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 year ended 31 March 2022.
Non-executive Directors’ Statement
Introduction
Following the departure of Dr Anne Brindley as Chief Executive Officer, and post period end, Dr Alastair Riddell as Executive Chairman, both to pursue other opportunities, 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.
To enhance the Group’s funding position to allow the continued work on the three assets in the pipeline, in December 2021, the Company undertook an equity fundraise, together with related sharing agreements, with Lanstead Capital Investors L.P., an institutional investor.
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 discover, develop and file patent applications on novel drug forms of existing, marketed drugs, that have improved physical properties, with the aim of developing novel products in new indications to bring 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 brand new 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 (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.
Idiopathic Pulmonary Fibrosis (“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 Company has already generated positive preclinical data on NXP002, demonstrating that:
– NXP002 can be formulated in a simple and stable solution suitable for inhaled delivery via nebulisation;
– NXP002 formulations for nebulisation can be efficiently delivered to the lung; and
– NXP002 can dose-dependently regulate the production of mediators relevant to lung fibrosis and inflammation following a lipopolysaccharide (“LPS”) challenge.
However, as announced post-period end on 30 May 2022, no conclusions could be drawn from an additional study undertaken to investigate the duration of action of NXP002 formulations. Subsequently further studies have been initiated to generate a robust pre-clinical data package to support the progression of NXP002, both in terms of product development and business development discussions.
These studies will directly address issues faced in the duration of action studies. Firstly, the Company will investigate a new formulation of NXP002 for inhalation, delivered using an alternative method designed to ensure consistent and controlled exposure is achieved. Secondly, the Company will explore a new range of doses to best optimise efficacy of treatment. The eventual aim of the studies is to confirm the formulation’s positive pharmacological profile towards the treatment of lung fibrosis and inflammation via inhalation and to assess its duration of action. Data from these inhalation studies will add to the Company’s current compelling pre-clinical dataset, to best support the development of NXP002 as a treatment for IPF and potentially other poorly treated fibrosing interstitial lung diseases.
Post-period, two abstracts describing NXP002 were peer-reviewed and accepted for presentation at the European Respiratory Society (“ERS”) International Congress 2022 being held in Barcelona on 4-6 September 2022.
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). On 23 September 2020, Nuformix granted an exclusive option to Oxilio Ltd (“Oxilio”), a privately held pharmaceutical development company, to license NXP001 globally for oncology indications on terms previously disclosed. The option was executed on 13 September 2021. Oxilio is investigating aprepitant for the potential new treatment of cancer indications. Oxilio has entered into a service agreement with Quotient Sciences and is conducting formulation development of NXP001 to determine whether it can achieve the bioavailability and subsequent dosing regimen required for this new indication.
NXP004 (novel forms of olaparib) – Oncology
The Group has discovered novel forms of olaparib, a drug currently marketed by AstraZeneca, under the Lynparza® brand name. 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, Lynparza® 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 these novel forms of olaparib with the potential for patent life to 2040/2041.
The Company previously demonstrated the enhanced performance of NXP004 cocrystals compared to olaparib. Subsequently further preformulation studies have allowed the Company to identify lead cocrystals from its patent estate to be progressed for further development.
Post-period, Nuformix reported that it initiated a programme of work to progress the NXP004 programme in three key areas:
· Commence the scale-up of lead cocrystal production processes;
· Directly 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.
Summary and Outlook
The strategy of the Group is to continue to optimise value from its existing assets while maintaining tight control of costs. In particular, the fundraise with Lanstead has enabled the Group to continue to advance and exploit the current assets within the portfolio through additional R&D and business development activities as set out above.
At the appropriate time for each asset, the Group plans to conduct business development/licensing activities for all its assets using a structured and data-driven approach, with the goal of seeking global licensing deals.
The Chairman last year acknowledged that there had been a series of changes over the years which we also experienced in the past year and more recently, however our focus and emphasis is on stability to progress the studies and achieve significant value creation to generate a real 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.
Julian Gilbert and Maddy Kennedy
Nuformix Non-Executive Directors
27 July 2022
