Probiodrug to present at BioCapital Europe and Swiss Biotech Day
Key patents on Glutaminyl Cyclase (QC) inhibition for the treatment of Alzheimer’s disease granted in Japan
Transformational year for Probiodrug
IPO at Euronext Amsterdam completed
Phase 2a study of novel treatment for Alzheimer’s disease ready for initiation in early 2015
First patient enrolled in March 2015
HALLE/SAALE, Germany, 31 March 2015 – Probiodrug AG (Euronext Amsterdam: PBD), a biopharmaceutical company developing novel therapeutic solutions to treat Alzheimer’s disease (AD), today announced its financial results for the twelve-month period ending 31 December 2014 prepared in accordance with German GAAP (“HGB”) and, on a voluntary basis, in accordance with IFRS as endorsed by the European Union. The Annual Reports are available on the company website (https://www.vivoryon.com/investors/reports-and-presentations/).
- Successful initial public offering (IPO) on Euronext, Amsterdam in October 2014 raising total gross proceeds of EUR 23.2 million. Proceeds to be used to develop novel treatments for Alzheimer’s disease
- Cash and cash equivalents of EUR 20.9 million as of 31 December 2014
- Net loss of EUR 11.4 million compared with EUR 9.8 million in 2013 – in line with company expectations
- Lead product for treating Alzheimer’s disease, PQ912, prepared for start of clinical Phase 2a “SAPHIR” study
- Strengthened Management Board with appointment of Inge Lues PhD as Chief Development Officer. Dr Lues served as key advisor to Probiodrug and was instrumental in bringing the program from early discovery to Phase 2
- Hubert Birner PhD appointed to the Supervisory Board, replacing Axel Polack, MD, who resigned from the Supervisory Board
POST PERIOD HIGHLIGHTS
- Enrolment of first patient in Phase 2a “SAPHIR” study at leading Alzheimer Center in Amsterdam
- Additional data on Glutaminyl Cyclases (QCs) in its relation to Alzheimer’s disease published in Acta Neuropathologica
Probiodrug will host a conference call open to the public today at 15:00 Central European Time (CET); the presentation will also be posted to the website. The conference will be held in English. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement:
Please dial one of the following access numbers, then enter your PIN Code 64986690#:
|Austria||0800301051 (EN)0800301052 (DE)||+43 19280492 (EN)+43 19280494 (DE)|
|Canada (Toronto)||+1 4162164186|
|Germany (Frankfurt)||08006270715||+49 69222229043 (EN)+49 69222229044 (DE)|
|Switzerland||0800005200 (EN)0800005205 (DE)||+41 225805970 (EN)+41 225805971 (DE)|
A Question and Answer session will follow the presentation of results.
Commenting on the results, Dr Konrad Glund, Chief Executive Officer of Probiodrug said: “This has been a transformational year for Probiodrug. The successful listing on Euronext Amsterdam was a major achievement for the company. It would not have been possible without the support of our shareholders and, in particular, the commitment and dedication of our employees, advisors and partners – many thanks to all of them for this achievement. We are very pleased to commence the Phase 2 “SAPHIR” study of our lead product PQ912 for treating Alzheimer’s disease. We believe our clearly differentiated approach presents a major opportunity for AD patients and will generate significant value for our shareholders.”
|In EUR k||unconsoli-
|Earnings, Financial and Net Assets Position|
|Net loss for the period||-11,437||-9,807||-9,929||-18,720||-16,307|
|Equity (end of the year)||15,971||-4,304||-4,224||5,365||14,945|
|Equity ratio (end of the year) (in %)||74.4 %||0||0||53,6||78.3|
|Balance sheet total (end of the year)||21,480||6,281||6,374||10,005||19,093|
|Cash flows from operating activities (year)||-10,589||-8,459||-8,526||-12,040||-14,321|
|Cash flows from operating activities (average)||-882||-705||-711||-1,003||-1,193|
|Cash flows from financing activities (net)||25,762||5,346||5,346||9,197||18,641|
|Cash and cash equivalents at the end of period||20,920||4,421||4,879||7,726||9,295|
|Total number of employees (incl. Board of management) (end of the year)||13||16||16||34||79|
|Average number of employees (incl. Board of management)||12.0||19.3||20.0||53.8||83.0|
|Earnings per share (basic/diluted) (in EUR)||-2.35||-2.30||-0.39||-0.77||-0.78|
|Number of shares issued (end of the year)||6,766||25,529||25,529||25,529||22,694|
* While the financial statements 2013 where prepared on a consolidated basis, the financial statements 2014 were prepared on an unconsolidated basis, since the subsidiary Ingenium was sold in July 2014. For comparison reasons the 2013 financials are also shown in an unconsolidated manner, leaving out Ingenium.
DETAILS OF THE FINANCIAL RESULTS (ACCORDING TO IFRS)
The comparison figures for the financial year 2013 shown below refer to the unconsolidated 2013 numbers.
