PledPharma AB
Interim information
Interim report second quarter 2015
FDA meeting planned for the fall
Stockholm, 2015-08-18 08:30 CEST (GLOBE NEWSWIRE) --
Significant events during the quarter
-- Net result for the period amounted to SEK
-11 433 (-
12 674
) k
-- Cash and cash equivalents at the end of the period amounted to SEK
69 586 (
47 799
) k
-- Cash flow from operating activities for the period amounted to SEK -17 694
(
-13 770
) k
-- Result per share for the period amounted to SEK
-0.4 (-0.5)
-- The Annual General Meeting held on April 14, 2015 re-elected Håkan Åström,
Andreas Bunge, Martin Nicklasson, Sten Nilsson and Eva Redhe Ridderstad as
members of the Board
-- Aladote
™
approved as a trademark in the EU
-- Further clinically relevant and statistically significant results
from the Phase IIb study with PledOx
®
presented
at the scientific congress MASCC.
Other significant events during 2015
-- Top-line results from phase IIb study presented in March - PledOx
®
reduces nerve damage in conjunction with chemotherapy by 43 percent
CEO comment
We are now approaching the next milestone on PledOx® way towards market
registration. A meeting with the FDA is planned to take place during the fall.
Together with US and Swedish registration experts, we are now working intensely
with preparations for this important meeting. We have completed an interim
report for the PLIANT-study and have developed a preliminary plan for the
future development. FDA's comments and guidance at the forthcoming so-called
End of Phase II/Pre Phase III-meeting will be important for the final design of
the Phase III program. This is in turn an important basis for the negotiations
with potential partners.
Interest for a drug that can help prevent the potentially debilitating
neuropathic side effects of chemotherapy is huge. Which was obvious when we in
June presented our clinical data at the scientific congress MASCC
(Multinational Association of Supportive Care in Cancer) in Copenhagen. PledOx®
has demonstrated a clinically relevant and statistically significant preventive
effect against chemotherapy induced nerve damage in the treatment of colorectal
cancer. Symptoms occur later and disappear faster after pretreatment with
PledOx®. The hope now is to, as quickly as possible, make it available for
patients worldwide to avoid the appearance of injuries that often can be
irreversible and cause problems with pain and fine motor skills throughout
life. At the same time an efficient prophylaxis against nerve damage could mean
that cancer patients are less likely to have to cancel or reduce the dose - and
thus diminishing the effect of their chemotherapy.
We are engaged in a well-structured process to find the ideal partner for the
continued development and launch of PledOx®. During the year, we have deepened
our analysis of the market and its players, strengthened our team by additional
internationally experienced business developers and continued the updating of a
group of interested pharmaceutical companies on our progress. However, we have
deliberately chosen to forego detailed discussions pending the outcome of the
PLIANT study and the upcoming meeting with the FDA. The more well-grounded
information we have about the effect of PledOx® and the design of the Phase III
program when we intensify the business discussions, the stronger our
negotiating position will be.
Furthermore, we continue preparations to start the Aladote™ study during in
2016.
Jacques Näsström
CEO, PledPharma AB (publ)
PledPharma in brief
PledPharma develops new drugs that protect the body against oxidative stress –
a condition that can be caused by chemotherapy treatment and acetaminophen
(paracetamol) poisoning. The company's most advanced project PledOx® reduces
nerve damage associated with chemotherapy. The drug candidate Aladote™ is being
developed to reduce the risk of acute liver failure associated with
acetaminophen poisoning. The project PP-099 seeks to limit the damage that
occurs to the heart muscle during myocardial infarction. PledPharma’s most
advanced project with PledOx® has completed Phase II trial. Pledpharma (STO:
PLED) is listed on Nasdaq First North. Erik Penser Bankaktiebolag is the
company’s Certified Adviser (tel +46 8 463 80 00). For more information, see
www.pledpharma.se
For further information contact:
Jacques Näsström, CEO cell +46 73 713 09 79
Johan Stuart, CFO cell +46 70 66 44 096
