Aptahem newsletter extra April 2018

CEO comments
It’s scarcely a month since our previous newsletter, but so much is happening at the moment that I wanted to give you an update on our activities earlier than planned. In this extra edition of the newsletter, I’m pleased to be able to tell you more about the results of the BIOEurope conference, give you an update about the development of our aptamer platform, along with details about our drug candidates, and the latest steps towards our goal of getting Apta-1 to sepsis patients as quickly as possible.

Conferences, partnerships and research co-operation
One of my main responsibilities as CEO is to identify, initiate, develop and maintain relationships that have the potential to support the company and our shareholders. This applies to all types of stakeholders with whom we come into contact: from investors to researchers and big pharma contacts, but also labs and other sub-suppliers, (such as clinical research organizations), and opinion builders. We put a significant amount of focus on finding the key ingredients in relationships that could be in the company’s and shareholders’ best interest. This is a continuous process. It is important to realize that the full potential of such relationships are not created overnight.

As I have previously indicated, there was considerable interest in the company and our aptamer technology during conferences that we attended in the spring. Discussions with several parties have developed since. Two particularly interesting and promising opportunities are currently being evaluated. One is a potential research collaboration with a highly regarded hospital in the US that specializes in sepsis, which would offer access to expertise and patients in one of our key target markets. The other opportunity that we are currently evaluating involves a number of different scientific co-operation requests in the sepsis segment that we have received from one of Europe’s best-known research institutes. This would also offer considerable advantages to the company. Naturally, we are not ruling out inititating both of these collaborations if we judge that they are beneficial for us. It now feels that we have reached a critical mass where interested parties have started contacting us about the results of our pre-clinical trials with Apta-1, and enquiring about the promising potential of our technologies (including Apta-2). In addition to the above, our dialogues with a number of large drug companies continue to the point where the next step is the exchange of confidential information. We are also starting to prepare for BIOInternational, (which will be held in June, in the US), to maximize the potential to build new contacts, and strengthen existing ones. I look forward to telling you more about this in due course.

Our aptamer platform
Our multiple discussions regarding our aptamer platform with drug companies, university hospitals and institutes continuously leads to new ideas and insights. Several of these stakeholders work with vulnerable patient populations that currently lack effective treatment, and are therefore constantly on the lookout for new treatment options. The multi-dimensional profile of our aptamers prompts discussions relating to opportunities to test our candidates on other types of conditions. To systematize these learnings, we have started to map typical and rare conditions that can be assigned an orphan drug designation, one which in turn can be compatible with our operational approach. This is work that, in addition to its purely technical aspects, will also incorporate commercial insights related to market potential, regulatory fast tracks, patentability, and licensing potential. The purpose of this work is, in time, to expand our product portfolio with additional development programmes.

Patent process: Apta-1
The patent application process is ongoing, and I know that many of our shareholders are desperate for its completion. This tends to happen a year after an application has been submitted, so I would like to provide a quick update. We have now received an initial communication from the European Patent Organisation (EPO) related to the formulation of our latest patent application. The statement is not final, of course, but it is clearly positive as all of our patent specifications meet the authority’s requirements in terms of being new, achieving a sufficient level of inventiveness, and being industrially applicable. We are now starting to add new data from study results that we generated following the submission of the application to further strengthen the scope of the patent. Our evaluation of the statement is therefore that our future patent has an excellent basis on which to be granted a broad scope of protection.

Develpoment programme: Apta-1
The development programme for Apta-1 continues at full tilt of course, and the next step is to start our non-GLP toxicology and safety programme. We have therefore spent a lot of time with our development partner Accelera in Italy in recent months. The study seeks to determine the Maximum Tolerated Dose (MTD), and will be followed by a dose escalation study. The programme is proceeding as planned, and we are getting even closer to a GLP toxicology study, and a finalized application for the initiation of clinical studies in humans.

Planned partnership activites
Shareholders sometimes contact me and ask where we are with our external dialogues, and why they take the time they take. Various regulatory framworks often prevent us from providing details on these activities, while publishing such details could weaken our negotiating position. I would therefore like to provide a more general update regarding our status in current dialogues by outlining two concrete activities that are ongoing. The first is that in several of our meetings with large drug companies it has emerged that they would like to see results of a specific sepsis model based on a primate trial. The result of such a trial can be considered the closest you can come to a clinical result without testing Apta-1 on patients. We are therefore preparing an initial pilot study with a subsequent trial involving comprehensive analytical tests: a study that will replicate clinical conditions in terms of doses and timings. This model is being launched now and a final report on all these studies is expected in the summer as such analytical tests are extremely time-consuming.

To further prepare our negotiating position, we have also launched an evaluation project with the aim of obtaining an independent evaluation of the project value of the Apta-1. The process will be conducted by an external advisor, and will be completed in the coming weeks.

Upcoming presentations
On Wednesday April 18, I will be a guest speaker at BioStock’s event in Skåne where I will deliver a presentation about the company and our activities. The event is live broadcast and recorded, which I think is good because naturally we realize that not everyone can attend.

Finally, I can reveal that we have recently been featured by one of science’s most respected titles, Nature, in their ‘BioPharma Dealmakers’ that is published only four times a year about different therapeutic areas considered to be highly topical. The issue that features Aptahem deals with infectious diseases, and will be out in June. Aptahem is featured with well-known drug and biotech companies. We’re delighted to have been included, and we hope that this will mean more potential partners and scientific fields will hear about Aptahem.

Contact info@aptahem.com if you have any questions; as you know, I’m happy to answer your questions. I will try to answer general questions about the company in the next newsletter, otherwise I will attempt to answer by email or phone. If you haven’t done so already, you can follow us on Facebook at: https://www.facebook.com/aptahem/.

Malmö in April 2018

Mikael Lindstam
CEO, Aptahem AB

Forward-looking statements
This communication contains forward-looking statements, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their nature, as is research and development work in the biotechnology segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios as described in this newsletter.