News Tag: Report

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

	Jul-Sep	Jul-Sep	Jan-Sep	Jan-Sep	Jan-Dec
kSEK	2024	2023	2024	2023	2023
Operating income	571	2,329	4,186	4,743	6,318
Operating result	-5,924	-3,899	-17,563	-13,857	-21,560
Result	-5,887	-3,882	-17,491	-13,720	-21,412
Balance sheet total	9,848	21,764	9,948	21,764	14,972
Cash flow	-2,985	-4,793	-1,887	-13,161	-19,956
Cash and cash equivalents	1,107	9,790	1,107	9,790	2,994
Equity ratio %	26	73	26	73	57
Per share data (SEK)
Number of shares	15,958,775	13,806,142	15,958,775	13,806,142	13,806,142
Result per share before and after dilution*	-0.37	-0.28	-1.10	-0.99	-1.55
Cash flow per share	-0.19	-0.35	-0.12	-0.95	-1.45
Equity per share	0.16	1.51	0.16	1.51	0.62

* Dilution effect is not calculated when the result is negative

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

	Apr-Jun		Apr-Jun	Jan-Jun	Jan-Jun	Jan-Dec
kSEK	2024		2023	2024	2023	2023
Operating income		367	1,776	3,615	2,414	6,318
Operating result		-7618	-5,060	-11,641	-9,995	-21,560
Result		-7,647	-4,965	-11,604	-9,837	-21,412
Balance sheet total		15,791	24,635	15,791	24,635	14,972
Cash flow		-4,967	-4,440	1,098	-8,368	-19,956
Cash and cash equivalents		4,092	14,583	4,092	14,583	2,994
Equity ratio %		52	80	52	80	57
Per share data (SEK)
Number of shares		15,372,258	13,806,142	15,372,258	13,806,142	13,806,142
Result per share before and after dilution*		-0.50	-0.36	-0.75	-0.71	-1.55
Cash flow per share		-0.34	-0.32	0.08	-0.61	-1.45
Equity per share		0.53	1.43	0.53	1.43	0.62

* Dilution effect is not calculated when the result is negative

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

	Q1		Q1	Jan-Dec
kSEK	2024		2023	2023
Operating income		3,248	-638	6,318
Operating result		-4,022	-4,936	-21,560
Result		–3,958	-4,872	-21,412
Balance sheet total		20,307	28,915	14,972
Cash flow		6,065	-3,928	-19,957
Cash and cash equivalents		9,059	19,023	2,994
Equity ratio %		65	85	57
Per share data (SEK)
Number of shares		15,372,258	13,806,142	13,806,142
Result per share before and after dilution*		-0.26	-0.35	-1.55
Cash flow per share		0,39	-0.28	-1.45
Equity per share		0.85	1.78	0.62

* Dilution effects is not calculated when the result is negative

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.

Financial summary	Q4	Q4	Jan-Dec	Jan-Dec
KSEK	2023	2022	2023	2022
Operating income	1,575	–	6,318	17
Operating result	-7,662	-8,067	-21,560	-28,955
Result	–7,692	-8,021	-21,412	-28,788
Balance sheet total	14,972	33,285	14,972	33,285
Cash flow	-6,796	-6,642	-19,956	10,678
Cash and cash equivalents	2,994	22,951	2,994	22,951
Equity ratio %	57	88	57	88
Per share data (SEK)
Number of shares	13,806,142	13,806,142	13,806,142	13,806,142
Result per share before and after dilution*	-0.56	-0.58	-1.55	-2.09
Cash flow per share	-0.49	-0.48	-1.45	0.78
Equity per share	0.62	2.12	0.62	2.12

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

Significant events during the quarter

• On July 17th the company announced it has signed an evaluation agreement with a major global Pharmaceutical Corporation. The agreement is to perform a funded feasibility study aiming to develop thermostable dry powder formulations in the partner mRNA/LNP projects, with a planned extension for stability testing and an option to license the LaminarPace technology.
• On September 5th the company announced that Xavier Turon has been appointed as Chief Operating Officer and he will assume his position on October 9th, 2023.

