Nanexa AB Concludes Rights Issue on Nasdaq First North Growth

Nanexa AB's rights issue, aimed at raising SEK 121m, concluded with a 34.7% subscription rate using rights and without. The company will utilize guarantee commitments for the remaining 27.1%. The rights issue, announced on September 21 with backing for 62% of the total, resulted in 33.5% of shares subscribed with rights and 1.2% without. The capital raised before transaction costs will be SEK 75m. Trading in BTAs will occur until registration is completed around week 45, 2023, with the new shares expected to trade on Nasdaq First North Growth by week 46, 2023.

Nanexa, founded in 2007, has evolved from working with Atomic Layer Deposition (ALD) technology for various applications to focusing on the pharmaceutical sector with its proprietary PharmaShell® system. PharmaShell® positions Nanexa in the burgeoning drug delivery market with a system that allows high-precision, long-acting injectable drug products. The company is developing its own products and also partners with multiple pharmaceutical firms, including AstraZeneca, leveraging the unique capabilities of its ALD-based technology to enhance drug delivery.

The controlled release is steered by modulating the coating thickness, the composition of the coating and process parameters. We are currently primarily using nontoxic aluminum oxide and zinc oxides in the ALD coating

Sources:

Nanexa AB - What is Pharmashell®

Nanexa AB - Nanexa announces outcome of rights issue

Nanexa receives orders for ALD coating of sensors for detection of nuclear detonations

Nanexa AB (www.nanexa.com) recently announced that the company has received two orders for a substantial number of sensors for detection of radioactive isotopes of the noble gas xenon, from two American customers, totaling approximately SEK 1.7 million. 

”The order are a strong confirmation of our unique competence within Atomic Layer Deposition (ALD), the core technology in our drug delivery system PharmaShell®. Although it is outside the scope of our core business, we are happy to continue to support our customers in this area”, said David Westberg, CEO of Nanexa. 

The sensors are key components in equipment developed for detection of nuclear detonations, even if they are carried out deep underground. Delivery of the coated sensors is expected during the autumn of 2021. The American customers consist of a leader in engineering and manufacturing of advanced technical systems for, among others, the defense and space industries, and a government laboratory.

Nanexa AB started the first clinical study with ALD based PharmaShell® at the Karolinska University Hospital

Nanexa AB (publ) today announces that the company has started its first clinical study with PharmaShell®, a phase I study in Nanexa's product project NEX-18, at the Karolinska University Hospital.

The study aims to show that the company's NEX-18 product, a long-acting formulation of azacitidine (the active substance in the drug Vidaza), provides the desired safety and pharmacokinetic profile. In the study, two doses of NEX-18 will be studied. The study will be conducted at Karolinska University Hospital in Stockholm and Akademiska Sjukhuset in Uppsala.

“The start of this study is a very big milestone in Nanexa's development. It is with great enthusiasm that we now see that the study is getting started. We expect the study to be completed during the third quarter.”, said David Westberg, CEO of Nanexa.

The NEX-18 product is being developed to improve the treatment of MDS (Myelodysplastic Syndrome), a form of hematological cancer that mainly affects the elderly. This is done by utilizing the unique properties of the PharmaShell® concept to create a controlled release depot formulation. Today's treatment means that injections are given at hospitals seven days in a row each month. The goal of the NEX-18 project is to simplify treatment by only having to give one injection. In addition to greatly simplifying for patients, Nanexa sees that NEX-18 will provide significant cost savings compared to current treatment.

“With the results of this study, we intend to continue the clinical development with a phase II study to achieve clinical Proof of Concept. After that, the goal is to run NEX-18 further towards commercialization, either through a license partner or as an own project, whatever option is deemed to create most value for Nanexa”, said David Westberg.

ALD – The coating technology behind the drug delivery system PharmaShell®

The technology used by Nanexa to manufacture the shells that make up PharmaShell® is Atomic Layer Deposition (ALD). In ALD, reactive gases are used which, with atomic layer by atomic layer, build up a surface coating with high precision. ALD has been used in the electronics industry for decades and is thus well established for larger scale production and automation.

ALD can also be used at low temperatures, down to room temperature, unlike other surface coating techniques which usually use considerably higher deposition temperatures, thereby risking inactivating the drug. A further advantage of ALD is that the coating is carried out under dry conditions, which makes it possible to coat drugs that are quickly dissolved in water or other solvents.

By building up an atomic layer for atomic layer with ALD, the thickness of the coating can be controlled with extremely high precision. Drug particles of various sizes and shapes can be coated since the only thing required for coating to be formed is that the reaction gases can reach the surface.

About Nanexa AB (publ)

Nanexa AB is a nanotechnology drug delivery company focusing on the development of PharmaShell®, a new and groundbreaking drug delivery system with great potential in a number of medical indications. Within the framework of PharmaShell®, Nanexa has partnership agreements with among others, AstraZeneca.

