Ziccum AB (publ) Interim report Q1 2024

INTERIM REPORT Q1, 1 JANUARY – 31 MARCH 2024

Significant events during the Quarter

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.
The assessment concluded that the resulting dry powder material demonstrated excellent mRNA activity when reconstituted and tested in in-vitro cell studies. The assessment also concluded that the LaminarPace™ treatment resulted in well-preserved mRNA content in LNP particles with adequate encapsulation efficiency. Furthermore, the treatment resulted in well-preserved lipid nanoparticles with good particle size and preserved size distribution.

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, totalling approximately MSEK 28 over the next thirty months.
The Board of Directors of Ziccum has also, based on the existing authorisation from the Annual General Meeting, decided to carry out a Rights Issue of units of a maximum of MSEK 10.4.
Considering the Directed New Share Issue, and provided that the Rights Issue is fully subscribed, Ziccum will receive initial proceeds totalling approximately MSEK 13.5.

* Volume-Weighted Average Price, VWAP, is calculated by totalling the SEK traded for every transaction (price multiplied by the volume) and then dividing by the total shares traded.

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.

Ziccums 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.

Significant events after the Quarter

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.


CEO statement

A quarter of intense partner interaction and significant mRNA/LNP milestones – beyond our expectations
The first quarter 2024 brought very important milestones, strongly confirming our mRNA capabilities including both excellent readouts from our partnered feasibility study and generating the first ever animal data for LaminarPace™-treated pharmaceuticals with perfect results. The results are surpassing our expectations of securing good proof for the LaminarPace™ performance for RNA materials, the most sought-after target, currently revolutionizing pharmaceutical and vaccine development world-wide!

Another important step completed was securing financing, where the rights issue, welcoming all existing owners to join, combined with adding a strong US investor in a directed issue on equal terms provided a sound setting for the company ahead. We are proud of the successful model, limited resulting dilution and good outcome in the current difficult market conditions. The quarter also brought significant revenue, thanks to our paid feasibility programs.

Proving LaminarPace™ for mRNA/LNP – the highest value segment with booming development in industry
Within the field of biopharmaceuticals, the most in-demand but also most demanding modality to turn into robust form, is the highly delicate mRNA in lipid nanoparticle formulation (mRNA/LNP). We are now proceeding from the stage of the exciting potential of treating mRNA, with initial studies during 2023, to the stage of solid datasets successfully proving mRNA/LNP treatments, including repeated external validations from reputable industry players – and including the all-important big step of animal data proof.

The animal study, so called in-vivo, reported end January could prove the preservation of full mRNA activity after LaminarPace™-drying. It is fantastic to get this result with such clarity in the first model chosen for in-vivo studies. Thanks to this we can proceed without repeated trials of the activity parameter in-vivo and move on to more specific parameters such as immunological responses. Furthermore, the internal mRNA/LNP trial runs have repeatedly delivered very high mRNA activity in-vitro for various lipid compositions – something we presented at the mRNA Summit in Berlin, where all the important industry leaders in the field gather, and this generated significant interest. The Berlin event was very insightful, seeing how industry leaders turned from discussing the vast possibilities of mRNA to addressing the concrete needs for better delivery forms and product stability – exactly what Ziccum is offering.

It is rewarding to so rapidly have reached critical results confirming how LaminarPace™ can enable new, better, more cost-efficient, and far more sustainable RNA treatments – and to see the industry demand for this come into focus.

Taking our Partnered Feasibility studies forward
In January we could communicate a very good Biotech partner readout, where all mRNA/LNP data were meeting the targets and the mRNA activity preservation was deemed excellent, by partner validation. Again, these results are exceeding our expectations, in our first partnered study for mRNA. For our Big Pharma partner, the mRNA project pilot runs were concluded with good results during the quarter and the project now continues with joint assessments.

Patience is now needed to see the development in these partnerships. Pharmaceutical development is always a lengthy process – even if the RNA platform opens up for quicker progress – and the decision processes within large organizations in pharmaceutical industry consist of many committee reviews. Like defined in our business plan, we strive to continuously build a pipeline of additional dialogues, as we have the great benefit of a platform that can be applied with many partners.

We also have reached a highly rewarding Market milestone during this quarter, with several large corporations now contacting us directly, as Ziccum and the need of LaminarPace™ treatment is getting more and more recognized in the industry. We have broadened the customer base further with highly relevant dialogues during the period, thanks to this keen interest. This was complemented with attending US events and conferences, to keep building Ziccum recognition in international industry.

Masterplan and Company development
The Ziccum team has come a long way in executing trial runs in our pilot facility very efficiently, and good efforts for sophisticated trial planning indeed has paid off. The Masterplan project is progressing nicely, with both our internal trials and the development of the LaminarPace™ rig. This includes the securing of a top-notch equipment manufacturing partner for both near term prototyping and long-term supply. With LaPaSim we are indeed happy to have reached the stage of the initial 3D-model now set up, after a highly productive workshop with our Swiss partners.

The quarter brought significant work for IP protection, where we are supporting the existing three patent applications with the important and solid data packages generated internally. We are also taking great strides in analytical development, quality assurance and planning for regulatory fulfilment – all to ensure GMP readiness – thanks to our organization being nicely strengthened in these areas during 2023.

We continue to carefully build our high caliber Ziccum team for best efforts, and I am happy to welcome a new colleague just after the period, Christo Vassilev, joining to strengthen our analytical and financing capabilities. Important new efforts thanks to this recruitment are that we are launching a structured initiative for soft funding, as well as better market analysis for efficient business dialogues.

All in all, what a productive quarter! My gratitude to everyone involved for great efforts, my warm welcome to our new investors and keen appreciation to everyone for continued, important support.

Lund, April 29, 2024
Ann Gidner, CEO

Financial highlights

January – March in brief

  • Operating income: kSEK 3,248 (638).
  • Result for the quarter: kSEK -3,958 (-4,872).
  • Earnings per share: SEK -0.26 (-0.35).
  • Cash flow for the quarter: kSEK 6,065 (-3,928).
  • Cash at the end of the reporting period: kSEK 9,059 (19,023).

