Ziccum AB (publ) Interim report Q2 2024

INTERIM REPORT Q2, 1 JANUARY – 30 JUNE 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 LaminarPaceTM 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 LaminarPaceTM.

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 27 April 2021, the Annual General Meeting of Ziccum AB (publ) ("Ziccum" or the "Company") resolved on a directed issue of no more than 46,000 employee stock options of series LTI 2021:1 (the "Stock Options") to certain employees and consultants in the Company. On June 3, Ziccum announced that 14,819 warrants of series 2021/2024 (the "Warrants"), in relation 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 after Q2 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.

CEO statement

Remarkable new technology advancement and keen international interest

After fully confirming our mRNA capabilities in first quarter 2024, we are happy to build such keen interest for our technology, across the international industry. Now seeing the ability to increase the mRNA activity for certain formulations, applying LaminarPace at optimal conditions, is amazing. The potential value of LaminarPace to achieve better and completely new biopharmaceuticals has reached new levels. This could eliminate interest for any tentative competing solutions.

Proving LaminarPace for mRNA/LNP – even increasing protein expression

While the LaminarPace technology has been successfully applied for all kinds of fragile, demanding biopharmaceuticals – proteins, peptides, antibodies and more – the current focus of Ziccum is to address the booming field of mRNA in lipid nanoparticle formulation (mRNA/LNP). This is no small feat. The amount of data generated in a short timeframe 2023/24 is rewarding, especially as every data set is positive; in a completely new field one could expect various outcomes. The first animal study performed gave very clear, good preservation of mRNA activity for LaminarPace material.

In addition to partnered trials during spring, Ziccum spent important efforts generating further mRNA data, optimizing performance both in pilot scale trials and in the 3D-modelling performed in parallel. In this work, we have been intrigued to see not only well preserved but also increased mRNA activity, in terms of protein expression in live cells. This triggered more investigation, and we are delighted to announce both the confirmation of this effect, and the continued work to understand the mechanisms behind it. We are thrilled to investigate this further.

Unique value creation for industry leading partners

We now have repeated external validations from reputable industry players. Also, we have reached a stage where the world’s largest pharmaceutical corporations are approaching Ziccum to learn more – a unique situation for a company our size. While it is very rewarding to see the industry interest, a lot of effort of course remains to get widespread industry recognition. Ziccum is not spending the marketing budgets of large corporations. But with hard work and using a significant industry network, we are already reaching out to key stakeholders and generating keen interest on a global scale.

While we have very good results in our partnered studies, with validation by world leading corporations, the current Big Pharma II partner has chosen not to proceed at the present time, having many competing priorities. This is well in line with the Ziccum strategy, where a pipeline of many collaborations will be needed considering the conservative approach in pharmaceutical industry – and as we have the great benefit of a technology platform. We are delighted to have signed with ReCode Therapeutics, especially as this is an mRNA pioneer, also working at the pharmaceutical forefront and open to new technology. We keep adding advanced dialogues to our portfolio. Obviously, having an even stronger potential value proposition, increasing mRNA activity in new therapies or vaccines, industry interest can be fuelled further.

Progressing with more convincing data

The Masterplan project work is intense. In addition to the studies in live cells, resulting in the new findings of higher mRNA activity, we are planning for further animal data. The inhalation studies with Copenhagen University are reconciled into a new format, to ensure timely delivery from our partner. We are excited to see the outcome. Old drying methods like lyophilization can rarely be applied to biologics at all, and could never give fine, tailor-made particles applicable by inhalation. For LNP formulations, inhalation has been considered impossible by industry – until LaminarPace was applied.

In addition to the animal studies proving mRNA activity, we are also progressing towards next level studies, to assess the immune response in animals.

LaminarPace development continues

The development of the LaminarPace rig continues with a keen focus having secured further partnerships with leading expertise. A main topic is the continuous product outtake, which will be key to high capacity. This work is strongly accelerated, using our 3D model to assess configurations quickly and easily.

