First patient enrolled in the phase III study CONCLUDE

“At the end of November, the first patient was enrolled in the phase III study CONCLUDE and I am proud that we have achieved this important milestone on the way towards market approval,” says Peter Zerhouni, CEO of InDex Pharmaceuticals.

Period October – December 2021

  • Net sales amounted to SEK 0.0 (0.0) million
  • Operating loss amounted to SEK –22.7 (–10.1) million
  • Result after tax amounted to SEK –22.8 (–10.1) million, corresponding to SEK –0.04 per share (–0.04) before and after dilution
  • Cash flow from operating activities amounted to SEK –43.9 (–8.1) million

Period January – December 2021

  • Net sales amounted to SEK 0.0 (0.0) million
  • Operating loss amounted to SEK –102.9 (–57.3) million
  • Result after tax amounted to SEK –103.0 (–57.4) million, corresponding to SEK –0.21 per share (–0.24) before and after dilution
  • Cash flow from operating activities amounted to SEK –124.1 (–70.7) million
  • Cash and cash equivalents at the end of the period amounted to SEK 428.4 (53.8) million
  • Number of employees at the end of the period was 9 (7)
  • Number of shares at the end of the period was 532,687,650

All comparative amounts in brackets refer to the outcome during the corresponding period 2020.

Significant events during the quarter

  • InDex enrolled the first patient in the phase III study CONCLUDE with cobitolimod in ulcerative colitis
  • InDex got new patent for cobitolimod granted in the US
  • InDex got new patent for cobitolimod granted in Canada

Other events

  • InDex enrolled the first patient in the PK study with cobitolimod

CEO statement

At the end of November, the first patient was enrolled in the phase III study CONCLUDE and I am proud that we have achieved this important milestone on the way towards market approval. The study evaluates the drug candidate cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis. With cobitolimod, we want to give new hope to the patients suffering from this severe disease. Given cobitolimod’s outstanding combination of efficacy and safety, the annual global peak sales at a successful commercialisation are estimated to have the potential to reach more than USD 1 billion.

The induction study will include approximately 440 patients and be conducted at several hundred clinics in over 30 countries including Europe, the Americas and the Asia-Pacific region. The contract research organisation (CRO) Parexel, contracted by InDex to conduct the phase III study, was recently ranked by clinics around the world as the best CRO to work with for clinical trials in the “WCG CenterWatch Global Site Relationship Benchmark Survey”.

We estimate that the study will take 18 to 24 months to complete. In the current start-up phase our focus is on obtaining approval to start the study in each country and activating the clinics there. The study is currently approved in 16 countries, and we expect several additional approvals in the coming weeks. The pandemic has continued to affect the start-up of new clinical studies, but we now see that it is easing up and that many clinics are eager to get started.

We have initiated the application process for a scientific advice meeting with the Japanese regulatory authority in 2022. The goal is to be able to include Japanese patients in the next induction study in the phase III program. An established regulatory development plan for the Japanese market will also be important in discussions with potential regional partners.

The first patient has also been enrolled in a smaller clinical pharmacokinetic study (PK study) with cobitolimod. The PK study will include at least 6 patients with moderate to severe ulcerative colitis and is conducted in parallel with the phase III study CONCLUDE. With the PK study, we aim to confirm the limited systemic uptake of cobitolimod shown in previous studies. This is a significant advantage compared to competing drugs for ulcerative colitis that act on the whole body and can cause severe side effects outside the inflamed colon.

Tomorrow we have a virtual investor presentation at HC Andersen Capital, and on March 14 we invite you to a Capital Markets Day. The focus of the Capital Markets Day will be on the phase III study CONCLUDE, cobitolimod’s market potential and InDex’s long-term strategies for commercialisation of cobitolimod. Hope to see you there now that the Swedish pandemic restrictions are gone!

For more information:
Peter Zerhouni, CEO
Phone: +46 8 122 038 50
E-mail: peter.zerhouni@indexpharma.com

The full report is attached as a PDF and is available on the company’s website https://www.indexpharma.com/en/financial-reports/

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 8:00 CET on February 23, 2022.

InDex Pharmaceuticals in brief
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 is being evaluated in the phase III study CONCLUDE as a novel treatment of moderate to severe 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.

InDex is based in Stockholm, Sweden. The company’s shares (ticker INDEX) are traded on Nasdaq First North Growth Market Stockholm. Redeye AB with email address certifiedadviser@redeye.se and phone number +46 8 121 576 90 is the company’s Certified Adviser. For more information, please visit www.indexpharma.com.