Market Newsdesk

CALGARY, Alberta, Dec. 19, 2024 (GLOBE NEWSWIRE) — XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, welcomes Dr. Michael Bumby, a biotech/pharma industry veteran, as its Chief Financial Officer replacing James Fairbairn, the Company’s current Chief Financial Officer.

Dr. Bumby, DVM, MBA, is currently a director and audit committee chair of MediPharm Labs following their successful acquisition of VIVO Cannabis Inc. where Dr. Bumby was CFO for six years. Dr. Bumby brings over 20 years of finance and leadership experience in the biotech/pharma industry. He had a 14-year career at Eli Lilly, including roles in corporate finance and investment banking at Lilly’s global headquarters in Indianapolis leading international business development activities for early- and late-stage assets, as well as working as a regional CFO in Europe. He left Lilly to move back to Canada and began working as a public company CFO, initially at Antibe Therapeutics which he helped go public via an Initial Public Offering in 2013, and more recently as the CFO of Merus Labs, an international specialty pharmaceutical company where he co-led that company’s acquisition by Norgine B.V. in 2017 for $340 million. Dr. Bumby has experience with TSX, TSX-V and NASDAQ listed companies and has led Human Resources, IT, Legal, and operations functions as well as acted as corporate secretary for a number of public companies.

Dr. Bumby holds a Doctor of Veterinary Medicine degree from the University of Guelph, a lean six-sigma blackbelt, and an MBA from the University of Toronto.

Anthony Giovinazzo, XORTX’s Chairman stated, “We are delighted to welcome Michael as XORTX’s CFO. His dual science-finance background and extensive business and drug development experience will help XORTX meet its near and longer term objectives.”

Dr. Davidoff, XORTX’s CEO added, “On behalf of XORTX, I would like to express our gratitude to Jim Fairbairn for his excellence and professionalism in his role as CFO. We will miss Jim as a team member and friend. I look forward to working with Michael. His well rounded background in the biotech/pharma industry will be a valuable asset in the next stages of XORTX’s development.”

In connection with the appointment of Dr. Bumby, XORTX has granted, in accordance with the Company’s stock option plan, 13,000 options to purchase common shares of the Company at an exercise price of $1.75 for a period of five years.

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with two clinically advanced products in development: 1) our lead, XRx-008 program for ADPKD; and 2) our secondary program in XRx-101 for acute kidney and other acute organ injury associated with Coronavirus / COVID-19 infection. In addition, XRx-225 is a pre-clinical stage program for Type 2 Diabetic Nephropathy. XORTX is working to advance its clinical development stage products that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit production of uric acid. At XORTX, we are dedicated to developing medications to improve the quality of life and health of kidney disease patients. Additional information on XORTX is available at www.xortx.com.

For more information, please contact:

Allen Davidoff, CEO	Nick Rigopulos, Director of Communications
[email protected] or +1 403 455 7727	[email protected] or +1 617 901 0785

Neither the TSX Venture Exchange nor Nasdaq has approved or disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

NEW YORK and LEAMINGTON, Ontario, Dec. 19, 2024 (GLOBE NEWSWIRE) — Tilray Brands, Inc. (“Tilray” or the “Company”) (Nasdaq: TLRY; TSX: TLRY), a leading global lifestyle and consumer packaged goods company, today announced that the Company will release its financial results for the second quarter ended November 30, 2024 before the financial market opens on January 9, 2025.

Live Conference Call and Audio Webcast

Tilray will host a live conference call, which will be webcast, to discuss these results at 8:30 a.m. Eastern Time. The webcast can be accessed on the Investors section of Tilray’s website at www.Tilray.com.

About Tilray Brands

Tilray Brands, Inc. (“Tilray”) (Nasdaq: TLRY; TSX: TLRY), is a leading global lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, and Latin America that is leading as a transformative force at the nexus of cannabis, beverage, wellness, and entertainment, elevating lives through moments of connection. Tilray’s mission is to be a leading premium lifestyle company with a house of brands and innovative products that inspire joy, wellness and create memorable experiences. Tilray’s unprecedented platform supports over 40 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and craft beverages.

For more information on how we are elevating lives through moments of connection, visit Tilray.com and follow @Tilray on all social platforms.

Media Contact:
[email protected]

Investor Contact:
[email protected]

MELBOURNE, Australia, Dec. 19, 2024 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces that it has completed the installation of two new cyclotrons at Telix Manufacturing Solutions (TMS) in Brussels South, Belgium, facilitating the production of radioisotopes and patient doses on-site from 2025¹.

The installation of cyclotrons from GE HealthCare and IBA (Ion Beam Applications S.A.), along with proprietary solid targets, establishes TMS Brussels South as a major nuclear medicine production facility, which will serve as the Company’s primary manufacturing site for the Europe Middle East and Africa (EMEA) region and beyond. One cyclotron will be dedicated to clinical and commercial supply, and the other to research and development (R&D), meaning TMS Brussels South will serve as a vital hub for manufacturing scale-up and production of next generation radiopharmaceuticals, including diagnostics and both alpha- and beta therapeutics².

Telix was granted an updated radiation licence in 2022 by the Belgian Federal Agency for Nuclear Control (FANC) for a broad range of commercially important medical isotopes³. Both cyclotrons have multi-isotope capacity and will have ARTMS’ QUANTM Irradiation System™ (QIS™) installed to support high efficiency, large-scale and cost-effective production. This includes clinical and commercial supply in Europe of gallium-68 (⁶⁸Ga), zirconium-89 (⁸⁹Zr), fluorine-18 (¹⁸F) and copper-64 (⁶⁴Cu), along with the capacity to produce R&D quantities of actinium-225 (²²⁵Ac) for targeted alpha therapy.

Darren Patti, Group Chief Operating Officer, Telix said, “This year, more than 10 million radiopharmaceutical procedures will be performed in the EU. These new cyclotrons, manufactured by the world leaders in particle accelerator technology, will deliver significant flexibility and reliable supply from Telix’s first bench-to-bedside manufacturing facility, to help meet this growing demand. Since acquiring the site in Brussels South in April 2020, the speed at which the team and our partners have decommissioned and built out this facility has been nothing short of extraordinary. We would like to thank the Wallonia regional government for grant funding, and the Wallonia Export & Investment Agency (AWEX) for access to financing solutions, in support of these buildout works.”

Commissioning of the cyclotrons is scheduled to begin in early Q1 2025, with first commercial good manufacturing practice (GMP) production anticipated in H2 2025, subject to requisite audits and accreditation.

About
Telix Manufacturing Solutions, Brussels South

Located in the heart of Belgium’s ‘Radiopharma Valley’, the 2,800 square metre facility is one of Europe’s largest radiopharmaceutical production facilities, with nine GMP lines, clean rooms, a radiopharmacy, and two cyclotrons. The site will enable improved access to radiopharmaceuticals for patients across the EMEA region and worldwide as a primary GMP capable manufacturing site for Telix’s clinical and commercial products.

TMS Brussels South also has extensive R&D capabilities, with a focus on alpha-emitting isotopes. The proximity of an alpha radiopharmaceutical laboratory (the ‘AlphaLab’) to a production GMP environment is a differentiated capability to our competition. We expect the site to evolve and develop as a hub for strategic collaborations via R&D facilities and a manufacturing line designated for university and small and medium-sized enterprise partners.

About
Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX).

Telix’s lead imaging product, gallium-68 (⁶⁸Ga) gozetotide injection (also known as ⁶⁸Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)⁴, by the Australian Therapeutic Goods Administration (TGA)⁵, and by Health Canada⁶. No other Telix product has received a marketing authorization in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn.

