SFI Health™ EMEA Announces Exclusive License Agreement with Curasense BV for Equazen® in the Netherlands and Belgium




SFI Health™ EMEA Announces Exclusive License Agreement with Curasense BV for Equazen® in the Netherlands and Belgium

– Partner Curasense will market Equazen^® products featuring a clinically researched combination of essential fatty acids across pharmacies, healthcare stores and online pharmacies.

LUGANO, Switzerland–(BUSINESS WIRE)–#GLAsupplements–SFI Health™ EMEA, the regional entity of SFI Health™, a global leader in natural healthcare, and Curasense BV (Curasense), a Belgian company specializing in the distribution and development of high-quality nutraceuticals and health products, are excited to announce that they have entered into an exclusive licensing agreement for Equazen^® food supplements in the Netherlands and Belgium.

Under the terms of the agreement, Curasense will hold exclusive rights to distribute, promote, market, and sell Equazen^® products within the licensed territories. Curasense will begin commercial activities following a transition period from SFI Health™’s previous licensee.

Together, Belgium and the Netherlands count over 6,500 pharmacies, alongside a strong presence of health stores — from 800 independents in Belgium to 2,000 outlets in the Netherlands. With well-established pharmacy and retail networks, plus growing online demand, the agreement positions the brand for strong visibility and reach across both markets.

Matthew Brabazon, GM of SFI Health™ EMEA commented: “We are very pleased to collaborate with Curasense, a company with extensive experience in the healthcare sector and a strong reputation among healthcare professionals and consumers. This partnership marks an important step in strengthening the Equazen^® brand, as we leverage Curasense BV’s expertise in bringing advanced scientifically naturally sourced health solutions to market. Together, we are committed to expand Equazen^®’s distribution and market share, establishing it as a reference point for brain health and cognitive wellness.”

Mr. Jelle D’Helft, CEO of Curasense, added: “We are thrilled to formalize our strategic partnership with SFI Health™ EMEA for the Equazen® brand in the Netherlands and Belgium. For Curasense, this agreement is a natural extension of our mission to deliver evidence-based health solutions that make a real impact. Equazen^®’s clinically supported formulations align closely with our vision and reflect our ambition to bridge conventional and complementary medicine. This collaboration will accelerate access to innovative, science-backed products for children, adolescents, and adults—while setting new benchmarks in the nutraceutical industry.”

The brain health supplement sector is emerging as one of the most dynamic segments within the global food supplements market. In Europe, it is expected to grow at a CAGR of 12.5% from 2023 to 2030, supported by increasing consumers’ focus on sustaining normal cognitive function and mental health.

Equazen^® is currently present in several EMEA markets, including Spain, Portugal, the United Kingdom, Switzerland, Poland, the Czech Republic, Slovakia, the Nordics, and the Baltics, with SFI Health™ aiming to broaden its reach into new markets to unlock its full sales potential and capitalize on the growing momentum in the brain food supplements sector.

About SFI Health™

SFI Health™ is a global leader in natural healthcare, specialized in the design, development and commercialization of clinically researched products in the areas of microbiome, cognition and wellbeing.

Guided by the belief in the healing potential of natural products, SFI Health™ combines a rigorous pharma-based approach with the benefits of naturally sourced solutions.

An extensive network of trusted business partners enables the company, headquartered in Australia, to market its own brands, reaching consumers in over 50 countries. The EMEA SFI Health™ regional office in Lugano, Switzerland, manages commercial operations across Europe, Middle East and Africa.

SFI Health™ is committed to fostering confidence in natural healthcare by sharing state-of-the-art research, technical expertise and comprehensive sales & marketing resources with consumers, healthcare professionals and partners worldwide.

For more information go to sfihealth.com or follow us SFI Health on LinkedIn.

About Curasense

Curasense BV is a Belgian company specializing in the distribution and development of high-quality nutraceuticals and health products. Building on more than 20 years of experience in the healthcare sector, Curasense delivers Health through Nature, Science and Innovation, addressing key needs like cognitive function, inflammation management, and overall vitality.

The company’s approach combines a strong foundation in scientific substantiation and strict compliance with European regulations, ensuring proven quality and effectiveness.

Through close collaboration with international partners and healthcare professionals, consumers gain access to our innovative products.

Based in Heist-op-den-Berg (Antwerp), Curasense serves both the Belgian and Dutch markets and continues to expand its ambition of making advanced health solutions available across Europe and beyond.

For more info go to curasense.com/ or follow us Curasense on LinkedIn.

About Equazen^®

Equazen^® is a science-based globally branded food supplement designed and studied to help nourish, enhance, and support the human brain’s potential across all life stages.

Each product of the Equazen^® range contains a balanced unique combination of essential fatty acids (Omega 3 and Omega 6), which has been clinically proven for more than 20 years to assist with learning capabilities, concentration and healthy brain development.

Equazen^® is available in multiple pharmaceutical formats and sizes to support optimal cognitive functions from infants to teenagers.

Currently marketed in 30 countries globally, Equazen^® is widely recommended by healthcare professionals and trusted by families for the last 25 years.

Equazen^® aims to advance human health naturally, delivering expertly formulated products that empower individuals to reach their cognitive potential.

For more info visit www.equazen.com

Contacts

For more information
SFI Health™ EMEA Contact
Elisabetta Bianchi

e-mail address: elisabetta.bianchi@sfihealth.com

Curasense BV Contact
Jelle D’Helft

e-mail address: jelle@curasense.be

KalVista Prices Upsized Offering of $125.0 Million of 3.250% Convertible Senior Notes Due 2031




KalVista Prices Upsized Offering of $125.0 Million of 3.250% Convertible Senior Notes Due 2031

FRAMINGHAM, Mass. & SALISBURY, England–(BUSINESS WIRE)–KalVista Pharmaceuticals, Inc. (“KalVista”) (NASDAQ: KALV), announced today the pricing of its offering of $125.0 million aggregate principal amount of 3.250% Convertible Senior Notes due 2031 (the “notes”) in a private placement to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The aggregate principal amount of the offering was increased from the previously announced offering size of $110.0 million. KalVista also granted the initial purchasers of the notes an option to purchase, for settlement within a 13-day period from, and including, the date on which the notes are first issued, up to an additional $18.75 million aggregate principal amount of notes. The sale of the notes is expected to close on September 29, 2025, subject to customary closing conditions.

