OKYO Pharma Strengthens World Class Leadership Team with Appointment of Flavio Mantelli, MD, PhD as Chief Medical Officer

Rhea-AI Summary

OKYO Pharma (Nasdaq: OKYO) appointed Flavio Mantelli, MD, PhD as Chief Medical Officer to lead clinical and regulatory strategy for urcosimod in neuropathic corneal pain (NCP). Mantelli previously led development and approval of Oxervate, which reached $1 billion sales in 2024. OKYO plans a ~150-subject Phase 2b/3 multiple-dose study expected to start in H1 2026; urcosimod holds FDA Fast Track designation and an authorized compassionate use pathway for NCP.

Positive

• Urcosimod holds FDA Fast Track designation for neuropathic corneal pain
• Planned ~150-subject Phase 2b/3 multiple-dose study expected to start H1 2026
• Flavio Mantelli appointed CMO after leading Oxervate to >$1B sales in 2024

Negative

• None.

Key Figures

Oxervate 2024 sales: >$1 billion Shelf registration size: $200,000,000 Planned Phase 2b/3 size: ~150 subjects +5 more

8 metrics

Oxervate 2024 sales >$1 billion Blockbuster orphan therapy sales in corneal disease (2024)

Shelf registration size $200,000,000 Maximum aggregate offering under Form F-3 shelf

Planned Phase 2b/3 size ~150 subjects Planned multiple-dose NCP trial for urcosimod

Phase 2 NCP sample 18 patients Proof-of-concept Phase 2 NCP study for urcosimod

High pain reduction rate 75% of per-protocol patients Achieved >80% pain reduction on VAS after 12 weeks

Dry eye Phase 2 size 240 patients Earlier Phase 2 dry eye disease trial with significant results

Cash on hand $4.2 million As of 31 March 2025, up from $1.6 million

Total comprehensive loss $3.0 million Six months ended 30 September 2025

Market Reality Check

Price: $1.99 Vol: Volume 141,919 is below t...

low vol

$1.99 Last Close

Volume Volume 141,919 is below the 20-day average of 294,213 (relative volume 0.48). low

Technical Shares at $1.99 are trading below the 200-day MA of $2.23, about 40.58% under the 52-week high and 97.03% above the 52-week low.

Peers on Argus

OKYO is up 3.65% while close peers show mixed moves (e.g., IRD up 12.29%, STRO d...

1 Up

OKYO is up 3.65% while close peers show mixed moves (e.g., IRD up 12.29%, STRO down 8.45%, ATRA up 2.47%), and only one biotech peer (QNCX) appears in the momentum scanner, also up sharply.

Historical Context

5 past events · Latest: Jan 30 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 30	ASCRS abstract	Positive	+0.5%	Phase 2 urcosimod NCP data accepted for presentation at ASCRS 2026.
Jan 28	FDA Type C meeting	Positive	+2.8%	FDA confirmed Phase 2b/3 NCP trial design, endpoints, and overall approach.
Jan 23	Compassionate use OK	Positive	-6.3%	FDA authorized single-patient expanded access IND for urcosimod in severe NCP.
Jan 05	CEO appointment	Positive	+7.6%	Industry veteran Robert J. Dempsey appointed CEO to advance urcosimod.
Dec 19	Nasdaq bell, pipeline	Positive	+8.6%	Nasdaq bell-ringing highlighting positive Phase 2 urcosimod data in NCP.

Pattern Detected

Recent positive ophthalmology and urcosimod milestones have usually coincided with positive next-day moves, with one notable negative reaction to favorable compassionate-use news.

Recent Company History

Over the last few months, OKYO has reported several milestones around urcosimod and leadership. A CEO transition to Robert J. Dempsey on Jan 5, 2026 and a Nasdaq bell-ringing in Dec 2025 both saw solid positive price reactions. Regulatory and clinical updates—FDA compassionate use, a successful Type C meeting, and ASCRS abstract acceptance—have generally been constructive for neuropathic corneal pain, though one compassionate-use update coincided with a -6.33% move. Today’s CMO appointment fits this pattern of building a specialized ophthalmology leadership bench around urcosimod.