Financial Summary

Q1 Q1 Jan-Dec
kSEK  2024 2023 2023
Operating income 3,248  -638 6,318
Operating result -4,022 -4,936 -21,560
Result 3,958 -4,872 -21,412
Balance sheet total 20,307 28,915 14,972
Cash flow 6,065 -3,928 -19,957
Cash and cash equivalents 9,059 19,023 2,994
Equity ratio % 65 85 57
Per share data (SEK)
Number of shares 15,372,258 13,806,142 13,806,142
Result per share before and after dilution* -0.26 -0.35 -1.55
Cash flow per share 0,39 -0.28 -1.45
Equity per share 0.85 1.78 0.62

* Dilution effects is not calculated when the result is negative

ZICCUM AB (publ) releases Interim report Q1 2023

To read the digital Report click here: https://reports-en.ziccum.com/interim-report-q1-2023/

SIGNIFICANT EVENTS Q1 2023 (JAN-MARCH)

On January 18, Ziccum announced that the company on 24 – 26 January would attend the mRNA-based Therapeutics Summit in Berlin, the leading European event for mRNA innovation expertise in Europe. At the event, CEO Ann Gidner presented LaminarPace with a presentation titled LaminarPace: a novel unit operation successfully drying mRNA/LNP by mass transfer to an audience of senior Pharmaceutical industry decision makers, scientists and key opinion leaders.

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

On March 10, Ziccum entered into a partnership with the FinTech platform eucaps.com, aiming to offer existing shareholders a new forum for news and dialogue whilst also increasing visibility to new investors beyond Sweden. A new portal dedicated to Ziccum was launched on the platform, containing new content on the company, reports and financials to be regularly updated, plus a secure chat forum for investors, to strengthen the resources and dialogue Ziccum offers to investors.

On March 17, Ziccum announced that the company on 20 – 22 March would attend the BIO-Europe Spring 2023 Conference in Basel, Switzerland. The event attracts pharma and biopharma corporations from across the globe. The latest updates from Ziccum technology development were presented at meetings at the event.

On March 20, Ziccum announced an update of the latest stage of its ongoing in-house mRNA/LNP project, last reported in Oct, 2022. In the previous stage, an mRNA-like molecule in LNP formulation was successfully nebulized and dried. The current stage has proceeded to nebulization and drying using active mRNA. Results from this stage confirm and strengthen findings from the previous stage: encapsulation efficiency (how much mRNA is kept inside the particles) and particle size preservation (keeping the right size of LNP particles, without aggregation) were excellent. Furthermore, mRNA activity testing has now been initiated, using a cell-based in vitro assay. Initial results are promising, with a commercially viable level of mRNA activity demonstrated in the material, after LaminarPace drying and reconstitution to liquid. Ziccum’s inhouse mRNA project aims to explore and evaluate the capabilities of its unique mass transfer drying technology, LaminarPace, in drying RNA materials to a thermostable dry powder form that could ultimately be more easily handled and transported by the industry, as well as prove suitable for novel administration routes such as inhalation.

During the first quarter CEO Ann Gidner bought 16,000 shares in Ziccum.

SIGNIFICANT EVENTS FOLLOWING THE REPORTING PERIOD
No significant events after the reporting period

CEO STATEMENT

Following up with a clear road ahead
Gathering the team for a Ziccum Day on March 31, nicely wrapping up the quarter, we could jointly conclude that a lot of major improvements and top priority plans now are in place, and we can spend our efforts more efficiently focusing on execution and delivery in a number of areas.

Positioning Ziccum in a booming field
The sharpened strategy with selected vaccine platforms and the next-generation mRNA vaccines and RNA therapeutics as top priority gives a clear road ahead for the Ziccum efforts. In January we presented Ziccum at the European mRNA Summit in Berlin, alongside world-leading Big Pharma and mRNA vaccine providers, and we felt that this visibility was very rewarding to position the company as an international mRNA player, in addition to our on-going successful relationship building. Our presence at the Berlin Summit and BIO-Europe Spring in Basel enabled good follow-up in existing dialogues as well as new interesting contacts to develop. We are pleased to have a good spread in dialogues, over Big Pharma as well as Biotech, European as well as US companies, and projects on several platforms. A key focus now is to get to signing of paid feasibility studies.

Internal Trials giving clear confirmations for mRNA/LNP
A truly significant milestone was achieved during the quarter, when we were able to confirm excellent drying results with actual messenger RNA in lipid nanoparticle formulation. Previous trials with a model molecule led the way to these trials on mRNA, which is a most demanding challenge in turning liquid biomolecules into dry powder. It is a great confirmation of how the gentle drying at ambient temperature allows such a delicate and complex molecule structure to keep its shape, size and structure. Confirming that the resulting mRNA also retains its genetic effect is of course crucial – and on-going trials in a cell-based model are confirming good activity, viable for commercial applications. These confirmations are indeed fuelling the industry interest for our technology.

Taking LaminarPace to real applicability in industry
Potential partners in the industry are keen to understand the long-term capabilities. Thanks to developing an ambitious plan for our 3D-modelling project LaPaSim last quarter, and the resulting full Eurostars funding awarded, we are able to move straight ahead with important fine-tuning and scaling of the technology. In February we gathered the Swiss and Swedish joint team for a Project kick-off and secured a high quality foundation in the project. Both sides are now generating results in real life versus digitally, to calibrate the model, and final design of the LaminarPace product outtake has started. The next step of scaling out for long term industrialization is not too far away.

We also keep moving forward with the final design of equipment components, like previously reported, with excellent industry partners. There will be new intellectual property generated for Ziccum thanks to these efforts.

Communication and team work
On the Investor relations side, we were pleased to take part as pioneers in the launch of a new European platform for trading and information. We are hoping this will nicely complement other channels for Ziccum information.

During the quarter we also implemented some further refinement in work processes, and it is a pleasure to have the high caliber Ziccum team taking great strides in our projects. I am happy to thank collaboration partners, consultants and owners as well, for continued support and fruitful dialogues.

