Iconovo AB (publ), that develops complete inhalation products for a global market today annonces that the company´s Quality Management System (QMS) has been upgraded to meet the US Quality System Regulation (QSR 21 CFR 820) for medical devices. The company´s development and documentation process must comply with this FDA regulation to enable registration and marketing of medical device products in the US.

This achievement is a crucial step to obtain future US market access for all Iconovo drug device combination products including ICOres, ICOpre, ICOone and ICOcap.

In 2020, Iconovo’s QMS became compliant with the international ISO 13485:2016 standard for medical devices. Thus, the QMS also complies with the EU Medical Device Regulation. This has enabled Iconovo to develop drug device combination products that will be ready for registration on the European market.

“Iconovo have global ambitions for our inhalation platforms and US is the biggest pharma market in the world. Compliance with the US regulations is a key component to advance existing projects and will unlock even more opportunity in our partnering and business development process,” said Johan Wäborg, CEO for Iconovo.

Pareto Securities´12th Annual Healthcare Conference

CEO Johan Wäborg presents Iconovo. 

 

Biostock published August 27th an article about Iconovo that can be found in its entirety below

Together with ISR, Iconovo is developing an inhaled Covid-19 vaccine in ICOone and a nasal version in ICOone Nasal. ISR has now signed a MoU agreement with the CRO Bangladesh Clinical Trials for a clinical phase I study with the vaccine, as well as with UniMed UniHealth Pharmaceuticals for manufacturing and distribution in Bangladesh. However, these agreements are only declarations of intent, not binding agreements, but they are nevertheless good news for Iconovo as it means significant progress within the vaccine project.

Iconovo develops inhalation products that are licensed to other companies to accelerate development and quickly reach the inhalation market.

One of Iconovo’s partners is ISR Immune System Regulation, a Stockholm-based pharmaceutical and research company that, among other things, has a vaccine candidate against SARS-CoV-2 under development.

ISR has developed two dosage forms of the Covid-19 vaccine, one for inhalation through the mouth down to the lungs and one for intranasal application (in the nose). ISR will test which of the routes of administration provides the best immune response and protection against the virus. The company has selected Iconovo’s inhalers ICOone and ICOone Nasal for this purpose.

Broadened collaboration

In late March, Iconovo and ISR announced an agreement giving ISR global exclusive rights to use Iconovo’s ICOoneinhaler for vaccination against SARS-CoV-2. Since then, the collaboration has been broadened to include a nasal version with Iconovo’s new platform ICOone Nasal. There can be great value in having two formulations according to ISR because they can individually lead to market registration. Ola Winqvist, CEO of ISR, said in a press release that he saw the collaboration as a start of a long-term partnership with Iconovo to develop a series of vaccines.

Several benefits with inhaled vaccines

Inhaled/nasal vaccines have a number of advantages over vaccines given in injection form. One advantage is its ease of use – with Iconovo’s inhalers ICOone and ICOone Nasal, patients can administer the vaccine themselves without the aid of a healthcare professional. Vaccine powder formulations for inhalation translated to cheaper transport and storage without the need for cooling or freezing temperature, which can be of great benefit in developing countries. In addition, needle sticks and handling of syringes and other contagious waste are avoided.

MoU agreement for clinical study in Bangladesh

ISR and Iconovo are preparing for a phase I clinical study with the inhaled/nasal Covid-19 vaccine to evaluate the safety, dose, route of administration, immunogenicity, and efficacy of the inhalable/nasal vaccine.

ISR is now evaluating the possibility of conducting the study in Bangladesh as the company has entered into a memorandum of understanding (MoU) with the CRO Bangladesh Clinical Trials, and the two principal investigators Prof Dr ABM Abdullah and Prof Dr Ahmedul Kabir at Mugda Medical College Hospital in Dhaka. In a recent press release, ISR’s CEO Ola Winqvist mentioned how pleased he is to have made contact with these experts:

»We are very pleased to work with experts from Bangladesh to conduct a phase I clinical study with our vaccine formulations designed for optimal immune response at the entrance for the SARS-CoV-2 virus, respiratory tract.«

MoU with UniMed for manufacturing and distribution

In addition to conducting the study in Bangladesh, ISR is also exploring the possibility of producing the Covid-19 vaccine in the country. In early August, ISR announced that it had entered into a MoU agreement with UniMed UniHealth Pharmaceuticals, one of the largest pharmaceutical companies in Bangladesh. The purpose of the MoU is to agree on a long-term cooperation agreement in which Unimed can potentially obtain exclusive rights to manufacture and distribute the vaccine against SARS-CoV-2 in Bangladesh.

