Bicycle Therapeutics Reports Recent Business Progress and Second Quarter 2025 Financial Results




Bicycle Therapeutics Reports Recent Business Progress and Second Quarter 2025 Financial Results

Continued advancement across research and development pipeline, with key program updates expected in 2H 2025

Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified non-small cell lung cancer open and actively recruiting patients

Strengthened clinical leadership and bolstered roster of scientific advisors with additions to Board of Directors and creation of Research and Innovation Advisory Board

Strategic cost realignment of approximately 30%, primarily through a workforce reduction

Cash and cash equivalents of $721.5 million as of June 30, 2025, with expected financial runway extended into 2028

CAMBRIDGE, England & BOSTON–(BUSINESS WIRE)–Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle^®) technology, today reported financial results for the second quarter ended June 30, 2025, and provided recent corporate updates.

“We continue to execute on our strategy, which is grounded in scientific rigor and focused on fulfilling our mission to develop next-generation precision-guided therapeutics that have the potential to help patients live longer and live well,” said Bicycle Therapeutics CEO Kevin Lee, Ph.D. “We are energized by the progress we are making across our pipeline, and with this momentum, we are pleased to welcome our new Research and Innovation Advisory Board members, as well as new Board member Charles Swanton, to further our innovation and strategic growth.”

Dr. Lee continued: “As we advance our various pipeline programs that hold strong potential for changing the treatment paradigm for patients with cancer and creating value for shareholders, Bicycle remains committed to disciplined capital allocation. Today we announced organizational streamlining efforts that provide us with operational flexibility to deliver potentially value-generating datasets while strengthening our financial position in uncertain market conditions. Saying goodbye to talented team members is very difficult, and we sincerely thank them for their dedication to our company. We believe Bicycle is strongly positioned to realize our strategic priorities and milestones and look forward to providing key program updates over the second half of this year.”

Second Quarter 2025 and Recent Events

• Presented additional human imaging data for an early Bicycle Radioconjugate^® (BRC^®) molecule targeting MT1-MMP at the American Association for Cancer Research (AACR) Annual Meeting 2025. A poster presentation included new data from a second patient who underwent MT1-MMP-PET/CT imaging that build on previously announced data. Altogether, the data continue to validate the potential of MT1-MMP as a novel cancer target and demonstrate the positive properties of BRC molecules for radiopharmaceutical imaging. Imaging data from these two patients are representative of the data generated to date in 12 out of 14 patients with various solid tumors.

  Bicycle Therapeutics continues to advance its emerging BRC pipeline, with initial EphA2 human imaging data expected in 2H 2025 and company-sponsored clinical trials planned for 2026.

• Presented two abstracts highlighting the development of Bicycle^® Drug Conjugate (BDC^®) zelenectide pevedotin for metastatic urothelial cancer (mUC) at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting. The abstracts outlined previously disclosed topline combination data for zelenectide pevedotin plus pembrolizumab in first-line mUC from the Phase 1/2 Duravelo-1 trial and provided an overview of the ongoing Phase 2/3 Duravelo-2 registrational trial for zelenectide pevedotin in mUC.

  Bicycle Therapeutics is on track to provide an update on dose selection from the Duravelo-2 trial and the accelerated approval pathway for zelenectide pevedotin in mUC following a meeting with the U.S. Food and Drug Administration planned for 4Q 2025.

• Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified non-small cell lung cancer (NSCLC) open and actively recruiting patients. Duravelo-4 is Bicycle Therapeutics’ second trial to leverage NECTIN4 gene amplification as a biomarker for patient selection and to expand the development of zelenectide pevedotin for additional solid tumors.

  With several trials underway assessing the potential for zelenectide pevedotin to treat mUC, breast cancer and lung cancer, the company has decided to pause the previously announced Phase 1/2 Duravelo-5 trial in multiple tumors.

• Expanded Board of Directors with the addition of Charles Swanton, M.D., Ph.D., FRS, FMedSci, FRCP, current chair of Bicycle Therapeutics’ Clinical Advisory Board. Dr. Swanton leads the Cancer Evolution and Genome Instability Laboratory at the Francis Crick Institute. His research focuses on how tumors evolve over space and time, developing an understanding of branching evolutionary histories of solid tumors, processes that drive cancer cell-to-cell variation and the impact of cancer diversity on effective immune surveillance and clinical outcomes. Dr. Swanton is a fellow of the Royal Society, a fellow of the Royal College of Physicians and a fellow of the Academy of Medical Sciences. He completed his M.D. and Ph.D. training at the Imperial Cancer Research Fund Laboratories.

• Formed Research and Innovation Advisory Board (RAB) to support scientific advancement and strategic growth across preclinical programs. The RAB replaces Bicycle’s Scientific Advisory Board. Inaugural RAB members include:

• Jose-Carlos Gutierrez-Ramos, Ph.D., is a director on the Bicycle Therapeutics Board of Directors. He also serves as the chief science officer at Danaher Corporation, leading the Danaher Innovation Centers and the Danaher Scientific Advisory Board. Previously, Dr. Gutierrez-Ramos was head of global drug discovery at AbbVie Inc., group senior vice president of biotherapeutics research and development (R&D) at Pfizer Inc., and senior vice president and CEDD head of immuno-inflammation at GlaxoSmithKline plc. He was also the founding CEO and president of Repertoire Immune Medicine, where he built and led a team focused on decoding the human immunome. Prior to that, he served as president and CEO of Synlogic, Inc. Dr. Gutierrez-Ramos earned a Ph.D. from the immunology department of the Center for Molecular Biology at the Universidad Autonoma de Madrid, and a B.S., summa cum laude, in chemistry with a minor in biochemistry from the Universidad Complutense de Madrid.
• Jason Lewis, Ph.D., is the Emily Tow Chair at Memorial Sloan Kettering Cancer Center (MSKCC) and currently serves as the deputy director at the Sloan Kettering Institute, overseeing the Office of Scientific Education and Training. He is also the scientific director of the Radiochemistry and Molecular Imaging Probe Core Facility at MSKCC. Dr. Lewis is a laboratory head in Sloan-Kettering Institute’s molecular pharmacology program and serves as a professor at the Gerstner Sloan-Kettering Graduate School of Biomedical Sciences and at Weill-Cornell Medical College. He earned a Ph.D. in biochemistry from the University of Kent and an M.S. and B.S. in chemistry from the University of Essex.
• Robert Lutz, Ph.D., is a consultant/advisor to biotech and pharma with more than 30 years of experience with a significant focus on the development of antibody-drug conjugates (ADCs). He currently serves as chief scientific officer of Iksuda Therapeutics and is a board member and chief development officer of Synthis Therapeutics. Prior to his consulting practice, Dr. Lutz was vice president of translational research and development at ImmunoGen, where he was responsible for the advancement of multiple ADC programs, including KADCYLA^® (ado-trastuzumab emtansine), the first ADC to be approved for solid tumor indications, and ELAHERE^® (mirvetuximab soravtansine). He earned a Ph.D. in biochemistry from Brandeis University and a B.S. in biochemistry from the University of New Hampshire.
• Michael Hofman, MBBS, FRACP, FAANMS, FICIS, GAICD, is a nuclear medicine physician and professor at the Sir Peter MacCallum Department of Oncology at the University of Melbourne in Australia. His research has been instrumental in advancing PSMA PET imaging and PSMA radioligand therapy, helping to revolutionize the diagnosis and treatment of prostate cancer. He was named Australia’s top researcher in nuclear medicine, radiotherapy and molecular imaging in both 2024 and 2025. Professor Hofman leads the PET/CT program and the Prostate Cancer Theranostics and Imaging Centre of Excellence at Peter MacCallum Cancer Centre. He earned a degree in medicine and surgery from Monash University in Australia and undertook a PET/CT fellowship at St. Thomas’ Hospital in London.