Lund, April 26, 2023
Ann Gidner,
CEO

Q1 2023

  • The result for the quarter amounted to -4,872 kSEK (-6,285 kSEK)
  • Cash flow for the quarter amounted to -3,928 kSEK (31,961 kSEK)
  • Cash and cash equivalents at the end of the quarter amounted to 19,023 kSEK (44 234 kSEK)
SUMMARY FINANCIAL HIGHLIGHTS KSEK Jan-March 2023 Jan-March 2022 Jan-
Dec 2022
Net revenue
Operating result -4,936 -6,340 -28,955
Result for the period -4,872 -6,285 -28,788
Balance sheet total 28,915 58,295 33,285
Cash flow for the period -3,928 31,961 10,678
Cash and cash equivalents 19,023 44,234 22,951
Equity ratio % 85% 88% 88%
Data per share <br>SEK<br>
Number of shares at the end of the period 13,806,142 13,806,142 13,806,142
Result per share before and after dilution* -0.35 – 0.46 – 2.09
Cash flow per share -0.28 2.41 0.78
Equity per share 1.78 3.73 2.12

ZICCUM AB (publ) Interim report Q1 2022

INTERIM REPORT Q1 2022: 1 JANUARY – 31 MARCH 2022

To read the digital Report click here: https://reports-en.ziccum.com/interim-report-q1-2022/

Q1 2022

  • The result for the quarter amounted to -6,285 kSEK (-4, 416 kSEK)
  • Cash flow for the quarter amounted to 31,961 kSEK (-4, 818 kSEK)
  • Cash and cash equivalents at the end of the quarter amounted to 44, 234 kSEK (28,802 kSEK)
SUMMARY FINANCIAL HIGHLIGHTS kSEK Jan-March 2022 Jan-March 2021 Jan-Dec 2021
Net revenue                    –                    –                    –  
Operating result             (6,340)           (4,387)         (21,117)
Result             (6,285)           (4,416)         (21,136)
Balance sheet total            58,295          35,715          39,591
Cash flow            31,961           (4,818)         (21,347)
Cashy and cash equivalents            44,234          28,802          12,273
Equity ratio % 0.88 0.90 0.75
Data per share SEK
Number of shares at end of period     13,806,142      9,606,200      11,006,056
Result per share before and after dilution* -0.46              -0.46    -2.17
Cash flow per share 2.41              -0.50    -2.19
Equity per sharee 3.73                3.33    2.70
* Dilution effects is not calculated when the result is negative

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 CFO for Ziccum, she takes office on May 9.

Significant events after the reporting period
The new CEO, Ann Gidner, has bought 15,000 shares in Ziccum. In addition, the Board members Andreas Pettersson also bought 20,000 shares and Kristian Kierkegaard 10,000 shares in the Company.

CEO Statement

This will be my final statement as acting CEO before our new CEO Ann Gidner assumes her new role on May 9. I am pleased that I will return to focusing fully on my CFO role having overseen a productive Quarter of renewed focus that I believe will serve as a basis for strong business development.

During the Quarter myself, together with Development Director Anna Lönn, an engaged Chairman and proactive Board member have worked intensively on reviewing the company’s business development and strategic focus. On March 3 we released an updated reappraisal of our strategic goals reaffirming the importance of licensing rights in our business model, and our commitment to generating further proof-of-concept data, and in particular mRNA / LNP data.

In the week leading up to this Q1 Report we shared with our investors additional details on our strategic and operational initiatives, and how they constitute a strong base for future growth. These focus areas are:

1. A STRENGTHENED FOCUS ON THREE VACCINE PLATFORMS
During 2022 – 2023 Ziccum will focus on three key vaccine platforms: the Viral Vector platform using Adenovirus, the subunit vaccine (adjuvanted) platform and the mRNA/LNP vaccine platform. mRNA/LNP is an area we value very high. The global trend and market dynamics in this specific field is also very strong. Read more HERE.

2. EXPANDED TOOLS, LAB FACILITIES AND mRNA/LNP CAPABILITIES
Strategic investments include a new cell lab that will enable in vitro studies of key biological properties and deliver specific advantages in the development of mRNA/LNP. We have also completed the investment and installation of the microfluidics system, ‘Ignite’ NanoAssemblr, that will enable us to generate our own mRNA/LNP materials at R&D scale. Read more HERE.

3. TARGETED TECHNOLOGY DEVELOPMENTS
To underpin Ziccum’s new strategic focus, key technology development programs have been selected for the company’s flagship drying system (LaminarPace or LAPA) as it progresses towards eventual GMP manufacturing status. Some are ongoing, some have been recently completed. These technology development programs include for instance a new powder collector solution, introduction of nitrogen (N2) as drying gas, nebulizer and membrane development.

These key priority areas and a committed and engaged organization will lead the way in LaminarPace’s development towards commercial partnerships and eventual GMP industrial manufacturing. Read more HERE.

In conclusion – ‘renewed focus’ is the key term that I want to emphasis. I believe that with the new more focused strategies and targets developed in this Quarter, and with the imminent arrival of our reputable CEO Ann Gidner, we are now in a strong position to move decisively forwards towards creating new partnerships and value for ourselves, our clients and our investors.

