Marginum HIVEN® for Neurosurgery Is Cleared for CE Mark at Record Speed

Marginum HIVEN® for Neurosurgery Is Cleared for CE Mark at Record Speed




Marginum HIVEN® for Neurosurgery Is Cleared for CE Mark at Record Speed

KUOPIO, Finland–(BUSINESS WIRE)–#hiven–Marginum announces a significant milestone as its flagship device, HIVEN®, is cleared for the CE mark. The underlying MDR certification signifies an important regulatory milestone.




Marginum, a Finnish medical technology company, made rapid strides in validating the aspirate tissue monitoring (ATM) technique and received the MDR certificate at a record-breaking speed, just over 4.5 years. Marginum’s team successfully developed a breakthrough class IIb medical device that addresses an unmet clinical need to accurately detect tumorous tissue during surgery, without compromising existing workflows.

New era of precision in cancer surgery

HIVEN® is a novel device for assisting in intraoperative margin assessment that provides near real-time feedback to support surgeons in achieving a safer and more complete tumour resection. By providing surgical teams with immediate insight into the tumour margins while resecting, the device aims to improve patient outcomes and reduce the likelihood of reoperations. HIVEN® is designed to detect fluorescent cancer tissue from aspirated tissue during surgery without disrupting standard workflow.

“Achieving clearance for the CE mark is a pivotal step in bringing the HIVEN® into clinical practice and improving outcomes for patients in Europe. This certificate reflects the hard work of our team and the strength of our scientific and clinical foundations,” says Juho Leskinen, CTO and co-founder of Marginum.

Clinical Benefits & Indications

The aspirate tissue monitoring technology aims to overcome surgical challenges that may damage healthy tissues and leave tumour cells undetected. Incomplete removal, damage to healthy tissues, and reoperations exacerbate patient suffering, compromised standard of care, and long-term complications – all directly escalating healthcare costs.

Critical structures like blood vessels often create blind spots – behind corners and tissue ridges – where cancerous tissue can be difficult to detect. The HIVEN® aspirate tissue monitoring device addresses this challenge by allowing resected tissue to be transported directly for fluorescence analysis. This provides surgeons with more comprehensive information about the surgical site.

“In glioma surgery, our ability to distinguish tumour from healthier tissues is limited by anatomical constraints, blood and compromised visibility, particularly in deep-seated areas. We wanted HIVEN® to provide critical feedback beyond sensory limitations; you can consider it a sixth sense for tumour detection,” comments docent Antti-Pekka Elomaa MD PhD, a consultant neurosurgeon and one of Marginum co-founders.

The HIVEN® is approved for fluorescence-guided neurosurgery of high-grade gliomas, where precise margin identification is critical. HIVEN® enhances surgical accuracy by enabling objective tissue detection in hard-to-reach areas and simplifying the procedure workflow.

About Marginum:

Marginum, a leading innovator in fluorescence-guided oncological surgery, is a medical technology company developing fluorescence-based tissue detection systems. HIVEN® by Marginum enables safe and efficient monitoring of tumour tissues during cancer surgery. www.marginum.com

Contacts

Media contact:
Samu Lehtonen, CEO & Co-Founder

Email: samu.lehtonen@marginum.com
Mobile: +358405797890

https://www.marginum.com

Corstasis Therapeutics and U.S. Heart and Vascular® Collaboration Will Seek to Improve Heart Failure Care with ENBUMYST™ (Bumetanide Nasal Spray)

Corstasis Therapeutics and U.S. Heart and Vascular® Collaboration Will Seek to Improve Heart Failure Care with ENBUMYST™ (Bumetanide Nasal Spray)




Corstasis Therapeutics and U.S. Heart and Vascular® Collaboration Will Seek to Improve Heart Failure Care with ENBUMYST™ (Bumetanide Nasal Spray)

The collaboration will seek to foster the adoption of appropriate protocols and pathways for the integration of ENBUMYST™ (bumetanide nasal spray) into clinical care with the goal of reducing readmissions, improving fluid management and enhancing outcomes through the novel delivery of diuretic therapy.


HENDERSON, Nev.–(BUSINESS WIRE)–#chf–Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiovascular and renal disease, today announced a strategic collaboration with U.S. Heart and Vascular® (USHV), the nation’s premier cardiovascular management services organization, seeking to enable earlier intervention and enhance outcomes for heart failure patients. Corstasis and USHV will co-develop, and seek to optimize, value-based care pathways for the outpatient treatment of fluid overload in patients with congestive heart failure, liver disease and chronic kidney disease with ENBUMYST™ (bumetanide nasal spray).

