Nuformix plc share price, company news, analysis and interviews
Nuformix plc (LON:NFX) is a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology using drug repurposing
The company uses their expertise in discovering, developing and patenting novel drug forms with improved physical properties, to develop new products in new indications that are differentiated from the original by way of: dosage, delivery route or presentation, thus creating new and attractive commercial opportunities.
Nuformix has an early-stage pipeline of preclinical and Phase 1-ready assets with potential for significant value and early licensing opportunities:
NXP001 (aprepitant) – oncology – Phase 1 ready
NXP001 is our new form of the drug aprepitant that is currently marketed as a product in the oncology supportive care setting
Aprepitant has a number of known properties, notably the NK-1 receptor that is involved in cellular responses.
Literature data suggests that aprepitant could have benefits in oncology, i.e., beyond the currently marketed indications. For example, it has shown antiproliferative properties in tumoral cell lines of glioma, neuroblastoma, retinoblastoma, pancreas, larynx, colon, and gastric carcinoma1
Licensing agreement
On 10 September 2021, Nuformix signed an exclusive global licensing agreement with Oxilio Ltd (“Oxilio”), a privately held pharmaceutical development company, for NXP001 (a proprietary new form of aprepitant) for oncology indications.
Under the terms of the licensing agreement, Oxilio has obtained an exclusive licence to research, develop and commercialise NXP001 globally for oncology indications. Nuformix is eligible to receive an undisclosed upfront payment, development milestone payments and a royalty on net sales, capped at £2 million per annum.
NXP002 (inhaled tranilast) for IPF -preclinical
NXP002 is Nuformix’s lead asset and a potential novel inhaled treatment for idiopathic pulmonary fibrosis
Repurposed new form of the drug tranilast, to be delivered in an inhaled formulation.
Tranilast has a long history of safe use as an oral drug for allergies but there is evidence (widely published in peer reviewed scientific papers) that supports its potential in fibrosis, including IPF.
Overall findings suggest that tranilast inhibits pulmonary fibrosis by suppressing TGFβ/SMAD2-mediated extra-cellular matrix (ECM) protein production, a major therapeutic target in IPF, presenting it as a promising and novel anti-fibrotic agent. 1
NXP002 is differentiated as it is a new form of tranilast and will be formulated for delivery direct to the lungs by inhalation, a new route of administration for this drug.
Delivery by the inhalation route is a well-known strategy for treatment of lung diseases to yield greater efficacy and reduce systemic side-effects compared to oral treatment.
We have filed two patent applications on new forms of tranilast, one of which is granted and the other is issued in the US and undergoing examination in other territories.
Our studies have yielded positive data underpinning the potential of NXP002 as an IPF treatment, including potential for use in combination with standard of care therapy and support continuing to develop this asset.
Our studies have yielded positive data underpinning the potential of NXP002 as an IPF treatment, including potential for use in combination with standard of care therapy and support continuing to develop this asset.
The first of these studies demonstrated that NXP002 can be efficiently delivered to the lung, achieving significant drug levels, whilst limiting systemic exposure compared to oral dosing
The second in vivo study evaluated the pharmacodynamics of NXP002 when delivered by nebulisation. This study showed that inhaled NXP002 could dose-dependently regulate the production of fibrosis-relevant mediators
The final planned study as part of the NXP002 pre-clinical data package is an in vivo study investigating the durability of the pharmacodynamic effect. The Company anticipates receiving the data for this study in early 2022 prior to seeking licensing/partnering opportunities.
Nuformix plc (LON:NFX) announces unaudited results for the six months ended 31 March 2024, highlighting progress in drug repurposing for fibrosis and oncology.
Nuformix plc (LON:NFX) to raise £150,000 through a subscription for 75,000,000 new ordinary shares to fund the NXP002 programme for idiopathic pulmonary fibrosis.
Nuformix plc (LON:NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, has announced its audited results for the eighteen months ended 30 September 2023 following the change in the Company’s accounting reference date from 31 March to 30 September.
Non-Executive Directors’ Statement
Introduction
The key priority for the directors continues to be to focus on the Company’s early-stage pipeline of preclinical assets and ensure strength in the areas of drug development, business development and financial control within the Group. We operate a lean structure with the limited Board and bring in specialists and consultants, experts in their field, to support the business as required.
Pipeline
Nuformix has an early-stage pipeline of preclinical assets in development to address the high unmet medical need in fibrosis and oncology. We target solutions using our expertise to develop and file patent applications on novel crystalline forms of existing, marketed drugs, that have improved physical properties, with the aim of developing novel products in new indications to create attractive commercial opportunities. Importantly, the commercial opportunity is optimised when the repurposed product is differentiated from the original marketed drug by way of either dose, route of administration or presentation.
Drug repurposing is a well-known and successful strategy for enhancing the therapeutic and commercial value of marketed drugs, and their development typically brings a greater probability of success compared to developing newly discovered drugs, due to the existing data that has been generated on the marketed drug. This existence of data may also result in lower overall development costs and shorter development timelines.
The Group’s business model is to take these assets to key value inflection points before partnering or licensing. We conduct our R&D activities through out-sourcing, to enable us to access the different types of expertise that are needed for drug R&D and to minimise our operational costs. We have a strong network of external contractors, with whom we have had relationships over many years.
