Regulatory Archives - Page 10 of 21

KALLELSE TILL ÅRSSTÄMMA I ZICCUM AB (PUBL)

Aktieägarna i Ziccum AB (publ), org.nr 559107-9412, (”Bolaget”) kallas härmed till årsstämma den 24 maj 2023 kl. 11.00 i Hörsalen i Bolagets lokaler på Scheelevägen 22 i Lund. Rösträttsregistrering startar kl. 10.30.

Rätt till deltagande
Rätt att delta vid årsstämman har den som dels upptagits som aktieägare i den av Euroclear Sweden AB förda aktieboken den 15 maj 2023, dels anmäler sin avsikt att delta senast den 17 maj 2023. Anmälan ska ske skriftligen via e-post till ziccum@fredersen.se eller per post till Ziccum AB (publ) c/o Fredersen Advokatbyrå, Turning Torso,
211 15 Malmö. Vid anmälan ska namn, adress, person- eller organisationsnummer samt telefonnummer, samt, i förekommande fall, antal biträden (högst två) anges.

Förvaltarregistrerade aktier
Aktieägare som har sina aktier förvaltarregistrerade, dvs. förvarade i en depå genom bank eller värdepappersinstitut, måste registrera aktierna i eget namn för att bli upptagen som aktieägare i framställningen av aktieboken. Sådan registrering, som kan vara tillfällig, måste vara verkställd senast den 17 maj 2023, vilket innebär att aktieägaren i god tid före detta datum måste instruera förvaltaren härom.

Ombud
Om aktieägare avser låta sig företrädas på stämman av ombud ska fullmakt utfärdas för ombudet. Fullmakten ska vara skriftlig, daterad och undertecknad av aktieägaren. Om aktieägaren är en juridisk person ska kopia av registreringsbevis eller motsvarande behörighetshandling bifogas anmälan. Fullmakt i original samt registreringsbevis och andra behörighetshandlingar bör i god tid före stämman insändas till Bolaget på den ovan angivna adressen. Om fullmakt och andra behörighetshandlingar inte insänts i förväg ska dessa kunna uppvisas vid stämman. Fullmaktsformulär finns tillgängligt hos Bolaget och på www.ziccum.com och sänds på begäran till aktieägare som uppger sin postadress.

Förslag till dagordning

Förslag till dagordning
1.                 Stämmans öppnande
2.                 Val av ordförande vid stämman
3.                 Upprättande och godkännande av röstlängd
4.                 Godkännande av dagordning
5.                 Val av en eller två justeringspersoner
6.                 Prövning av om stämman blivit behörigen sammankallad
7.                 Anförande av verkställande direktören
8.                 Framläggande av årsredovisningen och revisionsberättelsen
9.                 Beslut om
a)     fastställelse av resultaträkningen och balansräkningen
b)     dispositioner av Bolagets resultat enligt den fastställda balansräkningen
c)     ansvarsfrihet för styrelseledamöterna och verkställande direktören
10.              Beslut om antal styrelseledamöter och revisorer
11.              Fastställelse av styrelse- och revisorsarvoden
12.              Val av styrelseledamöter
13.              Val av styrelseordförande
14.              Val av revisor
15.              Beslut om principer för utseende av valberedning
16.              Beslut om bemyndigande för styrelsen att emittera aktier, teckningsoptioner eller konvertibler
17.              Styrelsens förslag till beslut om långsiktigt prestationsbaserat incitamentsprogram 2023 för medarbetare i Bolaget
a)     Antagande av LTI 2023:1
b)     Emission av teckningsoptioner och godkännande av överlåtelse/disposition av teckningsoptionerna till deltagare och tredje part
18.              Stämmans avslutande

Beslutsförslag

Val av stämmoordförande, styrelse, styrelseordförande och revisor, fastställande av arvoden samt beslut om valberedning (punkt 2 samt 10-15)
Förslag avseende beslut enligt punkterna 2 samt 10-15 kommer att redovisas i pressmeddelande före årsstämman.
Styrelsens förslag

Beslut om dispositioner av Bolagets resultat (punkt 9 b)
Styrelsen föreslår att ingen utdelning lämnas för räkenskapsåret 2022.

Beslut om bemyndigande för styrelsen att emittera aktier, teckningsoptioner eller konvertibler (punkt 16)
Styrelsen föreslår att stämman bemyndigar styrelsen att, vid ett eller flera tillfällen före nästa årsstämma, med eller utan avvikelse från aktieägarnas företrädesrätt, besluta om nyemission av aktier eller emission av konvertibler eller teckningsoptioner. Emission ska kunna ske mot kontant betalning, apport eller kvittning eller i annat fall på villkor som avses i 2 kap. 5 § andra stycket 1–3 och 5 aktiebolagslagen. Antalet aktier som ska kunna ges ut, eller, vid emission av konvertibler eller teckningsoptioner, tillkomma efter konvertering eller utnyttjande, med stöd av bemyndigandet ska vara begränsat till 30 procent av det vid tidpunkten för denna stämma antalet utestående aktier.

