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ThromboGenics Business Update - H1 2017
[September 07, 2017]

ThromboGenics Business Update - H1 2017


Press release                                                         
7 September, 2017
Regulated Information

Good Progress in Advancing Diabetic Eye Disease Portfolio

Oncurious NV grows pipeline with 5 immuno-oncology assets from VIB

Cash Position - €65.1 Million end H1 2017

Highlights

  • ThromboGenics is making good progress in advancing its portfolio of innovative medicines for the treatment of diabetic eye disease: its pipeline consists of 4 compounds targeting novel treatments for diabetic retinopathy (DR) - non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) - in the presence or absence of diabetic macular edema (DME)
     
  • ThromboGenics is conducting a Phase II clinical study evaluating THR-317 (anti-PlGF) for Diabetic Macular Edema (DME). The trial was initiated in January 2017 and assesses THR-317's ability to improve best-corrected visual acuity (BCVA) and to reduce central retinal thickness in subjects with DME. Study results are expected during Q1 2018.
     
  • ThromboGenics is conducting a Phase IIa clinical study (CIRCLE) evaluating THR-409 (ocriplasmin) to induce complete posterior vitreous detachment (total PVD) and to prevent progression to PDR (a serious sight threatening condition) in patients with NPDR.
     
  • ThromboGenics is making good progress with its late-stage preclinical pipeline:
    • THR-687 (integrin antagonist) is being developed to treat a broad range of patients with diabetic retinopathy, with or without DME. THR-687 is expected to enter the clinic in H1 2018
       
    • THR-149 (pKal inhibitor) is being developed to treat edema associated with diabetic retinopathy. THR-149 is expected to enter the clinic in H1 2018.
       
  • ThromboGenics and BioInvent amended their long-standing agreement, which covers co-development of the novel anti-PlGF monoclonal antibody products (known as THR-317 and TB-403). Under the revised agreement, ThromboGenics will gain full and exclusive ownership of THR-317 for development and commercialization in all non-oncology indications. BioInvent will have a 5% share in the economic value of THR-317. The agreement will also see BioInvent increase its economic stake in the TB-403 project from 40% to 50%. The costs of this project will continue to be shared equally.
  • The European Commission granted orphan drug designation to TB-403 in January 2017. Oncurious NV is developing TB-403 for treatment of medulloblastoma, the most common pediatric malignant brain tumor.
  • In August 2017, Oncurious announced agreement with VIB for expanding its pipeline with 5 unique next generation immuno-oncology (IO) assets for treatment of a broad spectrum of cancers.
     
  • In H1 2017, ThromboGenics reported overall revenues of €2.7 million from JETREA®, including €0.8 million in royalty income from its partner Alcon (Novartis).
     
  • Cash and investments were €65.1 million as of the end of June 2017. This compares to €80.1 million as of December 31, 2016.

Leuven, Belgium - 7 September 2017 - ThromboGenics NV (Euronext Brussels: THR), a biotechnology company developing novel medicines for diabetic eye disease, today issues a business update for the six month period ending 30 June, 2017.

ThromboGenics is developing an industry-leading pipeline of disease modifying drug candidates for diabetic eye disease, particularly diabetic retinopathy (DR) and diabetic macular edema (DME).

The clinical pipeline consists of THR-409 and THR-317, both from the Company's in-house research. The Company's pre-clinical candidates are THR-687, which was in-licensed from Galapagos NV in March 2016 and THR-149, which resulted from a research collaboration with Bicycle Therapeutics.

These products all have different modes of action and will allow the Company to address the four key segments of the rapidly growing diabetic eye disease market:

  • Non-proliferative DR
  • Proliferative DR
  • Non-proliferative DR with DME
  • Proliferative DR with DME

Dr. Patrik De Haes, ThromboGenics CEO, said: "ThromboGenics' pipeline, both clinical and pre-clinical, which is targeting the key segments of the diabetic eye disease market, is progressing well.  With first results from our Phase II clinical study for THR-317 in the treatment of Diabetic Macular Edema expected in Q1 2018, and our pre-clinical products candidates poised to enter the clinic, we are well positioned to deliver multiple milestones over the next 12 months that could create significant value for our shareholders."