• Welcomed Michael Method, M.D., as senior vice president of clinical development. Dr. Method is an academic and clinical gynecologic oncologist with extensive drug development experience. He most recently served as a senior vice president of clinical development at Karyopharm Therapeutics, Inc., after his time as an executive medical director at ImmunoGen, Inc. where he led global clinical development for gynecologic and female malignancies. Previously, Dr. Method was a senior medical advisor for global medical affairs at Eli Lilly, focused on breast cancer. He earned his M.D. and MPH from Northwestern University, and his B.S. in biochemistry and MBA from the University of Notre Dame.

Participation in Upcoming Investor Conferences

Bicycle Therapeutics management will participate in the following investor conferences in September:

• Cantor Global Healthcare Conference on Thursday, Sept. 4; fireside chat at 3:55 p.m. ET
• Morgan Stanley 23^rd Annual Global Healthcare Conference on Tuesday, Sept. 9; fireside chat at 7:45 a.m. ET

Live webcasts of the fireside chats will be accessible in the Investor section of the company’s website at www.bicycletherapeutics.com. Archived replays of the webcasts will be available following the fireside chat dates.

Second Quarter 2025 Financial Results

• Cash and cash equivalents were $721.5 million as of June 30, 2025, compared to $879.5 million as of December 31, 2024. The decrease in cash and cash equivalents is primarily due to cash used in operations, including increased cash payments for clinical program activities.
• R&D expenses were $71.0 million for the three months ended June 30, 2025, compared to $40.1 million for the three months ended June 30, 2024. The increase in expense of $30.9 million was primarily due to increased clinical program expenses for zelenectide pevedotin development, increased discovery, platform and other expenses, and increased personnel-related costs, offset by decreased clinical program expenses for Bicycle Tumor-Targeted Immune Cell Agonist^® (Bicycle TICA^®) molecules as well as higher U.K. R&D tax credits period over period.
• General and administrative expenses were $18.5 million for the three months ended June 30, 2025, compared to $15.9 million for the three months ended June 30, 2024. The increase in expense of $2.6 million was primarily due to increased personnel-related costs, as well as increased professional and consulting fees.
• Net loss was $79.0 million, or $(1.14) basic and diluted net loss per share, for the three months ended June 30, 2025, compared to net loss of $39.8 million, or $(0.77) basic and diluted net loss per share, for three months ended June 30, 2024.

In recognition of the evolving macroeconomic environment and the importance of preserving capital, Bicycle Therapeutics is implementing a workforce reduction and taking other steps to optimize its operations and extend the company’s expected financial runway. These strategic cost realignment efforts are being implemented to prioritize potentially high-impact, value-generating programs, which include the advancement of zelenectide pevedotin, BT5528, next-generation Bicycle^® Drug Conjugates and the company’s wholly owned pipeline of Bicycle^® Radioconjugates. Bicycle Therapeutics anticipates total operational savings of approximately 30% over the course of the financial runway period. These actions are expected to extend the financial runway into 2028 and strengthen the company’s ability to weather continued market uncertainty as it advances clinical programs through key milestones.

About Bicycle Therapeutics

Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle^® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle^® Drug Conjugate (BDC^®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist^® (Bicycle TICA^®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle^® Radioconjugates (BRC^®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle^® technology to develop therapies for diseases beyond oncology.

Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit bicycletherapeutics.com.

Forward Looking Statements

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the validation of MT1-MMP as a cancer target and BRC molecules having positive properties for radiopharmaceutical imaging; the initiation of new clinical trials, the progress of Bicycle’s ongoing clinical trials and the timing of EphA2 human imaging data and updates on dose selection in the Duravelo-2 clinical trial and accelerated approval pathway; the outcome of Bicycle’s strategic cost realignment efforts and Bicycle’s expected financial runway; and the use of Bicycle Therapeutics’ technology through various partnerships to develop therapies for diseases beyond oncology. Bicycle Therapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle Therapeutics’ product candidates; the risk that Bicycle Therapeutics may not realize the intended benefits of its cost realignment efforts; the risk that Bicycle’s projections regarding its expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Bicycle Therapeutics’ actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in Bicycle Therapeutics’ Annual Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 1, 2025, as well as in other filings Bicycle Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle Therapeutics expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Contacts

Investors:
Stephanie Yao

SVP, Investor Relations and Corporate Communications

stephanie.yao@bicycletx.com
857-523-8544

Matthew DeYoung

Argot Partners

ir@bicycletx.com
212-600-1902

Media:
Jim O’Connell

Weber Shandwick

media@bicycletx.com
312-988-2343

Revelation Biosciences, Inc. Announces Financial Results for the Three and Six Months Ended June 30, 2025




Revelation Biosciences, Inc. Announces Financial Results for the Three and Six Months Ended June 30, 2025

SAN DIEGO–(BUSINESS WIRE)–$REVB #AKI—Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on rebalancing inflammation to optimize health, today reported its financial results for the three and six months ended June 30, 2025.

Corporate Highlights

• Completed dosing of patients in PRIME Phase 1b Clinical Study of Gemini in CKD Patients
• Received gross proceeds of $4 million from public offering in May 2025

“The Revelation team continues to strategically maximize its financial resources to achieve our stated objectives and advance the Gemini program,” said James Rolke, Chief Executive Officer of Revelation. “We look forward to announcing data from the Phase 1b study later this quarter and engaging with the FDA later this year to further the clinical development of Gemini and enhance shareholder value.”

Results of Operations

As of June 30, 2025, Revelation had $5.2 million in cash and cash equivalents, compared to $6.5 million as of December 31, 2024. The decrease in cash and cash equivalents was primarily due to cash used for operating activities. Based on current operating plans and projections, Revelation believes that its current cash and cash equivalents are sufficient to fund operations through December 2025.

Revelation’s net cash used for operating activities for the three months ended June 30, 2025 was $4.7 million compared to net cash used for operating activities of $5.3 million for the same period in 2024. Revelation’s net loss for the three months ended June 30, 2025 was $2.4 million, or $(7.01) basic and diluted net loss per share compared to a net loss of $8.4 million, or $(246.27) basic and diluted net loss per share for the same period in 2024. Revelation’s net loss for six months ended June 30, 2025 was $4.5 million, or $(13.60) basic and diluted net loss per share compared to net loss of $11.1 million, or $(390.02) basic and diluted net loss per share for the same period in 2024.

About Gemini

Gemini is an intravenously administered, proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD^®) that reduces the damage associated with inflammation by reprogramming the innate immune system to respond to stress (trauma, infection, etc.) in an attenuated manner.

Gemini is being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program), and as pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-PSI program), or infection post severe burn (GEMINI-PBI). Gemini may also be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD program).

Revelation has conducted multiple preclinical studies demonstrating the therapeutic potential of Gemini in the target indications. Revelation previously announced positive Phase 1 clinical data for intravenous treatment with Gemini: the primary safety endpoint was met in the Phase 1 study, and results demonstrated statistically significant pharmacodynamic activity, as observed through expected changes in multiple biomarkers including upregulation of IL-10.

About Revelation Biosciences, Inc.

Revelation Biosciences, Inc. is a clinical stage life sciences company focused on harnessing the power of trained immunity for the prevention and treatment of disease using its proprietary formulation Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including as a prevention for post-surgical infection, as a prevention for acute kidney injury, and for the treatment of chronic kidney disease.

For more information on Revelation, please visit www.RevBiosciences.com.