If the two parties enter into a licensing agreement, it would mean that ISR would receive compensation in the form of payments upon signing and upon market approval, as well as a double-digit royalty. However, the MoU agreement with UniMed is only a preliminary agreement and not legally binding. The company is currently in negotiations with various parties regarding the delivery of the Covid-19 vaccine.

Great need for vaccine in Bangladesh

In a press release, Ola Winqvist emphasised that Bangladesh has been hit hard by the pandemic and is in dire need of a vaccine against Covid-19 and subsequent mutations. The goal is a quick path to market approval to reach the large population of 160 million people with the inhaled/nasal vaccine.

ISR’s and Iconovo’s vaccine project is now proceeding at a high pace. According to ISR, UniMed has the resources needed to produce and distribute the Covid-19 vaccine effectively. UniMed can produce up to 100 million vaccine units per year and the goal is to be able to produce up to 300 million units or more annually within 5 years. In addition, the ISR’s CEO believes that Iconovo’s platforms ICOone and ICOone Nasal can accelerate the development further: 

»The platform of ICOone with its flexibility enables a rapid, affordable and effective development of a SARS-CoV-2 vaccine for the respiratory tract. The platform can make ISR’s vaccine available on the global market shortly after conducting clinical studies.«

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

Japan Patent Office has announced the intention to grant a patent (Notice of Allowance) regarding Iconovo’s inhalation device, ICOres. Iconovo has previously granted ICOres patents in Japan, USA, Sweden, Europe (EPO) and China. The new patent covers the technology used in many of Iconovo’s projects like generic Symbicort©.

Japan Patent Office has announced the intention to grant a patent (Notice of Allowance) regarding Iconovo’s inhalation device, ICOres. Iconovo has previously granted ICOres patents in Japan, USA, Sweden, Europe (EPO) and China. The new patent covers the technology used in many of Iconovo’s projects like generic Symbicort©.

“This new patent strengthens our patent protection on the very large and important Japanese market. This provides an opportunity to our partners to launch ICOres products in Japan”, says CTO Dr. Orest Lastow.

Expanded agreement doubles royalty potential

Key figures in TSEK unless otherwise indicated  Apr-Jun 2021 Apr-Jun 2020 Jan-Jun 2021 Jan-Jun 2020 Jan-Dec 2020
Net turnover 3,496 2,425 5,641 4,357 17,792
Operating profit/loss -6,586 -5,819 -13,912 -10,800 -16,717
Cash flow for the period -6,911 -9,697 -15,433 -13,429 -27,467
Earnings per share (SEK) before full dilution -0.86 -0.82 -1.77 -1.37 -2.20
Cash and cash equivalents 46,256 75,727 46,256 75,727 61,689
Equity 79,001 99,220 79,001 99,220 92,729
Number of shares at period-end 7,776,000 7,776,000 7,776,000 7,776,000 7,776,000
Number of royalty agreements** 6 3 6 3 5

**Number of agreements at the end of the period.

Significant events 1 April – 30 June

  • In May, Iconovo announced the expansion of its agreement with Amneal regarding generic Symbicort to include the key US and Chinese markets and the Nordic sales rights, more than doubling the potential for future annual royalty income.
  • In May, Iconovo communicated its 5-year business targets at its first Capital Market Day. By 2026, the Company expects to achieve sales of SEK 200 million, with an operating margin of 50%. The Company also announced its long-term strategy, with three strategic areas made up of the original core operation of generic inhalation product development plus the new areas of innovative inhalation product development and pharmaceutical sales in the Nordics.
  • In May, Iconovo entered into an agreement with Respiratorius for the development of an inhalation product for the treatment of COPD. The agreement includes a tiered fee for project work, with a total value of up to SEK 3 million.
  • In April, the Company announced that the United States Patent and Trademark Office issued an intention to approve (Notice of Allowance) a patent for the ICOone inhalation platform. Iconovo already has approved patents for ICOone in Sweden, Europe (EPO) and India.
  • The Board has been further strengthened. Ann Gidner was elected to the Board at the AGM, and Gunnar Gårdemyr has taken over the role of Board Chair.