Progressing Preclinical and Clinical Development of Treatments for Diabetic Eye Disease

Diabetic retinopathy (DR) is the leading cause of visual disability and blindness among professionally active adults. More than one in three living with diabetes (35.4%) will develop some form of DR in their lifetime. One in five patients with DR presents with sight threatening diabetic macular edema (DME).

ThromboGenics pipeline comprises of:

  • THR-317 - a PlGF inhibitor under development for DME and potentially as a combination therapy with current anti-VEGF treatments for DME or DR. THR-317 entered the clinic at the beginning of 2017. First Phase II results are expected in Q1 2018.
  • THR-409 (ocriplasmin) - is being evaluated in a Phase IIa (CIRCLE) clinical study assessing the efficacy and safety of different dose levels of THR-409 in inducing total posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR).
  • THR-687 - an integrin antagonist under development to treat a broad range of patients with DR, with or without DME. THR-687 was in-licensed from Galapagos NV in 2016. THR-687 is expected to enter the clinic in H1 2018.
  • THR-149 - a selective plasma kallikrein inhibitor under development to treat the edema associated with DR. This compound results from the Company's research collaboration with Bicycle Therapeutics. ThromboGenics has started pivotal toxicology studies and is preparing for clinical development, expected to start in H1 2018.

THR-317 - anti-PlGF antibody to treat DME

ThromboGenics enrolled the first patients in a Phase II, single-masked, multicenter exploratory study evaluating the safety and efficacy of two dose levels of THR-317 for the treatment of diabetic macular edema (DME) in January 2017.

THR-317 (anti-PlGF) is a recombinant human monoclonal antibody directed against the receptor-binding site of human placental growth factor (PlGF).

The Phase II study will evaluate the safety of three intravitreal injections of two dose levels of THR-317 (4 mg or 8 mg). The trial will also assess THR-317's ability to improve best-corrected visual acuity (BCVA) and to reduce central retinal thickness in subjects with DME.

The study plans to enroll a total of 50 patients (including 10 anti-VEGF treatment resistant patients) over a period of about 12 months. The first results from the study are expected in Q1 2018.

ThromboGenics believes that THR-317 holds potential as a therapy for treatment of DME or DR, as a stand-alone therapy for patients who are not responding well to anti-VEGF, or as an add-on treatment with anti-VEGF medicines.

At the ARVO meeting's Diabetic Retinopathy session in May a presentation on THR-317, entitled "Neutralization of placental growth factor as a novel treatment option in diabetic retinopathy", took place. The study presented looked at the effects of PlGF inhibition on the hallmarks of DR and concluded that PlGF neutralization was equally efficacious compared to VEGF inhibition in terms of vascular leakage, but unlike VEGF inhibition, it also reduces inflammation and fibrosis, without triggering a neurodegenerative response.

In July 2017, ThromboGenics and BioInvent agreed to amend their long-standing agreement, which covers co-development of the novel anti-PlGF monoclonal antibody products, including THR-317 which ThromboGenics is developing for the treatment of DME. Under the amended arrangement, ThromboGenics gains full and exclusive ownership of THR-317 for development and commercialization in all non-oncology indications. ThromboGenics will continue to carry all costs for development of THR-317 in non-oncology indications, and BioInvent is entitled to five percent of the project's economic value. The definitive amended agreement will be put into place by Q3 2017.

THR-409 for Non Proliferative Diabetic Retinopathy - CIRCLE Study

The CIRCLE study is evaluating the ability of multiple doses of THR-409 (ocriplasmin) to induce a total PVD in patients with NPDR. The study is also assessing the safety of multiple doses of THR-409.

ThromboGenics aims to reduce the risk of disease progression to PDR by inducing a total PVD using THR-409. Research has suggested that total PVD, a complete separation of vitreous and retina, could prevent the progression of NPDR to PDR.

