Fortrea Pharmaceutical Research and Development (Beijing) Co., Ltd.

DURHAM, N.C., June 04, 2024 (GLOBE NEWSWIRE) -- Fortrea (Nasdaq: FTRE) a leading global contract research organization (“CRO”), today announced it has completed the divestiture of assets relating to its Enabling Services segment, namely its Endpoint Clinical (“Endpoint”) and Fortrea Patient Access (“FPA”) businesses, to Arsenal Capital Partners (“Arsenal”), a leading private equity firm specializing in building market-leading, technology-rich healthcare and industrial growth companies. Endpoint and FPA provide best-in-class Randomization and Trial Supply Management (RTSM) and patient access solutions respectively. They both represent strategically differentiated entry points within the pharmaceutical services value chain, where Arsenal holds significant domain, scientific and technical knowledge. Arsenal has appointed Sam Osman, former president of Fortrea’s Enabling Services segment, to serve as chief executive officer of the new entities, and Raymond (“Ray”) H. Hill, an operating partner within Arsenal’s healthcare team, will serve as chairman of the board. “Endpoint and FPA are distinctly positioned to support the patient journey across clinical trials and through access to novel therapeutics after approval,” said Sam Osman, chief executive officer of Endpoint and FPA. “With Arsenal as our partner, I am confident that both our businesses and our teams will benefit from accelerated growth opportunities as well as investment and executive focus, resulting in enhanced capabilities and solutions for customers.” “The successful closing of this transaction is a testament to the caliber of the teams involved, who have planned a smooth transition for colleagues, customers and the patients we serve,” said Fortrea Chairman and CEO Tom Pike. “This transaction enables both organizations to focus their leadership and resources on delivering optimal solutions for our customers. As previously disclosed, the net proceeds from this divestiture will be used to reduce a portion of Fortrea’s overall debt structure. As a pure-play clinical CRO, Fortrea remains committed to our mission of delivering solutions that bring life-changing treatments to patients faster.” Ray Hill, an operating partner of Arsenal and chairman of the board for Endpoint and FPA, said, “I am incredibly excited to be a part of Endpoint and FPA’s next chapter. I look forward to working with the management team in building a strategically important company that provides data-driven solutions for patients.” Endpoint ClinicalEndpoint operates in the high growth eClinical market as a leading provider of Randomization and Trial Supply Management (RTSM) solutions to biopharmaceutical and CRO customers with expertise in serving complex and late-stage clinical trials. For more than 15 years, Endpoint has had a successful track record of effectively supporting more than 1,750 clinical trials involving 875,000 patients across 90 countries and has cultivated a blue-chip customer base and nurtured long-standing strategic relationships. Fortrea Patient AccessFortrea Patient Access is a scaled leader in the HUB services and patient access market, serving the biopharmaceutical industry with comprehensive patient support, product access, affordability and adherence solutions for more than 30 years. Further advanced by its recently expanded non-commercial specialty pharmacy, FortreaRx™, to support enhanced distribution of cold-chain and ambient free goods products, Fortrea Patient Access is committed to driving patient outcomes and improving healthcare accessibility through its extensive experience while currently supporting more than 2.5 million patients and over 100 unique brands across more than 25 disease indications. About Arsenal Capital PartnersArsenal Capital Partners is a leading private equity investment firm that specializes in building market-leading industrial growth and healthcare companies. Since its inception in 2000, Arsenal has raised institutional equity investment funds totaling over $10 billion, completed more than 300 platform and add-on acquisitions, and achieved more than 35 realizations. The firm works with management teams to build strategically important companies with leading market positions, high growth and high value-add. For more information, visit www.arsenalcapital.com. About FortreaFortrea (Nasdaq: FTRE) is a leading global provider of clinical development solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, biotechnology, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients. Fortrea provides phase I-IV clinical trial management, clinical pharmacology and consulting services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter). Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act and Section 21E of the Exchange Act. Forward-looking statements by their nature address matters that are, to different degrees, uncertain, including the timing of the use of net proceeds to repay a portion of the Company’s outstanding debt. In this context, forward-looking statements often address expected future business and financial performance and financial condition, and often contain words such as “guidance,” “expect,” “assume,” “anticipate,” “intend,” “plan,” “forecast,” “believe,” “seek,” “see,” “will,” “would,” “target,” similar expressions, and variations or negatives of these words that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results could differ materially from these forward-looking statements due to a number of factors, including, but not limited to factors described from time to time in documents that the Company files with the SEC. For a further discussion of the risks relating to the Company’s business, see the “Risk Factors” Section of the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (the "SEC"), as such risk factors may be amended or updated from time to time in the Company’s subsequent periodic and other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included or incorporated by reference in the Company’s filings with the SEC. All forward-looking statements are made only as of the date of this release, and the Company does not undertake any obligation, other than as may be required by law, to update or revise any forward-looking statements to reflect future events or developments. Fortrea Contacts:Hima Inguva (Investors) – 877-495-0816, hima.inguva@fortrea.com Sue Zaranek (Media) – 919-943-5422, media@fortrea.com Kate Dillon (Media) – 646-818-9115, kdillon@prosek.com Arsenal Contact: Ellen Pavlovsky – epavlovsky@arsenalcapital.com

Leverages real-world data, patient insights and a systematic process to design, operationalize and measure the effectiveness of diversity action plans in clinical trialsDURHAM, N.C., May 30, 2024 (GLOBE NEWSWIRE) -- Fortrea (Nasdaq: FTRE) (the “Company”), a leading global contract research organization (CRO), today announced its comprehensive and integrated solution to improve the diversity and inclusion (D&I) of participants in clinical trials. Fortrea’s D&I solution is designed to expand patient access to participate in clinical trials and address the U.S. Food and Drug Administration (FDA) requirements, under The Food and Drug Omnibus Reform Act, to increase enrollment of underrepresented populations in clinical trials. Fortrea’s comprehensive process integrates five components of diversity action planning and execution: Real-world evidence advisors research relevant real-world data sets to inform diversity planning.Regulatory, development and clinical operational experts design the Diversity Action Plan, validate with patient groups and negotiate with regulators.Operational teams access multiple data platforms, Fortrea’s Site Advisory Board and technology-enabled solutions to implement the Diversity Action Plan as an integral part of Fortrea’s clinical trial execution.Monitoring and reporting are enabled by Fortrea’s exclusive Diversity and Inclusion Study Insights Dashboard, providing actionable data and visualizations for ongoing study management.Experienced report technical writers compile data and prepare reports for regulatory submission, with ongoing regulatory support provided as part of the D&I solution. "Clinical research that reflects a representative population provides better insight into how a potential treatment will work in a real-world setting,” said John Doyle, DrPH, president Fortrea Consulting. "Recent regulatory requirements codify progress over the last few years in biopharma’s approach to improving the inclusion of diverse populations in their development programs. Fortrea’s solution brings deep, real-world data expertise to design D&I plans that are effective and realistic, along with more than 30 years of experience across more than 20 therapeutic areas in trial execution. We also bring a steadfast commitment to D&I, not just in clinical trials but across our entire company as we pursue our purpose of bringing life-changing treatments to patients faster." Fortrea’s D&I solution incorporates a series of proprietary tools, including epidemiological and feasibility assessments that leverage an exclusive combination of large data