Ziccum AB (publ) Interim report Q1 2024

INTERIM REPORT Q1, 1 JANUARY – 31 MARCH 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

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

ZICCUM AB (publ) Year-End report Q4 2023

YEAR-END REPORT Q4 2023: 1 JANUARY – 31 DECEMBER 2023

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/

ZICCUM AB (publ) Interim report Q3 2023

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/

ZICCUM AB (publ) Interim report Q2 2023

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/

ZICCUM AB (publ) releases Interim report Q1 2023

To read the digital Report click here: https://reports-en.ziccum.com/interim-report-q1-2023/

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

ZICCUM AB (publ) Year-end report Q4 2022

YEAR-END REPORT Q4 2022: 1 JANUARY – 31 DECEMBER 2022

To read the digital Report, please click here:
https://reports-en.ziccum.com/year-end-report-q4-2022/start/
 

Significant events in Q4 (October – December)

On October 24, Ziccum announced proof of successful nebulization and drying of vaccine lipid nanoparticles (LNP) in its in-house mRNA project. This was carried out using LaminarPace, the company’s ambient drying technology. LNP is the preferred drug delivery component in today’s mRNA Covid-19 vaccines. The study resulted in a defined knowledge-space, defining the best operating conditions, and key read-out parameters were encapsulation efficiency, yield and particle size. The trials were repeated for confirmation.

On December 8, it was announced that Ziccum has signed an agreement contracting the ICP Institute of Computational Physics at the Zurich University of Applied Sciences’ School of Engineering (ZHAW) for the next phase of the project developing 3D modelling of LaminarPace. The project aims to accelerate industrial development of LaminarPace and will run over three years. The team at ZHAW is one of the most recognized internationally within industrial simulation and modelling.

On December 14, Ziccum launched a new, expanded website. With a new brand platform, the expanded site aims to strengthen the company’s dialogue with biopharmaceutical partners and prospects. It includes new technological, scientific and business content, and improved navigability.

On December 16, it was announced that Ziccum has been awarded a contribution of 10 mSEK by Eurostars for a joint grant application with ZHAW. Eurostars is the largest international funding programme for SMEs wishing to collaborate on R&D projects, and is co-funded by the EU Horizon 2020 Framework Programme and EUREKA. Ziccum will receive payments of 5 mSEK from the national funding body Vinnova during the project, they are consented to cover up to 50% of a project's costs. The rest of the contribution will go into the project and reduce the total project cost for Ziccum. The three year long project (LaPaSim) starts February 1 2023, and is to apply 3D-modelling to Ziccum’s ambient drying system for biopharmaceuticals, LaminarPace, resulting in a digital twin. International competition for the funding was intense, and the proposal was one of the highest-ranked applications.

During the fourth quarter CEO Ann Gidner bought 45,000 shares in Ziccum.

CEO statement

Creating a strong industry position in a booming market

It has been a very rewarding year for Ziccum (or eight months for my part), making such big strides towards a position as a top rank provider of game- changing technology to the international pharmaceutical industry, where achieving thermostable vaccines is highly desirable.

Setting the Ziccum direction

Defining a sharper strategy with selected vaccine platforms, and most importantly the high value next- generation mRNA vaccines and RNA therapeutics as top priority, has given consistent positive confirmations – from partnering dialogues, from our Biopharma licensing mRNA Market study and from our own internal trial results. We are confident going forward with this key focus.

The new business model defined, a classical Pharma out-licensing model starting with feasibility studies, has been well received and gives crisp clarity to business development efforts ahead. Given the strong interest in partnering dialogues, we have the Pharmaceutical Platform technology company business model strongly confirmed, giving licenses internationally, not producing as a contractor.

Pivotal transformation of the vaccine field and new applications of mRNA technology

Externally, the vaccine industry has gone through a complete transformation. From being a conservative, low margin segment of the Pharma industry, it has become a hot spot for rapid development, where existing players increase efforts significantly, and numerous new players want to enter the market. The Covid pandemic brought completely new insights, fuelling a strong industry desire for new vaccine development as well as for applying the novel mRNA approach in a range of new fields, like cancer vaccines and personalized therapeutics.

Business development progress

The booming market demand for new vaccine technology in combination with Ziccum’s unique drying concept enabling thermostable vaccines, now proven in a number of steps, makes for a great opportunity. Thanks to a clearly business-driven approach and an extensive industry network we are taking advantage of this, generating a significant number of partnering dialogues at four international conferences during fall. These are now pursued with in-depth dialogues going forward.

Proving the LaminarPace ability for mRNA/LNP

Getting the proof of successful drying of vaccine LNP particles at this point was most welcome. The LaminarPace drying has given good read-outs in terms of encapsulation, yield and particle preservation: keeping the LNP particles nicely in good shape and staying the correct size. We are delighted to bring these results to our business dialogues, and we are now setting up continued trials regarding vaccine activity; the verification that dried vaccine material is not only kept in good condition in high yields, but also giving a similar vaccine activity effect.

Developing ground-breaking technology, the smartest way

As novel, unique technology certainly needs development efforts, we took the important decision to run a multi-year 3D-Modelling project with a leading partner, the Zurich Institute of Applied Sciences. This way we efficiently come forward using the latest digital methods. We can run all the trials we want digitally, instead of a few selected, time-consuming physical trials. Ultimately, the project will also result in a Digital twin which can serve efficiently in tech transfer for successful process integration in the partner set-up.

