News Tag: Q3

Significant events after Q3 2024

• Ziccum intends to resolve on a rights issue of approximately SEK 30 million and raises a bridge loan

On October 10, The Board of Directors of Ziccum AB (publ) (“Ziccum” or the “Company”) announced its intention to carry out a new issue of shares and warrants (“Units”) with pre-emption rights for the Company’s shareholders (the ”Rights Issue”). The Board of Directors intends to publish a notice to an extraordinary general meeting planned to be held on 8 November 2024, to grant the Board of Directors an authorization to resolve on the Rights Issue and for the adoption of new articles of association. Each Unit consists of one (1) share and one (1) warrant free of charge of series TO 6 (“Warrants”). Upon full subscription in the Rights issue, the Company will initially receive approximately SEK 30 million in issue proceeds before issue costs. In connection with the Rights Issue, the Company has received subscription and guarantee undertakings amounting up to a total of approximately SEK 11.6 million, corresponding up to approximately 39 percent of the Rights Issue. The issue proceeds will primarily be used to further the technological development of LaminarPace®. To secure the Company’s liquidity needs until the completion of the Rights Issue, the Company has secured a SEK 6.5 million bridge loan from VIFC Nordic AB and Dariush Hosseinian.

Significant events during Q3 2024

• Ziccum investigates significant increase in mRNA activity achieved with LaminarPace®

On August 16, Ziccum AB (publ) announced important findings on an increase in mRNA drug activity after LaminarPace® treatment and the investigations of the potential mechanisms behind this effect, including the development of a new, unique analytical method to generate further proof for this effect.

• Ziccum announces trademarking LaminarPace in the USA

On 16 September, Ziccum announced that the appellation of its proprietary technology, LaminarPace, has been officially registered with the United States Patent and Trademark Office (USPTO) as a trademark since 23 July 2024. Obtaining trademark protection in the US, a market of primary importance to Ziccum, is a significant step in light of Ziccum’s growing industry presence, recognition as a commercial partner of choice, and Ziccum’s continuous scientific progress.

• Ziccum announces outcome of exercise of warrants of series TO5

On September 17, Ziccum AB (publ) (”Ziccum” or the ”Company”) announces the outcome of the exercise of warrants of series TO5 (the ”Warrants”), which were issued in connection with the Company’s rights issue of units that ended in February 2024. In total, 23,880 Warrants, corresponding to approximately 2.53 percent of the number of outstanding Warrants, were exercised for subscription of 23,880 shares at an exercise price of SEK 4.91 per share. Through the exercise of the Warrants, Ziccum will receive approximately SEK 117,000 in issue proceeds before issue costs.

• Ziccum announces change of Certified Adviser to Vator Securities

On September 26, Ziccum announced that the company has retained Vator Securities AB (“Vator Securities”) to serve as its Certified Adviser. The appointment of Vator Securities as Ziccum's Certified Adviser (CA) shall come into effect on September 27, 2024.

Significant events during Q2 2024

• Ziccum strengthens and streamlines business and finance functions
  On April 3, the company announced that it is reorganizing its administrative functions, due to the increased amount of business dialogues and to perform financial reporting in a more streamlined fashion. Two new roles of Business & Project Manager and a business-oriented, junior Financial Manager are introduced while the CFO role is eliminated.

