ZICCUM AB (publ) Interim report Q3 2023

Significant events during the quarter

  • On July 17th the company announced it has signed an evaluation agreement with a major global Pharmaceutical Corporation. The agreement is to perform a funded feasibility study aiming to develop thermostable dry powder formulations in the partner mRNA/LNP projects, with a planned extension for stability testing and an option to license the LaminarPace technology.
  • On September 5th the company announced that Xavier Turon has been appointed as Chief Operating Officer and he will assume his position on October 9th, 2023.

Other events during the quarter

  • On July 26-28, Ziccum participated at the 3rd Annual mRNA Summit in Boston. CEO Ann Gidner gave a presentation to an audience of senior pharmaceutical industry decision makers, scientists, and key opinion leaders. Ziccum also presented a Scientific poster (’A Novel Unit Operation Successfully Drying mRNA/LNP by Mass Transfer’) – the first scientific poster Ziccum has delivered at a major event.
  • On September 6, Ziccum participated in the conference New Updates in Drug Formulation and Bioavailability in Copenhagen.

Other events after the third quarter

  • On October 23, Ziccum announced that it had received data from external contract research (CRO) partner Truly Labs, confirming high activity levels in mRNA/LNP materials dried by LaminarPace, after continued internal confirmations. The in-vitro data validate the ability of Ziccum’s LaminarPace technology to transform delicate mRNA/LNP solution into stable, bioactive dry powder with excellent in-vitro characteristics.

CEO statement
Intensive data generation with world-leading Partners

After kicking this quarter off with signing the second of two milestone agreements with world-leading mRNA players, now generating significant revenue for Ziccum, we have had an exciting time both externally, participating in leading industry forums, and internally, building the Ziccum team further with strong competence and generating further important data for the mRNA/LNP platform.

Joining forces with world-leading Biotech and Big Pharma
Whilst our Biotech Corporation mRNA Feasibility collaboration is already running, we were delighted to take the Big Pharma Evaluation study negotiation to completion and signatures. The scope is more encompassing, with both a paid Feasibility study for the partner mRNA/LNP material, and a planned extension for stability testing and an option for the Big Pharma to license the LaminarPace technology. It is a great recognition, for Ziccum to be handpicked from the crowded lineup of potential partners for this international leader in vaccine development.
 
Apart from the very concrete and large business value if we can take these two collaborations forward, if the studies prove such good results for the mRNA/LNP entities at hand with LaminarPace as we expect, there is immediate value generated for Ziccum by the partnership interaction. It is a delight to exchange ideas and review progress with these highly skilled industry experts. And obviously it is a great milestone for Ziccum to be revenue generating, thanks to our successful execution of the new business model. This gives a most appreciated further extension of the financial runway ahead.
 
Furthermore, we are taking great strides when it comes to strengthening our academic collaborations, and we are planning additional analytical capabilities in-house to ensure that we are on top of trial readouts and particle assessments.
 
LaminarPace data generation at a new pace
The Ziccum team has made an excellent effort in increasing the productivity in trial execution, and we have been able to take both partnered studies and internal projects forward very efficiently. The initial findings regarding mRNA/LNP treatment with LaminarPace are continuously confirmed, which is extremely rewarding. To further validate the findings on mRNA activity after LaminarPace drying, we have engaged a good analytical services partner to make testing in several models, and the trials in cell-based assays have given distinct validation of the ability of LaminarPace to transform delicate mRNA/LNP solution into stable, bioactive dry powder with excellent in-vitro characteristics. We are moving to the next step of in-vivo studies now, looking forward to key read-outs.
 
Targeting the new era in pharmaceutical industry and getting significant recognition
After applying the technology successfully for the most delicate targets – mRNA in LNP formulation – during spring, it was a pleasure to take part in the Global mRNA Summit in Boston in July, a large gathering of the leading experts in this booming field. One can only be amazed at seeing how the entire, global pharmaceutical industry is racing to take RNA projects forward to market. Also, it was strongly emphasized how mRNA could become a cornerstone treatment for all kinds of indications – if only RNA can be made ‘user-friendly’, with solutions to delivery and stability limitations. This is exactly what Ziccum is enabling, with LaminarPace formulation and drying – so there is indeed a tremendous market need to meet here for our technology, in this highest value part of biopharmaceuticals.
 
There are several new dialogues initiated, existing talks taken forward and it is truly rewarding to see the recognition we are building up in industry.
 
Building the Ziccum professional level further
We were happy to welcome a new colleague during this quarter – Deepak Anand who is bringing a great scientific postdoc profile to the team. I am very pleased to build a diverse team with an impressively broad experience base, bringing valuable perspectives and ensuring a good outlook to stay abreast of industry developments. This was further emphasized as we were delighted to announce the appointment of a broadly experienced engineering manager, Xavier Turon from Barcelona, as our new Chief Operating Officer to join in October.
 
In our Quality Assurance we are taking structure and documentation initiatives forward, ensuring that there is an efficient path for fulfilling pharmaceutical standards, both short term in our running partnerships and long term to get LaminarPace industrialized. We are also assessing potential partners for equipment development and supply going forward.
 
We have a hectic time ahead, with a keen focus on executing on our partnership studies as well as taking the business dialogues and technology optimization forward. Let me thank the team for excellent efforts, as well as collaboration partners and owners for continued support and creative dialogues.
 
Lund, October 25, 2023
Ann Gidner, CEO

July- September in brief

  • Total revenues: SEK 2,329 (0) thousand.
  • Result for the quarter: SEK -3,882 (-6,674) thousand.
  • Earnings per share: SEK -0.28 (-0.48).
  • Cash flow for the quarter: SEK -4.793 (-7,064) thousand.
  • Cash at the end of the reporting period: SEK 9,790 (29,593) thousand.
Financial summary Q3 Q3 Jan-Sep Jan-Sep Full year
KSEK 2023 2022 2023 2022 2022
Net revenue 2,329  0 4,743  0 0
Operating result -3,899  -6,674 -13,857  -20,888 -28,955
Result -3,882  -6,599 -13,720  -20,767 -28,788
Balance sheet total 21,764  42,582 21,764  42,582 33,285
Cash flow -4,793  -7,054 -16,161  17,320 10,678
Cash and cash equivalents 9,790  29,593 9,790  29,593 22,951
Equity ratio % 73  87 73  87 88
Per share data (SEK)        
Number of shares 13,806,142 13,806,142 13,806,142 13,806,142 13,806,142
Result per share before and after dilution* -0.28  -0.48 -0.99  -1.50 -2.09
Cash flow per share -0.35  -0.52 -0.95  1.27 0.78
Equity per share 1.51  2.69 1.51  2.69 2.12

Link to report:
https://ziccum.com/investors/financial-reports/

ZICCUM AB (publ) Interim report Q3 2022

INTERIM REPORT Q3 2022: 1 JANUARY – 30 SEPTEMBER 2022.

