ZICCUM AB (publ) Year-End report Q4 2023

YEAR-END REPORT Q4 2023: 1 JANUARY – 31 DECEMBER 2023

Significant events during the Quarter

  • Collaboration agreement with University of Copenhagen
    On December 4th, the company announced that it had signed a Collaboration Agreement for a joint project with the Department of Pharmacy, University of Copenhagen (UCPH), on the engineering of inhalable solid dosage forms of mRNA vaccines which will include in-vivo studies of mRNA/LNP materials formulated and dried using Ziccum’s unique LaminarPace.
  • Certified Adviser
    On November 30th, Ziccum announced it had changed Certified Adviser from Erik Penser Bank AB to Carnegie Investment Bank AB (publ).
  • Agreement with US Biomanufacturing corporation
    On November 7th, Ziccum announced it had signed a Material Transfer and Evaluation Agreement for a Vaccine Evaluation project with one of the most important technology-focused Biomanufacturing corporations in the US. The project is funded and will focus on evaluating the potential for new dry, thermostable forms of an advanced viral vaccine, using Ziccum’s unique formulation and drying technology LaminarPace.
  • Validated data confirming mRNA activity in-vitro
    On October 23rd, Ziccum announced 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.

 
Significant events after the Quarter

  • Successful outcomes of LaminarPace Feasibility study with Biotech partner
    On January 10th, the company announced that, together with its Biotech Corporation collaboration partner, it has reviewed the outcomes of the LaminarPace Feasibility study of mRNA/LNP materials under the agreement signed on May 9th, 2023. The study was very successful, and both parties confirmed consistent, positive readouts in the Study’s major parameters.
    The assessment concluded that the resulting dry powder material demonstrated excellent mRNA activity when reconstituted and tested in in-vitro cell studies. The assessment also concluded that the LaminarPace treatment resulted in well-preserved mRNA content in LNP particles with adequate encapsulation efficiency. Furthermore, the treatment resulted in well-preserved lipid nanoparticles with good particle size and preserved size distribution. Finally, the partner assessment confirmed the consistent Ziccum findings, that LaminarPace-treated material can be reconstituted (dissolved back into liquid) very quickly and smoothly, with no foaming, precipitation, or other practical issues.
  • Financing secured through directed share issue and rights issue
    On January 22nd, the company announced that it has carried out a directed share issue of 622,371 shares of approximately SEK 4.2 million to the American professional investor Global Corporate Finance (GCF). The subscription price in the Private Placement was set at SEK 6.80 per share through arm's length negotiations between the Company and GCF and corresponds to a 7.36 per cent discount to the Company's volume weighted average price on Nasdaq First North Growth Market during the last five trading days.

    The Directed New Share Issue is part of a long-term financing arrangement with GCF under which Ziccum has the unilateral right to call for additional investments from GCF, in exchange for newly issued shares, totalling approximately SEK 28 million over the next thirty months.

    The Board of Directors of Ziccum has also, based on the existing authorisation from the Annual General Meeting, decided to carry out a rights issue of units of a maximum of SEK 10.4 million. The subscription price per Unit in the Rights Issue amounts to SEK 6.80 and each Unit consists of one share and one free warrant of series TO5, which means that the subscription price per share in the Rights Issue corresponds to the subscription price per share in the Directed New Share Issue.

    The Directed New Share Issue and the Rights Issue are carried out in combination to effectively secure working capital for continued intensive business and technical development. Considering the Directed New Share Issue, and provided that the Rights Issue is fully subscribed, Ziccum will receive initial proceeds totalling approximately SEK 13.5 million, after deduction of issue costs totalling approximately SEK 1 million.

    Furthermore, the company has revenue-generating evaluation agreements in place, which are estimated to bring in SEK 5 million during Q1 2024. The company was granted a Eurostars grant and expected payments from this during 2024 will be SEK 872 thousand. The Board and company management are assessing options for further soft funding opportunities on an ongoing basis. 
    * Volume-Weighted Average Price, VWAP, is calculated by totalling the SEK traded for every transaction (price multiplied by the volume) and then dividing by the total shares traded.

CEO statement

Taking Ziccum ahead towards new achievements, delivering milestones at a high pace

2023 has been an amazing year, taking Ziccum forward on all fronts – establishing professional operations, implementing a new business model very successfully and getting an established, reputable name in international pharmaceutical industry in general and in mRNA development forums more specifically.

Now we are looking forward to further milestones, getting readouts from partnered studies and further data points for our technology during 2024 – already starting in January with a very exciting partner readout, where all mRNA/LNP data were perfectly confirmed – as well as taking LaminarPace to optimal performance.

It is a privilege to take this unique technology forward, seeing the potential to greatly improve so many aspects of current vaccine management, as well as enabling entirely new treatments for unmet patient needs.
 
Executing on partnered projects and striking a third deal with a world-leader
The Biotech mRNA feasibility study was successfully completed during fourth quarter, with excellent, close collaborative efforts, and the outcome was rapidly assessed by our partner. As presented on January 9th all readouts matched very closely, all parameters gave good results, and the all-important mRNA activity was preserved on excellent levels. This is a fantastic, broad validation of the applicability for Laminar Pace for fragile and valuable mRNA/LNP compositions – it confirms the vast possibility to enable new, better, more cost-efficient and far more sustainable patient treatments thanks to LaminarPace.

The Ziccum team took up the Big Pharma study work, which is ongoing with efficient performance of trials, generating a lot of relevant data. If the initial feasibility testing is satisfactory, the next step of Stability testing has already been scoped out with the Big Pharma partner. We are expecting this go/no-go decision in mid-spring 2024.

On top of these two collaborations, we announced a third agreement signed in fourth quarter, and we have a pipeline of serious dialogues with Pharma and Biotech corporations discussing LaminarPace applications. Ziccum is very actively taking part in licensing partnering conferences as well as vaccine and mRNA top level summits, where we are becoming a name to reckon with.

Delivering on a high value, high level business model to demanding partners
Considering how LaminarPace technology was rather new to the industry and that all aspects of a high value licensing model had to be established, it is highly satisfying how we could sign agreements already during 2023 with the best possible partners. These large players, leading the race towards new vaccines and highly innovative RNA treatments, are offered interesting collaborations from numerous companies, regularly, so it is significant for Ziccum to be selected.

One still needs to be aware of the risk of bureaucracy, delays, and strategic reassessments due to the nature of these large organizations. There are no guarantees that these first partnered studies will immediately proceed to next stages, but Ziccum is well positioned and well equipped to take further collaborations ahead. We keep running an active business development pipeline of industry dialogues to ensure successful partnering for the technology.

The licensing business model offers the highest possible value for Ziccum taking LaminarPace to market, and the challenges of addressing highly demanding counterparts, reaching into strategic decision-making levels in the organizations and selling the technology while it is still in development have all been overcome, as nicely proven by the deals already signed. Having a Technology platform, we will be able offer licenses structured by application – with a large number of potential license deals possible.

Continued mRNA/LNP data generation
The Ziccum team has taken both partnered studies and the internal Masterplan project forward very efficiently. The increase in trial productivity has enabled us to deliver strongly to our partners, testing a number of parameters already in the feasibility stage. Then there is of course room for further improvement of results in next step optimization in application studies, once that stage is reached. For mRNA/LNP, the rewarding in-vitro potency results, showing that the mRNA is keeping its genetic code and activity level when given to cells after LaminarPace treatment, now are followed by our internal Masterplan trials to prove sufficient mRNA activity in animal testing, so called in-vivo trials, in mice.