Other events during the quarter

• On July 26-28, Ziccum participated at the 3rd Annual mRNA Summit in Boston. CEO Ann Gidner gave a presentation to an audience of senior pharmaceutical industry decision makers, scientists, and key opinion leaders. Ziccum also presented a Scientific poster (’A Novel Unit Operation Successfully Drying mRNA/LNP by Mass Transfer’) – the first scientific poster Ziccum has delivered at a major event.
• On September 6, Ziccum participated in the conference New Updates in Drug Formulation and Bioavailability in Copenhagen.

Other events after the third quarter

• On October 23, Ziccum announced that 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.

CEO statement
Intensive data generation with world-leading Partners

After kicking this quarter off with signing the second of two milestone agreements with world-leading mRNA players, now generating significant revenue for Ziccum, we have had an exciting time both externally, participating in leading industry forums, and internally, building the Ziccum team further with strong competence and generating further important data for the mRNA/LNP platform.

Joining forces with world-leading Biotech and Big Pharma
Whilst our Biotech Corporation mRNA Feasibility collaboration is already running, we were delighted to take the Big Pharma Evaluation study negotiation to completion and signatures. The scope is more encompassing, with both a paid Feasibility study for the partner mRNA/LNP material, and a planned extension for stability testing and an option for the Big Pharma to license the LaminarPace technology. It is a great recognition, for Ziccum to be handpicked from the crowded lineup of potential partners for this international leader in vaccine development.
 
Apart from the very concrete and large business value if we can take these two collaborations forward, if the studies prove such good results for the mRNA/LNP entities at hand with LaminarPace as we expect, there is immediate value generated for Ziccum by the partnership interaction. It is a delight to exchange ideas and review progress with these highly skilled industry experts. And obviously it is a great milestone for Ziccum to be revenue generating, thanks to our successful execution of the new business model. This gives a most appreciated further extension of the financial runway ahead.
 
Furthermore, we are taking great strides when it comes to strengthening our academic collaborations, and we are planning additional analytical capabilities in-house to ensure that we are on top of trial readouts and particle assessments.
 
LaminarPace data generation at a new pace
The Ziccum team has made an excellent effort in increasing the productivity in trial execution, and we have been able to take both partnered studies and internal projects forward very efficiently. The initial findings regarding mRNA/LNP treatment with LaminarPace are continuously confirmed, which is extremely rewarding. To further validate the findings on mRNA activity after LaminarPace drying, we have engaged a good analytical services partner to make testing in several models, and the trials in cell-based assays have given distinct validation of the ability of LaminarPace to transform delicate mRNA/LNP solution into stable, bioactive dry powder with excellent in-vitro characteristics. We are moving to the next step of in-vivo studies now, looking forward to key read-outs.
 
Targeting the new era in pharmaceutical industry and getting significant recognition
After applying the technology successfully for the most delicate targets – mRNA in LNP formulation – during spring, it was a pleasure to take part in the Global mRNA Summit in Boston in July, a large gathering of the leading experts in this booming field. One can only be amazed at seeing how the entire, global pharmaceutical industry is racing to take RNA projects forward to market. Also, it was strongly emphasized how mRNA could become a cornerstone treatment for all kinds of indications – if only RNA can be made ‘user-friendly’, with solutions to delivery and stability limitations. This is exactly what Ziccum is enabling, with LaminarPace formulation and drying – so there is indeed a tremendous market need to meet here for our technology, in this highest value part of biopharmaceuticals.
 
There are several new dialogues initiated, existing talks taken forward and it is truly rewarding to see the recognition we are building up in industry.
 
