Ziccum appoints senior biotech manager as new COO

Ziccum has appointed senior international biotech engineering manager Xavier Turon as its new Chief Operating Officer. Turon will lead the team developing LaminarPace, Ziccum’s unique mass transfer drying system, and is bringing extensive academic and industrial experience. His appointment follows the recruitment of a new CFO as Ziccum delivers on its strategy of growing its management capabilities.

As Ziccum is progressing with a successful new strategy and business model, rewarded by recent agreements with leading Pharma and Biotech partners, the company is introducing a new position in its management team. A Chief Operating Officer has been recruited to manage the Operations team and to lead the important LaPaSim project for 3D-modelling of the LaminarPace technology. This strengthening of the Ziccum team will contribute to the successful development of the core technology, as well as help delivering results in the partnered projects.

Xavier Turon brings excellent industrial and academic expertise to the company. His track record in Chemical engineering and Life Science management is a valuable fit for Ziccum; Turon has deep expertise in biological drying processes, including freeze-drying and spray drying, as well as specific experience working in proteins and peptides. Most recently as Industrial Biotech Manager at Lipotec, Lubrizol Life Science in Spain, he led a team designing, developing and scaling up GMP-quality manufacturing plants for pilot as well as commercial scale for bioactive ingredients.

In addition, Turon has significant academic expertise. From 2008 – 2016 he was Assistant Professor at the Chemical Institute of Sarrià (IQS) in Barcelona, leading the Bioprocesses unit in developing and scaling up bioprocesses from benchtop to pilot. His international experience includes three years as Associate Researcher at the State University of North Carolina in the US, as well as background as a Doctoral Researcher in Chemical Engineering at Polytechnique Montreal, Canada’s leading engineering university.

Xavier Turon: “I am pleased and excited to join Ziccum. LaminarPace is a genuinely unique technology which will contribute to developing better biotherapeutics. It clearly fills an industrial need – I look forward to contributing to its ongoing technological and industrial development while joining the excellent, growing team at Ziccum. The stage is set for a major breakthrough in biopharmaceutical drying".

Ziccum CEO Ann Gidner: “Xavier is a very valuable recruitment for Ziccum, and we welcome him warmly. His extensive knowledge in chemical engineering science will help ensure the best possible advancements in the LaPaSim project and further strengthen our dialogues with teams and prospects. The role will be pivotal in driving successful LaminarPace development forward, to enable new, user-friendly formulations of RNA and other vital biotherapeutics”.

Ziccum CEO Analyst interview part 2

In part two of her Analyst interview CEO Ann Gidner offers a deep dive into the second of the company’s recent milestone Feasibility agreements plus an analysis of mRNA, why it is generating such historic levels of investment, and how Ziccum’s unique drying technology LaminarPace could be a key enabler in unlocking its potential.

Watch Ziccum CEO Ann Gidner in the second part of her extended interview with Eucaps analyst Jonathan Furelid HERE.

Or visit Ziccum’s company page on Eucaps HERE.

Analyst interview with Ziccum CEO on significant milestones achieved

With two paid Evaluation agreements signed with world-leading mRNA partners, after having proven the LaminarPace technology for mRNA/LNP treatment, Q2 2023 was the most successful in Ziccum’s history. CEO Ann Gidner describes the company’s achievements and road ahead in the first of two CEO interviews.

Watch Ziccum CEO Ann Gidner in the first of two interviews with Eucaps analyst Jonathan Furelid HERE

Or visit Ziccum’s company page on Eucaps HERE.

Ziccum to present at Investor Conference BioFuture 2023 in New York

Ziccum AB is to present at the BioFuture 2023 conference in New York City, October 4 – 6 2023, a key industry event attracting top-tier investors to evaluate innovators in biopharmaceuticals.

