employees, employees of customers, clinical trial patients, healthcare professionals and employees of suppliers including health\nand medical information. The data privacy regime in the EU includes the General Data Protection Regulation, or GDPR, the e-Privacy Directive\n(2002/58/EC) and the e-Privacy Regulation (once in force) and the national laws and regulations implementing or supplementing each of\nthem.\n\n \n\nThe\nGDPR requires that personal data is only collected for specified, explicit and legal purposes as set out in the GDPR or local laws, and\nthe data may then only be processed in a manner consistent with those purposes. The personal data collected and processed must be adequate,\nrelevant and not excessive in relation to the purposes for which it is collected and processed, it must be held securely, not transferred\noutside of the EEA, (unless certain steps are taken to ensure an adequate level of protection) and must not be retained for longer than\nnecessary for the purposes for which it was collected. In addition, the GDPR requires companies processing personal data to take certain\norganizational steps to ensure that they have adequate records, policies, security, training and governance frameworks in place to ensure\nthe protection of data subject rights, including as required to respond to complaints and requests from data subjects. For example, the\nGDPR requires us to make more detailed disclosures to data subjects, requires disclosure of the legal basis on which we can process personal\ndata, makes it harder for us to obtain valid consent for processing, will require the appointment of a data protection officer where\nsensitive personal data (i.e., health data) is processed on a large scale, introduces mandatory data breach notification throughout the\nEU and imposes additional obligations on us when we are contracting with service providers.\n\n \n\n50\n\n \n\n \n\nIn\naddition, to the extent a company processes, controls or otherwise uses “special category” personal data (including patients’\nhealth or medical information, genetic information and biometric information), more stringent rules apply, further limiting the circumstances\nand the manner in which a company is legally permitted to process that data. Finally, the GDPR provides a broad right for Member States\nto create supplemental national laws which may result in divergence across Europe making it harder to maintain a consistent operating\nmodel or standard operating procedures. Such laws, for example, may relate to the processing of health, genetic and biometric data, which\ncould further limit our ability to use and share such data or could cause our costs to increase, and harm our business and financial\ncondition.\n\n \n\nWe\ndepend on a number of third parties in relation to the provision of our services, a number of which process personal data on our behalf.\nWith each such provider we enter into contractual arrangements to ensure that they only process personal data according to our instructions,\nand that they have sufficient technical and organizational security measures in place. Where we transfer personal data outside the EU,\nwe do so in compliance with the relevant data export requirements from time to time. We take our data protection obligations seriously,\nas any improper, unlawful or accidental disclosure, loss, alteration or access to, personal data, particularly sensitive personal data\n(i.e., special category), could negatively impact our business and/or our reputation.\n\n \n\nWe\nare also subject to EU laws on personal data export, as we may transfer personal data from the EU to other jurisdictions which are not\nconsidered by the European Commission to offer adequate protection of personal data. Such transfers need to be legitimized by a valid\ntransfer mechanism under the GDPR. There is currently ongoing litigation challenging the commonly used transfer mechanisms, the European\nCommission approved model clauses. In addition, the U.S. Privacy Shield is currently under review by the European Commission. As such,\nit is uncertain whether the Privacy Shield framework and/or model clauses will be invalidated in the near future. These changes may require\nus to find alternative bases for the compliant transfer of personal data from the EU to the United States and we are monitoring developments\nin this area. Invalidation of any mechanism on which we rely could require operational changes and increased costs and may lead to governmental\nenforcement actions, litigation, fines and penalties or adverse publicity that could have an adverse effect on our business.\n\n \n\nThe\nEU is in the process of replacing the e-Privacy Directive with a new set of rules taking the form of a regulation, which will be directly\nimplemented in the laws of each Member State, without the need for further enactment. The draft e-Privacy Regulation imposes strict opt-in\nmarketing rules with limited exceptions for business-to-business communications and alters rules on third-party cookies, web beacons\nand similar technology. Regulation of cookies and web beacons may lead to broader restrictions on online research activities, including\nefforts to understand users’ internet usage. The current draft also significantly increases fining powers to the same levels as\nGDPR (i.e., the greater of 20 million Euros or 4% of total global annual revenue). The European Commission proposed the ePrivacy Regulation\nin January 2017. It was intended to take effect alongside the EU GDPR (General Data Protection Regulation) on 25 May 2018.However, the\nfinal text is still to be agreed, with the Council of the European Union and the European Parliament disagreeing on a number of issues.\n\n \n\nThere\nare costs and administrative burdens associated with compliance with the GDPR and the resultant changes in the EU and EEA member states’\nnational laws and the introduction of the e-Privacy Regulation once it takes effect. Any failure or perceived failure to comply with\nglobal privacy laws carries with it the risk of significant penalties and sanctions of up to €20 million or 4% of global turnover.\nThese laws or new interpretations, enactments or supplementary forms of these laws, could create liability for us, could impose additional\noperational requirements on our business, could affect the manner in which we use and transmit patient information and could increase\nour cost of doing business. Claims of violations of privacy rights or contractual breaches, even if we are not found liable, could be\nexpensive and time-consuming to defend and could result in adverse publicity that could harm our business.\n\n \n\n51\n\n \n\n \n\n**C.\nOrganizational Structure**\n\n \n\nThe\nfollowing table sets out details of our only subsidiary:\n\n \n\nName \nPrincipal activity \nRegistered address \nPercentage shareholding  \nCountry of incorporation\n\n  \n  \n  \n    \n \n\nOKYO Pharma US Inc. \nClinical stage biotechnology company \n420 Lexington Avenue Suite 1402 New York, NY 10170 \n 100% \nUSA\n\n \n\n**D.\nProperty, Plant and Equipment**\n\n \n\nThe\nbelow table contains information regarding existing or planned material tangible fixed assets owned or leased by OKYO Pharma Ltd and\nits Subsidiary. We believe that suitable additional or substitute space will be available as needed to accommodate any future expansion\nof our operations.\n\n \n\nLocation \nTenure \nPrincipal use\n\n420 Lexington Avenue Suite 1402 New York, NY 10170 \n2 Months \nCEO Office"}