Press Release: Evommune Reports Third Quarter 2026 Financial Results and Provides Business Highlights

Dow Jones11-13 05:05

- Expanded pipeline with in-licensing of EVO570, a potential best-in-class oral VAV1 molecular glue degrader

- EVO301 late-breaking EADV data demonstrate clear therapeutic signal and favorable safety and tolerability profile, supporting Phase 2b trial in AD expected for mid-2027 initiation

- Additional clinical milestones expected in 2027, including initiation of the EVO570 Phase 1 trial in early 2027, the EVO301 Phase 2 trial in ulcerative colitis and the EVO646 Phase 1 study

- Key 2027 data expected to include Phase 1 healthy volunteer and biomarker data for EVO570 and EVO646, and top-line Phase 2b migraine data for EVO756

- Strong balance sheet with cash runway into 2H 2029 to deliver multiple key milestones across the pipeline

PALO ALTO, Calif. & NEW YORK--(BUSINESS WIRE)--November 12, 2026-- 

Evommune, Inc. $(EVMN)$ (the "Company" or "Evommune"), a clinical-stage biotechnology company developing innovative therapies that target key drivers of chronic inflammatory diseases, today announced financial results for the third quarter ended September 30, 2026, and provided a business update.

"We have built a portfolio of differentiated immunology assets spanning biologics and small molecules, each aimed at a distinct upstream driver of chronic inflammation. The in-licensing of EVO570 expands our reach into T- and B-cell-driven autoimmune diseases, while the EADV data strengthen our conviction that EVO301 has the potential to become a foundational therapy in atopic dermatitis, if approved," said Luis Peña, President and Chief Executive Officer at Evommune. "As we advance EVO301 into Phase 2b and expand into ulcerative colitis, 2027 will be a year of execution and clinical catalysts for Evommune, with additional new clinical studies across EVO646 and EVO570 and Phase 2b migraine top-line data expected from EVO756. With a strong balance sheet and an experienced team, we believe we are well positioned to deliver on these milestones and create meaningful value for patients and stockholders."

Recent Business Highlights and Upcoming Milestones

EVO301 -- Injectable IL-18 Binding Protein Fusion Protein

Anti-serum albumin Fab-associated (SAFA) IL-18BP fusion protein designed to neutralize IL-18 activity, which is aberrantly upregulated in many inflammatory and autoimmune diseases. Targeting IL-18 offers a novel upstream approach that extends beyond Th2 to address multiple inflammatory pathways, with the potential to serve a broad range of patients.

   --  Presented Data Showing EVO301's Clear Therapeutic Signal, Favorable 
      Safety and Tolerability Profile at EADV Congress: In October 2026, 
      Evommune presented additional data from its Phase 2a proof-of-concept 
      trial of EVO301 in adults with moderate-to-severe atopic dermatitis (AD) 
      in a late-breaking oral presentation at the European Academy of 
      Dermatology and Venereology (EADV) 2026 Congress. With only two 
      injections, EVO301 met the trial's primary endpoint, achieving a 55% 
      least-squares mean reduction from baseline in Eczema Area and Severity 
      Index $(EASI)$ at Week 12, eight weeks after the last dose, compared with 
      22% on placebo (p<0.01); responses continued to deepen throughout the 
      off-drug period. Biomarker analyses confirmed broad anti-inflammatory 
      activity across the Th2, Th1, Th17 and Th22 pathways, and EVO301 was well 
      tolerated, with no observed treatment-related serious or severe adverse 
      events and no conjunctivitis. (Press release). 
 
   --  Global Phase 2b AD Trial Expected to Initiate in Mid-2027: Evommune 
      continues to advance EVO301 toward the initiation of a Phase 2b 
      dose-ranging trial in approximately 200 adults with moderate-to-severe 
      AD. Nonclinical toxicology studies with a subcutaneous formulation of 
      EVO301 will initiate in early 2027. Dosing regimens have been selected 
      for the planned Phase 2b trial, where three dosing regimens of EVO301 
      will be tested against placebo for 16 weeks, with an off-drug follow-up 
      period out to 24 weeks. 
 
   --  Phase 2 Proof-of-Concept Trial in Ulcerative Colitis (UC) Planned to 
      Initiate in First Quarter of 2027, Data Expected in 2028: Evommune plans 
      to initiate a Phase 2 proof-of-concept trial of EVO301 in UC in the first 
      quarter of 2027, extending development beyond dermatology to inflammatory 
      bowel disease, where IL-18 and IL-22 are upregulated. In the Phase 2a AD 
      trial, EVO301 meaningfully reduced IL-22, a cytokine implicated in the 
      epithelial barrier dysfunction that is a key attribute of UC, and 
      inflammatory bowel disease more generally. 

