We look forward to be able to start the exciting final part of the study where KL1333 for the first time will be given to patients with primary mitochondrial disease

2019 was a good year for NeuroVive with significant advances in our projects for primary mitochondrial diseases. 2020 has the potential to be an even stronger year!

NeuroVive has an exciting future ahead. We have world-class expertise in primary mitochondrial disease – an area with high unmet medical needs.

The Fast Track designation and the recently approved IND (Investigational New Drug) are tremendous successes for our candidate drug NeuroSTAT, and a significant external validation of its quality and potential to address a tremendous unmet medical need. This will strengthen our position in the field and give us an advantage in partnering discussions concerning our planned Phase II efficacy study

The progress in the KL1333 programis a great step towards our plan of taking the project to a clinical efficacy study next year and important to our company. Our ultimate goal is to bring this possible life changing treatment to the market and to patients with mitochondrial disease, who currently have a high unmet medical need

We’re truly excited about the approved IND, which is also NeuroVive’s first. It’s a highly important milestone and a great recognition for the project, and also valuable in our discussions with possible external partners regarding non-dilutive funding and the continued development of NeuroSTAT

We are excited about this study which will take the KL1333 project further towards our goal of offering it to patients with severe genetic mitochondrial disease with few or no treatment options

The additional funding is truly valuable for NeuroVive and it will extend our runway to reach our goals as well as make a clear difference primarily to our continued clinical development activities of KL1333

In summarizing 2018, we can say that it was a very successful year for our focus projects

We are excited to be able to supply compounds from our succinate prodrug family designated exclusively for research use to the scientific community. Oroboros Instruments is the perfect partner to reach thousands of scientists in the field.

We are in a very exciting period in the Company's development where the financial resources now provided ensure the implementation of crucial value-creating activities in the coming year, primarily in our clinical phase projects, KL1333 for genetic mitochondrial disorders and NeuroSTAT - our brain injury project, but also in our preclinical projects, as well as in our business activities

This funding is of the greatest importance for effectively advancing the project and represents a mark of quality for our program

This is indeed very promising first efficacy data in a model highly relevant to patients with mitochondrial disease

MHRA approval is an important milestone ahead of the initiation of our study. It also verifies the quality of the work we have done during the planning and design stage

This early efficacy signal indicates that NeuroSTAT suppresses the secondary brain injury cascade and clearly supports our continued development of NeuroSTAT for TBI

The positive input from the FDA is welcomed and greatly helps us in the preparation of our important clinical efficacy study with NeuroSTAT in TBI patients

We are delighted by the news that our research partners at CHOP are receiving this grant. It further validates the extensive interest our novel succinate prodrug approach to treating mitochondrial diseases has generated. The grant will allow Dr. Kilbaugh and his team to thoroughly explore the therapeutic potential of our succinate prodrug compounds and advance them towards a novel treatment for acute energy crises in patients with genetic mitochondrial diseases for which there currently are only symptomatic treatment options available

The agreement with BridgeBio confirms the potential of NeuroVive’s projects and our ability to generate value for our shareholders.

The now published report provides important basic understandings regarding KL1333 and its potential in providing a novel treatment opportunity to patients with genetic mitochondrial disease. The data is important in our further planning of clinical trials and in communication with the scientific and medical community, as well as with regulatory bodies

The data from this fruitful collaboration with Penn has already generated significant interest when presented at scientific congresses, and now the whole scientific community will be able to access the study results of NeuroSTAT. A significant aspect of the data is that the protective capabilities are seen in outcome metrics that can directly be tested in our further clinical trials. This will facilitate the progression of the NeuroSTAT clinical program and our goal to deliver a medicine that improves the outcome of patients following TBI

The agreement with BridgeBio is important to both NeuroVive and our innovative NVP015 program, as it validates the quality of the program, our business development model and potential in a variety of mitochondrial disorders

We are very pleased and proud to announce our collaboration with TRACK-TBI. TRACK-TBI’s mission to transform the clinical trial landscape in TBI and our collaboration will provide important support to our precision-based patient selection and treatment effect evaluation approach. The collaboration not only grants us access to the world’s top TBI clinicians and researchers, it also validates the quality of our NeuroSTAT development activities in the TBI field and will facilitate our goal to deliver a medicine that protects the brain of TBI patients in the acute stage.

