Pfizer Receives Early Clearance from U.S. Federal Trade Commission for Metsera Acquisition




Pfizer Receives Early Clearance from U.S. Federal Trade Commission for Metsera Acquisition

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced the U.S. Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), with respect to Pfizer’s pending acquisition of Metsera (NASDAQ: MTSR).

The termination of the waiting period under the HSR Act satisfies the regulatory review requirements under the previously announced proposed acquisition of Metsera, which was set to expire on November 7.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Disclosure Notice

The information contained in this release is as of October 31, 2025. This release contains forward-looking information about, among other topics, Pfizer’s proposed acquisition of Metsera that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, risks and uncertainties related to the impact of Novo Nordisk’s proposal on the proposed acquisition; risks related to the satisfaction or waiver of the conditions to closing the proposed acquisition (including the failure to obtain the requisite vote by Metsera stockholders) in the anticipated timeframe or at all, including the possibility that the proposed acquisition does not close; the possibility that competing offers may be made or accepted; the risk that the merger agreement may be terminated; risks related to the ability to realize the anticipated benefits of the proposed acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships, including Metsera’s ability to attract and retain highly qualified management and other clinical and scientific personals; negative effects of this announcement or the consummation of the proposed acquisition on the market price of Pfizer’s or Metsera’s common stock and/or operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition or Metsera’s business; other business effects and uncertainties, including the effects of industry, market, business, economic, political or regulatory conditions; future exchange and interest rates; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws, regulations or policy; changes in tax and other laws, regulations, rates and policies; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer’s business and prospects, adverse developments in Pfizer’s markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment, tariffs and other trade policies or economies generally; future business combinations or disposals; uncertainties regarding the commercial success of Metsera’s pipeline products or Pfizer’s commercialized and/or pipeline products; risks associated with Metsera conducting clinical trials and preclinical studies outside of the United States; Metsera’s reliance on third parties to conduct clinical trials and preclinical studies and for the manufacture and shipping of its product candidates; the risk that Metsera’s product candidates are associated with side effects, adverse events or other properties or safety risks; risks associated with Metsera’s license and collaboration agreements and future strategic alliances; Metsera’s ability to obtain, maintain, defend and enforce patent or other intellectual property protection for current or future product candidates or technology; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with initial, preliminary or interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications may be filed in any jurisdictions for Pfizer’s or Metsera’s pipeline products for any potential indications; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such products will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of such products; uncertainties regarding the impact of COVID-19; and competitive developments.

You should carefully consider the foregoing factors and the other risks and uncertainties that affect Pfizer’s business described in the “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results” sections of Pfizer’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed from time to time with the U.S. Securities and Exchange Commission, all of which are available at www.sec.gov. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Pfizer assumes no obligation to, and does not intend to, update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law. Pfizer does not give any assurance that it will achieve its expectations.

Contacts

Media Contact: PfizerMediaRelations@Pfizer.com
Investor Contact: IR@Pfizer.com

Immunis Publishes Research Showing Body Fat Loss and Reversal of Liver Steatosis and Fibrosis, While Increasing Lean Muscle Mass, in Aged Models




Immunis Publishes Research Showing Body Fat Loss and Reversal of Liver Steatosis and Fibrosis, While Increasing Lean Muscle Mass, in Aged Models

IRVINE, Calif.–(BUSINESS WIRE)–#biologics—Immunis, Inc., a clinical-stage biotech developing innovative stem cell-derived biologics for age- and disease-related immune dysregulation, announces the publication of its peer-reviewed research in collaboration with Dr. Micah Drummond from the University of Utah. The study published in Obesity is titled, “Stem Cell Secretome Treatment Reduces Adiposity and Improves Glucose Handling During Obesity and Weight Loss in Mice.”

The National Center for Health Statistics reports that the percentage of Americans aged 65+ with obesity has doubled to 40% for both men and women. While pharmacotherapies like GLP-1 receptor agonists have demonstrated global commercial success for its ability to achieve rapid weight loss, 25-40% of the total weight lost from these drugs is attributed to a decrease in lean muscle, not fat. There is a critical need for pharmaceuticals that can promote fat loss without compromising muscle.

Immunis’ publication discusses the effects of its investigational therapeutic, IMM01-STEM, in aged mouse models of obesity. The key findings are as follows:

• IMM01-STEM significantly enhanced weight loss in obese mice by reducing the percentage of whole-body fat while increasing lean mass.

