News Tag: Yearend

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/

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

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/

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.