Significant events after the end of the second quarter

  • In July, Iconovo carried out a directed share issue and raised SEK 75 million before issue expenses. The issue has been subscribed by a number of Swedish and international institutional investors, including Alcur Fonder, FE Fonder and Humle Fonder, as well as a number of existing shareholders, including Andra AP-fonden, Fjärde AP-fonden, Handelsbanken Fonder and Länsförsäkringar Fonder. The proceeds of the issue will primarily be used for acceleration and value creation activities and investments linked to the Company’s new long-term strategy.
  • In July, Iconovo entered into an agreement with ISR (Immune System Regulation AB) for additional work on the ongoing inhaled COVID-19 vaccine project for the development of a nasal version of Iconovo’s ICOone inhaler. The additional work could provide up to SEK 4.9 million on top of the previous agreement. In addition, there is the possibility of future royalties.

A word from the CEO – Energised for growth

Long-term strategy with three areas In May, Iconovo held its first ever Capital Market Day, during which we launched our new long-term strategy. As a company, we are uniquely positioned to develop additional areas around inhalation, and we see great opportunities for growth by broadening our offering. Our future is now being shaped in three areas – Generic Inhalation Products, Innovative Inhalation Products and Pharmaceutical Sales in the Nordics.

An important area is the development of new, innovative inhalation drugs. These may be entirely new drugs, or new formulations of substances that were previously available only as injections, for example. We call this strategic area Innovative Inhalation Products. In the last six months, Iconovo has entered into three agreements in this innovative area, clearly demonstrating that our business model can be used in a very attractive way. Our offering allows our partners to invest in an inhalable drug in a high-quality, innovative inhaler – something that very few companies in the world can match.

In June, we further demonstrated the potential of our innovative projects when we entered into a supplemental agreement with ISR for the development of a nasal COVID-19 vaccine in a new Iconovo platform called “ICOone Nasal”. The order could provide Iconovo with an additional SEK 4.9 million on top of previously agreed amounts.

Development of generic asthma and COPD drugs is an area in which Iconovo is already well established, and it remains an important part of our operations. We anticipate significant future revenue from this area, primarily through royalties. We possess globally recognised expertise and can attract generics business on the global stage. The strategic area Generic Inhalation Products will be pursued with a continued focus on winning new business and continued deliveries towards the first market launches, expected in 2023.

When entering into development agreements with generic companies around the world, it is seen as very positive if you have a lot to gain from developing a fantastic product yourself. We therefore have a dual reason to sell generic products in the Nordic market ourselves.

This not only makes as a more attractive business partner, but becoming a Nordic pharmaceutical company helps us to build our own profitable drug portfolio. The strategic area Nordic Pharmaceutical Sales is being kicked off with establishment of Iconovo Pharma in 2021–2022. The first drug product launched is expected to be generic Symbicort in 2023, with a current market value of SEK 900 million in the Nordics.

Successful capital raising In early July, a directed share issue worth SEK 75 million was carried out. Several of our existing major shareholders took part in the issue, including Andra AP-fonden, Fjärde AP-fonden, Handelsbanken Fonder and Länsförsäkringar Fonder. We also specifically targeted Alcur, FE Fonder and Humle Fonder, which are known for investing in quality small companies with high potential and growth.

Five-year targets A strong cash position enables additional efforts and drive behind each of our three strategies. The strategies form the basis and plan for the work that will lead us to our set targets for 2026. We will reach a turnover of SEK 200 million from our generic projects and from Nordic pharmaceutical sales. In addition to this, the innovative projects with ISR have a potential upside worth SEK 100 million in 2026. Our business model is expected to lead to 50% operating margin from operations. The above targets are based on the projects we have right now, but we have also set an additional target of entering into 1–3 new customer agreements per year during the period up to 2026. Through new agreements, we can exceed the targets, and that is precisely why we want to invest now. To this end, we chose to raise capital via a directed issue.

Now that the strategy is in place, our focus is fully on implementation. We are now energised, well-funded and ready to focus heavily on our three strategic areas to maximise the value of our operations.