NXP002 (novel proprietary form of tranilast) – Idiopathic Pulmonary Fibrosis (“IPF”)
NXP002 is the Group’s preclinical lead asset and a potential novel inhaled treatment for IPF and possibly other fibrosing interstitial lung diseases (“ILDs”). It is a proprietary, new form of the drug tranilast, which allows the drug to be delivered in an inhaled formulation.
IPF is a devastating lung disease associated with a higher mortality rate than many cancers. Thus, IPF represents a high unmet medical need such that the requirement for improved treatment options represents a significant commercial opportunity. IPF is classified as a rare disease and presents a global commercial market that is forecast to grow to US$8.8bn by 2027. Sales of standard-of-care therapies OFEV and Esbriet (now off patent) achieved US$3.5bn and US$0.8bn respectively in 2022.
Tranilast has a long history of safe use as an oral drug for asthma, keloids and hypertrophic scarring, but there is growing evidence that supports its potential use in other fibrotic conditions, including IPF. NXP002 is differentiated as it is a patent protected new form of tranilast that has been enabled for formulation and delivery direct to the lungs by inhalation, a new route of administration for this drug. The inhalation route is a well-known strategy for treatment of lung diseases to yield greater efficacy and reduce systemic side-effects compared to oral treatment. Discontinuation rates for standard-of-care IPF therapies can be as high as 80% in certain patient groups due to their debilitating systemic side-effects.
Effective inhalation therapies offer the potential to overcome these limitations of oral therapies. Nuformix owns granted patents protecting new forms of tranilast, in addition to a recently filed patent protecting its use with SoC in IPF, with patent prosecution progressing in major pharmaceutical territories.
As a potential treatment for IPF, which is a rare disease, NXP002 is a likely candidate for Orphan Drug Designation, which could provide additional product protection against potential competitors. The positioning of NXP002 as an inhaled treatment for IPF could be either as added to Standards of Care (SoCs) or administered as a monotherapy for patients non-responsive to SoCs and those declining these therapies due to side effects which impact quality of life.
The preclinical inhalation strategy, initiated by the Company has significantly progressed NXP002 demonstrating:
· it can be delivered in-vivo by a range of nebulisers at the optimum particle size for delivery to the deep lung;
· very high doses appear to be well-tolerated; and
· an in-vivo inhalation dose response was observed for inflammatory and fibrotic biomarkers that is consistent with all ex-vivo human IPF tissue studies to date.
Nuformix plc conducted studies in a new iteration of a 3D human IPF lung tissue using a disease and species relevant model that has been advanced to significantly reduce output variability. The results from these studies of NXP002 alone and in combination with current SoC, can be summarised as follows:
· NXP002 is well tolerated in ex-vivo human lung tissue with no signs of toxicity events;
· NXP002 alone delivers a strong, consistent anti-fibrotic and anti-inflammatory effect as demonstrated by modulation of the release of multiple biomarkers of fibrosis and inflammatio
· both high and low concentrations of NXP002 show an additive anti-fibrotic and anti-inflammatory effect to SoC;
· in particular, the higher concentrations of NXP002 with SoC’s deliver a near complete ablation of fibrosis biomarker release, yet at lower concentrations than have been seen in other preclinical models to date; and
· the clear, pronounced additive benefit of NXP002 on top of SoCs observed suggests that NXP002 will provide additional efficacy, even in patients responding to SoC therapy. This raises the possibility that NXP002 targets additional disease pathways to SoC’s when increasing the combined anti-fibrotic and anti-inflammatory response.
As announced on 18 May 2023, following success in suppressing biomarkers of fibrotic disease progression in human IPF lung tissue, the same samples were analysed to assess additional mechanistic and anti-inflammatory benefits on top of SoC’s and the results are summarised as follows:
· NXP002 alone delivers a strong, consistent anti-inflammatory effect as demonstrated by suppression of the release of inflammatory cytokines by over 90% for all cytokines studied; and
· the results further suggests that NXP002 will provide additional efficacy in combination with SoC’s, even in patients responding to SoC therapy alone.
Nuformix has developed a Target Product Profile (“TPP”) that is consistent with twice daily inhalation administration. To assess NXP002’s duration of action in relation to the TTP, the Company initiated work in an exploratory model in healthy human lung tissue. The model also bridges the Company’s successful preclinical work across a variety of LPS-challenge studies. The results are summarised as follows:
· NXP002 suppresses the release of inflammatory cytokines by healthy human lung tissue following LPS challenge; and
· a strong anti-inflammatory effect remains at 12 hours post drug dosing demonstrated by continued suppression of the release of inflammatory cytokines following LPS challenge, confirming NXP002 has a suitable duration of action to support its TTP of twice daily dosing.
Overall, the results further strengthen NXP002’s potential for development as a new inhaled treatment for IPF either in addition to existing therapies or as a monotherapy. The Board continues to be encouraged by the progress of the studies and the positive data generated to date, in particular the recent duration of action study results and is focused on next steps which include:
· expansion of the current studies to include further human IPF tissue donors to demonstrate the robustness of NXP002’s anti-fibrotic response alone and in SoC combinations; and
· formally commencing the NXP002 partnering process.
Post-period end on 23 October 2023, the Company announced that it was issued with an Official Decision to Grant Notice of Allowance for Japanese National Phase Patent Application No. 2020-555115 entitled “CRYSTALLINE TRANILAST SALTS AND THEIR PHARMACEUTICAL USE”. This patent, which has already been granted in the US, describes proprietary new forms of the drug tranilast being progressed by the Company as a potential novel IPF treatment. These proprietary drug forms uniquely enable delivery via an inhaled nebulised formulation.
