Probiodrug reports financial results for H1 2016

HALLE (SAALE), Germany, 30 August 2016 – 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 first six months ending 30 June 2016, prepared in accordance with German GAAP (“HGB”) and, on a voluntary basis, in accordance with IFRS as endorsed by the European Union. The reports are available on the company website (https://www.vivoryon.com/investors/reports-and-presentations/).

 

KEY HIGHLIGHTS

• Announcement of favourable results of chronic toxicology studies with PQ912, Probiodrug’s ‘first- in-class’ Glutaminyl Cyclase (QC) inhibitor for the treatment of AD
• Annual Shareholders’ Meeting held on 19 May 2016
• Key patents for Probiodrug´s pGlu-Abeta targeting monoclonal antibody program for the treatment of AD granted in the US and Japan
• Two key patents on Glutaminyl Cyclase (QC) inhibition for the treatment of AD granted in Japan
• Probiodrug’s pGlu-Abeta approaches presented at the 14^th AAT Symposium on Advances in Alzheimer Therapy in Athens, Greece
• Probiodrug and Crossbeta Biosciences entered into a partnership in the field of AD biomarkers
• Probiodrug presented two posters at the 1st Meeting of the newly founded Society for CSF Analysis and Clinical Neurochemistry in Gothenburg, Sweden
• Expenditures and corresponding cash position in line with management expectations
• As of 30 June 2016, Probiodrug held EUR 14.2 million in cash and cash equivalents

 

POST PERIOD HIGHLIGHTS

At the Alzheimer’s Association International Conference 2016 (AAIC) held in Toronto in July 2016, Eli Lilly presented data from a patient trial of LY3002813, its antibody targeting pGlu-Abeta. LY3002813 (also referred to as N3pG) significantly reduced Abeta plaques by approximately 40% at the highest dose of 10mg/kg, while lower doses were ineffective. These results represent the first patient data from an approach targeting pGlu-Abeta and provide encouraging support for the emerging anti pGlu-Abeta field. Eli Lilly has meanwhile advanced LY3002813 into a patient study with longer treatment duration (NCT02624778).

 

Probiodrug announced changes to the Supervisory Board and Executive Management. Olivier Litzka, partner at Edmond de Rothschild Investment Partners (EdRIP) and member of the Supervisory Board since October 2009, will step down effective 12 September 2016. Mark Booth, Chief Business Officer has left the company for personal reasons as of 15 August 2016 and his responsibilities taken up by Dr Konrad Glund, CEO.

 

 

CONFERENCE CALL

Probiodrug will host a conference call open to the public today at 15:00 Central European Summer Time (CEST)/ 09:00 Eastern Daylight Time (EDT) 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: 19299710#

A Question & Answer session will follow the presentation of results.

 

Dial in coordinates

Country	Toll-free	Toll/Local
Austria	0800 301 051(EN) 0800 301 052(DE)	+43 192 80 492 (EN) +43 192 80 494 (DE)
Belgium		+32 11 500 307
Canada (Toronto)		+1 416 216 4186
Finland	0800 523 161	+35 898 171 0496
France	0805 110 449	+33 170 750 705
Germany (Frankfurt)	0800 62 707 15	+49 69 222 229 043 (EN) +49 69 222 229 044 (DE)
Luxemburg	0800 40 184	+35 227 300 157
Netherlands		+31 107 137 273
Sweden	0200 883 629	+46 850 556 469
Switzerland	0800 005 200(EN) 0800 005 205(DE)	+41 225 805 970 (EN) +41 225 805 971 (DE)
United Kingdom		+44 203 009 2452
USA		+1 855 402 7766

 

 

Commenting on the results, Dr Konrad Glund, Chief Executive Officer of Probiodrug said:

“In the first half of 2016, Probiodrug has accomplished important milestones in the development of its programs, targeting pGlu-Abeta in order to treat AD. We concluded the assessment of the results of the chronic toxicology studies with PQ912, our lead QC inhibitor. The results confirm the comfortable safety profile of PQ912, thereby providing an important de-risking event for our lead molecule. They also represent the regulatory prerequisite for long treatment clinical studies in AD patients. With key patents granted in major territories, we continue to make progress in further securing and broadening a robust IP estate around our programs in AD.

