Saniona on the paused Tesomet programmes and restructuring

4 April, 2022

Saniona has announced a voluntary pause of the two phase IIb clinical trials with Tesomet and a reduction of its workforce by approximtely 30 per cent, entirely due to funding limitations. While pursuing financing and/or partnering options that could allow Tesomet to advance, Saniona will be focusing on its other assets SAN711 and SAN903. The market reacted strongly, and the stock slumped by about 60 per cent during the week.

BioStock reached out to Saniona’s CEO Rami Levin for a comment on the measures that will be taken – and to get his view on Saniona’s future.

Rami Levin, why did you decide to pause the Tesomet trials?

– I want to start by saying that I understand that many investors have questions about our decision to pause the Tesomet trials, and we are working to address their questions. Over the past year Saniona has been evaluating multiple strategic financing options, and over the past six months has also been pursuing business development options. However, during this time, and particularly recently, the market conditions to raise capital have deteriorated significantly. While 2021 was a difficult year for biotech stocks, we were confident, and so were our investment banks, that we would be able to raise the money needed given our strong pipeline. Unfortunately, 2022 has started off even worse than 2021.

– Thus far in 2022, global macroeconomic conditions related to the war in Ukraine and rising interest rates have made it increasingly difficult to raise the amount of money we needed to fund the Phase 2b trials. Given these difficulties, we felt the most responsible thing to do is to immediately reduce costs to extend our cash runway. By far the largest expense to the company was the two phase 2b clinical trials, which is why we decided to pause the Tesomet trials and restructure our organization.

Why did you start the Phase 2b trials if you knew you did not have sufficient funding?

– We have evaluated multiple financing options, reached out to more than 150 large institutional investors, and met with many of them. We and our investment banks were confident that we would be able to raise the money needed, and during the process we received and evaluated term sheets from certain investors. Unfortunately, given the market conditions, many investors were focusing on larger cap companies with higher liquidity and near-term catalysts, which eventually precluded us from being able to raise the amount of money we needed and consummate a transaction on acceptable terms.

Why have you been unable to obtain funding or a BD deal?

– As I mentioned, we have met with and received positive feedback from multiple large institutional investors. In the last four months alone, we reached out to more than 150 large institutional investors. The feedback we have received is that they are positive on Tesomet, the ion channel platform, and our management team. However, given the market conditions, many investors were focusing on larger cap companies with higher liquidity and near-term catalysts. This precluded them from investing in companies like Saniona at this time. While we are still actively pursuing financing options, this has changed our strategy regarding the types of financing we would be able to raise.

– Regarding business development, we have been very active over the past six months on this front as well. The average timeline for completing a BD deal in the biotech industry is 12-18 months, but we have been evaluating options to accelerate this timeline. One of Saniona’s strongest differentiators is that we have multiple valuable assets – not only worldwide rights to Tesomet but also multiple potential first in class ion channel programs. We have now expanded our business development efforts to include any opportunities that could allow Tesomet to advance.

What will happen if Saniona cannot raise funding by the second half of 2022?

– We continue to believe in Tesomet and that the initial Phase 2 data support further development of Tesomet in HO and PWS; we also were able to secure orphan drug designation from FDA for both indications, and we were the first to achieve this in HO. We also believe there is significant value in our ion channel modulators. This is why, although we have paused the Tesomet trials, we are actively evaluating strategic financing options as well as business development opportunities that could allow Tesomet to advance, either with Saniona or with a third-party, as well as fund our future operations. That said, all businesses involve risks, and the risk in biotech is generally very high. There is no guarantee that we will be able to raise sufficient capital on acceptable terms, as we have outlined in the risk factors in our 2020 Annual Report.

Why would you halt Tesomet rather than the ion channel programs?

– The international Phase 2b Tesomet trials were by far the largest expenditure for Saniona, which is why we needed to halt them to immediately reduce our operating expenses. This also allowed us to further reduce expenses by restructuring our organization and eliminating certain positions. The strategic restructuring actions, which will take some time to be fully realized, are expected to decrease Saniona’s anticipated future average quarterly operating expenses by about 50%.

With Tesomet paused, what do you see as Saniona’s value proposition?

– To be clear, Tesomet remains a valuable asset to which Saniona holds worldwide rights. We continue to believe in Tesomet and that the initial Phase 2 data support further development in Hypothalamic obesity (HO) and Prader Willi Syndrome (PWS). Whether we advance Tesomet ourselves or potentially with a partner, the value and the market potential of this asset is unchanged. In addition, one of Saniona’s primary differentiators is our ion channel drug discovery engine and pipeline. Here too we have multiple potential first-in-class assets that we may advance ourselves or through partners. The industry remains interested in ion channels as evidenced by the continued BD deals done in this area of research during 2021 and early 2022.

In the beginning of March, you told BioStock that “the fundamentals of our business are very strong.” Has this changed since then?

– The fundamentals of Saniona’s business, meaning the progress we have been making with Tesomet and our ion channel modulators, absolutely remain strong – unfortunately, we currently do not have the funding to advance all of our programs simultaneously. We are focused on continuing to pursue strategic financing options and business development opportunities to remedy this.

Your largest investor RA Capital just disclosed the sale of some shares. How should investors think about this?

– As Saniona is a public company, each of our investors has the right to buy or sell shares according to their own investment strategy, which they have no obligation to disclose to us. Therefore, we cannot control or speak to their investment strategy. If we receive updated shareholder data, as we did with RA, we will update our website immediately.

Finally, what do you see as Saniona’s future?

– As I’ve said previously, we remain confident in the value of Tesomet and our ion channel pipeline. This is a challenging time for Saniona – we are extremely disappointed to have to undertake such drastic measures to conserve resources. I can assure our investors that we are tirelessly continuing to pursue strategic financing options and business development opportunities. The Board and management are determined and fully committed to lead the company through this difficult time. We see multiple possible paths forward that would allow Saniona to continue our mission to discover, develop and ultimately commercialize new medicines to treat rare diseases. This could involve a financing and/or various partnership strategies to advance Tesomet and our ion channel assets. We look forward to keeping the market updated.

Annexin’s CEO on ANXV’s potential and the plan for 2022

1 April, 2022

Biotechnology company Annexin Pharmaceuticals is approaching the initiation of a phase II study after positive phase I results and an established large-scale production of its primary drug candidate ANXV. The company’s goal is to position the candidate as First-In-Class, with vascular diseases as the targeted indication. BioStock has spoken with CEO Anders Haegerstrand to find out more about the company and its ambitions for 2022.

In addition to causing great suffering, cardiovascular disease (CVD) is the leading cause of death globally, and inflammation is a major factor contributing to the high incidence rate. Treatments with anti-inflammatory drugs, therefore, fulfil an important function in the field, but there are still a number of CVDs where there is a lack of effective treatments and where the medical need is quite significant.