During the quarter we secured significant intellectual property (IP) protection. We have progressed our patent applications to international PCT stage and added a high number of patent claims for all three fields, thanks to the high pace of internal trials. This is creating a strong, multilayered protection for Ziccum. Based on the investigations of LaminarPace giving higher mRNA activity, we may have the basis for further patent protection.

Developing Ziccum and planning ahead

To ensure the company’s financials for its ambitious growth plans while balancing low expenditures, to serve shareholders’ best interest, the company board of directors and management are assessing options for the company’s capital needs ahead. Without increasing costs, we have been able to recruit two new, talented colleagues to the international Ziccum team, strengthening our analytical, financing and business capabilities: most happy to welcome Christo Vassilev and Ilkim Atmaca.

We have very interesting results ahead. Let me thank everyone involved for such valuable efforts, give a warm welcome to new board members and my appreciation to partners, owners and investors for continued support. Looking forward to next steps together!

Lund, August 30th, 2024
Ann Gidner

Financial summary

Apr-Jun Apr-Jun Jan-Jun Jan-Jun Jan-Dec
kSEK 2024 2023 2024 2023 2023
Operating income 367 1,776 3,615 2,414 6,318
Operating result -7618 -5,060 -11,641 -9,995 -21,560
Result -7,647 -4,965 -11,604 -9,837 -21,412
Balance sheet total 15,791 24,635 15,791 24,635 14,972
Cash flow -4,967 -4,440 1,098 -8,368 -19,956
Cash and cash equivalents 4,092 14,583 4,092 14,583 2,994
Equity ratio % 52 80 52 80 57
Per share data (SEK)    
Number of shares 15,372,258 13,806,142 15,372,258 13,806,142 13,806,142
Result per share before and after dilution* -0.50 -0.36 -0.75 -0.71 -1.55
Cash flow per share -0.34 -0.32 0.08 -0.61 -1.45
Equity per share 0.53 1.43 0.53 1.43 0.62

* Dilution effect is not calculated when the result is negative

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/

ZICCUM AB (publ) Interim report Q2 2022

INTERIM REPORT Q2 2022: 1 JANUARY – 30 JUNE 2022.

To read the digital Report click here: https://reports-en.ziccum.com/interim-report-q2-2022/

Significant events during Q2 (April-June)

  • 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. Generating steep growth in leading, international Pharma CDMO corporations took her to senior global positions in the US and Germany. She has also been leading internationalization of mid-sized Life Science companies in Sweden and Germany, as well as building up Pharma technology licencing internationally. Recent years have given experience from CEO and Board positions in listed Swedish Life Science start-ups.
  • 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.
  • 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.
  • 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 during Q1 (Jan-March)

  • 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. 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 our existing collaborations into negotiations on commercial terms and license agreements.

  • On March 28, it was announced that Ann Gidner is appointed as new CEO for Ziccum, she takes office on May 9.

Significant events after the reporting period

  • 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.

CEO statement

From vision to action

It has been a true pleasure to join Ziccum at this intense stage of business-oriented action and help setting a sharper focus for the critical development needs and industrial partnering. The company has a very competent and dedicated team, and with a more precise focus we are taking great strides forward, both in the actual experimental work and in our partnering dialogues, creating value.

During the quarter a key strategic focus on three high potential vaccine platforms was defined. Ziccum is now prioritizing three key, high-potential vaccine platforms: adenovirus vaccine vectors, adjuvanted vaccines and mRNA vaccines using LNP delivery. All three platforms are used in major Covid-19 vaccines, and subject to intense development efforts in the pharmaceutical industry.

We also streamlined the project portfolio to three high-value ongoing feasibility studies corresponding to these platforms. Two are joint with leading pharma corporations, and one with an internationally leading vaccine research institute. I was delighted to help take these dialogues forward and to introduce new significant industry players to Ziccum. We were able to finish an important feasibility study and ship the pilot evaluation material to our key pharma collaborator, to now await the analysis and feedback.

