News Tag: English

April-June 2020

Net sales 0 KSEK (0)

Operating profit 4 709 KSEK (-2 296)

Earnings per share before and after dilution -0.64 SEK (-0.38)

January-June 2020

Net sales 0 KSEK (0)

Operating profit -8 690 KSEK (-3 998)

Earnings per share before and after dilution -1.19 SEK (-0.67)

Significant events during the second quarter 2020

• On May 20, we announced that Ziccum is taking the next step in one of its industrial collaborations with continued development work to formulate temperature-stable vaccines after the first step was positive.
• We signed a confidentiality agreement with an important NGO (Non-Governmental Organization) for further and more detailed discussions about how technology can help the most vulnerable.
• We announced on June 24 that Ziccum, with authorization from the Annual General Meeting on June 16, carried out a directed new issue of a total of 2,216,815 shares to a limited number of qualified private investors. The company received SEK 38.8 million before issue costs and approximately SEK 36.4 million after issue costs (of which approximately SEK 32.3 million was added during the second quarter and the remaining approximately SEK 6.5 million was added during July 2020).
• In light of the COVID-19 outbreak Ziccum has been closely monitoring developments and taking measures to minimize or eliminate the impact on the company's operations. Ziccum follows guidelines from the Swedish Public Health Agency, WHO and ECDC (European Center for Disease Prevention and Control). Ziccum has been able to continue its internal operations without significant impact from COVID-19. However, there is a risk of delays in the Company's external cooperation projects with players in other European countries.

Significant events during the reporting period (Jan-Jun) 2020

• Issue payment regarding warrants amounted to approximately SEK 13.9 million that was added to the company during the month of January 2020. The issue was registered by the Swedish Companies Registration Office on 14 January 2020.
• On March 26, 2020, we announced that Ziccum signed a letter of intent to investigate the integration of Ziccum's technology into an innovative vaccine manufacturing process with a company that has a new innovative vaccine production technology. The agreement includes an evaluation of the integration of Ziccum's formulation technology for measles and rubella vaccines. The goal is to significantly reduce the costs of childhood vaccines and to increase the availability of vaccines to all children in the world by manufacturing temperature-stable formulations.

Significant events after the reporting period

• A directed new share issue was carried out during the second quarter amounting to approximately SEK 38.8 million, of which approximately SEK 32.3 million was added during the second quarter and the remaining approximately SEK 6.5 million was added during July 2020.
• On 10/7/2020, a new patent application was filed regarding thermostable formulations of VLP-based vaccines (VLP).

Summary financial highlights

	2020 Apr-jun	2019      Apr-jun	2020            Jan-jun	2019          Jan-jun	2019 Jan-Dec
Net sales	–	–	–	–	–
Other income, KSEK	2	403	2	403	654
Operating profit, KSEK	-4 709	-2 296	-8 690	-3 998	-8 721
Profit after tax, KSEK	-4 709	-2 296	-8 690	-3 998	-8 723
Balance sheet total, KSEK	49 259	9 020	49 259	9 020	18 395
Cash flow during period, KSEK	28 668	-2 244	37 662	-3 579	-8 473
Cash flow per share (SEK)	3,88	-0,37	5,17	-0,60	-1,41
Cash and cash equivalents, KSEK	39 726	6 957	39 726	6 957	2 064
Result per share before and after dilution (SEK)	-0,64	0,38	-1,19	-0,67	-1,45
Equity per share (SEK)	6,08	1,33	6,08	1,33	2,86
Equity ratio, %	91%	89%	91%	89%	93%

CEO Statement

Vaccination is and for centuries has been one of the best ways to prevent pandemics and epidemics. The need has never been greater than today. New travel trends, population growth, climate change and overcrowding all increase the potential risk of epidemics and pandemics. Children are the most vulnerable; one child in five still does not receive adequate vaccination protection. Approximately 1.5 million children die each year from diseases for which vaccines are already available.

Ziccum has a world-unique, patented technology – LaminarPace ™ – which enables us to produce vaccines in dry powder form, not practically or economically possible using conventional techniques. The benefits are many: it increases the stability and so the lifespan of the vaccine, it facilitates the entire vaccine supply chain from factory to patient, and it enables the distribution of vaccines to new places where, for example, cold and freezer storage is a major challenge, meaning more vaccination for a lower cost.

Ziccum’s work focuses on three main areas: Development of thermostable formulations of vaccines, preparations for production on a commercial scale and external collaborations with industrial actors developing vaccines as well as, crucially in this field, NGOs (non-governmental organizations).