Focus on a vascular disease that affects the eye

Annexin Pharmaceuticals is a Stockholm-based pharmaceutical company with an immediate goal to offer new treatments for vascular diseases. With the biological drug candidate ANXV, First-In-Class treatments can be offered for a number of patient groups where there are currently no effective treatment alternatives.

The company’s main focus is to develop a treatment for retinal vein occlusion (RVO) – a vascular disease that affects the eye and causes partial or complete visual impairment and is one of the most common causes of blindness. Today, the approximately 16 million people who have the diagnosis are referred to procedures where drugs are injected into the eye. However, the treatment gives suboptimal treatment results, and most patients have persistent visual impairments.

Potential in major diseases – inflammation is a common denominator

ANXV is a recombinant human protein called Annexin A5 that occurs naturally in the body and has cell-protective anti-inflammatory properties. Common to several cardiovascular diseases is inflammation, and Annexin’s goal is for ANXV to counteract this parameter also within RVO.

In certain vascular diseases, but also in aging, the production of the body’s own Annexin A5 decreases. With ANXV, Annexin wants to increase the body’s ability to protect and repair blood vessels and counteract inflammation in the cardiovascular system. In the long run, the candidate’s properties mean that Annexin could also develop treatments for heart attack and peripheral occlusive artery disease, major diseases with very extensive market potential.

Maintaining and strengthening its lead position

In the company’s upcoming phase II study within RVO, which is now awaiting FDA approval to be able to start, the hope is to be able to demonstrate this capacity with ANXV. Results from phase I studies showed a well-tolerated substance with limited safety concerns. It is also favourable for the company that is has established a cell line for large-scale production of Annexin A5, whose production process is also patent pending with an approved patent in e.g. Europe and Japan. With that said, the company continues to maintain and strengthen its position in the Annexin A5 area for the treatment of a number of diseases, in order to become the world-leading Annexin company.

Optimising value before commercialisation

The company’s business model is based on independently conducting impact studies for at least phase II within the main indication, RVO. The intention is to optimise the value of the ANXV program before partnering, out licensing or selling. The company refers to independent market research that estimates that the global value of the main indication RVO to 32 billion USD by 2032. In parallel with the development of ANXV in RVO, the company plans to seek one or more partners for cooperation and commercialisation of ANXV in other diseases.

CEO tells us more

BioStock contacted Annexin’s CEO Anders Haegerstrand, who told us more about the company and the plans for the coming year.

Anders, can you start by telling us about your professional background and how you use your previous experience in the role of CEO of Annexin?

– In addition to my background as a physician and associate professor, I have experience in leading and working in companies that have taken biological drugs from pre-clinical studies to patients. I have held leading positions at Astra Pain Control AB and AstraZeneca LLC, which has given me broad experience in R&D and drug development. My previous role as CEO and Head of Research at NeuroNova, where we took two protein drugs into phase I / II studies that were later acquired, has also given me valuable experience in licensing deals, interactions with, for example, the FDA, work in listed companies and other value to lead Annexin to become the world leading Annexin company.

Annexin’s main candidate ANXV has cell-protective anti-inflammatory properties that are suitable for the treatment of a number of diseases. You have chosen to initially focus on RVO, how did the choice fall on this particular indication?

– In patients with RVO, the red blood cells often have a stickiness that is considered to be a cause of veins in the eye becoming clogged. Annexin A5 has the potential to prevent blood cells in patients from sticking to each other and the cells of the vessel wall. ANXV can also have other positive effects, such as repairing already damaged cells, preventing more cells from dying, and reducing inflammation where the latter otherwise leads to progressively poorer vision.

What benefits do you see that ANXV can offer patients?

– Patients will be able to have better eyesight than they would have received with other treatment. At present, only 2/10 patients regain the level of eyesight they had before. They also avoid getting a needle stuck in the eye almost every month for six or more months, which we know many people find very uncomfortable.

What is the competitive situation for ANXV, and how do you plan to position your candidate to achieve optimal market penetration?

– ANXV has a completely unique mechanism, so, within RVO, for example, we see no major direct competition, and ANXV then becomes a so-called First-in-Class treatment, which gives a strong market position. The vast majority of companies are developing variants of already proven treatments, such as anti-VEGF or cortisone preparations, but I have a hard time believing that these would have a dramatically better effect.

What are your market forecasts for your product?

– Independent market research estimates that the global value of the main indication RVO will reach 32 billion USD by 2032, of which ANXV – which offers a unique new treatment principle – should be able to take a relatively large share. A lot depends on the pricing and then it becomes important if ANXV gives such a good effect that patients do not need anti-VEGF treatment. Although ANXV is a complement to anti-VEGF or cortisone treatment and the combination as a whole provides a clear improvement for the patient, the potential is great.

But RVO is not the only indication that may be relevant for ANXV. Could you elaborate on that?

– Other diseases are, and may be, relevant to test the effects of ANXV. The company supports and provides ANXV for a Covid-19 study in the Netherlands. The researchers there have shown that the fatty substance that ANXV binds to (phosphatidylserine) is very likely to contribute to blood clot formation and inflammation that damages the lungs of patients with moderate or severe Covid-19. Other possibilities are in as far as different disease areas such as cancer, inflammatory bowel disease (Ulcerative colitis or Crohn’s disease), and sickle cell disease, the latter a genetic disease where blood cells also stick together and clog blood vessels in large parts of the body.

Annexin is based on a single candidate, ANXV. What advantages and possible disadvantages do you see with this approach?

– The advantage is that one and the same information package of toxicological studies in animals and the phase I study in healthy volunteers, which takes time and is costly, can be used to get approved for several phase II studies in different diseases. The downside may be that if we have problems with ANXV, we are more vulnerable. In general, it is still the case that the body’s own proteins that nature itself has developed offer fewer surprises when they are added to the body.

In conclusion, what milestones can one expect from Annexin in the coming year?

– FDA approval, our start and results in the phase II study, results that illustrate ANXV’s binding to the retina, activities in more disease areas where ANXV may be important, and granted patents.

Stockholm’s five top and bottom life science shares in Q1

1 April, 2022

The shaky start to the year on the stock market was marked by Omicron outbreaks and extended restrictions, combined with an increased focus on inflation control from central banks. Few had expected the extent of the invasion in Ukraine, something that was also a major theme for stock markets during the quarter.

Towards the end of March, stock markets recovered and returned to pre-war levels. Overall, however, the Stockholm Stock Exchange’s All Share Index slipped in the first quarter by 14 per cent, and OMXS30, which consists of the 30 most traded companies on the large-cap list, was not far behind with a decline of 13 per cent.

