Cereno Scientific announced today the successful completion of the second and final part of its phase I clinical trial evaluating drug candidate CS014 in healthy volunteers. The milestone was marked by the last patient’s last visit, and top-line results are expected in June 2025.
Cereno Scientific’s pipeline includes three drug candidates – CS1, CS014, and CS585 – all in parallel development for rare cardiovascular and pulmonary diseases. The phase I trial of CS014, conducted in collaboration with CRO partner CTC in Uppsala, is primarily designed to evaluate the candidate’s safety and tolerability in humans.
CS014 is a HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of rare cardiovascular and pulmonary diseases with high unmet needs such as idiopathic pulmonary fibrosis (IPF). Drug candidate CS014 has shown strong vascular remodeling effects in preclinical studies, which indicates a disease-modifying potential.
CEO highlights market potential and patient impact
The phase I study is divided into two parts, where CS014 was administered as a single ascending dose (SAD), followed by multiple ascending doses over seven days (MAD). The first part was completed in February 2025 and confirmed an acceptable safety and tolerability profile, supporting continued clinical development. The second part has now also been completed.
– We are excited to have reached the `last patient last visit’- milestone for the phase I trial. We believe that CS014 can bring much needed improvement for patients as a well-tolerated oral treatment with a favorable safety profile and disease-modifying capacity. Based on the indicative results from part one of the phase I trial combined with promising effects seen in preclinical models, CS014 has a large market potential with relevance as a treatment for rare cardiovascular and pulmonary diseases with high unmet medical needs, says Sten R. Sörensen, CEO of Cereno Scientific.
Countdown to top-line results
The phase I study evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CS014 in 48 healthy volunteers. Following the final follow-up in the MAD part, data processing will now begin, followed by database lock and final analysis. Top-line results are expected in June 2025.
Rahul Agrawal, CMO and Head of R&D of Cereno Scientific, looks forward to the continued development.
– We are pleased with the progress of the CS014 phase I trial, which has been well executed according to planned timelines. The CRO, CTC in Uppsala, has been an excellent partner in this trial. The safety and tolerability data observed from part one of the trial suggest that CS014 may have a favorable safety profile. We now eagerly look forward to the top-line results, and further clinical development exploring CS014’s potential.
Chordate Medical announces that the United States Patent and Trademark Office (USPTO) has approved the company’s application to register the trademark Ozilia in the U.S. – Securing U.S. trademark registration is, of course, an important part of our intellectual property, says CEO Anders Weilandt.
Chordate Medical has developed a neuromodulation treatment for chronic migraine and rhinitis, leveraging a medtech platform that delivers oscillatory stimulation. Formerly known as Kinetic Oscillation Stimulation (K.O.S.), the treatment was rebranded as Ozilia in 2023 as part of the company’s commercialisation strategy. The new trademark, Ozilia, was chosen to symbolise freedom while also referencing “oscillation” — the core of the company’s technology.
Ozilia now registered in five countries and the EU
The U.S. registration is the fifth national registration under the Madrid Protocol. The trademark is already protected in Israel, Japan, China, and the UK, as well as the European Union since 2023. An application for registration in Brazil is currently under review.
– The OZILIA trademark has been well received by the market, and protecting it through registrations is part of our IP strategy aimed at building long-term value in the company and making the business more attractive to potential buyers, says Anders Weilandt, CEO of Chordate Medical.
Q&A with CEO: how Chordate Medical strengthens its global position
Anders Weilandt, CEO of Chordate Medical
BioStock reached out to CEO Anders Weilandt to gain deeper insights into the recent trademark developments and the company’s strategy.
The Ozilia brand is now registered in five countries, including the United States, as well as in the EU. What does this mean for Chordate Medical’s long-term strategy?
– A cornerstone of our strategy is that our portfolio of intellectual property, including patents and trademarks, represents a significant part of the company’s value – something a potential buyer of the business will certainly assess. Securing U.S. trademark registration is, of course, an important part of our intellectual property.
Ozilia replaced the previous name K.O.S. What was behind the decision to rebrand the treatment?
– K.O.S. is an abbreviation of the technology. We determined that the product needed its own trademark – not least to create recognition and a positive emotional response from our patients. In retrospect, we can conclude that it was a good decision, and that Ozilia has actually performed better than we had hoped.
