JSR Life Sciences Enters Definitive Agreement to Transfer Crown Bioscience to Adicon Holdings Limited




JSR Life Sciences Enters Definitive Agreement to Transfer Crown Bioscience to Adicon Holdings Limited

Strategic Transaction Positions Crown Bioscience for Accelerated Growth in Translational Oncology

SAN DIEGO–(BUSINESS WIRE)–JSR Life Sciences LLC (“JSR Life Sciences”), a global leader in life sciences materials and services, today announced it has entered into a definitive agreement to transfer Crown Bioscience Inc. (“Crown Bioscience”) to Adicon Holdings Limited (“Adicon”), a premier independent clinical laboratory provider in China and a portfolio company of The Carlyle Group. The transaction, subject to customary closing conditions, is expected to close in 2026.

This strategic move will enable Crown Bioscience to operate as a standalone entity under Adicon’s ownership. Crown Bioscience’s comprehensive portfolio of translational oncology services, including its world-leading patient-derived xenograft (PDX) models, tumor organoid platforms, immuno-oncology assays, and bioinformatics solutions, will transition to Adicon, positioning the company to accelerate advancements in precision medicine and drug discovery for oncology.

Crown Bioscience’s Global Biospecimens business, headquartered in Hamburg, Germany, with facilities in Frederick, MD, will remain fully integrated within JSR Life Sciences. The Biospecimens team will continue to benefit from JSR’s robust global resources, innovation ecosystem, and focus on ethical sourcing, custom procurement, and advanced sample processing and storage capabilities.

“After careful strategic review, we believe this transaction represents an optimal path forward for both Crown Bioscience and JSR Life Sciences,” said Tim Lowery, President and CEO of JSR Life Sciences. “Adicon’s deep domain expertise and financial backing from The Carlyle Group will empower Crown to scale its groundbreaking oncology services to new heights. As part of our long-standing onshore strategy, Crown remains firmly committed to serving clients through its global network of facilities, including its headquarters in San Diego and recent investments in the US and Europe. Initiatives like the launch of new Model Development Center in North Carolina and the expansion of biomarker and imaging capabilities in the UK ensure that customers have access to the same exceptional Crown experience, no matter where they choose to conduct their study.”

Adicon, recognized as one of China’s largest independent clinical laboratory service providers, brings complementary strengths in high-throughput testing and data analytics to the partnership. Backed by global investment firm Carlyle’s extensive network and resources in healthcare and life sciences industry, Adicon is well-positioned to support Crown Bioscience’s growth trajectory.

Ms. Yang Ling, Chairwoman of Adicon and Head of Asia Healthcare at Carlyle, commented, “This acquisition represents an important milestone in Adicon’s growth journey. With Crown Bioscience’s world-class CRO capabilities, Adicon is expanding its reach across the global healthcare value chain– from clinical diagnostics to drug discovery and translational research. This transaction reinforces Adicon’s vision to become a trusted partner for biopharma innovation and precision diagnostics.”

Until the transaction closes, Crown Bioscience will continue to operate as a wholly owned subsidiary of JSR Life Sciences, with no anticipated disruptions to ongoing services, projects, or customer relationships. JSR and Adicon are committed to a smooth transition, maintaining the highest standards of quality, compliance, and innovation across all operations.

About JSR Life Sciences LLC

JSR Life Sciences LLC is a division of JSR Corporation, a Tokyo-based global leader in high-performance materials for life sciences, electronics, and other industries. With a focus on enabling breakthroughs in precision medicine, JSR Life Sciences delivers innovative solutions in cell culture, bioseparation, and bioprocessing, supporting customers from research to commercialization. For more information, visit www.jsrlifesciences.com.

About Crown Bioscience Inc.

Crown Bioscience, a JSR Life Sciences company and global CRO, specializes in oncology and immuno-oncology drug discovery and development. We partner with biotech and pharmaceutical companies to provide innovative, tailored solutions spanning preclinical research, translational platforms, and clinical trial support. With over 1000 tumor organoid models and the largest commercially available PDX collection, our expertise spans in vivo, in vitro, ex vivo, and in silico methods. We operate in multiple facilities across the US, Europe, and APAC, meeting the highest industry standards, including accreditation by the College of American Pathologists (CAP) and the International Organization for Standardization (ISO).

To learn more, visit www.crownbio.com.

About Adicon

Adicon Holdings Limited (HKEX: 9860.HK) is one of China’s leading independent clinical laboratory service providers, offering comprehensive diagnostic testing services primarily to hospitals, health check centers and biopharmaceuticals through an integrated network of self-operated laboratories across the country. The company provides a broad testing portfolio covering routine and esoteric tests across multiple disease areas, supported by internationally accredited laboratories that meet ISO15189 standards. With a proven track record of operational excellence, national coverage, and strong quality assurance, Adicon has established itself as a trusted partner to healthcare institutions and professionals, contributing to the advancement of precision diagnostics and improved healthcare outcomes in China.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially, including but not limited to regulatory approvals, market conditions, and integration challenges. For a discussion of these risks, please refer to the companies’ filings with relevant regulatory authorities.

Contacts

Media Inquiries:

Crown Bioscience

Sarah Martin-Tyrrell

pr@crownbio.com

Flipping the script: Scripta Therapeutics raises $12M to find disease-modifying drugs that alter transcription factor activity




Flipping the script: Scripta Therapeutics raises $12M to find disease-modifying drugs that alter transcription factor activity

• $12 million seed funding round led by Oxford Science Enterprises and Apollo Health Ventures, with AlbionVC, YZR Capital, and Parkwalk Advisors, and support from Oxford University Innovation
• Scripta takes a biology-first approach to discover disease-modifying drugs that modulate transcription factor activity and reprogram biology
• Ray Barlow joins board as Non-Executive Director

OXFORD, England–(BUSINESS WIRE)–Techbio startup Scripta Therapeutics emerges from stealth by announcing a $12 million seed round to upend conventional approaches to drug discovery.