sets. The solution also integrates inputs from patient groups to create insights into protocol tolerance and study conduct support requirements in different patient populations across multiple therapy areas and geographies. These insights inform global and local patient recruitment and retention plans to reach under-represented patient populations and address barriers to participation in clinical trials. “Ensuring the inclusion of diverse patient populations in clinical trials must go beyond a plan, it takes insight and action,” said Mark Morais, chief operating officer, Fortrea. “Because of our comprehensive Voice of Patient program and our collaboration with diverse investigator sites and site networks, we have a deep understanding of what it takes to be successful in reaching populations that have traditionally been under-represented in clinical trials. At Fortrea, we are informed by real-world data, enabled by innovative technologies, and driven by our passion to deliver new therapies for all patients.” Please visit Diversity and Inclusion in Clinical Trials on Fortrea.com for more information. About Fortrea Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, biotechnology, medical device and diagnostic companies to drive healthcare innovation that accelerates life-changing therapies to patients. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, consulting services, differentiated technology enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter) @Fortrea. Fortrea Contacts:Fortrea Media: Galen Wilson – 703-298-0802, media@fortrea.com Fortrea Media: Kate Dillon – 646-818-9115, kdillon@prosek.com

Total operating revenues in Q1 2024 amounted to $6.4M, compared to $4.3M in Q1 2023. As of May 9, 2024, Ryvu's cash position was $59.0M, inclusive of the first tranche of €8M in venture debt from the EIB, obtained in March. This cash position, and other secured funding sources, provide a runway through Q1 2026. In Q1 2024, Ryvu announced the initiation of two Phase II studies of RVU120 in relapsed/refractory acute myeloid leukemia (r/r AML) and high-risk myelodysplastic syndromes (HR-MDS). Updated clinical data on RVU120 in patients with r/r AML/HR-MDS as well as preclinical data in myelofibrosis (MF) will be presented at the upcoming 2024 EHA Congress, June 13-16. Additionally, a webinar highlighting RVU120's potential in myelofibrosis (MF) will take place on Friday, May 17, at 3:00 PM (CEST). In February 2024, Ryvu announced that it had achieved the second milestone under the license agreement with Exelixis and received $2.0M. In March 2024, Ryvu announced that it would receive a approximately $6.6M (26 million PLN) in grant funding over five years from the Polish Agency for Enterprise Development (PARP) to support Ryvu's proprietary ONCO Prime discovery platform. KRAKOW, Poland, May 15, 2024 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, today reported financial results for the first quarter, ended March 31, 2024, and provided a corporate update. Pawel Przewiezlikowski, co-founder, largest shareholder, and Chief Executive Officer of Ryvu Therapeutics, said: "We are progressing rapidly with our clinical and preclinical pipeline programs and expect several key milestones in 2024. With RVU120 now in Phase II, we have achieved our development goals established last year. By the end of this year, we anticipate RVU120, our first-in-class CDK8/19 inhibitor, enrolling patients across four independent and potentially high-value development paths. We are well-positioned with a cash runway through Q1 2026 and numerous potential non-dilutive capital sources ahead of us." Q1 2024 SUMMARY AND RECENT CORPORATE EVENTS RVU120 clinical development plan progress In early 2024, Ryvu launched two Phase II studies with RVU120: the RIVER-52 study investigating RVU120 as monotherapy in two genetically defined cohorts of patients with r/r AML or HR-MDS, and the RIVER-81 study investigating RVU120 in combination with venetoclax in patients with AML. POTAMI-61, a Phase II study evaluating the efficacy of RVU120 in patients with myelofibrosis (MF), is expected to initiate in Q3 2024. On March 28, Ryvu signed an agreement with Fortrea for the operational execution of POTAMI-61 clinical study. REMARK, a Phase II study of RVU120 in patients with low-risk myelodysplastic syndromes (LR-MDS), is expected to initiate in mid-2024. REMARK will be conducted as an investigator-initiated study through the EMSCO network with Prof. Uwe Platzbecker, a globally renowned expert in the field of LR-MDS, as the Coordinating Principal Investigator. The company