WELCOME TO PHARMALUNDENSIS AB!

Blood Sample

PharmaLundensis AB (publ) develops the following projects:
* A new, effective treatment for chronic obstructive pulmonary disease, COPD and chronic bronchitis.
* EcoFilter® which prevents the release of antibiotics and multi-resistant bacteria in hospital waste water.
* Treatment for influenza-induced lung failure.

PharmaLundensis shares are traded on Spotlight Stock Market.

Decision on rights issue of units consisting of shares and warrants

The Board of PharmaLundensis AB (publ), corporate identity number 556708-8074, has decided on today 13 November 2019, supported by authorization from the Annual General Meeting of 11 June 2019, to carry out a rights issue of no more than 1,185,648 units. Each unit consists of 3 new shares and 2 free-of-charge  warrants with the issue price of SEK 6 per unit, corresponding to a subscription price of SEK 2 per share. Each existing share gives entitlement to 1 unit right, and 20 unit rights give entitlement to subscribe for 1 unit. Subscription will take place with preference for existing shareholders. The subscription period is 29 November to 13 December 2019. Subscription for units without support of unit rights will take place in blocks of 250 units. At full subscription, PharmaLundensis will receive approximately SEK 7.1 million before issue costs, which are expected to be approximately SEK 250,000. Upon full exercise of the warrants, the company will in addition receive approximately SEK 4.7 million before issue costs.

Full text: ENG Press release 13 November 2019

Decision made concerning rights issue of convertible bonds
At the meeting of the Board of Directors in PharmaLundensis AB (publ) today, Thursday 4 April 2019, and with the support of the authorization of the Annual General Meeting held on 15 June 2018, it was resolved that the Company shall issue a convertible loan of nominally no more than SEK 4,732,500 through the issue of a maximum of 315,500 convertible bonds with preferential rights for existing shareholders. Each existing share in the Company on the record date of 11 April 2019 shall give entitlement to one subscription right, and 71 subscription rights shall give entitlement to subscription of a convertible bond at a subscription price of SEK 15. The subscription period is 15-30 April 2019. The loan shall have an annual interest rate of 13 percent from 15 May 2019 to 15 May 2025, and shall be paid in full after the due date. Thus 208.2% of the invested amount shall be repaid with interest on interest. The convertible bond will not be listed on any marketplace. At full subscription, PharmaLundensis will receive approximately SEK 4.73 million before issue costs. Issue costs are estimated to amount to approximately SEK 400,000.

EN PharmaLundensis press 190404

FINANCIAL STATEMENT 1 January 2018 to 31 December 2018

PDF: Pharmalundensis 2018 FINANCIAL STATEMENT

Final quarter (1 October 2018 to 31 December 2018)
– Net sales in the final quarter amounted to SEK 0 (0).

– Loss after financial items amounted to SEK -1 331 050 SEK (-7 368 968).
– Earnings per share* amounted to SEK -0.06 (-0.36).
– Equity ratio** on 31 December 2018 was 84%.

Full year (1  January 2018 to 31 December 2018)
– Net sales for the financial year amounted to SEK 0 (0).

– Loss after financial items amounted to SEK -5 487 129 SEK (-11 648 603).
– Earnings per share* amounted to SEK -0.24 (-0.57).
* Loss for the period divided by 22 400 569 (20 280 344) outstanding shares which includes shares subscribed for in the new share issue that was registered on 9 January 2019.
** Shareholders’ equity divided by total shareholders’ capital.

  • Chemical optimisation of Iodocarb continuing, with the aim of reducing the release of iodine, preferably down to zero. The next clinical trials of the new candidate medicine are planned for when optimisation is completed.
  • Discussions continuing with international pharmaceutical companies focused on pre-licensing agreements.
  • Realistic tests of an EcoFilter system have been performed. The mechanical results were good. Purification levels will be analysed soon. Contacts have been made with healthcare organizations to initiate sales.
  • Several patents from the company’s projects were approved during the year.
  • The company raised SEK 6 294 839.50 through two rights issue performed during the year.

