ThromboGenics Business Update - FY 2017

• Thomas Clay was elected as the new Chairman of the Board of Directors, effective June 15, 2017. Mr Clay joined the ThromboGenics Board as a non-executive in 2011.
• In 2017, the Board acknowledged the resignation of Viziphar Biosciences BVBA, represented by Mr. Staf Van Reet, Innov'Activ BVBA, represented by its permanent representative Patricia Ceysens, and Lugo BVBA, represented by its permanent representative Luc Philips, as Directors of the Board.
• In November 2017, ThromboGenics strengthened its leadership, welcoming two new members to the executive team: Susan Schneider, MD, was appointed Chief Medical Officer (CMO), and Vinciane Vangeersdaele was appointed Chief Commercial Officer (CCO).

Financial

• On January 26, 2018, the completion of an equity investment of €10 million by Novartis Pharma AG in ThromboGenics capital was confirmed as part of the settlement arrangement of September 15, 2017. Novartis Pharma AG now holds a 5.69% stake in ThromboGenics NV.  The cash will be used to progress ThromboGenics' novel diabetic eye disease pipeline.
• ThromboGenics generated overall income of €9.1 million in 2017.
• Inclusive of restricted cash freed up in 2018 through Novartis Pharma AG equity investment, ThromboGenics had, at the end of December 2017, €115.7 million in cash and investments, compared to €80.1 million as of the end of December 2016.

Leuven, Belgium - 15 March 2018 - ThromboGenics NV (Euronext Brussels: THR), a biotechnology company developing novel medicines focused on diabetic eye disease, issues today a business update and its financial update for the year ending December 31, 2017.

ThromboGenics is developing a broad pipeline of disease modifying drug candidates for the treatment of diabetic eye diseases, including:

THR-317 - a PIGF neutralizing monoclonal antibody being developed for the potential treatment of DR and/or DME. Initial top-line results for the Phase I/II study in DME are anticipated to be reported by end of Q1 2018.

THR-149 - a plasma kallikrein inhibitor being developed to treat DME. THR-149 is expected to enter the clinic in H1 2018.

THR-687 - a small molecule integrin antagonist being developed to treat a broad range of patients with DR and/or DME. THR-687 is expected to enter the clinic around mid-2018.

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

Further drug candidates are currently being explored for the treatment of diabetic eye disease and it is expected that at least one additional candidate will be moved into development in 2018.

Patrik De Haes, MD, ThromboGenics CEO, said: "We are pleased with our progress in 2017 and expect to build further momentum during 2018. With an expected 3 clinical studies activated ahead of the summer, we are rapidly executing our 'multiple shots on goal' diabetic eye disease development strategy. Our strong cash position provides us with the means to achieve several value generating milestones from our pipeline of novel drug candidates over the next 12 months."

Research & Development Activities

Diabetes, Diabetic Retinopathy and DME

According to the World Health Organization (WHO), 9% of adults 18 years and older had diabetes in 2014 (WHO, 2015)^[1].

Diabetic eye disease is caused by hyperglycemia (high blood glucose levels) associated with diabetes. If left unchecked hyperglycemia causes damage to the capillaries in the back of the eye (retina) and can result in vision loss and subsequently, blindness².

Diabetic retinopathy (DR) is the leading cause of vision loss among working-age adults, affecting approximately a third of all diabetes sufferers^[2]. Worldwide, the prevalence rate of vision-threatening PDR or DME was estimated to be 11.72% of the diabetic population in 2010 (Yau et al., 2012).

DR progresses from mild, non-proliferative to more severe or even proliferative stages. DME can occur at any point as a complication of DR. As DR progresses, there is a gradual closure of retinal vessels leading to impaired perfusion and retinal ischemia.

THR-317 - anti-PIGF antibody for treatment of DME or DR

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

ThromboGenics completed patient enrolment in a Phase I/II single-masked, multicenter study to evaluate the safety and efficacy of two dose levels of THR-317 for the treatment of DME in December 2017. The last patient has now completed treatment and initial top line results from the study are expected by end of Q1 2018.

