Karolinska Development: Q1 2019 Interim Report – January-March

STOCKHOLM – 21 May 2019. Karolinska Development AB (Nasdaq Stockholm: KDEV) today publishes its Interim Report for the period January – March 2019. The full report is available on the Company's website.

“We are working to solve Karolinska Development's convertible loan and negotiations are in progress with the largest holder of the convertible loan, but we have not yet reached a solution. The company also works with alternative solutions together with financial institutions. The objective is to be able to present a proposal to the Annual General Meeting.

Several of the portfolio companies reported progress in their clinical development projects during the first quarter of the year. Umecrine Cognition’s GR3027 showed a good safety profile, favourable pharmacokinetics, and indications of efficacy in a Phase II study, while Forendo presented positive results from a Phase I study of FOR6219. After the quarter end, Dilafor secured financing for the continued development of tafoxiparin and OssDsign submitted a request for listing on the NASDAQ First North Exchange. Aprea Therapeutics also announced positive results from a study of APR-246 in combination with immune checkpoint blockade, and the candidate drug received both Orphan Drug and Fast Status Designations from the FDA. The results of Modus Therapeutics’ Phase II study of sevuparin, however, were not what we had hoped for, with no clinically meaningful effect observed from the treatment”, says Viktor Drvota, CEO, Karolinska Development. 

Significant events during the first quarter

• Negotiations on the solution of the convertible loan are ongoing. There is still no solution, but the management and the board continue to work intensively with various possible solutions to solve the financial situation. The objective is to be able to present a proposal to the Annual General Meeting.
• Modus Therapeutics announced that patient enrollment for the Phase II study of sevuparin in patients with sickle cell disease (SCD) has been completed (January 2019).
• Umecrine Cognition presented the results of its Phase IIa study of the GR3027 candidate drug in patients with idiopathic hypersomnia. The primary study objectives were met in regard to safety and pharmacokinetics. The study also showed preliminary evidence of clinical efficacy in a subset of patients. Umecrine Cognition will analyze the data further before a decision to potentially move forward with the development of GR3027 in idiopathic hypersom­nia or other sleep disorders. In parallel, Umecrine Cognition will continue the clinical development of GR3027 for hepatic encephalo­pathy (January 2019).
• OssDsign announced the closing of a private placement of SEK 64 million. Swedish private investors and the French investment company Alto Invest took part in the private placement. (February 2019).
• Modus Therapeutics announced that they had successfully dosed the first cohort of patients in their Phase I study of subcutaneously administered sevuparin. The study is examining pharmacokinetics, safety, and tolerability in healthy subjects (February 2019). 
• Aprea Therapeutics announced that investment funds managed by Janus Henderson Investors have joined the Series C financing of the company as a new investor, raising the total amount of the financing from EUR 50 million to EUR 55 million (February 2019). 
• Forendo Pharma presented positive results from a Phase Ia study with the drug candidate FOR 6219 for the treat­ment of endometriosis. The results found FOR 6219 to be safe and well tolerated, with good pharmacokinetics at the doses tested (March 2019).
• Promimic announced a new partnership with the US company, Onkos Surgical® to commercialize Promimic’s proprietary Hydroxyapatite Surface Technologies in Limb Salvage Surgery (March 2019).
• Aprea Therapeutics appointed Dr. Eyal C. Attar as Senior Vice President and Chief Medical Officer. Dr. Attar joins Aprea from Agios Pharmaceuticals, where he was Senior Medical Director and IDH Hematology Medical Lead (March 2019).

Significant post-period events

• Aprea Therapeutics presented promising results from studies of APR-246 in combination with immuno-oncology agents. The results showed that APR-246 can improve the effects of immuno-oncology treatments (April 2019). 
• Aprea Therapeutics announced that APR-246 had been granted Orphan Drug Designation and Fast Track Designation by the FDA, for treatment of patients with MDS (April 2019).
• Dilafor announced completion of a capital raising and plans to start a new Phase 2b study of tafoxiparin to soften the cervix prior to labor induction. The transaction will increase the value of Karolinska Development’s holding in Dilafor and gives a positive effect on earnings by approximately SEK 16.8 million (April 2019).
• The Annual Report contained an update from The Board of Directors in Karolinska Development regarding the company's financial situation and actions taken to strengthen the company’s financials. The annual report also contains an emphasis of matter paragraph from the Auditor regarding going concern (April 2019).
• OssDsign announced application for listing on Nasdaq First North and published a prospectus in connection with a share issue of SEK 151,3 million (May 2019).
• The results of the Phase II study of sevuparin by our portfolio company, Modus Therapeutics, did not show any meaningful clinical effect in conjunction with acute Vaso Occlusive Crisis (VOC) in patients with sickle cell disease (SCD). Modus is now considering alternative options for the further development of sevuparin (May 2019). 

Financial update

First quarter

• The net profit/loss for the first quarter was SEK -18.6 million (SEK 14.9 million in the first quarter of 2018). Earnings per share totalled SEK -0.3 (SEK -0.3 in the first quarter of 2018). 
• The result of the Change in fair value of shares in portfolio companies amounted to SEK -0.01 million (SEK -4.8 during the first quarter of 2018).
• The total fair value of the portfolio was SEK 970.0 million at the end of March 2019, corresponding to an increase of SEK 17.7 million from SEK 952.3 million at the end of the previous quarter. The net portfolio fair value at that time was SEK 636.0 million, corresponding to an increase of SEK 17.1 million from SEK 618.9 million at the end of the previous quarter.
• Net sales totalled SEK 0.9 million during the first quarter of 2019 (SEK 0.7 million during the first quarter of 2018).
• Karolinska Development invested a total of SEK 17.1 million in portfolio companies during the first quarter. First quarter investments in portfolio companies by Karolinska Development and other specialised life sciences investors totalled SEK 121.4 million.
• Cash and cash equivalents decreased by SEK 24.0 million during the first quarter, totalling SEK 61.8 million on 31 March 2019.
• The Parent Company’s equity on 31 March 2019 was SEK 277.4 million.

The Q1 2019 Interim Report for Karolinska Development AB for the period January-March 2019 is available as a PDF at .

For further information, please contact:

Viktor Drvota, CEO, Karolinska Development AB

Phone: 2, e-mail:

Fredrik Järrsten, CFO, Karolinska Development AB   

Phone: +46 70 496 46 28, e-mail:

TO THE EDITORS

About Karolinska Development AB

Karolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investment company. The company focuses on identifying breakthrough medical innovations in the Nordic region that are developed by entrepreneurs and leadership teams. The Company invests in the creation and growth of companies that advance these assets into commercial products that are designed to make a difference to patients' lives while providing an attractive return on investment to shareholders.

Karolinska Development has access to world-class medical innovations at the Karolinska Institutet and other leading universities and research institutes in the Nordic region. The Company aims to build companies around scientists who are leaders in their fields, supported by experienced management teams and advisers, and co-funded by specialist international investors, to provide the greatest chance of success.

Karolinska Development has established a portfolio of ten companies targeting opportunities in innovative treatment for life-threatening or serious debilitating diseases.

The Company is led by an entrepreneurial team of investment professionals with a proven track record as company builders and with access to a strong global network.

For more information, please visit

This information is information that Karolinska Development AB (publ) (Nasdaq Stockholm: KDEV) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of Viktor Drvota, at 08:00 am CET on 21 May 2019.

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