Decision on rights issue of shares
PDF: Pressrelease 16 March 2018

Positive decisions concerning patents for EcoFilter®
Read the pressrelease in PDF-format here: Pressrelease 180227
The European Patent Office (EPO) has announced that the application (WO2017/076835) submitted by PharmaLundensis under the terms of the Patent Cooperation Treaty (PCT), and which aims to protect the company’s method for significantly reducing waste production in vaporisation processes, meets all the requirements for patents (novelty, level of invention and industrial applicability). This PCT application can therefore form the basis for national patents in most countries around the world. The patent process should therefore be especially quick in Europe as the same verifier usually assesses both PCT and EPO applications. A Swedish patent has already been granted for this application. Awapatent, the patent agency used by PharmaLundensis, considers the patent to be a very strong one that will prove very difficult for other companies to circumvent.

Another patent application (SE 1551420A1) submitted by PharmaLundensis to protect the use of an evaporator to isolate environmentally hazardous substances in hospital wastewater will be awarded a Swedish patent on 6 March 2018. The company has also received positive news concerning several requirements in the corresponding application to the Patent Cooperation Treaty. In addition, the company has submitted two further patent applications that protect the complete system. These applications have not yet been published.

CEO Dr Staffan Skogvall: Our patent protection for EcoFilter® is getting stronger. This reduces the risk that competitors can win shares of the large market for cleaning medicines from waste water while increasing our opportunities for bringing in good partners for our EcoFilter® project. There is a massive need for good solutions to the problem of medicine in wastewater. I am very confident about the future of EcoFilter®!

2017 Financial statement now published (16 February 2018)
Read the complete financial statement in PDF-format here: 2017 FINANCIAL STATEMENT
Financial statement in summary
Final quarter (1 October 2017 to 31 December 2017)
* Net sales in the final quarter amounted to SEK 0 (0).

* Loss after financial items amounted to SEK -7 368 968 (-921 308).
* Earnings per share* amounted to SEK -0.36 (-0.05).

* Equity ratio** on 31 December 2017 was 82%.

Full year (1  January 2017 to 31 December 2017)
* Net sales for the financial year amounted to SEK 0 (0).

* Loss after financial items amounted to SEK 11 648 603 (-3 938 736).
* Earnings per share* amounted to SEK -0.57 (-0.21).
* Loss for the period divided by 20 280 344 (18 796 418) outstanding shares.
** Shareholders’ equity divided by total shareholders’ capital.

  • The company’s further development of Iodocarb aimed at reducing the release of iodine has been successful. The new iodated carbon, Iodocarb novum, releases around 70% less iodinewhile retaining the full effect of binding mercury. It can therefore be expected that the same positive effects on lung function that were shown in the first study will be achieved, but without any side effects in the thyroid. Two new clinical studies focused on Iodocarb novum will start in 2018.
  • An EcoFilter® system has been developed that can eliminates all release of drug residues and multi-resistant bacteria in hospital wastewater. This technology is protected by four patent applications. Contacts have been made with a number of major actors in associated fields. Various types of financing are being considered. This project could generate large revenues in the future.
  • Good progress is being made in the development of ‘Bronkitstopp’, a medical technical product that treats coughing and mucus during chronic bronchitis. The new manufacturing method for high-quality iodated carbon will also benefit this product. An application to the Notified Body for CE marking of ‘Bronkitstopp’ is being prepared. There is great interest in this product and this could lead to significant revenues in the near future.
  • With the new iodated carbon recording significantly improved properties compared with the older product, the company has decided to perform future clinical studies with the new product. The COPD study recently started using IodoCarb comp has therefore been cancelled and the development expenses for this study have been capitalised for accounting purposes. The same applies for amounts reported previously in 2017. This produced a negative effect on earnings of SEK 4 061 210 for amounts capitalised in 2017 and a negative effect of SEK 1 874 060 for expenses capitalised in previous reports in 2017.

Successful development of new, high quality Iodocarb (29 january 2018)
Over the past year, PharmaLundensis has carried out a process to further develop the method of production of the company’s drug candidate, Iodocarb, for treatment of chronic obstructive pulmonary disease (COPD). The aim was to obtain a significant reduction in the release of iodine from the substance while retaining the full effect of binding mercury. This substance can be expected to show the same positive effects on lung capability that were shown in the company’s first COPD study, but without any side effects in the thyroid. This development process has now been completed successfully.

The new iodated carbon, Iodocarb Novum, releases around 70% less iodine at all iodine levels (3%, 6% and 9%) compared with the old iodated carbon, see Fig 1 below. The mercury-binding capability is at least as good, or better, see Fig 2 below.