• Ziccum CEO to present at first annual event for Biopharma/Biotech Disruptors hosted by major US bank in New York City
  On April 10, the company announced that on Tuesday May 14th, in New York City, Ziccum CEO Ann Gidner will present at the first event on high-value biotech and biopharma disruptor technologies to be hosted by CapitalOne, one of the US’ largest bank corporations. She will present as part of an expert panel regarding mRNA and gene therapeutics.
• Ziccum contracts RFR Solutions for GMP manufacturing in next phase of technology scale-out
  On April 26, the company announced that in addition to its existing network of high expertise suppliers and consultants, Ziccum has signed a long-term agreement with the GMP equipment specialist RFR Solutions, for the next phase in the industrialization and scale-out of the LaminarPace® equipment.
• Ziccum AB strengthens patent portfolio with three solid data PCT applications according to expanded IP strategy
  On April 30, the company announced that they have filed three PCT with ample and significant data covering years of equipment development and refinement, process parameter knowledge gained, plus key biopharmaceutical formulation expertise established. These various perspectives provide multi-layered protection to the company’s unique drying technology LaminarPace®.
• Ziccum partners with Dagens Industri for Investor Relations program
  On May 28, the company announced that they partner with Dagens Industri, the largest Nordic business paper, to improve shareholders’ access to news updates and raise broader awareness of its continuous scientific and commercial progress.
• Exercise of employee stock options of series LTI 2021:1 at Ziccum AB (publ)
  On June 3, the company announced on 27 April 2021, the Annual General Meeting of Ziccum AB (publ) ("Ziccum" or the "Company") resolved on a directed issue of not more than 46,000 employee stock options of series LTI 2021:1 (the "Stock Options") to certain employees and consultants in the Company. Today, Ziccum announces that 14,819 warrants of series 2021/2024 (the "Warrants"), related to LTI 2021:1, have been exercised for subscription of 23,709 new shares in the Company.
• Ziccum reports on developments in the portfolio of industry partner projects
  On June 11, the company announced that Ziccum is continuously engaged in business discussions with potential industrial partners. The status of Ziccum’s project portfolio is presented quarterly in the company interim reports. There are currently further updates to report.
• Ziccum signs Evaluation agreement with ReCode Therapeutics for LaminarPace® mRNA study
  On June 19, Ziccum AB signed an Evaluation Agreement with ReCode Therapeutics, Inc. (ReCode), a US clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, for evaluation of LaminarPace® enabling dry powder forms of ReCode’s proprietary therapeutic modalities.
• Ziccum calls for a second investment tranche in accordance with its financing agreement with GCF
  On June 25, the board of directors of Ziccum AB (publ) (“Ziccum” or the “Company”) called for a second investment tranche in accordance with the previously communicated financing agreement between the Company and Global Corporate Finance (“GCF”), and in connection therewith resolved to carry out a directed share issue.

Significant events during Q1 2024

• Successful outcomes of LaminarPace® Feasibility study with Biotech partner
  On January 10, 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.
• Financing secured through directed share issue and rights issue

On January 22, the company announced that it has carried out a directed share issue of 622,371 shares of approximately MSEK 4.2 to the American professional investor Global Corporate Finance (GCF).

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, totaling approximately MSEK 28 over the next thirty months.

The Board of Directors of Ziccum has also, based on the existing authorization from the Annual General Meeting, decided to carry out a Rights Issue of units of a maximum of MSEK 10.4.

Considering the Directed New Share Issue, and provided that the Rights Issue is fully subscribed, Ziccum will receive initial proceeds totaling approximately MSEK 13.5.

• Ziccum has proven excellent mRNA activity in animal study with LaminarPace® material
  On January 31, the company announced that it has performed an animal study, confirming excellent genetic activity of mRNA/LNP materials treated by LaminarPace®. The in-vivo data confirms the ability of Ziccum’s LaminarPace® technology to transform delicate mRNA/LNP liquid solution into stable dry powder form, now proving the preserved mRNA activity also in animal testing. Assessing the mRNA effect in animal trials is a significant step for Ziccum.

• Ziccum’s CEO Ann Gidner in Fireside Chat on mRNA development hosted by US Force Family Office

On February 12, the company announced that based on the growing reputation that Ziccum is building in the international pharmaceutical industry, Ziccum CEO Ann Gidner has taken part in a recorded Fireside Chat reviewing the mRNA arena, its tremendous growth, and the shortcomings of the RNA/LNP technology which can be addressed by treatment with the Ziccum technology LaminarPace®.

• Ziccum announces outcome in rights issue

On February 16, the company announced the outcome of the rights issue of units, consisting of shares and warrants, which ended on 14 February 2024 (the ”Rights Issue”). The Rights Issue has been subscribed to a total of approximately 61.5 percent, of which approximately 58.6 percent was subscribed with unit rights and approximately 2.9 percent was subscribed without unit rights. Through the Rights Issue, Ziccum thus receives approximately MSEK 6.4 before issuing costs.

• Ziccum reports significant progress in 3D-modelling project with model completion

On March 1, the company announced that Ziccum AB and project partner Zurich institute of Applied Sciences (ZHAW) have made a milestone review of the LaminarPace® simulation (LaPaSim) project progress and findings. The complex, dynamic model digitally replicating the LaminarPace® operation has been created and validated against comprehensive data sets created in physical trial runs and is now reaching a stage close to full completion. Ziccum can now perform trial runs in the 3D simulation environment, enabling the generation of vast amounts of data and in-depth understanding of optimal parameters and scale-out.