The CIRCLE study is a Phase II, randomized, double-masked, sham-controlled, multi-center study that will evaluate the efficacy and safety of up to 3 intravitreal injections of either 0.125mg or 0.0625mg of THR-409 in subjects with moderate to severe NPDR, to induce total PVD in order to reduce the risk of the patient developing sight-threatening PDR.

In December the protocol of the CIRCLE study was amended to allow the trial to recruit from a broader pool of patients. Patient recruitment has picked up following this protocol amendment.

The primary endpoint of the CIRCLE study is the percentage of patients with total PVD by the month 3 visit, confirmed by both B-scan ultrasound and SD-OCT.

Furthermore, 2 year follow up of patients may provide insights into THR-409's potential to reduce the risk of progressing from NPDR to PDR.

Further Supportive Ocriplasmin Clinical and Health Economics Data reported

ThromboGenics pioneered the pharmacological vitreolysis drug class through the development of JETREA® (ocriplasmin), the only pharmacological vitreolysis drug approved for the treatment of symptomatic vitreomacular adhesion and vitreomacular traction in over 54 countries globally. Since its first introduction in early 2013, over 27,000 patients have been treated with JETREA®.

ARVO 2017 Baltimore: Ocriplasmin data presentations underwrite continued interest

11 ocriplasmin-related presentations, abstracts and posters were delivered at ARVO (Association for Research in Vision and Ophthalmology) 2017 Annual Vision Research Meeting in Baltimore. These covered preclinical research findings, real-world clinical data, and further characterization of results from different studies, including OASIS and ORBIT and the cost effectiveness of ocriplasmin.

New Ocriplasmin clinical and health economic data were presented at ASRS 2017 meeting in Boston

At the 35th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) held in Boston, ThromboGenics delivered two poster presentations.

The first poster presentation was entitled "'Comparison of Visual Results in Patients Receiving Vitrectomy for Macular Hole in One Eye and Ocriplasmin for Vitreomacular Traction in the Fellow Eye' (by Arshad M. Khanani et al).

In his conclusion, Arshad M. Khanani MD, MA, Managing Partner and Director of Clinical Research, Sierra Eye Associates and Clinical Associate Professor, University of Nevada, Reno, commented:  "Patients who underwent PPV for FTMH benefited from early ocriplasmin treatment in their other eye with VMT that had not progressed to a FTMH. By administering ocriplasmin to these patients we could potentially avoid development of FTMH in the VMT eye with ocriplasmin administration, thus avoiding a second PPV."

In the second poster presentation, entitled 'Budget Impact Analysis of Ocriplasmin for the Treatment of Vitreomacular Traction in the United States', Peter K. Kaiser, MD, Department of Ophthalmology, Cole Eye Institute, Cleveland Clinic, Cleveland, OH presented data from the OASIS randomized trial, a 2-year follow-up study evaluating ocriplasmin for the treatment of symptomatic VMA (VMT) including macular hole. He also presented a new budget impact model that was developed in accordance with the principles of good practice published by the International Society for Pharmacoeconomics and Outcomes Research.

Dr. Kaiser concluded that "The use of ocriplasmin injections for VMT may be affordable to US health plans, as its costs could be offset by an expected reduction in the number of PPVs and a reduction in overall complications. Future research on the cost-effectiveness of ocriplasmin in patients with VMT will be forthcoming to further determine the economic impact of ocriplasmin injections."

Oncurious Update

Growing pipeline with 5 unique next generation immuno-oncology assets

In August 2017, Oncurious reached principle agreement with VIB to acquire exclusive licences to a portfolio of five unique next generation immuno-oncology assets, based on seminal work originating from the VIB-KU Leuven labs of Massimiliano Mazzone and Gabriele Bergers, and from the VIB-VUB lab of Jo Van Ginderachter.  With this acquisition, Oncurious broadens its ongoing clinical development activities in orphan pediatric oncology indications with preclinical research and drug development programs, resulting in an exciting pipeline of next-generation immuno-oncology drugs targeting a broad spectrum of cancers.

