Unaudited Half Year Results

Nuformix plc

("Nuformix" or "the Company"),

 

Unaudited Half Year Results

for the six months ended 30 September 2018

 

Significant Progress in Lead Programmes

 

Cambridge, UK, 20th December 2018: Nuformix (LSE: NFX), the pharmaceutical development company using cocrystal technology to unlock the therapeutic potential of approved small molecule drugs, announces the Company's unaudited results for the six months ended 30 September 2018.

 

KEY HIGHLIGHTS

 

·      Pipeline Update:

·      Key development milestone achieved for NXP001 in Oncology Supportive Care triggering payment of £500,000

·      Additional patent filing broadening NXP002 applications in fibrotic conditions

·      Continued growth of pre-clinical portfolio following the development of new drug cocrystals

 

·      Strengthening Board:

·      Dr Chris Blackwell appointed to the Nuformix Board as a Non-Executive Director

 

·      Financial Highlights:

·      Reported net loss for the period was £642,633 (2017: £127,546 loss)

·      Operating profit before exceptional items for the reported period was positive at £114,020 (2017: £170,725 loss)

 

POST PERIOD HIGHLIGHTS

 

·      Key milestone achieved for NXP002 programme in treating fibrosis:

·        Preclinical multi-patient tissue studies were completed in partnership with Newcastle University, UK in Q4 2018

·        Resulting data demonstrated NXP002 candidates strongly inhibit fibrosis ex-vivo, even in very severely fibrotic human lung tissue taken from patients at end stage with idiopathic lung fibrosis (IPF)

·      In addition, a very specific action was observed against key inflammatory targets

 

Commenting on the outlook, Dr Dan Gooding, CEO, Nuformix plc said: "We have achieved significant progress during the period, both operationally and within our lead programmes. The results strongly validate the Company's strategy of combining a 'lean burn' model and low operational costs with early revenues from both out-licensing and collaborative development. We have continued to progress our two lead programmes during the second half of 2018, reaching significant milestones for our oncology drug NXP001 and our fibrosis drug NXP002. We can look forward to achieving further clinical and commercial progress for both programmes in the first half of 2019 whilst maintaining low operating costs."

 

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement, this inside information is now considered to be in the public domain.

 

 

 

 

 

 

Enquiries:

 

Nuformix plc Dr Dan Gooding, Chief Executive Officer	+44 (0)1223 423667
Optimum Strategic Communications Supriya Mathur, Mary Clark Email: [email protected]	+44 (0) 203 950 9144

 

About Nuformix plc  

Nuformix is a pharmaceutical development company using cocrystal technology to unlock the therapeutic potential of approved small molecule drugs. Nuformix's risk-mitigated development strategy has resulted in a pipeline of discoveries through which it has developed and patented novel cocrystal forms of approved small molecules.

 

Nuformix has created an IP portfolio of granted patents covering cocrystal forms of five small molecule drugs.  Nuformix is targeting high-value unmet needs with its lead programmes in:

·      NXP001: Oncology supportive care

·      NXP002: Treating fibrosis

 

Nuformix was established in Cambridge in 2009 and has invested in pharmaceutical cocrystal R&D, establishing world-class capability and know-how in cocrystal discovery and development, yielding multiple product opportunities. 

 

Nuformix plc shares are traded on the London Stock Exchange's Official List under the ticker: NFX.L.

 

For further information, please visit www.nuformix.com.

 

 

 

 

 

Half Year Report

 

The Company is pleased to update shareholders regarding the Company's developments during the first half of the year ending 30 September 2018 and subsequent events to date in the second half.

 

Half Year Overview

 

The Company conducts pharmaceutical development activities, minimising risk in clinical development by creating innovative new therapies based on known drugs with proven safety. The Company's innovative therapies are made possible via cocrystal technology, which provides new intellectual property (IP) plus performance and commercial advantages to enable the development of new products.

 

Nuformix seeks to maximise the value of its existing IP portfolio by conducting clinical proof-of-concept studies for a small number of compelling assets prior to generating revenues from out-licensing.

 

The Company has achieved significant progress during the period, both operationally and within its lead programmes. The results strongly validate the Company's strategy of combining a 'lean burn' model and low operational costs with early revenues from both out-licensing and collaborative development.

 

As a result, the Company is able to report an operating profit before exceptional items for the period of £114,020 (2017: £170,657 loss). The net results for the period are impacted by share option charges, which are not cash reducing, of £765,667. Overall, the reported net loss for the period is £642,633 (2017: £127,546 loss).

 

Earlier this year the Company completed a full strategic review of the Nuformix lead programmes, NXP001 in oncology supportive care and NXP002 in the treatment of fibrosis and included both commercial and operational aspects. The review also looked at the Company's broader portfolio, including early-stage pipeline and potential additional projects. The review provided the Board and the Advisory Panel with a refreshed perspective on the overall commercial and development potential across the pipeline and the associated objectives for each work stream.

 

As a result of the strategic review, the management team identified development targets for its two lead programmes opportunities and has made significant progress during the year as follows:

 

NXP001 Programme: Oncology Supportive Care

 

·      On track to deliver its first human pharmacokinetic data in H1 2019

·      MHRA clearance expected in February 2019 and patients scheduled for dosing in March 2019

·      All clinical materials generated and ready for study commencement

·      Demonstration of bioequivalence to the reference product will trigger a £2 million milestone payment

·      First milestone was achieved and the first NSB payment of £500,000 was received in Q4 2018

·      In November, announced an expanded licensing agreement with NSB for the China market

·      Rest of the World discussions for NXP001 commenced

 

Following the expanded agreement announced in November with NSB, Nuformix will be carrying out an additional pre-clinical study for NXP001 in parallel to its on-going clinical studies, to further validate additional differentiated product opportunities. Completion of the additional study will result in a milestone payment of £500,000 from NSB.

