Ziccum reports successful mRNA/LNP Feasibility Study with major Biotech Corporation

Ziccum and its Biotech Corporation collaboration partner have now 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 confirm consistent, positive readouts in the Study’s major parameters.

 
The joint assessment meeting reviewing the readouts took place on January 9, 2024. It concluded that the LaminarPace treatment performed very successfully in the Study’s agreed-upon metrics:

mRNA activity: the assessment concluded that the resulting dry powder material demonstrated excellent mRNA activity, when reconstituted and tested in in-vitro cell studies. This is a must for the resulting mRNA treatment to have its effect, for vaccine immunisation or therapeutic effect.

Encapsulation efficiency: the assessment concluded that the LaminarPace treatment resulted in well-preserved mRNA content in LNP particles with adequate encapsulation efficiency. This is an important metric in the production economics of mRNA/LNP, preserving the very expensive mRNA materials.

Particle preservation and distribution: the assessment concluded that the treatment resulted in well preserved lipid nanoparticles with good particle size and preserved size distribution. This is important for having a final drug composition which can be administered to patients.

Product reconstitution: the partner assessment confirmed the consistent Ziccum findings that LaminarPace-treated material can be reconstituted (dissolved back into liquid) very quickly and smoothly, with no foaming, precipitation, or other practical issues.

The Ziccum evaluation and the Biotech Corporation partner’s evaluation both delivered consistent results that matched very closely.
 
Based on these clear, satisfactory results, a continued dialogue on the potential next phase of collaboration in potential applications may be initiated.

Ziccum CEO Ann Gidner: “These results, from a world-leading player in the field, confirm LaminarPace’s ability to turn mRNA/LNP liquid biological material into a thermostable dry powder, with all its advantages, retaining excellent mRNA activity in cells. This is exciting and rewarding news. We are grateful for excellent partner interaction, and our partner concluding that the collaboration was a success. Let me express my appreciation to the Ziccum team for their great efforts delivering these results”.

Ziccum Chairman Fredrik Sjövall: “It is of utmost importance to Ziccum to have this validation of the applicability of LaminarPace technology also for mRNA/LNP treatments. We are keenly looking forward to the potential of applying LaminarPace in this field, with many potential applications and partners.”

VDs Julhälsning 2023: Ett avgörande år med betydande resultat

I slutet av ett spännande och händelserikt år, sammanfattar Ziccums VD Ann Gidner de milstolpar som uppnåtts och den gedigna strategiska planen för Ziccum som ligger till grund för resultaten, samt ser fram emot ett hektiskt och dynamiskt 2024.

Kära kollegor, partners, aktieägare och vänner,

Jag vill tacka er alla för ett intensivt och mycket produktivt år tillsammans. Det är ett privilegium att få samarbeta med så engagerade människor i branschen för att ta en ny, spännande teknik framåt och förbättra läkemedelspotentialen för biologiska substanser, vilket i slutändan gynnar framgångsrika vacciner och botemedel för patienter.

Vi har gjort utmärkta framsteg och uppnått viktiga resultat:

  • Tre fullt finansierade Feasibility-studier signerade med världsledande bolag inom sina marknadssegment.
  • Mycket positiva resultat från effektivt utförda interna studier, inklusive validerade aktivitetsresultat i vårt mRNA/LNP-projekt.
  • Fortsatta framsteg i vår teknikutveckling, både i vår LaminarPaceTM-utveckling och i det digitala 3D-modelleringsprojektet LaPaSim, för att optimera tekniken, skala upp den och skapa en digital tvilling.
  • Tre nya patentansökningar med bred immaterialrättslig täckning och en betydligt förstärkt IP-position.
  • En robust pipeline för affärsdialoger, med fortsatt ökande intresse från den internationella industrin för vår teknologi.
  • Ett nytt samarbete med Köpenhamns Universitet kring inhalerbart mRNA/LNP.
  • Fortsatt organisationsutveckling som stärker Ziccums kompetens.

Som vi alla vet, bygger prestationer och framgångar alltid på tidigare professionell utblick, analys och fokuserad planering. Det här året har varit en framgångsrik implementering av den strategi och affärsmodell som vi införde för företaget under 2022.