Syftet med bemyndigandet är att öka Bolagets finansiella flexibilitet och styrelsens handlingsutrymme. Om styrelsen beslutar om emission utan företrädesrätt för aktieägarna så ska skälet vara att kunna bredda ägarkretsen, anskaffa eller möjliggöra anskaffning av rörelsekapital, öka likviditeten i aktien, genomföra företagsförvärv eller anskaffa eller möjliggöra anskaffning av kapital för företagsförvärv.

Styrelsens förslag till beslut om långsiktigt prestationsbaserat incitamentsprogram för medarbetare i Bolaget (punkt 17)
Styrelsen för Bolaget föreslår att bolagsstämman beslutar att inrätta ett prestationsbaserat incitamentsprogram för vissa anställda och konsulter inom Bolaget (”LTI 2023:1”) i enlighet med punkterna 17 (a) och (b) nedan.

Syftet med förslaget är att skapa förutsättningar för att behålla samt öka motivationen hos ledande befattningshavare, anställda och nyckelpersoner i Bolaget. Styrelsen anser att det ligger i samtliga aktieägares intresse att sådana personer, vilka bedöms vara viktiga för Bolagets utveckling, har ett långsiktigt intresse av en god värdeutveckling på aktien i Bolaget. Genom det föreslagna programmet skapas ett långsiktigt ägarengagemang, vilket förväntas stimulera ett ökat intresse för verksamheten och resultatutvecklingen i sin helhet.

Programmet löper under tre år och innebär att deltagarna vederlagsfritt tilldelas personaloptioner som ger rätt till att förvärva aktier i Bolaget till en teckningskurs motsvarande aktiens kvotvärde. LTI 2023:1 ger även deltagarna möjlighet att välja att delvis tilldelas syntetiska optioner som ger rätt till kontant ersättning istället för aktier.

Styrelsens förslag om införande av LTI 2023:1 enligt punkt 17 (a) och (b) nedan utgör ett sammantaget förslag och ska fattas som ett beslut.

Nedan beskrivs de närmare villkoren och principerna för LTI 2023:1.

Punkt 17 (a) – Antagande av LTI 2023:1

För LTI 2023:1 ska följande villkor gälla:

1. Högst 324 000 personaloptioner ska kunna tilldelas deltagarna i LTI 2023:1. Tilldelningen av personaloptioner ska kunna ske fram till årsstämman 2024 för att möjliggöra att även nya rekryteringar kan erbjudas personaloptioner inom ramen för villkoren nedan.

2. LTI 2023:1 ska omfatta högst 10 anställda och konsulter i Bolaget. Deltagarna är indelade i olika kategorier baserat på deras respektive roller inom Bolaget. Fördelningen av personaloptioner framgår av nedan:

Verkställande direktören kan erbjudas högst 100 000 personaloptioner;
Ledningsgrupp 1, bestående av högst 1 person, kan erbjudas sammanlagt högst 50 000 personaloptioner;
Ledningsgrupp 2, bestående av högst 3 personer, kan erbjudas sammanlagt högst 99 000 personaloptioner, varvid varje person inom kategorin kan erbjudas högst 33 000 personaloptioner; samt
Övriga anställda och nyckelpersoner, bestående av högst 5 personer, kan erbjudas sammanlagt högst 75 000 personaloptioner, varvid varje person inom kategorin kan erbjuds högst 15 000 personaloptioner.

De tilldelade personaloptionerna tjänas in efter tre år, räknat från första tilldelningstillfället.

3. I samband med att erbjudande om deltagande i LTI 2023:1 lämnas, har deltagaren möjlighet att välja om personaloptionerna delvis ska tilldelas som syntetiska optioner. Varje syntetisk option ger deltagaren rätt att erhålla en kontant utbetalning motsvarande värdet av en aktie vid utbetalningstillfället. Varje deltagare har rätt att växla maximalt 40 procent av tilldelade personaloptioner till syntetiska optioner.

4. Tilldelning av personaloptioner och kontant utbetalning motsvarande eventuella syntetiska optioner förutsätter att (i) deltagarens anställning eller uppdrag hos Bolaget inte har avslutats eller sagts upp, med vissa undantag, samt (ii) att deltagaren har ingått separat avtal gällande personaloptionerna och de syntetiska optionerna med Bolaget. Styrelsen ska tillse att avtalen med deltagarna innehåller bestämmelser om att optionerna och de syntetiska optionerna inte kan överlåtas eller pantsättas samt att, med vissa undantag, ej intjänade personaloptioner och syntetiska optioner förfaller värdelösa i samband med att deltagarens anställning eller uppdrag hos Bolaget upphör.