Regulatory & Risk Context

Active S-3 Shelf · $200,000,000

Shelf Active

Active S-3 Shelf Registration 2026-02-02

$200,000,000 registered capacity

An effective Form F-3 shelf filed on Feb 2, 2026 allows OKYO to offer up to $200,000,000 of ordinary shares, warrants, and units over time, providing flexibility to raise capital in multiple tranches as it advances urcosimod and other programs. The filing text highlights substantial ongoing losses, limited cash resources, and a going-concern warning, emphasizing reliance on future financings and successful trial outcomes.

Market Pulse Summary

This announcement adds a Chief Medical Officer with blockbuster orphan ophthalmology experience to a...

Analysis

This announcement adds a Chief Medical Officer with blockbuster orphan ophthalmology experience to a company already focused on Fast Track-designated urcosimod for neuropathic corneal pain. It extends a recent pattern of strengthening the leadership team around NCP and ocular surface disease. Against prior filings citing limited cash, ongoing losses, and a new $200,000,000 shelf, key factors to watch include progress into the planned ~150-subject Phase 2b/3 trial and any subsequent financing activity.

Key Terms

neuropathic corneal pain, orphan therapy, fast track designation, compassionate use, +2 more

6 terms

neuropathic corneal pain medical

"development program in neuropathic corneal pain (NCP), leveraging urcosimod’s FDA Fast Track"

Neuropathic corneal pain is chronic, often severe eye pain caused by damage or malfunction in the tiny nerves of the cornea, where the eye surface can feel burning, stinging, or like something is in it despite little visible damage. It matters to investors because it represents a persistent, hard-to-treat medical need that drives demand for new drugs, diagnostics, devices and regulatory approvals, similar to how fixing a frayed electrical wire stops false alarm signals.

orphan therapy medical

"FDA approval of Oxervate®, a blockbuster orphan therapy in corneal disease"

Treatments developed specifically for rare diseases that affect a small number of patients; they often receive special regulatory incentives such as faster reviews, tax credits, and periods of exclusive marketing. Investors watch orphan therapies because, like a niche product with premium pricing and legal protections, they can generate outsized revenue per patient despite a small market, but they also carry development and commercial risks tied to limited demand and clinical uncertainty.

fast track designation regulatory

"neuropathic corneal pain (NCP), leveraging urcosimod’s FDA Fast Track designation"

A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.

compassionate use regulatory

"recent authorization for compassionate use by FDA for urcosimod in NCP highlights"

Compassionate use is a regulated program that lets patients access an experimental drug or medical device outside a formal clinical trial when no approved treatment is available. For investors, it matters because such access can provide early real-world safety and demand signals, affect regulatory relationships and public perception, and slightly alter near-term revenue prospects or liability exposure — similar to a company offering a prototype to select customers before full approval.

orphan indications medical

"planned clinical trials for neuropathic corneal pain and additional orphan indications."

Treating an "orphan indication" means developing a medicine or medical device for a rare disease that affects a very small number of people. Investors care because regulators often offer incentives—such as faster reviews, fee breaks, or market protections—making the opportunity like a specialized niche product: smaller patient pools but often higher prices, less competition, and distinct regulatory and commercial risks that can sharply affect returns.

phase 2b/3 medical

"build upon the recent FDA alignment with the proposed Phase 2b/3 design"

A phase 2b/3 trial is a combined late-stage clinical study that first refines the best dose and measures how well a treatment works (phase 2b) then expands to a larger, definitive test of safety and effectiveness needed for regulatory approval (phase 3). For investors, results from a phase 2b/3 act like a dress rehearsal that turns into opening night: positive, well-controlled outcomes substantially raise the chance of approval and future sales, while failures can sharply reduce a drug’s value.

AI-generated analysis. Not financial advice.