To read the digital Report, please click here: https://reports-en.ziccum.com/interim-report-q3-2022/start/

Significant events during Q3 (July-September)

On July 19, Ziccum published the selected partner for the development of its crucial new nebulizer component for the LaminarPace system. The chosen partner TEKCELEO is an innovative mechatronic manufacturer with advanced knowledge of nebulizers. The component is central to the advanced drying capabilities and scaleup of Ziccum’s LaminarPace system.

On July 21, it was announced that Ziccum together with the Zurich University of Applied Sciences (ZHAW) are applying for funding from the Eurostars funding body for a joint project that will develop the 3D modelling stage of LaminarPace. The project aims to strengthen, support and accelerate the development of LaminarPace – offering high-value insights into its unique particle properties, and accelerating and optimizing industrialization.

On August 2, Ziccum informed about a reorganisation aiming to facilitate and accelerate its new strategic focus on key projects and vaccine platforms. As part of the reorganization, Senior Formulation Specialist Fabrice Rose was appointed Scientific Director. The reorganization was implemented on August 1, 2022.

Ziccum announced on September 1 that the company will be intensifying its partnering and networking dialogues by attending major industry events across Europe.

On September 14, Ziccum and Zurich University of Applied Sciences’s School of Engineering (ZHAW) did submit a joint application for Eurostars funding. The proposed project will develop 3D modelling, and ultimately a Digital Twin, of LaminarPace (LAPA) that will accelerate development and scale-up and promote tech transfer, partnering and ultimately sales.

On September 23, Ziccum received results from evaluation study with leading Pharmaceutical corporation, analyzing LaminarPace’s ability to dry four test substances. Data demonstrated excellent results on thermostability, positive results on particle appearance but significant loss of infectivity, requiring further development. The client has paused assessment of LaminarPace on the current vaccine platform, but will consider the technology in regard to other vaccine platforms, where dry formulation could be a higher priority.

On September 27, It was announced that Ziccum has reopened its application process for CEPI’s Call for Proposals from companies developing innovative technologies to improve vaccine thermostability. Ziccum will submit an Expression of Interest with a new partner – a well-established, innovative biotechnology company.

During the third quarter CEO Ann Gidner has bought 35,000 shares in Ziccum. In addition, the Chairman of the Board Fredrik Sjövall bought 40,000 shares in the Company.

Significant events during Q1-Q2 (Jan-June)

At the Extraordinary General Meeting held on January 18, in addition to approving the Board's proposal, it was decided to increase the limit on the number of shares and the size of the share capital in the Articles of Association, to enable the issue of the remaining 933,362 units in the private placement.

On January 18, an additional 2,800,086 shares and 1,866,724 warrants were registered, and all shares and warrants in the private placement are thus registered.

The last payments from the directed share issue were received by the company in January and February 2022, a total of 40 mSEK was added to the company after deduction of issue costs.

Ziccum announced on February 7 that it has become a member of the United Nations Global Compact, the world's largest corporate sustainability initiative.

On February 22, it was announced that Göran Conradson was terminated from his position as CEO. The company's CFO, Frida Hjelmberg, will be acting CEO for the time being.

On March 3, the Board released an update on strategy, goals and priorities. The company's strategy for entering into commercial agreements with industrial players has been and is clearly defined. It is based on four key priority activities:

  1. Drive an active business development agenda that proactively prepares for collaboration with existing and potential partners. This is partly to offer the opportunity to evaluate specific projects in combination with Ziccum's technology, and partly to understand the requirements placed on the technology before a decision on a license agreement can be made.
  2. Generate laboratory data that manifests and confirms the technology's capacity to dry different types of vaccines, so-called proof of concept.
  3. Develop the company's technology to adapt its functionality, capacity and quality to the licensees' required specifications.
  4. DevelopconceptualplansforhowZiccum'sdryingtechnologycanbeadaptedtothecommercialscaleand integrated into a commercial production environment.

With a new CEO, the Board's goal is to increase the pace of, above all, business development work – with the goal of entering into more industrial collaborations in order to evaluate LaminarPace and advance our existing collaborations into negotiations on commercial terms and license agreements.

Ziccum AB has significantly expanded its lab facilities and capabilities, particularly in the area of mRNA/LNP. Strategic investments include a new cell lab and a system for manufacturing and evaluating dry formulations of mRNA/LNP materials. On June 22, the company informed that the installation of the new cell lab was completed, enabling in-house in vitro research.

On June 3, it was announced that Ziccum has extended an ongoing pilot evaluation study agreement with a leading pharmaceutical corporation following the completion of the latest stage of the project.

On May 9 Ann Gidner took office as new CEO. Ann has 25+ years of experience from Life Science management internationally, with a significant track record in strategic development, focused leadship, deal making and sales growth.

Ziccum has been elected onto the Technical Activities Committee of the US National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). NIIMBL, co-funded by the US Department of Commerce, funds and initiates a wide range of public-private research projects throughout the US.

On May 6, the Board of Ziccum published the decision to officially change the company’s language to English for all external communications.

The current LAPA system is the fourth generation in development. On April 27, Ziccum informed about the selected key targeted technology developments of the LaminarPace system – some underway, and some recently completed:

  1. New powder collector – Ziccum has now installed a new sealed, contained collection unit that enables the inhouse study of a wider range of test substances. The new unit increases safety, reduces humidity and enables quicker, more efficient collection of drier formulations.
  2. New nitrogen usage – Ziccum has now introduced Nitrogen gas (N2) into the drying column to replace air. N2 is a highly efficient remover of moisture. The first nitrogen-based generation of LAPA is installed and has performed well in tests.
  3. New nebulizer – The LAPA system’s nebulizer feature is a key component in optimizing the system’s capacity, reproducibility and reliability.
  4. New membrane – Intensive work is currently underway in optimizing the membrane for future GMP compatibility – examining its porosity, mounting and materials for industrial setting.

On April 25, a strategic sharpening was announced informing the market that Ziccum is now targeting three key vaccine platforms in its research and development work through 2022 and 2023 – driven by input from external collaborations and new internal technology capabilities.

  1. Viral vector platform using Adenovirus – Four major Covid-19 vaccines already use adenovirus vaccine vectors as a platform. The platform enables efficient gene transduction and research is ongoing in a wide range of indications. Ziccum has worked extensively with adenovirus and submitted a patent application in January 2019 for a temperature-stable, dry formulation of Adenovirus.
  2. Subunit vaccine (adjuvanted) platform – This platform is also being used in major Covid-19 vaccine candidates. Instead of using the whole pathogen, protein-based adjuvant vaccines use a defined protein antigen from the pathogen which can be recognized by the body’s immune system to provoke an immune response. Protein-based vaccines have been successfully developed over recent decades to treat diseases from diphtheria to tetanus.
  3. mRNA/LNP vaccine platform – Generating data on dry-formulated mRNA/LNP materials is a key strategic priority for Ziccum. Covid-19 has highlighted the efficacy of mRNA/LNP as a vaccine platform enormously.

During the second quarter CEO Ann Gidner has bought 15,000 shares in Ziccum. In addition, the Board members Andreas Pettersson Rohman also bought 39,333 shares and Fredrik Sjövall 10,000 shares in the Company.

