OKYO PHARMA LIMITED

Poised to Reach Our New $8 Price Target

Rob Goldman

rob@goldmansmallcapresearch.com

June 11, 2025

OKYO PHARMA LIMITED (NASDAQ – OKYO – $2.07)

Industry: BioPharma

6-12 Mo. Price Target: $5.00

COMPANY SNAPSHOT

OKYO Pharma Limited Is a clinical stage bio-pharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP) and dry eye disease (DED), with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO’s lead drug candidate urcosimod successfully completed a 240-patient Phase 2 trial in DED patients and recently completed a 17-patient Phase 2 trial in NCP patients.

KEY STATISTICS

• Price as of 6/10/25$2.07
• 52 Wk High – Low$2.13 – $0.8080
• Est. Shares Outstanding34.0M
• Market Capitalization$70.4M
• Average Volume125,120
• Exchange:NASDAQ

COMPANY INFORMATION

OKYO Pharma Limited

14-15 Conduit Street
London W1S 2XJ
United Kingdom

Web:    www.OKYOPharma.com
Email:   info@okyopharma.com
Phone : 917.497.7560

INVESTMENT HIGHLIGHTS

Since our January 2025 report, OKYO’s shares and average daily volume have essentially doubled, due to key fundamental drivers. With potentially favorable milestones ahead in 3Q25, we believe these shares could reach our new $8.00 price target.

In April 2025, OKYO elected to conclude its Phase 2 NCP trial early and top-line results are expected to be released by mid-3Q25. OKYO is the first company to be granted an investigational new drug (IND) application for NCP by FDA for clinical trials in NCP patients, and the first company to launch and conclude a clinical trial in NCP patients specifically diagnosed with NCP. This trial is on the heels of a favorable DED Phase 2 trial of OK-101 which notably demonstrated statistical significance in an ocular pain secondary endpoint.

The potential size of the NCP market is in the billions and given the debilitating effects of the condition, plus the recently-granted Fast Track designation by the FDA for urcosimod to treat NCP patients, there is considerable interest being generated in this program.

We believe that given its positioning, and assuming data are favorable, OKYO will likely also attract a potential joint venture development partner or an acquirer. We believe the results from this trial represent a major binary event, serving as a critical catalyst for a re-valuation of the stock.

OKYO: WIND AT ITS BACK

Since our January 2025 company report, OKYO Pharma Limited (NASDAQ – OKYO) has been a stellar performer, nearly doubling its share price while achieving a new 52-week high earlier this week. Moreover, these shares have enjoyed a commensurate doubling of its average daily volume, led by a series of recent milestones that we outlined in our previous report. With potentially ground-breaking developmental news on the horizon during 3Q25, we believe that these shares have just begun their ascent toward our new, $8.00 price target.

OKYO may have discovered a first-of-its-kind treatment for a debilitating ocular pain condition called neuropathic corneal pain (NCP) that has no FDA approved, effective treatment. NCP is a debilitating condition affecting many tens of thousands worldwide, and is characterized by chronic, severe eye discomfort. A Phase 2 clinical trial for NCP commenced in October 2024 with top-line results slated to be released during 3Q25, an accelerated timeline from the original end of year estimate.

Urcosimod, the recently assigned official name by USAN for OKYO’s lead candidate, OK-101, was developed using a membrane-anchored-peptide (MAP) technology to produce a novel long-acting drug candidate for treating ocular front-of-the-eye diseases.

Urcosimod is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye and neurons and glial cells found on the dorsal root ganglion. ChemR23 is generally recognized as being responsible for the inflammatory response. Urcosimod was shown to produce anti-inflammatory and pain-reducing activities in mouse models of both dry eye disease and a neuropathic corneal pain animal model; and is designed to combat washout through the inclusion of the lipid ‘anchor’ contained in the candidate drug molecule to enhance the residence time of urcosimod within the ocular environment.

We estimate that the potential size of the market could be $6.4 billion or greater.