DME represents an area of unmet medical need; the current standard of care treatment with anti-VEGFs has been shown in some cases to result in suboptimal and late responses in patients.

In May 2017, during the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, preclinical data were presented supporting the therapeutic potential of THR-317 in DR. These data were subsequently published in Experimental Eye Research, a peer reviewed journal (the article can be found online here).

The data published showed that the murine form of THR-317 was able to reduce DR disease hallmarks; the authors confirm that the anti-PIGF antibody shared a common pharmacology towards vascular leakage in comparison to VEGF inhibitors but that anti-PlGF therapy might provide additional benefits in respect to the reduction of inflammation, the absence of a negative impact on the neuroretina, and the inhibition of fibrotic responses after retinal damage.

In July 2017, ThromboGenics and BioInvent agreed to amend their long-standing agreement covering co-development of novel anti-PIGF monoclonal antibody products, including THR-317. Under the amended arrangement, ThromboGenics has gained full and exclusive ownership of THR-317 for development and commercialization in all non-oncology indications. ThromboGenics continues to carry all costs for development of THR-317 in non-oncology indications, and BioInvent is entitled to 5% of the project's economic value.

THR-149 - a plasma kallikrein inhibitor for treatment of DME

THR-149 is a plasma kallikrein inhibitor being developed to treat DME. The compound is expected to enter the clinic in H1 2018.

Plasma kallikrein is considered a valid target for the treatment of DME through inhibition of the Plasma Kallikrein-Kinin (pKaI-kinin) System. Activation of the pKal-kinin system induces retinal vascular permeability, inflammation and angiogenesis. Based on literature data, patients with DME have elevated levels of plasma kallikrein, and the vitreous level of plasma kallikrein varies less compared to VEGF in these patients. Therefore, a plasma kallikrein inhibitor may be appropriate for the treatment of DME patients.

THR-687 - a small molecule integrin antagonist under development for Diabetic Retinopathy, with or without DME

ThromboGenics is developing THR-687, an integrin antagonist, for the treatment of a broad range of patients with DR, with or without DME. THR-687 is expected to enter the clinic mid-2018.

In September, ThromboGenics presented a poster at the European Association for Vision and Eye Research (EVER) 20th Annual Meeting, providing new preclinical evidence supporting the use of THR-687 for the treatment of back-of-the-eye vascular diseases. The poster was entitled "THR-687, a potent small molecule integrin receptor antagonist, holds promise as a therapeutic approach for back-of-the-eye vascular pathologies."

The studies presented concluded that THR-687 is a potent and safe treatment, highlighting its ability to inhibit various significant stages in pathologic angiogenesis, an important factor leading to vision loss in DR.

The data presented at EVER provide further support to the development of THR-687 in the treatment of DR ahead of its entry into the clinic.

THR-409 (ocriplasmin) CIRCLE Study discontinued

In December 2017, patient enrolment in the Phase II CIRCLE Study was discontinued due to the slow rate of patient recruitment.

CIRCLE was a Phase II, randomised, double-masked, sham-controlled, multicenter study to evaluate the efficacy and safety of ocriplasmin in inducing total posterior vitreous detachment (PVD) in patients with NPDR.

Ocriplasmin was found to be generally safe and well-tolerated with no new safety signals raised. Data from the study will be analyzed and shared with the scientific community via a publication in late 2018/early 2019.

Resources previously earmarked for the CIRCLE study will be re-allocated to progress the current clinical pipeline and advance new drug candidates for the treatment of diabetic eye disease into the clinic in 2018.

Oncurious Update

Growing pipeline with five unique next generation immuno-oncology assets

In September 2017, Oncurious reached an agreement with VIB to acquire a portfolio of five unique next generation immuno-oncology assets, based on seminal work originating from the VIB-KU Leuven and the VIB-VUB labs.

