Ziccum to present at ‘Inhaled Biologics’ live webinar with KOL Assoc Prof. Per Gerde

On Monday Dec 11 Ziccum presents as special guest at a live scientific webinar on ‘Inhaled Biologics’ with inhalation Key Opinion Leader Assoc. Prof. Per Gerde. New Ziccum COO Xavier Turon will present the company at the webinar, which addresses formulation scientists working on new, more stable formulations of biopharmaceuticals.

Register for the Webinar here.

The webinar will cover:

  1. how LaminarPace, Ziccum’s Mass Transfer technology, uniquely formulates and dries biologics, without exposing them to extreme temperatures, as stable, bioactive dry powders that are highly suited for inhalation
  2. Preclinical Testing solutions for Inhalable Formulations.

The Webinar is part of a series for industry developers hosted by Inhalation Sciences AB. This session, part of that series, is titled “INHALED BIOLOGICS: Realization and Preclinical Testing of Dry Powder Formulations”.

Inhalable solid dose forms of biologics including next-generation mRNA vaccines are of great interest to the biopharmaceutic industry at the moment, promising increased storage stability, simplified patient administration and an ability to stimulate the mucosal immune system. LaminarPace was originally developed by Associate Professor Gerde specifically to dry liquid biologics for inhalation.

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 launches News portal

Ziccum today launches a news portal – Ziccum Updates – on its website to share company news updates in a short, accessible format for investors, partners and followers..

The news posts will typically cover internal updates and initiatives, as well as scientific updates and reports from industry events, to complement the company’s regular press releases and give more insight into the company activities and progress.

Visit the portal here: www.ziccum.com

Ziccum CEO Analyst video interview: new industry Agreement, Q3 highlights

Watch Ziccum CEO Ann Gidner in an exclusive new video interview with Eucaps analyst Jonathan Furelid. It provides insights and analysis of Ziccum’s new Evaluation Agreement, its third in six months, plus the company’s Q3 highlights.

Watch the interview HERE.

Or visit Ziccum’s company page on Eucaps HERE.

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/

Ziccum reports positive results from external validation of mRNA activity after LaminarPace treatment

Ziccum AB (publ) has 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.

The external confirmation and extended data set of preserved mRNA activity after LaminarPace treatment was obtained with cell-based in-vitro assays by the CRO. The study was performed to validate the internal mRNA activity data previously reported on March 20th. The new data give a clear and distinctive confirmation of the ability of Ziccum’s LaminarPace technology to transform delicate mRNA/LNP solution into stable, bioactive dry powder with excellent in-vitro characteristics.

mRNA is one of the three target vaccine platforms Ziccum focuses on, and its in-house mRNA project is of central strategic importance, considering the market need and growth. In October 2022, Ziccum reported proof of successful nebulization and drying of a vaccine/LNP model substance. In March 2023, Ziccum reported the same positive confirmations regarding encapsulation and particle properties for actual mRNA/LNP trials, plus confirmed mRNA activity after LaminarPace drying and reconstitution to liquid. These findings have since then been repeatedly confirmed in continued internal studies. The new CRO activity read-outs are obtained in a different mRNA model – and having the same clear activity preservation in a second mRNA model makes the validation stronger.

Ziccum has recently signed two major agreements for Evaluation Studies on mRNA/LNP treatment with LaminarPace – the first in May with a leading Biopharmaceutical corporation, the second in July with a multinational Pharmaceutical corporation. These collaborations also will include in-vitro activity readouts.

CEO Ann Gidner: “Investment and innovation in RNA and mRNA therapies continue to grow and the industry efforts are very impressive. Solutions for stability and delivery that can enable new vaccine and drug projects could broadly expand the possibilities for this booming therapeutic platform. These distinct mRNA activity results for Ziccum constitute excellent and important confirmation. The next step is the in-vivo data, to see this confirmed in animal models. This work is starting now”.

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