Building the Ziccum professional level further
We were happy to welcome a new colleague during this quarter – Deepak Anand who is bringing a great scientific postdoc profile to the team. I am very pleased to build a diverse team with an impressively broad experience base, bringing valuable perspectives and ensuring a good outlook to stay abreast of industry developments. This was further emphasized as we were delighted to announce the appointment of a broadly experienced engineering manager, Xavier Turon from Barcelona, as our new Chief Operating Officer to join in October.
 
In our Quality Assurance we are taking structure and documentation initiatives forward, ensuring that there is an efficient path for fulfilling pharmaceutical standards, both short term in our running partnerships and long term to get LaminarPace industrialized. We are also assessing potential partners for equipment development and supply going forward.
 
We have a hectic time ahead, with a keen focus on executing on our partnership studies as well as taking the business dialogues and technology optimization forward. Let me thank the team for excellent efforts, as well as collaboration partners and owners for continued support and creative dialogues.
 
Lund, October 25, 2023
Ann Gidner, CEO

July- September in brief

• Total revenues: SEK 2,329 (0) thousand.
• Result for the quarter: SEK -3,882 (-6,674) thousand.
• Earnings per share: SEK -0.28 (-0.48).
• Cash flow for the quarter: SEK -4.793 (-7,064) thousand.
• Cash at the end of the reporting period: SEK 9,790 (29,593) thousand.

Financial summary	Q3	Q3	Jan-Sep	Jan-Sep	Full year
KSEK	2023	2022	2023	2022	2022
Net revenue	2,329	0	4,743	0	0
Operating result	-3,899	-6,674	-13,857	-20,888	-28,955
Result	-3,882	-6,599	-13,720	-20,767	-28,788
Balance sheet total	21,764	42,582	21,764	42,582	33,285
Cash flow	-4,793	-7,054	-16,161	17,320	10,678
Cash and cash equivalents	9,790	29,593	9,790	29,593	22,951
Equity ratio %	73	87	73	87	88
Per share data (SEK)
Number of shares	13,806,142	13,806,142	13,806,142	13,806,142	13,806,142
Result per share before and after dilution*	-0.28	-0.48	-0.99	-1.50	-2.09
Cash flow per share	-0.35	-0.52	-0.95	1.27	0.78
Equity per share	1.51	2.69	1.51	2.69	2.12

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

SIGNIFICANT EVENTS Q2 2023 (APRIL-JUNE)

• On May 9, Ziccum announced that it had signed a revenue generating Evaluation Agreement with a leading biopharma company to commence a Feasibility study regarding LaminarPace for ambient drying of mRNA/LNP materials and/or mRNA vaccine(s).
• The Annual General Meeting (AGM) held on May 24, 2023 re-elected Fredrik Sjövall, Mikaela Bruhammar and Andreas Pettersson Rohman and elected Per Gerde as new board member. Fredrik Sjövall was reelected as the chairman of the Board of Directors. The AGM adopted an incentive program (LTI2023:1) of 324,000 employee stock options for certain employees and consultants. The LTI2023:1 program will be awarded during quarter three 2023. The AGM furthermore resolved on an issue of not more than 425,801 warrants to ensure delivery of shares to the participants and to hedge costs connected to the program.
• On June 2, the company announced that Johny Humaloja was appointed as new CFO for the company, and he started his assignment in June.
• On June 5, the company announced that it had received a notification from CEPI (the Coalition for Epidemic Preparedness), that its joint Expression of Interest has not been selected for the next stage of application work. 

SIGNIFICANT EVENTS AFTER THE SECOND QUARTER

• On July 17, Ziccum announced it had signed a new Evaluation Agreement with one of the world’s top pharmaceutical corporations. The agreement is to perform a funded Feasibility study aiming to develop thermostable dry powder formulations in the partner mRNA/LNP projects, with a planned extension for stability testing and an option to license the LaminarPace technology.

