Cyxone comments on the clinical collaboration in the UK

28 March, 2024

Cyxone has entered into a research collaboration with a renowned British research group in Glasgow with the aim of conducting an exploratory phase II study with rabeximod in rheumatoid arthritis patients. BioStock reached out to CEO Carl-Magnus Högerkorp, who highlights the research group’s collaboration with the universities of Birmingham, Newcastle, and Oxford in the field.

Patients suffering from rheumatoid arthritis (RA) cannot currently count on their disease to be cured. RA is an inflammation of the joints that, if left untreated, often leads to the breakdown of bone and cartilage, functional impairments, pain, stiffness, and chronic fatigue.

Since there are no curative treatments, these patients are instead treated with symptom-relieving drugs. These include NSAIDs (non-steroidal anti-inflammatory drugs) and corticosteroids that are supposed to have a short-term effect. And then there are disease-modifying antirheumatic drugs, DMARDs, whose effect can only be measured after a period of treatment.

Cyxone wants to offer a better treatment option

Malmö-based Cyxone has identified the problem that many RA patients, up to 40–60 per cent of those treated with TNFα blockers, gradually stop responding to the treatment. Thus, this is the group of patients that the company focuses on.

The company’s pipeline consists of the lead candidate rabeximod for the treatment of rheumatoid arthritis (RA) and T20K for the treatment of multiple sclerosis (MS). Right now, the company is in clinical phase II development, intending to offer better treatments than today’s DMARDs, such as TNFα inhibitors.

New collaboration in the UK

Recently, Cyxone identified the biological target protein for rabeximod, which provided a more detailed insight into the mechanism of action, i.e. how the candidate affects the pro-inflammatory cells.

Having a good picture of the mechanism of action is important to move forward in partnering discussions. Proof of this came this week when the company announced a collaboration with researchers at the School of Infection & Immunity, University of Glasgow, led by Professor Iain McInnes. The goal of the collaboration is to conduct an exploratory phase II study with rabeximod in patients with rheumatoid arthritis.

According to Cyxone, this is one of the most distinguished centres in the world for research on RA and other immune-related inflammatory diseases.

In a press release, Professor McInnes expressed his interest in ascertaining more details about rabeximod’s mechanism of action:

»We are excited to enter this research collaboration with the Cyxone team. It is a very interesting project that we see before us. And having followed the development of rabeximod over the years I am looking forward to now learn more about how the molecule works in greater detail«

Comments from the CEO

BioStock spoke to Cyxone’s CEO Carl-Magnus Högerkorp to find out more about the collaboration.

How did this collaboration come about, and what significance has your latest research played in making it happen?

– It is incredibly exciting to establish this collaboration with the group in Glasgow. Professor McInnes is a world-leading rheumatologist and a leading researcher in the field who has strongly influenced the new direction of research in immune-mediated inflammatory diseases with an emphasis on precision medicine. The group in Glasgow is also at the forefront of research on the importance of macrophages in RA. Several very important scientific studies have therefore come from the group over the years.

– In line with our strategy of conducting studies with leading clinicians, we had a dialogue with Professor McInnes and several of his colleagues, where we began to discuss an exploratory study based on the framework for precision medicine studies that they have conducted in recent years. Since the Glasgow group also has a strong interest in the regulation of macrophages and had previous knowledge of rabeximod, we saw the value of conducting studies together.

Can you talk about the research group in Glasgow but also about the consortium RACE and what role Cyxone will play here?

– Glasgow is part of the RACE consortium, which consists of other very strong research environments linked to the universities of Birmingham, Newcastle and Oxford. Several of the experts in this consortium have also been consulted during the discussions that led to the collaboration. Among these, there is a shared interest in how rabeximod regulates macrophages, so we see great interest from RACE members in the study we are planning with Glasgow.

You will conduct an exploratory phase II study with rabeximod in patients with rheumatoid arthritis. Can you tell us how this will be implemented and what the timetable looks like?

– In line with our new strategy, we have focused on a new patient segment that we now intend to take a closer look at in exploratory studies. Preparations are underway and once all documentation is in place, a formal application to the UK Medicines and Healthcare products Regulatory Agency will be made. The idea is to conduct an open-label clinical study where we will document in detail how rabeximod works in patients with RA.

– The purpose of the studies is to provide significantly increased knowledge about the drug in order to facilitate continued development and to create a good basis for discussions with strategic partners.

Monthly of Sweden CEO talks launches, growth, and capital acquisition

28 March, 2024

MonthlyCup started up in 2015 and is now a prominent player in the menstrual cup market. The company is currently expanding its product offerings, changing its name to Monthly of Sweden and raising SEK 6 million in an investment round aimed at the international market. BioStock contacted CEO Lisa Perby to learn more about the company, the development of the new products, and how investors can be part of the journey.

Roughly one in four people is a woman of fertile age. The global menstrual protection market is enormous, and even though it is currently dominated by disposable products, more and more women are turning to more sustainable alternatives that are also gentler on the body. One product gaining ground is the menstrual cup, which sold for approximately USD 900 million in 2021 and is expected to constitute a market of around USD 1.4 billion by 2029.

In addition to the sustainability aspect, many choose the menstrual cup because it allows for more activities without feeling restricted. In fact, nine out of ten women who have tried the menstrual cup choose not to return to disposable products.

Predicting substantial sales increase in 2024

One company riding this wave is Halmstad-based Monthly of Sweden, which currently sells its menstrual cups, MonthlyCup, through over 1,200 retailers in 12 countries across Europe. Since its inception in 2015, the company has shown impressive growth figures. After a downturn due to the Covid-19 pandemic, they are now back on track for growth and had sales of over SEK 3.8 million in 2023. For 2024, they predict sales to exceed SEK 6 million.