The notes will be senior, unsecured obligations of KalVista, and will bear interest at a rate of 3.250% per year, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on October 1, 2026. The notes will mature on October 1, 2031, unless earlier converted, repurchased or redeemed in accordance with the terms of the notes. Prior to 5:00 p.m., New York City time, on the business day immediately preceding July 31, 2031, the notes will be convertible at the option of holders of the notes only upon satisfaction of certain conditions and during certain periods, and thereafter, the notes will be convertible at the option of holders at any time until 5:00 p.m., New York City time, on the second scheduled trading day immediately preceding the maturity date, regardless of whether such conditions have been met. Upon conversion, the notes may be settled in shares of KalVista’s common stock, cash or a combination of cash and shares of KalVista’s common stock, at the election of KalVista. The initial conversion rate is 59.4919 shares of KalVista’s common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $16.81 per share of KalVista’s common stock, representing an approximate 30.0% premium based on the last reported sale price of KalVista’s common stock on The Nasdaq Global Market on September 24, 2025 of $12.93 per share). The initial conversion rate will be subject to adjustment upon the occurrence of certain events, but will not be adjusted for any accrued and unpaid interest. Prior to October 5, 2028, the notes will not be redeemable. On or after October 5, 2028, and prior to July 1, 2031, KalVista may redeem for cash all or part of the notes, at its option, subject to a partial redemption limitation, if the last reported sale price of KalVista’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which KalVista provides notice of redemption.

Holders of the notes will have the right to require KalVista to repurchase for cash all or a portion of their notes at 100% of their principal amount, plus any accrued and unpaid interest, upon the occurrence of a fundamental change (as defined in the indenture relating to the notes). KalVista will also be required to increase, in certain circumstances, the conversion rate for holders who convert their notes in connection with certain fundamental changes occurring prior to the maturity date or convert their notes called (or deemed called) for redemption following the delivery by KalVista of a notice of redemption.

KalVista estimates that the net proceeds from the offering will be approximately $120.8 million (or approximately $139.0 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discount and estimated offering expenses payable by KalVista.

KalVista expects to use the net proceeds from the offering for working capital and other general corporate purposes, including the commercialization of EKTERLY. KalVista may also use a portion of the net proceeds from the offering for investments in and acquisitions of other companies, products or technologies in the future. However, KalVista has no commitments or specific plans with respect to any such investments in and acquisitions of other companies, products or technologies at this time.

This announcement is neither an offer to sell nor a solicitation of an offer to buy any of these securities (including the shares of KalVista’s common stock, if any, into which the notes are convertible) and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful. Any offers of the notes were made only by means of a private offering memorandum.

The offering is being made to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act. The notes and any shares of KalVista’s common stock issuable upon conversion of the notes have not been and will not be registered under the Securities Act, or any state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties, including, without limitation, statements regarding the timing and closing of KalVista’s offering of the notes and expected use of net proceeds from the offering. Statements containing words such as “could,” “believe,” “expect,” “intend,” “will,” or similar expressions constitute forward-looking statements. Factors that may contribute to such differences include, but are not limited to, risks related to whether KalVista will close the offering of the notes, the expected use of the net proceeds from the offering, which could change as a result of market conditions or for other reasons, prevailing market and other general economic, industry or political conditions in the United States or internationally, and whether KalVista will be able to satisfy the conditions required to close the sale of the notes. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. For information about other potential factors that could affect KalVista’s business and financial results, please review the “Risk Factors” described in KalVista’s Annual Report on Form 10-K for the year ended April 30, 2025 filed with the Securities and Exchange Commission (the “SEC”) on July 10, 2025 and in KalVista’s other filings with the SEC. Except as may be required by law, KalVista does not intend, and undertakes no duty, to update this information to reflect future events or circumstances.

Contacts

Investors:

Ryan Baker

Head, Investor Relations

(617) 771-5001

ryan.baker@kalvista.com

Media:

Molly Cameron

Director, Corporate Communications

(857) 356-0164

molly.cameron@kalvista.com

PepGen Announces Pricing of $100 Million Public Offering




PepGen Announces Pricing of $100 Million Public Offering

BOSTON–(BUSINESS WIRE)–PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company developing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced the pricing of an underwritten offering of 31,250,000 shares of its common stock at a price to the public of $3.20 per share. The aggregate gross proceeds to PepGen from this offering are expected to be $100 million, before deducting underwriting discounts and commissions and offering expenses payable by PepGen. The offering is expected to close on or about September 26, 2025, subject to customary closing conditions. In addition, PepGen has granted the underwriters a 30-day option to purchase up to 4,687,500 additional shares of common stock at the public offering price, less the underwriting discount.

Leerink Partners and Stifel are acting as joint bookrunning managers for the offering.

PepGen currently intends to use the net proceeds from this offering to fund its ongoing research and clinical development efforts, including the FREEDOM-DM1 and FREEDOM2-DM1 clinical trials, as well as for working capital and other general corporate purposes.

The securities are being offered pursuant to a registration statement on Form S-3 that was previously filed with, and subsequently declared effective on July 8, 2024, by the Securities and Exchange Commission (“SEC”). A final prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC, and are or will be available on the SEC’s website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Leerink Partners LLC, 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 or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, telephone: (415) 364‐2720 or by emailing syndprospectus@stifel.com.

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

About PepGen

PepGen Inc. is a clinical-stage biotechnology company developing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, the Company is generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.