Lund, April 28, 2022,
Frida Hjelmberg,
Acting-CEO,
CFO,
Ziccum AB

ZICCUM AB (publ) Delårsrapport Q1 2022

DELÅRSRAPPORT Q1: 1 JANUARI – 31 MARS 2022

För att läsa hela rapporten digitalt, klicka här: https://reports.ziccum.com/delarsrapport-q1-2022/

Q1 2022

  • Resultatet för kvartalet uppgick till -6 285 kSEK (-4 416 kSEK)
  • Kassaflödet för kvartalet uppgick till 31 961 kSEK (-4 818 kSEK)
  • Likvida medel uppgick vid utgången av kvartalet till 44 234 kSEK (28 802 kSEK)
Finansiell data i sammandrag kSEK jan-mars 2022 jan-mars 2021 jan-dec  2021
Nettoomsättning                    –                    –                    –  
Rörelseresultat             (6 340)           (4 387)         (21 117)
Resultat             (6 285)           (4 416)         (21 136)
Balansomslutning            58 295          35 715          39 591
Periodens kassaflöde            31 961           (4 818)         (21 347)
Likvida medel            44 234          28 802          12 273
Soliditet % 0,88 0,90 0,75
Nyckeltal per aktie SEK
Antal aktier vid periodens slut     13 806 142      9 606 200      11 006 056
Resultat per aktie före och efter utspädning* -0,46 -0,46    -2,17
Periodens kassaflöde per aktie 2,41 -0,50    -2,19
Eget kapital per aktie 3,73                3,33    2,70
* Utspädningseffekter omräknas ej vid negativt resultat

Väsentliga händelser Q1 (jan-mars)
På den extra bolagsstämma som bolaget höll den 18 januari beslutades att godkänna styrelsens beslut från den 16 december 2021 om en riktad nyemission om 1 333 314 units. Utöver detta godkändes även en höjning av gränsen för antalet aktier samt aktiekapitalets storlek i bolagsordningen, för att möjliggöra emissionen av resterande 933 362 units i den riktade emissionen.

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

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

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

Den 22 februari meddelades att Göran Conradson får lämna sin position som VD. Bolagets CFO, Frida Hjelmberg, blir tillförordnad VD tills vidare.

Den 3 mars lämnade styrelsen en uppdatering av Ziccums strategi, mål och prioriteringar. Strategin för att ingå kommersiella avtal med industriella aktörer har varit och är tydligt definierad och bygger på fyra prioriterade aktiviteter:

  1. Bedriva en aktiv affärsutvecklingsagenda där befintliga och potentiella partners bearbetas proaktivt. Dels för att erbjuda möjligheten att utvärdera specifika projekt i kombination med Ziccums teknologi, dels för att förstå vilka krav som ställs på teknologin innan ett beslut om licensavtal kan tas.
  2. Generera laborativa data som manifesterar och bekräftar teknologins kapacitet att torka olika typer av vaccin, s.k. proof of concept.
  3. Utveckla bolagets teknologi för att anpassa funktionalitet, kapacitet och kvalitet mot licenstagares kravspecifikationer.
  4. Utveckla konceptuella planer på hur Ziccums torkningsteknologi kan anpassas till kommersiell skala och integreras i en kommersiell produktionsmiljö.

Med ny ledning är det styrelsens mål att öka takten i framförallt affärsutvecklingsarbetet med målet att ingå fler industriella samarbeten för utvärdering av LaminarPace och avancera existerande samarbeten till förhandlingar om kommersiella villkor och licensavtal.

Den 28 mars meddelades att Ziccum har utsett Ann Gidner till ny VD, hon tillträder tjänsten den 9 maj 2022.

Väsentliga händelser efter rapportperioden
Tillträdande VD, Ann Gidner har köpt 15 000 aktier i Ziccum. Utöver det har även styrelsens ledamöter Andreas Pettersson köpt 20 000 aktier och Kristian Kierkegaard 10 000 aktier i Bolaget.

Ziccum Q1 2022
VD har ordet

Detta blir min sista summering som tillförordnad VD innan Ann Gidner tillträder som Ziccums nye VD den 9 maj. Jag ser fram emot att återvända och fokusera fullt ut på min roll som CFO efter att ha tagit Ziccum genom ett produktivt kvartal med förnyat fokus som jag tror kommer att ligga till grund för stark affärsutveckling framåt.

Tillsammans med vår utvecklingschef Anna Lönn, en engagerad ordförande och proaktiva styrelseledamöter har vi under kvartalet arbetat intensivt med att se över bolagets affärsutveckling och strategiska fokus. Den 3 mars släppte vi en uppdatering av våra strategiska mål som bekräftar vår affärsmodell men också förtydligar våra prioriteringar.

Under veckan som ledde fram till denna Q1-rapport har vi förtydligat detta ytterligare genom att presentera uppdateringar avseende strategiska och operativa initiativ, och hur de utgör en stark bas för framtida tillväxt. Dessa fokusområden är:

1. FOKUS PÅ TRE VACCINPLATTFORMAR
Under 2022 – 2023 kommer Ziccum att fokusera på tre viktiga vaccinplattformar: Adenovirus, Proteinbaserade adjuvansvacciner och mRNA/LNP. Just mRNA/LNP är ett område vi tror otroligt mycket på. Den globala trenden och marknadsdynamiken inom detta specifika område är också extremt spännande och potentialen enorm. Läs mer HÄR.

2. STRATEGISKA INVESTERINGAR I LAB OCH UTRUSTNING
Vi har gjort strategiska investeringar som inkluderar ett nytt cell-lab som kommer att möjliggöra in vitro-studier av viktiga biologiska egenskaper och ge specifika fördelar i utvecklingen av mRNA/LNP. Vi har också slutfört investeringen och installationen av mikrofluidik-systemet, 'Ignite' NanoAssemblr, som kommer att göra det möjligt för oss att generera vårt eget mRNA/LNP-material i FoU-skala. Läs mer HÄR.

3. NOGA UTVALDA UTVECKLINGSPROJEKT
För att stödja Ziccums nya strategiska fokus har vi valt ut ett antal prioriterade utvecklingsprojekt för LaminarPace-systemet. Några av projekten är pågående, och några har nyligen avslutats. Exempel på detta är bland annat en ny powder collector, introduktion av kväve (N2) som torkningsgas samt nebulisator- och membranutveckling.

Dessa prioriterade områden i kombination med en engagerad och dedikerad organisation kommer att leda vägen i LaminarPaces utveckling mot kommersiella partnerskap, och i förlängningen myndighetskontrollerad industriell tillverkning. Läs mer HÄR.