The leading U.S. indices also showed a similar trend, with the broad S&P 500 falling 5 per cent in Q1, while the Nasdaq lost 9 per cent. The life science-focused Nasdaq Biotechnology Index fell 12 per cent.

Inflation control on the agenda

There were several reasons for the negative start. One contributing factor was the highest inflation rate in 40 years – in February U.S. inflation reached a rate of 7.9 per cent – something that caused central banks to react. The signals of upcoming interest rate increases were sent during the winter, giving rise to speculation about both pace and scope of the hikes.

When the FED finally raised the interest rate by 25 basis points in March – the first hike since December 2018 – the chair also took the opportunity to flag for further hikes at each remaining meeting in 2022. The hawkish announcement effectively held back the stock markets, combined with other uncertainties in the markets.

The invasion caused further decline

The invasion of Ukraine was the second major cause of market turmoil during the quarter, which, in addition to creating mass displacement, humanitarian crises, and war casualties in the thousands, also exposed the world’s dependence on Russian natural resources and latent imbalances in other production chains and trade relations.

The war also affects the life science sector, most of the world’s largest pharmaceutical companies operate in the region and have faced ethical dilemmas about how to deal with the conflict without compromising the patient benefit. Read more about the topic in BioStock’s article here.

Winners and losers

Most individual shares in the life science sector have declined in the first quarter. Only 31 of the 214 Stockholm listed companies showed positive development.

A common denominator for the quarter’s losers in life science were shares of companies announcing new issues, which was not entirely unexpected. Although it is a natural part of the development of many of the sector’s companies, the reaction has been more negative than usual, which is also natural during times of turmoil. In the stock markets, investors with different time horizons come together and everyone has their task to fulfill, even the most short-term ones.

The biggest negative movement was observed in drug developer Saniona‘s share price. The company announced late in the quarter that it is temporarily suspending its phase IIb studies with the candidate Tesomet and will dismiss 30 per cent of its staff. The news surprised the market, which after a brief trading halt pushed down the stock, which in total during the quarter lost as much as 78 per cent.

For Lund-based Aegirbio, the first quarter also meant a major drop in the share price. A strong positive price movement in the first half of 2021 was followed by unfulfilled expectations, causing the stock to plummet in the second half of last year. In 2022, the company has been working to solve its problems, but those efforts have not yet made an impact in the share price, which also lost 78 per cent during the quarter.

When it comes to stocks with the largest positive price movements, in fifth place we find Danish Scandion Oncology, which develops treatments to help cancer patients against drug resistance. The company is in phase II with its leading candidate SCO-101 and the share has risen by 22 per cent during the quarter.

Fourth place is held by medtech Nanologica, which markets and produces nanoporous silica particles for life science applications. The company moved to the main list in March and attracted increased investor attention and the share price increased by 22 per cent.

In third place was medtech company ProstaLund, which, during the year, signed distribution agreements in the UK for its personalised heat treatment of benign prostate enlargement. The stock was up 32 per cent.

The shares of First North-listed SpectraCure rose by 49 per cent in the quarter. The company develops a treatment against solid cancer tumours, focusing on prostate cancer. In January, the company announced that it had made progress in restarting its clinical trial in the US, which was delayed by the pandemic. The stock thus claimed second place on the quarter’s top list.

At the top of the winner’s list for the first quarter was Gothenburg-based Vicore Pharma with an increase of 63 per cent after presenting positive interim results from its phase II study with the candidate C21 in patients with idiopathic pulmonary fibrosis.

Here is the list of winners and losers in the first quarter of 2022.

	Winners	Development		Losers	Development
1	Vicore Pharma	63%	1	Saniona	-79%
2	SpectraCure	49%	2	Aegirbio	-77%
3	ProstaLund	32%	3	PHI	-67%
4	Nanologica	22%	4	QuiaPEG	-64%
5	Scandion Oncology	22%	5	Brighter	-64%

PHI’s CEO eyes new business opportunities

31 March, 2022

In 2021, PHI entered into a partnership with the US-based RegenMed Development Organization with the goal of establishing the company’s HoloMonitor technology as the standard quality control equipment in the growing field of regenerative medicine. The company has also chartered a new course when it comes to marketing strategy, with a sharp increase in sales over the last 4 quarters as a result. BioStock contacted CEO Peter Egelberg to find out more about the rights issue of just over 72 million SEK that is currently underway, and his vision for the future.

Lund-based med-tech Phase Holographic Imaging (PHI) has developed the HoloMonitor system, an advanced research microscope with sophisticated software for non-invasive cell culture analysis.

The problem – and PHI´s solution

When a new drug or treatment is (preclinically) tested in cell cultures, a prediction is made on how patients will respond to the new drug. However, conventional laboratory instrumentation influence how cells respond to drugs, by requiring that the cells are either genetically manipulated or stained with toxic substances before analysis – a standard that requires an innovative update.

Unlike conventional cell analysis instruments that are largely based on decade-year-old technology, HoloMonitor uses digital holography which neither influences the cells in any way, nor results in uncharacteristic cell behaviour. This means that the cells are not affected by the measurement method itself, which is very relevant in drug development and basic medical research for accurate and cost-efficient research and consequently satisfying patient outcomes.

A sales boom in 2021

PHI has had a steep upwards sales curve in the last four fiscal quarters. This can be attributed largely to the strategic shift to online sales and marketing in 2021. This has changed the company’s organisation and sales processes profoundly, with customer communication now being done digitally rather than through physical meetings.

Also, system installations and service issues are being handled digitally, which has lowered costs and sped up the sales process. Instead of spending days handling support and service questions, the team can now do this in a matter of hours.

Now, the company has reached the level and knowledge to enter the significantly more lucrative market of clinical applications. PHI will diversify from a pre-clinical to clinical market, namely the rising field of regenerative medicine. Going there requires regulatory approvals, as HoloMonitor will be used for quality assessment for medical products.

Regenerative medicine

By treating patients with cultured cells rather than conventional drugs, regenerative medicine has the potential to cure a wide range of diseases that are incurable today.

The goal is to position HoloMonitor as a key component assessing cell cultures when developing new treatments for diseases such as cancer, Alzheimer’s, Parkinson’s, diabetes and cardiovascular diseases.

As the patient-specific cells will be transplanted back to the patient, it is paramount that these cells are not compromised with toxic entities, as required by conventional instrumentation.

Large scale implementation

Regenerative medicine is set out to be the future of medicine, however presently it still needs to transform into a large-scale industry to cost-efficiently be able to treat millions of patients per year.

In an effort to succeed, Wake Forest Institute For Regenerative Medicine (WFIRM) started the initiative RegenMed Development Organization (ReMDO). PHI is a partner in this initiative together with key players to make this vision come true. The first facility is set out to be up and running in April. The aim is to develop PHI’s technology to a next-generation HoloMonitor for quality control of patient cells in large-scale biomanufacturing.

