This financing enables a critical step forward in our clinical development and is a critical component in our journey to redefine how vascular disease can be treated by restoring natural biological function. With P-TEV, we are addressing a large, underserved patient population with a therapy designed to address the underlying cause of disease, not just manage the symptoms. The initiation of our pivotal trial brings us significantly closer to making this a clinical reality.

As an interventional cardiologist familiar with the technology, I believe it offers a new way forward. This is truly restorative, unlike so many of the available tools. Patency of the venous system, along with functional vein valves, has the potential to revolutionize venous therapy. This technology restores normal venous hemodynamics, a concept that, heretofore has been unimaginable.

I am very pleased to be leading the Phase II/III trial of P-TEV. In clinical practice, treatment options for patients with advanced CVI are limited. P-TEV represents a promising and scalable approach with the potential to restore physiological blood flow.

The Letter of Intent with SHINE represents an important step in strengthening the supply chain for our Radioligand Therapy projects. Reliable access to high quality Lu 177 is essential as we advance ABY 271 through clinical development and continue to expand our Radioligand Therapy pipeline

In December we reported highly encouraging initial results from the first cohort of patients in our ongoing Phase 1 study of ABY-271 in HER2-positive metastatic breast cancer. The clinical data is very well aligned with preclinical findings, validating the Affibody® platform as a foundation for next-generation RLTs. The new financing will allow us to accelerate the Phase 1 study by evaluating higher radioactivity levels as well as expanding our RLT portfolio.

Quality assurance is the responsibility of every Cellevate employee. Our mission has been from the start to bring to market cutting-edge, state-of-the-art products that truly meet the needs of our customers. In earning this certification, we are driven to not only adhere to our already high-quality assurance standards, but to continually improve upon them.

Securing ISO 9001 certification is more than a quality milestone. It reflects our commitment to operational excellence and to supporting our customers with the highest level of reliability a s we scale and intensify commercial operations.Combined with the new cleanroom, we now have a robust and scalable foundation for expanding manufacturing capacity and implementing GMP-ready processes for commercial volumes. These new advancements strengthen Cellevate’s position as a trusted partner and supplier to customers and collaborators across the biopharmaceutical and bioprocessing industry.

The initial data from the ABY-271 study are very promising. We observed a favorable safety profile and encouraging biodistribution data, supporting progression of the study to the next stage. These results offer important insight into how the therapy behaves in patients, and we are eager to advance the study to deepen our understanding of its clinical potential.

I am thrilled that these early clinical results with ABY-271 mirror the preclinical findings and dosimetry predictions remarkably well. I am especially excited about the low kidney uptake. The positive outcome not only marks an important milestone for this program but also for the Affibody® platform as a powerful technology for developing next-generation targeted radiotherapeutics.

We are excited to partner with Moderna, a pioneer and leader in the field of mRNA medicines, to explore the potential of our PharmaShell® platform and to support the development of improved products for Moderna. This agreement underscores the versatility of PharmaShell and its potential to address key challenges in the delivery of advanced biologics.”

This partnership has gone beyond traditional manufacturing. Through open and transparent collaboration, we’ve built not only a cell therapy infrastructure but also mutual capabilities. Together, we’ve grown stronger, technically, operationally, and strategically. Achieving GMP readiness and delivering clinical-grade material for Mendus’ upcoming clinical trials is a shared success story rooted in trust and innovation.

With the establishment of large-scale GMP production, we're delivering on an important milestone for the vididencel program. Reliable manufacturing is central to advance our clinical trials and go-to-market strategy in AML and CML. This milestone demonstrates the maturity of the vididencel production process and strength of our partnership with NorthX Biologics. It reflects the execution focus that defines Mendus, as we continue to build clinical momentum.

We are very encouraged by the strong confidence and enthusiasm shown by our existing and new investors, who recognize the potential of our lead asset. Their support is crucial for securing rapid execution and delivery of the potential new therapy to patients in need.

I am pleased that our subjects now have access to next-generation investigational therapies such as TH9619. This study opens new possibilities for cancer treatments where options remain limited, and we look forward to continuing collaborating with One-carbon Therapeutics.

