Corporate Information Archives - Page 17 of 33

From vision to action: new Ziccum CEO update

On May 9, 2022, Ann Gidner became new CEO of Ziccum, hitting the ground running with a raft of new strategies that included targeting three key high-potential vaccines, streamlining the company’s project pipeline and strengthening the focus on industrial partnering. Ahead of a profile in Dagens Industri, Ann Gidner expands on her first month in office, and the operations and opportunities Ziccum is focusing on.

On March 11, 2020 the pharmaceutical industry entered a new era, as the WHO declared COVID-19 a global pandemic: “The speed at which new vaccines were developed is fantastic, and that impetus and investment continues,” says Ann Gidner. “For us it means we no longer have to sell the big-picture benefits of thermostable vaccines. Now is the time for action in our work with pharmaceutical companies and CDMOs (Contract Development and Manufacturing Organizations). We are prioritizing building direct discussions and projects with those organizations.

“There are several synergies and strong connections to previous experiences and positions in my career and I believe I have a relevant network for enabling new partnering dialogues. We have had several initial discussions with industrial players since I started, and I experience a high level of interest in Ziccum’s technology. My specific experience driving new businesses for CDMOs will also be crucial for my position at Ziccum as this group of companies are an important new target for us.”

From vision to action – platforms and projects
Ann Gidner has brought a sharper focus to Ziccum’s projects and pipeline work in her first month as CEO. The company has streamlined its project portfolio down to three high-value ongoing feasibility and evaluation studies – two with leading pharma corporations, and one with a major research institute in vaccination in the Nordic region. Ziccum is also now prioritizing three key, high-potential vaccine platforms, including mRNA.

“It’s all about action and applicability,” says Ann Gidner. “We have eliminated demanding low-value projects and are focusing only on projects which will help accelerate our technology from concept to first licensing deal. Those projects which deliver absolutely the most value for us and our clients – in terms of patent potential and landing licensing deals.”

Ziccum recently announced that an ongoing pilot evaluation study agreement with a leading pharmaceutical corporation has been extended following the completion of the latest stage of the project. Ziccum will ship the dry-formulated study materials from its facilities in Lund to the corporation’s labs at the end of June, where they will be evaluated.

Explore Ziccum’s three key vaccine platforms.

Strong mRNA focus
Ziccum has made major strategic investments too into new facilities and equipment for mRNA/LNP (Lipid Nanoparticles), seen by many as representing a new era in vaccinology. LaminarPace, the company’s ambient drying system, has already achieved first results with early dry formulations of LNP materials, a dataset which will enable further optimization for these crucial delivery vehicles that enabled both the Pfizer-BioNTech and Moderna COVID-19 vaccines.

“Our work with LNP and mRNA materials is particularly exciting,” Ann Gidner says. “Remember, people were skeptical about mRNA COVID-19 vaccines at first, but the drive, research and investment in developing these created enormous opportunities. And those opportunities continue today. mRNA is one of the most high-potential areas in the industry right now.”

Read about Ziccum’s focus on mRNA vaccines here

Growing industrial maturity
Ziccum is continuously developing the industrial capabilities of LaminarPace, aiming for eventual GMP manufacturing status. The current system is the fourth generation, with nitrogen having replaced air, to further reduce moisture, a new sealed powder collector, to increase safety, and an advanced array of sensors to measure drying flow.

Ann Gidner: “We are very happy to just have the fourth generation equipment installed this week. Our technology development is maturing rapidly, achieved in parallel with ongoing project work, resulting in increased confidence from our external collaborators.”

“I have taken several technologies and products through to market and licensing deals, and I am convinced that Ziccum has excellent potential.” says Ann Gidner.

Long-term financing
Another important strategic objective is to secure long-term financing for Ziccum, increasingly important as global financial conditions are becoming more challenging.
“Generating revenues from early co-development and feasibility programs is one very important factor which can contribute significantly. Another opportunity is to continuously evaluate soft funding in the form of specific industry grants where we can identify a strong match with our technology and offering. We are currently working actively on a selection of soft funding opportunities where we believe the chances are favorable for being granted substantial contributions to our long-term financing plan.”

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.

From vision to action: new Ziccum CEO update

Ziccum further extends evaluation agreement with leading pharmaceutical corporation

Lund, June 3, 2022 —Ziccum AB (publ) (‘Ziccum’) has extended an ongoing pilot evaluation study agreement with a leading pharmaceutical corporation following the completion of the latest stage of the project. Ziccum will ship the dry-formulated study materials from its facilities in Lund to the corporation’s labs at the end of June, where they will be evaluated

The study is analyzing Ziccum’s drying capabilities on a major vaccine platform technology using LaminarPace TM – Ziccum’s ambient dry formulation system for vaccines and biologics. Ziccum is now in the process of packaging and labeling the dry formulated study materials and will ship them to the company’s labs at the end of June.