To invest into this initiative and others to come, PHI decided to conduct a share issue.

The CEO comments on the ongoing rights issue

BioStock reached out to the PHI’s CEO Peter Egelberg to learn more about the company, as well as how the proceeds of just over 72 million SEK from the ongoing rights issue will be used.

Peter, in terms of sales, 2021 was a strong year for PHI. What does the trend look like going forward?

– We see clear signs that sales will continue to increase. Also, we noticed a substantial demand within regenerative medicine for non-invasive technology. Here, we see HoloMonitor as a perfect fit.

– When cells, such as stem cells, are used to treat diseases, it is critically important that the cells are not influenced by external factors during this process. With HoloMonitor, the patient cells can be checked with numerous quantitative data, and therefore secure that they are in the same condition when transplanted back to the patient. So, in a sense, HoloMonitor represents a potential paradigm shift for the industry where our product would serve as a ‘quality filter’ throughout the whole process.

Can you talk about the changed sales strategy and how you intend to fine-tune it further?

– Of course, an overall goal for PHI is to increase sales further. This new post-pandemic world has given small-size companies like us the possibility to sell directly and faster to customers all around the world. The team could quickly adapt as PHI’s intention has never been to create a large-size sales force. We now have the possibility to sell directly cost-efficiently by ourselves. With that potential to increase sales by ourselves, we strongly believe that the value of the company will benefit.

– Also, we aim to establish a fast, reliable online customer support both before and after purchase. This support strategy will be optimised continuously.

– We will further shape our brand through product recommendations from peer-reviewed publications, online reviews, and recommendations from key opinion leaders.

– We are already growing our visibility as we speak. For example, placing our offer visible on various marketing platforms, e.g., WeChat in China. WeChat serves as a complete brand hub for gathering followers, targeting content, push marketing and service messages. All serious brands in China need a WeChat account to be trustworthy. So, we will be right there, among the big players in the field, with our own support channel to meet existing and future clients.

Which geographical areas do you think will contribute most to the core business in the coming years?

– China, USA, EU. These are the three biggest markets. In US, we already have a sales-representation office, and we are planning for one in China. As distances are short, the headquarter in Sweden will handle Europe. This way, we cover more than 80% of the world market. Our customers have collectively published over 200 scientific papers based on results created by our non-invasive cell analysis technology. To name some of our customers, we have HoloMonitors at Bayer AG, US National Institutes of Health, Harvard and Stanford University, and Novo Nordisk.

In 2021, you entered the field of regenerative medicine. What are you expecting to gain in partnership with WFIRM, and what role to you envision PHI will play within the field in the coming years?

– Our partnership will enable us to build a strong network of key players within regenerative medicine as well as regulatory and political institutions.

– Regenerative medicine will play a huge role in the future of healthcare with an increasing elderly population, while it is also a major emerging research area in our target markets with both strong political and financial support.

– HoloMonitor’s non-invasive properties make it particularly well-suited for regenerative medicine, as here the cells themselves are the treatment. The growth rate and advances in regenerative medicine have motivated big pharma companies to enter the field and the market for non-invasive cell culture analysis is expected to grow rapidly over the coming years.

Finally, PHI is currently carrying out a rights issue of just over SEK 72 million, guaranteed by 80 per cent. How will these proceeds be used?

– The future of medicine is here – and with it regenerative medicine. The rights issue does provide us with opportunity to enter this promising field and it will also allow us to enter the clinical market which exceeds the size of our current pre-clinical market. Regenerative medicine could hold the key to cure diseases such as Alzheimer’s, Parkinson’s, diabetes, or cancer. Who wouldn’t take the chance to become part of this future hope?

– Looking ahead, we will also head-on embrace the opportunities from data-rich online-based marketing to predict future sales.

– We believe we have a very solid offer to the industry, and I hope that people will appreciate this and take part in the ongoing rights issue.

See also: CEO Peter Egelberg presents the company at BioStock Investor Meeting, March 16 here.

Emplicure’s CEO on the strength of their business model

31 March, 2022

With its bioceramic platforms, Emplicure develops products at the interface between pharmacy and materials science, enabling high-precision drug delivery. But not only that, the technology can also be applied to consumer products and the company already has several lines of business. BioStock contacted CEO Torbjörn W. Larsson to find out more about the synergies that the platforms bring with them and what this means for the company’s business strategy.

Uppsala-based Emplicure was founded in 2014 and entered the stock market last year when it was listed on Nasdaq First North Growth Market. The company’s goal is to develop new and improved products by combining already approved substances with the company’s bioceramic platforms, which provide completely new products with tailor-made release profiles. The choice to focus on already approved substances means that the path to market – and thus the patient – will be both shorter and more efficient. In Emplicure’s other business area – consumer products – the company also utilises its bioceramic platforms to develop new and better products with an even shorter path to commercialisation.

Bioceramic platforms provides several benefits

But let’s start with the foundation of the business, namely the company’s three bioceramic platforms – Emplior, Empliderm, and Emplihale. These can be used to administer medical drugs in three forms: orally, via patches and by inhalation.

By combining already approved substances with bioceramics, the company obtains several advantages. Among the most important is the ability to create products that are tailored to specific needs. A clear example is that it is possible to control how the active substance is released, an ability that is particularly valuable in mitigating drug abuse, which leads us to Emplicure’s drug candidate Empli03.

Empli03 is heading for clinical studies

Empli03 is the company’s first drug candidate and is being developed for oral use. In Empli03, the company has combined its bioceramic materials with the opioid buprenorphine for the treatment of chronic pain. When discussing use of opioids it is important to consider that opioid abuse is a widespread problem. In the United States, more than 100,000 people died of drug overdoses last year, and opioid-related overdoses increased by nearly 35 per cent from the year before, according to the U.S. Centers for Disease Control and Prevention (CDC). In light of this trend, the fact that Emplicure’s business model shortens the time to market becomes extra relevant.

In December, Emplicure signed an agreement with British Quotient Sciences, who are responsible for manufacturing drugs for the pharmacokinetic study with Empli03. Quotient will also conduct the study.

Focus on consumer products in Amplicon

As previously mentioned, Emplicure does not only rest on one business pillar, in addition to drug development the company has also takes advantages of the potential of its technology platform by developing new consumer products. Subsidiary Amplicon is now working to develop tobacco-free nicotine products and the focus is on Amp01, a product for oral use where Amplicon is driving the development towards a finished product ready for large-scale production. In parallel, discussions are taking place with partners and potential licensees.

CEO comments

BioStock contacted Emplicure’s CEO Torbjörn W. Larsson to find out more about the company’s business structure and development.

Emplicure describes itself as a company that combines pharmacy and materials science, can you elaborate for our readers on what this means?