Forward Looking Statements

This press release contains forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any forward-looking statements in this press release are based on PepGen’s current expectations, estimates and projections only as of the date of this release 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. These risks and uncertainties related to completion of the offering on the anticipated terms, or at all, include, but are not limited to, market conditions and the satisfaction of customary closing conditions related to the offering. Additional risks concerning PepGen’s programs and operations are described in our most recent annual report on Form 10-K and quarterly report on Form 10-Q that are filed with the SEC. PepGen explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contacts

Investor Contact
Laurence Watts

New Street Investor Relations

laurence@newstreetir.com

Dr. Park CDMO Selects Thermo Fisher Scientific to Equip New Viral Vector Manufacturing Facility




Dr. Park CDMO Selects Thermo Fisher Scientific to Equip New Viral Vector Manufacturing Facility

Advanced bioprocessing solutions from Thermo Fisher to support large-scale production and global access to cell and gene therapies

WALTHAM, Mass.–(BUSINESS WIRE)–Thermo Fisher Scientific Inc., the world leader in serving science, today announced that Dr. Park, an emerging viral vector contract development and manufacturing organization (CDMO) based in South Korea, has selected Thermo Fisher to provide advanced bioreactors and consumables for its newest facility.

Dr. Park specializes in Adeno-associated virus-based (AAV-based) viral vector production and currently at 5,000 L per batch, producing up to 40 clinical-grade batches per year. The company’s new Phase 1 facility, which was inaugurated on August 5, 2025, is designed to achieve cGMP certification in 2026 and expand access to cell and gene therapies globally. Plans are also in place to further increase capacity to 10,000 L per batch in the future.

To support these ambitions, the new facility has integrated and set up several solutions from Thermo Fisher’s portfolio, including Thermo Fisher Scientific™ HyPerforma™ 1,000 L Single-Use Bioreactor, Thermo Scientific™ Nunc™ Automated Cell Factory Manipulator and Thermo Scientific™ DynaSpin™ Single-Use Centrifuge. These state-of-the-art technologies are designed to streamline upstream and downstream processes, reduce manual interventions and support rapid scale-up from clinical to commercial production. By improving process control and automation, these solutions will help enhance efficiency, scalability and consistency throughout the manufacturing process, helping meet growing demand for therapeutics while maintaining high standards of quality, safety and regulatory compliance.

“We are proud to collaborate with Dr. Park CDMO as they advance viral vector manufacturing in South Korea,” said Daniella Cramp, Senior Vice President and President, BioProduction at Thermo Fisher Scientific. “By providing our reliable and scalable bioprocessing solutions, we aim to speed up development and delivery of cell and gene therapies to patients who need them.”

Thermo Fisher and Dr. Park’s collaboration reflects the increasing importance of robust viral vector manufacturing as cell and gene therapies move from research to clinical and commercial use. Advanced manufacturing infrastructure is essential to accelerate development timelines and broaden patient access to life-changing treatments, particularly as global demand for gene therapy continues to rise.

“Our collaboration with Thermo Fisher Scientific has been instrumental in equipping our new facility with advanced bioproduction capabilities,” said Yong-Ho Park, CEO, Dr. Park. “Their cutting-edge technologies and deep expertise are critical enablers of our long-term vision and will strengthen our ability to serve customers globally.”

“Collaboration is essential in advancing scientific innovation and bringing new therapies to patients,” said Tony Acciarito, President, Asia Pacific and Middle East, Africa at Thermo Fisher Scientific. “Our work with Dr. Park CDMO reflects a shared commitment to building robust manufacturing capabilities in South Korea and across the region. By working together, we can progress cell and gene therapies and support the evolving needs of the industry.”

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

Contacts

Media Contact Information:
Kathy Bricaud

Thermo Fisher Scientific

Email: kathy.bricaud@thermofisher.com

3 Day Virtual Biostatistics for the Non-Statistician Training Course: Understand Statistical Concepts and Findings As Applies to Clinical Research (ONLINE EVENT: October 22-24, 2025) – ResearchAndMarkets.com




3 Day Virtual Biostatistics for the Non-Statistician Training Course: Understand Statistical Concepts and Findings As Applies to Clinical Research (ONLINE EVENT: October 22-24, 2025) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Biostatistics for the Non-Statistician Training Course (Oct 22nd – Oct 24th, 2025)” training has been added to ResearchAndMarkets.com’s offering.

Learn Biostatistics for the Non-Statistician

The focus of the seminar is to give you the information and skills necessary to understand statistical concepts and findings as applies to clinical research, and to confidently convey the information to others.

Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.

Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test?

This seminar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

Emphasis will be placed on the actual statistical (a) concepts, (b) application, and (c) interpretation, and not on mathematical formulas or actual data analysis. A basic understanding of statistics is desired, but not necessary.

Learning objectives

• Understand the statistical portions of most articles in medical journals.
• Do simple calculations, especially ones that help in interpreting published literature.
• Avoid being misled by foolish findings.
• Knowledge of which test when, why, and how.
• Perform simple analyses in statistical software.
• Communicate statistical findings to others more clearly.

Who Should Attend:

• Physicians
• Clinical Research Associates
• Clinical Project Managers/Leaders
• Sponsors
• Regulatory Professionals who use statistical concepts/terminology in reporting
• Medical Writers who need to interpret statistical reports
• Clinical research organizations, hospitals, researchers in health and biotech fields.
• Persons working in the medical or health sciences, pharmaceutical and or nutriceutical industries, clinical trials, clinical research, and clinical research organizations, physicians, medical students, graduate students in the biological sciences, researchers, and medical writers who need to interpret statistical reports.

