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Chiesi Group and Arbor Biotechnologies Announce a Global Strategic Partnership to Develop Novel Rare Disease Gene Editing Programs

Exclusive collaboration and license agreement for the development and global commercialization of Arbor’s clinical-stage gene editing program, ABO-101 for primary hyperoxaluria type 1 (PH1) Multitarget research collaboration and option agreement for Arbor’s innovative gene editing technologies for the development of additional rare liver disease targets Arbor eligible to receive up to $115M in upfront and near-term payments, along with $2B in potential development, regulatory and commercial milestones and low double-digit tiered royalties for products licensed under the agreements   PARMA, ITALY & CAMBRIDGE, MA, USA – October 6, 2025 - Chiesi Group, an international research-oriented biopharmaceutical company, together with Arbor Biotechnologies, Inc., a next-generation biotechnology company discovering and developing innovative approaches in genetic medicines, today announced an exclusive global collaboration and license agreement for Arbor’s clinical stage program ABO-101 in PH1 together with a multitarget option agreement for the use of Arbor’s advanced gene editing platform technology to develop novel liver targeted therapies for rare diseases.   At Chiesi Group, these programs are spearheaded by Chiesi Global Rare Diseases, the Group’s dedicated business unit focused on research, development, and commercialization of therapies for rare and ultra-rare conditions.   "This collaboration marks a transformative moment—not just for us, but for the entire rare disease community. It reflects our commitment to working towards more comprehensive therapeutic options. Achieving this means looking beyond current approaches and exploring the potential of gene editing." said Giacomo Chiesi, Executive Vice President, Chiesi Global Rare Diseases. "While this path holds immense promise, we know there is still a long journey ahead, and much to learn. That’s why we are proud to partner with Arbor Biotechnologies, a leader in the gene editing space with proven expertise in clinical development.  This strategic collaboration brings together complementary strengths and reinforces our unwavering mission: to bring lasting hope to patients and their families through meaningful innovation.”   “We're proud to join forces with Chiesi, a company that shares our deep commitment to improving outcomes for patients with rare and life-threatening diseases. Chiesi brings a strong track record in rare disease innovation, combined with our platform of advanced gene editors, we aim to deliver significant solutions that can redefine care for patients living with PH1 and other rare genetic diseases," said Devyn Smith, PhD, CEO of Arbor Biotechnologies.   Under the terms of the transaction, Chiesi will receive exclusive rights to develop and commercialize ABO-101 for PH1 and the option to leverage Arbor’s knockout (KO) and reverse transcriptase (RT) editing technology to advance additional rare disease targets, providing Arbor upfront and near-term payments of up to $115M. In addition, Arbor is eligible to receive up to $2B in total milestone payments and up to low double-digit tiered royalties. Arbor and Chiesi will collaborate on the ongoing Phase 1/2 redePHine (NCT06839235) clinical study of ABO-101 in PH1.   “Genomic medicines offer vast potential to impact the lives of patients around the world, especially those living with rare genetic diseases. We look forward to partnering with Chiesi’s experienced and committed team to help accelerate ABO-101 in the clinic and advance development of liver-targeted gene editing therapeutics for patients with PH1 and other rare diseases,” said Dan Ory, MD, Chief Medical Officer of Arbor Biotechnologies.   About Primary Hyperoxaluria Type I (PH1) Primary hyperoxaluria type 1 is an ultra-rare lifelong genetic disease, where a mutation in the AGXT gene leads to an enzyme deficiency in the liver resulting in an overproduction of oxalate by the liver and eventual buildup of oxalate crystals in the kidney and other organ systems. As the disease progresses, it can cause recurring kidney stones, kidney damage and eventually lead to end-stage kidney disease (ESKD) and systemic oxalosis. While two siRNA therapies are available for lifelong treatment, the only cure for PH1 is a dual liver and kidney transplant.   About ABO-101 ABO-101 is a novel, investigational gene editing medicine designed to be a one-time liver-directed gene editing treatment that potentially results in a permanent loss of function of the HAO1 gene in the liver to reduce PH1-associated oxalate production. ABO-101 is currently being evaluated for PH1 in the redePHine Phase 1/2 clinical study (NCT06839235). ABO-101 consists of a lipid nanoparticle (LNP), licensed from Acuitas Therapeutics, encapsulating messenger RNA expressing a novel Type V CRISPR Cas12i2 nuclease and an optimized guide RNA which specifically targets the human HAO1 gene. ABO-101 has not been approved for any use by the FDA or any other regulatory agency.   About the redePHine Study The Phase 1/2 redePHine study is an open label global multi-center dose escalation study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of a single dose of ABO-101 in participants with primary hyperoxaluria type 1. The trial will consist of 2 Study Periods. During the first Study Period, there will be 2 parts. In Part A, adult participants will be treated with a single ascending dose to identify a recommended dose. In Part B, pediatric participants will be treated with the recommended dose. Following the first Study Period, participants will start Study Period 2, a long-term monitoring program to comply with local and national requirements. For more information on redePHine (NCT06839235), please visit clinicaltrials.gov.   About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035.   With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden.   About Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have a therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system. For more information visit: www.chiesirarediseases.com.   About Arbor Biotechnologies, Inc. Arbor Biotechnologies™, a clinical stage, next-generation gene editing company based in Cambridge, MA, is advancing a pipeline of novel gene editing therapeutics to address a wide range of genetic conditions – from the ultra-rare to the most common genetic diseases. The company’s unique suite of optimized gene editors, which is capable of approaches ranging from gene knockout, excisions, reverse transcriptase editing, and large gene insertion, goes beyond the limitations of early editing technologies to unlock access to new gene targets and has fueled a robust pipeline of first-in-class assets focused on diseases of high unmet need. With Arbor’s clinical program, ABO-101 for the treatment of primary hyperoxaluria type 1, the company continues to focus its research and development efforts on genomic diseases of the liver and CNS for which there are no existing functional cures. For more information, please visit: arbor.bio.   For more information visit: www.arbor.bio   Chiesi Media Contact Chiara Travagin Head of Global Communications, Rare e-mail: c.travagin@chiesi.com Anna Bonisoli Alquati Head of Global External Communications: mediarelations@chiesi.com    PP-CH-00251 V1.0

