Nuformix plc (NFX) unaudited half year results for the six months ended 30 September 2020, highlighted the strengthening of the portfolio and management team during the period.

Operational Highlights

Leadership Team Expansion

During the period the clear focus was on the expansion of the leadership team, leading to the appointment of Dr Anne Brindley as CEO post period end and strengthening of the Board with two new Non-Executive Directors that bring additional R&D, business development and financial leadership experience to the Company.

Both appointments will be ‘extremely valuable’ as the Group moves forward with its near-term licensing opportunities and to provide the Board with additional and relevant experience. The experience that Maddy brings will strengthen the Group's financial governance as she takes up the role of Chair of the Audit Committee.

NXP002

Furthermoe, progress was also made on the commercialisation front with further the development of the lead Asset, NXP002 which led to evaluate the benefits of NXP002 alone and in combination with standard of care for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a serious lung disease.

Whilst discussions continue in Asia regarding the licensing of Asian rights to NXP002, the Group has also expanded its activities to evaluate additional licensing opportunities. 

With regards to other portfolio assets, the Company signed an exclusive option agreement with Oxilio Ltd for the development and exploitation of NXP001 in oncology indications, and continued to strengthen patent portfolio, especially on the early-stage asset NXP004

NXP001

An option to license the use of Nuformix patents covering NXP001, without the need for development commitment, was granted to Oxilio Ltd "Oxilio" and announced in September 2020.  The agreement with Oxilio triggered an undisclosed up-front payment for an exclusive option period of 6 months from September 2020 and within which period the global licensing agreement can be triggered.  Should Oxilio exercise the option, Nuformix will licence its patent estate and know-how on NXP001 in return for an upfront payment and additional development milestones, with a royalty on net sales, capped at £2m per annum.

NXP004

NXP004 uses Nuformix proprietary technology applied to the active drug of a multi-billion-dollar product currently marketed for oncology indications. 

Despite the commercial success of the marketed product, side-effects pose a significant challenge to its existing use and extension into new indications, that could benefit from the mechanism of action of NXP004. 

The Company is currently evaluating new IP that could overcome some of the challenges posed by the originator's formulation.

Additionally, in August, the Group reported results from a pre-clinical pilot study evaluating the anti-fibrotic and anti-inflammatory effects of NXP004 against standard of care, a therapeutic area not currently exploited by the originator of the drug. 

Financial Highlights

Total revenue decreased to £195,550 (1H19: £535,000), which led to Loss Before Tax of £475,874 (1H19: loss of £131,842).

Post a tax credit, loss on ordinary activities was £474,659 (1H19: loss of £131,842) with Loss per share 0.10p (1H19: 0.03p)

Net assets, as at 30 September 29020 was £4,301,236 (30 September 2019: £3,980,126) including £216,412 cash and cash equivalents (30 September 2019: £132,764)

Post Period End

The Company successfully completed a placing on 7 October 2020 raising additional cash of £650,000 before expenses for the Company post period end.

The Company has also appointed Allenby Capital as sole broker

After the period end, the Group submitted an application for an Innovate UK Grant to support the development of NXP002 in IPF and with potential in other respiratory diseases including respiratory complications arising as a result of Covid-19. 

Dr Chris Blackwell, Non-Executive Chairman of Nuformix, said: “A key priority for the Group was to establish strength in the areas of drug development, business development and financial control. With the successful appointment of an experienced CEO in Dr Anne Brindley, and our new Non-Executive Directors, Maddy Kennedy and Dr Julian Gilbert, we can now look forward to driving the value we all see in Nuformix. As our discussions continue on NXP002, I look forward to working with Anne and the rest of the Board, as the Group moves forward under its new leadership."

Outlook

The Company has already pencilled in significant Newsflow for 2021.

Firstly, Results from the pre-clinical studies to evaluate the benefits of NXP002 alone and in combination with standard of care for the treatment of IPF are expected are expected in the first quarter of 2021.

The Group will also announce their plans for NXP004, following the positive anti-fibrotic and anti-inflammatory effects of NXP004 against standard of care, a therapeutic area not currently exploited by the originator of the drug.

The Group will also receive notification from Innovate UK, as to its grant application. Whilst success would provide important finances for NXP002, it is by no means assured, and the Board is therefore in the process of considering contingencies and additional sources of investment to supplement its existing cash resources and to provide additional cash runway for the Group.

With an augmented Board and new CEO in place, bringing additional expertise and new leadership, the Group believes it is ‘now in a position to drive its near-term strategic priorities focussed on deriving optimal value through business development and licensing opportunities with its existing assets.’

Dr Anne Brindley, CEO of Nuformix, said: "One of the attractions of Nuformix when I joined the Company just three weeks ago was the opportunity to grow value from its key assets. I relish the opportunity to work with the team on our strategic priorities and will update the market further in Q1 2021.”

Reasons to follow Nuformix 

Nuformix is a pharmaceutical group which uses cocrystal technology to unlock the therapeutic potential of approved drugs with lead programmes in oncology supportive care and fibrosis.

The company announced its plans to raise around £0.65m at a price of 2.8p a share back in October 2020 in an effort to develop several of its assets to treat the effects of COVID-19.  

The proceeds will be used to maximise opportunities for the development pipeline, in particular for its lead asset, NXP002, which it believes could be used to treat hyperinflammation, a side effect seen in some patients suffering with severe COVID-19.  

It also believes NXP002 could be used in combination with existing marketed products in the treatment of idiopathic Pulmonary Fibrosis (“IPF”) a serious lung disease. In doing so, the group would be targeting the global IPF market which is valued at around US$2bn a year.  

The Board has prioritised this preclinical work alongside other IPF therapies because ‘it is likely that the adoption of new therapies for IPF will be on top of current standard of care.’

The Company said that it plans to exploit the potential for licensing NXP002 across global markets, and in particular to continue to pursue licensing opportunities in the Asian market. It also added that it wants to 'exploit value’ from NXP001 outside the field of oncology. 

The Board has been significantly strengthened over the past six months, culminating in the appointment of Dr Anne Brindley, as CEO in December 2020. Anne brings a wealth of relevant pharma experience coupled with leadership and Board experience that will clearly help the Group move forward with its strategic priorities.