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: [email protected]

Legal Notices

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our registration statement on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.  To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals® and Illuccix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.

______________________

¹ Subject to GMP accreditation.
² Subject to GMP accreditation and applicable regulatory approvals.
³ Telix media release December 2022.
⁴ Telix ASX disclosure 20 December 2021.
⁵ Telix ASX disclosure 2 November 2021.
⁶ Telix ASX disclosure 14 October 2022.

SAN FRANCISCO, Dec. 19, 2024 (GLOBE NEWSWIRE) — Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for NX-5948, a highly selective degrader of Bruton’s tyrosine kinase (BTK), for the treatment of adult patients with relapsed or refractory Waldenstrom’s macroglobulinemia (WM) after at least two lines of therapy, including a BTK inhibitor.

“Fast Track designation for NX-5948 is an important recognition of the unmet patient need in Waldenstrom’s macroglobulinemia, particularly in the growing number of patients whose cancer has progressed following BTK inhibitor therapy,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “This designation follows encouraging safety and efficacy data from our ongoing Phase 1 clinical trial, demonstrating early promise of clinical benefit with potential for durable outcomes. We continue to enroll Waldenstrom’s macroglobulinemia patients in the ongoing Phase 1b expansion cohort and anticipate sharing additional clinical data in 2025.”

In addition to the Fast Track designation announced today for Waldenstrom’s macroglobulinemia, NX-5948 previously received Fast Track designation in January 2024 for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) after at least two lines of therapy, including a BTK inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor. In November 2024, the European Medicines Agency (EMA) granted NX-5948 PRIME designation for the treatment of adult patients with relapsed or refractory CLL/SLL after at least a BTK inhibitor and a BCL2 inhibitor.

About Waldenstrom’s Macroglobulinemia

WM is a rare, slow growing type of non-Hodgkin’s lymphoma that is characterized by the replacement of normal bone marrow cells by malignant lymphocytic cells that produce monoclonal IgM. This replacement leads to anemia, bleeding, and impaired immune function, while the elevated IgM levels may cause neurologic symptoms. The incidence of Waldenstrom’s macroglobulinemia ranges from 0.36^1,2 to 0.57³ per 100,000 people in the United States or approximately 1,200 to 1,900 annually. With a median disease duration approaching 10 years,⁴ approximately 12,000 to 19,000 patients are living with Waldenstrom’s macroglobulinemia in the United States. Recommended first-line treatments including chemoimmunotherapy and BTK inhibitor therapy. There are no therapies approved to treat WM patients after BTKi.

About Fast Track Designation

The FDA’s Fast Track designation is intended to facilitate and expedite the development and review of drug candidates to treat serious conditions and fulfill an unmet medical need. To qualify, available clinical and non-clinical data need to demonstrate a therapeutic candidate’s potential to address this unmet medical need. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

About PRIME Designation

The PRIME initiative, launched by the EMA in 2016, offers early, proactive and enhanced support to developers of promising medicines to optimize development plans and accelerate evaluation so these medicines can reach patients faster. To be eligible for PRIME, medicines must target an unmet medical need and show potential benefit for patients based on early clinical data.

About NX-5948

NX-5948 is an investigational, orally bioavailable, brain penetrant, small molecule degrader of BTK. NX-5948 is currently being evaluated in a Phase 1 clinical trial in patients with relapsed or refractory B cell malignancies. Nurix has previously reported that NX-5948 is highly potent against a range of tumor cell lines that are resistant to current BTK inhibitor therapies, an important consideration in heavily pretreated CLL/SLL patient populations. Additional information on the ongoing clinical trial can be accessed at clinicaltrials.gov (NCT05131022).

About Nurix

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative small molecules and antibody therapies based on the modulation of cellular protein levels as a novel treatment approach for cancer, inflammatory conditions, and other challenging diseases. Leveraging extensive expertise in E3 ligases together with proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform, to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin-proteasome system to selectively decrease or increase cellular protein levels. Nurix’s wholly owned, clinical stage pipeline includes targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates activation of multiple immune cell types including T cells and NK cells. Nurix is headquartered in San Francisco, California. For additional information visit http://www.nurixtx.com.

Forward-Looking Statements

This press release contains statements that relate to future events and expectations and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When or if used in this press release, the words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “outlook,” “plan,” “predict,” “should,” “will,” and similar expressions and their variants, as they relate to Nurix, may identify forward-looking statements. All statements that reflect Nurix’s expectations, assumptions or projections about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements regarding Nurix’s plans and strategies with respect to NX-5948, the potential advantages and therapeutic benefits of NX-5948, including its potential role in the treatment of B-cell malignancies, including Waldenstrom’s macroglobulinemia, the planned timing for the provision of updates from the NX-5948 clinical trial, and the potential benefits of Fast Track designation. Forward-looking statements reflect Nurix’s current beliefs, expectations, and assumptions. Although Nurix believes the expectations and assumptions reflected in such forward-looking statements are reasonable, Nurix can give no assurance that they will prove to be correct. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, which could cause Nurix’s actual activities and results to differ materially from those expressed in any forward-looking statement. Such risks and uncertainties include, but are not limited to: (i) the risks inherent in the drug development process, including the unexpected emergence of adverse events or other undesirable side effects during clinical development; (ii) uncertainties related to the timing and results of clinical trials; (iii) whether Nurix will be able to fund its research and development activities and achieve its research and development goals; (iv) the impact of economic and market conditions and global and regional events on Nurix’s business, clinical trials, financial condition, liquidity and results of operations; (v) whether Nurix will be able to protect intellectual property and (vi) other risks and uncertainties described under the heading “Risk Factors” in Nurix’s Quarterly Report on Form 10-Q for the fiscal period ended August 31, 2024, and other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. The statements in this press release speak only as of the date of this press release, even if subsequently made available by Nurix on its website or otherwise. Nurix disclaims any intention or obligation to update publicly any forward-looking statements, whether in response to new information, future events, or otherwise, except as required by applicable law.

Contacts:

Investors

Jason Kantor, Ph.D.
Nurix Therapeutics
[email protected]

Elizabeth Wolffe, Ph.D.
Wheelhouse Life Science Advisors
[email protected]

Media

Aljanae Reynolds
Wheelhouse Life Science Advisors
[email protected]

________________________________
_{¹ Bibas M., Sarosiek S., Castillo J.J. Waldenström Macroglobulinemia – A State-of-the-Art Review: Part 1: Epidemiology, pathogenesis, clinicopathologic characteristics, differential diagnosis, risk stratification, and clinical problems. Mediterr J Hematol Infect Dis 2024, 16(1): e2024061.
² McMaster ML. The Epidemiology of Waldenström Macroglobulinemia. Semin Hematol. 2023 March; 60(2): 65–72.
³ Kyle Robert A, et al, 50 Year Incidence of Waldenström Macroglobulinemia in Olmsted County, Minnesota From 1961–2010: A Population-Based Study With Complete Case Capture and Hematopathologic Review. Mayo Clin Proc. 2018; 93(6): 739–746.
⁴ Gertz M.A., et.al., Waldenstrom Macroglobulinemia: 2023 update on diagnosis, risk stratification, and management. Am J Hematol. 2023;98(1):348-358.}

Investigational REGN7508 (catalytic domain) and REGN9933 (A2 domain) are being evaluated for their potential to control thrombosis while minimizing bleeding risk in a variety of patient populations and clinical settings

Evaluated against current standards of care, single doses of REGN7508 and REGN9933 administered 12 to 24 hours after total knee replacement demonstrated robust antithrombotic effects

Phase 3 program to be initiated in 2025

TARRYTOWN, N.Y., Dec. 19, 2024 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive Phase 2 results for two novel monoclonal antibodies targeting distinct domains of Factor XI. REGN7508 (catalytic domain) is designed to maximize anticoagulant activity while minimizing bleeding risk, and REGN9933 (A2 domain) is designed to provide an additional option for patients with the highest bleeding risk who would otherwise not be candidates for currently available anticoagulants. Per the Phase 2 results, there was a robust antithrombotic effect for each antibody, and no clinically relevant bleeding was observed in any treatment arm.

