tranilast inhalation (NXP002) / Nuformix - LARVOL DELTA

Nuformix raises £210,000 to advance NXP002 and US Orphan Drug Application (Directors Talk Interviews) - "Nuformix plc...has announced a conditional placing to raise gross proceeds of £210,000 through the issue of 300,000,000 new ordinary shares in the capital of the Company at a price of 0.07 pence per share...The net proceeds of the Placing will be used by the Company to drive forward partnering discussions for its NXP002 programme, an inhaled treatment for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), as well as to provide funding to enable the submission of an application for Orphan Drug Designation in the USA for NXP002 in the treatment of IPF, and for general corporate purposes."

Financing • Idiopathic Pulmonary Fibrosis

Nuformix to present NXP002 data at ATS 2025 (Directors Talk Interviews) - "Nuformix plc...has announced its attendance at the American Thoracic Society Congress, taking place in San Francisco, USA, from 18 to 21 May 2025...The positive results from the recent analysis of data from studies of NXP002 in a precision-cut lung slice disease models using tissue from IPF and autoimmune ILD patients will be presented on 21 May within the Wednesday morning session titled 'Drug Discovery and Development in IPF: Challenges and Opportunities'."

Preclinical • Idiopathic Pulmonary Fibrosis

Confirmation of European Orphan Drug Designation for NXP002 Programme in IPF (Nuformix Press Release) - "Nuformix plc...is pleased to announce, further to the Company's announcement on 28 January 2025, that it has received notification from the European Medicines Agency's ('EMA') Committee for Orphan Medicinal Products ('COMP') of its positive opinion regarding Orphan Drug Designation ('ODD') in Idiopathic Pulmonary Fibrosis ('IPF') for tranilast, the active drug substance enabled for inhaled delivery in Nuformix's NXP002 lead programme....In its communication, the COMP confirmed that NXP002 satisfies the criteria for orphan designation and that the Company has established that NXP002 has the potential to be of significant benefit to those affected by IPF. The COMP also concluded that NXP002's additive effect in combination with anti-fibrotic agents, as well its potential to be used in patients intolerant to these medicines constituted a clinically relevant advantage."

Orphan drug • Idiopathic Pulmonary Fibrosis

Nuformix reports positive NXP002 results in lung disease models (Directors Talk Interviews) - "Nuformix plc...as announced results following the re-analysis of data from previous studies of NXP002 in a precision-cut lung slice (PCLS) disease model using tissue explanted from lung-transplant receiving patients with idiopathic pulmonary fibrosis (IPF) and...patients suffering from autoimmune ILDs (e.g. rheumatoid arthritis or systemic scleroderma) also have a high-mortality progressive fibrotic disease course which is not currently adequately treated....A clear dose response to NXP002 was observed across both extra cellular matrix ('ECM') biomarkers and pro-fibrotic mediators suggesting NXP002’s activity in additional pathways to standards of care..."

Preclinical • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease • Rheumatoid Arthritis • Scleroderma

Notice of Allowance of NXP002 Patent in Japan (Nuformix Press Release) - "Nuformix plc...is pleased to announce that it has been 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'. NXP002 is the Company's lead asset and a potential novel inhaled treatment for Idiopathic Pulmonary Fibrosis ('IPF')."

Patent • Idiopathic Pulmonary Fibrosis

"Prof. Luca Richeldi stating yesterday at #ATS2023 that inhalation is part of a brighter future for #IPF treatment #NXP002 #NFX" (@NuformixPlc)

Nuformix loss narrows; near-term goal to focus on NXP002 asset (Morningstar UK) - "Nuformix PLC on Monday reported a narrowed annual loss as it made progress on optimising costs and furthering its lead asset, NXP002. Nuformix is a London-based pharmaceutical development company targeting unmet medical needs in fibrosis and oncology. Shares in the firm were 1.4% higher at 0.24 pence on Monday afternoon in London....During the year, Nuformix successfully conducted studies in human idiopathic pulmonary fibrosis lung tissue. The studies initially focused on the anti-fibrotic action of its lead asset, NXP002, in combination with current standards-of-care. The anti-inflammatory action of NXP002 was subsequently investigated, post-period end. Idiopathic pulmonary fibrosis is a lung disease associated with a higher mortality rate than many cancers."

