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ZICCUM AB (publ) Interim report Q2 2023

SIGNIFICANT EVENTS Q2 2023 (APRIL-JUNE)

On May 9, Ziccum announced that it had signed a revenue generating Evaluation Agreement with a leading biopharma company to commence a Feasibility study regarding LaminarPace for ambient drying of mRNA/LNP materials and/or mRNA vaccine(s).
The Annual General Meeting (AGM) held on May 24, 2023 re-elected Fredrik Sjövall, Mikaela Bruhammar and Andreas Pettersson Rohman and elected Per Gerde as new board member. Fredrik Sjövall was reelected as the chairman of the Board of Directors. The AGM adopted an incentive program (LTI2023:1) of 324,000 employee stock options for certain employees and consultants. The LTI2023:1 program will be awarded during quarter three 2023. The AGM furthermore resolved on an issue of not more than 425,801 warrants to ensure delivery of shares to the participants and to hedge costs connected to the program.
On June 2, the company announced that Johny Humaloja was appointed as new CFO for the company, and he started his assignment in June.
On June 5, the company announced that it had received a notification from CEPI (the Coalition for Epidemic Preparedness), that its joint Expression of Interest has not been selected for the next stage of application work.

SIGNIFICANT EVENTS AFTER THE SECOND QUARTER

On July 17, Ziccum announced it had signed a new Evaluation Agreement with one of the world’s top pharmaceutical corporations. 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.

OTHER EVENTS

On May 2, the company announced it had filed three patent applications as part of new, expanded strategy to strengthen patent protection. The new, expanded IP strategy will provide multi-layered protection to the company’s unique drying technology LaminarPace, turning liquid biopharmaceuticals into thermostable dry powders by mass transfer.

CEO statement

Taking amazing strides together, landing two deals for Ziccum
It is truly fantastic to now deliver great results in our key areas, having sorted and structured the company business model and operations during a build-up period. Now we are pleased to enter the next phase, delivering key milestone achievements for our valuable platform technology. Getting two agreements signed with world-leading players is indeed clear confirmation that we are on the right path.

Proving the technology for the most delicate targets
Our most significant technical milestone so far was achieved end of first quarter, confirming that we can turn mRNA in lipid nanoparticles (mRNA/LNP) into stable dry powder, with maintained activity. These results have been further validated during this quarter. We have tested various lipid compositions with resulting good mRNA activity, to build our proprietary knowledge further in this exciting field.

mRNA/LNP is a complex and very fragile structure, but so valuable for new pharmaceutical development that it is highly desirable for the industry to apply it – it opens the door to a completely new field of innovative drugs. Solving the issues of mRNA drug delivery and LNP stability will be key to making it a broad platform for new patient treatments. So we are indeed excited to have proven the ability to address this: Ziccum can help make mRNA/LNP available for many more vaccines and therapeutics, globally. Of course, one can also see the great potential to work on other vaccine platforms, as well as the broad range of other biopharmaceutical compounds.

Securing more Ziccum Intellectual property, broadly
Thanks to successful continued technology development and learnings in our internal programs, regarding both equipment configuration, process parameters when running LaminarPace and continuous learning regarding formulation, we have been able to file three new patent applications. It was a significant effort during the quarter to assess all new learnings and apply for patent protection. Also, after the filings announced in April, continued work is on-going to secure the best protection possible for our technology.

Signing up with a world leader in mRNA/LNP
Our progress is generating very good industry interest for the possibilities of our technology, and we are pursuing numerous dialogues with high calibre industry players, across the industry and in many geographies. It was with great pleasure we could communicate on May 9th that one first paid Feasibility study is agreed and signed. It is a very significant commercial milestone of course, for Ziccum to become revenue generating as of now. The project is running at full activity currently, and it is fantastic to work closely with such a successful and knowledgeable partner.

Just after the quarter closing, we could add a second, larger project collaboration being signed – now with a major global Pharmaceutical company. This time, the scope is both a paid Feasibility study with partner mRNA/LNP material, and a planned extension for stability testing and an option to license the LaminarPace technology.

