DGAP-News: PAION AG

DGAP-News: PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST QUARTER 2016

DGAP-News: PAION AG / Key word(s): Quarterly / Interim Statement PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST QUARTER 2016

11.05.2016 / 07:30 The issuer is solely responsible for the content of this announcement.

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PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST QUARTER 2016

- Financial results in line with plan

- Cash and cash equivalents of EUR 25.5 million; cash reach until the end

of the first quarter of 2017

- Positive pre-NDA meeting with Japanese authority PMDA

- European Phase III study (Remimazolam in general anesthesia in patients

undergoing cardiac surgery) discontinued due to insufficient patient recruitment

- Completion of patient recruitment of U.S. Phase III colonoscopy study with no drug-related serious adverse event

- Conference call (in English) today at 2:00 pm CET (1:00 pm GMT/8:00 am EDT)

Aachen (Germany), 11 May 2016 - The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today

reports its consolidated financial results according to International Financial Reporting Standards (IFRS) for the first quarter 2016.

"The discontinuation of our EU study at the beginning of this year was a difficult but necessary decision. With the completion of recruitment of the

first U.S. Phase III study, we have achieved an important step. The positive feedback of the Japanese authority PMDA during the pre-NDA meeting

is a reward for diligently working towards the ultimate goal of a first approval, which could potentially also be used in certain other jurisdictions. We are looking forward to a landmark year 2016 with the Phase III colonoscopy study data being a major upcoming value inflection point", Dr. Wolfgang Söhngen, CEO of PAION AG, commented.

Important events in the period covered

Development and commercial activities

After the decision to stop the EU Phase III trial in the first quarter 2016, PAION is now focusing on the development of Remimazolam in procedural

sedation for a U.S. approval. The patient recruitment in the first U.S. Phase III study was completed in April 2016 (after the period covered). This prospective, double-blind placebo-controlled, randomized, multi-center

open label vs. midazolam trial was performed in the indication procedural sedation with 460 patients undergoing colonoscopies. No drug-related serious adverse event has been reported. Headline data are expected mid 2016.

The U.S. Phase III program also includes a second confirmatory, prospective, double-blind placebo-controlled, randomized, multi-center open

label vs. midazolam trial in 420 patients undergoing bronchoscopies which started in June 2015, a smaller safety trial in 75 high-risk patients (double blind vs. placebo and open label vs. midazolam) undergoing colonoscopies, and in addition four ongoing Phase I trials for the purpose of further supporting Remimazolam's safety profile.

Patient recruitment in the Phase III bronchoscopy trial remains moderate; therefore, completion of patient recruitment could potentially be delayed into 2017. In consultation with the FDA, meanwhile, the total study size was reduced from 460 to 420 patients. The decrease by 40 patients relates to the midazolam treatment group and is not relevant for the approval as the primary endpoint of the study is defined versus placebo. In addition, certain co-medications are now allowed, as this was the major hurdle to the

study's patient recruitment so far. Assuming successful implementation of these and other ongoing counter measures such as the opening of additional study centers and a further intensified support of the study centers, PAION

expects filing for approval end of 2017 at the earliest.

Several safety reviews have been conducted by an independent data monitoring committee (DMC) since the start of the U.S. Phase III program. All safety reviews led to a positive DMC recommendation to continue the trials as scheduled.

In August 2015, the start of the multi-national, multi-center, randomized, single-blind, propofol-controlled, confirmatory EU Phase III study in patients undergoing major cardiac surgery was announced. Due to the complex

study design, the trial faced recruitment challenges. Despite intensive efforts to enhance patient recruitment, the trial proved to be difficult to

implement in practice. Therefore, in February 2016, PAION decided to discontinue the trial in order to avoid a long and expensive study with the

existing design. Subject to partnering and/or additional funding, we are planning to develop a new Phase III clinical study for the EU in the indication general anesthesia in general surgery.

A pre-NDA (New Drug Application) meeting with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) took place in January 2016. The PMDA stated that the non-clinical and the clinical data package of Remimazolam were regarded as complete for filing in the indication "Induction and maintenance of general anesthesia". In October 2015, PAION already reported

that the PMDA had confirmed that both the raw materials produced by PAION in Europe as well as the finished formulation of Remimazolam fulfill the requirements for filing in Japan.

Results of operations, financial position and net assets

As expected, no significant revenues were realized in the first quarter 2016.

Research and development expenses amounted to KEUR 6,502 in the first quarter 2016 and relate to Remimazolam. The increase of KEUR 739 compared to the prior-year period is due to the conduct of the Phase III program in the U.S. and the EU (discontinued), particularly the finalization of the U.S. Phase III colonoscopy trial.