One of the building blocks to achieve this is the launch of Monthly Wear, menstrual underwear containing TorTex – a patented naturally antibacterial textile. The underwear has an absorbent layer free from harmful metals, providing protection throughout the day.

However, this is not the only product under development. By 2026, Monthly of Sweden aims to launch Inconti, a medical continence support for women suffering from stress incontinence.

Raising SEK 6 million in capital round

To maintain momentum in market penetration and product development, the company is now raising SEK 6 million, with SEK 3 million already secured. The capital acquisition is part of two investment and development phases. The first is intended to finance, among other things, biocompatibility and cytotoxicity tests, a clinical study, the launch of Monthly Wear, and an expansion of the sales and marketing team.

Since Monthly of Sweden is not listed, investors need to contact the company directly to invest. The capital acquisition is ongoing until April 7th. More information can be found here.

CEO’s comments

BioStock has contacted Lisa Perby, CEO of Monthly of Sweden, to learn more about the company, ongoing market initiatives, and the capital acquisition they are undertaking.

Starting with the menstrual cup market, you have a prominent position in Sweden. What contributed to your success?

– We have always put the customer first, not only through a product manufactured in Sweden, that is traceable, and tested for internal use, but also through communication and development. We have dared to break new ground, contacting retailers who previously did not have menstrual cups on the shelf, resulting in our presence today with major players.

Menstrual underwear is a relatively new product category within menstrual health, and there has been controversy surrounding several companies’ menstrual underwear containing prohibited chemicals, leading to their withdrawal from the market. What are your thoughts on this, and how do you plan to ensure a successful launch of Monthly Wear?

– I understand how other players have thought – they don’t want the underwear to smell, so they add silver to kill bacteria. But silver is a controversial chemical that is extremely harmful to the environment, so we need to find other solutions. Instead, our underwear contains an antibacterial material called TorTex, which we use under exclusive license. It is naturally antibacterial, without added silver, making it suitable for the menstrual use case.

– We are looking forward to the launch in a couple of months, where we will first let our 2,500 shareholders act as a test panel before we reach the general public. Several of our current retailers have already shown great interest in these unique menstrual underwear.

After the setback from Covid-19, you showed growth again in 2023. What has contributed to this positive development?

– New retail chains, increased online sales, and investment in new and expanded areas all contribute to our growth. The fact that we have been quite prominent in the media also contributes to increased awareness.

How have sales developed in early 2024?

– Sales continue to rise. We will soon launch in another nationwide retail chain with 300 stores. This particular customer naturally affects sales, but is primarily a quality stamp for us. For the full year, we predict sales of over SEK 6 million.

Can you tell us a bit more about what needs to happen for that forecast to be met?

– There are three key areas that we are working on: our own online sales, increased distribution in stores, and the launch of menstrual underwear. Thanks to our extensive distribution network, we believe in early success for menstrual underwear in particular.

You are also working towards introducing a continence support. What does that segment look like, and what market potential do you see there?

– Up to 35 per cent of all women experience stress incontinence, but the actual number is believed to be much higher. Of these, 85 per cent do not seek treatment but suffer in silence. We want to help them with an easy-to-use product they can try out at home, which alleviates leakage and restores freedom. Considering the limitations caused by stress incontinence, we see significant market potential among the hundreds of thousands restricted in their daily lives. Incontinence products are sold for USD 10 billion annually.

You have a lot in the pipeline. Looking further ahead, where do you hope Monthly of Sweden will be in five years?

– We believe we will be one of the major companies in women’s health, with more exciting products in development. The goal is to have a presence in more international markets and to be listed on the stock exchange.

Finally, what are your best arguments for investing in Monthly of Sweden right now?

– Our menstrual cup has proven to change lives for so many. Now it’s time to take the next step with more products that can have the same impact on people and the planet. We have shown that we can achieve significant results with limited resources. If we had solely worked with menstrual cups today, the result would already be positive. I am convinced that our development projects will take us to our goals.

Spago Nanomedical’s CEO: “huge commercial opportunities are unfolding”

27 March, 2024

Spago_radiopharma_commercial_opportunity

Last week we saw the USD 2 billion buyout of Fusion Pharmaceuticals by AstraZeneca to accelerate the development of next-generation radioconjugates to treat cancer. The deal showcases rising interest in the field of radiopharmaceuticals. BioStock got in touch with Mats Hansen, CEO of Swedish radiopharma company Spago Nanomedical to get his take on the deal and where Spago is in its development of lead programme Tumorad.

Radiopharmaceuticals are quickly becoming a valid alternative or complement to existing cancer treatments, especially in cases of aggressive cancers. The idea is to offer targeted therapy, delivering radiation directly into cancer cells, thus minimising damage to healthy tissues. Their capacity to target tumours with high efficacy and fewer side effects than traditional radiation therapy has led to a significant rise in big pharma activity and investor venture funding within the field.

Big pharma taking notice

Novartis leads the way with several deals made since 2017 to gain access to nanotherapeutic technology platforms and pipeline candidates. Read more. Last year, Eli Lilly entered into a definitive agreement to acquire POINT Biopharma for approximately USD 1.4 billion, in a move designed to broaden its oncology portfolio with the addition of radioligand therapies.

Meanwhile, Peptidream and Genentech, a Roche Holding company, signed a deal worth up to USD 1 billion to discover and develop macrocyclic peptide-radioisotope (peptide-RI) drug conjugates.

Investors want in on the action

All of the big pharma activity is fuelling interest among investors. According to GlobalData, venture capital financing in US-based radiopharmaceutical companies has grown 550 per cent from USD 63 million in 2017 to USD 408 million in 2023.

In 2023, US-based biotech Mariana Oncology closed off an oversubscribed USD 175 million Series B financing round. Several major investment firms participated, including Deep Track Capital and Forbion, both of which specialise in the life science sector.