Despite Covid-19, our internal work of developing thermostable formulations of vaccines continues. This has, among other things, resulted in another patent application for thermostable formulations of Virus Like Particles, so-called VLPs which are an important platform for the development of vaccines, and which are used, among other things, for the production of HPV vaccines. This follows the previous strategy that resulted in a patent application for Adenovirus. In collaboration with our academic partner, the Emerging Viral Diseases Unit of the University of Marseille, world leaders in virus and vaccine research, several interesting and important projects are now underway to evaluate our capacity to develop thermostable versions of the most life-saving vaccines available, thereby increasing the commercial potential of the technology. A strong IP portfolio is the basis for being able to enter into commercial collaborations and create value for our shareholders.

Another cornerstone for making our technology commercially attractive is preparing for production on a commercial scale. This includes further development of our production system and adaptation to the industry's high demands on quality and traceability. It also means that we work to ensure that our technology can deliver an end product that is adapted to the wishes and requirements of both industry and, not least, end users. Our ambition is to be one step ahead and able to offer a unique complete solution for how a dry-formulated vaccine can be produced, handled and administered. The capital we raised during the summer will largely be used for this business area, thus accelerating the commercialization of our technology.

Our external network of contacts is constantly expanding, and we are receiving increasing recognition from a number of players in the industry. We have previously announced three industrial collaboration agreements with the aim of evaluating our technology in their respective projects. The ongoing pandemic has caused delays, partly due to shutdowns in the countries where our partners operate. Despite this though, we stand by our goal of strengthening at least one of these collaborations during the year through a license agreement.

We also continue to develop our commercial work by collaborating with various companies and groups that work for a better uptake of vaccinations worldwide, in order to increase knowledge about the importance of our method. We are developing stronger and ever more valuable relationships in these organizations and we have high hopes of being able to formalize a collaboration with one of these actors in the coming year.

In summary, we are well on our way to delivering on our goals for the current year and to position Ziccum for a very exciting future in an industry that will have a very large focus for a long time to come. Finally, I would like to welcome all our new shareholders who joined us in connection with the new share issue that took place at the end of June, and to thank all of our shareholders for their confidence and trust.

Lund on 20 August 2020

Göran Conradson, CEO

READ THE WHOLE REPORT HERE

For more information about Ziccum, please contact:

Göran Conradson: CEO Ziccum AB
E-mail: conradson@ziccum.com

Mobile: +46 709 61 55 99

About Ziccum

Ziccum AB (publ) develops new patented formulations of biological drugs where sensitivity to temperature differences, especially during transportation, currently limits medical and so commercial potential. The company’s patented technology, LaminarPace, develops dry powder formulations of drugs and vaccines that currently only exist in liquid form. By doing so Ziccum can increase the availability of drugs and vaccines in existing markets—and open up new ones.

This press release has been submitted for publication by the company's CEO at 08.00 (CET) on 20 August 2020.

Summary of Interim First Quarter Report 2020

Ziccum announced a further, third collaboration with an industrial partner that is developing a new, more effective method of producing measles and rubella vaccines. The goal is to both significantly reduce the cost, and increase the availability, of these childhood vaccines. We have also signed a confidentiality agreement with an important non-governmental organization (NGO) for further and more detailed discussions about how technology can help the most vulnerable.

January–March 2020

Net sales SEK 0 thousand (0)
Operating profit SEK -3 980 thousand (-1 689)
Earnings per share before and after dilution SEK -0.55 SEK (-0.28)

CEO Statement

Vaccination is, and has always been, one of the best ways to prevent pandemics and epidemics. The need for vaccination has never been greater than it is today. New global travelling habits, population growth, climate change, rapid urbanization-they all increase the potential risk of epidemics and pandemics. And children are the most vulnerable: one in five children still do not receive adequate vaccine protection. Approx. 1.5 million children die every year from vaccine-preventable diseases.

Our most recently announced collaboration (March 26) is with an industrial partner who is developing a new production process for measles and rubella vaccine. The number of measles cases more than doubled in 2018, with children under five having the highest mortality. According to UNICEF, measles vaccination has to increase significantly. In order to prevent more measles outbreaks, the WHO recommends a vaccination rate of 95% for all newborn babies, especially the two doses needed for full protection. The current vaccination rate is 85% for the first dose, but only 67% for the second.