Not only are these projects generating revenue and extending our financial runway, but also generating further knowledge and understanding of success factors for the mRNA field, and long term, giving business potential for future licensing if successful. We are delighted to collaborate with these leading players in the field.

Building the Ziccum operations and team
In parallel with the partnered projects, we pursue the internal development like mentioned, as well as the 3D-modelling project LaPaSim. The Swiss-Swedish team is working on component design and planning for the next step of scaling out for long term industrialization.

Seeing the increase in activities and projects, there are certainly investment and expansion considerations in the company – but at the same time, I am keen to keep good cost control. Both generating new results and income, while still reducing unnecessary spending, is a nice combination for sound company progress and financials.

One recruitment just completed, and adding financial competence, is the hiring of an experienced CFO from the Biotech industry: I am delighted to welcome Johny Humaloja to the team! Furthermore, we are looking for an experienced Chief Operating Officer, to complement the Ziccum staff.

We have an exciting outlook, going forward with our collaborations and plans! Let me thank all collaboration partners and owners as well, for your continued support and engaged dialogues.
Lund, July 18 2023
Ann Gidner, CEO

Q2 2023

The result for the quarter amounted to -4,965 kSEK (-7,882 kSEK)
Cash flow for the quarter amounted to – 4,440 kSEK (-7,587 kSEK)
Cash and cash equivalents at the end of the quarter amounted to 14,583 kSEK (36,647 kSEK)

Financial Highlights (kSEK)	Apr-Jun 2023	Apr-Jun 2022	Jan-Jun 2023	Jan-Jun 2022	Jan-Dec 2022
Net revenue	1,776	0	2,414	0	0
Operating result	-5,060	-7,873	-9,995	-14,213	-28,955
Result for the period	-4,965	-7,882	-9,837	-14,167	-28,788
Balance sheet total	24,635	51,100	24,635	51,100	33,285
Cash flow for the period	-4,440	-7,587	-8,368	24,374	10,678
Cash and cash equivalents	14,583	36,647	14,583	36,647	22,951
Equity ratio %	80	86	80	86	88

Data per share (SEK)
Number of shares at the end of the period	13,806,142	13,806,142	13,806,142	13,806,142	13,806,142
Result per share before and after dilution*	-0.36	– 0.57	-0.71	-1.03	-2.09
Cash flow per share	-0.32	-0.55	-0.61	1.85	0.78
Equity per share	1.43	3.17	1.43	3.17	2.12

Link to report:
https://reports-en.ziccum.com/interim-report-q2-2023/start/

About Ziccum

Ziccum is developing LaminarPaceTM, a unique ambient drying method for biopharmaceuticals and vaccines based on mass transfer, not heat transfer. The technology is offered by licensing to vaccine and biologics developers and manufacturers in the global pharmaceutical industry. By reducing drying stress to the active ingredient, LaminarPaceTM uniquely enables particle-engineered, thermostable dry powder biopharmaceuticals which can be easily handled and transported and are highly suitable for novel administration routes. The technology has been successfully applied to mRNA, peptides, proteins, antibodies, lipids and enzymes as well as excipients and adjuvants, and is well suited for industrial application. Ziccum is listed on the Nasdaq First North Growth Market.

Q2 2023 Ziccum

Ziccum signs Evaluation Agreement for Feasibility Study with major global Pharmaceutical Corporation

As of today, Ziccum AB (publ) (‘Ziccum’) has signed a new 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.

Ziccum’s new partner is one of the world’s top pharmaceutical corporations. The new agreement is for a funded Feasibility study aiming at developing dry powder versions of the partner’s mRNA/LNP materials. The formal terms of the agreement include a planned extension including stability testing, if the first step is successful, plus an option for the Pharmaceutical Corporation to negotiate a license to the LaminarPace technology.

Since May 2022, Ziccum has created a substantial pipeline of new dialogues within the pharmaceutical industry. In parallel the company strengthened its focus on mRNA in lipid nanoparticles (LNPs), with proof of drying mRNA/LNP materials with well-preserved vaccine activity in March 2023. mRNA in LNP formulation is the vaccine technology that was key to the rapid development of Covid-19 vaccines and is currently one of the most fast-developing fields within pharmaceutical development world-wide. During spring, CEO Ann Gidner has presented the Ziccum mRNA/LNP capabilities and findings, fueling industry interest, at several international summits and conferences.

