Source: BioVersys AG

• Offering targets primary-only proceeds of approx.CHF 80 million.No secondary tranche is envisaged in this transaction.
• The transaction is expected to take place in Q1 2025.
• Proceeds from the IPO envisaged to be primarily used to advance BioVersys’lead asset BV100 through Phase 3,aiming at a filing with the major regulatory agencies at the end of 2027,and to finance the Company’s operating expenses and capital expenditure requirements from 2025 into 2028 and the end of the pivotal Phase 3 study for BV100.Beyond BV100 proceeds are also expected to support ongoing Phase 2 development of alpibectir.
• BioVersys is leading the fight to overcome life-threatening infectious diseases by focusing on profitable indications within the antibiotic space which address two of the top three priorities of the World Health Organization(WHO).
• Antimicrobial resistance(AMR)currently represents an area of high unmet medical need.Besides the approx.5 million deaths associated annually to AMR globally,not having access to effective antibiotics could jeopardize modern healthcare.
• Potential for clear and sustainable commercial opportunity with further upside from new reimbursement and incentive schemes for antibiotics which are gradually being introduced within the G7/EU27 countries.
• BioVersys delivered very positive Phase 2 data for its two clinical-stage pipeline assets in 2024:BV100 demonstrated a survival benefit in ventilator associated bacterial pneumonia(VABP)caused by carbapenem resistant Acinetobacter baumannii(CRAB),while alpibectir achieved human proof of concept in pulmonary tuberculosis.
• The Phase 3 clinical trial for BV100 will start in H2 2025,expanding the successful Phase 2 study into a global registration study.We believe we have general alignment between the US FDA and EMA CHMP on the Phase 3 trial design.
• This offering is supported by existing shareholders including,among others,the AMR Action Fund and GSK.

BioVersys AG(the“Company”),a multi-asset,clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multidrug-resistant(MDR)bacteria,announced today that it plans to conduct an initial public offering(“IPO”)on the SIX Swiss Exchange in the first quarter of 2025.

High value clinical assets and rich preclinical pipeline
BioVersys’two clinical programs address life-threatening antibiotic resistant bacterial infections,focusing on profitable indications within the antibiotic space,in pneumonia,blood stream infections and meningitis.
      • BV100(Phase 3 ready)for hospital infections of carbapenem resistant Acinetobacter baumannii(CRAB)with a mortality rate of up to 50%,and
      • Alpibectir(Phase 2a),developed in partnership with GSK,for tuberculosis(TB)which is still the largest infectious disease killer globally.
      • Both drug candidates achieved FDA QIDP designation offering fast track and 5-years extended market exclusivity in the US.

BV100 has undergone extensive drug profiling in seven Phase 1 clinical trials resulting in robust pharmacokinetic/pharmacodynamic(PK/PD),safety and efficacy results in an open label Phase 2 clinical trial.The all-cause mortality within the clinical Phase 2 target population of CRAB was 25%in the BV100 treatment arm vs 60%in the best available therapy(BAT)control arm.Furthermore,the clinical cure rate,the number of ventilator-free days and the time in the intensive care unit,were all endpoints measured and where BV100 out-performed BAT in the study.Overall,these results demonstrate the superior efficacy of BV100 vs other marketed drugs and warrants further development of BV100.BioVersys plans to initiate a single,global Phase 3 trial and seek regulatory approval in the US,Europe and China.BioVersys also aims to support its Phase 3 program with a clinical Phase 2b trial aiming at further commercial differentiation.BioVersys believes BV100 has a best-in-class potential for treating CRAB in hospital acquired and ventilator associated bacterial pneumonia(HABP/VABP)and blood stream infections(BSI).

Alpibectir has undergone clinical Phase 1 first in human studies and a Phase 2a human proof of concept study that were conducted together with BioVersys’partner GSK.Alpibectir represents a first-in-class molecule for the treatment of pulmonary TB and TB meningitis.In collaboration with GSK further Phase 2 trials for alpibectir are set to commence in 2025.BioVersys is responsible for leading the ongoing development in TB meningitis.

BV100 and alpibectir address two of the top three priorities of the World Health Organization(WHO)for bacterial pathogens to prevent a global health crisis.CRAB and rifampicin resistant TB are classified by the WHO as“critical,with lowest level of treatability with today’s available antibiotics.”
 

BioVersys’two clinical assets are complemented by a pipeline of preclinical products as well as two proprietary technology platforms,the Ansamycin Chemistry platform and the TRIC platform.The fast-follower preclinical projects include BV500,targeting non-tuberculosis mycobacterial lung diseases(NTM-LD),and BV200,addressing Staphylococcus aureus on the skin microbiome for the treatment of atopic dermatitis.

BioVersys conducts its own development as well as in partnership with other renowned thought leaders and organizations.The long-term relationship with GSK and a consortium of the University of Lille,France for the development of alpibectir in tuberculosis is one such example.

Dr.Thomas Breuer(Chief Global Health Officer,GSK):“BioVersys is a trusted and long-standing collaboration partner for GSK and we are aligned in our mission to address major global health threats,such as tuberculosis.GSKis also committed to investing GBP 1 billion over next 10 years on global health R&D to get ahead of high burden infectious diseases,such as TB and Malaria,and addressing the high unmet medical need of broader bacterial infections resistant to current antibiotics.This commitment is demonstrated by several initiatives,including our recent support of the Flemming initiative.We are delighted to see the progress of our partner BioVersys in this important space and are excited to support the further development of the company.”
 