NXP004 (novel forms of olaparib) – Oncology
The Group discovered novel forms of olaparib, a drug currently marketed by AstraZeneca, as Lynparza®. Lynparza® was first approved in December 2014 for the treatment of adults with advanced ovarian cancer and deleterious or suspected deleterious germline BRCA mutation. Since then, it has secured similar approvals in breast, pancreatic and prostate cancers with further trials on-going. These approvals have propelled Lynparza® sales to US$2.6bn in 2022 with industry analysts forecasting annual sales of US$9.7bn by 2028.
The Group has filed two patent applications on its novel forms of olaparib with the potential for patent life to 2040/2041.
The Company demonstrated enhanced performance of NXP004 cocrystals compared to olaparib. Subsequently, further preformulation studies allowed the Company to identify lead cocrystals to be progressed for further development.
Results from in vitro dissolution studies demonstrated that the two lead NXP004 cocrystals out-performed Lynparza®, both in terms of rate and extent of dissolution and release of olaparib.
Enhancement of dissolution in the currently marketed formulation of Lynparza® resulted in improved bioavailability versus the initial marketed product. Therefore, the NXP004 programme may offer potential to further increase olaparib bioavailability. In addition, the potential simplicity of NXP004-based formulations may offer improvements in product cost-of-goods versus the currently marketed product, which requires complex manufacturing methods.
These attributes position NXP004 for applications in line-extensions for the currently marketed product, or for possible development in future first-to-generic products.
The Company will now consider the design and execution of suitable preclinical pharmacokinetic models to further investigate and validate NXP004’s potential for enhancing the oral absorption of olaparib. Securing these data will enable commencement of discussions with potential commercialisation partners.
This work will direct and support future out-licensing discussions for NXP004.
NXP001 (new form of aprepitant) – Oncology
NXP001 is a proprietary new form of the drug aprepitant that is currently marketed as a product in the oncology supportive care setting (chemotherapy induced nausea and vomiting) exclusively licensed to Oxilio for oncology indications.
On 18 September 2023, the Company announced that Oxilio had acquired ownership of its NXP001 patent estate for which Nuformix received new immediate and near-term undisclosed milestone payments, whilst retaining further development milestones and royalties capped at £2 million per year.
Fundraising
On 13 April 2023, Nuformix plc completed a subscription to raise gross proceeds of £70,000 through a subscription for 35,000,000 new ordinary shares of 0.1 pence each in the capital of the Company at a price of 0.20 pence per share. The Subscription was undertaken with a single UK-based FCA regulated institutional investor. The New Ordinary Shares represented approximately 4.7 per cent. of the Company’s enlarged issued share capital.
In addition, the participant in the Subscription was issued with one warrant for every one New Ordinary Share subscribed for with an exercise price of 0.25 pence per warrant. These warrants are exercisable for two years from 21 April 2023. If the Warrants are exercised in full, it would result in the issue of an additional 35,000,000 new ordinary shares raising a further £87,500 for the progression of the Company’s business activities. The New Ordinary Shares and Warrants were issued pursuant to the Company’s existing share issuance authorities.
The net proceeds of the Subscription are being used by the Company primarily to further advance its NXP002 programme for the inhaled treatment of IPF.
Lanstead Subscription and Sharing Agreements
During the period the Company received proceeds from the Company’s subscription and associated sharing arrangements with Lanstead Capital Investors L.P., as announced on 14 December 2021, 17 January 2022 and 12 April 2022. The sharing agreements ended in October 2023, concluding this arrangement and the Company is due no further funds from Lanstead.
Business Development
During the period the Company has switched its focus to business development activities to explore partnering opportunities for both its NXP002 and NXP004 programmes, attending both the European Respiratory Conference in Milan and the IPF Summit in Boston. Those partnering activities are ongoing.
Summary and Outlook
The strategy of Nuformix plc is to continue to optimise value from its existing assets while maintaining tight control of costs. The proceeds from the Lanstead Sharing Agreements, the April 2023 fundraise proceeds and the milestone payment received from Oxilio in September 2023 and post-period in December 2023 have enabled the Group to continue to advance and exploit the current assets within the portfolio through selective additional R&D and business development activities as set out above. The Group is conducting business development/licensing activities for all its assets using a structured and data-driven approach, with the goal of seeking global licensing deals. Our focus and emphasis is to progress our NXP002 and NXP004 programmes where required to complete licensing transactions and achieve value creation to generate a return for shareholders.
We would like to thank all stakeholders and in particular our shareholders for their continued support and we look forward to the remainder of the year and beyond with confidence that significant value can be realised from our portfolio of assets over time.
Nuformix Plc provides a patent update for its NXP002 and NXP004 programs in fibrosis and oncology. Learn more in this interview with Executive Director Dr. Dan Gooding.
Nuformix plc (LON:NFX) Executive Director Dan Gooding joins DirectorsTalk to discuss an update on its NXP001 exclusive licensing agreement.
In this interview Dr Dan Gooding outlines what the revised agreement covers, explains what it means for Nuformix and how it will benefit from NXP001 now and in the future, progressing its core NXP002 and NXP004 programmes and how Dan sees the outlook for the company.
https://vimeo.com/865834609
Nuformix plc (LON:NFX) is a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology using drug repurposing
The company uses their expertise in discovering, developing and patenting novel drug forms with improved physical properties, to develop new products in new indications that are differentiated from the original by way of: dosage, delivery route or presentation, thus creating new and attractive commercial opportunities.