• IMM01-STEM significantly reversed liver steatosis and fibrosis in aged mice on a high fat diet, to levels similar to that of healthy controls.

• IMM01-STEM provided major metabolic benefits during weight loss, including better glucose tolerance and lower fasting insulin levels, with treated mice achieving metabolic profiles similar to healthy controls.

• IMM01-STEM preserves muscle mass and enhances muscle quality by increasing muscle fiber size, increasing blood capillary density, and reducing fibrosis.

These data provide a promising basis for additional investigations of IMM01-STEM in supporting metabolic and tissue health during obesity and weight loss in humans. This research complements the findings from Immunis’ two additional published preclinical studies in GeroScience and Aging Cell, which show a reversal of deficits in aged skeletal muscle resulting in leaner, higher quality tissue with lower fat and fibrosis, thicker myofibers, greater overall strength, improved whole-body metabolism, reduced adiposity, and better balance and coordination.

“Publishing in a leading scientific journal like Obesity reaffirms the importance of our team’s research efforts. IMM01-STEM could possibly transform human healthspan by promoting a healthier form of weight loss. We are fortunate to explore the potential benefits of our multi-active drug when the interest in healthspan therapies is at an all-time high,” says Dr. Hans Keirstead, Immunis’ Chairman and publication author.

About Immunis, Inc.

Immunis is a clinical-stage biotechnology company developing multi-active stem cell-derived biologics for the various manifestations of age-related diseases and immune dysregulation. The investigational product line leverages Immunis’ leading-edge capabilities in stem cell secretome technology to deliver a product of all natural, all human immune modulators in their natural physiological concentrations.

For additional information about Immunis’ programs, please visit our Pipeline.

Cautionary Note Regarding Forward-Looking Statements

This communication contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as applicable. Forward-looking statements include, but are not limited to, statements regarding our plans, beliefs, expectations and assumptions, as well as other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only of the date as of which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry, which includes projections that are based on several assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions. This communication is neither an offer to sell nor a solicitation of an offer to buy any of the securities described herein.

Contacts

contact@immunisbiomedical.com

Appointment of Yves Decadt as Member of Poxel’s Board of Directors




Appointment of Yves Decadt as Member of Poxel’s Board of Directors

LYON, France–(BUSINESS WIRE)–Regulatory News:

POXEL SA (Euronext : POXEL – FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today announces the appointment of Yves Decadt as a member of its Board of Directors.

Following the governance changes implemented on July 31, this appointment further strengthens Poxel’s strategic and commercial organization. It will be submitted for shareholder approval at the Company’s next Annual General Meeting.

Yves Decadt brings over 25 years of international experience in the pharmaceutical industry. He spent nearly 20 years at Johnson & Johnson within the Global Business Development department, where he was responsible for licensing and deal negotiations, particularly across Asia. He has also held several senior executive positions in leading biopharma and medtech companies. Yves will bring to Poxel a unique combination of scientific and strategic expertise, as well as access to an extensive global network. Since August 2025, Yves has been working with Poxel’s teams under a consultancy agreement, supporting ongoing partnership discussions and conducting an in-depth assessment of the commercial development potential of Poxel’s main assets.

Yves Decadt holds degrees in Bio-Engineering and Industrial Business Administration from University of Ghent (Vlerick School), as well as in Pharmacology and Pharmaceutical Medicine from the Université Libre de Bruxelles. He also holds a Board Director Certification from Duke University.

In order to comply with gender balance requirements applicable to Poxel’s Board of Directors, which currently comprises fewer than eight members, it was agreed that the implementation of Yves Decadt’s appointment would entail the prior resignation of Nicolas Trouche from his position as Director. This ensures compliance with the minimum gender representation required by law.

Nicolas Trouche, Chief Executive Officer of Poxel, stated: “We are delighted to propose the appointment of Yves Decadt to Poxel’s Board of Directors. His expertise and proven track record in developing strategic partnerships will be invaluable in strengthening and accelerating value creation for Poxel and its stakeholders, while continuing to enhance the value of our product portfolio.”

About Poxel SA

Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R-pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG^® (Imeglimin), Poxel’s first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.

For more information, please visit: www.poxelpharma.com

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release.

