Atom Therapeutics Launches Multi-Regional Phase 2 Trial of ABP-745 for Atherosclerotic Cardiovascular Disease (ASCVD)

Atom Therapeutics Launches Multi-Regional Phase 2 Trial of ABP-745 for Atherosclerotic Cardiovascular Disease (ASCVD)




Atom Therapeutics Launches Multi-Regional Phase 2 Trial of ABP-745 for Atherosclerotic Cardiovascular Disease (ASCVD)

HANGZHOU, China–(BUSINESS WIRE)–Atom Therapeutics, a clinical stage biotechnology company developing best-in-class treatments for inflammatory and metabolic diseases, today announced FDA approval of a Phase II clinical trial application of ABP-745, a novel anti-inflammatory agent for atherosclerosis. The company has launched a multi-regional Phase II trial globally.


Atherosclerosis is a common cardiovascular disease and a key driver of major adverse cardiovascular events (MACE). Each year, cardiovascular diseases caused by atherosclerosis lead to approximately 18 million deaths worldwide. Risk factors including hypertension, hyperlipidemia, hyperglycemia, and chronic inflammation cause damage to the vascular endothelium, prompting the deposition and oxidation of low-density lipoprotein (LDL) and cholesterol, and eliciting local inflammatory responses. This leads to the formation of foam cells and lipid-rich plaques, ultimately resulting in vascular narrowing, hardening, reduced elasticity, thinning, and even rupture. Rupture of unstable plaques triggers thrombosis, leading to acute vascular stenosis, which may cause severe outcomes including myocardial infarction, stroke, and death.

Current treatments for atherosclerosis primarily rely on lipid-lowering therapies, including statins, ezetimibe, and PCSK9 inhibitors; however, precise targeted intervention against inflammation pathways associated with plaque formation has not yet been achieved. Chronic inflammation is involved in every stage of atherosclerosis. The release of inflammatory mediators not only further aggravates endothelial injury, promotes lipid deposition, and increases plaque instability, but also elevates the risk of plaque rupture, making inflammation an independent risk factor for cardiovascular events.

Colchicine became the first anti-inflammatory drug approved by the FDA in 2023 for the treatment of cardiovascular disease. On top of standard lipid-lowering therapy, colchicine further reduced the risk of MACE by 31% through its anti-inflammatory mechanism. Recent clinical studies have shown that colchicine combining with standard treatment significantly reduces atherosclerotic plaque burden. Notably, 1% regression in plaque volume is associated with a 25% reduction in the odds of MACE. However, the use of colchicine in ASCVD is still limited due to its narrow therapeutic window, which restricts the dosage, and its potential for drug-drug interactions. For example, co-administration with certain statins can further increase the risk of rhabdomyolysis, thereby limiting its broader clinical application.

Dr. William Dongfang Shi, Founder, Chairman and CEO of Atom Therapeutics, commented, “ABP-745’s entry into Phase II clinical trials for atherosclerosis represents a pivotal milestone, marking its expansion into diseases driven by chronic inflammation. This milestone enables Atom Therapeutics to establish a strategic foothold in the dual therapeutic areas of metabolism and cardiovascular diseases, thereby substantially strengthening the company’s core competitive edge in inflammatory diseases.”

ABP-745, administered orally, poses no risk of drug-drug interactions. Animal studies have shown that, compared with colchicine, its therapeutic safety window is significantly wider. ABP-745 inhibits activation of the NLRP3 inflammasome, suppresses the recruitment of inflammatory cells to plaque sites, and potently inhibits multiple key inflammatory cytokines, including IL-1β, IL-6, IL-18, TNF-α, and CRP, thereby covering the full inflammatory cascade of atherosclerosis from endothelial injury to plaque rupture. The study in mice showed that the administration of ABP-745 resulted in the reduction of aortic plaque area up to 56.1% compared with the model group. In another similar study, combination therapy of ABP-745 with statins reduced aortic plaque area by more than 75%. ABP-745 has demonstrated robust plaque-lowering effects.

ABP-745 has completed a favorable safety, tolerability and pharmacokinetic profile in its Phase I trial in the U.S. and China. A multi-regional Phase II trial for acute gout flares is currently advancing across the U.S., Australia, and China.

About Atom Therapeutics

Atom Therapeutics Co., Ltd (formerly Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd) is a fast-growing innovative clinical stage biotechnology company focused on development of best-in-class small molecule therapeutics for treatment of inflammatory and metabolic diseases. The company’s lead product, lingdolinurad (ABP-671), is in late-stage clinical development for treatment of chronic gout. Another small molecule ABP-745, for anti-inflammatory and autoimmune conditions, is in global Phase 2 clinical trials for acute gout. For more information, please visit: https://atomthera.us/

Contacts

Media Contact:
Daniel Eramian

Opus Biotech Communications

http://opusbiotech.com/
425-306-8716

Business Development Contact:
Roy J. Wu, MBA

Sr. Vice President, Business Development

Atom Therapeutics

Email: roy.wu@atombp.com

Tubulis to Present at the 44th Annual J.P. Morgan Healthcare Conference

Tubulis to Present at the 44th Annual J.P. Morgan Healthcare Conference




Tubulis to Present at the 44th Annual J.P. Morgan Healthcare Conference

MUNICH–(BUSINESS WIRE)–Tubulis today announced that its CEO and Co-founder Dominik Schumacher will present a company overview and update at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco.


The presentation will take place on Monday, January 12, 2026, at 3:00 pm PT in the Mission Bay Room (32nd Floor) at The Westin St. Francis.