Key Topics Covered:

Agenda Day 1: Basics

Session 1: Why Statistics

• Do we really need statistical tests?
• Sample vs. Population
• I’m a statistician not a magician! What statistics can and can’t do
• Descriptive statistics and measures of variability

Session 2: The many ways of interpretation

• Confidence intervals
• p-values
• Effect sizes
• Clinical vs. meaningful significance

Break – 10 mins

Session 3: Types of Data and Descriptive Statistics

• Levels of data: Continuous, Ordinal, Nominal
• Normal distribution and it’s importance
• Graphical representations of data
• Data transformations, when and how

Break 10 mins

Session 4: Common Statistical Tests

• Comparative tests
• Simple and Multiple regression analysis
• Non-parametric techniques

Q&A

Agenda Day 2: Special Topics

Session 1: Logistic Regression

• When and why?
• Interpretation of odd ratios
• Presentation of logistic regression analysis and interpretation
• Fun with contingency tables

Session 2: Survival Curves and Cox Regression

• History, theory, and nomenclature of survival analysis
• Kaplan-Meier Curves and Log Rank Tests
• Proportional Hazards
• Interpretation of hazard ratios
• Presentation of KM curves and Cox regression analysis and interpretation

Break 10 mins

Session 3: Bayesian Logics

• A different way of thinking
• Bayesian methods and statistical significance
• Bayesian applications to diagnostics testing
• Bayesian applications to genetics

Break 10 mins

Session 4: Systematic Reviews and Meta-Analysis

• Why perform a systematic reviews and/or meta-analysis?
• A bit of history and reasoning for systematic reviews and/or meta analysis
• Terminology
• Steps in Performing a Systematic Review
• Steps in Performing a Meta-Analysis

Agenda Day 3: Further Understanding in Clinical Research

Session 1: Other Tests

• Non-Parametric tests
• Test for equivalency
• Test for non-inferiority

Break 10 mins

Session 2: Power and Sample Size

• Theory, steps, and formulas for determining sample sizes
• Demonstration of sample size calculations with GPower software

Session 3: How to Review a Journal Article

• General steps on article review
• Determining the quality of a journal or journal article
• Looking for limitations (all studies have them)

Break 10 mins

Session 4: Developing a Statistical Analysis Plan

• Using FDA (for the U.S. audience) or MHRA (for the U.K. audience) guidance as a foundation, learn the steps and criteria needed to develop a statistical analysis plan (SAP)
• An SAP template will be given to all attendees

Speakers:

Elaine Eisenbeisz

Owner & Principal

Omega Statistics

Elaine Eisenbeisz is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers.

Elaine’s love of numbers began in elementary school where she placed in regional and statewide mathematics competitions. She attended the University of California, Riverside, as a National Science Foundation scholar, where she earned a B.S. in Statistics with a minor in Quantitative Management, Accounting. Elaine received her Master’s Certification in Applied Statistics from Texas A&M, and is currently finishing her graduate studies at Rochester Institute of Technology.

For more information about this training visit https://www.researchandmarkets.com/r/gqkq08

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
For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

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Pfizer to Acquire Metsera and its Next-Generation Obesity Portfolio




Pfizer to Acquire Metsera and its Next-Generation Obesity Portfolio

• Proposed acquisition to add four highly differentiated clinical-stage incretin and amylin programs to Pfizer’s pipeline
• Transaction valued at $47.50 per Metsera share in cash upon closing, for an initial enterprise value of $4.9 billion with a CVR of up to $22.50 per share in additional payments
• Pfizer to host a public webcast at 8 am EDT today

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and Metsera, Inc. (NASDAQ: MTSR) today announced the companies have entered into a definitive agreement under which Pfizer will acquire Metsera, a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and cardiometabolic diseases. The acquisition brings deep expertise and a portfolio of differentiated oral and injectable incretin, non-incretin and combination therapy candidates with potential best-in-class efficacy and safety profiles. The Boards of Directors of both Metsera and Pfizer have unanimously approved the transaction.

“Obesity is a large and growing space with over 200 health conditions associated with it. The proposed acquisition of Metsera aligns with our focus on directing our investments to the most impactful opportunities and propels Pfizer into this key therapeutic area,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We are excited to apply our deep cardiometabolic experience and manufacturing and commercial infrastructure to accelerate a portfolio that includes potential best-in-class injectables, with clinical data differentiated by efficacy, tolerability and durability supporting monthly dosing, with the aim to address the ongoing unmet needs associated with obesity and related diseases.”

Metsera has a portfolio of promising therapeutic candidates and combinations with four programs in clinical development and several next-generation programs with IND-enabling studies ongoing, aimed at addressing key unmet needs via fewer injections while achieving improved efficacy and tolerability. This includes MET-097i, a weekly and monthly injectable GLP-1 receptor agonist (RA), both in Phase 2 development; MET-233i, a monthly amylin analog candidate being evaluated as monotherapy and in combination with MET-097i in Phase 1 development; two oral GLP-1 RA candidates expected to begin clinical trials imminently; and additional preclinical nutrient-stimulated hormone therapeutics. Initial Phase 1 clinical results for MET-233i showcasing a potential best-in-class profile were presented on September 17 as a late-breaker at the 61^st Annual Meeting of the European Association for the Study of Diabetes (EASD).

Under the terms of the agreement, Pfizer will acquire all outstanding shares of Metsera common stock for $47.50 per share in cash at closing, representing an enterprise value of approximately $4.9 billion. Additionally, the agreement includes a non-transferable contingent value right (CVR) entitling holders to potential additional payments of up to $22.50 per share in cash tied to three specific clinical and regulatory milestones: $5 per share following the Phase 3 clinical trial start of Metsera’s MET-097i+MET-233i combination, $7 per share following U.S. Food and Drug Administration (FDA) approval of Metsera’s monthly MET-097i monotherapy, and $10.50 per share following FDA approval of Metsera’s monthly MET-097i+MET-233i combination, if achieved. The transaction is expected to close in the fourth quarter of 2025, subject to the satisfaction of customary closing conditions, including receipt of required regulatory approvals and approval by Metsera’s shareholders. Pfizer will provide any updates to its financial outlook in conjunction with its upcoming quarterly earnings.

“Since our founding in 2022, Metsera has worked tirelessly to reduce the physical, emotional, and economic burdens of obesity with a portfolio of next generation nutrient-stimulated hormone therapeutic candidates. Our team has invented and developed multiple injectable and oral candidate medicines and a category-leading peptide engineering platform, which together promise class-leading performance in a major sector of population health,” said Whit Bernard, Co-Founder and Chief Executive Officer of Metsera. “Today’s announcement sets a path for our portfolio to potentially transform the lives of hundreds of millions of people and represents an excellent outcome for our shareholders. We look forward to joining forces with Pfizer to leverage their global clinical, regulatory, manufacturing and commercial capabilities to realize the promise of improved human health at scale.”