Nuformix plc (LON:NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, has announced its unaudited results for the twelve months ended 31 March 2023 following the change in the Company’s accounting reference date from 31 March to 30 September.
Executive Director Dr Dan Gooding joins DirectorsTalk Interviews to discuss interim results and an update on its programme NXP002.
Dan talks us through the interim highlights, reminds us of what the NXP002 programme is and what it does, provides us with a summary of the Inflammation results, the Duration of Action results and explains what is next for the Company and NXP002.
https://vimeo.com/828915050
Operational highlights
· The Company successfully conducted studies in state-of-the-art 3D human Idiopathic Pulmonary Fibrosis (“IPF”) lung tissue, using a disease and species relevant model, which initially focused on the anti-fibrotic action of NXP002 in combination with current standards-of-care (“SoC”). The results indicated:
o NXP002 alone delivered a strong, consistent anti-fibrotic effect as demonstrated by modulation of the release of multiple biomarkers of fibrosis; and
o Both high and low concentrations of NXP002 showed an additive anti-fibrotic effect to SoC.
· The anti-inflammatory action of NXP002 was subsequently investigated, post period end, in the same model and the results indicated:
o NXP002 alone delivered a strong, consistent anti-inflammatory effect as demonstrated by modulation of the release of multiple biomarkers of inflammation; and
o NXP002 increased the performance of SoCs in modulating the release of a panel of inflammation biomarkers associated with the progression of fibrotic lung disease.
· The Company additionally successfully conducted duration of action studies using an exploratory 3D human lung tissue model offering species relevance and NXP002 dosage control. This allowed investigation of NXP002’s anti-inflammatory action at various timepoints following challenge with lipopolysaccharide (“LPS”), a stimulant that induces measurable endpoints and pathways relevant to IPF progression. The results indicated:
o NXP002 suppresses the release of inflammatory cytokines by healthy human lung tissue following LPS challenge; and
o A strong anti-inflammatory effect remains at 12 hours post drug dosing demonstrated by continued suppression of the release of inflammatory cytokines following LPS challenge, confirming NXP002 has a suitable duration of action to support its Target Product Profile of twice daily dosing.
· In vitro dissolution comparisons of NXP004 co-crystals to Lynparza® (commercially available olaparib) demonstrated that the two lead NXP004 cocrystals selected out-perform Lynparza®, in terms of rate and extent of dissolution and release of olaparib.
Financial Highlights for the twelve months ended 31 March 2023
· Loss before tax £761,299 (31 March 2022: loss of £1,270,273).
· Loss on ordinary activities (after tax credit) of £760,136 (31 March 2022: loss of £1,108,994).
· Loss per share 0.11p (31 March 2022: loss per share 0.19p).
· Net assets of £4,228,204 (31 March 2022: £4,737,961) including £259,259 of cash and cash equivalents at 31 March 2023 (31 March 2022: £464,095).
· The Company’s accounting reference date and financial year end was changed from 31 March to 30 September.
· Post period end, on 13 April 2023, a subscription for 35,000,000 new ordinary shares at a price of 0.20 pence per share raised gross proceeds of £70,000. The subscription was undertaken with a single UK-based FCA regulated institutional investor. In addition, the participant in the subscription was issued with one warrant for every one new ordinary share subscribed for with an exercise price of 0.25 pence per warrant. These warrants could result in the issue of an additional 35,000,000 new ordinary shares raising a further £87,500 for progression of the Company’s business activities.
Dr Dan Gooding, Executive Directorof Nuformix, said:“Our interim report demonstrates the Company is continuing to generate value-adding data for its lead programmes whilst further optimising its operational costs. For NXP002, our pre-clinical strategy has delivered consistently positive results that allow us to tell a complete pre-clinical story to potential licensing partners for the first time anddemonstrate that inhaled treatment of IPF via NXP002 is a viable concept. Our near-term goals focus on our NXP002 programme, as we continue to generate robust data to support our out-licensing objectives, all achievable using existing funds thanks to our lean operational model which will continue to operate. We are greatly encouraged by our recent work in close-to-patient human tissue models, in particular the new data supporting NXP002’s duration of action and Target Product Profile. I am excited by our prospects for the remainder of the year as we formally commence partnering activities and look forward to sharing results as they emerge.”
Chairman’s statement
Following the change of the Company’s accounting reference date from 31 March to 30 September these interim results cover the 12 month period to 31 March 2023. The Company’s interim results for the six month period ended 30 September 2022 were announced on 13 December 2022 and the operational review below covers the subsequent period from 30 September 2022 to 31 March 2023, a period of further progress for the Company’s assets NXP002 and NXP004.
Operational review
NXP002 (new form of tranilast) – Idiopathic Pulmonary Fibrosis (IPF)
NXP002 is the Group’s pre-clinical lead asset and a potential novel inhaled treatment for IPF and possibly other fibrosing interstitial lung diseases (“ILDs”). It is a proprietary, new form of the drug tranilast, to be delivered in an inhaled formulation.
IPF is a devastating lung disease associated with a higher mortality rate than many cancers. Thus, IPF represents a high unmet medical need such that the requirement for improved treatment options represents a significant commercial opportunity. IPF is classified as a rare disease and presents a global commercial market that is forecast to grow to US$8.8bn by 2027. Sales of standard-of-care therapies OFEV and Esbriet achieved US$2.5bn and US$1bn respectively in 2021.
