Ziccum AB (publ) Interim report Q3 2024

Significant events after Q3 2024

• Ziccum intends to resolve on a rights issue of approximately SEK 30 million and raises a bridge loan

On October 10, The Board of Directors of Ziccum AB (publ) (“Ziccum” or the “Company”) announced its intention to carry out a new issue of shares and warrants (“Units”) with pre-emption rights for the Company’s shareholders (the ”Rights Issue”). The Board of Directors intends to publish a notice to an extraordinary general meeting planned to be held on 8 November 2024, to grant the Board of Directors an authorization to resolve on the Rights Issue and for the adoption of new articles of association. Each Unit consists of one (1) share and one (1) warrant free of charge of series TO 6 (“Warrants”). Upon full subscription in the Rights issue, the Company will initially receive approximately SEK 30 million in issue proceeds before issue costs. In connection with the Rights Issue, the Company has received subscription and guarantee undertakings amounting up to a total of approximately SEK 11.6 million, corresponding up to approximately 39 percent of the Rights Issue. The issue proceeds will primarily be used to further the technological development of LaminarPace®. To secure the Company’s liquidity needs until the completion of the Rights Issue, the Company has secured a SEK 6.5 million bridge loan from VIFC Nordic AB and Dariush Hosseinian.

Significant events during Q3 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.

• Ziccum announces trademarking LaminarPace in the USA

On 16 September, Ziccum announced that the appellation of its proprietary technology, LaminarPace, has been officially registered with the United States Patent and Trademark Office (USPTO) as a trademark since 23 July 2024. Obtaining trademark protection in the US, a market of primary importance to Ziccum, is a significant step in light of Ziccum’s growing industry presence, recognition as a commercial partner of choice, and Ziccum’s continuous scientific progress.

• Ziccum announces outcome of exercise of warrants of series TO5

On September 17, Ziccum AB (publ) (”Ziccum” or the ”Company”) announces the outcome of the exercise of warrants of series TO5 (the ”Warrants”), which were issued in connection with the Company’s rights issue of units that ended in February 2024. In total, 23,880 Warrants, corresponding to approximately 2.53 percent of the number of outstanding Warrants, were exercised for subscription of 23,880 shares at an exercise price of SEK 4.91 per share. Through the exercise of the Warrants, Ziccum will receive approximately SEK 117,000 in issue proceeds before issue costs.

• Ziccum announces change of Certified Adviser to Vator Securities

On September 26, Ziccum announced that the company has retained Vator Securities AB (“Vator Securities”) to serve as its Certified Adviser. The appointment of Vator Securities as Ziccum's Certified Adviser (CA) shall come into effect on September 27, 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 LaminarPace® 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 LaminarPace®.
• 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 June 3, the company announced 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.
• 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 during Q1 2024

• 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.
• 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, totaling approximately MSEK 28 over the next thirty months.

The Board of Directors of Ziccum has also, based on the existing authorization 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 totaling approximately MSEK 13.5.

• 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.

• Ziccum’s 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.

CEO statement

Sharpening our focus and executing intensively on new abilities

Based on the generation of strong, extensive data with LaminarPace for mRNA in lipid formulations, we have validated an excellent position for this top development target. With such clear results for this most fragile entity, we have a solid position to address all types of biopharmaceuticals with LaminarPace.

We have updated our strategic focus accordingly, to address biological therapeutics as well as vaccines. In this large field we zoom in on the complex, fragile RNAs, plus protein-based drugs and vaccines. The therapeutic applications of the revolutionary mRNA technology are advancing fast, and this offers perfect timing to get new technology introduced in early stages of drug development. Drug projects, so called therapies, are also a good fit with LaminarPace capacity. This focus on the highest possible value for Ziccum, is complemented with a continued focus for new and better vaccines.

Proving LaminarPace for mRNA/LNP – even making inhalation possible

After proving excellent mRNA activity, both in partnered client studies and in our first animal trials, we are currently progressing with a more specialized animal study - the testing of inhaled mRNA/LNP. This is the sharpest edge of LaminarPace performance; no other technology has created inhalable mRNA/LNP so far.

In addition to the on-going project, engineering inhalable mRNA/LNP together with world-leading expertise, where the animal trials are just being completed, Ziccum has been invited to a new collaboration. A leading European institution was considering inhaled mRNA/LNP impossible - until seeing Ziccum present. A large international consortium is now in the works, to develop several mucosal applications of mRNA/LNP. All such applications require dry powder drug forms – which may be enabled by Ziccum technology. We look forward to announcing this when formalized.

For the topic of increased mRNA activity, the interesting work to understand the cellular mechanisms behind it is continuing, and we are preparing to add further patent protection for the valuable findings currently being generated.

Adding more partner projects for key clients

The project execution for ReCode Therapeutics with a specific mRNA/LNP therapeutic entity is just completed at Ziccum’s side. Resulting materials have been shipped to the client for assessment. As the potential benefits of dry powder forms of mRNA/LNP are significant for Recode, this client has asked Ziccum to present two more project offers – to ensure we evaluate the important potential. We are eager to look further into this.

Just after the quarter closing, we were happy to welcome a significant vaccine developer (Biotech Corp V) for a site visit in Lund, further assessing a collaboration and visiting our pilot facility. It is important to keep building the pipeline of dialogues. We are scheduling partnering meetings at the upcoming BIO-Europe conference for existing and new dialogues.

Executing on all the development projects, building intellectual property

The execution of Masterplan projects is continuously intense. In the recent period, the hardworking pilot team has generated LaminarPace materials for animal studies, process optimization work, nebulizer tests and the investigation of mRNA activity. This high capacity load is making it important to be careful about our client projects in parallel, selecting opportunities for the best near term and long term outcome.

The new expertise partnerships for optimizing the Ziccum-specific equipment components are rewarding, with good delivery of results while keeping strict budgets. The updated plan and new partner for the continuous processing project has enabled good savings on external costs. We will have a keen focus on this step in the Master plan in the quarter to come, and the 3D-modelling is a vital component.

The protection of immaterial rights is progressing, with an internal workshop for strategic planning held this quarter to ensure the best possible management. The international PCT patent families are taken forward and we are preparing for a next patent application based on new data.

Ensuring our solid progress ahead

To ensure the company’s financial foundation for continued development plans, the board of directors decided to propose a rights issue during fourth quarter to best serve Ziccum value and shareholder interests. In the current stock market climate it is not an easy feat, but initial proceedings already have generated good interest and secured new investors. We know we are building fantastic company value. Ziccum has generated solid proof for the disruptive technology possibilities, addressing the highest value market segment, and is pursuing collaborations with world-leading partners. We have the most interesting journey to take forward.

I want to extend my warmest gratitude to everyone involved in lots of enjoyable efforts – the team, our clients and partners, our owners and new investors, thank you!

Lund, October 29th, 2024

Ann Gidner

• Operating income: kSEK 571 (2,329)
• Result for the quarter: kSEK -5,887 (-3,882)
• Earnings per share: SEK -0.37 (-0.28)
• Cash flow for the quarter: kSEK -2,985 (-4,793)
• Cash at the end of the reporting period: kSEK 1,107 (9,790)

Financial summary

* Dilution effect is not calculated when the result is negative