Ziccum CEO Ann Gidner will present Ziccum’s unique drying technology for biopharmaceuticals, LaminarPace, and its market potential at BioFuture 2023. Uniquely, LaminarPace enables new delivery and greatly improved stability for biopharmaceuticals, potentially making new treatments available for patients world-wide. Most importantly, the enormous potential of the mRNA/LNP therapy and vaccine platform could be unlocked if delivery and stability challenges were solved. Ziccum presented excellent data in mRNA/LNP trials during spring 2023, followed by two prestigious industrial feasibility agreements being signed.

Driven by public & private initiatives, BioFuture has emerged as a hub for innovation in the life sciences and digital health space. LifeSciNY is allocating 500 MUSD in investment to build the Life Science arena.

Ziccum has been represented at a series of high-profile industry events throughout the year – including the Global mRNA Therapeutic Summit in Boston, Mass. and the invitation-only Longwood Healthcare Leaders Spring Conference. In June / July, Ziccum reported signing two major new Evaluation Agreements for Feasibility Studies for mRNA/LNP projects with major Pharmaceutical/Biotech corporations leading the mRNA-field.

Ann Gidner: “it is exciting to participate at BioFuture in New York. We are proud to be presenting the Ziccum core concept, successful data and the very significant mRNA market outlook to US investors, taking a next step in our international outreach”.

Ziccum säkrar andra Feasibility-avtalet på två månader: VD-intervju på svenska

Den 17 juli tillkännagav Ziccum ett nytt betalt utvärderingsprojekt – det andra avtalet signerat på bara två månader med ett stort globalt Pharma/Biotech-företag. Denna nyhet kom en dag före publiceringen av Ziccums kvartalsrapport för andra kvartalet 2023, vilket redan var ett riktigt starkt kvartal i företagets historia. Här svarar Ziccums VD Ann Gidner på frågor om det nya avtalet.

F: Att teckna två stora avtal på bara drygt två månader – båda med ledande företag inom sina områden – är en fantastisk prestation. Vad säger det oss om företaget och dess teknik?

AG: Ja, det är fantastiskt att teckna ett andra Ziccum-avtal med ett världsledande läkemedelsföretag. Det visar på väldigt goda framsteg inom vår affärsutveckling. Ziccum har nått en riktigt bra nivå av trovärdighet och engagemang inom branschen.

Våra partners i båda dessa affärer är ledande, inom mRNA och vacciner, och de är globala spelare. Vi kan faktiskt inte önska oss bättre partners, för samarbete kring hur LaminarPace allra bäst kan tillämpas för att behandla mRNA. Vi är hedrade över att få samarbeta och ta del av både engagemang och expertis här. Förutom ordentliga intäkter, vilket säkrar att kassan räcker längre för Ziccum, så är det givetvis fantastiskt att få ha tekniska och vetenskapliga diskussioner med deras team.

F: Detta senaste avtal innehåller två extra komponenter utöver Feasibility-studien – en planerad förlängning för stabilitetstestning och en option att licensiera LaminarPace-tekniken. Hur viktigt är detta?

AG: Det är givetvis positivt att det här avtalet har tre komponenter: vi har kommit längre i gemensam planering för framtiden. Samtidigt ska man vara medveten om att allt hänger på resultaten – om det inte blir tillräckligt bra bevarande av mRNA-substanserna under försökskörningarna, så stoppar samarbetet där. Så vi hoppas verkligen kunna bevisa potentialen hos LaminarPace i första delen, så att vi sen får fortsätta med denna intressanta utvärdering. Och det är också med tanke på riskerna i varje projekt, som det är så viktigt att vi fortsätter att bygga upp en bred och robust pipeline.

F: Vad menas egentligen med stabilitetstestning?

AG: Stabilitetstestning är en viktig del av all läkemedelsutveckling. Man placerar en produkt i olika temperaturkammare, tar sedan ut prover med jämna mellanrum – över flera månader – och testar produkten för att övervaka den potentiella stabiliteten eller nedbrytningen av innehållet. I vårt fall är hela poängen med LaminarPace att skapa ett termostabilt pulver, så det är viktigt att köra stabilitetstestning för de aktuella produkterna. Samtidigt tar det lång tid – 6 månaders ”stab” tar ju 6 månader – och det kostar en hel del.