Taking LaminarPace forward, developing unique components for our technology
In the fourth quarter, we were delighted to welcome our new Chief Operating Officer, the engineering manager Xavier Turon joining Ziccum from Barcelona. He indeed had to hit the ground running, as we were in the midst of intense equipment development for LaminarPace. The Masterplan project contains the development of key components for LaminarPace, and after selecting several new international engineering partners during the year, we have made great progress in this area. The nebulizer development has reached a mature stage. The largest on-going effort is now the product outtake, to design efficient operation for sufficient capacity. The characteristics of these key components then go straight into the 3D-simulation work, LaPaSim, our on-going effort jointly with Zurich partners.

The successful technology development is made possible thanks to strong team efforts, combining our Ziccum expertise with excellent input from engineering partners as well as our Board of Directors. It is an iterative process, where trial readouts help us finetune component design for optimal performance. During 2023, we also have integrated proper quality and regulatory assurance, to ensure our work and its documentation fulfill pharmaceutical standards.

An exciting 2024 lies ahead
We have exciting times ahead, with continued execution on our partnership studies as well as taking interesting business dialogues and the technology optimization forward. Efficiently securing additional funding, both having a strong new investor on-board and allowing our existing shareholders to take part in a well-supported rights issue, together with income from industrial partners, will make it possible to keep up the high-paced development, deliver on all-important partnerships, generate further data and make the most of our unique technology.

Let me thank the Ziccum team as well as collaboration partners for excellent efforts, and our owners for continued, important support and engaged dialogues.

Lund, January 26, 2024
Ann Gidner, CEO

October – December in brief

  • Operating income: SEK 1,575 (0) thousand.
  • Result for the quarter: SEK -7,692 (-8,021) thousand.
  • Earnings per share: SEK -0.56 (-0.58).
  • Cash flow for the quarter: SEK -6,796 (-6,642) thousand.
  • Cash at the end of the reporting period: SEK 2,994 (22,951) thousand.

 
January – December in brief

  • Operating income: SEK 6,318 (17) thousand.
  • Result: SEK -21,412 (-28,788) thousand.
  • Earnings per share: SEK -1.55 (-2,09).
  • Cash flow: SEK -19,957 (10,678) thousand.
  • Cash at the end of the year: SEK 2,994 (22,951) thousand.

Financial summary Q4 Q4 Jan-Dec Jan-Dec
KSEK 2023 2022 2023 2022
Operating income 1,575  – 6,318 17 
Operating result -7,662 -8,067 -21,560 -28,955
Result 7,692 -8,021 -21,412 -28,788
Balance sheet total 14,972 33,285 14,972 33,285
Cash flow -6,796 -6,642 -19,956 10,678
Cash and cash equivalents 2,994 22,951 2,994 22,951
Equity ratio % 57 88 57 88
Per share data (SEK)        
Number of shares 13,806,142 13,806,142 13,806,142 13,806,142
Result per share before and after dilution* -0.56 -0.58 -1.55 -2.09
Cash flow per share -0.49 -0.48 -1.45 0.78
Equity per share 0.62 2.12 0.62 2.12

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

ZICCUM AB (publ) Year-end report Q4 2022

YEAR-END REPORT Q4 2022: 1 JANUARY – 31 DECEMBER 2022

To read the digital Report, please click here:
https://reports-en.ziccum.com/year-end-report-q4-2022/start/
 

Significant events in Q4 (October – December)

On October 24, 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.

On December 8, it was announced that Ziccum has signed an agreement contracting the ICP Institute of Computational Physics at the Zurich University of Applied Sciences’ School of Engineering (ZHAW) for the next phase of the project developing 3D modelling of LaminarPace. The project aims to accelerate industrial development of LaminarPace and will run over three years. The team at ZHAW is one of the most recognized internationally within industrial simulation and modelling.

On December 14, Ziccum launched a new, expanded website. With a new brand platform, the expanded site aims to strengthen the company’s dialogue with biopharmaceutical partners and prospects. It includes new technological, scientific and business content, and improved navigability.

On December 16, it was announced that Ziccum has been awarded a contribution of 10 mSEK by Eurostars for a joint grant application with ZHAW. Eurostars is the largest international funding programme for SMEs wishing to collaborate on R&D projects, and is co-funded by the EU Horizon 2020 Framework Programme and EUREKA. Ziccum will receive payments of 5 mSEK from the national funding body Vinnova during the project, they are consented to cover up to 50% of a project's costs. The rest of the contribution will go into the project and reduce the total project cost for Ziccum. The three year long project (LaPaSim) starts February 1 2023, and is to apply 3D-modelling to Ziccum’s ambient drying system for biopharmaceuticals, LaminarPace, resulting in a digital twin. International competition for the funding was intense, and the proposal was one of the highest-ranked applications.

During the fourth quarter CEO Ann Gidner bought 45,000 shares in Ziccum.

CEO statement

Creating a strong industry position in a booming market

It has been a very rewarding year for Ziccum (or eight months for my part), making such big strides towards a position as a top rank provider of game- changing technology to the international pharmaceutical industry, where achieving thermostable vaccines is highly desirable.

Setting the Ziccum direction

Defining a sharper strategy with selected vaccine platforms, and most importantly the high value next- generation mRNA vaccines and RNA therapeutics as top priority, has given consistent positive confirmations – from partnering dialogues, from our Biopharma licensing mRNA Market study and from our own internal trial results. We are confident going forward with this key focus.

The new business model defined, a classical Pharma out-licensing model starting with feasibility studies, has been well received and gives crisp clarity to business development efforts ahead. Given the strong interest in partnering dialogues, we have the Pharmaceutical Platform technology company business model strongly confirmed, giving licenses internationally, not producing as a contractor.

Pivotal transformation of the vaccine field and new applications of mRNA technology

Externally, the vaccine industry has gone through a complete transformation. From being a conservative, low margin segment of the Pharma industry, it has become a hot spot for rapid development, where existing players increase efforts significantly, and numerous new players want to enter the market. The Covid pandemic brought completely new insights, fuelling a strong industry desire for new vaccine development as well as for applying the novel mRNA approach in a range of new fields, like cancer vaccines and personalized therapeutics.

Business development progress

The booming market demand for new vaccine technology in combination with Ziccum’s unique drying concept enabling thermostable vaccines, now proven in a number of steps, makes for a great opportunity. Thanks to a clearly business-driven approach and an extensive industry network we are taking advantage of this, generating a significant number of partnering dialogues at four international conferences during fall. These are now pursued with in-depth dialogues going forward.

Proving the LaminarPace ability for mRNA/LNP

Getting the proof of successful drying of vaccine LNP particles at this point was most welcome. The LaminarPace drying has given good read-outs in terms of encapsulation, yield and particle preservation: keeping the LNP particles nicely in good shape and staying the correct size. We are delighted to bring these results to our business dialogues, and we are now setting up continued trials regarding vaccine activity; the verification that dried vaccine material is not only kept in good condition in high yields, but also giving a similar vaccine activity effect.

