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Extraordinary general meeting in Karessa Pharma on 18 December 2019

An extraordinary general meeting in Karessa Pharma Holding AB (publ) (”Karessa”) was held today, on 18 December 2019, in Hamilton Advokatbyrå’s office, Hamngatan 27, in Stockholm whereby the shareholders made the following resolution.Approval of merger plan The extraordinary general meeting resolved, by required majority, to approve the merger plan adopted by the board of directors of Karessa and Klaria Pharma AB (publ) (“Klaria”) on 5 November 2019, according to which the merger is undertaken by way of absorption, with Klaria as the absorbing company and Karessa as the transferring

NOTICE OF EXTRAORDINARY GENERAL MEETING IN KARESSA PHARMA HOLDING AB (PUBL)

The shareholders of Karessa Pharma Holding AB (publ), org.nr 556942-1596 (the ”Company”), are hereby invited to the extraordinary general meeting on 18 December 2019 at 13.00 CET at Hamilton Advokatbyrå, Hamngatan 27, in Stockholm. Registration for the extraordinary general meeting will open at 12.45 CET.RIGHT TO PARTICIPATE AND NOTICE OF ATTENDENCE Shareholders who wish to participate in the extraordinary general meeting must: · be recorded as a shareholder in the shareholder register maintained by Euroclear Sweden AB on 12 December 2019, and · no later than 12 December 2019,

Statement by the Board of Directors of Karessa Pharma in relation to the Merger with Klaria Pharma

The Board of Directors of Karessa Pharma unanimously recommends that the shareholders of Karessa Pharma vote in favour of the Merger. [1]Background This statement is made by the Board of Directors (the "Board") of Karessa Pharma Holding AB (publ) ("Karessa") pursuant to Section II.19 of the Swedish Corporate Governance Board’s Takeover Rules for certain trading platforms (the "Takeover Rules"). Today, on 5 November 2019, Klaria Pharma Holding AB (publ) ("Klaria") and Karessa jointly announced that the board of Klaria and the board of Karessa have agreed on a statutory merger between

Klaria Pharma Holding and Karessa Pharma Holding merge to create a focused drug development company with a strong pipeline and a wholly-owned drug-delivery technology platform

Important InformationIn the information below, “this press release” refers to this document, its content or part thereof, oral presentations, question papers and written or oral material discussed or distributed in connection therewith. This press release is not a notice to attend an extraordinary general meeting or a merger document. This press release is also not an offer to sell, or a solicitation or invitation to submit an offer to buy, acquire or subscribe for, securities, or an incentive to make any investment, and there will be no sale of securities in jurisdictions where such an

Resolution at Karessa Pharma’s extraordinary general meeting on 22 October 2019

An extraordinary general meeting of Karessa Pharma Holding AB (publ) was held on 22 October 2019, whereby the shareholders made the following resolutions.The extraordinary general meeting resolved, in accordance with the proposal from shareholders representing approximately 49.8 per cent of the shares and votes in the company, to elect Kristina Lidén Mascher and Neal Meacham as new members of the board of directors for the period until the end of the annual general meeting 2020. The nature of this information requires Karessa Pharma Holding AB (publ.) to publish it as provided in the

Shareholders’ proposal ahead of the extraordinary general meeting in Karessa Pharma on 22  October 2019

Shareholders’ representing approximately 49.8% of the shares and votes in the company propose, ahead of the extraordinary general meeting in Karessa Pharma Holding AB (publ) (”Karessa Pharma”) on 22 October 2019 that Kristina Lidén Mascher and Neal Meacham are elected as new board members.Karessa Pharma has, at the request of shareholders representing approximately 49.8% of the shares and votes in the company convened an extraordinary general meeting at 10:00 on 22 October 2019 to consider the election of new board members. Information regarding the board members proposed for new

Vardenafil, Karessa, project K03, in erectile dysfunction into a new development phase

Karessa has now finalized the reformulation of project K03, Vardenafil, Karessa, a decision made spring 2018.The development has been documented in preclinical studies. A comparison between Vardenafil, Karessa, and vardenafil tablet in corresponding doses resulted in Cmax(maximum plasma concentration) the ratio 0.91 and for AUC (Area Under the curve) 1.03. These are the essential pharmacokinetic parameters for pharmaceutical registration and in comparison, to reference (tablet), the values should be within ±20% limit (the ratio 0,8-1,2) The company will now enter next phase in further