 

Total milestone payments from NSB will therefore increase from £2.5 million to £3 million, following the addition of this second pre-clinical milestone, which Nuformix expects to achieve in Q1 2019. The resulting data will support regulatory submissions in China to facilitate market approval of multiple NXP001-derived products.

 

NXP002 Programme: Treating Fibrosis

 

·      Preclinical multi-patient tissue studies were conducted in partnership with Newcastle University, UK ·     Resulting data demonstrated NXP002 candidates strongly inhibit fibrosis ex-vivo, even in very severely fibrotic human lung tissue taken from patients at end stage with IPF

·      In addition, a very specific action was observed against key inflammatory targets

·      NXP002 candidates out-performed current treatment standard of care (Pirfenidone, Esbriet ®)

·      Leading edge human tissue trial model closely replicates real-life patient disease

·     First results of their kind to be released in partnership with Newcastle University, UK. Positive trial results achieved against a high challenging model (end-stage patients)

·      These data provide strong support for wider applications in other fibrotic lung conditions

·      Additional patent filing made to broaden NXP002 applications in fibrotic conditions

 

 

 

 

The Company is highly encouraged by the first results from its partnership with Newcastle University (UK) and using cutting-edge human tissue disease models, Nuformix has demonstrated the potential for NXP002 candidates to attenuate progression in established lung fibrosis.

 

Life expectancy has not changed for patients diagnosed with IPF. Few patients respond to the two currently approved treatments and have to tolerate severe side effects that dramatically impact quality of life - severe vomiting on one therapy or severe diarrhoea on the other. The promising data from the NXP002 study gives us confidence in its ability to both inhibit fibrosis and address inflammation in patients without these side effects.

 

Nuformix announced in September an additional patent filing, which provides further strength and breadth to the existing NXP002 patent portfolio. The additional patent filing allows Nuformix to consider a wider range of options in the treatment of fibrosis, delivering wider benefit for patients whilst maximising value for investors.

 

Fibrotic disease is typically associated with high patient mortality, increasing prevalence and a lack of safe and effective treatments. Whilst, fibrosis treatments are in their infancy the emerging lung fibrosis market demonstrates their blockbuster potential. Markets for other fibrotic conditions are under-developed, with large and growing patient populations (e.g. the global liver disease market is predicted to reach $12.1 billion by 2022).

 

Strategy

 

The Company is focussed on building value for shareholders through its activities in drug development and out-licensing. Nuformix uses cocrystal technology to re-engineer the crystalline form of known small molecule drugs. The resulting novel drug cocrystals have new and improved physical properties that can enable advantageous new products, in addition to strategic benefits. Furthermore, the resulting drug cocrystals are protected with new 'substance of matter' IP protection.

 

Nuformix's cocrystal technology expertise generates value and revenue by developing new cocrystal-based therapies using known drugs and licensing them to pharmaceutical companies post proof-of-concept. The initial product development focus is in the fields of oncology supportive care and fibrosis. However, the Company is building a pipeline of additional products behind its lead programmes, which it will continue to develop both in-house and in collaboration with external partners.

 

Strengthening Company Board

 

During the period, the Company has strengthened the Board of Directors with Dr Chris Blackwell's appointment to the Nuformix Board as a Non-Executive Director. His addition brings a wealth of proven expertise in life sciences value creation and broadens the Company's network.

 

Outlook

 

The Company will continue to progress its two lead programmes during the second half of the financial year ending 31st March 2019, with the commencement of clinical studies during Q1 of the calendar year for its NXP001 programme in oncology supportive care, which is on track to achieve significant development and commercial milestones during the period.

 

The Company will also continue to execute its commercial strategy as it seeks to out-license Rest of World marketing rights for NXP001, in addition to entering new collaborative development partnerships.

 

In fibrosis, the Company will seek to optimise delivery of candidates within its NXP002 programme, focussing on the treatment of unmet needs within idiopathic fibrosis.

 

In addition, the Company will continue to execute its product development strategy of using cocrystal technology to enable the redevelopment of small molecule drugs with therapeutic promise, adding value to its IP portfolio and pipeline, whilst maintaining low operating costs.

 

 

Dr Dan Gooding, CEO   20 December 2018

Dr David Tapolczay, Chairman

 

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement, this inside information is now considered to be in the public domain.

 

 

 

 

Nuformix plc

(Registration number: 09632100)

Unaudited Interim Results

Consolidated Income Statement and Statement of Comprehensive Income for the

Half Year Ended 30 September 2018

  

 

	Note	30 September 2018 Unaudited £	30 September 2017 Unaudited £	31 March 2018 Audited £
Revenue		610,000	5,000	15,000
Cost of sales		(79,433)	(12,682)	(203,868)
Gross profit/(loss)		530,567	(7,682)	(188,868)
Administrative expenses before exceptional items		(419,410)	(170,725)	(729,016)
Exceptional Items	4	(765,667)	-	(1,062,142)
Total administrative expenses		(1,185,077)	(170,725)	(1,791,158)
Other operating income		2,863	7,750	18,520
Operating profit/(loss) before exceptional items		114,020	(170,657)	(899,364)
Operating loss after exceptional items		(651,647)	(170,657)	(1,961,506)
Finance (costs)/income		(10,986)	7,384	(3,547)
Loss before tax		(662,633)	(163,273)	(1,965,053)
Income tax receipt		20,000	35,727	126,790
Loss for the year and total comprehensive income for the period		(642,633)	(127,546)	(1,838,263)
Loss per share - basic and diluted	5	(0.14)p	(127.5)p	(0.49)p