UNICEF points out that globally 450 million doses of measles vaccines are needed, yet presently only 270 million doses a year are produced. This is explained by a lack of production capacity, and the destruction and waste of vccines during transport and handling. At present, vaccines require extensive, costly and extensive refrigerated transport to reach the poor, usually hot and often extremely inaccessible places where they are needed most.

UNICEF estimated the total measles vaccine market to be worth 450 million USD in 2018.

Ziccum has a globally unique, patented technology – LaminarPace^TM – that allows us to produce vaccines in dry powder form, which is not practically possible or economically feasible using conventional vaccine formulation technologies. The benefits of dry powder vaccines are many. Dry powder formulation increases the stability and shelflife of the vaccine, so facilitating the entire supply chain from factory to field patient and enabling vaccines to reach new sites where, for example, refrigeration and freezer storage is a major challenge. The overall result is more people vaccinated, at a lower cost.

Despite Covid-19, our own work in the lab continues, as we develop new formulations and carry out stability analyses that can form the basis for new patent applications and partnerships. The further development of our production system, focusing on preparing for future production of vaccines on a commercial scale, is also proceeding according to plan, without being impacted by Covid-19. We continue to develop our commercial work by collaborating with a range of policy groups that are working to improve vaccination coverage worldwide. We have, for example, signed a confidentiality agreement with a vaccine NGO in order to deepen discussions. European vaccine manufacturers now know us, and we are starting to make contact with American vaccine developers. The dialogue with our current partners, including our two previous evaluation agreements, also continues but we can state that the current coronavirus pandemic will lead to delays as these organizations are currently suffering from limited access to their labs.

In summary, we are well on our way to delivering this year's goals on target, whilst positioning Ziccum well for an exciting future in an industry that will have a strong focus for a long time to come – we have entered into three evaluation agreements with industrial players to develop stable, dry powder vaccine formulations, we have a world-leading academic partner who will continue to strengthen our technology and patent portfolio, and we have processes and projects in place to develop a commercial version of our product. We now look forward to maintaining a continued high rate of development for our competitive technology, enabling us to generate new. significant patents and create exceptional value for our shareholders.

Lund, April 17, 2020

Göran Conradson

CEO, Ziccum AB

 READ THE WHOLE REPORT, IN SWEDISH, HERE

For more information about Ziccum, please contact:

Göran Conradson: CEO Ziccum AB
E-mail: conradson@ziccum.com

Mob: +46 709 61 55 99

About Ziccum

Ziccum AB (publ) develops new patented formulations of biological drugs where sensitivity to temperature differences, especially during transportation, currently limits medical and so commercial potential. The company's patented technology, LaminarPace, develops dry powder formulations of drugs and vaccines that currently only exist in liquid form. By doing so Ziccum can increase the availability of drugs and vaccines in existing markets-and open up new ones.

This press release has been submitted for publication by the company's CEO at. 08.00 (CET) on April 16 2020.

CEO Statement

Ziccum has a unique, patented technology – LaminarPace^TM – that enables us to manufacture biological drugs in dry form. In principle, dry form is always sought after in the development of new drugs and the benefits are many. It increases the stability of the product and thus its service life, it facilitates the entire transport and supply chain from factory to patient and it enables distribution of medicines to new places where, for example, refrigeration and freezer storage is a major challenge. This means that patients who do not have treatment or treat themselves in their homes can have access to safer and more effective vaccines and medicines.

In 2019, we filed two patent applications, one on a very important component in the development of new vaccines – Adenovirus, and on viruses in the same family as the measles virus. As a result, several industrial players have taken note of our technology. We have also announced that we have entered into agreements with two of these companies for the purpose of evaluating LaminarPace^TM in combination with their particular projects. In both collaborative projects, we have delivered test materials dried in our LaminarPace technology and at present, each counterparty is working on evaluating these materials in their own models and methods. When this is clear, we look forward to discussing the next step with each company. Our hope is that this will happen in the first half of this year. Further patent applications and industrial collaborations continue to be the cornerstones of our business.

We continue to work in-depth with a consortium of several important players – both industrial and academic – including Aix-Marseille University, France, which has the opportunity to work on virtually all vaccines and pathogenic viruses on its own premises. There is a common strong interest in developing temperature-stable formulations together, which gives us further opportunities. This new partnership will provide us with many benefits as well as a significant extension of our resources. During Q1, we will deliver a system to their high-security laboratory to further develop new temperature-stable formulations. Work developing LaminarPace^TM systems adapted for large-scale industrial production of biological drugs and vaccines is proceeding according to plan. This will continue to be a very important project in 2020, better positioning us for future partnership discussions.

