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  • 17 May 21
Varoglutamstat on crest of Alzheimer therapy wave

Recent data suggests that we may be turning a corner in the quest for a disease modifying drug for Alzheimer's Disease ("AD"}. With Lilly's Phase 2 posive donanemab data supporng its mode of acon ("MoA"), VVY's varoglutamstat (PQ912) is on crest of the new AD therapy wave. With signs of efficacy from SAPHIR Phase 2a, the drug is well-placed to become one of the first AD modifying drugs. Orally delivered with acceptable tolerability, it should also be well suited to combinaon therapy that wil

Companies: Vivoryon Therapeutics N.V.

goetzpartners securities Limited
  • 28 Sep 20
Leading in Alzheimer's with major deals in pipeline

With its Phase IIb VIVIAD trial fully funded and recruiting, Vivoryon ("VVY") leads in next generation Alzheimer's Disease ("AD") therapy. Targeting both neurotoxic and inflammatory components of AD via glutaminyl cyclase ("QPCT"), varoglutamstat ("PQ912") has already shown efficacy in early disease. A positive outcome in the current Phase IIb trial should provide the basis for substantial licensing deal and even conditional approval in 2023E / 2024E, Nearer term, with QPCT activity strongly imp

Companies: Vivoryon Therapeutics N.V.

goetzpartners securities Limited
  • 20 Mar 19
$15m cash injection from NIH for US Phase IIb in early Alzheimer's

Probiodrug announced that it has received a $15m grant from the National Institutes of Health ("NIH") to partially fund the Phase IIb trial for PQ912, a small molecule glutaminyl cyclase ("QC") inhibitor in development for Alzheimer’s disease (“AD”). In addition to providing much needed cash, it provides a strong endorsement for the development of PQ912 in early AD, particularly taking into account that obtaining an NIH grant is a highly competitive process. Preparations for the US Phase IIb tri

Companies: Vivoryon Therapeutics N.V.

goetzpartners securities Limited
  • 20 Jan 19
Probiodrug - Suspension of coverage

Edison Investment Research is suspending coverage on Probiodrug (PBD). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant.

Companies: Vivoryon Therapeutics N.V.

Edison
  • 01 Nov 18
Probiodrug - Support for Abeta theory from Biogen/Eisai

We believe one of the main reasons for the devaluation of Probiodrug’s shares over the past year was the largely disappointing industry newsflow frustrating research on Abeta theory, even though Probiodrug’s technology is differentiated from all other Abeta therapies studied in late-stage trials. The recent surprise announcement of disease-modifying effect obtained by Biogen/Eisai with their MAb BAN2401 in a Phase II trial may reignite interest in the amyloid theory and in the Alzheimer’s diseas

Companies: Vivoryon Therapeutics N.V.

Edison
  • 15 Oct 18
Loss announcement a non-event

Probiodrug announced to the market that a cumulative loss of more than half of the nominal share capital of the company has been incurred, due to operating losses resulting from ordinary business operations. Management will therefore need to summon an extraordinary general meeting ("EGM") without undue delay. Invitation and agenda will be provided in due course. We note that this is a technicality required to comply with the German Stock Corporation Act and has no further consequences beyond the

Companies: Vivoryon Therapeutics N.V.

goetzpartners securities Limited
  • 03 Sep 18
Phase IIb trial prep for PQ912 in AD continues

The key takeaways of Probiodrug's H1/2018 results were (1) additional details about the US Phase IIb trial for PQ912 in early Alzheimer's disease ("AD"), (2) a progress update for the EU Phase IIb trial, and (3) confirmation that the company is financed until at least Q1/2019E, but potentially Q3, depending on the level of investment into the PQ912 Phase IIb programme. Management remains focused on raising funds and all options are on the table, including debt, equity and a licensing deal with a

Companies: Vivoryon Therapeutics N.V.

goetzpartners securities Limited
  • 13 Jul 18
Positive read-across from BAN2401 Phase II data

Eisai / Biogen recently reported positive top-line data for the 856-patient Phase II trial Study 201 for the anti-amyloid beta ("Abeta") protofibril mAb BAN2401 in early Alzheimer's disease ("AD"). This is the first time a late-stage trial in AD shows disease-modifying effects with regard to both Abeta reduction in the brain and an improvement of clinical function. Importantly, the data supports the Abeta hypothesis for AD therapy and is a much-needed development following a string of late-stage