Scripta combines AI, imaging, and unique patient-derived models to create and modulate disease maps based on transcriptional networks, building a new biology-first paradigm to decode and undo the programs that drive disease.

The round is led jointly by Oxford Science Enterprises (OSE) and Apollo Health Ventures, with further investment from AlbionVC, YZR Capital, and Parkwalk Advisors, and support from Oxford University Innovation.

Modulating transcription factor activity to reprogram biology

Scripta’s unique approach is based on the concept that transcription factors, the master controllers of gene expression, are core drivers of disease and act as detailed and dynamic maps of the mechanisms that underpin it.

Through a data-rich, lab-in-the-loop combination of experimental biology with cutting-edge AI and informatics, Scripta aims to efficiently identify therapeutics that modulate these maps to restore healthy cell states.

Biology decoded, disease undone

While the platform can be applied to any disease, the team is focusing first on Alzheimer’s disease and other neurodegenerative conditions in collaboration with scientific co-founder Noel Buckley, Professor of Neurobiology at the University of Oxford.

Peter Hamley, founder and CEO of Scripta, said, “We’re flipping the script on conventional target-based drug discovery to find therapies that genuinely move the needle for patients. By focusing on understanding and manipulating the master controllers of biology, we’re searching for drugs with the potential not just to delay disease progression but to stop it in its tracks.”

Experienced biotech business builder Ray Barlow, CEO of SynOx Therapeutics, has also been brought on to strengthen Scripta’s board as a Non-Executive Director.

He said, “Scripta brings fresh thinking and a novel biology-led, data-rich approach to a traditionally challenging area of drug discovery. I am looking forward to working with this outstanding team to deliver effective new medicines that are long overdue for so many patients.”

Claire Brown, Partner at OSE and board member of Scripta, said, “We’re proud to be backing Scripta – a brilliant team that exemplifies the next generation of technology-enabled drug discovery and capitalises on the strength of the University of Oxford and the wider Oxford ecosystem.”

Marianne Mertens, Partner at Apollo Health Ventures, said, “Manipulating transcription factors in disease has long been seen as an intractable challenge, yet it holds tremendous promise for treating neurodegeneration and other life-limiting conditions. Scripta’s innovative approach could deliver transformational therapies and exemplifies one of Apollo’s key investment strategies: reprogramming diseased cells into healthy ones to tackle the root causes of age-related diseases and enable disease-modifying treatments.”

Find out more at scriptatherapeutics.com.

About Scripta Therapeutics

Scripta Therapeutics is an Oxford-based techbio company on a mission to deliver transformative therapeutics through cutting edge technology. By focusing on altering the activity of transcription factors – the master controllers of biology – Scripta is searching for drugs with the potential not just to delay disease progression, but to halt or even reverse it. Combining pharma, biotech, and disease biology expertise with the computational power to push the boundaries of biology, Scripta aims to deliver disease-modifying therapeutics that transform outcomes for patients.

Contacts

Media contact: Kat Arney scripta@firstcreatethemedia.com

Virometix AG Announces Completion of $15 Million Financing Round to Advance Development of V-212 and Next-Generation Synthetic Vaccines




Virometix AG Announces Completion of $15 Million Financing Round to Advance Development of V-212 and Next-Generation Synthetic Vaccines

SCHLIEREN, Switzerland–(BUSINESS WIRE)–Virometix AG, a clinical-stage biotechnology company pioneering fully synthetic vaccines, today announced the completion of a $15 million financing round from existing shareholders. The funds will support continued clinical and development activities for V-212, Virometix’s lead serotype-independent pneumococcal vaccine candidate, currently in Phase I clinical evaluation.

Proceeds from the financing will be used to:

• Advance the ongoing Phase I clinical trial of V-212, with topline results expected in Q1 2026.
• Prepare for a planned Phase Ib combination trial evaluating V-212 with an approved pneumococcal conjugate vaccine (PCV).
• Complete OPK assay validation to support immunogenicity and functional data read-outs.
• Implement platform enhancements to the company’s proprietary Synthetic Virus-Like Particle (SVLP) technology.
• Progress next-generation serotype-independent pneumococcal vaccine programs toward preclinical development.

“This financing demonstrates the continued confidence and commitment of our investors to Virometix’s mission and platform,” said Anna Sumeray, Chief Executive Officer of Virometix. “Our fully synthetic SVLP technology enables the design of broad-spectrum, self-adjuvanted vaccines with highly scalable manufacturing. With V-212 in clinical development, we are well positioned to deliver a truly next-generation approach to pneumococcal prevention.”

About V-212

V-212 is a fully synthetic, serotype-independent, peptide-based vaccine designed to prevent Streptococcus pneumoniaeinfections. The vaccine incorporates multiple conserved antigenic epitopes from key pneumococcal surface proteins conjugated to Virometix’s proprietary SVLP nanoparticles, which include built-in adjuvant elements such as T-helper epitopes and Toll-like receptor (TLR) ligands. This unique design eliminates dependence on biological carrier proteins and allows for a streamlined, fully synthetic manufacturing process.

Preclinical studies demonstrated robust and durable immunogenicity in mouse and rabbit models, protection against lethal sepsis, and cross-reactivity with multiple pneumococcal serotypes, including non-PCV-13 types—underscoring V-212’s potential for broad protection.