Tranilast has a long history of safe use as an oral drug for asthma, keloids and hypertrophic scarring, but there is growing evidence that supports its potential in other fibrotic conditions, including IPF. NXP002 is differentiated as it is a patent protected new form of tranilast that has been enabled for formulation and delivery direct to the lungs by inhalation, a new route of administration for this drug. The inhalation route is a well-known strategy for treatment of lung diseases to yield greater efficacy and reduce systemic side-effects compared to oral treatment. Discontinuation rates for standard-of-care IPF therapies can be as high as 80% in certain patient groups due to systemic side-effects. Effective inhalation therapies offer the potential to overcome these limitations of oral therapies. Nuformix has two patent families protecting new forms of tranilast, both of which have already been granted in major pharmaceutical territories, with patent prosecution progressing in additional territories of interest. In addition, in March 2022, a method of use patent application was filed specific to IPF treatment.
As a potential treatment for IPF, which is a rare disease, NXP002 is a likely candidate for Orphan Drug Designation, which could provide additional product protection against potential competitors. The positioning of NXP002 as an inhaled treatment for IPF could be either as added to SoC’s or administered as a monotherapy for patients non-responsive to SoCs and those declining these therapies due to side effects which impact quality of life.
The pre-clinical inhalation strategy, initiated by the Company has significantly progressed NXP002 demonstrating:
· it can be delivered in-vivo by a range of nebulisers at the optimum particle size for delivery to the deep lung;
· very high doses appear to be well-tolerated; and
· an in-vivo inhalation dose response was observed for inflammatory and fibrotic biomarkers that is consistent with all ex-vivo human IPF tissue studies to date.
The Company conducted studies in a new iteration of a 3D human IPF lung tissue using a disease and species relevant model that has been advanced to significantly reduce output variability. The results from these studies of NXP002 alone and in combination with current standards of care (“SoC”), can be summarised as follows:
· NXP002 is well tolerated in ex-vivo human lung tissue with no signs of toxicity events;
· NXP002 alone delivers a strong, consistent anti-fibrotic and anti-inflammatory effect as demonstrated by modulation of the release of multiple biomarkers of fibrosis and inflammation;
· both high and low concentrations of NXP002 show an additive anti-fibrotic and anti-inflammatory effect to SoC;
· in particular, the higher concentrations of NXP002 with SoC’s deliver a near complete ablation of fibrosis biomarker release, yet at lower concentrations than have been seen in other pre-clinical models to date; and
· the clear, pronounced additive benefit of NXP002 on top of SoCs observed suggests that NXP002 will provide additional efficacy, even in patients responding to SoC therapy. This raises the possibility that NXP002 targets additional disease pathways to SoC’s when increasing the combined anti-fibrotic and anti-inflammatory response.
As announced on 18 May 2023, following success in suppressing biomarkers of fibrotic disease progression in human IPF lung tissue, the same samples were analysed to assess additional mechanistic and anti-inflammatory benefits on top of SoC’s and the results are summarised as follows:
· NXP002 alone delivers a strong, consistent anti-inflammatory effect as demonstrated by suppression of the release of inflammatory cytokines by over 90% for all cytokines studied; and
· the results further suggests that NXP002 will provide additional efficacy in combination with SoC’s, even in patients responding to SoC therapy alone.
Nuformix has developed a Target Product Profile that is consistent with twice daily inhalation administration. To assess NXP002’s duration of action in relation to the Target Product Profile, the Company initiated work in an exploratory model in healthy human lung tissue. The model also bridges the Company’s successful pre-clinical work across a variety of LPS-challenge studies. The results are summarised as follows:
· NXP002 suppresses the release of inflammatory cytokines by healthy human lung tissue following LPS challenge; and
· a strong anti-inflammatory effect remains at 12 hours post drug dosing demonstrated by continued suppression of the release of inflammatory cytokines following LPS challenge, confirming NXP002 has a suitable duration of action to support its Target Product Profile of twice daily dosing.
Overall, the results further strengthen NXP002’s potential for development as a new inhaled treatment for IPF either in addition to existing therapies or as a monotherapy. The Board continues to be encouraged by the progress of the studies and the positive data generated to date, in particular the recent duration of action study results and is focused on next steps which include:
· expansion of the current studies to include further human IPF tissue donors to demonstrate the robustness of NXP002’s anti-fibrotic response alone and in SoC combinations; and
· formally commencing the NXP002 partnering process.
NXP004 (novel forms of olaparib) – Oncology
The Group discovered novel forms of olaparib, a drug currently marketed by AstraZeneca, a Lynparza®. Lynparza® was first approved in December 2014 for the treatment of adults with advanced ovarian cancer and deleterious or suspected deleterious germline BRCA mutation. Since then, it has secured similar approvals in breast, pancreatic and prostate cancers with further trials on-going. These approvals have propelled Lynparza® sales to US$2.7bn in 2021 with industry analysts forecasting annual sales of US$9.7bn by 2028.
The Group has filed two patent applications on its novel forms of olaparib with the potential for patent life to 2040/2041.
The Company demonstrated enhanced performance of NXP004 cocrystals compared to olaparib. Subsequently, further preformulation studies allowed the Company to identify lead cocrystals to be progressed for further development.
