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.

This trial represents another significant milestone for the company, and I am very impressed and grateful that the trial results are now peer-reviewed and published. I also want to extend my sincere thanks to all teams involved for their extraordinary dedication and effort in working towards finding a treatment that could improve the lives of ALS patients

We are very excited about the clinical potential for ILB®, which may prove to be a game changing treatment for many devastating neuro-degenerative diseases.

Having Billbäck join us is a huge affirmation that the hard work we are putting into saving patients’ lives with Dermalyser is not only providing a societal benefit, but also addressing a strong commercial potential. Billbäck will be a mentor to my team and guide my personal transformation from an R&D CEO into a commercial one. BoneSupport is a highly innovative company transforming an outdated standard of care in the field of orthopedic surgery. We at AI Medical Technology intend to follow a similar path and aspire for Dermalyser to improve and replace current melanoma diagnosis workflows.

About Peter Löwendahl - Both clearance and reimbursement are key for our company. We have an incredible technology with a truly unique value proposition and fantastic user feedback. Our next step is ensuring that we are fully compliant with robust reimbursement model in place ahead of a successful market launch.

I am very much looking forward to working with the team at Elypta in the exciting field of early cancer detection. The team is working on a mass-spectrometer based detection platform where I see a great opportunity as the technology expands into routine use.

I am pleased that Dr Eva Pisa has decided to join the board of Elypta. With her background and experience she will help the company to deliver a unique diagnostic technology to patients and society.

We are excited to have Dr. Pisa join our board. She brings a wealth of experience within IVD and Life Science development and commercialization. This will be very helpful as Elypta approaches the commercialization phase.

I am delighted to be raising more money to support the ongoing development of Dermalyser. To have yet another oversubscribed round just shows that Dermalyser is in a league of its own when it comes to new diagnostic tools for skin cancer. With fantastic clinical results, excellent user feedback, and a passionate team who really believe in making a difference, we will continue to move from strength to strength. Our roadmap is now consolidated – we will raise more funds in a Series A round this year and plan for an IPO in 2027-2028.

We are extremely impressed with the results achieved in the multicenter, clinical trial thereby further increasing our confidence that AI Medical Technology and Dermalyser will be successful, and we are happy to participate in the investment round alongside other current and new shareholders.

We are delighted to have Bob Kain join our board of advisors. Not only is it a huge vote of confidence in us and our technology, but also a vote of confidence in the future of sequencing.

It is the first truly disruptive architecture I have seen that has the ability to reach the $10 per genome price point.

Early detection of cancers through screening can reduce mortality. However, screening excludes individuals not considered at be at an increased risk of developing cancer as determined by age, sex, or tobacco use. No molecular biomarker is routinely used to predict risk. Therefore, implementing urine GAGomes to risk-stratify screening could identify adults with an increased risk of developing cancer who are currently excluded from screening based on their age and/or sex. Considering that urine GAGomes can be sampled at home, this could also reduce inequalities in cancer screening.

This marks an important step in the ABY-025 program as we are now demonstrating use in gastroesophageal cancer. We appreciate for our close collaboration with the leading clinical experts at Karolinska Institutet and Karolinska University Hospital and believe that the study results will pave the way for our therapeutic candidate ABY-271 in this patient population.

68Ga-ABY-025 has demonstrated the ability to visualize HER2 metastases with low-HER2 expression in our recently published study of metastatic breast cancer patients. I am excited about the opportunity to investigate this further in additional patients.

“Patients with gastroesophageal cancer may have a high degree of variability of HER2 expression level in different tumor lesions. It is important to understand HER2 receptor status in this patient population to guide the use of HER2 targeted treatment.

Dr. Uwe Gottschalk's appointment as new Chairman marks a major milestone for Cellevate. With his extensive industry knowledge, decades of experience, and invaluable network connections, Dr. Uwe Gottschalk is well-suited to lead Cellevate into its next phase of growth and commercialization. I am confident that under Dr. Gottschalk's guidance, Cellevate will continue to thrive and achieve new heights of success.

I am thrilled to be Joining Cellevate as the new Chairman and to become part of such a dynamic and innovative company. I am looking forward to working with the Board of Directors and the Cellevate team to contribute to successful launch and commercialization of our unique nanotechnology in the field of bioprocessing.

The clinical decision support tool evaluated in this investigation showed high diagnostic accuracy when used prospectively on primary care patients, which could add significant clinical value for PCPs in assessing skin lesions to detect melanoma. Additionally, a further clear impression from this trial is that the medical personnel involved in the trial were willing to put a high level of trust in Dermalyser, strongly indicating it can be easily worked into current clinical routines.

In recent years, the precision of AI in analysing dermatoscopic images to identify melanoma has reached or even surpassed experienced dermatologists. Yet, only a limited number of studies have tested these systems under real-world conditions. This study is notable for its execution in a real clinical setting, which makes its findings especially compelling. I am enthusiastic about the results and anticipate being a part of a future where systems like Dermalyser, supported by rigorous research and in full compliance with all necessary regulations, are integrated into routine healthcare. This includes both general dermatology and specifically the diagnosis of skin cancer. The fundamental goal is, of course, to improve clinical decision-making processes for more precise and, therefore, safer diagnoses.