Developing ground-breaking technology, the smartest way

As novel, unique technology certainly needs development efforts, we took the important decision to run a multi-year 3D-Modelling project with a leading partner, the Zurich Institute of Applied Sciences. This way we efficiently come forward using the latest digital methods. We can run all the trials we want digitally, instead of a few selected, time-consuming physical trials. Ultimately, the project will also result in a Digital twin which can serve efficiently in tech transfer for successful process integration in the partner set-up.

We also applied to the EU organization Eurostars jointly with the Zurich Institute for soft funding of this ambitious effort, and just before Christmas we had the fantastic news of getting top ranking and receiving the full grant! This way we certainly can begin 2023 with full steam ahead.

Wrapping up 2022

An extra bonus was the launching of the new Ziccum website end of year, a total remake much better reflecting our offering: our technology and our team. Also, I was happy to present Ziccum at BioStock Life Science, getting significant interest. Finally, we had the great pleasure to expand our team with a Quality specialist, warm welcomes to Fatemeh starting in January.

Many thanks to the Ziccum team for great efforts and enthusiasm all year, taking the new strategy forward together, and to all supporting parties, owners and business partners for engaging in fruitful dialogues and supporting our efforts!

Lund, January 27, 2023

Ann Gidner, CEO

Significant events in Q1 (January-March)

On January 18, a Extraordinary General Meeting was held, 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.

On February 7, Ziccum announced 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 the employment of the CEO Göran Conradson was terminated. The company's CFO, Frida Hjelmberg was appointed acting CEO.

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 was defined, based on four key priority activities:

1. Drive an active business development agenda that proactively prepares for collaboration with existing and potential partners. This to offer the opportunity to evaluate specific projects in combination with Ziccum's technology, and to understand the requirements placed on the technology before a decision on a license agreement can be made.

2. Generate laboratory data that manifest and confirm 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. Develop conceptual plans for how Ziccum's drying technology can be adapted to the commercial scale and 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 existing collaborations into negotiations on commercial terms and license agreements.

Significant events in Q2 (April – June)

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.

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.

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.

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

1. New powder collector – A new sealed, contained collection unit is installed 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 May 6, the Board of Ziccum published the decision to officially change the company’s language to English for all external communications.

On May 9, it was announced that 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 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 leadership, deal making and sales growth.

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

During the second quarter CEO Ann Gidner 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 in 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.

On September 1, Ziccum announced 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 bought 35,000 shares in Ziccum. In addition, the Chairman of the Board Fredrik Sjövall bought 40,000 shares in the company.

Significant events after the reporting period

On January 24 – 26, Ziccum will attend the mRNA-based Therapeutics Summit in Berlin, the leading European event for mRNA innovation expertise in Europe. On the event, CEO Ann Gidner will present LaminarPace with a presentation titled LaminarPace: a novel unit operation successfully drying mRNA/LNP by mass transfer to an audience of senior Pharmaceutical industry decision makers, scientists and key opinion leaders.

On January 23, Ziccum announced that the company has submitted its Expression of Interest application for CEPI’s Call for Proposals for funding of innovations that improve vaccine thermostability. The Coalition for Epidemic Preparedness (CEPI), in 2022 invited players developing innovative technologies to improve vaccine thermostability to apply for a funding opportunity.

Q4 2022

  • The result for the quarter amounted to -8 021 kSEK (-6 450 kSEK)
  • Cash flow for the quarter amounted to -6 642 kSEK (-7 291 kSEK)
  • Cash and cash equivalents at the end of the quarter amounted to 22 951 kSEK (12 273 kSEK)
Summary Financial Highlights kSEK Oct-Dec 2022 Oct-Dec 2021 Jan-Dec 2022 Jan-Dec 2021
Net revenue
Operating result (8 067) (6 474) (28 955) (21 117)
Result for the period (8 021) (6 450) (28 788) (21 136)
Balance sheet total 33 285 36 900 33 285 36 900
Cash flow for the period (6 642) (7 291) 10 678 (21 347)
Cash and cash equivalents 22 951 12 273 22 951 12 273
Equity ratio % 0,88 0,81 0,88 0,81
Data per share SEK
Number of shares at the end of the period 13 806 142 11 006 056 13 806 142 11 006 056
Result per share before and after dilution* -0,58 – 0,65 -2,09 -2,17
Cash flow per share -0,48 – 0,73 0,78 -2,19
Equity per share 2,12 2,70 2,12 2,70

ZICCUM AB Year-end report 2021

INTERIM REPORT 1 JANUARY – 31 DECEMBER 2021

To read the digital Report in full click here: https://reports-en.ziccum.com/bokslutskommunike-q4-2021/start/

Q4 2021

  • The result for the quarter amounted to -6 450 kSEK (-3 448 kSEK)
  • Cash flow for the quarter amounted to -7 291 kSEK (-5 941 kSEK)
  • Cash and cash equivalents at the end of the quarter amounted to 12 273 kSEK (33 620 kSEK)
SUMMARY FINANCIAL HIGHLIGHTS
kSEK
Oct-Dec 2021 Oct-Dec 2020 Jan-Dec 2021 Jan-Dec 2020
Net revenue 0 0 0 0
Operating result -6, 474 -3,423 -21,117 -17,235
Result -6,450 -3,448 -21,136 -17,289
Balance sheet total 39,591 39,640 39,591 39,640
Cash flow 7,291 -5,941 -21,347 31,556
Cash and cash equivalents 12,273 33,620 12,273 33,620
Equity ratio 75% 92% 75% 92%
Data per share
SEK
Number of shares at the end of period 11,006,056 9,606,200 11,006,056 9,606,200
Results per share before and after dilution* -0.65 -0.36 -2.17 -2.06
Cash flow per share -0.73 -0.62 -2.19 3.75
Equity per share 2.70 3.79 2.70 3.79
* Dilution effect is not calculated when the result is negative

Significant events during Q4 (Oct-Dec)
Ziccum announced on November 23 that the company has made a further extension of the evaluation agreement that was originally initiated on October 3, 2019 with Janssen Vaccine & Prevention B.V., one of Janssen's pharmaceutical companies belonging to Johnson & Johnson. The purpose is to complete the analysis of Ziccum's air drying technology with Janssen's vaccine platforms.

On December 16, Ziccum announced that the company had successfully carried out tests which confirm that its air-drying technology could be used to produce thermostable dry powder vaccines across four major platforms – Protein Subunits (PS), Viral Vectors (VV), Inactivated Virus (IV) and Virus Like Particles (VLP). 70% of Covid-19 vaccines approved (Phase IV) and 67% in clinical studies use one of these four platforms. Ziccum is carrying out ongoing studies to produce corresponding data around the mRNA vaccine platform.

Directed share issue
On December 16, Ziccum carried out a directed share issue of 1 333 314 units, of which one unit consists of three shares and two free warrants (series 2021/2022). Ziccum will thus receive a total of 44 mSEK (before issue costs), provided that the share issue is approved at an Extraordinary General Meeting. Ziccum can be added a further maximum of approximately 35 mSEK upon full exercise of all warrants.

