Bioversys Ag · SIX:BIOV
Bioversys — Q3 2026 Earnings Presentation
46 slides from Bioversys's earnings presentation, Sep 9, 2026
Slide 1: Saving Lives in Resistant Times
Most Compelling Investment Opportunity in AMR space January 2023 SAVING LIVES IN RESISTANT TIMES Ticker on SIX: “BIOV” Q3 2026 September 2026| BioVersys – Proprietary Material Q3 2026 BIOVERSYS - PROPRIETARY MATERIAL 1
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS This presentation (the “Presentation”) has been prepared by BioVersys AG (“the Company” and together with its subsidiaries, “we”, “us” or the “Group”) solely for informational purposes. Certain statements in this Presentation are forward-looking statements, beliefs or opin
Slide 3: Introducing BioVersys
INTRODUCING BIOVERSYS At a glance ❖ Listed on the SIX Stock Exchange with, Ticker: BIOV ❖ As of Feb 2025: first biotech IPO in seven years, and the largest European biotech IPO in five Marc Gitzinger Hernan Levett Glenn E. Dale Daniel Ritz years Chief Executive Chief Financial Chief Development Chie
Slide 4: Innovative, Diverse and De-risked Pipeline
INNOVATIVE, DIVERSE AND DE-RISKED PIPELINE Next-Generation Antimicrobial Drugs, Two Proprietary Platforms Expected Key Commercial Program Indication R&D/Preclinical Phase 1 Phase 2 Phase 3 Potential Catalyst Rights Hospital infections $800m in Expected BV100 Phase 3 trial (RIV-TARGET) FPFV: April 20
Slide 5: Key Investment Highlights
KEY INVESTMENT HIGHLIGHTS Late-Stage Anti-Infective Company with Differentiated Development Approach and Strong News Flow • Diversified portfolio of anti-infectives targeting infections with high health burden and significantly derisked Strong news flow offering multiple • Lead asset BV100 is safe a
Slide 6: Key Highlights
KEY HIGHLIGHTS A strong half-year focused on execution and disciplined capital allocation BV100 PHASE 3 Alpibectir PHASE 2 Carbapenem-resistant Acinetobacter baumannii infections Multi-drug resistant pulmonary and meningeal tuberculosis › First-patient-first-visit reported in RIV-TARGET (April 2026)
Slide 7: AMR (Anti-Microbial Resistance): Market Opportunity
AMR (Anti-MICROBIAL RESISTANCE): MARKET OPPORTUNITY
Slide 8: A Matter of Time
A MATTER OF TIME Anti-Microbial Resistance On Track to Kill more People than all Cancers Together1 1.27M ~5M deaths globally deaths globally attributable to associated with AMR2,5 AMR 2,5 Any 2nd ~20% surgery can become leading cause of death globally for the 9.8m of hospitalized Covid-19 patients l
Slide 9: Focusing on Life-Threatening Diseases with High Resistance Rates
FOCUSING ON LIFE-THREATENING DISEASES WITH HIGH RESISTANCE RATES Highest medical need & best Very High commercial positioning Resistant but not severe Business Case: High resistance and life-threatening Alpibectir BV100 TB-M / MDR A. baumannii Targeted and Specialty assets Examples: Resistance Non-l
Slide 10: Solving the AMR Commercial Uptake Challenge
SOLVING THE AMR COMMERCIAL UPTAKE CHALLENGE Keys to Commercial Success BioVersys Approach ✓ All recent AMR successes addressed MRSA with US prevalence of >50% Indication of high global resistance and great severity ✓ Avoid ”gateway indications” (e.g. UTI, ABSSI) Clinical & Regulatory Generating addi
Slide 11: BV100: Severe hospital infections caused by carbapenem resistant Acinetobacter baumannii
BV100: Severe hospital infections caused by carbapenem resistant Acinetobacter baumannii
Slide 12: BV100 Targeting Carbapenem-Resistant Acinetobacter (CRAB) in Pneumonia