– We combine two disciplines, materials science and pharmacy, and in the interface between the two we create products with unique functions and properties, for better and safer drug treatment and improved consumer products.

You have chosen to focus your first drug candidate Empli03 on pain relief, why did you choose this indication?

– Pain, and in this case chronic pain, affects both the individual and society. It is also a condition that is becoming increasingly common, driven by an ageing population, welfare diseases and an increasing need for care. Twenty per cent of the U.S. population is affected by chronic pain, that is equivalent to about 67 million people. The U.S. has also fallen foul of the use of strong pain drugs like opioids and this has led to widespread abuse, which in turn has led to a stigmatisation of opioids as drugs and the doctors who prescribe them. Unfortunately, this then results in many patients with chronic pain not getting the pain relief they need.

– The U.S. has a higher rate of opioid abuse than the rest of the world, but we are also seeing an increasing trend on a global scale. Here, Emplicure can make a difference! We can give the drugs release profiles that counteract so-called dose dumping both during proper use and if you try to manipulate the drug for abuse purposes. With our bioceramics, we can develop opioid drugs with ADF properties (Abuse Deterrent Formulation) which in plain language means that it becomes more difficult to use them for abuse purposes – we put a seat belt on the drugs!

What other indication areas with similar problems might be relevant to explore with the technology?

– Basically all drugs where you want to be able to control the release and create new release curves for an optimised treatment. Take ADHD as an example, here you want a dosage that provides focus and function during school hours / working hours, and then fades off. Side effects of ADHD drugs are sleep disorder and loss of appetite, side effects that we could help minimise.

– Anesthesia for surgical procedures is another area. Here you want the effect to occur rapidly and to then be able to control how long the effect lasts depending on the type of procedure. These are just two of several areas that we are evaluating for future products.

As mentioned, high-precision drug delivery has clear advantages when it comes to healthcare. But what is the picture like in consumer products, specifically when it comes to nicotine, your first focus area?

– One of the USPs of our bioceramics is that we can control the release profiles, and this is also the case for nicotine. With Amp01 we can create a tobacco-free nicotine product with a release curve that gives a direct release of taste and nicotine, with the added benefit that both of these, taste and nicotine, have a longer duration – this is something that there is a demand for on the market.

You are currently in discussions with potential partners regarding Amp01. What can you tell us about these discussions?

– In addition to the release profile that I just mentioned, we are also developing our products on our own patented platforms. This means that a licensing- or co-operation partner will gain access to a their own unique IP for Amp01 which gives unique and significant business advantages. The same is of course true for our other products.

If we look ahead a bit, what other consumer products might be of interest when it comes to future development?

– Our platforms in combination with our development model basically gives us infinite possibilities. As I see it, we have a number of further business areas, e.g. dental care, skin care, healthcare, and veterinary products to just mention a few.

What can you tell us about the synergies between the two pillars of your business?

– The co-operations between the two pillars are extensive, where we develop products based on the same technologies as well as share old and new knowledge. There are also significant synergy benefits in the fact that any new IP that is produced can have several areas of use thanks to this. We also obtain a larger critical mass per project than the one that exists in the single project.

Finally, what are Emplicure’s focus areas for 2022?

– Our immediate focus is on completing the ongoing plans for Emplicure and the development of Amp01 towards a finished product. In addition, there are several exciting projects that we are preparing to get stuck into, but I would like to get back to this at a later point.

Lipum on the CRO collaboration for phase I

30 March, 2022

The biopharmaceutical company Lipum recently reached a significant milestone when entering an agreement with QPS Netherlands for the execution of the first clinical study with the drug candidate SOL-116 against chronic inflammatory diseases. The preparatory work for the phase I study is proceeding according to plan and Lipum is now looking forward to starting the clinical study, according to Dr. Agneta Wennerholm in an interview with BioStock.

Lipum is developing the biological drug candidate SOL-116 which provides a novel mechanism of action for the treatment of inflammatory diseases. The candidate is an antibody that blocks bile salt-stimulated lipase (BSSL), a protein that plays an essential role in the inflammatory process.

The company initially focuses on the treatment of rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA) both of which are characterised by painful symptoms and a great medical need.

Preparations for First-in-Human study with SOL-116

The company is now in the final preparations before starting a clinical phase I study with SOL-116. GMPmanufacturing has been completed by Abzena Inc in San Diego. The final manufacturing step – aseptic fill and finish to ensure that the product is sterile – will be carried out by Umeå-based Apotek Produktion & Laboratories (APL).

Once the final part of the preclinical program is completed, Lipum will submit a clinical trial application (CTA) to be able to start the clinical study.

QPS Netherlands with extensive experience as CRO

The upcoming study will be conducted in collaboration with QPS Netherlands, which CEO Einar Pontén expressed his satisfaction with in a recent press release:

»We are, according to plan, proceeding towards a significant milestone in our development and are indeed looking forward to start clinical studies in collaboration with QPS Netherlands later this year«

QPS Netherlands is a clinical contract research organisation (CRO) founded in 1995. The company complies with the requirements for GLP/GCP/GMP and supports pharmaceutical and biotechnology companies in their preclinical and clinical drug development. The choice of QPS as a partner was easy for Lipum given their beneficial combination of clinical facilities for both healthy volunteers and patients, as well as their solid laboratory capabilities. The company has regional laboratories and testing facilities in the US, Europe, India and Asia.

Healthy volunteers and RA patients

The phase I study with SOL-116 will be conducted at QPS facilities in Groningen and Leeuwarden in the Netherlands. The study is randomised, double-blind and placebo-controlled and aims to evaluate the safety, tolerability and pharmacokinetics after single ascending doses of SOL-116 in healthy subjects and patients with RA.

Interview with Agneta Wennerholm

A key person in the planning of the clinical program with SOL-116 is Dr. Agneta Wennerholm, who has a doctoral degree in clinical pharmacology at Karolinska Institutet, as well as more than 20 years of experience inpharma/biotech companies, academic research and clinical CROs. Since 2016, Wennerholm has worked as an independent consultant in clinical research and drug development. Previously, she has worked with clinical development in Biogen, SDS, SBL Vaccin and A+ Science.

BioStock had the opportunity to talk to Agneta Wennerholm about Lipum’s collaboration with QPS Netherlands and the preparations for the first clinical study with SOL-116.

First of all, Agneta, could you tell us about your role in Lipum’s project team?

– I am responsible for the clinical drug development, and as the first step in 2022 will be to start our first clinical study, a so-called phase I study. It is a broad assignment with a lot of communication internally and externally with our partners.

You have recently signed an agreement with the CRO QPS Netherlands for the execution of the phase I study with SOL-116. Why did you choose QPS?

– We did a comprehensive evaluation of about seven different CROs and several were well qualified. The choice fell on QPS primarily based on their extensive experience from phase I studies and also experience from clinical studies with antibodies. They also have a laboratory that will now in 2022 develop the analytical methods we need for this first clinical study.