VIB Discovery Sciences is taking the lead in the preclinical development of these new projects.  As part of this agreement, VIB increased its equity share in Oncurious to 18.33% with remainder being owned by ThromboGenics as majority shareholder. VIB will also receive a royalty on future sales of any of these assets. As part of this deal, ThromboGenics will invest an additional €2.1 million in Oncurious which after incorporation in Capital will bring VIB's share back to 14.2%.

The newly acquired assets have resulted in an exciting pipeline of next-generation immuno-oncology drugs targeting a broad spectrum of cancers, in addition to Oncurious' ongoing clinical development activities in orphan pediatric oncology with TB-403.

Clinical Update: TB-403 for Pediatric Brain Cancers

Recruitment is on-going in a Phase I/IIa study with TB-403, 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.

The study, initiated in May 2016 and being conducted by Beat Childhood Cancer (formerly known as NMTRC), aims to recruit 27 patients with Relapsed or Refractory Medulloblastoma.

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.

The European Commission confirmed orphan drug designation for TB-403 for medulloblastoma in January 2017. 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 2017, ThromboGenics and BioInvent amended their long-standing monoclonal antibody development agreement. As per the amended agreement, BioInvent has assumed the project lead for development of TB-403 in all oncology indications and has increased its share in the economic value of TB-403 from 40% to 50%. Both parties continue to share equally the costs of developing TB-403 for oncology indications.

JETREA^® US and Global Update

JETREA^® Commercial

In September 2017, ThromboGenics announced that it regained the non-US rights to JETREA^® from Alcon, a Novartis company, based on a mutual settlement agreement that ThromboGenics is a better fit for building a smaller but sustainable long-term business with this unique drug for the treatment of vitreomacular adhesion/vitreomacular traction.

As part of this agreement, ThromboGenics received €53.7 million in cash and an equity investment by Novartis Pharma AG of €10 million in ThromboGenics capital, which will be used to progress ThromboGenics' novel diabetic eye disease pipeline.

ThromboGenics generated JETREA^® sales of €2.9 million in the US in 2017 and received €1.3 million in royalties from Alcon/Novartis's ex-US sales up to 15 September, 2017. From 16 September 2017, ThromboGenics received €1.7 million in profit transfer as result of a transition agreement following the return of ex-US rights from Alcon/Novartis.

ARVO 2017: Ocriplasmin data presentations demonstrate continued interest

11 ocriplasmin-related presentations, abstracts and posters were delivered at the May 2017 ARVO meeting. These covered real-world clinical data, further characterization of results from different studies, including OASIS and ORBIT, and the cost effectiveness of ocriplasmin.

New Ocriplasmin clinical and health economic data presented at ASRS 2017

ThromboGenics delivered two poster presentations at the 35th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) in August 2017.

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). The conclusion of the presentation was that patients who had to receive a pars plana vitrectomy (PPV) for full-thickness macular hole (FTMH) in one eye, may be able to avoid a second PPV in their other eye with vitreomacular traction by potentially preventing its deterioration to FTMH via early treatment with ocriplasmin.

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.

Corporate Update

CMO and CCO appointments - announced 8 November 2017

Susan Schneider, MD, has been appointed as Chief Medical Officer (CMO). Dr. Schneider is responsible for the development and execution of the Company's global clinical and medical programs. She brings nearly 15 years of experience in clinical drug development and was, most recently, Vice President & Therapeutic Area Head of Retina & Glaucoma at Allergan.

Vinciane Vangeersdaele has been appointed as Chief Commercial Officer (CCO). Vinciane will lead and develop the overall commercial strategy for the Company's recently formed global JETREA^® business unit, created following ThromboGenics regaining the full global rights to JETREA^® from Alcon/Novartis. She will also lead strategic marketing activities for any new compound that emerges from the Company's clinical development pipeline. Vinciane has over 15 years of experience in sales and marketing leadership in the global pharmaceutical industry, the latest being the Head of the Ophthalmology Franchise Europe at Novartis Pharma AG. 

