Ziccum AB (publ) Interim report Q2 2024

Significant events during Q2 2024

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.

Ziccum AB strengthens patent portfolio with three solid data PCT applications according to expanded IP strategy
On April 30, the company announced that they have filed three PCT 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 partners with Dagens Industri for Investor Relations program
On May 28, the company announced that they partner 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.

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 no more than 46,000 employee stock options of series LTI 2021:1 (the "Stock Options") to certain employees and consultants in the Company. On June 3, Ziccum announced that 14,819 warrants of series 2021/2024 (the "Warrants"), in relation to LTI 2021:1, have been exercised for subscription of 23,709 new shares in the Company.

Ziccum reports on developments in the portfolio of industry partner projects
On June 11, the company announced that 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.

Ziccum signs Evaluation agreement with ReCode Therapeutics for LaminarPace mRNA study
On June 19, Ziccum AB 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 calls for a second investment tranche in accordance with its financing agreement with GCF
On June 25, the board of directors of Ziccum AB (publ) (“Ziccum” or the “Company”) 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.

Significant events after Q2 2024

Ziccum investigates significant increase in mRNA activity achieved with LaminarPace
On August 16, Ziccum AB (publ) announced 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.

CEO statement

Remarkable new technology advancement and keen international interest

After fully confirming our mRNA capabilities in first quarter 2024, we are happy to build such keen interest for our technology, across the international industry. Now seeing the ability to increase the mRNA activity for certain formulations, applying LaminarPace at optimal conditions, is amazing. The potential value of LaminarPace to achieve better and completely new biopharmaceuticals has reached new levels. This could eliminate interest for any tentative competing solutions.

Proving LaminarPace for mRNA/LNP – even increasing protein expression

While the LaminarPace technology has been successfully applied for all kinds of fragile, demanding biopharmaceuticals - proteins, peptides, antibodies and more - the current focus of Ziccum is to address the booming field of mRNA in lipid nanoparticle formulation (mRNA/LNP). This is no small feat. The amount of data generated in a short timeframe 2023/24 is rewarding, especially as every data set is positive; in a completely new field one could expect various outcomes. The first animal study performed gave very clear, good preservation of mRNA activity for LaminarPace material.

In addition to partnered trials during spring, Ziccum spent important efforts generating further mRNA data, optimizing performance both in pilot scale trials and in the 3D-modelling performed in parallel. In this work, we have been intrigued to see not only well preserved but also increased mRNA activity, in terms of protein expression in live cells. This triggered more investigation, and we are delighted to announce both the confirmation of this effect, and the continued work to understand the mechanisms behind it. We are thrilled to investigate this further.

Unique value creation for industry leading partners

We now have repeated external validations from reputable industry players. Also, we have reached a stage where the world’s largest pharmaceutical corporations are approaching Ziccum to learn more - a unique situation for a company our size. While it is very rewarding to see the industry interest, a lot of effort of course remains to get widespread industry recognition. Ziccum is not spending the marketing budgets of large corporations. But with hard work and using a significant industry network, we are already reaching out to key stakeholders and generating keen interest on a global scale.

While we have very good results in our partnered studies, with validation by world leading corporations, the current Big Pharma II partner has chosen not to proceed at the present time, having many competing priorities. This is well in line with the Ziccum strategy, where a pipeline of many collaborations will be needed considering the conservative approach in pharmaceutical industry – and as we have the great benefit of a technology platform. We are delighted to have signed with ReCode Therapeutics, especially as this is an mRNA pioneer, also working at the pharmaceutical forefront and open to new technology. We keep adding advanced dialogues to our portfolio. Obviously, having an even stronger potential value proposition, increasing mRNA activity in new therapies or vaccines, industry interest can be fuelled further.

Progressing with more convincing data

The Masterplan project work is intense. In addition to the studies in live cells, resulting in the new findings of higher mRNA activity, we are planning for further animal data. The inhalation studies with Copenhagen University are reconciled into a new format, to ensure timely delivery from our partner. We are excited to see the outcome. Old drying methods like lyophilization can rarely be applied to biologics at all, and could never give fine, tailor-made particles applicable by inhalation. For LNP formulations, inhalation has been considered impossible by industry – until LaminarPace was applied.

In addition to the animal studies proving mRNA activity, we are also progressing towards next level studies, to assess the immune response in animals.

LaminarPace development continues

The development of the LaminarPace rig continues with a keen focus having secured further partnerships with leading expertise. A main topic is the continuous product outtake, which will be key to high capacity. This work is strongly accelerated, using our 3D model to assess configurations quickly and easily.

During the quarter we secured significant intellectual property (IP) protection. We have progressed our patent applications to international PCT stage and added a high number of patent claims for all three fields, thanks to the high pace of internal trials. This is creating a strong, multilayered protection for Ziccum. Based on the investigations of LaminarPace giving higher mRNA activity, we may have the basis for further patent protection.

Developing Ziccum and planning ahead

To ensure the company’s financials for its ambitious growth plans while balancing low expenditures, to serve shareholders’ best interest, the company board of directors and management are assessing options for the company’s capital needs ahead. Without increasing costs, we have been able to recruit two new, talented colleagues to the international Ziccum team, strengthening our analytical, financing and business capabilities: most happy to welcome Christo Vassilev and Ilkim Atmaca.

We have very interesting results ahead. Let me thank everyone involved for such valuable efforts, give a warm welcome to new board members and my appreciation to partners, owners and investors for continued support. Looking forward to next steps together!

Lund, August 30th, 2024
Ann Gidner

Financial summary

* Dilution effect is not calculated when the result is negative