Contacts

Investor relations / Media
NewCap

Aurélie Manavarere, Théo Martin / Arthur Rouillé

investors@poxelpharma.com
+33 1 44 71 94 94

IVI RMA Research Study Wins Best Paper Prize Award at ASRM 2025 with Juno Genetics




IVI RMA Research Study Wins Best Paper Prize Award at ASRM 2025 with Juno Genetics

Company Receives Three Additional Honors for Research into PGT Testing, Progesterone Surges During IVF, and Nutrition Interventions During IVF

MADRID & BASKING RIDGE, N.J.–(BUSINESS WIRE)–IVI RMA, the world’s leading reproductive medicine group, announced that joint research with Juno Genetics that utilized data from the Foundation for Embryonic Competence and RMA New Jersey won the Best Paper Prize at the American Society for Reproductive Medicine (ASRM) 2025 Annual Scientific Congress & Expo, held in San Antonio, Texas, October 25-29.

The research looked at the reproductive potential of segmental aneuploid embryos (embryos in which pieces of chromosomes are missing or gained) to learn more about how many of these embryos can result in a live birth, helping inform doctors and patients as they navigate results of preimplantation testing for aneuploidy (PGT-A).

Three other IVI RMA studies also won recognition at ASRM, with the company winning the top two paper prizes, the second-place poster prize, and the Nutrition Special Interest Group (SIG) prize. This prize-winning research explored the need for more industry standardization in preimplantation genetic testing of embryos, the impact of progesterone surges during ovarian stimulation for IVF outcomes, and the impact of nutrition interventions on IVF outcomes. Three out of four studies were led by fellows and clinicians from Jefferson-RMA Fellowship, a leading fellowship affiliated with IVI RMA, that trains the next generation of reproductive endocrinologists.

“This recognition from our industry peers is a testament to the cutting-edge research we do in concert with partners like Juno, the pre-eminent center for embryo genetic diagnostics, at our global network of research centers. In these spaces, we study the most important questions in reproductive medicine with the scale and efficacy few can rival,” said Dr. Juan A. García-Velasco, Global Chief Scientific Officer at IVI RMA Global. “This award strengthens our commitment to research the science that will make assisted reproductive care more effective and accessible for individuals and families worldwide.”

With five international research centers, over 500 clinical researchers, and 240+ peer-reviewed publications in 2024 alone, IVI RMA research consistently leads innovation in reproductive medicine science with the goal of improving patient care. More than 100 IVI RMA fertility experts from five countries had 65 papers selected to present at this year’s congress.

“Juno Genetics is the worldwide leader in evidence-based PGT embryo testing, utilizing the clinically validated PGTseq platform, and we are proud to present outcome data that helps clinicians and patients make informed decisions,” said Chaim Jalas, CEO & Director of Technology Development at Juno Genetics.

The winning paper, “Investigating the Reproductive Potential of Non-Mosaic Segmental Aneuploidy: A Double-Blinded, Multicenter Non-Selection Study Of 176 Single Frozen Embryo Transfers” was presented by author and attending physician Stephanie Willson, MD, IVI RMA Global Research Alliance, and Jefferson-RMA Fellowship Graduate, 2025. Other authors include Amber Kaplun MS, IVI RMA America; David Ferrando, Yiping Zhan PHD, Xin Tao PHD; Emily Mounts MS, Antonio Capalbo PHD; Chaim Jalas of Juno Genetics; and Richard T Scott MD, of the Foundation for Embryonic Competence.

Other Award-Winning Research

The three other IVI RMA winning submissions were authored by professionals from IVI RMA’s Global Research Alliance and other IVI RMA brands including Boston IVF and Reproductive Medicine Associates (RMA) in Basking Ridge, NJ, with outside partners and the Jefferson-RMA Fellowship program:

Prize Paper – Second Place

“PGT-A Provider Strategies Influence Embryo Selection And Live Birth Rates: A Multicenter Study Of 40,308 Blastocyst Biopsy Results And 8,491 Euploid Embryo Transfers”
Presenting Author: Denny Sakkas, PhD, Boston IVF and principal investigator Mina Popovic, PHD Impact: Clinics need to weigh the trade-offs between embryo availability and success rates when choosing a PGT-A provider, aligning strategies with patient needs and outcome goals.