Significant events after the reporting period

Ziccum announced proof of successful nebulization and drying of vaccine lipid nanoparticles (LNP) in its in- house mRNA project. This was carried out using LaminarPace, the company’s ambient drying technology. LNP is the preferred drug delivery component in today’s mRNA Covid-19 vaccines. The study resulted in a defined knowledge-space, defining the best operating conditions, and key read-out parameters were encapsulation efficiency, yield and particle size. The trials were repeated for confirmation.

CEO statement

Strategic focus reinforcement

We are rapidly going forward in Ziccum, implementing the new focus and executing on its actions, generating results. Just after quarter closing, we had the much-anticipated and important proof of successful drying of vaccine LNP particles, setting the mRNA/LNP offering center-stage – a major step for us.

Strategic focus

We have progressed significantly in our strategic development, where a number of factors assessed have helped defining our market targeting: the ground-breaking new technology, the value proposition, the small volume applicability and the regulatory pathway all point to a focus on high value, delicate, next-generation mRNA vaccines and RNA therapeutics as the top priority. We should apply our technology where it will bring the most value. This guidance is now directing efforts on all fronts.

Business development and Partnering

We have ambitious business development as a top priority, to build a broad pipeline of opportunities. Participating at Nordic Life Science Days and the World Vaccine Congress we had good meeting schedules, and were rewarded with serious interest from Pharma, Biotech and vaccine manufacturing industry – also clearly confirming the high-value strategic focus. We are currently going into secrecy agreements with a number of companies to take dialogues further.

Partnering in Pharma industry can be a lengthy process, and there are always some projects closing, so we are delighted to have many new dialogues established. The pandemic awareness and intensive efforts in vaccine development globally certainly are fuelling interest for new technology such as ours. Furthermore, we have commissioned a market study with mRNA target projects from a qualified US biopharma licensing bureau.

Technology development and Feasibility studies

Internally, the technology development program involves having a customized, top performing nebulizer rapidly developed, plus progress in membrane development and more. These steps are ensuring we are meeting our technology selling points of gentle and efficient processing in an optimized manner. Apart from developing the LaminarPace performance, we are running feasibility studies, nicely filling the new capacity installed last quarter.

The internal trials on LNP particles for mRNA have been pursued with great intensity during the quarter. It is indeed rewarding to see the outcome, where the drying step has given good read-outs in terms of encapsulation, yield and particle preservation. This is a great confirmation of the applicability of LaminarPace, giving a clear path forward for the continued development, verifying that sufficient activity is preserved.

For the existing collaboration getting read-outs end September, results were mixed. Seeing that the technology is promising but will need further development, the partner may consider a more delicate platform – very much in line with our own strategic conclusions to apply the technology to the highest value segments like mRNA/LNP.

3D- Modelling and Soft funding

Starting up the 3D-modelling is important– the LaminarPace development and scale-out can be accelerated and significantly improved, ensuring optimal design. We are happy to have submitted the application for a Eurostars grant covering this scope, jointly with our new top-notch Swiss engineering partner. We also agreed with a key European Biotech partner to build an attractive case for the CEPI grant for Thermostable vaccines, basing our case on mRNA/LNPs.

Company structure

The new organization was implemented on August 1st, bringing clarity on responsibilities and setting a strong focus. The sharpened setup is giving good savings as we eliminate consultant expenditure, both avoiding unnecessary efforts and changing roles into employment. I am delighted to welcome a new member of staff, Tony, this quarter.

I want to express my gratitude to the Ziccum team for fantastic efforts, stepping up to the new strategy and taking activities forward on all fronts. Also, we are most happy for excellent support from our collaboration partners, consultants and owners.

Lund, October 27, 2022

Ann Gidner, CEO

Q3 2022

The result for the quarter amounted to -6,599 kSEK (-5,043 kSEK)
Cash flow for the quarter amounted to -7,054 kSEK (- 6,414 kSEK)
Cash and cash equivalents at the end of the quarter amounted to 29,593 kSEK (19,564 kSEK)

Summary of financial highlights

Summary Financial Highlights July-Sept 2022 July-Sept 2021 Jan-
Sept
2022
Jan-Sept 2021 Jan-
Dec 2021
Net revenue
Operating result (6,674) (5,045) (20,888) (14,643) (21,117)
Result (6,599) (5,043) (20,767) (14,686) (21,136)
Balance sheet total 42,582 29,348 42,582 29,348 39,591
Cash flow (7,054) (6,141) 17,320 (14,056) (21,347)
Cash and cash equivalents 29,593 19,564 29,593 19,564 12 273
Equity ratio % 0.87 0.82 0.87 0.82 0.75
Data per share SEK
Number of shares at the end of the period 13,806,142 9,806,200 13, 806,142 9,806,200 11,006,056
Result per share before and after dilution* -0.48 – 0.51 -1.50 -1.51 -2.17
Cash flow per share -0.52 – 0.63 1.27 -1.456 -2.19
Equity per share 2.69 2.46 2.69 2.46 2.70
* Dilution effects is not calculated when the result is negative

ZICCUM AB Interim report Q3 2021

INTERIM REPORT 1 JANUARY – 30 SEPTEMBER 2021

To read the digital Report click here: https://reports-en.ziccum.com/delarsrapport-q3-2021/start/

Q3 2021

  • The result for the quarter amounted to -5 043 kSEK (-5 346 kSEK)
  • Cash flow for the quarter amounted to -6 414 kSEK (-165 kSEK)
  • Cash and cash equivalents at the end of the quarter amounted to 19 564 kSEK (39 561 kSEK)
Summary of financial higlhights in kSEK July-Sept 2021 July-Sept 2020 Jan’-Sept 2021 Jan’-Sept 2020 Jan’-Dec’ 2020
Net revenue o 0 0 0 0
Operating result -5 045 -5 317 -14 643 -14 006 -17 235
Result -5 043 -5 346 -14 686 -14 035 -17 289
Balance sheet total 29 348 42 720 29 348 42 720 39 640
Cash flow -6 141 -165 -14 056 37 497 31 556
Cash and cash equivalents 19 564 39 561 19 564 39 561 33 620
Equity ratio % 82% 93% 82% 93% 92%
   
Data per share, SEK
No. of shares at end of period 9 806 200 9 606 200 9 806 200 9 606 200 9 606 200
Result per share before and after dilution* -0.51 -0.56 -1.51 -1.75 -2.06
Cash flow per share -0.63 -0.02 -1.45 4.68 3.75
Equity per share 2.46 4.13 2.46 4.13 3.79
* Dilution effects not calculated when effect is negative

Significant events during Q3 (July-Sept’)

On the 1st of September Anna Lönn was appointed as Development director

Significant events during Q1-Q2 (Jan’-June)

Ziccum published its goals for 2021 on January 12. The major goals are to enter into the first licensing agreement for one or more dry-formulated vaccines, and to present a detailed plan for establishing a modular Fill and Finish production facility for filling and final packaging of dry, thermostable powder vaccines, including the necessary partnerships and financing plans. Ziccum’s medium-term goal (2–3 years) is to establish the first Fill and Finish facility for dry-formulated vaccines in Sweden.