Citi is acting as Pfizer’s financial advisor for the transaction with Wachtell, Lipton, Rosen & Katz acting as legal advisor. Metsera’s financial advisors for the transaction are Goldman Sachs & Co. LLC, Guggenheim Securities, LLC, BofA Securities, Inc., and Allen & Company LLC with Paul, Weiss, Rifkind, Wharton & Garrison LLP acting as legal advisor.

Investor Call Details

Pfizer Inc. invites Pfizer investors and the general public to view and listen to a webcast of a live conference call with investment analysts at 8 a.m. EDT on Monday, September 22, 2025.

To view and listen to the webcast visit Pfizer’s web site at www.pfizer.com/investors or directly at https://onlinexperiences.com/Launch/QReg/ShowUUID=7F348066-0A7A-4167-A63D-F43BA26B6867&LangLocaleID=1033&GroupID=Onyx. Information on accessing and pre-registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to pre-register in advance of the conference call.

You can listen to the conference call by dialing either 800-456-4352 in the United States or Canada or 785-424-1086 outside of the United States and Canada. The password is “73086.” Please join the call five minutes prior to the start time to avoid operator hold times.

The transcript and webcast replay of the call will be made available on Pfizer’s web site at www.pfizer.com/investors within 24 hours after the end of the live conference call and will be accessible for at least 90 days.

About Metsera

Metsera is a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases. Metsera is advancing a broad portfolio of oral and injectable incretin, non-incretin and combination therapies with potential best-in-class profiles to address multiple therapeutic targets and meet the future needs of a rapidly evolving weight loss treatment landscape. Metsera was founded in 2022 and is based in New York City. For more information, please visit us at www.metsera.com.

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 175 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 X 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 September 22, 2025.

This release contains forward-looking information about, among other topics, Pfizer’s proposed acquisition of Metsera, Pfizer’s and Metsera’s pipeline products, including their potential benefits, potential best-in-class status, differentiation, profile and dosing, potential clinical trials, and the anticipated timing of completion of the proposed acquisition, 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 related to the satisfaction or waiver of the conditions to closing the proposed acquisition (including the failure to obtain necessary regulatory approvals and 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; 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 the businesses of Pfizer and Metsera described in the “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results” (in the case of Pfizer) and “Special Note regarding Forward Looking Statements” (in the case of Metsera) sections of their respective Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed by either of them from time to time with the U.S. Securities and Exchange Commission (the “SEC”), 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 and Metsera assume no obligation to, and do 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. Neither Pfizer nor Metsera gives any assurance that it will achieve its expectations.

Additional Information and Where to Find It

In connection with the proposed transaction, Metsera will be filing documents with the SEC, including preliminary and definitive proxy statements relating to the proposed transaction. The definitive proxy statement will be mailed to Metsera’s stockholders in connection with the proposed transaction. This communication is not a substitute for the proxy statement or any other document that may be filed by Metsera with the SEC. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PRELIMINARY AND DEFINITIVE PROXY STATEMENTS AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Any vote in respect of resolutions to be proposed at Metsera’s stockholder meeting to approve the proposed transaction or other responses in relation to the proposed transaction should be made only on the basis of the information contained in Metsera’s proxy statement. Investors and security holders may obtain free copies of these documents (when they are available) and other related documents filed with the SEC at the SEC’s web site at www.sec.gov, or at www.metsera.com.

No Offer or Solicitation

This communication is for information purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law.

Participants in the Solicitation

Metsera and its directors, executive officers and other members of management and employees, under SEC rules, may be deemed to be “participants” in the solicitation of proxies from stockholders of Metsera in favor of the proposed transaction. Information about Metsera’s directors and executive officers is set forth in Part III of Metsera’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the SEC on March 26, 2025. Additional information concerning the interests of Metsera’s participants in the solicitation, which may, in some cases, be different than those of Metsera’s stockholders generally, will be set forth in Metsera’s proxy statement relating to the proposed transaction when it becomes available. These documents are available free of charge at the SEC’s web site at www.sec.gov and at www.metsera.com.

Category: Corporate, Research and Pipeline

Contacts

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

Bayer First Company to Advance Cell Therapy as Well as Gene Therapy Against Parkinson’s Disease




Bayer First Company to Advance Cell Therapy as Well as Gene Therapy Against Parkinson’s Disease

• First investigational allogeneic pluripotent stem cell derived therapy pivotal Phase III clinical trial exPDite-2 with bemdaneprocel started
• Phase II gene therapy trial REGENERATE-PD with AB-1005 initiated randomizing participants in United Kingdom and Poland, with Germany following shortly and ongoing in the USA
• Parkinson’s disease second most common and fastest growing neurodegenerative disease affecting more than 10 million people worldwide

BERLIN–(BUSINESS WIRE)–Bayer announced today progress for two potential therapies against Parkinson’s disease (PD). A first participant received randomized treatment in the pivotal Phase III clinical trial, exPDite-2, of bemdaneprocel, an investigational cell therapy for PD. At the same time, first European participants have been randomized in REGENERATE-PD, a Phase II clinical trial of AB-1005, an investigational gene therapy. Both therapies are focused on treating moderate-stage PD and are being developed in collaboration with Bayer’s wholly owned, independently operated subsidiary companies, BlueRock Therapeutics LP (bemdaneprocel) and AskBio Inc. (AB-1005) respectively.

“Our dual approach in addressing Parkinson’s disease through both cell and gene therapies exemplifies our strategic vision and maximizes our chances of offering renewed hope for Parkinson’s patients who have been waiting for new therapies for too long,” said Christian Rommel, Global Head of Research and Development of Bayer’s Pharmaceutical Division. “We are energized by being at the forefront of the development of disease modifying therapies that have the potential to make a meaningful impact on Parkinson’s patients lives.”