Shortly thereafter, RayzeBio, also based in the US, greatly exceeded its IPO expectations when it raked in USD 311 million instead of an expected USD 210 million. This stirred a lot of interest and propelled the company’s market valuation to USD 1.4 billion. Then, late in the year, Bristol Myers Squibb announced that they will acquire RayzeBio for a total equity value of approximately USD 4.1 billion.

AstraZeneca’s acquisition of Fusion Pharmaceuticals

The radiopharma party is not showing signs of stopping. Just last week, AstraZeneca announced that it had acquired the North American clinical stage oncology company Fusion Pharmaceuticals. Fusion is focused on developing next-generation radioconjugates (RCs) as precision medicines for treating cancer. The company’s most advanced programme, FPI-2265, is a potential new treatment for patients with metastatic castration-resistant prostate cancer (mCRPC). The acquisition, worth more than USD 2 billion, marks yet another sign of big pharma learning hard into the radiopharma concept for cancer therapy.

The deal means a boost for the Swedish venture capital firm HealthCap, which owns about 5 per cent of the portfolio company. BioStock spoke with Founder and Managing Partner at HealthCap Björn Odlander to get his take on the transaction:

“HealthCap as an early investor has received a good return in Fusion. We were also early to invest in the new modality of radiopharmaceuticals. The first investment was in Algeta ASA which was sold to Bayer for USD 2.9 billion. HealthCap is now a partner in two other radio-pharma companies, Precirix and Ariceum.

Read the article here (in Swedish).

A closer look at Sweden – Spago Nanomedical

Staying in Sweden, a company focused on this field is Spago Nanomedical. The company’s Tumorad programme is aimed at developing a new radionuclide therapy for cancer. The drug candidate ¹⁷⁷Lu-SN201 is currently being evaluated in a phase I/IIa trial, and the first patient was dosed late last year.

Then, in January, Spago announced receiving the approval for a dose-escalation study with ¹⁷⁷Lu-SN201 with the aim of testing the candidate’s safety and tolerability. Read more.

Spago’s CEO comments on the AstraZeneca deal

BioStock reached out Spago’s CEO Mats Hansen to get his take on the AstraZeneca/Fusion deal and where things stand with Spago’s candidate.

Mats, why do you think there is such a big interest in the field right now?

– Radiopharmaceuticals have long been known to provide effective cancer treatment. The challenges has been to solve selective targeting to tumours (to spare non-target organs, especially the kidneys), radiostability of carrier molecules, isotope availability, and the logistical issues associated with production and clinical supply. As these issues have gradually been overcome, and success stories in the form of new approvals and availability of these drugs for effective use in major cancer indications have become more widespread, the huge commercial opportunities are unfolding.

What was your reaction to the AstraZeneca/Fusion deal?

– It is another example of a Big Pharma taking position in the field. I suspect more will follow.

Fusion Pharmaceuticals refer to their candidates as “next-generation radioconjugates.” How does this concept differ from Spago’s?

– Similar to many other approved or pipeline products, their lead candidate is molecularly targeted, mainly towards prostate cancer. They are using the isotope actinium-225, which emits alpha-particles (helium nuclei). In Tumorad, we use the beta-radiating (electrons) isotope lutetium-177 strongly bound to our patented polymeric material to form the candidate drug ¹⁷⁷Lu-SN201. Lu177 is a readily available, logistically suitable isotope that is clinically validated by means of the approved drugs Lutathera and Pluvicto by Novartis.

Fusion’s lead candidate targets a specific type of prostate cancer. Are radiopharmaceuticals in general more suited for this type of cancer or is there potential to go into multiple cancer indications?

– With Tumorad, we are exploiting physiological accumulation of optimised particles in solid tumours. This provides for expasion opportunities and use in cancers that cannot yet be treated with radiopharmaceuticals. Our vision is to bring this type of effective treatment to patients with aggressive cancer, e.g. ovarian- or triple-negative breast cancer.

Finally, where is Spago in the development of the Tumorad project at the moment?

– The clinical trial Tumorad-01 with ¹⁷⁷Lu-SN201 in cancer patients is progressing according to plan. The set-up in Australia is cost effective and, so far, we see a high interest among clinicians and good availability of patients. As the study progresses, we aim to expand the study into further sites and regions. In parallel to this, we are conducting a non-clinical study of 177Lu-SN201 and a selected group of standard cancer drugs in a model of triple-negative breast cancer. The aim is to provide data that can support positioning in this and other indications. We expect to provide a public update on the progress and results so far during Q2.

WntResearch’s new CEO comments on his first month in the position

27 March, 2024

Development company WntResearch recently recruited the first patient for the expansion part of the ongoing phase II study, NeoFox. This coincided with Per Norlén’s first days at the helm of the company. BioStock contacted him to find out how he sees the potential of Foxy-5, and how he, with a long career as CEO of several biotech companies, wants to contribute to advancing the positions of the project.

Foxy-5 is a peptide-based drug candidate that has been developed to mimic WNT5A, an endogenous protein that counteracts cancer. Among other things, WNT5A has been shown to prevent the spread of cancer, both by reducing the ability of cancer cells to detach from parent tumours, and by counteracting their ability to establish themselves in healthy tissue. With Foxy-5, WntResearch wants to use this effect to offer a new kind of treatment for patients suffering from colon cancer.

The company received a lot of attention in 2022, after ad hoc observations from a phase II study that pointed to an inhibitory effect on local tumour spread after just three weeks of treatment. This led to a pause in recruitment to redesign the study in order to optimise the possibilities of demonstrating this particular effect. The trial was re-started shortly thereafter.

First patient recruited

Recently, the company announced the completion of the first dose-finding part of the study. After receiving support to proceed with a significantly higher dose, the first patient in the subsequent expansion part has been enrolled. The plan is to recruit a total of 80 patients, half of whom are on active treatment, and to conduct an initial efficacy analysis once a sufficient number of patients have been treated. This analysis is expected to take place by the end of 2024.