This is the second agreement Ziccum has signed with a leading global pharmaceutical corporation in just over two months, thanks to the significant scientific and commercial progress the company has made based on new strategy and new leadership. The agreement signing is a milestone achievement in Ziccum’s Project Portfolio.

The current project is expected to commence in July 2023 and the first stage will run for a number of months. Both parties will be evaluating the properties of the resulting materials.

CEO Ann Gidner: “The Ziccum team is certainly excited to begin this important and well-designed project in such a valuable field. Partnering up with this high caliber Pharma Corporation is an honor for us, and it brings significant future business potential. Hopefully generating excellent results, this collaboration can enable important advantages in the development of mRNA/LNP treatments for our partner.”

About Ziccum

Ziccum signs Evaluation Agreement for Feasibility Study with major global Pharmaceutical Corporation

Ziccum sponsors the Global mRNA-Based Therapeutics Summit, Boston MA, July 26-28

Ziccum AB (publ) is sponsoring one of the most well-attended international events in the field of mRNA-based therapeutics in Boston MA, July 26-28. Ziccum CEO Ann Gidner will present the company’s unique drying technology for biopharmaceuticals. Furthermore, the company will exhibit a Poster on its current in-house mRNA project, successfully drying active mRNA materials into a thermostable bioactive dry powder.

mRNA-based therapeutics and vaccines is one of the fastest-growing fields within biopharmaceutics, with over 800 mRNA drug projects currently in development. A central event in the scientific and business calendar for mRNA professionals is the Global mRNA-Based Therapeutics Summit. The 3rd summit will take place July 26-28 in Boston MA.

Ziccum CEO Ann Gidner will present on Day 1 of the event, Thursday July 27. Her Presentation is titled A Novel Unit Operation Successfully Drying mRNA/LNP by Mass Transfer. It will cover the technology principle allowing for ambient drying, its valuable thermostability effects and the implementation for industrial use.

Ziccum will also take part in the Poster Exhibition at the event, outlining aspects from the latest stage of its milestone in-house mRNA project. On March 20, 2023, the company announced that it had successfully nebulized and dried active mRNA materials, plus demonstrated a commercially viable level of mRNA activity.

CEO Ann Gidner: “The Summit is a landmark event for the international business and scientific mRNA community – and we believe that our unique capabilities within mRNA make our technology a key topic here. We look forward to sponsoring, networking and presenting at the event.”

About Ziccum

Ziccum sponsors the Global mRNA-Based Therapeutics Summit, Boston MA, July 26-28

Ziccum joint proposal not selected for detailed application in current CEPI Call

Ziccum AB (publ) (‘Ziccum’) has received notification from CEPI (the Coalition for Epidemic Preparedness), that its joint Expression of Interest, submitted in partnership with an mRNA-focused biotech company in January 2023, has not been selected for the next stage of application work. In its notification, CEPI points Ziccum towards an upcoming 2023 Call for Proposals on vaccine manufacturing innovation that “may be a good fit with your technology” and “an opportunity for you to collaborate with CEPI in the future”.

Ziccum AB (publ) (‘Ziccum’) has received notification from the CEPI Secretariat, that its joint January 2023 Expression of Interest, submitted in partnership with an mRNA-focused biotech company, has not been selected for further development. In the CEPI notification, the Secretariat points Ziccum towards an upcoming 2023 Call for Proposals for Applications on vaccine manufacturing innovation including that it “may be a good fit with your technology” and “an opportunity for you to collaborate with CEPI in the future”.

After initially communicating that it would not submit a proposal, Ziccum did submit a first stage brief application, a so called Expression of Interest, to CEPI with a Biotech partner in January 2023, before the company’s recent announcement of a fully funded mRNA Feasibility Study with an international Biotech leader in mRNA development.