Chairman and Board of Directors

ThromboGenics' long-time non-executive director Mr. Thomas Clay was appointed Chairman of the Board of Directors, effective June 15, 2017. Mr. Clay succeeded Staf Van Reet, PhD.

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 in 2001 when the Company was private.

Effective June 15, 2017, Viziphar Biosciences BVBA, represented by Mr. Staf Van Reet, retired from the Board of Directors of ThromboGenics NV.

Effective September 8, 2017, Luc Philips (Lugo BVBA) and Patricia Ceysens (Innov'Activ BVBA) retired from the Board of ThromboGenics NV. The Board of Directors decided not to replace Viziphar Biosciences BVBA, Lugo BVBA and Innov'Activ BVBA.

Financial review

In 2017, ThromboGenics had total income of €9.1 million, including €2.9 million sales in the US, €1.3 million in royalties, €1.7 million in profit transfer as a result of transition arrangements with Alcon/Novartis and €3.3 million in settlement from previous dispute on vial price.

The latter settlement makes up part of €53.7 million cash ThromboGenics obtained from Alcon/Novartis together with the return of the ex-US JETREA^® rights.

This compares to a 2016 total revenue of €7.1 million, including €4.4 million of JETREA^® sales in the US, €2.2 million in royalties from Alcon/Novartis based on its ex-US sales of JETREA^®,  
€0.3 million from other royalties and €0.2 million from other income.

In 2017, ThromboGenics' R&D expenses amounted to €23.2 million, excluding intangibles amortization.  This compares with €24.7 million of R&D expenses in 2016. 

The current level of R&D spending is the result of the Company's decision to refocus its activities and resources towards drug development, and to start executing the development pipeline of its novel disease-modifying drugs for the treatment of DR, with or without DME.

In 2017, the selling and marketing expenses amounted to €4.2 million compared to €4.3 million in 2016, US commercial operations reached break-even.

In 2017, ThromboGenics obtained other income of €50.4 million, €45.0 million and €4.5 million were received from Alcon/Novartis in compensation respectively for ending the JETREA^® ex-US commercialization agreement and for intervention in obsolescent drug materials.

As a result, ThromboGenics made an operating profit of €23.3 million in 2017 compared to a loss of €60.8 million in 2016.

ThromboGenics had a financial income of €0.4 million in 2017. In 2016, the Company reported a financial income of €0.5 million.

The finance expenses in 2017 amounted to €1.0 million.

In 2017, ThromboGenics made a net profit of €22.6 million resulting in diluted earnings per share of €0.62 versus €1.67 negative diluted earnings per share in 2016.

ThromboGenics had, at the end of December 2017, €115.7 million in cash and investments, inclusive of restricted cash freed up in January 2018 when the Novartis Pharma AG equity investment was completed. This compares with €80.1 million as of the end of December 2016.

The total balance sheet per December 31, 2017 amounted to €150.4 million with cash, cash equivalents, restricted cash and investments representing 77% of the total balance sheet. The Group has no external financial debts.

END

For further information please contact:

Conference call & Q&A

Patrik De Haes, MD, Chief Executive Officer, and Dominique Vanfleteren, Chief Financial Officer, will host a conference call and Q&A at 18:30 CET / 17:30 GMT / 13:30 EDT to discuss the update.

The call will be conducted in English and a replay will be available via the company's website.

To access the conference call, please dial one of the appropriate numbers below quoting the conference ID:

Belgium +32 2 403 58 16
France: +33 (0)1 72 72 74 03
Germany: +49 (0)69 222 225 429
Netherlands: + 31 207 095 119
Switzerland +41 445831805
UK: +44 (0)20 7194 3759
US: +1 8442860643

Conference ID: 36364546#

To access the webcast, please register here

To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled start timing.

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