About Tubulis

Tubulis generates uniquely matched antibody-drug conjugates with superior biophysical properties that have demonstrated durable on-tumor delivery and long-lasting anti-tumor activity in preclinical models and first clinical proof-of-concept in platinum-resistant ovarian cancer. The two lead programs from our growing pipeline, TUB-040, targeting NaPi2b, and TUB-030, directed against 5T4, are being evaluated in the clinic in high-need solid tumor indications. We will solidify our leadership position by continuing to innovate on all aspects of ADC design leveraging our proprietary platform technologies. Our goal is to expand the therapeutic potential of this drug class for our pipeline, our partners and for patients. Visit www.tubulis.com or follow us on LinkedIn.

Contacts

For Tubulis
Dominik Schumacher, CEO & Co-founder

Phone: +49 (0) 175 800 5594

Email: contact@tubulis.com

Media Requests for Tubulis
Trophic Communications

Stephanie May, PhD

Phone: +49 (0) 171 185 56 82

Email: tubulis@trophic.eu

Latent Labs Announces Latent-X2: AI-Generated Antibodies With Drug-Like Developability and Low Ex Vivo Immunogenicity

Latent Labs Announces Latent-X2: AI-Generated Antibodies With Drug-Like Developability and Low Ex Vivo Immunogenicity




Latent Labs Announces Latent-X2: AI-Generated Antibodies With Drug-Like Developability and Low Ex Vivo Immunogenicity

LONDON & SAN FRANCISCO–(BUSINESS WIRE)–Today, Latent Labs announces Latent-X2, a frontier AI model that can design drug-like biologics without iteration. Drug hunters can use Latent Lab’s AI platform, built on Latent-X2, to access difficult targets and accelerate development timelines by reducing wet lab work. The generated designs display drug-like properties including low ex vivo immunogenicity, significantly shortening the path from hit to clinical candidate. Alongside the release, Latent Labs welcomes Stefan Oschmann, former CEO of Merck KGaA, to its strategic advisory board. Latent Labs is opening access to the model for selected partners.


The Development Bottleneck. Current wet lab approaches are costly not merely in development effort but in clinical failure. Hits rarely possess properties needed for clinical success, and optimization to address liabilities frequently fails or produces zero-sum tradeoffs. Suboptimal starting points risk costly downstream failure in clinical programs, and addressing shortcomings requires long development timelines.

Latent Labs Platform. Through the Latent Labs Platform, partners and customers can generate antibodies and peptides for disease targets of their choice. It produces high-affinity binders across VHH, scFv, and macrocyclic peptide formats – approaching drug-like quality from the first generation. The platform provides a scientist-friendly workflow, accessible to customers via web browser or by integrating their own systems with the Latent Labs API.

Zero-Shot Antibody and Peptide Design. Latent-X2 generates antibodies that bind challenging targets from the first generation – achieving hits against half of 18 targets selected for diversity and difficulty, with picomolar to nanomolar affinities and each requiring only 4 to 24 designs. The model generalizes beyond antibodies: macrocyclic peptides bind K-Ras, long considered undruggable, matching or exceeding hits from trillion-scale mRNA display screens while testing 11 orders of magnitude fewer sequences.

Drug-Like by Default. Antibodies designed by Latent-X2 exhibit developability profiles matching or exceeding approved therapeutic controls in head-to-head comparison. This extends to proxies for immunogenicity: in the first such assessment of any AI-generated antibody, de novo VHH binders were evaluated across a ten-donor human panel in ex vivo T-cell activation and cytokine release assays, confirming both potent target engagement and low immunogenicity. While animal studies and clinical trials remain ahead, these results demonstrate that AI-generated molecules can now clear preclinical hurdles that previously required lengthy optimization.

“Semiconductors, satellites and aircraft once required repeated build-test cycles, consuming years and billions of dollars. Today they’re designed computationally before anything is fabricated. With Latent-X2, drug discovery can move towards that same step change – designing the right molecule from the start,” said Simon Kohl, CEO and founder of Latent Labs.

Strategic Advisory Board. Latent Labs announces the appointment of Stefan Oschmann, former CEO of Merck KGaA (until 2021), to its strategic advisory board. “The pharmaceutical industry has spent decades optimizing around the limitations of iterative lab work. Latent Labs is doing something different – building the capability to design molecules that work from first principles. That shift, if it holds, changes the entire logic of drug discovery,” said Oschmann.

Access. Latent-X2 will be available to selected partners. Interest for access can be expressed at partnerships@latentlabs.com.

Latent-X2 builds on the success of Latent-X1, released just five months ago. Latent-X1 has been adopted by industry and academic groups worldwide, who value its performance and no-code interface for real lab applications.

Ten months ago Latent Labs announced its $50M funding round, co-led by Radical Ventures and Sofinnova Partners, with participation by Anthropic’s CEO Dario Amodei, Eleven Labs’ CEO Mati Staniszewski, and Google’s Chief Scientist Jeff Dean. The team includes former AlphaFold 2 co-developers and ex-DeepMind team leads, with experience from Microsoft, Apple, Exscientia, Mammoth Bio, Altos Labs, and Zymergen.

Q&A

Commercial questions

What are the terms for commercial use?

  • Latent-X2 is available on request and through commercial partnerships. For partnership inquiries, reach out to partnerships@latentlabs.com.

How can I get in touch for commercial partnerships?

Scientific questions

What is a typical application for Latent-X2?

  • Typical applications include the design of antibodies (VHH, scFv) and macrocyclic peptides for drug development programs. The model is particularly suited for generating drug-like antibody molecules.