F: Sedan finns det även en option till licens i avtalet?

AG: Ja, det stämmer. Det är ett sätt för motparten att göra klart att man vill bli först till kvarn, i förhandlingar om licensrättigheter. Det är verkligen positivt att ha denna bekräftelse på intresse för framtida tillämpning, från en storspelare. Det är inte heller någon direkt begränsning gentemot andra parter – det finns ju en rad varianter på vaccin och andra mRNA-produkter som Ziccum potentiellt skulle kunna arbeta med i framtiden.

Jag tror att våra nya partners är väl medvetna om att det verkligen skulle förändra spelplanen att kunna uppnå termostabila mRNA-vacciner.

F: Hur långa var förhandlingarna och hur såg de ut?

AG: Förhandlingarna var positiva och konstruktiva, och tog relativt lång tid – som man kan förvänta sig av ett avtal med flera steg planerade. Själv har jag väldigt bra erfarenhet på området efter att ha förhandlat stora avtal med Big Pharma (på nivån tiotals miljoner USD) sedan två decennier, och det gav trygghet under resans gång för såväl teknik, juridik som affärsupplägg, tillsammans med bra support från Ziccums team. Vi har byggt bra relationer med både det tekniska teamet och affärssidan hos vår partner. Vi är helt klart tacksamma över att få arbeta med ett så starkt team.

F: Hur lång tid kommer projektet att ta?

AG: Detta kommer att vara ett projekt som sträcker sig in i 2024. Det förstärker också vår ekonomiska trygghet och kommer att ge ännu mer fokus och motivation till den industriella utvecklingen av LaminarPace. Vi är mycket glada över att kunna gå vidare.

Open post

Ziccums Q2-rapport – VD-uppdatering på svenska

Q2 2023 har utan tvekan varit ett av de mest spännande och produktiva kvartalen i Ziccums historia – med två betalda utvärderingsavtal, tre nya patentansökningar och fortsatt bekräftelse av bolagets mRNA/LNP-resultat. VD Ann Gidner ger en inblick i den senaste utvecklingen.

F: Vilka är de viktigaste händelserna under kvartalet?

AG: Ja, vi har unika bolagshändelser både vad gäller affärer och teknik!

Två utvärderingsavtal som ger rejäla intäkter är naturligtvis historiska milstolpar. Hela omstöpningen av Ziccum under det senaste året, och den kraftfulla satsningen på proffsig affärsutveckling på den internationella arenan, ger nu verkligen resultat. Men det här kvartalet har också inneburit utmärkta framsteg på en rad andra områden. Det finns tre viktiga områden med stora milstolpar under kvartalet, som alla är avgörande för vår framtida framgång.

F: Vilka är de tre områdena?

1: Fortsatt starka mRNA-resultat i interna studier

AG: Nummer ett är de fortsatta framstegen i våra egna mRNA-studier. I slutet av första kvartalet meddelade vi att vi hade uppnått en milstolpe i branschen genom att omvandla mRNA i lipid-nanopartiklar (mRNA/LNP) till stabilt, torrt pulver med bibehållen aktivitet. Under Q2 har vi fortsatt dessa studier och verifierat vad gäller aktivitet i ett antal olika lipidformuleringar med fina resultat. Dessa resultat är en viktig etapp på vägen, där vi steg för steg bevisar att LaminarPace helt kan förändra landskapet för nya mRNA-behandlingar. Det öppnar fler dörrar för oss inom hela branschen.

2: Förstärkt patentposition

AG: Det här kvartalet har vi tagit företaget till en ny nivå när det gäller att skydda vår s.k. intellectual property (IP). Vi har lämnat in tre nya patentansökningar inom tre områden: utrustning, processparametrar och produktformulering.

Området utrustning täcker en rad förbättringar i konfigureringen av vår torkkolonn LaminarPace. Området processparametrar avser hur vi kör utrustningen. Och slutligen formulering innefattar ny kunskap inom hur man bäst formulerar läkemedelssubstanser för att ge optimala resultat med LaminarPace. Att ’formulera’ betyder inom läkemedel mer precist hur man använder olika tillsatsämnen till läkemedelsmolekylen, för att få den att fungera som behandling.