The ongoing Phase I clinical trial (NCT06975319) is a randomized, double-blind, placebo-controlled, first-in-human study being conducted at the Centre for Vaccinology (CEVAC), Ghent University Hospital. Sixty healthy volunteers aged 18–45 have been enrolled, and topline safety and immunogenicity data are anticipated in the first quarter of 2026.

About Virometix

Virometix AG is a privately held biotechnology company developing a new generation of fully synthetic vaccines to elicit targeted and protective immune responses against infectious diseases and cancer. The company’s proprietary Synthetic Virus-Like Particle (SVLP) platform combines rational molecular design and chemical synthesis to rapidly generate optimized vaccine candidates with superior safety, efficacy, manufacturability, and stability profiles.

Learn more at www.virometix.com

Contacts

Media Contact
David Rosen

Argot Partners

Phone: +1 646.461.6387

Email: david.rosen@argotpartners.com

Innate Pharma Reports Third Quarter 2025 Business Update and Financial Results




Innate Pharma Reports Third Quarter 2025 Business Update and Financial Results

• Following FDA clearance for confirmatory Phase 3 trial TELLOMAK-3, lacutamab is progressing toward Phase 3 initiation in H1 2026 and potential accelerated approval in Sézary syndrome
• IPH4502 Nectin-4 ADC Phase 1 enrollment continues to progress well – pharmacologically active dose reached
• Monalizumab PACIFIC-9 on track to deliver data in H2 2026
• Cash position of € 56.4 million¹ as of September 30, 2025, anticipated cash runway until end Q3-2026
• Conference call to be held today at 2:00 p.m. CET / 8:00 a.m. ET

MARSEILLE, France–(BUSINESS WIRE)–#immunotherapy–Regulatory News:

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced its business update and financial results for the first nine months of 2025.

“This quarter highlights strong execution across our key programs,” said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. “With FDA clearance to initiate TELLOMAK-3, we are advancing lacutamab toward its confirmatory Phase 3 and potential accelerated approval in Sézary syndrome. We remain on track for dose-escalation data, from IPH4502, our Nectin-4 ADC, in the first half of 2026, followed by monalizumab PACIFIC-9 results in the second half of 2026. Together, these milestones position us well to deliver meaningful value for patients and shareholders as we continue to advance our differentiated portfolio.”

Pipeline highlights:

Strategic focus

As previously announced, Innate Pharma is prioritizing its investment on what it believes are its highest-value clinical assets, IPH4502, lacutamab, and monalizumab (partnered with AstraZeneca); and advancing the next Antibody Drug Conjugates (ADCs) toward development, leveraging its pipeline of innovative targets.

Lacutamab (anti-KIR3DL2 antibody):

Cutaneous T Cell Lymphoma

• The Company announced on November 10 that the U.S. Food and Drug Administration (FDA) has completed its review of the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas (CTCL), with no further comments, clearing the trial to proceed.
• The planned confirmatory Phase 3 trial, TELLOMAK-3, is an open-label, randomized study designed to demonstrate the efficacy of lacutamab in patients with Sézary syndrome and Mycosis fungoides, who failed at least one prior line of systemic therapy. The trial will include two independent cohorts: one enrolling patients with Sézary syndrome post-mogamulizumab treatment randomized 1:1 to receive lacutamab or romidepsin, and one enrolling patients with Mycosis fungoides randomized 1:1 to receive lacutamab or mogamulizumab. The primary endpoint of the study for both cohorts is progression-free survival (PFS) evaluated by blinded central review.
• Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. With this feedback from FDA, the Company is progressing towards the initiation of the confirmatory Phase 3 TELLOMAK-3 trial in H1 2026. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome, once the Phase 3 trial is underway.
• The Company held a KOL event on October 28, 2025 on lacutamab and provided updates on the planned Phase 3 trial, the regulatory pathway in CTCL, and the commercial opportunity for lacutamab.

Peripheral T Cell lymphoma (PTCL)

• The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an investigator-sponsored, randomized controlled trial led by the Lymphoma Study Association (LYSA) to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL is ongoing and continues to recruit patients.

IPH4502 (Nectin-4 exatecan ADC):

• The Phase 1 trial will assess the safety, tolerability, and preliminary efficacy of IPH4502 in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers. The study plans to enroll approximately 105 patients.
• The first patient was dosed in the Phase 1 study in January 2025. Enrollment of the dose escalation part continues to progress well and is expected to be completed at the end of 2025 or in the first quarter of 2026. Pharmacologically active dose has been reached.

Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

• The Phase 3 PACIFIC-9 trial run by AstraZeneca evaluating durvalumab (anti-PD‑L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT) is ongoing. Enrollment in the trial is complete, and data readouts are expected in H2 2026.

Other Clinical stage assets

IPH6501 (ANKET^® anti-CD20 with IL-2V, proprietary): The Phase 1/2 clinical trial is evaluating IPH6501 in B-cell Non-Hodgkin’s lymphoma (B-NHL). The study is planned to enroll up to 184 patients. Clinical sites are open in the US, Australia, and France. Enrollment in the dose escalation phase of the trial is complete. Clinical data are expected to be presented in 2026.

IPH6101 (ANKET^® anti-CD123, proprietary): Innate regained the rights to SAR’579/IPH6101 in July 2025. Data from the Sanofi-led Phase 1/2 study and Phase 2 preliminary dose expansion of the trial have been transferred to Innate and the Company is evaluating potential next steps.

IPH5201 (anti-CD39 antibody, partnered with AstraZeneca): The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201, an anti CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, is ongoing, and recruitment is on track.

