News Archives - Page 6 of 33

Ziccum reports on developments in the portfolio of industry partner projects

Ziccum is continuously engaged in business discussions with potential industrial partners. The status of Ziccum’s project portfolio is presented quarterly in the company interim reports. There are currently further updates to report.

Several new dialogues have been initiated, involving different types of drug modalities to be tested with LaminarPace technology. A broader pipeline including several customer and therapeutic segments increases the business potential for Ziccum and significantly reduces the risk taking the technology to market.

One Big Pharma collaboration has reached the readout stage, and is subject to further evaluation, while one new dialogue has emerged, and one is in final negotiation for a paid study.

The mRNA/LNP Field

For mRNA/LNP projects, where Ziccum has generated very important data recently, more advanced discussions now include one more US Biotech Corporation (Biotech IV) where feasibility study negotiations are reaching final stages; the parties have agreed on the scope of the work plan and are currently reviewing legal terms. The modality to be tested is mRNA in a partner specific LNP formulation, where organ targeting is an extra technology edge for the mRNA/LNP partner portfolio.

The Big Pharma II Feasibility study, signed in July 2023, has reached completion and readout stage. Ziccum can report very good results for the technical parameters: encapsulation efficiency as well as LNP particle size and size distribution.

While the first part of this joint project has been completed, the Big Pharma II is currently assessing whether to initiate the second step.

The Feasibility study with Biotech Corp II achieved excellent results in first quarter 2024 as previously reported. The partner has not taken any decision for next potential steps as of yet.

Protein subunit vaccines

The Biotech Corp V dialogue has progressed, where the partner is planning to propose the scope for a Feasibility study within short. As Ziccum’s organization has very good knowledge in the field of subunit vaccines, it may be a welcome addition to the project portfolio and would provide further scientific support for the LaminarPace technology.

Lentivirus vaccines

The US-based CDMO Partner (CDMO I) project is currently on pause as communicated in the Q1 report, with the partner assessing which application may be utilized, to best achieve competitive advantages of the LaminarPace technology. There is great enthusiasm for Ziccum’s disruptive technology in the partner organization.

Protein Biopharmaceuticals

There are several new Big Pharma dialogues with large industry players having approached Ziccum recently. This has resulted in large forum presentations of the LaminarPace technology to scientific teams mainly in the UK, US and Sweden, and new project opportunities in review.

One of these partners, Big Pharma III has proposed a joint Feasibility project for testing of a protein pharmaceutical modality with LaminarPace, and to jointly make a scientific publication with Ziccum. Big Pharma III has important resources in vaccines as well as in therapeutics. This fruitful dialogue has progressed rapidly and is new to the Portfolio overview.

Ziccum’s CEO Ann Gidner: “We are delighted to keep on broadening our business scope with further serious industry dialogues with top class partners in Biotech and Big Pharma. The LaminarPace technology is here to solve the significant practical problems when advancing new biological modalities into real patient treatments – and the need for solutions is getting more into industry focus every day. In coming months, we hope to progress our collaborative pipeline further, while maintaining awareness of and respect for the many complex judgements needed when implementing new, unique technology in pharmaceutical development.

Ziccum Portfolio overview as of May 31st attached.

About Ziccum

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

Ziccum reports on developments in the portfolio of industry partner projects

Project Portfolio Overview May 2024

Exercise of Employee Stock Options of Series LTI 2021:1 at Ziccum AB (publ)

On 27 April 2021, the Annual General Meeting of Ziccum AB (publ) ("Ziccum" or the "Company") resolved on a directed issue of not more than 46,000 employee stock options of series LTI 2021:1 (the "Stock Options") to certain employees and consultants in the Company. Today, Ziccum announces that 14,819 warrants of series 2021/2024 (the "Warrants"), related to LTI 2021:1, have been exercised for subscription of 23,709 new shares in the Company.

At the Annual General Meeting of Ziccum on 27 April 2021, it was resolved to adopt a long-term incentive program directed to senior executives and key employees in the Company, whereby 42,456 Stock Options were subscribed, of which 14,819 Stock Options have been exercised by the participants in the incentive program who, in accordance with the terms and conditions of LTI 2021:1, are entitled to exercise the Stock Options for allotment of Warrants, which in turn entitle the holder to subscribe for new shares in the Company. Each Stock Option entitles the holder to acquire one Warrant, which in turn entitles the holder to subscribe for, after recalculation in accordance with the terms and conditions of the Warrants, 1.60 new shares in the Company during the exercise period running from and including 1 May 2024 up to and including 31 May 2024, at a subscription price per share corresponding to SEK 0.17. All non-expired Stock Options have been exercised for allotment of Warrants.