Prize Poster – Second Place

“Is Premature Progesterone Surge During Ovarian Stimulation For In Vitro Fertilization (IVF) Associated with Impaired Embryologic Outcomes: A Propensity Score–Matched Analysis”
Presenting Author: Devika Sachdev, MD, IVI RMA Global Research Alliance, Fellow, Jefferson-RMA Fellowship Program, 2024-2027

Other Authors: Christine Whitehead MS, IVI RMA Global Research Alliance; Erkan Kalafat MD, Lea George MD, IVI RMA Global Research Alliance; Marie Werner MD, IVI RMA Global Research Alliance; Juan Garcia-Velasco MD PHD, IVI RMA Global Research Alliance; Emre Seli MD, IVI RMA Global Research Alliance

Impact: Premature progesterone surge is associated with a decrease in oocyte maturation and blastulation rates, but not enough to be clinically meaningful.

Nutrition Prize Paper – Winner

“The Impact Of Nutrition Intervention On Reproductive Outcomes Of Women Undergoing In Vitro Fertilization (IVF): A Retrospective Matched Cohort Study Of 3,919 IVF Cycles”
Presenting Author: Andres Reig, MD, RMA Basking Ridge, attending physician, Jefferson-RMA Fellowship graduate, 2024

Other Author: Marisa Sweeney, MS RDN CSSD RYT, Be Well Integrative Health Services

Impact: Nutrition counseling was significantly associated with improved IVF outcomes, supporting incorporation into fertility treatment plans.

Earlier in the conference, it was also announced that Boston IVF Chief Scientific Officer Denny Sakkas, PHD was awarded the 2025 ASRM Distinguished Researcher Award, one of the most prestigious awards in reproductive medicine, for his groundbreaking research into sperm DNA damage, fertilization, early embryo development, and male infertility.

“These recognitions from ASRM highlight the innovation and teamwork that define IVI RMA’s research across North America and around the world,” said Dr. Denny Sakkas, Chief Scientific Officer at Boston IVF. “Achievements like these are never the result of one individual – they are the outcome of a shared vision and the dedication of hundreds of experts working together to give patients the greatest chance to build their families.”

“We are incredibly proud to see our fellow and clinicians’ research recognized among the best at this year’s ASRM,” said Dr. Marie Werner, Program Director, Jefferson-RMA Fellowship in Reproductive Endocrinology & Infertility. “Our fellow Dr. Devika Sachdev and attending Drs. Stephanie Willson and Andres Reig each exemplify our shared commitment to advancing evidence-based reproductive medicine and improving patient outcomes.”

More information is available at: https://www.ivi-rmainnovation.com/

About IVI RMA Global

IVI RMA Global is the global leader in reproductive medicine, committed to delivering personalized, high-quality fertility care backed by science. With more than 5,000 employees across 200+ fertility clinics in 15 countries, the company empowers individuals and couples to build the families they dream of—safely, effectively, and with unwavering support at every step. Learn more at https://www.ivirma.com/

About Juno Genetics

Juno Genetics is the worldwide leader in evidence-based PGT embryo testing, providing evidence-based PGT and genetic testing to IVF clinics and patients. Learn more at https://www.junogenetics.com/

Contacts

Media Contact
Sneha Satish

Ssatish@stantonprm.com
646-502-3556

20/20 Onsite Tops 20+ CNS Trials, Driving Quality Ocular Endpoint Protection at Scale




20/20 Onsite Tops 20+ CNS Trials, Driving Quality Ocular Endpoint Protection at Scale

BOSTON–(BUSINESS WIRE)–#ClinicalTrials–20/20 Onsite today announced it has supported 23 central nervous system (CNS)/neurology studies to date (including epilepsy, MDD, and bipolar disorder), including 10 studies in the last 10 months, with additional trials launching in the coming quarters. The milestone underscores growing sponsor demand for quality ocular endpoint protection delivered at the point of need, all backed by secure data workflows that streamline submissions and protect timelines.

Across its portfolio, 20/20 Onsite has achieved a 95+ patient Net Promoter Score (NPS), 100% screening timelines met, and 85,000+ ophthalmic assessments conducted across 48 states. In verified studies, the company has maintained ~91% patient retention versus an industry Phase 3 average near 70%, helping sponsors reduce re-visits, protect endpoints, and keep programs on schedule.

“CNS and neurology trials can live or die by the consistency and integrity of their ocular endpoints,” said Ivan Quiroz, VP, Clinic Operations, 20/20 Onsite. “Sponsors trust us because we bring certified teams, validated equipment, and a patient-first workflow directly to the point of need—sites, homes, or community locations—so they get high-quality data without adding burden to patients or sites. Our job is to get it done, and get it done right, every time.”