The directed share issue consists of a total of 1 333 314 units, corresponding to 3 999 942 shares and 2 666 628 free warrants, and was decided by the Board of Directors of Ziccum. The issue of 399 952 units, corresponding to 1 199 856 shares and 799 904 warrants, has been made on the basis of existing authorization from the Annual General Meeting 2021. The issue of the remaining 933 362 units, corresponding to 2 800 086 shares and 1 866 724 warrants, was conditional of a change in the Articles of Association and the approval of an Extraordinary General Meeting.

On December 21, 1 199 856 new shares and 799 904 warrants were registered as a first part of the transaction.

Significant events during Q1-Q3 (Jan-Sep)
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.

On the 1st of September Anna Lönn started as Development director.

Significant events after the reporting period
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 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.

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. Not least due to the Covid-19 pandemic, which has proven the enormous benefits vaccines have on society as whole. New travelling 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.

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.
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.

Our collaboration, for instance with Janssen continues as planned. At the same time, we continue discussions with new partners about new collaborations.

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.

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. Our collaboration, for instance with Janssen continues as planned. At the same time, we continue discussions with new partners about new collaborations.
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.

We are also seeing completely new trends among national procurement in Western countries who are now beginning to make demands on traditional vaccine manufacturers to deliver products that are better adapted to meet the climate change. In the current situation, work is being done to change the packaging so that it takes up less space in the cold chain. At the same time, we believe that this can only partially address climate change because the cold chain is still needed.

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. Furthermore, we are dependent on our partners' decisions, which we can not control when they are made. Therefore, we try to build Ziccum to become more independent, by being able to take projects further up the value chain. Thus becoming a more competent partner to facilitate the industrialization of LaminarPace.

Lund, February 17, 2022
Göran Conradson,
CEO

Expected future development
The company’s long term goals are to:

  • Enter into a first licensing agreement regarding one or more vaccine
  • 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
  • Expand international collaborations
  • Continue to set a high pace in Research and Development activities, with the aim of generating new data that can form the basis for further patent applications
  • Expand process development for the formulation process and adapt it for industrial production
  • Apply for grants
  • Continue to hire, to strengthen the opportunity to deliver on the company goals

Licensing agreements

Based on the collaboration agreements and the ongoing positive dialogues with established parties on the market, it’s Ziccum’s goal to generate at least one license agreement based on commercial terms.

Process development

Ziccum puts a lot of effort into developing the process of producing thermostable vaccines and adapting the technology for industrial production. This work is done with the aim of furthering effective, ongoing and upcoming discussions with industrial partners. The project includes upscaling of production capacity, automatization, and adaption to regulatory standards.

Production economy

During 2020 Ziccum have accomplished a conceptual design of a manufacturing facility together with KeyPlants AB based on their modular system. This study pointed out many advantages compared to traditional lyophilization (freeze-drying):

80% less electricity
65% less Operational costs (OPEX) 50% less Investment cost (CAPEX)

The conceptual design has been well received by the industry and different stakeholders within the vaccine field. By showing large production gains in a fill and finish plant, Ziccum's offer to industrial actors and end customers of vaccines can be clarified and the value significantly increase.

International cooperation

A key to success is to make sure that stakeholders within the vaccine market know and understand that Ziccum’s technology can develop new vaccine formulations that are less dependent on the cold chain. In that way, those stakeholders can demand and influence established vaccine producers to make a change towards thermostable vaccines.

Patent

It is the company’s ambition to continue setting a high pace on its own Research and Development activities with the aim of generating new data that can form the basis for new patent applications, primarily regarding more types of vaccines.

Grant applications

The vaccine market offers several different opportunities to receive various forms of grants. Ziccum will apply for such grants that the company deems to be in Ziccum’s interest and opportunity to receive.

Organizational development

We will continue to have a great need to employ competent and experienced staff to further strengthen the company's ability to deliver on its set goals.

To read the digital Report in full click here: https://reports-en.ziccum.com/bokslutskommunike-q4-2021/start/

ZICCUM AB Bokslutskommuniké 2021

DELÅRSRAPPORT 1 JANUARI – 31 DECEMBER 2021

För att läsa hela rapporten digitalt, klicka här: https://reports.ziccum.com/bokslutskommunike-q4-2021/start/

Q4 2021

  • Resultatet för kvartalet uppgick till -6 450 kSEK (-3 448 kSEK)
  • Kassaflödet för kvartalet uppgick till -7 291 kSEK (-5 941kSEK)
  • Likvida medel uppgick vid utgången av kvartalet till 12 273 kSEK (33 620 kSEK)
FINANSIELL DATA I SAMMANDRAG
kSEK
Okt-dec 2021 Okt-dec 2020 Jan-dec 2021 Jan-dec 2020
Nettoomsättning
Rörelseresultat (6 474) (3 423) (21 117) (17 235)
Resultat (6 450) (3 448) (21 136) (17 289)
Balansomslutning 39 591 39 640 39 591 39 640
Periodens kassaflöde 7 291 (5 941) (21 347) 31 556
Likvida medel 12 273 33 620 12 273 33 620
Soliditet % 0,75 0,92 0,75 0,92
Nyckeltal per aktie
SEK
Antal aktier vid periodens slut 11 006 056 9 606 200 11 006 056 9 606 200
Resultat per aktie före och efter utspädning* -0,65 – 0,36 -2,17 -2,06
Periodens kassaflöde per aktie -0,73 – 0,62 -2,19 3,75
Eget kapital per aktie 2,70 3,79 2,70 3,79
* Utspädningseffekter omräknas ej vid negativt resultat

Väsentliga händelser Q4 (okt-dec)
Ziccum meddelade den 23 november 2021 att bolaget har gjort ytterligare en förlängning av det utvärderingsavtal som ursprungligen slöts den 3 oktober 2019 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 16 december presenterade Ziccum Proof of Concept-data som bekräftade att bolagets teknologi kan användas för att producera temperaturstabilt pulvervaccin för fyra större vaccinplattformar; Protein Subunits (PS), Viral Vectors (VV), Inactivated Virus (IV) och Virus Like Particles (VLP). I dagsläget används någon av dessa fyra plattformar för 70% av de godkända Covid-19 vaccinerna på marknaden. Ziccum arbetar med att ta fram motsvarande data för vaccinplattformen mRNA.

Riktad emission
Den 16 december genomförde Ziccum en riktad emission av 1 333 314 units, där en unit består av tre aktier och två vederlagsfria teckningsoptioner (serie 2021/2022). Ziccum tillförs härigenom sammanlagt 44 mSEK (före emissionskostnader), under förutsättning att emissionen godkänns på en extra bolagsstämma. Ziccum kan tillföras ytterligare högst cirka 35 MSEK vid fullt utnyttjande av samtliga teckningsoptioner.

Den riktade emissionen består totalt av sammanlagt 1 333 314 units, motsvarande 3 999 942 aktier och 2 666 628 vederlagsfria teckningsoptioner, och beslutades av styrelsen i Ziccum. Emissionen av 399 952 units, motsvarande 1 199 856 aktier och 799 904 teckningsoptioner, har fattats med stöd av befintligt bemyndigande från årsstämman 2021. Emissionen av resterande 933 362 units, motsvarande 2 800 086 aktier och 1 866 724 teckningsoptioner, var villkorad av ändring av bolagsordningen samt av godkännande av en extra bolagsstämma.