We see the oversubscribed Rights Issue as a clear sign of trust in our projects and how we conduct our business. The financial resources now provided ensure the implementation of crucial value-creating activities in the coming year and we are confidently looking forward to delivering continued success in our mitochondrial disease projects, our brain injury project, other parts of the project portfolio, and our business activities

The ODD approval by the US FDA is a validation of the quality of the KL1333 documentation to date and yet an important milestone for NeuroVive and the KL1333 project. The ODD will be beneficial to us in our efforts to rapidly document the effects and safety of KL1333 in genetic mitochondrial diseases and bring this novel treatment opportunity to the market and patients who are in great need of it

The completion of the first clinical KL1333 study is a substantial milestone, which means we can now confidently initiate our clinical phase I MAD study as planned. This is an important step towards our goal of bringing a novel treatment for patients with severe orphan diseases with few or no treatment options

NeuroVive has an exciting year ahead. Through a successful Rights issue, we will be able to take several important steps in our clinical development projects, NeuroSTAT and KL1333, for both of which new clinical studies are set to start in 2018. In addition, we will be able to take other drug development projects to critical milestones

The results from the study is an important milestone in NeuroVive’s NVP025 project. The study shows that our cyclophilin inhibitors can be further developed towards the goal of offering mitochondrial myopathy patients a novel treatment option. We are now taking the project into its next phase, where we will optimize a candidate drug suitable for further development for patients with different types of muscle disorders

We are very excited about the progress of the first KL1333 clinical study. Along with the recent positive opinion on European orphan drug designation, it brings us one step closer to initiating our own clinical phase Ib study, and to our ultimate goal of providing a treatment opportunity to patients with different genetic mitochondrial disorders, where there is a high medical need and in most cases no specific treatments available.

We are excited about the collaboration with NeuroVive, and the initiation of this clinical program is a significant step forward in the development of innovative medicines in this area with great medical needs.

The NVP015 project has the potential to significantly improve the lives of patients, usually children, suffering from this type of mitochondrial disease. The grant is central for efficiently proceeding the project and a quality label for our program.

The NeuroSTAT effects observed in our state-of-the art experimental model for TBI are very promising. Our collaborative approach on preclinical study design will set a completely novel standard in the development of new drugs in the field.

The NeuroVive team is extremely pleased to acquire the rights to the clinical stage candidate drug KL1333 for genetic mitochondrial disorders, an area of high unmet medical need. The project is a perfect fit with our existing project portfolio in mitochondrial disorders. The addition of KL1333 is perfectly in line with our business model focusing on the development of orphan indication project all the way to the market. We look forward to working with Yungjin Pharm on this opportunity, with the aim to bring relief to patients suffering from genetic mitochondrial diseases.

We are encouraged by the confirmation of an anti-fibrotic effect of NV556 in a second well validated experimental model. Also, the preventive effect on liver cancer development is a highly appealing observation that adds to the attractiveness of NV556 as a possible treatment candidate for patients with progressing NASH for which there is a high unmet medical need.

I am very pleased that Philippe Gallay and Massimo Pinzani have joined our efforts in advancing the research and development of our NASH and HCC treatment opportunities. Their scientific guidance as experts in the field of liver disease mechanisms and clinical management will be most valuable in the continued development of our project pipeline, as well as in the ultimate positioning of our candidate drugs in the future treatment landscape.

We are very impressed by the anti-cancer potency that has been revealed in these studies. This new sanglifehrin-based compound class, which we have optimized for anti-cancer activity, offers a very much needed new therapeutic opportunity to combat HCC through a unique mechanism of action.