Purpose-Built to Protect Ocular Endpoints in Neuro Trials

20/20 Onsite’s model pairs field-based ophthalmic experts with validated imaging and exam equipment deployed via mobile vision clinics, mobile vision pods, and mobile clinic suites. This point-of-need approach reduces travel, improves consistency across timepoints, and increases access for underrepresented populations. These are key advantages for neurology programs where protocol adherence and patient experience directly influence data quality.

Outcomes Sponsors Can Measure

• 23 CNS/Neuro studies supported (10 in the last 10 months); additional programs in startup
• 95+ NPS from patients, reflecting high satisfaction and reduced burden
• 100% screening timelines met, enabling on-schedule enrollment and visits
• 85,000+ ophthalmic assessments completed across 48 states
• ~91% patient retention vs ~70% Phase 3 industry average, helping protect endpoints and reduce costly re-visits

“Every neuro sponsor we serve asks the same questions: Will our endpoints be protected, will our patients stay engaged, and will we hit our dates?” added Quiroz. “Our answer is operational: certified people, standardized workflows, validated equipment, and a delivery model that meets patients where they are. That’s how we keep trials moving.”

With more neurology studies in early trial phases, 20/20 Onsite continues to expand capacity and geographic coverage to help sponsors scale consistently — from single-site studies to multi-region programs — without sacrificing quality or speed.

About 20/20 Onsite

20/20 Onsite is a clinical trial solutions company specializing in quality ocular endpoint protection through its nationwide point-of-need fleet. By bringing advanced ophthalmic assessments directly to clinical trial participants—whether at sites, homes, or community locations—20/20 Onsite makes it easier for sponsors, CROs, and sites to collect critical data, reduce patient burden, and improve trial outcomes.

20/20 Onsite has supported over 40 clinical trials, served more than 85,000 patients, achieved 100% of screening timelines, and consistently delivered patient Net Promoter Scores (NPS) above 95.

To learn more about how 20/20 Onsite delivers quality ocular endpoint protection at scale, visit www.2020onsite.com.

Contacts

Josh Anderson

Senior Director of Marketing

janderson@2020onsite.com

Immunome to Present at 2nd Annual Guggenheim Healthcare Innovation Conference




Immunome to Present at 2nd Annual Guggenheim Healthcare Innovation Conference

BOTHELL, Wash.–(BUSINESS WIRE)–Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced that Immunome management will present at the 2nd Annual Guggenheim Healthcare Innovation Conference on Tuesday, Nov. 11, 2025 at 8:30 a.m. ET.

Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

About Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors. For more information, visit www.immunome.com.

Contacts

Investor Contact

Max Rosett

Chief Financial Officer

investors@immunome.com

Austria Oncology KOLs Fair-Market Value Compensation Rates Report: An Independent Reference for Negotiations with Thought Leaders (KOLs) and Healthcare Providers (HCPs) – ResearchAndMarkets.com




Austria Oncology KOLs Fair-Market Value Compensation Rates Report: An Independent Reference for Negotiations with Thought Leaders (KOLs) and Healthcare Providers (HCPs) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Fair-Market Value Compensation Rates for Oncology KOLs – Austria” report has been added to ResearchAndMarkets.com’s offering.

KOL Compensation Austria Oncology presents fair-market value (FMV) compensation rates for Austria KOLs – Oncology, by percentiles, with averages, for four (4) levels of Thought Leader influences (rare, international, national and local). KOL Compensation Austria Oncology.

Payments made to physicians and thought leaders have been under scrutiny for a few years and companies have been working to adjust their rates to level with industry standards. Adjustments to “market” rates should be done periodically and are best done through 3rd party research, providing a fair and balanced assessment of rates.

Establishing fair-market value compensation rates will:

• reduce the external perception of inappropriate inducement and limit regulatory and compliance risks.
• provide an independent reference for negotiations with Thought Leaders (KOLs) and Healthcare Providers (HCPs).
• refine and support the development of fee schedules that are aligned with market conditions.
• competitively position the organization and support good business practices.

The data included in each report are an aggregate of collected data and not individual rates. In no event, companies and individuals who provided the data are identified to protect their identity.

Engage with Thought Leaders early. Recent research shows that less than 25% of pharmaceutical organizations begin working and involving Key Opinion Leaders during or before the clinical phase. Most – 63% – wait during phases 2 and 3 to start exchanging with Thought Leaders. This most likely does not yield the desired results for companies who look to maximize the outcome of any promising product.