Den 21 december registrerades 1 199 856 nya aktier och 799 904 teckningsoptioner som en första del av den riktade emissionen.

Väsentliga händelser Q1-Q3 (jan-sep)
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.

Den 1 september tillträde Anna Lönn rollen som Development director.

Väsentliga händelser efter rapportperioden
På den extra bolagsstämma som bolaget höll den 18 januari beslutades utöver ett godkännande av styrelsens förslag även en höjning av gränsen för antalet aktier samt aktiekapitalets storlek i bolagsordningen, för att möjliggöra emissionen av resterande 933 362 units i den riktade emissionen.

Den 18 januari registerandes ytterligare 2 800 086 aktier samt 1 866 724 teckningsoptioner, och alla aktier och teckningsoptioner i den riktade nyemissionen är därmed registrerade.

Inbetalningarna från den riktade nyemissionen har inkommit till bolaget i januari och februari 2022, sammanlagt tillfördes bolaget 40 mSEK efter avdrag för emissionskostnader.

Ziccum meddelade den 7 februari att de har blivit medlemmar i United Nations Global Compact, världens största hållbarhetsinitiativ för företag.

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.

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 skala. Arbetet med detta är högt prioriterat för att påskynda våra externa samarbetsdiskussioner och för att vi ska ha ett attraktivt erbjudande till våra partners.

Våra samarbeten, bla med Janssen fortsätter planenligt. Fortsättningsvis, för vi diskussioner med nya partners om nya samarbeten.

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.

Vi ser även helt nya trender bland nationella inköpare i västländerna som nu börjar ställa krav på de traditionella vaccintillverkarna att leverera produkter som är bättre anpassade till att möta klimatförändringarna. I nuvarande läge arbetar man med att anpassa förpackningarna så att de tar mindre plats i kylkedjan. Samtidigt, som vi bedömer att detta bara delvis kan adressera klimatförändringarna eftersom kylkedjan fortfarande behövs.

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. Samtidigt, är vi beroende av våra partners beslut, som vi inte kan kontrollera när de tas. Därför försöker vi att bygga Ziccum framöver så att vi blir mer oberoende, genom att vi själva kan ta projekt längre upp i värdekedjan. Därmed bli en mer kompetent partner för att underlätta industrialiseringen av LaminarPace.

Lund den 17 februari 2022, Göran Conradson, VD

Förväntad framtida utveckling

Bolagets långsiktiga målsättningar är att:

  • Ingå ett första licensavtal avseende ett eller flera vacciner
  • Presentera en detaljerad plan för att etablera en produktionsanläggning för fyllning och slutförpackning (fill and finish) av torra, termostabila pulvervacciner inklusive nödvändiga partnerskap och finansieringsplan
  • Utöka sina internationella samarbeten
  • Hålla fortsatt högt tempo på den egna forsknings- och utvecklingsverksamheten med syfte att generera nya data som kan ligga till grund för ytterligare patentansökningar
  • Utökad processutveckling för att anpassa tekniken till industriell produktion
  • Ansöka om anslag
  • Fortsätta att anställa för att ytterligare stärka bolagets möjlighet att leverera på uppsatta målsättningar

Licensavtal
Baserat på de samarbetsavtal som ingåtts och de positiva dialoger som förs med etablerade aktörer på marknaden, är det Ziccums målsättning att omsätta dessa till licensavtal på kommersiella villkor.

Processutveckling
Ziccum lägger stor vikt vid att utveckla processer av temperaturstabila vacciner och anpassa tekniken för industriell produktion, detta i sin tur med syfte att effektivisera pågående och kommande samarbetsdiskussioner med industriella partners. Projektet innefattar att öka produktionskapaciteten och att automatisera hanteringen av systemet och processer samt anpassa till myndighetskontrollerad vaccinproduktion.
Produktionsekonomi

Under 2020 har Ziccum genomfört en konceptstudie tillsammans med KeyPlants AB baserat på deras modulsystem. Denna studie visade på flera fördelar med Ziccums teknologi i jämförelse med (traditionell) frystorkning;

  • 80% lägre elförbrukning
  • 65% lägre rörelsekostnader (OPEX)
  • 50% lägre investeringskostnader (CAPEX)

Konceptstudien har blivit mycket väl mottagen av industrin och olika aktörer inom vaccinationsområdet. Genom att påvisa stora produktionsvinster med en anläggning för fyllning och slutförpackning (fill and finish) kan Ziccums erbjudande till industriella aktörer och slutkunder av vacciner förtydligas och värdet väsentligt ökas.

Internationella samarbeten

En nyckel för framgång är att tillse att vaccinmarknadens aktörer känner till och förstår att Ziccums teknologi kan utveckla nya beredningsformer som är mindre beroende av kylkedjan. På så sätt kan dessa organisationer sätta krav och driva på etablerade vaccinproducenter till ett förändringsarbete för att leverera temperaturstabila vaccin.

Patent

Det är Bolagets ambition att även fortsättningsvis ha hög takt på den egna forskning- och utvecklingsverksamheten med syfte att generera nya data som kan ligga till grund för ytterligare patentansökningar avseende i första hand fler typer av vacciner.

Anslagsansökningar
Vaccinmarknaden erbjuder ett antal olika möjligheter att erhålla olika former av anslag. Ziccum kommer att göra ansökningar av sådana anslag som bolaget bedömer ligger i Ziccums intresse och möjlighet att erhålla.

Organisationsutveckling
Fortsättningsvis kommer vi att ha ett stort behov av att anställa kompetent och erfaren personal för att ytterligare stärka bolagets möjlighet att leverera på uppsatta målsättningar.
För att läsa hela rapporten digitalt, klicka här: https://reports.ziccum.com/bokslutskommunike-q4-2021/start/

ZICCUM AB Year-end report January 1- December 31, 2020

Summary of year-end report, fourth quarter 2020

During the fourth quarter, Ziccum announced that it had carried out a pilot study on large-scale production of temperature-stable vaccines. The pilot study centred on a Fill and Finish facility (the last step in vaccine production), with the aim of evaluating the technical and financial viability of commercial production of temperature-stable vaccines. The results of the study show that there are significant economic benefits to Ziccum's LaminarPace technology. The pilot study was carried out in collaboration with KeyPlants AB, a leading specialist company in modular plants for pharmaceutical production.

In collaboration with Keyplants AB, Ziccum has also published a White Paper and a blueprint describing the world's first Fill and Finish plant for large-scale production of temperature-stable vaccines. Compared with today's standard Fill and Finish plants with freeze-drying as the core technology, new thermostable vaccines can be produced with an estimated 65 percent lower OPEX, and 50 percent lower CAPEX.

On December 1, Ziccum made a list change to Nasdaq First North Growth Market.