BV100 TARGETING CARBAPENEM-RESISTANT ACINETOBACTER (CRAB) IN PNEUMONIA BV100 FDA QIDP FDA priority review Carbapenem-resistant Acinetobacter (CRAB) in pneumonia ~50% Death rate1 19 days Spent in ICU1 => estimated $ 200,0002,3 cost in the US Early appropriate antibiotic-therapy is critical to surviva
Slide 13: Workhorse Antibiotic Class Is Failing
WORKHORSE ANTIBIOTIC CLASS IS FAILING >50% Overall Resistance Against Carbapenems (CRAB) South & US East Europe >70% China 40-50% 60-70% Percentage of isolates with resistance <5% 40 to <50% 5 to <10% 50 to <60% 10 to <20% 60 to <70% 20 to <30% 70 to <80% 30 to <40% 80 to <90% Source: Management est
Slide 14: BV100 – A Differentiated Drug with a New MOA
BV100 – A DIFFERENTIATED DRUG WITH A NEW MOA Differentiated Candidate Mode of Action Superior Drug Characteristics Rifabutin: Overcomes known resistances Safe drug class, three decades of oral application FhuE of A. baumannii Drug New Mode of Action unlocks BV100 uptake therapeutic potential Known S
Slide 15: Large Phase 1 Data Package Shows Good Safety, PK and Strong Lung Distribution
LARGE PHASE 1 DATA PACKAGE SHOWS GOOD SAFETY, PHARMACOKINETIC AND STRONG LUNG DISTRIBUTION Safe and Well Tolerated No Dose Adjustments Needed Lung Distribution Tested in c. 200 healthy volunteers Mild inducer of CYP3A4 enzyme Very good distribution of across 9 Phase 1 studies leading to <50% of mida
Slide 16: Phase 2 Clinical Trial Set-up
PHASE 2 CLINICAL TRIAL SET-UP CRAB Ventilator Associated Bacterial Pneumonia Endpoints Primary endpoint Part A Best Available Therapy (BAT) • PK of BV100 Patients (n=30) with Safety endpoint documented BV100 (200 mg q12h) plus Polmyxin B • Overview of AEs Acinetobacter VABP Main Efficacy endpoints B
Slide 17: BV100 Shows Clear Survival Benefit
BV100 SHOWS CLEAR SURVIVAL BENEFIT BV100 Part A versus BAT: Day 14 and Day 28 ACM in micro-ITT* (LPLV 27.09.2024) Treatment difference = -30.5% pts. Treatment difference = -31.5% pts. Additional Findings1 ✓ Colistin + 1 or 2 additional AB’s BAT targeting A. baumannii ✓ 6 patients in total, 4 microbi
Slide 18: Overview of Adverse Events
OVERVIEW OF ADVERSE EVENTS Safety population1 Part A Part B BV100 + Poly B BAT BV100 + BAT (N=21) (N=10) (N=8) TEAE 19 (90.5%) 56 7 (70%) 22 8 (100%) 30 TEAE (Grade 3/4/5)2 13 (61.9%) 27 7 (70%) 11 7 (87.5%) 12 Serious TEAE 8 (38.1%) 11 6 (60%) 8 3 (37.5%) 4 Fatal TEAE 6 (28.6%) 6 6 (60%) 6 3 (37.5%
Slide 19: Improved Microbiological and Clinical Response with BV100
IMPROVED MICROBIOLOGICAL AND CLINICAL RESPONSE WITH BV100 BV100 Part A versus BAT: Carbapenem-resistant micro-ITT1 Microbiological favorable response2 at ToC Clinical Cure3 at ToC 100% 100% TREATMENT DIFFERENCE TREATMENT DIFFERENCE 90% 90% 25% points 45% points 80% 80% 70% 70% 75% 75% 60% 60% 50% 50
Slide 20: Phase 3 RIV-TARGET
PHASE 3 RIV-TARGET Dual-Trial Strategy for Approval & Adoption GOAL: Demonstrate non-inferiority (with test for superiority) vs. Colistin based therapy for regulatory submissions initially in the US, Europe and China BV100 + low- dose PolB Key Endpoints Part A 248 evaluable Patients ∼ 300 Patients m
Slide 21: Phase 2b RIV-CARE
PHASE 2B RIV-CARE Dual-Trial Strategy for Approval & Adoption GOAL: Generate 'real-world' data for physician adoption and improved initial commercial uptake BV100 + low-dose PolB cef/avi background Part A Study conducted in 90 Patients ∼ 100 Patients BV100 + low-dose PolB collaboration with 1:1:1 wi
Slide 22: Estimating the Market for BV100