Starting in this report we give a portfolio overview, to help the understanding of the overall status of our external projects. For these projects however, collaborating with pharmaceutical corporations, one needs to respect the decision-making of the counterpart and the demand for perfect confidentiality; in pharmaceutical development, every relevant project is subject to strict secrecy due to the large business potential. Hence, one must be very careful making public predictions or disclose any details.

Internally, we had a great range of technical improvements and installations made, including powder collection equipment and nitrogen gas usage, and we were most pleased to have the fourth generation LaminarPace units installed during the quarter. We also had the new cell lab installation nicely completed. Important decisions were taken regarding the development strategy, which resulted in selection of a new nebulizer partner, Tekceleo, which we expect to give a very efficient development project like communicated. We also took an important decision to partner with the ZHAW Institute in Zurich, Switzerland to consider LaminarPace 3D modelling and jointly apply for a Eurostars grant.

The sharpened company focus and elimination of non-strategic activities provide better clarity for our hard- working team, which boosted energy and efforts. We also had the pleasure of moving into new office and lab facilities, creating a good setting for the work ahead.

All in all, we had a very intense quarter. I want to thank Frida Hjelmberg for her good contributions as interim CEO, and I am most grateful for the efforts by Chairman Fredrik Sjövall, initiating the new company focus and enabling a smooth CEO transition. We jointly want to thank our collaborators, partners and owners for excellent interaction and support.

Lund,

August 23, 2022

Ann Gidner, CEO

Q2 2022

The result for the quarter amounted to -7,882 kSEK (-5 ,228 kSEK)
Cash flow for the quarter amounted to -7,587 kSEK (-3096 kSEK)
Cash and cash equivalents at the end of the quarter amounted to 36,647 kSEK (25,706 kSEK)

Summary Financial Highlights April-June 2022 April-June 2021 Jan-
June 2022
Jan-June 2021 Jan-
Dec 2021
Net revenue
Operating result -7,873) -5,212) -14,213) -9,598) -21,117
Result -7,882 -5,228) 14,167) -9,643) -21,136
Balance sheet total 51,100 33,647 51,100 33,647 39,591
Cash flow -7,587 -3,,096 24, 374 -7, 914 -21,347
Cash and cash equivalents 36,647 25,706 36,647 25,706 12, 273
Equity ratio % 86%6 878% 86%& 87% 75%
Data per share SEK
Number of shares at the end of the period 13 ,806,142 9, 806,200 3,.806,142 9,806,200 11,006,056
Result per share before and after dilution* -0.57 – 0.55 -1.03 -1.01 -2.17
Cash flow per share -0.55 – 0.32 1.85 -0.82 -2.19
Equity per share 3.17 2.97 3.17 2.97 2.70
* Dilution effects is not calculated when the result is negative

Ziccum AB (publ) releases Q2 Report 2021

(Lund, Sweden, 26 August 2021) Ziccum AB today releases its Q2 Report for 2021. For the first time the Report will also be released in a digital online format allowing subscribers and readers to more easily interact with and navigate every aspect of the Report.

Read the Q2 Report in its new digital format here:   https://reports.ziccum.com/delarsrapport-q2-2021/start/

The PDF of the Report is attached to this Press Release, and is available on the company’s website on: https://ziccum.com/investors/financial-reports/

Ziccum AB (publ) publicerar delårsrapport för andra kvartalet 2021

(Lund, Sverige, 26 augusti 2021) Ziccum AB meddelar att bolagets Q2-rapport för 2021 nu är tillgänglig. För första gången kommer rapporten också att släppas i ett digitalt onlineformat som gör det enklare att navigera och ta del av rapporten.