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions. We caution investors that forward-looking statements are based on management’s expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth profitability and retain its key employees; the possibility that the Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation’s product candidates; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected duration over which Revelation’s balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.

Contacts

Mike Porter

Investor Relations
Porter LeVay & Rose Inc.

Email: mike@plrinvest.com

Chester Zygmont, III

Chief Financial Officer
Revelation Biosciences Inc.

Email: czygmont@revbiosciences.com

Medical Gas Market Trends and Forecast Report 2025-2033 | Home Healthcare Trends, Chronic Disease Burden, and Medical Tech Advancements Drive Growth – ResearchAndMarkets.com




Medical Gas Market Trends and Forecast Report 2025-2033 | Home Healthcare Trends, Chronic Disease Burden, and Medical Tech Advancements Drive Growth – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Medical Gas Market Share Analysis and Size – Growth Trends and Forecast Report 2025-2033” report has been added to ResearchAndMarkets.com’s offering.

The Global Medical Gas Market is expected to reach US$ 28.61 billion by 2033 from US$ 14.41 billion in 2024, with a CAGR of 7.92% from 2025 to 2033. Some of the key reasons driving the market are the growing tendency toward home healthcare and telemedicine, the prevalence of chronic illnesses including respiratory and cardiovascular diseases (CVDs), and many developments in medical technology.

Global Medical Gas Industry Overview

The aging population, rising rates of chronic respiratory conditions, and improvements in healthcare infrastructure are all contributing to the substantial expansion of the worldwide medical gas market. Medical gases, such as carbon dioxide, nitrous oxide, and oxygen, are necessary for a number of therapeutic and diagnostic uses in ambulatory surgery centers, home healthcare settings, and hospitals. The need for portable medical gas solutions, such oxygen concentrators, has increased due to the growing demand for home healthcare services.

Due to growing healthcare sectors and government expenditures in medical infrastructure, the Asia-Pacific region is expected to develop at the highest rate, while North America already has a significant market share. The availability and distribution of medical gases may be impacted by supply chain interruptions and strict regulatory restrictions, which provide difficulties for the sector.

The need for medicinal gases is also being fueled by the increasing incidence of asthma. The Australian Institute of Health and Welfare (AIHW) estimates that in 2023, asthma accounted for 35% of the entire burden related to all respiratory disorders and 2.5% of the overall illness burden. Nitrous oxide, carbon dioxide, nitrogen, oxygen, and medical air are some of the most often utilized medical gases in hospitals.

One of the leading companies, Air Liquide Healthcare, provides medicinal gases to 20,000 hospitals and new healthcare facilities, and assists over 2 million people in managing chronic illnesses. Medical gases including heliox, oxygen, and lung gas mixes are widely employed in the diagnosis and treatment of certain respiratory conditions.

Additionally, the need for portable medical gases, such as oxygen concentrators, is rising as more people choose home-based healthcare. In order to ensure that chronic patients receive the oxygen therapy they require at home, this change places an emphasis on convenience and continuity of care. Home healthcare has become increasingly popular in recent years and is predicted to continue to grow. Many medical illnesses may now be successfully treated at home, including those that require ventilator assistance, mixed gas therapies, and long-term oxygen therapy.

Additionally, it is anticipated that rising home healthcare reimbursement would support market expansion throughout the projection period. The Firesafe Cannula Valve, for example, was formally covered by Iowa Medicaid in November 2023 and was given the HCPCS number E0700 for reimbursement. In the event that the oxygen tubing downstream burns, this novel mechanism functions as a thermal fuse and instantly stops the oxygen supply. Thermal fuses must be installed in all home oxygen systems in the United Kingdom. Interestingly, the US has a 20-fold greater risk of death from oxygen-related flames than England, where installing firebreaks has been required since 2006.

Growth Drivers for the Medical Gas Market

Numerous Medical Technology Advancements

Laparoscopy and endoscopy are examples of minimally invasive (MI) surgical techniques that have been made possible by technological breakthroughs. Surgeons can execute treatments with fewer incisions, quicker patient recovery, and less tissue stress when medical gases like carbon dioxide are utilized to provide a clean operating field. Furthermore, more specialized and individualized treatment for respiratory problems is now possible because to developments in respiratory therapy equipment.

The World Health Organization reports that asthma and other chronic respiratory diseases (CRDs) are on the rise worldwide, with 3.2 million deaths from COPD and 262 million cases of asthma in 2019. Advanced oxygen treatment equipment, such as portable oxygen delivery systems and oxygen concentrators, are used to supply medical gases like oxygen. Additionally, a number of developments in dermatology and cryosurgery have increased the use of medicinal gases, such as liquid nitrogen, to freeze and remove sick or aberrant tissue. The market is being driven by the regulated and focused treatment that cryotherapy equipment provides, which minimizes harm to nearby healthy tissue.

Growing Preference for Telemedicine and Home Healthcare

Medical gases, such as oxygen, are frequently given to patients in their homes as part of home healthcare. To control their symptoms and enhance their quality of life, patients with long-term respiratory diseases like COPD need oxygen treatment. Medical oxygen gases are in greater demand as a result of the shift toward home healthcare, which enables patients to obtain oxygen therapy without the need for extended hospital stays. Furthermore, nebulization, pain relief, and respiratory therapies are only a few of the uses for medical gases that go beyond oxygen therapy. As a result of this trend, fewer extended hospital stays are required, which raises the requirement for medical oxygen.

Additionally, as cardiovascular disorders are thought to cause 17.9 million deaths worldwide each year, medicinal gases – such as oxygen – are essential for treating associated ailments, which raises the need for at-home therapies. The need for medical gases is further increased by the growth of telemedicine and home healthcare, which enables patients to receive a greater variety of medical gas treatments in the convenience of their own homes.

Rising Rates of Chronic Conditions, Including Heart and Respiratory Conditions

Medical gases like oxygen are necessary for respiratory support because to the rising prevalence of respiratory conditions such asthma, interstitial lung disorders, and chronic obstructive pulmonary disease (COPD). Chronic respiratory disorders (CRDs), such as asthma, interstitial lung diseases, and chronic obstructive pulmonary disease (COPD), are on the rise, according to the World Health Organization (WHO). According to the Global Asthma Report, asthma affects an estimated 262 million people globally, and COPD alone was responsible for almost 3.2 million deaths in 2019.

Oxygen treatment is necessary for patients who have trouble breathing in order to keep their blood oxygen levels sufficient and to relieve their symptoms. Furthermore, medicinal gases are frequently needed for diagnostic and therapeutic purposes in cardiovascular illnesses, such as heart failure, coronary artery disease, and hypertension. In order to ensure patient comfort and stability during cardiovascular procedures, nitrous oxide is used as an anesthetic agent. Additionally, medicinal gases are essential for palliative care for individuals with chronic illnesses that have progressed.

Challenges in the Medical Gas Market

Stringent Regulatory Compliance

Because medical gases are essential to patient care and safety, the market is subject to strict regulatory compliance. To guarantee that medical gases fulfill therapeutic needs, regulatory agencies impose stringent criteria for purity, labeling, packing, and transportation. Operational complexity can be further increased by the constant monitoring, certification procedures, and thorough paperwork that are frequently required to comply with these rules. To maintain compliance, manufacturers must spend more on qualified staff and sophisticated quality control systems, which raises prices. Furthermore, managing disparate regional restrictions might make international distribution plans more difficult. Although these regulations guarantee patient safety and product dependability, they also place a financial and logistical strain on manufacturers, particularly newly established smaller businesses.

