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Basel, Switzerland. January 21, 2025, 7am CET
 

• 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. GSK is 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 of the 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 us for 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.

BioVersys contact 
Hernan Levett, CFO, Tel. +41 61 633 22 50; Mail: Hernan.levett@bioversys.com
Website: www.bioversys.com

Disclaimer 
This document is not an offer to sell or a solicitation of offers to purchase or subscribe for shares. This document is not a prospectus within the meaning of the Swiss Financial Services Act and not a prospectus under any other applicable laws. Copies of this document may not be sent to, distributed in or sent from jurisdictions in which this is barred or prohibited by law. The information contained herein shall not constitute an offer to sell or the solicitation of an offer to buy, in any jurisdiction in which such offer or solicitation would be unlawful prior to registration, exemption from registration or qualification under the securities laws of any jurisdiction. 

A decision to invest in securities of BioVersys AG should be based exclusively on the issue and listing prospectus available from the Company, if and when published for such purpose. 

This document is not for publication or distribution in the United States of America (including its territories and possessions, any State of the United States and the District of Columbia), Canada, Japan or Australia or any other jurisdiction into which the same would be unlawful. This document does not constitute an offer or invitation to subscribe for or purchase any securities in such countries or in any other jurisdiction into which the same would be unlawful. In particular, the document and the information contained herein should not be distributed or otherwise transmitted into the United States of America or to publications with a general circulation in the United States of America. The securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the Securities Act), or the laws of any state and may not be offered or sold in the United States of America absent registration under or an exemption from registration under the Securities Act. There will be no public offering of the securities in the United States of America.

The information contained herein does not constitute an offer of securities to the public in the United Kingdom. No prospectus offering securities to the public will be published in the United Kingdom. In the United Kingdom this document is only directed at persons who are (A) qualified investors within the meaning of Article 2(e) of Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018, as amended, and who are also (B)(i) investment professionals falling within article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the FSMA Order); (ii) persons falling within Articles 49(2)(a) to (d), “high net worth companies, unincorporated associations, etc.” of the FSMA Order or (iii) persons to whom an invitation or inducement to engage in investment activity within the meaning of Section 21 of the Financial Services and Markets Act 2000 may otherwise be lawfully communicated or caused to be communicated (all such persons together being referred to as relevant persons). The securities are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents. 

In any member state of the European Economic Area (each a Relevant State) this document is only addressed to qualified investors in that Relevant State within the meaning of the Prospectus Regulation. 

Information to UK Distributors: Solely for the purposes of the product governance requirements of Chapter 3 of the FCA Handbook Product Intervention and Product Governance Sourcebook (the “UK Product Governance Requirements”), and disclaiming all and any liability, whether arising in delict, tort, contract or otherwise, which any “manufacturer” (for the purposes of the UK Product Governance Requirements), may otherwise have with respect thereto, the Shares have been subject to a product approval process by each Manager established in the UK, which has determined that the Share are: (i) compatible with an end target market of retail investors, as defined in the FCA Handbook Conduct of Business Sourcebook (“COBS”), investors who meet the criteria of professional clients, as defined in Regulation (EU) No 600/2014 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018, as amended, and eligible counterparties, as defined in the COBS; and (b) eligible for distribution through all permitted distribution channels (the “UK Target Market Assessment”). Notwithstanding the UK Target Market Assessment, “distributors” should note that: the price of the Shares may decline and investors could lose all or part of their investment; the Shares offer no guaranteed income and no capital protection; and an investment in the Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. 

The UK Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Offer. Furthermore, it is noted that, notwithstanding the UK Target Market Assessment, the Managers established in the UK will only procure investors who meet the criteria of professional clients and eligible counterparties. For the avoidance of doubt, the UK Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of Chapter 9A or 10A respectively of the COBS; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the Shares. Each distributor is responsible for undertaking its own target market assessment in respect of the Shares and determining appropriate distribution channels. 

Information to EEA Distributors: Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II and (c) local implementing measures (together, the “MiFID II Product Governance Requirements”), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Shares have been subject to a product approval process by each Manager established in the EEA, which has determined that the Shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the Target Market Assessment). Notwithstanding the Target Market Assessment, Distributors should note that: the price of the Shares may decline and investors could lose all or part of their investment; the Shares offer no guaranteed income and no capital protection; and an investment in the Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. 

The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Offer. Furthermore, it is noted that, notwithstanding the Target Market Assessment, the Managers established in the EEA will only procure investors who meet the criteria of professional clients and eligible counterparties. For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the Shares. Each distributor is responsible for undertaking its own target market assessment in respect of the Shares and determining appropriate distribution channels.

Certain statements in this announcement are forward-looking statements. Forward looking statements are statements that are not historical facts and may be identified by words such as “plans”, “targets”, “aims”, “believes”, “expects”, “anticipates”, “intends”, “estimates”, “will”, “may”, “continues”, “should” and similar expressions. These forward-looking statements reflect, at the time, BioVersys’ beliefs, intentions and current targets/aims concerning, among other things, BioVersys’ results of operations, financial condition, industry, liquidity, prospects, growth and strategies and are subject to change. The estimated financial information is based on management's current expectations and is subject to change. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions, intense competition in the markets in which BioVersys operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting the BioVersys’ markets, and other factors beyond the control of BioVersys). Neither BioVersys nor its shareholders, directors, officers, employees, advisors, or any other person is under any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this announcement. Statements contained in this announcement regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. Some of the information presented herein is based on statements by third parties, and no representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, reasonableness, accuracy, completeness or correctness of this information or any other information or opinions contained herein, for any purpose whatsoever. 

Except as required by applicable law, BioVersys AG has no intention or obligation to update, keep updated or revise this publication or any parts thereof following the date hereof.

None of the underwriters, the selling agents or any of their respective subsidiary undertakings, affiliates or any of their respective directors, officers, employees, advisers, agents, alliance partners or any other entity or person accepts any responsibility or liability whatsoever for, or makes any representation, warranty or undertaking, express or implied, as to the truth, accuracy, completeness or fairness of the information or opinions in this announcement (or whether any information has been omitted from the announcement) or any other information relating to the group, its subsidiaries or associated companies, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of this announcement or its contents or otherwise arising in connection therewith. Accordingly, each of the underwriters, the selling agents and the other foregoing persons disclaim, to the fullest extent permitted by applicable law, all and any liability, whether arising in tort or contract or that they might otherwise be found to have in respect of this announcement and/or any such statement.