On January 25 Ziccum announced the extension of the evaluation agreement with Janssen Vaccine & Prevention B.V. (one of the Janssen Pharmaceutical Companies of Johnson & Johnson) that was entered into on October 3, 2019. The purpose is to finalize the analysis of Ziccum’s air-drying capabilities on one of Janssen’s vaccine platform technologies.

On March 17 Ziccum announced that the company has been accepted as a member of NIIMBL, the US National Institute for Innovation in Manufacturing Biopharmaceuticals. NIIMBL drives innovation and uptake of new technologies within biopharmaceutical manufacturing in the US. NIIMBL is among others funded by the US National Institute of Standards and Technology (NIST) and the U.S. Department of Commerce and is able to distribute federal grants.

At the General Meeting it was decided to adopt two long-term incentive programs: one for the Board of Directors, consisting of warrants (LTI 2021/2024), and another one for the employees consisting of employee stock options (LTI 2021:1).

The warrant program LTI 2018/2021 has also closed, and all warrants were exercised. The warrant program was assigned to the Board of Directors and consisted of 200 000 warrants, with a vesting period during 26 April – 26 May 2021. To finance the share subscription, the warrant holders have sold 120 000 warrants to a long-term investor, who has also exercised the warrants. The exercise price was 11 SEK per share, hence 2.2 mSEK was added to Ziccum through the share subscriptions. The exercised warrants increased the number of shares and votes with 200 000 and the total amount of shares is hereby 9 806 200.

Significant events after the reporting period

Nothing significant to report

CEO statement
Vaccinations are and have long been one of the best ways to prevent pandemics and epidemics. Right now the need has never been greater. New travellin habits, population growth, climate change and overcrowding all potentially increase the risk of epidemics and pandemics, and 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. With the Covid-19 pandemic, many countries have come to realize the importance of taking responsibility for vaccine production, not least many countries on the African continent. Our solution, described in a White Paper on our website, of a Fill & Finish production facility, may therefore be very suitable.
 
Ziccum has a unique and patented technology – LaminarPace ™ – 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 so 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. The result is greater vaccination coverage at a lower cost.
 
Ziccum's key strategic priorities focus on three major areas: Developing thermostable formulations of vaccines, preparing for production on a commercial scale and building external collaborations with industrial actors who develop vaccines and, importantly for the industry, Non-Governmental Organizations (NGOs) and International Governmental Organizations (IGO). Several IGOs, including the WHO, are very clear that vaccine production must be increased in developing countries in so-called regional hubs, so that an equitable vaccine supply can achieved. We are currently in discussions at a senior level with one of these regional hubs.

Driven by the ongoing pandemic, our work on developing thermostable formulations of vaccines is focused increasingly on Covid-19 vaccines. For example, we taken on work evaluating whether LaminarPace can dry vaccines built on mRNA technology. Good results in this would broaden our offer to the vaccine industry significantly. It should also be mentioned that Covid-19 vaccines are mainly based on 4-5 different technology platforms – we feel comfortable that our technology can be used effectively on a number of these.

In parallel, we are continuing our work developing a system for large-scale industrial production of dry thermostable vaccines. This is a top priority that will speed up our discussions with external collaborators and make our offering more attractive to partners. During the quarter, we have achieved important successes in this, and we now have an updated system onsite in our laboratory which we are evaluating. The updated system is a big step forward and is being prepared for GMP (Good Manufacturing Practice) requirements and scaling up.

Our collaboration with Janssen continues as planned. We have also initiated a new collaboration with a prominent academic partner and we have several discussions ongoing with new partners, both industrial and academic, about new collaborations.

It should also be mentioned that we were invited to participate in a Vinnova grant focusing on gene therapy, this grant was granted, to GeneNova, and is 5 years old. The aim is for more efficient production of gene therapy for individualized treatment. KTH is the coordinator for this innovative project and AstraZeneca, AlfaLaval and CombiGene among others are included as important partners. The grant money is distributed only to the academic partners. Gene therapy uses viruses, and in this area too, transport, often at -80 ° C, is considered a major challenge to be solved in order for gene therapy to break through as a treatment, hence our interest.

We have two main goals for 2021, to partly develop concrete plans to build and establish a demonstration Fill and Finish facility for filling and final packaging of vaccines based on LaminarPace, and to continue our work of licensing our technology. A license agreement would validate LaminarPace and be a clear acknowledgment of the commercial value of Ziccum's offering. This work is continuing.

We are gratified to see the large number of new initiatives being taken worldwide to greatly increase the regional production capacity of vaccines. This means that the traditional customer base for our technology, ie large global vaccine companies, is being expanded with several new players, especially in developing countries. Our solution for thermostable vaccines provides a very strong competitive advantages, as many Covid-19 vaccines still have to be transported and stored at temperatures all the way down to -80 ° C. Yet storing and transporting vaccines at -80 ° C in large parts of the world with undeveloped infrastructure and insecure access to stable electricity networks is an enormous challenge.

In summary, we are well positioned for a very exciting future in an industry that will remain a key priority area globally for a long time to come.

Lund, October 28, 2021 Göran Conradson
VD

ZICCUM AB Delårsrapport Q3 2021

DELÅRSRAPPORT 1 JANUARI – 30 SEPTEMBER 2021

För att läsa hela rapporten digitalt, klicka här: https://reports.ziccum.com/delarsrapport-q3-2021/start/

Q3 2021

  • Resultatet för kvartalet uppgick till – 5 043 kSEK (-5 346 kSEK)
  • Kassaflödet för kvartalet uppgick till -6 141 kSEK (-165 kSEK)
  • Likvida medel uppgick vid utgången av kvartalet till 19 564 kSEK (39 561kSEK)
Finansiell data i sammandrag kSEK Juli-sep 2021 Juli-sep 2020 Jan-sep 2021 Jan-sep 2020 Jan-dec 2020
Nettoomsättning 0 0 0 0 0
Rörelseresultat -5 045 -5 317 -14 643 -14 006 -17 235
Resultat -5 043 -5 346) -14 686 -14 035 -17 289
Balansomslutning 29 348 42 720 29 348 42 720 39 640
Periodens kassaflöde -6 141 -165 -14 056 37 497 31 556
Likvida medel 19 564 39 561 19 564 39 561 33 620
Soliditet % 82% 93% 82% 93% 92%
   
Nyckeltal per aktie, SEK
Antal aktier vid periodens slut 9 806 200 9 606 200 9 806 200 9 606 200 9 606 200
Resultat per aktie före och efter utspädning* -0,51 -0,56 -1,51 -1,75 -2,06
Periodens kassaflöde per aktie -0,63 -0,02 -1,45 4,68 3,75
Eget kapital per aktie 2,46 4,13 2,46 4,13 3,79
* Utspädningseffekter omräknas ej vid negativt resultat

Väsentliga händelser Q3 (juli-sep)

Den 1 september tillträde Anna Lönn rollen som Development director.