 

“Furthermore, the collaboration with Crossbeta provides Probiodrug with a unique technology for validating sensitive and specific assays for Abeta- and pGlu-Abeta-oligomers to be used in the clinical studies of Probiodrug’s lead candidate, QC inhibitor PQ912.

 

“Finally, Eli Lilly presented results from its anti pGlu-Abeta antibody at the AAIC in July, where we saw for the first time clinical data from an approach targeting pGlu-Abeta. These results provide encouraging support for the field pursuing anti pGlu-Abeta approaches as a promising strategy for AD.”

 

KEY FIGURES (ACCORDING TO IFRS)

	Jan – June 2016	Jan – June 2015	Jan – Dec 2015
In EUR k, unless otherwise stated
Earnings, Financial and Net Assets Position
Revenues	0	0	0
Operating loss	-5,987	-6,177	-13,393
Net loss for the period	-6,044	-6,233	-13,505
Equity (end of the reporting period)	10,465	10,160	16,133
Equity ratio (end of the reporting period) (in %)	66.6%	66.0 %	73.8 %
Balance sheet total (end of the reporting period)	15,740	15,383	21,866
Cash flows from operating activities (cum.)	-7,000	-6,119	-12,147
Cash flows from operating activities (monthly average)	-1,167	-1,020	-1,012
Cash flows from financing activities (net)	0	0	12,598
Cash and cash equivalents at the end of the reporting period	14,245	14,793	21,361
Personnel
Total number of employees (incl. Board of management) (end of the reporting period)	16	16	16
Probiodrug-Share
Loss per share (basic/diluted) (in EUR)	-0,81	-0.92	-1.97
Number of shares issued (end of the reporting period)	7,442	6,766	7,442

 

 

DETAILS OF THE FINANCIAL RESULTS (ACCORDING TO IFRS)

 

The comparison figures for the first six months 2016 shown below refer to the corresponding 2015 numbers.

 

Net loss

The net loss amounts to EUR 6,044k (Jan – June 2015: EUR 6,233k), thereof EUR 5,987k (Jan – June 2015: EUR 6,177k) are to be attributed to the operating loss and EUR 57k (Jan – June 2015: EUR 56k) to the financial loss, all in line with the expectations of Probiodrug. The operating loss is primarily driven by research and development expenses amounting to EUR 4,711k (Jan – June 2015: EUR 4,511k) and to a lesser degree by the general and administrative expenses of EUR 1,325k (Jan – June 2015: EUR 1,872k). The slight increase in research and development expenses reflects primarily the development activities of PQ912. The decrease in the general and administrative expenses results mainly from lower administration expenses after the implementation of post listing requirements in 2015.

 

Equity

As of 30 June 2016, the equity amounts to EUR 10,465k (as of 31 December 2015: EUR 16,133k), corresponding to an equity ratio of 66.6% (as of 31 December 2015: 73.8%).

 

Cash

Cash and cash equivalents were EUR 14,245k compared with EUR 21,361k as of 31 December 2015.

 

Noncurrent/ current liabilities

The noncurrent liabilities amount to EUR 820k (as of 31 December 2015: EUR 822k), consisting completely of the net commitment (defined benefit liability) of the pension commitments. The current liabilities amount to EUR 4,454k (as of 31 December 2015: EUR 4,911k), consisting mainly of the tax liabilities of EUR 2,691k (as of 31 December 2015: EUR 2,641k), comprising the Company’s (disputed) 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 1,386k (as of 31 December 2015: EUR 1,629k) resulting from of the ordinary course of business. They have a remaining term of up to one year.

 

OPERATIONAL REVIEW

 

Pipeline update

Probiodrug’s development program targets pyroglutamate-Abeta (pGlu-Abeta, also called N3pG 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 approach is based on the development of specific inhibitors for the enzyme Glutaminyl Cyclase (QC), which is essential for 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.