Karessa starts preclinical studies with Midazolam

With the project K21, Midazolam, Karessa, we see improved treatment possibilities in various important therapy areas.It concerns treatment of seizures in pediatric epilepsy, calming/anxiolytic effects in minor operations and before dental visits. Midazolam is routinely used globally in these indications. The existing products in the market are relatively difficult to use and it may take time before effects is reached. Before visit to the dentist; todays alternatives should be taken in good time before treatment is initiated. Midazolam, Karessa, may give a direct absorption from the oral

Midazolam – first step taken

Karessa has now completed the first step in the development of Midazolam, Karessa.Now there is a stable product to continue with in the next preclinical phase, which is expected to be completed in the first half of 2019.  The market for Midazolam in various indication areas is very large. Karessa looks brightly at the possibility of improving the situation for many patients and meeting medical needs that can also provide commercially important successes.

Karessa – new research and development area

Karessa Pharma Holding AB (Publ) has received an exclusive license from Uppsalagruppen Medical AB for development of preparations within the benzodiazepine group based on the patented transbuccal drug delivery platform. The objective is with limited contributions develop a prioritized product including preclinical phase, thereafter, finalizing agreements with partners for further development. This means the company will expand to further development area except erectile dysfunction.New area - A wide global market The development will start with midazolam, a pharmaceutical with wide usage

Karessa Pharma announces today that the company's license has been reinforced through patent granted in Europe

The European Patent Office (EPO) has issued a granted patent regarding patent application for the use and formulation of buccal films based on alginate. The grant of the patent with number 1976562 will be published by EPO's European Patent Bulletin on 21st of February 2018.Karessa Pharma AB ("Karessa") develops effective pharmaceuticals for treatment of erectile dysfunction based on a patented buccal film technology with a matrix based on alginate. The Film patent, owned by Uppsalagruppen AB with an exclusive, eternal, royalty-free license to Karessa in the therapeutic area of erectile

Karessa Pharma Holding AB announces today that a patent application for Vardenafil buccal film has been submitted to the European Patent Office

On the 20th of December 2017, Karessa submitted an application to the European Patent Office concerning the use and formulation of buccal film with Vardenafil.Karessa develops effective pharmaceuticals based on our patented buccal film and proven pharmaceutical substances in the therapeutic area of erectile dysfunction. As a result of this work, Karessa has now been able to submit a patent application for the use and formulation of the buccal film with Vardenafil. The patent application for the buccal film ("Film patent") was submitted in 2005 and the patent application has so far been

Karessa Pharma Holding AB announces today that the last patient is dosed in the company's clinical study with K-03 Vardenafil buccal film

The final dose of healthy volunteers in Karessa's clinical trial with K-03/1 buccal film is now performed and the study will be completed as planned today, the 15th of December 2017.The study is a Phase I, open, randomized, single-center study on healthy male subjects in order to determine the PK profile in the body (pharmacokinetic profile) of Vardenafil given as K-03/1 buccal film. The study consists of comparing the PK profile of four different variants of K-03/1 buccal film. Except for the evaluating of PK profile, the safety and tolerability of Karessa's K-03/1 buccal film has also

Karessa Pharma Holding AB announces today that the first patient is dosed in the company's clinical study with K-03 Vardenafil buccal film

Today, the dosing of healthy volunteers begins in Karessa's clinical trial K-03/1 buccal film. The study will last for five weeks and is planned to be completed on 15th of December 2017.The study is a Phase I, open, randomized, single-center study on healthy male subjects in order to determine the PK profile in the body (pharmacokinetic profile) of Vardenafil given as K-03/1 buccal film. The study consists of comparing the PK profile of four different variants of K-03/1 buccal film. Except for the evaluating of PK profile, the safety and tolerability of Karessa's K-03/1 buccal film will

Karessa Pharma AB presents at Stora Aktiedagen the 13th of  November 2017

Michael Brobjer, CEO at Karessa Pharma AB will present the company's latest development and updates at Stora aktiedagen at Sheraton in Stockholm on Monday the 13thof November. The presentation will be live streamed and can be followed at http://www.aktiespararna.se/tv/live. About Karessa's pharmaceutical projects for treatment of erectile dysfunctionCurrent treatment of impotence is well proven and has a favorable safety profile, but many patients are bothered by the delayed onset and that it may vary depending on food intake. These problems are a consequence of the drug being given as

Karessa Pharma Holding AB announces today that they have been approved by the MPA to start a clinical study with K-03 Vardenafil buccal film