Results from in vitro dissolution studies demonstrated that the two lead NXP004 cocrystals out-performed Lynparza®, both in terms of rate and extent of dissolution and release of olaparib.
Enhancement of dissolution in the currently marketed formulation of Lynparza® resulted in improved bioavailability versus the initial marketed product. Therefore, the NXP004 programme may offer potential to further increase olaparib bioavailability. In addition, the potential simplicity of NXP004-based formulations may offer improvements in product cost-of-goods versus the currently marketed product, which requires complex manufacturing methods.
These attributes position NXP004 for applications in line-extensions for the currently marketed product, or for possible development in future first-to-generic products.
The Company will now consider the design and execution of suitable pre-clinical pharmacokinetic models to further investigate and validate NXP004’s potential for enhancing the oral absorption of olaparib. Securing these data will enable commencement of discussions with multiple potential commercialisation partners.
This work will direct and support future out-licensing discussions for NXP004.
NXP001 (new form of aprepitant) – Oncology
NXP001 is a proprietary new form of the drug aprepitant that is currently marketed as a product in the oncology supportive care setting (chemotherapy induced nausea and vomiting). Nuformix granted an exclusive license to Oxilio Ltd (“Oxilio”), a privately held pharmaceutical development company, to license NXP001 globally for oncology indications on terms previously disclosed. A programme of formulation development was defined. Significant progress has been made exploring numerous formulation adaptations. This work is detailed, time consuming and ongoing. Despite Covid related supply chain issues Oxilio have generated more cocrystal supplies to allow this work to continue.
Fundraising
Post period end, on 13 April 2023, the Company completed a subscription to raise gross proceeds of £70,000 through a subscription for 35,000,000 new ordinary shares of 0.1 pence in the capital of the Company (the “New Ordinary Shares”) at a price of 0.20 pence per share (the “Subscription”). The Subscription was undertaken with a single UK-based FCA regulated institutional investor. The New Ordinary Shares represent approximately 4.7 per cent. of the Company’s enlarged issued share capital.
In addition, the participant in the Subscription was issued with one warrant for every one New Ordinary Share subscribed for with an exercise price of 0.25 pence per warrant. These warrants will be exercisable for two years from Admission (“Warrants”). If the Warrants are exercised in full, it would result in the issue of an additional 35,000,000 new ordinary shares raising a further £87,500 for progression of the Company’s business activities. The New Ordinary Shares and Warrants were issued pursuant to the Company’s existing share issuance authorities.
The net proceeds of the Subscription will be used by the Company primarily to further advance its NXP002 programme for the inhaled treatment of IPF.
Outlook
The Company to continues to advance and exploit the current assets within the portfolio through the R&D and business development activities as set out above. The sharing agreement with Lanstead provides cash on a monthly basis until October 2023 to the Company to fund its lean operations and together with the funds raised in the April 2023 Subscription will provide the Company with sufficient financial resources until any such time that the Group’s R&D and targeted partnering activities require further resource.
The strategy of the Group is to continue to increase the value of its existing assets while maintaining tight control of costs, including conducting business development/licensing activities using a structured and data-driven approach, with the goal of seeking global licensing deals.
Financial Review
In the period, the Board has continued to focus expenditure on R&D activities that add value to the current assets while optimising the operation to minimise administrative expenditure and the operational cost-base.
Dr Julian Gilbert
Non-Executive Chairman
22 May 2023
Statement of Directors’ Responsibilities
We confirm that to the best of our knowledge:
1. this interim condensed set of financial statements has been prepared in accordance with UK adopted IAS 34 ‘Interim Financial Reporting’;
2. the condensed set of financial statements has been prepared in accordance with ASB’s 2007 Statement Half-Yearly Reports;
3. the condensed set of financial statements give a true and fair view of the asset, liabilities, financial position and profit or loss of the group and the undertakings included in the consolidation as a whole as required by DTR 4.2.4R; and
4. the interim management report includes a fair review of the information required by:
4.1. DTR 4.2.7R of the Disclosure Guidance and Transparency Rules, being an indication of important events that have occurred during the first six months of the financial year and their impact on the condensed set of financial statements; and a description of the principal risks and uncertainties for the remaining six months of the year; and
4.2. DTR 4.2.8R of the Disclosure Guidance and Transparency Rules, being related party transactions that have taken place in the first six months of the current financial year and that have materially affected the financial position or performance of the entity during that period; and any changes in the related party transactions described in the last annual report that could do so.
The directors of Nuformix plc are listed in the Group’s 2022 Annual Report and Accounts and the current board are set out on the Investors Information section of Nuformix’s website.
Nuformix plc (LON:NFX) Executive Director Dan Gooding joins DirectorsTalk to discuss an update on its NXP002 study results.
https://vimeo.com/812326995
Dan is delighted to remind us of what the NXP002 programme is and its purpose, take us through the key findings and explains the next steps following the success achieved.
Nuformix is a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing.
Nuformix plc (LON:NFX) Executive Director Dr. Dan Gooding reveals insights on new patents for NXP002 & NXP004, interim results, and future plans in an exclusive interview.
Nuformix plc (LON:NFX) Executive Director Dan Gooding caught up with DirectorsTalk for an exclusive interview to discuss the revised agreement with Oxilio for NXP001 and the progress on NXP002 & NXP004.