5. Personaloptionerna eller syntetiska optioner ska tilldelas deltagarna vederlagsfritt.

6. Förutsatt att personaloptioner tilldelats och intjänats, samt förutsatt uppfyllandet av prestationsvillkor, berättigar varje personaloption innehavaren att under tiden från och med den 1 juni 2026 till och med den 30 juni 2026 enligt Bolagets bestämmande, antingen (a) förvärva en (1) aktie till ett pris motsvarande kvotvärdet på aktien (Bolaget nuvarande kvotvärde är 0,17 kronor per aktie) eller (b) vederlagsfritt erhålla en teckningsoption som berättigar till teckning av en (1) aktie i Bolaget till en teckningskurs motsvarande kvotvärdet på aktien.

7. Deltagande i LTI 2023:1 förutsätter dels att sådant deltagande lagligen kan ske, dels att sådant deltagande enligt Bolagets bedömning kan ske med rimliga administrativa kostnader och ekonomiska insatser.

8. Styrelsen ska ansvara för den närmare utformningen av avtalen med deltagarna och hanteringen av LTI 2023:1. I samband därmed ska styrelsen äga rätt att göra anpassningar för att uppfylla särskilda regler eller marknadsförutsättningar utomlands. Styrelsen äger vidare i extraordinära fall rätt att begränsa omfattningen av eller i förtid avsluta LTI 2023:1, helt eller delvis.

9. Antalet aktier som varje personaloption kan berättiga till förvärv av eller syntetisk option kan berättiga kontant utbetalning motsvarande, ska omräknas i händelse av aktiesplit, företrädesemission och liknande bolagshändelser med målsättningen att det ekonomiska värdet av en personaloption respektive syntetisk option inte ska påverkas av sådana händelser.

Utspädning och kostnader m m

Den maximala utspädningen för befintliga aktieägare till följd av LTI 2023:1, inklusive teckningsoptioner som kan komma att emitteras till följd av säkringsåtgärder på grund av sociala avgifter som kan uppstå, är 2,88 procent av totala antalet aktier i Bolaget. Utspädningen har beräknats såsom antalet tillkommande aktier i förhållande till befintligt antal jämte tillkommande aktier.

Med beaktande även av andra incitamentsprogram i Bolaget kan den maximala utspädningen komma att bli 6,66 procent. För en beskrivning av Bolagets övriga långsiktiga incitamentsprogram hänvisas till Bolagets hemsida, www.ziccum.com.

Optionerna kommer att kostnadsföras som personalkostnader över intjänandeperioden, utan påverkan på Bolagets kassaflöde. Om personaloptioner utnyttjas kommer LTI 2023:1 därutöver att medföra kostnader i form av sociala avgifter. De totala kostnaderna för sociala avgifter beror dels på deltagarens anställningsförhållande, dels hur många optioner eller syntetiska optioner som tjänas in, dels på värdet av den förmån som deltagaren slutligen erhåller, dvs. optionernas eller de syntetiska optionernas värde vid utnyttjandet 2026. Sociala avgifter kommer att kostnadsföras i resultaträkningen under intjänandeperioden. Bolaget avser att säkra hela kostnaden för sociala avgifter genom en emission av teckningsoptioner på det sätt som framgår av styrelsens förslag enligt punkt 17 (b) nedan, vilka kan komma att utnyttjas av en finansiell mellanhand i samband med utnyttjandet av personaloptionerna. Om Bolaget väljer att genomföra sådana säkringsåtgärder kommer inte de sociala avgifterna att påverka Bolagets kassaflöde.

Baserat på antagandet att samtliga optioner som ingår i LTI 2023:1 tjänas in, en antagen aktiekurs om 7,17 kronor vid utnyttjandet av optionerna eller syntetiska optionerna och en antagen genomsnittlig procentsats för sociala avgifter om cirka 31,42 procent, beräknas de totala kostnaderna för programmet, inklusive sociala avgifter, att uppgå till 2,5 miljoner kronor, vilket motsvarar cirka 27 procent av Bolagets totala lönekostnader för anställda (inklusive sociala avgifter) beräknat på lönekostnaderna för räkenskapsåret 2022.

Beredning av förslaget

Styrelsen har utarbetat LTI 2023:1 i samråd med externa rådgivare.

Punkt 17 (b) – Emission av teckningsoptioner och godkännande av överlåtelse/disposition av teckningsoptionerna till deltagare och tredje part

Styrelsen föreslår att Bolaget ska emittera högst 425 801 teckningsoptioner, varav 324 000 teckningsoptioner ska emitteras för att säkerställa leverans av aktier, teckningsoptioner eller kontant vederlag till deltagarna i LTI 2023:1 enligt villkoren för programmet, och 101 801 teckningsoptioner ska emitteras för säkring av Bolagets exponering mot kostnader för sociala avgifter som kan uppstå till följd av utnyttjandet av personaloptioner. Aktiekapitalet kan öka med högst 72 386,17 kronor.

