Desentum will run a clinical trial on its allergy vaccine this winter supported by 4 M€ of new investments

Finnish biopharmaceutical company Desentum is about to initiate a first-in-human clinical trial with its birch pollen hypoallergen designed to improve immunotherapeutic treatment of birch pollen allergy. In a funding round arranged by Springvest Oy, the company raised 4 million euros that it intends to use for funding clinical trials, developing new hypoallergens and advancing business goals.

Desentum develops novel type of immunotherapeutic hypoallergens, so called allergy vaccines. The hypoallergens are biotechnologically produced, modified allergen proteins aimed for improving the efficiency of allergen immunotherapy while also reducing the time required for treatment. The lead product candidate, birch pollen hypoallergen DM-101 (Bet v 1 dm), has produced good results in preclinical tests assessing allergenicity and immunogenicity, and is now advancing to clinical phase.

In clinical trials, the safety and efficacy of a new medicinal product is demonstrated in volunteer study subjects. The primary objective of Desentum’s first clinical trial is to confirm the safety of DM-101, but information about the immunological response generated by the hypoallergen is also collected.

“For the past couple of years, we have worked together with international allergen immunotherapy experts to prepare for the clinical studies. The first study plan was submitted for regulatory and ethics evaluation in the summer of 2019. The study will be performed in Finland and the dosing is scheduled to be completed before 2020 birch pollen season”, explains Pekka Mattila, CEO of Desentum.

To strengthen the company’s financial position, Desentum initiated a funding round in September. It was carried out by a Finnish investment service company Springvest Oy. The public offering was fully subscribed, which translates to approximately 4 million euros of collected capital. Desentum plans on using the majority of the proceeds for funding early-stage clinical trials. The remaining funds will be used for the research and development of new hypoallergens as well as for partnering activities to support late-stage clinical trials and market access.

“We are very happy with the results of the public offering. The collected capital enables us to focus on our primary goal, which is testing the novel immunotherapeutic allergy treatment and bringing it to the market. Today, allergy affects a huge number of people, and I believe that in addition to the expectation of financial return, many investors also hope that our technology could solve a health problem that impacts the life of their family or friends”, says Mattila and continues: “This is our target as well. We have started by looking at birch pollen allergy, but our platform can be used for producing hypoallergens from other allergens, too. We are already developing similar products to address peanut, grass pollen, dog and horse allergies.”

Immunotherapy in allergy treatment

Allergy is one of the most common chronic conditions in Europe. Today, more than 150 million Europeans suffer from allergic diseases. For one in five patients the condition is severe enough to create a constant threat of a severe allergic reaction or an asthma attack. European Academy of Allergy and Clinical immunology (EAACI) predicts that by 2025 allergy will affect half the population in Europe. Allergies cause social and economic burden such as health care costs, missed school and work days and impact on the daily lives of the patients.

Allergies are generally managed by medication that alleviates the symptoms. The most common medications are antihistamines and corticosteroids. Immunotherapy is the only treatment currently known that affects the mechanism of allergy. It re-educates the immune system to tolerate the allergen, decreasing the need for medication. Immunotherapy can be administered as injections or sublingual tablets or drops, and the treatment usually takes a few years. The novel immunotherapeutic products that are under development aim for speeding up the treatment as well as improving the safety, efficacy and convenience.

About Desentum Oy: Desentum is a biopharmaceutical company based in Espoo, Finland. It is specialized in developing a novel type of allergen immunotherapy based on switching the immune system’s response to allergens from hypersensitivity to tolerance by utilizing modified hypoallergens. Desentum, founded in 2011, is a spin-off company from VTT Technical Research Centre of Finland Ltd. In 2013 VTT received an EARTO (European Association of Research and Technology Organisations) Innovation Prize for the work behind the immunotherapeutic products. In 2018, Desentum was awarded a 1,9 M€ grant from the highly competitive Horizon 2020 SME instrument for the first-in-human clinical trial and business development.

Contact:

Pekka Mattila, CEO
Desentum Oy
Tel. +358-500-512934
info@desentum.fi
www.desentum.com

Business Risks – Threats that nullify the company’s ability to meet its financial goals

The company has always exposed to uncertainties that are called business risks. They may affect a firm’s aim to gain its goals. The danger of loss is in the form of machinery breakdown, strikes, change of trends, etc.