Q1: You’ve announced that Nuformix has entered into a revised agreement with Oxilio for NXP001. We understand that Oxilio already has an exclusive licence for NXP001 so could you outline what this revised agreement actually covers?
A1: Nuformix, which is central to all of its programmes, has used various technologies to secure intellectual property. In this case, and in all cases, actually in all of our programmes, intellectual property that protects re-enabled existing drugs to do new things and have improved performance and properties.
So, we’d licenced the intellectual property related to NXP001 to Oxilio in the past, and Oxilio have then been progressing the development of that asset exclusively under their R&D control. They have felt that that’s an asset that they would like to take 100% control of and actually own it as an asset instead of just having a simple licence.
That means that the terms of the licence agreement were transferred from that to a purchase agreement. Broadly, what that means is that there are new upfront payments due to NFX as Oxilio is a private company, the exact details of those payments remain commercially confident to Oxilio.
The net effect to us as a company is that we were responsible previously, under the terms of the licencing agreement, for the upkeep of that patent to estate, that that responsibility now sits with Oxilio. So, the net effect of these additional upfront payments and the reduced cost of having to maintain the IP estate are a material impact to the company in its current cash position.
So, both parties are very happy with the transaction. The details of the transaction previously were described as having development milestones and royalties, and, as we can see from the announcement today, there are development milestones retained and the royalties remain as previously announced.
Q2: What does the revised agreement for the group now and for in the future?
A2: It’s validation of the technology. Oxilio has worked with the technology in looking at how it might take the technology into various development programmes that it’s considering, it’s obviously happy with what it’s seen and has opted to take ownership of the asset.
So, it’s validation of the technology, additional upfront payments that we weren’t previously going to receive before, and then, as I’ve mentioned, a net impact on not having to maintain that IP estate.
What that means for us is that we now have additional reserves in which to focus into our NXP002 and NXP004 programmes which as previously described remain the core programmes to the business.
Q3: You’ve just mentioned NXP002 and NXP004 programmes, obviously you can progress those now, but can you just remind us where you are with those programmes?
A3: For those that are not familiar, NXP002 is a treatment for idiopathic lung fibrosis that the business is looking to progress. We have undergone a quite significant pre-clinical R&D process where we’ve been able to significantly de-risk numerous aspects of that programme as an inhalation therapy to treat IPF. As previously communicated, we are now focusing on business development opportunities for that programme and looking to engage with partners at that programme to take that programme forward collaboratively or exclusively with a partner, those discussions are ongoing.
Actually, we’re in a similar position with NXP004, we have data that supports potential applications of that for improved oncology products, and we are in discussions with potential partners on that.
Therefore, typically what happens is that during these discussion, data is presented to potential partners, sometimes partners like to see an additional experiment repeated or an additional data point collected. A transaction such as these will allow Nuformix to go off and do that, effectively dealing with any objections or questions it receives as part of that partnering process.
So, as communicated before, partnering these two core programmes remains our absolute focus and transactions such as these allow us to that really effectively given the process we’re undertaking.
Q4: Is there anything else you’d like to say to our listeners before we conclude?
A4: I think that those that are familiar with the business knows the phase that we’re currently in and focusing on the out-licencing of these assets, we’re running an effective process.
Out-licencing as an activity is not something that we are a stranger to as a business, either myself or the Chairman Julian Gilbert, in terms of programmes that he’s been involved with previously that are really quite analogous to what we’re trying to do with NXP002.
So, delighted with the progress that we’re making there and look forward to reporting back any development as we look to move forward our BD activities with both NXP002 AND NXP004.
Nuformix plc (LON:NFX) Executive Director Dan Gooding caught up with DirectorsTalk discuss what the NXP002 programme is & its purpose, key findings from the results, and what’s next for the company and the programme.
Q1: You’ve provided an update regarding the Company’s NXP002 programme, could you just remind us of what that programme is and its purpose?
A1: Before answering the question, I just want to step back a bit and give people that maybe haven’t heard of Nuformix story a little introduction to what the business is about exactly.
We are involved in drug development and that means that we develop various programmes up towards a proof of concept, demonstrating proof of concept, before looking to out-licence our programmes to a development partner. Also, you mentioned the keyword that differentiates us, we’re reprofiling, that means that we’re reusing old drugs and developing them in new ways.
So, that whole piece; licencing, reprofiling, M&A etc, is an area in which the team have proven quantity. What enables us to do this in a unique way is the IP that we have. We find ways of solving historic problems with drugs that have prevented their development or certainty caused problems in their development.
We’re able to finance solutions, patent those solutions and then look to out-licence the results of those improved drug forms indications for which we’re involved. The two indications which we’re are focussed is oncology and then also fibrosis, specifically the idiopathic lung fibrosis, and that’s the news that we’ve released with the updated results that we have. So, that’s the background to the business.
In terms of the work, it’s probably also useful just to describe a little bit about the molecule we’re developing, a little bit about the disease area as well so that the actual impact of the results that we announced could be understood.
Going back to the concept of drug reprofiling, we have a molecule known as ‘tranilast’, we have some improved proprietary forms of that molecule, this molecule is approved across Asia for oral use in Asthma and scar prevention.
More recently, it’s shown immense promise in fibrotic disease which have been validated during COVID so you had this kind of COVID-induced fibrosis. One of the limitations with this molecule is it can’t be developed orally for chronic diseases, for long term use.
