ZICCUM AB interim report January 1-September 30, 2020

Summary of interim report, third quarter 2020

During the third quarter Ziccum made great progress in its work of industrializing its unique process for producing vaccines in dry powder form. Major economic and production-technical advantages have been demonstrated, as well as the fact that dry vaccines offer a significantly simplified and cost-effective logistics chain.

Jul-Sep 2020

Net sales SEK 0 KSEK (0)

Operating profit -5,317 KSEK (-1,380)

Earnings per share before and after dilution -0.56 SEK (-0.23)

Jan-Sep 2020

Net sales 0 KSEK (0)

Operating profit -14,006 KSEK (-5,378)

Earnings per share before and after dilution -1.75 SEK (-0.90)

Significant events during the third quarter (Jul-Sep) 2020

  • The company has completed a private placement 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 36.6 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
  • The patent application has been filed regarding thermostable formulations of VLP (Virus Like Particles) based vaccines as well as two patent applications regarding improved function of the LaminarPace system for commercial vaccine production

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

  • Issue receipts regarding warrants amounted to approximately SEK 13.9 million that was added to the company during January 2020. The issue was registered by the Swedish Companies Registration Office 2020-01-14
  • 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 production technology for vaccines. 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 producing temperature-stable formulations
  • 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 has been successful.
  • We announced on June 24 that Ziccum, with the support of an 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 36.6 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 outbreak of the coronavirus and COVID-19, Ziccum closely monitors developments and takes 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 on COVID-19. However, there is a risk of delays in the Company's external cooperation projects with players in other European countries

Significant events after the reporting period

  • Ziccum has conducted a pilot study on large-scale production of temperature-stable vaccines in partnership with KeyPlants
  • Ziccum has published a White Paper describing the world's first plant for large-scale production of temperature-stable vaccines
  • On October 26, we announced that Frida Hjelmberg has been appointed CFO. Frida will take office on 1 January 2020

Summary financial highlights

2020 2019 2020 2019 2019
Jul-Sep Jul-Sep Jan-Sep Jan-Sep Jan-Dec
Net sales
Other income, KSEK 2 251 2 655 654
Operating profit, KSEK -5 317 -1 380 -14 006 -5 378 -8 721
Profit after tax, KSEK -5 346 -1 380 -14 035 -5 378 -8 723
Balance sheet total, KSEK 42 720 7 249 42 720 7 249 18 395
Cash flow during period, KSEK -165 -1 718 37 497 -5 297 -8 473
Cash flow per share (SEK) -0,02 -0,29 4,68 -0,88 -1,41
Cash and cash equivalents, KSEK 39 561 5 239 39 561 5 239 2 064
Results per share before and after dilution (SEK) -0,56 -0,23 -1,75 -0,90 -1,45
Equity per share (SEK) 4,13 1,10 4,13 1,10 2,86
Equity ratio, % 93% 91% 93% 91% 93%

CEO Statement

Vaccinations are and have long been one of the best ways to prevent pandemics and epidemics. The need has never been greater than today. New travel habits, population growth, climate change and overcrowding are all potential risk factors for epidemics and pandemics. It is children who are 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 available.

Ziccum has a world-unique and patented technology – LaminarPaceTM – which enables us to produce vaccines in dry powder form, which is not practically or economically possible with conventional technologies. The benefits are many. It increases the stability and thus the lifespan of the vaccine, it facilitates the entire transport 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 – enabling more vaccination at a lower cost.

Ziccum's focus is in three main areas. Development of thermostable formulations of vaccines, preparations for production on a commercial scale and external collaborations with industrial actors who develop vaccines and also, very importantly for the industry, NGOs – non-governmental organizations.