Sammanfattningsvis vill jag betona vikten av "förnyat fokus" som vägen framåt för Ziccum. Jag tror att med de nya mer fokuserade strategier och mål som utvecklats under det här kvartalet, och med Ann Gidner som ny VD, är vi nu i en stark position för att skapa nya partnerskap och värde för oss själva, våra kunder och våra aktieägare.

Lund, den 28 april, 2022,
Frida Hjelmberg,
tf VD & CFO,
Ziccum AB

ZICCUM AB Interim Report January 1-March 31, 2021

Summary of interim report, first quarter 2021

Ziccum has announced its goals for 2021, the main goals are to enter into a first licensing agreement for one or more vaccines and to present a detailed plan to establish a production facility for filling and final packaging of dry powder, thermostable vaccines including necessary partnerships and financing plan.
 
During the first quarter, Ziccum extended the evaluation agreement that was concluded on October 3, 2019 with Janssen Vaccine & Prevention B.V., one of Janssen's pharmaceutical companies belonging to Johnson & Johnson. The purpose is to complete the analysis of Ziccum's air drying technology with Janssen's vaccine platforms.
 
During Q1, Ziccum was accepted as a member of NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals. NIIMBL's mission is to accelerate the development of new biomedical manufacturing technologies in the United States.
 
Jan – Mar 2021
Net sales 0 KSEK (0)
Operating profit -4 387 KSEK (-3 980)
Earnings per share before and after dilution -0.46 SEK (-0.55)
 
Significant events during the first quarter 2021
On January 12, Ziccum announced its goals for 2021, the main goals being to enter into a first licensing agreement for one or more vaccines and to present a detailed plan to establish a production facility for filling and final packaging of dry powder, thermostable vaccines including necessary partnerships and financing plan. In the medium term (2-3 years), the goal is to establish a first facility in Sweden.
 
Ziccum announced on January 25 that the company has extended the evaluation agreement that was concluded on October 3, 2019 with Janssen Vaccine & Prevention B.V., one of Janssen's pharmaceutical companies belonging to Johnson & Johnson. The purpose is to complete the analysis of Ziccum's air drying technology with Janssen's vaccine platforms.
 
On March 17, Ziccum announced that the company had been accepted as a member of NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals. NIIMBL's mission is to accelerate the development of new biomedical manufacturing technologies in the United States. Among others, the US National Institute of Standards and Technology (NIST) and the U.S. Department of Commerce founder, giving the organization opportunities to distribute federal grants to its members.
 
Significant events after the reporting period
No significant events occurred after the reporting period.

Summary Financial Highlights
  2021
Jan-Mar
2020
Jan-Mar
2020
Jan-Dec
Net sales
Operating profit, KSEK -4 387 -3 980 -17 235
Profit after tax, KSEK -4 416 -3 980 -17 289
Balance sheet total, KSEK 35 715 14 271 39 640
Cash flow during period, KSEK -4 818 8 995 31 556
Cash flow per share, (SEK) -3.00 1.25 3.75
Cash and cash equivalents, KSEK 28 802 11 058 33 620
Results per share before and after dilution (SEK) -0.46 -0.55 -2.06
Equity per share, (SEK) 3.33 1.77 3.79
Equity ratio, % 90% 91% 92%

CEO Statement
Vaccinations are and have been one of the best ways to prevent pandemics and epidemics. Now, the need has never been greater. New travel 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 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 thus the lifespan of the vaccine, it facilitates the entire transport chain from factory to patient and it enables the distribution of vaccines to new places where, for example, cold- and freezer storage is a major challenge. The result is greater vaccination coverage at a lower cost.
 
Ziccum's focus is described in three main areas: Development of thermostable formulations of vaccines, preparations for production on a commercial scale and external collaborations with industrial actors who develop vaccines and also, for the industry very importantly, NGOs, "non-governmental organizations".
 
Despite Covid-19, our internal work continues to develop thermostable formulations of vaccines. In collaboration with our academic partner, the world-leading University of Marseilles’ virus and vaccine department, several interesting and important projects are now underway. The results are very promising and are in good agreement with what we have seen before. Our work on developing a system for an industrial production environment is progressing well, and we have also worked on mathematical simulated models of the process, which has given us a deeper insight into commercial production.
 
We have two main goals for 2021, partly to develop concrete plans to build and establish a Fill & Finish production facility for filling and final packaging of vaccines in Sweden, and partly to continue licensing our technology. The goal of concluding a license agreement remains from the previous year. License revenues continue to be a central part of Ziccum's business model. A license agreement would validate LaminarPace and be a clear acknowledgment of the commercial value of Ziccum's offering.  We are of course pleased to have entered into an extension of our collaboration agreement with Janssen, which is owned by Johnsson & Johnsson, for further evaluation of our technology in combination with their vaccine program. We are expected to be able to come up with new updates about this project during the second half of the year. We have already presented a detailed proposal on what a Fill & Finish production facility based on our technology will look like. The response from industry players has been positive and we are constantly making new contacts with potential key players to be able to carry out the project. We have shown that a Fill & Finish production facility based on our LaminarPace technology has the potential to lead to significant cost savings compared to conventional freeze-drying technology, in addition to the fact that dry vaccines can be produced without dependence on the costly and complicated Cold Chain.
 
Vaccines are a low-cost product in large parts of the world, which is why these results are so important. Now that we can describe a production facility, we have expanded our business model and added additional revenue opportunities. We can now have another type of discussion with both bulk vaccine suppliers and International Vaccine Organizations. The ambition to establish a production facility for dry vaccines also means that we now focus a lot on ensuring that our technology can deliver an end product that is adapted to the industry's and not least the end users' wishes and requirements. Our ambition is to be one step ahead and be able to offer a unique complete solution for how a dry-formulated vaccine is to be produced, handled and administered.
 
We also continue to develop our commercial work by actively processing and engaging in dialogue with various companies, interest groups and even nation states that work for better vaccine coverage worldwide. We are building deeper and stronger relationships in these arenas, we have high hopes of being able to formalize one or more collaboration in the coming year.
 