Chiesi Completes Clinical Development Program for Carbon-Minimal Pressurized Metered-Dose Inhalers (pMDIs), Paving the Way for Regulatory Submissions

Key highlights: Successfully completed the TRECOS Phase III study*, supporting the long-term safety of Chiesi’s carbon minimal pressurized metered dose inhaler (pMDI) platform1 Aiming to become the first pharmaceutical company to transition its broad pMDI portfolio to a next generation propellant, significantly reducing lifecycle carbon footprint2 Advancing the Group’s plans to deliver on its Net Zero commitment across the full product portfolio and value chain by 2035†2 Delivering sustainable respiratory care without compromise—maintaining clinical choice and continuity for patients as we reduce the environmental footprint of our inhaler portfolio   Parma, Italy, 26 September 2025 – Chiesi Group, an international research-focused biopharmaceutical company, today announced the completion of its Phase III TRECOS study, a key milestone in the development of its carbon minimal pMDI portfolio1. The study evaluated the long-term safety and tolerability of HFA-152a, a next-generation propellant with significantly lower global warming potential (GWP). This marks an important step in Chiesi’s commitment to delivering sustainable respiratory care in line with its ambition to become the first pharmaceutical company to reach Net Zero across its full value chain by 20352.   “Completing the TRECOS study marks an important milestone in our efforts to advance more sustainable respiratory care” said Michelle Soriano, Executive Vice President Air Franchise. “This achievement reflects our determination to align innovation with environmental responsibility. We believe that by delivering sustainable change while retaining a broad portfolio of pMDIs we can lead the way. We are changing, so patients don’t have to“.   Redesigning Respiratory Care for a Net Zero Future   Chiesi’s carbon minimal inhaler program forms part of a broader ambition to achieve Net Zero greenhouse gases emissions by 2035, making Chiesi the first pharmaceutical company globally to adopt such a target across its full value chain2. Central to this journey is the transition to the next generation propellant HFA-152a, which tackles the largest single source of Chiesi’s greenhouse gas emissions and represents one of the most impactful actions in its Net Zero roadmap.   Building on this, the TRECOS Phase III long term safety study adds to a comprehensive preclinical and clinical program indicating that the formulations containing HFA-152a perform comparably versus current ones, while enabling up to 90% lower carbon footprint versus today’s products3. Together with Chiesi’s dry powder inhaler (DPI) options, this portfolio of pMDIs with next-generation propellant are designed to support a seamless transition to carbon-minimal respiratory care, so patients and clinicians can continue with the most appropriate therapies and devices.   As part of its long-term sustainability and development strategy, Chiesi intentionally selected HFA-152a as the next-generation propellant for its carbon minimal inhalers. The choice, made in 2018, was based not only on the low GWP, but as well on the availability of a robust safety and non-toxicity data package4.   “The completion of our clinical development program with the TRECOS Phase III study paves the way for regulatory submissions,” said Diego Ardigò, Global Head of Research & Development. “Across the program, the formulation containing the next-generation propellant HFA-152a has demonstrated a reassuring safety and performance profile. If approved, this innovation could help patients and clinicians maintain familiar inhaler options with a lower climate impact.”   Chiesi at ERS 2025: The Role of Next-Generation Propellants in Reducing Environmental Impact Chiesi will further explore the future of sustainable respiratory care at the European Respiratory Society Congress (ERS) 2025 in Amsterdam where it will contribute to scientific discussions on patient-centered treatment and environmental innovation.   