Fourth quarter (Oct-Dec 2020)
Net sales 0 KSEK (0)
Operating profit -3 423 KSEK (-3 344)
Earnings per share before and after dilution -0.36 SEK (-0.56)

Reporting period (Jan-Dec) 2020
Net sales 0 KSEK (0)
Operating profit -17 235 KSEK (-8 721)
Earnings per share before and after dilution -2.06 SEK (-1.45)

Significant events during the fourth quarter 2020

  • Ziccum has carried out a pilot study into the large-scale production of thermostable vaccines in partnership with KeyPlants.
  • Ziccum has published a White Paper describing the world's first facility for large-scale production of thermostable vaccines.
  • On October 26, we announced that Frida Hjelmberg has been appointed CFO. Frida took office on January 1, 2021.
  • On December 1, Ziccum made a list change to Nasdaq First North Growth Market

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

  • Issue receipts regarding warrants amounted to approximately SEK 13.9 million received to the company during 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 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 manufacturing thermostable 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.
  • 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 received during the second quarter and the remaining approximately SEK 6.5 million received during July 2020.
  • A 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 after the reporting period

  • On January 12, Ziccum released its corporate goals for 2021, the main goals being to enter into a first licensing agreement for one or more vaccines and to present a detailed plan to establish a Fill and finish production facility for the filling and final packaging of dry powder, thermostable vaccines including necessary partnerships and financing plans. In the medium term (2-3 years), the goal is to establish a first facility in Sweden.
  • On January 25, Ziccum announced that the company has extended the evaluation agreement that was concluded on October 3, 2019 with Janssen Vaccine & Prevention B.V., one of Janssen's pharmaceutical companies belonging to Johnson & Johnson. The purpose is to complete the analysis of Ziccum's air drying technology with Janssen's vaccine platforms.
Summary financial highlights
  2020
Oct-Dec
2019
Oct-Dec
2020
Jan-Dec
2019
Jan-Dec
Net sales
Other income, KSEK 3 5 654
Operating profit KSEK -3 423 -3 344 -17 235 -8 721
Profit after tax, KSEK -3 448 -3 346 -17 289 -8 723
Balance sheet total, KSEK 39 640 18 395 39 640 18 395
Cash flow during period KSEK -5 941 -3 176 31 556 -8 473
Cash flow per share (SEK) -0.62 -0.53 3.75 -1.41
Cash and cash equivalents, KSEK 33 620 2 064 33 620 2 064
Results per share before and after dilution (SEK) -0.36 -0.56 -2.06 -1.45
Equity per share (SEK) 3.79 2.86 3.79 2.86
Equity ratio, % 92% 93% 92% 93%

 
CEO Statement
Vaccinations are and have always 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 all increase the potential risk of epidemics and pandemics, and 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 – LaminarPace™ – which makes it possible to produce vaccines in dry powder form, which is neither practical nor economical using conventional techniques. 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 – vaccinating more people at a lower cost.

Ziccum's focus is described 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, importantly for the industry, "non-governmental organizations".

Despite Covid-19, our internal work continues to develop thermostable formulations of vaccines. In collaboration with our academic partner, the world-leading university in viruses and vaccines in Marseille, several interesting and important projects are now underway. The results are promising and positively confirm what we have seen before, we will also strengthen our patent portfolio further with these results. A strong IP portfolio is the basis for being able to enter into commercial collaborations and create value for our shareholders.

We have two main goals for 2021, to develop plans for a Fill and Finish production facility for the filling and final packaging of vaccines to be established in Sweden, and to continue to license our technology. For the production facility, we are in discussion with a number of partners who are important in being able to carry out such a project. The goal of concluding a license agreement remains from the previous year. License revenues continue to be a central part of Ziccum's business model. A license agreement would validate LaminarPace and be a clear acknowledgment of the commercial value of Ziccum's offering. We signed an extension agreement with Janssen, owned by Johnsson & Johnsson, for further evaluation. This is following positive results that have been achieved so far.

Our external contacts are constantly being expanded and we are receiving an increasing response from the various players in the industry. Not least, our White Paper (available on our website) which broadly describes what a production facility based on our technology could look like has been much appreciated by important key players. We can see that we can make large cost savings in production in comparison with conventional freeze-drying technology.

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, enabling us to have other types of discussion with both bulk vaccine suppliers and International Vaccine Organizations.

It also means that we can now work in a way that ensures that our technology can deliver an end product that is adapted to the needs and wishes of both the 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. We have previously announced three industrial collaboration agreements with the aim of evaluating our technology in their respective projects.

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

In conclusion, we are well on our way towards delivering on our goals for the current year and to position Ziccum for a very exciting future within an industry that will continue to be focused on for a long time to come – finally, I would like to welcome all those new shareholders who have joined during the quarter, and to thank them for their trust and confidence.

Lund, 11 February 2021
Göran Conradson
CEO

READ THE WHOLE REPORT HERE

This press release has been submitted for publication by the company's CEO at 08.00 (CET) on February 11, 2021.

ZICCUM AB Bokslutskommuniké 1 januari- 31 december 2020

Sammanfattning av delårsrapporten – fjärde kvartalet 2020

Under fjärde kvartalet meddelade Ziccum att en pilotstudie på storskalig produktion av temperaturstabila vacciner har genomförts. Pilotstudien avser en Fill and finish-anläggning (sista steget vid vaccinproduktion), med syfte att utvärdera den tekniska- och finansiella bärkraften av kommersiell produktion av temperaturstabila vacciner. Resultatet av studien visar att det finns signifikanta ekonomiska fördelar med Ziccums LaminarPace-teknologi. Pilotstudien är genomförd i samarbete med KeyPlants AB, ett ledande specialistföretag på modulanläggningar för läkemedelsproduktion.

I samarbete med Keyplants AB har Ziccum även publicerat ett White Paper och ett blueprint som beskriver världens första Fill and finish-anläggning för storskalig produktion av temperaturstabila vacciner. Jämfört med dagens standardiserade Fill and finish-anläggningar där frystorkning utgör kärnan, kan nya vacciner produceras med en beräknad OPEX som är 65 procent lägre, samt en CAPEX som är 50 procent lägre.

Den 1 december genomförde Ziccum ett listbyte till Nasdaq First North Growth Market.

Fjärde kvartalet (okt-dec) 2020
Nettoomsättning 0 tkr (0)
Rörelseresultat -3 423 tkr (-3 344)
Resultat per aktie före och efter utspädning -0,36 SEK (-0,56)

Rapportperioden (jan-dec) 2020
Nettoomsättning 0 tkr (0)
Rörelseresultat -17 235 tkr (-8 721)
Resultat per aktie före och efter utspädning -2,06 SEK (-1,45)

Väsentliga händelser under det fjärde kvartalet 2020

  • 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 tillträdde den 1 januari 2021.
  • Den 1 december genomförde Ziccum ett listbyte till Nasdaq First North Growth Market

Väsentliga händelser under rapportperioden (jan-dec) 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.
  • 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 efter rapportperioden

  • Ziccum offentligjorde 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. På medellång sikt (2-3 år) är målsättningen att etablera en första anläggning i Sverige.
  • 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.
Utvalda finansiella data i sammandrag
  2020
Okt-dec
2019
Okt-dec
2020
Jan-dec
2019
Jan-dec
Nettoomsättning
Övriga intäkter 3 5 654
Rörelseresultat, tkr -3 423 -3 344 -17 235 -8 721
Resultat efter skatt, tkr -3 448 -3 346 -17 289 -8 723
Balansomslutning, tkr 39 640 18 395 39 640 18 395
Periodens kassaflöde, tkr -5 941 -3 176 31 556 -8 473
Periodens kassaflöde per aktie (SEK) -0,62 -0,53 3,75 -1,41
Kassa och bank, tkr 33 620 2 064 33 620 2 064
Resultat per aktie före och efter utspädning (SEK) -0,36 -0,56 -2,06 -1,45
Eget kapital per aktie (SEK) 3,79 2,86 3,79 2,86
Soliditet, % 92% 93% 92% 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.