Business risks refer to the threat to the company's ability to meet its financial goals. It indicates the risk of uncertainty or loss in profit and the risk of some eventuality in the future, which can make a business fail.

Factors Causing Business Risks

Business risks result in less profit or even loss. The factors that lead to risks can be Internal or External.

  1. Internal Business Risks: risks that arise due to some event happening within a firm are internal risks. However, the firm can control them. Internal risks occur by:
  • Technological factors
  • Human factors
  • Physical factors
  • Operational factors

Examples: New technology, fire, cost-cutting, etc.

  1. External Business Risks: External risks occur by any event happening outside the firm. However, the firm’s management cannot control them. The factors that lead to external risks are:
  • Natural factors
  • Economic factors
  • Political factors

Examples: Floods, price pressure, riots, etc.

Types of Business Risks

Risks have divided into five kinds:

  1. Strategic Risk: The risks associated with business operations are strategic risks. They arise when the business plans fail. Poor business decisions lead to failure, e.g., marketing risk, project risk, competitive risk, etc.
  2. Financial Risks: These risks related to business events and finance. It adds to shareholders by debt financing, along with equity.

For example, there can be losses by movement in stock prices, interest rates, etc.

  1. Operational Risks: These risks linked with official procedures of a business. There is a failure to connect to internal policies.

For example, some events like frauds, computer hacking, etc. affect a company’s daily activities

  1. Compliance Risks: Such risks occur by state rules and commands. When the company fails to follow laws, it has to face legal penalties. These risks ensure that the firm runs justly.

For example, corrupt practices, social responsibility, etc.

  1. Reputation Risks: The negative publicity of a firm/product leads to this risk. There is a chance that a company’s name can damage.

For example, a mobile company issues a phone that breaks easily. But then it markets a new and better model.

Business risks refer to the threat to the company's ability to meet its financial goals. It indicates the risk of uncertainty or loss in profit and the risk of some eventuality in the future, which can make a business fail.

Ways to Manage Business Risks

You can plan to manage the exposure of risks.

  • Mitigate the risk: You need to keep a contingency plan. In case if the risk materializes, you must have a second plan to follow.
  • Avoid the risk: It’s better to avoid than to bear a loss. Sometimes the launch of a product leads to affect the company financially. You can postpone it until your company stabilizes.
  • Transfer the risk: You can pass financial risks to someone else. For instance, fire insurance is the best example of it.
  • Accept the risk: If the risks are likely to happen, you can opt for small damage. So, examine the other option and make the right decision to accept the risk.

Business risks lead to uncertainties, but a good businessman takes them as a challenge. Risks lead to new clients and more sales. You can, however, manage to minimize the worst to happen.

See also about Financial Riska Management

Trade War: Vehicle Companies Are Feeling the Pinch in Modern Europe

Car manufacture on the continent riddled with looming trade war seems headed for a dead-end.

Remember the good old days when the biggest challenges the European car industry faced were the oil crisis, the rise of Japanese carmakers, and disgruntled unions? Today, the car industry is fighting for its very survival as the mobility sector is transformed by new technologies.

Car manufacture on the continent riddled with looming trade war seems headed for a dead-end.

One can forgive European carmakers for being a bit distracted by shorter-term concerns like the threat of US tariffs, slumping Chinese demand, and stricter emission standards.

Europe and its car industry are already dealing with US steel and aluminium tariffs imposed in 2018 as part of the trade war. In May 2019, the US Department of Commerce announced that foreign cars and car parts were a threat to US national security. Tariffs of up to 25 percent could be imposed, with a decision to be made within 180 days of the announcement. Negotiations behind closed doors must be frantic. EU governments are sit-ting down to agree on a unified, post-European elections approach. German car executives have already been to the US to try to reason with President Donald Trump.

Escalating trade war that involves vehicle companies

An escalating trade war would be disastrous not just because of the direct impact on demand, but also because the European car industry is a global supply chain. Cars and parts are made around the world and assembled in various countries. Tariffs will drive up costs, and may cause carmakers to relocate their production centres.

Brexit is a similar problem but on a smaller scale — and with less certainty. Already several carmakers have closed or reduced production in Britain. Honda is closing its Swindon plant, Nissan is moving some future production back to Japan, and even Dyson has moved its electric car subsidiary to Singapore.

