-- Phase 2b top-line data from EVO756 in chronic spontaneous urticaria (CSU) and atopic dermatitis $(AD)$ on track for June 2026 and 3Q26, respectively, with enrollment complete in both trials
-- Phase 2b clinical trial evaluating a subcutaneous formulation of EVO301 in AD planned, following positive proof-of-concept (POC) data reported in February 2026
-- Plans to initiate a Phase 2b dose-ranging clinical trial of EVO756 in migraine prophylaxis in mid-2026
PALO ALTO, Calif. & NEW YORK--(BUSINESS WIRE)--May 07, 2026--
Evommune, Inc. $(EVMN)$ ("Evommune" or the "Company"), a clinical-stage biotechnology company developing innovative therapies that target key drivers of chronic inflammatory diseases, today announced financial results for the first quarter ended March 31, 2026, and provided a business update.
"We continue to make meaningful progress across our broad chronic inflammation targeted pipeline and remain on track to deliver top-line Phase 2b data for EVO756 in CSU in June and in AD in the third quarter of 2026. We also expect to initiate a Phase 2b clinical trial in a third indication, migraine prophylaxis, in mid-2026, where we believe the biology and opportunity are both very compelling. For EVO301, we recently reported positive Phase 2a proof-of-concept data in AD and look forward to presenting more data from that trial at an upcoming medical meeting," said Luis Peña, President and Chief Executive Officer at Evommune. "With a strong cash position expected to support our operations through 2028, we believe we are well positioned to execute on key milestones and further advance our pipeline of therapies addressing inflammatory diseases where the biology is strong, the patient need is clear, and the path to development is well defined."
Business Highlights, Recent Developments and Upcoming Milestones
EVO756 -- Oral MRGPRX2 Antagonist Program
Potential first and best-in-class, potent and highly selective small molecule antagonist of Mas-related G protein-coupled receptor X2 (MRGPRX2), a receptor predominantly found on both mast cells and peripheral sensory neurons. This dual expression allows MRGPRX2 to uniquely modulate the neurogenic inflammation feedback loop between nerves and immune cells that drive chronic inflammation.
-- Upcoming Phase 2b Top-Line Data Readout in CSU: Enrollment is complete
in a Phase 2b dose-ranging clinical trial (N=160) in moderate-to-severe
CSU and the Company expects to report top-line results in June 2026.
-- Upcoming Phase 2b Top-Line Data Readout in AD: Enrollment is complete
in a Phase 2b dose-ranging clinical trial (N=120) in moderate-to-severe
AD patients and the Company expects to report top-line results in the
third quarter of 2026.
-- Highlighted Role of MRGPRX2 in Migraine and Planned Phase 2b
Development Program: The Company recently hosted a virtual event,
alongside key opinion leaders, overviewing the role of MRGPRX2 in
migraine and its plans to initiate a Phase 2b dose-ranging clinical trial
in migraine prophylaxis in mid-2026. Top-line data from the trial are
anticipated in 2027.
-- New Translational Data to be Presented at Two Upcoming Scientific
Conferences: At the Federation of Clinical Immunology Societies (FOCIS)
Annual Meeting, being held June 9-12, 2026 in San Francisco, CA, Evommune
will present two posters: the first highlighting shared pathology data in
chronic inducible urticaria (CIndU) and CSU patient samples, and the
second providing an comprehensive and unprecedented in silico assessment
of patient samples identifying MRGPRX2 as a persistent driver of disease
in AD. The Company will also present a poster highlighting the pivotal
role of MRGPRX2 impacting both meningeal mast cells and trigeminal
neurons in migraine pathophysiology at the American Headache Society
(AHS) Annual Scientific Meeting being held June 4-7, 2026 in Orlando,
FL.
EVO301 -- Injectable IL-18 Binding Protein Fusion Protein
Long-acting fusion protein consisting of an IL-18 binding protein and an anti-serum albumin Fab-associated domain with potential for more effective distribution to inflamed tissues than traditional monoclonal antibodies.
