It’s perhaps worthwhile to review key events and company announcements for NEU throughout 2017 to get a sense of the company's intended direction in 2018.
02/02/17Investor Presentation
Strategy to realise value
Generate clinical data in Phase 2 trials
Define optimum pathway towards New Drug Applications
Optimise manufacturing processes for commercial product supply
Engage with commercial partners
23/02/17Preliminary Final Report
….the directors intend that the Company will enter into a commercial partnering arrangement in 2017, the timing and terms of which are presently unknown and that should the nature and/or timing of the commercial partnering arrangement differ from the current intention, the directors would consider securing other sources of funding, including additional capital, depending on circumstances at the time…
22/03/17Neuren Announces results of Ph2 trial of Trofinetide in Paediatric Rett syndrome
These results provide strong evidence of biological activity of the high dose across multiple symptom areas, indicating the potential for disease modification rather than simply addressing isolated symptoms. In addition, trofinetide was well tolerated and had a good safety profile in these younger subjects, with no dose-limiting effects observed.
28/04/17Annual Report
In order to support the future plans for Rett syndrome and other indications, the Neuren Board is currently giving careful attention to a range of possible funding and partnering options, guided by two principles – speed to market for the families affected by these conditions and value for our shareholders. I look forward to updating shareholders as we reach conclusions on those options.
29/06/17Announcement of Funding Arrangement
Neuren Pharmaceuticals today announced that it has secured funding to enable initiation of key activities on the critical path for commencing a Phase 3 trial in Rett syndrome. The placement of new ordinary shares raising A$11.5 million at 6.2 cents per share is anchored by A$10 million from UK fund Lanstead Capital, with supporting investments from Rettsyndrome.org and Neuren’s directors and management…
Neuren can now initiate the following key manufacturing and nonclinical activities that are required to be completed before a Phase 3 trial can commence:
Conclude optimisation of the drug substance manufacturing process for commercial supply
Conclude stability testing and analytical validation of the new to-be-marketed liquid drug formulation 2 of 3
Conduct non-clinical toxicity study in a second species, which is required for a Phase 3 trial with longer dosing and subsequently to support a New Drug Application to the FDA The cash flow for these activities will occur in the second half of 2017 and the first half of 2018.
29/06/17 AGM Chairman’s Address
This morning we have announced an important financing that provides Neuren with the funding to approach both our anticipated meeting with the FDA Division of Neurology and partnering discussions in a strong position, whilst at the same time being able to commit to continuing the key activities on the critical path for commencing a Phase 3 trial….
The structure and timing of the financing is particularly suited to the current needs and future prospects of the Company. We are not activating the previously approved facility to issue shares to Walker Corporation, which we put in place as a contingency until 30 June 2017. This means that the shareholdings of Lang Walker interests will remain below 20%.
Following the announcement of the Rett syndrome study results in March, Neuren has continued to receive a wide level of interest in the trofinetide programs from pharmaceutical companies around the world. We have nevertheless formed a view that partnering options are better considered once Neuren has met with the FDA. As always, the Board is guided by two important principles, these being, speed to market for the families affected by these conditions and maximising the commercial value to Neuren and our many shareholders…
After issue of all the placement shares, there will be approximately 2 billion ordinary shares on issue. We intend to consolidate the shares into a smaller number in order to remove an impediment to investment for some US institutions...
24/08/17 Half Yearly Report and Accounts
Neuren has an End of Phase 2 Type B Meeting with the US Food and Drug Administration (FDA) Division of Neurology Products scheduled in October 2017, to discuss the remaining development for trofinetide to treat Rett syndrome, including the Phase 3 trial design. Following the meeting, the Directors will consider options, including partnering, to fund and execute the Phase 3 trial.
13/10/17 FDA Meeting
We are pleased to have held a very constructive meeting with the FDA Division of Neurology Products. It has provided necessary confirmation on the key issues relating to our proposed Phase 3 trial in Rett syndrome. We are now able to progress the final stages of development with full confidence.
16/11/17Share Consolidation
Neuren announces consolidation of its share register.
29/12/17 Bruce Hancox retires from Board
It is announced that Bruce Hancox, advisor to major shareholder, Lang Walker, has retired from his directorship of the NEU Board.
NEU Price at posting:
$3.30 Sentiment: Hold Disclosure: Held
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