Johan Wäborg, CEO

Biostock published July 16th an article about Iconovo that can be found in its entirety below

Earlier this year, two Swedish life science companies, Iconovo, which develops complete inhalation products, and ISR, which develops immunotherapies, came together to start working on an inhalable Covid-19 vaccine using Iconovo’s ICOone platform. Now, the two companies have announced another agreement, this time for developing a nasal application of the vaccine using Iconovo’s new version of ICOone, called ICOone Nasal. The new application will lead to a faster track through clinical studies and thus a quicker path to market for this much-needed therapy.

In March, BioStock reported the news that Lund-based Iconovo had signed an agreement with Stockholm-based immunotherapy company ISR Immune System Regulation for the development of an inhaled Covid-19 vaccine. Through that agreement ISR would develop a dry-powder formulation of the vaccine able to be administered with Iconovo’s the single-use inhaler ICOone, thus making it particularly user-friendly and more cost-effective since it does not require refrigeration and is cheaper to transport.

New agreement introduces ICOone Nasal

Now, the partners have signed a new agreement, this time for the development of dry powdered vaccine, which reaches the airways by inspiratory flow to the nasal cavity instead of inhalation to the lungs through the mouth using Iconovo’s new proprietary version of ICOone – ICOone Nasal.

ICOone Nasal works similarly to ICOone, in that it is a single-dose, user-friendly device with a design that leads to low manufacturing costs. Since the new device is driven by inspiratory flow rather than being sprayed into the nasal cavity, it leads to a more even and natural distribution over the nasal mucosa. This gives ICOone Nasal a unique position versus competitors such as Aptar Pharma’s Unidose (UDS) Systems, which relies on spray performance and is used by Eli Lilly for its FDA-approved nasal glucagon powder in treating hypoglycemia.

A faster path to market

Thanks to this new agreement, there are now two dosage forms of a dry-powder Covid-19 vaccine currently in development – an inhaled application and a nasal application. With both applications, the vaccine reaches the gateway for the virus directly, thus creating a local immune response instead of a systemic response. Furthermore, the addition of the nasal application will help accelerate development and generate a fast track through clinical studies and thus a quicker path to market.

ISR’s CEO Ola Winqvist further explained the benefits of having two dosage forms in a recent press release:

»We have chosen to develop two dosage forms to evaluate which route of administration provides the optimal immune response and the best protection against infection. Administration of vaccines via the respiratory tract is so far relatively new and knowledge is needed to determine the best route for activating the immune system. By broadening the collaboration with Iconovo AB, we are investing in knowledge and time to be able to clinically provide a simple vaccine as quickly as possible for countries where cold chains are not secured.«

Potential paradigm shift in vaccination

The new agreement gives ISR an exclusive global right to use ICOone Nasal for the treatment of Covid-19 and its variants with a technology based on spike proteins with an adjuvant. Moreover, ISR also has a future option to use its vaccination technology with ICOone Nasal in influenza, RS-virus and new strands of coronavirus vaccines based on the same technology.

The total value of the deal is 10.4 MSEK, which equals to an added 4.9 MSEK to the previously communicated contractual sums. Payments are expected to be divided into 9.1 MSEK over the coming six months and the remaining amount over the next 24 months. Upon signing of the order, an initial payment of 1.3 MSEK will be paid.

Iconovo’s CEO Johan Wäborg is also excited about this new opportunity:

»This order provides a great opportunity to evaluate the new platform ICOone Nasal in a clinical study for Covid-19. We give the project the highest priority to support ISR in their efforts to advance the project according to the aggressive timelines required during a pandemic. This project could be the start of a paradigm shift that opens the door to inhaled vaccines instead of injectable vaccines. A shift where Iconovo is well positioned to take the lead.«

Significant market potential

According to the WHO, an estimated 11.6 billion vaccine doses are needed for global vaccination to stop the spread of SARS-CoV-2, an estimate that is now being re-evaluated since data suggest that a third round of vaccination may be required for adequate protection from new variants. If successful, this new development track for a new Covid-19 vaccine using ICOone Nasal could have a profound impact, particularly in developing countries that have restricted access to refrigeration and where the vaccination programs have not advanced yet.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

 Iconovo AB (publ), a company developing complete inhalation products for a global market, today announced that it has received an order from the immunotherapy company ISR Immune System Regulation AB (ISR), a subsidiary of ISR Immune System Regulation Holding AB (publ), for additional work for the ongoing project with inhaled COVID-19 vaccine with a development of a nasal version of Iconovo’s inhaler ICOone. The additional order may give Iconovo up to 4.9 MSEK in addition to previously announced agreement.