• Ziccum inhalable mRNA/LNP project confirms excellent properties obtained by LaminarPace®

On March 14, the company announced that it has generated very good findings in the first stages of its collaborative project to engineer inhalable mRNA/LNP together with the University of Copenhagen. The results demonstrate that LaminarPace® successfully produces inhalable particles with special, desirable properties. The project will continue with in-vivo studies comparing inhalation versus injection.

CEO statement

Sharpening our focus and executing intensively on new abilities

Based on the generation of strong, extensive data with LaminarPace for mRNA in lipid formulations, we have validated an excellent position for this top development target. With such clear results for this most fragile entity, we have a solid position to address all types of biopharmaceuticals with LaminarPace.

We have updated our strategic focus accordingly, to address biological therapeutics as well as vaccines. In this large field we zoom in on the complex, fragile RNAs, plus protein-based drugs and vaccines. The therapeutic applications of the revolutionary mRNA technology are advancing fast, and this offers perfect timing to get new technology introduced in early stages of drug development. Drug projects, so called therapies, are also a good fit with LaminarPace capacity. This focus on the highest possible value for Ziccum, is complemented with a continued focus for new and better vaccines.

Proving LaminarPace for mRNA/LNP – even making inhalation possible

After proving excellent mRNA activity, both in partnered client studies and in our first animal trials, we are currently progressing with a more specialized animal study – the testing of inhaled mRNA/LNP. This is the sharpest edge of LaminarPace performance; no other technology has created inhalable mRNA/LNP so far.

In addition to the on-going project, engineering inhalable mRNA/LNP together with world-leading expertise, where the animal trials are just being completed, Ziccum has been invited to a new collaboration. A leading European institution was considering inhaled mRNA/LNP impossible – until seeing Ziccum present. A large international consortium is now in the works, to develop several mucosal applications of mRNA/LNP. All such applications require dry powder drug forms – which may be enabled by Ziccum technology. We look forward to announcing this when formalized.

For the topic of increased mRNA activity, the interesting work to understand the cellular mechanisms behind it is continuing, and we are preparing to add further patent protection for the valuable findings currently being generated.

Adding more partner projects for key clients

The project execution for ReCode Therapeutics with a specific mRNA/LNP therapeutic entity is just completed at Ziccum’s side. Resulting materials have been shipped to the client for assessment. As the potential benefits of dry powder forms of mRNA/LNP are significant for Recode, this client has asked Ziccum to present two more project offers – to ensure we evaluate the important potential. We are eager to look further into this.

Just after the quarter closing, we were happy to welcome a significant vaccine developer (Biotech Corp V) for a site visit in Lund, further assessing a collaboration and visiting our pilot facility. It is important to keep building the pipeline of dialogues. We are scheduling partnering meetings at the upcoming BIO-Europe conference for existing and new dialogues.

Executing on all the development projects, building intellectual property

The execution of Masterplan projects is continuously intense. In the recent period, the hardworking pilot team has generated LaminarPace materials for animal studies, process optimization work, nebulizer tests and the investigation of mRNA activity. This high capacity load is making it important to be careful about our client projects in parallel, selecting opportunities for the best near term and long term outcome.

The new expertise partnerships for optimizing the Ziccum-specific equipment components are rewarding, with good delivery of results while keeping strict budgets. The updated plan and new partner for the continuous processing project has enabled good savings on external costs. We will have a keen focus on this step in the Master plan in the quarter to come, and the 3D-modelling is a vital component.

The protection of immaterial rights is progressing, with an internal workshop for strategic planning held this quarter to ensure the best possible management. The international PCT patent families are taken forward and we are preparing for a next patent application based on new data.

Ensuring our solid progress ahead

To ensure the company’s financial foundation for continued development plans, the board of directors decided to propose a rights issue during fourth quarter to best serve Ziccum value and shareholder interests. In the current stock market climate it is not an easy feat, but initial proceedings already have generated good interest and secured new investors. We know we are building fantastic company value. Ziccum has generated solid proof for the disruptive technology possibilities, addressing the highest value market segment, and is pursuing collaborations with world-leading partners. We have the most interesting journey to take forward.

I want to extend my warmest gratitude to everyone involved in lots of enjoyable efforts – the team, our clients and partners, our owners and new investors, thank you!