Per Norlén takes over as CEO

WntResearch is not only recruiting patients. Heading the company during this exciting period will be Per Norlén, who took over as the new CEO from Pernilla Sandwall at the beginning of March. Per brings solid experience in drug development, heading companies like Alligator Bioscience, Targinta and Evaxion Biotech.

BioStock reached out to Norlén to find out more about his background, how he views the project with Foxy-5, and to get his impressions of BIO-Europe Spring, which recently took place in Barcelona.

First of all, Per, for those who don’t already know you, can you start by telling us a little about your background?

– Over the past 10 years, I have been the CEO of several different biotech companies, including Alligator Bioscience, which I brought to Nasdaq Midcap in 2016, but later also at Targinta and Evaxion Biotech. I am a medical doctor, board certified specialist in clinical pharmacology, and have an associate professorship in pharmacology. For the past 20 years, I have been involved in clinical drug development, within the healthcare system, at big pharma, and for the past almost 15 years in biotech.

What do you see as your main strengths, and how can they best be used where WntResearch stands right now?

– I believe that the combination of solid scientific and clinical expertise, and broad experience in IR and business development, can create value for WntResearch. The company is in a critical phase where the ongoing study will determine the future and where the goal is to obtain positive data that will lead to a major partnership.

– I believe that my experience of entering into significant partnerships with both big pharma and biotech companies will be positive in this regard.

If we turn our attention to the Foxy-5 project – what do you think about it?

– The most crucial thing about Foxy-5 is that the pre-clinical findings are now strengthened by clinical data showing a clear effect on local spread of colon cancer. The effect is both clinically meaningful and statistically significant, and based on a sample of 110 patients in a randomised controlled study.

– The previous study was unfortunately not fully sized to demonstrate an effect on clinical outcomes such as disease-free survival. The main reason for this was that there were fewer patients who relapsed than expected. This is probably due to improved diagnostics, surgery and post-surgery treatment in recent years. But instead, powerful effects on local spread were seen, already after three weeks of treatment before surgery, indicating that Foxy-5 has great potential in colon cancer.

– In the ongoing study, our hope is to show that this positive effect is of such a magnitude that Foxy-5 can become a truly value-creating drug.

The company is at a very important stage. What are your thoughts on the ongoing phase II study?

– It is important to understand the context in which Foxy-5 is being developed. The drug candidate is given to patients with localised colon cancer immediately after diagnosis. Thus, these patients do not yet have metastatic disease, as far as can be assessed with today’s diagnostic methods. The treatment then continues until the tumour is surgically removed, which normally occurs within 3 – 5 weeks. However, about 20 per cent of these patients will have a relapse with metastatic disease within a couple of years, and then the prognosis is extremely poor.

– The purpose of Foxy-5 is to reduce the number of patients who relapse after initial surgery. This clinical outcome is however not studied in the current study, where we focus entirely on showing that Foxy-5 reduces local spreading during the short treatment period up to surgery. We can analyse this very precisely through histological assessment of the surgically removed material, and compare effects between treated and untreated patients.

– In the previous study, we observed a clear reduction in local spread, despite the fact that the patients had received only part of the total treatment at that time. In the new design, the treatment is intensified during the first three weeks, where we increase both the dose and the number of doses, so that the total exposure to the drug candidate increases more than seven times. This could further enhance the effect.

You recently raised SEK 31.4 million in your rights issue. How does this affect your plans going forward?

– This was done in order to be able to continue the ongoing study which is essential in order to document the effects of Foxy-5 in colon cancer. The observations we have seen so far are very promising but need to be confirmed if we are to enter into a larger partnership. The current study is thus extremely important for the company, and we hope to be able to present initial efficacy data from the recruited patients already towards the end of the year.

You participated in BIO-Europe Spring. What impressions did you take with you from there and how would you describe the interest in your project?

– Building long-term relationships with potential partners is instrumental for successful business development, and BIO-Europe Spring is one of the many events that we participate in for this very purpose. Preparing for partnering is a continuous effort where you try to get as many stakeholders as possible to be aware of the company and the product candidate, so that they are interested in evaluating the clinical data as soon as we can share it.

– Due to our positive ad hoc observations, a lot of people want to talk to us, and most are interested in moving forward in these discussions as soon as we can confirm our previous findings.

Alligator to maximise immuno-oncology innovation

27 March, 2024

With ongoing partnering discussion for the phase III trial with mitazalimab, Alligator Bioscience can put more focus on accelerating the development of ATOR-4066. To reach this goal, and push other pipeline projects further, the company now seeks to raise approximately SEK 150.9 million in a rights issue.

When it comes to cancer immunotherapy development, Alligator Bioscience is leveraging its expertise in the CD40 protein – a molecular target that plays a major role in immune response regulation.

Through this expertise, the Swedish biotech has been making headways with the clinical development of CD40 agonist mitazalimab. At the beginning of the year, Alligator posted positive topline data in a phase II trial with mitazalimab in first-line pancreatic cancer patients. When combined with chemotherapy (mFOLFIRINOX), the CD40 agonist leads to improved clinical outcomes for these patients. Read the full story here.

Maximising value through the Neo-X-Prime platform

The positive phase II data generated with mitazalimab in pancreatic cancer 9 months earlier than initially anticipated, has demonstrated that the changes made in Alligator’s operations and strategy a few years ago are paying off and that Alligator has a truly differentiated platform able to generate safe and efficacious therapies where other players have failed.