1. Rätt att teckna de nya teckningsoptionerna ska, med avvikelse från aktieägarnas företrädesrätt, endast tillkomma Bolaget. Vidareöverlåtelse av 324 000 teckningsoptioner ska kunna ske, vid ett eller flera tillfällen, till deltagarna i LTI 2023:1 eller annars till tredje part för att leverera aktier eller kontant vederlag till deltagarna, i enlighet med villkoren för LTI 2023:1. Vidareöverlåtelse av 101 801 teckningsoptioner ska kunna ske till tredje part med vilken/vilka Bolaget ingått en överenskommelse i syfte att inbringa kapital för täckning av sociala avgifter kopplade till utnyttjandet av personaloptioner.

2. Skälet för avvikelsen från aktieägarnas företrädesrätt är införandet av LTI 2023:1.

Teckningsoptionerna emitteras vederlagsfritt.
Teckning av teckningsoptionerna ska ske inom två månader från dagen för emissionsbeslutet. Styrelsen äger rätt att förlänga teckningstiden.
Teckningsoptionerna ska ge rätt att teckna aktier under en period som löper från och med den 1 juni 2026 till och med den 30 juni 2026.
Varje teckningsoption ska berättiga till teckning av en (1) aktie till en teckningskurs motsvarande kvotvärdet på aktien. Omräkning ska kunna ske i enlighet med de fullständiga villkoren för teckningsoptionerna. Eventuell överkurs ska tillföras den fria överkursfonden.

3. De nyemitterade aktierna ska medföra rätt till utdelning första gången på den avstämningsdag som infaller närmast efter det att aktieteckning verkställts.

4. För teckningsoptionerna ska i övrigt gälla de villkor som framgår av de fullständiga villkoren för teckningsoptionerna.

Styrelsen, eller den styrelsen utser, föreslås bemyndigas att vidta de smärre justeringar som kan visa sig nödvändiga i samband med registreringen av beslutet hos Bolagsverket.

Majoritetskrav
För giltigt beslut under punkten 16 krävs att det biträds av aktieägare med minst två tredjedelar av såväl de avgivna rösterna som de vid stämman företrädda aktierna. För giltigt beslut under punkten 17 krävs att det biträds av aktieägare med minst nio tiondelar av såväl de avgivna rösterna som de vid stämman företrädda aktierna.

Övrig information
Vid tidpunkten för denna kallelse uppgår det totala antalet aktier och röster i Bolaget till 13 806 142. Bolaget innehar inga egna aktier.

Årsredovisning och revisionsberättelse, fullmaktsformulär, styrelsens fullständiga förslag samt relaterade handlingar kommer att hållas tillgängliga hos Bolaget och på Bolagets hemsida åtminstone tre veckor före stämman. Handlingarna sänds på begäran till aktieägare som uppger sin postadress.

Aktieägarna erinras om sin rätt att begära upplysningar enligt 7 kap 32 § aktiebolagslagen.

Bolaget har sitt säte i Lund.

Behandling av personuppgifter
För information om hur dina personuppgifter behandlas se
https://www.euroclear.com/dam/ESw/Legal/Integritetspolicy-bolagsstammor-svenska.pdf

Lund i april 2023
Ziccum AB (publ)
Styrelsen

KALLELSE TILL ÅRSSTÄMMA I ZICCUM AB (PUBL)

ZICCUM AB (publ) releases Annual Report 2022

Ziccum’s Annual Report for 2022 is available from today on the company’s website, www.ziccum.com To read the digital Report in full (in Swedish) click here: https://reports.ziccum.com/arsredovisning-2022/ziccum-2022/

Ziccum’s Annual Report for 2022 (in Swedish) is now available on www.ziccum.com
Read the digital Report (in Swedish) here: https://reports.ziccum.com/arsredovisning-2022/ziccum-2022/

About Ziccum

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

Ziccum Årsredovisning 2022 FINAL

ZICCUM AB (publ) Year-end report Q4 2022

YEAR-END REPORT Q4 2022: 1 JANUARY – 31 DECEMBER 2022

To read the digital Report, please click here:
https://reports-en.ziccum.com/year-end-report-q4-2022/start/

Significant events in Q4 (October – December)

On October 24, Ziccum announced proof of successful nebulization and drying of vaccine lipid nanoparticles (LNP) in its in-house mRNA project. This was carried out using LaminarPace, the company’s ambient drying technology. LNP is the preferred drug delivery component in today’s mRNA Covid-19 vaccines. The study resulted in a defined knowledge-space, defining the best operating conditions, and key read-out parameters were encapsulation efficiency, yield and particle size. The trials were repeated for confirmation.

On December 8, it was announced that Ziccum has signed an agreement contracting the ICP Institute of Computational Physics at the Zurich University of Applied Sciences’ School of Engineering (ZHAW) for the next phase of the project developing 3D modelling of LaminarPace. The project aims to accelerate industrial development of LaminarPace and will run over three years. The team at ZHAW is one of the most recognized internationally within industrial simulation and modelling.

On December 14, Ziccum launched a new, expanded website. With a new brand platform, the expanded site aims to strengthen the company’s dialogue with biopharmaceutical partners and prospects. It includes new technological, scientific and business content, and improved navigability.