High Production and Storage Costs

Complex infrastructure and procedures are needed to produce and store medicinal gases, which raises supply chain costs. To guarantee purity and safety, the gases need to be produced under exacting circumstances, which calls for cutting-edge technology and strict adherence to regulations. Energy-intensive systems are needed for compression and liquefaction, and storage facilities need to be built to withstand temperature changes, pollution, and leakage.

Specialized, frequently temperature-controlled containers that adhere to stringent rules are also necessary for the transportation of these gases. Long-term costs are further increased by continuing storage system monitoring and maintenance. These elements work together to make medical gases far more expensive to produce, handle, and distribute than many other medical supplies, which puts a strain on both healthcare providers and suppliers.

Key Players Analyzed: Overview, Key Persons, Recent Development & Strategies, Revenue Analysis

• Air Liquide
• Linde PLC
• Atlas Copco Group
• INOX-Air Products Inc.
• TAIYO NIPPON SANSO CORPORATION
• MATHESON TRI-GAS, INC.
• HORIBA Group
• SOL India Private Limited

Key Attributes:

Key Topics Covered:

1. Introduction

2. Research Methodology

2.1 Data Source

2.1.1 Primary Sources

2.1.2 Secondary Sources

2.2 Research Approach

2.2.1 Top-Down Approach

2.2.2 Bottom-Up Approach

2.3 Forecast Projection Methodology

3. Executive Summary

4. Market Dynamics

4.1 Growth Drivers

4.2 Challenges

5. Global Medical Gas Market

5.1 Historical Market Trends

5.2 Market Forecast

6. Medical Gas Market Share Analysis

6.1 By Product

6.2 By Application

6.3 By End Use

6.4 By Countries

7. Product

7.1 Pure Gases

7.2 Gas Mixtures

8. Application

8.1 Therapeutics

8.2 Diagnostics

8.3 Others

9. End Use

9.1 Hospitals

9.2 Pharmaceutical & Biotechnology Companies

9.3 Ambulatory Surgical Centers

9.4 Diagnostic & Research Laboratories

9.5 Academic & Research Institutes

9.6 Home Healthcare

10. Countries

10.1 North America

10.1.1 United States

10.1.2 Canada

10.2 Europe

10.2.1 France

10.2.2 Germany

10.2.3 Italy

10.2.4 Spain

10.2.5 United Kingdom

10.2.6 Belgium

10.2.7 Netherlands

10.2.8 Turkey

10.3 Asia-Pacific

10.3.1 China

10.3.2 Japan

10.3.3 India

10.3.4 South Korea

10.3.5 Thailand

10.3.6 Malaysia

10.3.7 Indonesia

10.3.8 Australia

10.3.9 New Zealand

10.4 Latin America

10.4.1 Brazil

10.4.2 Mexico

10.4.3 Argentina

10.5 Middle East & Africa

10.5.1 Saudi Arabia

10.5.2 UAE

10.5.3 South Africa

11. Porter’s Five Forces Analysis

11.1 Bargaining Power of Buyers

11.2 Bargaining Power of Suppliers

11.3 Degree of Rivalry

11.4 Threat of New Entrants

11.5 Threat of Substitutes

12. SWOT Analysis

12.1 Strength

12.2 Weakness

12.3 Opportunity

12.4 Threat

13. Key Players Analysis

For more information about this report visit https://www.researchandmarkets.com/r/er19ws

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Devonian Announces Closing of a Private Placement of Units




Devonian Announces Closing of a Private Placement of Units

Not for distribution to United States newswire services or for dissemination in the United States

QUEBEC CITY–(BUSINESS WIRE)–Devonian Health Group Inc. (“Devonian” or the “Corporation”) (TSXV: GSD; OTCQB: DVHGF), a clinical stage corporation focused on developing unique solutions to inflammatory diseases, announces that it has closed its non-brokered private placement for aggregate gross proceeds of $2,272,999.85 (the “Offering”). The Offering consisted of the issuance of 15,153,332 units of the Corporation (the “Units”) at a price of $0.15 per Unit. Each Unit consists of one subordinate voting share of the Corporation (a “Share”) and one Share purchase warrant (a “Warrant”). Each Warrant entitles the holder thereof to purchase one Share at an exercise price of $0.20 per Share for a period of 24 months from the date of issuance thereof.

The proceeds of the Offering will primarily be used to finance working capital related to the Corporation’s corporate overhead and research and development activities.

A total of $2,700.00 cash finder’s fees were paid in connection with this Offering. The Shares and the Warrants issued pursuant to this Offering are subject to a restricted hold period of four months and one day, ending on December 8, 2025, under applicable Canadian securities laws. The Offering remains subject to the final approval of the TSX Venture Exchange.

About Devonian

Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune inflammatory conditions with novel therapeutic approaches to targeting unmet medical needs. Devonian’s core strategy is to develop prescription drugs for the treatment of inflammatory autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian’s focus is further supported by a U.S. Food and Drug Administration set of regulatory guidelines favoring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines.

Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian also owns a commercialization subsidiary, Altius Healthcare Inc., focused on selling prescription pharmaceutical products in Canada, under license from brand name pharmaceutical companies.

Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Québec, Canada where it owns a state-of-the art extraction facility with full traceability ‘from the seed to the pill’. Devonian is traded publicly on the TSX Venture Exchange (the “Exchange”) (TSXV: GSD) and on OTCQB exchange (OTCQB: DVHGF).

For more information, visit www.groupedevonian.com

Cautionary Note Regarding Forward-Looking Statements

All statements, other than statements of historical fact, contained in this press release including, but not limited to those relating to the intended use of proceeds, the final approval of the TSX Venture Exchange in connection with the Offering and generally, the above “About Devonian” paragraph, which essentially describes the Corporation’s outlook, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release.

Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Corporation as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.

By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of Canada. The Corporation disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) and may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable state securities laws. “United States” and “U.S. person” are as defined in Regulation S under the U.S. Securities Act.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contacts

Dr André P. Boulet, PhD

Chairman and Chief Executive Officer

Devonian Health Group inc.

Telephone: (450) 979-2916

Email: investors@groupedevonian.com

Viridian Therapeutics Highlights Recent Progress and Reports Second Quarter 2025 Financial Results




Viridian Therapeutics Highlights Recent Progress and Reports Second Quarter 2025 Financial Results

– Robust execution with multiple upcoming near-term milestones, including planned Biologics License Application (BLA) submission for veligrotug on track in 2H 2025 and expected U.S. commercial launch in 2026 –

– Breakthrough Therapy Designation (BTD) for veligrotug announced in May 2025, a designation granted by the Food and Drug Administration (FDA) to drug candidates where clinical evidence shows they may offer substantial improvement over existing therapies –

– Veligrotug showed a strong durability of proptosis response and continued to be generally well-tolerated at 52 weeks in THRIVE –

– Announced exclusive license agreement with Kissei Pharmaceutical to develop and commercialize veligrotug and VRDN-003 in Japan for $70 million upfront and potential future milestones up to $315 million and royalties –

– Cash position of $563.4 million as of June 30, 2025, supporting cash runway into 2H 2027 –

WALTHAM, Mass.–(BUSINESS WIRE)–Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing and commercializing potential best-in-class medicines for serious and rare diseases, today reported recent business highlights and financial results for the second quarter ended June 30, 2025.

“Veligrotug’s recent Breakthrough Therapy Designation as well as the continued and consistent performance of veligrotug across all of the endpoints and timepoints in our pivotal clinical trials, including the latest update on durability of response, showcase the momentum Viridian is building as we approach our planned BLA filing and expected commercial launch,” said Steve Mahoney, Viridian’s President and CEO. “We are making extraordinary progress on our commercial preparation and we plan to be launch-ready on a Priority Review designation timeline, if we receive it. In parallel to U.S. commercial launch planning, the recently announced license agreement with Kissei to develop and commercialize veligrotug and VRDN-003 in Japan further validates the value of our TED programs and the potential broad global opportunities in front of us. Overall, we are very pleased with our progress across our portfolio, including continuing to advance our FcRn inhibitors, VRDN-006 and VRDN-008, and look forward to sharing the outcomes from our upcoming milestones.”