We also applied to the EU organization Eurostars jointly with the Zurich Institute for soft funding of this ambitious effort, and just before Christmas we had the fantastic news of getting top ranking and receiving the full grant! This way we certainly can begin 2023 with full steam ahead.

Wrapping up 2022

An extra bonus was the launching of the new Ziccum website end of year, a total remake much better reflecting our offering: our technology and our team. Also, I was happy to present Ziccum at BioStock Life Science, getting significant interest. Finally, we had the great pleasure to expand our team with a Quality specialist, warm welcomes to Fatemeh starting in January.

Many thanks to the Ziccum team for great efforts and enthusiasm all year, taking the new strategy forward together, and to all supporting parties, owners and business partners for engaging in fruitful dialogues and supporting our efforts!

Lund, January 27, 2023

Ann Gidner, CEO

Significant events in Q1 (January-March)

On January 18, a Extraordinary General Meeting was held, in addition to approving the Board's proposal, it was decided to increase the limit on the number of shares and the size of the share capital in the Articles of Association, to enable the issue of the remaining 933,362 units in the private placement.

On January 18, an additional 2,800,086 shares and 1,866,724 warrants were registered, and all shares and warrants in the private placement are thus registered.

The last payments from the directed share issue were received by the company in January and February 2022, a total of 40 mSEK was added to the company after deduction of issue costs.

On February 7, Ziccum announced that it has become a member of the United Nations Global Compact, the world's largest corporate sustainability initiative.

On February 22, it was announced that the employment of the CEO Göran Conradson was terminated. The company's CFO, Frida Hjelmberg was appointed acting CEO.

On March 3, the Board released an update on strategy, goals and priorities. The company's strategy for entering into commercial agreements with industrial players was defined, based on four key priority activities:

1. Drive an active business development agenda that proactively prepares for collaboration with existing and potential partners. This to offer the opportunity to evaluate specific projects in combination with Ziccum's technology, and to understand the requirements placed on the technology before a decision on a license agreement can be made.

2. Generate laboratory data that manifest and confirm the technology's capacity to dry different types of vaccines, so-called proof of concept.

3. Develop the company's technology to adapt its functionality, capacity and quality to the licensees' required specifications.

4. Develop conceptual plans for how Ziccum's drying technology can be adapted to the commercial scale and integrated into a commercial production environment.

With a new CEO, the Board's goal is to increase the pace of, above all, business development work – with the goal of entering into more industrial collaborations in order to evaluate LaminarPace and advance existing collaborations into negotiations on commercial terms and license agreements.

Significant events in Q2 (April – June)

On April 25, a strategic sharpening was announced informing the market that Ziccum is now targeting three key vaccine platforms in its research and development work through 2022 and 2023 – driven by input from external collaborations and new internal technology capabilities.

1. Viral vector platform using Adenovirus – Four major Covid-19 vaccines already use adenovirus vaccine vectors as a platform. The platform enables efficient gene transduction and research is ongoing in a wide range of indications.

2. Subunit vaccine (adjuvanted) platform – This platform is also being used in major Covid-19 vaccine candidates. Instead of using the whole pathogen, protein-based adjuvant vaccines use a defined protein antigen from the pathogen which can be recognized by the body’s immune system to provoke an immune response.

3. mRNA/LNP vaccine platform – Generating data on dry-formulated mRNA/LNP materials is a key strategic priority for Ziccum. Covid-19 has highlighted the efficacy of mRNA/LNP as a vaccine platform enormously.

On April 27, Ziccum informed about the selected key targeted technology developments of the LaminarPace system, the fourth generation in development – some underway, and some recently completed:

1. New powder collector – A new sealed, contained collection unit is installed that enables the inhouse study of a wider range of test substances. The new unit increases safety, reduces humidity and enables quicker, more efficient collection of drier formulations.

2. New nitrogen usage – Ziccum has now introduced Nitrogen gas (N2) into the drying column to replace air. N2 is a highly efficient remover of moisture. The first nitrogen-based generation of LAPA is installed and has performed well in tests.

3. New nebulizer – The LAPA system’s nebulizer feature is a key component in optimizing the system’s capacity, reproducibility and reliability.

4. New membrane – Intensive work is currently underway in optimizing the membrane for future GMP compatibility – examining its porosity, mounting and materials for industrial setting.

On May 6, the Board of Ziccum published the decision to officially change the company’s language to English for all external communications.

On May 9, it was announced that Ziccum has been elected onto the Technical Activities Committee of the US National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). NIIMBL, co-funded by the US Department of Commerce, funds and initiates a wide range of public-private research projects throughout the US.

On May 9, Ann Gidner took office as new CEO. Ann has 25+ years of experience from Life Science management internationally, with a significant track record in strategic development, focused leadership, deal making and sales growth.

On June 3, it was announced that Ziccum has extended an ongoing pilot evaluation study agreement with a leading pharmaceutical corporation following the completion of the latest stage of the project.