I takt med att vi utökar vår pipeline och ingår fler partnerskapsprojekt, blir det allt viktigare att vi skyddar vår unika teknik. Med tre ansökningar inlämnade kan vi nu fylla på mer data, för att arbeta mot starka godkända patent.

3: Nya avtal med världsledande Pharma/Biotech-bolag

AG: Det är en bedrift för oss att ha slutit två avtal – båda med globala, ledande aktörer – på två månader. Särskilt med tanke på att affär nr2 också omfattar möjlighet till flera steg, utöver Feasibility-studien. Detta visar hur värdefull vår nya strategi och satsning på professionell, internationell affärsutveckling är.

Båda våra nya partners är av högsta kaliber. Vårt partnerskap med sådana högklassiga spelare visar på den trovärdighet och det goda intresse vi har fått i branschen, tack vare vår gedigna utveckling som bolag och även mitt internationella nätverk i industrin.

Utvecklingen av ny teknik blir naturligtvis mer eller mindre framgångsrik beroende på data. Framgång är aldrig garanterad. Det är därför det är så viktigt för oss att fortsätta driva nya projekt med flera partners och flera substanser: det gäller att ha många seriösa dialoger för att få projekt, och det gäller att ha flera projekt för att nå marknad, när det gäller läkemedelsutveckling. Därav en ordentlig satsning på internationell affärsutveckling!

Med framsteg inom alla dessa tre nyckelområden går vi in i en spännande period av genomförande av viktiga projekt, expansion och fortsatt bra exponering av Ziccum och våra framsteg på den internationella arenan. Jag ser fram emot att tillsammans med hela teamet och våra partners fortsätta denna spännande utveckling!

ZICCUM AB (publ) Interim report Q2 2023

SIGNIFICANT EVENTS Q2 2023 (APRIL-JUNE)

  • On May 9, Ziccum announced that it had signed a revenue generating Evaluation Agreement with a leading biopharma company to commence a Feasibility study regarding LaminarPace for ambient drying of mRNA/LNP materials and/or mRNA vaccine(s).
  • The Annual General Meeting (AGM) held on May 24, 2023 re-elected Fredrik Sjövall, Mikaela Bruhammar and Andreas Pettersson Rohman and elected Per Gerde as new board member. Fredrik Sjövall was reelected as the chairman of the Board of Directors. The AGM adopted an incentive program (LTI2023:1) of 324,000 employee stock options for certain employees and consultants. The LTI2023:1 program will be awarded during quarter three 2023. The AGM furthermore resolved on an issue of not more than 425,801 warrants to ensure delivery of shares to the participants and to hedge costs connected to the program.
  • On June 2, the company announced that Johny Humaloja was appointed as new CFO for the company, and he started his assignment in June.
  • On June 5, the company announced that it had received a notification from CEPI (the Coalition for Epidemic Preparedness), that its joint Expression of Interest has not been selected for the next stage of application work. 


SIGNIFICANT EVENTS AFTER THE SECOND QUARTER

  • On July 17, Ziccum announced it had signed a new Evaluation Agreement with one of the world’s top pharmaceutical corporations. The agreement is to perform a funded Feasibility study aiming to develop thermostable dry powder formulations in the partner mRNA/LNP projects, with a planned extension for stability testing and an option to license the LaminarPace technology.

OTHER EVENTS

  • On May 2, the company announced it had filed three patent applications as part of new, expanded strategy to strengthen patent protection. The new, expanded IP strategy will provide multi-layered protection to the company’s unique drying technology LaminarPace, turning liquid biopharmaceuticals into thermostable dry powders by mass transfer.

CEO statement
 
Taking amazing strides together, landing two deals for Ziccum
It is truly fantastic to now deliver great results in our key areas, having sorted and structured the company business model and operations during a build-up period. Now we are pleased to enter the next phase, delivering key milestone achievements for our valuable platform technology. Getting two agreements signed with world-leading players is indeed clear confirmation that we are on the right path.
 