Bayer is setting a global benchmark in the development, manufacturing, and commercialization of cell and gene therapies based on the establishment of a comprehensive end-to-end approach that covers the entire spectrum from research to production and includes state-of-the-art production facilities worldwide.

“Parkinson’s disease is characterized by the loss of dopamine producing cells in the brain resulting in motor impairments,” said Gabi Belfort, MD, PhD, Senior Vice President and Bemdaneprocel Product Lead at BlueRock Therapeutics. “Bemdaneprocel aims to replace these lost cells with new dopamine producing neurons and we are excited that the pivotal Phase III exPDite-2 clinical trial to explore this approach is now underway.”

“We believe there is a significant need for neurorestorative therapies in Parkinson’s, and AskBio is committed to exploring the potential of investigational gene therapy AB-1005 in the treatment of this severe, progressive chronic disease,” said Adrian Kells, PhD, Senior Vice President, Integrated Product Team Lead, Parkinsons and MSA, at AskBio. “We are excited to share the news of the advancement of our REGENERATE-PD clinical trial in Europe, which we believe is an important update for patients and the medical community.”

Bemdaneprocel and AB-1005 are investigational therapies which have not been approved by any regulatory authority, and their efficacy and safety have not been established or fully evaluated.

About Parkinson’s Disease

Parkinson’s disease (PD) is a progressive neurodegenerative disease. It has a significant impact on a person’s daily life. In PD, the death of dopamine producing nerve cells in the brain leads to the continuous loss of motor function. Symptoms include tremors, muscle rigidity, and slowness of movement. Additionally, people with PD experience non-motor symptoms, including fatigue and lack of energy, cognitive issues, and depression. Symptoms typically intensify over time and make everyday tasks demanding. The prevalence of PD has doubled over the past 25 years. Today, more than 10 million people worldwide are estimated to be living with PD. This makes it the world’s second most prevalent neurodegenerative disease. It is also the most frequent movement disorder. At present there is no cure, and current treatment options are inadequate and lack the holistic management of symptoms so there is an urgent need for new therapies.

About Bemdaneprocel (BRT-DA01)

Bemdaneprocel (BRT-DA01) is an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease. These dopaminergic neuron precursors are derived from human embryonic pluripotent stem cells that continue developing into mature dopamine neurons after implantation. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson’s disease. When transplanted, they have the potential to re-form neural networks that have been severely affected by Parkinson’s disease and to potentially restore motor and non-motor function to patients. In 2021 bemdaneprocel received Fast Track Designation and in 2024 a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. Data from the Phase I trial’s 12 participants presented at the 2024 International Congress of Parkinson’s Disease and Movement Disorders (MDS) demonstrated good tolerability, with no serious adverse events related to drug product at 24 months post-surgery. Further, encouraging trends were observed in secondary endpoints related to motor impairments at 24 months post-surgery. These participants continue in the long term Continued Evaluation Study. Bemdaneprocel has not been approved for treatment of any disease or medical condition by any health authority.

About exPDite-2

exPDite-2 is the first Phase III pivotal clinical trial for an investigational allogeneic pluripotent stem cell derived therapy to treat Parkinson’s disease. In a Phase I study with 12 participants, bemdaneprocel was well tolerated, with no serious adverse events related to drug product at 24 months post-surgery. In addition, encouraging trends were observed in secondary endpoints related to motor impairments at 24 months post-surgery. Building on these results, exPDite-2 is a multicenter, double-blind trial that will assess the efficacy, safety and overall impact of bemdaneprocel compared to a sham surgery control. The trial is designed to enroll approximately 102 participants with Parkinson’s disease. The primary endpoint of the study is change from baseline to week 78 in PD diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day. In addition, the trial will incorporate secondary endpoints designed to assess objective measures of movement, non-motor symptoms, safety and tolerability, and instruments that capture activities of daily living and quality of life. For more information about the exPDite-2 clinical trial, visit clinicaltrials.gov (NCT06944522), or visit bluerocktx.com.

Depending upon the outcome, the results from this trial are intended to be part of a data package to support regulatory submissions for marketing authorization.

About AB1005

AB-1005 is an investigational gene therapy based on adeno-associated viral vector serotype 2 (AAV2) containing the human glial cell line-derived neurotrophic factor (GDNF) transgene, which allows for stable and continuous expression of GDNF in localized regions of the brain after direct neurosurgical injection with MRI-monitored convection enhanced delivery. In nonclinical studies, GDNF has been shown to promote the survival and morphological differentiation of dopaminergic neurons. Recombinant GDNF has long been evaluated as a potential treatment for diseases, such as PD, marked by progressive degeneration of midbrain dopaminergic neurons. Through a combination of an investigational gene therapy and innovative neurosurgical delivery approach, one can now test the GDNF hypothesis in PD by getting this neurotrophic factor to these degenerating nigrostriatal neurons in a potentially more clinically relevant fashion.

About REGENERATE-PD

REGENERATE-PD is a Phase II, randomized, double-blind, surgery controlled trial of the efficacy and safety of intraputaminally administered investigational gene therapy AB-1005 in the treatment of adults (45–75 years) with moderate-stage Parkinson’s disease. The trial will include an estimated 87 participants with trial sites located in Germany, Poland, the United Kingdom, and the United States. For more information about the REGENERATE-PD clinical trial, visit clinicaltrials.gov (NCT06285643), or visit askbio.com.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at www.bayer.com.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contacts

Contact for media inquiries:
Elaine Colón

Ph: +1-732-236-1587

Email: elaine.colon@bayer.com

Abselion Introduces Protein G Total Antibody Quantification Kit




Abselion Introduces Protein G Total Antibody Quantification Kit

New kit enables rapid, accurate titre measurement across broad range of IgG subclasses and species on Amperia platform

CAMBRIDGE, England–(BUSINESS WIRE)–#Abselion–Abselion, a pioneering life sciences technology company focused on simplifying biomolecule quantification, today announced the launch of its Protein G Total Antibody Quantification Kit. The new kit is designed for use with the company’s Amperia™ benchtop platform and complements the existing Protein A-based format, enabling researchers to quantify a broader range of antibody isotypes and species using the same protocol-guided, user-friendly workflow and highly sensitive electrochemical readout. Abselion’s extended antibody quantification offering reflects continued investment in expanding the capabilities of its flexible Amperia platform to help streamline decision-making and optimise bioprocess workflows for scientists working across diverse antibody discovery and development settings.