How is Latent-X2 different from Latent-X1?

  • Latent-X1 focused on macrocyclic peptides and protein mini-binders with strong binding affinities. Latent-X2 advances to antibodies (VHH, scFv) with drug-like developability and demonstrated low ex vivo immunogenicity in initial studies. These profiles emerge without post-generation iteration.

How many designs are typically needed?

  • Latent-X2 achieves strong lab results with 4 to 24 designs per target for antibodies, representing efficiency gains of many orders of magnitude compared to conventional screening methods.

What targets has Latent-X2 been validated against?

  • We tested antibody designs against 18 soluble proteins, achieving picomolar to nanomolar hits against half the targets. Macrocyclic peptides were validated against 2 targets including K-Ras.

Do generated molecules require optimization?

  • In our validation studies, developability profiles emerged directly from the model without iteration, on par or better than approved therapeutics. Nonetheless, we expect some designs to require further development and optimization.

Broader questions

How does Latent Labs ensure safe usage of the technology?

  • Latent Labs actively participates in biosafety and biosecurity discussions with government and regulatory authorities regarding responsible development and preventing potential misuse of emerging technologies. Latent Labs continuously assesses its technologies and restricts access to its services in compliance with international sanctions lists from the EU and UK.

 

Contacts

contact@latentlabs.com

TreeFrog Therapeutics Announces Changes to Executive Committee With the Arrival of Mark Rothera as Chief Executive Officer & Board Member to Spearhead Next Phase of Growth

TreeFrog Therapeutics Announces Changes to Executive Committee With the Arrival of Mark Rothera as Chief Executive Officer & Board Member to Spearhead Next Phase of Growth




TreeFrog Therapeutics Announces Changes to Executive Committee With the Arrival of Mark Rothera as Chief Executive Officer & Board Member to Spearhead Next Phase of Growth

BORDEAUX, France–(BUSINESS WIRE)–#CellTherapyForAll–TreeFrog Therapeutics, a French biotech focused on bringing regenerative medicine to millions through their proprietary cell technology, C-Stem™ is delighted to announce the appointment of skilled biotech leader, Mark Rothera, as Chief Executive Officer and Board member. He succeeds Frédéric Desdouits, who is stepping down after five years in the role. In the new leadership configuration, co-founders Kévin Alessandri and Maxime Feyeux will transition from daily operations to focus on their roles on the Board.




Elsy Boglioli, Chair of the Board of TreeFrog Therapeutics, commented “On behalf of the Board, we are delighted to welcome Mark to TreeFrog. His 30+ years of biopharma leadership, including most recently, three biotech CEO roles in gene therapy and biologics, will be invaluable as we advance our Parkinson’s and liver programs, further strengthen our regenerative medicine platform and pursue strategic partnerships such as the one in place with Vertex for their Type 1 Diabetes pipeline. I would like to thank Frédéric for his leadership over the past 5 years which have been transformational for TreeFrog, moving from an early-stage research platform to a development engine with operations in France and in the US.”

Mark Rothera has built a strong reputation, driving the successful scale up of multiple biotech companies, including most recently, Viracta, Silence Therapeutics and Orchard Therapeutics. Renowned for building strong leadership teams that advance novel medicines through development to regulatory approval and commercialization, Mark has focused much of his career on specialty diseases and novel modalities including gene therapy and RNAi therapies. In his earlier career, he held commercial lead roles in PTC Therapeutics, Aegerion, Shire, and GSK. Mark serves on the Board of GenPharm and holds an M.A. in Natural Sciences from Cambridge University and an M.B.A. from the European Institute for Business Administration (INSEAD).

“I am excited to join TreeFrog at this pivotal moment,” said Rothera. “I am proud to take the lead on delivering the vision of the co-founders – ‘Cell Therapy for All’. The company has developed technology that can unlock the potential of regenerative medicine to transform outcomes across a range of serious conditions. I am looking forward to working with the talented team at TreeFrog and our partners to advance breakthrough medicines to millions of patients.”

Ends

About TreeFrog Therapeutics

TreeFrog Therapeutics is a French-based regenerative medicine biotech set to unlock access to cell therapies for millions of patients. TreeFrog is unique in its approach to cell therapy development, bringing together biophysicists, cell biologists and bioproduction engineers to address the challenges of the industry – producing and differentiating cells of quality at unprecedented scale, cost-effectively. To succeed in their mission of Cell Therapy for all, TreeFrog operates a business model that includes its own therapeutic programs and partnerships with leading biotech and industry players. Since 2021, the company has raised $82 million to advance a pipeline of stem cell-based therapies in regenerative medicine.

For further information, visit www.treefrog.fr

Contacts

Media Contact
Rachel Mooney

Chief Communications Officer, TreeFrog Therapeutics

Tel: +33 674 06 34 61

Email: Rachel.mooney@treefrog.fr

LEO Pharma Appoints Marika Murto to Lead Global Product Strategy

LEO Pharma Appoints Marika Murto to Lead Global Product Strategy




LEO Pharma Appoints Marika Murto to Lead Global Product Strategy

  • Marika Murto brings over 20 years of pharmaceutical expertise in product strategy, innovation, and business transformation
  • Her appointment as SVP of Global Product Strategy will help unlock LEO Pharma’s portfolio potential, driving patient impact and supporting sustainable growth

BALLERUP, Denmark–(BUSINESS WIRE)–LEO Pharma, a global leader in medical dermatology, announces the appointment of Marika Murto, PhD, as SVP of Global Product Strategy and member of the Global Leadership Team.