The Warrants have been exercised by the Company's Scientific Director Fabrice Rose for subscription of 6,691 shares, the Company's Technical Operations Manager Rasmus Lund for subscription of 6,836 shares and the Company's former CFO Frida Hjelmberg for subscription of 10,182 shares.

A total of 14,819 Warrants have thereby been exercised for subscription of 23,709 new shares in the Company, which means that Ziccum will receive SEK 4,030.53. The exercise of the Warrants means that the Company’s share capital will increase by SEK 3,951.50, from SEK 2,562,043.000003 to SEK 2,565,994.500003, and the number of shares in the Company will increase by 23,709 shares, from 15,372,258 shares to 15,395,967 shares, corresponding to a dilution effect of approximately 0.15 percent of the number of shares and votes in the Company.

About Ziccum

Exercise of Employee Stock Options of Series LTI 2021:1 at Ziccum AB (publ)

Bulletin from the Annual General Meeting of Ziccum AB (publ)

The following resolutions were passed at the Annual General Meeting (the “AGM”) of Ziccum AB (publ) (the “Company”) on the 29th of May 2024 in Lund.

Adoption of income statement and balance sheet and discharge from liability
The AGM resolved to adopt the income statement for the financial year 2023 as well as the balance sheet as of 31 December 2023. The members of the Board of Directors and the managing director were discharged from liability for the financial year 2023.

Allocation of profit or loss
The AGM resolved, in accordance with the Board of Directors’ proposal, that no dividend shall be paid for 2023 and that the results of the Company shall be carried forward.

Board of Directors and auditor
The AGM resolved, in accordance with the Nomination Committee’s proposal, on re-election of Mikaela Bruhammar, Andreas Pettersson Rohman and Per Gerde and election of Jonas Ekblom and Valentina Screpanti Sundquist as board members. Jonas Ekblom was elected as the chairman of the Board of Directors. The AGM elected the audit firm Öhrlings PricewaterhouseCoopers AB as auditor.

The AGM further resolved on remuneration to the Board of Directors in accordance with the Nomination Committee’s proposal. The AGM furthermore resolved in accordance with the Nomination Committee’s proposal, that remuneration to the auditor shall be paid in accordance with approved invoice.

Nomination Committee for the next Annual General Meeting
The AGM resolved, in accordance with the Nomination Committee’s proposal, that the principles for appointing the Nomination Committee adopted at the AGM of 2022 shall apply also for the AGM to be held in 2025.

Resolution on issue authorization
The AGM resolved, in accordance with the Board of Directors’ proposal, to authorize the Board of Directors to, at one or several occasions and for the period up until the next AGM, resolve to increase the Company’s share capital by issuing new shares, convertibles or warrants. Such issue resolution may be carried out with or without deviation from the shareholders’ preferential rights and with or without provisions for contribution in kind, set-off or other conditions. The number of shares that can be issued, or, in case of issuance of convertibles or warrants, added after conversion or exercise, with the support of authorization shall be limited to 40 percent of the number of outstanding shares at the time of this AGM.

The reason for deviating from the shareholders’ pre-emption rights is to increase the Company’s financial flexibility and the Board of Directors’ scope of action as well as to be able to complete the financing arrangement with Global Corporate Finance, which the Company announced in a press release on 22 January 2024, in a manner favorable to the shareholders. If the Board of Directors decides on an issue deviating from the shareholders’ pre-emption rights, the reason shall be to enable widening of the ownership circle, to acquire or enable the acquisition of working capital (for example by completing the financing arrangement with Global Corporate Finance), to increase the liquidity of the share, to carry out company acquisitions or to acquire or enable the acquisition of capital for company acquisitions.

Incentive program for members of the Board of Directors
The AGM resolved, in accordance with the Nomination Committee’s proposal, to adopt an incentive program for members of the Board of Directors elected at the AGM 2024 consisting of qualified employee stock options. In short, the incentive program includes an issue of not more than 100,000 qualified employee stock options. The AGM furthermore resolved on an issue of not more than 100,000 warrants to ensure delivery of warrants to the participants. Each qualified employee stock option entitles the holder to, free of charge, acquire a warrant entitling the holder to subscribe for one (1) share in the Company during the period from 1 July 2027 up to and including 14 July 2027 at a subscription price corresponding to the quota value of the share.

