Ziccum AB (publ) Interim report Q1 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

 * Dilution effects is not calculated when the result is negative