Key Topics Covered:

• Use of the Publisher’s Copyrighted Materials
• Research Methodology
• Definitions
• Therapeutic Area
• Thought Leader Levels
• Salary Data versus Market Rates
• Flat Rates
• Hourly Rates

For more information about this report visit https://www.researchandmarkets.com/r/p5jwiq

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

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Sensient Technologies Corporation Reports Results for the Quarter Ended September 30, 2025




Sensient Technologies Corporation Reports Results for the Quarter Ended September 30, 2025

MILWAUKEE–(BUSINESS WIRE)–Sensient Technologies Corporation (NYSE: SXT), a leading provider of flavors and colors for the food, pharmaceutical, and personal care markets, today reported financial results for the third quarter ended September 30, 2025.

Third Quarter Consolidated Results

• Reported revenue increased 5.0% to $412.1 million in the third quarter of 2025 versus last year’s third quarter results of $392.6 million. On a local currency basis⁽¹⁾, revenue increased 3.5%.
• Reported operating income increased 14.2% to $57.7 million compared to $50.5 million recorded in the third quarter of 2024. In the third quarter of 2025, the Company recorded $3.3 million of costs related to its Portfolio Optimization Plan versus last year’s $1.2 million in the third quarter. Local currency adjusted operating income⁽¹⁾ and local currency adjusted EBITDA⁽¹⁾ increased 15.7% and 14.3%, respectively, in the third quarter.
• Reported earnings per share increased 13.0% to 87 cents in the third quarter of 2025 compared to 77 cents in the third quarter of 2024. Local currency adjusted diluted EPS⁽¹⁾ increased 17.5% in the third quarter.

“Sensient’s dedication to customer service while continuing to innovate and drive new sales wins has resulted in strong results. I remain very confident about our performance and am excited about the opportunities in front of us, particularly in natural colors,” said Paul Manning, Sensient’s Chairman, President, and Chief Executive Officer.

The Flavors & Extracts Group reported third quarter 2025 revenue of $203.0 million, a decrease of $0.3 million versus the prior year’s third quarter. The Group’s revenue was unfavorably impacted by lower volumes in agricultural ingredients (formerly natural ingredients). This decline was partially offset by higher prices and volumes in our flavors, extracts, and flavor ingredients product lines. Segment operating income was $28.0 million in the third quarter of 2025, an increase of $2.2 million compared to the prior year’s third quarter. The increase in segment operating income was driven by strong profitability of the flavors, extracts, and flavor ingredients product lines despite the decline in the revenue of agricultural ingredients.

The Color Group reported revenue of $178.2 million in the third quarter of 2025, an increase of $16.1 million compared to the prior year’s third quarter. The Group’s revenue increase was driven by higher prices and strong volume growth in the food and pharmaceutical product lines. Segment operating income was $37.7 million in the third quarter of 2025, an increase of $7.9 million compared to the prior year’s third quarter results.

The Asia Pacific Group reported revenue of $42.1 million in the third quarter of 2025, an increase of $0.3 million compared to the prior year’s third quarter. Segment operating income was $9.5 million in the quarter, an increase of $0.2 million compared to the prior year’s third quarter.

Corporate & Other reported operating expenses of $17.6 million in the third quarter of 2025, compared to $14.5 million of operating expenses reported in the prior year’s third quarter. The higher operating expenses were primarily due to higher Portfolio Optimization Plan costs in the quarter. Local currency adjusted operating expenses⁽¹⁾ for Corporate & Other increased $1.0 million compared to the prior year’s third quarter, primarily due to higher performance-based compensation costs recorded in 2025.

2025 OUTLOOK

The Company’s guidance is based on current conditions and economic and market trends in the markets in which the Company operates and is subject to various risks and uncertainties as described below.

USE OF NON-GAAP FINANCIAL MEASURES

The Company’s non-GAAP financial measures eliminate the impact of certain items, which, depending on the measure, include: currency movements, depreciation and amortization, Portfolio Optimization Plan costs, and non-cash share-based compensation. These measures are provided to enhance the overall understanding of the Company’s performance when viewed together with the GAAP results. Refer to “Reconciliation of Non-GAAP Amounts” at the end of this release.

CONFERENCE CALL

The Company will host a conference call to discuss its 2025 third quarter financial results at 8:30 a.m. CDT on Friday, October 31, 2025. To participate in the conference call, contact Chorus Call Inc. at (844) 492-3726 or (412) 317-1078, and ask to join the Sensient Technologies Corporation conference call. Alternatively, the call can be accessed by using the webcast link that is available on the Investor Information section of the Company’s web site at www.sensient.com.