Despite Covid-19, our internal work continues on developing thermostable formulations of vaccines. In collaboration with our academic partner, the world-leading university of viruses and vaccines in Marseille, several interesting and important projects are now underway. The results are very promising, and strongly consistent with what we have seen before, we will also strengthen our patent portfolio further using these results. 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 to prepare for production on a commercial scale. In collaboration with Swedish KeyPlants AB, we have developed a so-called Conceptual Design of a facility for filling and packaging dry vaccines based on our technology. We see large cost savings in production when compared to freeze-drying, which is a very common, but expensive, way of stabilizing vaccines. On the one hand, large capital costs are saved, but above all the need for energy is reduced by about 80%, which is in line with the UN's seventh development goal: Sustainable energy for all. The plant can produce up to 300 million doses per year. Vaccines are a low-cost product in large parts of the world, which is why these results are so important. Now that we can describe a production facility, we have expanded our business model and added additional revenue opportunities. We can now have another type of discussion with both bulk vaccine suppliers and international organizations in vaccination. We have published a so called White-Paper on our homepage which summarizes the advantages and significant cost savings possible with our technology.

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. Our White Paper has been much appreciated by a significant key player. 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. Thus, our goal to enter into collaboration in at least one license agreement during the year may be delayed intil 2021. At the same time, the Covid-19 pandemic clearly indicates the need to solve the cold chain problem.

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 during the quarter and to thank all of our shareholders for their confidence.

Lund, November 6, 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

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 November 6, 2020.

ZICCUM AB releases blueprint of world’s first industrial plant producing air-dried vaccines requiring no Cold Chain

"Vaccinating the world against COVID-19 will be one of the largest mass undertakings in human history" – as UNICEF, the WHO, analysts, NGOs and governments worldwide warn of the escalating challenge the Cold Chain represents to vaccine coverage in both the developed and developing world, Swedish vaccine formulation company Ziccum releases its blueprint of the world’s first industrial plant for producing thermostable, ambient-dried vaccines at volume. The new vaccines could be produced at an estimated 65% lower OPEX and 50% lower CAPEX cost than today’s freeze-dried vaccines.

The blueprints are part of a White Paper that describes in detail how Ziccum AB’s LaminarPace technology can be integrated into an agile, modular Fill and Finish (F/F) facility formulating and packaging the new thermostable air-dried vaccines. The vaccines produced could be stored and transported at ambient temperatures, requiring no Cold Chain—fully meeting WHO CTC (Controlled Temperature Chain) requirements that vaccines should be able to withstand one journey outside the cold chain for 3 days at 40oC.

The vast majority of today’s F/F plants – the final stage in vaccine manufacture and distribution – formulate vaccines as liquid or lyophilized (freeze-dried) solutions—both are complex, costly processes that require energy-intensive freezing or refrigeration and still produce end products that can require storage and transportation at up to -700 C to be viable. The White Paper’s analysis of the costs of the new facility finds that the proposed plant could produce up to 30 million vials of thermostable vaccines at an estimated 80% less energy use, 65% less OPEX costs, 50% less CAPEX costs and 80% yield compared to freeze-drying.

The plant has been co-designed by KeyPlants AB, a leading modular plant construction specialist who have designed and produced more than 50 modular projects globally, including F/F vaccine facilities.

Ziccum CEO Göran Conradson: "This is an idea whose time has come. As our understanding of pandemics and immunization grows not a day goes by without the world’s medical and healthcare experts flagging up the shortcomings and challenges of the Cold Chain. When it comes to vaccines we’re all increasingly understanding that the Cold Chain’s limitations now threaten the developed as well as developing world – and that thermostable vaccines need to be an integral part of any solutions for future immunization and pandemic preparation. At its core, air-drying is not a new technology. We all consume many of life’s essentials in dry form every day, without even thinking about it, because that way they can reach more people, quickly and cost-effectively. So why can’t we do the same with vaccines? The fact is—we can. Let’s set vaccines free. The time for action is now."

Read the complete White Paper on https://ziccum.com/resources/

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 vaccines 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 vaccines that currently only exist in liquid, or in lyophilized 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 on Monday 2 November 2020.

ZICCUM to publish White Paper on world’s first industrial air-drying of vaccines using its LaminarPace technology

The White Paper will describe in detail the integration of Ziccum AB’s LaminarPace technology into a Fill and Finish (F/F) manufacturing facility of the world’s first plant for formulating and packaging thermostable air-dried vaccines at volume. The new vaccines could be produced at an estimated -65% lower OPEX and -50% lower CAPEX cost than today’s freeze drying (lyophilization) F/F plants. The vaccines produced could be stored and transported at ambient temperatures, requiring no Cold Chain.  