Abselion’s Amperia benchtop platform is a simple-to-use solution for rapid and accurate automated quantification of a range of biomolecules, without optics or fluidics. The Protein G Total Antibody Quantification Kit is supplied in a ready-to-use format, including Protein G-coated sensor strips, assay plates, detection reagents, and assay buffers. The kit is suitable for use with purified or partially purified antibody samples in research and process development settings. Combined with Amperia’s intuitive software and step-by-step guidance, it allows researchers to generate reliable antibody titre data without the need for complex setup or specialised training.

The assay uses sensor strips pre-coated with Protein G, enabling direct capture of antibodies from a sample. After incubation, a labelled detection molecule binds to any remaining unoccupied Fc-binding sites on the sensor. The assay takes place directly on the sensor tip, where the bound analyte triggers an electrical signal, which is read instantaneously by Amperia. As antibody concentration increases, fewer sites are available for detection, resulting in a lower signal. This inverse occupancy format produces a signal that is inversely proportional to antibody concentration.

Current quantitative methods, such as bio-layer interferometry and surface plasmon resonance, are often limited to centralised analytical laboratories due to their cost and complexity of operation. This can lead to analytical delays and requirements for sample storage. Abselion’s Amperia system offers a robust, cost-effective, automated alternative for efficient, accurate antibody titre measurement. By introducing a Protein G-based option, users working with humanised antibodies, rodent IgGs, or engineered variants can now run reliable titre measurements without the need for revalidating or redesigning their assay setup.

Dr Ruizhi Wang, CEO and Founder, Abselion, said: “Antibody-based research and development often involves a wide variety of formats, subclasses, and species. Having the flexibility to choose the most appropriate assay without adjusting workflows can simplify decision-making and improve efficiency.

This launch reflects Abselion’s commitment to evolving its platform in response to real-world research needs. Expanding our antibody quantification offering with Protein G allows us to better support scientists working with a broader range of antibody formats, and reflects our ongoing focus on making practical, application-driven tools more accessible.”

For further information about Abselion’s Protein G Total Antibody Quantification Kit, please visit: https://www.abselion.com/assay-kits or download the application note “Supporting Antibody Quantification in Biologic Development”.

Meet the Abselion team at Festival of Biologics from 30 Sep–02 Oct in Basel, Switzerland (Booth 240) and ELRIG Drug Discovery 2025 from 21–22 Oct in Liverpool, UK (Booth H06) to learn more.

Please contact Codon Communications for high-resolution images.

Contacts

Codon Communications
Dr Michelle Ricketts

Tel: +44 7789 053885

Email: michelle.ricketts@codoncommunications.com

Positive Phase III Results Show Genentech’s Giredestrant Significantly Improved Progression-Free Survival in ER-positive Advanced Breast Cancer




Positive Phase III Results Show Genentech’s Giredestrant Significantly Improved Progression-Free Survival in ER-positive Advanced Breast Cancer

– evERA met its co-primary endpoints; giredestrant plus everolimus demonstrated significant benefit in ITT and ESR1-mutated populations in the post-CDK inhibitor setting, compared with standard of care plus everolimus –

– The all-oral combination was well tolerated and adverse events were consistent with the known safety profiles of the individual study treatments; no new safety signals were observed –

– evERA is the first positive head-to-head Phase III trial investigating an all-oral selective estrogen receptor degrader-containing regimen versus a standard of care combination –

– Data will be presented at an upcoming medical meeting and shared with health authorities –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase III evERA study evaluating investigational giredestrant in combination with everolimus in people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer previously treated with a cyclin-dependent kinase (CDK) 4/6 inhibitor and endocrine therapy. The study met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in both the intention-to-treat and ESR1-mutated populations, compared with standard-of-care endocrine therapy plus everolimus. Overall survival (OS) data were immature, but a clear positive trend was observed. Follow-up continues to the next OS analysis. The giredestrant combination was well tolerated. Adverse events were consistent with the known safety profiles of the individual study treatments, and no new safety signals were observed. This is the first positive head-to-head Phase III trial investigating an all-oral selective estrogen receptor degrader-containing regimen versus a standard of care combination.

“These results show that the giredestrant combination provides a meaningful benefit for ER-positive breast cancer patients whose disease has progressed following treatment with a CDK inhibitor,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We look forward to discussing these results with regulatory authorities with the goal of making this giredestrant-based regimen available to many people with advanced ER-positive breast cancer.”

ER-positive breast cancer accounts for approximately 70% of breast cancer cases. Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity. Resistance to endocrine therapies, particularly in the post-CDK inhibitor setting, increases the risk of disease progression and is associated with poor outcomes. Combination therapies, such as giredestrant plus everolimus, could address this by targeting two different signaling pathways, with the potential for improved patient outcomes. Additionally, as an all-oral combination, this regimen could help minimize the impact of treatment on people’s lives without the need for injections.

Our extensive giredestrant clinical development program spans multiple treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.

Data from the evERA study will be submitted to health authorities with the view of bringing this potential treatment option to patients as soon as possible.

About the evERA Breast Cancer study

evERA Breast Cancer [NCT05306340] is a Phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of giredestrant in combination with everolimus versus standard-of-care endocrine therapy in combination with everolimus in people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor and endocrine therapy, either in the adjuvant or locally advanced/metastatic setting.