plans to enroll approximately 100 patients across all RVU120 Phase II studies this year and aims to present initial Phase II data by the end of 2024. Preclinical updates At the 2024 American Association for Cancer Research (AACR) Annual Meeting (April 5-10, San Diego, California), Ryvu presented preclinical data from its synthetic lethality pipeline and RVU120: Ryvu's PRMT5 inhibitors have potentially best-in-class profiles and favorable drug-like, oral administration properties, including a solid antiproliferative effect on MTAP-deleted cell lines and a good safety window for MTAP WT cells. Ryvu anticipates nominating a PRMT5 clinical candidate and initiation of IND-enabling studies in 2024. Ryvu's WRN inhibitor program demonstrates target engagement and selective potency with a synthetic lethal effect, providing pharmacological proof-of-concept; in vivo efficacy studies showed pronounced tumor growth inhibition in an MSI-H colorectal cancer xenograft model and supported WRN inhibition as a new, targeted oncological therapy. RVU120 shows efficacy both as a monotherapy and synergistically in combination with ruxolitinib in preclinical myeloproliferative neoplasms models (MPN), including myelofibrosis (MF) and polycythemia vera. UPCOMING INDUSTRY AND INVESTOR EVENTS Myelofibrosis Webinar, Friday, May 17 at 3:00 PM CEST: Ryvu will host a webinar discussing RVU120 and spotlighting MF. Registration is available at: 10th Annual Oncology Innovation Forum, Chicago, May 31: Ryvu will give a corporate presentation and conduct investor/partner meetings. Pekao I Technology & Consumer Conference, Warsaw, June 3: Ryvu will conduct investor meetings Erste | CEE Consumer & Technology Conference 2024, Warsaw, June 4: Ryvu will conduct investor meetings EHA Congress, Madrid, June 13-16: Ryvu will present clinical and preclinical data from RVU120 and host an exhibition booth; three posters will be presented on RVU120: Updated data from the Phase Ib trial of RVU120 in patients with relapsed/refractory acute myeloid leukemia (r/r AML) or high-risk myelodysplastic syndromes (HR-MDS) demonstrate promising clinical activity. Preclinical data support the synergistic combination of RVU120 and venetoclax in patients with AML, including RVU120's potential to overcome resistance to venetoclax treatment. In vivo data further supported CDK8 inhibition as a potential novel therapeutic strategy in myeloproliferative neoplasms (MPNs), focusing on myelofibrosis (MF). Q1 2024 FINANCIAL UPDATE Cash Position – On March 31, 2024, Ryvu Therapeutics held $62.7M in cash, cash equivalents, and bonds, compared to $63.7M on December 31, 2023. On May 9, 2024, Ryvu Therapeutics held $59.0M in cash, cash equivalents, and bonds, including €8M of venture debt from the EIB, received on March 13. 2023. Operating Revenues— In Q1 2024, Ryvu recognized total operating revenues (including grants) of $6.4M, compared to $4.3M in Q1 2023. Operating costs, related primarily to research and development expenditures, excluding the valuation of NodThera shares and non-cash cost of valuation of the Incentive Program ($0.3M) in Q1 2024, amounted to $11.7M, compared to $7.5M in Q1 2023. Net Loss Attributable to Common Shareholders – In Q1 2024, the net loss attributable to common shareholders, excluding the non-cash cost of valuation of the Incentive Program, amounted to $4.6M compared to $3.3M in the same period last year. About Ryvu Therapeutics Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel small-molecule therapies that address emerging targets in oncology. Internally discovered pipeline candidates use diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinase, synthetic lethality, and immuno-oncology targets. Ryvu's most advanced programs include RVU120, a selective CDK8/CDK19 kinase inhibitor with the potential to treat hematological malignancies and solid tumors, currently in Phase II development (i) as a monotherapy for the treatment of patients with relapsed/refractory acute myeloid leukemia (r/r AML) and high-risk myelodysplastic syndromes (HR-MDS) as well as (ii) in combination with venetoclax for the treatment of patients with r/r AML. Another clinical program, SEL24 (MEN1703), is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group. Ryvu Therapeutics has signed multiple partnering and licensing deals with global companies, including BioNTech and Exelixis. The Company was founded in 2007 and is headquartered in Kraków, Poland. Ryvu is listed on the Warsaw Stock Exchange and is a component of the mWIG40 index. For more information, please see . SOURCE Ryvu Therapeutics