A replay of the call will be available one hour after the end of the conference call through November 7, 2025, by calling (877) 344-7529 and using access code 1491278. An audio replay and written transcript of the call will also be posted on the Investor Information section of the Company’s web site at www.sensient.com on or after November 4, 2025.

This release contains statements that may constitute “forward-looking statements” within the meaning of Federal securities laws including in the quote from our Chairman, President, and Chief Executive Officer and under “2025 Outlook” above. Such forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties, and other factors concerning the Company’s operations and business environment. Important factors that could cause actual results to differ materially from those suggested by these forward-looking statements and that could adversely affect the Company’s future financial performance include the following: the Company’s ability to manage general business, economic, and capital market conditions, including actions taken by customers in response to such market conditions, and the impact of recessions and economic downturns; the impact of macroeconomic and geopolitical volatility, including inflation and shortages impacting the availability and cost of raw materials, energy, and other supplies, disruptions and delays in the Company’s supply chain, and the conflicts between Russia and Ukraine and in the Middle East; industry, regulatory, legal, and economic factors related to the Company’s domestic and international business; the effects of tariffs, trade barriers, and disputes; the availability and cost of labor, logistics, and transportation; the pace and nature of new product introductions by the Company and the Company’s customers; the Company’s ability to anticipate and respond to changing consumer preferences, changing technologies, and changing regulations; the Company’s ability to successfully implement its growth strategies; the outcome of the Company’s various productivity-improvement and cost-reduction efforts, acquisition and divestiture activities, and Portfolio Optimization Plan; growth in markets for products in which the Company competes; industry and customer acceptance of price increases; actions by competitors; the Company’s ability to enhance its innovation efforts and drive cost efficiencies; currency exchange rate fluctuations; and other factors included in “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and in other documents that the Company files with the SEC. The risks and uncertainties identified above are not the only risks the Company faces. Additional risks and uncertainties not presently known to the Company or that it currently believes to be immaterial also may adversely affect the Company. Should any known or unknown risks and uncertainties develop into actual events, these developments could have material adverse effects on our business, financial condition, and results of operations. This release contains time-sensitive information that reflects management’s best analysis only as of the date of this release. Except to the extent required by applicable laws, the Company does not undertake to publicly update or revise its forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied herein will not be realized.

ABOUT SENSIENT TECHNOLOGIES

Sensient Technologies Corporation is a leading global manufacturer and marketer of colors, flavors, and other specialty ingredients. Sensient uses advanced technologies and robust global supply chain capabilities to develop specialized solutions for food and beverages, as well as products that serve the pharmaceutical, nutraceutical, and personal care industries. Sensient’s customers range in size from small entrepreneurial businesses to major international manufacturers representing some of the world’s best-known brands. Sensient is headquartered in Milwaukee, Wisconsin.

www.sensient.com

Category: Earnings

Source: Sensient Technologies Corporation

Contacts

David Plautz

(414) 347-3706

investor.relations@sensient.com

Calluna Pharma Announces U.S. FDA Orphan Drug Designation Granted to CAL101 for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)




Calluna Pharma Announces U.S. FDA Orphan Drug Designation Granted to CAL101 for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

CAL101 is a first-in-class monoclonal antibody targeting S100A4, a DAMP protein implicated in severe, life-threatening fibrotic diseases

CAL101 being investigated in Phase 2 IPF Study; enrollment ongoing at sites in the USA, UK, EU, Turkey and South Korea

OSLO, Norway & BOSTON–(BUSINESS WIRE)–Calluna Pharma AS, a clinical stage biotechnology company pioneering first-in-class antibodies to treat inflammatory and fibrotic diseases, today announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for CAL101, its lead clinical candidate currently being evaluated in patients with idiopathic pulmonary fibrosis (IPF).

“Orphan drug designation speaks to the importance of developing new treatments for debilitating rare diseases like IPF, for which treatment options are limited,” said Margrethe Sørgaard, Calluna Pharma’s Senior Vice President of Clinical Operations and Pharmacovigilance. “Our ongoing IPF study (AURORA) aims to demonstrate that CAL101 prevents the disease-specific activation of fibroblasts that lead to decreased lung function, and the progressive decline these patients face.”

The FDA grants Orphan Drug Designation to support the development and evaluation of new treatments for rare diseases, conditions affecting fewer than 200,000 people in the USA. Benefits of this designation include potential eligibility for expedited review pathways, tax credits for qualified clinical trials, fee waivers, and seven years of market exclusivity after approval.