Karessa submitted an application to the Swedish Medical Products Agency on 31st of August to perform a Phase I study on healthy volunteers of male subjects. Today, the Medical Products Agency announced that they approved the application.The study is a Phase I, open, randomized, single-center study on healthy male subjects in order to determine the PK profile in the body (pharmacokinetic profile) of Vardenafil given as K-03/1 buccal film. The study consists of comparing the PK profile of four different variants of K-03/1 buccal film. Except for the evaluating of PK profile, the safety and

Update and status of Karessa Pharma's project K-03

Karessa Pharma Holding AB is working actively to operate the most advanced project, K-03 Vardenafil buccal film, through its various development phases as effectively as possible.Status project K-03 Vardenafil buccal film Karessa submitted an application for a clinical trial with K-03 Vardenafil buccal film to the Medical Products Agency on 31stof August, which the market has previously been informed of. The company has received questions from the Medical Products Agency that has been answered and an approval is expected to arrive in late October. The project is proceeding according to

Leading executives in Karessa Pharma AB acquire stock options in Karessa Pharma Holding AB

Karessa Pharma Holding AB announces today that the stock option program adopted at the Annual General Meeting on 29th of May 2017 has now been implemented. Of the total of 330,000 options in Karessa Incentive AB, 280,000 have been allocated to leading executives.Karessa Pharma Holding AB's wholly owned subsidiary, Karessa Incentive AB, has transferred 230,000 options to CEO Michael Brobjer and 50,000 to Chief technology officer Erik Mascher in Karessa Pharma Holding AB. The options were issued by a decision at Karessa Pharma Holding AB's Annual General Meeting 2017. Each options entitle

Karessa has today submitted an application for clinical trial for project K-03 to the Medical Products Agency

Karessa Pharma Holdning AB announces today that an application for a clinical trial with Vardenafil within the project K-03 has been submitted to the Swedish Medical Products Agency.The study is a Phase I, open, randomized, single-center study on healthy male subjects in order to determine the PK profile in the body (pharmacokinetic profile) of Vardenafil given as K-03/1 buccal film. The study consists of comparing the PK profile of four different variants of K-03/1 buccal film. Except for the evaluating of PK profile, the safety and tolerability of Karessa's K-03/1 buccal film will also be

Bulletin from Annual General Meeting in Karessa Pharma Holding AB (publ) on the 29th of May 2017

At Karessa Pharma Holding AB (publ)'s Annual General Meeting on May 29th 2017, all members of the Board of Directors and the Chairman of the Board were re-elected. The Annual General Meeting approved a directed issue of stock options.The Annual General Meeting decided that the result of the year, SEK 0, shall be carried forward. The Annual General Meeting approved to re-elect all members of the Board; Ulf Lindberg, Scott Boyer, Stefan Arver and Michael Brobjer. Ulf Lindberg was re-elect as the Chairman of the Board. Moreover, the Annual General Meeting approved payment of remuneration to

Karessa has signed an agreement with PCG Clinical Services AB for performance of a clinical study within the project K-03

Karessa Pharma Holding AB announces today that an agreement between Karessa and PCG Clinical Services AB has been signed for the performance of a first human study within the project K-03.The study, which is the first one with Vardenafil formulated in Karessa's unique buccal film for delivery via the mucous membrane in the mouth, aim to evaluate different doses and formulations in a pharmacokinetic study on healthy human. The goal is to show which dose and formulation that are most suitable to use in a pivotal study. The start of the agreed study is scheduled to take place in the fourth

Notice of Annual General Meeting 2017 in Karessa Pharma Holding AB (publ)

The shareholders of Karessa Pharma Holding AB (publ) are hereby invited to participate in the Annual General Meeting to be held on May 29, 2017 at 2 p.m. at Advokatfirman Lindberg & Saxon's office, Cardellgatan 1, Stockholm, Sweden.Registration etc To participate the Annual General Meeting, shareholders must be registered in the shareholders' register held by Euroclear Sweden AB on 22nd of May 2017, and to report their participation to the company by the latest on 22nd of May 2017 by mail to Karessa Pharma Holding AB, Lahällsvägen 48, 183 30 Täby, Sweden, by phone 08-768 22 33 or by e-

Karessa has signed an agreement for manufacturing of clinical trial material for the project K-03

Karessa Pharma Holding AB announces today that an agreement for manufacture of clinical trial material has been signed between Karessa and Recipharm. The intention is to manufacture clinical trial material that will be used for Proof of Concept studies later this year.Manufacturing of clinical trial materials is a prerequisite to be able to perform clinical trials on humans. The manufacturing is performed according to GMP (Good Manufacturing Practice) to ensure that the material to be used for clinical trials have the quality required to complete the study. Karessa Pharma's

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