On June 22, the company informed that the installation of a new cell lab was completed, enabling in-house in vitro research. Ziccum has significantly expanded its lab facilities and capabilities, particularly in the area of mRNA/LNP. Strategic investments in addition to the new cell lab are for example a system for manufacturing and evaluating dry formulations of mRNA/LNP materials.

During the second quarter CEO Ann Gidner bought 15,000 shares in Ziccum. In addition, the Board members Andreas Pettersson Rohman also bought 39,333 shares and Fredrik Sjövall 10,000 shares in the Company.

Significant events in Q3 (July – September)

On July 19, Ziccum published the selected partner for the development of its crucial new nebulizer component for the LaminarPace system. The chosen partner TEKCELEO is an innovative mechatronic manufacturer with advanced knowledge of nebulizers. The component is central to the advanced drying capabilities and scaleup of Ziccum’s LaminarPace system.

On July 21, it was announced that Ziccum together with the Zurich University of Applied Sciences (ZHAW) are applying for funding from the Eurostars funding body for a joint project that will develop the 3D modelling stage of LaminarPace. The project aims to strengthen, support and accelerate the development of LaminarPace – offering high-value insights into its unique particle properties, and accelerating and optimizing industrialization.

On August 2, Ziccum informed about a reorganisation aiming to facilitate and accelerate its new strategic focus on key projects and vaccine platforms. As part of the reorganization, Senior Formulation Specialist Fabrice Rose was appointed Scientific Director. The reorganization was implemented on August 1, 2022.

On September 1, Ziccum announced that the company will be intensifying its partnering and networking dialogues by attending major industry events across Europe.

On September 14, Ziccum and Zurich University of Applied Sciences’s School of Engineering (ZHAW) did submit a joint application for Eurostars funding. The proposed project will develop 3D modelling, and ultimately a Digital Twin, of LaminarPace (LAPA) that will accelerate development and scale-up and promote tech transfer, partnering and ultimately sales.

On September 23, Ziccum received results from evaluation study with leading Pharmaceutical corporation, analyzing LaminarPace’s ability to dry four test substances. Data demonstrated excellent results on thermostability, positive results on particle appearance but significant loss of infectivity, requiring further development. The client has paused assessment of LaminarPace on the current vaccine platform, but will consider the technology in regard to other vaccine platforms, where dry formulation could be a higher priority.

On September 27, It was announced that Ziccum has reopened its application process for CEPI’s Call for Proposals from companies developing innovative technologies to improve vaccine thermostability. Ziccum will submit an Expression of Interest with a new partner – a well-established, innovative biotechnology company.

During the third quarter CEO Ann Gidner bought 35,000 shares in Ziccum. In addition, the Chairman of the Board Fredrik Sjövall bought 40,000 shares in the company.

Significant events after the reporting period

On January 24 – 26, Ziccum will attend the mRNA-based Therapeutics Summit in Berlin, the leading European event for mRNA innovation expertise in Europe. On the event, CEO Ann Gidner will present 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 has 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.

Q4 2022

  • The result for the quarter amounted to -8 021 kSEK (-6 450 kSEK)
  • Cash flow for the quarter amounted to -6 642 kSEK (-7 291 kSEK)
  • Cash and cash equivalents at the end of the quarter amounted to 22 951 kSEK (12 273 kSEK)
Summary Financial Highlights kSEK Oct-Dec 2022 Oct-Dec 2021 Jan-Dec 2022 Jan-Dec 2021
Net revenue
Operating result (8 067) (6 474) (28 955) (21 117)
Result for the period (8 021) (6 450) (28 788) (21 136)
Balance sheet total 33 285 36 900 33 285 36 900
Cash flow for the period (6 642) (7 291) 10 678 (21 347)
Cash and cash equivalents 22 951 12 273 22 951 12 273
Equity ratio % 0,88 0,81 0,88 0,81
Data per share SEK
Number of shares at the end of the period 13 806 142 11 006 056 13 806 142 11 006 056
Result per share before and after dilution* -0,58 – 0,65 -2,09 -2,17
Cash flow per share -0,48 – 0,73 0,78 -2,19
Equity per share 2,12 2,70 2,12 2,70

ZICCUM AB (publ) Interim report Q3 2022

INTERIM REPORT Q3 2022: 1 JANUARY – 30 SEPTEMBER 2022.

To read the digital Report, please click here: https://reports-en.ziccum.com/interim-report-q3-2022/start/

Significant events during Q3 (July-September)

On July 19, Ziccum published the selected partner for the development of its crucial new nebulizer component for the LaminarPace system. The chosen partner TEKCELEO is an innovative mechatronic manufacturer with advanced knowledge of nebulizers. The component is central to the advanced drying capabilities and scaleup of Ziccum’s LaminarPace system.

On July 21, it was announced that Ziccum together with the Zurich University of Applied Sciences (ZHAW) are applying for funding from the Eurostars funding body for a joint project that will develop the 3D modelling stage of LaminarPace. The project aims to strengthen, support and accelerate the development of LaminarPace – offering high-value insights into its unique particle properties, and accelerating and optimizing industrialization.

On August 2, Ziccum informed about a reorganisation aiming to facilitate and accelerate its new strategic focus on key projects and vaccine platforms. As part of the reorganization, Senior Formulation Specialist Fabrice Rose was appointed Scientific Director. The reorganization was implemented on August 1, 2022.

