Cobitolimod

STOCKHOLM, Jan. 19, 2024 /PRNewswire/ -- InDex Pharmaceuticals Holding AB (publ) ("InDex Pharmaceuticals") today announced that remaining commitments for the company have been quantified, and the expected cash balance per March 31, 2024, amounts to SEK 180-190 million. The amount includes all closing costs for the phase III program CONCLUDE, even though activities for closing the phase III program will continue also after March 31, 2024. The company will have additional operating costs required to fulfill obligations of a listed company after March 31, 2024 amounting to SEK 0.6-0.8 million per month. InDex Pharmaceuticals is currently looking at alternatives for the company's future. The company's cash and cash equivalents as of December 31, 2023, amounts to SEK 294 million. The concluding results from the terminated Induction Study 1 of the phase III program CONCLUDE are expected in the latter part of February 2024 and will be communicated at that timepoint. For more information: Jenny Sundqvist, CEO Phone: +46 8 122 038 50 E-mail: jenny.sundqvist@indexpharma.com Johan Giléus, CFO and deputy CEO Phone: +46 8 122 038 50 E-mail: johan.gileus@indepharma.com Publication This information is information that InDex Pharmaceuticals Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the contact person set out above at 10.10 CET on January 19, 2024. This is an English translation of the Swedish press release. In case of discrepancies between the English translation and the Swedish press release, the Swedish press release shall prevail. Information in this press release is intended for investors. InDex Pharmaceuticals in brief InDex Pharmaceuticals has a vision to help patients with immunological diseases where there is a high unmet medical need. The company is focusing on the drug candidate cobitolimod, a first in class mode-of-action, with the aim to offer an effective and safe treatment option. Cobitolimod was being evaluated in the phase III program CONCLUDE for moderate to severe left-sided ulcerative colitis – a debilitating, chronic inflammation of the large intestine. InDex Pharmaceuticals is based in Stockholm, Sweden. The company's shares (ticker INDEX) are traded on Nasdaq First North Growth Market Stockholm. Redeye AB is the company's Certified Adviser. For more information, please visit . The following files are available for download: View original content: SOURCE InDex Pharmaceuticals Company Codes: ISIN:SE0008966295, Stockholm:INDEX

Viatris paid $10 million for the Japanese rights to cobitolimod in May. InDex Pharmaceuticals may be struggling to think of reasons to be thankful. The Swedish biotech has rocked investors with news it is stopping a phase 3 ulcerative colitis trial early in response to lackluster efficacy, sending its share price down 60%. The study was testing cobitolimod, a TLR9 agonist that is delivered directly to the inflamed colon via an enema. InDex identified the approach as a way to quickly induce mucosal healing and relieve ulcerative colitis symptoms without the complications of systemic exposure and off-target effects. Management recently tipped the drug to generate blockbuster sales and landed a deal with Viatris in Japan. Optimism faded fast after the Swedish market closed Tuesday. InDex revealed an interim analysis of the first 133 patients found its phase 3 trial is unlikely to meet its primary endpoint. The analysis, which was designed to check for futility and to choose the best dose, prompted the independent data monitoring committee to recommend stopping the study.  “This surprising and disappointing news confirms the complexity of the disease and the need for further research within this field, especially as moderate to severe ulcerative colitis is an indication with high unmet medical need for new treatment options,” InDex CEO Jenny Sundqvist said in a statement. “We will conduct a comprehensive analysis of all the study data before announcing next steps.” The induction stage of the trial was assessing the proportion of patients in clinical remission at Week 6, by which point patients had received two rounds of treatment with cobitolimod or placebo. No safety concerns emerged, but, based on an analysis of the first 30% of planned patients, neither dose was on course to improve on the remission rate achieved by placebo. Investors responded by sending InDex’s share price down 60% to 0.27 Swedish krona. The crash reflects the rapid revision of expectations for the biotech’s lead candidate. InDex predicted the therapy could claim 20% to 30% of the moderate to severe left-sided ulcerative colitis market, a share that would translate into sales in excess of $1 billion.    The biotech’s efforts to persuade others of the promise of the program brought some successes. Viatris paid $10 million for the Japanese rights to the candidate in May as part of a deal that is worth up to $40 million in development and sales milestones. The upfront payment helped InDex increase its cash pile to 412.5 million Swedish krona ($39.5 million) by the end of June.