MOB-015 HAS RECEIVED NATIONAL APPROVALS IN 10 EU COUNTRIES, ANOTHER 3 APPROVALS ARE EXPECTED
NINE-MONTH PERIOD (JAN-
- EBITDA
SEK -17.4 million (-13.7) -
Operating profit (EBIT)
SEK -19.2 million (-15.6) -
Profit after tax
SEK -14.6 million (-12.6) -
Total profit
SEK -14.6 million (-12.6) -
Diluted earnings per share
SEK -1.24 (-1.84) -
Cash and cash equivalents amounted to
SEK 101.5 million (142.5)
THIRD QUARTER (JUL-
- EBITDA
SEK -6.6 million (-4.6) -
Operating profit (EBIT)
SEK -7.3 million (-5.3) -
Profit after tax
SEK -5.8 million (-4.3) -
Total profit
SEK -5.8 million (-4.3) -
Diluted earnings per share
SEK -0.36 (-0.43) -
Cash and cash equivalents amounted to
SEK 101.5 million (142.5)
SIGNIFICANT EVENTS IN THE THIRD QUARTER
- National approvals have been received in the following countries:
Austria ,Czech Republic ,Denmark ,Finland ,France ,Hungary ,Ireland ,Norway ,Spain andSweden . Moberg Pharma's rights issue ofSEK 100 million was oversubscribed - subscription rate 130%. The rights issue of units comprised of shares and warrants was resolved by the Board of Directors onJune 28 . The Board of Directors also resolved on a directed issue to guarantors in the rights issue. The Board of Directors' resolutions were approved by the Extraordinary General Meeting onAugust 8 and the Extraordinary General Meeting onOctober 9 .
SIGNIFICANT EVENTS AFTER THE QUARTER
- Enrollment to the North American study is now completed by a wide margin in 2023; 384 patients have been randomized at 33 study centers in the
U.S. andCanada . Topline results are expected inJanuary 2025 . -
Management changes where
Robert Ehrl succeedsJesper Lind as Head of Supply andChristina Erixon succeeds Agneta Larhed as Vice President Pharmaceutical Innovation & Development.
STATEMENT FROM THE CEO
Both the regulatory process, with additional national approvals during the quarter, and the North American study where patient enrollment was completed by a wide margin in 2023 are important achievements for the company.
The completion of enrollment in
We have now received national approvals in a total of ten countries, and are awaiting approval in the three remaining countries included in the DCP process.
One of our focus areas is to secure a long-term supply of terbinafine ahead of the planned pan-European rollout together with our partner Bayer. We continue to work together with our intended API supplier, which we expect to apply to include in the file in H1 2024. We are also actively looking for an additional API source and have commenced discussions with potential candidates through our manufacturer to secure a stable long-term supply of terbinafine.
The rights issue that we completed during the quarter despite the challenging market climate was oversubscribed and provided the company with proceeds of
In summary, the third quarter was a productive quarter in which we continued to deliver according to plan with the national approvals, progress in the North American study and preparations for the forthcoming launch. We continue to work diligently to realize our vision - to make MOB-015 the leading nail fungus treatment worldwide.
ABOUT THIS INFORMATION
This information is information that
FOR ADDITIONAL INFORMATION
https://news.cision.com/moberg-pharma/r/moberg-pharma-s-interim-report-january---september-2023,c3870190
https://mb.cision.com/Main/1662/3870190/2410224.pdf
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