Dosing the first subject in our ODIN study represents a significant step in turning our cutting-edge science into first-in-class therapies. TH9619 embodies our unique strategy of targeting one-carbon metabolism proteins, by killing cancer cells while sparing normal cells and bringing new hope to subjects with high unmet medical need. We are deeply grateful to the investigators, clinical teams, our collaborators, and most importantly, the subjects who make this progress possible.

With this new product launch, Cellevate demonstrates the versatility of its next-generation, nanofiber-based microcarrier platform across all areas of adherent cell cultivation. Breakthrough medicine requires breakthrough innovations in biomanufacturing and Cellevate will keep delivering on that paradigm.

The key challenges in vaccine manufacturing are to bring new vaccines to the market faster and at lower production costs, only achievable through implementation of disruptive technologies. With more than 13-fold increase in viral vaccine titers, Cellevat3d® VAX nanofiber microcarriers have the potential to transform the way viral vaccines are manufactured and to accelerate vaccine development and patient access.

Naturally, we are delighted that Dermalyser is now cleared for the European market and we already have doctors waiting for using our tool – a clear testament to the trust in our solution. With Dermalyser, doctors can confidently avoid unnecessary referrals and procedures, which results in significant cost savings for healthcare and reduces patients' anxiety over uncertain skin assessments. For me, this is the culmination of years of dedicated and hard work to improve the way skin cancer is diagnosed: Dermalyser will save lives. I believe we will rapidly gain traction throughout Europe ahead of a US launch in 2027.

At Sand Clinic, our mission is to stay ahead of disease through prevention, performance, and early intervention. Integrating Dermalyser into our practice will assist us in detecting melanoma with exceptional precision, right at the point of care. This is not just a technological breakthrough, it’s a shift in how we approach skin cancer diagnostics. For our patients, it means faster diagnosis, fewer unnecessary surgeries and potentially life-saving decisions made sooner.

Last patient last visit is an important milestone, and one that we could not have reached without the long-standing support and hard work of the study’s Principal Investigators, their clinical centre teams, and the hundreds of patients who consented to AUR87A. We now eagerly look forward to seeing the study results.

This is an important step in the external validation of the GAG score as a biomarker for recurrence monitoring in clear cell renal cell carcinoma. This phase of the study is essential to confirm the initial findings from AUR87A Cohort 1 under broader clinical conditions. I would like to thank all participating sites for their steady commitment to reaching this stage. With follow-up completed, we now have the necessary foundation to carry out a thorough analysis of the data in the coming months

This is a critical moment for VERIGRAFT and for the millions of patients suffering from CVI without effective long-term treatment options. Our P-TEV product continues to demonstrate excellent safety and strong clinical potential. We are now accelerating toward late-stage development, with growing confidence and momentum.

Now, more than ever, life science companies need to communicate clearly and consistently if they are to succeed. Over the last thirty years I have helped create multiple communications agencies suited to the existing climate. 59 North builds on this experience, offering medtech, biopharma and service providers an agile, innovative and refreshing solution to their communications challenges.

We operate in a crowded space in which tens of thousands of companies compete for attention from global investors, in-licencing teams and other stake holders. Sharing information on a website and on LinkedIn is not enough to build awareness and brand recognition – and thereby value. At 59 North, we have a track record of fruitful partnerships with some of the most exciting and promising life science companies – many in the Nordics – and we are passionate about helping more companies to stand out from the crowd.

There is a clear and urgent need to improve cancer detection for Lynch Syndrome, and the PREDI-LYNCH project is designed to make a true difference in the lives of LS carriers. Elypta is honoured and excited to be a main contributing partner in this important project. We look forward to combining the results from Elypta’s GAG-based biomarker tests with the consortium’s expertise.

We are very grateful for receiving funding from Eurostar and we are looking forward to collaborating with Fraunhofer IBMT and OLS on this exciting project. Human induced pluripotent stem cells exhibit significant potential for regenerative medical treatments due to their pluripotency and proliferation capacity. However, the large-scale production required for allogeneic therapies necessitates efficient and scalable culture systems. The newly launched Cellevat3d® nanofiber microcarriers product with their extremely large surface area and the three-dimensional scale-up that is fast and easy, could solve the challenges for the iPSCs large-scale production in suspension bioreactor cultures.