OTHER EVENTS

• On May 2, the company announced it had filed three patent applications as part of new, expanded strategy to strengthen patent protection. The new, expanded IP strategy will provide multi-layered protection to the company’s unique drying technology LaminarPace, turning liquid biopharmaceuticals into thermostable dry powders by mass transfer.

CEO statement
 
Taking amazing strides together, landing two deals for Ziccum
It is truly fantastic to now deliver great results in our key areas, having sorted and structured the company business model and operations during a build-up period. Now we are pleased to enter the next phase, delivering key milestone achievements for our valuable platform technology. Getting two agreements signed with world-leading players is indeed clear confirmation that we are on the right path.
 
Proving the technology for the most delicate targets
Our most significant technical milestone so far was achieved end of first quarter, confirming that we can turn mRNA in lipid nanoparticles (mRNA/LNP) into stable dry powder, with maintained activity. These results have been further validated during this quarter. We have tested various lipid compositions with resulting good mRNA activity, to build our proprietary knowledge further in this exciting field.
 
mRNA/LNP is a complex and very fragile structure, but so valuable for new pharmaceutical development that it is highly desirable for the industry to apply it – it opens the door to a completely new field of innovative drugs. Solving the issues of mRNA drug delivery and LNP stability will be key to making it a broad platform for new patient treatments. So we are indeed excited to have proven the ability to address this: Ziccum can help make mRNA/LNP available for many more vaccines and therapeutics, globally. Of course, one can also see the great potential to work on other vaccine platforms, as well as the broad range of other biopharmaceutical compounds.
 
Securing more Ziccum Intellectual property, broadly
Thanks to successful continued technology development and learnings in our internal programs, regarding both equipment configuration, process parameters when running LaminarPace and continuous learning regarding formulation, we have been able to file three new patent applications. It was a significant effort during the quarter to assess all new learnings and apply for patent protection. Also, after the filings announced in April, continued work is on-going to secure the best protection possible for our technology.
 
Signing up with a world leader in mRNA/LNP
Our progress is generating very good industry interest for the possibilities of our technology, and we are pursuing numerous dialogues with high calibre industry players, across the industry and in many geographies. It was with great pleasure we could communicate on May 9th that one first paid Feasibility study is agreed and signed. It is a very significant commercial milestone of course, for Ziccum to become revenue generating as of now. The project is running at full activity currently, and it is fantastic to work closely with such a successful and knowledgeable partner.
 
Just after the quarter closing, we could add a second, larger project collaboration being signed – now with a major global Pharmaceutical company. This time, the scope is both a paid Feasibility study with partner mRNA/LNP material, and a planned extension for stability testing and an option to license the LaminarPace technology.
 
Not only are these projects generating revenue and extending our financial runway, but also generating further knowledge and understanding of success factors for the mRNA field, and long term, giving business potential for future licensing if successful. We are delighted to collaborate with these leading players in the field.
 
 
Building the Ziccum operations and team
In parallel with the partnered projects, we pursue the internal development like mentioned, as well as the 3D-modelling project LaPaSim. The Swiss-Swedish team is working on component design and planning for the next step of scaling out for long term industrialization.
 
Seeing the increase in activities and projects, there are certainly investment and expansion considerations in the company – but at the same time, I am keen to keep good cost control. Both generating new results and income, while still reducing unnecessary spending, is a nice combination for sound company progress and financials.
 
One recruitment just completed, and adding financial competence, is the hiring of an experienced CFO from the Biotech industry: I am delighted to welcome Johny Humaloja to the team! Furthermore, we are looking for an experienced Chief Operating Officer, to complement the Ziccum staff.
 