Incentive program for employees
The AGM resolved, in accordance with the Nomination Committee’s proposal, to adopt an incentive program for certain employees consisting of qualified employee stock options. In short, the incentive program includes an issue of not more than 372,000 qualified employee stock options. The AGM furthermore resolved on an issue of not more than 372,000 warrants to ensure delivery of warrants to the participants. Each qualified employee stock option entitles the holder to, free of charge, acquire a warrant entitling the holder to subscribe for one (1) share in the Company during the period from 1 November 2027 up to and including 14 November 2027 at a subscription price corresponding to the quota value of the share.

Amendment of the Articles of Association
The AGM resolved, in accordance with the Board of Directors’ proposal, to amend the Articles of Association. In addition to editorial changes, amendments were made in order to (i) change the business object to better reflect the object of the Company and (ii) enable the Company to hold digital general meetings following a legislative amendment in the Swedish Companies Act that allows for digital general meetings.

For further information, please contact:
Ann Gidner, CEO, Ziccum AB (publ)
Tel: +46 722 14 01 41
E-mail: gidner@ziccum.com

About Ziccum

Bulletin from the Annual General Meeting of Ziccum AB (publ)

Kommuniké från årsstämma i Ziccum AB (publ)

Ziccum AB (publ) (”Bolaget”) avhöll den 29 maj 2024 årsstämma i Lund. Vid stämman fattades bland annat följande beslut.

Fastställande av årsbokslut och ansvarsfrihet
Stämman beslutade att fastställa resultat- och balansräkning för Bolaget för räkenskapsåret 2023. Stämman beslutade även om ansvarsfrihet för styrelseledamöterna och verkställande direktören för deras förvaltning av Bolagets angelägenheter under räkenskapsåret 2023.

Resultatdisposition
Stämman beslutade, i enlighet med styrelsens förslag, att Bolagets 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 Mikaela Bruhammar, Andreas Pettersson Rohman och Per Gerde samt om nyval av Jonas Ekblom och Valentina Screpanti Sundquist. Jonas Ekblom valdes även till styrelseordförande. Till revisor valdes vidare revisionsbolaget Öhrlings PricewaterhouseCoopers AB.

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 att de principer för utseende av valberedning som antogs på årsstämman 2022 ska fortsätta att gälla även inför årsstämman 2025.

Emissionsbemyndigande
Stämman beslutade, i enlighet med styrelsens förslag att bemyndiga styrelsen att, vid ett eller flera tillfällen före nästa årsstämma besluta om att öka Bolagets aktiekapital genom nyemission av aktier eller emission av konvertibler eller teckningsoptioner. 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 40 procent av det vid tidpunkten för denna stämma antalet utestående aktier.

Syftet med bemyndigandet är att öka Bolagets finansiella flexibilitet och styrelsens handlingsutrymme samt att på ett för aktieägarna gynnsamt sätt kunna fullfölja finansieringsupplägget med Global Corporate Finance, vilket Bolaget genom pressmeddelande den 22 januari 2024 har informerat om. Om styrelsen beslutar om emission utan företrädesrätt för aktieägarna så ska skälet vara att kunna bredda ägarkretsen, anskaffa eller möjliggöra anskaffning av rörelsekapital (till exempel genom att fullfölja finansieringsupplägget med Global Corporate Finance), öka likviditeten i aktien, genomföra företagsförvärv eller anskaffa eller möjliggöra anskaffning av kapital för företagsförvärv.

Incitamentsprogram för styrelseledamöter
Stämman beslutade i enlighet med valberedningens förslag, att anta ett incitamentsprogram till de styrelseledamöter i Bolaget som väljs vid årsstämman 2024 i form av kvalificerade personaloptioner. Incitamentsprogrammet innebär i korthet en emission av högst 100 000 kvalificerade personaloptioner. Stämman beslutade vidare att emittera högst 100 000 teckningsoptioner för att säkerställa leverans av teckningsoptioner till deltagare. Varje kvalificerad personaloption ger rätt att vederlagsfritt erhålla en teckningsoption som berättigar till teckning av en (1) aktie i Bolaget under tiden från och med den 1 juli 2027 till och med den 14 juli 2027 till en teckningskurs motsvarande kvotvärdet per aktie.

Incitamentsprogram för medarbetare
Stämman beslutade, i enlighet med styrelsens förslag, att anta ett incitamentsprogram för vissa anställda inom Bolaget i form av kvalificerade personaloptioner. Incitamentsprogrammet innebär i korthet en emission av högst 372 000 kvalificerade personaloptioner. Stämman beslutade vidare att emittera högst 372 000 teckningsoptioner för att säkerställa leverans av teckningsoptioner till deltagare. Varje kvalificerad personaloption berättigar innehavaren att vederlagsfritt erhålla en teckningsoption som berättigar till teckning av en (1) aktie i Bolaget under tiden från och med den 1 november 2027 till och med den 14 november 2027 till en teckningskurs motsvarande kvotvärdet per aktie.