Could you tell us a little more about the collaboration with QPS Netherlands?

– We as sponsor company are responsible for the quality and safety of the study while QPS will be responsible for the practical implementation at its two clinical sites in the Netherlands. We will work closely together and use expertise from both Lipum and QPS. I and the project manager from QPS will be like spiders on the web.

Could you also provide some further details about the study design and the purpose of the phase I study with SOL-116?

– In this first study, we will evaluate the safety (side effects) and pharmacokinetics (how the drug is absorbed, brokendown, excreted, etc.) of a single dose of SOL-116 (or placebo). A safety committee will evaluate the results at each dose level before the dose is increased. We will also study whether safety and pharmacokinetics differ between healthy volunteers and a group of patients with rheumatoid arthritis.

»There is incredible expertise in the company and we have worked for a long time to reach this step«

Finally, what do you find particularly exciting about Lipum’s drug development?

– The fact that we are now entering the first-in-human study is very exciting. There is incredible expertise in the company and we have worked for a long time to reach this step. Then it is also very exciting that SOL-116 has a new mechanism of action in a disease area where many patients still do not have an optimal treatment (rheumatoid arthritis).

The Ukraine crisis – an ethical dilemma for the life science sector

29 March, 2022

Russia’s inhumane invasion of Ukraine is putting pressure on the life science sector. The major pharmaceutical companies are now pausing clinical studies and other activities in Russia, but exports of pharmaceuticals and medical devices continue, citing patient health as a priority.

It has been just over a month since Russia’s invasion of Ukraine, and, while the West has imposed far-reaching restrictions, the world’s leading life science companies face a real ethical dilemma when it comes to their operations in Russia.

Patient care comes first

Pharmaceutical giants such as Pfizer, GSK, Bayer, and Novartis have announced that they have pulled the brake on further expansion in Russia, but do not intend to exit the Russian market completely. Big Pharma companies claim that they have an ethical obligation to provide pharmaceuticals to vulnerable patients in Russia, even if the country is at war.

Clinical trials halted

Most of the largest players have communicated that they will not initiate any new studies in Russia, and patient recruitment has stopped in already started studies. According to GlobalData, Merck is the company with the most clinical trials in Russia (96), closely followed by Novartis (89), Roche (79), AstraZeneca (75) and J&J (59), all of which have announced that they have suspended patient recruitment for their ongoing clinical trials in the country.

In addition, BMS, GSK, Novartis, Novo Nordisk, and Pfizer have also communicated that they will not initiate any new studies in Russia. However, despite the slowdown in activities, Big Pharma will continue to provide drugs to patients who are already enrolled in studies to fulfil the commitment to these individuals.

The companies will also continue to deliver already approved pharmaceutical products on the grounds that even Russian patients have the right to care.

Thus, sales in Russia continue, but for moral reasons, several Big Pharma companies have stated that the profits from the Russian market will be donated to humanitarian efforts in Ukraine, e.g., by donating life-saving medicines or donations to non-governmental organisations (NGOs).

The situation in the Nordic life science sector

When it comes to Nordic life science companies, it is difficult to compile how many that have operations in Russia. What can be said, however, is that it is unlikely that small Nordic players will initiate new clinical trials or product manufacturing in Russia before the Ukraine crisis is resolved.

One company that will continue its already initiated clinical activities in Russia is Stayble Therapeutics. The company believes that the phase IIb study with STA363 can continue without risking patient safety or study quality. Rather, the company argues that continuing the study ensures that patients have access to the care and the follow-up they are entitled to, and that they will not be exposed to unnecessary risk. An argument that aligns well with that of Big Pharma.

Going in the opposite direction, oncology company Ascelia Pharma has decided to discontinue all clinical activities in Russia. The company will end all activities at 13 – out of a total of 47 – clinical sites in Russian that are included in their phase III study. The decision will result in an extended study period, and an updated estimate states that the patient recruitment can now be completed by the end of the year, as compared to the previously communicated H1 timeline.

Pharma’s response to medical needs in Ukraine

From an industry perspective, the outbreak of war poses not just ethical dilemmas regarding operations in Russia, but also major challenges in the delivery of necessary medicines and medical devices to war-torn Ukraine.

The human suffering caused by Russia’s invasion of Ukraine is worsened by logistical challenges that cause shortages of medicines such as painkillers and insulin. Hence, life science companies are trying to find alternative ways and methods to transport medicines and materials to healthcare facilities, emergency medical care, and ongoing clinical trials in the country.

In Sweden, the Swedish Medical Products Agency, Läkemedelsverket, on behalf of the government, will support Swedish companies matching the urgent medical needs in Ukraine.

To solve the ethical dilemma that pharmaceutical companies have faced in Russia, and to overcome the logistical challenges in Ukraine, the industry, like most others, is crying out for constructive talks on a ceasefire and a peaceful resolution of the conflict. Given the latest news reports, however, such prospects seem far away.

DexTech’s stock under pressure despite broadened pipeline

29 March, 2022

The stock market turbulence of recent months has also left its mark on the biotechnology sector, and one of many companies affected is DexTech, whose shares are down 40 per cent since the turn of the year. However, the stock has lost value ever since the phase IIb results in 2018 and the 2-year follow-up in 2020, while the company has continued to pursue partnerships and broaden its pipeline. In this article, BioStock takes a closer look at how the market values the potential that the company believes lies in the research.

The foundation of Uppsala-based DexTech’s work is the CDC platform GuaDex, which can be likened to a molecular box of lego. The main component of the kit is the carbohydrate molecule dextran, which can be combined with other active substances to develop drugs aimed at the treatment of cancer.

The company’s main project, OsteoDex, focuses on castration-resistant prostate cancer (mCRPC), an advanced form of prostate cancer in which metastases have taken hold in the skeleton. The goal of the treatment is to prevent the vicious circle that occurs when the cancer interacts with the bone cells and grows strong, whilst the skeleton breaks down.

Clear efficacy results

In 2018, the company was able to present positive efficacy data from a phase IIb study; data that was then confirmed in a two-year follow-up in 2020. At follow-up, the majority of patients who responded to the OsteoDex treatment were still alive, a positive outcome in patients with advanced cancer.

The data read-out had a major impact on the share price, which in 2018 reached SEK 129. The positive notes reflected the market’s hopes that the study results would lead to a value-adding license agreement for the company relatively soon.

However, since then, DexTech’s CEO Anders R Holmberg has been careful to remind the market that such an agreement process can take time, and that it is more important for the company to get the right agreement than for it to happen quickly.