Recent Business Highlights

Veligrotug for Active and Chronic Thyroid Eye Disease

• Positive Pivotal Trial Readouts. Veligrotug achieved all primary and secondary endpoints across proptosis, Clinical Activity Score (CAS), and diplopia in each of its two pivotal phase 3 clinical trials, THRIVE and THRIVE-2 for patients with active and chronic TED respectively.
• Robust Clinical Profile. This is the first and only drug candidate in chronic TED to demonstrate statistically significant and clinically meaningful improvement and resolution of diplopia in a global phase 3 clinical trial to date.
• Generally Well Tolerated Safety Profile. Veligrotug was generally well-tolerated in its pivotal phase 3 clinical trials, THRIVE and THRIVE-2.
• Breakthrough Therapy Designation. The FDA granted Breakthrough Therapy Designation (BTD) to veligrotug for the treatment of TED.
  • Our application was based on veligrotug’s (i) consistent and robust improvement and resolution of diplopia in chronic TED, and (ii) rapid onset of proptosis response.
  • BTD supports eligibility for Priority Review which, if received, could accelerate our timing for veli commercial launch.
• Durability of Response. Demonstrated positive long-term durability data in THRIVE, with 70% of proptosis responders at 15 weeks maintaining that response at 52 weeks, which is 40 weeks after patients received their last dose in the clinical trial.
• Biologics License Application. Viridian is on track to submit a BLA to the U.S. FDA in the second half of 2025 and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first half of 2026.

VRDN-003 for Active and Chronic Thyroid Eye Disease

• Topline Data – Pivotal Clinical Trials. Anticipate topline data from both REVEAL-1 and REVEAL-2 in the first half of 2026; BLA submission planned for year-end 2026.
• Planned Commercial Profile. Plan to launch VRDN-003, if approved, with a commercially validated, low-volume autoinjector designed for patients to infrequently self-administer at home.

Japan Licensing with Kissei Pharmaceutical

• As announced in July, Viridian entered into an exclusive license agreement with Kissei Pharmaceutical to develop and commercialize veligrotug and VRDN-003 in Japan.
  • Viridian will receive an upfront cash payment of $70 million, with the potential to receive an additional $315 million in development, regulatory, and commercial milestones.
  • Viridian also receives tiered royalties on net sales in Japan with percentages ranging from the 20s to mid-30s.
  • Kissei will be responsible for all development, regulatory, and commercialization activities, and associated costs, in Japan.

FcRn Inhibitor Portfolio

• VRDN-006 Healthy Volunteer Data. Viridian expects data from the VRDN-006 phase 1 clinical trial in healthy volunteers in Q3 2025, including proof-of-concept IgG reduction
• VRDN-008 Investigational New Drug (IND). Submission on track for year-end 2025
  • As previously disclosed, after a single, high dose in non-human primates, VRDN-008 showed a longer half-life head-to-head versus efgartigimod and a more sustained IgG reduction.

Expected Upcoming Milestones

• Veligrotug
  • BLA submission in second half 2025
  • U.S. commercial launch in 2026, if approved
  • MAA submission in first half 2026
• VRDN-003
  • Topline data in first half 2026
• VRDN-006
  • Healthy volunteer clinical data in Q3 2025
• VRDN-008
  • IND submission year-end 2025

Financial Results

• Cash Position: Cash, cash equivalents, and short-term investments were $563.4 million as of June 30, 2025, compared with $636.6 million as of March 31, 2025. The company believes that its current cash, cash equivalents, and short-term investments will be sufficient to fund its currently planned operations into the second half of 2027.

• R&D Expenses: Research and development expenses were $86.6 million during the three months ended June 30, 2025, compared to $56.2 million during the three months ended June 30, 2024. The increase in research and development expenses was driven by increased costs associated with conducting more clinical trials than the same period last year, including multiple ongoing phase 3 clinical trials for both veligrotug and VRDN-003 and a phase 1 clinical trial for VRDN-006, as well as increased personnel-related costs as a result of increased headcount.

• G&A Expenses: General and administrative expenses were $20.2 million during the three months ended June 30, 2025, compared to $16.1 million during the three months ended June 30, 2024. The increase was driven by increased costs associated with preparatory commercial activities for veligrotug, as well as increased legal, accounting, and other professional service costs and personnel-related costs to support the growing organization.

• Shares Outstanding: As of June 30, 2025, Viridian had 100,320,386 shares of common stock outstanding on an as-converted basis, which included 81,651,186 shares of common stock and an aggregate 18,669,200 shares of common stock issuable upon the conversion of 134,864 and 145,160 shares of Series A and Series B preferred stock, respectively.

About Viridian Therapeutics

Viridian is a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas.

Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED) and a portfolio of inhibitors to the neonatal Fc receptor (FcRn). In TED, the company is conducting a pivotal program for veligrotug, including two global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. Both THRIVE and THRIVE-2 reported positive topline data, meeting all the primary and secondary endpoints of each study. For the FcRn portfolio, Viridian is developing VRDN-006, a Fc fragment that inhibits FcRn, and VRDN-008, a half-life extended FcRn inhibitor.

About Veligrotug

Veligrotug is an intravenously delivered, anti-insulin-like growth factor-1 receptor (IGF-1R) antibody in phase 3 development for thyroid eye disease, with the potential to be the IV treatment-of-choice for active and chronic TED patients. Based on clinical data to date, veligrotug has demonstrated robust clinical activity and was generally well-tolerated.

In its pivotal phase 3 clinical trials, THRIVE and THRIVE-2, veligrotug demonstrated a rapid onset of treatment effect and statistically significant and clinically meaningful reduction and resolution of diplopia. Both THRIVE and THRIVE-2 reported positive topline data, meeting all the primary and secondary endpoints of each study. This is the first data set from a global phase 3 clinical trial in chronic TED patients to demonstrate statistically significant diplopia response and resolution.

About VRDN-003

VRDN-003 is a subcutaneously delivered, half-life extended, potential best-in-class anti-IGF-1R antibody. VRDN-003 has the same binding domain as veligrotug and was engineered to have a longer half-life. In a phase 1 healthy volunteer clinical trial, VRDN-003 showed a half-life of 40-50 days, 4-5x that of veligrotug. Pharmacokinetics modeling predicted that VRDN-003 exposure levels after Q4W and Q8W dosing achieve the range of veligrotug exposures that showed robust clinical activity in a two-infusion phase 2 clinical trial in TED. Viridian is conducting a pivotal program for VRDN-003, including two phase 3 clinical trials assessing VRDN-003 dosed Q4W and Q8W in active and chronic TED, REVEAL-1 and REVEAL-2, respectively.

About VRDN-006 and VRDN-008

VRDN-006 is a highly selective Fc fragment which inhibits FcRn and is designed to be a convenient subcutaneous and self-administered option for patients. Viridian is studying VRDN-006 in a first-in-human phase 1 clinical trial in healthy volunteers.