It is also, of course, very gratifying that we have very recently been admitted as members of the American organization NIIMBL (The National Institute for Innovations in Manufacturing Biopharmaceuticals). One of NIIMBL's main purposes is to ultimately strengthen American competitiveness in the manufacture of biological drugs, and we now have direct contact with the heavy American biotech industry. To become a member, you must in principle have some form of business in the US, which we do not have, but sometimes they make exceptions for companies with particularly interesting technology. With membership, we also have the right to apply for US federal grants channelled through NIIMBL and we can be invited to participate directly in projects without having to make applications.
 
In summary, we are well positioned for a very exciting future in an industry that will remain a top priority for all of us for a long time to come.
 
Lund, 23 April 2021
Göran Conradson
CEO
 
Read the full report HERE.
 
This press release has been submitted for publication by the company's CEO at 08.45 (CET) on April 23, 2021.

ZICCUM AB Delårsrapport 1 januari-31 mars 2021

Sammanfattning av delårsrapporten – första kvartalet 2021

Ziccum har offentligjort sina mål för 2021, huvudmålen är att ingå ett första licensavtal avseende ett eller flera vacciner samt att presentera en detaljerad plan för att etablera en produktionsanläggning för fyllning och slutförpackning av torra, termostabila pulvervacciner inklusive nödvändiga partnerskap och finansieringsplan.

Under första kvartalet har Ziccum förlängt det utvärderingsavtal som den 3 oktober 2019 slöts med Janssen Vaccine & Prevention B.V., ett av Janssens läkemedelsbolag som tillhör Johnson & Johnson. Syftet är att slutföra analysen av Ziccums lufttorkningsteknologi med Janssens vaccinplattformar.

Ziccum blev under Q1 antagna som medlemmar i NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals. NIIMBLs uppdrag är att accelerera utvecklingen av nya biomedicinska tillverkningstekniker i USA.

Jan-Mars 2021
Nettoomsättning 0 tkr (0)
Rörelseresultat -4 387 tkr (-3 980)
Resultat per aktie före och efter utspädning -0,46 SEK (-0,55)

Väsentliga händelser under det första kvartalet 2021
Ziccum offentligjorde den 12 januari sina mål för 2021, huvudmålen är att ingå ett första licensavtal avseende ett eller flera vacciner samt att presentera en detaljerad plan för att etablera en produktionsanläggning för fyllning och slutförpackning av torra, termostabila pulvervacciner inklusive nödvändiga partnerskap och finansieringsplan. På medellång sikt (2-3 år) är målsättningen att etablera en första anläggning i Sverige.

Ziccum publicerade den 25 januari att bolaget har förlängt det utvärderingsavtal som den 3 oktober 2019 slöts med Janssen Vaccine & Prevention B.V., ett av Janssens läkemedelsbolag som tillhör Johnson & Johnson. Syftet är att slutföra analysen av Ziccums lufttorkningsteknologi med Janssens vaccinplattformer.

Den 17 mars informerade Ziccum att bolaget hade blivit antaget som medlem i NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals. NIIMBLs uppdrag är att accelerera utvecklingen av nya biomedicinska tillverkningstekniker i USA. Bland annat är US National Institute of Standards and Technology (NIST) och U.S. Department of Commerce grundare, vilket ger organisationen möjligheter att dela ut federala anslag till sina medlemmar.

Väsentliga händelser efter rapportperioden
Det har inte inträffat några väsentliga händelser efter rapportperioden.

Utvalda finansiella data i sammandrag
  2021
jan-mar
2020
jan-mar
2020
jan-dec
Nettoomsättning
Rörelseresultat, tkr -4 387 -3 980 -17 235
Resultat efter skatt, tkr -4 416 -3 980 -17 289
Balansomslutning, tkr 35 715 14 271 39 640
Periodens kassaflöde, tkr -4 818 8 995 31 556
Periodens kassaflöde per aktie (SEK) -3,00 1,25 3,75
Likvida medel, tkr 28 802 11 058 33 620
Resultat per aktie före och efter utspädning (SEK) -0,46 -0,55 -2,06
Eget kapital per aktie (SEK) 3,33 1,77 3,79
Soliditet, % 90% 91% 92%

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. I och med Covid-19 pandemin har många länder kommit till insikt av vikten att själva ta ansvar för vaccinproduktion, inte minst många länder på den afrikanska kontinenten. Vår lösning, som finns beskrivet i ett sk White Paper på vår hemsida, av en Fill & Finish produktionsanläggning kan därför komma att passa mycket bra.

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

Ziccums fokus beskrivs i tre huvudområden. Utveckling av termostabila formuleringar av vacciner, förberedelser för produktion i kommersiell skala och externa samarbeten med industriella aktörer som utvecklar vacciner och dessutom, för branschen, mycket viktiga ”non-governmental organizations”.

Trots Covid-19 fortsätter vårt interna arbete med att utveckla termostabila formuleringar av vacciner. I samarbete med vår akademiska partner, det inom virus och vacciner världsledande universitetet i Marseille pågår nu flera intressanta och viktiga projekt. Resultaten är mycket lovande och stämmer väl överens med det vi sett tidigare. Vårt arbete med att utveckla ett system för produktionsmiljö framskrider väl, och vi har även arbetat med simulering av processen som tillsammans har gett oss en djupare insikt inför kommersiell produktion.

Vi har två huvudmål för 2021, dels att ta fram konkreta planer för att bygga och etablera Fill & Finish produktionsanläggning för fyllning och slutförpackning av vacciner i Sverige, dels fortsätta med att licensiera ut vår teknologi. Målet att ingå ett licensavtal kvarstår från föregående år. Licensintäkter utgör fortsatt en central del i Ziccums affärsmodell. Ett licensavtal skulle validera LaminarPace och vara ett tydligt kvitto på det kommersiella värdet i Ziccums erbjudande. Vi är naturligtvis glada över att ha ingått en förlängning av vårt samarbetsavtal med Janssen, som ägs av Johnsson & Johnsson, för vidare utvärdering av vår teknologi i kombination med deras vaccinprogram. Vi förväntas oss kunna komma med nya uppdateringar om detta projekt under årets andra hälft. Vi har redan presenterat ett detaljerat förslag på hur en Fill & Finish produktionsanläggning baserad på vår teknologi kommer att se ut. Responsen från branschens aktörer har varit positiv och vi knyter hela tiden nya kontakter med potentiella nyckelspelare för att kunna genomföra projektet. Vi har visat att en Fill & Finish produktionsanläggning baserad på vår LaminarPace teknologi har potential att leda till stora kostnadsbesparingar i jämförelse med konventionell frystorkningsteknologi, i tillägg till det faktum att torra vacciner kan produceras utan beroende av den kostsamma och komplicerade kylkedjan.

