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 six months ended 30 September 2022.
Operational highlights (including post-period end)
· Initial pre-clinical inhalation studies undertaken with NXP002 demonstrated:
o the proprietary novel form can be delivered in-vivo by a range of nebulisers at the optimum particle size for delivery to the deep lung;
o very high doses appear to be well-tolerated in the lung; and
o an in-vivo inhalation dose response was observed for both inflammatory and fibrotic biomarkers associated with disease progression.
· Subsequently, the Company initiated studies in a state-of-the-art 3D human Idiopathic Pulmonary Fibrosis (“IPF”) lung tissue, using a disease and species relevant model, which will focus firstly on the anti-inflammatory and anti-fibrotic action of NXP002 in combination with current standards-of-care and secondly investigate duration of action.
· The Company presented NXP002 for the first time to the global IPF medical and pharmaceutical specialist community at the ERS Congress in Barcelona.
· A programme of work to progress NXP004 was initiated:
o scale-up of lead cocrystal production processes; and
o in-vitro dissolution comparison of lead co-crystals to Lynparza® (commercially available olaparib).
· Oxilio, the licensee of NXP001, is investigating aprepitant for the potential new treatment of cancer indications. Continuing efforts are being made with Quotient Sciences to explore the formulation development options of NXP001 to understand the feasibility of achieving bioavailability and a dosing regime adequate for treatment of this indication. This work, which is contingent on the manufacturing and supply of additional cocrystal material for testing and evaluation, is underway.
· Leadership team enhanced with the appointments of:
o Dr Julian Gilbert as Non-Executive Chairman, who brings significant pharma and biotech business development, corporate development and general leadership experience; and
o Dr Dan Gooding as Executive Director, who is a co-founder of Nuformix and was the Company’s CEO until June 2020. He instigated the Company’s NXP002 programme as an inhaled therapy for the treatment of IPF and has been acting as a consultant to the Company since March 2022.
Financial Highlights
· Loss before tax £423,677 (30 September 2021: loss of £449,023)
· Loss on ordinary activities (after tax credit) of £422,514 (30 September 2021: loss of £449,023)
· Loss per share 0.06p (30 September 2021: 0.08p)
· Net assets of £4,591,964 (30 September 2021: £5,250,968) including £389,840 of cash and cash equivalents at 30 September 2022 (30 September 2021: £1,071,831)
Dr Dan Gooding, Executive Director of Nuformix, said: “Our pre-clinical efforts to date demonstrate that inhaled treatment of IPF and related fibrotic lung diseases via NXP002 is a viable concept, a concept that it is becoming increasingly validated by clinical data emerging from the public domain. I expect our on-going penultimate pre-clinical studies to conclude that our data and IP support the progression of the programme towards patients for whom I believe NXP002 can address both the side effect and efficacy limitations of existing IPF treatment options. We hope to announce results for both NXP002 and NX004 in the near-term, with work on both programmes underway. Programme progression is being achieved using existing funds thanks to a lean operational model, which will continue to operate until our R&D and targeted partnering activities require further resource. I am excited by our prospects for the remainder of the year and look forward to sharing results as they emerge.”
Chairman’s statement
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 and where there is a need for additional treatment options. Thus, IPF represents a high unmet medical need and 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 allergies, but there is evidence that supports its potential in fibrosis, including IPF. NXP002 is differentiated as it is a new form of tranilast that is being formulated for 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. Nuformix has two patent families protecting new forms of tranilast, some members of which have been granted in major pharmaceutical territories, while others are still in prosecution. In addition, in March 2022 a method of use patent application was filed.
NXP002, as a potential treatment for IPF, is a likely candidate for Orphan Drug Designation which could provide additional product protection against potential competitors. The positioning of such an inhaled treatment for IPF could be either added to standard of care or administered as a monotherapy.
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;
· 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 previous ex-vivo human IPF tissue studies.
However, the pre-clinical inhalation disease model chosen proved to be complex, and unlike previous studies in human IPF tissue, it continues to be challenging to achieve consistent and reproducible results, which will likely increase in the study of combination therapies, which are now clearly required given the clinical trends intelligence gathered at the ERS. As a consequence, the Company initiated studies in 3D human IPF lung tissue using a disease and species relevant model that is now available commercially via a CRO. Work will focus on NXP002 in combination with current standards-of-care, with the ultimate aim of reducing their negative side effects whilst enhancing their efficacy.
NXP002 combinations have already shown great promise in human diseased IPF tissue, showing a pleasing synergistic efficacy effect with low doses of standards-of-care, resulting in the Group filing a new combination patent application earlier in 2022. The change in pre-clinical strategy, supported by intelligence gathered at ERS, is therefore aligned with and further enhances the Company’s overall patent position as it continues to build assets for eventual out-licensing.
The Company presented NXP002 for the first time to the global IPF medical and pharmaceutical specialist community at the ERS Congress in Barcelona. The Company’s NXP002 poster sessions were well-attended by, amongst others, potential licensing partners, while the conference confirmed that inhalation is now widely accepted as a future IPF treatment modality.
Overall, the Board is encouraged by the progress of the studies and the positive data generated to date and is considering next steps, including potential further R&D studies to add further value and licensing activities.
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.
The Company initiated work to progress the NXP004 programme in three key areas:
· commence scale-up of lead cocrystal production processes;
· compare in-vitro dissolution performance of lead co-crystals to the marketed Lynparza product; and
· based on the results from these studies a formulation development programme may be initiated. The aims of this work will be to develop prototype formulations that offer the potential to be both bioequivalent and ‘bio-better’ versus the Lynparza product.
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 licence to Oxilio Ltd (“Oxilio”), a privately held pharmaceutical development company, to license NXP001 globally for oncology indications on terms previously disclosed. Continuing efforts are being made with Quotient Sciences to explore the formulation development options of NXP001 to understand the feasibility of achieving bioavailability and a dosing regime adequate for treatment of this indication. This work which is contingent on the manufacturing and supply of additional cocrystal material for testing and evaluation is underway.
Board changes
In the period from April 2022 to September 2022 a number of Board changes have occurred:
· appointment of Dr Julian Gilbert as Non-Executive Chairman, previously a Non-executive Director, replacing Dr Alastair Riddell who resigned in May 2022
· appointment of Dr Dan Gooding as an Executive Director who is a was a co-founder of Nuformix and the Company’s CEO until June 2020
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 to the Company to fund its lean operations until 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 first half of the financial year, 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
12 December 2022
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 at: Investors Information – Nuformix
Dr Julian Gilbert
Non-Executive Chairman
12 December 2022
Further copies of this document are available from the company’s registered address and will be available on the company’s website later today.