 

PQ912

Probiodrug is currently running a Phase 2a study, the “SAPHIR” study, of its lead product candidate PQ912. 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. The study is led by internationally renowned experts in AD in seven European countries at about 20 sites, with the Alzheimer Center, VU Medical Center (VUmc), Amsterdam being the lead center. 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.

 

SAPHIR is in full swing. Headline data are expected to be available end of 2016, while the full picture of all exploratory results are expected to be finally evaluated about three to four months thereafter.

 

PBD-C06

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. For the first time for an anti-pGlu-Abeta approach PBD-C06 has not only shown the ability to reduce Abeta/plaques but also to significantly improve cognitive deficits in aged Alzheimer’s mice. Moreover, no evidence was found of increased microhemorrhages after treatment with PBD-C06. This is in line with findings obtained with the murine version mE8 of Eli Lilly’s pGlu-Abeta specific antibody in mice which they were able to confirm in patients.

 

PQ1565

PQ1565 is a QC-inhibitor, currently in preclinical stage. The product candidate has shown attractive drug-like properties in preclinical studies. The GMP process for this molecule is ongoing.

 

 

CORPORATE REVIEW

 

Annual Shareholders’ Meeting 2016

On 19 May 2016, Probiodrug held its 2016 Annual Shareholders’ Meeting. All resolutions proposed by the Company’s Management and Supervisory Board were approved at the meeting, including:

• Adoption of a resolution to approve the actions of the management board members for the financial year 2015
• Adoption of a resolution to approve the actions of the supervisory board members for the financial year 2015
• Election of the financial statements auditor for the financial year 2016
• Elections of the supervisory board
• Remuneration of the supervisory board
• Adoption of a resolution to increase the Authorized Capital 2014 as well as the corresponding amendments to the articles of association
• Adoption of a resolution on the adjustment of the Stock Option Program 2014 and the Conditional Capital 2014/I as well as the corresponding amendments to the articles of association
• Adoption of a resolution on the extension of the exercise periods for the Option Programs 2007/2008 and 2010

 

Supervisory Board

Dr Erich Platzer, Dr Dinnies von der Osten, Dr Jörg Neermann and Dr Olivier Litzka were re-elected as members of the Supervisory Board, with Dr Platzer being appointed as chairman and Dr von der Osten being appointed as vice-chairman.

 

OUTLOOK

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 completion of the first patient study in a Phase 2a trial in 2017 and the evaluation and design of a long -term treatment.
• Compiling further supporting data and securing intellectual property protection for the therapeutic concept of QC inhibition as a novel approach for the treatment of AD and other diseases.
• Further progression of the development of the anti pGlu-Abeta specific antibody (PBD-CO6) as well as of PQ1565.
• Progressing preclinical studies to further evaluate the potential of Probiodrug’s therapeutic candidates in combinations for the treatment of AD and for use in other indications.

 

FINANCIAL STATEMENTS January to June 2016

Probiodrug has finalized its financial statements for the first six months 2016 according to German GAAP (“HGB”) and IFRS. The auditor KPMG has reviewed the IFRS statements. The reports are available on the company website (https://www.vivoryon.com/investors/reports-and-presentations/).

 

Financial calendar 2016

 

10 November 2016                 Interim Management Statement Q3 2016

 

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For more information please contact:

 

Probiodrug
Dr Konrad Glund, CEO
Email:

 

Hume Brophy
Mary Clark, Supriya Mathur, Eva Haas
Tel: +44 (0) 207 862 6475
Email:

 

The Trout Group
Tricia Truehart
Tel: +1 646 378-2953
Email:

 

 

Notes to Editors:

 

About Probiodrug AG

Headquartered in Halle (Saale), Germany, Probiodrug AG (Euronext Amsterdam: PBD) 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 46 million people worldwide currently live with the condition and this number is expected to increase to 132 million by 2050. Alzheimer’s also has an estimated, global societal cost of US$ 818 billion (World Alzheimer Report 2015).

 

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.