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Patent approval for Respiratorius after complicated process

Respiratorius US patent

Patent approval for Respiratorius after complicated process

5 July, 2024

It has been a long and arduous process, but the long-awaited announcement is finally here. The US Patent and Trademark Office has approved Respiratorius’ patent application for VAL001.

– This is great news that we hope will increase interest in the project, CEO Johan Drott tells BioStock.

The announcement comes a few months after the Appeals Board of the US Patent and Trademark Office (USPTO) revoked the agency’s decision to reject Respiratorius patent application in the country. All of the examiner’s objections to individual claims were annulled and the Board did not see any obstacles to the patent.

The patent relates to the oral formulation of sodium valproate, which forms the basis of the VAL001 project. The drug candidate is being developed as a pre-treatment for R-CHOP – today’s standard treatment for diffuse large B-cell lymphoma (DLBCL).

Protected in the US until 2036

Now, Respiratorius has received a so-called Notice of Allowance from the USPTO, reaching the end of a long and complicated patent application process. VAL001 is thus protected in the country until at least 2036. In addition to the US, the company has previously also received patent approvals in Japan and Canada.

– The patent finally being granted in the US as well is very positive for us, as the US is the single most important market for VAL001, says Johan Drott.

In addition to the patent approval in the US for the oral formulation, Respiratorius is also working on a global patent application for the newly developed formulation of the product, where direct release is combined with a delayed release of valproate.

Important part of the ongoing partnering process

The announcement is an important piece of the puzzle for Respiratorius, which is currently working to obtain additional co-financing for the phase III study, which is next in line in development. During the partnering process, several players have shown interest and so far, the company has had in-depth discussions with one potential partner that has expressed interest in being part of the journey. This, however, comes with the condition that Respiratorius finds additional partners to help fund the planned study.

– We hope that the patent approval will lead to an increased interest in VAL001 and thus also the partnering process.

Strengthened cash position by SEK 14 million

Respiratorius recently strengthened its cash position by just over SEK 14 million through a rights issue of units. The company estimates that the proceeds received will be sufficient to continue the business for at least 24 months. In addition to newly issued shares, each unit also consists of series TO2 warrants, which, if exercised in the second half of 2025, can contribute an additional SEK 4 million.

– It is encouraging that such a large proportion of our owners have chosen to support Respiratorius on our continued journey towards the commercialization of VAL001. Through the rights issue, we have now secured the operation of the company for approximately two years, which gives us good conditions to focus on the partner process in order to bring VAL001 to the market.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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