We are very encouraged by the feedback from surgeons at the workshop. It reinforces our view that the Resitu devices will play an important role in breast tumor management. The feedback also confirms that Resitu’s devices are easy to use, applicable to a wide patient population, and an important response to an unmet global need.

By radically rethinking breast tumor management, we will be able to offer healthcare providers a much-needed excision-led, minimal invasive approach for large tissue removal. This solution will not only ease the strain on healthcare systems but, most importantly, it will shorten the stressful time patients experience during the diagnostic process. This is the way forward for 21st Century care.

Hilja’s deep expertise in commercializing diagnostics will be invaluable as we aim to launch our first diagnostic products next year.

I am excited to join Elypta at this pivotal moment as the company prepares to bring its diagnostic solutions to market, and I look forward to contributing to Elypta’s commercial success.

Hilja’s wealth of experience in commercializing diagnostics will be instrumental in ensuring maximal impact of Elypta’s technology and advancing our mission to prevent cancer mortality through early detection.

After showing the clinical benefits of accelerated healing, the primary effect, and learning first hand the clinical reality of use of antibiotics in patients, even in Sweden, we have been focused to understand the medical need and potential for ILP100 treating sites with pan- and multi drug resistant bacterial pathogens. The team have been working in stealth mode for two years, there is a patent pending, we are now looking for partners in this field to validate the findings in the most relevant patients

These findings show the potentially transformative impact a urine-based test may have in the surveillance of recurrent disease for kidney cancer patients

A urine test can offer a less invasive and more comfortable alternative for post-operative monitoring, potentially transforming kidney cancer follow-up care

I am delighted to take on the role of CTO at Cellevate. The company’s commercially available nanofiber-based cell culture systems have already shown great potential in biomanufacturing, and I look forward to supporting the team as we now have moved into commercialization and scale-up.

Bringing Dr. Fenge into the management team strengthens our ability to accelerate the commercialization and the strategic partnerships with customers and turnkey solution providers in bioprocessing. Her deep expertise in upstream bioprocessing, combined with strategic leadership, will be invaluable as we continue to commercialize and implement Cellevat3d® nanofiber cell culture solutions in new therapeutic large-scale applications, develop new product families and position our company as a proven provider in this industry.

I’m incredibly excited to join Cellevate at such a key time, as we are bringing Cellevat3d® nanofiber-based cell culture systems to the U.S. market. This innovative technology provides the solution to many of the challenges in upstream bioprocessing, especially for cell and gene therapy, and I look forward to working closely with our leadership teams to achieve the milestones that will fuel our expansion and success.

We are thrilled to welcome Jennifer Valdes to the Cellevate team. Jennifer’s extensive experience and deep understanding of the biopharma and biotech industries, combined with her collaborative leadership style will be invaluable in driving Cellevate’s success and growth in the US market. She will play a key role in advancing the commercialization of our Cellevat3d® nanofiber-based cell culture systems in viral vector biomanufacturing. Additionally, her insights will help strengthen partnerships with key opinion leaders and strategic collaborators.

The whole team at Elypta is delighted to be part of the club. With multiple clinical studies in the works – including EU Horizon 2020 funded AURORAX-0087A , which aims to support registration of the first ever urine test for detection of recurring kidney cancer – Elypta is well positioned to scale significantly. I look forward to the coming year, and all the work we will do with the club.

Scaling up at Testa Center in 10 L stirred tank bioreactor with our new category of nanofiber-based cell culture systems, while maintaining all the cell culture parameters unchanged from lab scale, is a great achievement. The study also demonstrated the ease of use and ease of implementation in bioreactors and our ability to meet industrial bioprocessing scale up demand. We have now added the last piece of the puzzle in securing the success of the global commercial launch of the world’s first nanofiber-based cell culture systems designed to boost viral vector productivity, in just a few weeks in November 2024 at BIO-Europe in Stockholm.

