Stockholm, 2014-03-24 17:35 CET (GLOBE NEWSWIRE) -- The pharmaceutical company PledPharma proposes a rights issue that can provide the company with up to 20.25 million SEK. The proposal will be tabled at an EGM in conjunction with the AGM on April 8. The positive data from the first part of PLIANT study resulted in an adjustment of the dose in the remaining study in order to further optimize the positive effects of PledOx ® . As a consequence the number of patients will be increased, which will be financed by proposed rights issue.
As expected, the results from the first part of the PLIANT study showed that PledOx ® was well tolerated by the patients treated with FOLFOX chemotherapy. Treatment with FOLFOX often causes severe painful sensory disorders known as neuropathies. These severe side-effects did not occur in patients that were pre-treated with PledOx. The lower dose of PledOx also indicated a reduction of severe white blood cell-related side effects. According to these data, the lower dose of PledOx seems to give the better effect. PledPharma has therefore applied to the regulatory authorities for reduction of the higher dose of 10 ?mol/kg to 5 ?mol/kg while keeping the lower dose at 2 ?mol/kg.
This change in dose means that the full number (i.e. 42) of randomized patients on the new dose must be included for the statistical evaluation, which results in an expansion of the study and an extension of the trial period. Patients treated with the new dose will, however, replace the majority of patients that otherwise should have been treated with the 10 ?mol/kg dose.
“The study is fully up and running and patients are recruited as expected, says CEO Jacques Näsström. To date 18 patients have been included in the study and some additional 20 patients are identified for participation. Our current estimation is that all patients from all participating countries in Europe and the U.S. will be included in the study by the end of 2014 and overall (top-line) results should be present towards the end of the first quarter of 2015” ends Näsström.
PledPharma’s proposed rights issue can provide the company with up to approximately 20.25 million SEK before the issue costs that are low. The rights issue is carried out with a simplified procedure without producing a prospectus. PledPharma will, however, produce a short information folder for the rights issue, which will be distributed to all registered shareholders. Reference will be made to the newly published annual report for 2013 and the interim report for January-March 2014, which will be available on April 25.
Subscription commitments corresponding to at least respective owners pro rata share have been received from Staffan Persson, Peter Lindell, Carl Rosvall, Thomas Bill, B&E Participation, Anders Ström and all of the company's board of directors and management. The subscription commitments represent more than 50% of the rights issue. No compensation for the subscription commitments has been issued. The subscription commitments are not secured by advance payment or any other security. The remainder of the issue is not guaranteed or otherwise secured.
The company will shortly issue the notice summoning the extraordinary general meeting that shall decide on the rights issue. This meeting will be held on April 8, 2013 at 16:00 after the AGM. The notice is also available on the company website www.pledpharma.se.
Issue terms:
- The right to subscribe for one (1) new share for every thirteen (13) existing shares, resulting in 1,687,314 of new shares upon full subscription (equivalent to a dilution of approximately 7%)
- Price per share: 12 SEK
Process & schedule:
Extraordinary General Meeting, April 8, 2014 at 16:00
Last day of trading in PledPharma shares with the right to receive subscription rights, April 14, 2014
First day of trading in PledPharma shares without right to receive subscription rights, April 15, 2014
Record date for participation in the share issue, April 17, 2014
Subscription period, 25 April to 9 May 2014
Trading in subscription rights, 25 April to 6 May 2014
First day of trading of the new shares is expected during week 24 (9-13 of June).
Issuer agent in connection with the rights issue is Sedermera Fondkomission. Erik Penser Bankaktiebolag is the company's Certified Adviser.
For further information, please contact:
Jacques Näsström, CEO
+46 737 13 09 79
Jacques.nasstrom@pledpharma.se
Michaela Gertz, CFO
+46 709 26 17 75
Michaela.gertz@pledpharma.se
About PledPharma
PledPharma is a Swedish pharmaceutical company that develops new therapies for the treatment of life threatening diseases related to oxidative stress. The initial objective is to develop a drug, PledOx ® , which reduces severe side-effects associated with chemotherapy. The current market for supportive cancer care is some USD 10 billion. PledPharma also evaluates an existing medicines possibility to reduce the damage that occurs on the heart muscle when patients suffer from acute myocardial infarction. In addition to these projects, the company is also evaluating opportunities of using our technology platform in additional areas where there is a significant unmet medical need. PledPharma has the potential to offer patients valuable and unique treatments for serious life-threatening diseases where there is an opportunity fast registration in the US through "breakthrough therapy" designation. This means that the company has the potential to offer shareholders a good return on their investment. PledPharma (STO:PLED) is listed on NASDAQ OMX First North. Erik Penser Bankaktiebolag is the Certified Adviser. For further information, please visit www.pledpharma.se