VIB Discovery Sciences will take the lead in the pre-clinical development of these new projects.  As part of this agreement, VIB will increase its stake in Oncurious, with ThromboGenics remaining the majority shareholder. VIB will also receive a royalty on future sales of any of these assets. ThromboGenics invests an additional €2.1 million in Oncurious.

Clinical Update: TB-403 for Pediatric Brain Cancers

TB-403 is a humanized monoclonal antibody against placental growth factor (PlGF). PlGF is expressed in several types of cancer, including medulloblastoma. High expression of the PlGF receptor neuropilin 1 has been shown to correlate with poor overall survival.

Medulloblastoma is the most common pediatric malignant brain tumor, accounting for 20% of all brain tumors in children. Treatment with TB-403 in relevant animal models for medulloblastoma has demonstrated beneficial effects on tumor growth and survival.

In May 2016, a Phase I/IIa study was initiated with TB-403. The study, which is being conducted by Beat Childhood Cancer (formerly known as NMTRC), aims to recruit 27 patients with Relapsed or Refractory Medulloblastoma. Patient recruitment is on-going.

In January 2017, the European Commission confirmed orphan drug designation for TB-403 for medulloblastoma. The orphan designation allows a pharmaceutical company to benefit from incentives from the European Union to develop a medicine for a rare disease, such as reduced fees and protection from competition once the medicine is on the market.

TB-403 is being developed by Oncurious in conjunction with BioInvent International.

In July, ThromboGenics and BioInvent amended their long-standing monoclonal antibody development agreement. In the amended agreement, BioInvent assumes the project lead for the development of TB-403 in all oncology indications and will increase its share in the economic value of TB-403 from 40% to 50%. Both parties will continue to share equally the costs of developing TB-403 for oncology indications. The definitive amended agreement will be put into place by Q3 2017.

Financial & Corporate Update

Financial Update

In the first half of 2017, ThromboGenics generated total revenues of €2.7 million, including €1.9 million of product sales in the US and €0.8 million in royalty income based on ex-US sales of JETREA®. In the corresponding period in 2016, ThromboGenics reported a total income of €4 million.

During the first six months of 2017, the group reported a gross profit of €0.8 million.

ThromboGenics' R&D expenses for the first half of 2017 amounted to €10.5 million, compared to €12.0 million for the same period in 2016. The first half of 2017 figure included €1.6 million for amortization of intangible assets relating to the ocriplasmin Phase III program in the VMA/VMT indication, compared with €3.4 million in the same period in 2016.

In the first half of 2017, selling and marketing expenses amounted to €2.1 million compared with €2.2 million in H1 2016.

For the first half of 2017, ThromboGenics reported a net loss of €15.2 million, or €0.42 per share. This is on a par with the corresponding period in 2016 when the Company reported a net loss of €15.0 million or €0.42 per share.

As of June 30 2017, ThromboGenics had €65.1 million in cash and investments. This compares to €80.1 million as of December 31, 2016.

Corporate Update: Chairman and Board of Directors

Effective 15 June 2017, ThromboGenics' long-time non-executive director Mr. Thomas Clay was appointed Chairman of the Board of Directors. The appointment coincided with the retirement of Staf Van Reet, PhD (former Chairman of the Board) from ThromboGenics.

Thomas Clay is Vice-President of East Hill Management, a US-based investment company. He also serves as the Chairman and CEO of Golden Queen Mining Co., Ltd., and is a Director of the Clay Mathematics Institute.

Thomas Clay has been a non-executive Director of ThromboGenics NV since 2011. In that year, he replaced his father, Landon T. Clay, who led the first external investment in ThromboGenics back in 2001 when the Company was private.

Effective 8 September 2017, Luc Philips (Lugo BVBA) and Patricia Ceysens (Innov'Activ BVBA) retire from the Board of ThromboGenics nv.