VRDN-008 is a half-life extended FcRn inhibitor comprising an Fc fragment and an albumin-binding domain designed to prolong IgG suppression and provide a potentially best-in-class subcutaneous option for patients. VRDN-008 showed a longer half-life than efgartigimod and led to a more sustained IgG reduction after a single, high dose in non-human primates.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “become,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: preclinical development, clinical development, and anticipated commercialization of Viridian’s product candidates veligrotug (formerly VRDN-001), VRDN-003, VRDN-006, and VRDN-008; anticipated data results and timing of their disclosure, including VRDN-003 topline data from the REVEAL-1 and REVEAL-2 trials in the first half of 2026 and anticipated VRDN-006 clinical data, including proof-of-concept IgG reduction data, in the third quarter of 2025; regulatory interactions and anticipated timing of regulatory submissions, including the anticipated BLA submissions for veligrotug in the second half of 2025 and VRDN-003 by year-end 2026, MAA submission for veligrotug in the first half of 2026, and IND submission for VRDN-008 by year-end 2025, pending data; the impact of Breakthrough Therapy Designation, including eligibility for Priority Review, or any other FDA designations; the potential utility, efficacy, potency, safety, clinical benefits, clinical response, convenience, and number of indications of veligrotug, VRDN-003, VRDN-006, and VRDN-008, including Viridian’s view of the strength of the THRIVE durability and safety resolution data and veligrotug’s robust clinical profile; veligrotug’s potential to be the IV treatment-of-choice for active and chronic TED; potential market sizes and market opportunities, including for Viridian’s product candidates; Viridian’s product candidates potentially being best-in-class; Viridian’s expectations regarding the potential commercialization of veligrotug and VRDN-003, if approved, including the anticipated U.S. launch of veligrotug in 2026, plans to launch VRDN-003 with a low-volume autoinjector, and in Japan under the agreement with Kissei; Viridian’s partnership with Kissei, including that it supports the potential for broad global opportunities; Viridian’s ability to receive development, regulatory, and commercial milestone payments and receive royalties on the commercial sale of our product candidates, if approved, pursuant to the agreement with Kissei; and that Viridian’s cash, cash equivalents and short-term investments will be sufficient to fund its operations into the second half of 2027.

New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of Viridian’s product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; the timing, progress and plans for our ongoing or future research, preclinical, and clinical development programs; changes to trial protocols for ongoing or new clinical trials; expectations and changes regarding the timing for regulatory filings; regulatory interactions; expectations and changes regarding the timing for enrollment and data; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in our clinical programs; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates; manufacturing risks; competition from other therapies or products; estimates of market size; other matters that could affect the sufficiency of existing cash, cash equivalents, and short-term investments to fund operations; our financial position and projected cash runway; our future operating results and financial performance; Viridian’s intellectual property position; the timing of preclinical and clinical trial activities and reporting results from same; that our product candidates may not be commercially successful, if approved; and other risks described from time to time in the “Risk Factors” section of our filings with the Securities and Exchange Commission (SEC), including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date hereof.

Contacts

IR@viridiantherapeutics.com
Media@viridiantherapeutics.com

Cencora Reports Fiscal 2025 Third Quarter Results




Cencora Reports Fiscal 2025 Third Quarter Results

Revenue of $80.7 billion for the Third Quarter, an 8.7 percent Increase Year-Over-Year

Third Quarter GAAP Diluted EPS of $3.52 and Adjusted Diluted EPS of $4.00

Adjusted Diluted EPS Guidance Range Raised to $15.85 to $16.00 for Fiscal 2025

CONSHOHOCKEN, Pa.–(BUSINESS WIRE)–Cencora, Inc. (NYSE: COR) reported that in its fiscal year 2025 third quarter ended June 30, 2025, revenue increased 8.7 percent year-over-year to $80.7 billion. On the basis of U.S. generally accepted accounting principles (GAAP), diluted earnings per share (EPS) was $3.52 for the third quarter of fiscal 2025 compared to $2.42 in the prior year third quarter. Adjusted diluted EPS, which is a non-GAAP financial measure that excludes items described below, increased 19.8 percent to $4.00 in the fiscal third quarter from $3.34 in the prior year third quarter.

Cencora is updating its outlook for fiscal year 2025. The Company does not provide forward-looking guidance on a GAAP basis as discussed below in Fiscal Year 2025 Expectations. Adjusted diluted EPS guidance has been raised from the previous range of $15.70 to $15.95 to a range of $15.85 to $16.00.

“Cencora delivered strong financial results in the third fiscal quarter, driven by our pharmaceutical-centric strategy and focus on our growth priorities,” said Robert P. Mauch, President and Chief Executive Officer of Cencora.

“Our teams are fueling our growth as they identify opportunities and customer-centric solutions that strengthen our value proposition as the partner of choice,” Mauch continued. “We are guided by our purpose and focused on our strategic drivers of digital transformation, investing in our talent and culture, prioritizing growth-oriented investments and increasing productivity.”

Third Quarter Fiscal Year 2025 Summary Results

Below, Cencora presents descriptive summaries of the Company’s GAAP and adjusted (non-GAAP) quarterly results. In the tables that follow, GAAP results and GAAP to non-GAAP reconciliations are presented. For more information related to non-GAAP financial measures, including adjustments made in the periods presented, please refer to the “Supplemental Information Regarding Non-GAAP Financial Measures” following the tables.

Third Quarter GAAP Results

• Revenue: In the third quarter of fiscal 2025, revenue was $80.7 billion, up 8.7 percent compared to the same quarter in the previous fiscal year, due to an 8.5 percent increase in revenue within the U.S. Healthcare Solutions segment and a 10.5 percent increase in revenue within the International Healthcare Solutions segment.

• Gross Profit: Gross profit in the third quarter of fiscal 2025 was $2.9 billion, a 20.6 percent increase compared to the same quarter in the previous fiscal year, primarily due to the increase in gross profit in both reportable segments and a LIFO credit in the current year quarter in comparison to LIFO expense in the prior year quarter, offset in part by lower gains from antitrust litigation settlements in the current year quarter. Gross profit as a percentage of revenue was 3.60 percent, an increase of 35 basis points from the prior year quarter due to the increase in U.S. Healthcare Solutions gross profit margin, driven primarily from the January 2025 acquisition of Retina Consultants of America (RCA).

• Operating Expenses: In the third quarter of fiscal 2025, operating expenses were $2.0 billion, a 17.3 percent increase compared to the same quarter in the previous fiscal year, primarily driven by an increase in distribution, selling, and administrative expenses as a result of the January 2025 acquisition of RCA and to support our revenue growth.

• Operating Income: In the third quarter of fiscal 2025, operating income was $0.9 billion, an increase of 29.0 percent compared to the same quarter in the previous fiscal year due to the increase in gross profit, offset in part by the increase in operating expenses. Operating income as a percentage of revenue was 1.08 percent in the third quarter of fiscal 2025 compared to 0.91 percent in the prior year quarter.

• Interest Expense, Net: In the third quarter of fiscal 2025, net interest expense was $81.8 million, an increase of $50.5 million from the prior year quarter primarily due to an increase in interest expense as a result of our issuance of senior notes and a variable-rate term loan to finance a portion of the January 2025 acquisition of RCA, and increased revolving credit facility borrowings to cover short-term working capital needs.

• Effective Tax Rate: The effective tax rate was 23.0 percent for the third quarter of fiscal 2025 compared to 22.4 percent in the prior year quarter.

• Diluted Earnings Per Share: Diluted earnings per share was $3.52 in the third quarter of fiscal 2025, a 45.5 percent increase compared to $2.42 in the previous fiscal year’s third quarter.

• Diluted Shares Outstanding: Diluted weighted average shares outstanding for the third quarter of fiscal 2025 were 195.2 million, a decrease of 2.4 percent versus the prior year third quarter primarily due to share repurchases.