The vast majority of today’s F/F plants – the final stage in vaccine manufacture and distribution – formulate and package vaccines as liquid or lyophilized (freeze-dried) solutions. Both are complex, costly processes requiring energy-intensive freezing or refrigeration. Ziccum AB has now produced a White Paper that includes costings and a detailed blueprint of a modular F/F plant that would be the first in the world to formulate and package thermostable dry powder vaccines, at volume, that met WHO CTC (Controlled Temperature Chain) requirements. CTC is a specification for vaccines to withstand one trip outside the cold chain for 3 days at 40oC.

The plant has been co-designed by Ziccum collaboration partner KeyPlants AB, a global leader in modular solutions who have designed and produced more than 50 modular projects globally, including F/F vaccine facilities.

The plant is a 36 m x 27 m two-floor modular facility that could be assembled within 24 months on any greenfield site. The waste and cost reductions in particular have attracted interest from key NGOs. The pilot study analyzes the costs of the proposed new air-drying facility in comparison to the standard costs of a current freeze drying, or lyophilization, facility. It found that the proposed plant offers:  

80% less energy use. The facility’s core air-drying technology, LaminarPace, does not require refrigeration or freezing, including energy-intensive steam, chilled water or Water for Injection, all key elements in lyophilization. 80% energy reduction aligns with UN Strategic Development Goals.

65% less OPEX costs. Half the number of staffs would be required to run an air-dried facility compared to a freeze-drying one, calculated at 200 days of operation/year and 65% usage of utilities.

50% less CAPEX costs. Lyophilization is capital- as well as energy-intensive. Typically, it can take three days at minus 80 degrees C to minus 40 degrees C using large-scale capital equipment that needs to be washed between each batch using cubic meters of the solvent Water-for-Injection, which is itself expensive to generate.

A typical process yield of 80%. This is in sharp contrast to lyophilization, where a 0.5 – 0.7 log titer reduction is not uncommon, resulting in the end production of only 20% effective vaccine. In much lyophilization stabilizing additives need to be added to manage these losses, with five times more vaccine bulk needing to be produced to compensate for losses specifically due to lyophilization. Overall, waste is an urgent challenge in vaccine manufacture. The WHO estimates that more than 50% of vaccines may be wasted globally every year because of temperature control, logistics and shipment-related issues.

The Fill and Finish machine itself, installed within an aseptic isolator room, could process between 20-30 million vials of vaccine per year, formulating 20–300 million individual dried vaccines doses (depending on number of doses per vial).

The active dry vaccine powder produced will be blended with bulking agent then compacted into a 10 cubic mm (0.01 cubic cm) dry-powder plug. Ziccum is exploring offering a range of administration route packages—including a dual blister pack for injection (one chamber containing the plug, the other sterilized water for rehydration) to non-injectables such as Microarray patches. The active dry powder plug of vaccine itself, able to be transported and stored for extended periods without refrigeration, remains at the core of the operation. The White Paper is attracting interest from some leading vaccine NGOs.

Ziccum CEO Göran Conradson: ""This is an idea whose time has come. When we scale up LaminarPace, our dry-formulation technology, we also scale up its signature benefits, producing a low-waste competitive solution that can produce cost-effective, affordable vaccines – at volume – that meet WHO CTC requirements.

"And let’s remember, at its core, air-drying is not a new technology. We all consume many of life’s essentials in dry form every day, without even thinking about it, because that way they can reach more people, quickly and cost-effectively. So why can’t we do the same with vaccines? The fact is, we can. With 1.5 million children a year dying from vaccine-preventable diseases, and the need for vaccines growing urgently worldwide, we all know why we need to improve vaccine coverage. I believe this pilot study now shows us how."

The complete White Paper will be released on www.ziccum.com within the next two weeks.

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 vaccines 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 vaccines that currently only exist in liquid, or in lyophilized 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 Monday 19 October 2020.