Ziccum announced on September 1 that the company will be intensifying its partnering and networking dialogues by attending major industry events across Europe.

On September 14, Ziccum and Zurich University of Applied Sciences’s School of Engineering (ZHAW) did submit a joint application for Eurostars funding. The proposed project will develop 3D modelling, and ultimately a Digital Twin, of LaminarPace (LAPA) that will accelerate development and scale-up and promote tech transfer, partnering and ultimately sales.

On September 23, Ziccum received results from evaluation study with leading Pharmaceutical corporation, analyzing LaminarPace’s ability to dry four test substances. Data demonstrated excellent results on thermostability, positive results on particle appearance but significant loss of infectivity, requiring further development. The client has paused assessment of LaminarPace on the current vaccine platform, but will consider the technology in regard to other vaccine platforms, where dry formulation could be a higher priority.

On September 27, It was announced that Ziccum has reopened its application process for CEPI’s Call for Proposals from companies developing innovative technologies to improve vaccine thermostability. Ziccum will submit an Expression of Interest with a new partner – a well-established, innovative biotechnology company.

During the third quarter CEO Ann Gidner has bought 35,000 shares in Ziccum. In addition, the Chairman of the Board Fredrik Sjövall bought 40,000 shares in the Company.

Significant events during Q1-Q2 (Jan-June)

At the Extraordinary General Meeting held on January 18, in addition to approving the Board's proposal, it was decided to increase the limit on the number of shares and the size of the share capital in the Articles of Association, to enable the issue of the remaining 933,362 units in the private placement.

On January 18, an additional 2,800,086 shares and 1,866,724 warrants were registered, and all shares and warrants in the private placement are thus registered.

The last payments from the directed share issue were received by the company in January and February 2022, a total of 40 mSEK was added to the company after deduction of issue costs.

Ziccum announced on February 7 that it has become a member of the United Nations Global Compact, the world's largest corporate sustainability initiative.

On February 22, it was announced that Göran Conradson was terminated from his position as CEO. The company's CFO, Frida Hjelmberg, will be acting CEO for the time being.

On March 3, the Board released an update on strategy, goals and priorities. The company's strategy for entering into commercial agreements with industrial players has been and is clearly defined. It is based on four key priority activities:

  1. Drive an active business development agenda that proactively prepares for collaboration with existing and potential partners. This is partly to offer the opportunity to evaluate specific projects in combination with Ziccum's technology, and partly to understand the requirements placed on the technology before a decision on a license agreement can be made.
  2. Generate laboratory data that manifests and confirms the technology's capacity to dry different types of vaccines, so-called proof of concept.
  3. Develop the company's technology to adapt its functionality, capacity and quality to the licensees' required specifications.
  4. DevelopconceptualplansforhowZiccum'sdryingtechnologycanbeadaptedtothecommercialscaleand integrated into a commercial production environment.

With a new CEO, the Board's goal is to increase the pace of, above all, business development work – with the goal of entering into more industrial collaborations in order to evaluate LaminarPace and advance our existing collaborations into negotiations on commercial terms and license agreements.

Ziccum AB has significantly expanded its lab facilities and capabilities, particularly in the area of mRNA/LNP. Strategic investments include a new cell lab and a system for manufacturing and evaluating dry formulations of mRNA/LNP materials. On June 22, the company informed that the installation of the new cell lab was completed, enabling in-house in vitro research.

On June 3, it was announced that Ziccum has extended an ongoing pilot evaluation study agreement with a leading pharmaceutical corporation following the completion of the latest stage of the project.

On May 9 Ann Gidner took office as new CEO. Ann has 25+ years of experience from Life Science management internationally, with a significant track record in strategic development, focused leadship, deal making and sales growth.

Ziccum has been elected onto the Technical Activities Committee of the US National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). NIIMBL, co-funded by the US Department of Commerce, funds and initiates a wide range of public-private research projects throughout the US.

On May 6, the Board of Ziccum published the decision to officially change the company’s language to English for all external communications.

The current LAPA system is the fourth generation in development. On April 27, Ziccum informed about the selected key targeted technology developments of the LaminarPace system – some underway, and some recently completed:

  1. New powder collector – Ziccum has now installed a new sealed, contained collection unit that enables the inhouse study of a wider range of test substances. The new unit increases safety, reduces humidity and enables quicker, more efficient collection of drier formulations.
  2. New nitrogen usage – Ziccum has now introduced Nitrogen gas (N2) into the drying column to replace air. N2 is a highly efficient remover of moisture. The first nitrogen-based generation of LAPA is installed and has performed well in tests.
  3. New nebulizer – The LAPA system’s nebulizer feature is a key component in optimizing the system’s capacity, reproducibility and reliability.
  4. New membrane – Intensive work is currently underway in optimizing the membrane for future GMP compatibility – examining its porosity, mounting and materials for industrial setting.

On April 25, a strategic sharpening was announced informing the market that Ziccum is now targeting three key vaccine platforms in its research and development work through 2022 and 2023 – driven by input from external collaborations and new internal technology capabilities.