You have previously announced that you are working to obtain market approval in the U.S. from the FDA. How is that process progressing?
– Since we are now in the final strategic phase of finding a buyer for the business, we are focusing all resources – and thus costs – on that process. The paused work with the FDA can be resumed at any time, either by us or by the future owner of the business.
Aptahem, a biotech company developing RNA-based treatments for severe inflammatory conditions, announces a strategic collaboration with Hongene Biotech, a global leader in RNA and Oligo manufacturing. The partnership aims to explore and implement new, cutting-edge production methods that significantly reduce manufacturing costs and enhance sustainability for Aptahem’s lead candidate, Apta-1.
The collaboration brings together Aptahem’s pharmaceutical development capabilities with Hongene Biotech’s expertise in RNA and oligonucleotide production. Hongene, which operates production facilities in China and plans to expand to Hungary in 2027, will work with Aptahem to implement next-generation manufacturing technologies for its lead candidate Apta-1.
– This collaboration is an exciting development for Aptahem and a clear demonstration of our commitment to innovation, cost-efficiency, and sustainability. With Hongene’s advanced capabilities and global reach, we are taking an important step towards de-risking our manufacturing strategy and reinforcing our position in the global biotech landscape, says Mikael Lindstam, CEO of Aptahem
The partnership aims to substantially lower the cost of goods (CoGs) for Apta-1 while also achieving higher product purity. The process innovations under review include solvent recycling, time-efficient workflows, and streamlined formulation steps – each contributing to a smaller environmental footprint and improved manufacturing scalability.
Strategic fit in a global production network
Cost-efficiency remains a critical factor in evaluating drug candidates, especially for companies preparing for late-stage development or licensing opportunities. By partnering with Hongene, Aptahem not only reduces its manufacturing costs but also strengthens its supply chain against global disruptions.
The collaboration adds a third pillar to Aptahem’s global manufacturing infrastructure, which already includes LGC in the United States and Ajinomoto in Japan. This diversified approach is designed to ensure uninterrupted supply and flexibility across regions – an increasingly valuable asset amid growing geopolitical uncertainty.
According to Aptahem, Hongene Biotech is currently at the forefront of novel manufacturing methods for nucleic acid-based products, making them an ideal partner for the company. Aptahem’s Chemistry, Manufacturing, and Controls (CMC) advisor, Thomas Rupp, played an integral role in initiating and leading the strategic discussions with Hongene.
Advancing Apta-1 toward the market
Apta-1, currently in early clinical development, is an RNA-based therapeutic designed to treat life-threatening conditions involving coagulation, inflammation, and tissue damage. The candidate has shown promising preclinical results in models of sepsis – a condition for which treatment options remain limited and mortality rates are high.
With Apta-1’s multi-functional mechanism of action – combining anti-thrombotic, immunomodulatory, and tissue-repairing effects – Aptahem aims to position it as a potential breakthrough in sepsis care. Cost-effective and sustainable production is therefore not just a technical objective, but a strategic imperative as the company moves closer to the later stages of clinical development and eventual market entry.
An investigator-initiated phase II study has been launched with SynAct Pharma’s lead candidate, resomelagon, in patients with dengue in Brazil. This trial runs in parallel with the ongoing study in rheumatoid arthritis. BioStock spoke with the company’s CSO, Thomas Jonassen, who sees strong potential for resomelagon in both RA and dengue, as well as other indications:
– We work behind the scenes to expand our pipeline and look forward to presenting the next program(s) once we are ready, says Jonassen.
These efforts reflect SynAct Pharma’s broader mission to develop therapies that restore immune balance and resolve inflammation by activating the melanocortin system. Unlike traditional treatments, resomelagon is designed to provide both anti-inflammatory and pro-resolving effects without suppressing the immune system.
This approach is relevant in several diseases and conditions connected to excessive inflammation, for example viral-induced hyperinflammation. Several viral infections, including dengue, can trigger a cytokine storm – an excessive and dysregulated immune response that can lead to severe complications.
Growing dengue threat highlights unmet medical need
Dengue is a mosquito-borne viral illness that primarily affects people in tropical and subtropical regions. In recent years, however, the virus has spread into temperate areas, including parts of Europe and the US – a shift likely driven by climate change.