Ändring av bolagsordningen
Stämman beslutade, i enlighet med styrelsens förslag, att ändra bolagsordningen. Utöver redaktionella ändringar gjordes ändringar i syfte att (i) ändra verksamhetsföremålet för att bättre återspegla Bolagets nuvarande verksamhet och (ii) införa möjlighet för Bolaget att hålla digitala bolagsstämmor i enlighet med den lagändring i aktiebolagslagen som möjliggör digitala bolagsstämmor.

För mer information, kontakta:
Ann Gidner, VD, Ziccum AB (publ)
Tel: +46 722 14 01 41
E-post: gidner@ziccum.com

Om Ziccum

Ziccum utvecklar LaminarPace, en unik metod för torkning av biologiska läkemedel och vacciner i rumstemperatur. Metoden bygger på massöverföring istället för värmeöverföring. Tekniken licensieras ut till utvecklare och tillverkare av vaccin och biologiska läkemedel inom den globala läkemedelsindustrin. Genom att minska den stress som den aktiva substansen utsätts för under torkningen erbjuder LaminarPace en unik möjlighet att ta fram termostabila biologiska läkemedel med partikel-teknologi i en torr pulverberedning. Dessa är enkla att hantera och transportera och lämpar sig utmärkt för nya administreringssätt. Tekniken har framgångsrikt tillämpats på mRNA, peptider, proteiner, antikroppar, lipider och enzymer, samt på hjälpämnen och adjuvanter, och lämpar sig väl för industriell tillämpning. Ziccum är noterat på Nasdaq First North Growth Market.

Kommuniké från årsstämma i Ziccum AB (publ)

Ziccum partners with Dagens Industri for Investor Relations program

Ziccum partners with Dagens Industri, the largest Nordic business paper, to improve shareholders’ access to news updates and raise broader awareness of its continuous scientific and commercial progress.

Ziccum AB has signed a partnership with the Investor Relations arm of Dagens Industri, joining a select group of Nordic SMEs in a bid to ensure timely, efficient, and professional dissemination of its increasing information flow. The scope includes interviews in text and video format as well as company coverage in smaller and larger features in the main DI paper.

Operating at the cutting edge of science, developing a disruptive technology enabling new and much improved biopharmaceuticals and continuously gaining increased recognition from international Pharma & Biotech industry, Ziccum sees the need to keep its loyal regional investor base well-apprised by providing systematic and accessible updates on its progress. Ziccum could not ask for a better partner than Dagens Industri, an institution of business reporting among the Nordic investment community for decades.

Ziccum’s CEO, Ann Gidner: “Now that Dagens Industri are selecting a few smaller Swedish listed companies to be well featured, we are delighted to be included and it is perfect timing with our need for better visibility in investors’ circles”.

About Dagens Industri:

Dagens Industri was founded in 1976 and is currently owned by the Swedish media group Bonnier AB. DI’s online edition, di.se, has been consistently voted as Sweden’s “best economics online site” for 20 years (from 1999 to 2019) in a competition held by the PR firm Hallvarsson & Halvarsson.

About Ziccum

Ziccum partners with Dagens Industri for Investor Relations program

KOMPLETTERING TILL KALLELSEN TILL ÅRSSTÄMMA I ZICCUM AB (PUBL), ATT HÅLLAS DEN 29 MAJ 2024, KL. 15.00 I BOLAGETS LOKALER PÅ SCHEELEVÄGEN 22 I LUND

Den 25 april 2024 offentliggjorde Ziccum AB (publ) (”Bolaget”) pressmeddelande innehållande kallelse till Bolagets årsstämma att hållas den 29 maj 2024. I kallelsen angavs att förslag avseende beslut enligt punkterna 2 samt 10-15 kommer att redovisas i pressmeddelande före årsstämman.