On December 16, it was announced that Ziccum has been awarded a contribution of 10 mSEK by Eurostars for a joint grant application with ZHAW. Eurostars is the largest international funding programme for SMEs wishing to collaborate on R&D projects, and is co-funded by the EU Horizon 2020 Framework Programme and EUREKA. Ziccum will receive payments of 5 mSEK from the national funding body Vinnova during the project, they are consented to cover up to 50% of a project's costs. The rest of the contribution will go into the project and reduce the total project cost for Ziccum. The three year long project (LaPaSim) starts February 1 2023, and is to apply 3D-modelling to Ziccum’s ambient drying system for biopharmaceuticals, LaminarPace, resulting in a digital twin. International competition for the funding was intense, and the proposal was one of the highest-ranked applications.

During the fourth quarter CEO Ann Gidner bought 45,000 shares in Ziccum.

CEO statement

Creating a strong industry position in a booming market

It has been a very rewarding year for Ziccum (or eight months for my part), making such big strides towards a position as a top rank provider of game- changing technology to the international pharmaceutical industry, where achieving thermostable vaccines is highly desirable.

Setting the Ziccum direction

Defining a sharper strategy with selected vaccine platforms, and most importantly the high value next- generation mRNA vaccines and RNA therapeutics as top priority, has given consistent positive confirmations – from partnering dialogues, from our Biopharma licensing mRNA Market study and from our own internal trial results. We are confident going forward with this key focus.

The new business model defined, a classical Pharma out-licensing model starting with feasibility studies, has been well received and gives crisp clarity to business development efforts ahead. Given the strong interest in partnering dialogues, we have the Pharmaceutical Platform technology company business model strongly confirmed, giving licenses internationally, not producing as a contractor.

Pivotal transformation of the vaccine field and new applications of mRNA technology

Externally, the vaccine industry has gone through a complete transformation. From being a conservative, low margin segment of the Pharma industry, it has become a hot spot for rapid development, where existing players increase efforts significantly, and numerous new players want to enter the market. The Covid pandemic brought completely new insights, fuelling a strong industry desire for new vaccine development as well as for applying the novel mRNA approach in a range of new fields, like cancer vaccines and personalized therapeutics.

Business development progress

The booming market demand for new vaccine technology in combination with Ziccum’s unique drying concept enabling thermostable vaccines, now proven in a number of steps, makes for a great opportunity. Thanks to a clearly business-driven approach and an extensive industry network we are taking advantage of this, generating a significant number of partnering dialogues at four international conferences during fall. These are now pursued with in-depth dialogues going forward.

Proving the LaminarPace ability for mRNA/LNP

Getting the proof of successful drying of vaccine LNP particles at this point was most welcome. The LaminarPace drying has given good read-outs in terms of encapsulation, yield and particle preservation: keeping the LNP particles nicely in good shape and staying the correct size. We are delighted to bring these results to our business dialogues, and we are now setting up continued trials regarding vaccine activity; the verification that dried vaccine material is not only kept in good condition in high yields, but also giving a similar vaccine activity effect.

Developing ground-breaking technology, the smartest way

As novel, unique technology certainly needs development efforts, we took the important decision to run a multi-year 3D-Modelling project with a leading partner, the Zurich Institute of Applied Sciences. This way we efficiently come forward using the latest digital methods. We can run all the trials we want digitally, instead of a few selected, time-consuming physical trials. Ultimately, the project will also result in a Digital twin which can serve efficiently in tech transfer for successful process integration in the partner set-up.

We also applied to the EU organization Eurostars jointly with the Zurich Institute for soft funding of this ambitious effort, and just before Christmas we had the fantastic news of getting top ranking and receiving the full grant! This way we certainly can begin 2023 with full steam ahead.

Wrapping up 2022

An extra bonus was the launching of the new Ziccum website end of year, a total remake much better reflecting our offering: our technology and our team. Also, I was happy to present Ziccum at BioStock Life Science, getting significant interest. Finally, we had the great pleasure to expand our team with a Quality specialist, warm welcomes to Fatemeh starting in January.

Many thanks to the Ziccum team for great efforts and enthusiasm all year, taking the new strategy forward together, and to all supporting parties, owners and business partners for engaging in fruitful dialogues and supporting our efforts!

Lund, January 27, 2023

Ann Gidner, CEO

Significant events in Q1 (January-March)

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

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

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

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

On February 22, it was announced that the employment of the CEO Göran Conradson was terminated. The company's CFO, Frida Hjelmberg was appointed acting CEO.

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

1. Drive an active business development agenda that proactively prepares for collaboration with existing and potential partners. This to offer the opportunity to evaluate specific projects in combination with Ziccum's technology, and to understand the requirements placed on the technology before a decision on a license agreement can be made.

2. Generate laboratory data that manifest and confirm the technology's capacity to dry different types of vaccines, so-called proof of concept.