END
For further information please contact:

ThromboGenics
Wouter Piepers,
Global Head of Corporate Communications & IR

 

+32 16 75 13 10 / +32 478 33 56 32
wouter.piepers@thrombogenics.com

 
Citigate Dewe Rogerson
David Dible/Sylvie Berrebi/Isabelle Andrews

 

Tel: +44 20 7282 2867 
david.dible@citigatedr.co.uk
Sylvie.berrebi@citigatedr.co.uk

About ThromboGenics

ThromboGenics is a biopharmaceutical company focused on developing innovative treatments for diabetic eye disease. The company's pipeline of disease modifying drug candidates is targeting the key segments of the diabetic eye disease market.

ThromboGenics is currently enrolling patients in a Phase II clinical study evaluating THR- 317, a PlGF inhibitor that is being developed for the treatment of diabetic macular edema, as a stand-alone or as a combination therapy with anti-VEGF treatments.

ThromboGenics is also conducting a Phase IIa clinical trial evaluating multiple doses of THR-409 (ocriplasmin) to induce a total Posterior Vitreous Detachment in patients with Non-Proliferative Diabetic Retinopathy (NPDR).

In addition, THR-149, a plasma kallikrein inhibitor, which has resulted from research collaboration with Bicycle Therapeutics, and THR-687, an integrin antagonist, which was in-licensed from Galapagos, are in late stage pre-clinical development.

ThromboGenics pioneered a new drug category of pharmacological vitreolysis with JETREA® (ocriplasmin) which is now approved for the treatment of vitreomacular traction in 54 countries worldwide. ThromboGenics is commercializing JETREA® via its subsidiary ThromboGenics, Inc. in the US. Novartis commercializes JETREA® outside the United States.

ThromboGenics is headquartered in Leuven, Belgium, and is listed on the NYSE Euronext Brussels exchange under the symbol THR.  More information is available at www.thrombogenics.com

Important information about forward-looking statements

Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.

This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction.  No securities of ThromboGenics may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.

Consolidated key figures as of June 30, 2017

Unaudited Consolidated statement of financial position

In '000 euro (for the period ended on) June 30, 2017 December 31, 2016
     
Property, plant and equipment 1,455 1,743
Intangible assets 24,323 25,902
Goodwill 0 0
Other non-current assets 161 202
Non-current tax receivable 996 2,350
Inventories 2,296 2,614
Trade and other receivables 6,600 7,672
Current tax receivable 2,073 1,085
Investments 21,720 21,817
Cash and cash equivalents 43,417 58,251
Employee benefits 0 0
Total assets 103,041 121,636
Total equity 94,733 109,859
Current liabilities 8,308 11,777
Total equity and liabilities 103,041 121,636

Unaudited Consolidated statement of profit and loss

In '000 euro (for the period ended on June 30) 2017 2016
     
Income 2,746 3,980
Operating result -15,012 -14,988
Finance income 67 141
Finance expense -273 -155
Result before income tax -15,218 -15,002
Income tax expense -3 -10
Loss of the period -15,221 -15,012
Result per share    
Basic earnings per share (euro) -0.42 -0.42
Diluted earnings per share (euro) -0.42 -0.42

Condensed consolidated interim financial statements


Unaudited consolidated statement of profit and loss

In '000 euro (for the period ended on June 30) 2017 2016
     
Income 2,746 3,980
Sales 1,886 2,570
License income 0 0
Income from royalties 860 1,410
Cost of sales -1,996 -1,429
Gross profit 750 2,551
Research and development expenses -10,544 -12,012
General and administrative expenses -3,176 -3,381
Selling expenses -2,062 -2,201
Other operating income 20 55
Impairment losses 0 0
Operating result -15,012 -14,988
Finance income 67 141
Finance expense -273 -155
Result before income tax -15,218 -15,002
Taxes -3 -10
Loss of the period -15,221 -15,012
     
Attributable to:    
Equity holders of the company -15,214 -15,016
Non-controlling interest -7 4
     
Result per share    
Basic earnings per share (euro) -0.42 -0.42
Diluted earnings per share (euro) -0.42 -0.42