IPH5301 (anti-CD73, proprietary): The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing.

Corporate update

• As previously announced, in line with its strategic focus, the Company intends to streamline its organization. Planned layoffs will be implemented through a redundancy plan, expected to be completed during the first half of 2026. A consultation with the Workers’ Council is ongoing and the plan is subject to endorsement by the French authorities (Dreets).
• The ATM program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million of American Depositary Shares (“ADS”) is still in place. As of September 30, 2025, no sales have been made under the program.

Financial Results

Cash, cash equivalents and financial assets of the Company amounted to €56.4 million as of September 30, 2025. At the same date, financial liabilities amounted to €24.8 million.

Revenues for the first nine months of 2025 amounted to €2.3 million (€10.2 million for the same period in 2024). For the nine-month period, ended September 30, 2025, revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi.

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Leveraging its expertise on antibody-engineering and innovative target identification, Innate Pharma is developing innovative and differentiated next-generation antibody therapeutics.

Innate Pharma is advancing a portfolio of differentiated potential first- and/or best-in-class assets, focused on areas of high unmet medical need, including IPH4502, a differentiated Nectin-4 ADC developed in solid tumors, lacutamab, an anti-KIR3DL2 antibody developed in cutaneous T cell lymphomas and peripheral T cell lymphomas, and monalizumab, an anti-NKG2A antibody developed in collaboration with AstraZeneca in non-small cell lung cancer.

Innate Pharma has established collaborations with leading biopharmaceutical companies, including Sanofi and AstraZeneca, as well as renowned academic and research institutions, to advance innovation in immuno-oncology.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.

Information about Innate Pharma shares

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, including the statements regarding the timing of dose-escalation data for IPH4502, the timing of results for monalizumab PACIFIC-9, the timing of lacutamab Phase 3 and potential acceleration thereof, the contours and planned enrollment of the upcoming trials and studies, and the planned streamlining of the organization, including layoffs. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release.

In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Contacts

For additional information, please contact:

Innate Pharma
Stéphanie Cornen

stephanie.cornen@innate-pharma.fr

Investor Relations
investors@innate-pharma.fr

Medias
communication@innate-pharma.fr

Ionis Prices Convertible Notes Offering to Refinance 2026 Convertible Notes




Ionis Prices Convertible Notes Offering to Refinance 2026 Convertible Notes

– Refinancing transaction with proceeds to be utilized to repurchase or repay the 2026 Convertible Notes prior to or at maturity

CARLSBAD, Calif.–(BUSINESS WIRE)–Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today the pricing of $700.0 million aggregate principal amount of 0.00% Convertible Senior Notes due 2030 (the “notes”) in a private placement (the “offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Ionis also granted the initial purchasers of the notes an option to purchase, within the 13-day period beginning on, and including, the date on which the notes are first issued, up to an additional $70.0 million aggregate principal amount of notes from Ionis. The sale of the notes is expected to close on November 17, 2025, subject to customary closing conditions.

The notes will be general unsecured obligations of Ionis, and will not bear regular interest and the principal amount of the notes will not accrete. The notes will mature on December 1, 2030, unless earlier converted, redeemed or repurchased.

Ionis estimates that the net proceeds from the offering will be approximately $682.8 million (or approximately $751.2 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Ionis.

Ionis expects to use approximately $267.6 million of the net proceeds from the offering to repurchase for cash $200.0 million in aggregate principal amount of its 0% Convertible Senior Notes due 2026 (the “2026 notes”) pursuant to the concurrent note repurchase transactions described below. Ionis expects to use the remaining net proceeds from the offering for additional repurchases of the 2026 notes from time to time following the offering, including the repayment of any remaining 2026 notes at maturity, and for general corporate purposes.

Before September 1, 2030, holders will have the right to convert their notes only upon the satisfaction of specified conditions and during certain periods. On or after September 1, 2030 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their notes at any time. Upon conversion, Ionis will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The conversion rate for the notes will initially be 10.1932 shares of Ionis’ common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $98.10 per share of Ionis’ common stock). The initial conversion price represents a premium of approximately 35.0% over the last reported sale price of $72.67 per share of Ionis’ common stock on November 12, 2025. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued or unpaid special interest, if any.

Ionis may not redeem the notes prior to December 6, 2028. Ionis may redeem for cash all or any portion of the notes (subject to certain limitations), at its option, on a redemption date on or after December 6, 2028 if the last reported sale price of Ionis’ common stock has been at least 130% of the conversion price for the notes 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 Ionis provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid special interest, if any, to, but excluding, the redemption date. However, Ionis may not redeem less than all of the outstanding notes unless at least $100.0 million aggregate principal amount of notes are outstanding and not called for redemption as of the time Ionis sends the related notice of redemption. No sinking fund is provided for the notes.

If Ionis undergoes a “fundamental change” (as defined in the indenture that will govern the notes), then, subject to certain conditions and limited exceptions, holders may require Ionis to repurchase for cash all or any portion of their notes at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid special interest, if any, to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date or if Ionis delivers a notice of redemption, Ionis will, in certain circumstances, increase the conversion rate for a holder who elects to convert its notes in connection with such a corporate event or convert its notes called (or deemed called) for redemption during the related redemption period (as defined in the indenture that will govern the notes), as the case may be.

Concurrently with the pricing of the notes in the offering, Ionis entered into separate and individually negotiated transactions with certain holders of the 2026 notes to repurchase for cash $200.00 million in aggregate principal amount of the 2026 notes on terms negotiated with each holder (each, a “concurrent note repurchase transaction”). This press release is not an offer to repurchase the 2026 notes, and the offering of the notes is not contingent upon the repurchase of any of the 2026 notes.

