Significant events during the Quarter

• Collaboration agreement with University of Copenhagen
  On December 4th, the company announced that it had signed a Collaboration Agreement for a joint project with the Department of Pharmacy, University of Copenhagen (UCPH), on the engineering of inhalable solid dosage forms of mRNA vaccines which will include in-vivo studies of mRNA/LNP materials formulated and dried using Ziccum’s unique LaminarPace.
  
• Certified Adviser
  On November 30th, Ziccum announced it had changed Certified Adviser from Erik Penser Bank AB to Carnegie Investment Bank AB (publ).
  
• Agreement with US Biomanufacturing corporation
  On November 7th, Ziccum announced it had signed a Material Transfer and Evaluation Agreement for a Vaccine Evaluation project with one of the most important technology-focused Biomanufacturing corporations in the US. The project is funded and will focus on evaluating the potential for new dry, thermostable forms of an advanced viral vaccine, using Ziccum’s unique formulation and drying technology LaminarPace.
  
• Validated data confirming mRNA activity in-vitro
  On October 23rd, Ziccum announced it had received data from external contract research (CRO) partner Truly Labs, confirming high activity levels in mRNA/LNP materials dried by LaminarPace, after continued internal confirmations. The in-vitro data validate the ability of Ziccum’s LaminarPace technology to transform delicate mRNA/LNP solution into stable, bioactive dry powder with excellent in-vitro characteristics.

 
Significant events after the Quarter

• Successful outcomes of LaminarPace Feasibility study with Biotech partner
  On January 10th, 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. Finally, the partner assessment confirmed the consistent Ziccum findings, that LaminarPace-treated material can be reconstituted (dissolved back into liquid) very quickly and smoothly, with no foaming, precipitation, or other practical issues.
• Financing secured through directed share issue and rights issue
  On January 22nd, the company announced that it has carried out a directed share issue of 622,371 shares of approximately SEK 4.2 million to the American professional investor Global Corporate Finance (GCF). The subscription price in the Private Placement was set at SEK 6.80 per share through arm's length negotiations between the Company and GCF and corresponds to a 7.36 per cent discount to the Company's volume weighted average price on Nasdaq First North Growth Market during the last five trading days.
  
  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 SEK 28 million 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 SEK 10.4 million. The subscription price per Unit in the Rights Issue amounts to SEK 6.80 and each Unit consists of one share and one free warrant of series TO5, which means that the subscription price per share in the Rights Issue corresponds to the subscription price per share in the Directed New Share Issue.
  
  The Directed New Share Issue and the Rights Issue are carried out in combination to effectively secure working capital for continued intensive business and technical development. Considering the Directed New Share Issue, and provided that the Rights Issue is fully subscribed, Ziccum will receive initial proceeds totalling approximately SEK 13.5 million, after deduction of issue costs totalling approximately SEK 1 million.
  
  Furthermore, the company has revenue-generating evaluation agreements in place, which are estimated to bring in SEK 5 million during Q1 2024. The company was granted a Eurostars grant and expected payments from this during 2024 will be SEK 872 thousand. The Board and company management are assessing options for further soft funding opportunities on an ongoing basis. 
  * 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.

CEO statement

Taking Ziccum ahead towards new achievements, delivering milestones at a high pace

2023 has been an amazing year, taking Ziccum forward on all fronts - establishing professional operations, implementing a new business model very successfully and getting an established, reputable name in international pharmaceutical industry in general and in mRNA development forums more specifically.

Now we are looking forward to further milestones, getting readouts from partnered studies and further data points for our technology during 2024 - already starting in January with a very exciting partner readout, where all mRNA/LNP data were perfectly confirmed – as well as taking LaminarPace to optimal performance.

It is a privilege to take this unique technology forward, seeing the potential to greatly improve so many aspects of current vaccine management, as well as enabling entirely new treatments for unmet patient needs.
 
Executing on partnered projects and striking a third deal with a world-leader
The Biotech mRNA feasibility study was successfully completed during fourth quarter, with excellent, close collaborative efforts, and the outcome was rapidly assessed by our partner. As presented on January 9th all readouts matched very closely, all parameters gave good results, and the all-important mRNA activity was preserved on excellent levels. This is a fantastic, broad validation of the applicability for Laminar Pace for fragile and valuable mRNA/LNP compositions – it confirms the vast possibility to enable new, better, more cost-efficient and far more sustainable patient treatments thanks to LaminarPace.