In a recent BioStock interview, Alligator’s CEO Søren Bregenholt had this to say about the company’s priorities throughout 2024:

»We remain completely focused on our dual goals of maximising our chances of developing innovative immuno-oncology therapies while ensuring the best returns for our stakeholders.«

One of Alligator’s other projects, ATOR-4066 (“4066”), stems from the knowledge gathered developing mitazalimab. Through this knowledge, Alligator has developed the proprietary immunotherapy technology platform Neo-X-Prime with the aim of generating bispecific antibodies targeting CD40 alongside antigens expressed in a highly specific manner by the tumour. This allows for the activation of the CD40 only at the heart of the tumour, which is expected to translate to best-in-class efficacy, safety and tolerability.

And that is what 4066 has been shown to do in a preclinical setting. So, while the company scouts for potential partners to carry out a phase III trial with mitazalimab in pancreatic cancer, Alligator can put its efforts in bringing 4066 to the clinic and generating strong clinical data.

Raising capital for project advancements

Given the extent of Alligator’s development, which also includes ATOR-1017 (“1017”), and ALG-APV.527 (“527”), two compounds that target the 4-1BB molecule – read more here – the company is raising capital to push forward with its goal to develop best-in-class tumor-directed antibody drugs for hard-to-treat cancers.

For this purpose, Alligator has decided to carry out a rights issue of approximately SEK 150.9 million. If the interest in participating is high, the company may resolve on an over-allotment issue of a maximum of approximately SEK 100 million.

The company has received subscription undertakings from a number of its largest existing shareholders, including Koncentra Holding (part of Allegro Investment Fund) and Roxette Photo. Several members of the company’s Board of Directors and management, including the company’s chairman of Anders Ekblom and CEO Søren Bregenholt, have also committed to subscribe to the issue. The total pledged undertakings amount to approximately SEK 59.8 million, corresponding to about 40 per cent of the issue, highlighting their strong belief in the long-term potential of the company.

To secure the company’s liquidity needs until the completion of the rights issue, Alligator has entered into a bridge loan agreement for a total consideration of approximately SEK 58.8 million with Koncentra and Roxette Photo.

The offering in summary

Terms	Existing shareholders will receive three unit rights for each existing share. 14 unit rights entitle the holder to subscribe for one unit. Each unit consists of one ordinary share and one series TO 9 warrant.
Subscription period	March 21 – April 5, 2024
Subscription price	SEK 1.07 per unit
Issue volume	150.9 MSEK + proceeds from warrants
Dilution	Excluding over-allotment, the dilution will be 17.6 per cent upon full subscription in the rights issue. There will be a further dilution of 15.0 per cent if the TO 9 series warrants are fully exercised.

Information and subscription

Subscription at Avanza

Subscription at Nordnet

IMPORTANT INFORMATION

This material constitutes an introduction to the rights issue of units in Alligator (the ”Rights Issue”) and should be regarded as marketing material. The material is not and shall not be considered to constitute a prospectus in accordance with applicable laws and regulations. Invitation to shareholders and the public to subscribe for units in the Rights Issue takes place only through the prospectus that has been approved and registered by the Swedish Financial Supervisory Authority (the ”Prospectus”), and which has been published on www.alligatorbioscience.se/en/investors/preferential-rights-issue-q1-2024/. The Swedish Financial Supervisory Authority’s approval of the Prospectus shall not be construed as an approval of the new shares or warrants. In order for an investor to fully understand the potential risks and benefits associated with the decision to participate in the Rights Issue, any investment decision should only be made based on the information in the Prospectus. Investors are advised to read the full Prospectus.

Mentice updates strategy and goals at Capital Markets Day

26 March, 2024

On March 21, Mentice arranged a Capital Markets Day in Stockholm, where the management presented the company’s updated financial targets and strategic direction. The event was also attended by two guest lecturers, Dr. Demetrius Lopes and Michael Lee, who discussed the benefits of Mentice’s simulation solutions for healthcare and the medical technology sector.

Gothenburg-based Mentice is a market leader in the development of simulation solutions for endovascular surgery, i.e. Image Guided Interventional Therapies (IGIT). These are minimally invasive procedures used to diagnose and treat vascular diseases – diseases that affect the vessels or related organs such as the brain or heart. The IGIT market is experiencing robust growth driven by a notable shift from open surgery to minimally invasive procedures.Formulärets överkant

Mentice’s simulation systems can be seen as “flight simulators” for healthcare that allows physicians to practice the procedures in a safe, realistic and patient-specific environment before they are carried out in real life situations. In addition, the simulation can be used as decision support during the procedures and for evaluation afterwards – all to optimize the physicians’ skills, patient safety and the outcome.

During the Capital Markets Day, strategic direction was presented

On March 21, Mentice arranged its first Capital Markets Day since its IPO on Nasdaq First North in 2019. The event began with CEO Göran Malmberg presenting the company, which today has over 120 employees globally. This was followed by a newly produced company film – watch it here.

That same morning, Mentice published a press release announcing an updated strategic direction, to get closer to clinical operations. The strategy includes continued investments in R&D to develop the next generation technology platform and standardization of the product portfolio.

In addition, the company plans to further develop OEM (Original Equipment Manufacturer) channels and continue to establish strategic partnerships with the company’s key customers in the medical device industry. For OEMs, it is a matter of establishing relationships with suppliers to Catheterization Laboratories (Cath Lab), where IGIT interventions are performed.

Financial target: continued growth and improved profitability

During the Capital Markets Day, CFO Ulrika Drotz Voksepp also spoke about the company’s financial figures and the updated financial targets. Ulrika pointed out that Mentice aims to continue to grow at a steady pace, while at the same time, they want to improve profitability gradually and maintain positive cash flow. She also commented that Mentice should be assessed on an annual basis or on a rolling 12-month perspective as the company continues to be sensitive to individual orders and the distribution of sales during the year.

The company presented updated financial targets where the plan is to achieve a 20-30 per cent annual growth in net sales, as well as an EBITDA margin of 20 per cent in the medium term (three years) and a long-term target of 30 per cent for EBITDA.