Från de kortsiktiga målen i Ziccums färdplan till de viktiga milstolparna i vår strategiska plan för att ta vår teknik till marknaden – detta gedigna ramverk har möjliggjort framstegen under 2023, och kommer att fortsätta att göra det under 2024, i vad som blir ett hektiskt och spännande år. Vår nya affärsmodell – att erbjuda teknologilicenser till industripartners via betalda Feasibililty-studier – har framgångsrikt satts i verket, och den har redan genererat fullt finansierade avtal med världsledande bolag, vilket också tog Ziccum till intäktsgenerering under 2023.

Jag vill tacka alla kollegor, aktieägare, partners och vänner i industrin för ert fortsatta engagemang och skicka er alla varma önskningar för en härlig julledighet,

Ann Gidner
VD
Ziccum AB

CEO’s Seasons Greetings 2023: A pivotal year of significant results

At the end of an exciting and eventful year, Ziccum CEO Ann Gidner summarizes the milestones reached, the robust Ziccum Strategic roadmap underpinning them and looks forward to a busy and dynamic 2024.

Dear colleagues, partners, shareholders and friends,

I’d like to thank all of you for an intense and very productive year together. It is a privilege to be collaborating with highly committed industry professionals to take a new, exciting technology forward to improve the pharmaceutical potential for biologics, for the ultimate benefit of successful vaccines and patient cures.

We have delivered excellent progress and results:

  • Three fully funded Feasibility studies signed, with leading corporations in their sector.
  • Highly positive results from efficient internal trials, including externally validated activity confirmations in our internal mRNA/LNP project.
  • Continued progress in our technology development, in both our LaminarPaceTM development project and the digital 3D-modelling LaPaSim project, for optimizing the technology, scale-out and creating a digital twin.
  • Three new patent applications with broad intellectual property coverage and a strengthened IP position.
  • A robust Business development pipeline with increasing industry interest for our technology.
  • A new collaboration started with the University of Copenhagen on inhalable mRNA/LNP.
  • Continued organizational development, strengthening Ziccum’s capabilities.

As we all know, today’s achievements and success are always built on yesterday’s professional outlook, analysis, and focused planning. This year has been the successful realization of the strategy and business model that we put in place for the company in 2022.

From the near-term goals of the Ziccum roadmap to the key milestones in our Strategic plan taking our technology to market, this robust strategic framework has enabled the progress during 2023 and will continue to do so in 2024, in what is set to be a busy and exciting year. Our new business model – offering technology licensing to industry partners via paid feasibility studies – has been proven with great success, already generating fully funded agreements with world-leading corporations, which turned Ziccum into a revenue generating company in 2023.

I’d like to thank all colleagues, shareholders, partners, and peers for your continued commitment, and send you all warm wishes for enjoyable holidays,

Ann Gidner
CEO
Ziccum AB

Ziccum signs Academic Collaboration with University of Copenhagen on inhalable mRNA vaccine project

Ziccum AB (publ) has signed a Collaboration Agreement for a project jointly with the Department of Pharmacy, University of Copenhagen (UCPH), on the engineering of inhalable solid dosage forms of mRNA vaccines which will include in-vivo studies of mRNA/LNP materials formulated and dried using Ziccum’s unique LaminarPace. The UCPH counterpart is international vaccine Key Opinion Leader (KOL) Prof Camilla Foged, the author of 130 papers and the leader of UCPH Department of Pharmacy’s international Vaccine Design and Delivery group.

The project is of strategic significance for Ziccum, who explored collaborating with several institutions before finalizing the agreement with UCPH. It will use Ziccum’s unique formulation and drying technology for biologics, LaminarPace, which transforms delicate liquid mRNA/LNPmaterials into stable, bioactive dry powder without exposing them to extreme temperatures, stress factors or degradation – setting it apart from legacy pharmaceutical drying systems. 

The project will include in-vivo studies comparing LaminarPace-formulated solid dosage forms of mRNA/LNP materials and liquid dosage forms in head-to-head mice studies. The purpose is to further validate the LaminarPace performance academically with a potential of scientific publications.

Project phases and timeline
The project is structured in several phases from physicochemical characterization and in-vitro testing to in-vivo imaging and immunogenicity. The project will compare the solid dosage forms with liquid dosage forms in mice studies, then evaluate the most promising solid dosage forms. The project is scheduled to run 2023 – 2024.