In connection with any repurchase of the 2026 notes, Ionis expects that holders of the 2026 notes who agree to have their 2026 notes repurchased and who have hedged their equity price risk with respect to such notes (the “hedged holders”) will unwind all or part of their hedge positions by purchasing Ionis’ common stock and/or entering into or unwinding various derivative transactions with respect to Ionis’ common stock. The amount of Ionis’ common stock to be purchased by the hedged holders or in connection with such derivative transactions may be substantial in relation to the historic average daily trading volume of Ionis’ common stock. This activity by the hedged holders could increase (or reduce the size of any decrease in) the market price of Ionis’ common stock, including concurrently with the pricing of the notes, resulting in a higher effective conversion price of the notes. Ionis cannot predict the magnitude of such market activity or the overall effect it will have on the price of the notes or Ionis’ common stock.

The notes and any shares of Ionis’ common stock issuable upon conversion of the notes have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

About Ionis Pharmaceuticals

For three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis has marketed medicines and a leading pipeline in neurology, cardiometabolic and other areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients.

Ionis’ Forward-looking Statement

This press release includes forward-looking statements regarding the offering, including statements regarding the anticipated completion and timing of the offering, the expected repurchase of 2026 notes, including the concurrent note repurchase transactions, the expected unwind by the hedged holders of their hedge positions and the anticipated effects of such actions, and Ionis’ expected use of proceeds from the offering. Any statement describing Ionis’ expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including, without limitation, changes in market conditions, whether Ionis will be able to satisfy closing conditions related to the offering, whether and on what terms Ionis may repurchase or repay any of the 2026 notes, the concurrent note repurchase transactions, the actions of the hedged holders and unanticipated uses of capital. Ionis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis’ programs are described in additional detail in Ionis’ annual report on Form 10-K for the year ended December 31, 2024 and most recent Form 10-Q, which are on file with the Securities and Exchange Commission, as well as other subsequent filings Ionis makes with the Securities and Exchange Commission from time to time. Copies of these and other documents are available from Ionis.

In this press release, unless the context requires otherwise, “Ionis,” “Company,” “we,” “our,” and “us” refers to Ionis Pharmaceuticals and its subsidiaries.

Ionis Pharmaceuticals^® is a trademark of Ionis Pharmaceuticals, Inc.

Contacts

Ionis Investor Contact:
D. Wade Walke, Ph.D.

IR@ionisph.com
760-603-2331

Ionis Media Contact:
Hayley Soffer

media@ionis.com
760-603-4679

enGene Announces Pricing of $130 Million Public Offering of Common Shares and Pre-Funded Warrants




enGene Announces Pricing of $130 Million Public Offering of Common Shares and Pre-Funded Warrants

BOSTON & MONTREAL–(BUSINESS WIRE)–enGene Holdings Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced the pricing of its previously announced underwritten public offering of 12,558,823 common shares at a public offering price of $8.50 per share and pre-funded warrants to purchase 2,735,295 shares of its common shares at an offering price of $8.4999 per pre-funded warrant, in each case, before underwriting discounts and commissions. The aggregate gross proceeds to enGene from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by enGene, are expected to be approximately $130 million. All securities to be sold in the offering will be offered by enGene. In addition, enGene has granted to the underwriters a 30-day option to purchase up to 2,294,117 additional common shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about November 14, 2025, subject to the satisfaction of customary closing conditions.

Jefferies, Leerink Partners and Wells Fargo Securities are acting as joint book running managers for the offering. Raymond James and Van Lanschot Kempen are acting as co-lead managers for the offering. H.C. Wainwright & Co. is acting as co-manager for the offering.

The securities described above are being offered by enGene pursuant to its effective shelf registration statement on Form S-3 (File No. 333-283201) filed with the U.S. Securities and Exchange Commission (the “SEC”) on November 13, 2024 and declared effective on November 21, 2024. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website at http://www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, telephone: (877) 821-7388, or by emailing prospectus_department@jefferies.com; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; or Wells Fargo Securities, LLC, 90 South 7th Street, 5th Floor, Minneapolis, MN 55402, by telephone at (800) 645-3751 (option #5), or by email at WFScustomerservice@wellsfargo.com.

No securities are being offered or sold, directly or indirectly, in Canada or to any resident of Canada.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state or other 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 other jurisdiction.

About enGene

enGene is a clinical-stage biotechnology company mainstreaming genetic medicine through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene’s lead program is detalimogene voraplasmid (also known as detalimogene, and previously EG-70) for patients with non-muscle invasive bladder cancer (NMIBC), a disease with a high clinical burden. Detalimogene is being evaluated in the ongoing multi-cohort LEGEND Phase 2 trial, which includes a pivotal cohort studying detalimogene in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive patients with carcinoma in situ (CIS) with or without concomitant papillary disease. Detalimogene was developed using enGene’s proprietary Dually Derivatized Oligochitosan® (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA.

Forward-Looking Statements

Certain statements contained in this press release may constitute “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). enGene’s forward-looking statements include, but are not limited to, statements regarding enGene’s management teams’ expectations, hopes, beliefs, intentions, goals, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements, and they may also include statements express or implied, about enGene’s expectations regarding the offering, including the timing, structure and completion of the offering on the anticipated size and terms, the grant to the underwriters of the option to purchase additional shares and the potential value and clinical benefit of enGene’s product candidates. The words “anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “intends”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “seek”, “should”, “would”, and similar expressions (or the negative version of such words or expressions) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.

