Revolo Biotherapeutics Ltd.

In allergen-driven models of atopic dermatitis, subcutaneous (SQ) administration of ‘1104 demonstrated comparable performance to intravenous administration (IV)In multiple preclinical models evaluated in single-dose toxicity studies, there were no ‘1104-related local tolerability adverse effects after treatment with the ‘1104 SQ formulation at dose levels substantially higher than planned for clinical evaluationData reinforces Revolo’s commitment to prioritizing SQ ‘1104 in clinical studies GAITHERSBURG, Md. and CAMBRIDGE, United Kingdom, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Revolo Biotherapeutics Limited (“Revolo”) today announced new preclinical data demonstrating that subcutaneous (SQ) administration of ‘1104 performed comparably to intravenous (IV) administration in allergen-driven models of atopic dermatitis (AD), effectively reducing key markers of skin inflammation and inflammatory mediators, with excellent local tolerability. "The comparable and consistent response of SQ and IV dosing of ‘1104 in AD, now observed across multiple disease models, reinforces our commitment to prioritizing a SQ formulation in our clinical studies,” said Woody Bryan, Ph.D., President and Chief Executive Officer of Revolo. “Our top priority is to initiate a clinical study with SQ formulation in eosinophilic esophagitis early in 2025, while also planning to evaluate the SQ formulation in a clinical study in AD. Our combined preclinical and clinical datasets continue to demonstrate the disease-agnostic mechanism of action of ‘1104 and its potential for flexible dosing through SQ and sublingual routes. This, together with the upstream mechanism of action and favorable safety, offers a highly competitive profile with the potential to disrupt the current treatment landscape for patients with eosinophilic esophagitis, our lead indication for ‘1104, and other allergic conditions. We look forward to launching Phase 2 trials early next year while continuing productive partnering discussions to advance our growing pipeline.” Key results when comparing SQ versus IV administration in a murine allergen-driven model of AD: Comparable reductions in inflammatory biomarkers in serum, reaching levels similar to naïve control individuals and equivalent to those observed in positive control individuals treated with the anti-inflammatory dexamethasone. This includes key T helper 2 (Th2) cytokines, like interleukin 4 (IL-4), IL-5, and IL-13, to cytokines specific to AD, including CCL17 and CCL22, and IL-31, a cytokine specific to itch, overall consistent with the mechanism of action for ‘1104. Comparable reductions in skin pathology indicators were observed, including a reduction in skin thickness and a reduction of skin pathology indicators such as erythema and skin erosion. Key results of single-dose toxicity studies evaluating tolerability and pharmacokinetics (PK) of the SQ formulation in two preclinical models: There were no local tolerability adverse effects (redness or swelling) in preclinical models administered the SQ formulation at dose levels substantially higher than planned for clinical evaluation.PK profiles from SQ administration in two preclinical models across a range of doses were dose proportional and showed similar exposure profiles when compared to PK profiles generated from IV administration in prior toxicity studies in the same models and at the same dose levels. About ‘1104‘1104 is a first-in-class peptide that is involved in restoring immune homeostasis, impacting both the regulatory and effector arms of the immune system. Revolo has recently advanced ‘1104 through two Phase 2a trials: one in patients with eosinophilic esophagitis (EoE) and one in patients with allergen sensitivity, while exploring its potential for other allergic diseases. Revolo is planning to advance a commercially differentiated subcutaneous dosage form into clinical studies for EoE and other type 2 allergic conditions. About Revolo BiotherapeuticsRevolo is developing therapies that restore immune homeostasis, targeting the immune system upstream for the treatment of autoimmune and allergic diseases. Its two drug candidates, ‘1805 and ‘1104, a protein and a peptide respectively, offer a unique mechanism of action through impact on both the regulatory and effector arms. This upstream, disease-agnostic and dual-action approach results in a rapid and prolonged effect without broad immune suppression, providing a platform for the development of treatments for multiple autoimmune and allergic conditions. Revolo’s assets also have the potential to offer dosing optionality through subcutaneous and sublingual routes, offering a highly competitive profile. For further information, please visit www.revolobio.com. Company ContactWoody Bryan, Ph.D.President and CEOwbryan@revolobio.com Media ContactMichael RubensteinLifeSci Communications+1 561-289-7981mrubenstein@lifescicomms.com