The net loss amounts to EUR 11,437k (2013: EUR 9,807k), thereof EUR 11,276k (2013: EUR 9,701k) are to be attributed to the operating loss and EUR 170k (2013: EUR 106k) to the financial loss, all in line with the expectations of Probiodrug. The operating loss is primarily driven by the research and development expenses amounting to EUR 8,087k (2013: EUR 8,004k) and to a lesser degree by the general and administrative expenses of EUR 3,430k (2013: EUR 2,444k). The increase in operating expenses reflects primarily IPO preparation costs and the post-listing requirements Probiodrug had to meet. The financial loss is largely driven by the costs incurred with a venture loan line, secured during the IPO preparation.
The equity amounts to EUR 15,971k (2013: EUR -4,304k), corresponding to an equity ratio of 74.4%.
Cash and cash equivalents were EUR 20,920k, compared with EUR 4,421k as at the end of 2013 and reflect the cash inflow from the IPO.
Noncurrent/ current liabilities
The noncurrent liabilities amount to EUR 929k (2013: EUR 1,265k), consisting completely of the net commitment (defined benefit liability) of the pension commitments (defined benefit obligations) of EUR 929k (2013: EUR 535k). The current liabilities amount to EUR 4,580k (2013: EUR 9,320k), consisting primarily of the tax liabilities of EUR 2,543k (comprising the Company’s payment obligations as a result of the tax audit for the period 2002 through 2005 including interest for late payment) and trade payables. The trade payables amounted to EUR 1,036k (2013: EUR 1,314k) resulting from of the ordinary course of business. They have a remaining term of up to one year.
The development approaches of Probiodrug are targeting pyroglutamate-Abeta (pGlu-Abeta) as a therapeutic strategy to fight Alzheimer’s disease. This modified Abeta is considered to be linked with disease initiation and progression by seeding the formation of soluble neurotoxic amyloid oligomers. Probiodrug is developing proprietary product candidates to target toxic pGlu-Abeta via two modes of action: by (i) inhibiting the production of pGlu-Abeta; and (ii) clearing existing pGlu-Abeta from the brain.
Probiodrug’s innovative approaches comprise the development of specific inhibitors for the enzyme Glutaminyl Cyclase (QC), which is instrumental in the creation of pGlu-Abeta. In addition, the company is developing a monoclonal antibody targeting pGlu-Abeta to enhance its clearance.
To date, Probiodrug’s pipeline consists of two small molecule inhibitors of the QC-enzyme, PQ912 and PQ1565, and a monoclonal antibody, PBD-C06, targeting pGlu-Abeta.
In 2014, Probiodrug prepared its lead product candidate PQ912 for a Phase 2a study, the “SAPHIR” study. In a preceding Phase 1 study with healthy young and elderly volunteers PQ912 was shown to be safe and well tolerated and revealed high QC-inhibition.
PQ912 is the first QC-inhibitor being tested in patients. The Phase 2a study is a randomized, double-blind multi-center study which plans to enrol a total of 110 patients with early stage Alzheimer’s disease. Led by internationally renowned experts in AD in five European countries at about 14 sites, the primary endpoint of the trial is the safety and tolerability of PQ912 compared with placebo over a three-month treatment period. Additionally, a set of exploratory read-outs comprising cognitive tests, functional assessments by EEG and functional MRI and new molecular biomarkers in CSF will be used to evaluate the compound’s effect on the pathology of the disease. First data of the “SAPHIR” study are expected mid-2016.
In March 2015, the first patient was enrolled in the Phase 2a study at the Alzheimer Center, VU Medical Center (VUmc), Amsterdam.
PBD-C06 is a monoclonal antibody, currently in preclinical stage. PBD-C06 targets pGlu-Abeta, aiming to selectively clear the brain of pGlu-Abeta while leaving non-toxic forms of Abeta untouched. PBD-C06 has been successfully humanized and also de-immunized to avoid detection by the patient’s endogenous immune system.
PQ1565 is a QC-inhibitor, currently in preclinical stage. The product candidate has shown attractive drug-like properties in preclinical studies. Regulatory toxicology studies are in preparation and production of this molecule is being scaled up.
In January 2015, additional data on Glutaminyl Cyclases (QCs) in its relation to Alzheimer’s disease was published in the journal Acta Neuropathologica. The study provides further evidence of the strong correlation between QCs and AD pathology in human brain biopsies underlining QC-inhibition as a therapeutic approach.
In 2014, Probiodrug’s IP position was further strengthened by important patent applications being granted. These include:
- Patent no. 8,809,010 B2 issued by the U.S. Patent and Trademark Office, covering a broad method of prophylactically treating AD
- Patent no. CA 2,524,009 granted in Canada. Claims of this patent cover the use of glutaminyl cyclase inhibitors for the prevention and treatment of AD
The company issued EUR 4,276k of convertible bonds in May 2014. The conversion rights associated with this convertible bond were completely exercised in August 2014, before the IPO.