Declining value despite maintaining project status

But the market is, as we know, impatient and the company’s share price has seen a downward trend since the beginning of 2019, and with the recent stock market turmoil, DexTech’s price decline has been accentuated. The market cap currently amounts to approximately 130 million SEK, which can be compared to the peak in 2018 when the market cap was 1.9 billion SEK.

From an investment perspective, it may be interesting to compare the company’s market cap with other players in the field of oncology drug development. It may be difficult to make direct comparisons between biotechnology companies, as there are many aspects to take into account, but it still gives an indication of how the market values this type of project in the current climate.

A reasonably close example is RhoVac, which also has a candidate aimed at prostate cancer and has a market cap of just over 600 million SEK. Another example is Spectracure, a prostate cancer-oriented company that, like RhoVac, is currently conducting a phase II study and is valued at approximately SEK 740 million.

Considerable willingness-to-pay

Furthermore, by looking at completed deals in the sector, it can be concluded that there is a willingness-to-pay among the larger players when it comes to adding the right prostate cancer projects to the portfolio. An example of this is Bayer‘s purchase of Norwegian Algeta for 2.9 billion USD in 2013, which gave them access to the prostate cancer drug Xofigo. This deal is interesting from DexTech’s perspective. Professor Sten Nilsson, co-founder of DexTech, was involved in designing and conducting the clinical studies with Xofigo, which also has a similar mechanism of action as OsteoDex.

Broadened pipeline

In addition to the results in mCRPC, DexTech has chosen to investigate OsteoDex’s potential in multiple myeloma, which would open the door to another large market and add a new project to the company’s pipeline. Here, too, the willingness of major players to pay is great. An example of this came last year when French Sanofi signed a licensing agreement with US-based Eureka Therapeutics worth about 1 billion USD.

High valuations in myeloma

In Sweden, DexTech has several listed industry colleagues with treatments within multiple myelom. The perhaps most prominent example is Oncopeptides, whose candidate Pepaxto was developed to target patients with relapsed or refractory multiple myeloma. However, for Oncopeptides it all come to a halt last year in phase III, which forced a major repositioning. The company is now winding down most of its commercial operations and returning to being a research company, with a focus on developing new drug candidates based on its PDC platform.

Despite the setback, Oncopeptides currently has a market cap above 700 million SEK and it is worth mentioning that at its height the company was valued at almost 15 billion SEK.

Comparison can provide value benchmark

As mentioned earlier, it is difficult to directly compare biotech companies, as they differ in parameters such as portfolio width, intended target market, development steps, treatment concepts and more. At the same time, other companies’ stock market values can be seen as benchmarks. After all, how other players are valued is an sign of the market’s expectations of an approved candidate in the company’s indication areas. Previous deals within the same treatment space also testify to possible taker’s interest in the segment, which in turn affects possible contract values going forward.

Agreement should reflect the full potential of OsteoDex

In the positive column for DexTech is, as we have previously mentioned, that the company has achieved positive phase IIb results. Now they are also working on further strengthening the value of the portfolio through the myeloma initiative and will soon conduct a clinical proof-of-concept study in about 20 patients. The results from the iniative within myeloma will be visible early on and continuously as the study is unblinded. The company will communicate interim results on an ongoing basis during the planned myeloma study.

The fact that a potential agreement now seems to be delayed further may certainly be in some investors’ negative column, espeically of those who have been waiting for a deal since 2018. From the company’s side, however, the message is clear: it will not enter into a license agreement that does not reflect the potential that the company sees for OsteoDex in both mCRPC and multiple myeloma.

For those who are prepared to wait, DexTech offers a prostate cancer project with positive phase IIb data and an investment in multiple myeloma at a package price of 130 million SEK (at the time of writing). Whether or not the valuation of DexTech is high or low, the future will tell, but what we can conclude is that elsewhere there are similar projects that the market is currently paying significantly more for.

Principal investigator on Idogen’s clinical study with IDO 8

28 March, 2022

Idogen recently announced that they have received approval from the Swedish Medical Products Agency for the clinical phase I/IIa study with IDO 8. The cell therapy is aimed at patients with severe haemophilia A who have developed antibodies to their substitution therapy with coagulation factor VIII. BioStock contacted Professor Jan Astermark, Principal Investigator in the clinical study, to find out more about the unmet medical need of these patients.

Idogen develops tolerogenic cell therapies to counteract the immune system’s unwanted activation. The ambition is to teach the immune system to tolerate the specific antigen that elicits unwanted activation.

The company’s lead candidate IDO 8 aims to create tolerance for coagulation factor VIII (FVIII) in patients with haemophilia A who have formed antibodies to their vital FVIII treatment to prevent and treat bleeding.

A large proportion of haemophilia A patients develop antibodies to their treatment

Haemophilia A is caused by a lack of FVIII, a glycoprotein needed for the blood to coagulate. Severe haemophilia A is usually treated every two or three days with an injection of factor concentrate containing the missing coagulation factor.

However, the immune system can recognise the substitution treatment as something foreign and harmful, which leads to that about a third of the patients develop inhibitory antibodies, so-called inhibitors, which inactivate FVIII and render the treatment ineffective. This means that patients no longer respond to FVIII treatment, which increases the tendency to bleed.

IDO 8 to enable treatment with FVIII again

Idogen wants to counteract this problem with the cell therapy IDO 8, which is intended to prevent the immune system from attacking FVIII, and thereby enable the patient to be treated with FVIII again.

The company plans to start a clinical phase I/II with IDO 8 during the second quarter of 2022. The Principal Investigator for the study will be Jan Astermark, Professor of Clinical Coagulation Medicine at Lund University, as well as Chief Physician and Head of the Coagulation Unit at the Skane University Hospital in Malmö.

Interview with Professor Jan Astermark

Professor Astermark’s many years of research have primarily been focused on hereditary bleeding disorders and how to optimize the treatment of haemophilia patients. He has been involved in the training of professionals worldwide and has a wide, international network of contacts in the field.

In the below interview with BioStock, Jan Astermark talks more about the standard treatment for haemophilia A today and why there is a need for new drugs.

Jan, first of all, what is haemophilia A?

– Haemophilia A is the most common form of haemophilia and is due to a congenital deficiency of factor VIII (FVIII), which is a protein that is needed to stop bleeding if, for example, you injure yourself. Patients have either a total absence of FVIII or a partial deficiency of FVIII. The disease is therefore divided into mild, moderate and severe haemophilia A.

How do you treat haemophilia A today?

– Patients with severe haemophilia A have an immeasurable level of FVIII and are treated preventively with intravenous injections of FVIII preparations, so-called factor concentrates. The treatment starts at the age of one year and is given about once a week in the beginning, and then increases to about every other day. The FVIII treatment creates good protection against bleeding and prevents joint injuries that are otherwise a major problem in these patients. Without preventive treatment with FVIII, there is a high risk of deformed joints and severe bleeding.