3. Develop the company's technology to adapt its functionality, capacity and quality to the licensees' required specifications.

4. Develop conceptual plans for how Ziccum's drying technology can be adapted to the commercial scale and integrated into a commercial production environment.

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

Significant events in Q2 (April – June)

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

1. Viral vector platform using Adenovirus – Four major Covid-19 vaccines already use adenovirus vaccine vectors as a platform. The platform enables efficient gene transduction and research is ongoing in a wide range of indications.

2. Subunit vaccine (adjuvanted) platform – This platform is also being used in major Covid-19 vaccine candidates. Instead of using the whole pathogen, protein-based adjuvant vaccines use a defined protein antigen from the pathogen which can be recognized by the body’s immune system to provoke an immune response.

3. mRNA/LNP vaccine platform – Generating data on dry-formulated mRNA/LNP materials is a key strategic priority for Ziccum. Covid-19 has highlighted the efficacy of mRNA/LNP as a vaccine platform enormously.

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

1. New powder collector – A new sealed, contained collection unit is installed that enables the inhouse study of a wider range of test substances. The new unit increases safety, reduces humidity and enables quicker, more efficient collection of drier formulations.

2. New nitrogen usage – Ziccum has now introduced Nitrogen gas (N2) into the drying column to replace air. N2 is a highly efficient remover of moisture. The first nitrogen-based generation of LAPA is installed and has performed well in tests.

3. New nebulizer – The LAPA system’s nebulizer feature is a key component in optimizing the system’s capacity, reproducibility and reliability.

4. New membrane – Intensive work is currently underway in optimizing the membrane for future GMP compatibility – examining its porosity, mounting and materials for industrial setting.

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

On May 9, it was announced that Ziccum has been elected onto the Technical Activities Committee of the US National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). NIIMBL, co-funded by the US Department of Commerce, funds and initiates a wide range of public-private research projects throughout the US.

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

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

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

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

Significant events in Q3 (July – September)

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

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

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

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

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

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

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

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

Significant events after the reporting period

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

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

Q4 2022

The result for the quarter amounted to -8 021 kSEK (-6 450 kSEK)
Cash flow for the quarter amounted to -6 642 kSEK (-7 291 kSEK)
Cash and cash equivalents at the end of the quarter amounted to 22 951 kSEK (12 273 kSEK)

Summary Financial Highlights kSEK	Oct-Dec 2022	Oct-Dec 2021	Jan-Dec 2022	Jan-Dec 2021
Net revenue	–	–	–	–
Operating result	(8 067)	(6 474)	(28 955)	(21 117)
Result for the period	(8 021)	(6 450)	(28 788)	(21 136)
Balance sheet total	33 285	36 900	33 285	36 900
Cash flow for the period	(6 642)	(7 291)	10 678	(21 347)
Cash and cash equivalents	22 951	12 273	22 951	12 273
Equity ratio %	0,88	0,81	0,88	0,81

Data per share SEK
Number of shares at the end of the period	13 806 142	11 006 056	13 806 142	11 006 056
Result per share before and after dilution*	-0,58	– 0,65	-2,09	-2,17
Cash flow per share	-0,48	– 0,73	0,78	-2,19
Equity per share	2,12	2,70	2,12	2,70

About Ziccum

Year End Report Q4 2022 FINAL (1)

Ziccum awarded 10 MSEK Eurostars funding for 3D-modeling and Digital twin project

Ziccum AB has been awarded non-dilutive funding of 10 MSEK by Eurostars for a joint application with the Institute of Computational Physics (ICP) at the School of Engineering at Zurich University of Applied Sciences (ZHAW). The project (application # 2,199 LaPaSim) is to apply 3D-modelling to Ziccum’s ambient drying system for biopharmaceuticals, LaminarPace, resulting in a digital twin. International competition for the funding was intense, and the proposal was one of the highest-ranked applications.

On September 14th, 2022 Ziccum and ZHAW announced their joint Eurostars application for funding towards a project applying 3D-modelling and developing a Digital twin of LaminarPace. Ziccum has now received notification that the project has been awarded the maximum 10 MSEK in funding. The project begun in June 2022 and will run over three years, where Ziccum is engaging the Research Area Multiphysics Modeling and Imaging team of ICP at ZHAW’s School of Engineering, led by Prof. Dr. Gernot Boiger, for advanced 3D-modeling.

The project is accelerating the industrial development, tech transfer and scaleout of LaminarPace as a unit of pharmaceutical production. As an ambient drying technology, LaminarPace uniquely is drying biopharmaceuticals by mass transfer instead of heat transfer, avoiding heat stress as well as mechanical stress to the delicate active ingredients – thus enabling high yields, thermostability and processing benefits.

Competition for the Eurostars funding was intense. The joint proposal was praised for its quality and strong business plan by the Eurostars evaluation team who pointed out the “very tough international assessment the applications go through”. The joint proposal was one of the highest-ranking projects.