Companies: Vivoryon Therapeutics N.V.

goetzpartners securities Limited
  • 13 Apr 18
Probiodrug - Emerging details of PQ912 late-stage development

The highlight of Probiodrug’s FY17 results presentation was the rather detailed introduction of the Phase IIb development programme for the lead asset PQ912, a small molecule inhibitor of glutaminyl cyclase (QC) for Alzheimer’s disease (AD) patients. Two Phase IIb trials (in Europe and the US) are designed to gather the amount of data that, if sufficiently positive, could allow for accelerated or conditional regulatory approval. The first Phase IIb study in Europe is expected to start by end 201

Companies: Vivoryon Therapeutics N.V.

Edison
  • 10 Apr 18
Lifting the veil on Phase IIb design

The key updates at Probiodrug’s FY2017 results were the overall strategy for the Phase IIb programme and the detailed design of the European study for lead compound PQ912, a small molecule glutaminyl cyclase ("QC") inhibitor in development for Alzheimer’s disease (“AD”). The trial design incorporates the draft guidance provided by the FDA and the EMA in February 2018 for the development of drugs in early AD patients, with a focus on detecting changes in cognition thus building on the clinical da

Companies: Vivoryon Therapeutics N.V.

goetzpartners securities Limited
  • 30 Nov 17
Q3 positive, Phase IIb on track

Probiodrug provided a positive Q3 business update confirming that the Phase IIb clinical programme for lead compound PQ912 for Alzheimer's disease ("AD") remains on track. R&D expenses of €1.13m came in below Q1 and Q2 levels (due to the completion of the Phase IIa SAPHIR study) and below our estimates, suggesting a narrower FY 2017 net loss than we currently model. Reported cash of €11.7m should allow Probiodrug to fund operations through at least 2018 in the absence of a licensing deal. We rei

Companies: Vivoryon Therapeutics N.V.

goetzpartners securities Limited
  • 16 Oct 17
Optimising the dose - phase IIb to start

PQ912, the oral first-in-class QC inhibitor for AD showed encouraging data from the phase IIa SAPHIR study in June. Probiodrug has quickly defined the Phase IIb strategy with 2 core studies that aim to optimise dose in order to maintain good QC inhibition and avoid any early adverse events. We forecast PQ912 annual global sales of c.$15bn in an AD market worth c.$73bn by 2025. Other drug classes in clinical development for AD have experienced setbacks so PQ912 is now looking even more attractive

Companies: Vivoryon Therapeutics N.V.

goetzpartners securities Limited
  • 27 Sep 17
Signs of synaptic improvement

Probiodrug's lead product, PQ912 is an oral first-in-class QC inhibitor for AD. The phase IIa SAPHIR study showed it to be safe and tolerated at a high dose resulting in >90% occupancy. High target occupancy against QC means lower doses can be used in Phase IIb/III. Several indicators of efficacy concurred on signs of synaptic improvement; biomarkers, EEG and NTB. We forecast PQ912 annual global sales of c.$15bn in an AD market worth c.$73bn by 2025. Other drug classes in clinical development fo

Companies: Vivoryon Therapeutics N.V.

goetzpartners securities Limited
  • 18 Sep 17
- Focusing on further PQ912 development strategy

Operating costs in H117 were largely in line with our expectations, while a one-off payment was a welcome resolution of Probiodrug’s long-outstanding potential tax liability. Following the overall positive Phase IIa data with PQ912 for Alzheimer’s disease (AD) released in June 2017, Probiodrug reiterated in its H117 report that all strategic options for further development are on the table. Depending on available funding, the company could initiate the next study looking at the long-term treatme

Companies: Vivoryon Therapeutics N.V.

Edison
  • 16 Jun 17
First data paint a positive overall picture

Probiodrug presented the first data from its flagship Phase IIa clinical trial with its lead drug candidate PQ912, a glutaminyl cyclase (QC) inhibitor, for early Alzheimer’s disease (AD) patients. Overall, we find the data positive, with several secondary endpoints and exploratory clinical tests especially piquing our interest. Our valuation is increased to €487m or €60/share.

Companies: Vivoryon Therapeutics N.V.

Edison

Vivoryon Therapeutics N.V.

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