The co-primary endpoints are investigator-assessed progression-free survival in the intention-to-treat and ESR1-mutated populations, defined as the time from randomization to the time when the disease progresses or a patient dies from any cause. The trial has been enriched for ESR1-mutated patients above the natural prevalence to assess the efficacy in this population. In the post-CDK inhibitor setting, up to 40% of people with ER-positive disease have ESR1 mutations. Key secondary endpoints include overall survival, objective response rate, duration of response, clinical benefit rate and safety.

About estrogen receptor (ER)-positive breast cancer

Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year. Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases. A defining feature of ER-positive breast cancer is that its tumor cells have receptors that attach to estrogen, which can contribute to tumor growth.

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity. Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy. There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.

About giredestrant

Giredestrant is an investigational oral, next-generation selective estrogen receptor degrader (SERD) and full antagonist.

Giredestrant is designed to block estrogen from binding to the estrogen receptor (ER), triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.

Giredestrant has an extensive clinical development program and is being investigated in five company-sponsored Phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

• Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in ER-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)
• Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)
• Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)
• Giredestrant plus investigator’s choice of a cyclin-dependent kinase (CDK) 4/6 inhibitor versus fulvestrant plus a CDK 4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)
• Giredestrant plus dual HER2 blockade versus dual HER2 blockade in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)

About Genentech in Breast Cancer

Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including estrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers.

About Genentech

Founded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Media Contact: Jared Preston, (650) 467-6800

Advocacy Contact: Katie Creme Henry, (202) 258-8228

Investor Contacts: Loren Kalm, (650) 225-3217

Bruno Eschli, +41 616875284

Scoring Big With Fans: Balchem Spotlights the Power of Vitamin K2 at FC Bayern Women’s Season Opener




Scoring Big With Fans: Balchem Spotlights the Power of Vitamin K2 at FC Bayern Women’s Season Opener

MONTVALE, N. J.–(BUSINESS WIRE)–Balchem, a leading global manufacturer of specialty ingredients for human nutrition and health – and official partner of FC Bayern (FCB) Women’s football team – has launched its first ever direct-to-consumer initiative, showcasing the power of vitamin K2 to FCB fans. The company promoted its K2VITAL™ brand with an exhibition stand at the Allianz Arena in Munich, during the opening game of the Bundesliga (German football league) on 6 September. This initiative is part of Balchem’s latest marketing strategy, which aims to raise consumer awareness of the health benefits vitamin K2 has to offer, bridging the gap between B2B and B2C markets.

Co-Branded K2 Health Vitamins Hit the Pitch

The opening event of the season provided a unique platform for Balchem to promote K2VITAL™, a patented, typically 99.7% all-trans K2 MK-7 supplement ingredient, to 57,762 football fans in attendance – a new German record. The company spotlighted co-branded products of its customer, Natsana, within the Natural Elements® brand portfolio. As part of the pre-match celebrations, visitors to the booth were encouraged to learn more about the health benefits of K2 from Balchem’s experts with a digital quiz and a cornhole game for the chance to win FCB Women co-branded merchandise. Also highlighted at the booth was a dedicated K2VITAL™ promotion page, offering fans a discount code and the chance to explore the co-branded Natural Elements® product range – including liquid drops, capsules and solutions that combine K2 with vitamin D for bone health support.

“When we initiated the partnership with FC Bayern Women, our goal was to educate consumers about vitamin K2 and reinforce the high-quality standards embodied in our K2VITAL™. The team proved to be the perfect partner – acting as outstanding ambassadors of health with over a billion fans worldwide,” comments Dominik Mattern, VP Science, Business Development and Marketing, Balchem Human Nutrition and Health. “Now, we’re taking the next step by hosting our first-ever direct-to-consumer event and harnessing the value of our branded ingredients to drive differentiation. We are so glad to be able to integrate in this first experience a collaboration with our partner Natsana, creating a mutual opportunity for growth.”

“Women’s sports are gaining popularity, especially football, with a rapidly growing global fanbase. Balchem’s partnership with FC Bayern Munich gave us the perfect opportunity to showcase the co-branded products range to a large, engaged audience,” concludes Mattern. “Featuring a trusted branded ingredient like K2VITAL™ not only strengthens confidence, but also provides a direct path for consumers to purchase our customers’ products – demonstrating how supplier-brand partnerships can deliver tangible business results.”

For more information about Balchem and its brand K2VITAL™, visit: https://balchem.com/hnh/mn/

Notes to Editors:

About Balchem Corporation

Balchem Corporation develops, manufactures, and markets specialty ingredients that improve and enhance the health and well-being of life on the planet, providing state-of-the-art solutions and the finest quality products for a range of industries worldwide. The company reports three business segments: Human Nutrition & Health; Animal Nutrition & Health; and Specialty Products. The Human Nutrition & Health segment delivers customized food and beverage ingredient systems, as well as key nutrients into a variety of applications across the food, supplement and pharmaceutical industries. The Animal Nutrition & Health segment manufactures and supplies products to numerous animal health markets. Through Specialty Products, Balchem provides specialty-packaged chemicals for use in healthcare and other industries, and also provides chelated minerals to the micronutrient agricultural market.

About K2VITAL™

K2VITAL™ is patented, typically 99.7% all-trans K2 MK-7. Identical to the K2 molecule found in nature, all-trans MK-7 is the biologically active form of vitamin K2, a fat-soluble vital vitamin that supports calcium metabolism. Vitamin K2 activates vitamin K-dependent proteins, which help direct calcium away from the arteries and deposit it into the bone, supporting bone and heart. K2VITAL™ offers uncompromising quality and stability, providing the maximum benefits of vitamin K2.

More information at:

https://balchem.com/human-nutrition-health/

Follow on LinkedIn:

https://www.linkedin.com/company/balchemhumannutritionandhealth/

Follow on Facebook:

https://www.facebook.com/BalchemHNH

Contacts

For further details, contact:

Matilde Martinuzzi
Senior PR Account Executive

BDB Global

matilde.martinuzzi@bdb.co.uk

Bettina Bendig
Director Marketing Consumer Strategy & B2B2C Growth

Balchem Human Nutrition and Health

Bettina.bendig@balchem.com