Unaudited consolidated statements of other comprehensive income

In '000 euro (for the period ended on June 30) 2017 2016
Loss of the period -15,221 -15,012
Exchange differences on translation of foreign operations 7 -30
Other comprehensive income, net of income tax 7 -30
Other comprehensive income that may be reclassified to profit or loss 0 0
Other comprehensive income that will not be reclassified to profit or loss 7 -30
Total comprehensive income for the period -15,214 -15,042
Attributable to:    
Equity holders of the company -15,207 -15,046
Non-controlling interest -7 4

Unaudited consolidated statement of financial position

In '000 euro (for the period ended on) June 30, 2017 December 31, 2016
     
ASSETS    
Property, plant and equipment 1,455 1,743
Intangible assets 24,323 25,902
Goodwill 0 0
Other non-current assets 161 202
Non-current tax receivable 996 2,350
Non-current assets 26,935 30,197
Inventories 2,296 2,614
Trade and other receivables 6,600 7,672
Current tax receivable 2,073 1,085
Investments 21,720 21,817
Cash and cash equivalents 43,417 58,251
Current assets 76,106 91,439
Total assets 103,041 121,636
     
EQUITY AND LIABILITIES    
Share capital 151,991 151,991
Share premium 157,661 157,661
Accumulated translation differences -178 -185
Other reserves -13,229 -13,317
Retained earnings -201,548 -186,334
Equity attributable to equity holders of the company 94,697 109,816
Non-controlling interest 36 43
Total equity 94,733 109,859
Trade payables 3,082 5,941
Other short-term liabilities 5,226 5,836
Current liabilities 8,308 11,777
Total equity and liabilities 103,041 121,636

Unaudited consolidated statement of cash flows

In '000 euro (for the period ended on June 30) 2017 2016
     
Cash flows from operating activities    
(Loss) profit for the period -15,221 -15,012
Finance expense 273 155
Finance income -67 -141
Depreciation on property, plant and equipment 379 453
Amortization of intangible assets 1,579 3,401
Increase in accruals and employee benefits 0 0
Equity settled share-based payment transactions 88 78
Change in trade and other receivables including tax receivables and stock 1,756 170
Change in short-term liabilities -3,469 2,433
Net cash (used) from operating activities -14,682 -8,463
     
Cash flows from investing activities    
Disposal of property, plant and equipment (following a sale) 48 45
Change in investments 97 -16,463
Interest received and similar income 10 45
Acquisition of intangible assets 0 -1,000
Acquisition of property, plant and equipment -139 -473
Acquisition (divestments) of other non-current assets 41 38
Net cash (used in) generated by investing activities 57 -17,808
     
Cash flows from financing activities    
Proceeds from issue of share capital 0 0
Paid interests -5 -2
Net cash (used in) generated by financing activities -5 -2
     
Net change in cash and cash equivalents -14,630 -26,273
Cash and cash equivalents at the start of the period 58,251 93,341
Effect of exchange rate fluctuations -204 -86
Cash and cash equivalents at the end of the period 43,417 66,982

Unaudited consolidated statement of changes in equity

  Share capital Share premium Cumulative translation differences Other reserves Retained earnings Attributable to equity holders of the company Non-controlling interest Total
Balance as at January 1, 2016 151,991 157,661 -221 -13,473 -126,020 169,938 77 170,015
Loss of the period 2016 0 0 0 0 -15,016 -15,016 4 -15,012
Change to foreign currency translation difference and revaluation reserve 0 0 -30 0 0 -30 0 -30
Share-based payment transactions 0 0 0 78 0 78 0 78
Balance as at June 30, 2016 151,991 157,661 -251 -13,395 -141,036 154,970 81 155,051
                 
Balance as at January 1, 2017 151,991 157,661 -185 -13,317 -186,334 109,816 43 109,859
Loss of the period 2017 0 0 0 0 -15,214 -15,214 -7 -15,221
Change to foreign currency translation difference and revaluation reserve 0 0 7 0 0 7 0 7
Net change in fair value of investments 0 0 0 0 0 0 0 0
Issue of ordinary shares 0 0 0 0 0 0 0 0
Share-based payment transactions 0 0 0 88 0 88 0 88
Balance as at June 30, 2017 151,991 157,661 -178 -13,229 -201,548 94,697 36 94,733

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