The order covers the development of a nasally administered COVID-19 vaccine that will become a new fast track to the market due to a faster development process. The project for a nasal administration of a COVID-19 vaccine will use ICOone Nasal, which is a new nasal platform based on ICOone. It is a unique and proprietary nasal powder delivery device.

ISR and Iconovo pushes the project for an inhaled COVID-19 vaccine forward with high speed. Therefore, ISR has decided to accelerate development by adding a nasally administered vaccine that provides a faster path through the clinical studies. This COVID-19 vaccine, with administration to the nasal cavity, is meant to be a fast track that can either lead to a separate registration or it could pave the way for an orally inhaled vaccine for administration to the lung. The new nasal vaccine will be developed by Iconovo in the new platform ICOone Nasal.

The new agreement gives ISR an exclusive global right to use ICOone Nasal under the current agreement as a line extension to ICOone, for the treatment of COVID-19 and its variants with a technology based on so-called spike proteins with an adjuvant. Under the current agreement, ISR also has a future option to use its vaccination technology in ICOone in influenza, RS-virus and new strands of covid-virus vaccines based on the same technology.

The total value of the order is 10.4 MSEK, which is 4.9 MSEK in addition to previously communicated contractual sums. Iconovo will contractually develop a nasal vaccine and manufacture clinical trial material to a phase 1 study that takes priority into phase 1 over the inhaled lung product. Payments are expected to be divided into 9.1 MSEK over the coming six months and the remaining amount over the next 24 months. Upon signing of the order, an initial payment of 1.3 MSEK will be paid.

“This order provides a great opportunity to evaluate the new platform ICOone Nasal in a clinical study for COVID-19. We give the project the highest priority to support ISR in their efforts to advance the project according to the aggressive timelines required during a pandemic. This project could be the start of a paradigm shift that opens the door to inhaled vaccines instead of injectable vaccines. A shift where Iconovo is well positioned to take the lead”, says Johan Wäborg, CEO of Iconovo.

An inhaled formulation for nasal or lung administration gives important benefits such as ease of use, cheaper transportation, storage without the need for refrigeration and no handling of needles and syringes. Removing the need for refrigeration and the handling of contagious material represent a large savings potential and can potentially eliminate the risk of spreading disease through infected needles. Another important benefit is that the vaccine directly reaches the airways and provides both a local protection in the airways and an activation of the systemic immune defense.

”The platform of ICOone with its flexibility enables a rapid, affordable and effective development of a SARS-CoV-2 vaccine for the respiratory tract. The platform can make ISR’s vaccine available on the global market shortly after conducting clinical studies. The collaboration is now deepening and broadened to include both nasal and lung administration, which we see as a great advantage, as different respiratory pathogens may have different entry ports in the airways. We see the collaboration with Iconovo as a long-term partnership with the aim of establishing a series of different vaccines”, says Ola Winqvist, CEO of ISR.

About ISR

ISR is an innovation-driven development company of pharmaceuticals within immunotherapy. The business idea is to convert preclinical immunological research to clinical development stimulating the the immune system to fight chronic infections like HIV, HBV and cancer by developing the company’s pipeline of immunostimulants Immunolider and Immunorheliner and utilize the immune system to develop designer vaccines. The company has its headquarter in Stockholm. Mangold Fondkommision AB is the certified advisor and can be reached at telephone +46 8 503 01 550.

About ICOone®

ICOone is a unique, patented dry powder inhaler for single use. The smart design generates an ultra-low manufacturing cost combined with simple and discreet use. It is particularly suitable for short-term treatment and as-needed use as it provides an unsurpassed low treatment cost and price point for treatments with a low number of doses. The simple design also enables patients and caregivers to learn how to handle the inhalers with minimal training. ICOone can deliver large inhalation doses that are well protected against moisture, an important factor for many biomolecules.