Läs Q2-rapporten i sitt nya digitala format här: https://reports.ziccum.com/delarsrapport-q2-2021/start/

PDF-fil bifogas på detta pressmeddelande, och finns på företagets webbplats på:  https://ziccum.com/investors/financial-reports/

ZICCUM AB Delårsrapport 1 januari-30 juni 2020

Sammanfattning av delårsrapporten under andra kvartalet 2020  

Bolaget har genomfört en riktad nyemission om totalt 2 216 815 aktier till ett begränsat antal kvalificerade privata investerare. Bolaget tillfördes 38,8 MSEK före emissionskostnader och cirka 36,4 Mkr efter emissionskostnader (varav cirka 32,3 Mkr tillfördes under det andra kvartalet och resterande cirka 6,5 Mkr tillfördes under juli månad 2020). Under det andra kvartalet har bolaget erhållit lån från Almi Företagspartner Skåne AB uppgående till 2,0 MSEK.

Apr-jun 2020

Nettoomsättning 0 tkr (0)

Rörelseresultat -4 709 tkr (-2 296)

Resultat per aktie före och efter utspädning -0,64 SEK (-0,38)

Jan-jun 2020

Nettoomsättning 0 tkr (0)

Rörelseresultat -8 690 tkr (-3 998)

Resultat per aktie före och efter utspädning -1,19 SEK (-0,67)

Väsentliga händelser under det andra kvartalet 2020

  • Den 20 maj meddelade vi att Ziccum tar nästa steg i ett av sina industriella samarbeten med fortsatt utvecklingsarbete med att formulera temperaturstabila vacciner efter att första steget fallit väl ut.
  • Vi har skrivit ett konfidentialitetsavtal med en viktig så kallad NGO (Non-Governmental Organization) för vidare och mer detaljerade diskussioner om hir vår teknologi kan hjälpa de mest utsatta.
  • Vi meddelade den 24 juni att Ziccum med stöd av bemyndigande från årsstämman den 16 juni, genomfört en riktad nyemission om totalt 2 216 815 aktier till ett begränsat antal kvalificerade privata investerare. Bolaget tillfördes 38,8 MSEK före emissionskostnader och cirka 36,4 Mkr efter emissionskostnader (varav cirka 32,3 Mkr tillfördes under det andra kvartalet och resterande cirka 6,5 Mkr tillfördes under juli månad 2020).
  • Mot bakgrund av utbrottet av coronaviruset och COVID-19 följer Ziccum händelseutvecklingen noga och vidtar åtgärder för att minimera eller eliminera påverkan på bolagets verksamhet. Ziccum följer riktlinjer från Folkhälsomyndigheten, WHO och ECDC (Europeiskt centrum för förebyggande och kontroll av sjukdomar). Ziccum har kunnat fortsätta sin interna verksamhet utan betydande påverkan av COVID-19. Det finns dock risk för förseningar i Bolagets externa samarbetsprojekt med aktörer i andra europeiska länder.

Väsentliga händelser under rapportperioden (jan-jun) 2020

  • Emissionslikvid avseende teckningsoptioner uppgick till cirka 13,9 MSEK som tillfördes bolaget under januari månad 2020. Emissionen registrerades av Bolagsverket 2020-01-14.
  • Den 26 mars 2020 meddelade vi att Ziccum tecknade en avsiktsförklaring att undersöka integration av Ziccums teknologi i en innovativ vaccintillverkningsprocess med ett företag som har en ny innovativ produktionsteknologi för vacciner. Avtalet omfattar utvärdering av integrering av Ziccums formuleringsteknologi för mässling och röda hund (rubella) vacciner. Målsättningen är att betydligt sänka kostnaderna av barnvaccin samt att öka tillgängligheten av vaccin till världens alla barn genom att tillverka temperaturstabila formuleringar.

Väsentliga händelser efter rapportperioden

  • Riktad nyemission genomfördes under det andra kvartalet uppgående till cirka 38,8 MSEK varav cirka 32,3 Mkr tillfördes under det andra kvartalet och resterande cirka 6,5 Mkr tillfördes under juli månad 2020.
  • 10/7/2020 lämnades en ny patentansökan in avseende termostabila formuleringar av VLP baserade vacciner (VLP).