CEO Dr Staffan Skogvall: “The new iodated carbon provides a significantly reduced release of iodine compared with the old iodated carbon, while the mercury-binding capability is at least as good. I consider that we have therefore solved the problems relating to the side effects in the thyroid. In 2018 we plan to initiate two new clinical studies for Iodocarb Novum. We will also end the current study concerning Iodocarb comp, because the new iodated carbon releases so little iodine that there is no need for adding perchlorate. Performing clinical studies with a drug that only contains iodated carbon (without perchlorate) will significantly simplify the registration process. Another advantage with the new iodated carbon is that it can be protected as a new patent family. We can therefore maintain patents in many countries where we currently do not have patent protection, and strengthen our protection in the countries where we do currently have approved patents.”

In summary I consider that the development of the new, high-quality Iodocarb Novum is an important milestone for our COPD project. It can be the key to success for this project!  

Fig 1: Release of iodine from new (blue) and old type of Iodocarb.

Fig 1

Fig 2: Mercury binding capacity in new (blue) and old type of Iodocarb.

Fig 2

Approved Swedish Trademark Registration (22 Nov 2017)
The Swedish Patent and Registration Office (PRV) has announced that it has approved “Bronkitstopp PharmaLundensis” as a trademark. The trademark applies to Group 5 (Pharmaceuticals) and Group 10 (Medical Devices and Instruments). Trademark registration is valid for up to 10 years. Registration Number: 542356.

CEO Dr Staffan Skogvall: “PharmaLundensis´ various projects continue to develop well, and now the name of the medical device that treats chronic bronchitis has been approved. As described in the recently published quarterly report (16 November 2017), we are awaiting the result of the ongoing adjustment of the production of iodinated activated charcoal before we submit the Bronkitstopp registration application.”

Share acquisition by CEO (13 oct 2017)
CEO
Staffan Skogvall has recently acquired 4 221 PharmaLundensis shares. During 2017 he has purchased a total of 22 511 PharmaLundensis shares.

Patent for the treatment of chronic bronchitis is granted in Europe (21 september 2017)
The European Patent Office (EPO) has announced that it approves PharmaLundensis patent application entitled “Activated carbon comprising an adsorbed iodide salt in a method for treating chronic bronchitis WO2014084763. The patent is valid until 2032 with the option of a 5 year extension.

A patent for this project has previously been granted in Japan and applications are currently being assessed in China and South Korea.

CEO Dr Staffan Skogvall: “PharmaLundensis´patent portfolio is developing very well. Recently, the first national patent for the COPD treatment Iodocarb comp was granted and now the patent that protects the treatment of chronic bronchitis has been approved on the company’s main market in Europe. I am pleased that the patent authorities understand and approve our innovative products!”

First patent for Iodocarb comp granted (8 September 2017)
PharmaLundensis patent application protecting activated carbon impregnated with iodine or iodine salts in combination with perchlorate (Iodocarb comp WO2015075111) for treatment of chronic obstructive pulmonary disease (COPD) has now been granted in South Africa. The patent lasts for at least 16 years, with the possibility of a 5 year extension.

This is the first patent for Iodocarb comp that has been granted. PharmaLundensis has also filed national patent applications  in nine other markets (USA, Europe, China, Japan, Chile, Israel, Saudi Arabia, South Korea and Russia). As described in the Year-end Report, February 16, 2017, the company has the strategy of securing patent protection in the four major markets (EU, US, Japan and China), but also in at least one smaller country per continent outside the major markets. The plan is that a pharmaceutical company in that country licenses Iodocarb comp and then is responsible for sales across the region. A pharmaceutical company in South Africa will thus be responsible for the sale of Iodocarb in the majority of the African countries.

CEO Dr Staffan Skogvall: “It is very positive that the first national patent for Iodocarb comp is now granted. There is  therefore a great likelihood of positive results in other regions. I think we will benefit greatly from this patent, which will also be able to protect the new, improved iodinated carbon that we are developing.”

Japanese patent for KI-impregnated activated carbon granted
PharmaLundensis has now received Patent in Japan for potassium iodide impregnated charcoal for treatment of chronic bronchitis:
Japanese KI-patent