Symptoms typically include high fever, severe headaches, muscle and joint pain, nausea, and skin rashes. In some cases, dengue can progress into a severe and potentially life-threatening form, marked by internal bleeding, organ damage, and circulatory shock. Despite its growing global spread and severity, no targeted pharmacological treatments are currently available once symptoms develop – a gap SynAct Pharma aims to address.
By targeting immune resolution, resomelagon presents a novel therapeutic strategy to address this critical unmet medical need. According to SynAct Pharma’s CSO, Thomas Jonassen, preclinical studies have shown promising results:
– Resomelagon has shown to reduce severity of Dengue in experimental animal models and to reduce the proinflammatory activity of human white cells challenged with Dengue Virus, says Jonassen.
Dengue study underway in Brazil as part of RESOVIR collaboration
To explore the potential of resomelagon as an add-on therapy for severe viral infections, SynAct Pharma has established the RESOVIR collaboration (Resolution Therapy for Viral Inflammation Research) in partnership with the Universidade Federal de Minas Gerais (UFMG) in Brazil and Queen Mary University of London.
As part of this initiative, a phase II clinical study in dengue patients has been launched, led by Professor Mauro Teixeira at UFMG, with clinical sites spread across Brazil. SynAct Pharma notes that patient recruitment and study progression will depend on the severity of this year’s dengue outbreak in these regions.
The study will assess the efficacy of once-daily oral resomelagon compared to placebo in 120 patients with symptomatic dengue. The primary endpoint is time to disease resolution, while secondary endpoints include reducing early warning signs and preventing progression to severe dengue.
Previously, under the same collaboration, resomelagon has demonstrated positive clinical outcomes as an add-on therapy in a phase II study involving hospitalised COVID-19 patients – further supporting its potential to address inflammation in severe viral infections.
Q&A with CSO
Thomas Jonassen, CSO, SynAct Pharma
BioStock spoke with SynAct Pharma’s CSO, Thomas Jonassen, to gain deeper insight into the potential of resomelagon as a novel treatment for virus-induced inflammation.
What motivated SynAct to expand its pipeline to dengue?
– During the pandemic we set up the RESOVIR collaboration aimed to investigate the potential of our resomelagon compound and other compounds that induce inflammatory resolution. The first study we conducted was in COVID-19 patients where we showed that resomelagon significantly reduced time clinical resolution of severe respiratory insufficiency with the result that the patients were faster discharged from hospital. For us, it is very clear that the potential of the compound was not restricted to Covid-19 virus, but had the potential as being a new treatment approach to reduce severity of viral infections, a so-called host-directed therapy to remodulate the overactivity in the immune system induced by a given virus.
– We therefore continue the work in the RESOVIR collaboration to further substantiate the clinical potential of the compound and among the diseases of interest is Dengue.
– Dengue is an arboviral infection, i.e. a viral infection transmitted from the bite of infected mosquitos. The incidence of the disease is increasing and the mosquitos that transmit the disease are spreading outside the tropical and subtropical part of the world, most likely due to climate changes. As a result, mosquito is now established in Europe and US with increased reports of local infections.
– When epidemics are present, one example is Brazil last year, several thousand new cases can develop every day with many severe cases needing hospitalization. It is estimated that more than 100 million people around the world get infected with the virus every year.
– As Dengue can develop into severe disease and no specific treatment is available, we found it logical to evaluate the compounds potential in Dengue and found very promising data in disease models including human white cells infected with the virus. The next step was therefore to continue with the RESOVIR-2 study.
Can you tell us a bit more about what resomelagon could mean for those suffering from dengue fever?
– Dengue is associated with fever and other signs of infections not so different from what we know for influenza and in most cases the disease will be self-limiting with days, but some patients develop severe symptoms with hemoconcentration and increased risk of bleeding that further can develop with shock symptoms, internal bleeding, organ failure and death. These severe symptoms are associated with what is called a hyperinflammatory response, i.e. that the virus infection induces an inappropriate response in the immune system. In principle, through mechanisms, comparable from what was seen in severe COVID-19 infections. In other words, the virus induces the disease, but the overactivity in the immune system induced by the virus induces life-threatening symptoms.
