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PAION AG (PA8G.F)

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Latest Key Developments (Source: Significant Developments)

Paion AG says Remimazolam met its primary efficacy endpoint in U.S. Phase III clinical trial
Wednesday, 28 Jun 2017 02:15pm EDT 

June 28 (Reuters) - Paion Ag ::Positive headline data in U.S. Phase III trial with Remimazolam for procedural sedation undergoing bronchoscopy.Primary efficacy endpoint successfully achieved.Remimazolam met its primary efficacy endpoint in U.S. Phase III clinical trial in procedural sedation in patients undergoing bronchoscopy.  Full Article

Paion Q1 revenues at EUR 2.051 mln
Wednesday, 10 May 2017 01:44am EDT 

May 10 (Reuters) - PAION AG ::PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST QUARTER OF 2017.REVENUES IN Q1 OF 2017 AMOUNTED TO EUR 2.051 MLN COMPARED TO EUR 3 MLN IN PRIOR-YEAR PERIOD.NET LOSS FOR Q1 2017 AMOUNTED TO EUR 2.218 MLN.CASH AND CASH EQUIVALENTS DECREASED BY EUR 1.379 MLN IN Q1 2017.PAION CONFIRMS ITS OUTLOOK FOR 2017 MADE ON 16 MARCH 2017 WITH PUBLICATION OF 2016 FINANCIAL RESULTS.PAION'S MAJOR GOALS FOR 2017 ARE CONTINUATION AND COMPLETION OF ONGOING CLINICAL DEVELOPMENT PROGRAM IN U.S. AND HANDOVER OF COMPLETED WORK TO COSMO.POSITIVE DATA ANNOUNCED IN U.S. SAFETY TRIAL WITH REMIMAZOLAM IN HIGH-RISK COLONOSCOPY PATIENTS.FINANCIAL RESULTS IN LINE WITH PLAN.  Full Article

Paion FY net loss shrinks to 20.1 million euros
Thursday, 16 Mar 2017 02:30am EDT 

Paion AG : Cash position of 30.1 million euros ($32.32 million) as of Dec. 31, 2016 . FY revenues amounted to 4.3 million euros in reporting period, an increase of 4.2 million euros compared to previous year . FY research and development costs amounted to 23.4 million euros, a decrease of 6.0 million euros compared to prior year . Net loss of 20.1 million euros was below range of 24.5 million euros to 27.5 million euros projected for fiscal year 2016 (2015: 28.2 million euros) . Positive remimazolam data in pivotal U.S. Phase III study for procedural sedation during colonoscopy . To conduct a phase III program in EU, paion currently expects funding needs of approximately 20 million to 25 million euros up until filing, subject to further discussions with regulatory authorities . In 2017, Paion expects revenues of approximately 5.8 million euros .Expects research and development expenses to be between approximately 18 million and 20 million euros for 2017, depending on progress of development.  Full Article

Paion AG says COO Jürgen Raths agrees to resign before contract ends
Thursday, 9 Mar 2017 07:20am EST 

Paion AG : Says it made changes in the management board .Says COO Jürgen Raths agreed to resign from office prior to end of his current appointment expiring on August 31, 2017 and will leave management board of company in March 2017.  Full Article

Paion FY revenues up at 4.3 million euros
Tuesday, 7 Feb 2017 02:52am EST 

Paion AG : Capital increase; preliminary, unaudited key group financial figures for 2016 . Net loss in 2016 amounted to 20.1 million euros (previous year: net loss of 28.2 million euros) . Revenues in 2016 amounted to 4.3 million euros (previous year: 0.1 million euros) . Cash and cash equivalents amounted to 30.1 million euros as of 31 december 2016 (31 december 2015: 32.7 million euros) .Should development, filing and approval through cosmo in procedural sedation in U.S. go according to plan, paion will not need additional funding to bring remimazolam to U.S. Market.  Full Article

Paion to issue about 2.4 mln shares at EUR 2.05 per share
Tuesday, 7 Feb 2017 02:51am EST 

Paion AG : To issue about 2.4 million shares at 2.05 euros per share in capital increase with subscription rights . Paion will receive gross proceeds of about 4.99 million euros ($5.33 million) for capital increase with subscription rights . To increase company's registered share capital against contribution in cash from 55,757,094.00 euros by 2,439,023.00 euros to 58,196,117.00 euros .Intends to use proceeds of capital increase primarily to prepare and submit an application for market approval of Remimazolam in Japan.  Full Article

PAION completes patient recruitment in U.S. clinical safety trial of remimazolam
Tuesday, 20 Dec 2016 01:31am EST 

PAION AG : Announced on Monday successful completion of patient recruitment in U.S. clinical safety trial of remimazolam in high-risk patients undergoing colonoscopy . Said no drug-related serious adverse events have been reported .Headline data expected in the first half of 2017.  Full Article

Paion 9-month net loss narrows to 16.06 million euros
Wednesday, 9 Nov 2016 01:30am EST 

Paion AG : Net loss for first nine months of 2016 amounted to 16.061 million euros compared to a net loss of 20.391 million euros in prior-year period . Cash and cash equivalents amounted to 35.906 million euros as of 30 September 2016, an increase of 3.226 million euros compared to 31 December 2015 . Confirms its outlook for current fiscal year announced on 10 August 2016 . Expects revenues of approximately 4 million euros in 2016 resulting primarily from upfront payment of 10 million euros received from Cosmo in July 2016 . Remaining approximately 6 million euros of upfront payment are expected to be recognized as revenues in 2017 . Financial outlook assumes that no further license agreements are entered into during 2016 .FY net loss is expected to be between 21.5 million and 24 million euros, a decrease compared to previous year (2015: 28.2 million euros).  Full Article

Paion H1 net loss widens to 13.2 million euros
Wednesday, 10 Aug 2016 01:30am EDT 

Paion AG : In first half of 2016, revenues were 0.2 million euros ($222,980.00) . Expects revenues of approx. 4 million euros in 2016, which is portion of 10 million euros upfront payment received from Cosmo that will be recognized as revenues in 2016 . Expects research and development expenses to be between 24 million euros and 27 million euros depending on progress of development for FY . Net loss was 13.2 million euros for first half-year 2016 compared to a loss of 11.3 million euros for prior-year period .Net loss is expected to be between 21.5 million euros and 24 million euros, a decrease compared to previous year (2015: 28.2 million euros) for FY.  Full Article

Paion, unit of Cosmo Pharmaceuticals enter into license deal for Remimazolam
Friday, 24 Jun 2016 02:12pm EDT 

Paion Ag : Co and Cosmo Technologies Ltd, unit of Cosmo Pharmaceuticals NV, entered into license agreement for Remimazolam . Under license agreement, Paion will receive a eur 10 million upfront licence fee payment .Another unit of Cosmo entered into investment agreement with co, pursuant to which it has committed to invest eur 10 mln in shares of co.  Full Article

BRIEF-Paion Q1 revenues at EUR 2.051 mln

* PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST QUARTER OF 2017