  1. Viral vector platform using Adenovirus – Four major Covid-19 vaccines already use adenovirus vaccine vectors as a platform. The platform enables efficient gene transduction and research is ongoing in a wide range of indications. Ziccum has worked extensively with adenovirus and submitted a patent application in January 2019 for a temperature-stable, dry formulation of Adenovirus.
  2. Subunit vaccine (adjuvanted) platform – This platform is also being used in major Covid-19 vaccine candidates. Instead of using the whole pathogen, protein-based adjuvant vaccines use a defined protein antigen from the pathogen which can be recognized by the body’s immune system to provoke an immune response. Protein-based vaccines have been successfully developed over recent decades to treat diseases from diphtheria to tetanus.
  3. mRNA/LNP vaccine platform – Generating data on dry-formulated mRNA/LNP materials is a key strategic priority for Ziccum. Covid-19 has highlighted the efficacy of mRNA/LNP as a vaccine platform enormously.

During the second quarter CEO Ann Gidner has bought 15,000 shares in Ziccum. In addition, the Board members Andreas Pettersson Rohman also bought 39,333 shares and Fredrik Sjövall 10,000 shares in the Company.

Significant events after the reporting period

Ziccum announced proof of successful nebulization and drying of vaccine lipid nanoparticles (LNP) in its in- house mRNA project. This was carried out using LaminarPace, the company’s ambient drying technology. LNP is the preferred drug delivery component in today’s mRNA Covid-19 vaccines. The study resulted in a defined knowledge-space, defining the best operating conditions, and key read-out parameters were encapsulation efficiency, yield and particle size. The trials were repeated for confirmation.

CEO statement

Strategic focus reinforcement

We are rapidly going forward in Ziccum, implementing the new focus and executing on its actions, generating results. Just after quarter closing, we had the much-anticipated and important proof of successful drying of vaccine LNP particles, setting the mRNA/LNP offering center-stage – a major step for us.

Strategic focus

We have progressed significantly in our strategic development, where a number of factors assessed have helped defining our market targeting: the ground-breaking new technology, the value proposition, the small volume applicability and the regulatory pathway all point to a focus on high value, delicate, next-generation mRNA vaccines and RNA therapeutics as the top priority. We should apply our technology where it will bring the most value. This guidance is now directing efforts on all fronts.

Business development and Partnering

We have ambitious business development as a top priority, to build a broad pipeline of opportunities. Participating at Nordic Life Science Days and the World Vaccine Congress we had good meeting schedules, and were rewarded with serious interest from Pharma, Biotech and vaccine manufacturing industry – also clearly confirming the high-value strategic focus. We are currently going into secrecy agreements with a number of companies to take dialogues further.

Partnering in Pharma industry can be a lengthy process, and there are always some projects closing, so we are delighted to have many new dialogues established. The pandemic awareness and intensive efforts in vaccine development globally certainly are fuelling interest for new technology such as ours. Furthermore, we have commissioned a market study with mRNA target projects from a qualified US biopharma licensing bureau.

Technology development and Feasibility studies

Internally, the technology development program involves having a customized, top performing nebulizer rapidly developed, plus progress in membrane development and more. These steps are ensuring we are meeting our technology selling points of gentle and efficient processing in an optimized manner. Apart from developing the LaminarPace performance, we are running feasibility studies, nicely filling the new capacity installed last quarter.

The internal trials on LNP particles for mRNA have been pursued with great intensity during the quarter. It is indeed rewarding to see the outcome, where the drying step has given good read-outs in terms of encapsulation, yield and particle preservation. This is a great confirmation of the applicability of LaminarPace, giving a clear path forward for the continued development, verifying that sufficient activity is preserved.

For the existing collaboration getting read-outs end September, results were mixed. Seeing that the technology is promising but will need further development, the partner may consider a more delicate platform – very much in line with our own strategic conclusions to apply the technology to the highest value segments like mRNA/LNP.

3D- Modelling and Soft funding

Starting up the 3D-modelling is important– the LaminarPace development and scale-out can be accelerated and significantly improved, ensuring optimal design. We are happy to have submitted the application for a Eurostars grant covering this scope, jointly with our new top-notch Swiss engineering partner. We also agreed with a key European Biotech partner to build an attractive case for the CEPI grant for Thermostable vaccines, basing our case on mRNA/LNPs.

Company structure

The new organization was implemented on August 1st, bringing clarity on responsibilities and setting a strong focus. The sharpened setup is giving good savings as we eliminate consultant expenditure, both avoiding unnecessary efforts and changing roles into employment. I am delighted to welcome a new member of staff, Tony, this quarter.

I want to express my gratitude to the Ziccum team for fantastic efforts, stepping up to the new strategy and taking activities forward on all fronts. Also, we are most happy for excellent support from our collaboration partners, consultants and owners.