Bolagets kallelse till årsstämma under rubriken Val av stämmoordförande, styrelse, styrelseordförande och revisor, fastställande av arvoden samt beslut om valberedning (punkt 2 samt 10-15) kompletteras med följd att de har nedan innehåll:

Beslutsförslag

Valberedningens förslag (punkt 2 samt 9-15)
Valberedningen som bestått av William Lithander, Göran Conradson och Kenneth Hopp, föreslår:
att advokaten Hannes Mellberg väljs till stämmoordförande,
att styrelsen ska bestå av fem (tidigare fyra) ledamöter, utan suppleanter,
att ett registrerat revisionsbolag utan revisorssuppleant ska utses,
att styrelsearvode ska utgå med 3,6 prisbasbelopp för år 2024 motsvarande 206 280 (tidigare 220 000) kronor till styrelseordförande och med 2,2 prisbasbelopp för år 2024 motsvarande 126 060 (tidigare 110 000) kronor vardera till övriga styrelseledamöter,
att arvode till revisor ska utgå enligt godkänd räkning,
att Mikaela Bruhammar, Andreas Pettersson Rohman och Per Gerde omväljs, samt att Jonas Ekblom och Valentina Screpanti Sundquist väljs, till styrelseledamöter för tiden intill slutet av nästa årsstämma. Fredrik Sjövall har avböjt omval,
att Jonas Ekblom väljs till styrelseordförande,
att Öhrlings PricewaterhouseCoopers AB väljs till revisionsbolag (Öhrlings PricewaterhouseCoopers AB har upplyst att auktoriserade revisorn Ola Bjärehäll utses till huvudansvarig revisor om stämman beslutar enligt förslaget), samt
att de principer för utseende av valberedning som antogs på årsstämman 2022 ska fortsätta att gälla även inför årsstämman 2025.

Beskrivning av föreslagna ledamöter

Jonas Ekblom, född 1965, är docent i farmakologi vid Uppsala Universitet, har en B.Sci i kemi vid Stockholms universitet och Ph.D. i experimentell neurologi från Uppsala universitet, och post-doktorala studier från University of Southern California, School of Pharmacy i Los Angeles. Han har över 25 års erfarenhet inom life science. Jonas har haft seniora och exekutiva chefsroller i företag inom bioteknik i Sverige, USA och Schweiz, i företag som Pharmacia, Biovitrum, Promore Pharma, Sequenom, Invitrogen och BOWS Pharmaceuticals SA. Han har även utbildning inom strategisk planering och företagsledning. Jonas har publicerat mer än 60 artiklar i expertgranskade tidskrifter. Jonas är även styrelseordförande i CombiGene AB (publ) och Oblique Therapeutics AB (publ) samt styrelseledamot i Emplicure AB (publ) och Moberg Pharma AB (publ). Jonas är oberoende i förhållande till Bolaget, bolagsledningen och större aktieägare. Jonas innehar inga aktier i Bolaget.

Valentina Screpanti Sundquist, född 1972, har en M.Sci i molekylärbiologi vid Stockholms universitet och Ph.D. i immunologi från Wenner-Grens institutet vid Stockholms universitet, och post-doktorala studier från Center for Infectious Medicine, Karolinska Institutet. Hon har närmare 20 års erfarenhet inom life science. Hon har haft seniora och chefsroller i företag inom bioteknik i Sverige, i företag som BioArctic Neuroscience, Astra Zeneca, Crucell (Johnson and Johnson) och Valneva. Valentina representerar för närvarande Sverige, med uppdrag från Läkemedelsverket, som expert i den europeiska farmakopén, grupp för vacciner och immunsera, vid den europeiska direktoratet för läkemedelskvalité (EDQM, Europarådet). Valentina är oberoende i förhållande till Bolaget, bolagsledningen och större aktieägare. Valentina innehar inga aktier i Bolaget.

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

Lund i maj 2024
Ziccum AB (publ)
Styrelsen

Om Ziccum

KOMPLETTERING TILL KALLELSEN TILL ÅRSSTÄMMA I ZICCUM AB (PUBL), ATT HÅLLAS DEN 29 MAJ 2024, KL. 15.00 I BOLAGETS LOKALER PÅ SCHEELEVÄGEN 22 I LUND

Ziccum CEO Analyst video interview: Q1, 2024 highlights

Watch Ziccum CEO Ann Gidner in a comprehensive interview with analyst Jonathan Furelid on the highlights of Ziccum’s Q1 2024 report and the company’s current and coming status.

CEO Ann Gidner provides investors with updates and insights on its new data readouts in mRNA/LNP, the status of Ziccum’s current partner projects and business dialogues, as well as technology development with significantly strengthened IP plus two new appointments within BD and Finance.

Watch the interview here.

About Ziccum

Ziccum CEO Analyst video interview: Q1, 2024 highlights

Ziccum AB strengthens patent portfolio with three solid data PCT applications according to expanded IP strategy

Ziccum AB (publ) (‘Ziccum’) has filed three PCT applications with ample and significant data covering years of equipment development and refinement, process parameter knowledge gained, plus key biopharmaceutical formulation expertise established. These various perspectives provide multi-layered protection to the company’s unique drying technology LaminarPaceTM.