About ICOone® Nasal

ICOone Nasal is a unique and patented nasal powder delivery device driven by the inhalation of the user for single use. The smart design generates an ultra-low manufacturing cost combined with simple and discreet use. It is particularly suitable for short-term treatment and as-needed use as it provides an unsurpassed low treatment cost and price point for treatments with a low number of doses. The simple design also enables patients and caregivers to learn how to handle the nasal delivery device with minimal training. ICOone Nasal is driven by the inhalation of the user that gives an even and natural distribution of the powder on the nasal mucosa. The patented design gives a stable product avoiding the need for refrigerator-cold transport and minimize the need for preservatives.

Biostock published July 8th an article about Iconovo that can be found in its entirety below

All Covid-19 vaccines on the market are given in injection form by healthcare professionals and require transport and storage at low temperatures. Inhalation company Iconovo and immunotherapy company ISR want to change this by developing an inhaled Covid-19 vaccine that can be stored at room temperature and is easily administered by the patients themselves with Iconovo’s disposable inhaler ICOone. The inhaled vaccine reaches the affected area of the lungs directly, which is expected to create a protective effect against the virus.

Lund-based Iconovo develops inhalers with associated drug preparations that are mainly used to develop treatments for asthma and COPD, but also new types of inhaled drugs such as vaccines.

At the end of March, the company announced signing an agreement with ISR Immune System Regulation for the development of an inhaled Covid-19 vaccine. The agreement means that ISR has exclusive global rights touse Iconovo’s single-use inhaler ICOone for vaccination against SARS-CoV-2 using a technology based on thespike protein on the surface of the virus along with adjuvant (substances that enhance the immune response). The vaccine project has received a lot of attention, especially after a feature in TV 4 where Iconovo’s founder Orest Lastow and CEO Johan Wäborg talked about the benefits of the inhalable Covid-19 vaccine.

Iconovos single-dose inhaler ICOone

ISR develops the vaccine and Iconovo provides the inhaler

Stockholm-based ISR has developed the candidate Covid-19 vaccine ISR52, which will now be used in a powder formulation in Iconovo’s disposable inhaler ICOone. An inhaled preparation has several advantages: ease of use, not requiring the presence of healthcare professionals to administer the vaccine, cheaper transportation and storage without the requirement of refrigeration or freezing. In addition, the risk of transmission of blood-borne viruses through needles and syringes is avoided.

Another advantage is that the vaccine reaches the affected area of the lung tissue directly, which is expected to give a more adequate and local immune response in the lung in addition to the systemic immune reaction.

Iconovo and ISR believe that an inhaled vaccine will be of greatest use in developing countries with restricted access to refrigeration and where the vaccination programs have not advanced yet. In the TV 4 feature, Iconovo’s CEO said that he sees a future where inhalable vaccines can be distributed to large parts of the population so that millions of people can take the vaccine at the same time. 

Several Covid-19 vaccines already approved 

However, there are many other Covid-19 vaccines in development, and several have already received market approval. In the EU, the vaccines from Pfizer/BioNTechModernaAstraZeneca/University of Oxford and Janssen/Johnson & Johnson have been approved.

Both Pfizer’s and Moderna’s Covid-19 vaccines are based on a relatively new technology using mRNA (messenger RNA) encoding the spike protein on the surface of the SARS-CoV-2 virus. The body’s immune system identifies the spike protein as something foreign and begins to produce antibodies to the protein, creating protection against the virus.

AstraZeneca’s and Janssen’s/Johnson & Johnson’s Covid-19 vaccines send instructions for the formation of the spike protein via double-stranded DNA encoded into an adenovirus vector – a common and harmless coldvirus. These vaccines do not need to be stored as cold as those based on mRNA, which require storage atvery low temperatures (-20 degrees for Modern and -70 degrees for Pfizer).

 Iconovo’s/ISR’s vaccine is a subunit vaccine

There is also another type of vaccine technology called subunit vaccine, which means that the vaccinecontains certain harmless parts of the virus. The US company Novavax is developing the subunit vaccine NVX-CoV2373 containing the spike protein located on the surface of the SARS-CoV-2 virus that is synthetically produced and not taken directly from the virus.

In June, Novavax presented positive results from a phase III study showing that the company’s vaccine candidate has 90.4 per cent efficacy, and that it has a 100 per cent protection against severe and moderate Covid-19.

The Covid-19 vaccine developed by Iconovo and ISR is similar to Novavax’s vaccine technology, with the difference being that it is inhaled instead of injected.

