Full focus on closing phase III program
Period October - December 2023
- Net sales amounted to SEK 0.0 (0.0) million
- Operating loss amounted to SEK -107.9 (-58.2) million
- Result after tax amounted to SEK -105.5 (-56.3) million, corresponding to SEK -0.20 per share (-0.11) before and after dilution
- Cash flow from operating activities amounted to SEK -47.0 (-34.2) million
Period January - December 2023
- Net sales amounted to SEK 97.5 (0.0) million
- Operating result amounted to SEK -107.4 (-103.2) million
- Result after tax amounted to SEK -95.3 (-100.3) million, corresponding to SEK -0.18 per share (-0.19) before and after dilution
- Cash flow from operating activities amounted to SEK -38.0 (-129.4) million
- Cash and cash equivalents at the end of the period amounted to SEK 294.3 (344.9) million
- Number of employees at the end of the period was 7 (6)
- 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
- InDex discontinued the phase III program with cobitolimod
Significant events after the reporting period
- InDex announced expected cash balance per March 31, 2024
Other events
- InDex announced that all patients for the cobitolimod dose selection had completed Induction Study 1 of the phase III program CONCLUDE
- InDex attended the UEGW 2023 congress
- InDex was granted a new patent for cobitolimod in South Korea
CEO statement
Naturally, the quarter was overshadowed by the news of the negative futility analysis in our phase III study at the end of November. It was certainly an unexpected result. After the initial shock subsided, the team has been fully focused and committed to closing down the phase III program according to regulations and good practice. Data from the study has been collected with the goal of analyzing it to further understand the lack of efficacy and see if there is any notable difference across any subgroups. We expect to be able to communicate the result of this analysis at the end of February.
Only the critical team members necessary to close down, and report, the study according to regulatory requirements will stay with InDex during the first half of 2024. We expect all our commitments related to the phase III program to have been fulfilled before summer. As announced on January 19, 2024, our expected remaining cash balance at the end of Q1, SEK 180-190 million, includes all closing costs for the study, even those that will occur after March 31.
Simultaneously, we have been evaluating possible paths forward for InDex. Various alternatives are being considered, for example liquidation, reverse merger, and public bids. The clear goal of the process is to, if possible, find options which could generate more value to our shareholders than a company liquidation.
I would like to thank all InDex team members who have already left the company for the valuable work they have contributed over the past years. I would also like to thank the individuals remaining for their loyalty and commitment in doing the work ahead of us that is not necessarily easy nor inspirational.
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 February 21, 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.
InDex Pharmaceuticals in brief
InDex Pharmaceuticals has a vision to help patients with immunological diseases where there is a high unmet medical need. The drug candidate 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.