Ziccum has progressed to the filing of three PCT patent applications, following up on a series of European patent applications as part of a stronger IP strategy. The PCT filings come on the heels of PC (Paris Convention) filings last year, according to the well-established practice, to ensure comprehensive geographic protection of Ziccum’s intellectual property. The specific Ziccum strategy is a multi-layered approach to cover and protect the full range of Ziccum’s innovations, with three key PCT applications as follows.

1) ‘SYSTEMS FOR DRYING OF COMPOSITIONS AND RELATED METHODS’
covering updated equipment for LaminarPaceTM drying
The largest effort is the application covering new equipment configuration in the LaminarPaceTM drying unit. Not only is the current PCT filing covering recent modifications in design, enabling higher nebulization rates providing a significantly higher production capacity, but now also covering a vast number of additional principle modifications and fine adjustments performed during years of development of the LaminarPaceTM unit at Ziccum. The application contains a large number of new claims.

2) ‘DRYING OF COMPOSITIONS’
covering optimized parameters for LaminarPaceTM drying
The application regarding the parameters used for optimal LaminarPaceTM drying, based on valuable learnings in the on-going work in internal trials, is an important extra level of protection and secures the Ziccum position carrying unique knowledge of how to apply the LaminarPaceTM technology for the best pharmaceutical product quality and attributes.

3) ‘NANOPARTICLE FORMULATIONS’
covering formulations that are optimized for LaminarPaceTM drying
This application covers a number of aspects of Ziccum’s formulation expertise. Lipid nanoparticles (LNPs) is the preferred formulation type in the booming field of (m)RNA development for new therapeutics and vaccines. Ziccum announced very good applicability for LaminarPaceTM in the mRNA field during 2023, followed by a partnered study and the first animal study in early 2024, confirming excellent results with high preservation of mRNA activity both in-vitro and in-vivo. The company has gained extensive knowledge in the complex LNP formulation field. The patent application covers these strong data sets as well as formulation knowledge also in a broader sense.

Ziccum CEO Ann Gidner: “Ziccum has generated an impressive amount of data in the recent year, now strongly underpinning these next stage applications. We are proud to complement our 2023 patent efforts with such solid additional input, and grateful to be protecting many years of equipment development as well. Robust IP is at the heart of a technology platform company, protecting our innovations and enabling our licensing”.

About PCT patent applications:
Applications under the Patent Cooperation Treaty are filed with the World Intellectual Property Organization, allowing for a single international patent application and, thus, simplifying the process of international search and preliminary examination. Having more than 150 contracting states, PCT is widely recognized not only for effective international patent protection, but also for efficiency, eliminating the need for filing numerous costly applications with individual countries and navigating multiple jurisdictional settings.

About Ziccum

Ziccum AB strengthens patent portfolio with three solid data PCT applications according to expanded IP strategy

Ziccum AB (publ) Interim report Q1 2024

INTERIM REPORT Q1, 1 JANUARY – 31 MARCH 2024

Significant events during the Quarter

Successful outcomes of LaminarPace™ Feasibility study with Biotech partner

On January 10, the company announced that, together with its Biotech Corporation collaboration partner, it has 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 confirmed consistent, positive readouts in the Study’s major parameters.
The assessment concluded that the resulting dry powder material demonstrated excellent mRNA activity when reconstituted and tested in in-vitro cell studies. The assessment also concluded that the LaminarPace™ treatment resulted in well-preserved mRNA content in LNP particles with adequate encapsulation efficiency. Furthermore, the treatment resulted in well-preserved lipid nanoparticles with good particle size and preserved size distribution.

Financing secured through directed share issue and rights issue

On January 22, the company announced that it has carried out a directed share issue of 622,371 shares of approximately MSEK 4.2 to the American professional investor Global Corporate Finance (GCF).
The Directed New Share Issue is part of a long-term financing arrangement with GCF under which Ziccum has the unilateral right to call for additional investments from GCF, in exchange for newly issued shares, totalling approximately MSEK 28 over the next thirty months.
The Board of Directors of Ziccum has also, based on the existing authorisation from the Annual General Meeting, decided to carry out a Rights Issue of units of a maximum of MSEK 10.4.
Considering the Directed New Share Issue, and provided that the Rights Issue is fully subscribed, Ziccum will receive initial proceeds totalling approximately MSEK 13.5.

* Volume-Weighted Average Price, VWAP, is calculated by totalling the SEK traded for every transaction (price multiplied by the volume) and then dividing by the total shares traded.