LaminarPace TM can gently dry liquid biologics and vaccines at room temperature with the active ingredient remaining intact. Dry-formulated thermostable vaccines could be transported with no need for refrigerated transport or storage – potentially solving a perennial challenge for the global vaccine industry. Ziccum has recently sharpened the focus of its research onto three major vaccine platforms that are the base for many existing vaccines on the market, and a wide range of new vaccines in development.

Ziccum has continued the technological development of LaminarPace TM throughout the present collaboration as it continues the system’s scale-up towards eventual GMP (Good Manufacturing Practice) status for industrial manufacture.

Ziccum CEO Ann Gidner: ”The positive and constructive commitment on both sides through this collaboration underlines how valuable the project is for all of us. At Ziccum now we are focused firmly on this kind of high-value project – projects which can generate new data, new formulations and ultimately new patents and partnerships.”

Ziccum further extends evaluation agreement with leading pharmaceutical corporation

ZICCUM AB’s Anna Lönn elected to NIIMBL Technical Activities Committee

Ziccum’s Director of Development Anna Lönn has now been elected onto the Technical Activities Committee of the US National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), which will have its first meeting on May 23, 2022. NIIMBL, co-funded by the US Department of Commerce, funds and initiates a wide range of public-private research projects throughout the US.

Ziccum is one of a few European members invited to join NIIMBL, becoming a member in March 2021. NIIMBL is a public-private partnership that helps fund an ambitious range of research projects to accelerate biopharmaceutical innovation in manufacturing and supply. Members include industry, academic and government organizations within pharmaceutical manufacture and supply.

Anna Lönn, Ziccum’s Development Director has been elected to NIIMBL’s Technical Activities Committee (TAC) for the period 2022 – 2023. Anna, who joined Ziccum in September 2021 from TetraPak, has driven significant development throughout the company together with a highly skilled development team. Since September they have established the company’s expanded lab facilities and mRNA capabilities, and driven ahead its ambitious Quality by Design-led program of technological development. Fellow NIIMBL members on the TAC include representatives from noted vaccine developers, biologics companies working on viral vectors and viral vaccines, and academics from leading US universities within bioprocesses and pharmaceutics.

Ziccum Chairman Fredrik Sjövall: “The election of Anna really reflects her outstanding professionalism and expertise; she will bring fantastic qualities to fascinating work. We welcome the opportunities for networking and partnerships that TAC brings, and the possibilities for soft funding that can come through involvement with organizations like NIIMBL and CEPI (the Coalition for Epidemic Preparedness Innovation.) Our recent invitation from CEPI to submit an application for their soft-funded project on innovation in thermostable vaccines, plus our ongoing work with NIIMBL, are all good examples of the awareness and interest in the industry around our technology. We look forward to making a valuable contribution.”

Read more about NIIMBL here.
Read more about LaminarPace here.

ZICCUM AB’s Anna Lönn elected to NIIMBL Technical Activities Committee

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

Kommuniké från årsstämma i Ziccum AB (publ)

Ziccum AB (publ) (”Ziccum”) avhöll den 28 april årsstämma i Lund. Vid stämman fattades bland annat följande beslut.

Fastställande av årsbokslut och ansvarsfrihet
Stämman beslutade att fastställa resultat- och balansräkning för Ziccum för räkenskapsåret 2021. Stämman beslutade även om ansvarsfrihet för styrelseledamöterna och verkställande direktören för deras förvaltning av bolagets angelägenheter under räkenskapsåret 2021.

Resultatdisposition
Stämman beslutade, i enlighet med styrelsens förslag, att Ziccums resultat ska balanseras i ny räkning, och att någon utdelning således inte lämnas.

Styrelse och revisor
Stämman beslutade, i enlighet med valberedningens förslag, om omval av Fredrik Sjövall, Mikaela Bruhammar och Andreas Pettersson Rohman samt om nyval av Christina Herder och Martina Banyay som styrelseledamöter. Fredrik Sjövall omvaldes även till styrelseordförande. Till revisor omvaldes vidare revisionsbolaget Ernst & Young Aktiebolag.

Stämman beslutade vidare om styrelsearvode i enlighet med valberedningens förslag. Stämman beslutade även, i enlighet med valberedningens förslag, att revisorsarvode ska utgå enligt godkänd räkning.

