The board of directors of
The Rights Issue is fully covered by subscription undertakings and guarantee commitments from existing shareholders and new investors, including amongst others
The Rights Issue in brief
The intention of the Rights Issue is to fund the important initial induction study in a sequential phase III program for the Company's lead drug candidate, cobitolimod, including drug manufacturing and in addition, to finance general corporate purposes as well as create financial flexibility.
For each existing share held on the record date, five (5) subscription rights are received. The subscription rights entitle the holder to subscribe for new shares with preferential rights, whereby one (1) subscription right gives the right to subscribe for one (1) new share, i.e. a subscription ratio of 5:1.
The subscription price has been set at
The Rights Issue is fully covered by subscription undertakings from certain existing shareholders, amongst others Linc,
The subscription period will run from
The record date for participation in the Rights Issue with preferential rights is
Trading in subscription rights will take place on the Nasdaq First North Growth Market during the period from
Through the Rights Issue, a maximum of 443,906,375 new shares may be issued.
In order not to lose the value of the subscription rights, the holder must either use these to subscribe for new shares within the subscription period or sell the subscription rights that are not to be exercised within the period for trading in subscription rights.
1Whereof approximately MSEK 12 consists of compensation for guarantee commitments.
'The investments from leading domestic and international life sciences specialists, representing both new and current shareholders participating in the transaction, is an acknowledgement of InDex's potential. Thanks to its outstanding combination of efficacy and safety, as well as the novel and unique mechanism of action, our drug candidate cobitolimod can make a significant difference for many patients that suffer from ulcerative colitis. With the equity financing secured until the next pivotal read-out of clinical data, we look forward to starting the phase III program.'
Background and reasons
InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The Company's lead asset is the drug candidate cobitolimod, which InDex is developing as a novel therapy for moderate to severe ulcerative colitis. Given the outstanding combination of efficacy and safety, InDex is now advancing cobitolimod into phase III, which is the final stage of development before application for market approval.
Ulcerative colitis is a chronic disease caused by inflammation of the large intestine. Today approximately 2 million people in
Cobitolimod is a first-in-class Toll-like receptor 9 (TLR9) agonist that can provide an anti-inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis. Cobitolimod met the primary endpoint in the phase IIb study CONDUCT and demonstrated an outstanding combination of efficacy and safety. The results were recently published in the reputable medical journal, The Lancet Gastroenterology & Hepatology.
Following the results of the phase IIb study CONDUCT, InDex received positive response from the
The important initial induction study, which is intended to be financed through the Rights Issue, is planned to include approximately 400 patients. The primary endpoint of clinical remission is to be measured at week 6. In addition to the 250 mg dose, the study is also planned to evaluate a higher dose, 500 mg, in an adaptive study design. This higher dose has the potential to provide an even better efficacy than what was observed in the phase IIb study CONDUCT. The Company estimates the first induction study will take 18 to 24 months to complete from initiation. Upon a positive read-out of the first study, InDex plans to initiate the second induction study.
InDex's key focus is to start phase III development as soon as possible on the back of the positive results in the phase IIb study CONDUCT, the positive regulatory response and the supportive findings from the market research commissioned by InDex underpinning the Company's belief in the market potential of cobitolimod. With cobitolimod's novel and unique mechanism of action, competitive efficacy and excellent safety profile, InDex estimates that the drug candidate has significant commercial potential.
The board of directors' decision to carry out the Rights Issue is an important step in order to conduct the first induction study and ensure continued successful development in accordance with the Company's business plan and strategy. The intention of the Rights Issue is to fund the important initial induction study in a sequential phase III program for the Company's lead drug candidate, cobitolimod, including drug manufacturing and in addition, to finance general corporate purposes as well as create financial flexibility.
Contact:
Tel: +46 (0) 8 122 038 50
Email: peter.zerhouni@indexpharma.com
This information is information that
InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The Company's foremost asset is the drug candidate cobitolimod, which is in late stage clinical development for the treatment of moderate to severe active ulcerative colitis - a debilitating, chronic inflammation of the large intestine. 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 the treatment of various immunological diseases.
Forward-looking statements
Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as 'believe', 'expect', 'anticipate', 'intends', 'estimate', 'will', 'may', 'continue', 'should' and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.
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