AURORA is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of CAL101 in patients with IPF. The study aims to enroll 150 individuals with IPF across more than 50 sites, primarily in the USA, UK, EU, Turkey and South Korea. After an initial 28-day screening period, patients will be randomized to receive seven monthly intravenous infusions of CAL101 or placebo at a randomization ratio of 3:2, respectively. The study’s primary endpoint is lung function, measured by forced vital capacity, or how much air can forcibly be exhaled, versus an individual’s baseline.

About CAL101

CAL101 is a systemically administered monoclonal antibody targeting the DAMP protein S100A4. S100A4 is activated when tissue is stressed or injured, triggering multiple downstream pathways. It is associated with pathological activation and proliferation of fibroblasts (the key effector cells driving progression of fibrosis), and pro-fibrotic immune response connected to fibrotic disease. Targeting S100A4 has the potential to re-establish tissue homeostasis by switching off the downstream pathways involved in the persistent and maladaptive scar tissue formation characteristic of IPF.

A randomized, double-blind, placebo-controlled Phase 1 study of CAL101 demonstrated a favorable safety profile, with balanced frequency and types of AEs, compared to placebo, across all dose levels. Preclinical studies have shown CAL101 to prevent and treat fibrosis and modify the disease-specific activation of fibroblasts.

About IPF

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease where an inappropriately activated wound-healing response causes the lung tissue to become thickened and scarred, making it difficult to breathe. The exact triggers of IPF are unknown, but it is believed to be a combination of genetic and environmental factors. Over time, the scarring in the lungs worsens, leading to respiratory failure and ultimately death, with a 3-5-year median survival rate. Primarily found in older adults, the disease impacts approximately 233,000 people in the USA and EU.

About Calluna Pharma www.callunapharma.com

Calluna Pharma is a global clinical stage company pioneering a breakthrough approach to treating inflammatory and fibrotic diseases by leveraging the body’s innate immune system. The Company’s therapeutic approach targets upstream amplifiers of disease, offering potential applicability across a diverse array of medical conditions. Calluna Pharma has a pipeline of selective antibodies targeting immunological diseases with enhanced efficacy and tolerability.

Calluna Pharma is incorporated in Oslo, Norway and operates globally.

Contacts

Media Contact:
Jason Glashow

Glashow Strategic Communications

Email: Jason@glashowstrategic.com
Tel: +1 617-510-1800

Arcus Biosciences Announces Pricing of $250 Million Public Offering of Common Stock




Arcus Biosciences Announces Pricing of $250 Million Public Offering of Common Stock

HAYWARD, Calif.–(BUSINESS WIRE)–Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, inflammatory and autoimmune diseases, today announced the pricing of an underwritten public offering of 13,700,000 shares of its common stock at a price to the public of $18.25 per share. Gross proceeds to Arcus Biosciences from the offering are expected to be $250 million, before deducting underwriting discounts and commissions and offering expenses. All of the shares of common stock are being offered by Arcus Biosciences. In addition, Arcus Biosciences has granted the underwriters a 30-day option to purchase up to 2,055,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on November 3, 2025, subject to customary closing conditions.

Leerink Partners, Goldman Sachs & Co. LLC, Cantor, Mizuho and Truist Securities are acting as joint bookrunning managers for the offering.

A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission (SEC) on February 28, 2023, and automatically became effective upon filing. This offering is being made solely by means of a prospectus. A copy of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at syndicate@leerink.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by emailing prospectus@cantor.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Arcus Biosciences, Inc.

Arcus Biosciences is a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, inflammatory and autoimmune diseases.

Forward Looking Statements

This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the timing and completion of the offering and the satisfaction of customary closing conditions related to the offering. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to risks associated with: the consummation of the offering; the completion of the offering on the anticipated terms or at all; uncertainties related to market conditions; the satisfaction of customary closing conditions related to the offering; and the impact of general economic, health, industrial or political conditions in the United States or internationally. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release except to the extent required by law.

The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.

Contacts

Investor Inquiries:
Pia Eaves

VP of Investor Relations & Strategy

(617) 459-2006

peaves@arcusbio.com

Media Inquiries:
Holli Kolkey

VP of Corporate Affairs

(650) 922-1269

hkolkey@arcusbio.com

Maryam Bassiri

AD, Corporate Communications

(510) 406-8520

mbassiri@arcusbio.com