As part of the program, Chiesi will sponsor a scientific symposium on Sunday, 28 September, from 17:30 to 19:00 CET, focusing on personalized respiratory care, examining the clinical and sustainability considerations linked to device selection and the importance of maintaining options and clinical choice in treatment. The session will also include insights into the development of carbon minimal pMDIs and the role of next-generation propellants in reducing the carbon footprint of the healthcare sector.   *About the TRECOS Study The TRECOS study was a large-scale, global Phase III clinical trial led by Chiesi to evaluate the long-term safety and tolerability of its next-generation, carbon-minimal inhaler platform. Enrolling over 820 adult asthma patients across more than 140 sites in 15 countries, the study compared two versions of the combination inhaler CHF5993—one using HFA-134a, a traditional propellant with a GWP of 1,430, and the other using HFA-152a, a breakthrough alternative with a GWP of just 124. The aim of the study was to determine whether the HFA-152a-based inhaler is clinically safe in treating asthma, while also offering a substantial reduction in greenhouse gas emissions1. In addition to clinical outcomes, the study also contributed to a broader understanding of the environmental implications of inhaler propellants, supporting Chiesi’s efforts to align respiratory care with its 2035 Net Zero target. Some of the clinical pharmacology studies have already been presented and/or published5-7. Results from the study will be shared with regulatory authorities, with first submissions expected in the coming months and further details to be shared at upcoming scientific congresses.   †Net Zero Commitment Chiesi plans to be the first pharmaceutical company to achieve Net Zero greenhouse gas emissions across its entire value chain by 2035, 15 years ahead of the European Climate Neutrality target. This commitment covers all emission scopes.Chiesi’s targets were validated by the Science Based Targets initiative (SBTi) in April 2024. The Group has consolidated its greenhouse gas inventory in line with ISO 14064 and the GHG Protocol standards, with annual audits carried out by independent third parties.   The transition to the next-generation propellant HFA-152a is one of the most impactful actions in Chiesi’s Net Zero roadmap, as inhaler propellants represent the single largest source of the Group’s greenhouse gas emissions.   ******  About Chiesi Group   Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment.    By adopting the legal form of Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035.    With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden.  ******    Press info:  Vera Valota  Head of Global Communications, AIR & CARE  Tel: +44 734 188 99 92  Email: v.valota@chiesi.com     References NCT06264674 - Comparison Between CHF5993 pMDI 200/6/5 µg HFA-152a VS CHF5993 pMDI 200/6/12.5 µg HFA-134a in Subjects With Asthma (TRECOS). https://clinicaltrials.gov/study/NCT06264674 Chiesi Sustainability Report 2024. https://www.chiesi.com/en/about-us/annual-report-and-csr/ Panigone S. et al 2020, BMJ Open Respiratory Research: Environmental impact of inhalers for respiratory diseases: decreasing the carbon footprint while preserving patient-tailored treatment. https://doi.org/10.1136/bmjresp-2020-000571 Orbia Fluor & Energy Materials - Zephex® 152a. https://www.kouraglobal.com/applications/medical-propellants/zephex-152a/ Rony F. et al 2024, Pulmonary Pharmacology & Therapeutics: Evaluating the pharmacokinetics of beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide delivered via pressurized metered-dose inhaler using a low global warming potential propellant. https://doi.org/10.1016/j.pupt.2024.102299 Rony F. et al 2025, Pulmonary Pharmacology & Therapeutics: Impact on beclometasone dipropionate pharmacokinetics when switching to a low global warming potential propellant in a pressurized metered-dose inhaler. https://doi.org/10.1016/j.pupt.2025.102356 Salvadori M. et al 2025, Pulmonary Pharmacology & Therapeutics: The low global warming potential propellant HFA-152a does not induce bronchoconstriction or impair mucociliary clearance. https://doi.org/10.1016/j.pupt.2025.102358

