Torbjörn Bjerke, CEO, comments: ”Positive new clinical data continued to be reported from our portfolio companies during the third quarter and after the reporting period Umecrine Cognition signed a partnering agreement. As a result, four potentially groundbreaking therapies for diverse patient groups have taken an important leap forward in their development.
Every year, millions of women around the world experience pain and discomfort during intrauterine device (IUD) insertion and other gynaecological procedures. There are few treatment options with proven safety and efficacy currently available to them. Pharmanest’s product, called SHACT, aims to treat this pain and discomfort and is based on an innovative formulation of the well-known anesthetic lidocaine and a proprietary application device developed to simplify topical application in the cervix and uterus. A recently concluded Phase II study shows that women who received SHACT during IUD insertion experienced a significant reduction in pain and less discomfort in general compared with patients who received placebo. The study results provide a clinical foundation for possible future market approvals.
The recruitment of patients to Akinion’s Phase I/II-study with AKN-028 in acute myeloid leukemia (AML) has been slower than planned. The company has discovered that the biological uptake of AKN-028 in the blood can be reduced when administered to patients who are also taking a certain class of over-the-counter medication. While the matter is now resolved, a delay has accumulated and data from the first part of the trial is now expected around mid-year 2014. Furthermore, the processes of finding partners for Dilafor and Axelar have been slower than anticipated. The delays have affected the valuation of the three portfolio companies negatively which also affects the net result for the third quarter.
In a clinical study of patients with chronic leg ulcers, Pergamum’s therapeutic peptide LL-37 increased the average healing rate up to six-fold compared with placebo and the drug was well tolerated. The 15 million patients who suffer from hard-to-heal wounds have for decades been administered dated therapies that in many cases have lacked efficacy, creating a great need for innovative new medications. Lipidor showed that one of the cornerstones of psoriasis treatment – the substance calcipotriol – can be administered with the help of the AKVANO® technology with as good results as the market leading product. The benefit with Lipidor’s AKVANO® technology is the efficient delivery of the pharmaceutical ingredient, and that it leaves a pleasant feeling on the skin and a cosmetically appealing result. In October, the portfolio company Umecrine Cognition signed a partnering agreement with CleveXel Pharma. According to the agreement, CleveXel will co-fund the preclinical and clinical development of Umecrine Cognition’s lead program in hepatic encephalopathy through to clinical proof-of-concept.
Karolinska Development evaluates more than 200 investment opportunities each year, of which we select a few of the most promising and then support the projects until they are ready to be licensed out or sold to major pharmaceutical companies. With 16 projects in clinical trials and the progress within the portfolio we are convinced that we are on the right track.“
Summary of significant events during and after the third quarter 2013
- Pergamum announced positive data from Phase I/II study of LL-37 in patients with chronic leg ulcers
- All endpoints met in Pharmanest’s Phase II study of SHACT
- Lipidor reported positive clinical Phase I/II data in treatment of psoriasis
- Oss-Q completed financing, initiated clinical study and changed name to OssDsign
- Karolinska Development repurchased shares to cover social security fees related to the PSP 2013, long term incentive program
Financial summary
| Group | 2013 | 2012 | 2013 | 2012 | |
| Amounts in SEKm | Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | |
| Income statement | |||||
| Revenue | 2.8 | 1.8 | 7.3 | 7.4 | |
| Profit/loss after tax | -90.7 | -126.7 | 301.2 | -315.9 | |
| Balance sheet | |||||
| Cash and cash equivalents | 77.5 | 202.7 | |||
| Short-term investments | 167.2 | 213.2 | |||
| Total cash, cash equivalents and short-term investments | 244.7 | 415.9 | |||
| Share information | |||||
| Earnings per share before and after dilution (SEK) | -1.85 | -2.47 | 6.38 | -5.99 | |
| Net asset value per share (SEK) | 42.89 | 40.43 | |||
| Share price, last trading day in the reporting period (SEK) | 31.0 | 16.3 | |||
| Portfolio information | |||||
| Investments in portfolio companies | 2.7 | 91.3 | 176.9 | 207.0 | |
| Of which investments not affecting cash flow | 0.0 | 72.8 | 3.8 | 72.8 | |
| Valuation of total portfolio holdings | 1,767.8 | 1,535.6 |
For further information, please contact: Torbjörn Bjerke, CEO, Karolinska Development AB Phone: +46 (0)72 744 41 23, e-mail: torbjorn.bjerke@karolinskadevelopment.com
Robin Wright, CFO, Karolinska Development AB Phone: +44 (0)7720 30 00 25, e-mail: robin.wright@karolinskadevelopment.com
Benjamin Nordin, IRO, Karolinska Development AB Phone: +46 (0)73 093 60 80, e-mail: benjamin.nordin@karolinskadevelopment.com
TO THE EDITORS
About Karolinska Development AB Karolinska Development aims to create value for patients, researchers, investors and society by developing innovations from world class science into products that can be sold or out-licensed with high returns. The business model is to: SELECT the most commercially attractive medical innovations; DEVELOP innovations to the stage where the greatest return on investment can be achieved; and COMMERCIALIZE the innovations through the sale of companies or out-licensing of products. An exclusive deal flow agreement with Karolinska Institutet Innovations AB, along with other cooperation agreements with leading universities, delivers a continuous flow of innovations. Today, the portfolio consists of 35 projects, of which 16 are in clinical development. For more information, please visit www.karolinskadevelopment.com.
Karolinska Development is listed on NASDAQ OMX. Karolinska Development may be required to disclose the information provided herein pursuant to the Securities Markets Act.