Sublingual (SL) formulation of ‘1104 achieved comparable responses to subcutaneous (SQ) and intravenous (IV) injections‘1104 SC and SL dosing options create opportunities for highly differentiated product profiles in eosinophilic esophagitis (EoE) and other allergic diseases versus currently available therapiesData provides additional validation for the differentiated upstream mechanism of action (MOA) of ‘1104, already confirmed in the clinic GAITHERSBURG, Md. and CAMBRIDGE, United Kingdom, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Revolo Biotherapeutics Limited (“Revolo”) today announced new preclinical data demonstrating the potential of its lead allergic-disease treatment candidate, ‘1104, as a SL formulation. The data shows that when administered sublingually via a dissolvable tablet in a lung model of allergic disease, ‘1104 achieves comparable positive results across multiple inflammatory immune cells and other markers of allergic inflammation to those seen with SQ or IV injections of ‘1104. Additionally, the data continues to demonstrate the differentiated upstream MOA of ‘1104, restoring immune homeostasis by impacting both the effector and regulatory arms of the immune system with a persistence of effect for multiple weeks. Specifically, SL dosing of ‘1104 resulted in reduced inflammatory cell infiltration, including eosinophils and neutrophils, comparable to SQ and IV routes. SL dosing of ‘1104 also led to a reduction of key T2 cytokines and allergen specific immunoglobulin (Ig)E, similar to reductions seen with SQ and IV administration. “If successfully translated to the clinic, a sublingual option could represent a breakthrough in the treatment landscape for people living with EoE and other allergic diseases,” said Kari Brown, M.D., Chief Medical Officer at Revolo. “The differentiated upstream MOA by which ‘1104 acts, alongside a favorable safety profile across multiple Phase 1-2 clinical studies and its potential flexibility in route of administration, highlights its potential use as a future first-line therapy.” There is a strong need for additional treatment options for patients with EoE and other allergic diseases. Current therapeutics for EoE, the lead indication for ‘1104, include chronic subcutaneous monoclonal antibodies and oral options with significant safety considerations. Woody Bryan, Ph.D., President and Chief Executive Officer of Revolo, added, “Following data announced earlier this year, which supports the development of a subcutaneous formulation of ‘1104, these positive oral results provide Revolo with an exciting path forward. As we look to the future, we will prioritize the SQ formulation of ‘1104, with plans to initiate a new Phase 2 study in EoE in 2025 and potentially atopic dermatitis. However, we will continue to gather data on the SL formulation in parallel to inform our future strategy, including ongoing discussions with strategic partners. Our goal is to provide people with chronic allergic conditions a new effective and convenient treatment option without the burden of limiting side effects.” About ‘1104‘1104 is a first-in-class peptide that is involved in restoring immune homeostasis, uniquely impacting both the regulatory and effector arms of the immune system. Revolo has recently advanced ‘1104 through a Phase 2a trial in eosinophilic esophagitis (EoE) and a clinical mapping study in patients with allergic rhinitis, while exploring its potential for other allergic diseases. Revolo is planning to advance a commercially differentiated subcutaneous dosage form into clinical studies for EoE and other type 2 allergic conditions while advancing development of a sublingual formulation. About Revolo BiotherapeuticsRevolo is developing therapies that work upstream in the immune cascade for the treatment of allergic and autoimmune diseases, without the immune system suppression seen with current therapies. Its two drug candidates, ‘1104 and ‘1805, a peptide and a protein respectively, restore immune homeostasis to prevent the chronic pro-inflammatory immune response that results in allergic or autoimmune disease. The disease-agnostic mechanism of action of Revolo Biotherapeutic’s assets provides a potential platform for the development of treatments for multiple allergic and autoimmune diseases. For further information, please visit www.revolobio.com. Company ContactWoody Bryan, Ph.D.President and CEOwbryan@revolobio.com Media ContactMichael RubensteinLifeSci Communications+1 561-289-7981mrubenstein@lifescicomms.com