Chiesi Announces Results of the Tanimilast Phase III PILASTER Clinical Study in Chronic Obstructive Pulmonary Disease (COPD)

Chiesi Group today announced the results of the tanimilast Phase III PILASTER clinical study in Chronic obstructive pulmonary disease (COPD). The study did not meet its primary and secondary endpoints. There were no safety signals observed during the study. The company would like to thank the internal teams, all the investigators and patients involved in the study for their partnership and commitment during the study. The quality of their work and excellence have been truly outstanding throughout this program.

Chiesi Group accelerates sustainable growth in H1 2025, delivering strong financial results and reaffirming commitment to Shared Value

Positive first-half performance underpins full-year 2025 outlook; the Group highlights resilience amid the macro-economic headwinds while advancing its Patients-Planet-People-Prosperity strategy HIGHLIGHTS € 1.86 billion sales revenues, 13.2% organic growth at constant exchange rates (CER). EBITDA margin remains robust and continues five-year trend of profitability R&D investment of € 409 million, amounting to 22% of revenue Strong growth across all business units and franchises; Rare Disease BU, growing 30% vs H124, contributes 50% of Group’s growth and now 25% of Group sales Opportunity to beat 2025 outlook despite currency volatility and evolving trade policy impacts in the US market.   Parma (Italy), 16 September 2025 - Chiesi Group (“Chiesi” or the “Group”) today announced financial results for the six months ended June 30, 2025 (“H1 2025”). Revenues totaled € 1.86 billion, growing € 201 million (13.2% at CER) versus H1 2024, and EBITDA margin confirmed at around 30% reflecting strong sales growth and disciplined cost management.   Giuseppe Accogli, CEO of Chiesi Group commented on results: “H1 2025 marks another step forward on our journey to create significant shared value, in line with the Group’s mission and vision. Robust top-line growth, disciplined cost control and continuous investment in innovation position us well for the challenges and opportunities ahead.”   Strong performance across all business units and franchises – Air, Care and Rare. In particular, sales growth was led by the Rare Diseases business unit, which delivered an outstanding performance with double-digit growth (+31.4%).   The US and the emerging markets continue to grow at double-digit rates, confirming the global footprint the Group has built in recent years. In particular, the US market, propelled by the Rare Diseases business unit’s strong performance, realized +26% growth vs H1 2024 or € 85 Million. Today the US represents almost 23% of Chiesi’s sales. The Group continued to expand in the EU market (+5%), powered by the Air franchise portfolio expansion, despite the additional impact of generic competition.   The Group’s net financial position remains solid. In H1 2025, Chiesi Group deployed capital bolstering innovation and growth initiatives and improving manufacturing resilience, creating value for patients and stakeholders while maintaining balance-sheet strength.    Chiesi continued to invest in R&D, with resources focused on pipeline development and on strategic partnerships and acquisitions aimed at delivering new solutions across the three main business areas.   The Group continued to invest significantly to strengthen its manufacturing capacity and resilience, for the benefit of patients. First-semester investments—primarily industrial—totaled € 170 million, entirely financed by cash generated from operations. The regeneration of the recently acquired Nerviano site accounted for 46% of total H1 2025 spending. The around € 400 million Biotech Center of Excellence in Parma is now fully operational, underscoring Chiesi’s commitment to strengthen European manufacturing and nurture scientific talent to global patient benefit.   These investments further advance Chiesi Group’s commitment to respiratory health, rare-disease treatment and primary care and support sustainable healthcare solutions aligned with the Group’s sustainability strategy and net-zero pathway.     