Vi har två huvudmål för 2021, dels att ta fram planer för en produktionsanläggning för fyllning och slutförpacknig av vacciner för etablering i Sverige, dels fortsätta med att licensiera ut vår teknologi. För produktionsanläggningen är vi i diskussion med ett flertal aktörer som är viktiga för att kunna genomföra ett sådant projekt. Målet att ingå ett licensavtal kvarstår från föregående år. Licensintäkter utgör fortsatt en central del i Ziccums affärsmodell. Ett licensavtal skulle validera LaminarPace och vara ett tydligt kvitto på det kommersiella värdet i Ziccums erbjudande. Vi skrev ett förlängningsavtal med Janssen, ägs av Johnsson & Johnsson, för vidare utvärdering. Detta efter att goda resultat har uppnåtts hittills.

Våra externa kontakter utökas hela tiden och vi får allt större respons från branschens olika aktörer. Inte minst på vårt White Paper (finns på vår hemsida) som i stora drag beskriver hur en produktionsanläggning baserat på vår teknologi skulle kunna se ut har uppskattats mycket från viktig nyckelspelare. Vi kan se att vi kan göra stora kostnadsbesparingar i produktionen i jämförelse med konventionell frystorkningsteknologi.

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.

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. Vi har sedan tidigare annonserat tre industriella samarbetsavtal med syfte att utvärdera vår teknologi i deras respektive projekt.

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 11 februari 2021
Göran Conradson
VD

Läs hela rapporten HÄR.

Pressmeddelandet har ingivits för publicering av bolagets CEO kl. 08.00 (CET) den 11 februari 2021.

Ziccum AB (publ): Bokslutskommuniké 1 januari – 31 december 2019

LUND, SVERIGE – 13 februari, 2020. Ziccum AB (publ), sammanfattning av bokslutskommunikén – fjärde 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 vaccinformuleringar samt biologiska läkemedel.

VD kommenterar

Ziccum har en världsunik och patenterad teknologi – LaminarPace™ – som gör det möjligt för oss att framställa biologiska läkemedel i torr form. Torr form eftersträvas i princip alltid vid utveckling av nya läkemedel och fördelarna är många. Det ökar produktens stabilitet och därmed livslängd, det underlättar hela transportkedjan från fabrik till patient och det möjliggör distribution av läkemedel till nya platser där exempelvis kyl och frysförvaring är en stor utmaning. Detta medför att patienter som saknar behandling eller behandlar sig själva i sina hem kan få tillgång till säkrare och effektivare vacciner och läkemedel.

Under 2019 har vi lämnat in två patentansökningar, dels på en mycket viktig komponent vid utveckling av nya vacciner – Adenovirus, dels på virus inom samma familj som mässlingsvirus. Detta har medfört att flera industriella aktörer har fått upp ögonen för vår teknologi. Vi har också meddelat att vi har ingått avtal med två av dessa bolag i syfte att utvärdera LaminarPace™ i kombination med just deras projekt. I båda samarbetsprojekten har vi levererat test-material torkat i vår LaminarPace teknologi och i nuläget jobbar respektive motpart med att utvärdera dessa material i sina egna modeller och metoder. När detta är klart ser vi fram emot att diskutera nästa steg med respektive bolag. Vår förhoppning är att detta kommer att ske under första halvåret i år. Ytterligare patentansökningar och industriella samarbeten fortsätter att utgöra hörnstenar i vår verksamhet.

Vi arbetar fortsättningsvis och fördjupat med ett konsortium av flera viktiga aktörer – både industriella och akademiska – bland annat med Aix-Marseille Universitetet, Frankrike, som har möjlighet att i egna lokaler arbeta med i stort sett alla vacciner och patogena virus. Det finns ett gemensamt starkt intresse att tillsammans utveckla temperaturstabila beredningar vilket medför ytterligare möjligheter för oss. Detta nystartade samarbete kommer att ge oss många fördelar samt är en betydande utökning av våra resurser. Vi kommer under Q1 att leverera ett system till deras högrisk laboratorium för att ytterligare utveckla nya temperaturstabila formuleringar. Arbetet för att vidareutveckla LaminarPace™-system anpassat för storskalig industriell produktion av biologiska läkemedel och vacciner fortlöper enligt plan. Detta kommer att fortsättningsvis utgöra ett mycket viktigt projekt under 2020 för att positionera oss bättre inför framtida diskusioner om partnerskap.

Vi kommer under 2020 att utveckla vårt kommersiella arbete genom att samarbeta med olika policygrupper som verkar för ett bättre upptag av vaccinationer världen över, för att på så sätt öka medventenheten av betydelsen av vår metod. Europeiska tillverkande vaccinbolag känner väl till oss och under 2020 kommer vi att utöka vårt arbete med utomeuropeiska tillverkare.

Sammanfattningsvis kan jag även detta kvartal konstatera att vi är på god väg att leverera på allt vi utlovade vid noteringen av vår aktie – att inom ett år ingå i tre pilotstudier för att utveckla stabila, torra vaccinformuleringar samt biologiska läkemedel. Nu ser vi fram emot att hålla en fortsatt hög utvecklingstakt av vårt konkurrenskraftiga erbjudande, där vi kan generera såväl betydande patientnytta som värdeskapande för våra aktieägare.

Okt-dec 2019

  • Nettoomsättning 0 tkr (35)
  • Rörelseresultat -3 344 tkr (-1 734)
  • Resultat per aktie före och efter utspädning -0,56 SEK (-0,32)

Jan-dec 2019

  • Nettoomsättning 0 tkr (227)
  • Rörelseresultat -8 721 tkr (-4 210)
  • Resultat per aktie före och efter utspädning -1,45 SEK (-1,27)

Väsentliga händelser under det fjärde kvartalet 2019

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.

Ett ny patentansökan på en ny temperaturstabil formulering av virus inom samma familj som mässling skickades in i december 2019.

Samarbete med en världsledande virologigrupp i Marseille startades.

Vi har initierat arbete med påverkansarbete av internationella policygrupper för vaccinanvändning.

Per balansdagen (vilket utgjorde sista teckningsdag) hade utestående teckningsoptioner tecknats till 92,6 procent av totalt antal utestående teckningsoptioner vilket motsvarar cirka 13,9 MSEK.

Väsentliga händelser under rapportperioden (jan-dec) 2019

Ziccum rapporterade den 10 januari 2019 att bolaget inlämnat patentansökan på Adenovirus med torr och temperaturstabil formulering vilken möter WHOs krav för CTC- status. Den torra formuleringen ("pulvret") som genereras med Ziccums teknologi i LaminarPaceTM 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.

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 har på uppdrag från ett vaccinutvecklingsbolag, genomfört en förstudie avseende utveckling av stabila vacciner. Arbetet är väl genomfört och proverna har skickats tillbaka för vidare utvärdering. Även i ett andra samarbete som tidigare har annonserats har vi levererat torkat material. I nuläget jobbar respektive motpart med att utvärdera dessa material i sina egna modeller och metoder. När detta är klart ser vi fram emot att diskutera nästa steg med respektive bolag. Vår förhoppning är att detta kommer att ske under första halvåret i år. 