The successful application is a firm validation of Ziccum’s sharpened strategic focus, technology development ambitions and new business plan. This plan encompasses critical technology optimization and the offering of new formulation and technology licenses to pharma, biotech and drug manufacturing partners.

Ziccum CEO Ann Gidner: “We are indeed happy and proud to have been awarded this grant, thanks to a high-ranking proposal developed in close collaboration with the ZHAW expert team. It is an excellent validation of our strategic focus and newly developed business plan. We used no external agency to produce this proposal – it was the product of our combined internal expertise. We look forward to moving ahead together on this important project.”

Ziccum Chairman Fredrik Sjövall: “I congratulate Ann and our team for their outstanding proposal and focused technology development. This is also a welcome financial reinforcement for Ziccum. This project is at an exciting stage in development, and I look forward to seeing it move ahead.”

About ICP and ZHAW

The Research Area Multiphysics Modeling and Imaging team of the ICP at at the School of Engineering at ZHAW is made up of 20 simulation experts, physicists, mathematicians and engineers led by Prof. Dr. Gernot Boiger. The team has carried out projects modeling particle flow across industries including pharmaceuticals, aerospace, energy, automotive and more.

About Eurostars

The Eurostars organization specializes in projects that partner SMEs such as Ziccum with larger companies, universities and research organizations. It funds R&D collaborations across 37 member countries. Eurostars is co-funded by the EU Horizon 2020 Framework Programme and EUREKA, the world’s largest public network for international cooperation in R&D and innovation.

The above is information that Ziccum is obliged to make public pursuant to EU Market Abuse Regulations (MAR). The information was submitted for publication, through the agency of the contact persons set out above, on 2022-12-16 at 20:00 CEST.

About Ziccum

Ziccum is developing new thermostable versions of vaccines and biologic materials for licensing to vaccine providers, developers and manufacturers in the global pharmaceutical industry. Ziccum’s patented drying technology, LaminarPace, is unique. It formulates next-generation biomolecules at room temperature as particle-engineered powders that are thermostable and also highly suitable for novel administration routes. LaminarPace has formulated biomolecules from mRNA to proteins, peptides, antibodies, lipids and enzymes – and worked successfully with a range of excipients, adjuvants and antigens. Ziccum is listed on the Nasdaq First North Growth Market.

Ziccum awarded 10 MSEK Eurostars funding for 3D-modeling and Digital twin project

ZICCUM AB (publ) Interim report Q3 2022

INTERIM REPORT Q3 2022: 1 JANUARY – 30 SEPTEMBER 2022.

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

Significant events during Q3 (July-September)

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

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

Significant events during Q1-Q2 (Jan-June)

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

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

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

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

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

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

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.
Generate laboratory data that manifests and confirms the technology's capacity to dry different types of vaccines, so-called proof of concept.
Develop the company's technology to adapt its functionality, capacity and quality to the licensees' required specifications.
DevelopconceptualplansforhowZiccum'sdryingtechnologycanbeadaptedtothecommercialscaleand integrated into a commercial production environment.

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

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

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

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

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

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

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

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

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

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

Significant events after the reporting period

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

CEO statement

Strategic focus reinforcement

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

Strategic focus

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

Business development and Partnering

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

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

Technology development and Feasibility studies

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

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

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

3D- Modelling and Soft funding

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

Company structure

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

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

Lund, October 27, 2022

Ann Gidner, CEO

Q3 2022

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

Summary of financial highlights

Summary Financial Highlights	July-Sept 2022	July-Sept 2021	Jan- Sept 2022	Jan-Sept 2021	Jan- Dec 2021
Net revenue	–	–	–	–	–
Operating result	(6,674)	(5,045)	(20,888)	(14,643)	(21,117)
Result	(6,599)	(5,043)	(20,767)	(14,686)	(21,136)
Balance sheet total	42,582	29,348	42,582	29,348	39,591
Cash flow	(7,054)	(6,141)	17,320	(14,056)	(21,347)
Cash and cash equivalents	29,593	19,564	29,593	19,564	12 273
Equity ratio %	0.87	0.82	0.87	0.82	0.75

Data per share SEK
Number of shares at the end of the period	13,806,142	9,806,200	13, 806,142	9,806,200	11,006,056
Result per share before and after dilution*	-0.48	– 0.51	-1.50	-1.51	-2.17
Cash flow per share	-0.52	– 0.63	1.27	-1.456	-2.19
Equity per share	2.69	2.46	2.69	2.46	2.70

* Dilution effects is not calculated when the result is negative

About Ziccum

Ziccum is developing new thermostable versions of vaccines and biologic materials for licensing to vaccine providers, developers and manufacturers in the global pharmaceutical industry. Ziccum’s patented drying technology, LaminarPace, is unique. It can dry-formulate temperature-sensitive vaccine materials at room temperature with high yields and low waste. These robust, thermostable dry powders could be stored and transported worldwide with no need for cold chain refrigeration or freezing. Ziccum is listed on the Nasdaq First North Growth Market.