Marika joins LEO Pharma from Amgen, where she most recently served as Associate Vice President and U.S. Commercial Lead for Bone Health, driving strategic brand positioning and cross‑functional collaboration. Her career at Amgen included senior global and affiliate leadership roles, including General Manager for the Netherlands, Global Product Team Lead for Bone Health, and Country Director for Finland. She has also held senior commercial positions at Pfizer and Roche, gaining expertise across oncology, vaccines, specialty medicines, and portfolio strategy.

“I’m very excited to join LEO Pharma and lead Global Product Strategy at such an important point in the company’s journey. Effective product strategy is about uniting great science, market insight, and organizational excellence to create meaningful results for patients. I’m passionate about empowering diverse, results driven teams and embedding innovation in all that we do,” says Marika Murto.

With her deep global experience and ability to combine scientific understanding with strategic execution, Marika will play a key role in shaping the direction of LEO Pharma’s portfolio, ensuring it is positioned to deliver strong impact for patients and sustainable growth for the company.

“Marika’s strong international background, strategic mindset, and ability to connect vision with delivery make her an outstanding choice to lead Global Product Strategy. She has shown throughout her career that she can shape complex portfolios and succeed across diverse markets. I very much look forward to welcoming her to the LEO Pharma team,” says Christophe Bourdon, CEO.

“I’d like to sincerely thank Lisa Elliot for stepping in as interim head of Global Product Strategy during this important period. I’m truly pleased that she will continue to contribute her expertise, dedication, and deep knowledge of our company in her previous role within Global Asset & Payer Strategy,” says Christophe.

Marika Murto will join LEO Pharma as Senior Vice President of Global Product Strategy on February 1, 2026.

Contacts

Jeppe Ilkjær

Director, Strategic Communication and Projects

Corporate Affairs

Mobile +45 3050 2014

Mail JEILK@leo-pharma.com

RoslinCT and Ayrmid Ltd. Announce Expansion of Strategic Partnership to Manufacture Omisirge® (omidubicel-onlv) for Second FDA-Approved Indication in Severe Aplastic Anemia (SAA)

RoslinCT and Ayrmid Ltd. Announce Expansion of Strategic Partnership to Manufacture Omisirge® (omidubicel-onlv) for Second FDA-Approved Indication in Severe Aplastic Anemia (SAA)




RoslinCT and Ayrmid Ltd. Announce Expansion of Strategic Partnership to Manufacture Omisirge® (omidubicel-onlv) for Second FDA-Approved Indication in Severe Aplastic Anemia (SAA)

  • RoslinCT is performing technology transfer and will support commercial manufacture of Omisirge® for an additional indication following successful clinical trials
  • Omisirge® now FDA-approved for an expanded patient population in hematology
  • RoslinCT continues to support and advance multiple cell therapy projects at its Hopkinton, MA facility

BOSTON–(BUSINESS WIRE)–Ayrmid Ltd., the parent company of Gamida Cell Inc., a pioneering cell therapy company transforming cells into powerful therapeutics, and RoslinCT, a global leader in cell and gene therapy contract development and manufacturing, today announced the expansion of their strategic partnership to include the execution of a commercial supply agreement to support production of Omisirge® (omidubicel-onlv).


Following positive clinical trial results, Omisirge® has received FDA approval for a second indication, broadening its use in the treatment of hematology patients. Under the commercial supply agreement, RoslinCT will complete technology transfer and support commercial manufacturing of Omisirge® for this additional indication at its state-of-the-art cGMP cell therapy manufacturing facility in Hopkinton, MA.

We are excited to expand our collaboration with RoslinCT to add US manufacturing as Omisirge® moves into its next phase with the recent FDA approval for patients suffering from severe aplastic anemia,” said Dr Joe Wiley, Chairman and Chief Executive Officer of Ayrmid Ltd.This important strategic partnership enhances our dual sourcing approach and secures patient supply in the longer term.”

The expansion of Omisirge®’s commercial manufacturing at RoslinCT demonstrates the strength of our partnership and the capability of our facilities to support innovative therapies at scale,” said Peter Coleman, Chief Executive Officer of RoslinCT.Alongside Omisirge®, we continue to progress multiple cell therapy projects, reflecting our commitment to enabling transformative treatments for patients worldwide.”

About Omisirge®

Omisirge® is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from the youngest donor source, designed for ease of infusion. The product is FDA-approved and commercialized for patients with hematologic malignancies. With the new indication, Omisirge® now provides treatment options for a broader patient population, enhancing its potential to improve outcomes.

About RoslinCT

RoslinCT is a leading global contract development and manufacturing services organization (CDMO) focused on Advanced Cell and Gene Therapies. Established in 2005 and built upon the ground-breaking technology cloning of Dolly the Sheep at the Roslin Institute in 1996, RoslinCT has harnessed cutting-edge science to advance the development of human medicines. With a remarkable heritage in the field, the company has achieved significant milestones. These include being among one of the first in the world to produce clinical-grade human pluripotent stem cells. In collaboration with the partners, RoslinCT also developed the first CRISPR-edited cell therapy product for a major inherited disorder, taking it from early development to commercialization.

Equipped with 22 purpose-built cGMP cell therapy processing suites in Edinburgh, Scotland, and Hopkinton, Massachusetts, RoslinCT provides innovative process and analytical development, cGMP clinical and commercial manufacturing for a range of cell types for both autologous and allogeneic processes, and cGMP iPSC cell line development, gene editing, and differentiation.