Lund, October 27, 2022

Ann Gidner, CEO

Q3 2022

The result for the quarter amounted to -6,599 kSEK (-5,043 kSEK)
Cash flow for the quarter amounted to -7,054 kSEK (- 6,414 kSEK)
Cash and cash equivalents at the end of the quarter amounted to 29,593 kSEK (19,564 kSEK)

Summary of financial highlights

Summary Financial Highlights July-Sept 2022 July-Sept 2021 Jan-
Sept
2022
Jan-Sept 2021 Jan-
Dec 2021
Net revenue
Operating result (6,674) (5,045) (20,888) (14,643) (21,117)
Result (6,599) (5,043) (20,767) (14,686) (21,136)
Balance sheet total 42,582 29,348 42,582 29,348 39,591
Cash flow (7,054) (6,141) 17,320 (14,056) (21,347)
Cash and cash equivalents 29,593 19,564 29,593 19,564 12 273
Equity ratio % 0.87 0.82 0.87 0.82 0.75
Data per share SEK
Number of shares at the end of the period 13,806,142 9,806,200 13, 806,142 9,806,200 11,006,056
Result per share before and after dilution* -0.48 – 0.51 -1.50 -1.51 -2.17
Cash flow per share -0.52 – 0.63 1.27 -1.456 -2.19
Equity per share 2.69 2.46 2.69 2.46 2.70
* Dilution effects is not calculated when the result is negative

ZICCUM AB (publ) Interim report Q2 2022

INTERIM REPORT Q2 2022: 1 JANUARY – 30 JUNE 2022.

To read the digital Report click here: https://reports-en.ziccum.com/interim-report-q2-2022/

Significant events during Q2 (April-June)

  • Ziccum AB has significantly expanded its lab facilities and capabilities, particularly in the area of mRNA/LNP. Strategic investments include a new cell lab and a system for manufacturing and evaluating dry formulations of mRNA/LNP materials. On June 22, the company informed that the installation of the new cell lab was completed, enabling in-house in vitro research.
  • On June 3, it was announced that Ziccum has extended an ongoing pilot evaluation study agreement with a leading pharmaceutical corporation following the completion of the latest stage of the project.
  • On May 9 Ann Gidner took office as new CEO. Ann has 25+ years of experience from Life Science management internationally, with a significant track record in strategic development, focused leadship, deal making and sales growth. Generating steep growth in leading, international Pharma CDMO corporations took her to senior global positions in the US and Germany. She has also been leading internationalization of mid-sized Life Science companies in Sweden and Germany, as well as building up Pharma technology licencing internationally. Recent years have given experience from CEO and Board positions in listed Swedish Life Science start-ups.
  • Ziccum has been elected onto the Technical Activities Committee of the US National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). NIIMBL, co-funded by the US Department of Commerce, funds and initiates a wide range of public-private research projects throughout the US.
  • On May 6, the Board of Ziccum published the decision to officially change the company’s language to English for all external communications.
  • The current LAPA system is the fourth generation in development. On April 27, Ziccum informed about the selected key targeted technology developments of the LaminarPace system – some underway, and some recently completed.
  • On April 25, a strategic sharpening was announced informing the market that Ziccum is now targeting three key vaccine platforms in its research and development work through 2022 and 2023 – driven by input from external collaborations and new internal technology capabilities.
  • During the second quarter CEO Ann Gidner has bought 15,000 shares in Ziccum. In addition, the Board members Andreas Pettersson Rohman also bought 39,333 shares and Fredrik Sjövall 10,000 shares in the Company.

Significant events during Q1 (Jan-March)

  • At the Extraordinary General Meeting held on January 18, in addition to approving the Board's proposal, it was decided to increase the limit on the number of shares and the size of the share capital in the Articles of Association, to enable the issue of the remaining 933 362 units in the private placement.
  • On January 18, an additional 2 800 086 shares and 1 866 724 warrants were registered, and all shares and warrants in the private placement are thus registered.
  • The last payments from the directed share issue were received by the company in January and February 2022, a total of 40 mSEK was added to the company after deduction of issue costs.
  • Ziccum announced on February 7 that it has become a member of the United Nations Global Compact, the world's largest corporate sustainability initiative.
  • On February 22, it was announced that Göran Conradson was terminated from his position as CEO. The company's CFO, Frida Hjelmberg, will be acting CEO for the time being.
  • On March 3, the Board released an update on strategy, goals and priorities. The company's strategy for entering into commercial agreements with industrial players has been and is clearly defined. It is based on four key priority activities:
  1. Drive an active business development agenda that proactively prepares for collaboration with existing and potential partners. This is partly to offer the opportunity to evaluate specific projects in combination with Ziccum's technology, and partly to understand the requirements placed on the technology before a decision on a license agreement can be made.
  2. Generate laboratory data that manifests and confirms the technology's capacity to dry different types of vaccines, so-called proof of concept.
  3. Develop the company's technology to adapt its functionality, capacity and quality to the licensees' required specifications.
  4. Develop conceptual plans for how Ziccum's drying technology can be adapted to the commercial scale and integrated into a commercial production environment.

With a new CEO, the Board's goal is to increase the pace of, above all, business development work – with the goal of entering into more industrial collaborations in order to evaluate LaminarPace and advance our existing collaborations into negotiations on commercial terms and license agreements.

  • On March 28, it was announced that Ann Gidner is appointed as new CEO for Ziccum, she takes office on May 9.