Focus on inhaled treatments
Inhalable solid dosage forms of mRNA vaccines are of great interest to the biopharmaceutic industry. They promise increased storage stability compared to liquid formulations, simplified patient administration avoiding injections and an ability to stimulate the mucosal immune system. LaminarPace was originally developed specifically to dry liquid biologics into aerosols for inhalation. It offers particle engineering and characterization capabilities, major advantages when formulating inhalable dosage forms.

Ziccum recently reported external mRNA activity data that confirmed high activity levels and excellent in-vitro characteristics of mRNA/LNP material formulated and dried by LaminarPace. The company has recently signed agreements with two multinational Pharmaceutical Corporations for Evaluation Studies assessing LaminarPace’s capabilities on mRNA/LNP materials.

Ziccum CEO Ann Gidner: “We are excited to be partnering with UCPH’s Vaccine Design and Delivery group, an international team working on a range of vaccine delivery systems. Also, I am delighted to tie this Key Opinion Leader in vaccine development, Professor Camilla Foged, to Ziccum’s network of international, senior expertise. This is a great step to taking LaminarPace forward in new stable delivery forms for next-generation vaccines.”

Ziccum Scientific Director Fabrice Rose: “We are in a period of intensive data generation, both externally and in our internal mRNA/LNP project. This collaboration is an important part of that progress, addressing the inhalation field. We are very happy to address LaminarPace for inhaled applications in an advanced academic setting”.

Ziccum AB (publ) changes Certified Adviser to Carnegie Investment Bank AB (publ)

Ziccum today announces a change of Certified Adviser from Erik Penser Bank AB to Carnegie Investment Bank AB (publ).

Ziccum has entered into an agreement with Carnegie Investment Bank AB (publ) regarding the position as Certified Adviser. Carnegie Investment Bank AB (publ) will take over as Certified Adviser on November 30, 2023. Until then, Erik Penser Bank AB will continue to act as Certified Adviser to the company..

Feasibility studies and continued revenue generation after third agreement signed with leading industry player: CEO Interview

Ziccum’s third funded Feasibility Study signed in recent months, announced on November 7, will provide further LaminarPace data and Ziccum revenues. CEO Ann Gidner discusses how the unique formulation and drying technology of Ziccum is being evaluated by leading industry partners.

On November 7, Ziccum announced it had signed a new funded Feasibility Study with a US biomanufacturing corporation specializing in vaccine manufacturing and pandemic preparedness. The news intensified interest in the data and revenues Ziccum is generating. So, what exactly are the Projects, how are they structured and what will they deliver?

CEO Ann Gidner: “I expect substantial new data from all three of these projects that will strengthen our case and ultimately our licensing position. Each collaboration will also offer significant learnings, as the Ziccum staff interact closely with world-leading experts”.

Project summary
Project 1: Big biotech – On May 5, the company announced the signing of a Feasibility study for a major Biotechnology Corporation, focusing on assessing LaminarPace for transformation of delicate liquid mRNA/LNP material into robust dry powder that will not require cryogenic storage or delicate handling. The project will deliver new data to complement positive results already reported in Ziccum’s in-house mRNA/LNP project.

Project 2: Big pharma – On July 17, Ziccum entered an Evaluation Agreement, beginning with a Feasibility Study, with a global Pharmaceutical Corporation to assess LaminarPace treatment of mRNA/LNP vaccine and/or products. This collaboration includes a planned extension for stability testing and an option to license the LaminarPace technology.

Project 3: Big manufacturing – November 7, came the announcement of a deal with a US Biopharmaceutical Manufacturing corporation focused on vaccines and pandemic preparedness. This project will examine LaminarPace’s capabilities for the Viral Vector platform, assessing thermostable Lentivirus.

Feasibility and Evaluation studies
All three project partnerships are to carry out a Feasibility Study, which is the standard first stage of evaluation in the industry. In the ‘big pharma’ project, this Feasibility Study is part of an overall Evaluation Agreement that also includes next-stage Evaluation studies, if the results of the first stage are positive. So what exactly takes place in Feasibility and Evaluation studies?

