PHASE II CLINICAL TRIAL IN MEN WITH ERECTILE DYSFUNCTION

**RIO DE JANEIRO, BRAZIL – MAY 11th, 2025** BIOZEUS BIOPHARMACEUTICALS S.A. IS PLEASED TO ANNOUNCE THE SUCCESSFUL COMPLETION OF ITS PHASE II CLINICAL TRIAL EVALUATING THE BZ371A EFFICACY AND SAFETY IN MEN WITH ERECTILE DYSFUNCTION FOLLOWING PROSTATECTOMY DUE TO PROSTATEC CANCER. THE STUDY MET ITS PRIMARY ENDPOINTS AND ACHIEVED ALL PRE-DEFINED DEVELOPMENT MILESTONES, CONFIRMING BOTH THE SAFETY AND EFFICACY OF BZ371A IN THIS HIGH-NEED POPULATION. NOTABLY, BZ371A DEMONSTRATED SUPERIORITY COMPARED TO THE CURRENT STANDARD OF CARE, DAILY TADALAFIL. THESE PROMISING RESULTS SUPPORT THE ADVANCEMENT OF BZ371A INTO PHASE III CLINICAL TRIALS AND REINFORCE ITS POTENTIAL TO ADDRESS OTHER FORMS OF ERECTILE DYSFUNCTION IN BROADER PATIENT POPULATIONS, SUCH AS THOSE WITH DIABETES AND HYPERTENSION, WHICH INVOLVE LESS COMPLEX ETIOPATHOGENESIS. **ABOUT BZ371A** BZ371A IS A FIRST-IN-CLASS THERAPEUTIC PEPTIDE DERIVED FROM A NEW CLASS OF NITRIC OXIDE SYNTHASE (NOS) ENHANCERS. TOPICALLY APPLIED, BZ371A INDUCES LOCALIZED VASODILATION AND INCREASED BLOOD FLOW WITHOUT SYSTEMIC EXPOSURE OR THE NEED FOR EXTERNAL STIMULI. WITH A FAVORABLE SAFETY PROFILE DEMONSTRATED IN BOTH PRECLINICAL AND CLINICAL STUDIES. BZ371A REPRESENTS A POTENTIALLY TRANSFORMATIVE SOLUTION FOR PATIENTS WITH LIMITED TREATMENT OPTIONS. **PHASE II MEN’S TRIAL: SYNERGISTIC DESIGN, TRANSFORMATIVE OUTCOMES** THE TRIAL FOCUSED ON MEN WITH PROSTATE CANCER THAT DEVELOPED ED SECONDARY TO RADICAL PROSTATECTOMY — A GROUP AT RISK FOR IRREVERSIBLE ERECTILE TISSUE DAMAGE WITHOUT EARLY INTERVENTION. THE THREE-ARM STUDY INCLUDED: 1. TADALAFIL ALONE: 4% SUCCESS RATE AT 30 DAYS; 13% AT 60 DAYS 2. BZ371A ALONE: 15% SUCCESS AT 30 DAYS; 32% AT 60 DAYS 3. BZ371A + TADALAFIL (COMBINATION THERAPY): 38% SUCCESS AT BOTH 30 AND 60 DAYS (SUCCESS RATE MEANS PERCENTAGE OF RESPONDERS, DEFINED AS AN INCREASE OF MORE THAN 4 POINTS IN IIEF QUESTIONNAIRE) THE COMBINATION THERAPY SHOWED A NEARLY TENFOLD IMPROVEMENT OVER TADALAFIL ALONE AT 30 DAYS, UNDERSCORING BZ371A’S RAPID EFFICACY AND SYNERGISTIC POTENTIAL. THESE FINDINGS SUGGEST THAT PROMPT ADMINISTRATION POST-SURGERY MAY HELP PREVENT IRREVERSIBLE ERECTILE DAMAGE. IMPORTANTLY, BZ371A CONTINUED TO EXHIBIT A STRONG SAFETY PROFILE ACROSS ALL TREATMENT ARMS. **ABOUT BIOZEUS BIOPHARMACEUTICALS S.A.** BIOZEUS IS A BRAZILIAN CLINICAL-STAGE BIOTECHNOLOGY COMPANY DEVELOPING A PORTFOLIO OF NOVEL THERAPEUTIC PEPTIDES TO ADDRESS SIGNIFICANT UNMET MEDICAL NEEDS. . **A GLOBAL APPROACH TO SEXUAL HEALTH INNOVATION** BIOZEUS IS ALSO DEVELOPING A FEMALE VERSION OF BZ371A, CODENAMED APHRA, CURRENTLY IN PHASE II FOR THE TREATMENT OF FEMALE SEXUAL DYSFUNCTION. THE COMPANY HAS RECENTLY ENTERED INTO AN AGREEMENT WITH ANOTHER DAY PHARMA LTD. (https://www.anotherdaypharma.com), A UK-BASED LEADER IN PERSONAL HEALTH INNOVATION. THIS PARTNERSHIP AIMS TO ACCELERATE THE GLOBAL REACH OF THIS GROUNDBREAKING THERAPEUTIC FOR BOTH MEN AND WOMEN. **FOR INQUIRIES, PARTNERSHIPS, OR ADDITIONAL INFORMATION** [email protected] OR [email protected] APHRA is a fictitious name used for internal identification purposes only and is not yet registered.

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