SynOx Therapeutics – Synox

SynOx Therapeutics Strengthens Board of Directors with Leading Experts in Commercialisation and Corporate Development Amid Continued Corporate Progress

Charles “Chip” Romp and Tom Heyman join SynOx’s Board, bringing deep launch, lifecycle, and corporate development expertise as the company advances its next-generation therapy emactuzumab toward key regulatory and commercial milestones

DUBLIN, IRELAND, OXFORD, UK, and PHILADELPHIA, PA — October 21, 2025

SynOx Therapeutics Limited (“SynOx”), a late-stage clinical biopharmaceutical company developing emactuzumab for Tenosynovial Giant Cell Tumours (TGCT), today announced the appointments of Charles “Chip” R. Romp and Tom J. Heyman to its Board of Directors. These appointments further align SynOx’s business with its forward strategy as the company nears topline data for emactuzumab and continues its focus on regulatory and commercial activities. In August 2025, SynOx completed enrollment in the Phase 3 TANGENT clinical trial; topline data are expected in the first quarter of 2026.

Ray Barlow, Chief Executive Officer of SynOx Therapeutics, said:

“We are delighted to welcome Chip and Tom to SynOx. Chip brings an exceptional depth of commercial leadership to the Board, with a proven track record of building launch organisations, establishing new oncology standards of care, and driving lifecycle expansion across multiple blockbuster brands at Seagen and Genentech. Tom is one of the most accomplished corporate development leaders in our industry, with nearly four decades experience guiding transformational partnerships, licensing deals, and global strategic growth initiatives at Johnson & Johnson.”

“Together, their complementary expertise significantly strengthens SynOx’s readiness for commercialisation, partnering, and other strategic pathways as we continue to advance emactuzumab’s late-stage clinical program and prepare for the milestones ahead. I would also like to take this opportunity to sincerely thank Jon Edwards, who has stepped off the Board, for his invaluable contributions and guidance during an important period of SynOx’s growth.”

New Board Appointees

Charles “Chip” R. Romp is a seasoned oncology commercial executive with more than 25 years of experience leading U.S. and global launches and lifecycle strategies. He currently serves as President & CEO of Secura Bio and previously was EVP, U.S. Commercial at Seagen, where he was a member of the Executive Committee and helped lead the launch and commercial growth of Adcetris®, Padcev®, Tukysa®, and Tivdak®. Earlier, he spent 12 years at Genentech in senior oncology and immunology roles, including as National Sales Director for Avastin® and Rituxan®. He also serves on the Board of Minds and Assembly.
Tom Heyman is joining the SynOx Board as Bioqube Ventures’ representative. He spent 37 years at Johnson & Johnson, including as President of JJDC (Johnson & Johnson Development Corporation) and Global Head of Business Development at Janssen, where he led and oversaw major licensing, M&A, and strategic collaborations. He currently serves on the boards of Exelixis (NASDAQ: EXEL), Legend Biotech (NASDAQ: LEGN), Akero Therapeutics (NASDAQ: AKRO), and IMEC.

SynOx Progress and Near-Term Milestones
In August 2025, SynOx completed enrollment in TANGENT, its global, randomized, double-blind, placebo-controlled registrational Phase 3 trial of emactuzumab in TGCT patients who are not amenable to or would not benefit from surgery. Top-line data are expected in the first quarter of 2026.

Emactuzumab previously received Fast Track Designation from the U.S. Food and Drug Administration for TGCT, reflecting the seriousness of the disease and the unmet medical need.

Based on clinical work to date, SynOx believes that emactuzumab represents a next-generation therapeutic option with the potential to address key patient needs by offering an effective, short-course treatment with rapid onset and a durable response — enabling individuals with TGCT to better manage their disease and move forward with their lives.

About TGCT and Emactuzumab
TGCT is a rare, locally aggressive tumour of the synovium, tendon sheaths, and bursa membranes that can cause substantial pain, stiffness, reduced mobility, and diminished quality of life; more than 50% of diffuse TGCT cases recur within three years after surgery.

Emactuzumab is a humanised monoclonal antibody targeting CSF-1R, designed to inhibit and deplete macrophages in tumour tissue; in clinical studies it has shown rapid tumour reduction, functional improvement, and a manageable safety profile in TGCT.

Additional details on TANGENT are available at ClinicalTrials.gov (NCT05417789).

About SynOx Therapeutics
SynOx Therapeutics Limited is a Dublin, Oxford and Philadelphia-based, late-stage biopharmaceutical company developing emactuzumab, a next-generation, best-in-class monoclonal antibody against CSF-1R, for the treatment of Tenosynovial Giant Cell Tumour (TGCT) and other CSF-1-related and macrophage-driven disorders. SynOx is led by an experienced team of industry professionals with a successful track record of developing and bringing products to commercialization. The company is backed by a strong syndicate of premier life science investors including Forbion, Gilde Healthcare, HealthCap, Bioqube Ventures, and Medicxi.