Sale of subsidiary Ingenium
The sale of wholly owned subsidiary Ingenium Pharmaceuticals GmbH was completed July 2014. In April 2014, the last instalment of the sales price for the CDK 9 project was collected from AstraZeneca and Ingenium sold afterwards. There are no remaining post contractual obligations.
Adjustment of capital structure in preparation of an IPO
After all existing convertible bonds being converted into equity, the different classes of preference shares were uniformly converted into ordinary shares and the existing investment and shareholder agreements were rescinded. Finally, the ordinary shares issued subsequent to conversion were reduced in a reverse split in the ratio of 6:1.
Execution of the IPO
On 27 October 2014, Probiodrug shares were first listed on Euronext, Amsterdam. 1,524,205 new shares (including the Greenshoe Option) were issued at EUR 15.25 per share and gross proceeds of EUR 23.2 million were generated. The order book had been built with high-quality demand from institutional investors in Europe and the United States of America, as well as demand from Dutch retail investors. Existing shareholders of the Company supported the IPO by purchasing 1,031,454 Offer Shares for a total of approximately EUR 15.7 million. Kempen & Co acted as Sole Global Coordinator and Bookrunner, Petercam acted as Co-Bookrunner, and Close Brothers Seydler acted as Selling Agent.
Management and Supervisory Board
Inge Lues, PhD was appointed as Chief Development Officer in November 2014. Dr Lues joined Probiodrug as R&D advisor in 2008 and has acted as Chief Development Officer since 2013. As a member of the Management Board she is responsible for all research and development activities of Probiodrug.
Axel Polack, MD resigned as member of the Supervisory Board in July 2014 and Hubert Birner, PhD, was elected as new member of the Supervisory Board in August 2014.
The mid-term focus of Probiodrug’s business activities can be summarised as follows:
- Further preclinical and clinical testing of the development candidate PQ912, in particular execution of the first patient study in a Phase 2a “SAPHIR” trial in 2015/ 2016
- Securing further supporting data and intellectual property protection for the therapeutic concept of QC inhibition as a fundamental novel approach for the treatment of Alzheimer’s disease and other diseases
- Further progression of the anti pGlu Abeta specific anti-body (PBD-C06) as well as of PQ1565, an additional small molecule QC inhibitor.
As a result of the additional costs being incurred for development activities, the Company estimates a net loss for the financial year 2015, approximately comparable with that of 2014.
ANNUAL FINANCIAL REPORT 2014
Probiodrug has finalized its financial statements for the year ended 31 December 2014 according to German GAAP (“HGB”) and IFRS. The auditor KPMG has issued an unqualified auditors report for both statements. The reports are available on the company website (https://www.vivoryon.com/investors/reports-and-presentations/).
13 May 2015 Interim Management Statement Q1 2015
10 June 2015 Annual General Meeting of Shareholders in Berlin
27 August 2015 Interim Report, H1 2015
19 November 2015 Interim Management Statement Q3 2015
For more information please contact:
Dr Konrad Glund, CEO,
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 (203) 440-5653
Notes to Editors:
About Probiodrug AG
Headquartered in Halle, Germany, Probiodrug AG is a biopharmaceutical company focused on the development of new therapeutic products for the treatment of Alzheimer’s disease.
Founded in 1997, the company successfully developed a novel therapeutic concept for diabetes – the DP4 inhibitors – which provided the basis for a novel class of antidiabetics – the gliptins. Its core capabilities are based on its long-standing expertise in the elucidation of the structure and function of enzymes involved in the modification of proteins and peptides, which play a central role in pathological conditions.
Today Probiodrug’s aim is to become a leading company in the development of Alzheimer’s disease treatments and to thereby provide a better life for Alzheimer’s disease patients. It has identified a new therapeutic concept linked to disease initiation and progression. The development approaches are targeting pyroglutamate-Abeta (pGlu-Abeta) as a therapeutic strategy to fight Alzheimer’s disease. The Company has medical use and composition of matter patents related to the inhibition of Glutaminyl Cyclase (QC) and anti-pGlu-Abeta- specific monoclonal antibodies, providing it, in the Company’s view, with a leading position in this field of research. www.probiodrug.de
About Alzheimer’s disease
Alzheimer’s disease is a neurological disorder, which is the most common form of dementia, and ultimately leads to death. Because Alzheimer’s disease cannot be cured and is degenerative, the affected patients must increasingly rely on others for assistance. Today, over 35 million people worldwide currently live with the condition and this number is expected to double by 2030 and to more than triple by 2050 to 115 million (World Alzheimer Report 2013).
Forward Looking Statements
Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgment of Probiodrug AG as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.