Ziccum has proven excellent mRNA activity in animal study with LaminarPace™ material

On January 31, the company announced that it has performed an animal study, confirming excellent genetic activity of mRNA/LNP materials treated by LaminarPace™. The in-vivo data confirms the ability of Ziccum’s LaminarPace™ technology to transform delicate mRNA/LNP liquid solution into stable dry powder form, now proving the preserved mRNA activity also in animal testing. Assessing the mRNA effect in animal trials is a significant step for Ziccum.

Ziccums CEO Ann Gidner in Fireside Chat on mRNA development hosted by US Force Family Office

On February 12, the company announced that based on the growing reputation that Ziccum is building in the international pharmaceutical industry, Ziccum CEO Ann Gidner has taken part in a recorded Fireside Chat reviewing the mRNA arena, its tremendous growth, and the shortcomings of the RNA/LNP technology which can be addressed by treatment with the Ziccum technology LaminarPace™.

Ziccum announces outcome in rights issue

On February 16, the company announced the outcome of the rights issue of units, consisting of shares and warrants, which ended on 14 February 2024 (the ”Rights Issue”). The Rights Issue has been subscribed to a total of approximately 61.5 percent, of which approximately 58.6 percent was subscribed with unit rights and approximately 2.9 percent was subscribed without unit rights. Through the Rights Issue, Ziccum thus receives approximately mSEK 6.4 before issuing costs.

Ziccum reports significant progress in 3D-modelling project with model completion

On March 1, the company announced that Ziccum AB and project partner Zurich institute of Applied Sciences (ZHAW) have made a milestone review of the LaminarPace™ simulation (LaPaSim) project progress and findings. The complex, dynamic model digitally replicating the LaminarPace™ operation has been created and validated against comprehensive data sets created in physical trial runs and is now reaching a stage close to full completion. Ziccum can now perform trial runs in the 3D simulation environment, enabling the generation of vast amounts of data and in-depth understanding of optimal parameters and scale-out.

Ziccum inhalable mRNA/LNP project confirms excellent properties obtained by LaminarPace™

On March 14, the company announced that it has generated very good findings in the first stages of its collaborative project to engineer inhalable mRNA/LNP together with the University of Copenhagen. The results demonstrate that LaminarPace™ successfully produces inhalable particles with special, desirable properties. The project will continue with in-vivo studies comparing inhalation versus injection.

Significant events after the Quarter

Ziccum strengthens and streamlines business and finance functions

On April 3, the company announced that it is reorganizing its administrative functions, due to the increased amount of business dialogues and to perform financial reporting in a more streamlined fashion. Two new roles of Business & Project Manager and a business-oriented, junior Financial Manager are introduced while the CFO role is eliminated.

Ziccum CEO to present at first annual event for Biopharma/Biotech Disruptors hosted by major US bank in New York City

On April 10, the company announced that on Tuesday May 14th, in New York City, Ziccum CEO Ann Gidner will present at the first event on high-value biotech and biopharma disruptor technologies to be hosted by CapitalOne, one of the US’ largest bank corporations. She will present as part of an expert panel regarding mRNA and gene therapeutics.

Ziccum contracts RFR Solutions for GMP manufacturing in next phase of technology scale-out

On April 26, the company announced that in addition to its existing network of high expertise suppliers and consultants, Ziccum has signed a long-term agreement with the GMP equipment specialist RFR Solutions, for the next phase in the industrialization and scale-out of the LaminarPaceTM equipment.

CEO statement

A quarter of intense partner interaction and significant mRNA/LNP milestones – beyond our expectations
The first quarter 2024 brought very important milestones, strongly confirming our mRNA capabilities including both excellent readouts from our partnered feasibility study and generating the first ever animal data for LaminarPace™-treated pharmaceuticals with perfect results. The results are surpassing our expectations of securing good proof for the LaminarPace™ performance for RNA materials, the most sought-after target, currently revolutionizing pharmaceutical and vaccine development world-wide!

Another important step completed was securing financing, where the rights issue, welcoming all existing owners to join, combined with adding a strong US investor in a directed issue on equal terms provided a sound setting for the company ahead. We are proud of the successful model, limited resulting dilution and good outcome in the current difficult market conditions. The quarter also brought significant revenue, thanks to our paid feasibility programs.

Proving LaminarPace™ for mRNA/LNP – the highest value segment with booming development in industry
Within the field of biopharmaceuticals, the most in-demand but also most demanding modality to turn into robust form, is the highly delicate mRNA in lipid nanoparticle formulation (mRNA/LNP). We are now proceeding from the stage of the exciting potential of treating mRNA, with initial studies during 2023, to the stage of solid datasets successfully proving mRNA/LNP treatments, including repeated external validations from reputable industry players – and including the all-important big step of animal data proof.