Contacts:
SynOx Therapeutics
Ray Barlow
Chief Executive Officer
Tel: +44 (0) 208 058 5619
Email: [email protected]

SynOx Therapeutics Completes Enrollment in Registrational Phase 3 TANGENT Clinical Trial Significantly Ahead of Timeline

Top-Line Results from Study Evaluating Emactuzumab for Tenosynovial Giant Cell Tumours (TGCT) Expected in First Quarter of 2026

DUBLIN, IRELAND, OXFORD, UK, and PHILADELPHIA, PA – August 5, 2025

SynOx Therapeutics Limited (“SynOx”), a late-stage clinical biopharmaceutical company developing emactuzumab for Tenosynovial Giant Cell Tumours (TGCT), today announced completion of patient enrolment in the TANGENT study. TANGENT is the company’s global, multi-centre, randomized, double-blind, placebo-controlled registrational Phase 3 trial of emactuzumab in patients with TGCT who are not amenable to or who would not benefit from surgery. SynOx expects to report top-line data from the study in the first quarter of 2026.

Emactuzumab is a potentially best-in-class CSF-1 receptor (CSF-1R) inhibiting monoclonal antibody (mAb). Clinical evaluation to date has demonstrated the compound to be a promising, next-generation mAb therapy with the potential to offer a short treatment cycle, rapid onset and long duration of response that differentiates it from chronically administered oral agents. This potentially best-in-class profile helped drive strong interest in the TANGENT trial among patients and clinical investigators across sites in the United States, Canada, Europe and Asia, leading to rapid study enrollment.

“Completion of enrollment in our registrational TANGENT trial marks an important milestone for SynOx and for the TGCT community,” said Elyse Seltzer, M.D., Chief Medical Officer of SynOx Therapeutics. “We are deeply grateful to the patients, families, investigators, and clinical sites whose dedication has made this study possible and allowed SynOx to fully enroll the trial significantly ahead of our projected timeline. We remain committed, data permitting, to delivering a much-needed new treatment option for this debilitating condition.”

“This is a transformational time for SynOx as we advance emactuzumab through its pivotal Phase 3 program,” said Ray Barlow, Chief Executive Officer of SynOx. “We’re excited about the next steps and look forward to delivering top-line data that we hope demonstrate how emactuzumab can transform care for patients with this grievous disease.”

About the TANGENT Study

TANGENT (ClinicalTrials.gov Identifier: NCT05417789) is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy and safety of emactuzumab in patients with TGCT who are not amenable to or would not benefit from surgery. Patients who consent and meet eligibility criteria are randomized in a 2:1 fashion to receive either emactuzumab (1000 mg every two weeks for five doses) or matched placebo.

The primary endpoint is objective response rate (ORR) as assessed by RECIST criteria at six months post-randomization. Key secondary endpoints include patient-reported outcomes (PROMIS-PF), functional assessments of range of motion, pain, stiffness, durability of response, and safety. Patients are followed for two years from randomization, with those demonstrating disease progression after the six-month assessment eligible to receive open-label emactuzumab during follow-up.

For the full press release see here: SynOx Completion of TANGENT Study PR

SynOx Therapeutics Receives Fast Track Designation from U.S. Food and Drug Administration for Emactuzumab for Tenosynovial Giant Cell Tumours (TGCT)

DUBLIN, IRELAND and OXFORD, UK, April 14, 2025 – SynOx Therapeutics Limited (“SynOx”), a late-stage clinical biopharmaceutical company developing of emactuzumab for Tenosynovial Giant Cell Tumours (TGCT), today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to emactuzumab for the treatment of TGCT patients that are not amenable to or who would not benefit from surgery. Emactuzumab, a potentially best-in-class CSF-1 receptor (CSF-1R) inhibiting monoclonal antibody, is currently being evaluated in the TANGENT study, a global, multi-centre, randomized, double-blind, placebo-controlled registrational Phase 3 trial.

TGCT is a rare, non-malignant but aggressively growing tumour of the synovium, tendon sheaths and bursa membranes primarily located in knee, hip, and ankle joints and caused by excessive production of CSF-1. It is a chronically debilitating disease for patients causing loss of function of the affected joints, as well as pain, stiffness and limited range of motion. Receipt of FTD for TGCT was supported by data from Phase 1/2 clinical studies demonstrating rapid, robust tumour reduction and durable response combined with a manageable safety profile. Emactuzumab has also previously received Orphan Medicinal Project designation from the European Medicines Agency.

“The granting of FTD for emactuzumab in TGCT highlights the devastating toll that this disease has on patients, as well as the critical need that remains for new treatment options,” said Elyse Seltzer, M.D., Chief Medical Officer of SynOx Therapeutics. “Based on our clinical work to date, we believe that emactuzumab has significant potential to address key patient needs by offering an effective, short-course treatment with rapid onset and a durable response that allows individuals suffering from TGCT to better manage their disease and move forward with their lives. We look forward to completing the ongoing TANGENT study and progressing emactuzumab toward potential commercialization.”

About Fast Track Designation

The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track status allows for enhanced communication and collaboration between the FDA and drug developers, potentially speeding up the delivery of life-saving treatments to patients.

For the full press release see here: SynOx U.S Fast Track Designation PR