Financing to advance lead asset RTX001, an engineered, pro-regenerative macrophage therapy with first-in-class potential for end-stage liver disease, into the Phase I/II EMERALD study

Proceeds also strengthen manufacturing capabilities and support macrophage therapy pipeline growth in inflammatory and fibrotic indications beyond liver disease

Paul Sekhri, seasoned life sciences executive with decades of drug development and extensive business development experience, appointed Chair of the Board of Directors

EDINBURGH, Scotland and LONDON, Oct. 3, 2024 /PRNewswire/ -- Resolution Therapeutics Limited ("Resolution"), a clinical-stage biopharmaceutical company focused on unlocking the regenerative potential of macrophage therapy for the treatment of inflammatory and fibrotic diseases, today announces it has raised £63.5 million in Series B financing. The financing was led by Syncona Ltd. Alongside the financing, Resolution also announces the appointment of Paul Sekhri as Chair of the Board of Directors.

"As we prepare to advance RTX001, our lead investigational macrophage therapy with first-in-class potential for the treatment of end-stage liver disease, into the clinic this year, we are grateful for Syncona's continued support," said Amir Hefni, Ph.D., Chief Executive Officer of Resolution. "In addition, we are pleased to welcome Paul Sekhri to our Board of Directors. Paul brings a wealth of experience leading top-tier companies to develop breakthrough medicines, including novel treatments for patients with autoimmune disease. The team and I look forward to working with Paul to bring novel macrophage therapies, like RTX001, to patients in need."

Amir continued, "On behalf of the Board of Directors, I would also like to thank Lisa Bright for her impactful contributions as Chair of Resolution over the last 4 years. Her vision and leadership have been instrumental in driving our strategic initiatives, fostering a culture of scientific excellence and getting Resolution to clinical stage. We wish her all the best."

The proceeds from the Series B financing will be used to advance Resolution's lead candidate, RTX001, an autologous, engineered, pro-regenerative macrophage cell therapy specifically designed to deliver transformative outcomes in patients with end-stage liver disease. EMERALD, Resolution's first-in-human Phase I/II clinical trial, will be conducted in the UK and Spain and is anticipated to initiate patient recruitment in Q4 2024. Additional uses of proceeds include investment in the Company's manufacturing platform and expansion of its pipeline into other inflammatory and fibrotic indications, including graft-vs-host disease (GVHD) and lung fibrosis.

"The data that Resolution has generated to date in this emerging area of medicine is encouraging and, in our view, demonstrates the potential that macrophages have in treating end-stage liver disease. This is a potential first-in-class product being developed for a disease where patients have no effective therapeutic options and typically face a liver transplant or further deterioration of their condition, which is often fatal," said Edward Hodgkin, Managing Partner of Syncona Investment Management Limited and Non-Executive Director of Resolution. "We are delighted to continue to support Resolution with our commitment to its Series B financing, in-line with Syncona's focus on allocating capital to clinical-stage assets and assets approaching clinical entry. We are also very pleased to welcome to Resolution Paul Sekhri, who brings a demonstrable track record in supporting companies through the development cycle and will act as a valuable sounding board for the company's growing executive team."

Paul Sekhri has been appointed as Chair of the Board of Directors. Paul has over 35 years of experience in the life sciences industry, including leading business development and strategy in major pharmaceutical and biotechnology companies where he has a successful track record of partnering, M&A and financing. Currently, Paul is President and Chief Executive Officer of vTv Therapeutics, Inc. Before that, he served as President and Chief Executive Officer of eGenesis, Inc. and Lycera Corp. Prior to that, he held positions of increasing responsibility at Sanofi, Teva Pharmaceutical Industries, Ltd., TPG Biotech, Cerimon Pharmaceuticals, Inc., ARIAD Pharmaceuticals, Inc., and Novartis AG. Paul holds a B.S. degree from the University of Maryland and completed post-graduate studies at the University of Maryland School of Medicine.

Paul Sekhri, Chair of the Board of Directors, said, "I am delighted to join Resolution at such an exciting time as it prepares to enter the clinic with RTX001 and expand pipeline efforts into new indications where significant unmet patient need exists. I look forward to collaborating with Amir, the entire Resolution team and supporting the Company as it expands its leadership in macrophage therapy."

About RTX001

RTX001 is an engineered autologous macrophage cell therapy designed to deliver increased anti-fibrotic and anti-inflammatory effects in patients with end-stage liver disease. The product candidate is engineered using a unique combination of therapeutic genes known to be expressed in macrophages to enhance the inherent regenerative properties of the modality for superior efficacy and durability. The clinical development program for RTX001 currently consists of two clinical studies. The ongoing OPAL study is a multi-center natural history study in patients with liver cirrhosis who have been hospitalized for the first time with hepatic decompensation. The objective of the OPAL study is to generate novel data on disease trajectory to act as the control arm for the EMERALD study. The Phase I/II EMERALD study is an open-label first-in-human study of RTX001 in end-stage liver disease measuring clinical events as the primary efficacy endpoint. The EMERALD study has received clinical trial authorization from the UK MHRA and is expected to initiate patient recruitment in the fourth quarter of 2024.

About Resolution Therapeutics

Resolution Therapeutics is a clinical-stage biopharmaceutical company focused on unlocking the regenerative potential of macrophage therapy for the treatment of inflammatory and fibrotic diseases. The Company leverages its proprietary cell characterisation and engineering platform to develop autologous macrophages with distinct pro-regenerative properties for superior patient outcomes across the spectrum of inflammatory and fibrotic diseases. Resolution's initial focus is on developing RTX001, its lead product candidate with first-in-class potential supported by preclinical data demonstrating anti-fibrotic and anti-inflammatory advantages relative to non-engineered macrophages, for patients diagnosed with end-stage liver disease. The Company is also advancing efforts to expand the potential of its platform into indications beyond liver disease where engineered macrophages have therapeutic potential. Resolution, a spinout from Professor Stuart Forbes's lab at the University of Edinburgh, is based in Edinburgh and London. Learn more by visiting and engage with us on LinkedIn.

About Syncona

Syncona's purpose is to invest to extend and enhance human life. We do this by creating, building and scaling companies to deliver transformational treatments to patients in areas of high unmet need.

We aim to build and maintain a diversified portfolio of 20-25 globally leading life science businesses, across development stage, modality and therapeutic area, for the benefit of all our stakeholders. We focus on developing treatments that deliver patient impact by working in close partnership with world-class academic founders and experienced management teams. Our balance sheet underpins our strategy, enabling us to take a long-term view as we look to improve the lives of patients with no or poor treatment options, build sustainable life science companies and deliver strong risk-adjusted returns to shareholders.

SOURCE Resolution Therapeutics