– Consequently, if you had a treatment option to rebalance the immune system, not just suppress it, it could protect the development of severe Dengue and or reduce the severity of the symptoms in established severe Dengue. Resomelagon is one such treatment option as it has the potential to be introduced in established disease with the potential to reduce symptoms and reduce the likelihood of developing severe Dengue.
The first patient has now been dosed with resomelagon in the RESOVIR-2 study in Brazil. What can we expect?
– We had set the study up with the potential to recruit at several sites in Brazil with the aim to focus our activities where the disease is present. Last year it would have been very easy to recruit as most metropolitan areas experienced large epidemic. In fact, even Buenos Aires in Argentina had, for the first time ever, a large out brake. This is not the case this year where no real epidemic has been present in big metropolitan areas including Belo Horizonte, the hometown of the principal investigator, Professor Mauro Teixeira. Further, we are already in the late season for the mosquito and thereby Dengue in Brazil, meaning that the recruitment rate will be slower than what would be possible during an epidemic. Or phrased differently, we are not able to give more information about timing at this time point. However, we know that the mosquitos will come back and then we will be ready.
How is the RESOVIR-2 dengue study financed?
– The study is as the previous clinical study in the RESOVIR collaboration set up as an investigator-driven study. It means that the investigator and not the company is the one who gets the approvals and runs the study. This is a much more cost-effective approach than a sponsor (company) initiated study, and can, in the right format, as we have through the RESOVIR collaboration, be a very attractive way of running the study. From a financial perspective, it means that we can run it within our current budget.
Will SynAct consider other indications beyond rheumatoid arthritis and dengue?
– Absolutely. We see two very attractive parallel development paths for resomelagon.
– The first is a novel treatment option in inflammatory and autoimmune diseases, where the compound though its mode of action could be a game changer with regard to early and patient-friendly intervention. Here is our current rheumatoid arthritis program the front runner project, but we do not see the potential restricted to RA. We are looking into other indication where we from a setup as the one applied to the RESOVIR-2 study, will have the possibility to run smaller proof of concept studies, without breaking the bank, in collaboration with key opinion leaders to support the potential of the compound.
– The second path for the potential of the compound is host-directed treatment in viral infections. Here the RESOVIR-2 study is the next step, but definitively not the only opportunity. Not only COVID-19 virus induces severe viral infection with development acute respiratory insufficiency. Infuenza virus and RS virus do the same and we have seen and will see significant manifestations of these virus infections where resomelagon potentially could reduce the severity of the disease.
– In other words, even though we are not ready to commit to development in additional diseases, we work behind the scenes to expand our pipeline and look forward to presenting the next program(s) once we are ready.
Any implication on your business development strategy?
– We continue to see a strong interest for partnerships and an additional indication adds value to the total deal potential for us. So yes, further discussions are in progress and now more indications to discuss.
Elicera Therapeutics has received the green light from the Data Safety and Monitoring Board (DSMB) to continue its phase I/IIa clinical trial, CARMA, evaluating the CAR T-cell therapy candidate ELC-301 for B-cell lymphoma. Armed with immune-activating properties via the company’s iTANK platform, the therapy is a key component of Elicera’s broader immunotherapy strategy. The approval comes as the company prepares to present preliminary efficacy data from the first patient cohort in May.
The CARMA trial, conducted in collaboration with Uppsala University, is designed to assess the safety and efficacy of ELC-301. In the trial’s first part – a dose-escalation phase involving 12 patients – a complete response was observed in the first patient treated with 1/10 of the planned max dose at the one-month follow-up, with no serious adverse events reported. Since then, two additional patients have been treated at the same low dose in cohort 1.
Following the DSMB’s evaluation, the study is now cleared to proceed to the next dosing level. Elicera intends to report results after each completed cohort, with the first preliminary efficacy data set to be presented at the 7th Swedish Cancer Research Meeting in Malmö on May 22.