Utvalda finansiella data i sammandrag

2020 

   Apr-jun

2019   

   Apr-jun

     2020     

      Jan-jun

2019      

     Jan-jun

2019      

Jan-dec

Nettoomsättning
Övriga intäkter, tkr 2 403 2 403 654
Rörelseresultat, tkr -4 709 -2 296 -8 690 -3 998 -8 721
Resultat efter skatt, tkr -4 709 -2 296 -8 690 -3 998 -8 723
Balansomslutning, tkr 49 259 9 020 49 259 9 020 18 395
Periodens kassaflöde, tkr 28 668 -2 244 37 662 -3 579 -8 473
Periodens kassaflöde per aktie (SEK) 3,88 -0,37 5,17 -0,60 -1,41
Likvida medel, tkr 39 726 6 957 39 726 6 957 2 064
Resultat per aktie före och efter utspädning (SEK) -0,64 0,38 -1,19 -0,67 -1,45
Eget kapital per aktie (SEK) 6,08 1,33 6,08 1,33 2,86
Soliditet, % 91% 89% 91% 89% 93%

VD kommenterar

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

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

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

Trots Covid-19 fortsätter vårt interna arbete med att utveckla termostabila formuleringar av vacciner. Detta har bland annat resulterat i ytterligare en patentansökan på termostabila formuleringar av Virus Like Particles, s.k. VLPs som är viktig plattform för utveckling av vacciner och som bland annat används för framställning av HPV-vacciner. Detta följer den tidigare strategin som resulterade i en patentansökan på Adenovirus. I samarbete med vår akademiska partner, det inom virus och vacciner världsledande universitetet i Marseille pågår nu flera intressanta och viktiga projekt för utvärdering av vår kapacitet att utveckla termostabila versioner av de mest livsavgörande vacciner som finns och därmed öka den kommersiella potentialen av teknologin. En stark IP portfölj är grunden till att kunna ingå kommersiella samarbeten och skapa värden för våra aktieägare.

En annan hörnsten för att göra vår teknologi kommersiellt attraktiv är att förbereda för produktion i kommersiell skala. Detta innefattar vidareutveckling av vårt produktionssystem och anpassning till branschens högt ställda krav på kvalité och spårbarhet. Det innebär också att vi arbetar med att säkerställa att vår teknologi kan leverera en slutprodukt som är anpassad till industrins och inte minst slutanvändarnas önskemål och krav. Vår ambition är att ligga ett steg före och kunna erbjuda en unik helhetslösning för hur ett torrformulerat vaccin skall produceras, hanteras och administreras. Det kapital som vi reste under sommaren kommer till stor del användas till detta verksamhetsområde och därmed för att accelerera kommersialiseringen av vår teknologi.

Våra externa kontakter utökas hela tiden och vi får allt större respons från branschens olika aktörer. Vi har sedan tidigare annonserat tre industriella samarbetsavtal med syfte att utvärdera vår teknologi i deras respektive projekt. Den pågående pandemin har orsakat förseningar, bland annat på grund av nedstängningar i de länder våra partners verkar. Trots detta står vi fast vid vår målsättning att under året fördjupa minst ett av dessa samarbeten genom ett licensavtal.

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

Sammanfattningsvis är vi är på god väg att leverera på våra mål för innevarande år och för att Ziccum AB Delårsrapport Q2 2020 Sida 4 av 20 positionera Ziccum för en mycket spännande framtid i en bransch som kommer att ha ett mycket stort fokus under lång tid framöver – slutligen vill jag välkomna alla nya aktieägare som tillkom i samband med den nyemission som genomfördes under slutet av juni, samt tacka alla aktieägare för förtroendet.

Lund den 20 augusti 2020

Göran Conradson, VD

Läs hela rapporten HÄR.

För mer information om Ziccum, vänligen kontakta:

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

Mobil: +46 709 61 55 99

Om Ziccum

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

Pressmeddelandet har ingivits för publicering av bolagets CEO kl. 08.00 (CET) den 20 augusti 2020.

ZICCUM AB interim report January 1-June 30, 2020

Summary of the interim report – second quarter 2020

During the second quarter the company carried out 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 36.4 million after issue costs (of which approximately SEK 32.3 million was added during the second quarter and the remaining approximately SEK 6.5 million was added during July 2020). During the second quarter, the company received a loan from Almi Företagspartner Skåne AB amounting to SEK 2.0 million.