General administrative and selling expenses decreased by KEUR 157 to KEUR 1,180 in the first quarter 2016. General administrative expenses decreased by KEUR 89 to KEUR 781 and selling expenses decreased by KEUR 68 to KEUR 399.

Income taxes amounted to KEUR 1,330 in the first quarter 2016 (prior-year period: KEUR 1,274) and relate to tax claims for reimbursement of parts of the research and development costs from the British tax authorities.

The net loss for the first quarter 2016 amounted to KEUR 6,729. In the prior-year period, a net loss of KEUR 4,703 was reported. This means an increase of the net loss in the amount of KEUR 2,026 compared to the prior- year period.

Cash and cash equivalents decreased by KEUR 7,218 in the first quarter 2016. As of 31 March 2016, PAION's cash and cash equivalents amounted to KEUR 25,462. Including the receipt of tax credits expected in the middle of

2016, this secures a cash reach until the end of the first quarter of 2017 under current planning.

Outlook 2016 PAION confirms its outlook for 2016 made on 22 March 2016 with the publication of the annual financial results for 2015. PAION's major goals for 2016 are the further conduct of the Phase III development program with Remimazolam in the U.S. and the production development for Remimazolam, in particular the validation of the production at market scale. PAION expects filing for approval in the U.S. end of 2017 at the earliest and accordingly

market approval end of 2018 at the earliest.

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Key consolidated financial figures, IFRS



(all figures in KEUR unless Q1 2016 Q1 2015 otherwise noted) Revenues 3 33 Research and development -6,502 -5,763 expenses General administrative and -1,180 -1,337 selling expenses Income taxes 1,330 1,274 Net result for the period -6,729 -4,703 Earnings per share in EUR for -0.13 -0.09 the period (basic) Earnings per share in EUR for -0.13 -0.09 the period (diluted)

Cash flows from operating -7,055 -5,761 activities Cash flows from investing -137 -4 activities Cash flows from financing 0 3 activities Change in cash and cash -7,218 -5,717 equivalents (incl. exchange rate differences) Average number of group 39 26 employees

31 Mar. 2016 31 Dec. 2015 Intangible assets 3,053 3,362 Prepaid expenses and other 7,942 7,371 assets Cash and cash equivalents 25,462 32,680 Equity 28,533 35,562 Non-current liabilities 40 6 Current liabilities 8,100 7,900 Balance sheet total 36,673 43,468



Conference call and webcast In addition to the publication of the results, the Management Board of PAION AG will host a public conference call (conducted in English) on 11 May 2016 at 2 p.m. CEST (1 p.m. BST, 8 a.m. EDT) to present the financial results of the first quarter 2016, highlight the most important events and provide a pipeline and strategy update and financial outlook.

To access the English call starting at 2 p.m., participants may dial from

* Germany +49 (0) 69 7104 45598,

* UK +44 (0) 20 3003 2666 and

* U.S. +1 212 999 6659

* Other countries: please use the UK number

When prompted, you will be asked to give the password "PAION". The conference call will be supplemented by a webcast presentation which can be

accessed during the call under the following link: https://paion- events.webex.com/paion-events/j.php?MTID=m7016163b2d2de2105c2891f8721aa208.

About PAION PAION AG is a publicly listed Specialty Pharmaceutical Company headquartered in Aachen (Germany) with further sites in Cambridge (United Kingdom) and New Jersey (USA).

PAION's lead substance, Remimazolam, is an intravenous ultra-short-acting anesthetic that is currently in Phase III clinical development for procedural sedation and general anesthesia. Remimazolam is designed to complement and improve currently available treatment options for patients requiring sedation and anesthesia.



PAION is focusing its clinical development activities on Remimazolam and has initiated pre-commercial activities according to PAION's vision to become an acknowledged "PAIONeer" in sedation and anesthesia.

For more information please visit www.paion.com

Contact Ralf Penner Director Investor Relations / Public Relations PAION AG Martinstrasse 10-12 52062 Aachen - Germany Phone +49 241 4453-152 E-mail r.penner@paion.com www.paion.com

Disclaimer: This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG's management as of the date of this release. They are subject to a

number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from the Company's assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward- looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward- looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.

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11.05.2016 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement.

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Language: English Company: PAION AG Martinstr. 10-12 52062 Aachen Germany Phone: +49 (0)241-4453-0 Fax: +49 (0)241-4453-100 E-mail: info@paion.com Internet: www.paion.com ISIN: DE000A0B65S3 WKN: A0B65S Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart End of News DGAP News Service ---------------------------------------------------------------------------

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