However, what we have done is we have intellectual property that unlocks the ability to deliver tranilast to the lung, and it’s direct delivery to the lung and avoids the oral delivery problems. So, we’re actually progressing our NXP002 programme using tranilast as an inhaled treatment for IPF.
IPF, Idiopathic Pulmonary Fibrosis is a progressive lung disease with a really quite high mortality, you have lung tissue that becomes scarred and you have this progressive scarring effect, resulting in a loss of function. This means an ability to take on oxygen. So, if diagnosed with this disease, you have something like 2.5-5 years left in terms of median survival and those are quite unpleasant years as well.
It’s a rare disease but saying that there are two existing treatments that are approved, they don’t change the trajectory of a disease progression much. They are blockbusters in terms of sales, in spite of some quite severe side effects, even so severe that quite a few patients actually decline treatment. So, in summary, the disease area is commercially attractive and that’s a great unmet need.
Typically, patients are older males, anything from late 50’s to early 60’s, it’s a complex disease and it’s initiated by probably a lung injury event which I guess then incubates for something like a 10-20 year period.
The reason I’m mentioning this is because this complexity means it’s very difficult to reduce the disease down to a model that one can understand well and develop drugs for before moving into patients. The existing models don’t really reflect the disease very well and so, this is what today’s announcement is about. We’ve been able to access a model that uses human tissue and patients who are at really end-stage of the disease.
One of the few treatment options that’s actually successful in prolonging life in lung transplantation so patients that are at that end-stage of the disease who are lucky enough to be eligible for a transplant, we’ve actually found a way of getting access to the tissue once it’s removed from the patient.
We’ve been able to then, thanks to developments in the model, test NXP002 against human disease tissue and see how well we’re able to stop that progressive fibrotic process.
So, the results we’re announcing today, use a new iteration of that model that really decrease the variability in the results. This means we’re able to take a really high confidence view on what NXP002 can achieve alone but also in combination with standard care in stopping the progression of fibrosis in IPF.
Q2: Like you say, you’ve received results from the studies, could you give us a summary of those findings?
A2: One of the reasons that we’ve approached the study in the way that we have is that the last 6 months have seen data emerge for existing treatments, also standards of care, which mean that all patients diagnosed with IPF, unless they decline standard of care, will actually be receiving one of two drugs that are approved for use for IPF.
Given some of the side effect profiles that these drugs have, this is quite unexpected but caused this shift in how regulators and potentially development partners are considering new therapies.
So, we had to adapt really to that new thinking in line with standard of care and how new potential therapies in IPF will perform alongside those standards of care.
The objectives of this study were to use this new improved iteration of the human tissue model that allows us to test the much greater number of samples. It allows us to look at NXP002 alone, and in combination with standard of care to better understand the extent to which NXP002 can improve disease treatment.
What we saw were three key things:
Firstly, we saw no evidence of any toxic events, this is important because we’re taking a drug that’s been delivered orally in the past and now delivering it straight to the lung, we need to understand if there’s going to be any tolerability issues. All the data to that end was great.
We saw that NXP002 alone produced a really strong antifibrotic effect so this is looking at halting the progression of fibrosis in IPF.
Really, quite importantly, what we saw was that NXP002 when it was combined with standard of care, after 4 days of treatment of these tissue samples, only tissue samples treated with drug combinations of NXP002 and standard of care had lower levels of fibrosis biomarkers than when the study started.
So, really, this is absolutely the best case scenario that we could’ve wished for when thinking about the objectives of the study.
Q3: Just following the success achieved, what will be next for Nuformix and NXP002?
A3: As we are building out towards being able to initiate discussions with potential development partners and licencing partners, what we’re talking about is a switch of an oral drug into an inhaled treatment for a new disease. There’s a few things that we need to demonstrate as part of that process.
It’s really well accepted, I think now, that the particular drug in question here, tranilast, at the heart of NXP002 is an important molecule for treating fibrosis, I think that aspect is really well validated.
What we also demonstrated really well is that our IP allows inhaled delivery of this particular molecule, and that when we can deliver that molecule in an inhalation setting, that the molecule can leverage its pharmacology following inhalation. These are all boxes that we’ve nicely ticked as we move forward to initiating out-licencing discussions.
So, now what we’re looking at doing is really strongly validating this additive effect of NXP002 and standard of care. So, we’ve done this first study in one tissue donor, in order for licensees and potential partners to have confidence in that data, we need to demonstrate that in up to three donors of tissue. So, that’s one thing we’ll be looking at doing.
The other thing that we’ll be doing is taking existing samples from the study that we’ve just done. We’ve only looked at antifibrotic biomarkers in the study to date, now we’ve seen the data, we can have confidence and go and look at those existing samples in terms of anti-inflammation biomarkers, which is another really important component of treatment. So, that’ll be a second that we’ll do.
The last box, if you like, that we need to tick as well, is to demonstrate that following inhalation, or certainly that this molecule has a long duration of action in terms of the time for which it exerts its pharmacology. We’re actually using a healthy human lung tissue model to that and that’s work that’s just started so we’ll be looking at completing those studies as well in the coming weeks and months.
Depending on those results, we ‘re also looking to get to a point where we can demonstrate in three donors of healthy lung tissue, that we can show a really strong duration of action.
So, once we have this combined data set, duration of action shown, additive effect in terms of what NXP002 offers alongside standard of care and reducing fibrosis, we’ll be in a really strong position for which to initiate discussions. That is what the company will start to work on once we get to that point.
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