ZICCUM takes lead on new pilot study of vaccine plant producing cost-effective thermostable vaccines at volume with KeyPlants as engineering partner

Ziccum has produced a pilot study, including blueprints and costings, exploring the technical and financial viability of a Fill and Finish plant producing thermostable air-dried vaccines at volume. The plan, produced in collaboration with leading modular plant construction specialist KeyPlants AB, indicates significant financial benefits from formulating and packaging vaccines based on Ziccum’s LaminarPace ambient dry-formulation technology. Ziccum will now move forward and seek strategic partnerships for establishing a pilot plant for vaccine manufacturing.

One of Ziccum’s key strategic goals has always been the integration of its dry-formulation technology LaminarPace into large-scale vaccine manufacturing – as demonstrated by recent patent applications on key technical aspects of its technology.

Ziccum CEO Göran Conradson: "We have long stated our commitment to integrating LaminarPace into an industrial GMP environment. The detailed project planning we have carried out with KeyPlants has clarified for us the enormous scale of the savings our technology offers over today’s standard lyophilization processes, and how achievable the concept is as well. With KeyPlants we have a partner with high expertise not only in pharmaceutical facility design and engineering, but also in vaccine production and aseptic processing solutions. The core and modular technology for these new facilities is already available, and the limitations of our present vaccine supply chain are clear. This is a historic opportunity."

Ziccum AB’s air-drying technology transforms liquid vaccine solutions into thermostable dry powders. Unlike currently available commercial vaccines and vaccines in development, these dry powder vaccines can be stored and transported at ambient temperatures for extended periods. They require no Cold Chain and meet WHO CTC (Controlled Temperature Chain) requirements.

Ziccum has identified ‘Fill and Finish’ (F/F), the third and final stage of vaccine production, where medical vials are filled with vaccine solutions and packaged for distribution, as a key target area of vaccine production that would profit from Ziccum capabilities. The vast majority of today’s F/F plants formulate, store and pack vaccines as liquid or lyophilized (freeze-dried) solutions – both are complex, costly, energy-intensive processes compared to ambient air drying.

Together with KeyPlants AB, a global leader in agile modular solutions who have carried out more than 50 projects globally, including F/F vaccine facilities, Ziccum has now drawn up detailed blueprints for a 36 m x 27 m two-floor F/F plant that would be able to produce up to 30 million doses of dry-formulated vaccine a year at an estimated 65% lower OPEX cost and 50% lower CAPEX cost than today’s standard lyophilization F/F plants. The pilot study report is attracting interest from some leading vaccine industry peers.

David Lindholm, head of Sales at KeyPlants: "We currently see a strong demand for new vaccine facilities and we’re currently working on several vaccine projects for customers worldwide. At KeyPlants we’re proud to be a key partner to Ziccum and we see great benefits with their LAPA-technology. This technology will not only significantly reduce facility CAPEX- and OPEX-costs, but also increase vaccine access and safety through the removal of the cold chain distribution."

Ziccum CEO Göran Conradson: "We have made great progress with our other two key strategy areas – growing our IP portfolio of dry-formulated vaccines for license, and increasing our collaborations with vaccine research and stakeholder groups – we absolutely intend to keep developing those. Now, with the scale of potential savings revealed by our pilot study, we are focusing on building new collaborations and strategic partnerships to unlock funding and investment and move ahead towards capturing this extraordinary opportunity.   

"Our roots are in dry-powder aerosol technology, bringing the benefits of dry-formulation to vaccines could benefit millions around the world. We all consume essential food and pharma products in dry form as standard every day – knowing it means they can be stored and transported to more people, more cost-effectively. So why can’t we do the same with vaccines? The fact is we can. Now is the time for realistic new solutions for vaccine distribution. As an industry, we need to look again at what’s possible."

For more information about Ziccum, please contact:

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

Mobile: +46 709 61 55 99

For more information about KeyPlants, please contact:

David Lindholm: Head of Sales KeyPlants AB
E-mail: david.lindholm@keyplants.com 

Mobile: +46 703 295 868

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.