Many factors, risks, uncertainties, and assumptions could cause the Company’s actual results, performance, or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, uncertainties related to market conditions, the satisfaction of customary closing conditions related to the offering, general economic conditions, , and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission (“SEC”) on EDGAR, including those described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2024 (copies of which may be obtained at www.sedarplus.ca or www.sec.gov).

You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene’s assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.

Contacts

For media contact:

media@engene.com

For investor contact:

investors@engene.com

Niagen Bioscience Announces Results from First-Ever Randomized Controlled Trial Exploring Niagen (Patented Nicotinamide Riboside, NR) Supplementation in Long COVID




Niagen Bioscience Announces Results from First-Ever Randomized Controlled Trial Exploring Niagen (Patented Nicotinamide Riboside, NR) Supplementation in Long COVID

Findings show a significant increase in NAD+ levels and within-group benefits in fatigue, depression, and sleep quality

LOS ANGELES–(BUSINESS WIRE)–$NAGE #Biotech—Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today shared promising results from the first-of-its-kind clinical trial published today in The Lancet peer-reviewed journal eClinicalMedicine demonstrating that daily supplementation with Niagen^®, Niagen Bioscience’s patented nicotinamide riboside (NR) ingredient, significantly increased NAD+ levels and improved executive functioning, fatigue, depression, and sleep quality, when compared to their baseline levels, in some individuals with long COVID, also known as post-acute sequelae of SARS-CoV-2 infection (PASC).

The 58 participant, randomized, double-blind, placebo-controlled study was led by Edmarie Guzmán-Vélez, PhD, formerly an Assistant Professor in the Department of Psychiatry and the McCance Center for Brain Health at Massachusetts General Hospital, and now Assistant Professor in the Department of Neurology at the Robert Wood Johnson Medical School, and the Center for Health Aging Research (CHAR) at the Institute for Health, Rutgers University.

“These findings demonstrate that ten weeks of Niagen NR supplementation increased NAD+ levels and improved long COVID symptoms of fatigue, sleep quality, and depression, compared to symptoms before treatment,” said Rob Fried, Chief Executive Officer of Niagen Bioscience. “As part of our mission to advance the science of cellular health, we are pleased to see Niagen NR used in research exploring the lasting impact of COVID-19 and look forward to future studies that further our understanding of NAD+ augmentation in recovery and resilience.”

Long COVID continues to affect a significant number of individuals around the globe, with no proven treatments available. According to the U.S. Centers for Disease Control and Prevention, between August and September 2024, 5.3% of adults in the U.S. reported that they are currently experiencing long COVID.

“Our goal with this study was to understand whether increasing NAD+ levels with NR could improve cognitive performance primarily, but also other common symptoms in individuals with long COVID,” said Dr. Guzmán-Vélez. “We saw encouraging within-group improvements in fatigue, sleep, and mood, although we did not observe statistically significant differences between people taking NR and those taking a placebo. These findings suggest that restoring NAD+ remains a promising avenue for recovery and advancing our understanding of how to help individuals affected by long COVID. More research is needed to confirm and expand on these findings.”

The Connection Between NAD+ & Long COVID

A multi-system disorder, long COVID symptoms persist months or years after infection, including common fatigue, breathlessness, cognitive impairment or “brain fog” (attention, memory, sleep), muscle aches, depression, and anxiety (Taher et al., 2025, Soriano et al., 2022, Ely et al., 2024, Taquet et al., 2022, Davis et al., 2021). Emerging evidence suggests that interacting mechanisms underlie long COVID, including immune dysregulation, mitochondrial dysfunction, oxidative stress, disrupted cellular energy metabolism, and depletion of NAD+, a molecule crucial for cellular energy and repair (Block et al., 2022).

“Long COVID presents with a wide range of symptoms because coronaviruses disturb NAD+ and thereby disturb multiple organ systems,” commented Charles Brenner, PhD, Alfred E Mann Family Foundation Chair in Diabetes and Cancer Metabolism at City of Hope, Chief Scientific Advisor to Niagen Bioscience, and study co-author. “What is encouraging is that despite variability among patients, we observed consistent signals of improvement with elevation of NAD+ levels. This suggests that restoring the NAD+ system can restore multiple biological pathways implicated in long COVID — including mitochondrial function, inflammation, and cellular repair. It is a compelling indication that NAD+ biology can be effectively targeted in conditions of metabolic stress such as long COVID.”

Study Overview

This 24-week, randomized, double-blind, placebo-controlled, parallel group study analyzed the effects of elevating NAD+ with Niagen NR supplementation on cognitive and symptomatic recovery in individuals with long COVID.

A total of 58 non-hospitalized adults (mean age, 45.1 years) with persistent symptoms following COVID-19 infection were randomized to receive either Niagen NR (2,000 mg/day) for 20 weeks or placebo for 10 weeks, followed by Niagen NR for an additional 10 weeks. The study included a two-week placebo lead-in period and a two-week follow-up period.

The primary endpoint analyzed the change in cognitive performance, measured using validated scales and tests, including the Everyday Cognition (ECog), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and Trail Making Test-B (TMT-B). Secondary endpoints were assessed using standardized scales to evaluate fatigue, mood, and sleep quality (FSS, BDI, BAI, and PSQI).

Study Highlights

• NAD+ levels increased up to 3.1-fold after 5–10 weeks of Niagen NR supplementation, confirming NAD+ restoration in whole blood.
• In the post-hoc exploratory analysis, significant within-group improvements were observed in fatigue severity (FSS), sleep quality (PSQI), and depressive symptoms (BDI) following 10 weeks of Niagen NR supplementation.
• Niagen NR was well-tolerated, with no significant differences in adverse events between the Niagen NR and placebo groups.
• Statistically significant differences between the Niagen NR and placebo groups were not observed for primary or secondary outcomes, likely due to the small sample size and high dropout rates resulting from reinfection, relocation, and medication changes, which reduced statistical power. This underscores the need for larger studies to further understand the observed trends in symptom improvement.