With tailored CDMO solutions, RoslinCT enables partners to efficiently progress from development to commercialisation and deliver life-saving Cell and Gene Therapies worldwide. RoslinCT is a GHO Capital portfolio company. Discover more about our services at www.roslinct.com.

About Ayrmid Ltd. and Gamida Cell

Ayrmid Ltd. is the parent company of Gamida Cell Inc., a pioneering cell therapy company developing novel treatments designed to turn cells into powerful therapeutics. Gamida Cell Inc. currently has two FDA approved products on the market in the US, namely Omisirge (please see the current full Prescribing Information, including boxed warning, here) and APHEXDA® (please see the current full Prescribing Information here). Gamida Cell operates as a wholly owned subsidiary of Ayrmid Limited, a UK entity. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.

Contacts

Gamida Investor and Media Contact:

e-mail: BD@Gamida-Cell.com

RoslinCT Media Contact:

Katerina Tsita

Katerina.Tsita@roslinct.com
+44 (0)7867 494071

Calluna Pharma Announces the Appointment of Gijs van den Brink, MD, PhD, as Independent Director

Calluna Pharma Announces the Appointment of Gijs van den Brink, MD, PhD, as Independent Director




Calluna Pharma Announces the Appointment of Gijs van den Brink, MD, PhD, as Independent Director

OSLO, Norway & BOSTON–(BUSINESS WIRE)–Calluna Pharma AS, a clinical stage biotechnology company pioneering first-in-class antibodies to treat inflammatory and fibrotic diseases, today announced that Gijs van den Brink, MD, PhD, has been appointed as an independent director to the company’s Board of Directors. Dr. van den Brink is a highly accomplished researcher and drug developer, having led immunology research and clinical development at both Roche and GSK.


“Gijs brings an exceptional blend of scientific depth, clinical insight, and strategic leadership to our board of directors,” said Calluna CEO Mark Gaffney. “We are thrilled to welcome him and are confident his expertise will strengthen our mission as we advance our pipeline in fibrotic and other inflammatory disorders.”

Dr. van den Brink had a distinguished tenure at Roche, where he served on the Pharma Research and Early Development (pRED) leadership team and was SVP and Global Head of Immunology, CVM, Infectious Diseases, and Ophthalmology Discovery and Early Development. Prior to Roche he was SVP and Global Head of Immunology Discovery, Early- and Late-Stage Clinical Development at GSK. He is presently the chief scientific officer of Granite Bio and an Operating Partner at Forbion.

“I am delighted to join the Calluna board and support its talented management team and their innovative programs,” said Dr. van den Brink. “Calluna is pursuing highly promising innate immunity targets across its pipeline, and the company is deeply committed to advancing novel medicines that have the potential to transform care for patients. Their work has far-reaching implications for a broad spectrum of inflammatory and fibrotic disorders, an area that has been central to my research and industry career, and I look forward to contributing to its next stage of scientific and clinical progress.”

Dr. van den Brink earned his MD and PhD from the University of Amsterdam Medical Center and completed his training in internal medicine and gastroenterology in Amsterdam, Geneva, and Leiden. He later served as a board-certified gastroenterologist and Professor of Experimental Gastroenterology at the University of Amsterdam, where he spearheaded pioneering research in inflammatory bowel disease. He has authored more than 150 peer-reviewed publications.

About Calluna Pharma www.callunapharma.com

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

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

Contacts

Media Contact:
Jason Glashow

Glashow Strategic Communications

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

Zoetis Announces Pricing of $1.75 Billion Convertible Senior Notes Offering

Zoetis Announces Pricing of $1.75 Billion Convertible Senior Notes Offering




Zoetis Announces Pricing of $1.75 Billion Convertible Senior Notes Offering

Substantially All of Net Proceeds Expected to Be Used to Repurchase Approximately $1.6 Billion of Common Stock and for Capped Call Transactions

PARSIPPANY, N.J.–(BUSINESS WIRE)–$ZTS #animalhealth–Zoetis Inc. (NYSE: ZTS) (the “Company” or “Zoetis”) today announced that it has priced its previously announced offering of $1.75 billion aggregate principal amount of 0.25% convertible senior notes due 2029 (the “Notes”) in a private offering to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A of the Securities Act of 1933, as amended (the “Securities Act”). Zoetis has also granted the initial purchasers of the Notes an option to purchase, for settlement within a 13-day period beginning on, and including, the date on which the Notes are first issued, up to an additional $250 million aggregate principal amount of Notes. The offering is expected to close on December 18, 2025, subject to the satisfaction of customary closing conditions.


Use of Proceeds – Share Repurchases and Capped Call Transactions

Zoetis estimates that the net proceeds from the offering will be approximately $1,723.2 million (or approximately $1,969.6 million if the initial purchasers exercise their option to purchase additional Notes in full), after deducting the initial purchasers’ discounts and estimated expenses payable by Zoetis. Zoetis intends to use the net proceeds from the offering as follows, the net effect of which is expected to result in Zoetis repurchasing approximately $1.6 billion of common stock (or approximately $1.8 billion of common stock if the initial purchasers exercise their option to purchase additional Notes in full):

  • Approximately $163.3 million to fund the cost of entering into the capped call transactions described below;
  • Approximately $250.3 million to purchase approximately 2.1 million shares of Zoetis’ common stock, par value $0.01 per share, in privately negotiated transactions entered into concurrently with the pricing of the offering effected with or through one of the initial purchasers or its affiliate; and
  • The remaining $1,309.6 million to repurchase additional shares of Zoetis’ common stock after the offering, which the Company expects to complete by no later than the first quarter of 2026.