Väsentliga händelser Q1-Q2 (jan-juni)

Ziccum offentliggjorde den 12 januari sina mål för 2021. Huvudmålen är att ingå ett första licensavtal avseende ett eller flera vacciner, samt att presentera en detaljerad plan för att etablera en produktionsanläggning för fyllning och slutförpackning av torra, termostabila pulvervacciner inklusive nödvändiga partnerskap och finansieringsplan.

Ziccum publicerade den 25 januari att bolaget har förlängt det utvärderingsavtal som den 3 oktober 2019 slöts med Janssen Vaccine & Prevention B.V., ett av Janssens läkemedelsbolag som tillhör Johnson & Johnson. Syftet är att slutföra analysen av Ziccums lufttorkningsteknologi med Janssens vaccinplattformar.

Den 17 mars informerade Ziccum att bolaget hade blivit antaget som medlem i NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals. NIIMBLs uppdrag är att accelerera utvecklingen av nya biomedicinska tillverkningstekniker i USA. Bland annat är US National Institute of Standards and Technology (NIST) och U.S. Department of Commerce medgrundare, vilket ger organisationen möjligheter att dela ut federala anslag till sina medlemmar.

Årsstämman har beslutat, efter förslag från styrelsen respektive valberedningen, att anta ett långsiktigt incitamentsprogram för styrelseledamöter (LTI 2021/2024) i Ziccum bestående av teckningsoptioner, samt ett långsiktigt incitamentsprogram för medarbetarna bestående av personaloptioner (LTI 2021:1).

Utöver detta har även optionsprogrammet LTI 2018/2021 avslutats och samtliga teckningsoptioner har utnyttjats. Teckningsoptionerna riktades till Ziccums styrelseledamöter och omfattade 200 000 teckningsoptioner, med utnyttjandeperiod under perioden 26 april – 26 maj 2021. För att finansiera aktieteckningen har optionsinnehavarna sålt 120 000 teckningsoptioner till en enskild långsiktig investerare, som nu också utnyttjat dessa teckningsoptioner. Lösenpriset uppgick till 11 SEK per aktie, innebärande att Ziccum, genom aktieteckningen, tillförs 2,2 mSEK. Genom utnyttjandet kommer antalet aktier och röster att öka med 200 000 och totalt antal aktier kommer därmed uppgå till 9 806 200.

Väsentliga händelser efter rapportperioden

Inget väsentligt att rapportera

VD har ordet

Vaccinationer är och har varit ett av de bästa sätten att förebygga pandemier och epidemier. Behovet har aldrig varit större än i dessa dagar. Inte minst Covid-19 pandemin har visat på den enorma nyttan vacciner gör på hela samhällen. Nya resvanor, befolkningstillväxt, klimatförändringar och trångboddhet är alla potentiella risker för nya epidemier och pandemier. Det är barnen som är mest utsatta; ett barn av fem får fortfarande inte fullgott vaccinationsskydd. Cirka 1,5 miljoner barn dör varje år i sjukdomar som det finns vacciner för. I och med Covid- 19 pandemin har även vuxna blivit hårt drabbade och många länder kommit till insikt av vikten att själva ta ansvar för vaccinproduktion.

Ziccum har en världsunik och patenterad teknologi – LaminarPaceTM – som gör det möjligt att framställa temperaturstabila vacciner i torr pulverform vilket inte är praktiskt eller ekonomiskt möjligt med konventionella tekniker. Samtidigt är fördelarna många. Det ökar stabiliteten och därmed livslängden på vaccinet, det underlättar hela transportkedjan från fabrik till patient och det möjliggör distribution av vacciner till nya platser där exempelvis kyl- och frysförvaring är en stor utmaning. Vaccination till fler och till lägre kostnad alltså.

Ziccums fokus beskrivs i tre huvudområden. Utveckling av termostabila formuleringar av vacciner, förberedelser för produktion i kommersiell skala och externa samarbeten med industriella aktörer som utvecklar vacciner och dessutom, för branschen, mycket viktiga Non-Governmental Organizations (NGO)och International Governmental Organizations (IGO). Flera IGOs, bland annat WHO är mycket tydliga med att vaccinproduktionen måste utökas i utvecklingsländerna i sk regionala hubbar, så att jämlik vaccintillgång kan uppnås. Vi för diskussioner på senior nivå med en av dessa hubbar.

Drivet av den pågående pandemin har vårt arbete med att utveckla termostabila formuleringar av vacciner fokuserats mer och mer kring Covid-19 vacciner. T.ex. har vi tagit upp arbetet med att utvärdera LaminarPace för att kunna torka vacciner som bygger på sk mRNA-teknik. Goda resultat skulle bredda vårt erbjudande till vaccinindustrin avsevärt. Det bör också nämnas att Covid-19 vacciner baseras i huvudsak på 4–5 olika teknologiplattformar, och vi känner oss mycket komfortabla med att vår teknik kan användas på ett flertal av dessa.

Parallellt fortsätter vårt arbete med att utveckla ett system för industriell produktion i stor skalaArbetet med detta är högt prioriterat för att påskynda våra externa samarbetsdiskussioner och för att vi ska ha ett attraktivt erbjudande till våra partners. Under kvartalet har vi nått viktiga framgångar och vi har nu ett uppdaterat system på plats i vårt laboratorium som vi utvärderar. Det uppdaterade systemet är ett stort steg framåt och är förberett för GMP (Good Manufacturing Practice) krav och uppskalning.

Vårt samarbete med Janssen fortsätter planenligt. Vi har även initierat ett nytt samarbete med en framstående akademisk partner och vi för flera diskussioner med nya partners, både industriella och akademiska, om nya samarbeten.

Vi har två huvudmål för 2021, dels att ta fram konkreta planer för att bygga och etablera en demonstrationsanläggning för fyllning och slutförpackning av vacciner baserat på LaminarPace, dels fortsätta vårt arbete med att licensiera ut vår teknologi. Ett licensavtal skulle validera LaminarPace och vara ett tydligt kvitto på det kommersiella värdet i Ziccums erbjudande. Detta arbete pågår fortsättningsvis.

Vi ser att många nya initiativ tas runt om i världen för att kraftigt utöka produktionskapaciteten av vacciner, detta medför att den traditionella kundbasen, dvs stora globala vaccinbolag, utökas med flera nya aktörer framför allt i utvecklingsländer. Där vår lösning med temperaturstabila vacciner ger mycket starka konkurrensfördelar, då många Covid-19 vacciner måste transporteras och lagras ända ned till -80°C. Att lagra och transportera vacciner i -80°C i stora delar av världen med outvecklad infrastruktur och osäker tillgång till stabila elnät är en mycket stor utmaning.

Sammanfattningsvis är vi väl positionerade för en mycket spännande framtid i en bransch som kommer att ha ett mycket stort fokus under lång tid framöver.

Lund den 28 oktober 2021

Göran Conradson VD

ZICCUM AB Delårsrapport 1 januari-30 september 2020

Sammanfattning av delårsrapporten under tredje kvartalet 2020  

Ziccum har under tredje kvartalet gjort stora framsteg i arbetet med att industrialisera sin unika process för att framställa vacciner i torr pulverform. Stora ekonomiska och produktionstekniska fördelar har kunnat påvisas jämte det faktum att torra vacciner erbjuder en signifikant förenklad och kostnadseffektiv logistikkedja.