Vacciner är en lågkostnadsprodukt i stora delar av världen, därför är dessa resultat så viktiga. Nu när vi kan beskriva en produktionsanläggning, har vi utvidgat vår affärsmodell och lagt till ytterligare möjligheter till intäkter. Vi kan nu föra en annan typ av diskussion med både leverantörer av bulkvacciner och Internationella organisationer verksamma inom vacciner. Ambitionen att etablera en produktionsanläggning för torra vacciner innebär också att vi nu lägger mycket fokus på 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.

Vi fortsätter också att utveckla vårt kommersiella arbete genom att aktivt bearbeta och föra dialog med olika företag, intresseorganisationer och även nationer som verkar för ett bättre upptag av vaccinationer världen över. Vi kommer allt djupare in i dessa relationer och vi har stora förhoppningar om att kunna formalisera ett eller flera samarbeten under det kommande året.

Det är även naturligtvis mycket glädjande att vi alldeles nyligen blivit upptagna som medlemmar i den amerikanska organisationen NIIMBL (The National Institute for Innovations in Manufacturing Biopharmaceuticals). Ett av NIIMBLs huvudsyfte är att ytterst förstärka amerikansk konkurrenskraft inom tillverkning av biologiska läkemedel, och vi får nu direktkontakt med den tunga amerikanska biotech industrin. För att bli medlem måste man i princip ha någon form av verksamhet i USA, vilket vi inte har, men ibland gör de undantag för bolag med särskild intressant teknologi. I och med medlemskapet så har vi också rätt att ansöka US federala anslag som kanaliseras genom NIIMBL och vi kan bli inbjudna att delta direkt i projekt utan att behöva göra ansökningar.

Sammanfattningsvis är vi väl positionerade för en mycket spännande framtid i en bransch som kommer att ha ett mycket stort fokus under lång tid framöver.

Lund den 23 april 2021
Göran Conradson
VD

Läs hela rapporten HÄR.

Pressmeddelandet har ingivits för publicering av bolagets CEO kl. 08.45 (CET) den 23 april 2021.

ZICCUM AB Delårsrapport Q1 2020

Sammanfattning av delårsrapport för Ziccum AB (publ)- första kvartalet 2020.

Sammanfattning av delårsrapporten – första kvartalet 2020

Ziccum annonserade ytterligare ett tredje samarbete med en industriell partner, en partner som utvecklar en ny effektivare metod att producera mässlings- och rubella vacciner. Målsättningen är att både kraftigt sänka kostnaden och öka tillgängligheten av dessa barnvacciner. Vi har även skrivit ett konfidentialitetsavtal med en viktig så kallad NGO (Non-Govermental Organsiation) för vidare och mer detaljerade diskussioner om vår hur teknologi kan hjälpa de mest utsatta.

Jan-mar 2020

Nettoomsättning 0 tkr (0)
Rörelseresultat -3 980 tkr (-1 689)
Resultat per aktie före och efter utspädning -0,55 SEK (-0,28)

Väsentliga händelser under det första kvartalet 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

Det har inte inträffat några väsentliga händelser efter rapportperioden

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.

Vårt senast (26 mars) annonserade samarbete är med en industriell partner som utvecklar en ny produktionsprocess för vaccin mot mässling och röda hund. Antalet mässlingsfall mer än fördubblades under 2018 och barn under 5 år är de som har högsta dödligheten. Enligt UNICEF måste mässlingsvaccinering öka kraftigt. För att förhindra fler mässlingsutbrott rekommenderar WHO en vaccinationsgrad på 95% av alla nyfödda barn, framförallt de två doser som behövs för fullgott skydd. Nuvarande vaccinationsgrad ligger på 85% för den första dosen, men bara 67% för den andra.

UNICEF pekar på att det globala behovet av antal mässlingsdoser ligger på 450 miljoner per år, medan endast 270 miljoner doser produceras per år. Detta förklaras av bristande produktionskapacitet och att vacciner förstörs under transport och hantering. För närvarande kräver vacciner omfattande, kostsamma och vidsträckta kyltransporter i fattiga, oftast varma länder och till ytterst otillgängliga platser.

UNICEF uppskattade den totala marknaden för mässlingsvacciner till 450 Miljoner USD under 2018.

Ziccum har en världsunik och patenterad teknologi – LaminarPaceTM – 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.

Trots Covid-19 fortsätter vårt arbete i labbet med att utveckla nya formuleringar och genomföra stabilitetsanalyser som sedan kan ligga till grund för nya patentansökningar och partnerskap. Vidareutvecklingen av vårt produktionssystem med fokus på att förbereda för framtida produktion av vacciner i kommersiell skala pågår också enligt plan och utan att påverkas av Covid-19. Vi fortsätter att utveckla vårt kommersiella arbete genom att samarbeta med olika policygrupper som verkar för ett bättre upptag av vaccinationer världen över, för att på så sätt öka kunskapen om betydelsen av vår metod. Vi tycker oss få ett större genomslag och uppmärksamhet. Vi har exempelvis skrivit ett konfidentialitetsavtal med en sådan organisation för att fördjupa diskussionerna. Europeiska tillverkande vaccinbolag känner väl till oss och vi börjar få kontakt med amerikanska. Dialogen med våra partners, bland annat våra två tidigare utvärderingsavtal fortsätter också. Här kan vi dock konstatera att pandemin kommer att leda till fördröjningar då dessa aktörer i nuläget lider av begränsad tillgång till sina lab.