European car makers are also reeling from a slump in car sales in China, recording 11 months of de-creasing sales by this May. Many carmakers are desperate for an improvement in the second half of the year, but there is little optimism for a quick turnaround. China became the biggest car market in 2010, and in 2017 had 35 percent of the passenger car market; the EU was the next-biggest at 21 percent, with the US following at nine percent. The slump is a major cause for concern.

To take advantage of the growing market and to meet Chinese government requirements, many Europe-an carmakers have set-up production in China, mostly with joint ventures. Volkswagen produces close to 40 percent of its total production in China, Peugeot (PSA) close to 20 percent.

European carmakers have bet big on China trying to navigate the trade war — and now they are facing the costly prospect of stricter emission regulations as well. In the wake of the 2015 “Dieselgate” scandal, European policymakers are determined to cut emissions from motor vehicles. They are proposing a 15 percent cut in average CO2 emissions for cars produced in Europe by 2025, and 35 percent by 2030. Many cities have announced future bans and restrictions on diesel vehicles, including Paris, Hamburg, Berlin, and London. This is forcing a costly transition on European carmakers — but in forcing them from diesel to electric, it may be a strategic blessing in disguise.

All these pressing concerns represent serious challenges, but European carmakers must also look ahead to other existential challenges.

Vehicle companies in 2030

By 2030, 30 percent of a car’s value will be in its software, but Europe is lacking the relevant expertise. The biggest software advances are being made in Autonomous Vehicles (AV), followed by increased connectivity. Self-driving cars will communicate with others to manage traffic, while passengers benefit from a range of new services and entertainment. High-end cars already have around four times more lines of code than a F-35 fighter jet — twice that of the CERN Large Hadron Collider.

The leaders in AV are US tech firms, notably Google and Apple, as well as Tesla and the Chinese firm Baidu. European carmakers are behind the pack, but attempting to catch-up through acquisitions and strategic alliances. Ford and Volkswagen have made an agreement to share AV technology; Fiat-Chrysler have aligned themselves to Google; Audi, BMW and Daimler (Mercedes-Benz) have bought a digital mapping company. Daimler has also been working with Uber; BMW with Intel and Israeli firm Mobileye, and Renault-Nissan has partnered with Microsoft.

Technology is changing how cars are used and could impact the trade war. Ridesharing will challenge the concept of the private car — and Europe is trailing here also. In 2017 it was estimated that 338 million people used ridesharing ser-vices like Uber, Lyft and China’s Didi Chuxin. That growth could become exponential when companies introduce AVs dedicated to ridesharing. By 2030 it is estimated that one in 10 cars will be shared. Euro-pean carmakers are scrambling to join forces with former competitors and ridesharing platforms to make up for lost ground: BMW and Daimler have merged their ride-sharing divisions, and Volvo is working with Uber.

Trade war: electrification

Another big technological disruptor to European carmakers is electrification. Electric cars are not new, but recent improvements in batteries, drivetrains and public charging infrastructure have started to make electric cars a viable alternative. China is the leader here, with 400 electric car options on the market; in Europe there are six. The biggest electric carmaker in the world is China’s BYD. China, Japan, and South Korea are leaders in battery production. Tesla has a Gigafactory in Nevada, and one under construction near Shanghai.

Europe is currently at the mercy of Asian suppliers. Volkswagen and BMW have announced plans to produce their own batteries, in co-operation with Goldman Sachs, Ikea, and a small Swedish battery pro-ducer Northvolt — but the first examples will not be ready until 2022.

The transition to electric cars will also have an impact on the workforce. Electric cars are less complicat-ed, requiring fewer workers. A typical electric engine has just 200 components; a diesel engine has 1400. By 2030, as a result, it is estimated that 300,000 manufacturing jobs will be lost in Europe. More will be lost indirectly. The industry currently employs 13.3 million people, 3.4 million of them in manufacturing.

European carmakers are feeling the pressure. The CEO of Volkswagen, Herbert Diess, recently said that the European car industry could mirror the demise of that in Detroit. That seems an extreme scenario, as European carmakers are now making swift, bold decisions. The industry has a long history, and is de-termined to have a bright future.

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