Ziccum investigates significant increase in mRNA activity achieved with LaminarPace

Ziccum AB (publ) announces important findings on an increase in mRNA drug activity after LaminarPace treatment and the investigations of the potential mechanisms behind this effect, including the development of a new, unique analytical method to generate further proof for this effect.

Ann Gidner, CEO: “This potential effect after LaminarPace processing is of great significance and we have made rather extensive testing to verify it. With this potential for increasing mRNA activity, Ziccum may progress into a new value proposition for LaminarPace for certain formulations. This is in addition to the already proven benefits unlocking new treatments on the booming RNA platform, as well as for biopharmaceuticals in general. We are thrilled to investigate this further”.

Fabrice Rose, Scientific Director: “We found it important to determine not only the protein expression increase, but also the potential reasons behind it. Drug delivery mechanisms are always complex, but now we have a clear hypothesis, and we have developed a new method to investigate this further. I am very proud of the team efforts and the results this far”.

In Ziccum’s internal Master Plan work, several different formulation options for mRNA have been tested for optimization during spring 2024. The lipid nanoparticle (LNP) formulation field is currently subject to intense development, as the industry is rapidly advancing new RNA treatments. Ziccum has performed a successful development plan, assessing improved LNP compositions to work well with LaminarPace processing.

During this work, a special effect has been discovered for certain lipid compositions, where the drug product mRNA activity is not only preserved, but significantly increased after LaminarPace treatment. The effect is studied by measuring protein expression in live cells treated with mRNA.

At the present time the following has been established:

  1. A very significant increase in mRNA protein expression occurs after LaminarPace processing for several different lipid formulations.
  2. The protein expression is multiplied in the best cases.
  3. The increase effect only occurs for certain variants of lipid nanoparticle compositions.
  4. An LNP structural phenomenon involved has been identified.
  5. This special LNP structure is well described in scientific literature.
  6. Ziccum has identified a potential mechanism on cellular level for the resulting protein expression increase.

The industrial value of increased mRNA activity as a consequence of LaminarPace processing can potentially be significant for several reasons.

  • Cost: If this increase in effectiveness can be translated into lower mRNA drug and vaccine doses, the consumption of very expensive mRNA substances can be reduced.
  • Dose barrier: The current LNP formulations which have enabled vaccines and therapies based on mRNA have a limitation regarding mRNA content. With increased activity through LaminarPace processing, it may be possible to break these barriers and create more efficient new treatments.

The understanding of the mechanism underlying this increase is of importance for Ziccum to better understand the potential value to the pharmaceutical industry.

Ziccum therefore has developed a specific, proprietary analytical method to study nanoparticle (mRNA/LNP) trafficking from the cellular uptake to the mRNA release and to the translation to the protein. This analytical method has now been established and tested.

The next step is to apply the new analytical tool for continued investigation of the increase mechanism, with the aim of creating a clear explanation for the effect taking place. This work will be pursued with high priority in the coming months.

There will also be a need for stability testing further on. It should be noted that the current effect is noted directly after treatment, while the long-term effects remain to be studied.

The current findings have been established in cell-based testing, not yet in animal studies.

Analyst interview with Ziccum’s CEO on new project and expanding business dialogues

In a Swedish video interview, Ziccum’s CEO Ann Gidner answers questions from analyst Jonathan Furelid on the topic of business dialogues and agreements.

Apart from elaborating on the significance of the recently concluded Feasibility Study Agreement with ReCode Therapeutics, a leader in the booming mRNA field, Ann Gidner also concludes on the successful completion of the first stage of the Big Pharma II Feasibility Study. Furthermore, Ziccum’s CEO underscores the increasing industry-wide interest generated by Ziccum’s technology, LaminarPaceTM, as evidenced by the growing number of leading industry players reaching out to Ziccum.