The company’s previous target, set in 2019, was to achieve an average annual sales growth of 30-40 per cent, as well as an EBITDA margin of 30 per cent.

Ulrika noted that these financial targets have been changed to adapt to today’s conditions, as well as to the strategic plan presented during the Capital Markets Day, where the company continues to invest in the technology platform and development of the market.

Last year, sales increased by 25.5 per cent, from 218 million SEK to 273.6 million SEK. Sales per employee increased by 30 per cent.

Market position and opportunities for expansion

The next speaker on stage was Martin Harris, Vice President Marketing, who talked about Mentice’s market position and how the company’s simulation solutions handle clinical challenges. In hospitals around the world, Mentice’s simulations are used for training and planning procedures. In addition, the products are used by leading medical technology companies for clinical evaluation, market launch of new products and training of healthcare professionals. Sales to the medical technology industry are already well established, and Mentice aims to deepen its presence in hospitals and clinics.

Focus on benefits for healthcare and patients

During the event, COO Jonatan Sjöström talked more about the company’s market position and strategic direction, as well as his first months as COO at Mentice. He emphasized that he appreciates that Mentice’s culture is permeated by a desire to constantly improve the doctors’ skills and ensure the best possible care for patients. In addition, he talked about the possibility of expansion through the development of the core technology, software, opportunities for complementary products, and the use of AI.

Jonatan also talked about the company’s plans to add sales resources and continue to enter strategic collaborations with medtech companies, along with an even greater focus on working with Key Opinion Leaders to get closer to the hospital market. The company’s sales are primarily focused on the US, Europe, Japan and China.

Successful customer examples

The Capital Markets Day also included two guest presenters, the first of whom was Dr. Demetrius Lopes, Director Cerebrovascular and Comprehensive Stroke Center at Advocate Health Care. Dr. Demetrius Lopes is a surgeon in neuroendovascular procedures and a renowned Key Opinion Leader in the field. He is also an experienced user of Mentice’s simulation tools. Dr Lopes described just how he utilizes both Mentice VIST, flow models as well as Ankyras for his day-to-day operations. Ankyras are an important part of surgery planning as it helps them to better assess the conditions of each specific patient and which clinical instrument is most suitable.

The second guest speaker was Michael Lee, director of EBR Systems, which has developed the world’s first wireless and implantable heart stimulation system for heart failure. For this particular procedure, a well-developed training program for the doctors is crucial to ensure patient safety and good results. The company has chosen Mentice simulation technology, as it is believed that it provides realistic training for the implant. According to Michael Lee, Mentice’s simulation platform was instrumental in performing the studies required to obtain FDA approval.

Realistic experience is important in simulation

CTO Henrik Storm went through the basic components of the weight of Mentice’s technology, as well as what is important to consider when it comes to the company’s research and development. Among other things, he talked about the work of always improving in the way that Mentice replicates reality through visual realism, anatomical realism, instrument and device realism, haptic realism and procedural realism. The expectation from the market is that the total environment in such a realistic way replicates reality in terms of both X-ray and ultrasound images, anatomy models, and clinical instruments.

CEO sums up the Capital Markets Day

The Capital Markets Day concluded with a summary comment from CEO Göran Malmberg. During the event, there was also an opportunity to get a demonstration of Mentice products and ask questions directly to the presenters.

BioStock reached out to Göran to get his thoughts on the Capital Markets Day.

What do you think were the highlights of the Capital Markets Day?

– For us, I think the presentations from Dr. Lopes and Michael Lee, in a good way show how important our products are to our customers. Of course, it was a good opportunity for us to clarify and give our audience a clearer picture of what we do.
A key part of the updated strategy seems to be to reach out to the hospital market. What challenges do you see in reaching out to the day-to-day clinical operations?

– There are several challenges, but little of what we talked about during the Capital Markets Day is both financing and issues related to the reimbursement of doctors for training. There are structures for reimbursement regarding the initial training of specialists, but the structures for continuous training are not as clear.

During the Capital Markets Day, you had two customers present, Dr Demetrius Lopes and Michael Lee, who presented the benefits of Mentice’s products in their business. What was the most important message in their presentations?

– Dr. Lopes is one of the world’s most accomplished and recognized neurosurgeons. The fact that he can tell us how he uses all our main products in his business, I think, is an essential message and exactly in line with our ambition.

– EBR System is a highly innovative company and I think it shows once again how valuable our products are for the entire value chain from device development, via launch, to safe use in healthcare. I think it was important, as Michael told me, that they implemented a structure where doctors simulate before each procedure on the patient to make sure that you are always prepared in the right way for a procedure.

You also presented updated financial targets during the event. Why do you choose to lower your goals?

– Our previous goals were set in 2019 when Mentice was half the size. At the time, we expected that our sales through our strategic channel would develop significantly faster. Since then, we have managed to double the size of the company, i.e. maintained an average growth of 22 – 23 per cent while improving our profitability.

– With the new goals, we would like to emphasize a few key points: Mentice is a growth company with the ambition to continue to grow at a high pace, i.e. 20 – 30 per cent. We also see that we need to invest in our long-term growth, both in terms of development, sales and marketing. This means that we will reinvest in growth and therefore set a target of 3 years to increase our profit from just under 10 percent in 2023 to 20 percent in 2026. By 2026, we will see continued growth towards an EBITDA margin of 30 per cent. I would see this as a continuation of an ambitious and aggressive growth plan, which is now adapted to the conditions we see in today’s market.

So far, you’ve acquired seven companies to bolster your product portfolio. How do you perceive the potential for further acquisitions?

– We are constantly monitoring what is happening in the market and there are many exciting opportunities, even if the current situation makes it more difficult to use our shares as a means of payment. Acquisitions will continue to be an important part of our development, but our base and targets are based on organic growth.