Just as in analysing mammograms for diagnosing breast cancer or neuroimaging for Alzheimer’s disease, we believe this trial has decisively proven that using AI can revolutionise melanoma diagnosis. This will save lives and also remove the anxiety and often devasting consequences of false results. The European market is still our first priority for Dermalyser, but the recently approved AI-powered device for detecting skin cancer by the FDA has also established a clear regulatory pathway for us and we are now accelerating our plans for entering the US market.

We are pleased that the Swedish Medical Products Agency has given the go-ahead for the start of our clinical study with ELC-301 in difficult-to-treat or recurrent B-cell lymphoma. The treatment has the potential to become a very important alternative for those patients whose disease no longer respond to standard therapy and thus lack effective treatment options. The study is also an important step in proving the enhancing function of our technology platform iTANK, which has the potential to activate the body's own immune system against cancer cells.

We are very excited to partner with the expert team at Offspring. With their vast experience developing innovative biomarker and assay solutions, we are very confident that our combined offerings will bring a unique and valuable combination of translational and clinical capabilities to our development partners.

Together, Flagship Biosciences and Offspring Biosciences will provide a seamless and comprehensive suite of preclinical and clinical services, empowering our clients to accelerate drug development and bring lifesaving therapies to patients faster.

We are delighted to welcome Dr. Chiò to join our SAB. With his vast experience and expertise spanning from the phenotypic heterogeneity of ALS to familial ALS, his advice will be of great importance as we advance our clinical program for the drug candidate ILB for treatment of ALS.

Understanding the phenotypic heterogeneity and identifying the causative genetic mutations is key to developing new treatments for ALS, and I look forward to contributing the knowledge gained by my various research teams in this area and ALS in general to TikoMed’s SAB.

We are thrilled to welcome Dr. Shefner to join our SAB. We are confident that his expertise within biomarker development for ALS diagnosis and experience from the NEALS consortium will be of great value for progressing our drug candidate ILB for treatment of ALS through the clinical program.

I am pleased to join the TikoMed Scientific Advisory Board, and look forward to assisting the company in reaching the next stage of clinical development. The company has an ambitious plan to design and implement a study with solid and reliable readouts to ensure accurate assessment of their experimental therapeutic agent.

We are thrilled to have gained tremendous support from such a strong syndicate of investors, who share our vision of transforming biomanufacturing. This investment represents a significant milestone for our company and a valuable endorsement for the potential of our Cellevat3d™ nanotechnology, allowing us to take the next pivotal steps on our journey. The financing will enable us to accelerate commercialization and to progress towards our goal of making a lasting impact in the global healthcare landscape.

We are impressed by Cellevate's groundbreaking technology and the team behind it. This investment reflects our commitment to supporting pioneering companies that have the potential to revolutionize the industry. We look forward to a long-term partnership with Cellevate as they advance their mission of driving innovation in biomanufacturing.

As cell culture and biomanufacturing processes do play an increasingly important role, we are looking for start-ups like Cellevate that have the potential to set new industry standards.

The EIC Fund has established itself as a strong force in EU deep-tech investments. This unique form of financing via EIC - combining grants and equity – is proving itself highly attractive to Europe's most promising start-ups. Our investment will provide Cellevate with means to scale up their nanotechnology and accelerate their global commercial launch.

Since joining Affibody, I have been thoroughly impressed with my colleagues’ expertise and the potential of the product pipeline. I am excited to contribute to our strategic growth initiatives and taking the Company to the next level.

The preliminary results are promising and open up a new therapeutic opportunity for patients with severe CVI.

We are presenting this news because we believe the progress so far demonstrates our key premise – that our P-TEV grafts offer a solution to the problem with transplantation of vascular grafts. It follows the recent one-year disease-free milestone reached by our first patients. We now look forward to completing TECVI-1 and advancing the other programs in our pipeline including arteries.

We are excited to welcome Dr. Ingre to join our SAB. Caroline is a world renowned clinical and scientific thought leader. We look forward to her providing TikoMed with informed counsel in the months and years ahead, as we further our clinical efforts with our drug candidate ILB for treatment of ALS.

I am delighted to join TikoMed’s SAB at this exciting time for both ALS research in general and ILB in particular. I hope my extensive clinical development and trials experience can be utilized to the benefit of patients suffering from this devasting disease.

We are excited to welcome Dr. Cudkowicz to join our SAB. Merit, is a world renowned clinical and scientific thought leader. She can provide TikoMed with relevant and informed counsel in the months and years ahead, as we further our clinical efforts.

I feel very enthusiastic about joining the TikoMed SAB and I looking forward to contributing my experience to the upcoming clinical study.