– The positive recommendation to continue the trial with the next dose level is an important validation of our approach. We are now accelerating patient recruitment and moving to the next dosing level with the goal of demonstrating ELC-301’s full clinical potential, Elicera’s CEO Jamal El-Mosleh says in a comment to BioStock.
iTANK platform enhances ELC-301’s potential
At the heart of Elicera’s therapeutic innovation is the iTANK platform, a proprietary technology that augments CAR T-cell therapies by enabling parallel immune activation. In ELC-301 and across its pipeline, this dual-action mechanism is designed to extend the treatment’s effectiveness, enhancing the ability to target and destroy cancer cells. Elicera believes this dual mechanism of action could be especially effective in combating hard-to-treat solid tumours, where conventional CAR T-cell therapies often fall short.
ELC-301 is one of three drug candidates in Elicera’s pipeline using the iTANK platform, alongside ELC-401 and ELC-201. While ELC-301 targets B-cell lymphoma, the latter two are in preclinical development for solid tumours. Encouraged by preclinical efficacy data, Elicera is also advancing commercial opportunities by offering iTANK to external CAR T-cell developers under non-exclusive licenses.
Jamal El-Mosleh, CEO Elicera Therapeutics
– With iTANK, we are not just developing new treatments, we are enhancing what CAR T-cells can achieve. Our ambition is to establish iTANK as a standard complement in next-generation immunotherapy, El-Mosleh says.
Clinical and strategic milestones ahead
2025 is shaping up to be a milestone-rich year for Elicera. In addition to readouts from cohorts 1 and 2 in the CARMA trial, the company plans to complete the dose-escalation phase of its oncolytic virus candidate ELC-100. Parallel efforts are underway to secure funding and partnerships for advancing ELC-201 and ELC-401 into the clinic.
The company is also actively pursuing licensing agreements for the iTANK platform, which has the potential to generate non-dilutive revenue. While Elicera remains optimistic about these developments, El-Mosleh has noted that securing new partnerships or funding cannot be guaranteed within the year. Nevertheless, the company remains focused on these key growth opportunities.
The financial runway extends into 2027
Elicera’s ability to move forward confidently is supported by the successful exercise of its TO2 warrants in March 2025. The warrants were subscribed to approximately 96.3 per cent, generating SEK 21.2 million before issue costs. The round was fully covered through subscriptions and underwriting, ensuring funding is in place for clinical milestones and operations to at least the second half of 2027.
The company has confirmed that no new clinical studies are planned within the scope of this capital raise. Instead, the focus remains on advancing the CARMA trial and sustaining research momentum across its pipeline without requiring further dilution.
– With a solid financial runway and strong early data, we are now well-positioned to accelerate our development efforts in 2025 and beyond. The CARMA trial is a critical part of that journey and an opportunity to showcase the power of our iTANK platform in action, Jamal El-Mosleh concludes.
Curasight has announced a rights issue aiming to raise approximately 100 million DKK. The company has already secured approximately DKK 65 million in financing, comprising around DKK 47 million through pre-subscriptions and guarantee commitments in the rights issue. In addition, Curasight has secured and renegotiated approximately DKK 18 million in loan facilities. Nearly half of the secured capital in the rights issue is attributable to support from Curium International Trading B.V and Pentwater Capital Management Europe LLP. Proceeds will be used to secure clinical development towards key milestones, including the completion of phase II for the company’s diagnostic platform uTRACE in prostate cancer and phase I for the therapeutic platform uTREAT in aggressive brain cancer – glioblastoma. We spoke with CEO Ulrich Krasilnikoff to learn more.
Danish biotech company Curasight is pioneering a novel imaging and therapeutic approach based on the urokinase-type plasminogen activator receptor (uPAR). By combining the targeted uTREAT radiation therapy with the precise uTRACE diagnostics, the technology aims to minimize irradiation of healthy tissue. Several investigator-led phase II trials have been completed or are ongoing, including a prostate cancer study in collaboration with Curium, a global leader in radiopharmaceuticals.
Curasight is also generating clinical data for uTRACE and uTREAT across multiple cancer types, including bladder cancer, glioblastoma, neuroendocrine tumors, head and neck cancer, non-small cell lung cancer, and pancreatic cancer. Each indication representing a distinct development opportunity. Building on emerging clinical evidence, the company plans to engage experienced partners for later-stage development – as demonstrated by its collaboration with Curium.