Finally, what concrete changes will take place based on the new strategy and the new financial targets?

– The most important message to the market is that we are investing in growth, i.e. we are focusing on our technology platform and we are expanding by continuing to increase our sales and support organization.

BioStock Investor Pitch: Alligator Bioscience

25 March, 2024

How is Alligator Bioscience preparing to move forward after FDA approval? CEO Søren Bregenholt presents the company, which develops tumour-directed antibodies, and gives us the latest developments.

Watch the presentation below:

IMPORTANT INFORMATION

This material constitutes an introduction to the rights issue of units in Alligator (the ”Rights Issue”) and should be regarded as marketing material. The material is not and shall not be considered to constitute a prospectus in accordance with applicable laws and regulations. Invitation to shareholders and the public to subscribe for units in the Rights Issue takes place only through the prospectus that has been approved and registered by the Swedish Financial Supervisory Authority (the ”Prospectus”), and which has been published on www.alligatorbioscience.se/en/investors/preferential-rights-issue-q1-2024/. The Swedish Financial Supervisory Authority’s approval of the Prospectus shall not be construed as an approval of the new shares or warrants. In order for an investor to fully understand the potential risks and benefits associated with the decision to participate in the Rights Issue, any investment decision should only be made based on the information in the Prospectus. Investors are advised to read the full Prospectus.

The content of the article is sponsored by the company in question that appears in the text. BioStock does not provide investment advice, transmit investment orders and accepts no liability for any actions and/or any loss or damage of any kind based on the use of content published on BioStock.se. Instead, each investment decision is made independently by the individual investor.

Asgard’s CEO on the EUR 30 million Series A financing

22 March, 2024

Cristiana Pires, CEO Asgard Therapeutics

Asgard Therapeutics is a biotech based in Lund developing an immune “Trojan horse” to defeat cancer. The company recently announced a EUR 30 million Series A financing to advance its cell reprogramming platform for immuno-oncology. Asgard’s CEO and co-founder Cristiana Pires stopped by the BioStock Studio to tell us all about it.

Watch the interview here:

Lipum has included first RA patient

22 March, 2024

Lipum recently announced that the first patient with rheumatoid arthritis has been included and dosed in ongoing phase I clinical trial with SOL-116 in the Netherlands. Previously, only healthy subjects were included in the study, but now the first patient has received a dose of SOL-116 or placebo. To find out more, we contacted Lipum’s Clinical Project Leader, Agneta Wennerholm, who is involved in the design and project management of the study.

The Swedish biopharmaceutical company Lipum is driving the development of the drug candidate SOL-116 – a humanised antibody that blocks Bile-Salt Stimulated Lipase (BSSL), which is a previously overlooked target molecule of the immune system.

SOL-116 has the potential to provide millions of patients suffering from chronic inflammatory diseases with a safer and more effective treatment. Initially, the company’s focus is directed towards treatment of rheumatoid arthritis (RA).

Progress in First-in-Human study

The company is currently conducting a double-blind, randomised and placebo-controlled clinical phase I study evaluating the drug candidate’s safety, pharmacokinetics and exploratory effect markers.

The company has announced positive safety and pharmacokinetic results from the first part of the study – single dose escalation (SAD) in five groups of healthy subjects. The second part includes a group of eight healthy subjects receiving multiple doses of SOL-116, and this part is expected to be completed in March.

In addition, the company recently started the third and final study phase where eight patients with RA will be included. The first patient has been included and dosed, which means that the company is one step closer to the completion of the study and thus the next phase in development.

Interview with Agneta Wennerholm

About two years ago, we talked to Agneta Wennerholm about the preparations for the phase I study and the collaboration with the company’s CRO in the Netherlands. Now, as the study approaches its conclusion, BioStock has taken the opportunity to once again ask her some questions.

You have now initiated the final part of the phase I study, which includes RA patients. How does it feel now that the study is approaching its conclusion?

– We are very pleased to have reached the milestone of the first RA patient dosed, thus nearing the end of the study and analysis of collected data. The clinic, Lipum team, and CRO have collaborated well to achieve this.

What are the most exciting observations from the study so far?

– The preliminary data we have obtained so far look promising both in terms of safety and pharmacokinetics in healthy volunteers. We have also been able to demonstrate that SOL-116 reduces BSSL levels (our target protein) in plasma in healthy volunteers.

What insights and results do you expect to achieve in the part of the study involving RA patients?

– We are very interested to see if the pharmacokinetics and safety data correspond between patients with RA and healthy volunteers.

Finally, what are you currently focusing on in the planning for phase II?

– There is a broad focus right now; planning for the evaluation of the phase I study, discussions about phase II study design, meetings with external clinical advisors, scheduling, planning for CRO procurement, and much more.

Scandion kommenterar ytterligare positiva fas IIa-data

22 March, 2024

Scandion Oncology har meddelat uppdaterade positiva interimsresultat från den tredje och sista delen av den pågående fas IIa-studien CORIST med SCO-101 i metastaserad kolorektalcancer. BioStock kontaktade bolagets CMO, Lars Damstrup, som menar att tidiga tecken på förbättrad total överlevnad är en viktig parameter för regulatoriska myndigheter inför kommande fas IIb-studier.

Scandion Oncology utvecklar läkemedel för behandling av kemoterapiresistent metastaserad kolorektalcancer (mCRC) respektive bukspottkörtelcancer där läkemedelsresistens drabbar 90 procent av patienterna, vilket innebär att de är resistenta mot nuvarande behandlingsalternativ.

Huvudkandidaten SCO-101 utvärderas i fas II- och Ib-studierna CORIST och PANTAX. I CORIST behandlas heavily pre-treated mCRC-patienter med SCO-101 i kombination med cellgiftsbehandlingen FOLFIRI, som för närvarande är standardbehandlingen för denna indikation.