-- Subcutaneous Formulation Work Complete: Evommune has completed work on
a high-concentration subcutaneous formulation of EVO301 and manufacturing
has been initiated.
-- Phase 2b Trial to Initiate in Mid-2027: The Company plans to build on
the positive Phase 2a POC data by optimizing the subcutaneous dosing
regimen in the Phase 2b clinical trial to explore the potential for even
further improvement in AD patient outcomes. The planned Phase 2b,
placebo-controlled, dose-ranging clinical trial is expected to include at
least three dosing regimens of EVO301 tested over a 16-week treatment
period, with a planned trial start in mid-2027 following completion of
standard scale-up and toxicology activities.
-- Evaluating Additional Indication Expansion Opportunities: The Company
continues to evaluate additional indications for EVO301, including
ulcerative colitis, certain cardiovascular-related inflammatory
conditions and food allergy, as potential new Phase 2 clinical trials.
-- Upcoming Preclinical Data Presentation at Society for Investigative
Dermatology $(SID)$ 2026 Annual Meeting: The Company will present
preclinical data highlighting the mechanism of action of IL-18 inhibition
for the treatment of AD and the uniqueness of EVO301's binding protein
approach at the upcoming SID Annual Meeting being held May 13-16, 2026 in
Chicago, IL.
"We are excited to present a robust set of preclinical and translational findings at upcoming scientific conferences," said Dr. Jeegar Patel, Chief Scientific Officer at Evommune. "We continue to build a compelling body of evidence supporting shared disease biology across CIndU and CSU, while further elucidating the role and expression of the MRGPRX2 receptor in AD. Importantly, our migraine-focused research expands this understanding into the neuroinflammatory setting, demonstrating MRGPRX2's involvement in both meningeal mast cells and trigeminal neurons. Collectively, these findings reinforce our conviction in MRGPRX2 as a highly differentiated and potentially broad therapeutic target, continuing to build momentum as we look ahead to upcoming top-line Phase 2b data in CSU next month."
First Quarter 2026 Financial Results
-- Cash, Cash Equivalents and Investments: As of March 31, 2026, the
Company had cash, cash equivalents and investments of $307.0 million,
compared to $216.7 million as of December 31, 2025.
-- Revenue: Revenue was zero for the first quarter ended March 31, 2026,
compared to $3.0 million for the same period in 2025, attributable to the
Company's strategic collaboration with Maruho related to licensing EVO756
in Japan.
-- Research and Development Expenses: Research and development expenses
were $17.3 million for the first quarter ended March 31, 2026, compared
to $14.4 million for the same period in 2025.
-- General and Administrative Expenses: General and administrative
expenses were $6.6 million for the first quarter ended March 31, 2026,
compared to $3.7 million for the same period in 2025.
-- Net Loss: Net loss totaled $21.7 million for the first quarter ended
March 31, 2026, compared to $14.6 million for the same period in 2025.
About Evommune, Inc.
Evommune, Inc. is a clinical-stage biotechnology company developing innovative therapies that target key drivers of chronic inflammatory diseases. The Company's mission is to improve patients' daily lives and prevent the long-term effects of uncontrolled inflammation that are a consequence of the limitations of existing therapies. To achieve this, Evommune is advancing a portfolio of differentiated product candidates that target key drivers of chronic inflammation. For more information, please visit www.evommune.com and follow us on LinkedIn.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are "forward-looking statements." These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the potential therapeutic benefit of EVO756 and EVO301, the design, objectives, initiation, timing, progress and results of current and future preclinical studies and clinical trials of the Company's product candidates, including the ongoing Phase 2 clinical trials for EVO756 and EVO301; anticipated cash runway through 2028; and continued advancement of the Company's portfolio. These forward-looking statements are based on the Company's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause the Company's clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the Company's limited operating history and historical losses; the potential that success in preclinical testing and earlier clinical trials does not ensure that later
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