• ThromboGenics’ strategy is to deliver shareholder value as a drug development company focused on innovative treatments for back of the eye disease, with a focus on diabetic eye disease
• ThromboGenics is presenting for the first time its exciting drug development pipeline which is targeting diabetic eye disease on March 18 at an IR R&D meeting which will be held in London. This event will be webcast through the ThromboGenics website
• The Company has cash resources of over €100 million which is expected to support its development plans for the next 3 years
• ThromboGenics right-sized its commercial organization supporting JETREA® to ensure its US operations are cash flow neutral in 2016
Research & Development
• ThromboGenics R&D activities are focused on delivering innovative treatments for back of the eye disease, with a focus on diabetic eye disease
• The Company is aiming at delivering novel treatments for diabetic retinopathy (DR) (proliferative diabetic retinopathy (PDR) and non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME))
• The Company has built an exciting and broad pipeline containing novel compounds designed to treat diabetic eye disease in its different forms and severities, and to prevent the progressive loss of vision
• ThromboGenics has initiated a Phase IIa clinical study (CIRCLE) assessing the ability of multiple doses of ocriplasmin (THR-409) to induce a complete posterior vitreous detachment (PVD), and so prevent patients with non-proliferative diabetic retinopathy progressing to proliferative diabetic retinopathy, a serious sight threatening condition
• ThromboGenics’ spun out its oncology research activities into Oncurious NV, a newly created company focused on developing orphan drugs for the treatment of pediatric cancer. Oncurious has been created in conjunction with the VIB (Flanders Institute for Biotechnology), with ThromboGenics being the majority shareholder
• US FDA performed a safety review of its Investigational New Drug (IND) Application for its TB-403 anti-PlGF and concluded that the proposed pediatric clinical study could proceed
• Oncurious plans to commence a Phase I/IIa study with TB-403 for the treatment of medulloblastoma, the most common form of brain cancer in children
• Oncurious signed a collaboration agreement with the Neuroblastoma and Medulloblastoma Translational Research Center (NMTRC), a non-profit US organisation and clinical trial network with the mission to bring forward new effective therapies against neuroblastoma and medulloblastoma. This agreement will provide Oncurious with access to patients for its Phase I/IIa study with TB-403 which will start in Q2 2016
JETREA® - Clinical and Commercial Update
• In 2015, ThromboGenics achieved overall revenues of € 11.2 million from JETREA®. This includes a € 3.2 million in royalty income from its partner Alcon
• ThromboGenics reduced the size of its US organization to reflect the market demand for JETREA® in H2 2015. ThromboGenics Inc. is now a lean customer-centric organization that is continuing to supply JETREA® via a well-established distribution network. As a result, the Company expects its US commercial operations to be cash neutral from 2016 onwards
• ThromboGenics reported positive top-line results from the OASIS study in November 2015. The reported data analysis of the 2 year follow up safety data showed no new safety signals were identified
• Dominique Vanfleteren (as permanent representative of D&V Consult BVBA) was appointed as ThromboGenics Chief Financial Officer (CFO) in January 2015
• Emmanuèle Attout (as permanent representative of Investea sprl) was appointed Independent Non-Executive Director of the Board of ThromboGenics NV on May 5, 2015 and is also a member of the Company’s Audit Committee
• Philippe Baron Vlerick was appointed as Non-Executive Director of the Board of ThromboGenics NV at an extraordinary shareholders’ assembly in August 2015
• In 2015, ThromboGenics achieved overall revenues of € 11.2 million. This includes a € 3.2 million in royalty income from its partner Alcon
• Cash and investments were €101.4 million as of the end of December 2015, compared with €127.1 million at the end of December 2014
• Cash and investments together with revenues received from the commercial sales of JETREA® should support the Company’s activities
Leuven, Belgium – 17 March 2016 - ThromboGenics NV (Euronext Brussels: THR), a clinical stage biotechnology company focused on developing novel medicines for back of the eye disease, particularly diabetic eye disease, today issues a business update and its financial update for the year ending December31, 2015.
In August, ThromboGenics took a strategic decision to focus its resources on drug development. ThromboGenics’ resources are now focused on developing novel medicines for diabetic eye disease, particularly diabetic retinopathy and diabetic macular edema. This decision was driven by the significant potential of the Company’s exciting and broad pipeline of next generation medicines that are targeting novel treatments for this significant and growing unmet medical need.
ThromboGenics significantly reduced the resources for commercializing JETREA® in the US in the second half of 2015, while retaining an organization able to support the existing business opportunity. As a result the Company’s US commercial operations are expected to be cash flow neutral for 2016.
ThromboGenics’ diabetic eye disease pipeline, which is one of the strongest in the industry, includes:
THR-409 – an ongoing Phase IIa (CIRCLE) clinical study is evaluating the efficacy and safety of multiple doses of ocriplasmin in inducing total posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR).
THR-317 – a PLGF neutralizing monoclonal antibody is being developed for DME and/or for use in combination therapy with current anti-VEGF treatments. THR-317 is expected to enter clinical development in H2 2016.
THR-149 – a plasma kallikrein inhibitor is being developed to treat edema associated with diabetic retinopathy. (This compound has resulted from the Company’s research collaboration with Bicycle Therapeutics)
THR-687 – a small molecule integrin antagonist being developed to treat a broad range of patients with diabetic retinopathy, with or without DME. (In-licensed from Galapagos NV)
The Company will outline the full details of its drug development pipeline on March 18, 2016 at a London organized Investor Relations meeting focused on its Ophthalmology Research and Development plans.
In addition, ThromboGenics, through its oncology spin-off Oncurious, is about to start a Phase I/IIa clinical trial in children assessing TB-403 for the treatment of medullablastoma, a pediatric brain tumor.
Dr. Patrik De Haes, ThromboGenics’ CEO, said: “In recent months it has become clear that we have an opportunity to generate important returns for our shareholders by focusing on our exciting drug development pipeline of potential new disease modifying medicines for the treatment of diabetic eye disease. Diabetic Retinopathy and Diabetic Macular Edema (DME) are significant indications where there are clear unmet needs and a strong demand for improved or add-on treatment options. We now have THR-409 (ocriplasmin) in a Phase IIa study to assess whether multiple doses can prevent the progression of NPDR to PDR, a sight threatening condition which is currently treated poorly. In addition, we have 3 other compounds under development, one of which is expected to enter the clinic before the end of 2016, giving ThromboGenics one of the industry’s strongest pipelines targeting diabetic eye disease.
Our oncology company, Oncurious, has the potential to become another important source of value as we continue the clinical development of TB-403 for pediatric brain cancers and potential other orphan indications.
With our current cash resources of over €100 million, we can support our activities for 3 years, allowing us to demonstrate the value of our exciting pipeline.”