We have an exciting outlook, going forward with our collaborations and plans! Let me thank all collaboration partners and owners as well, for your continued support and engaged dialogues.
Lund, July 18 2023
Ann Gidner, CEO

Q2 2023

• The result for the quarter amounted to -4,965 kSEK (-7,882 kSEK)
• Cash flow for the quarter amounted to – 4,440 kSEK (-7,587 kSEK)
• Cash and cash equivalents at the end of the quarter amounted to 14,583 kSEK (36,647 kSEK)

Financial Highlights (kSEK)	Apr-Jun 2023	Apr-Jun 2022	Jan-Jun 2023	Jan-Jun 2022	Jan-Dec 2022
Net revenue	1,776	0	2,414	0	0
Operating result	-5,060	-7,873	-9,995	-14,213	-28,955
Result for the period	-4,965	-7,882	-9,837	-14,167	-28,788
Balance sheet total	24,635	51,100	24,635	51,100	33,285
Cash flow for the period	-4,440	-7,587	-8,368	24,374	10,678
Cash and cash equivalents	14,583	36,647	14,583	36,647	22,951
Equity ratio %	80	86	80	86	88
Data per share (SEK)
Number of shares at the end of the period	13,806,142	13,806,142	13,806,142	13,806,142	13,806,142
Result per share before and after dilution*	-0.36	– 0.57	-0.71	-1.03	-2.09
Cash flow per share	-0.32	-0.55	-0.61	1.85	0.78
Equity per share	1.43	3.17	1.43	3.17	2.12

Link to report:
https://reports-en.ziccum.com/interim-report-q2-2023/start/

SIGNIFICANT EVENTS Q1 2023 (JAN-MARCH)

On January 18, Ziccum announced that the company on 24 – 26 January would attend the mRNA-based Therapeutics Summit in Berlin, the leading European event for mRNA innovation expertise in Europe. At the event, CEO Ann Gidner presented LaminarPace with a presentation titled LaminarPace: a novel unit operation successfully drying mRNA/LNP by mass transfer to an audience of senior Pharmaceutical industry decision makers, scientists and key opinion leaders.

On January 23, Ziccum announced that the company had submitted its Expression of Interest application for CEPI’s Call for Proposals for funding of innovations that improve vaccine thermostability. The Coalition for Epidemic Preparedness (CEPI), in 2022 invited players developing innovative technologies to improve vaccine thermostability to apply for a funding opportunity.

On March 10, Ziccum entered into a partnership with the FinTech platform eucaps.com, aiming to offer existing shareholders a new forum for news and dialogue whilst also increasing visibility to new investors beyond Sweden. A new portal dedicated to Ziccum was launched on the platform, containing new content on the company, reports and financials to be regularly updated, plus a secure chat forum for investors, to strengthen the resources and dialogue Ziccum offers to investors.

On March 17, Ziccum announced that the company on 20 – 22 March would attend the BIO-Europe Spring 2023 Conference in Basel, Switzerland. The event attracts pharma and biopharma corporations from across the globe. The latest updates from Ziccum technology development were presented at meetings at the event.

On March 20, Ziccum announced an update of the latest stage of its ongoing in-house mRNA/LNP project, last reported in Oct, 2022. In the previous stage, an mRNA-like molecule in LNP formulation was successfully nebulized and dried. The current stage has proceeded to nebulization and drying using active mRNA. Results from this stage confirm and strengthen findings from the previous stage: encapsulation efficiency (how much mRNA is kept inside the particles) and particle size preservation (keeping the right size of LNP particles, without aggregation) were excellent. Furthermore, mRNA activity testing has now been initiated, using a cell-based in vitro assay. Initial results are promising, with a commercially viable level of mRNA activity demonstrated in the material, after LaminarPace drying and reconstitution to liquid. Ziccum’s inhouse mRNA project aims to explore and evaluate the capabilities of its unique mass transfer drying technology, LaminarPace, in drying RNA materials to a thermostable dry powder form that could ultimately be more easily handled and transported by the industry, as well as prove suitable for novel administration routes such as inhalation.

During the first quarter CEO Ann Gidner bought 16,000 shares in Ziccum.

