STOCKHOLM, Aug. 11, 2020 /PRNewswire/ -- The Primary
endpoint was met in the Phase 3 study
TWELVE MONTH PERIOD (JUL 2019-JUN
2020)
- Net revenue SEK 50.5 million
(15.6) *
- EBITDA SEK 29.0 million (-3.0)
*
- Operating profit (EBIT) SEK 26.4
million (-4.2) *
- Profit after tax SEK 20.0 million
(-4.7) *
- Total comprehensive income SEK 20.0
million (499.4)
- Diluted earnings per share SEK
1.06 (-0.27) *
- Cash and cash equivalents amounted to SEK 36.3 million (919.1)
Comparative figures for the period refer to January 2019 - June
2019 (Note: 12 months vs. 6 months due to shortened fiscal
year)'
FOURTH QUARTER (APR-JUN
2020)
- Net revenue SEK 0.0 million (0.0)
*
- EBITDA SEK -5.7 million (-8.5)
*
- Operating profit (EBIT) SEK -6.3
million (-9.2) *
- Profit after tax SEK -5.2 million
(-7.6) *
- Total comprehensive income SEK -5.2
million (-5.1)
- Diluted earnings per share SEK
-0.28 (-0.42) *
- Cash and cash equivalents amounted to SEK 36.3 million (919.1)
Comparative figures for the fourth quarter refer to April 2019 - June
2019
* All comparative figures refer to continuing
operations
SIGNIFICANT EVENTS IN THE FOURTH QUARTER (APR-JUN 2020)
- In June, the results were presented from the European Phase 3
study. As in the previously published North American study, MOB-015
met the primary endpoint and no serious adverse effects were
identified. The EU study showed that treatment with MOB-015 is
non-inferior to treatment with ciclopirox. Mycological cure was
achieved in 84 percent of patients, which is unprecedented for a
topical treatment and even higher than reported for oral
treatments. The pattern is consistent with the results from the
North American Phase 3 study, with low complete cure despite the
high mycologically cure.
- An Extraordinary General Meeting on May
28 resolved, among other things, to authorize the Board of
Directors to issue convertibles and to introduce a long-term
incentive program.
- To date, Moberg Pharma's operations have not been materially
affected by COVID-19.
SIGNIFICANT EVENTS AFTER THE END OF THE FOURTH
QUARTER
- Dr Cindy Wong was appointed
Chief Medical Officer and a member of the Executive Management. Dr
Wong comes most recently from Metz Pharmaceuticals, where she was
Vice President and Head of Global Clinical Development.
STATEMENT FROM THE CEO
In June, the results were presented from the second of two
clinical studies in the Phase 3 program for MOB-015. As in the
North American study, the European study met the primary endpoint
and no serious adverse effects were identified. The superior
mycological cure rate for MOB-015 has now been confirmed in two
pivotal studies, strengthening our conviction that MOB-015 has the
potential to become the future market leader in onychomycosis. We
now look forward to finding the best path to approval in dialogue
with our partners and regulatory agencies.
The European study was conducted at sites in Germany, the UK and Poland and included 452 patients with mild to
moderate distal subungual onychomycosis (DSO) affecting 20-60
percent of the great toenail. Patients were randomized to daily
treatment for 48 weeks, either with MOB-015 or 8 percent
ciclopirox, the most widely used topical drug for
onychomycosis.
Mycological cure was achieved in 84 percent of patients, which
is unprecedented for a topical treatment and even higher than
reported for oral treatments. The pattern is consistent with the
results from the North American Phase 3 study, with a low complete
cure rate despite the high mycological cure rate. The primary
endpoint was met in the EU study as MOB-015 showed non-inferiority
versus ciclopirox in achieving a complete cure at 52 weeks. The
study results validate the previously presented conclusions: i)
MOB-015 delivers a very high mycological cure rate, comparing
favorably to oral antifungal drugs with the advantage of earlier
onset of action; and ii) the vehicle enables efficient terbinafine
delivery but also causes transient whitening/discoloration in
nails, which contributes to the low complete cure rate
reported.
With the primary endpoint achieved in both the North American
study and the European study, the two studies can serve as a basis
for product registration in Europe. For market approval in the U.S., the
FDA normally requires two studies that show superiority
(statistically superior to the comparator) for the primary
endpoint. Consequently, an additional study is likely needed for
U.S. registration.
This is an unusual situation that requires further dialogue with
regulatory agencies and partners, since the outcomes of clinical
studies normally are more uniform. In this case, the results for
the two main parameters - complete cure and mycological cure - are
fundamentally different. The very high mycological cure (ability to
kill the fungus) is unprecedented but does not lead to a high
complete cure rate, probably due to the observed transient
whitening and discoloration of the nail, which complicates the
assessment of clinical and complete cure. All experts engaged by
Moberg Pharma agree that the high antifungal effect is extremely
compelling, and that the product should over time be able to
achieve a high rate of complete cure. We are therefore now
discussing next steps for MOB-015 with our partners and regulatory
agencies.
Anna Ljung, CEO of Moberg
Pharma
CONFERENCE CALL - August 11,
2020 at 3:00 p.m.
CET
CEO Anna Ljung
will present the report at a telephone conference on August 11, 2020, at 3:00
p.m. CET.
Dial-in: SE: +46-8-505-583-50, US: +1-833-526-8382
ABOUT THIS INFORMATION
This information is information that Moberg Pharma AB is obliged
to make public persuant to the EU Market Abuse Regulation. The
information was submitted for publication, through the agency of
the contact persons set out below, at 8.00
a.m. CET on August 11th,
2020
CONTACT:
Anna
Ljung
CEO
Phone: +46-70-766-60-30
e-mail: anna.ljung@mobergpharma.se
Mark Beveridge,
VP Finance
Phone: +46-76-805-82-88
e-mail: mark.beveridge@mobergpharma.se
This information was brought to you by Cision
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https://news.cision.com/moberg-pharma/r/interim-report-april---june-2020,c3166323
The following files are available for download:
https://mb.cision.com/Main/1662/3166323/1289232.pdf
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SOURCE Moberg Pharma