This decision is completely in line with the new corporate strategy and will enable us to further focus on developing the company’s project portfolio by releasing resources to progress the early R&D projects as efficiently and effectively as possible”, said Erik Kinnman, CEO at NeuroVive. We want to thank our colleagues in Taiwan for a good collaborative spirit in the work to date and in this process and wish them all the best in their future activities.

We feel fortunate to be able to initiate this collaboration with a well-recognized institution like CHOP and Dr. Marni Falk, a well-esteemed leader in the mitochondrial disease field. This is an important step in further advancing and strengthening our NVP015 program, as well as in the development of novel treatment opportunities for people with mitochondrial medicine disorders

We are now adding the exciting and challenging cancer area to our portfolio, expanding our core competence field within mitochondrial medicine. The addition of Dr. Michele Tavecchio to our team has accelerated the internal development process in this area, and the team has done a great job in exploring this new therapeutic opportunity for the company’s sanglifehrin-based compounds

We are now adding mitochondrial myopathy to our genetic mitochondrial disease portfolio, which is very exciting. We are also very glad to be able to explore this area together with Håkan Westerblad’s skilled team at Karolinska Institutet and are looking forward to our continued collaboration.

We are extremely happy to be able to add Dr. Tavecchio to our research team. His research expertise in the ciclophilin D area and related metabolic effects fits hand in glove with NeuroVive’s project portfolio. In combination with his extensive knowledge within the oncology area, Dr. Tavecchio’s primary task for NeuroVive will be to explore new therapeutic opportunities for the company’s ciclophilin inhibitor compounds

The current experimental result in NASH is an excellent example of the strength of the research within NeuroVive and the successful collaboration with Isomerase. The result at hand is an important step forward in our continued development for out-licensing in this therapeutic area

Given the huge patient population and the high unmet medical need, we see our results and activities in NASH as high potential near term value drivers and potential revenue sources in NeuroVive’s pipeline

We have appreciated the interactions with Arbutus and there are a number of valuable learnings that have come out of the preclinical development activities. As we see several very exciting potential treatments with NVP018 in areas with unmet medical need, the R&D team is currently exploring various options for further development of these opportunities. The material provided by Arbutus will be most useful in these activities.

The CiPRICS study has been excellently conducted by the team, led by Associate Professor Bjursten at Skåne University Hospital, with clear results. Moreover, it has verified the effectiveness of the network partnership model for NeuroVive’s early clinical development. We will continue to develop and build our portfolio, and I see several potential upcoming milestone events in our strong and diversified mitochondrial medicine portfolio.

I have been involved in NeuroVive in different roles since 2010 and it has been fantastic to be part of the development of the company to the position it holds today. The company has a very interesting project portfolio and a strong organization. The transition to our new CEO is now concluded which makes the timing right for me to seek new challenges. I will of course follow the company’s continued development with greatest interest.

Jan Nilsson has with great dedication, in combination with his vast knowledge and experience, played a key role in NeuroVive, not only as COO but also as a Director and for a period as interim CEO. Jan has been instrumental in managing the challenges faced by NeuroVive in recent years. On behalf of the entire company and its shareholders, I express our respect and appreciation for Jan and wish him all the best in his new endeavors.

One important event during the quarter was the preferential rights issue, generating approximately SEK 77 million, performed to accelerate NeuroVive’s extensive research and development program. Once again, I would like to thank everyone who participated in the rights issue for the trust and confidence they have shown in the company’s plans and operations. As earlier announced, the preferential rights issue was fully subscribed, which gives us the strength to fully carry out the necessary preparations that are vital to develop the project portfolio and advance forward our pre-clinical projects to clinical trials.

We are very happy with how our collaboration with Isomerase has evolved throughout the years. We have together with Isomerase been able to efficiently advance our prioritized research program NVP015 and generate new compounds that currently are evaluated in experimental models.

We’ve now obtained important safety data on what we’ve designated to be the lower dose of NeuroSTAT® for treating patients with traumatic brain injury. We can now move on to include patients that will be treated with a higher dose. This means that the study has reached an important milestone in the clinical trial program of NeuroSTAT®

NeuroVive’s CEO Mikael Brönnegård