“Our Factor XI antibodies targeting the catalytic and A2 domains were rigorously evaluated alongside current standards of care and showed clear evidence of antithrombotic effect with an encouraging safety profile after a convenient single dose,” said George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer at Regeneron. “These latest Phase 2 results add to our preclinical data that showed prolongation of activated partial thromboplastin clotting time was greater with REGN7508 and similar with REGN9933, compared to other Factor XI-targeted agents. Together, these clinical and preclinical data, along with compelling genetic evidence, give us confidence in targeting multiple distinct domains of Factor XI to potentially offer tailored therapies for patients with different bleeding risk profiles and in a variety of treatment settings. We are eager to advance REGN7508 and REGN9933 into a broad Phase 3 program beginning in 2025.”

Regeneron conducted two open-label, active-controlled Phase 2 trials (ROXI-VTE-I and ROXI-VTE-II) in the same centers under similar protocols to evaluate REGN7508 and REGN9933 for the prevention of asymptomatic (detected by venogram between day 8 and 12) or symptomatic venous thromboembolism (VTE) after unilateral total knee arthroplasty. In ROXI-VTE-I, patients were randomized to receive either a single intravenous (IV) dose of REGN9933, daily enoxaparin, or twice daily doses of apixaban until the time of venography. In ROXI-VTE-II, patients were randomized to receive a single IV dose of REGN7508 or daily enoxaparin until the time of venography. In contrast to trials evaluating other Factor XI antibodies, administration of all treatments began 12 to 24 hours after surgery (generally one day post-operation) in both trials, consistent with the approved administration of the active comparators.

On the measure of VTE rates at venogram following surgery, a pooled analysis across both trials showed REGN7508 was superior to enoxaparin and non-inferior to apixaban, and REGN9933 was non-inferior to enoxaparin. All VTE events were asymptomatic, except for one symptomatic case of pulmonary embolism in the apixaban arm. Results were as follows:

	REGN7508	REGN9933	enoxaparin	apixaban		Historical control (placebo) 1
Patients with VTE events	7% (8 of 113 patients)	17% (20 of 116 patients)	21% (36 of 175 patients)	12% (14 of 113 patients)		48% (43 of 89 patients)
Difference in VTE incidence (95% confidence interval)	REGN7508 vs enoxaparin: -14% (-21% to -6%)* REGN7508 vs apixaban: -5% (-13% to 2%)^ REGN9933 vs enoxaparin: -3% (-13% to 6%)^

* Superiority met
^ Non-inferiority met with a margin of 9%

There was no major bleeding (including surgical site bleeding) or clinically relevant non-major bleeding in any arm; the only treatment-related adverse events (AE) in any arm was one case of minimal bleeding (contusion) reported in the enoxaparin arm of ROXI-VTE-I.

There were no treatment-related serious AEs (SAEs) in any arm. There were also no AEs in any arm leading to trial discontinuation or dose interruption/modification, and no AEs of special interest or deaths in these trials. Across both trials, AE rates were generally similar among the treatment arms (ROXI-VTE-I: REGN9933=22%, enoxaparin=21%, apixaban: 25%; ROXI-VTE-II: REGN7508=22%, enoxaparin: 25%).

The safety and efficacy of REGN7508 and REGN9933 have not been evaluated by any regulatory authority.

About Thrombosis

Thrombosis, otherwise known as clot formation, is responsible for one in four deaths worldwide. Due to bleeding concerns, current standard-of-care anticoagulants are underutilized and current oral agents are often associated with poor adherence. There is an unmet need for treatments that can help prevent thrombosis without increased bleeding risk.

About Regeneron’s

VelocImmune



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Technology

Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite^® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent^® (dupilumab), Libtayo^® (cemiplimab-rwlc), Praluent^® (alirocumab), Kevzara^®, Evkeeza^® (evinacumab-dgnb), Inmazeb^® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz^® (pozelimab-bbfg). In addition, REGEN-COV^® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024.

About Regeneron

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for over 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite^® technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center^®, which is conducting one of the largest genetics sequencing efforts in the world.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn.

Forward-Looking Statements and Use of Digital Media

This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation REGN7508 and REGN9933, two novel monoclonal antibodies targeting distinct domains of Factor XI (together, the “Factor XI Product Candidates”); uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as any of the Factor XI Product Candidates); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as any regulatory approval of any of the Factor XI Product Candidates; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as any of the Factor XI Product Candidates) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees (including the Phase 2 studies evaluating the Factor XI Product Candidates discussed in this press release) may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron’s business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA

^®

(aflibercept) Injection), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney’s Office for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2023 and its Form 10-Q for the quarterly period ended September 30, 2024. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (

https://www.linkedin.com/company/regeneron-pharmaceuticals

).

Contacts: Regeneron Media Relations Mary Heather Tel: +1 914-847-8650 [email protected]	Investor Relations Mark Hudson Tel: +1 914-847-3482 [email protected]

¹ Fuji T, Fujita S, Tachibana S, Kawai Y. A dose-ranging study evaluating the oral factor Xa inhibitor edoxaban for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty. J Thromb Haemost. 2010 Nov;8(11):2458-68. doi: 10.1111/j.1538-7836.2010.04021.x. PMID: 20723033.

HOUSTON, Dec. 19, 2024 (GLOBE NEWSWIRE) — Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize^® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today reported that results from preclinical studies of BP1001-A for obesity demonstrated enhanced insulin sensitivity, confirming BP1001-A as a potential treatment for obesity and related metabolic diseases in Type 2 diabetes patients.

BP1001-A downregulates growth factor receptor-bound protein 2 (Grb2) expression to increase insulin sensitivity and helps lower blood glucose level in Type 2 diabetes patients. Scientific evidence suggests that by downregulating Grb2 expression, BP1001-A could help lower blood glucose level by affecting insulin signaling. Bio-Path conducted preclinical studies that confirmed the effectiveness of BP1001-A in affecting insulin signaling and its potential efficacy as a therapeutic treatment for obese patients who have Type 2 diabetes.   The study results showed:

• BP1001-A reduced Grb2 protein expression in myoblast cells
• BP1001-A increased the levels of phosphorylated AKT and phosphorylated FOXO-1 in myoblast and hepatoma cells in the presence of insulin

These initial data confirmed that by downregulating Grb2 expression, BP1001-A could enhance insulin-induced metabolic events by affecting the insulin/phosphoinositol-3 kinase (PI3K)/AKT pathway and increase insulin sensitivity. 