Relevance

This study is the first randomized controlled trial to demonstrate that Niagen NR supplementation safely and effectively elevates NAD+ levels in individuals with long COVID, a condition marked by fatigue, cognitive dysfunction, and sleep disturbance.

While between-group differences were not statistically significant, these findings show within-group improvements from baseline in key symptoms and establish NAD+ restoration as a measurable biological response, suggesting a potential therapeutic role of NAD+ in post-viral recovery and energy metabolism.

These results build upon a growing body of evidence linking NAD+ repletion to improved mitochondrial function and cellular resilience, suggesting a possible new avenue for addressing persistent symptoms associated with long COVID. Further large-scale, placebo-controlled studies are warranted to build upon these early findings.

The study was funded by the McCance Center for Brain Health at Mass General Hospital and by Niagen Bioscience. While Niagen Bioscience partially funded the study and provided Niagen NR and placebo materials, it had no role in study design, conduct, outcomes, analyses, or study publication.

For additional information on the science supporting Niagen, visit www.niagenbioscience.com.

About Niagen Bioscience:

Niagen Bioscience, Inc. (NASDAQ: NAGE), formerly ChromaDex Corp., is the global leader in NAD+ (nicotinamide adenine dinucleotide) science and healthy-aging research. As a trusted pioneer of NAD+ discoveries, Niagen Bioscience^™ is dedicated to advancing healthspan through precision science and innovative NAD+-boosting solutions.

The Niagen Bioscience team, composed of world-renowned scientists, works with independent investigators from esteemed universities and research institutions around the globe to uncover the full potential of NAD+. A vital coenzyme found in every cell of the human body, NAD+ declines with age and exposure to everyday lifestyle stressors. NAD+ depletion is a key contributor to age-related changes in health and vitality.

Distinguished by state-of-the-art laboratories, rigorous scientific and quality protocols, and collaborations with leading research institutions worldwide, Niagen Bioscience sets the gold standard for research, quality, and innovation. There’s a better way to age.

At the heart of its clinically proven product portfolio is Niagen^® (patented nicotinamide riboside, or NR), the most efficient, well-researched, high-quality, and legal NAD+ booster available.

Niagen Bioscience’s robust patent portfolio protects NR and other NAD+ precursors. Niagen Bioscience maintains a website at www.niagenbioscience.com, where copies of press releases, news, and financial information are regularly published.

Forward Looking Statements:

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, without limitation, statements related to the potential health benefits of Niagen^® (nicotinamide riboside) supplementation, the interpretation of clinical study findings, future research directions, and matters related to the infringement or non-infringement of intellectual property rights. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as “expects,” “anticipates,” “intends,” “estimates,” “plans,” “potential,” “possible,” “probable,” “believes,” “seeks,” “may,” “will,” “should,” “could,” or the negative of such terms, or other similar expressions.

Forward-looking statements are based on current expectations, assumptions, and scientific understanding, and are subject to numerous risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those described or implied. These risks and uncertainties include, but are not limited to: the inherent variability of scientific research and clinical outcomes; the possibility that future studies may not confirm the results described herein; the ability to obtain and maintain necessary regulatory approvals; the scientific, regulatory, and commercial challenges inherent in dietary supplements and healthy-aging research; market acceptance of the Company’s products and educational initiatives; the outcome of ongoing or future clinical studies; the protection and enforcement of intellectual property; competition; and other factors described in Niagen Bioscience’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Q.

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement, and Niagen Bioscience undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as required by applicable law.

Contacts

Niagen Bioscience Media Contact:
Kendall Knysch, Senior Director of Public Relations & Communications

310.405.5227

kendall.knysch@niagenbio.com

Niagen Bioscience Investor Relations Contact:
ICR, LLC

Reed Anderson

(646) 277-1260

Stephanie Carrington

(646) 277-1282

niagenir@icrinc.com

LabGenius Therapeutics Announces Poster Presentation at the ESMO Immuno-Oncology Congress 2025




LabGenius Therapeutics Announces Poster Presentation at the ESMO Immuno-Oncology Congress 2025

LONDON–(BUSINESS WIRE)–#AI—LabGenius Therapeutics (“LabGenius”), a drug discovery company combining artificial intelligence (AI) and high-throughput experimentation to advance next-generation multispecific antibodies for solid tumours, today announced a scientific poster will be presented at the ESMO Immuno-Oncology Congress 2025, being held December 10 – 12, 2025, at the Queen Elizabeth II Centre in London, United Kingdom. LabGenius’ presentation will debut the pre-clinical in vivo efficacy (>90% tumour growth inhibition) and tolerability data for their lead asset, a highly tumour selective bispecific T-cell engager (TCE).

Poster Presentation Details

Bispecific TCE Overview

For the selected target, LabGenius has developed a selectivity-enhanced TCE. The company’s lead optimisation platform, EVA™, was used to discover and concomitantly optimise a TCE with improved killing selectivity, potency, efficacy, and manufacturability. The biological mechanism underlying this enhanced selectivity is based on the principle of avidity. By harnessing avidity-driven selectivity, the optimised TCE can distinguish between healthy and diseased cells based on differential tumour-associated antigen expression.