OUTLOOK 2025 The Group sees an opportunity to beat its previously announced revenue growth guidance of mid-single digits for FY 2025, and expects to deliver a strong EBITDA margin for the year. While external headwinds—such as currency volatility and evolving trade policies—are expected to persist, Chiesi’s financial strength and solid capital position underpin resilience and continued investment in long-term growth. Giuseppe Accogli also said: “Chiesi Group’s long-term sustainable growth strategy is delivering. We reaffirm 2025 guidance and remain confident about the road ahead. Our leadership team—now reinforced by the recent arrival of CFO Jean-Marc Bellemin—continues to execute with discipline. Above all, we can count on the passion and dedication of our people across Chiesi. Their commitment makes me optimistic about what we can achieve today and in the future.” ******   About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By adopting the legal form of Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For further information please visit www.chiesi.com   ****** Press Info: Anna Bonisoli Alquati, Head of Global External Communications: mediarelations@chiesi.com Michela Lijoi, Global External Communications Sr. Manager: mobile +39 328.6353044, e-mail: m.lijoi@chiesi.com Davide Paterlini, Global External Communications Sr. Manager: mobile +39 345.7983132, e-mail: d.paterlini@chiesi.com

Chiesi Global Rare Diseases receives Swissmedic approval for FILSUVEZ® topical gel for the treatment of epidermolysis bullosa

Parma, Italy and Villars-sur-Glâne SA, Switzerland , 11 August 2025 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative solutions for people living with rare diseases, announced today that FILSUVEZ® (Oleogel-S10, dry extract from birch bark) was approved by Swissmedic (the Swiss surveillance authority for medicines and medical devices) on 25 July 2025 for the treatment of superficial wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients aged 6 months and older.   This is the first time a medicine has received regulatory approval in Switzerland for the treatment of this condition. The approval is based on the double-blind, controlled phase 3 EASE study involving 223 patients.   EB is a serious hereditary and debilitating skin disease, that causes a person’s skin to be so fragile it can be injured just from touch. This rare, chronic, and distressing disorder affects infants, children and adults and is intensely painful; recurrent blistering and chronic wounds can result in intolerable pain with limited mobility. Living with EB entails daily challenges to navigate, including slow-healing wounds at risk of infection and painful dressing changes.   FILSUVEZ® is administered at home, allowing it to be integrated into existing treatment routines. The product is applied directly to the wound or wound dressing each time the dressing is changed.   About epidermolysis bullosa   Epidermolysis bullosa (EB) is a rare genetic disorder characterised by extreme skin fragility and blistering. Severe forms lead to chronic blisters, ulcerations, scarring, joint contractures, oesophageal strictures, a high risk of squamous cell carcinoma, infections and premature death.   About FILSUVEZ® topical gel   FILSUVEZ® (Oleogel-S10, dry extract from birch bark) is approved for patients aged six months and older who are affected by dystrophic or junctional EB. The gel is applied directly to the cleaned wound surface in a layer approximately 1 mm thick and then covered with a sterile, non-adhesive wound dressing. Alternatively, the gel can also be applied to the wound dressing, which is then placed on the wound so that the gel is in direct contact with the wound.   About the EASE study   The EASE Study was a Phase III, double-blind, randomised, vehicle-controlled trial conducted to assess a potential treatment for inherited forms of EB, including dystrophic and junctional subtypes. The subjects were randomised and treated for three months in a double-blind manner with either Oleogel-S10 or a placebo gel consisting of refined sunflower oil, yellow beeswax and carnauba wax. The respective gel was applied in a 1 mm thick layer to all wounds each time the wound dressing was changed, i.e. every one to four days.   A superficial wound with an area of 10 to 50 cm2 was selected as the target wound by the investigator at the start of the study. This wound was used to determine the primary efficacy endpoint: the proportion of patients in whom the target wound had completely closed for the first time by day 45. After completion of the double-blind phase of the study, it was continued as an open-label study and all patients were treated with Oleogel-S10.   The primary efficacy endpoint was achieved in 41.3 percent of patients in the verum group and in 28.9 percent of patients in the placebo group. In other words, the probability of complete closure of the target wound was increased by 44% with Oleogel-S10.   Side effects occurred with similar frequency in both comparison groups and were mostly mild to moderate.   Long-term observation of participants in the EASE study showed a significant and sustained reduction of approximately 50% in total wound area in patients treated with Oleogel-S10.   About the Chiesi Group   Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment.    By changing its legal status to a Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035.    With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. 