SIGNIFICANT EVENTS FOLLOWING THE REPORTING PERIOD
No significant events after the reporting period

CEO STATEMENT

Following up with a clear road ahead
Gathering the team for a Ziccum Day on March 31, nicely wrapping up the quarter, we could jointly conclude that a lot of major improvements and top priority plans now are in place, and we can spend our efforts more efficiently focusing on execution and delivery in a number of areas.

Positioning Ziccum in a booming field
The sharpened strategy with selected vaccine platforms and the next-generation mRNA vaccines and RNA therapeutics as top priority gives a clear road ahead for the Ziccum efforts. In January we presented Ziccum at the European mRNA Summit in Berlin, alongside world-leading Big Pharma and mRNA vaccine providers, and we felt that this visibility was very rewarding to position the company as an international mRNA player, in addition to our on-going successful relationship building. Our presence at the Berlin Summit and BIO-Europe Spring in Basel enabled good follow-up in existing dialogues as well as new interesting contacts to develop. We are pleased to have a good spread in dialogues, over Big Pharma as well as Biotech, European as well as US companies, and projects on several platforms. A key focus now is to get to signing of paid feasibility studies.

Internal Trials giving clear confirmations for mRNA/LNP
A truly significant milestone was achieved during the quarter, when we were able to confirm excellent drying results with actual messenger RNA in lipid nanoparticle formulation. Previous trials with a model molecule led the way to these trials on mRNA, which is a most demanding challenge in turning liquid biomolecules into dry powder. It is a great confirmation of how the gentle drying at ambient temperature allows such a delicate and complex molecule structure to keep its shape, size and structure. Confirming that the resulting mRNA also retains its genetic effect is of course crucial – and on-going trials in a cell-based model are confirming good activity, viable for commercial applications. These confirmations are indeed fuelling the industry interest for our technology.

Taking LaminarPace to real applicability in industry
Potential partners in the industry are keen to understand the long-term capabilities. Thanks to developing an ambitious plan for our 3D-modelling project LaPaSim last quarter, and the resulting full Eurostars funding awarded, we are able to move straight ahead with important fine-tuning and scaling of the technology. In February we gathered the Swiss and Swedish joint team for a Project kick-off and secured a high quality foundation in the project. Both sides are now generating results in real life versus digitally, to calibrate the model, and final design of the LaminarPace product outtake has started. The next step of scaling out for long term industrialization is not too far away.

We also keep moving forward with the final design of equipment components, like previously reported, with excellent industry partners. There will be new intellectual property generated for Ziccum thanks to these efforts.

Communication and team work
On the Investor relations side, we were pleased to take part as pioneers in the launch of a new European platform for trading and information. We are hoping this will nicely complement other channels for Ziccum information.

During the quarter we also implemented some further refinement in work processes, and it is a pleasure to have the high caliber Ziccum team taking great strides in our projects. I am happy to thank collaboration partners, consultants and owners as well, for continued support and fruitful dialogues.

Lund, April 26, 2023
Ann Gidner,
CEO

Q1 2023

• The result for the quarter amounted to -4,872 kSEK (-6,285 kSEK)
• Cash flow for the quarter amounted to -3,928 kSEK (31,961 kSEK)
• Cash and cash equivalents at the end of the quarter amounted to 19,023 kSEK (44 234 kSEK)

SUMMARY FINANCIAL HIGHLIGHTS KSEK	Jan-March 2023	Jan-March 2022	Jan- Dec 2022
Net revenue	–	–	–
Operating result	-4,936	-6,340	-28,955
Result for the period	-4,872	-6,285	-28,788
Balance sheet total	28,915	58,295	33,285
Cash flow for the period	-3,928	31,961	10,678
Cash and cash equivalents	19,023	44,234	22,951
Equity ratio %	85%	88%	88%
Data per share <br>SEK<br>
Number of shares at the end of the period	13,806,142	13,806,142	13,806,142
Result per share before and after dilution*	-0.35	– 0.46	– 2.09
Cash flow per share	-0.28	2.41	0.78
Equity per share	1.78	3.73	2.12