Cyrano Therapeutics Announces Presentation of Positive Phase 2 FLAVOR Data Demonstrating Statistically Significant Improvement in Smell Function with CYR-064 in Patients with Post-Viral Smell Loss

Data selected for first oral presentation in the "Top 5 Clinical Science" track at the 72^nd Annual Meeting of the American Rhinologic Society

DELRAY BEACH, Fla., Oct. 16, 2026 /PRNewswire/ -- Cyrano Therapeutics, Inc., a clinical-stage regenerative medicine company developing novel treatments for smell and taste disorders, today announced results from its Phase 2 FLAVOR clinical trial evaluating CYR-064 for persistent post-viral loss of smell (hyposmia) are being presented today in an oral presentation at the 72^nd Annual Meeting of the American Rhinologic Society (ARS) in Los Angeles, California. The FLAVOR Trial data will be featured in the first presentation slot of the ARS General Session and will lead the "Oral Presentations: Top 5 Clinical Science" track.

The presentation, titled, "FLAVOR phase 2 RCT: Theophylline nasal spray for persistent post-viral hyposmia," will be delivered by Masayoshi Takashima, MD, FARS, Principal Investigator of the FLAVOR trial. Dr. Takashima will present findings from the Phase 2 randomized, double-blind, placebo-controlled trial evaluating CYR-064 in patients with persistent post-viral hyposmia across 14 clinical sites in the U.S.

The FLAVOR trial enrolled 151 patients and met its primary safety endpoint, with no treatment-related serious adverse events. Among patients under 60 years of age, representing 66% of study enrollment, the high dose of CYR-064 demonstrated statistically significant improvements in smell function compared with placebo on two prespecified measures of smell function at Week 24. On the 0-3 Visual Rating Scale (VRS), high-dose CYR-064 demonstrated a mean 0.72-point improvement at Week 24 compared with 0.12 for placebo (p=0.002), while on the 0-10 Numerical Rating Scale (NRS-11), high-dose CYR-064 demonstrated a mean 2.08-point improvement compared with 0.68 for placebo (p=0.029). VRS and NRS-11 are patient-reported measures of smell function, with VRS assessing smell loss on a weekly 0-3 scale and NRS-11 assessing smell function daily on a 0-10 scale.

"The FLAVOR results demonstrate that CYR-064 can improve smell function in patients with persistent post-viral hyposmia," said Masayoshi Takashima, MD, FARS, Principal Investigator of the FLAVOR trial. "We observed statistically significant improvements across two independent measures of smell function, along with a favorable safety profile and continued improvement through the end of the 24-week study. For a condition with no approved pharmaceutical therapy and few effective treatment options, these findings represent an important advance and provide strong support for the continued clinical development of CYR-064."

"The strength of the FLAVOR results reinforces our belief that CYR-064 has the potential to become the first approved pharmaceutical therapy for persistent post-viral smell loss and address a substantial global market with significant unmet need," said Rick Geoffrion, President and CEO of Cyrano Therapeutics. "With these positive Phase 2 data, we believe CYR-064 represents a valuable late-stage clinical asset with the potential to transform the treatment of smell loss associated with viral infection. We look forward to building on this momentum as we prepare to advance CYR-064 into Phase 3 development."

CYR-064 is a patent-protected, intranasal formulation of a broad-spectrum phosphodiesterase (PDE) inhibitor with a patent-protected targeted delivery system designed to enhance olfactory neuron excitability and restore the sense of smell. 

Key findings from the FLAVOR trial being presented at ARS include:

• Scores from the VRS and NRS-11 smell patient-reported outcomes (PROs) to determine efficacy were evaluated for their psychometric properties in the context of the FLAVOR Trial and both demonstrated reliability and content validity. For this purpose, the Company was advised by a firm with subject matter expertise in PRO development, evaluation and validation for pharmaceutical trials.
  
  
• VRS efficacy: Among patients under 60 years of age, high-dose CYR-064 demonstrated a mean 0.72-point improvement on the 0-3 VRS scale at Week 24 compared with 0.12 for placebo (p=0.002). A difference that was beyond measurement error. 58% of these patients experienced a "clinically meaningful" improvement in smell by an average of 1.3 points, representing a 43% improvement on the scale.
  
  
• NRS-11 efficacy: NRS-11 efficacy gives a validation signal: among patients under 60 years of age, high-dose CYR-064 demonstrated a mean 2.08-point improvement on the 0-10 NRS-11 scale at Week 24 compared with 0.68 for placebo (p=0.029). 69% of these patients improved by an average of 3.2 points, representing a 32% improvement on the scale.
  
  
• Continued improvement through Week 24: Patients receiving high-dose CYR-064 continued to demonstrate improvement in smell function through the end of the 24-week treatment period on both VRS and NRS-11 measures, while improvement in the placebo group plateaued earlier.
  
  
• Efficacy in patients with severe smell loss: Among patients under 60 years of age with severe smell loss at baseline (VRS=3), high-dose CYR-064 demonstrated a 1.10-point mean improvement compared with 0.30 for placebo (p=0.005). 82.4% of these patients experienced a "clinically meaningful" improvement in smell, compared to 31.3% in the placebo arm.
  
  
• Primary safety endpoint achieved: CYR-064 demonstrated a favorable safety profile across the 151 patients evaluated for safety, with no treatment-related serious adverse events. Overall adverse event, treatment-emergent adverse event and serious adverse event rates were comparable between CYR-064 and placebo.

About Cyrano Therapeutics, Inc.

Cyrano Therapeutics is a private, venture-backed clinical stage regenerative medicine company. Since its foundation, Cyrano has been working diligently to develop therapies for people struggling with the loss of smell and taste. To learn, more please visit https://cyranotherapeutics.com/

Contact:
Tiberend Strategic Advisors, Inc. 
David Irish (investors)
[email protected]
(231) 632-0002

Casey McDonald (media)
[email protected]
(646) 577-8520

SOURCE Cyrano Therapeutics