HUDDINGE, Sweden, Feb. 14, 2019 /PRNewswire/ -- Two new projects
into clinic
October – December
Significant events during the quarter
- The first patient was dosed in the phase II study with
birinapant and Keytruda® as combination therapy in colorectal
cancer.
- The first patient with advanced cancer in the liver was dosed
with the company's drug candidate MIV-818 in a phase Ia study.
- MIV-828 was selected as a candidate drug for the treatment of
acute myeloid leukemia (AML) and other forms of blood cancer.
- Dr Uli Hacksell was appointed
new CEO of Medivir.
- A reorganization, with the aim of focusing the internal
resources on the company's clinical development projects, was
carried out. The organization was reduced from 75 to a total of 17
employees.
- In the quarter Medivir has recorded SEK
38.1 million as restructuring costs.
Financial summary
- Net turnover totaled SEK 13.6
million (4.2 m).
- The loss before interest, tax, depreciation and amortization
(EBITDA) totaled SEK -96.6 million
(-92.6 m). Basic and diluted earnings
per share were SEK -4.72 (-5.08) and
-4.72 (-5.08) respectively.
- The cash flow from operating activities amounted to
SEK -72.4 million (-88.9 m).
January - December
Financial summary
- Net turnover totaled SEK 23.9
million (36.6 m).
- The loss before interest, tax, depreciation and amortization
(EBITDA) totaled SEK -326.5 million
(-342.6 m). Basic and diluted
earnings per share were SEK -14.62
(-16.40) and -14.62 ( -16.40) respectively.
- The cash flow from operating activities amounted to
SEK -320.5 million (-358.5 m).
- Liquid assets and short-term investments totaled SEK 286,3 million (467.8
m) at the period end.
Significant events after the period end
- CFO Erik Björk has decided to
leave the company but will remain during a transition period.
Process to recruit a new CFO has been initiated.
Conference call for investors, analysts and the media
The Year End report 2018 will be presented by Medivir's
President & CEO, Uli
Hacksell.
Time: Thursday, February 14, 2019,
at 15.00 (CET).
Phone numbers for participants from:
Sweden + 46-8-505-583-55
Europe +44-33-3300-9030
US + 1-646-722-4957
The conference call will also be streamed via a link on the
website: www.medivir.com
The presentation will be available on Medivir's website after
completion of the conference.
For further information, please contact
Uli Hacksell
CEO
+46(0)8-5468-3100
Erik Björk
CFO
+46(0)72-228 2831
CEO's comments
Medivir's reorganization is now complete. We have entered
2019 with a slimmed organization that has a clear focus on the
exciting clinical projects.
An important event in 2018 was the reorganization that was
presented in connection with me becoming CEO on October 15. To ensure that our resources are used
where we can create the greatest value, we have concentrated our
operations on clinical development. Fundamentally, the measures are
based on the positive development of our clinical projects.
Through the redundancies, primarily within research and
administration, the organization has been reduced from 75 to a
total of 17 employees. The measures will free up resources for
Medivir's clinical development projects as they are expected to
reduce our cost base by about two thirds.
The most important task for Medivir is to develop and realize
the value of our clinical development portfolio, which consists of
four programs.
Remetinostat is Medivir's topical HDAC inhibitor
being developed for the treatment of mycosis fungoides, the most
common form of cutaneous T-cell lymphoma, (MF-CTCL), a form of
blood cancer that is primarily manifested in the skin. At the end
of the year, we had clarifying and positive discussions with the
FDA regarding the design of the phase III program for MF-CTCL. One
successful phase III study is expected to be sufficient to enable a
marketing approval for the treatment of patients with early stage
MF-CTCL. At the same time, there are strict requirements regarding
the design of such a study. Medivir is now further developing the
phase III design based on the clarifications from the FDA. We
intend to seek a partner for the continued development and
commercialization of remetinostat.
In our collaboration with Stanford
University School of Medicine in California, the first patient was dosed with
remetinostat in their investigator-initiated phase II study on
patients with basal cell cancer in early August.
Birinapant is a SMAC mimetic that is being studied
for treatment in combination with MSD's anti-PD-1 treatment
Keytruda® (pembrolizumab) in patients with solid tumors. In
October, an interim analysis of the phase I study comprising the
first 12 patients in the study was presented. The analysis showed a
positive safety profile and, in addition, an interesting efficacy
signal was noted, since one of the patients with
microsatellite-stable (MSS) colorectal cancer, a cancer form in
which treatment with Keytruda® alone rarely produces effect,
achieved a confirmed partial response (according to RECIST 1.1)
which remained at the last evaluation. The patient remains on
treatment more than one year after the start of therapy. Three
additional patients have had periods of stable disease lasting up
to 18 weeks after the start of treatment.
The inclusion of the first colorectal cancer patient in the
phase II part of the study took place just before Christmas.
MIV-818 is Medivir's nucleotide prodrug that is
being developed for the treatment of liver cancer. In an ongoing
phase I study, four patients have been included. The purpose of
this first-in-human study is to study safety, tolerability and
pharmacokinetics of MIV-818 in patients with advanced cancer in the
liver, a fatal disease with very few available treatment
options.
At the end of November, we were able to announce an exciting
addition to the development portfolio as MIV-828 was chosen
as a candidate drug for the treatment of acute myeloid leukemia
(AML) and other forms of blood cancer.
At the end of the second quarter, we were able to present an
acceptable safety and tolerability profile in our phase II
extension study with MIV-711, Medivir's cathepsin K
inhibitor for the treatment of osteoarthritis. Top-line results,
presented at the end of July, showed that treatment with MIV-711
for a total of 12 months resulted in a continuing treatment effect
on joint bone area growth and prevention of cartilage degradation.
In August, the FDA published new preliminary guidance for the
development of disease-modifying treatments for osteoarthritis. The
FDA modified its previous approach to structural end-points and the
new guidance discuss structural impact as treatment goals in
clinical studies and how it could potentially be used for so-called
"accelerated approval". Medivir continues to aim to establish a
license or collaboration agreement for MIV-711.
The clinical projects have successfully moved forward. This
shows that Medivir's research and development has consistently been
of high quality. However, to ensure our ability to continue to
develop and benefit from the potential that lies in our clinical
portfolio, we chose to concentrate our operations and took measures
that entailed announcing redundancies and reducing Medivir's
preclinical research. Once again, I would like to thank our
employees leaving the company for their valuable contribution to
Medivir. They have worked loyally, diligently and professionally
for Medivir, many for numerous years. We wish those who leave
Medivir success in their future pursuits.
Medivir has now been turned into a organization with good
ability to work virtually and with high flexibility. We have
experience of both drug development and business development.
Medivir's increased focus on clinical development gives us a
positive view of the future. I look forward to an exciting
2019.
Uli Hacksell
President and CEO
The information was submitted for publication at 08.30 CET on
14 February 2019.
This information was brought to you by Cision
http://news.cision.com
http://news.cision.com/medivir/r/medivir-ab---year-end-report--january---december-2018,c2740500
The following files are available for download:
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https://mb.cision.com/Main/652/2740500/990621.pdf
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YEAR END REPORT,
JANUARY â€" DECEMBER 2018 (PDF)
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SOURCE Medivir