“The success of our initial preclinical testing, which supports the mechanism of action and highlights the efficacy of BP1001-A to enhance insulin sensitivity, further validates BP1001-A as a potential treatment for obesity in Type 2 diabetes patients. The failure of leading weight loss medications to induce weight loss in obese patients who have Type 2 diabetes creates a compelling need for an alternative method of lowering blood glucose in obese patients who have Type 2 diabetes,” said Peter H. Nielsen, President and Chief Executive Officer of Bio-Path. “We are excited by the rapid progress we have made advancing BP1001-A as a potential treatment for obesity and related metabolic diseases in Type 2 diabetes patients based on previous BP1001-A preclinical studies as they support our continued and rapid development of this promising program.”

Bio-Path has initiated animal studies to confirm the efficacy of BP1001-A as a potential treatment for obesity and related metabolic diseases in Type 2 diabetes patients. If successful, Bio-Path anticipates initiating a first-in-human Phase 1 clinical trial in 2025 to further validate safety, measure pharmacokinetics and establish dosing for potential pivotal trials.

About Bio-Path Holdings, Inc.

Bio-Path is a biotechnology company developing DNAbilize^®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous infusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers, and BP1001-A, a drug product modification of prexigebersen, is in a Phase 1/1b study for solid tumors. The Company’s second product, BP1002, which targets the Bcl-2 protein, is being evaluated for the treatment of blood cancers and solid tumors, including acute myeloid leukemia. In addition, an IND application is expected to be filed for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide developed by Bio-Path as a specific inhibitor of STAT3.

For more information, please visit the Company’s website at http://www.biopathholdings.com.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. These statements are based on management’s current expectations and accordingly are subject to uncertainty and changes in circumstances. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Bio-Path’s ability to raise needed additional capital on a timely basis in order for it to continue its operations, have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies, the accuracy of such data, limited patient populations of early stage clinical studies and the possibility that results from later stage clinical trials with much larger patient populations may not be consistent with earlier stage clinical trials, the maintenance of intellectual property rights, that patents relating to existing or future patent applications will be issued or that any issued patents will provide meaningful protection of our drug candidates, the impact, risks and uncertainties related to global pandemics, including the COVID-19 pandemic, and actions taken by governmental authorities or others in connection therewith, and such other risks which are identified in Bio-Path’s most recent Annual Report on Form 10-K, in any subsequent quarterly reports on Form 10-Q and in other reports that Bio-Path files with the Securities and Exchange Commission from time to time. These documents are available on request from Bio-Path Holdings or at www.sec.gov. Bio-Path disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact Information:


                        
Investors

Will O’Connor
Stern Investor Relations, Inc.
212-362-1200
[email protected]   

Doug Morris
Investor Relations
Bio-Path Holdings, Inc.
832-742-1369

Pharmacokinetic and safety data from healthy volunteers anticipated in the second half of 2025

On track to initiate a proof-of-concept study in psoriasis in the second half of 2025, with initial efficacy data expected in the second half of 2026

Preclinical data with ORKA-001 demonstrate the potential for once- or twice-yearly dosing, a significant improvement over standard of care

MENLO PARK, Calif., Dec. 19, 2024 (GLOBE NEWSWIRE) — Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today announced that it has initiated dosing of healthy volunteers in its first clinical trial of ORKA-001, the Company’s novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-23p19.

“The initiation of this Phase 1 study of ORKA-001 marks an important milestone for Oruka, which our team has delivered ahead of schedule,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “We look forward to sharing initial data for ORKA-001 in the second half of 2025, which could validate ORKA-001’s half-life and safety profile, supporting extended dosing intervals and best-in-class potential.”

The ORKA-001 Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of ORKA-001 in healthy volunteers. The study is expected to enroll approximately 24 healthy volunteers across three subcutaneous dose cohorts. Oruka expects to share interim data from this study in the second half of 2025.

Pending data from the Phase 1 trial, Oruka plans to initiate a proof-of-concept study of ORKA-001 in moderate-to-severe psoriasis in the second half of 2025. This study is anticipated to evaluate the safety and efficacy of a single dose level of ORKA-001 versus placebo in approximately 80 subjects, followed by randomization to one of two maintenance dosing arms. In one maintenance arm, subjects will receive ORKA-001 every six months. In the other, subjects will receive only induction dosing to assess the length of time patients maintain clear skin, which could support once-yearly dosing or even longer-term durability in some patients. Subjects then can continue to an open-label extension study. The company expects to share initial data from the proof-of concept study in the second half of 2026.

“We believe that ORKA-001 has the potential to set a new standard in the treatment of plaque psoriasis in terms of both depth and duration of response,” said Joana Goncalves, MBChB, Chief Medical Officer of Oruka. “We hear consistently that people with psoriasis want to achieve freedom from their disease, and that is what we hope to offer with this program. The initiation of this Phase 1 study brings us one step closer to that goal.”

Additionally, the Company announced that it has entered into a license agreement with Paragon Therapeutics granting it worldwide exclusive rights to ORKA-001 in all indications other than inflammatory bowel disease.

About ORKA-001

ORKA-001 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-23p19. Inhibitors of IL-23p19 have become the preferred first-line therapy for patients with moderate-to-severe PsO given their strong efficacy and safety profile. Currently approved therapies are dosed four to six times per year and deliver PASI 100, or fully clear skin, for less than half of patients after four months. ORKA-001 has the potential to be dosed just once or twice a year and is designed to achieve higher exposures than currently marketed IL-23p19 antibodies, which could lead to higher rates of disease clearance. Data from studies in non-human primates and other preclinical assays show that ORKA-001 binds to a similar epitope with similar affinity as risankizumab and has a significantly extended half-life over three times longer than risankizumab.

About Oruka Therapeutics

Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn.

Forward Looking Statements

Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001, including timelines to clinical and data release milestones, the details of its proof of concept study and the potential half-life of ORKA-001 and its potential dosing interval. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its registration statement on Form S-1 and its Quarterly Reports on Form 10-Q. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements.

Investor Contact:

Alan Lada
(650)-606-7911
[email protected]

IRVINE, Calif., Dec. 19, 2024 (GLOBE NEWSWIRE) — Lantronix Inc. (NASDAQ: LTRX), a global leader in IoT compute and connectivity IoT solutions, today announced that Saleel Awsare, CEO and Brent Stringham, Interim CFO, will deliver in-person presentations on Tuesday, Jan. 14, and Wednesday, Jan. 15, 2025, at the 27^th Annual Needham Growth Conference at the Lotte New York Palace Hotel in New York City.

The live audio webcast and replay of the presentations will be available approximately two hours following the live event and will be accessible for 90 days in the investor relations section of the Lantronix website.

Interested investors should contact Lantronix at [email protected] for availability for a one-on-one meeting.

For more information on the conference, visit the Needham Growth Conference website here.

About Lantronix   

Lantronix Inc. is a global leader of compute and connectivity IoT solutions that target high-growth industries including Smart Cities, Automotive and Enterprise. Lantronix’s products and services empower companies to succeed in the growing IoT markets by delivering customizable solutions that address each layer of the IoT Stack. Lantronix’s leading-edge solutions include Intelligent Substations infrastructure, Infotainment systems and Video Surveillance, supplemented with advanced Out-of-Band Management (OOB) for Cloud and Edge Computing. 