CEO Ann Gidner: “With the funding secured in our new Feasibility Study, plus the soft funding received from Eurostars in December for our 3D modelling project with the Zurich University of Applied Sciences, this current news does not significantly affect or change Ziccum’s current funding position. It does however potentially open up another door for us with CEPI, which we will consider carefully. We are very pleased to continue intensifying our present Partnering Pipeline with ongoing and new dialogues as part of our industrial and business development. We are focused firmly on promising options ahead for us and our unique drying technology.”

About Ziccum

Ziccum joint proposal not selected for detailed application in current CEPI Call

Ziccum appoints senior biopharma executive as new CFO

Ziccum AB (publ) has appointed Johny Humaloja as its new CFO. Johny is a financial executive with decades of experience in the biopharma and biotech industries in Europe and the US. He will assume his new position on June 15. CEO Ann Gidner: “Johny’s profile is a perfect fit for us, as we keep moving forward. His appointment both contributes to and confirms our current international trajectory. We welcome him warmly”.

Johny Humaloja has extensive experience as a financial and controller executive in biopharma, biotech and medtech. He has served in senior positions in Europe and the US and is joining Ziccum from the position as CFO of Amniotics AB, where amongst other achievements he led the company through a successful IPO and listing on Nasdaq first north (in 2021). He will assume his new role at Ziccum on June 15th 2023.

Johny has an Executive MBA in Economics & Management from Lund University as well as a BSc in Business Administration & Economics. He brings extensive operational and industrial experience; he has served as a CFO, Financial and Logistics Director, Financial Control Director and as Plant Controller in the US of a large-scale biotech manufacturing facility with an annual budget of 110 MUSD. This is valuable additional expertise for Ziccum, which is taking its unique pharmaceutical drying technology LaminarPace forward to industrialization through international partnering by its licensing business model.

Johny’s appointment is part of the dynamic growth and development agenda at Ziccum. The company is currently also seeking to recruit a Chief Operating Officer, with international biopharma experience, as it continues to broaden and strengthen its strategic executive expertise. Ziccum’s current CFO, Frida Hjelmberg, will remain in the company for a good transition period.

CEO Ann Gidner: “I am delighted to welcome Johny to Ziccum. As we go forward driving partnered projects for licensing, a new team member with relevant, in-depth industry experience will be a great asset. I would like to thank Frida Hjelmberg for her dedicated work over the last few years. It has been a pleasure working with her. We look forward to having Johny onboard”.

Johny Humaloja: “this is a highly interesting opportunity and I’m very excited to join Ziccum, a true leader in its field with a unique technology and with significant potential. I look forward to helping the company realize that potential, moving Ziccum forward on its financial, operational, and transformational path, and driving an accelerated long-term growth journey”.

About Ziccum

Ziccum appoints senior biopharma executive as new CFO

1612187544507

Aerosol and inhalation authority Per Gerde joins Board of Directors of Ziccum AB

New Ziccum Board member Assoc. Prof. Per Gerde has over 55 peer-reviewed scientific papers and six patent families to his name. He is the original inventor of Ziccum’s drying technology for pharmaceuticals, LaminarPace, and an authority on aerosol exposure technologies and inhalation toxicology. “Per brings decades of industry expertise to our Board, as well as his background knowledge of LaminarPace” says Ziccum Chairman Fredrik Sjövall, “we are delighted to welcome him”.

Per Gerde is Associate Professor of Inhalation Toxicology at the Division of Physiology, Institute of Environmental Medicine at Karolinska Institutet (retired, but remains associated), and the founder in 2004 of Inhalation Sciences AB (ISAB), Ziccum’s original parent company, for whom he remains CSO.

Gerde is a recognized authority in inhalation research and development and inhalation toxicology. His previous roles include research scientist at the Swedish National Institute of Occupational Health and postdoctoral fellow and visiting scientist at the influential Lovelace Respiratory Research Institute in New Mexico, USA. He is a Key opinion leader within inhalation and is the inventor of ISAB’s precision aerosol generation system PreciseInhale, which is installed at development and research facilities in Europe, the US and Asia.

Ziccum’s’ pharmaceutical drying system LaminarPace was first developed by Assoc. Prof. Gerde to generate dry powder micronized particles suitable for aerosolization in PreciseInhale. As LaminarPace’s unique ability to deliver dried, thermostable particles of even delicate biologics and biopharmaceuticals emerged, Inhalation Sciences decided to spin the technology out, in 2017, into the subsidiary Ziccum AB.