Strengthening the financial foundation
The final terms are expected to be announced on April 24. The subscription price will be set at 65% of the Theoretical Ex-Rights Price (TERP), calculated based on the 10-day Volume Weighted Average Price (VWAP) at the time of the board’s formal resolution to proceed with the rights issue.
If fully subscribed, the rights issue is expected to generate gross proceeds of approximately DKK 100 million for Curasight, before deduction of transaction costs. The net proceeds, estimated at DKK 91.9 million, will be used to finance:
Completion of the Phase II trial for uTRACE in prostate cancer, with topline data in H2 2025 and final data in H1 2026.
Completion of the Phase I trial for uTREAT in glioblastoma (brain cancer), with efficacy readouts end of H2 2025 and final data in H1 2026.
Preparation for Part II of the uTREAT trial to begin in H1 2026.
Ongoing working capital needs.
Strong backing from new and existing stakeholders
Curium International Trading B.V has committed approximately DKK 17.8 million, reinforcing its confidence in the company’s uPAR-based platform. This commitment builds on the strategic partnership established between Curium and Curasight in 2023, which has the potential to generate up to USD 70 million in milestone payments, along with double-digit royalties linked to the future commercialization of uTRACE.
Another pre-subscriber is Pentwater Capital Management Europe LLP, a new institutional investor, that will subscribe for approximately 10 percent of the final issue volume, with a minimum commitment of approximately DKK 4.7 million.
In addition, Curasight’s management, board and existing shareholders have pledged approximately DKK 5.2 million.
Ulrich Krasilnikoff, CEO Curasight
The CEO comments
BioStock reached out to CEO Ulrich Krasilnikoff to learn more about the rights issue.
What is the strategic significance of having Curium and Pentwater on board as shareholders?
– We are very pleased to have received strong backing from both Curium and Pentwater as new shareholders in Curasight. We believe this provides further validation of our theranostic approach for better diagnosis and more precise treatment for cancers via our uTRACE and uTREAT platforms. Attracting these two new investors allows us to continue parallel development of our diagnostic and therapeutic platforms and brings us closer to fulfilling our ambition of helping a large number of cancer patients.
How does Curium’s investment build on your existing partnership for uTRACE?
– As a strategic partner already, Curium has strong insight into our ground-breaking uPAR-based technology and our skilled approach to development of precision diagnostics with targeted therapy. This partnership validates Curasight’s innovative approach, solidifying its position as a leader in the field and paving the way for revolutionary advancements in oncology care worldwide as well as confirm that the business case behind the partnership agreement with Curium in prostate cancer still is valid.
How do you view the timing and structure of the share issue, given the challenging funding climate?
– There is an extremely challenging funding climate currently, so we are pleased to have attracted backing for almost half the rights issue already. The participation of both Curium and Pentwater is important as it further underlines the potential of our theranostic approach to provide new solutions to patients for better diagnosis and more accurate treatment of certain types of cancer.
Finally, can you elaborate on how the proceeds will support the next steps in your pipeline development?
– The proceeds will support our strategy to develop both diagnostic and therapeutic solutions in parallel and move uTRACE and uTREAT towards key clinical milestones. These include the completion of the Phase II trial for uTRACE in prostate cancer, with topline data end of H2 2025 and final data in H1 2026, the completion of the Phase I trial for uTREAT in glioblastoma (aggressive brain cancer), with efficacy readouts end of H2 2025 and final data in H1 2026. This funding allows us to continue our journey on developing much needed theranostic solutions to improve the diagnosis and treatment of certain types of cancer.
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This material has been created for marketing purposes and is not and should not be considered a prospectus under applicable laws and regulations. The complete terms and conditions for the rights issue and more information about the company have been presented in a prospectus published on the mentioned company’s website.
Clinical Laserthermia Systems announces that the proposed U.S. tariffs are expected to have minimal impact on the company, despite the fact that its products are manufactured in the EU and shipped to the U.S. The company’s U.S. operations are fully managed by its subsidiary, CLS Americas Inc., which gives CLS control over the import process. Additionally, the company’s agreements with partners already include clear terms on how tariffs are to be handled.
Clinical Laserthermia Systems (CLS) is currently working to strengthen its market position in neurosurgery with the ClearPoint Prism Neuro Laser Therapy System for MRI-guided laser ablation. The system is marketed and sold in the U.S. through the company’s partner, ClearPoint Neuro.
