First regulatory approvals to start the phase III study CONCLUDE

“We will initiate patient recruitment when the clinics are up and running again after the summer as the healthcare situation has started to normalise,” says Peter Zerhouni, CEO of InDex Pharmaceuticals.

Period April – June 2021

  • Net sales amounted to SEK 0.0 (0.0) million
  • Operating loss amounted to SEK –42.6 (–15.6) million
  • Result after tax amounted to SEK –42.6 (–15.6) million, corresponding to SEK –0.08 per share (–0.07) before and after dilution
  • Cash flow from operating activities amounted to SEK –53.4 (–32.8) million

Period January – June 2021

  • Net sales amounted to SEK 0.0 (0.0) million
  • Operating loss amounted to SEK –51.9 (–39.6) million
  • Result after tax amounted to SEK –52.0 (–39.6) million, corresponding to SEK –0.11 per share (–0.17) before and after dilution
  • Cash flow from operating activities amounted to SEK –62.0 (–54.7) million
  • Cash and cash equivalents at the end of the period amounted to SEK 478.8 (70.6) million
  • Number of employees at the end of the period was 7 (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 announced that patient recruitment for the phase III study CONCLUDE is planned to initiate after the summer

Significant events after the quarter

  • InDex received first regulatory approval from the Swedish MPA to start the phase III study CONCLUDE with cobitolimod
  • InDex received FDA clearance to start the phase III study CONCLUDE

Other events

  • InDex got patent for additional DIMS compounds granted in Europe
  • The annual general meeting in InDex Pharmaceuticals Holding AB was held on June 3, 2021. Board members Wenche Rolfsen (also chairman), Marlene Forsell, Uli Hacksell and Lennart Hansson were re-elected. Yilmaz Mahshid and Stig Løkke Pedersen had ahead of the annual general meeting declined re-election

CEO statement

We are now close to the start of the phase III study CONCLUDE to evaluate cobitolimod as a new treatment for patients with moderate to severe left-sided ulcerative colitis. It is a global clinical study which will include 440 participants and be conducted at several hundred clinics in over 30 countries.  The process of applying for and obtaining approval from the relevant authorities in the participating countries is ongoing, and in July we received the first regulatory approval to start the study from the Swedish MPA and yesterday from the US FDA.

We will initiate patient recruitment when the clinics are up and running again after the summer as the healthcare situation has started to normalise. Together with our CRO we are finalising the practical preparations.

To strengthen our clinical development organisation, we have hired two new employees, Anders Bröijersén as Senior Medical Director Clinical Operations and Johan Levin as Project Manager Clinical Operations. Both have long and broad experience of clinical development and conducting clinical studies. I am pleased that we have been able to attract two such qualified employees and welcome Anders and Johan to the team. Much of their time will be devoted to support the clinics in the study as ambassadors for InDex and the CONCLUDE study, which was a successful model for patient recruitment in our previous study CONDUCT.

In parallel with the phase III study, we will conduct a smaller clinical pharmacokinetic study (PK study) with cobitolimod in Sweden. We have received approval from the Swedish MPA to start also this study. The purpose of the study is to evaluate the systemic uptake of cobitolimod, and the data will support future regulatory applications for market approval of cobitolimod. Previous preclinical and clinical studies have shown that the systemic uptake of cobitolimod is very limited, which likely contributes to the excellent safety profile. This is a significant advantage compared to the current systemically administered drugs for ulcerative colitis that can cause severe off-target effects.

Besides cobitolimod for ulcerative colitis, InDex has a preclinical portfolio of more than 150 DNA-based ImmunoModulatory Sequences (DIMS), of which we are testing a selected number of candidates in models of other inflammatory diseases. In April, a new European patent was granted that provides protection for 19 different DIMS substances. This patent has previously been granted in the US and Canada, and we are very pleased that also the European Patent Office confirms the novelty of our DIMS platform.

In June, we had the Annual General Meeting and although we had postponed it as much as possible, we were unfortunately not able to welcome the shareholders to a physical meeting this year either. On September 2, I will present the company at the Pareto Securities Healthcare Conference, which will be held virtually also this year.

Soon I hope we can start meeting each other in person again and I look forward to welcoming the first patient in the phase III study CONCLUDE.

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-and-presentations/

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 August 25, 2021.

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 in late stage clinical development for the 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. 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.