For more information, visit the Lantronix website.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: This news release contains forward-looking statements within the meaning of federal securities laws, including, without limitation, statements related to the SmartLV AI-Enabled IoT Edge Compute Cellular Gateway for Qualcomm developers. These forward-looking statements are based on our current expectations and are subject to substantial risks and uncertainties that could cause our actual results, future business, financial condition, or performance to differ materially from our historical results or those expressed or implied in any forward-looking statement contained in this news release. The potential risks and uncertainties include, but are not limited to, such factors as the effects of negative or worsening regional and worldwide economic conditions or market instability on our business, including effects on purchasing decisions by our customers; our ability to mitigate any disruption in our and our suppliers’ and vendors’ supply chains due to the COVID-19 pandemic or other outbreaks, wars and recent tensions in Europe, Asia and the Middle East, or other factors; future responses to and effects of public health crises; cybersecurity risks; changes in applicable U.S. and foreign government laws, regulations, and tariffs; our ability to successfully implement our acquisitions strategy or integrate acquired companies; difficulties and costs of protecting patents and other proprietary rights; the level of our indebtedness, our ability to service our indebtedness and the restrictions in our debt agreements; and any additional factors included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2024, filed with the Securities and Exchange Commission (the “SEC”) on Sept. 9, 2024; as well as in our other public filings with the SEC. Additional risk factors may be identified from time to time in our future filings. The forward-looking statements included in this release speak only as of the date hereof, and we do not undertake any obligation to update these forward-looking statements to reflect subsequent events or circumstances. 

Lantronix Media Contact:         
Gail Kathryn Miller 
Corporate Marketing & 
Communications Manager 
[email protected] 
949-212-0960 

Lantronix Analyst and Investor Contact:         
[email protected]

WELLESLEY HILLS, Mass., Dec. 19, 2024 (GLOBE NEWSWIRE) — December 19, 2024 – Climb Bio, Inc. (Nasdaq: CLYM) today announced that the company will be added to the NASDAQ Biotech Index (Nasdaq: NBI) as part of the annual reconstitution of the 2024 Nasdaq indexes. Climb Bio’s inclusion in the Nasdaq Biotechnology Index will be effective prior to market open on Monday, December 23, 2024.

The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® (Nasdaq®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). The NASDAQ Biotechnology Index is calculated under a modified capitalization-weighted methodology. Companies in the NASDAQ Biotechnology Index must meet eligibility requirements, including minimum market capitalization, average daily trading volume, and seasoning as a public company, among other criteria. Nasdaq selects constituents once annually in December.

For more information about the NASDAQ Biotechnology Index, please visit https://indexes.nasdaqomx.com/Index/Overview/NBI.

About Climb Bio, Inc.

Climb Bio, Inc. is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. The Company’s lead product candidate, budoprutug, is an anti-CD19 monoclonal antibody that has demonstrated B-cell depletion and has potential to treat a broad range of B-cell mediated diseases. For more information, please visit climbbio.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding: future expectations, plans and prospects for Climb Bio; the anticipated benefits of the acquisition of Tenet Medicines, Inc.; expectations regarding budoprutug’s therapeutic benefits, clinical potential and clinical development; plans to optimize the administration of budoprutug; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “will,” “working” and similar expressions. Forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. Climb Bio 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. These risks and uncertainties include, but are not limited to, important risks and uncertainties associated with: the ability of Climb Bio to timely and successfully achieve or recognize the anticipated benefits of its acquisition of Tenet Medicines, Inc.; changes in applicable laws or regulation; the possibility that Climb Bio may be adversely affected by other economic, business and/or competitive factors; Climb Bio’s ability to advance budoprutug on the timelines expected or at all and to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities; obtaining and maintaining the necessary approvals from investigational review boards at clinical trial sites and independent data safety monitoring boards; replicating in clinical trials positive results found in early-stage clinical trials of budoprutug; competing successfully with other companies that are seeking to develop treatments for primary membranous nephropathy, immune thrombocytopenia and systemic lupus erythematosus and other immune-mediated diseases; maintaining or protecting intellectual property rights related to budoprutug and/or its other product candidates; managing expenses; and raising the substantial additional capital needed, on the timeline necessary, to continue development of budoprutug and any other product candidates Climb Bio may develop. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Climb Bio’s actual results to differ materially from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in Climb Bio’s most recent filings with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Climb Bio’s views as of the date hereof and should not be relied upon as representing Climb Bio’s views as of any date subsequent to the date hereof. Climb Bio anticipates that subsequent events and developments will cause Climb Bio’s views to change. However, while Climb Bio may elect to update these forward-looking statements at some point in the future, Climb Bio specifically disclaims any obligation to do so, except as required by law.

Investors

Chris Brinzey
ICR Healthcare
[email protected]
339-970-2843

Media

Jon Yu
ICR Healthcare
[email protected]
475-395-5375

• Q1 GAAP revenues of $568.7 million, up 4.9% from Q1 2024.
• Organic Q1 ASV of $2,258.8 million, up 4.5% year over year.
• Q1 GAAP operating margin of 33.6%, down approximately 120 bps year over year, and adjusted operating margin of 37.6%, consistent with the prior year.
• Q1 GAAP diluted EPS of $3.89, up 1.3% from the prior year, and adjusted diluted EPS of $4.37, up 6.1% year over year.

NORWALK, Conn., Dec. 19, 2024 (GLOBE NEWSWIRE) — FactSet (“FactSet” or the “Company”) (NYSE:FDS) (NASDAQ:FDS), a global financial digital platform and enterprise solutions provider, today announced results for its first quarter fiscal 2025 ended November 30, 2024.

First Quarter Fiscal 2025 Highlights

• GAAP revenues increased 4.9%, or $26.5 million, to $568.7 million for the first quarter of fiscal 2025 compared with $542.2 million in the prior year period. Organic⁽¹⁾ revenues grew 4.7% year over year to $567.7 million during the first quarter of fiscal 2025. Growth in GAAP and Organic revenues this quarter was driven by wealth, asset owners and institutional asset managers.
• Annual Subscription Value (“ASV”) was $2,265.9 million at November 30, 2024, compared with $2,159.4 million at November 30, 2023. Organic ASV was $2,258.8 million at November 30, 2024, up 4.5% or $98.1 million year over year⁽²⁾.
• Organic ASV increased $3.4 million over the last three months. Please see the “ASV” section of this press release for details.
• GAAP operating margin decreased to 33.6% compared with 34.9% for the prior year period, mainly due to an increase in amortization of intangible assets and professional fees, partially offset by growth in revenues and a decrease in employee compensation costs. Adjusted operating margin was 37.6%, consistent with the prior year period.
• GAAP diluted earnings per share (“EPS”) increased 1.3% to $3.89 compared with $3.84 for the same period in fiscal 2024, primarily due to growth in revenues and a decrease in employee compensation costs, partially offset by an increase in amortization of intangible assets and professional fees. Adjusted diluted EPS increased 6.1% to $4.37 compared with $4.12 in the prior year period, driven by growth in revenues, offset by higher operating expenses and a higher tax rate.
• Net cash provided by operating activities was $86.4 million for the first quarter of fiscal 2025, driven by net income, partially offset by variable compensation payments, resolution of a sales tax dispute and timing of vendor payments. Free cash flow decreased to $60.5 million for the first quarter of fiscal 2025, compared with $138.7 million for the prior year period, a decrease of 56.4%, primarily due to lower net cash provided by operating activities and an increase in capital expenditures.
• GAAP effective tax rate for the first quarter of fiscal 2025 increased to 16.5% compared with 15.2% for the first quarter of fiscal 2024. The primary driver of the higher rate in the first quarter of fiscal 2025 is the revaluation of a deferred tax asset associated with a foreign tax rate change.