If the initial purchasers exercise their option to purchase additional Notes, Zoetis expects to use a portion of the net proceeds from the sale of the additional Notes to enter into additional capped call transactions and to use the remainder of such net proceeds for additional repurchases of common stock following the date of the offering. All share repurchases will be conducted pursuant to the Company’s existing $6 billion share repurchase program and may be made on the open market or in privately negotiated transactions and may be made pursuant to a Rule 10b5-1 plan or otherwise.

Key Terms of the Notes

The Notes will be senior, unsecured obligations of Zoetis, and will accrue interest at a rate of 0.25% per annum, payable semi-annually in arrears on June 15 and December 15 of each year, beginning on June 15, 2026. The Notes will mature on June 15, 2029, unless earlier redeemed, repurchased or converted.

The initial conversion rate will be 6.7476 shares of Zoetis’ common stock per $1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $148.20 per share of Zoetis’ common stock). The initial conversion price of the Notes represents a premium of approximately 22.50% over the last reported sale price of Zoetis’ common stock on the New York Stock Exchange (“NYSE”) on December 15, 2025. At any time prior to the close of business on the business day immediately preceding March 15, 2029, the Notes will be convertible at the option of the holders of the Notes only upon the satisfaction of specified conditions and during certain periods. On or after March 15, 2029, until the close of business on the second scheduled trading day immediately preceding the maturity date, the Notes will be convertible at the option of the holders of the Notes at any time regardless of these conditions.

Upon any conversion of the Notes, Zoetis will pay cash up to the aggregate principal amount of the Notes to be converted and pay or deliver, as the case may be, cash, shares of Zoetis’ common stock or a combination of cash and shares of Zoetis’ common stock, at Zoetis’ election, in respect of the remainder, if any, of Zoetis’ conversion obligation in excess of the aggregate principal amount of the Notes being converted, based on the then applicable conversion rate.

Zoetis may redeem for cash all or any portion (subject to certain limitations) of the Notes, at its option, on or after December 20, 2027 and prior to the 21st scheduled trading day immediately preceding the maturity date, if the last reported sale price of Zoetis’ 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 Zoetis 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 interest to, but excluding, the redemption date. No sinking fund is provided for the Notes.

Subject to certain conditions, if Zoetis undergoes a “fundamental change” (as defined in the indenture that will govern the Notes), holders of the Notes may require Zoetis 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 any accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, upon certain corporate events that occur prior to the maturity date or upon redemption, Zoetis will, under certain circumstances, increase the conversion rate for holders who elect to convert their Notes in connection with any such corporate event or convert their Notes called (or deemed called) for redemption during the related redemption period, as the case may be.

Capped Call Transactions – 75% Premium ($211.7150 Cap Price)

In connection with the pricing of the Notes, Zoetis entered into privately negotiated capped call transactions with certain of the initial purchasers or their respective affiliates and certain other financial institutions (the “option counterparties”). The capped call transactions will cover, subject to anti-dilution adjustments, the number of shares of Zoetis’ common stock initially underlying the Notes. The capped call transactions are expected generally to reduce potential dilution to Zoetis’ common stock upon any conversion of Notes and/or offset any cash payments Zoetis is required to make in excess of the principal amount of any converted Notes, as the case may be, with such reduction and/or offset subject to a cap based on a cap price initially equal to $211.7150 per share, which represents a premium of 75.0% over the last reported sale price of Zoetis’ common stock on NYSE on December 15, 2025.

Zoetis has been advised that the option counterparties or their respective affiliates, in connection with establishing their initial hedges of the capped call transactions, expect to purchase shares of Zoetis’ common stock and/or enter into various derivative transactions with respect to Zoetis’ common stock concurrently with or shortly after the pricing of the Notes. This activity could increase (or reduce the size of any decrease in) the market price of Zoetis’ common stock or the Notes at that time. In addition, the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Zoetis’ common stock and/or purchasing or selling Zoetis’ common stock or other securities of Zoetis in secondary market transactions following the pricing of the Notes and prior to the maturity of the Notes (and are likely to do so (x) during any observation period related to a conversion of Notes or following any repurchase of Notes in connection with any “fundamental change” or “optional redemption” (each as defined in the indenture for the Notes) and (y) following any other repurchase of Notes if Zoetis elects to unwind a portion of the capped call transactions in connection with such repurchase). This activity could also cause or avoid an increase or decrease in the market price of Zoetis’ common stock or the Notes, which could affect the ability of noteholders to convert the Notes and, to the extent the activity occurs during any observation period related to a conversion of Notes, it could affect the amount and value of the consideration that noteholders will receive upon conversion of the Notes.

In addition, the concurrent repurchases of shares of Zoetis’ common stock described above may result in Zoetis’ common stock trading at prices that are higher than would be the case in the absence of these repurchases and may have affected the initial terms of the Notes, including the initial conversion price.

Neither the Notes nor the shares of Zoetis’ common stock potentially issuable upon conversion of the Notes, if any, have been, or will be, registered under the Securities Act, the securities laws of any other jurisdiction or any state securities laws and, unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state laws. The Notes will be offered and sold only to persons reasonably believed to be qualified institutional buyers in the United States pursuant to Rule 144A under the Securities Act. This news release is for informational purposes only and does not constitute an offer to sell, or a solicitation of an offer to buy, the Notes, nor shall there be any sale of the Notes in any state or jurisdiction in which such offer, solicitation or sale is unlawful.

About Zoetis

As the world’s leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After innovating ways to predict, prevent, detect, and treat animal illness for more than 70 years, Zoetis continues to stand by those raising and caring for animals worldwide – from veterinarians and pet owners to livestock producers. The company’s leading portfolio and pipeline of medicines, vaccines, diagnostics and technologies make a difference in over 100 countries.