Valberedning inför nästa årsstämma
Stämman beslutade, i enlighet med valberedningens förslag, om principer för utseende av valberedningen.

Emissionsbemyndigande
Stämman beslutade, i enlighet med styrelsen förslag, att bemyndiga styrelsen att, vid ett eller flera tillfällen fram till nästa årsstämma besluta om att öka bolagets aktiekapital genom nyemission av aktier, teckningsoptioner eller konvertibler. Sådant emissionsbeslut ska kunna fattas med eller utan avvikelse från aktieägarnas företrädesrätt. Emissionen ska kunna ske mot kontant betalning, apport eller kvittning eller andra villkor. 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.

Incitamentsprogram
Stämman beslutade, i enlighet med valberedningens förslag, att anta ett incitamentsprogram till styrelseledamöter i form av personaloptioner. Incitamentsprogrammet innebär i korthet en emission av högst 165 000 personaloptioner. Stämman beslutade vidare att emittera högst 216 843 teckningsoptioner för att säkra leverans av aktier till deltagare och för att säkra kostnader förknippade med programmet. Varje personaloption ger rätt att antingen förvärva en aktie till ett pris motsvarande kvotvärdet av aktien eller vederlagsfritt erhålla en teckningsoption som berättigar till teckning av en aktie i Ziccum till en teckningskurs som motsvarar kvotvärdet på aktien under tiden från och med den 1 maj 2025 till och med den 31 maj 2025.

Stämman beslutade därutöver, i enlighet med styrelsens förslag, att anta ett incitamentsprogram till medarbetare i form av personaloptioner. Incitamentsprogrammet innebär i korthet en emission av högst 256 000 personaloptioner. Stämman beslutade vidare att emittera högst 336 436 teckningsoptioner för att säkra leverans av aktier till deltagare och för att säkra kostnader förknippade med programmet. Varje personaloption ger rätt att antingen förvärva en aktie till ett pris motsvarande kvotvärdet av aktien eller vederlagsfritt erhålla en teckningsoption som berättigar till teckning av en aktie i Ziccum till en teckningskurs som motsvarar kvotvärdet på aktien under tiden från och med den 1 maj 2025 till och med den 31 maj 2025.

För mer information, kontakta:
Frida Hjelmberg, tf VD, Ziccum AB
Tel: +46 793 415 531
E-post: hjelmberg@ziccum.com

Kommuniké från årsstämma i Ziccum AB (publ)

ZICCUM AB (publ) Interim report Q1 2022

INTERIM REPORT Q1 2022: 1 JANUARY – 31 MARCH 2022

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

Q1 2022

The result for the quarter amounted to -6,285 kSEK (-4, 416 kSEK)
Cash flow for the quarter amounted to 31,961 kSEK (-4, 818 kSEK)
Cash and cash equivalents at the end of the quarter amounted to 44, 234 kSEK (28,802 kSEK)

SUMMARY FINANCIAL HIGHLIGHTS kSEK	Jan-March 2022	Jan-March 2021	Jan-Dec 2021
Net revenue	–	–	–
Operating result	(6,340)	(4,387)	(21,117)
Result	(6,285)	(4,416)	(21,136)
Balance sheet total	58,295	35,715	39,591
Cash flow	31,961	(4,818)	(21,347)
Cashy and cash equivalents	44,234	28,802	12,273
Equity ratio %	0.88	0.90	0.75

Data per share SEK
Number of shares at end of period	13,806,142	9,606,200	11,006,056
Result per share before and after dilution*	-0.46	-0.46	-2.17
Cash flow per share	2.41	-0.50	-2.19
Equity per sharee	3.73	3.33	2.70

* Dilution effects is not calculated when the result is negative

Significant events during Q1 (Jan-March)
At the Extraordinary General Meeting held on January 18, in addition to approving the Board's proposal, it was decided to increase the limit on the number of shares and the size of the share capital in the Articles of Association, to enable the issue of the remaining 933,362 units in the private placement.

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

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

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

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

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

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 CFO for Ziccum, she takes office on May 9.