April-June 2020

Net sales 0 KSEK (0)

Operating profit 4 709 KSEK (-2 296)

Earnings per share before and after dilution -0.64 SEK (-0.38)

January-June 2020

Net sales 0 KSEK (0)

Operating profit -8 690 KSEK (-3 998)

Earnings per share before and after dilution -1.19 SEK (-0.67)

Significant events during the second quarter 2020

  • 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 was positive.
  • We signed a confidentiality agreement with an important NGO (Non-Governmental Organization) for further and more detailed discussions about how technology can help the most vulnerable.
  • We announced on June 24 that Ziccum, with authorization from the Annual General Meeting on June 16, carried out a directed new issue of a total of 2,216,815 shares to a limited number of qualified private investors. The company received SEK 38.8 million before issue costs and approximately SEK 36.4 million after issue costs (of which approximately SEK 32.3 million was added during the second quarter and the remaining approximately SEK 6.5 million was added during July 2020).
  • In light of the COVID-19 outbreak Ziccum has been closely monitoring developments and taking measures to minimize or eliminate the impact on the company's operations. Ziccum follows guidelines from the Swedish Public Health Agency, WHO and ECDC (European Center for Disease Prevention and Control). Ziccum has been able to continue its internal operations without significant impact from COVID-19. However, there is a risk of delays in the Company's external cooperation projects with players in other European countries.

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

  • Issue payment regarding warrants amounted to approximately SEK 13.9 million that was added to the company during the month of 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 vaccine production technology. 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 temperature-stable formulations.

Significant events after the reporting period

  • A directed new share issue was carried out during the second quarter amounting to approximately SEK 38.8 million, of which approximately SEK 32.3 million was added during the second quarter and the remaining approximately SEK 6.5 million was added during July 2020.
  • On 10/7/2020, a new patent application was filed regarding thermostable formulations of VLP-based vaccines (VLP).

Summary financial highlights

2020

Apr-jun

2019

     Apr-jun

     2020    

       Jan-jun

2019 

        Jan-jun

2019

Jan-Dec

Net sales
Other income, KSEK 2 403 2 403 654
Operating profit, KSEK -4 709 -2 296 -8 690 -3 998 -8 721
Profit after tax, KSEK -4 709 -2 296 -8 690 -3 998 -8 723
Balance sheet total, KSEK 49 259 9 020 49 259 9 020 18 395
Cash flow during period, KSEK 28 668 -2 244 37 662 -3 579 -8 473
Cash flow per share (SEK) 3,88 -0,37 5,17 -0,60 -1,41
Cash and cash equivalents, KSEK 39 726 6 957 39 726 6 957 2 064
Result per share before and after dilution (SEK) -0,64 0,38 -1,19 -0,67 -1,45
Equity per share (SEK) 6,08 1,33 6,08 1,33 2,86
Equity ratio, % 91% 89% 91% 89% 93%

CEO Statement

Vaccination is and for centuries has been one of the best ways to prevent pandemics and epidemics. The need has never been greater than today. New travel trends, population growth, climate change and overcrowding all increase the potential risk of epidemics and pandemics. 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.

Ziccum has a world-unique, patented technology – LaminarPace ™ – which enables us to produce vaccines in dry powder form, not practically or economically possible using conventional techniques. The benefits are many: it increases the stability and so the lifespan of the vaccine, it facilitates the entire vaccine supply 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, meaning more vaccination for a lower cost.

Ziccum’s work focuses on three main areas: Development of thermostable formulations of vaccines, preparations for production on a commercial scale and external collaborations with industrial actors developing vaccines as well as, crucially in this field, NGOs (non-governmental organizations).