Third Quarter Adjusted (non-GAAP) Results

• Revenue: No adjustments were made to the GAAP presentation of revenue. In the third quarter of fiscal 2025, revenue was $80.7 billion, up 8.7 percent compared to the same quarter in the previous fiscal year, due to an 8.5 percent increase in revenue within the U.S. Healthcare Solutions segment and a 10.5 percent increase in revenue within the International Healthcare Solutions segment.

• Adjusted Gross Profit: Adjusted gross profit in the third quarter of fiscal 2025 was $2.9 billion, a 20.7 percent increase compared to the same quarter in the previous fiscal year due to the increase in gross profit in both reportable segments. Adjusted gross profit as a percentage of revenue was 3.55 percent in the fiscal 2025 third quarter, an increase of 36 basis points from the prior year quarter due to the increase in U.S. Healthcare Solutions gross profit margin, driven primarily from the January 2025 acquisition of RCA.

• Adjusted Operating Expenses: In the third quarter of fiscal 2025, adjusted operating expenses were $1.8 billion, a 20.8 percent increase compared to the same quarter in the previous fiscal year, primarily driven by an increase in distribution, selling, and administrative expenses as a result of the January 2025 acquisition of RCA and to support our revenue growth.

• Adjusted Operating Income: In the third quarter of fiscal 2025, adjusted operating income was $1.1 billion, a 20.6 percent increase compared to the same quarter in the prior fiscal year due to the increase in gross profit, offset in part by the increase in operating expenses. Adjusted operating income as a percentage of revenue was 1.31 percent in the fiscal 2025 third quarter, an increase of 13 basis points when compared to the prior year quarter.

• Interest Expense, Net: No adjustments were made to the GAAP presentation of net interest expense. In the third quarter of fiscal 2025, net interest expense was $81.8 million, an increase of $50.5 million from the prior year quarter primarily due to an increase in interest expense as a result of our issuance of senior notes and a variable-rate term loan to finance a portion of the January 2025 acquisition of RCA, and increased revolving credit facility borrowings to cover short-term working capital needs.

• Adjusted Effective Tax Rate: The adjusted effective tax rate was 20.7 percent for the third quarter of fiscal 2025 compared to 21.0 percent in the prior year quarter.

• Adjusted Diluted Earnings Per Share: Adjusted diluted earnings per share was $4.00 in the third quarter of fiscal 2025, a 19.8 percent increase compared to $3.34 in the previous fiscal year’s third quarter.

• Diluted Shares Outstanding: No adjustments were made to the GAAP presentation of diluted shares outstanding. Diluted weighted average shares outstanding for the third quarter of fiscal 2025 were 195.2 million, a decrease of 2.4 percent versus the prior year third quarter primarily due to share repurchases.

Segment Discussion

The Company is organized geographically based upon the products and services it provides to its customers under two reportable segments: U.S. Healthcare Solutions and International Healthcare Solutions.

U.S. Healthcare Solutions

U.S. Healthcare Solutions revenue was $72.9 billion in the third quarter of fiscal 2025, an increase of 8.5 percent compared to the same quarter in the previous fiscal year due to overall market growth primarily driven by unit volume growth, including increased sales of products labeled for diabetes and/or weight loss in the GLP-1 class and specialty products to physician practices and health systems. Segment operating income of $0.9 billion in the third quarter of fiscal 2025 was up 29.1 percent compared to the same quarter in the previous fiscal year primarily due to the increase in gross profit, as a result of increased product sales and the January 2025 acquisition of RCA, offset in part by the increase in operating expenses.

International Healthcare Solutions

International Healthcare Solutions revenue was $7.8 billion in the third quarter of fiscal 2025, an increase of 10.5 percent compared to the previous fiscal year’s third quarter. Segment operating income in the third quarter of fiscal 2025 was $156.2 million, a decrease of 12.9 percent, primarily due to lower operating income at our global specialty logistics business and our specialized consulting services business. On a constant currency basis, International Healthcare Solutions revenue increased by 8.8 percent in the third quarter of fiscal 2025 compared to the previous fiscal year’s third quarter, while segment operating income decreased by 16.2 percent.

Recent Company Highlights & Milestones

• Good Neighbor Pharmacy, Cencora’s national franchise for independent pharmacies, brought together in July 2025 more than 4,000 community pharmacy owners, industry experts and partners for its 14^th annual ThoughtSpot, the flagship tradeshow and conference serving as a celebration of Good Neighbor Pharmacy and its member pharmacies.

Fiscal Year 2025 Expectations

The Company does not provide forward-looking guidance on a GAAP basis as to certain financial information, where the probable significance of the information cannot be determined, is not available or cannot be reasonably estimated. Please refer to the Supplemental Information Regarding Non-GAAP Financial Measures following the tables for additional information.

Fiscal Year 2025 Expectations on an Adjusted (non-GAAP) Basis

Cencora is now updating its fiscal year 2025 financial guidance primarily to reflect stronger earnings growth in the U.S. Healthcare Solutions segment. The Company now expects:

• Revenue growth to be approximately 9 percent, from the previous range of 8 to 10 percent;
  • U.S. Healthcare Solutions segment revenue growth to be in the range of 9 to 10 percent, from the previous range of 9 to 11 percent;
  • International Healthcare Solutions segment revenue growth to be in the range of 6 to 7 percent, from the previous range of 3 to 4 percent;
    • On a constant currency basis, International Healthcare Solutions segment revenue growth to be in the range of 7 to 8 percent, from the previous range of 6 to 8 percent; and
• Adjusted diluted EPS to be in the range of $15.85 to $16.00, from the previous range of $15.70 to $15.95.

Additional expectations now include:

• Adjusted consolidated operating income growth to be in the range of 15 to 16 percent, from the previous range of 13.5 to 15.5 percent;
  • U.S. Healthcare Solutions segment operating income growth to be in the range of 20 to 21 percent, from the previous range of 17.5 to 19.5 percent;
  • International Healthcare Solutions segment operating income decline of approximately 6 percent, from the previous range of a decline of 1 to 4 percent;
    • On a constant currency basis, International Healthcare Solutions segment operating income decline of approximately 5 percent, from the previous range of a decline of 3 percent to flat; and
• Adjusted effective tax rate to be in the range of 20.5 to 21 percent, from the prior expectation of approximately 21 percent.

All other previously communicated aspects of the Company’s fiscal year 2025 consolidated financial guidance and assumptions remain the same.

Dividend Declaration

The Company’s Board of Directors declared a quarterly cash dividend of $0.55 per common share, payable September 3, 2025, to stockholders of record at the close of business on August 15, 2025.

Conference Call & Slide Presentation

The Company will host a conference call to discuss its operating results at 8:30 a.m. ET on August 6, 2025. A slide presentation for investors has also been posted on the Company’s website at investor.cencora.com. Participating in the conference call will be:

• Robert P. Mauch, President & Chief Executive Officer
• James F. Cleary, Executive Vice President & Chief Financial Officer

The dial-in number for the live call will be +1 (833) 470-1428. From outside the United States and Canada, dial +1 (404) 975-4839. The access code for the call will be 015103. The live call will also be webcast via the Company’s website at investor.cencora.com. Users are encouraged to log on to the webcast approximately 10 minutes in advance of the scheduled start time of the call.

Replays of the call will be made available via telephone and webcast. A replay of the webcast will be posted on investor.cencora.com approximately one hour after the completion of the call and will remain available for one year. The telephone replay will also be available approximately one hour after the completion of the call and will remain available for seven days. To access the telephone replay from within the U.S. and Canada, dial +1 (866) 813-9403. From outside the United States, dial +1 (929) 458-6194. The access code for the replay is 676245.