About KeyPlants

KeyPlants provides fast track process and facility solutions for the Life Science and Advanced Technology Industries. KeyPlants is a global leader in modular facility solutions, having executed more than 50 modular projects globally. Pharmaceutical manufacturers around the world benefit from their modular off-site construction. Headquartered in Stockholm, Sweden, KeyPlants also provide engineering solutions and execute conventional pharmaceutical facility projects in the Nordic countries. Capabilities include full in-house design and construction as well as Subject Matter Expertise in Biomanufacturing, Aseptic Filling, Containment and Manufacturing of APIs and Oral Solids.

ZICCUM AB: global vaccine cold chain moves to top of news agenda as world calls for action

The challenge facing global vaccine supply chains has moved firmly to the top of the global news and healthcare agenda over the last week. From UNICEF to the BBC to the University of Birmingham, headlines like ‘8,000 jumbo jets needed to deliver doses globally says IATA’ (BBC) reflect a new understanding of the challenges of the Cold Chain—and the urgent need for new creativity and collaboration around global vaccine supply.

The global vaccine Cold Chain is in the spotlight as never before. With 321 vaccine candidates currently in development urgent attention is now turning to how a successful vaccine will be able to be distributed globally in the required volumes once approved, as well as disruption and delay to present immunization due to Covid-19. The extensive number of articles highlighting the Cold Chain recently include the following:

UNICEF The Time to Prepare for COVID-19 Vaccine Transport is Now. "Vaccines must be handled and transported in line with international regulatory requirements, at controlled temperatures and without delay to ensure the quality of the product… it is clear that the scale of activity will be vast, that Cold Chain facilities will be required and that delivery to every corner of the planet will be needed."

The Telegraph: Daunting task of distribution exposed as it emerges some vaccines must be 'deep frozen' at -70C

The BBC World vaccine delivery 'will need 8,000 jumbo jets'. "Not all planes are suitable for delivering vaccines as they need a typical temperature range of between 2 and 8C for transporting drugs. Some vaccines may require freezing temperatures which would exclude more aircraft."

ABC News: Pfizer may win the COVID vaccine race. But distributing it could be another matter. Needing deep-freeze storage could complicate a massive rollout.

University of Birmingham: Scientists create blueprint to vaccinate in Bangladesh and beyond – "Universal vaccine access is already a major challenge in low-income countries, due to the lack of robust refrigerated cooling networks especially to remote communities. Mass vaccination for COVID-19 will need to deliver vaccines to people globally at scale and speed never before considered."

Ziccum CEO Goran Conradson: "As we get nearer to a Covid-19 vaccine, attention is finally turning to how we will be able to deliver it when it is actually approved. As well as the alarming backlog of undelivered, un-administered vaccines we’re seeing build up because of the Covid-19 emergency. The fact is that as a species we need vaccines right now as we’ve never needed them before. Yet vaccine access and coverage is suffering everywhere we look. Dry powder vaccines could reach the people who need them most anywhere in the world with no need for a cold chain, achieving WHO CTC requirements. The answer is there, so we’re pleased to see now more and more people asking the question – can the Cold Chain deliver?"

Ziccum Chairman Fredrik Sjövall: "This is a tipping point in scientific as well as public opinion. These are not just journalistic articles. This kind of focus over an issue shows that the time is now for new collaboration and creativity around the Cold Chain. We don’t have time to wait."

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 15 September 2020.

ZICCUM AB: global vaccine cold chain moves to top of news agenda as world calls for action

The challenge facing global vaccine supply chains has moved firmly to the top of the global news and healthcare agenda over the last week. From UNICEF to the BBC to the University of Birmingham, headlines like ‘8,000 jumbo jets needed to deliver doses globally says IATA’ (BBC) reflect a new understanding of the challenges of the Cold Chain—and the urgent need for new creativity and collaboration around global vaccine supply.

The global vaccine Cold Chain is in the spotlight as never before. With 321 vaccine candidates currently in development urgent attention is now turning to how a successful vaccine will be able to be distributed globally in the required volumes once approved, as well as disruption and delay to present immunization due to Covid-19. The extensive number of articles highlighting the Cold Chain recently include the following:

UNICEF The Time to Prepare for COVID-19 Vaccine Transport is Now. "Vaccines must be handled and transported in line with international regulatory requirements, at controlled temperatures and without delay to ensure the quality of the product… it is clear that the scale of activity will be vast, that Cold Chain facilities will be required and that delivery to every corner of the planet will be needed."