“ENBUMYST was developed with the goal of giving providers a new, self-administered outpatient option,” said Brian Kolski M.D., Chief Medical Officer of Corstasis Therapeutics. “Our collaboration with USHV reflects a shared commitment to health system innovation, value-based care delivery and patient-centered outcomes.”

The collaboration between Corstasis and USHV will seek to:

  • Develop and validate protocols and clinical workflows that are consistent with approved labeling and enable adoption of early intervention via nasal spray diuresis when clinically indicated
  • Develop associated provider and staff training to ensure seamless integration of this important new intervention into clinical care
  • Capture outcomes and healthcare economic data to support payer engagement and future reimbursement strategies

“At USHV, we are continuously seeking new tools that empower our affiliated physicians and deliver measurable value to patients and payers,” said Emily Rash, Chief Value-Based Care Officer, USHV. “We believe an outpatient-friendly alternative represents a meaningful step forward in ambulatory heart failure care and we’re proud to work with Corstasis to bring this innovation into practice.”

The U.S. Food and Drug Administration (FDA) recently approved ENBUMYST for the treatment of edema associated with congestive heart failure (CHF), and hepatic and renal disease, including nephrotic syndrome in adults.

This effort is intended to put Corstasis and USHV at the forefront of improving outpatient heart failure management, with the goal of enabling the option of earlier intervention, reduced escalation of care and a more cost-effective path to euvolemia. Fluid overload associated with CHF, liver disease and chronic kidney disease is responsible for driving millions of hospitalizations and readmissions annually.

About ENBUMYST

ENBUMYST is a nasal spray loop diuretic indicated for the treatment of edema associated with congestive heart failure, and hepatic and renal disease, including nephrotic syndrome in adults.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR ENBUMYST™ (BUMETANIDE NASAL SPRAY).

INDICATION

ENBUMYST is indicated for the treatment of edema associated with congestive heart failure, and hepatic and renal disease, including nephrotic syndrome in adults.

IMPORTANT SAFETY INFORMATION

ENBUMYST is contraindicated in patients with anuria, who are in hepatic coma and have a history of hypersensitivity to bumetanide.

ENBUMYST is a diuretic that may cause fluid, electrolyte, and metabolic abnormalities. Excessive fluid loss can lead to dehydration, decreased blood volume, and increased risk of blood clots. Abnormalities may include changes in blood electrolytes, nitrogen, glucose, and uric acid. The chance of getting these abnormalities is higher in people who are elderly, use higher doses or who do not get enough electrolytes by mouth.

If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue bumetanide.

Although unlikely at the recommended doses, the potential for ototoxicity must be considered a risk of intravenous therapy, at high doses, repeated frequently in the face of renal excretory function impairment.

Avoid use in patients with significant nasal mucosal or structural abnormalities, such as acute episodes of rhinitis or congestion due to any cause.

Advise lactating women treated with ENBUMYST to monitor their infants for excessive urine output, dehydration, and lethargy.

Most common adverse reactions are hypovolemia, headache, muscle cramps, dizziness, hypotension, nausea and encephalopathy (in patients with pre-existing liver disease).

These are not all of the possible side effects of ENBUMYST. To report suspected adverse reactions, contact Corstasis Therapeutics at 1-877-300-5339 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for ENBUMYST.

About Corstasis Therapeutics

Corstasis Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on transforming the treatment of fluid overload in patients with heart failure, liver disease, and kidney disease. Its lead asset, ENBUMYST™ (bumetanide nasal spray), was approved by the FDA on September 12, 2025 and is designed to offer rapid, reliable diuresis outside the hospital setting. For more information, please visit www.corstasis.com.

About U.S. Heart and Vascular (USHV)

Formed in 2021 in Nashville, TN, US Heart and Vascular is a physician-led management platform enabling independent cardiologists to expand patient access, improve outcomes, and reduce costs to the healthcare system. USHV builds collaborative partnerships with best-in-class cardiovascular practices, providing non-clinical management solutions and resources that allow practices to expand access to compassionate and comprehensive care, improve patient outcomes, and strategically reduce costs to the healthcare system. Currently investing in practices across five states, USHV is actively seeking new partnerships with quality cardiovascular practices and entrepreneurial physicians across the U.S. Visit https://usheartandvascular.com/.