Proving the technology for the most delicate targets
Our most significant technical milestone so far was achieved end of first quarter, confirming that we can turn mRNA in lipid nanoparticles (mRNA/LNP) into stable dry powder, with maintained activity. These results have been further validated during this quarter. We have tested various lipid compositions with resulting good mRNA activity, to build our proprietary knowledge further in this exciting field.
 
mRNA/LNP is a complex and very fragile structure, but so valuable for new pharmaceutical development that it is highly desirable for the industry to apply it – it opens the door to a completely new field of innovative drugs. Solving the issues of mRNA drug delivery and LNP stability will be key to making it a broad platform for new patient treatments. So we are indeed excited to have proven the ability to address this: Ziccum can help make mRNA/LNP available for many more vaccines and therapeutics, globally. Of course, one can also see the great potential to work on other vaccine platforms, as well as the broad range of other biopharmaceutical compounds.
 
Securing more Ziccum Intellectual property, broadly
Thanks to successful continued technology development and learnings in our internal programs, regarding both equipment configuration, process parameters when running LaminarPace and continuous learning regarding formulation, we have been able to file three new patent applications. It was a significant effort during the quarter to assess all new learnings and apply for patent protection. Also, after the filings announced in April, continued work is on-going to secure the best protection possible for our technology.
 
Signing up with a world leader in mRNA/LNP
Our progress is generating very good industry interest for the possibilities of our technology, and we are pursuing numerous dialogues with high calibre industry players, across the industry and in many geographies. It was with great pleasure we could communicate on May 9th that one first paid Feasibility study is agreed and signed. It is a very significant commercial milestone of course, for Ziccum to become revenue generating as of now. The project is running at full activity currently, and it is fantastic to work closely with such a successful and knowledgeable partner.
 
Just after the quarter closing, we could add a second, larger project collaboration being signed – now with a major global Pharmaceutical company. This time, the scope is both a paid Feasibility study with partner mRNA/LNP material, and a planned extension for stability testing and an option to license the LaminarPace technology.
 
Not only are these projects generating revenue and extending our financial runway, but also generating further knowledge and understanding of success factors for the mRNA field, and long term, giving business potential for future licensing if successful. We are delighted to collaborate with these leading players in the field.
 
 
Building the Ziccum operations and team
In parallel with the partnered projects, we pursue the internal development like mentioned, as well as the 3D-modelling project LaPaSim. The Swiss-Swedish team is working on component design and planning for the next step of scaling out for long term industrialization.
 
Seeing the increase in activities and projects, there are certainly investment and expansion considerations in the company – but at the same time, I am keen to keep good cost control. Both generating new results and income, while still reducing unnecessary spending, is a nice combination for sound company progress and financials.
 
One recruitment just completed, and adding financial competence, is the hiring of an experienced CFO from the Biotech industry: I am delighted to welcome Johny Humaloja to the team! Furthermore, we are looking for an experienced Chief Operating Officer, to complement the Ziccum staff.
 
We have an exciting outlook, going forward with our collaborations and plans! Let me thank all collaboration partners and owners as well, for your continued support and engaged dialogues.
Lund, July 18 2023
Ann Gidner, CEO

Q2 2023

  • The result for the quarter amounted to -4,965 kSEK (-7,882 kSEK)
  • Cash flow for the quarter amounted to – 4,440 kSEK (-7,587 kSEK)
  • Cash and cash equivalents at the end of the quarter amounted to 14,583 kSEK (36,647 kSEK)
Financial Highlights (kSEK) Apr-Jun
2023
Apr-Jun
2022
Jan-Jun
2023
Jan-Jun
2022
Jan-Dec
2022
Net revenue 1,776 0 2,414 0 0
Operating result -5,060 -7,873 -9,995 -14,213 -28,955
Result for the period -4,965 -7,882 -9,837 -14,167 -28,788
Balance sheet total 24,635 51,100 24,635 51,100 33,285
Cash flow for the period -4,440 -7,587 -8,368 24,374 10,678
Cash and cash equivalents 14,583 36,647 14,583 36,647 22,951
Equity ratio % 80 86 80 86 88
Data per share (SEK)
Number of shares at the end of the period 13,806,142 13,806,142 13,806,142 13,806,142 13,806,142
Result per share before and after dilution* -0.36 – 0.57 -0.71 -1.03 -2.09
Cash flow per share -0.32 -0.55 -0.61 1.85 0.78
Equity per share 1.43 3.17 1.43 3.17 2.12