Data continues to differentiate ‘1104 as a potential allergic disease treatment that acts upstream in the immune cascade‘1104 reduces key indices of skin inflammation and inflammatory mediators in a chronic allergen-driven model of atopic dermatitis (AD) GAITHERSBURG, Md. and CAMBRIDGE, United Kingdom, Sept. 18, 2024 (GLOBE NEWSWIRE) -- Revolo Biotherapeutics Limited (“Revolo”) today announced new data from preclinical studies that validate atopic dermatitis (AD) as a target indication for the Company’s lead clinical asset, ‘1104. The data reinforces the broad clinical applicability of ‘1104, through a novel upstream mechanism of action (MOA), demonstrating its impact across skin disease measures and a wide range of inflammatory cytokines and chemokines associated with AD pathology. Key results include: In a chronic allergen-driven murine model of atopic dermatitis, ‘1104 significantly reduced skin pathology indicators and serum biomarkers of AD to levels close to naïve control individuals and comparable to positive control individuals treated with the anti-inflammatory dexamethasone. This includes a reduction in skin thickness and a reduction of skin pathology indicators such as erythema and skin erosion. ‘1104 reduced allergen-specific immunoglobulin E (IgE) levels and key T helper 2 (Th2) cytokines in serum, such as interleukin 4 (IL-4), IL-5 and IL-13, in addition to non-Th2 cytokines like tumor necrosis factor (TNF) alpha, IL-1 beta, interferon (IFN) gamma, and IL-17.‘1104 also reduced key serum biomarkers classically associated with AD pathology such as chemokine ligand 17 (CCL-17), CCL-22, and Th2 cytokine IL-31, which is associated with pruritus and disruption of the skin barrier. “The ability of ‘1104 to affect a broad range of inflammatory mediators associated with allergic disease, while also impacting disease pathology, is both unique and impressive,” said Kari Brown, M.D., Chief Medical Officer at Revolo. “These new data support the initiation of a clinical trial evaluating ‘1104 in patients with atopic dermatitis. ‘1104 has the potential to offer patients a treatment that addresses the underlying inflammatory response, rather than just targeting inflammation after it occurs, which differentiates it from current treatments.” Woody Bryan, Ph.D., President and Chief Executive Officer of Revolo, added, “At Revolo, our priority has been to develop a product for patients with allergic diseases that can offer increased efficacy and dosing convenience. This compelling dataset in a preclinical model of atopic dermatitis is yet another convincing validation of the potential that ’1104 has across an array of allergic diseases, including Th-2 and non-Th2 conditions. We look forward to evaluating ‘1104 in a new clinical trial in AD and continuing to build on the positive data shown in the completed Phase 2 study of ‘1104 in eosinophilic esophagitis.” About ‘1104‘1104 is a first-in-class peptide that is involved in restoring immune homeostasis, impacting both the regulatory and effector arms of the immune system. Revolo has recently advanced ‘1104 through two Phase 2a trials: one in patients with eosinophilic esophagitis (EoE) and one in patients with allergen sensitivity while exploring its potential for other allergic diseases. Revolo is planning to advance a commercially differentiated subcutaneous dosage form into clinical studies for EoE and other type 2 allergic conditions. About Revolo BiotherapeuticsRevolo is developing therapies that work upstream in the immune cascade for the treatment of autoimmune and allergic diseases, without the immune system suppression seen with current therapies. Its two drug candidates, ‘1805 and ‘1104, a protein and a peptide respectively, restore immune homeostasis to prevent the chronic pro-inflammatory immune response that results in autoimmune or allergic disease. The disease-agnostic mechanism of action of Revolo Biotherapeutic’s assets provides a potential platform for the development of treatments for multiple autoimmune and allergic diseases.For further information, please visit www.revolobio.com. Company ContactWoody Bryan, Ph.D.President and CEOwbryan@revolobio.com Media ContactMichael RubensteinLifeSci Communications+1 561-289-7981mrubenstein@lifescicomms.com