Nanexa AB signs USD 3 million Investment Agreement with Applied Materials to scale-up GMP production site for ALD-coated pharmaceuticals

Nanexa AB (publ) today announced that the company has entered into an investment agreement with Applied Ventures, LLC, the venture capital arm of Applied Materials, Inc., whereby Applied Ventures intends to invest up to USD 3 million in Nanexa during 2021 to support continued development and expansion. USD 1 million will be invested in January 2021 and additional investments of up to USD 2 million are planned later in 2021. The investment will be made through a directed issue to Applied Ventures of a mix of shares and share warrants decided upon by Nanexa with support of the authorization of the Annual General Meeting held on June 2, 2020 (the “Directed Issue”).

As announced today in a separate press release, Nanexa and Applied Materials have entered into a joint development agreement to validate, adapt and scale up Nanexa’s production of ALD-coated injectable drugs. Simultaneously, Nanexa has entered into an investment agreement with Applied Ventures, pursuant to which Nanexa has undertaken to, as authorized by the Annual General Meeting held on June 2, 2020, resolve to issue up to a total of 4 244 770 new shares and share warrants of series 2020/2021 in Nanexa, and Applied Ventures has undertaken to subscribe for newly issued shares and share warrants. In total, Applied Ventures has committed to invest at least USD 1 million, but the Directed Issue is intended to raise around USD 3 million before transaction costs.

“We are very pleased to welcome Applied Ventures as a new industrial investor in Nanexa. Their support is a great recognition of the PharmaShell® technology and Nanexa’s future potential,” says David Westberg, CEO of Nanexa.

The Directed Issue is divided into two tranches where the first tranche amounts to an investment of USD 1 million. The subscription price for the shares of the first tranche shall equal the volume weighted average price (“VWAP”) during the period from and including December 22, 2020 until and including January 11, 2021, less five percent. The SEK investment amount in the first tranche shall be determined by the average USD/SEK exchange rate during the same measurement period.

For the second tranche Applied Ventures has the option, but not the obligation, to exercise warrants of series 2020/2021 to subscribe for up to the number of shares equal to 4 244 770 shares less the number of shares issued in the first tranche. The warrants can be exercised during two different subscription periods; 1-15 April 2021 and 1-15 December 2021. Applied Ventures will take a decision on how many warrants to exercise in each subscription period. The subscription price in the second tranche shall equal the VWAP during the ten trading days immediately preceding the respective subscription periods, less ten percent.

The maximum potential dilution from the Directed Issue is 16.7 percent of the number of shares in Nanexa after the Directed Issue and full exercise of the issued share warrants.

“Applied Ventures is excited to invest in Nanexa and help the company scale up its unique approach of using an atomic layer deposition process on APIs to enable key benefits for the end drugs. This is a good example of how Applied’s core competency in materials engineering can be extended to new markets. It also reflects Applied Ventures’ focus on investing globally in companies across their full life-cycle and adds to our growing portfolio of investments in Europe,” said Anand Kamannavar, Global Head of Applied Ventures.

About Applied Ventures

Applied Ventures, LLC, the venture capital arm of Applied Materials, invests in innovative technology companies globally that have the potential to deliver exceptional strategic and financial returns. Its investments help develop technologies and markets that provide natural extensions to Applied Materials’ core business and stimulate the application of materials engineering for semiconductors, displays, and related products and services. Learn more at www.appliedventures.com or follow @Applied_VC.

About Nanexa AB (publ) (LINK)

Nanexa AB is a nanotechnology drug delivery company focusing on the development of PharmaShell®, a new and groundbreaking drug delivery system with great potential in a number of medical indications. Within the framework of PharmaShell®, Nanexa has partnership agreements with among others, AstraZeneca.

The US Patent Office has approved Nanexa’s expanded patent application for the drug delivery platform PharmaShell®

[Press release, Nanexa AB LINK] The US Patent Office has today approved another patent application for Nanexa. The currently approved patent has broader protection than the patent that was approved earlier this year and includes the use of PharmaShell® products for multiple administration methods, such as parenteral injection, inhalation, and oral preparations.

Swedish Nanexa’s PharmaShell® patent approved in Japan

[Nanexa AB, LINK] The Japanese Patent Office has approved Nanexa’s patent application for the drug delivery platform PharmaShell®.

Nanexa’s drug delivery system PharmaShell® is suitable for parenteral drug administration. The drug delivery system enables drug release in a well-controlled manner from a couple of weeks to really long depots of up to one year. By adjustments in the manufacturing process of PharmaShell®, the depot time can be controlled to the desired length.

The properties of PharmaShell®, with extremely high so-called drug load and the ability to control the initial release, make it unique in the market. The system enables depot preparations from simple small molecule drugs to proteins. The mentioned properties are in demand by the pharmaceutical industry to create new and more effective drugs with the possibility of limiting the side effects of the drug.