Despite Covid-19, our internal work of developing thermostable formulations of vaccines continues. This has, among other things, resulted in another patent application for thermostable formulations of Virus Like Particles, so-called VLPs which are an important platform for the development of vaccines, and which are used, among other things, for the production of HPV vaccines. This follows the previous strategy that resulted in a patent application for Adenovirus. In collaboration with our academic partner, the Emerging Viral Diseases Unit of the University of Marseille, world leaders in virus and vaccine research, several interesting and important projects are now underway to evaluate our capacity to develop thermostable versions of the most life-saving vaccines available, thereby increasing the commercial potential of the technology. A strong IP portfolio is the basis for being able to enter into commercial collaborations and create value for our shareholders.

Another cornerstone for making our technology commercially attractive is preparing for production on a commercial scale. This includes further development of our production system and adaptation to the industry's high demands on quality and traceability. It also means that we work to ensure that our technology can deliver an end product that is adapted to the wishes and requirements of both industry and, not least, end users. Our ambition is to be one step ahead and able to offer a unique complete solution for how a dry-formulated vaccine can be produced, handled and administered. The capital we raised during the summer will largely be used for this business area, thus accelerating the commercialization of our technology.

Our external network of contacts is constantly expanding, and we are receiving increasing recognition from a number of players in the industry. We have previously announced three industrial collaboration agreements with the aim of evaluating our technology in their respective projects. The ongoing pandemic has caused delays, partly due to shutdowns in the countries where our partners operate. Despite this though, we stand by our goal of strengthening at least one of these collaborations during the year through a license agreement.

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

In summary, we are well on our way to delivering on our goals for the current year and to position Ziccum for a very exciting future in an industry that will have a very large focus for a long time to come. Finally, I would like to welcome all our new shareholders who joined us in connection with the new share issue that took place at the end of June, and to thank all of our shareholders for their confidence and trust.

Lund on 20 August 2020

Göran Conradson, CEO

READ THE WHOLE REPORT HERE

For more information about Ziccum, please contact:

Göran Conradson: CEO Ziccum AB
E-mail: 
conradson@ziccum.com

Mobile: +46 709 61 55 99

About Ziccum

Ziccum AB (publ) develops new patented formulations of biological drugs where sensitivity to temperature differences, especially during transportation, currently limits medical and so commercial potential. The company’s patented technology, LaminarPace, develops dry powder formulations of drugs and vaccines that currently only exist in liquid form. By doing so Ziccum can increase the availability of drugs and vaccines in existing markets—and open up new ones.

This press release has been submitted for publication by the company's CEO at 08.00 (CET) on 20 August 2020.

ZICCUM AB Half Year Report Q2 2019

Summary of Half Year Report second quarter 2019: This has been an eventful year for Ziccum.

Summary of Half Year Report, second quarter 2019

2019 has been eventful for Ziccum: We have filed a patent application for an important component in the development of new vaccines, Adenovirus. This has resulted in several industrial players showing new interest in our technology. We also announced that we have entered into a Contract Research agreement with one of these companies, aimed at evaluating LaminarPace ™ in combination with their own project. In the second quarter we also got together groups of leading industrial and academic players to take part in developing dry formulations of many new vaccines and viruses, in the process furthering LaminarPace’s progress towards adapting to large-scale industrial production of biological drugs and vaccines. Consequently we are well on the way to delivering on the targets we set during our share listing – namely carrying out three pilot studies within one year to develop stable, dry vaccines and biological drugs.

April-June 2019

Net sales SEK 0 thousand (2) Net sales SEK 0 thousand (192)

Operating profit SEK -2,296 thousand (-573) Operating profit SEK -3,998 thousand (-728)

Earnings per share before and after dilution SEK -0.38 (-0.24)

January-June 2019

Net sales SEK 0 thousand (192)

Operating profit SEK -3,998 thousand (-728)

Earnings per share before and after dilution SEK -0.67 (-0.32)

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

Ziccum reported on January 10, 2019 that the company filed a patent application for a dry, temperature-stable formulation of Adenovirus, so meeting WHO requirements for CTC status. The dry formulation ("the powder") generated by Ziccum"s technology LaminarPace ™ can be rapidly dissolved back into solution by the addition of sterile water, after which vaccination or treatment can be carried out.