The Telegraph: Daunting task of distribution exposed as it emerges some vaccines must be 'deep frozen' at -70C

The BBC World vaccine delivery 'will need 8,000 jumbo jets'. "Not all planes are suitable for delivering vaccines as they need a typical temperature range of between 2 and 8C for transporting drugs. Some vaccines may require freezing temperatures which would exclude more aircraft."

ABC News: Pfizer may win the COVID vaccine race. But distributing it could be another matter. Needing deep-freeze storage could complicate a massive rollout.

University of Birmingham: Scientists create blueprint to vaccinate in Bangladesh and beyond – "Universal vaccine access is already a major challenge in low-income countries, due to the lack of robust refrigerated cooling networks especially to remote communities. Mass vaccination for COVID-19 will need to deliver vaccines to people globally at scale and speed never before considered."

Ziccum CEO Goran Conradson: "As we get nearer to a Covid-19 vaccine, attention is finally turning to how we will be able to deliver it when it is actually approved. As well as the alarming backlog of undelivered, un-administered vaccines we’re seeing build up because of the Covid-19 emergency. The fact is that as a species we need vaccines right now as we’ve never needed them before. Yet vaccine access and coverage is suffering everywhere we look. Dry powder vaccines could reach the people who need them most anywhere in the world with no need for a cold chain, achieving WHO CTC requirements. The answer is there, so we’re pleased to see now more and more people asking the question – can the Cold Chain deliver?"

Ziccum Chairman Fredrik Sjövall: "This is a tipping point in scientific as well as public opinion. These are not just journalistic articles. This kind of focus over an issue shows that the time is now for new collaboration and creativity around the Cold Chain. We don’t have time to wait."

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 15 September 2020.

ZICCUM AB submits patent applications for improved operation of the LaminarPace system for commercial vaccine production

Ziccum's LaminarPace system for the production of temperature-stable vaccines is already protected by approved patents. However, during ongoing work to further develop and prepare LaminarPace for commercial production, a number of new, innovative solutions have been developed. By submitting two more patent applications for central design elements Ziccum intends to strengthen and extend the protection of the company's unique production method.

Ziccum CEO Göran Conradson: "We are further expanding our Intellectual Property portfolio around LaminarPace, including key details that are important for improved routine production of vaccines. Submitting these applications now gives the opportunity to extend our IP position on the LaminarPace system, laying the foundation for future industrial applications and collaborations. We have strong protection for our LaminarPace technology—demonstrated by several approved patents describing the basic drying method. These new patent applications add another important dimension to our patent protection and exclusivity in the market. It is also proof that we create new values. as we evaluate new vaccines and further develop our commercial-scale production method. "

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.

ZICCUM AB interim report January 1-June 30, 2020

Summary of the interim report – second quarter 2020

During the second quarter the company carried out a private placement 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). During the second quarter, the company received a loan from Almi Företagspartner Skåne AB amounting to SEK 2.0 million.

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.

ZICCUM AB submits patent application for thermostable dry-powder formulations of VLP-based vaccines (Virus-Like Particles)

Ziccum’s new patent application centers on using its unique drying technology, LaminarPace, to prepare new formulations of VLP-based vaccines that do not require today’s cold chain conditions to be transported. Approved VLP-based vaccines currently on the market against HPV (human papilloma virus, which causes cervical cancer), are Cervarix and Gardasil.

Ziccum’s dry-powder formulation technology, LaminarPace, formulates vaccines that can meet, and surpass, WHO’s CTC (Cold Temperature Chain) requirements for vaccines, set at +40 degrees C. This unique formulation method could lead to a significant increase in the number of people globally who can be vaccinated.

"We are currently expanding our IP portfolio including the various virus types and compositions that are available and widely used for developing and manufacturing vaccines. By filing this patent application, we have further strengthened our IP position and laid the foundation for future industrial applications and collaborations," says CEO Göran Conradson. "We already have strong protection for LaminarPace technology, demonstrated by several approved patent that describe the basic drying method—but patent applications like this one add another dimension to the potential patent protection and exclusivity period a marketed dry-powder product can achieve."

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.

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