ESTIMATING THE MARKET FOR BV100 Major Markets1 China & Emerging Markets1 Life-threatening infections caused by Indication Overview Acinetobacter baumannii # of A. baumannii Infections (2027 Projected Incidence)2 ~215k >2.5m % Multi-drug Resistant / Carbapenem Resistant A. baumannii3 ~40-60% ~60– 80%
Slide 23: Peak Sales Guidance for BV100
PEAK SALES GUIDANCE FOR BV100 Major Markets1 China and Emerging Markets1 Major Markets (MM) Emerging Markets (EM) Geography United States EU17 Japan China Emerging Markets Est. # of diagnosed A. baumannii cases2 67k 112k 37k >2.1m 426k Reported CRAB rate | Empiric therapy rate3 50% | 27% 45% | 37% 5
Slide 24: BV100 – Differentiated Medical Benefits
BV100 – DIFFERENTIATED MEDICAL BENEFITS 10 Clinical Trials Completed for BV100 Distributes Well No Pre-existing Mode of Approved API with Synergy Development Product Company into Lung Resistance Action Good Safety with SoC Phase BV100 NEW ✓ Phase 3 ready Polymyxin / Colistin Generic (Standard of Car
Slide 25: Alpibectir: Pulmonary and meningeal Tuberculosis
Alpibectir: Pulmonary and meningeal Tuberculosis
Slide 26: BioVersys Tackling the Top Priority Superbugs
BIOVERSYS TACKLING THE TOP PRIORITY SUPERBUGS Alpibectir FDA QIDP & OD Designated FDA priority review FDA fast track approval Tuberculosis (TB) 1.3m People in the world died from TB in 20221 mortality rates in TB meningitis in adults. In 50% children, survivors suffer from life long disabilities2 10
Slide 27: Eto Bioactivation via a Novel Pathway
ETO BIOACTIVATION VIA A NOVEL PATHWAY Mode of Action Superior Drug Characteristics Simplified Illustration Patent Protection/ Exclusivity: Ethionamide (Eto) Alpibectir + Eto = AlpE 20371 (+5 years in the US) Alpibectir InhA New chemical entity, low InhA dose, orally bioavailable and crosses the bloo
Slide 28: Bactericidal Activity Demonstrated in Phase 2a Trial
BACTERICIDAL ACTIVITY DEMONSTRATED IN PHASE 2A TRIAL Part A (completed) Isoniazid (300 mg) Patients (n=18) with newly diagnosed (n=3) Endpoints drug sensitive TB Eto (250 mg) plus Part B (87/87 patients) Primary endpoint 9 mg alpibectir (n=15) Isoniazid (300 mg) • Estimate the 7-Day antimycobacter
Slide 29: Phase 2a: Human Proof of Concept Achieved
PHASE 2A: HUMAN PROOF OF CONCEPT ACHIEVED AlpE Outperforms Eto Alone and Shows Comparable Activity to INH Preliminary Results1 Early Bactericidal Activity (EBA) 150 ➢ Efficacy in time-to-positivity (TTP) from start to end of treatment ΔmeanTPP (Hours) 100 ➢ The higher the TPP, the bigger is the EBA
Slide 30: Phase 2a+b Ongoing in Pulmonary Tuberculosis Conducted by GSK
PHASE 2A+B ONGOING IN PULMONARY TUBERCULOSIS CONDUCTED BY GSK WITH EXPECTED READ-OUT IN H1 2026 1. Phase 2a+ randomized, open-label trial to evaluate the EBA, 2. Multi-arm, multi-stage (MAMS), phase 2B/C, open-label, safety, tolerability, and dose-response of oral Alpibectir in randomized, controlle
Slide 31: Phase 2 TBM Trial
PHASE 2 TBM TRIAL • A multicenter, open-label, randomized, active-controlled, Phase 2 study to evaluate the plasma and CSF pharmacokinetics, safety and exploratory efficacy of ethionamide in combination with alpibectir (AlpE) in patients with newly diagnosed tuberculosis meningitis (TBM). HRZE-AlpE3
Slide 32: Estimating the Market for Alpibectir
ESTIMATING THE MARKET FOR ALPIBECTIR Major Markets1 China & Emerging Markets1 Pulmonary TB – Isoniazid Mono-Resistant Tuberculosis (INH Mono-Resistance TB), Indication Overview Multi-Drug Resistant Tuberculosis (MTR-TB); TB-Meningitis (TBM) # of Tuberculosis Cases (2028 Projected Incidence)2 >50k >1