Please watch the full interview (in Swedish) here: https://youtu.be/-dnOT8oFLHs

Ziccum calls for a second investment tranche in accordance with its financing agreement with GCF

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, NEW ZEALAND, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, RUSSIA, BELARUS OR IN ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL, REQUIRE REGISTRATION OR ANY OTHER MEASURES THAN THOSE REQUIRED BY SWEDISH LAW. SEE ALSO THE SECTION “IMPORTANT INFORMATION” BELOW.

The board of directors of Ziccum AB (publ) (“Ziccum” or the “Company”) has called for a second investment tranche in accordance with the previously communicated financing agreement between the Company and Global Corporate Finance (“GCF”), and in connection therewith resolved to carry out a directed share issue.

On 22 January 2024, the Company announced in a press release, inter alia, that it had entered into a long-term financing agreement with GCF (the “Financing Agreement”), pursuant to which Ziccum has the unilateral right to call for investments from GCF in separate tranches totaling the equivalent of USD 2.7 million over a period of 30 months, thereby securing rapid access to capital injections to cover the Company’s budgeted costs until 2025.

The board of directors of Ziccum has now called for a second investment tranche under the Financing Agreement and has today resolved, based on the authorization granted by the Annual General Meeting on 29 May 2024, to carry out a directed share issue to GCF of a total of 538,928 shares for proceeds of approximately SEK 2,650,253 (the “Directed Share Issue”). The subscription price in the Directed Share Issue has been set at SEK 4.91764 per share in accordance with the terms and conditions set out in the Financing Agreement and as further described in the Company’s press release dated 22 January 2024.

Prior to the Directed Share Issue, the Company’s board of directors has made an overall assessment and carefully considered the possibility of raising capital through a new share issue with pre-emption rights for the Company’s existing shareholders. However, the board of directors considers that there are reasons to deviate from the shareholders’ pre-emption rights given that the Directed Share Issue can be carried out in a more time-efficient manner, at a lower cost and with less complexity than a rights issue. In addition, the board of directors considers the speed and predictability of the procedure with the Directed Share Issue, in light of the Financing Agreement, as a significant advantage, as it is deemed to facilitate the Company to act in the current market and to safeguard the Company’s interests, in line with the Company’s strategy and overall objectives. Taking into account the above, the board of directors considers, after an overall assessment, that the Directed Share Issue is the most appropriate and favorable option for Ziccum and all its shareholders.

As the subscription price in the Directed Share Issue has been determined in accordance with the terms and conditions set out in the Financing Agreement, it is the board of directors’ assessment that the subscription price has been secured on market terms.

Through the Directed Share Issue, the number of outstanding shares and votes in Ziccum increases by 538,928 from a total of 15,372,258 to a total of 15,911,186 shares and votes. The share capital increases by SEK 89,821.333333 from SEK 2,562,043.000003 to SEK 2,651,864.333336. Further, the Directed Share Issue entails a dilution of approximately 3.39 per cent of the number of shares and votes in the Company following the completion of the Directed Share Issue. Taking into account also the exercise of the series 2021/2024 warrants relating to LTI 2021:1, which was communicated by press release on 3 June 2024 and has yet to be registered with the Swedish Companies Registration Office, the number of outstanding shares and votes in Ziccum will increase by a further 23,709 to a total of 15,934,895 shares and votes. The share capital will increase by a further SEK 3,951.50 to SEK 2,655,815.833336 and the dilution effect will be a further 0.15 percentage points, totaling approximately 3.54 per cent.

Important information
The publication, announcement or distribution of this press release may, in certain jurisdictions, be subject to legal restrictions and persons in the jurisdictions where this press release has been published or distributed should inform themselves about and observe such legal restrictions. The recipient of this press release is responsible for using this press release and the information contained herein in accordance with the applicable rules in each jurisdiction. This press release does not constitute an offer or an invitation to acquire or subscribe for any securities in Ziccum in any jurisdiction, neither from Ziccum nor from anyone else.

This press release is not a prospectus within the meaning of Regulation (EU) 2017/1129 (the ”Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction. No prospectus will be prepared by the Company and published on the Company’s website in connection with the Directed Share Issue.