Today’s LaminarPace is the fourth generation, with extensive development work completed towards its scale out as a unique unit of pharmaceutical production, including advanced 3D modeling being carried out in partnership with the ICP Institute of Computational Physics at the Zurich University of Applied Sciences’s School of Engineering (ZHAW).

Assoc. Prof. Per Gerde: “I am pleased and excited to be involved again with LaminarPace. The technological development and progress Ziccum has made in advancing the system from its early iterations is impressive and exciting. I am very happy to see the extent of that progress, and to be able to return to and contribute once more towards the system’s development, as a Board member. I look forward to working with the Ziccum team”.

Ziccum Chairman of the Board Fredrik Sjövall: “Per brings decades of industry expertise and wisdom to our Board of Directors, as well as his significant background knowledge of LaminarPace. His expertise and commitment to developing successful new systems that add new value to their sector is powerful and proven. We are delighted to welcome him to the Board”.

About Ziccum

Aerosol and inhalation authority Per Gerde joins Board of Directors of Ziccum AB

Per 2

Ziccum CEO to present at BioStock Life Science Spring Summit

The CEO presentation held at the Annual General Meeting of Ziccum AB on May 24th will also be given at BioStock Life Science Spring Summit on May 30-31, 2023 by CEO Ann Gidner. The presentation in Swedish will focus on the company’s recent major milestone achievements, in successful technology development and in partnering with a leading Biopharmaceutical corporation focused on mRNA.

Ziccum’s pharmaceutical drying technology LaminarPace, is unique. Its mass transfer principle enables liquid biopharmaceuticals – including vaccines and biologics – to be dried as thermostable dry powder with no elevated temperatures, avoiding heat stress and resulting degradation, unlike today’s legacy drying technologies.

CEO Ann Gidner will present the company’s recent milestone achievements – confirmation of succesful drying of active mRNA/LNP materials with in-vitro activity, the filing of three new patents in its new IP strategy and a new fully-funded Feasibility study with a leading Biopharmaceutical corporation focused on mRNA. The presentation will also describe LaminarPace and its unique capabilities within biologics and vaccines, with market overviews.

CEO Ann Gidner: “Vaccine development, and mRNA platform technologies in particular, are attracting historic levels of investment right now. LaminarPace has unique capabilities to make new, valuable patient treatments possible, addressing the issue of vaccine or mRNA stability and administration. I am looking forward to sharing our great updates with individual and institutional investors in Sweden.”

About Ziccum

Ziccum CEO to present at BioStock Life Science Spring Summit

Bulletin from the Annual General Meeting of Ziccum AB (publ)

The following resolutions were passed at the Annual General Meeting (the “AGM”) of Ziccum AB (publ) (“the Company”) on the 24th of May 2023 in Lund.

Adoption of income statement and balance sheet and discharge from liability
The AGM resolved to adopt the income statement for the financial year 2022 as well as the balance sheet as of 31 December 2022. The members of the Board of Directors and the managing director were discharged from liability for the financial year 2022.

Allocation of profit or loss
The AGM resolved, in accordance with the Board of Directors’ proposal, that no dividend shall be paid for 2022 and that the results of the company shall be carried forward.

Board of Directors and auditor
The AGM resolved, in accordance with the proposal of a group of shareholders consisting of Per Gerde, Tigerstaden AS and others, on re-election of Fredrik Sjövall, Mikaela Bruhammar and Andreas Pettersson Rohman and election of Per Gerde as board members. Fredrik Sjövall was re-elected as the chairman of the Board of Directors. The AGM re-elected the audit firm Ernst & Young Aktiebolag as auditor.

The AGM further resolved on remuneration to the Board of Directors in accordance with the proposal of a group of shareholders consisting of Per Gerde, Tigerstaden AS and others. The AGM furthermore resolved, in accordance with the above-mentioned shareholders' proposal, that remuneration to the auditor shall be paid in accordance with approved statement of costs.