• Dr. Mantelli, former Chief Medical Officer at Dompé, spearheaded the successful clinical development program and FDA approval of Oxervate®, a blockbuster orphan therapy in corneal disease
  
• Dr. Mantelli will lead the clinical and regulatory strategy to advance the company’s development program in neuropathic corneal pain (NCP), leveraging urcosimod’s FDA Fast Track designation
  
• This appointment, following the recent CEO appointment, further strengthens OKYO's world-class ophthalmology leadership team
  

LONDON and NEW YORK, Feb. 10, 2026 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and for inflammatory eye diseases, today announced the appointment of Flavio Mantelli, MD, PhD as Chief Medical Officer. Dr. Mantelli brings unparalleled experience in ocular surface drug development, having led the clinical development, regulatory approval, and global medical strategy of Oxervate® (cenegermin-bkbj) at Dompé farmaceutici S.p.A. which achieved blockbuster status with sales topping $1 billion in 2024 and is widely considered one of the most successful orphan drug launches in ophthalmology.

Dr. Mantelli is a highly regarded ophthalmologist with an extensive background in cornea and ocular surface diseases, neurotrophic keratopathy, and inflammatory eye conditions. He brings critical knowledge and experience to OKYO in developing therapeutics from first-in-human studies through to global regulatory approval. As the clinical leader behind the transformation of a novel biologic into a first-in-class, FDA approved topical ophthalmic therapy, he set a new benchmark for orphan drug clinical development for treatments of corneal disease. Dr. Mantelli graduated in Medicine and Surgery summa cum laude from Università Campus Bio-Medico of Rome, where he also completed his residency in ophthalmology and a PhD in regenerative medicine. He further pursued a postdoctoral fellowship in ocular surface glycobiology at the Schepens Eye Research Institute, Harvard Medical School.

In his new role at OKYO Pharma, Dr. Mantelli will oversee the company's clinical development strategy, including the advancement of urcosimod in planned clinical trials for neuropathic corneal pain and additional orphan indications. He intends to build upon the recent FDA alignment with the proposed Phase 2b/3 design, to help ensure the upcoming trial is positioned as a potential pivotal study to bring this important therapy to patients with no FDA approved therapy.

“Neuropathic corneal pain represents one of the most debilitating and underserved areas in ophthalmology. OKYO Pharma’s focus on differentiated, mechanism-based approaches to inflammatory eye diseases and neuropathic corneal pain resonates strongly with my career-long dedication to translating breakthrough science into approved innovative therapies. The fast-track designation and the recent authorization for compassionate use by FDA for urcosimod in NCP highlights the urgency and potential in this area of high unmet medical need,” said Flavio Mantelli, MD, PhD, Chief Medical Officer of OKYO Pharma. “I am excited to join OKYO and work alongside Robert Dempsey and the entire team to advance urcosimod and the broader portfolio, seeking to ensure our development strategy remains grounded in strong science, regulatory rigor, and a clear focus on improving outcomes for patients and eyecare providers.”

“Subsequent to the release of our Phase 2 data in neuropathic corneal pain, OKYO Pharma has attracted two exceptional leaders in ophthalmology, commencing with the appointment of our CEO, Robert Dempsey, and followed by today’s appointment of Dr. Flavio Mantelli as our Chief Medical Officer,” said Gabriele Cerrone, Chairman and Founder of OKYO Pharma. “Dr. Mantelli’s clinical leadership role and experience in developing Oxervate® into a blockbuster drug with annual sales exceeding $1 billion for a rare eye disease, will be invaluable for OKYO’s development of urcosimod for patients with NCP.”   

“Bringing Dr. Mantelli into the executive team is tremendously important as we continue to build a world class organization focused on ocular surface disease,” said Robert Dempsey, CEO of OKYO Pharma. “Dr. Mantelli is an exceptional clinical developer whose leadership of a highly successful orphan drug development program in ophthalmology demonstrates his ability to advance complex corneal programs, capabilities that will be critical as we advance urcosimod forward for neuropathic corneal pain.”

As previously announced, urcosimod was granted the first IND application for the treatment of patients with NCP and was awarded fast track designation by the Food and Drug Administration (FDA). The company expects to initiate a ~150 subject Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.

About Flavio Mantelli, MD, PhD

Dr. Mantelli joins OKYO Pharma from Dompé where he served as the Chief Strategy & Innovation Officer, acting as the key link between the company and external partners, with the goal of promoting groundbreaking research initiatives and assessing new opportunities aligned with industry innovations. Previously he served as Chief Medical Officer and Head of R&D for the Ophthalmology and Neurotrophin platforms, leading all research and clinical development programs in ophthalmology.