Slide 33: Peak Sales Guidance for Alpibectir
PEAK SALES GUIDANCE FOR ALPIBECTIR INH-Resistant | MDR | TBM Major Markets1 China & Emerging Markets1 Other Upper / Mid Income Geography United States Other High Income Countries China Mid / Low Income Countries1 Countries1 Est. # of TB cases2 7k 43k 645k 239k >9.5m INH-Resistant Rate | 7.5% | 4.5%
Slide 34: TB Partnership with GSK Extended to Reach Patients in Need
TB PARTNERSHIP WITH GSK EXTENDED TO REACH PATIENTS IN NEED Completed In Progress Next Steps Phase 1 Phase 2a Phase 2 Phase 3 Tuberculosis • TBM offers potential for a Meningitis small Phase 3 study based on unmet medical need and LPAD • Phase 1 (Complete): Study Phase 2 TBM (to start in H2 2026) to
Slide 35: Next generation candidates & discovery platform
Next generation candidates & discovery platform
Slide 36: Discovery Platforms and Other Pipeline Assets: BV200
DISCOVERY PLATFORMS AND OTHER PIPELINE ASSETS BV200 Overview Phase Preclinical Indication Atopic dermatitis (mild – moderate) Topical treatment – inhibits AgrA (accessory gene regulator A) and MoA toxins production in S.aureus, preventing skin damage and flares Platform TRIC Data-to-date Preclinical
Slide 37: Discovery Platforms and Other Pipeline Assets: BV500
DISCOVERY PLATFORMS AND OTHER PIPELINE ASSETS BV500 Overview Phase Preclinical Indication Non-tuberculous Mycobacteria (NTM) infections Partnership with . MoA Oral treatment – Novel NTM focused ansamycin class NCEs Platform Ansamycin Up to CHF479 million ($604 million) in Data-to-date Preclinical da
Slide 38: Financials
Financials
Slide 39: Financials
FINANCIALS Lean and efficient organization Strong Institutional Investor Basis • 38 Full-Time Equivalents • Ca. 82% of operating expenses dedicated to R&D • Equity raised CHF 170 million • Excellent track record with non-dilutive funding CHF 29 15.98% million • EIB €20 million loan facility 5.69% •
Slide 40: Closing observations
VERSYS Closing observations
Slide 41: Updated WHO Priority Pathogen List 2024
UPDATED WHO PRIORITY PATHOGEN LIST 2024 Source: WHO Bacterial Priority Pathogens List, 2024: bacterial pathogens of public health importance to guide research, development and strategies to prevent and control antimicrobial resistance. BioVersys pipeline addresses with two clinical assets the two mo
Slide 42: Compelling Investment Opportunity
COMPELLING INVESTMENT OPPORTUNITY Leading the Fight to Overcome Life-threatening Infectious Diseases Addressing unmet medical needs Highly experienced management team Credible, founder-led management team, supported by an Among the highest priority pathogens industry leading Scientific Advisory Boar
Slide 43: AMR – upside potential
VERSYS AMR - upside potential
Slide 44: Pull Incentives Worldwide
PULL INCENTIVES WORLDWIDE Progress update. Source: BEAM Alliance Implemented € € € € UK Subscription German high-price Italian secured Swedish revenue guarantee model model reimbursement model Up to £23.7m/year subscription « Reserve antibiotic » status AWaRe/BPPL antibiotics are Only intended to gu
Slide 45: BioVersys Opportunity
BIOVERSYS OPPORTUNITY Peak Sales ($m) BioVersys Today1 Upside not Included in the Plan ✓ Compelling, sustainable commercial opportunity BV100 Label Expansion Expected 50% share of ✓ Diversified pipeline with peak sales with two candidates in Phase 2 ~$400 ~$1,200 Next Generation Candidates ~$800 ✓ D
Slide 46: Q&A Contact Information
Q&A Contact information: Website: www.bioversys.com IR mail: IR@bioversys.com