Significant events after the reporting period

  • On July 19, Ziccum published the selected partner for the development of its crucial new nebulizer component for the LaminarPace system. The chosen partner TEKCELEO is an innovative mechatronic manufacturer with advanced knowledge of nebulizers. The component is central to the advanced drying capabilities and scaleup of Ziccum’s LaminarPace system.
  • On July 21, it was announced that Ziccum together with the Zurich University of Applied Sciences (ZHAW) are applying for funding from the Eurostars funding body for a joint project that will develop the 3D modelling stage of LaminarPace. The project aims to strengthen, support and accelerate the development of LaminarPace – offering high-value insights into its unique particle properties, and accelerating and optimizing industrialization.
  • On August 2, Ziccum informed about a reorganisation aiming to facilitate and accelerate its new strategic focus on key projects and vaccine platforms. As part of the reorganization, Senior Formulation Specialist Fabrice Rose was appointed Scientific Director. The reorganization was implemented on August 1, 2022.

CEO statement

From vision to action

It has been a true pleasure to join Ziccum at this intense stage of business-oriented action and help setting a sharper focus for the critical development needs and industrial partnering. The company has a very competent and dedicated team, and with a more precise focus we are taking great strides forward, both in the actual experimental work and in our partnering dialogues, creating value.

During the quarter a key strategic focus on three high potential vaccine platforms was defined. Ziccum is now prioritizing three key, high-potential vaccine platforms: adenovirus vaccine vectors, adjuvanted vaccines and mRNA vaccines using LNP delivery. All three platforms are used in major Covid-19 vaccines, and subject to intense development efforts in the pharmaceutical industry.

We also streamlined the project portfolio to three high-value ongoing feasibility studies corresponding to these platforms. Two are joint with leading pharma corporations, and one with an internationally leading vaccine research institute. I was delighted to help take these dialogues forward and to introduce new significant industry players to Ziccum. We were able to finish an important feasibility study and ship the pilot evaluation material to our key pharma collaborator, to now await the analysis and feedback.

Starting in this report we give a portfolio overview, to help the understanding of the overall status of our external projects. For these projects however, collaborating with pharmaceutical corporations, one needs to respect the decision-making of the counterpart and the demand for perfect confidentiality; in pharmaceutical development, every relevant project is subject to strict secrecy due to the large business potential. Hence, one must be very careful making public predictions or disclose any details.

Internally, we had a great range of technical improvements and installations made, including powder collection equipment and nitrogen gas usage, and we were most pleased to have the fourth generation LaminarPace units installed during the quarter. We also had the new cell lab installation nicely completed. Important decisions were taken regarding the development strategy, which resulted in selection of a new nebulizer partner, Tekceleo, which we expect to give a very efficient development project like communicated. We also took an important decision to partner with the ZHAW Institute in Zurich, Switzerland to consider LaminarPace 3D modelling and jointly apply for a Eurostars grant.

The sharpened company focus and elimination of non-strategic activities provide better clarity for our hard- working team, which boosted energy and efforts. We also had the pleasure of moving into new office and lab facilities, creating a good setting for the work ahead.

All in all, we had a very intense quarter. I want to thank Frida Hjelmberg for her good contributions as interim CEO, and I am most grateful for the efforts by Chairman Fredrik Sjövall, initiating the new company focus and enabling a smooth CEO transition. We jointly want to thank our collaborators, partners and owners for excellent interaction and support.

Lund,

August 23, 2022

Ann Gidner, CEO

Q2 2022

The result for the quarter amounted to -7,882 kSEK (-5 ,228 kSEK)
Cash flow for the quarter amounted to -7,587 kSEK (-3096 kSEK)
Cash and cash equivalents at the end of the quarter amounted to 36,647 kSEK (25,706 kSEK)

Summary Financial Highlights April-June 2022 April-June 2021 Jan-
June 2022
Jan-June 2021 Jan-
Dec 2021
Net revenue
Operating result -7,873) -5,212) -14,213) -9,598) -21,117
Result -7,882 -5,228) 14,167) -9,643) -21,136
Balance sheet total 51,100 33,647 51,100 33,647 39,591
Cash flow -7,587 -3,,096 24, 374 -7, 914 -21,347
Cash and cash equivalents 36,647 25,706 36,647 25,706 12, 273
Equity ratio % 86%6 878% 86%& 87% 75%
Data per share SEK
Number of shares at the end of the period 13 ,806,142 9, 806,200 3,.806,142 9,806,200 11,006,056
Result per share before and after dilution* -0.57 – 0.55 -1.03 -1.01 -2.17
Cash flow per share -0.55 – 0.32 1.85 -0.82 -2.19
Equity per share 3.17 2.97 3.17 2.97 2.70
* Dilution effects is not calculated when the result is negative

ZICCUM AB (publ) Interim report Q1 2022

INTERIM REPORT Q1 2022: 1 JANUARY – 31 MARCH 2022

To read the digital Report click here: https://reports-en.ziccum.com/interim-report-q1-2022/

Q1 2022

  • The result for the quarter amounted to -6,285 kSEK (-4, 416 kSEK)
  • Cash flow for the quarter amounted to 31,961 kSEK (-4, 818 kSEK)
  • Cash and cash equivalents at the end of the quarter amounted to 44, 234 kSEK (28,802 kSEK)
SUMMARY FINANCIAL HIGHLIGHTS kSEK Jan-March 2022 Jan-March 2021 Jan-Dec 2021
Net revenue                    –                    –                    –  
Operating result             (6,340)           (4,387)         (21,117)
Result             (6,285)           (4,416)         (21,136)
Balance sheet total            58,295          35,715          39,591
Cash flow            31,961           (4,818)         (21,347)
Cashy and cash equivalents            44,234          28,802          12,273
Equity ratio % 0.88 0.90 0.75
Data per share SEK
Number of shares at end of period     13,806,142      9,606,200      11,006,056
Result per share before and after dilution* -0.46              -0.46    -2.17
Cash flow per share 2.41              -0.50    -2.19
Equity per sharee 3.73                3.33    2.70
* Dilution effects is not calculated when the result is negative