En andra patentansökan har lämnats in för en grupp av virus som tillhör mässlingsvirusfamiljen.

Vi har initierat samarbetet med en fransk virologi grupp på Aix-Marseille universitet. Ett LaminarPace system kommer under första kvartalet att placeras i deras BSL3 (BioSafety Level 3), för vidare utveckling av nya formuleringar. Gruppen är även samordnare av ett stort EU finansierat globalt samarbete kring distribution olika virusstammar för forskning, utveckling och som referens material vid diagnostik och för vaccinbolag, EVAg, European Virus Archive Global.

Vi har påbörjat påverkansarbete av internationella policygrupper för förbättrat upptag av vaccinationer. De europeiska vaccinbolagen känner väl till oss.

Väsentliga händelser efter rapportperioden

Emissionslikvid avseende teckningsoptioner uppgick till cirka 13,9 MSEK som tillfördes bolaget under januari månad 2020. Emissionen registrerades av Bolagsverket 2020-01-14.

Det har i övrigt inte inträffat några väsentliga händelser efter rapportperioden.

Lund den 13 februari 2020

Göran Conradson
VD 

För mer information om Ziccum, vänligen kontakta:

Göran Conradson: VD 
E-mail:
conradson@ziccum.com

Mob: +46 709 61 55 99

Om Ziccum AB (publ)
Ziccum utvecklar och kommersialiserar den patenterad teknologin LaminarPace för torkning av primärt biologiska läkemedelssubstanser som är känsliga för konventionella torkningsmetoder. Torr form är önskvärt i de allra flesta läkemedelsprojekten då det ökar stabiliteten, förlänger hållbarheten och förenklar vid tillverkning, logistik och förvaring.

Pressmeddelandet har ingivits för publicering av bolagets CEO kl. 08.00 (CET) den 13 februari 2020.

 

Ziccum AB (publ) Year-end report January 1 – December 31, 2019

LUND, SWEDEN – 13 February 2020. Ziccum AB (publ), summary of the year-end report – fourth quarter 2019: Ziccum is well on its way to delivering what we promised when listing our share – to start three projects during the year to develop stable, dry vaccine formulations as well as biological drugs.

CEO Statement

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

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

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

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

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

Oct-Dec 2019

· Net sales SEK 0,0 (35)

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

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

Jan-Dec 2019

· Net sales SEK 0,0 (227)

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

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

Significant events during fourth quarter 2019

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Significant events after the reporting period

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

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

Lund, February 13, 2020

Göran Conradson

CEO

For more information on Ziccum, please contact:

Göran Conradson: CEO 
Email:
conradson@ziccum.com

Mob: +46 709 61 55 99

About Ziccum AB

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

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

ZICCUM AB (publ) Bokslutskommuniké 2018 (Correction)

(The following contains a correction to 09.00 Thursday 21 Feb Press Release, the Year End report is unchanged). Ziccum AB CEO Göran Conradson: ’Vi har en världsunik och patenterad teknologi i LaminarPace som gör det möjligt för oss att framställa biologiska läkemedel i torr form. Det är ett konkurrenskraftigt erbjudande på en enorm och intressant marknad, där vi kan generera såväl betydande patientnytta som värdeskapande för våra aktieägare’

Sammanfattning av delårsrapport – fjärde kvartalet och helåret 2018

Den 3 oktober 2018 avslutades teckningstiden i Ziccums nyemission av units inför noteringen på Spotlight. Under året uppnådde Ziccum proof-of-concept genom torkning av utvalda anti-kroppar och erhöll sin första order avseende ett feasibility projekt för en kund med en substans under preklinisk utveckling. Nyemissionen om 15,8 MSEK tecknades till cirka 52,7 MSEK vilket motsvarar en teckningsgrad om cirka 334%. Ziccums aktier noterades på Spotlight den 25 oktober 2018.

Utvalda finansiella data i sammandrag
2018
okt-dec
2017
okt-dec
2018
jan-dec
2017
apr-dec*
Nettoomsättning 35 227
Övriga intäkter 179
Rörelseresultat, tkr -1 734 -123 -4 210 -338
Resultat efter skatt, tkr -1 734 -174 -4 571 -389
Balansomslutning, tkr 12 785 1 737 12 785 1 737
Periodens kassaflöde, tkr 9 721 28 10 256 280
Periodens kassaflöde per aktie (SEK) 1,80 0,01 2,85 0,10
Likvida medel, tkr 10 536 280 10 536 280
Resultat per aktie före och efter utspädning (SEK) -0,32 -0,06 -1,27 -0,14
Eget kapital per aktie (SEK) 2,00 0,57 2,00 0,57
Soliditet, % 94% 98% 94% 98%
* Bolaget bildat 2017-04-05

VD kommenterar

Många och stora läkemedel kan inte framställas i torr form. Det medför komplicerade transporter då de flesta biologiska läkemedlen och vaccinerna kräver stora resurser i form av paketering, hantering och transport vilket i sin tur leder till att patienter inte får tillgång till behandling eller vaccinering.

Vi har en världsunik och patenterad teknologi i LaminarPace som gör det möjligt för oss att framställa biologiska läkemedel i torr form. Torr form eftersträvas i princip alltid vid utveckling av nya läkemedel och fördelarna är många. Det ökar produktens stabilitet och därmed livslängd, det underlättar hela transportkedjan från fabrik till patient, det möjliggör distribution av läkemedel till nya platser där exempelvis kyl och frysförvaring är en stor utmaning och det medför att patienter som behandlar sig själva i sina hem kan få tillgång till säkrare och effektivare l äkemedel.

För närvarande fortgår utvärderingen och utvecklingen av nya beredningsformer med goda resultat. Genom LaminarPace kan vi söka patent på nya beredningsformer och därmed bredda vårt existerande patent på den grundläggande LaminarPace-metoden, vilket är ryggraden i Ziccum. Baserat på dessa goda resultat är det glädjande att vi under januari månad 2019 har skickat in en patentansökan en mycket viktig komponent vid utveckling av nya vacciner – Adenovirus. Studieresultaten stärker oss i vår bedömning att vi har ett för branschen och marknaden högintressant erbjudande. Vi kan lösa problem ingen hittills löst, vilket vi bedömer ger Ziccum goda förutsättningar på en stor och växande marknad.

Vi har sedan tidigare beviljats Fas 1-anslaget i Horizon 2020 – det mest ambitiösa och omfattande finansieringsprogrammet för forskning och innovation i EUs historia. Under kvartalet har vi påbörjat vår Fas 2-ansökan med målet att liksom tidigare kommunicerats inlämna denna i början av Q2 2019. Vi har även påbörjat diskussioner med ett antal vaccinbolag och akademiska grupper som visat intresse för Ziccums teknologi och som vi bedömer vara intressanta inför kommersialisering av vårt erbjudande.

Sammanfattningsvis kan jag liksom tidigare konstatera att vi har ett konkurrenskraftigt erbjudande på en enorm och minst sagt intressant marknad, där vi kan generera såväl betydande patientnytta som värdeskapande för våra aktieägare.

Göran Conradson
VD
 

LÄSA 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. 09.00 (CET) den 21 februari 2019.

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