DISCLOSURE NOTICES

Forward-Looking Statements:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.

These forward-looking statements include, but are not limited to, statements regarding the anticipated completion of the offering and capped call transactions, the anticipated effects of entering into the capped call transactions, the intended use of the net proceeds from the offering, any repurchases of common stock, including any impact to the common stock’s trading prices, and other future events. These statements are not guarantees of future performance or actions and important factors (many of which are beyond the Company’s control) could cause actual results to differ materially from those set forth in the forward looking statements, including risks and uncertainties associated with market conditions, including market interest rates, the trading price and volatility of Zoetis’ common stock, and risks relating to the offering, the Company’s business and operations and results of financing efforts. Forward-looking statements are subject to risks and uncertainties. If one or more of these risks or uncertainties materialize, or if management’s underlying assumptions prove to be incorrect, actual results may differ materially from those contemplated by a forward-looking statement. Forward-looking statements speak only as of the date on which they are made. Zoetis expressly disclaims any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. A further list and description of risks, uncertainties and other matters can be found in Zoetis’ most recent Annual Report on Form 10-K, including in the sections thereof captioned “Forward-Looking Statements and Factors That May Affect Future Results” and “Item 1A. Risk Factors,” in Zoetis’ Quarterly Reports on Form 10-Q, in Zoetis’ Current Reports on Form 8-K and in other documents on file with the U.S. Securities and Exchange Commission.

ZTS-COR

ZTS-IR

ZTS-FIN

Contacts

Media Contacts:

Jennifer Albano

1-862-399-0810 (o)

jennifer.albano@zoetis.com

Laura Panza

1-973-975-5176 (o)

laura.panza@zoetis.com

Investor Contacts:

Steve Frank

1-973-822-7141 (o)

steve.frank@zoetis.com

Nick Soonthornchai

1-973-443-2792 (o)

nick.soonthornchai@zoetis.com

Bicycle Therapeutics Establishes Multiple Strategic Partnerships to Create End-to-End Supply Chain to Support its Wholly Owned Radiopharmaceutical Pipeline

Bicycle Therapeutics Establishes Multiple Strategic Partnerships to Create End-to-End Supply Chain to Support its Wholly Owned Radiopharmaceutical Pipeline




Bicycle Therapeutics Establishes Multiple Strategic Partnerships to Create End-to-End Supply Chain to Support its Wholly Owned Radiopharmaceutical Pipeline

Execution of a 15-year contract including an option to renew with UK Nuclear Decommissioning Authority for access to up to 400 tonnes of reprocessed uranium (RepU), with the potential to deliver tens of thousands of doses of 212Pb every year

Partnership with the United Kingdom National Nuclear Laboratory (UKNNL) to scale up the extraction of 228Th from RepU for onward processing into a 212Pb generator

Agreement with SpectronRx to develop a bespoke wholly owned 212Pb generator, with initial quantities of 212Pb successfully produced

CAMBRIDGE, England & BOSTON–(BUSINESS WIRE)–Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced it has entered into a 15-year contract including an option to renew with the UK Nuclear Decommissioning Authority (NDA) for access to up to 400 tonnes of reprocessed uranium (RepU). RepU continually regenerates providing a potentially sustainable supply of 212Pb. Bicycle intends to utilize the RepU provided by this agreement in its development of potential lifesaving therapies.


In addition, Bicycle announced a collaboration with United Kingdom National Nuclear Laboratory (UKNNL), pursuant to which it plans to extract 228Th from the RepU obtained from NDA. The extracted 228Th will then be further processed into 224Ra and loaded into a bespoke 212Pb generator being developed exclusively for Bicycle by SpectronRx. 212Pb is a radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha Therapy (TAT).

Collectively, this bespoke set of arrangements is designed to support the potential discovery, development, and commercial supply of a portfolio of Bicycle® Radioconjugates (BRC®) containing 212Pb.

“Cancer is a disease that affects millions worldwide, and tears too many families apart. Breakthroughs in medical science are giving more cancer patients and their loved ones hope, and this unique partnership could help take that work even further. Turning nuclear material into cutting-edge cancer treatments sounds like science fiction – but thanks to the brilliance of scientists, researchers and doctors, it could be a life-saving reality. Work like this shows exactly why we’re determined to support our life sciences innovators to make groundbreaking new treatments possible,” said Liz Kendall, Secretary of State.

“These new collaborations are testaments to the potential of Bicycle to advance a differentiated and exciting isotope agnostic radiopharmaceuticals portfolio. We believe we now have the resources and infrastructure we need to create the world’s first end-to-end 212Pb radiopharmaceutical ecosystem from discovery through development to commercial supply. We believe the potential of BRCs and our ability to incorporate the appropriate isotopes for specific patient needs is unique and creates significant value-creating capabilities,” said Mike Hannay, D.Sc., FRPharmS, chief product and supply chain officer of Bicycle Therapeutics. “We are incredibly grateful to the UK government for their recognition of Bicycle’s potential to develop BRCs with a 15-year access agreement for reprocessed uranium, and to our partners SpectronRx with whom we are developing a bespoke 212Pb generator. We look forward to advancing these dynamic collaborations and developing our pipeline of radiopharmaceuticals with the potential of improving lives for cancer patients around the globe.”