How is CLS affected by U.S. tariffs?
With the US introducing new tariffs, questions have arisen about the potential impact on Swedish companies. On Tuesday, CLS addressed the situation, stating that the tariffs are not expected to significantly affect its operations. This resilience is attributed to its U.S.-based subsidiary, EU-centered production, and well-defined agreements that outline how tariffs are to be managed.
The company’s import and sales in the US are entirely managed by its wholly owned subsidiary, CLS Americas Inc. This structure gives CLS full control over its business in the U.S. and reduces the risk of external disruptions. The tariffs will only apply to CLS AB’s priced products exported to CLS Americas Inc.
Clear agreements on tariff management and EU-based supply chain
CLS has included specific clear terms in its agreements with partners that govern how any potential tariffs are to be handled between the companies. This creates stability and predictability – a clear structure is already in place defining who is responsible for the associated costs.
The company’s production and supply chain are based within the EU, which minimizes exposure to other regions that may be affected by the tariffs. By relying on EU-based production, CLS is not dependent on third-party countries that may be more severely impacted by U.S. trade measures.
CLS CEO Dan Mogren comments on the situation:
– Our structure is designed to be resilient. Thanks to our EU-based supply chain, U.S. operations run by our own subsidiary, and clear agreements with partners, we are well positioned to continue delivering on our growth plans.
BioInvent is reinforcing its position as a partner in antibody development. This was made evident as global pharmaceutical giant Takeda has initiated a phase III trial with mezagitamab (TAK-079) – an antibody originally identified using BioInvent’s proprietary n-CoDeR platform. As a result, a milestone payment of USD 1 million to BioInvent has been triggered.
Mezagitamab is being developed as a potentially best-in-class monoclonal antibody targeting CD38 for the treatment of chronic or persistent primary immune thrombocytopenia (ITP) – an autoimmune disease characterised by low platelet count and an increased risk of bleeding.
Takeda is developing the drug candidate under a royalty and milestone agreement with XOMA Corporation, through which Takeda has sublicensed the rights to the antibody from Swedish company BioInvent. Mezagitamab has already received both Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of ITP.
– We are excited to see mezagitamab progress into phase 3 trials, marking a significant step for Takeda and our n-CoDeR platform, says Martin Welschof, CEO of BioInvent.
Validating the science-driven platform
The advancement of mezagitamab into phase III is not only a testament to the fruitful collaboration with Takeda and XOMA – it also reflects the scientific foundation on which BioInvent’s discovery platform is built, and thus its business model. The candidate was identified through BioInvent’s proprietary n-CoDeR antibody library. BioInvent’s high-quality n-CoDeR library contains over 30 billion human antibody genes. Following screening and analysis in both in vitro and in vivo models, mezagitamab was selected as one of the most promising candidates for further development.
– This milestone not only validates the consistent high quality of drug candidates identified from our n-CoDeR antibody library, but it also highlights the success of our out-licensing strategy and its ability to drive real-world impact through strategic partnerships, says Martin Welschof.
Advancing a diverse clinical pipeline
BioInvent currently has two proprietary drug candidates in phase II clinical trials: BI-1808 (anti-TNFR2) for the treatment of CTCL and solid tumours, and BI-1206 (anti-FcγRIIB), which is being developed for non-Hodgkin’s lymphoma and solid tumours. In addition, the company has three more programs in early clinical phases: BI-1607, BI-1910, and BT-001, targeting various types of cancer.
Moreover, BioInvent has five clinical-stage projects that have been licensed out to Mitsubishi Tanabe, Abcentra, Daiichi-Sankyo, and Hope Medicine/Bayer, as well as Takeda – which has now delivered a milestone payment of USD 1 million.
With two ongoing phase II and four phase I studies, BioInvent can look forward to several milestones and expected data readouts during the year, including additional phase II data from its two lead programs in mid-2024. Read more.
Pernilla Abrahamsson has served as COO at Lipum since 2019 and has since played a key role in the company’s operations. Her background includes a successful exit and several years of experience in product development and as a laboratory engineer. – One key takeaway is the importance of building a sustainable company for the long term – focusing on patient benefit, a strong team, and a solid foundation, says Pernilla in an interview with BioStock.