Respiratory tract and lungs – the virus’s doorway into the body   

The nose, airways and lungs are the most common entryways to the body for SARS-CoV-2 and other respiratory viruses. Iconovo/ISR want to take advantage of this fact by generating protection against the virus already in the lungs with the inhalation vaccine.

However, Iconovo and ISR are not alone in researching the opportunity to develop an inhalable Covid-19 vaccine. The Chinese company CanSino Biologics also has an inhalable Covid-19 vaccine under development. CanSino Biologics believes that an inhaled variant may be more effective than in injection form, as the inhaled vaccine also activates antibodies and T-cells in the airways, according to Pharmaceutical Technology.

There are also a number of companies and researchers who want to develop nasal spray Covid-19 vaccines, such as AstraZeneca and the University of Helsinki and the University of Eastern Finland. Finnish researchers believe that a Covid-19 vaccine in this form can create immunity to the virus in the mucous membranes of the upper respiratory tract and nose, which can stop the virus at an early stage.

Great future potential for inhaled vaccines 

ISR has previously shown in mouse studies that the Covid-19 vaccine candidate gives good protection against the virus. ISR and Iconovo are now planning to start a clinical trial with the inhalable Covid-19 vaccine using ICOone during the second half of 2021. The goal is to take rapid steps in the development in order to reach the market as quickly as possible and take a strong position in the ongoing race for vaccine development.

The technology of Inhaled vaccines may also be applicable to other respiratory viruses. ISR has a future option to use its vaccine technology in ICOone to create vaccines against influenza, respiratory syncytial virus and new coronaviruses. According to Iconovo’s CEO Johan Wäborg, there is a huge market potential for inhalation vaccines, an area in which the company is a pioneer in according to a press release regarding the agreement with ISR: 

»The potential for an innovation like this will be huge if it reaches the market. We believe that ICOone has the potential to replace injections of vaccines and other important molecules, thereby offering a smarter way to administer these pharmaceuticals. Iconovo is a global leader and wants to act as a driving force in this development« — Johan Wäborg, CEO Iconovo

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

Biostock published July 6th an article about Iconovo that can be found in its entirety below

Last week Iconovo carried out a directed share issue of 75 MSEK at a subscription price of 70 SEK per share. A large part of the proceeds from the issue will be used to expand the project portfolio in the field of innovative inhalation products and to build up the Nordic sales of pharmaceuticals through the pharmaceutical division Iconovo Pharma. BioStock contacted Iconovo’s CEO Johan Wäborg to find out more about which doors are opened thanks to the directed share issue.

Iconovo develops ready-to-use inhalation products, i.e. inhalers and associated dry powder formulations that are used to develop both generic and innovative inhalation drugs through partnering and licensing agreements. The company currently has four inhalation platforms in its portfolio – ICOres, ICOcap, ICOone and ICOpre.

On Thursday evening last week Iconovo announced that they had completed a directed share issue of 75 MSEK before issue costs. According to Iconovo, the issue was carried out to enable continued high pace in the company’s development and initiatives connected to their long-term strategy consisting of three focus areas:

  • Own sales of generic inhalation products in the Nordics
  • Development of innovative inhalation products
  • Development of generic inhalation products.

Read more about Iconovo’s long-term strategy in the financial targets for 2026

New and existing owners subscribed to the issue

The directed share issue was carried out at a subscription price of 70 SEK, which was determined through an accelerated bookbuilding procedure. The issue was subscribed to by several new Swedish and international institutional investors, such as Alcur FonderFE Fonder and Humle Fonder, as well as several existing owners, for example Andra AP-fonden, Fjärde AP-fonden, Handelsbanken Fonder and Länsförsäkringar Fondförvaltning.

Investments in innovative inhalation drugs and own sales

Approximately 40 per cent of the issue proceeds are intended to be used to expand the project portfolio within innovative inhalation products. An equal share of the proceeds will be used to build and scale up the company’s own sales in the Nordic market via Iconovo Pharma.

Iconovo Pharma is the company’s pharmaceutical division in the Nordic region which was started in connection with Iconovo acquiring the rights from Amneal to sell generic Symbicort in the multi-dose inhaler ICOres on the Nordic market. This was the first building block in creating a portfolio of inhalation products for sale through its own organisation in the Nordic region.