Sammanfattningsvis kan jag även detta kvartal konstatera att vi är på god väg att leverera på mål för innevarande år och för att positionera Ziccum för en mycket spännande framtid i en bransch som kommer att ha ett mycket stort fokus under lång tid framöver – vi har ingått tre utvärderingsavtal med industriella aktörer för att utveckla torra, stabila, vaccinformuleringar, vi har en världsledande akademisk partner som kommer att stärka vår teknologi och patentportfölj ytterligare och vi har processer och projekt på plats för att utveckla en kommersiell version av vårt produktionssystem. Nu ser vi fram emot att hålla en fortsatt hög utvecklingstakt av vår konkurrenskraftiga metod där vi kan generera betydande patientnytta såväl som värdeskapande för våra aktieägare.

Lund den 17 april 2020

Göran Conradson

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 17 april 2020.

ZICCUM AB First Quarter Report, Q1 2020

Summary of Interim First Quarter Report 2020: Further industrial and NGO collaborations.

Summary of Interim First Quarter Report 2020

Ziccum announced a further, third collaboration with an industrial partner that is developing a new, more effective method of producing measles and rubella vaccines. The goal is to both significantly reduce the cost, and increase the availability, of these childhood vaccines. We have also signed a confidentiality agreement with an important non-governmental organization (NGO) for further and more detailed discussions about how technology can help the most vulnerable.

JanuaryMarch 2020

Net sales SEK 0 thousand (0)
Operating profit SEK -3 980 thousand (-1 689)
Earnings per share before and after dilution SEK -0.55 SEK (-0.28)

CEO Statement

Vaccination is, and has always been, one of the best ways to prevent pandemics and epidemics. The need for vaccination has never been greater than it is today. New global travelling habits, population growth, climate change, rapid urbanization-they all increase the potential risk of epidemics and pandemics. And children are the most vulnerable: one in five children still do not receive adequate vaccine protection. Approx. 1.5 million children die every year from vaccine-preventable diseases.

Our most recently announced collaboration (March 26) is with an industrial partner who is developing a new production process for measles and rubella vaccine. The number of measles cases more than doubled in 2018, with children under five having the highest mortality. According to UNICEF, measles vaccination has to increase significantly. In order to prevent more measles outbreaks, the WHO recommends a vaccination rate of 95% for all newborn babies, especially the two doses needed for full protection. The current vaccination rate is 85% for the first dose, but only 67% for the second.

UNICEF points out that globally 450 million doses of measles vaccines are needed, yet presently only 270 million doses a year are produced. This is explained by a lack of production capacity, and the destruction and waste of vccines during transport and handling. At present, vaccines require extensive, costly and extensive refrigerated transport to reach the poor, usually hot and often extremely inaccessible places where they are needed most.

UNICEF estimated the total measles vaccine market to be worth 450 million USD in 2018.

Ziccum has a globally unique, patented technology – LaminarPaceTM – that allows us to produce vaccines in dry powder form, which is not practically possible or economically feasible using conventional vaccine formulation technologies. The benefits of dry powder vaccines are many. Dry powder formulation increases the stability and shelflife of the vaccine, so facilitating the entire supply chain from factory to field patient and enabling vaccines to reach new sites where, for example, refrigeration and freezer storage is a major challenge. The overall result is more people vaccinated, at a lower cost.

Despite Covid-19, our own work in the lab continues, as we develop new formulations and carry out stability analyses that can form the basis for new patent applications and partnerships. The further development of our production system, focusing on preparing for future production of vaccines on a commercial scale, is also proceeding according to plan, without being impacted by Covid-19. We continue to develop our commercial work by collaborating with a range of policy groups that are working to improve vaccination coverage worldwide. We have, for example, signed a confidentiality agreement with a vaccine NGO in order to deepen discussions. European vaccine manufacturers now know us, and we are starting to make contact with American vaccine developers. The dialogue with our current partners, including our two previous evaluation agreements, also continues but we can state that the current coronavirus pandemic will lead to delays as these organizations are currently suffering from limited access to their labs.

In summary, we are well on our way to delivering this year's goals on target, whilst positioning Ziccum well for an exciting future in an industry that will have a strong focus for a long time to come – we have entered into three evaluation agreements with industrial players to develop stable, dry powder vaccine formulations, we have a world-leading academic partner who will continue to strengthen our technology and patent portfolio, and we have processes and projects in place to develop a commercial version of our product. We now look forward to maintaining a continued high rate of development for our competitive technology, enabling us to generate new. significant patents and create exceptional value for our shareholders.

Lund, April 17, 2020

Göran Conradson

CEO, Ziccum AB

 READ THE WHOLE REPORT, IN SWEDISH, 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 April 16 2020.

Ziccum Q1 Report 2019 released

(Stockholm May 9, 2019)  Ziccum AB today releases its Q1 Report for 2019. The Report is now available on the company’s website.

Summary of interim report – first quarter 2019: Successful development of a dry, temperature-stable formulation of Adenovirus resulted in a filed patent application and a significant milestone for Ziccum. Dialogue with potential Customers and partners continue with increased intensity, and an application has been submitted to Horizon 2020 step 2.

January – March 2019

Net sales SEK 0,0 (190)

Operating profit SEK -1,689 thousand (-137)

Earnings per share before and after dilution SEK -0.28 (-0.05)

Significant events during First Quarter 2019

  • Ziccum reported on January 10, 2019 that the company had filed the patent application for Adenovirus with dry and temperature-stable formulation that meets WHO"s CTC status requirements. The dry formulation ("powder") generated by Ziccum"s technology in LaminarPace© is rapidly dissolved when adding sterile water after which vaccination or treatment can be performed.
  • During the first quarter of 2019, we submitted our Phase 2 application for Horizon 2020

For further information please visit www.ziccum.com

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.

The information above was provided by Ziccum AB (publ) through the above contact person, for publication on May 9, 2019.

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