Lipum is developing the biological drug candidate SOL-116 for the treatment of chronic inflammatory diseases. SOL-116 has shown promising results in a phase I trial and is now transitioning into phase II, with a focus on the treatment of rheumatoid arthritis (RA).
One of the key persons behind this development is Pernilla Abrahamsson, who has been the company’s COO for nearly six years. She began her career as a laboratory engineer at Norrland University Hospital in Umeå, where she identified a way to analyse metabolites on the surface of organs to detect complications during and after surgery – a concept that later formed the basis of her doctoral thesis.
Developed product for organ monitoring
Based on her research, Pernilla founded the medtech company MD Biomedical, where she developed OnZurf Probe – a microdialysis probe for monitoring the surface of organs. The product attracted market interest and led to a acquisition of the company by the publicly listed company Senzime in 2015.
Following the acquisition, Pernilla continued to work on further development and commercialisation of OnZurf Probe at Senzime, where she held roles including Product Development Manager and Director of Sales & Marketing.
Pernilla joined Lipum 2019
After four years at Senzime, Pernilla was recruited in 2019 as COO of Lipum. Since then, she has played a key role in coordinating the company’s operations and projects, driving its progress from preclinical development through phase I, and now into a pivotal next stage: a phase II trial with SOL-116 in patients with rheumatoid arthritis.
Pernilla Abrahamsson, COO of Lipum
BioStock spoke with Pernilla to gain insight into both Lipum’s development journey and her own career path.
Which of your previous experiences have been particularly valuable in your role as COO at Lipum?
– The experience of founding and running MD Biomedical AB has been invaluable. It gave me hands-on insight into product development and a clear understanding of what it takes to bring a company from idea to commercialisation.
– Working with the OnZurf Probe – from research to market launch – has given me a broad perspective that I apply daily at Lipum. My research background in anesthesiology also helps me understand the medical needs we aim to address.
You have now been COO at Lipum for nearly six years. What has been important in building and structuring the company?
– A key aspect has been creating structure and clarity in all areas of our business. We have built an organisation that is both flexible and stable enough to meet the demands of development. Finding the right partners, for example in manufacturing and clinical trials, is crucial. We always keep the patient’s needs in mind – it is one of the main driving forces behind what we do.
You’ve previously achieved a successful exit in medtech. What lessons do you bring into the potential future exit of Lipum?
– One key takeaway is the importance of building a sustainable company for the long term – focusing on patient benefit, a strong team, and a solid foundation. At Lipum, we continuously work to develop our business in a way that makes it attractive both clinically and commercially. By being transparent with our strategy and progress, we aim to show that what we are building has value – not only for patients but also for future partners, licensees, or owners, should such an opportunity arise.
What would you say are the biggest differences between developing medtech products and pharmaceuticals?
– The timelines and regulatory requirements differ significantly. In medtech, you can often reach the market more quickly, and there is usually room for development even after launch. Drug development is more resource-intensive, with longer timelines, complex clinical trials, and even stricter regulatory demands. It requires a different level of patience and long-term commitment.
Lipum’s drug candidate SOL-116 is now entering phase II for rheumatoid arthritis. What are your expectations based on the phase I results?
– We are very optimistic. The phase I study confirmed a good safety profile, high tolerability, and predictable pharmacokinetics, which is an important first step. It gives us a solid foundation as we now enter phase II, where we can begin evaluating the efficacy in patients with RA. We hope SOL-116 can offer a new treatment option for patients for whom current therapies are ineffective or inadequate.
In addition to planning for phase II, Lipum has other ongoing projects. Can you provide a brief overview of those and their goals?
– In parallel with developing SOL-116 for RA, we are also investigating other inflammatory diseases where the target protein BSSL may play a key role. The goal is to broaden the therapeutic potential of SOL-116 while building a pipeline that reflects our ambition to become a leading player in treating chronic inflammatory diseases.
In March, Spago Nanomedical announced that the independent Data Monitoring Committee had recommended a dose escalation in the ongoing phase I/IIa study with the company’s cancer drug candidate. This marks an important step in the study, which Paul Hargreaves, CDO at Spago Nanomedical, discusses further in an interview with BioStock.