CEO Ann Gidner: “In a Feasibility Study the applicability of the technology – LaminarPace and its specific formulation – is assessed for a specific modality, a drug or vaccine candidate of the partner company. After finding a good window of operation, formulated and dried product material is produced and delivered also to the partner for assessment on both sides – regarding particle properties, yield and in-vitro activity generally.

If this first step delivers positive results and proves the applicability of the technology, it will then typically be followed by the second stage, an Evaluation study. Here the technology is not just tested for feasibility but further optimized with more extensive testing. An evaluation study may involve, for example, in-vivo testing or stability testing”.

Generating new revenue
All three agreements also inject revenue into the company and highlight the company’s new and successful revenue model.

What are Ziccum’s current revenue streams, and how much do they generate?

CEO Ann Gidner: “Ziccum currently has two revenue streams: We have Project revenues from our three current external projects and Soft funding revenues.

“The Project revenues currently add up to 10 MSEK, of which 6-8 MSEK is expected to be realized in 2023 and 2-4 MSEK in 2024. If successful, today’s projects will move on to further stages such as Evaluation studies, with the potential for in-vivo assessment, also likely to add further revenue”.

And Soft funding revenues? “Our soft funding revenue stream is our current Eurostars / Vinnova-funded project on 3D digital modelling of LaminarPace” says Ann Gidner, “in collaboration with the ICP Institute of Computational Physics at the Zurich University of Applied Sciences’ School of Engineering (ZHAW). This stream totals 10 MSEK in revenues for Ziccum, with the combined gain of Ziccum and ZHAW portions, and will run until 2026 with the funding distributed throughout the remaining years of the project”.

Ziccum signs agreement for Vaccine Evaluation project with major US Biomanufacturing corporation

Ziccum AB (publ) (‘Ziccum’) has signed a Material Transfer and Evaluation Agreement for a Vaccine Evaluation project with one of the most important technology-focused Biomanufacturing corporations in the US. The project is funded and will focus on evaluating the potential for new dry, thermostable forms of an advanced viral vaccine, using Ziccum’s unique formulation and drying technology LaminarPace. Ziccum has signed three agreements for funded partner studies since May 2023, and these add up to combined revenues of 10 MSEK.

The new agreement is the third major partner contract for funded Feasibility studies that Ziccum has signed in recent months. It significantly broadens the company’s strategic and biotherapeutic position. Strategically, it is the first agreement for the company with a Biomanufacturing corporation- a vital industry segment in vaccine manufacturing.

The project aims to evaluate Ziccum’s unique formulation and drying technology, LaminarPace, for treatment of an advanced viral vaccine material. The material belongs to one of the three high-potential vaccine platforms that Ziccum targets and has worked on in-house. If successful, the project will represent a significant step forward in demonstrating LaminarPace’s potential across markets and modalities.

Ziccum’s new partner company is one of the US’ largest technology-focused Biomanufacturing corporations. It has a portfolio of domestic and international partners providing advanced, end-to-end manufacturing solutions for comprehensive pandemic preparedness. The company has capabilities in vaccines, gene therapy, cell therapy, nucleic acids and more.

This third agreement for funded studies signed with a major, international corporation in recent months confirms the significant acceleration Ziccum has made in its business development and strategic and scientific progress over the last year since the appointment of new CEO Ann Gidner in 2022. In total, the three agreements for partner studies give Ziccum a combined revenue of 10 milion SEK for the initial steps agreed upon.

Ziccum Chairman Fredrik Sjövall: “This is a great step forward for us strategically, covering a new vaccine platform and an important new key market segment. We can’t wait to get the project started!”

CEO Ann Gidner: “We are honored that our technology will be evaluated by such an important partner for technological and medical advancement. As someone with extensive experience in Biomanufacturing industry right from its inception, I’m aware of the competitive advantage the future use of LaminarPace could generate for this type of partner. This Agreement reflects that innovation in vaccine formulation, and new stable and thermostable formulations, could play a fantastic role in making the world better prepared for pandemics.”

Ziccums Q3-rapport – VD-uppdatering på svenska

Det tredje kvartalet 2023 har varit intensivt och produktivt för Ziccum – med det andra av två större utvärderingsavtal undertecknade, betydande intäkter genererade och extern validering av viktiga mRNA-data. Här delar VD Ann Gidner med sig av sina insikter till svenska investerare.