^{(1) References to “organic” figures in this press release exclude the current year impact of acquisitions and dispositions completed within the past 12 months and the current year impact from changes in foreign currency.}

^{(2) Beginning in fiscal 2025, FactSet is
reporting
Organic ASV, rather than Organic ASV plus Professional Services, to focus on
th
e recurring nature of our revenues. This underscores the shift of FactSet’s offerings toward providing more managed services and less project-based
services
.}

“Clients increasingly look to us as a partner of choice to bring greater productivity and unlock efficiencies across their enterprise workflows,” said Phil Snow, CEO of FactSet. “As we enter our second quarter, we have a robust pipeline fueled by the strength of our diverse portfolio of innovative solutions that deliver value and resonate with our clients.”

Key Financial Measures*

(Condensed and Unaudited)	Three Months Ended
	November 30,
(In thousands, except per share data)		2024			2023		Change
Revenues	$	568,667		$	542,216		4.9	%
Organic revenues	$	567,673		$	542,216		4.7	%
Operating income	$	191,335		$	189,040		1.2	%
Adjusted operating income	$	213,750		$	203,965		4.8	%
Operating margin		33.6	%		34.9	%
Adjusted operating margin		37.6	%		37.6	%
Net income	$	150,022		$	148,555		1.0	%
Adjusted net income	$	168,132		$	159,127		5.7	%
EBITDA	$	229,856		$	219,002		5.0	%
Diluted EPS	$	3.89		$	3.84		1.3	%
Adjusted diluted EPS	$	4.37		$	4.12		6.1	%

         ^{* See reconciliation of U.S. GAAP to adjusted key financial measures in the back of this press release.}

“We are off to a good start in fiscal 2025 and achieved solid operating performance through sustained cost discipline and execution against our growth initiatives and capital strategy,” said Helen Shan, FactSet’s CFO. “FactSet has a proven track record of consistent growth through all cycles and we remain committed to delivering on both our annual guidance and the medium-term outlook we shared at our Investor Day.”

Annual Subscription Value (ASV)

ASV at any given point in time represents the forward-looking revenues for the next 12 months from all subscription services currently supplied to clients.

ASV was $2,265.9 million at November 30, 2024, compared with $2,159.4 million at November 30, 2023. Organic ASV was $2,258.8 million at November 30, 2024, up $98.1 million from the prior year, for a growth rate of 4.5%. Organic ASV increased $3.4 million over the last three months.

The buy-side and sell-side organic ASV annual growth rates as of November 30, 2024 were 4.3% and 3.5%, respectively. Buy-side clients, including institutional asset managers, wealth managers, asset owners, partners, hedge funds and corporate clients, accounted for 82% of organic ASV. The remaining organic ASV came from sell-side firms, including broker-dealers, banking and advisory firms, and private equity and venture capital firms. Supplementary tables covering organic buy-side and sell-side ASV growth rates may be found on the last page of this press release.

Segment Revenues and ASV

ASV from the Americas was $1,464.5 million compared with ASV in the prior year period of $1,393.1 million. Organic ASV increased 4.5% to $1,456.4 million. Americas revenues for the quarter increased to $367.2 million compared with $348.3 million in the first quarter of last year. The Americas quarterly organic revenues growth rate was 5.2% over the prior year period.

ASV from the EMEA was $572.4 million compared with ASV in the prior year period of $551.7 million. Organic ASV increased 3.6% to $572.4 million. EMEA revenues were $143.8 million compared with $139.6 million in the first quarter of fiscal 2024. The EMEA quarterly organic revenues growth rate was 2.7% over the prior year period.

ASV from the Asia Pacific was $229.0 million compared with ASV in the prior year period of $214.6 million. Organic ASV increased 7.0% to $230.0 million. Asia Pacific revenues were $57.7 million compared with $54.3 million in the first quarter of fiscal 2024. The Asia Pacific quarterly organic revenues growth rate was 6.2% over the prior year period.

Operational Highlights – First Quarter Fiscal 2025

• Client count as of November 30, 2024 was 8,249, a net increase of 32 clients in the past three months, driven by an increase in partners, private equity and venture capital and wealth. The count includes clients with ASV of $10,000 and more.
• User count increased by 1,886 to 218,267 in the past three months, primarily driven by an increase in wealth management users.
• Annual ASV retention was greater than 95%. When expressed as a percentage of clients, annual retention was 91%.
• Employee headcount was 12,575 as of November 30, 2024, up 0.5% over the last 12 months, with the increase primarily in the content and technology groups. FactSet’s Centers of Excellence account for approximately 68% of the Company’s employees.
• A quarterly dividend of $39.6 million, or $1.04 per share, is being paid on December 19, 2024, to holders of record of FactSet’s common stock at the close of business on November 29, 2024.
• FactSet hosted an Investor Day on November 14, 2024, to provide an in-depth look into the Company’s strategic priorities, present its new medium-term financial outlook, and preview its new innovations and tailored workflow solutions.
• FactSet unveiled its Intelligent Platform initiative, which builds on the success of its AI Blueprint published last year and introduces the integration of conversational AI at the platform level. In the quarter, FactSet also launched Internal Research Notes (IRN) 2.0, a major enhancement to its Research Management Solutions for buy-side and wealth professionals, and its new Data as a Service (DaaS) solution, which provides data collection, management, and integration to data management teams at financial institutions and is part of FactSet’s growing Managed Services offering.
• FactSet acquired Irwin, an investor relations and capital markets solution for innovative public companies and their advisors. The acquisition builds on a recent successful partnership that integrates Irwin’s award-winning investor relations (IR) CRM with the FactSet Workstation to equip IR professionals with a unified solution to manage investor engagement, conduct research, and streamline corporate access on a single platform.
• FactSet announced its joint initiative with J.P. Morgan Securities Services to deliver FactSet’s industry-leading performance, reporting and portfolio analytics solutions through J.P. Morgan’s award-winning Fusion data management platform. This joint offering enables asset managers and asset owners to focus on investment insights and generating alpha while benefiting from reduced total cost of ownership and flexibility to outsource or insource their portfolio analytics needs.
• FactSet announced the appointment of Christopher McLoughlin as Executive Vice President, Chief Legal Officer. Mr. McLoughlin has over 20 years of legal experience and was most recently General Counsel of S&P Global Market Intelligence. Before joining S&P Global, he was Deputy General Counsel and Company Secretary of IHS Markit.
• FactSet announced the appointment of Barak Eilam to its Board of Directors. Mr. Eilam brings nearly three decades of experience scaling enterprise software companies into global market leaders. He is serving as Chief Executive Officer of NICE, a leading enterprise software company specializing in analytics and AI solutions, through the end of the year.

Share Repurchase Program

FactSet repurchased 104,475 shares of its common stock for $48.8 million at an average price of $467.00 during the first quarter of fiscal 2025 under the Company’s share repurchase program. As of November 30, 2024, $251.2 million remained available for share repurchases under this program.    

Annual Business Outlook

FactSet is reaffirming its outlook for fiscal 2025, originally provided on September 21, 2024. The following forward-looking statements reflect FactSet’s expectations as of today’s date. Given the risk factors, uncertainties, and assumptions discussed below, actual results may differ materially. FactSet does not intend to update its forward-looking statements prior to its next quarterly results announcement.

Fiscal 2025 Expectations

• Organic ASV is expected to grow in the range of $90 million to $140 million during fiscal 2025.
• GAAP revenues are expected to be in the range of $2,285 million to $2,305 million.
• GAAP operating margin is expected to be in the range of 32.5% to 33.5%.
• Adjusted operating margin is expected to be in the range of 36.0% to 37.0%.
• FactSet’s annual effective tax rate is expected to be in the range of 17% to 18%.
• GAAP diluted EPS is expected to be in the range of $15.10 to $15.70.
• Adjusted diluted EPS is expected to be in the range of $16.80 to $17.40.