“I am delighted with the progress we are making in establishing ourselves as a potential leader in radiopharmaceutical R&D. Today’s announcement builds on our previous announcements concerning our agreement with Eckert & Ziegler to supply a range of radioisotopes for the manufacture of BRC products as well as the formation of our Research and Innovation Advisory Board (RAB) comprising some of the worlds most esteemed experts in radiopharmaceuticals,” said Bicycle Therapeutics CEO Kevin Lee, Ph.D. “As we continue to advance our emerging BRC pipeline, currently with novel targets EphA2 and MT1-MMP, we look forward to presenting initial EphA2 human imaging data in the first half of 2026 and initiating our own Bicycle study in 2026.”

About Bicycle Therapeutics

Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Drug Conjugate (BDC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radioconjugates (BRC®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology.

Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit bicycletherapeutics.com.

Forward Looking Statements

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: Bicycle’s expectations with respect to the benefits of its agreements and collaborations with NDA, UKNNL, and SpectronRx, respectively; Bicycle’s ability to advance a differentiated and exciting isotope agnostic radiopharmaceuticals portfolio; Bicycle’s ability to leverage its agreements with NDA and SpectronRx and collaboration with UKNNL to create the world’s first end-to-end 212Pb radiopharmaceutical ecosystem; Bicycle’s ability to incorporate the appropriate isotopes for specific patient needs to support significant value-creating capabilities; the initiation of new clinical trials, the progress of Bicycle’s clinical trials, reporting data from Bicycle’s clinical trials and the timing of EphA2 human imaging data; the development of BRC molecules for radiopharmaceutical use; and the use of Bicycle Therapeutics’ technology through various partnerships to develop therapies for diseases beyond oncology. Bicycle Therapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle Therapeutics’ product candidates; the risk that Bicycle may not realize the intended benefits of its technology or partnerships; the risk that Bicycle may not achieve any of its clinical development strategies; timing of results from clinical trials; whether the outcomes of preclinical studies and prior clinical trials will be predictive of future clinical trial results; the risk that trials may have unsatisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle’s product candidates; and other important factors, any of which could cause Bicycle Therapeutics’ actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in Bicycle Therapeutics’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on October 30, 2025, as well as in other filings Bicycle Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle Therapeutics expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Contacts

Investors:

Matthew DeYoung

Argot Partners

ir@bicycletx.com
212-600-1902

Media:

Deborah Elson

Argot Partners

media@bicycletx.com

Esco Aster Signs Exosome Clinical cGMP Manufacturing Contract With Shine-On Biomedical For A Novel First-In-Class HLA-G Targeting Exosome Drug Delivery Platform

Esco Aster Signs Exosome Clinical cGMP Manufacturing Contract With Shine-On Biomedical For A Novel First-In-Class HLA-G Targeting Exosome Drug Delivery Platform




Esco Aster Signs Exosome Clinical cGMP Manufacturing Contract With Shine-On Biomedical For A Novel First-In-Class HLA-G Targeting Exosome Drug Delivery Platform

SINGAPORE–(BUSINESS WIRE)–Esco Aster, a vertically integrated cell and derivatives CRDMO based at JTC LaunchPad Singapore, announced CMC manufacturing support for Shine-On Biomedical’s HLA-G targeted exosome program. Shine-On Biomedical sponsored Esco Aster in 2023 for cGMP services, starting with high-yield exosome development using Esco Aster’s cell line platform. The technical reports of process, analytical, and formulation development, exosome drug loading, GMP engineering runs, and stability studies supported Shine-On’s IND submission. The IND was cleared by the U.S. FDA in Q1 2025.


Furthermore, Esco Aster is providing technical services for exploratory exosome loading feasibility studies per Shine-On’s instruction. Shine-On Biomedical is an emerging innovator in exosome-based drug delivery.

ShineOn’s proprietary product, SOB100, a HLA-G targeted exosome drug delivery carrier, has passed the U.S. FDA IND review and ongoing Phase I study, making it as a first-in-class–potential HLA-G targeted exosome platform for drug development.

Statement From Hung-Che Chiang, General Manager of Shine-On Biomedical

“Preclinical studies have shown promising biodistribution characteristics supporting further exploration across small-molecule, nucleic acid, and protein-based payloads.”

In parallel, Esco Aster, providing Mitosis™ Enterprise Solutions to support potential future evaluation of single-use cGMP workflows at China Medical University Hospital.

This collaboration strengthens Esco Aster’s position as Singapore’s first fully homegrown CRDMO offering end-to-end engineered cancer exosome development—from cell line creation to GMP manufacturing using its patented 3D Tide Motion™ bioreactor. This technology lowers COGS by enabling multiple conditioned media harvests per run. Esco Aster also co-develops autologous cell therapy programs in ASEAN, including a T-cell reactivation platform targeting non-G12C KRAS mutation NSCLC.

Esco Aster supports Asia-Pacific innovators through biomanufacturing scale-up, market access, and commercialization across South Asia, ASEAN, and Oceania—a region valued at ~USD 10.5 trillion GDP with ~2.6 billion people. Supported by a network of medical centres and clinician-scientists, Esco Aster facilitates IIT and FIM studies, especially in Australia, where R&D incentives lower costs. The company advances its “One World BioSolutions for One Health” vision, enabling high yield at low GMP cost to strengthen Singapore’s and Asia’s bioeconomy.

© 2025 Esco Aster Pte. Ltd. and Shine-On Biomedical Co., Ltd. All rights reserved.

Contacts

Esco Aster Pte. Ltd.
mail@escoaster.com
Website: https://escoaster.com/

Shine-On Biomedical Co., Ltd.
service@shineon-bio.com
Website: https://en.shineon-bio.com/