F: Vilka är höjdpunkterna under kvartalet, vad bör vi fokusera på?

AG: Det finns mycket att välja mellan! När det gäller fortsatt framgång och trygghet finns det tre aspekter att belysa framför allt.

För det första – tydliga resultat av den nya affärsstrategin.

Vi har rustat Ziccum och stöpt om huvudstrategin, och vi levererar starka resultat löpande. Vi har i en affärsmodell som bygger på utlicensiering, det maximerar värdet av vår plattform och vi har fått bekräftelse på intresset genom affärsdialoger med världsledande aktörer. Vi har gedigen försöksverksamhet med starka data och en riktigt vass teknikutveckling, både digitalt och med fysiska försök. Vi har en väldigt spännande teknologi i LaminarPace, och vi vill ta den framåt på bästa vis så att den verkligen ger stort värde i den internationella läkemedelsindustrin, och för patienter i slutändan.

En central del av vår strategi är att få intäkter redan tidigt i samarbetet med kund. Med utvärderingsavtal mot bra betalning, säkerställer vi att projektet är viktigt hos kunden och att vi får dialog med rätt beslutsfattare. Det är inte alltid så lätt att nå ut i tidig fas, men vi har levererat databevis på teknologins stora potentiella värde nu, och nått ut framgångsrikt till internationella spelare med detta budskap tack vare gediget arbete med affärsutveckling i värdefulla nätverk.

Det var ett riktigt stort steg att få avtal på plats nu i juli med en världsledande läkemedelskoncern – en Big Pharma – för flera steg av utvärdering med LaminarPace för deras mRNA/LNP-projekt. Det ger intäkter direkt, och har en option till ett licensavtal i nästa steg, helt enligt vår affärsmodell. Det är givetvis inte säkert att just detta samarbete leder hela vägen dit, men vi har verkligen kommit igång med bästa tänkbara motspelare, med detta och vårt befintliga Biotech-avtal. Förutom ekonomiska värden så ger själva samarbetet i sig omedelbar nytta – det ger oss dialoger med världsledande utvecklingsteam när det gäller mRNA/LNP-utveckling, och vi bygger kunskap kontinuerligt.

För det andra – klok hantering av våra finanser.

Vi tar in flera miljoner kronor från externa projekt det här kvartalet, plus Eurostars-medel till vår teknologiutveckling, och intäktsströmmarna kommer att fortsätta. I kombination med smarta besparingar innebär det att vår förbrukning (”netto-burn rate”) har minskat med 11 miljoner kronor i år hittills jämfört med förra året. Detta samtidigt som vi levererar resultat på en helt annan nivå än tidigare. Med vårt framgångsrika arbete som levererar milstolpe efter milstolpe känner vi oss trygga vad gäller fortsatt finansiering. Det befintliga kapitalet plus intäkter räcker åtminstone nio månader till.

För det tredje – stark datagenerering.

Varje life science-företag är beroende av styrkan i sina data, oavsett om det handlar om affärssamarbeten, immateriella rättigheter eller investerar-dialoger. Vi genererar nu starka data i hög takt, såväl i våra partnerprojekt, våra interna projekt för både mRNA och utrustningsoptimering, som externt med ett analyslabb-samarbete vilket bekräftar våra utmärkta mRNA/LNP-resultat i fler cell-modeller och med en ny mRNA-effekt (s.k. rapportör).

Denna externa validering ger en solid bekräftelse på att LaminarPace gör jobbet, utan att den ömtåliga och dyrbara mRNA-substansen tappar nämnvärt i aktivitet. Såvitt vi kan se i detta steg av utvecklingen har vår teknologi förmågan att erbjuda torrpulverhantering – med allt vad det möjliggör – fullt ut, vilket inte är fallet med andra lösningar som testas i industrin. Det är en utmaning att lyckas med både högt utbyte (s.k. enkapsulering) och bibehållen vaccin-aktivitet samtidigt, och äldre teknologier ger dessutom svårhanterad produkt som ofta klibbar och aggregerar.