Significant events after the reporting period

  • Ziccum will, on behalf of a vaccine development company, carry out a feasibility study on the development of stable vaccines. At this stage, the preliminary study does not entail any financial compensation, but aims to investigate the compatibility of Ziccum"s air-drying capability and the vaccine company"s new formulation.
  • Otherwise, no significant events have occurred after the reporting period

READ THE WHOLE REPORT HERE

For more information about Ziccum, please contact:

Göran Conradson: CEO Ziccum AB
E-mail: conradson@ziccum.com

Mob: +46 709 61 55 99

About Ziccum

Ziccum AB (publ) develops new patented formulations of biological drugs where sensitivity to temperature differences, especially during transportation, currently limits medical and so commercial potential. The company’s patented technology, LaminarPace, develops dry powder formulations of drugs and vaccines that currently only exist in liquid form. By doing so Ziccum can increase the availability of drugs and vaccines in existing markets—and open up new ones.

This press release has been submitted for publication by the company"s CEO at. 08.00 (CET) on August 21, 2018.

ZICCUM AB Delårsrapport Q2 2019

Sammanfattning av delårsrapport – andra kvartalet 2019. 2019 har varit händelserikt för Ziccum.

Sammanfattning av delårsrapport – andra kvartalet 2019

2019 har varit händelserikt för Ziccum. Vi har bland annat lämnat in en patentansökan på en mycket viktig komponent vid utveckling av nya vacciner – Adenovirus – vilket har medfört att flera industriella aktörer har fått upp ögonen för vår teknologi. Vi har också meddelat att vi har ingått ett avtal med ett av dessa bolag som syftar till att utvärdera LaminarPace™ i kombination med just deras projekt. Under andra kvartalet har vi dessutom fått ihop grupper av ledande industriella och akademiska aktörer för att dels utveckla torra formuleringar av många nya vacciner och virus samt vidareutveckla LaminarPace™-system anpassat för storskalig industriell produktion av biologiska läkemedel och vacciner. Vi kan även konstatera att vi är på god väg att leverera på allt vi utlovade vid noteringen av vår aktie – att inom ett år ingå i tre pilotstudier för att utveckla stabila, torra vaccin samt biologiska läkemedel.

Apr-jun 2019

Nettoomsättning 0 tkr (2) Nettoomsättning 0 tkr (192)

Rörelseresultat -2 296 tkr (-573) Rörelseresultat -3 998 tkr (-728)

Resultat per aktie före och efter utspädning -0,38 SEK (-0,24)

Jan-juni 2019

Nettoomsättning 0 tkr (192)

Rörelseresultat -3 998 tkr (-728)

Resultat per aktie före och efter utspädning -0,67 SEK (-0,32)

Väsentliga händelser under rapportperioden (jan-jun) 2019

Ziccum rapporterade den 10 januari 2019 att bolaget inlämnat patentansökan på Adenovirus med torr och temperaturstabil formulering vilken möter WHOs krav för CTCstatus. Den torra formuleringen ("pulvret") som genereras med Ziccums teknologi i LaminarPace™ löses snabbt upp vid tillsättning av sterilt vatten varefter vaccinering eller behandling kan utföras.

Väsentliga händelser efter rapportperioden

  •  Ziccum ska på uppdrag från ett vaccinutvecklingsbolag, genomföra en förstudie avseende utveckling av stabila vacciner. Förstudien medför i detta läge ingen ekonomisk ersättning, utan syftar till att undersöka kompatibiliteten för Ziccums lufttorkningsförmåga och vaccinbolagets nya formulering
  •  Det har i övrigt inte inträffat några väsentliga händelser efter rapportperioden

LÄS HELA RAPPORTEN HÄR

För mer information om Ziccum, vänligen kontakta:

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

Mobil: +46 709 61 55 99

Om Ziccum

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

Pressmeddelandet har ingivits för publicering av bolagets CEO kl. 08.00 (CET) den 21 augusti 2018.