Recce Pharmaceuticals Expands MENA Reach with Exclusive Distribution Deal and Advances Diabetic Foot Infection Treatment to Phase 3

Exclusive Licensing Agreement Targets Middle East and North Africa Market

On 27 May 2026, Recce Pharmaceuticals announced a non-binding term sheet with a leading Middle Eastern pharmaceutical company for an exclusive licensing deal covering commercial sales and distribution of RECCE® 327 Topical Gel (R327G) in the Middle East and North Africa. The term sheet outlines key terms for a proposed 10-year exclusive license, with both parties collaborating to finalize a definitive agreement expected next quarter, subject to ongoing negotiations, due diligence, final approvals, and customary conditions.

The licensee is a prominent pharmaceutical company in the MENA region, with a strong portfolio across dermatology, endocrinology, infectious diseases, and other therapeutic areas. With established market access, the partner is well-positioned to accelerate R327G adoption and distribution in key markets including Saudi Arabia, GCC countries (UAE, Kuwait, Oman, Bahrain, Qatar), and North African countries such as Egypt, Algeria, and Morocco. Recce will retain manufacturing and supply responsibilities for R327G under the agreement.

Commercial Structure and Revenue Potential for R327G

The commercial terms offer Recce multiple revenue streams, including an upfront signing fee and milestone payments totaling up to USD $3.5 million (approximately A$5 million). Recce will also receive 30% of the net selling price plus a 6% annual royalty on net sales exceeding USD $50 million per year, providing escalating returns as market penetration grows.

The proposed treatment price is USD $1,500 per course, subject to approval by Saudi Arabia’s regulatory authority. Recce’s clinical development program is expected to supply a robust data package supporting regulatory submissions in Saudi Arabia. The Indonesian Registrational Phase III Clinical Trial for diabetic foot infection is ongoing, with an approvable interim data readout anticipated after enrolling 155 patients. The full trial plans to enroll 310 patients randomized to R327G or placebo, with expedited regulatory review expected to lead to commercial approval by year-end. No additional clinical trials are anticipated for Saudi marketing authorization contingent on positive Phase 3 results from Indonesia.

HREC Approval Advances Australian Trial to Phase 3 with Expanded Protocol

The Human Research Ethics Committee (HREC) has approved a protocol amendment upgrading Recce’s Australian Phase II clinical trial of R327G to a pivotal Phase 3 study for diabetic foot infections. New patients will be enrolled under the revised Phase 3 protocol. To date, 18 of the planned 200 patients have been treated, with an interim analysis scheduled after 50% completion. The trial complies with Australian Therapeutic Goods Administration (TGA) and US Food and Drug Administration (FDA) standards, targeting full enrollment by the end of 2027.

The amendment broadens eligibility to include moderate diabetic foot infections alongside mild cases, covering approximately 80% of presentations. The study now includes infected ulcers below the knee, enabling additional primary endpoint analyses at the ulcer level, enhancing statistical power and trial success probability. The primary endpoint assesses clinical response via the Lipsky Scale, with secondary endpoints evaluating total wound score and R327G’s safety profile.

Indonesian Regulatory Inspection Confirms Compliance with Global Standards

The Indonesian National Agency of Drug and Food Control (Badan POM or BPOM) completed a comprehensive routine inspection of Recce’s Phase 3 clinical trial site in Indonesia. The review covered trial conduct, site processes, data integrity, and adherence to Good Clinical Practice (GCP) standards. No changes or corrective actions were requested, confirming full compliance with regulatory requirements.

This successful inspection reassures investors about the quality and integrity of clinical data from the Indonesian site, a critical component for regulatory approval. The outcome demonstrates Recce’s adherence to international regulatory standards and strengthens confidence in the data supporting R327G’s approval pathway. The absence of compliance issues marks an important milestone in the product’s development timeline.

Capital Raise Strengthens Financial Position to Support Clinical Development

Recce completed an institutional placement raising A$4.0 million at A$0.40 per share, attracting strong support from new and existing institutional, sophisticated, and professional investors. The funds will support ongoing clinical development and operational activities. Following the placement, the company launched a Share Purchase Plan offering eligible shareholders the opportunity to participate on the same terms, enabling retail investor access.

Including proceeds from the placement and before costs, Recce’s pro-forma cash position at quarter-end stood at approximately A$33.1 million. The company has not disclosed detailed allocation of these funds but intends to use the capital to advance Phase 3 trials in Australia and Indonesia, engage with regulatory authorities internationally, and fulfill manufacturing and supply commitments under the proposed MENA licensing agreement.

Recce’s Innovative Synthetic Anti-Infective Platform

Recce Pharmaceuticals is a pioneer in developing a new class of synthetic anti-infectives. Its proprietary technology targets infectious diseases, with RECCE® 327 Topical Gel as its lead candidate for diabetic foot infections—a condition affecting millions worldwide and a leading cause of lower limb amputations and hospitalizations among diabetic patients, representing a significant unmet medical need.

Recce’s R&D strategy focuses on advancing R327G through clinical pathways aligned with Australian TGA and US FDA standards, positioning the product for commercialization across multiple international markets. Regulatory submissions are planned for Australia, Indonesia, and the MENA region, supporting a diversified commercial approach. The company operates from Sydney, Australia, with clinical trials conducted in partnership with sites in Australia and Indonesia.

Manufacturing and Supply Role Under Licensing Agreement

Under the proposed 10-year exclusive licensing deal, Recce will retain responsibility for manufacturing and supplying RECCE® 327 Topical Gel to the licensee for distribution across the MENA region. This arrangement allows Recce to maintain control over product quality, manufacturing processes, and supply chain management, while the licensee manages regulatory registration, marketing, and distribution within licensed territories.

This division leverages Recce’s pharmaceutical development and manufacturing expertise alongside the licensee’s strengths in market access and distribution across over 30 international markets. Specific manufacturing capacity, timelines, and facility locations related to supply obligations have not been disclosed.

Regulatory Strategy and Approval Timeline for Saudi Arabia

Recce’s regulatory approach for the Middle East leverages clinical data from its global development program to support marketing authorization submissions in Saudi Arabia. Pending positive outcomes from the ongoing Indonesian Phase 3 trial, no additional clinical studies are expected for Saudi approval, accelerating the regulatory timeline.

The Indonesian trial is progressing with an interim data readout expected after 155 patients enrolled out of 310 planned. Conducted to TGA and FDA standards, the data will meet international regulatory requirements, including those in the MENA region. Expedited regulatory review is anticipated to yield commercial approval by year-end, enabling Recce to support MENA regulatory submissions under the licensing agreement.

Strategic Licensing Partner’s Market Strengths

The proposed licensee is a leading publicly listed pharmaceutical company in the MENA region with a diverse portfolio spanning dermatology, endocrinology, infectious diseases, and other therapeutic areas. Its established commercial presence and extensive distribution network across over 30 international markets position it as a strategic partner for rapid market penetration and commercialization of RECCE® 327 Topical Gel.

With a multi-billion-dollar market capitalization and publicly audited financials reviewed by Recce during due diligence, the partner demonstrates strong financial capacity to meet payment obligations under a definitive agreement. This partnership aligns with Recce’s strategy to collaborate with established regional pharmaceutical companies for efficient market access and commercial success across multiple territories.