The Japanese Patent Office has approved Nanexa’s patent application on May 30, 2019. The now approved patent covers the product PharmaShell® itself and the method of its manufacture and formulation of PharmaShell® coated drugs. The approved patent has patent number JP6516729.

CEO David Westberg comments:

In January, we got the PharmaShell® patent approved in the US and I can now conclude that it has also been approved in Japan. The Japanese market is large and important for Nanexa and with an approved patent our commercial opportunities in the future will increase.

Our continuous work on patent applications begins to yield results and together with our more recently filed patent applications, I assess that we have a strong patent portfolio.

Previous News on Nanexa:

Nanexas PharmaShell® patent approved in the United States

Nanexa order a third Picosun ALD System to meet production demand for PharmaShell®

Nanexa has completed a safety laboratory for the PharmaShell® process

New method using ALD enables storage and controlled release of pharmaceutical substances in the body

Nanexas PharmaShell® patent approved in the United States

The US Patent Office has approved Nanexa's patent application for the PharmaShell® drug delivery platform.

Nanexa AB is a nanotechnology drug delivery company focusing on the development of PharmaShell®, which is a new and groundbreaking drug delivery system that is expected to have great potential in a number of medical indications. Within the framework of PharmaShell®, Nanexa has partnership agreements with among others, AstraZeneca.

The US Patent Office has approved Nanexa's patent application on January 1, 2019. The now-approved patent covers the product PharmaShell® as well as the method of its manufacture and formulation of PharmaShell® coated drugs. The approved patent has patent number US 10166198.

CEO David Westberg comments:

It is with great satisfaction that I can now conclude that the PharmaShell® patent is approved in the United States. We have always felt secure in our patent situation, but it still means a lot to get it confirmed by the US Patent Office. The US is our largest market and now that we have an approved patent, we can have a more interesting position in discussions with potential partners.

Source : Nanexa (in Swedish, LINK)

Nanexa order a third Picosun ALD System to meet production demand for PharmaShell®

[Picosun, LINK] ESPOO, Finland, 4th January 2019 – Picosun Group, a leading, global supplier of ALD (Atomic Layer Deposition) thin film coating technology, and Nanexa AB, a nanotechnology company focused on nano-enabled drug delivery solutions, solidify their collaboration in pharmaceutical ALD.

Picosun is now delivering their third ALD system to Nanexa’s facilities in Sweden, where it will be utilized in production expansion of nano-functionalized pharmaceuticals for drug delivery. Stock-listed Nanexa AB has two patents pending for their technology platform PharmaShell®. With this technology, ALD-functionalized pharmaceuticals can stay effective in the body for long periods of time and have a tailored release profile that minimizes side effects and eliminates the need for constant re-dosing. Picosun has been aiding Nanexa in their undertaking to develop their technology to an industrially mature state by supplying ALD tool solutions and consultancy.

Picosun provides various ALD solutions specially optimized to meet the needs of the medical industries where quality, reliability, efficiency, patient safety and minimized side effects are of utmost importance.

“We are very pleased to order our third PICOSUN™ ALD system. We have reached a point where the demand from our commercial partner to invest in our technology platform PharmaShell® is rapidly increasing. To be able to meet this demand we are now procuring a new ALD tool to extend our production capacity for efficient delivery of materials to our customers,” says David Westberg, CEO of Nanexa.

“We are happy to provide yet more PICOSUN™ ALD equipment to our long-time partner Nanexa, where our technology is used in manufacturing state-of-the-art medicines to combat some of the most difficult diseases. Our aim is to utilize ALD to enable solutions that benefit the whole humanity, which is why we are especially glad that healthcare industries are now seizing the potential of ALD on so many fronts,” continues Dr. Jani Kivioja, CTO of Picosun.

Nanexa has completed a safety laboratory for the PharmaShell® process

[www.nanexa.se] Nanexa has now finalized a laboratory in Uppsala Sweden, which enables the company to work with cytostatics and other potent drugs. The laboratory has been built according to current occupational health and safety regulations and is adapted to produce materials for use in preclinical and clinical studies. Nanexa now has the capacity to produce clinical trials for, among other things, the company's product project NEX-18.

 

VD David Westberg presenterar bolaget (in Swedish)

 

Nanexa's CEO David Westberg comments: As we see it, this is a truly unique unit. It is highly likely that it is the first ALD (Atomic Layer Deposition) facility that is capable of coating potent drugs and is also qualifoed to manufacture under Good Manufacturing Practice (GMP) conditions, which is a necessity for materials to be used for clinical trials. 

 

It is also a significant strength that we have built up the capacity within the Company, which enables us to work flexibly with permanent staff and without being dependent on other companies' entries and priorities.