Nomination Committee for the next Annual General Meeting
The AGM resolved, in accordance with the proposal of a group of shareholders consisting of Per Gerde, Tigerstaden AS and others, that the principles for appointing the Nomination Committee adopted at the AGM of 2022 shall apply also for the AGM to be held in 2024.

Resolution on issue authorization
The AGM resolved, in accordance with the Board of Directors’ proposal, to authorize the Board of Directors to, at one or several occasions and for the period up until the next AGM, resolve to increase the company’s share capital by issuing new shares, convertibles or warrants. Such issue resolution may be carried out with or without deviation from the shareholders’ preferential rights and with or without provisions for contribution in kind, set-off or other conditions. The number of shares that can be issued, or, in case of issuance of convertibles or warrants, added after conversion of exercise, with the support of authorization shall be limited to 30 percent of the number of outstanding shares at the time of this AGM.

The reason for deviating from the shareholders’ pre-emption rights is to increase the Company’s financial flexibility and the Board of Directors' scope of action. If the Board of Directors decides on an issue deviating from the shareholders’ pre-emption rights, the reason must be to enable widening of the ownership circle, to acquire or enable the acquisition of working capital, to increase the liquidity of the share, to carry out company acquisitions or to acquire or enable the acquisition of capital for company acquisitions.

Incentive program
The AGM resolved, in accordance with the Board of Directors’ proposal, to adopt an incentive program for certain employees and consultants consisting of employee stock options. In short, the incentive program includes an issue of not more than 324 000 employee stock options. The AGM furthermore resolved on an issue of not more than 425 801 warrants to ensure delivery of shares to the participants and to hedge costs connected to the program. Each employee stock option entitles the holder to either acquire one share at a price corresponding to the quota value of the share or to receive, free of charge, a warrant entitling the holder to subscribe for one share in the Company at a subscription price corresponding to the quota value of the share during the period from 1 June 2026 up to and including 30 June 2026.

About Ziccum

Bulletin from the Annual General Meeting of Ziccum AB (publ)

Ziccum signs Evaluation Agreement with Biopharmaceutical Corporation focused on mRNA technologies

Ziccum AB (publ) (‘Ziccum’) has signed an Evaluation agreement with a Biopharmaceutical Corporation focused on mRNA technologies to commence a Feasibility study regarding LaminarPace for ambient drying of mRNA/LNP materials and/or mRNA vaccine(s). mRNA is a top strategic priority for Ziccum, and in March 2023 it announced positive results in its in-house project, drying active mRNA in LNP formulation.

Ziccum AB (publ) (‘Ziccum’) has signed an Evaluation agreement with a Biopharmaceutical Corporation focused on mRNA technologies. This new agreement is for a fully financed Feasibility study, formulating and drying mRNA/LNP materials with LaminarPace ambient drying.

The Evaluation agreement signing is a milestone achievement in one of the highlighted partnering dialogues in Ziccum’s regularly updated Project Portfolio overview. Since 2022, following new leadership and a significant strategic refocus, Ziccum has successfully pursued a dynamic partnering agenda, creating a pipeline of industrial dialogues.

The agreement is the result of keen interest in the LaminarPace technology to generate dry powder materials in mRNA/LNP technology development. This is based on successful results on the mRNA/LNP platform for LaminarPace, an entirely new drying technology making dry powder biopharmaceuticals possible. The Feasibility study is expected to start in May 2023.

CEO Ann Gidner: “We are delighted to sign this agreement with such an important, leading mRNA player and to continue work in this highly interesting field. For us at Ziccum this collaboration confirms the strong interest for our novel technology, enabling thermostable biopharmaceuticals in general and the most fragile mRNA/LNP in particular, and it confirms our outreach in the international Pharma industry. We are indeed excited to move forward.”

Chairman Fredrik Sjövall: “This agreement is a breakthrough for Ziccum and a strong acknowledgement of what our technology can offer the key players in this industry. It also confirms our new strategy, business model and capability to move partnering dialogues forward, thanks to the combination of good leadership and strong technical data being generated in well-defined internal trials.”

About Ziccum

Ziccum signs Evaluation Agreement with Biopharmaceutical Corporation focused on mRNA technologies

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