About LabGenius Therapeutics

LabGenius Therapeutics is a drug discovery company pioneering the discovery of next-generation therapeutic antibodies. The company’s discovery platform, EVA™, integrates several cutting-edge technologies drawn from the fields of artificial intelligence, robotic automation and synthetic biology. LabGenius Therapeutics operates a hybrid business model that includes partnering with biotech and pharmaceutical companies in parallel with pursuing a wholly-owned therapeutic pipeline. For more information, please visit www.labgeniustx.com, or connect on LinkedIn.

Contacts

Media: press@labgeni.us
Corporate / business development: partnerships@labgeni.us

Indero Announces Breakthrough Method for Early-Phase Evaluation of Topical Drugs Using Quantitative Gene Expression




Indero Announces Breakthrough Method for Early-Phase Evaluation of Topical Drugs Using Quantitative Gene Expression

MONTREAL–(BUSINESS WIRE)–Indero is proud to announce the successful completion of an internally funded study that introduces a novel approach to evaluating topical new chemical entities (NCE) in early-phase clinical research. This innovative method leverages quantitative gene expression analysis to assess drug efficacy rapidly and cost effectively.

Dr. Robert Bissonnette, Executive Chairman and Founder of Indero, who initiated and led the study, shared his excitement about the results:

“Our goal was to rethink how to study topical drugs in early phase studies. The results of this study demonstrate that microdosing for only 3 days can provide meaningful efficacy signals. Within just 24 hours, we observed alterations in gene expression after applying a microdose of mid-potency corticosteroid on the skin of patients. By 72 hours, Th2, Th22 and Th17-specific biomarkers were significantly reduced. This outcome is exactly what we hoped for and opens the door to faster, smarter drug development strategies, demonstrating the potential for this method to be used effectively in early phase 1 studies.” The study highlights several advantages of this approach:

• Rapid efficacy insights with limited preclinical toxicology requirements and reduced phase 1 costs (3-day study vs. 8–12 weeks).
• Ability to compare multiple NCEs, concentrations, and vehicles within the same patient in short-duration studies.
• Opportunity to benchmark NCEs against approved topical drugs efficiently.

Emma Guttman, Professor and Chair of Dermatology at Mount Sinai, who performed gene expression analysis, emphasized its impact:

“This strategy represents a paradigm shift in topical drug development. It allows physicians and researchers to accelerate innovation while minimizing patient exposure and resource use. The implications for both industry and patients are tremendous,” said Emma Guttman-Yassky, MD, PhD, Waldman Professor and System Chair, Department of Dermatology and Director, Asness Family Center of Excellence in Eczema and Allergic Conditions, and Director, Laboratory of Inflammatory Skin Diseases, the Icahn School of Medicine at Mount Sinai.

This breakthrough puts Indero ahead in dermatology research, creating a faster, safer, and more affordable way to develop topical treatments.

About Indero

Indero is a dual-focus CRO for dermatology and rheumatology, with over 25 years of experience in clinical research and trial delivery. Our full-service approach which includes everything from protocol design and patient recruitment to trial monitoring and biometrics provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Latin America, and Asia-Pacific; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal partner for clinical needs at global scale.

Contacts

For more information:
Valerie Coveney

Communications Specialist

Indero

Vcoveney@inderocro.com

Fresenius Kabi’s Adaptive Nomogram used on Aurora Xi Plasmapheresis System Now Operating Nationwide at BioLife Plasma Centers




Fresenius Kabi’s Adaptive Nomogram used on Aurora Xi Plasmapheresis System Now Operating Nationwide at BioLife Plasma Centers

LAKE ZURICH, Ill.–(BUSINESS WIRE)–#CommittedToLife–Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced today the successful completion of the U.S. rollout of the Adaptive Nomogram technology used on its Aurora Xi Plasmapheresis System across BioLife Plasma Services’ network of plasma donation centers. The implementation, which began in March 2025 in a phased approach, has been completed ahead of schedule, marking a significant milestone in helping plasma centers advance plasma collection efficiency and donation personalization.

The Adaptive Nomogram technology, used with Fresenius Kabi’s Aurora Xi Plasmapheresis System, optimizes plasma collection by tailoring donation volumes based on each donor’s individual body attributes. This data-driven approach enables more personalized and efficient plasma collection, supporting both donor safety and the sustainability of the plasma supply.

“We are proud to see our Adaptive Nomogram technology fully deployed at BioLife Plasma Services’ donation centers and delivering measurable impact while meeting BioLife’s expectations,” said Dr. Christian Hauer, President, MedTech at Fresenius Kabi. “This innovation brings a new level of personalization to plasma donations, helping our customers enhance efficiency and strengthen the sustainability of the plasma supply that is essential for lifesaving therapies.”

The nationwide rollout at BioLife Plasma Services’ donation centers began in March 2025 with pilot centers and was executed in a strategic, phased manner to ensure a smooth integration process while maintaining donor and plasma safety.

“Completing the rollout of this technology ahead of schedule reflects the thoughtful and phased approach taken that allowed us to avoid any business disruption while improving operational efficiency and continuing to maintain the safety of our plasma donors,” said Hema Tallman, Senior Vice President and Global Head of BioLife Plasma Services. “Working closely with Fresenius Kabi on this implementation has enabled us to strengthen our plasma supply and continue providing people in need with the life-sustaining and lifesaving medicines that BioLife produces from plasma.”

About Fresenius Kabi

As a global health care company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status – notably as the only corporation offering both product groups. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.

Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of health care.

Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing health care solutions on a global scale.

For more information, please visit www.fresenius-kabi.com. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook.

Contacts

Media contact
Matt Kuhn (847) 220-3033

matt.kuhn@fresenius-kabi.com