Det är också viktigt att peka på vår starkt förbättrade hantering av försökskörningar. Med min erfarenhet från att bygga framgångsrika B2B-verksamheter inom internationell Pharma, har jag infört en egen Ziccum-modell för feasibility-studier så att vi styr planeringen – och inte bara gör vad partnern föreslår. Det säkerställer en aktiv försöksplanering för bästa förutsättningar för LaminarPace att hitta rätt parametrar för bra data. Vår kompetens, både generellt för LaminarPace-behandling och specifikt kring mRNA och LNP-formuleringar, som vi bygger upp kan då komma till sin rätt.

F: Det leder oss till nästa fråga. Varför är mRNA så viktigt för Ziccum – och visar alla dessa goda aktiviteter kring det området att Ziccum blir alltmer mRNA-centrerat?

AG: Det står alltmer klart att läkemedelsindustrin är på väg i en helt ny fas, med alla de möjligheter man ser med RNA-behandlingar. Det är ett paradigmskifte som pågår, och enorma pengar som investeras runt om i världen i projekt som vill utnyttja mRNA. Dock finns det tydliga begränsningar vad gäller stabilitet, degradering och administrationsformer. Ziccums teknologi riktar in sig på att lösa just de problem som håller mRNA-teknologin tillbaka – så vi har verkligen ett behov att fylla! Vid mRNA-toppmötet i Boston i juli betonades behovet av nya, stabilare och mer användarvänliga formuleringar. Vi får också i allt högre grad intresse i branschen för LaminarPace som en potentiell lösning.

Men vi fokuserar inte bara på mRNA. Både virusvektor-vacciner och adjuvant-vacciner är fortsatt viktiga för oss och vi har dialoger och nyckelkompetens inom dessa områden också. Som utvecklare av en flexibel plattformsteknologi med många applikationer har vi inget intresse av att lägga alla ägg i samma korg, så strategin med tre vaccin-plattformar ligger kvar.

F: Ziccum-teamet utökades med nya medarbetare under kvartalet och tonvikt lades på ökad industriell erfarenhet. Hur viktigt är detta?

AG: Det är avgörande – i ett litet, fokuserat team är varje pusselbit viktig. Jag är mycket glad och tacksam att ha ett så bra Ziccum-team, och med vår förbättrade organisation har vi ett effektivt samarbete där alla bidrar till våra snabba resultat. Nu är vi glada att tillföra mer kompetens med välmeriterade nya medarbetare! Det här kvartalet skrev vi på med en ny COO – Xavier Turon, en chefsingenjör som ansluter med intressant industriell och akademisk bakgrund från flera länder, och den välmeriterade forskaren Deepak Anand har redan startat som en ny, välkommen kollega i vårt internationella team.

Vi jobbar vidare och ser verkligen fram emot leverans av resultat i våra partnerprojekt – ett i relativ närtid, och ett med resultat senare under 2024 – och fortsatt intensiv utveckling av vår teknologi, dess industriella kapacitet och inte minst vår affär!

ZICCUM AB (publ) Interim report Q3 2023

Significant events during the quarter

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

Other events during the quarter

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

Other events after the third quarter

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

CEO statement
Intensive data generation with world-leading Partners

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

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

July- September in brief

  • Total revenues: SEK 2,329 (0) thousand.
  • Result for the quarter: SEK -3,882 (-6,674) thousand.
  • Earnings per share: SEK -0.28 (-0.48).
  • Cash flow for the quarter: SEK -4.793 (-7,064) thousand.
  • Cash at the end of the reporting period: SEK 9,790 (29,593) thousand.
Financial summary Q3 Q3 Jan-Sep Jan-Sep Full year
KSEK 2023 2022 2023 2022 2022
Net revenue 2,329  0 4,743  0 0
Operating result -3,899  -6,674 -13,857  -20,888 -28,955
Result -3,882  -6,599 -13,720  -20,767 -28,788
Balance sheet total 21,764  42,582 21,764  42,582 33,285
Cash flow -4,793  -7,054 -16,161  17,320 10,678
Cash and cash equivalents 9,790  29,593 9,790  29,593 22,951
Equity ratio % 73  87 73  87 88
Per share data (SEK)        
Number of shares 13,806,142 13,806,142 13,806,142 13,806,142 13,806,142
Result per share before and after dilution* -0.28  -0.48 -0.99  -1.50 -2.09
Cash flow per share -0.35  -0.52 -0.95  1.27 0.78
Equity per share 1.51  2.69 1.51  2.69 2.12

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

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