Significant events during Q1 (Jan-March)
At the Extraordinary General Meeting held on January 18, in addition to approving the Board's proposal, it was decided to increase the limit on the number of shares and the size of the share capital in the Articles of Association, to enable the issue of the remaining 933,362 units in the private placement.

On January 18, an additional 2,800,086 shares and 1,866,724 warrants were registered, and all shares and warrants in the private placement are thus registered.

The last payments from the directed share issue were received by the company in January and February 2022, a total of 40 mSEK was added to the company after deduction of issue costs.

Ziccum announced on February 7 that it has become a member of the United Nations Global Compact, the world's largest corporate sustainability initiative.

On February 22, it was announced that Göran Conradson was terminated from his position as CEO. The company's CFO, Frida Hjelmberg, will be acting CEO for the time being.

On March 3, the Board released an update on strategy, goals and priorities. The company's strategy for entering into commercial agreements with industrial players has been and is clearly defined. It is based on four key priority activities:

  1. Drive an active business development agenda that proactively prepares for collaboration with existing and potential partners. This is partly to offer the opportunity to evaluate specific projects in combination with Ziccum's technology, and partly to understand the requirements placed on the technology before a decision on a license agreement can be made.
  2. Generate laboratory data that manifests and confirms the technology's capacity to dry different types of vaccines, so-called proof of concept.
  3. Develop the company's technology to adapt its functionality, capacity and quality to the licensees' required specifications.
  4. Develop conceptual plans for how Ziccum's drying technology can be adapted to the commercial scale and integrated into a commercial production environment.

With a new CEO, the Board's goal is to increase the pace of, above all, business development work – with the goal of entering into more industrial collaborations in order to evaluate LaminarPace and advance our existing collaborations into negotiations on commercial terms and license agreements.

On March 28, it was announced that Ann Gidner is appointed as new CFO for Ziccum, she takes office on May 9.

Significant events after the reporting period
The new CEO, Ann Gidner, has bought 15,000 shares in Ziccum. In addition, the Board members Andreas Pettersson also bought 20,000 shares and Kristian Kierkegaard 10,000 shares in the Company.

CEO Statement

This will be my final statement as acting CEO before our new CEO Ann Gidner assumes her new role on May 9. I am pleased that I will return to focusing fully on my CFO role having overseen a productive Quarter of renewed focus that I believe will serve as a basis for strong business development.

During the Quarter myself, together with Development Director Anna Lönn, an engaged Chairman and proactive Board member have worked intensively on reviewing the company’s business development and strategic focus. On March 3 we released an updated reappraisal of our strategic goals reaffirming the importance of licensing rights in our business model, and our commitment to generating further proof-of-concept data, and in particular mRNA / LNP data.

In the week leading up to this Q1 Report we shared with our investors additional details on our strategic and operational initiatives, and how they constitute a strong base for future growth. These focus areas are:

1. A STRENGTHENED FOCUS ON THREE VACCINE PLATFORMS
During 2022 – 2023 Ziccum will focus on three key vaccine platforms: the Viral Vector platform using Adenovirus, the subunit vaccine (adjuvanted) platform and the mRNA/LNP vaccine platform. mRNA/LNP is an area we value very high. The global trend and market dynamics in this specific field is also very strong. Read more HERE.

2. EXPANDED TOOLS, LAB FACILITIES AND mRNA/LNP CAPABILITIES
Strategic investments include a new cell lab that will enable in vitro studies of key biological properties and deliver specific advantages in the development of mRNA/LNP. We have also completed the investment and installation of the microfluidics system, ‘Ignite’ NanoAssemblr, that will enable us to generate our own mRNA/LNP materials at R&D scale. Read more HERE.

3. TARGETED TECHNOLOGY DEVELOPMENTS
To underpin Ziccum’s new strategic focus, key technology development programs have been selected for the company’s flagship drying system (LaminarPace or LAPA) as it progresses towards eventual GMP manufacturing status. Some are ongoing, some have been recently completed. These technology development programs include for instance a new powder collector solution, introduction of nitrogen (N2) as drying gas, nebulizer and membrane development.

These key priority areas and a committed and engaged organization will lead the way in LaminarPace’s development towards commercial partnerships and eventual GMP industrial manufacturing. Read more HERE.

In conclusion – ‘renewed focus’ is the key term that I want to emphasis. I believe that with the new more focused strategies and targets developed in this Quarter, and with the imminent arrival of our reputable CEO Ann Gidner, we are now in a strong position to move decisively forwards towards creating new partnerships and value for ourselves, our clients and our investors.

Lund, April 28, 2022,
Frida Hjelmberg,
Acting-CEO,
CFO,
Ziccum AB

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