In 2020, we will develop our commercial work by collaborating with various policy groups that are working to improve the uptake of vaccinations around the world, so increasing awareness of the importance of our method. European manufacturing vaccine companies know us well and in 2020 we will expand our work with overseas manufacturers.

In conclusion, we are well on our way to delivering on everything we promised when listing our company – we have three pilot studies ongoing within the year to develop stable, dry vaccine formulations and biological drugs. We now look forward to maintaining a continued high rate of development of our competitive offering, where we can generate significant benefits for patients as well as create value for our shareholders.

Oct-Dec 2019

· Net sales SEK 0,0 (35)

· Operating income SEK -3,344 thousand (-1,734)

· Earnings per share before and after dilution SEK -0.56 (-0.32)

Jan-Dec 2019

· Net sales SEK 0,0 (227)

· Operating profit SEK -8,721 thousand (-4,210)

· Earnings per share before and after dilution SEK -1.45 (-1.27)

Significant events during fourth quarter 2019

In early October, an agreement was concluded for evaluation with a global pharmaceutical and vaccine company, where together we will evaluate Ziccum"s technology to generate stable and temperature-stable vaccines.

A new patent application for a new temperature-stable formulation of virus in the same family as measles was filed in December 2019.

Collaboration with a world-leading virology group in Marseille was started.

We have initiated work on impact work by international policy groups on vaccine use.

As of the balance sheet date (which was the last subscription day), outstanding warrants had been subscribed for 92.6 percent of the total number of outstanding warrants, which corresponds to approximately SEK 13.9 million.

Significant events during the reporting period (Jan-Dec) 2019

Ziccum reported on January 10, 2019 that the company filed a patent application for Adenovirus with dry and temperature-stable formulation which meets WHO"s requirements for CTC status.

The dry formulation (the "powder") generated by Ziccum"s technology in LaminarPace ™ dissolves rapidly upon the addition of sterile water, after which vaccination or treatment can be performed.

Final liquidity from EU support for FORMBECC was received during the second quarter amounting to approximately SEK 315 thousand.

Ziccum has been granted SEK 200,000 in research grants from Vinnova. The research grant will be used to evaluate Ziccum"s method for developing dry preparations of vaccines.

Ziccum has hired additional staff with expertise in the formulation of vaccines.

We received a special invitation to attend the Global Vaccine Summit in Brussels where several important contacts were made.

Ziccum, on behalf of a vaccine development company, has conducted a feasibility study on the development of stable vaccines. The work is underway and the samples have been sent back for further evaluation. In the second collaboration, we have delivered dried material. Respective collaborator are evaluating the material with their own methods and models. Results from both collaborations are expected to come in the first half of 2020.

A second patent application has been filed for a group of viruses belonging to the measles virus family.

We have initiated collaboration with a French virology group at Aix-Marseille University. A LaminarPace system will be placed in their BSL3 (BioSafety Level 3) facility during the first quarter, for further development of new formulations. The group is also a co-ordinator of a large EU-funded global collaboration on the distribution of various virus strains for research, development and as reference material in diagnostics and for vaccine companies, EVAg, European Virus Archive Global.

We have begun the impact work of international policy groups to improve the uptake of vaccinations. The European vaccine companies know us well.

Significant events after the reporting period

The issue proceeds relating to warrants amounted to approximately SEK 13.9 million, which were added to the company in January 2020. The issue was registered by the Swedish Companies Registration Office on 2020-01-14.

Otherwise, no significant events have occurred since the reporting period.

Lund, February 13, 2020

Göran Conradson

CEO

For more information on Ziccum, please contact:

Göran Conradson: CEO 
Email: conradson@ziccum.com

Mob: +46 709 61 55 99

About Ziccum AB

Ziccum AB develops and commercializes the patented spray-drying instrument LaminarPace®. LaminarPace is an innovative, CE-labelled instrument that dries small amounts of drug substances with very low losses. The vast majority of pharmaceutical projects prefer substances in dry powder form, as it increases their stability, durability and simplifies logistics and transportation. LaminarPace is also unique in its ability to handle temperature-sensitive materials such as proteins and peptides.

The information above was provided by Ziccum AB (publ) through the above contact person, for publication on 08.00 February 13, 2020.