Upcoming Investor Events

Cencora management will be attending the following investor events in the coming months:

• Wells Fargo Healthcare Conference, September 5, 2025;
• Baird Healthcare Conference, September 9, 2025;
• Morgan Stanley Global Healthcare Conference, September 10, 2025; and
• Nephron Healthcare Summit, September 16, 2025.

Please check the website for updates regarding the timing of the live presentation webcasts, if any, and for replay information.

About Cencora

Cencora is a leading global pharmaceutical solutions organization centered on improving the lives of people and animals around the world. We partner with pharmaceutical innovators across the value chain to facilitate and optimize market access to therapies. Care providers depend on us for the secure, reliable delivery of pharmaceuticals, healthcare products, and solutions. Our 51,000+ worldwide team members contribute to positive health outcomes through the power of our purpose: We are united in our responsibility to create healthier futures. Cencora is ranked #10 on the Fortune 500 and #18 on the Global Fortune 500 with more than $290 billion in annual revenue. Learn more at investor.cencora.com

Cencora’s Cautionary Note Regarding Forward-Looking Statements

Certain of the statements contained in this press release are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Securities Exchange Act”). Words such as “aim,” “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “opportunity,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “strive,” “sustain,” “synergy,” “target,” “will,” “would” and similar expressions are intended to identify such forward-looking statements, but the absence of these words does not mean the statement is not forward-looking. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances and speak only as of the date hereof. These statements are not guarantees of future performance and are based on assumptions and estimates that could prove incorrect or could cause actual results to vary materially from those indicated. A more detailed discussion of the risks and uncertainties that could cause our actual results to differ materially from those indicated is included (i) in the “Risk Factors” and “Management’s Discussion and Analysis” sections in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2024 and elsewhere in that report and (ii) in other reports filed by the Company pursuant to the Securities Exchange Act. The Company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by the federal securities laws.

Contacts

Bennett S. Murphy
Senior Vice President, Head of Investor Relations and Treasury
bennett.murphy@cencora.com

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BeOne Medicines Announces Second Quarter 2025 Financial Results and Business Updates




BeOne Medicines Announces Second Quarter 2025 Financial Results and Business Updates

• Second quarter total revenues increased 42% to $1.3 billion versus second quarter 2024
• Global BRUKINSA revenues increased 49% to $950 million versus second quarter 2024
• Reported diluted GAAP Earnings per American Depositary Share (ADS) of $0.84, non-GAAP diluted Earnings per ADS of $2.25
• Anticipate 20+ milestones in next 18 months across hematology and solid tumor pipeline

SAN CARLOS, Calif.–(BUSINESS WIRE)–$ONC #BeOne—BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the second quarter of 2025.

“Our strong second quarter performance reinforces our trajectory as a global oncology powerhouse and underscores our proven ability to deliver sustainable, long-term growth,” said John V. Oyler, Co-Founder, Chairman and CEO of BeOne. “We are executing with purpose and advancing our mission to deliver transformative medicines to more patients worldwide. BRUKINSA, the backbone of our hematology franchise, continues to set the standard as the best-in-class BTK inhibitor with the most approved indications and market leader in the US, a position earned from superior efficacy, favorable safety, and positive patient outcomes across its five indications. Building on this momentum, our two additional Phase 3 hematology assets, BCL2 inhibitor sonrotoclax and BTK CDAC BGB-16673, have the potential to further expand our franchise leadership with pivotal data readouts and new trial initiations anticipated in the near-term. At our recent Investor R&D Day, we outlined a bold path forward with more than 20 expected R&D milestones in the next 18 months. This includes potentially promising advances across our expansive solid tumor pipeline, where we are building future global franchises targeting a range of highly prevalent cancers.”

(Amounts in thousands of U.S. dollars and unaudited)

Second Quarter 2025 Financial Results

Revenue for the second quarter of 2025 was $1.3 billion, compared to $929 million in the prior-year period driven primarily by growth in BRUKINSA (zanubrutinib) product sales in the U.S. and Europe.

Product Revenue totaled $1.3 billion for the second quarter of 2025 compared to $921 million in the prior-year period. The increase in product revenue was primarily attributable to increased sales of BRUKINSA. The U.S. continued to be the Company’s largest market, with product revenue of $685 million compared to $479 million in the prior-year period. In-licensed products from Amgen and TEVIMBRA (tislelizumab) also contributed to product revenue growth.

• U.S. sales of BRUKINSA totaled $684 million in the second quarter of 2025, representing growth of 43% over the prior-year period driven primarily by robust demand growth across all indications and modest benefit due to net pricing. BRUKINSA continues to maintain its leading new patient share across the BTKi class due to its differentiated, best-in-class clinical profile. BRUKINSA sales in Europe totaled $150 million in the second quarter of 2025, representing growth of 85% compared to the prior-year period, driven by increased market share across all major European markets, including Germany, Italy, Spain, France and the UK.
• Sales of TEVIMBRA totaled $194 million in the second quarter of 2025, representing growth of 22% compared to the prior-year period.

Gross Margin as a percentage of global product sales for the second quarter of 2025 was 87.4% compared to 85.0% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in our portfolio. Gross margin also benefited from cost of sales productivity improvements for both BRUKINSA and TEVIMBRA. On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of product sales increased to 88.1% for the second quarter of 2025, compared to 85.4% in the prior-year period.

Operating Expenses

The following table summarizes operating expenses for the second quarter of 2025:

The following table summarizes operating expenses for the first half of 2025:

Research and Development (R&D) Expenses increased for the second quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis primarily due to advancing preclinical programs into the clinic and early clinical programs into late stage, and offset by lower development upfront and milestone fees. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled $0.5 million and $12 million in the second quarter of 2025 and 2024, respectively.

Selling, General and Administrative (SG&A) Expenses increased for the second quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment in global commercial expansion, primarily in the U.S. and Europe. SG&A expenses as a percentage of product sales were 41% for the second quarter of 2025, compared to 48% in the prior-year period.

Net Income/(Loss) and GAAP/Non-GAAP Earnings Per Share

GAAP net income for the second quarter of 2025 was $94 million, an increase of $215 million over the prior-year period loss, primarily attributable to revenue growth and improved operating leverage.

For the second quarter of 2025, basic and diluted earnings per share was $0.07 and $0.06 per share and $0.87 and $0.84 per American Depositary Share (ADS), respectively, compared to basic loss of $0.09 per share and $1.15 per ADS in the prior-year period.

Free Cash Flow for the second quarter of 2025 was $220 million, an increase of $425 million over the prior-year period.

For further details on BeOne’s Second Quarter 2025 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the second quarter of 2025 filed with the U.S. Securities and Exchange Commission.

Full Year 2025 Guidance

BeOne has updated its full year 2025 revenue guidance and maintained its expense guidance. Guidance is summarized below:

BeOne’s total revenue guidance for full year 2025 of $5.0 billion to $5.3 billion includes expectations for strong revenue growth driven by BRUKINSA’s U.S. leadership position and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the mid- to high-80% range due to mix and production efficiencies as compared to 2024. BeOne’s guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth in both commercial and research at a pace that continues to deliver meaningful operating leverage. Non-GAAP operating expenses, which exclude costs related to share-based compensation, depreciation and amortization expense, are expected to track with GAAP operating expenses, with reconciling items unchanged from existing practice. Operating expense guidance does not assume any potential new, material business development activity or unusual/non-recurring items.

Second Quarter Business Highlights

Core Marketed Products

BRUKINSA (zanubrutinib)

• BRUKINSA is now approved in 75 markets globally with five new or expanded reimbursements in the quarter.
• Received U.S. Food and Drug Administration (FDA) approval and a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of a new film-coated tablet formulation for all approved indications.

TEVIMBRA (tislelizumab)