Contacts

Media Contacts:
Ben Esque, CEO

Corstasis Therapeutics Inc.

Phone: 702-541-9222

Email: Info@corstasis.com

Carrie Moore, VP Communications

U.S. Heart & Vascular

Email: carrie.moore@usheartandvascular.com

ClearNote Health Receives In Vitro Diagnostic Approval in United Kingdom for Avantect® Multi-Cancer Detection Test and Avantect® Ovarian Cancer Test

ClearNote Health Receives In Vitro Diagnostic Approval in United Kingdom for Avantect® Multi-Cancer Detection Test and Avantect® Ovarian Cancer Test




ClearNote Health Receives In Vitro Diagnostic Approval in United Kingdom for Avantect® Multi-Cancer Detection Test and Avantect® Ovarian Cancer Test

SAN DIEGO–(BUSINESS WIRE)–#5hmCClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced that it has received a United Kingdom Conformity Assessed (UKCA) marking for its Avantect® Multi-Cancer Detection Test and Avantect® Ovarian Cancer Test. Part of the UK’s independent product safety framework following its departure from the European Union, this designation confirms compliance with UK medical device regulations and is a prerequisite for selling products in the UK. The company’s Avantect Pancreatic Cancer Test received the same certification in July 2025.


The Avantect Multi-Cancer Detection Test is a simple blood test designed to screen for several types of cancer simultaneously in asymptomatic, generally healthy persons. It targets some of the deadliest cancers by analyzing both the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) and genomic features in circulating cell-free DNA. Unlike conventional methods, ClearNote Health’s 5hmC-based approach measures changes in active biology, offering a highly specific signal of early cancer development and identifying the likely tissue of tumor origin.

This test was one of only two assays recently selected for the critical Vanguard Study funded by the National Cancer Institute, part of the National Institutes of Health, following a thorough evaluation of 23 emerging multi-cancer detection technologies. The Vanguard Study implemented a stringent, multi-stage selection process to evaluate multi-cancer detection assays based on sensitivity, specificity, tissue of origin prediction accuracy, and assay failure rates. Key selection criteria included early-stage detection performance for at least three cancer types. The study includes nine geographically diverse clinical trial hubs and will enroll up to 24,000 total participants to assess the implementation of multi-cancer detection testing.

The Avantect Ovarian Cancer Test was designed to aid in earlier diagnosis of cancer in women at elevated risk, particularly those with inherited genetic mutations, such as BRCA1 and BRCA2, Lynch syndrome, or a strong family history of ovarian, breast, uterine, or colorectal cancer, as well as other significant risk factors. The test uses ClearNote Health’s underlying Virtuoso™ epigenomics platform to measure the presence or absence of an abnormal signal associated with ovarian cancer in cell-free DNA.

“By achieving UKCA markings for all three of our Avantect cancer tests, ClearNote Health is well poised to deliver on our mission of helping to eradicate the deadliest forms of cancer through early detection,” said Dave Mullarkey, CEO at ClearNote Health. “These regulatory milestones are a testament to the dedication of our cross-functional team as we expand into new international markets and bring our innovative, life-saving technology to more patients worldwide.”

For more information on the Avantect cancer tests, please visit www.avantect.com.

About ClearNote Health

ClearNote Health is a privately held company dedicated to improving early detection and monitoring for some of the deadliest forms of cancer. Developed by scientists in the Stephen Quake laboratory at Stanford University, the company’s patented core Virtuoso™ epigenomics platform builds on the latest advances in artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample. Its highly sensitive, noninvasive Avantect® pancreatic and ovarian diagnostic tests may identify cancers in high-risk patient populations earlier than conventional approaches, when patients may be more likely to benefit from treatment. ClearNote Health’s headquarters and CLIA-certified, CAP-accredited laboratory are located in San Diego. For more information, visit www.clearnotehealth.com or follow the company on LinkedIn.

ClearNote Health, the ClearNote Health logo, and Avantect are registered trademarks of ClearNote Health.

Contacts

Media Contact
Andrew Noble

415-722-2129

andrew@bioscribe.com

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




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




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




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




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




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

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Pfizer to Acquire Metsera and its Next-Generation Obesity Portfolio

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 61st 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




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