Chiesi Group and Serna Bio announce strategic collaboration to discover and develop RNA-targeted small molecules for respiratory diseases

Chiesi Group and Serna Bio have entered into a collaboration agreement to discover and develop novel small molecule drugs directed to respiratory diseases. The partnership will leverage Serna’s proprietary RNA-targeting small molecule discovery platform. Serna Bio's innovative technology enables the rational design of small molecules that specifically target RNA, shifting away from protein-centric drug development and opening new therapeutic avenues. The partnership underlines Chiesi Group’s commitment to continuous research and innovation to develop impactful therapeutic solutions while enhancing and preserving patient health. Serna Bio will receive success-based near-term payments and future milestone payments plus single digit deferred contingent payments and commercial milestones on product sales.     Parma, Italy and San Francisco, California, USA, July 24, 2025 – Chiesi Farmaceutici S.p.A (“Chiesi Group”) and Serna Bio (“Serna”) today announced the execution of a global drug discovery and collaboration agreement to discover and develop novel small molecule drugs that target RNA against an undisclosed ‘hard-to-drug’ target of interest for respiratory diseases.    Using a combination of in vitro assays and machine learning tools, Serna Bio has developed a unique understanding of RNA architecture, defining druggable, functional RNA motifs. This technology and approach will enable Chiesi Group to explore more effective new therapeutic options, in alignment with Chiesi’s mission: improve people’s quality of life and act responsibly towards both the community and the environment.              “As part of its unwavering quest to invent and develop impactful respiratory healthcare solutions, Chiesi is committed to explore innovative strategies to  engage pharmacological targets that are difficult to address with conventional approaches,” said Diego Ardigò, Executive Vice-President, Global Research & Development at Chiesi Group, “Serna Bio has unique capabilities in designing molecules that act by modulating RNA biology and we look forward to exploring how we can utilize this emerging area of science to improve the life of people with chronic respiratory conditions worldwide.”   The companies will work together to advance this program through hit finding and early lead development. Chiesi Group will have the option to acquire all rights, title, and interest to develop and commercialize any potential products identified through the collaboration.    Rabia Khan, CEO of Serna, added “We are excited to bring our platform to bear on diseases with high unmet medical needs, working with a highly experienced partner. We acknowledge and appreciate Chiesi’s significant commitment and expertise in the development of drugs in the respiratory field and we believe this partnership will help unlock the full potential of Serna Bio’s platform to address these critical needs.”   Under the terms of the agreement, Serna Bio will receive success-based near-term payments and development and regulatory milestones. Chiesi Group will fund all discovery, development, and global commercialization activities, reflecting its strategic commitment to delivering best-in-class respiratory care that goes beyond treatments, and focusing on improving the overall patient experience.