Recent Events have Served as Fundamental Drivers

In March 2025, OKYO filed a Fast Track designation application with the FDA for urcosimod, and on May 1, 2025, OKYO announced the FDA has granted Fast Track designation for urcosimod to treat NCP. Receipt of this designation typically leads to accelerating further clinical development as turn-around time for meetings with the FDA is shortened, as well as the potential for a rolling FDA review of the New Drug Application (NDA) to treat NCP.

On March 31, 2025, OKYO announced successfully establishing that urcosimod has been shown to be stable for over two and a half years in single-use ampoules used for administration of the drug to patients. Achieving this objective is a key, core component in meeting CMC (Chemistry, Manufacturing and Controls) requirements for a successful New Drug Application with the FDA. The FDA requires long-term shelf life of drugs as part of the approval process.

Early Closure of Phase 2 Trial a Major Plus

In late April 2025, OKYO reached its most significant step to date with respect to the urcosimod Phase 2 trial designed to treat 48 patients with NCP. After the completion of 17 patients of the intended 48 patients designed for the study, OKYO leadership elected to close the trial early to enable initiating analysis of the clinical data. This decision to close the trial was driven by OKYO’s strong desire to access the currently masked data in the randomized, placebo-controlled trial, and to use it to start planning further development of urcoisimod, assuming the top-line data are positive. Notably, OKYO pointed out that patients participating in the trial have all been diagnosed with long term chronic neuropathic corneal pain and had previously been treated with multiple therapies with very limited or no response.

Significant interest was also reported to be seen in the trial from long-term sufferers of NCP, and OKYO believed it should plan to expand the development program and move forward with a multicenter trial.

The implications of the early trial completion plus desire to immediately analyze clinical results and release top-line data suggest two immediate outcomes, pending positive top-line results, in our view. One, it has been reported by OKYO that a considerable number of potential patients have expressed an interest in participating in a future registrational trial. Two, a number of patients also have requested compassionate use of urcosimod which OKYO announced it is seeking to arrange with Tufts Medical Center, subject to the necessary FDA consents. While this is not a demonstration of evidentiary efficacy of urcosimod, it is a compelling set of observations that suggests a potential drug effect and illustrates the challenging condition in which the patients suffer and the need for the Fast Track designation by the FDA.

LOOKING AHEAD

Management believes that concluding the trial early enables OKYO to save time in advancing the program to a meeting with FDA to discuss further development of urcosimod. Moreover, the analysis of the data from the 17 patients in the study could lead to the release of top-line results in the first half of 3Q25. Considering that urcosimod has already demonstrated favorable safety and placebo-like tolerability in OKYO’s previous 240 patient Phase 2 trial, we believe that OKYO leadership has reasons to be encouraged.

If top-line results are favorable when announced in the next quarter, the Company would likely seek to request an end-of-phase 2 meeting with FDA to explore accelerated plans for the drug’s further clinical development. Topics would likely include future trial design and protocols, primary and secondary endpoints, along with subject size and the number of sites. At this stage it is too early to speculate on the timing and roadmap of future development. However, the key takeaway for investors is that the acceleration of the release of potentially favorable top-line Phase 2 data, assuming the data are positive, should shorten the time that we believe these shares would take to reach our upgraded, $8.00 price target.

Against this backdrop, if an updated roadmap is announced due to favorable data, timelines, and prospective outcomes bode well for OKYO.

Our original $5.00 price target reflected a longer Phase 2 trial that would lead to later published results. However, we have elected to raise our price target to reflect a change in status, in our view. These changes include the acceleration of the closing of the trial, the desire of some patients to utilize the drug on a compassionate basis, and the Fast Track designation. These are all new events since our January 2025 report. As a first-mover that has the potential to publish favorable results for a debilitating condition that has a serious unmet need, and represents a multi-billion-dollar market, we believe these shares could reach the $8 level or higher, in short order. Furthermore, we believe that given the M&A activity in the ocular space, a deal with a partner could occur, and that the Company would benefit from the aforementioned re-valuation of these shares.

RECENT TRADING HISTORY FOR OKYO

(Source: www.StockCharts.com)