This press release does not constitute an offer or invitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended (the ”Securities Act”), and may not be offered or sold in the United States absent registration or an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of such securities in the United States. The information contained in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, in or into the United States, Australia, Hong Kong, Japan, Canada, New Zealand, Switzerland, Singapore, South Africa, South Korea, Russia, Belarus or any other jurisdiction where such announcement, publication or distribution of this information would be contrary to applicable law or where such action is subject to legal restrictions or would require additional registration or other measures than those required by Swedish law. Actions in contravention of this guidance may constitute a breach of applicable securities laws.

In the United Kingdom, this document and other materials relating to the securities referred to herein are only being distributed and directed to, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, ”qualified investors” (as defined in section 86(7) of the Financial Services and Markets Act 2000) who are (i) persons who have professional experience in matters relating to investments and who fall within the definition of ”investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the ”Order”); or (ii) ”high net worth entities” as referred to in Article 49(2)(a) to (d) of the Order (all such persons together being referred to as ”relevant persons”). An investment or investment activity to which this communication relates is available in the United Kingdom only to relevant persons and will be engaged in only with relevant persons. Persons who are not relevant persons should not take any action based on this announcement and should not act or rely on it.

The Company considers that it carries out activities worthy of protection under the Swedish Screening of Foreign Direct Investments Act (2023:560) (the “FDI Act”). In accordance with the FDI Act, the Company must inform prospective investors that the Company’s activities may fall within the scope of the regulation and that the investment may be notifiable. In the event that an investment is notifiable, it must be notified to the Inspectorate for Strategic Products (ISP) prior to it being carried out.

Forward-looking statements
This press release contains forward-looking statements that reflect the Company’s intentions, beliefs or expectations regarding the Company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that do not relate to historical facts and can be identified by the fact that they contain expressions such as ”believes”, ”expects”, ”anticipates”, ”intends”, ”estimates”, ”will”, ”may”, ”assumes”, ”should”, ”could” and, in each case, negatives thereof, or similar expressions. The forward-looking statements in this press release are based on various assumptions, many of which are based on additional assumptions. Although the Company believes that the assumptions reflected in these forward-looking statements are reasonable, there can be no assurance that they will materialise or that they are accurate. Because these assumptions are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcomes may differ materially from those in the forward-looking statements for a variety of reasons. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied by the forward-looking statements in this press release. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are correct and any reader of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements expressed or implied herein speak only as of the date of this press release and are subject to change. Neither the Company nor anyone else undertakes to review, update, confirm or publicly announce any revision to any forward-looking statement to reflect events that occur or circumstances that arise in relation to the content of this press release, unless required by law or First North’s Rulebook for Issuers.

Ziccum signs Evaluation agreement with ReCode Therapeutics for LaminarPace mRNA study

Ziccum AB (publ) has signed an Evaluation Agreement with ReCode Therapeutics, Inc. (ReCode), a US clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, for evaluation of LaminarPace enabling dry powder forms of ReCode’s proprietary therapeutic modalities.

Ziccum AB signed an Evaluation agreement with ReCode on June 19th, 2024. The study will focus on evaluating Ziccum’s formulation and drying technology LaminarPace to enable dry powder forms of ReCode material: therapeutic messenger-RNA in specific liquid lipid nanoparticle formulation, mRNA/LNP, on ReCode’s proprietary SORT platform.

The LaminarPace performance will be evaluated by analytical assessment of the resulting mRNA/LNP dry product, with technical parameters as well as mRNA activity in cell transfection.

CEO Ann Gidner: “We are delighted to take our dialogue with ReCode forward to a formal collaboration. The potential of enabling new and optimal applications of the targeting mRNA technology of ReCode, and their position as a leader in the intensely growing mRNA field, is indeed enticing. We are most happy to add such a strong partner and look forward to getting this work started.”

Open post

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.

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.

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

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.

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.

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