Jul-sep 2020

Nettoomsättning 0 tkr (0)

Rörelseresultat -5 317 tkr (-1 380)

Resultat per aktie före och efter utspädning -0,56 SEK (-0,23)

Jan-sep 2020

Nettoomsättning 0 tkr (0)

Rörelseresultat -14 006 tkr (-5 378)

Resultat per aktie före och efter utspädning -1,75 SEK (-0,90)

Väsentliga händelser under tredje kvartalet 2020

  • Bolaget har genomfört en riktad nyemission om totalt 2 216 815 aktier till ett begränsat antal kvalificerade privata investerare. Bolaget tillfördes 38,8 MSEK före emissionskostnader och cirka 36,6 Mkr efter emissionskostnader varav cirka 32,3 Mkr tillfördes under det andra kvartalet och resterande cirka 6,5 Mkr tillfördes under juli månad 2020
  • Patentansökan har inlämnats avseende termostabila formuleringar av VLP (Virus Like Particles) baserade vacciner samt två patentansökningar avseende förbättrad funktion av LaminarPace systemet för kommersiell vaccinproduktion

Väsentliga händelser under rapportperioden (jan-sep) 2020

  • Emissionslikvid avseende teckningsoptioner uppgick till cirka 13,9 MSEK som tillfördes bolaget under januari månad 2020. Emissionen registrerades av Bolagsverket 2020-01-14
  • Den 26 mars 2020 meddelade vi att Ziccum tecknade en avsiktsförklaring att undersöka integration av Ziccums teknologi i en innovativ vaccintillverkningsprocess med ett företag som har en ny innovativ produktionsteknologi för vacciner. Avtalet omfattar utvärdering av integrering av Ziccums formuleringsteknologi för mässling och röda hund (rubella) vacciner. Målsättningen är att betydligt sänka kostnaderna av barnvaccin samt att öka tillgängligheten av vaccin till världens alla barn genom att tillverka temperaturstabila formuleringar
  • Den 20 maj meddelade vi att Ziccum tar nästa steg i ett av sina industriella samarbeten med fortsatt utvecklingsarbete med att formulera temperaturstabila vacciner efter att första steget fallit väl ut
  • Vi meddelade den 24 juni att Ziccum med stöd av bemyndigande från årsstämman den 16 juni, genomfört en riktad nyemission om totalt 2 216 815 aktier till ett begränsat antal kvalificerade privata investerare. Bolaget tillfördes 38,8 MSEK före emissionskostnader och cirka 36,4 Mkr efter emissionskostnader (varav cirka 32,3 Mkr tillfördes under det andra kvartalet och resterande cirka 6,5 Mkr tillfördes under juli månad 2020)
  • Mot bakgrund av utbrottet av coronaviruset och COVID-19 följer Ziccum händelseutvecklingen noga och vidtar åtgärder för att minimera eller eliminera påverkan på bolagets verksamhet. Ziccum följer riktlinjer från Folkhälsomyndigheten, WHO och ECDC (Europeiskt centrum för förebyggande och kontroll av sjukdomar). Ziccum har kunnat fortsätta sin interna verksamhet utan betydande påverkan av COVID-19. Det finns dock risk för förseningar i Bolagets externa samarbetsprojekt med aktörer i andra europeiska länder

Väsentliga händelser efter rapportperioden

  • Ziccum har genomfört en pilotstudie på storskalig produktion av temperaturstabila vacciner i partnerskap med KeyPlants
  • Ziccum har publicerat en White Paper som beskriver världens första anläggning för storskalig produktion av temperaturstabila vacciner
  • Den 26 oktober meddelade vi att Frida Hjelmberg utsetts till CFO. Frida tillträder den 1 januari 2020

Utvalda finansiella data i sammandrag

2020 2019 2020 2019 2019
Jul-sep Jul-sep Jan-sep Jan-sep Jan-dec
Nettoomsättning
Övriga intäkter 2 251 2 655 654
Rörelseresultat, tkr -5 317 -1 380 -14 006 -5 378 -8 721
Resultat efter skatt, tkr -5 346 -1 380 -14 035 -5 378 -8 723
Balansomslutning, tkr 42 720 7 249 42 720 7 249 18 395
Periodens kassaflöde, tkr -165 -1 718 37 497 -5 297 -8 473
Periodens kassaflöde per aktie (SEK) -0,02 -0,29 4,68 -0,88 -1,41
Likvida medel, tkr 39 561 5 239 39 561 5 239 2 064
Resultat per aktie före och efter utspädning (SEK) -0,56 -0,23 -1,75 -0,90 -1,45
Eget kapital per aktie (SEK) 4,13 1,10 4,13 1,10 2,86
Soliditet, % 93% 91% 93% 91% 93%

VD kommenterar

Vaccinationer är och har varit ett av de bästa sätten att förebygga pandemier och epidemier. Behovet har aldrig varit större än i dessa dagar. Nya resvanor, befolkningstillväxt, klimatförändringar och trångboddhet är alla potentiella risker för epidemier och pandemier. Det är barnen som är mest utsatta; ett barn av fem får fortfarande inte fullgott vaccinationsskydd. Cirka 1,5 miljoner barn dör varje år i sjukdomar som det finns vacciner för.

Ziccum har en världsunik och patenterad teknologi – LaminarPace™ – som gör det möjligt för oss att framställa vacciner i torr pulverform vilket inte är praktiskt eller ekonomiskt möjligt med konventionella tekniker. Samtidigt är fördelarna många. Det ökar stabiliteten och därmed livslängden på vaccinet, det underlättar hela transportkedjan från fabrik till patient och det möjliggör distribution av vacciner till nya platser där exempelvis kyl- och frysförvaring är en stor utmaning. Vaccination till fler och till lägre kostnad alltså.

Ziccums fokus beskrivs i tre huvudområden. Utveckling av termostabila formuleringar av vacciner, förberedelser för produktion i kommersiell skala och externa samarbeten med industriella aktörer som utvecklar vacciner och dessutom, för branschen, mycket viktiga "non-governmental organizations".

Trots Covid-19 fortsätter vårt interna arbete med att utveckla termostabila formuleringar av vacciner. I samarbete med vår akademiska partner, det inom virus och vacciner världsledande universitetet i Marseille pågår nu flera intressanta och viktiga projekt. Resultaten är mycket lovande och stämmer väl överens med det vi sett tidigare, vi kommer dessutom att stärka vår patentportfölj ytterligare med dessa resultat. En stark IP portfölj är grunden till att kunna ingå kommersiella samarbeten och skapa värden för våra aktieägare.