The Ziccum team took up the Big Pharma study work, which is ongoing with efficient performance of trials, generating a lot of relevant data. If the initial feasibility testing is satisfactory, the next step of Stability testing has already been scoped out with the Big Pharma partner. We are expecting this go/no-go decision in mid-spring 2024.

On top of these two collaborations, we announced a third agreement signed in fourth quarter, and we have a pipeline of serious dialogues with Pharma and Biotech corporations discussing LaminarPace applications. Ziccum is very actively taking part in licensing partnering conferences as well as vaccine and mRNA top level summits, where we are becoming a name to reckon with.

Delivering on a high value, high level business model to demanding partners
Considering how LaminarPace technology was rather new to the industry and that all aspects of a high value licensing model had to be established, it is highly satisfying how we could sign agreements already during 2023 with the best possible partners. These large players, leading the race towards new vaccines and highly innovative RNA treatments, are offered interesting collaborations from numerous companies, regularly, so it is significant for Ziccum to be selected.

One still needs to be aware of the risk of bureaucracy, delays, and strategic reassessments due to the nature of these large organizations. There are no guarantees that these first partnered studies will immediately proceed to next stages, but Ziccum is well positioned and well equipped to take further collaborations ahead. We keep running an active business development pipeline of industry dialogues to ensure successful partnering for the technology.

The licensing business model offers the highest possible value for Ziccum taking LaminarPace to market, and the challenges of addressing highly demanding counterparts, reaching into strategic decision-making levels in the organizations and selling the technology while it is still in development have all been overcome, as nicely proven by the deals already signed. Having a Technology platform, we will be able offer licenses structured by application – with a large number of potential license deals possible.

Continued mRNA/LNP data generation
The Ziccum team has taken both partnered studies and the internal Masterplan project forward very efficiently. The increase in trial productivity has enabled us to deliver strongly to our partners, testing a number of parameters already in the feasibility stage. Then there is of course room for further improvement of results in next step optimization in application studies, once that stage is reached. For mRNA/LNP, the rewarding in-vitro potency results, showing that the mRNA is keeping its genetic code and activity level when given to cells after LaminarPace treatment, now are followed by our internal Masterplan trials to prove sufficient mRNA activity in animal testing, so called in-vivo trials, in mice.

Taking LaminarPace forward, developing unique components for our technology
In the fourth quarter, we were delighted to welcome our new Chief Operating Officer, the engineering manager Xavier Turon joining Ziccum from Barcelona. He indeed had to hit the ground running, as we were in the midst of intense equipment development for LaminarPace. The Masterplan project contains the development of key components for LaminarPace, and after selecting several new international engineering partners during the year, we have made great progress in this area. The nebulizer development has reached a mature stage. The largest on-going effort is now the product outtake, to design efficient operation for sufficient capacity. The characteristics of these key components then go straight into the 3D-simulation work, LaPaSim, our on-going effort jointly with Zurich partners.

The successful technology development is made possible thanks to strong team efforts, combining our Ziccum expertise with excellent input from engineering partners as well as our Board of Directors. It is an iterative process, where trial readouts help us finetune component design for optimal performance. During 2023, we also have integrated proper quality and regulatory assurance, to ensure our work and its documentation fulfill pharmaceutical standards.

An exciting 2024 lies ahead
We have exciting times ahead, with continued execution on our partnership studies as well as taking interesting business dialogues and the technology optimization forward. Efficiently securing additional funding, both having a strong new investor on-board and allowing our existing shareholders to take part in a well-supported rights issue, together with income from industrial partners, will make it possible to keep up the high-paced development, deliver on all-important partnerships, generate further data and make the most of our unique technology.

Let me thank the Ziccum team as well as collaboration partners for excellent efforts, and our owners for continued, important support and engaged dialogues.

Lund, January 26, 2024
Ann Gidner, CEO

October - December in brief

• Operating income: SEK 1,575 (0) thousand.
• Result for the quarter: SEK -7,692 (-8,021) thousand.
• Earnings per share: SEK -0.56 (-0.58).
• Cash flow for the quarter: SEK -6,796 (-6,642) thousand.
• Cash at the end of the reporting period: SEK 2,994 (22,951) thousand.

 
January - December in brief

• Operating income: SEK 6,318 (17) thousand.
• Result: SEK -21,412 (-28,788) thousand.
• Earnings per share: SEK -1.55 (-2,09).
• Cash flow: SEK -19,957 (10,678) thousand.
• Cash at the end of the year: SEK 2,994 (22,951) thousand.

Link to report: https://ziccum.com/investors/financial-reports/