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

CEO Statement

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

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

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

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

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

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

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

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

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

Interim Report Q1 2022 FINAL (1)

ZICCUM AB (publ) Delårsrapport Q1 2022

DELÅRSRAPPORT Q1: 1 JANUARI – 31 MARS 2022

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

Q1 2022

Resultatet för kvartalet uppgick till -6 285 kSEK (-4 416 kSEK)
Kassaflödet för kvartalet uppgick till 31 961 kSEK (-4 818 kSEK)
Likvida medel uppgick vid utgången av kvartalet till 44 234 kSEK (28 802 kSEK)

Finansiell data i sammandrag kSEK	jan-mars 2022	jan-mars 2021	jan-dec 2021
Nettoomsättning	–	–	–
Rörelseresultat	(6 340)	(4 387)	(21 117)
Resultat	(6 285)	(4 416)	(21 136)
Balansomslutning	58 295	35 715	39 591
Periodens kassaflöde	31 961	(4 818)	(21 347)
Likvida medel	44 234	28 802	12 273
Soliditet %	0,88	0,90	0,75

Nyckeltal per aktie SEK
Antal aktier vid periodens slut	13 806 142	9 606 200	11 006 056
Resultat per aktie före och efter utspädning*	-0,46	-0,46	-2,17
Periodens kassaflöde per aktie	2,41	-0,50	-2,19
Eget kapital per aktie	3,73	3,33	2,70

* Utspädningseffekter omräknas ej vid negativt resultat

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

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

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

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

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

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

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

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

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

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

Ziccum Q1 2022
VD har ordet

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

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

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

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

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

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

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

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

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

Ziccum Delarsrapport Q1 2022 FINAL

ZICCUM AB: key targeted technology developments underpin new strategic focus

Select key technology developments will underpin Ziccum’s new strategic focus of generating further data in three vaccine platforms, including mRNA/LNP, so strengthening its position as an attractive industrial partner. The key technology developments will run in parallel with Ziccum’s streamlined project program. Chairman Fredrik Sjövall: “These projects will enable and drive forward business development and strengthen the company’s offering and data to industrial partners.”

Ziccum is now focusing on a targeted program of technology development, in parallel with a streamlined project program targeting three key vaccine platforms. The strategy will focus and drive forward business development and significantly strengthen the company’s offering to industrial partners. It will also serve as a foundation for generating new patents – not least in the area of mRNA.

Chairman Fredrik Sjövall: “Our early collaborations and discussions with external parties provided strong guidance on where we should put our focus in terms of technological development in order to increase the probability of entering commercial agreements. For example, we needed to have an industrial conceptual design for LaminarPace (LAPA), so we did that with our Fill and Finish blueprint with KeyPlants. These new targeted developments are also built on key learnings from external collaborations.”

Driven by QbD

As it progresses towards its ultimate long-term goal of establishing LaminarPace (LAPA) as an integrated part of the industrial production of vaccines, Ziccum works using a highly focused Quality by Design (QbD) approach. QbD is a systematic risk-based methodology, recognized and encouraged in pharmaceutical manufacture by the FDA, that identifies potential risks and variables in all aspects of product manufacture and development.

The current LAPA system is the fourth generation in development, with several key improvements having been implemented – from critical components and material selection and design (for example Teflon tubing replacing silicon and Nitrogen replacing air to further reduce moisture), to advanced sensor arrays inside the system to map and monitor the flow of the drying procedure itself, to software and control optimization and sealed glovebox collection to ensure the safety of the operator and the product.

Key priority areas in LAPA’s development towards eventual GMP industrial manufacturing status include continuing to explore ways to optimize production capacity, reproducibility, reliability, cleanability and sterilization. The current focus areas all impact on these metrics.

KEY TECHNOLOGY DEVELOPMENTS UNDERWAY – AND 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: LAPA has been used throughout its history to dry small amounts of test substance in a lab setting. The system’s nebulizer feature is a key component in optimizing the system’s capacity, reproducibility and reliability. Ziccum has carried out a first phase in optimizing the nebulization step and is now collaborating with a specialist engineering partner in a second evaluation stage. These external collaborations and partnerships are expected to continue in LAPA’s ongoing development. The current stage of nebulizer development is estimated to be completed by H2 2023.

New membrane: The central membrane in LAPA’s drying column is a critical component. Intensive work is currently underway in optimizing the membrane for future GMP compatibility – examining its porosity, mounting and materials for industrial setting. This current development stage will be completed by H2 2023.

Fredrik Sjövall: “LAPA is a highly innovative system with unique capabilities. The projects we are now focusing on are crucial steps towards reaching the industrial production environment – increasing the value of our technology, and therefore the opportunities for it to enter into commercial agreements. The projects will be run in parallel with our evaluation programs together with external partners, and our internal mRNA / LNP work, and will form the basis for new patent applications – both for ourselves and our customers.”

ZICCUM AB: key targeted technology developments underpin new strategic focus

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