En annan hörnsten för att göra vår teknologi kommersiellt attraktiv är att förbereda för produktion i kommersiell skala. Vi har i samarbete med svenska KeyPlants AB, tagit fram en så kallad Conceptual Design av en anläggning för fyllning och förpackning av torra vacciner baserad på vår teknologi. Vi ser stora kostnadsbesparingar i produktionen när man jämför med frystorkning, som är ett mycket vanligt, men dyrt, sätt att stabilisera vacciner. Dels sparar man stora kapitalkostnader, men framförallt minskas energibehovet med cirka 80%, som stämmer väl överens med FNs sjunde utvecklingsmål: Hållbar energi för alla. Anläggningen kan producera upp till 300 miljoner doser per år. Vacciner är en lågkostnadsprodukt i stora delar av världen, därför är dessa resultat så viktiga. Nu när vi kan beskriva en produktionsanläggning, har vi utvidgat vår affärsmodell och lagt till ytterligare möjligheter till intäkter. Vi kan nu föra en annan typ av diskussion med både leverantörer av bulkvacciner och Internationella organisationer verksamma inom vacciner. Vi har publicerat på vår hemsida ett s.k. White Paper som sammanfattar fördelarna och de stora kostnadsbesparingarna som kan göras med vår teknologi.

Det innebär också att vi nu kan arbeta på ett annat sätt att säkerställa att vår teknologi kan leverera en slutprodukt som är anpassad till industrins och inte minst slutanvändarnas önskemål och krav. Vår ambition är att ligga ett steg före och kunna erbjuda en unik helhetslösning för hur ett torrformulerat vaccin skall produceras, hanteras och administreras. Det kapital som vi reste under sommaren kommer till stor del användas till detta verksamhetsområde och därmed för att accelerera kommersialiseringen av vår teknologi.

Våra externa kontakter utökas hela tiden och vi får allt större respons från branschens olika aktörer. Inte minst på vårt nya White Paper som har uppskattats mycket från viktig nyckelspelare. Vi har sedan tidigare annonserat tre industriella samarbetsavtal med syfte att utvärdera vår teknologi i deras respektive projekt. Den pågående pandemin har orsakat förseningar, bland annat på grund av nedstängningar i de länder våra partners verkar. Detta gör att vår målsättning som var att under året fördjupa minst ett av dessa samarbeten genom ett licensavtal, kan komma att skjutas in på 2021. Samtidigt, pekar Covid-19 pandemin på ett tydligt behov av att lösa kylkedjeproblematiken.

Vi fortsätter också att utveckla vårt kommersiella arbete genom att samarbeta med olika företag och grupper som verkar för ett bättre upptag av vaccinationer världen över, för att på så sätt öka kunskapen om betydelsen av vår metod. Vi kommer allt djupare in i dessa organisationer och vi har stora förhoppningar om att kunna formalisera samarbetet med någon av dessa aktörer under det kommande året.

Sammanfattningsvis är vi är på god väg att leverera på våra mål för innevarande år och för att positionera Ziccum för en mycket spännande framtid i en bransch som kommer att ha ett mycket stort fokus under lång tid framöver – slutligen vill jag välkomna alla nya aktieägare som tillkommit under kvartalet samt tacka för förtroendet.

Lund, den 6 november 2020

Göran Conradson VD

Läs hela rapporten HÄR.

För mer information om Ziccum, vänligen kontakta:

Göran Conradson: VD Ziccum AB
E-post: conradson@ziccum.com 

Mobil: +46 709 61 55 99

Om Ziccum

Ziccum AB (publ) utvecklar nya, patenterade beredningar av biologiska läkemedel där känslighet vid temperaturskillnader inte minst vid transporter begränsar medicinsk och därmed kommersiell potential. Med bolagets patenterade teknologi LaminarPace utvecklas torra beredningsformer av läkemedel och vaccin som i nuläget enbart finns i vätskeform. Därigenom kan Ziccum öka tillgängligheten av läkemedel och vaccin på befintliga – och öppna nya – marknader.

Pressmeddelandet har ingivits för publicering av bolagets CEO kl. 08.00 (CET) den 6 november 2020.

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 Third Quarter Report, 2019

Summary of Interim Third Quarter Report 2019: Ziccum well on way to delivering promises made during listing.

Summary of interim report – third quarter 2019

Ziccum is well on its way to delivering on the promises made when we first listed our stock – that during the year we would start three projects to develop stable, dry vaccines and biological drugs. So far during 2019 we have entered into two industrial collaborations, one with a global pharmaceutical company. We have also filed a patent application for a very important component in the development of new vaccines – Adenovirus. We continue to work with leading industrial and academic players to further develop the technology and adapt it for large-scale industrial production of biological drugs and vaccines. This is to position us for future discussions about partnership.

Jul-Sep 2019

Net sales KSEK 0 (0)

Operating income KSEK -1,380 (-1,714)

Earnings per share before and after dilution SEK -0.23

(-0.62)

Jan-Sep 2019

Net sales KSEK 0 (192)

Operating profit KSEK -5,378 (-2,442)

Earnings per share before and after dilution SEK -0.90

(-0.93)

Significant events during the third quarter of 2019

  • 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 new contacts were made
  • Ziccum, on behalf of a vaccine development company, will conduct a feasibility study development of stable vaccines. The preliminary study does not entail any financial compensation at this stage but aims to investigate the compatibility of Ziccum air drying capability with the company"s new formulation

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

  • On January 10, 2019, Ziccum reported that the company had filed a patent application for its dry and temperature-stable formulation, which meets the WHO"s requirements for CTC status. The dry formulation (the "powder") generated by Ziccum"s technology in LaminarPace ™ dissolves quickly when sterile water is added and then vaccination or treatment can be performed
  • Final payment from the 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 should used to evaluate Ziccum"s method for preparing dry preparations of vaccines

Significant events after the reporting period

  • At the beginning of October, an agreement was concluded for evaluation with a global drug and vaccine company, where together we evaluate Ziccum"s technology to generate stable and temperature-stable vaccines

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 7, 2019.

ZICCUM AB Delårsrapport för tredje kvartalet 2019

Sammanfattning av delårsrapport: ’Ziccum är på god väg att leverera det vi utlovade vid noteringen av vår aktie’

Sammanfattning av delårsrapport – tredje kvartalet 2019

Ziccum är på god väg att leverera det vi utlovade vid noteringen av vår aktie – att under året starta tre projekt för att utveckla stabila, torra vaccin samt biologiska läkemedel. Hittills under 2019 har vi ingått 2 industriella samarbeten, varav ett med ett globalt läkemedels- och vaccinbolag. Vi har dessutom lämnat in en patentansökan på en mycket viktig komponent vid utveckling av nya vacciner – Adenovirus. Vi fortsätter samarbeten med ledande industriella och akademiska aktörer för att dels vidare utveckla tekniken och anpassa den för storskalig industriell produktion av biologiska läkemedel och vacciner. Detta för att positionera oss inför framtida diskussioner om partnerskap.