Many patients develop inhibitory antibodies to FVIII. How extensive would you say this problem is?

– If the body has never seen the coagulation factor before, it is not that unexpected that the immune system can react by producing antibodies to the factor concentrate fairly quickly after starting the treatment. The antibodies counteract the effect of FVIII, which means that the treatment no longer works. This is noticeable when the patient suddenly begins to bleed abnormally. The treatment thus no longer has a haemostatic effect.

– Unfortunately, antibodies to FVIII are a fairly common problem affecting about one-third of patients with severe haemophilia A.

»Unfortunately, antibodies to FVIII are a fairly common problem affecting about one-third of patients with severe haemophilia A.«

Patients with antibodies are treated with an intensified treatment with FVIII to induce tolerance, which is also called Immune Tolerance Induction (ITI). Could you tell us a little more about this?

– With the help of immune tolerance treatment, an attempt is made to get rid of the antibodies. The patients are often treated with relatively high doses of the FVIII preparation for a longer period, up to several years, to “exhaust” the immune system. In about two-thirds of cases, this succeeds and the patient becomes tolerant, while the remaining third have to live with antibodies that prevent them from being treated with FVIII.

– The immune tolerance treatment can be very stressful for both the child and the family because you usually give daily doses of a lot of factor concentrate. A port-a-cath or the like may be needed to provide the treatment. As if that was not enough, the child also has an increased risk of bleeding.

Are there other treatment options for patients with FVIII inhibitory antibodies?

– There are currently a few other treatment options that can improve the situation for haemophilia A patients who do not get rid of their antibodies. For example, bleeding can be treated with recombinant factor VIIa, which is a so-called bypass product. The treatment can also be given for preventive purposes but is not as effective as FVIII in this respect. Then there is Hemlibra, a relatively new drug that contains an antibody that has been developed to function as FVIII. The advantage of Hemlibra is that it is given subcutaneously about once a week, instead of injections into the vessels several times a week.

– However, none of these treatment options provides adequate protection against bleeding. Should the patient undergo surgery or be seriously injured, additional medication must be added. Basically, factor concentrate is the best treatment because it contains the protein that the patient lacks.

– Since haemophilia A is a genetic disease, it is also conceivable that some of the patients could be treated with gene therapy, which is under development today.

What drives doctors to participate in clinical trials with new drugs in haemophilia?

– There is definitely a great need to make patients tolerant to the treatment that contains the protein they lack and need, i.e. FVIII.

– We in healthcare always wants to have the patient’s best interest at heart. I want to be able to offer all my haemophilia A patients, including those with antibodies to FVIII, the best possible treatment. Therefore, I choose to participate in research and clinical trials in the field.

What do you think is particularly interesting about Idogen’s development of cell therapy to treat antibodies to FVIII?

– Idogen is developing a treatment with a completely new mechanism for creating tolerance to FVIII in patients with haemophilia A. Research on why and how the immune system produces antibodies to FVIII and what can be done to counteract this has been going on for a long time. Idogen uses the knowledge about which regulatory molecules and cells that are involved in the immune response to be able to reset the immune system so that it does not react to the factor concentrate.

What effect do you want to achieve with IDO 8?

– Idogen’s cell therapy is aimed at haemophilia A patients who have difficulty getting rid of their antibodies to FVIII with immune tolerance therapy. It would be extremely valuable if we could succeed in making these patients tolerant to FVIII. Then you would be sure that treatment with FVIII provides effective protection against bleeding and that the effect of FVIII is easy to measure when the patient is bleeding or needs surgery.

– In the upcoming clinical phase I/II study with IDO 8, which is a First-in-Human study, we want to see that the treatment quenches the immune response to FVIII and that the antibody reaction disappears. The goal is for IDO 8 to enable the immune system to accept FVIII so that the patient can once again be treated with factor concentrate.

»I do not know of any other company, or research group, that uses the same technology as Idogen, so it will be extremely exciting to be a part of their development.«

What is the interest in research and development in haemophilia A?

– Haemophilia is a relatively costly disease for society that in many cases has a significant impact on patients’ life situation. There is, therefore, a great socio-economic interest in optimising the treatment and counteracting injuries and bleeding in these patients.

– In general, there is great interest in research and development of new treatments in the area. I do not know of any other company, or research group, that uses the same technology as Idogen, so it will be extremely exciting to be a part of their development.

BioStock Life Science Spring Summit, June 8-9, 2022

26 March, 2022

BioStock life science spring summit 2022

The BioStock Life Science Spring Summit is our first flagship event of 2022! Over the course of two days in early June, around 30 companies from a wide range of therapeutic areas presented their projects and innovations, in a packed program that also offers valuable insights from investment experts and industry profiles. The event was digital and broadcasted from BioStock’s TV studios in Lund and Stockholm.

BioStock Life Science Spring Summit offers an important platform for Nordic innovation companies, who get the chance to pitch their projects to Swedish and international investors, industry colleagues and potential partners.

BioStock Life Science Spring Summit offers a broad line-up of Nordic innovation companies, that despite a relatively small local market, manage to attract industrial partnerships, research collaborations, acquisitions and not least capital and attention from both the rest of Europe and from across the Atlantic Ocean.

As in previous yers, the 2022 BioStock Life Science Spring Summit included companies active in biotechnology and drug development, as well as medtech and diagnostics, operating in an impressive range of treatment areas and indications.

The programme

Watch all presentations and expert insights on BioStock’s YouTube-channel.

The companies who presented at the BioStock Life Science Spring Summit 2022 are listed below. In addition, the programme included insights from both financial and business development experts within the life science industry.

DAY 1: WEDNESDAY JUNE 8, 2022

10:00 BioArctic
10:20 Stayble Therapeutics
10:40 Evaxion Biotech
11:00 Cline Scientific
11:20 Chordate Medical
11:40 Alzinova
12:00 Spago Nanomedical
12:20 Cereno Scientific
12:40 Redwood Pharma
13:00 Idogen
13:20 Lipum
13:40 Expert Insights: Partnering & Dealmaking
14:00 Klaria
14:20 Respiratorius
14:40 Arcede Pharma

DAY 2: THURSDAY JUNE 9, 2022

10:00 Xintela
10:20 Immunicum
10:40 Alligator Bioscience
11:00 Lumito
11:20 Ectin Research
11:40 Sprint Bioscience
12:00 Invent Medic
12:20 BrainCool
12:40 Iconovo
13:00 WntResearch
13:20 CLS
13:40 Hemcheck
14:00 Brain+
14:20 SynAct Pharma

BioStock’s other 2022 events

You can read more about BioStocks 2022 event via the links below.

Stay tuned by following us on biostock.se, our social media and subscribe to our newsletter by filling out the registration form on the right hand side of this page. Also, don’t forget to subscribe to BioStock’s YouTube channel.

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