Link to report:
https://reports-en.ziccum.com/interim-report-q2-2023/start/

Ziccum signs Evaluation Agreement for Feasibility Study with major global Pharmaceutical Corporation

As of today, Ziccum AB (publ) (‘Ziccum’) has signed a new 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.

Ziccum’s new partner is one of the world’s top pharmaceutical corporations. The new agreement is for a funded Feasibility study aiming at developing dry powder versions of the partner’s mRNA/LNP materials. The formal terms of the agreement include a planned extension including stability testing, if the first step is successful, plus an option for the Pharmaceutical Corporation to negotiate a license to the LaminarPace technology.

Since May 2022, Ziccum has created a substantial pipeline of new dialogues within the pharmaceutical industry. In parallel the company strengthened its focus on mRNA in lipid nanoparticles (LNPs), with proof of drying mRNA/LNP materials with well-preserved vaccine activity in March 2023. mRNA in LNP formulation is the vaccine technology that was key to the rapid development of Covid-19 vaccines and is currently one of the most fast-developing fields within pharmaceutical development world-wide. During spring, CEO Ann Gidner has presented the Ziccum mRNA/LNP capabilities and findings, fueling industry interest, at several international summits and conferences.

This is the second agreement Ziccum has signed with a leading global pharmaceutical corporation in just over two months, thanks to the significant scientific and commercial progress the company has made based on new strategy and new leadership. The agreement signing is a milestone achievement in Ziccum’s Project Portfolio. 

The current project is expected to commence in July 2023 and the first stage will run for a number of months. Both parties will be evaluating the properties of the resulting materials.

CEO Ann Gidner: “The Ziccum team is certainly excited to begin this important and well-designed project in such a valuable field. Partnering up with this high caliber Pharma Corporation is an honor for us, and it brings significant future business potential. Hopefully generating excellent results, this collaboration can enable important advantages in the development of mRNA/LNP treatments for our partner.”

Ziccum sponsors the Global mRNA-Based Therapeutics Summit, Boston MA, July 26-28

Ziccum AB (publ) is sponsoring one of the most well-attended international events in the field of mRNA-based therapeutics in Boston MA, July 26-28. Ziccum CEO Ann Gidner will present the company’s unique drying technology for biopharmaceuticals. Furthermore, the company will exhibit a Poster on its current in-house mRNA project, successfully drying active mRNA materials into a thermostable bioactive dry powder.

mRNA-based therapeutics and vaccines is one of the fastest-growing fields within biopharmaceutics, with over 800 mRNA drug projects currently in development. A central event in the scientific and business calendar for mRNA professionals is the Global mRNA-Based Therapeutics Summit. The 3rd summit will take place July 26-28 in Boston MA.

Ziccum CEO Ann Gidner will present on Day 1 of the event, Thursday July 27. Her Presentation is titled A Novel Unit Operation Successfully Drying mRNA/LNP by Mass Transfer. It will cover the technology principle allowing for ambient drying, its valuable thermostability effects and the implementation for industrial use.

Ziccum will also take part in the Poster Exhibition at the event, outlining aspects from the latest stage of its milestone in-house mRNA project. On March 20, 2023, the company announced that it had successfully nebulized and dried active mRNA materials, plus demonstrated a commercially viable level of mRNA activity.

CEO Ann Gidner: “The Summit is a landmark event for the international business and scientific mRNA community – and we believe that our unique capabilities within mRNA make our technology a key topic here. We look forward to sponsoring, networking and presenting at the event.”

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