Dr.Henry Skinner(CEO AMR Action Fund):“Carbapenem-resistant Acinetobacter baumannii is a serious and rapidly growing threat to patients around the world for which new,effective treatments are urgently needed.BV100 has the potential to deliver significant benefits to patients suffering from intractable infections caused by this pathogen and we are pleased to support BioVersys as it advances this promising therapeutic candidate into Phase 3 testing.”
 

Positive evolving developments in global reimbursement landscape
In recent years,governments worldwide,particularly in G7 and G20 nations,have advocated for new reimbursement schemes that decouple rewards for antibiotic innovation from initial sales volume expectations.The United Kingdom was first to implement an annual subscription model for new antibiotics,while Sweden has implemented a guaranteed annual revenue for selected antibiotics.Similarly,Canada is working on,and Japan is piloting a volume-independent reimbursement system that prioritizes access to new medicines over traditional sales volume metrics.Other countries are also actively looking to improve pricing and reimbursement for antibiotics including the US which is working on a Bipartisan Bill,called the Pasteur Act.
 

The new reimbursement pathways for novel antibiotics are set to significantly enhance revenue streams for antibiotic developers,creating a sector specific upside that BioVersys is well-positioned to benefit from as these initiatives are implemented.
 

Details of the Proposed Offering-proceeds from planned IPO targeted to take BV100 through Phase 3 to regulatory submission,and progressing alpibectir in TB meningitis
BioVersys is targeting exclusively primary proceeds of approximately CHF 80 million and expects to allocate a majority of such proceeds to the development of its lead asset BV100.Alpibectir will also be progressed in its clinical development towards regulatory approval together with GSK and with additional support of non-dilutive grant money.The remaining proceeds are expected to be allocated to the preclinical pipeline complementing existing non-dilutive funding to progress BioVersys’fast follower assets towards clinical development.Based on the current capex forecasts,BioVersys will be funded with the IPO proceeds into 2028.

Dr.Marc Gitzinger,CEO of BioVersys:“The envisaged listing on the Swiss Stock Exchange represents a key milestone for our company since its inception.We plan to use the proceeds to primarily advance BV100 through Phase 3 clinical development and regulatory submission and advance the clinical development for alpibectir together with our partner GSK to reach the next critical clinical milestone.The proceeds will also enable the development of our preclinical candidates,BV200 and BV500,as fast followers.These efforts are aimed at sustaining our momentum,maintaining a competitive edge,and capitalizing on the positive reimbursement developments in the antibiotic field.Delivering new first-in-class and best-in-class medicines to address the dire unmet needs in the AMR sector,remains our top priority.”
 

The Proposed Offering

AMR Action Fund and GSK,both of which are existing shareholders of BioVersys,are supportive of the envisaged IPO.AMR Action Fund and GSK have both expressed an intention to commit further investment in the IPO following on from their past equity investments.
 

The Offering is expected to be conducted as a public offering in Switzerland and in the form of private placements in a number of jurisdictions,including in the United States,to certain qualified institutional buyers(“QIBs”)in each case as defined in the applicable securities laws and regulations.BioVersys intends to have its shares admitted to trading and listed on the SIX Swiss Exchange in the course of the first quarter of 2025.
 

The directors ofthe Company and its executive management committed to a customary lock-up period of 360 days and all existing investors committed to a lock-up period of 180 days.
 

Dr.Seng Chin Mah,Chairman of BioVersys:“BioVersys has always aspired to bring its products through clinical development and ultimately to patients in need of new AMR therapies.The planned SIX listing will allow us to advance BV100 towards the market and to address a WHO top three priority pathogen.With alpibectir,we address tuberculosis,a tangible UN sustainable development goal.These programs underpin our adherence to sustainable global research and development.From employees to shareholders,we are committed to environmental,social and governance-based healthcare practices jointly with our partners.It is especially gratifying to see the same shareholders and partners supporting usfor the listing and even increasing their contribution to our company.”
 

Citi,UBS and Stifel are acting as joint global coordinators,with Octavian and Mirabaud as selling agents.
 

For information on the public offering of securities of BioVersys AG in Switzerland,for those legally permitted,please visit www.bioversys.com/investors/IPO.
    

About Antimicrobial Resistance(AMR)
AMR has been widely recognized as the top priority health threat by the World Health Organization(WHO),the G7 and G20.AMR has resulted in the majority of our antimicrobial therapies becoming obsolete thereby leaving the world’s population completely susceptible to an ever-increasing range of infections.More than 1’270’000 lives are lost every year to AMR,a figure which is predicted to rise to 10 million by 2050.In Europe alone,about 4 million hospital-acquired infections(HAIs)occur annually,and AMR is responsible for an estimated 33’000 deaths per year,with associated EUR 1.5 billion in healthcare costs and productivity losses every year.Resistant infections threaten the advancements of modern medicine,where patients undergoing surgery,treatments for cancer,or viral infections(COVID-19)are put in jeopardy of contracting an untreatable bacterial infection because appropriate working antibiotics are no longer available.

About BioVersys
BioVersys AG is a multi-asset,clinical stage biopharmaceutical company focused on identifying,developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant(“MDR”)bacteria.Derived from the Company’s two internal technology platforms(TRIC and Ansamycin Chemistry),candidates are designed and developed to overcome resistance mechanisms,block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields.This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders.The Company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii(BV100,Phase 3 ready),and tuberculosis(alpibectir,Phase 2a,in collaboration with GlaxoSmithKline(GSK)and a consortium of the University of Lille,France).BioVersys is located in the biotech hub of Basel,Switzerland.