The remaining share of the proceeds, approximately 20 per cent, will be used to increase the company’s project capacity and thereby reduce the risk in the portfolio and increase the likelihood of launch of additional products to the market. In addition, it will be used to strengthen the commercialisation efforts connected to Iconovo’s three strategic focus areas.

Johan Wäborg, CEO Iconovo

Iconovo’s CEO comments

BioStock spoke to Iconovo’s CEO Johan Wäborg to find out what the directed share issue means for the company.

 Iconovo’s finances are now strengthened by 75 MSEK before issue costs. Why did you choose to do this right now and why through a directed share issue?

– We see an opportunity to continue to maintain a strong drive and create even greater value for shareholders by both accelerating and increasing the number of projects.

– It was a very good time for us to raise capital. In May, we launched our long-term strategy with three strategic focus areas; Nordic Pharmaceutical Sales, Innovative Inhalation Products and Generic Inhalation Products. We want to invest a significant part of the capital in the great opportunities that we see in innovative inhalation products. In the last six months, we have signed three agreements in this area, and we see great opportunities to reach more customers.

– Funds that specialise in small companies with high growth potential, e.g. Alcur, FE Fonder and Humle, have participated in the directed share issue. The issue was also subscribed to by several of our existing owners – among others AP2, AP4, Länsförsäkringar and Handelsbanken showed their confidence in what Iconovo can achieve with this money.

What opportunities are now opening up for Iconovo through the strengthened financial position?

– The money we had before the issue is sufficient for our communicated generic projects and for the first innovative projects. With the proceeds from this issue, we want to increase capacity and commercialisation and build a portfolio of projects in the strategic area of innovative inhalation products. Capital is also needed to establish Iconovo Pharma and set up a small but efficient sales business for a number of generic products in the Nordic markets.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

The Board of Directors of Iconovo AB (publ) (”Iconovo” or the ”Company”) has, pursuant to the authorisation granted by the Annual General Meeting of the Company that was held on 19 May 2021, resolved on a directed share issue of 1,071,500 new shares, corresponding to approximately 13.8 per cent of the total number of shares outstanding, at a subscription price of SEK 70 per share (the “Issue”). This means that the Company receives SEK 75,005,000 before transaction costs. The subscription price in the Issue has been determined through an accelerated bookbuilding procedure (the ”Bookbuilding”). The Issue was subscribed for by several new Swedish and international institutional investors, such as Alcur Fonder, FE Fonder and Humle Fonder, as well as several existing owners, such as Andra AP-fonden, Fjärde AP-fonden, Handelsbanken Fonder and Länsförsäkringar Fondförvaltning AB.

The Company intends to use the proceeds from the Issue for accelerating and value-creational development and initiatives connected to the Company’s new long term strategy. Approximately 40 per cent of the proceeds intends to be used to build a value-creating portfolio of projects within the strategic area Innovative inhalation products. Another approximately 40 per cent of the proceeds intends to be used for building and scaling up the Company’s Nordic sales of pharmaceuticals through licencing of products to Iconovo Pharma. Remaining share of the proceeds intends to be used for increasing the Company’s project capacity, which would reduce the risk in the portfolio and increase the likelihood of launch of additional products to market, and increased commercialisation connected to Iconovo’s three strategic focus areas (i) own sales of generic inhalation products in the Nordics, (ii) development of innovative inhalation products, and (iii) development of generic inhalation products.

The Company believes that using the flexibility provided by a non-pre-emptive placing is the most appropriate transaction structure in order to raise capital in a time- and cost-effective manner, whilst also further diversifying the Company’s shareholder base.

The Issue results in that the total number of shares outstanding in Iconovo increases by 1,071,500, from 7,776,000 to 8,847,500, and the share capital increases by 107,150, from SEK 777,600 to SEK 884,750, which implies a dilution effect of approximately 12.1 per cent of the share capital in relation to the number of shares in Iconovo after the Issue.

In connection with the Issue, the Company has agreed to a lock-up undertaking on future share issuance for a period of 180 days, subject to customary exceptions. In addition, the Company’s CEO, CFO and Board of Directors who hold shares in the Company at the time of the transaction, have undertaken not to sell any shares in Iconovo during the same period, subject to customary exceptions.

Advisers
In connection with the Issue, the Company has retained Danske Bank as sole bookrunner and Bird & Bird Advokat as legal adviser.