Adjusted operating margin and adjusted diluted EPS guidance do not include certain effects of any non-recurring benefits or charges that may arise in fiscal 2025. Please see the back of this press release for a reconciliation of GAAP to adjusted metrics.

Conference Call

First Quarter 2025 Conference Call Details

Date:		Thursday, December 19, 2024
Time:		11:00 a.m. Eastern Time
Participant Registration:		FactSet Q1 2025 Earnings Call Registration

Please register for the conference call using the above link before the call start time. The conference call platform will register your name and organization and provide dial-in numbers and a unique access pin. The conference call will have a live Q&A session.

A replay will be available on the Company’s investor relations website after 1:00 p.m. Eastern Time on December 19, 2024, through December 19, 2025. The earnings call transcript will be available via FactSet CallStreet.

Forward-looking Statements

This news release contains forward-looking statements based on management’s current expectations, estimates, forecasts and projections about industries in which FactSet operates and the beliefs and assumptions of management. All statements that address expectations, guidance, outlook or projections about the future, including statements about the Company’s strategy for growth, product development, revenues, future financial results, anticipated growth, market position, subscriptions, expected expenditures, trends in FactSet’s business and financial results, are forward-looking statements. Forward-looking statements may be identified by words like “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “intends,” “projects,” “indicates,” “predicts,” “potential,” or “continue,” and similar expressions. These statements are not guarantees of future performance and involve a number of risks, uncertainties and assumptions. Many factors, including those discussed more fully elsewhere in this release and in FactSet’s filings with the Securities and Exchange Commission, particularly its latest annual report on Form 10-K and quarterly reports on Form 10-Q, as well as others, could cause results to differ materially from those stated. Forward-looking statements speak only as of the date they are made, and FactSet assumes no duty to and does not undertake to update forward-looking statements. Actual results could differ materially from those anticipated in forward-looking statements and future results could differ materially from historical performance.

About Non-GAAP Financial Measures

Financial measures in accordance with U.S. GAAP including revenues, operating income and margin, net income, diluted earnings per share and cash provided by operating activities have been adjusted.

FactSet uses these adjusted financial measures both in presenting its results to stockholders and the investment community and in its internal evaluation and management of the business. The Company believes that these adjusted financial measures and the information they provide are useful to investors because they permit investors to view the Company’s performance using the same tools that management uses to gauge progress in achieving its goals. Investors may benefit from referring to these adjusted financial measures in assessing the Company’s performance and when planning, forecasting and analyzing future periods and may also facilitate comparisons to its historical performance. The presentation of this financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP.

Organic revenues excludes from revenues the current year impact of revenues from acquisitions and dispositions completed within the past 12 months and the current year impact from changes in foreign currency. Adjusted operating income and margin, adjusted net income, and adjusted diluted earnings per share exclude acquisition-related intangible asset amortization and non-recurring items. EBITDA represents earnings before interest expense, provision for income taxes and depreciation and amortization expense. The Company believes that these adjusted financial measures help to fully reflect the underlying economic performance of FactSet.

Cash flows provided by operating activities has been reduced by purchases of property, equipment, leasehold improvements and capitalized internal-use software to report non-GAAP free cash flow. FactSet uses this financial measure both in presenting its results to stockholders and the investment community and in the Company’s internal evaluation and management of the business. Management believes that this financial measure is useful to investors because it is an indication of cash flow that may be available to fund further investments in future growth initiatives.

About FactSet

FactSet (NYSE:FDS | NASDAQ:FDS) helps the financial community to see more, think bigger, and work better. Our digital platform and enterprise solutions deliver financial data, analytics, and open technology to more than 8,200 global clients, including over 218,000 individual users. Clients across the buy-side and sell-side as well as wealth managers, private equity firms, and corporations achieve more every day with our comprehensive and connected content, flexible next-generation workflow solutions, and client-centric specialized support. As a member of the S&P 500, we are committed to sustainable growth and have been recognized amongst the Best Places to Work in 2023 by Glassdoor as a Glassdoor Employees’ Choice Award winner. Learn more at www.factset.com and follow us on X and LinkedIn. 

FactSet

Investor Relations Contact:                         
Yet He                                
+1.212.973.5701
[email protected]

Media Contact:
Megan Kovach
+1.512.736.2795
[email protected]  

                                

Consolidated Statements of Income (Unaudited)
	Three Months Ended
	November 30,
(In thousands, except per share data)		2024				2023
Revenues	$	568,667			$	542,216
Operating expenses
Cost of services		258,779				251,621
Selling, general and administrative		118,553				101,555
Total operating expenses		377,332				353,176
Operating income		191,335				189,040
Other income (expense), net
Interest income		2,701				3,012
Interest expense		(14,400	)			(16,738	)
Other income (expense), net		103				(118	)
Total other income (expense), net		(11,596	)			(13,844	)
Income before income taxes		179,739				175,196
Provision for income taxes		29,717				26,641
Net income	$	150,022			$	148,555
Basic earnings per common share	$	3.95			$	3.91
Diluted earnings per common share	$	3.89			$	3.84
Basic weighted average common shares		38,005				38,016
Diluted weighted average common shares		38,517				38,643

Consolidated Balance Sheets (Unaudited)
(In thousands)	November 30, 2024			August 31, 2024
ASSETS
Cash and cash equivalents	$	289,168		$	422,979
Investments		69,623			69,619
Accounts receivable, net of reserves of $15,755 at November 30, 2024 and $14,581 at August 31, 2024		252,521			228,054
Prepaid taxes		78,682			55,103
Prepaid expenses and other current assets		60,702			60,093
Total current assets		750,696			835,848
Property, equipment and leasehold improvements, net		81,524			82,513
Goodwill		1,085,200			1,011,129
Intangible assets, net		1,870,332			1,844,141
Deferred taxes		40,317			61,337
Lease right-of-use assets, net		117,514			130,494
Other assets		96,000			89,578
TOTAL ASSETS	$	4,041,583		$	4,055,040
LIABILITIES
Accounts payable and accrued expenses	$	151,297		$	178,250
Current debt		62,460			124,842
Current lease liabilities		31,434			31,073
Accrued compensation		51,760			93,279
Deferred revenues		157,062			159,761
Current taxes payable		44,551			40,391
Dividends payable		39,572			39,470
Total current liabilities		538,136			667,066
Long-term debt		1,296,643			1,241,131
Deferred taxes		8,046			8,452
Deferred revenues, non-current		914			1,344
Taxes payable		41,896			40,452
Long-term lease liabilities		161,372			177,521
Other liabilities		3,015			6,614
TOTAL LIABILITIES	$	2,050,022		$	2,142,580
STOCKHOLDERS’ EQUITY
TOTAL STOCKHOLDERS’ EQUITY	$	1,991,561		$	1,912,460
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	4,041,583		$	4,055,040