The animal study, so called in-vivo, reported end January could prove the preservation of full mRNA activity after LaminarPace™-drying. It is fantastic to get this result with such clarity in the first model chosen for in-vivo studies. Thanks to this we can proceed without repeated trials of the activity parameter in-vivo and move on to more specific parameters such as immunological responses. Furthermore, the internal mRNA/LNP trial runs have repeatedly delivered very high mRNA activity in-vitro for various lipid compositions – something we presented at the mRNA Summit in Berlin, where all the important industry leaders in the field gather, and this generated significant interest. The Berlin event was very insightful, seeing how industry leaders turned from discussing the vast possibilities of mRNA to addressing the concrete needs for better delivery forms and product stability – exactly what Ziccum is offering.

It is rewarding to so rapidly have reached critical results confirming how LaminarPace™ can enable new, better, more cost-efficient, and far more sustainable RNA treatments – and to see the industry demand for this come into focus.

Taking our Partnered Feasibility studies forward
In January we could communicate a very good Biotech partner readout, where all mRNA/LNP data were meeting the targets and the mRNA activity preservation was deemed excellent, by partner validation. Again, these results are exceeding our expectations, in our first partnered study for mRNA. For our Big Pharma partner, the mRNA project pilot runs were concluded with good results during the quarter and the project now continues with joint assessments.

Patience is now needed to see the development in these partnerships. Pharmaceutical development is always a lengthy process – even if the RNA platform opens up for quicker progress – and the decision processes within large organizations in pharmaceutical industry consist of many committee reviews. Like defined in our business plan, we strive to continuously build a pipeline of additional dialogues, as we have the great benefit of a platform that can be applied with many partners.

We also have reached a highly rewarding Market milestone during this quarter, with several large corporations now contacting us directly, as Ziccum and the need of LaminarPace™ treatment is getting more and more recognized in the industry. We have broadened the customer base further with highly relevant dialogues during the period, thanks to this keen interest. This was complemented with attending US events and conferences, to keep building Ziccum recognition in international industry.

Masterplan and Company development
The Ziccum team has come a long way in executing trial runs in our pilot facility very efficiently, and good efforts for sophisticated trial planning indeed has paid off. The Masterplan project is progressing nicely, with both our internal trials and the development of the LaminarPace™ rig. This includes the securing of a top-notch equipment manufacturing partner for both near term prototyping and long-term supply. With LaPaSim we are indeed happy to have reached the stage of the initial 3D-model now set up, after a highly productive workshop with our Swiss partners.

The quarter brought significant work for IP protection, where we are supporting the existing three patent applications with the important and solid data packages generated internally. We are also taking great strides in analytical development, quality assurance and planning for regulatory fulfilment – all to ensure GMP readiness – thanks to our organization being nicely strengthened in these areas during 2023.

We continue to carefully build our high caliber Ziccum team for best efforts, and I am happy to welcome a new colleague just after the period, Christo Vassilev, joining to strengthen our analytical and financing capabilities. Important new efforts thanks to this recruitment are that we are launching a structured initiative for soft funding, as well as better market analysis for efficient business dialogues.

All in all, what a productive quarter! My gratitude to everyone involved for great efforts, my warm welcome to our new investors and keen appreciation to everyone for continued, important support.

Lund, April 29, 2024
Ann Gidner, CEO

Financial highlights

January – March in brief

Operating income: kSEK 3,248 (638).
Result for the quarter: kSEK -3,958 (-4,872).
Earnings per share: SEK -0.26 (-0.35).
Cash flow for the quarter: kSEK 6,065 (-3,928).
Cash at the end of the reporting period: kSEK 9,059 (19,023).

Financial Summary

	Q1		Q1	Jan-Dec
kSEK	2024		2023	2023
Operating income		3,248	-638	6,318
Operating result		-4,022	-4,936	-21,560
Result		–3,958	-4,872	-21,412
Balance sheet total		20,307	28,915	14,972
Cash flow		6,065	-3,928	-19,957
Cash and cash equivalents		9,059	19,023	2,994
Equity ratio %		65	85	57
Per share data (SEK)
Number of shares		15,372,258	13,806,142	13,806,142
Result per share before and after dilution*		-0.26	-0.35	-1.55
Cash flow per share		0,39	-0.28	-1.45
Equity per share		0.85	1.78	0.62

* Dilution effects is not calculated when the result is negative

About Ziccum

2024 Q1 Ziccum Report 240429 (1)

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