EVO756 -- Oral MRGPRX2 Antagonist for Migraine Prophylaxis

Potent and highly selective small-molecule antagonist of Mas-related G protein-coupled receptor X2 (MRGPRX2), a receptor found predominantly on peripheral sensory neurons and mast cells.

   --  Top-Line Data from Phase 2b Migraine Trial Anticipated in Second Half 
      of 2027: The Phase 2b dose-ranging trial of EVO756 in adults with 
      refractory migraine is underway, with top-line data expected in the 
      second half of 2027. In September 2026, Evommune discontinued development 
      of EVO756 in AD after a Phase 2b trial did not meet its primary endpoint. 
      (Press release). 

EVO570 -- Oral VAV1 Molecular Glue Degrader

Oral, highly selective VAV1 molecular glue degrader (MGD) designed to deliver JAK-like efficacy in autoimmune disease. VAV1 is a signaling protein, largely restricted to immune cells, that drives T- and B-cell activation across a wide range of chronic inflammatory diseases.

   --  In-Licensed EVO570 from Hinova Pharmaceuticals Inc. (SSE: 688302, 
      "Hinova"): In November 2026, Evommune entered into an exclusive license 
      agreement with Hinova granting Evommune worldwide rights outside of 
      Greater China to develop, manufacture and commercialize EVO570 (formerly 
      HC118). Evommune paid $30 million upfront, consisting of $20 million in 
      cash and $10 million in the form of pre-funded warrants to purchase 
      Evommune common stock. Hinova is eligible to receive additional 
      development, regulatory and commercial milestones, as well as tiered 
      royalties on net sales outside Greater China. (Press release). 
 
   --  Phase 1 Trial Expected to Begin in Q1 2027: Investigational New Drug 
      (IND) applications have been submitted in China and opened in the United 
      States. A Phase 1 trial is expected to begin in the first quarter of 2027 
      with healthy volunteer and biomarker data expected mid-2027. Evommune 
      plans to initiate a Phase 2 program in rheumatoid arthritis in 2H 2027. 
 

EVO646 -- Oral TLR7/8 Antagonist

Selective oral TLR7/8 antagonist with the potential to offer a more targeted approach to controlling upstream drivers of lupus and other interferon-, myeloid inflammation- and autoantibody-driven conditions.

   --  Program to Enter the Clinic in the First Half of 2027: Evommune plans 
      to initiate a Phase 1 trial for EVO646 in the first half of 2027 with 
      healthy volunteer and biomarker data expected in the second half of 2027. 
      EVO646 was discovered through a partnership with Accutar Biotech. TLR7/8 
      inhibition has demonstrated significant clinical benefit in cutaneous and 
      systemic lupus erythematosus, and Evommune estimates approximately six 
      million patients across its initial potential indications. 
 
   --  Achieved Preclinical Development Milestone in Accutar Research 
      Collaboration: In November 2026, Accutar Biotech announced the 
      achievement of a preclinical development milestone in its multi-year, 
      multi-target research collaboration with Evommune. (Press release). 

Corporate Updates

   --  Announced Concurrent $30 Million Private Placement: In November 2026, 
      concurrent with the in-licensing of EVO570, Evommune entered into a 
      securities purchase agreement to sell 4,966,889 shares of its common 
      stock at $6.04 per share to a select group of dedicated healthcare 
      institutional investors, for gross proceeds of approximately $30 million. 
      Evommune intends to use the net proceeds to advance its clinical 
      development programs, including EVO570, and for general corporate 
      purposes. (Press release). 

Third Quarter 2026 Financial Results

   --  Cash, Cash Equivalents and Investments: As of September 30, 2026, the 
      Company had cash, cash equivalents and investments of $262.3 million, 
      compared to $216.7 million as of December 31, 2025. 
 
   --  Revenue: The Company did not generate any revenue for the three and 
      nine months ended September 30, 2026, compared to revenue of $10.0 
      million and $13.0 million for the three and nine months ended September 
      30, 2025, attributable to the Company's strategic collaboration with 
      Maruho for EVO756 in Japan. 
 
   --  Research and Development Expenses: Research and development expenses 
      were $24.6 million and $68.3 million for the three and nine months ended 
      September 30, 2026, compared to $19.6 million and $53.6 million for the 
      three and nine months ended September 30, 2025, primarily due to increase 
      in preclinical research expenses for undisclosed discovery programs and 
      personnel costs, and partially offset by a decrease in clinical trial 
      expenses. 
 
   --  General and Administrative Expenses: General and administrative 
      expenses were $8.8 million and $23.9 million for the three and nine 
      months ended September 30, 2026, compared to $3.7 million and $10.7 
      million for the three and nine months ended September 30, 2025. 
 
   --  Net Loss: Net loss totaled $30.9 million and $84.8 million for the 
      three and nine months ended September 30, 2026, compared to $12.5 million 
      and $40.6 million for the three and nine months ended September 30, 
      2025. 

About Evommune, Inc.

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