Consolidated Statements of Cash Flows (Unaudited)
	Three Months Ended
	November 30,
(In thousands)		2024			2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net income	$	150,022		$	148,555
Adjustments to reconcile net income to net cash provided by operating activities
Depreciation and amortization		35,717			27,068
Amortization of lease right-of-use assets		7,572			7,618
Stock-based compensation expense		13,592			14,310
Deferred income taxes		21,943			6,703
Other, net		890			3,860
Changes in assets and liabilities, net of effects of acquisitions
Accounts receivable		(23,377	)		(9,758	)
Prepaid expenses and other assets		(5,697	)		(7,164	)
Accounts payable and accrued expenses		(38,793	)		31,284
Accrued compensation		(40,663	)		(60,348	)
Deferred revenues		(7,269	)		(2,542	)
Taxes payable, net of prepaid taxes		(17,806	)		5,341
Lease liabilities, net		(9,759	)		(9,783	)
Net cash provided by operating activities		86,372			155,144
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property, equipment, leasehold improvements and capitalized internal-use software		(25,874	)		(16,466	)
Acquisition of businesses, net of cash and cash equivalents acquired		(115,199	)		—
Purchases of investments		(3,987	)		(8,753	)
Net cash provided by (used in) investing activities		(145,060	)		(25,219	)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from debt		55,000			—
Repayments of debt		(62,500	)		(62,500	)
Dividend payments		(39,246	)		(37,053	)
Proceeds from employee stock plans		38,850			28,404
Repurchases of common stock		(48,790	)		(59,910	)
Other financing activities		(13,385	)		(13,505	)
Net cash provided by (used in) financing activities		(70,071	)		(144,564	)
Effect of exchange rate changes on cash and cash equivalents		(5,052	)		1,050
Net increase (decrease) in cash and cash equivalents		(133,811	)		(13,589	)
Cash and cash equivalents at beginning of period		422,979			425,444
Cash and cash equivalents at end of period	$	289,168		$	411,855

Certain prior year figures have been conformed to the current year’s presentation.

Reconciliation of U.S. GAAP Results to Adjusted Financial Measures

Financial measures in accordance with U.S. GAAP, including revenues, operating income and margin, net income, diluted EPS and cash provided by operating activities, have been adjusted below. FactSet uses these adjusted financial measures both in presenting its results to stockholders and the investment community and in its internal evaluation and management of the business. The Company believes that these adjusted financial measures and the information they provide are useful to investors because they permit investors to view the Company’s performance using the same tools that management uses to gauge progress in achieving its goals. Adjusted measures may also facilitate comparisons to FactSet’s historical performance.

Organic Revenues

Organic revenues exclude the current year impact of revenues from acquisitions and dispositions completed within the past 12 months and the current year impact from changes in foreign currency. The table below provides a reconciliation of revenues to organic revenues:

(Unaudited)	Three Months Ended
	November 30,
(In thousands)		2024			2023		Change
Revenues	$	568,667		$	542,216		4.9	%
Acquisition revenues		(696	)		—
Currency impact		(298	)		—
Organic revenues	$	567,673		$	542,216		4.7	%

Non-GAAP Financial Measures

The table below provides a reconciliation of operating income, operating margin, net income and diluted EPS to adjusted operating income, adjusted operating margin, adjusted net income, EBITDA and adjusted diluted EPS.

	Three Months Ended
	November 30,
(in thousands, except per share data)		2024			2023		% Change
Operating income	$	191,335		$	189,040		1.2	%
Intangible asset amortization		16,581			17,344
Business acquisition and related costs		3,753			—
Sales tax dispute(1)		2,398			—
Restructuring/Severance		(317	)		(2,419	)
Adjusted operating income	$	213,750		$	203,965		4.8	%
Operating margin		33.6	%		34.9	%
Adjusted operating margin (2)		37.6	%		37.6	%
Net income	$	150,022		$	148,555		1.0	%
Intangible asset amortization		12,397			12,368
Business acquisition and related costs		2,806			—
Sales tax dispute(1)		1,793			—
Restructuring/Severance		(237	)		(1,725	)
Income tax items		1,351			(71	)
Adjusted net income(3)	$	168,132		$	159,127		5.7	%
Net income		150,022			148,555		1.0	%
Interest expense		14,400			16,738
Income taxes		29,717			26,641
Depreciation and amortization expense		35,717			27,068
EBITDA	$	229,856		$	219,002		5.0	%
Diluted EPS	$	3.89		$	3.84		1.3	%
Intangible asset amortization		0.32			0.32
Business acquisition and related costs		0.08			—
Sales tax dispute(1)		0.05			—
Restructuring/Severance		(0.01	)		(0.04	)
Income tax items		0.04			0.00
Adjusted diluted EPS(3)	$	4.37		$	4.12		6.1	%
Weighted average common shares (diluted)		38,517			38,643

<sup>(1)   Sales tax dispute relates to a resolved matter with the Massachusetts Department of Revenue.

(2)   Adjusted operating margin is calculated as Adjusted operating income divided by Revenues.

(3)   For purposes of calculating Adjusted net income and Adjusted diluted EPS, all adjustments for the three months ended November 30, 2024 and November 30, 2023 were taxed at an adjusted tax rate of 25.2% and 28.7%, respectively.</sup>

Business Outlook Operating Margin, Net Income and Diluted EPS

(Unaudited)
Figures may not foot due to rounding	Annual Fiscal 2025 Guidance
(In millions, except per share data)	Low end of range			High end of range
Revenues	$	2,285		$	2,305
Operating income	$	765		$	749
Operating margin		33.5	%		32.5	%
Intangible asset amortization		80			81
Adjusted operating income	$	845		$	830
Adjusted operating margin (a)		37.0	%		36.0	%
Net income	$	598		$	577
Intangible asset amortization		66			66
Discrete tax items		(4	)		(3	)
Adjusted net income	$	660		$	640
Diluted earnings per common share	$	15.70		$	15.10
Intangible asset amortization		1.73			1.73
Discrete tax items		(0.03	)		(0.03	)
Adjusted diluted earnings per common share	$	17.40		$	16.80

^{(a)   Adjusted operating margin is calculated as Adjusted operating income divided by Revenues.}

Free Cash Flow

(Unaudited)	Three Months Ended
	November 30,
(In thousands)		2024			2023		Change
Net Cash Provided for Operating Activities	$	86,372		$	155,144
Less: purchases of property, equipment, leasehold improvements and capitalized internal-use software		(25,874	)		(16,466	)
Free Cash Flow	$	60,498		$	138,678		(56.4	)%

Supplementary Schedules of Historical ASV by Client Type

The following table presents the percentages and growth rates of organic ASV by client type, excluding the impact of currency movements, and may be useful to facilitate historical comparisons. Organic ASV excludes acquisitions and dispositions completed within the last 12 months and the effects of foreign currency movements.

The numbers below do not include professional services or issuer fees.

	Q1’25	Q4’24	Q3’24	Q2’24	Q1’24	Q4’23	Q3’23	Q2’23
% of ASV from buy-side clients	82.1%	82.0%	82.3%	82.0%	82.0%	81.8%	82.1%	82.8%
% of ASV from sell-side clients	17.9%	18.0%	17.7%	18.0%	18.0%	18.2%	17.9%	17.2%
ASV Growth rate from buy-side clients	4.3%	4.9%	5.3%	5.6%	7.2%	6.9%	7.3%	8.1%
ASV Growth rate from sell-side clients	3.5%	3.8%	3.7%	5.5%	7.6%	9.3%	12.3%	15.8%

The following table presents the calculation of organic ASV.

(In millions)	As of November 30, 2024
As reported ASV	$	2,265.9
Currency impact (a)		2.0
Acquisition ASV (b)		(9.1	)
Organic ASV	$	2,258.8
Organic ASV annual growth rate		4.5	%

<sup>(a)   The impact from foreign currency movements.

(b)   Acquired ASV from acquisitions completed within the last 12 months.</sup>