Interim Report Q3 2022 FINAL

Ziccum receives results from evaluation study with leading Pharmaceutical Corporation

Ziccum AB (publ) (‘Ziccum’) has today received readout results from the latest stage of an evaluation agreement study carried out with a leading pharmaceutical corporation (previously communicated on June 3, 2022) analyzing LaminarPace’s ability to dry four test substances. Data demonstrated excellent results on thermostability, positive results on particle appearance but significant loss of infectivity, requiring further development. The client has paused assessment of LaminarPaceTM on the current vaccine platform, but will consider the technology in regard to other vaccine platforms, where dry formulation could be a higher priority.

The study analyzed LaminarPace’s ability to dry four test formulations from one of the client’s vaccine platform technologies from liquid into dry powders that would remain active and thermostable. Data were gathered from three key metrics: its virus count (an important metric of thermostability), the powder’s infectivity (its capability for vaccination efficiency), and its particle distribution. Also, the samples were exposed to so-called ‘temperature excursions’, with extended storage at both 40 and 55 degree C.

The readouts reveal that the LaminarPaceTM drying provides a very clear positive effect on thermostability, where the LaminarPaceTM technology preserves the viral particle count on excellent levels after prolonged heated storage, even in the extreme 55 degree C temperature testing. However, for the infectivity measures, this stage of testing resulted in significant loss of infectivity units, which will need further development work.

Regarding particle appearance, the LaminarPaceTM drying has given impressive particle preservation in microscopy analysis of the samples exposed to heated storage, compared to how these elevated temperatures normally are detrimental to the vaccine particles.

The study shows good potential for the LaminarPaceTM technology in vaccine drying.

Considering the need for continued development, the partner company is planning to stay with liquid formulations for the platform at hand at the present time, but will assess further information on the LaminarPaceTM technology since there are other vaccine platforms where dry formulation could be a higher priority.

Ziccum CEO Ann Gidner: “We are delighted to see this clear confirmation of thermostability, where LaminarPace is a game-changer. The activity preservation needs to be improved in further development for this vaccine platform, and we are happy to have recently implemented improved methodology for better experimental plan design, to address this and take the development forward.”

“Both parties in this collaboration learnt significantly from this process, and we achieved encouraging results. Our team at Ziccum has grown in capabilities and confidence over the course of this project, and we are delighted to have a good dialogue with our partner.”

About Ziccum

Ziccum is developing new thermostable versions of vaccines and biologic materials for licensing to vaccine providers, developers, manufactures and CDMOs in the global pharmaceutical industry. Ziccum’s patented drying technology, LaminarPace, is unique. It can dry-formulate temperature-sensitive vaccine materials at room temperature with high yields and low waste. These robust, thermostable dry powders could be stored and transported worldwide with no need for cold chain refrigeration or freezing. Ziccum is listed on the Nasdaq First North Growth Market

Ziccum receives results from evaluation study with leading Pharmaceutical Corporation

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:

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.
Generate laboratory data that manifests and confirms the technology's capacity to dry different types of vaccines, so-called proof of concept.
Develop the company's technology to adapt its functionality, capacity and quality to the licensees' required specifications.
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

About Ziccum

Interim Report Q2 2022

Ziccum AB changes its external communications language to English

The Board of Ziccum AB has decided to officially change the company’s language to English for all external market communications as from Friday May 6 2022. Key factors in the decision are that Ziccum has an extensive network of international stakeholders and operates in the intrinsically global market of vaccines.

On April 28, 2022 the Board of Ziccum AB decided to officially adopt English as its external communications language. From May 6, 2022 all investor-facing information such as Press Releases and Financial Reports, will be in English.

Ziccum has long had an extensive network of international stakeholders and operates in the intrinsically global market of vaccines. Commercially and scientifically Ziccum collaborates with a wide range of organizations beyond Sweden and identifies key opportunities in global collaborations and partnerships.

Ziccum AB changes its external communications language to English

Ziccum AB ändrar språk för informationsgivning till engelska

Styrelsen för Ziccum AB har beslutat att ändra bolagets språk till engelska för all extern marknadskommunikation från och med fredagen den 6 maj 2022. Viktiga faktorer bakom beslutet är att Ziccum har ett omfattande nätverk av internationella intressenter, och verkar på en global vaccinmarknad.

Den 28 april 2022 beslutade styrelsen för Ziccum AB att anta engelska som sitt externa kommunikationsspråk. Från och med den 6 maj 2022 kommer all information som riktar sig till investerare, t.ex. pressmeddelanden och finansiella rapporter, att vara på engelska.

Ziccum har länge haft ett omfattande nätverk av internationella intressenter och verkar på en global vaccinmarknad. Kommersiellt och vetenskapligt samarbetar Ziccum med ett brett spektrum av organisationer utanför Sverige och ser stora möjligheter i globala samarbeten och partnerskap.

Ziccum AB ändrar språk för informationsgivning till engelska

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