We’re thrilled to have supported Cellevate in their recent 3-week project at Testa Center, where they utilized our XDR10 bioreactor to scale up mammalian adherent cells. It’s fantastic to see innovative biotech companies like Cellevate leveraging our facilities to push the boundaries of cell culture technology. We’re proud to play a part in fostering advancements that help accelerate novel biotherapies development and production.

This trial seeks to determine whether AI-powered tools like Dermalyser can enhance our ability to assess melanoma thickness. Such insights can help prioritize patients for surgery, guide surgeons on optimal excision margins during the first operation and provide patients with more accurate information before surgery. The primary goal is to identify practical applications for AI in routine healthcare that can enhance clinical decision-making. One promising use case is the preoperative assessment and profiling of lesions suspected to be melanoma, particularly in estimating their thickness. We believe this represents a strong starting point for integrating AI to support diagnostic accuracy and improve patient outcomes.

In a previous study, published in March 2024 in the peer-reviewed British Journal of Dermatology, Dermalyser demonstrated a high level of sensitivity and specificity when used by primary care physicians, achieving rates of 95% and 85%, respectively. These figures rose to 100% sensitivity and 93% specificity for detecting invasive melanomas. I am happy to announce the approval to embark on the next study in the clinical validation program for Dermalyser as we strive for making it easier, faster and more reliable to diagnose for patients with skin lesions suspected to be cancerous.

Scalable, sustainable and single use, Cellevat3d® nanofiber microcarriers closely mimic the human extracellular environment, providing higher cell densities and enhancing yield for viral vector production compared to current standard microcarriers based processes. Our nanofiber microcarriers effectively address the key challenges of low productivity and high manufacturing costs facing the industry. With this pre-launch of Cellevat3d® nanofiber microcarriers starter pack, at CPHI Milan, we’re excited to provide early access to a completely new category of cell culture systems currently unavailable on the market. Cellevat3d® nanofiber-based cell culture systems truly have the potential to transform biomanufacturing for advanced therapies and take a significant step toward making these therapies more accessible to patients.

The City of Stockholm is a firm believer in the central role innovation districts play in fostering and sustaining innovation. The conference will be held in Hagastaden, a great example of a successful innovation district that has helped Sweden to become a leading innovator.

Looking ahead, we hope the conference will stimulate debate and influence policy-making to see innovation districts as an important driver of sustainable economic growth

We are delighted that the Phase 3 HS trial of izokibep was successful, again confirming the strength of the Affibody® platform in immunology and inflammation. Today’s positive HS data and previously announced psoriatic arthritis (PsA) data support a path to approval for izokibep. Our partner ACELYRIN has determined that a program of this breadth and size is best brought to market by a larger organization with the resources and existing footprint in these indications. Given our continuing confidence in izokibep’s best-in-class potential, underpinned by the breadth of efficacy and safety data generated across multiple indications, we will work with ACELYRIN to bring izokibep to patients in need of novel treatments.

We are pleased that the Phase 3 HS trial of izokibep met its primary endpoint and provided clinically meaningful responses as early as week 12 in this devastating disease. Importantly, we are further encouraged by the deepening responses seen at week 16, with a quarter of the patients achieving HiSCR100. Past experience tells us these responses will deepen even further with continued treatment. These results demonstrate that targeting IL-17A alone with greater potency can achieve the same or greater clinical responses than agents targeting IL-17 subunits more broadly, without their associated safety liabilities.

This trial demonstrated the good safety profile of long-term weekly injected ILB® in patients with ALS. I am very grateful for the engaging participation by the patients in especially difficult circumstances due to the onset of the pandemic during the trial period.

Taken together, the previous study at the Sahlgrenska Hospital in Gothenburg and the more recent Birmingham trial demonstrate the safety and tolerability of ILB® in patients with ALS and further suggest a long-term slowing of disease progression in addition to the already reported rapid improvements in patient biochemistry and residual motor function. The delivery of fast functional benefit alongside long-term disease stabilisation would make ILB® a unique treatment option for this devastating disease. These encouraging results indicate the future potential of ILB® to be the first disease-modifying drug to treat both familial and sporadic ALS with minimal side-effects.