Lund, October 29th, 2024

Ann Gidner

• Operating income: kSEK 571 (2,329)
• Result for the quarter: kSEK -5,887 (-3,882)
• Earnings per share: SEK -0.37 (-0.28)
• Cash flow for the quarter: kSEK -2,985 (-4,793)
• Cash at the end of the reporting period: kSEK 1,107 (9,790)

Financial summary

	Jul-Sep	Jul-Sep	Jan-Sep	Jan-Sep	Jan-Dec
kSEK	2024	2023	2024	2023	2023
Operating income	571	2,329	4,186	4,743	6,318
Operating result	-5,924	-3,899	-17,563	-13,857	-21,560
Result	-5,887	-3,882	-17,491	-13,720	-21,412
Balance sheet total	9,848	21,764	9,948	21,764	14,972
Cash flow	-2,985	-4,793	-1,887	-13,161	-19,956
Cash and cash equivalents	1,107	9,790	1,107	9,790	2,994
Equity ratio %	26	73	26	73	57
Per share data (SEK)
Number of shares	15,958,775	13,806,142	15,958,775	13,806,142	13,806,142
Result per share before and after dilution*	-0.37	-0.28	-1.10	-0.99	-1.55
Cash flow per share	-0.19	-0.35	-0.12	-0.95	-1.45
Equity per share	0.16	1.51	0.16	1.51	0.62

* Dilution effect is not calculated when the result is negative

Significant events during the quarter

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

Other events during the quarter

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

Other events after the third quarter

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

CEO statement
Intensive data generation with world-leading Partners

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

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

July- September in brief

• Total revenues: SEK 2,329 (0) thousand.
• Result for the quarter: SEK -3,882 (-6,674) thousand.
• Earnings per share: SEK -0.28 (-0.48).
• Cash flow for the quarter: SEK -4.793 (-7,064) thousand.
• Cash at the end of the reporting period: SEK 9,790 (29,593) thousand.

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

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

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

Significant events during Q3 (July-September)

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

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

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

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

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

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

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

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

Significant events during Q1-Q2 (Jan-June)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Significant events after the reporting period

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

CEO statement

Strategic focus reinforcement

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

Strategic focus

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

Business development and Partnering

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

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

Technology development and Feasibility studies

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

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

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

3D- Modelling and Soft funding

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

Company structure

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

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

Lund, October 27, 2022

Ann Gidner, CEO

Q3 2022

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

Summary of financial highlights

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

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

Q3 2021

• The result for the quarter amounted to -5 043 kSEK (-5 346 kSEK)
• Cash flow for the quarter amounted to -6 414 kSEK (-165 kSEK)
• Cash and cash equivalents at the end of the quarter amounted to 19 564 kSEK (39 561 kSEK)

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

Significant events during Q3 (July-Sept’)

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

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

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

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

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

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

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

Significant events after the reporting period

Nothing significant to report

CEO statement
Vaccinations are and have long been one of the best ways to prevent pandemics and epidemics. Right now the need has never been greater. New travellin habits, population growth, climate change and overcrowding all potentially increase the risk of epidemics and pandemics, and children are the most vulnerable; one child in five still does not receive adequate vaccination protection. Approximately 1.5 million children die each year from diseases for which vaccines are already available. With the Covid-19 pandemic, many countries have come to realize the importance of taking responsibility for vaccine production, not least many countries on the African continent. Our solution, described in a White Paper on our website, of a Fill & Finish production facility, may therefore be very suitable.
 
Ziccum has a unique and patented technology – LaminarPace ™ – which enables us to produce vaccines in dry powder form, which is not practically or economically possible with conventional technologies. The benefits are many. It increases the stability and so the lifespan of the vaccine, it facilitates the entire transport chain from factory to patient and it enables the distribution of vaccines to new places where, for example, cold- and freezer storage is a major challenge. The result is greater vaccination coverage at a lower cost.
 
Ziccum's key strategic priorities focus on three major areas: Developing thermostable formulations of vaccines, preparing for production on a commercial scale and building external collaborations with industrial actors who develop vaccines and, importantly for the industry, Non-Governmental Organizations (NGOs) and International Governmental Organizations (IGO). Several IGOs, including the WHO, are very clear that vaccine production must be increased in developing countries in so-called regional hubs, so that an equitable vaccine supply can achieved. We are currently in discussions at a senior level with one of these regional hubs.

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

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

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

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

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

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

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

Lund, October 28, 2021 Göran Conradson
VD