Jul-sep 2019

Nettoomsättning 0 tkr (0)

Rörelseresultat -1 380 tkr (-1 714)

Resultat per aktie före och efter utspädning -0,23 SEK

(-0,62)

Jan-sep 2019

Nettoomsättning 0 tkr (192) 

Rörelseresultat -5 378 tkr (-2 442) 

Resultat per aktie före och efter utspädning -0,90 SEK

(-0,93)

Väsentliga händelser under det tredje kvartalet 2019

  •  Ziccum har anställt ytterligare personal med expertis inom formulering av vacciner
  •  Vi fick en särskild inbjudan att deltaga på Global Vaccine Summit i Bryssel där flera viktiga kontakter knöts
  •  Ziccum ska på uppdrag från ett vaccinutvecklingsbolag, genomföra en förstudie avseende utveckling av stabila vacciner. Förstudien medför i detta läge ingen ekonomisk ersättning, utan syftar till att undersöka kompatibiliteten för Ziccums lufttorkningsförmåga och vaccinbolagets nya formulering.

Väsentliga händelser under rapportperioden (jan-sep) 2019

  •  Ziccum rapporterade den 10 januari 2019 att bolaget inlämnat patentansökan på Adenovirus med torr och temperaturstabil formulering vilken möter WHOs krav för CTCstatus. Den torra formuleringen ("pulvret") som genereras med Ziccums teknologi i LaminarPace™ löses snabbt upp vid tillsättning av sterilt vatten varefter vaccinering eller behandling kan utföras
  •  Slutlikvid från EU-stöd avseende FORMBECC har erhållits under det andra kvartalet uppgående till cirka 315 KSEK
  •  Ziccum har beviljats 200 KSEK i forskningsanslag från Vinnova. Forskningsanslaget ska användas till att utvärdera Ziccums metod för framtagande av torra beredningar av vacciner

Väsentliga händelser efter rapportperioden

  •  I början av oktober ingicks ett avtal för utvärdering med ett globalt läkemedels- och vaccinbolag, där vi tillsammans ska utvärdera Ziccums teknologi att generera stabila och temperaturstabila vacciner

För mer information om Ziccum, vänligen kontakta:

Göran Conradson: VD Ziccum AB
E-post: conradson@ziccum.com

Mobil: +46 709 61 55 99

Om Ziccum

Ziccum AB (publ) utvecklar nya, patenterade beredningar av biologiska läkemedel där känslighet vid temperaturskillnader inte minst vid transporter begränsar medicinsk och därmed kommersiell potential. Med bolagets patenterade teknologi LaminarPace utvecklas torra beredningsformer av läkemedel och vaccin som i nuläget enbart finns i vätskeform. Därigenom kan Ziccum öka tillgängligheten av läkemedel och vaccin på befintliga – och öppna nya – marknader.

Pressmeddelandet har ingivits för publicering av bolagets CEO kl. 08.00 (CET) den 07 novemberi 2019.

ZICCUM AB Interim Report Q.3 2018

Stockholm, Sweden, November 15 2018, Summary of interim report – Third Quarter and first nine months 2018: During the first nine months, Ziccum AB generated capital  through borrowing 2.25 MSEK, achieved proof of concept by drying selected antibodies, and received its first order regarding a feasibility project for a customer with a substance in preclinical development. On October 3, 2018 the subscription period for Ziccum"s new issue of units ahead of the planned listing on Spotlight was completed. The new share issue of 15.8 MSEK was subscribed to approx. SEK 52.7 million, a subscription ratio of approx. 334%. Ziccum"s shares were listed on Spotlight on October 25, 2018.

July-September 2018

0 KSEK

(0) Net sales

-1 714 KSEK

(-103) Operating profit

-0.62 SEK

Earnings per share before dilution

-0.62 SEK

Earnings per share after dilution

January-September 2018

192 KSEK

(0) Net sales

-2 442 KSEK

(-215) Operating profit

-0.93 SEK

Earnings per share before dilution

-0.93 SEK

Earnings per share after dilution

CEO statement

Many pharmaceuticals cannot be formulated as dry powders. It entails complicated and expensive handling, leading to many patients not getting treatments and vaccinations. This is where Ziccum can make a difference. And I’m delighted to welcome so many new shareholders on board helping us as we continue on that journey.

We have a unique, patented technology in LaminarPace. It makes it possible to manufacture biological pharmaceutical as stable dry powders. There are many advantages with dry powder; transportation, handling and storage are all simpler. Stable dry powders make it possible to reach patients all over the world even where access to the cold temperature chain is limited, and to enable patients with chronic diseases to take their therapies with them wherever they go.

Our evaluation and development of new formulations continues with very good results. Results we intend to apply patents for, so broadening our Intellectual Property portfolio, and adding to our already existing patent on LaminarPace’s methodology and system. We have already started with a new patent application based on these encouraging results, and these results strengthen our position on the international market. We solve problems no one has been able to solve previously – giving Ziccum strong opportunities in a global and growing market.

The European Commission granted our application for phase 1 Horizon H2020 funding– the most ambitious program for innovation and development in the history of EU. This further strengthens our belief that we have a very strong and competitive offering, which has the potential to make a significant impact on large patient populations. We will shortly commence our report for Phase 1, and start the Phase 2 application to be submitted in the beginning of Q2 2019.

In conclusion – we have a strong and competitive offering in a very interesting and large market. A market where we can make a significant difference for patients, and create value for our shareholders. I wish all new shareholders a warm welcome, and I am look forward to reporting to them on our continued journey.

Göran Conradson

Chief Executive Officer

Highlights, Q.3 (July-September)

During the third quarter a new share issue was initiated ahead of the planned issue of 15.8 MSEK before issue costs which was fully subscribed as of October 3, 2018.

Highlights during reporting period (January-September)

  •  In January, capital was raised through loans totalling 2.25 MSEK
  •  The company received its first order regarding a feasibility project for a customer with a substance during preclinical development
  •  Achieved proof-of-concept in antibody test. New results showed that Ziccum"s system for drying, LaminarPace® can produce a dry, stable powder of immunoglobulin antibodies – with retained activity
  •  At the AGM on 25 April, new Board members Ola Camber, Mattias Münnich and Kristian Kierkegaard
  •  On July 11, it was announced that Ziccum had been awarded 0.5 M Euro funding in Horizon 2020 phase 1 for a preliminary study for the scaling up of a major and aseptic system for GMP production of therapies. The funding is a clear quality stamp on Ziccum’s technology and business potential

Highlights after reporting period

On October 3, 2018, the subscription period of Ziccum"s new issue of share units was completed prior to its planned listing on Spotlight. The new issue of 15.8 MSEK was subscribed to approx. 52.7 MSEK including subscription commitments, a subscription ratio of approx. 334%. Ziccum thus raised a total of 15.8 MSEK before issue costs of approx. 1 MSEK, with number of shareholders increasing to about 1000. The offer included a maximum of 3,000,000 units, which means max 3,000,000 shares and max 3,000,000 warrants of series TO1. Two warrants of Series TO1 give the right to subscribe for a new share with subscription period in December 2019 at one exercise price of SEK 10 per share.

Following the completed rights issue, Ziccum is no longer a subsidiary of Inhalation Sciences

Sweden AB, however, Ziccum is an associated company of Inhalation Sciences.

On October 25, 2018, Ziccum"s shares were listed on Spotlight Stock Markets.

To read the full Q.3 Report in PDF go 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.

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