Prior to joining Dompé, Dr. Mantelli researched the application of neurotrophins in ophthalmic and neurodegenerative diseases and was an adjunct associate professor of biology at Temple University in Philadelphia, PA. His professional experience includes positions at the IRCCS G.B. Bietti Foundation in Rome as a clinical scientist and as a consultant ophthalmologist at the Campus Biomedico University of Rome and the Cornea and Ocular Surface Unit of the Vita-Salute San Raffaele University of Milan. 

Graduating in Medicine and Surgery summa cum laude, Dr. Mantelli completed his residency program in ophthalmology and a PhD at the Campus Bio-Medico University of Rome. He also completed a postdoctoral fellowship in ocular surface glycobiology at the Schepens Eye Research Institute of Massachusetts Eye and Ear at Harvard Medical School in Boston. 

About Neuropathic Corneal Pain (NCP)

Neuropathic corneal pain (NCP) is a chronic, often debilitating condition characterized by severe pain and sensitivity of the eyes, and in some cases the face or head. It is thought to result from damage or dysfunction of corneal sensory nerves, often in combination with inflammatory processes, and may occur in patients with a range of underlying ophthalmic conditions. There are currently no FDA-approved therapies specifically for NCP, resulting in patients being treated with limited or no success using various topical and systemic medications in an off-label manner.

About Urcosimod (formerly called OK-101)

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 responsible for the inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion. Urcosimod has been shown to produce anti-inflammatory and pain-reducing activities in a mouse model of dry eye disease and in a neuropathic corneal pain mouse model, respectively. OKYO recently announced positive data on NCP pain reduction in a randomized, placebo-controlled, double-masked Phase 2a trial involving 18 neuropathic corneal pain patients. Urcosimod has shown significant pain reduction in an earlier 240-patient Phase 2, multi-center, double-masked, placebo-controlled trial in DED, which supports the development rationale in NCP.

About OKYO Pharma

OKYO Pharma Limited (Nasdaq: OKYO) is a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP) and inflammatory eye diseases, with ordinary shares listed for trading on the Nasdaq Capital Market. OKYO is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and other ocular diseases. OKYO recently completed a successful phase 2 trial of its flagship drug urcosimod in patients with NCP and plans to initiate a ~150 subject Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.

For further information, please visit www.okyopharma.com.

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. These and additional risks and uncertainties are described more fully in the company’s filings with the SEC, including those factors identified as “Risk Factors” in our most recent Annual Report on Form 20-F, for the fiscal year ended March 31, 2025. The company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements, except as may be required by law.

For further inquiries:

OKYO Pharma Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
Email: info@okyopharma.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5cf9ede5-810f-4085-8f70-0818346bb549

FAQ

Who is Flavio Mantelli and what does his appointment mean for OKYO (OKYO) clinical programs?

Flavio Mantelli is OKYO’s new Chief Medical Officer with deep ocular surface experience. According to the company, he led Oxervate’s clinical development and regulatory approval and will direct urcosimod’s clinical and regulatory strategy to advance planned pivotal trials for NCP.

What are OKYO’s planned clinical next steps for urcosimod in 2026 (OKYO)?

OKYO plans to initiate a ~150-subject Phase 2b/3 multiple-dose study in the first half of 2026. According to the company, the design aligns with recent FDA input and aims to position the trial as a potential pivotal study for NCP.

Does urcosimod have any special regulatory designations from the FDA for NCP (OKYO)?

Yes. Urcosimod has been granted FDA Fast Track designation for neuropathic corneal pain. According to the company, urcosimod also received authorization for compassionate use from the FDA for NCP patients.

How does Mantelli’s prior experience with Oxervate relate to OKYO’s strategy (OKYO)?

Mantelli previously led Oxervate’s development to global regulatory approval and commercialization success. According to the company, his experience is intended to guide urcosimod’s pathway from clinical development through potential regulatory approval and commercialization.

What timeline did OKYO (OKYO) provide for starting the Phase 2b/3 study of urcosimod?

OKYO expects to start the Phase 2b/3 study in the first half of 2026. According to the company, the upcoming trial will be a ~150-subject multiple-dose study aligned with prior FDA discussions and fast-track objectives.