Fas II-studien CORIST

Scandion kunde redan vid inledningen av 2024 meddela positiva topline-resultat från den pågående tredje delen av fas II-studien CORIST. Resultaten visade inte bara på en tumörenreducering och en väsentligt ökad progressionsfri överlevnad, det pekade även på att SCO-101 – i kombination med FOLFIRI – leder till en hög klinisk nytta samtidigt som behandlingen är säker och tolereras av patienterna.

En påföljande analys av top line-data visade att Clinical Benefit Rate (CBR) ökade till från 46 procent i del två av CORIST – till 76 procent efter åtta veckors behandling i del tre. En av patienterna uppvisade en markant tumörreducering på över 30 procent. Tumören tycktes med andra ord minska eller stabiliseras, ju längre behandlingen pågår. I början av mars kunde bolaget konstatera att ytterligare en patient har haft en partiell respons med en tumörminskning på mer än 30 procent.

Därmed har en klinisk nytta påvisats i totalt två av sex patienter i den sista studiekohorten. Vd Francois Martelet framhöll i en intervju med BioStock att resultatet är imponerande med tanke på den mycket höga dödligheten i sjukdomen.

»Overall, these results further strengthen the positive data from CORIST part 2 and the earlier data from CORIST 3« — Lars Damstrup, CMO Scandion Oncology

CMO kommenterar

Den 21 mars kunde Scandion Oncology presentera ytterligare uppdaterade positiva interimsresultat från den sista och tredje delen av CORIST.

Bolaget har nu utforskat optimerade dosscheman vilket resulterade i förväntade förändringar i exponering mot SCO-101 och cellgiftsbehandlingen FOLFIRI. Dessutom kunde en ny potentiell biomarkör, genotypen UGT1A1, kopplas till längre progressionsfri överlevnad och total överlevnad.

BioStock kontaktade bolagets Chief Medical Officer Lars Damstrup för en kommentar.

Lars, can you discuss the overall findings of the interim results?

— Overall, these results further strengthen the positive data from CORIST part 2 and the earlier data from CORIST 3. We reported that we now have two partial responses in the SCO-101 250 mg cohort in the 4-day schedule. At this dose of SCO-101 we did not see any dose limiting toxicity. This further substantiates that SCO-101 in combination with FOLFIRI is well tolerated.

How do the optimized dosing schedules affect exposure to SCO-101 and FOLFIRI?

— The optimized dosing schedules in Part 3 included a different timing of FOLFIRI in relation to SCO-101 than what was used in Part 1 and 2. It also included a 6-day and a 4-day administration of SCO-101. Furthermore, the dose of the 5FU component in the FOLFIRI was increased from 50% to 100% of the recommended standard dose. Compared to Part 1, we observed that the optimized dosing schedules resulted in a minor reduction in the peak value (Cmax) for the active metabolite of irinotecan, named SN-38, by roughly 20% compared to in Part 1. Additionally, the SCO-101 initial peak was higher compared to Part 1.

— This slight reduction of SN-38 and the higher peak initial peak of SCO-101 was what we hoped to observe since this would be predicted to cause less toxicity from SN-38 and a stronger initial SCO-101 target engagement. The overall exposure to SN-38 and SCO-101 was roughly the same as in Part 1. However, the optimized design allowed to increase the SCO-101 dose to 250 mg in a 4-day schedule and in this specific cohort, we observed proof-of-concept anti-cancer effects as 2 of the six patients in this cohort had partial tumour reductions, which are rarely observed in this patient population.

The novel potential biomarker was positively associated with longer progression free survival and overall survival. Why is this important for the upcoming development steps?

— We have analysed two potential biomarkers in CORIST: The bilirubin index (BI) and the genotype of UGT1A1. In CORIST Part 2, we observed that patients with a low BI had a significantly longer median OS. This was reflected in CORIST Part 3 by demonstrating that a low BI is associated with longer PFS and OS. In CORIST Part 3, we analyzed a novel potential biomarker, the UGT1A1 genotype. The biological reasoning is that SCO-101 targets UGT1A1 and that patients with fully functional UGT1A1 (i.e. UGT1A1 wild-types) would respond better to SCO-101. Topline data in CORIST Part 3 supports this rationale since patients with UGT1A1 wild-type appeared to have longer PFS and OS than patients with mutated UGT1A1. Importantly, the CORIST Part 3 data are interim and we plan to report the final data in H2 2024.

— With these potential biomarkers, we may be able to select patients who will benefit the most from the combination of SCO-101 and FOLFIRI. We will ultimately select the right biomarker based on the outcome of the randomized Phase 2b clinical trial.

What makes overall survival the gold standard in oncology trials, and how would regulatory authorities perceive indications of enhanced overall survival in CORIST?

— Overall survival is a gold standard in oncology as it is a hard endpoint which can easily be ascertained. In some situations, for example, first line treatment overall survival can be very long. Therefore, in these cases, progression-free survival may be a valid primary endpoint. In last line treatment of patients with colorectal cancer, overall survival is up to 1 year. This means that overall survival is the preferred primary endpoint in this disease and line of therapy.

Finally, the next step on your roadmap entails broadening part 3 data with additional smaller patient cohorts to further optimise the dosing regimen. When can we expect results from these cohorts?

— Our ultimate goal is to conduct a randomized clinical trial in this patient population. At this point in time, we have a safe and tolerated dose of SCO-101 given in the 4-day schedule in combination with FOLFIRI where irinotecan is given at 50% of the standard dose and 5-FU and folinic acid is given at 100%.

— In preparation for the best dose to be implemented in the randomized phase 2a, we will increase the dose of irinotecan from 50% to 65 and ultimately to 80%. This will be done in the classical manner with a 3+3 design.

— It is difficult to pin-point the time for data read out from this as it depends on when we see signs of toxicity.

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