Flerie

”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. We are incredibly grateful to all the patients, investigators and study personnel for their engagement to date. We will conduct a comprehensive analysis of all the study data before announcing next steps,” said Jenny Sundqvist, CEO of InDex Pharmaceuticals.

Period July – September 2023

• Net sales amounted to SEK 0.0 (0.0) million
• Operating loss amounted to SEK –42.1 (–4.5) million
• Result after tax amounted to SEK –37.9 (–3.5) million, corresponding to SEK –0.07 per share (–0.01) before and after dilution
• Cash flow from operating activities amounted to SEK –47.8 (–23.8) million

Period January – September 2023

• Net sales amounted to SEK 97.5 (0.0) million
• Operating result amounted to SEK 0.6 (–45.0) million
• Result after tax amounted to SEK 10.3 (–44.0) million, corresponding to SEK 0.02 per share (–0.08) before and after dilution
• Cash flow from operating activities amounted to SEK 9.0 (–95.2) million
• Cash and cash equivalents at the end of the period amounted to SEK 363.7 (398.3) 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 2022.

Significant events during the quarter

• A new patent has been granted in Europe for the commercial formulation of cobitolimod

Significant events after the reporting period

• InDex discontinues cobitolimod phase III program

Other events

• The positive results from PK study with cobitolimod selected as one of the best abstracts for poster presentation at UEGW

CEO statement
Clearly, anything that happened in Q3 feels rather insignificant in light of the advice we received from the Data Monitoring Committee (DMC) on Nov 21 that we should stop Induction Study 1 of the CONCLUDE phase III program. We have therefore decided to discontinue our ongoing phase III program.

Our dose selection analysis served, among other things, the purpose of being able to stop the study if there was a low likelihood of cobitolimod (irrespective of dose) showing a statistically significant benefit over placebo in terms of clinical remission at study completion.

The news that DMC advises that we stop the study reached us a couple of days ago, so we are still in shock, truly disappointed and surprised.

It is important to note that we will not make any decisions on next steps until we fully understand the reason for the DMC advice. We do not want to rush to any conclusions, and we have seen many examples of companies changing their view on a study or compound after having analyzed and understood data.

What happens now?

No more doses (neither cobitolimod nor placebo) will be administered to patients in the phase III program. The study will be unblinded and all patients will be followed up as per protocol. All available data will be collected and quality controlled. After that, we will analyze the data and ensure we understand it completely before making any decisions on how to proceed. At this point, it serves no purpose to speculate what might be the reason for the DMC outcome or what we shall do next.

Approximately 40% of phase III trials fail. It varies somewhat by therapy area and company, but failure happens both at small biotechs and big pharma. If we knew the outcome of a phase III trial, we would not have to do it. This shows the true complexity and challenge of drug development.

It is heartbreaking to see what so many co-workers, patients, medical staff and partners have hoped for not pan out as we wished. All data from the around 400 patients treated with cobitolimod to date pointed to an efficacious and safe treatment, so this result was not expected.

I want to extend my sincere gratitude to everyone who has devoted their dedication, grit and perseverance to date.

Jenny Sundqvist, CEO

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@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 November 28, 2023.

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.

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 www.indexpharma.com.