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August 19, 2016 – The Board of InDex Pharmaceuticals today announced its intention to proceed with an Initial Public Offering of the drug development company on Nasdaq First North during the autumn. A new share issue in order to raise capital for the development of the company’s lead drug candidate – cobitolimod – is planned in connection with the listing.
“A public listing and a broadened ownership is the logical step when the development now is accelerating and is entering a decisive stage”, said Dr. Wenche Rolfsen, Chairman of the Board.
The planned share issue will primarily fund the upcoming Phase IIb study with the drug candidate cobitolimod. The design of the clinical study was approved earlier this year by the US Food and Drug Administration, FDA.
Cobitolimod is a potential new treatment for the serious and today often difficult to treat, chronic inflammatory bowel disease, ulcerative colitis. Extensive clinical studies conducted by InDex Pharmaceuticals show that treatment with cobitolimod, compared to placebo treatment, can improve the main symptoms of the disease. A major strength is that these improvements have been achieved relatively quickly and without the patients suffering from any side effects compared to the control group.
InDex Pharmaceutical’s CEO Peter Zerhouni commented on the potential of cobitolimod:
“Ulcerative colitis is a debilitating disease. Many of the worst affected patients are not helped by the currently available drugs and there is a high unmet medical need. We have in previous clinical studies with cobitolimod observed a greater effect than what has been reported for the currently approved biological drugs and with a, in comparison, very favorable safety profile”, said Peter Zerhouni.
The market for the approved biological drugs to treat ulcerative colitis amounts to approximately USD 4 billion per year, although many patients experience side effects or do not respond to the treatments.
For more information:
Peter Zerhouni, CEO
Tel: +46 8 508 847 35
[email protected]
About cobitolimod
Cobitolimod is InDex Pharmaceutical’s lead drug candidate in late-stage clinical development for moderate to severe active ulcerative colitis, a debilitating, chronic inflammation of the large intestine. Cobitolimod is a first-in-class TLR9 agonist that functions as an immunomodulatory agent by mimicking microbial DNA, the natural ligand of the receptor.
Cobitolimod has achieved clinical proof-of-concept in moderate to severe active ulcerative colitis, with a very favorable safety profile. Data from four placebo-controlled clinical trials indicate that cobitolimod has statistically significant effects on those endpoints that are most relevant in this disease, both from a regulatory and clinical perspective. These endpoints include the key clinical symptoms such as blood in stool, number of stools, and mucosal healing, respectively.
In January 2016, WHO recommended the INN name cobitolimod. The substance is also known as Kappaproct® and DIMS0150.
About InDex Pharmaceuticals
InDex Pharmaceuticals is based in Stockholm, Sweden. Among the main shareholders are SEB Venture Capital, Industrifonden and NeoMed Management.
The Company’s lead drug candidate is cobitolimod (Kappaproct®) – a new type of drug that can help patients with moderate to severe active ulcerative colitis back to a normal life. InDex has also developed a platform of patent protected discovery stage substances, so called DNA based immunomodulatory sequences (DIMS), with the potential to be used in treatment of various immunological diseases.
For more information, please visit www.indexpharma.com
Important information
This announcement is not and does not form a part of any offer for sale of securities.
Copies of this announcement are not being made and may not be distributed or sent into the United States, Australia, Canada, Japan or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures.
Any offering referred to in this announcement will be made by means of a prospectus. This announcement is not a prospectus for the purposes of Directive 2003/71/EC. Investors should not subscribe for any securities referred to in this announcement except on the basis of information contained in such prospectus.