Sales • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

Nuformix raises GBP70,000 to fund NXP002 programme (Morningstar UK) - "Nuformix PLC on Monday said it has raised GBP70,000 through a subscription for 35.0 million new shares at a price of 0.20 pence each....The net proceeds of the subscription will be used by Nuformix primarily to further advance its NXP002 programme. NXP002 is a new form of tranilast which Nuformix is developing as a novel inhaled treatment for idiopathic pulmonary fibrosis."

Financing • Idiopathic Pulmonary Fibrosis

"#nfx Inhaled NXP002 attenuates LPS-induced inflammatory and fibrotic mediator production in the rat lung #pharma #azn #fipp #ciz @FiercePharma @fwpharma https://t.co/b7yqwEs2uu" (@watchtowerinv)

Preclinical • Fibrosis

Nuformix plc announces an update on the company's Nxp002 program (Market Screener) - "Nuformix...announced an update on the company's NXP002 program, a novel form of tranilast being developed as a new inhaled treatment for Idiopathic Pulmonary Fibrosis. The company recently announced the initiation of studies with a new iteration of a 3D lung tissue model for human IPF - a high-challenge, disease- and species-relevant preclinical model, in collaboration with its partner Fibrofind. The improvements in this model were intended to significantly reduce output variability."

Licensing / partnership • Preclinical • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

Nuformix Advances NXP002 Trial After Acquiring Human Tissue [Google translation] (Zonebourse) - "Nuformix PLC announced on Wednesday that, despite a longer than expected wait, human disease tissue has been acquired for its NXP002 program. Nuformix is ​​a London-based pharmaceutical development company targeting unmet medical needs in fibrosis and oncology through drug rehabilitation. NXP002 is a new form of tranilast that Nuformix is ​​developing as a new inhaled treatment for idiopathic pulmonary fibrosis. The company has already begun 3D human lung tissue studies of IPF using a disease- and species-relevant model, and is working with its partner, Fibrofind, focusing on NXP002 in combination with standards of care current....'We had to wait a little longer than expected to acquire suitable tissues, but I am delighted that the main part of this pivotal study, the further evaluation of NXP002 combination therapies, is now underway and I look forward to share the results when they become available.'"

M&A • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

Nuformix sees interims show a period of operational progress (Proactiveinvestors) - "Nuformix PLC...announced its unaudited results for the six months ended 30 September 2022, showing a period of operational progress....'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.'"

Preclinical • Idiopathic Pulmonary Fibrosis

Nuformix showcases proprietary tranilast programme to potential licensing partners (Proactiveinvestors) - "Nuformix PLC...presented NXP002, the company’s proprietary new form of tranilast, to a well-attended convergence of potential licensing partners at the European Respiratory Society (ERS) Congress in Barcelona....In a pre-clinical update, Nuformix stated that: NXP002 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 dose response was observed for inflammatory and fibrotic biomarkers that is consistent with previous ex-vivo human IPF tissue studies...Results will continue to be generated throughout 2022 with further updates to be announced in due course."

Preclinical • Idiopathic Pulmonary Fibrosis

Nuformix plc Announces Update Regarding the Company's NXP002 Programme, A Proprietary New Form of Tranilast, Being Developed as A Novel Inhaled Treatment for Idiopathic Pulmonary Fibrosis (Market Screener) - "Nuformix plc announced the following update regarding the Company's NXP002 programme, a proprietary new form of tranilast, being developed as a novel inhaled treatment for Idiopathic Pulmonary Fibrosis. The Company recently 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....Results will continue to be generated throughout second half of 2022 with further updates announced in due course, as appropriate."

Preclinical • Idiopathic Pulmonary Fibrosis

In vitro and ex-vivo evaluation of anti-inflammatory and anti-fibrotic effects of NXP002 in rat and human cells and lung tissue (ERS 2022) - "Introduction These studies investigated anti-inflammatory (AI) and anti-fibrotic (AF) effects of NXP002, a new salt form of tranilast and potential novel inhaled treatment for Idiopathic Pulmonary Fibrosis (IPF), in rodent and human cells and lung tissue. Conclusion NXP002 consistently demonstrated AI and AF effects in rat and human cells and lung tissue. Reductions in key biomarkers of fibrosis in IPF tissue support further evaluation of NXP002 as an inhaled therapy in IPF."

Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Pulmonary Disease • Respiratory Diseases • Transplantation • COL1A1 • FN1 • IL10 • IL6 • TGFB1

Inhaled NXP002 attenuates LPS-induced inflammatory and fibrotic mediator production in the rat lung (ERS 2022) - "Introduction Oral tranilast has been shown to attenuate fibrosis clinically but has limited use due to low bioavailability and systemic side effects. Conclusions This study demonstrates that inhaled NXP002 is well tolerated. Inhaled delivery has a superior effect on fibrosis related mediators whilst having a reduced systemic exposure than oral dosing."

Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Inflammation • Pulmonary Disease • Respiratory Diseases

Nuformix initiates inhalation studies using new delivery method (Proactiveinvestors) - "Results are expected to be generated throughout the second half of 2022 as development milestones are achieved....Beginning in August, the further studies are part of its plans to generate a robust pre-clinical data package to support the progression of NXP002, both in terms of product development and business development discussions, the company said, after the inconclusive results of a recent study."

Preclinical • Idiopathic Pulmonary Fibrosis

Nuformix Shares Drop After NXP002 Trial Results Were Inconsistent, Failure to Identify New Chief (Market Watch) - "Shares in Nuformix PLC dropped on Monday after it said that results from a final preclinical study of its NXP002 treatment for idiopathic pulmonary fibrosis were inconsistent with the first in-vivo study...Shares in the company at 0715 GMT were down 0.31 pence, or 36%, at 0.55 pence.The U.K. pharmaceutical-development company also said the search for a new chief executive has failed to identify a suitable candidate.Further studies of NXP002 will examine it as an inhaled product and test its efficacy in repeat lipopolysaccharide challenge studies, it said. Results are expected in or before the first quarter of 2023."

Preclinical • Stock price • Idiopathic Pulmonary Fibrosis

In vitro and vivo study of tranilast protects from acute respiratory distress syndrome and early pulmonary fibrosis induced by smoke inhalation. (PubMed, Burns) - "This study indicates that tranilast had a protective effect on acute respiratory distress syndrome and early pulmonary fibrosis of rats in vivo. In addition, tranilast promotes proliferation of AT-II and PMVECs but inhibits PFs proliferation, down-regulates secretion of inflammatory cytokines and alleviates oxidative stress of AT-II, PMVECs and PFs after smoke stimuli in vitro."

Journal • Preclinical • Acute Respiratory Distress Syndrome • Allergy • Asthma • Fibrosis • Hematological Disorders • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • IL1B • TGFB1 • TNFA

Nuformix 'delighted' with preclinical data for lead lung scarring treatment (Proactiveinvestors) - "Nuformix PLC...chief executive Dr Anne Brindley said she was ‘delighted’ by the readout from preclinical studies of one of its lead assets. Researchers assessed the potential of using NXP002 as an inhaled drug delivered directly to the lungs....Scientists carried out a lab-based evaluation to assess whether the compound could be reconstituted to be delivered by a nebuliser....The Nuformix team found this was possible. It was also able to show that the NXP002 made its way efficiently to the lung. Importantly, the study showed the drug could dose-dependently regulate the production of 'fibrosis-relevant mediators'."

Preclinical • Idiopathic Pulmonary Fibrosis

Notice of Allowance of Patent in US (Nuformix Press Release) - Nuformix...is pleased to announce that it has received a Notice of Allowance for a U.S. National Phase Patent Application No. 17/051,592 entitled 'CRYSTALLINE TRANILAST SALTS AND THEIR PHARMACEUTICAL USE'....NXP002 is the Company’s pre-clinical lead asset and a potential novel inhaled treatment for Idiopathic Pulmonary Fibrosis ('IPF'). It is a repurposed, new form of the drug tranilast, to be delivered in an inhaled formulation. Nuformix filed two patent applications on new crystalline forms of tranilast, one of which has been granted globally and this second patent application has now been allowed in the US and has also been approved for the 'Patent Prosecution Highway' which may accelerate examination in other countries."

Patent • Idiopathic Pulmonary Fibrosis

Nuformix CEO says £1.6mln of new funding will help take lead asset to ’next value inflexion point’ (Proactiveinvestors) - “…Nuformix PLC, has conditionally raised just under £1.6mln via an oversubscribed placing of shares at 2p each...the proceeds will be put to work to assess the feasibility of developing an inhaled version of NXP002, which has been developed to target idiopathic pulmonary fibrosis (IPF).…'We can drive forward the preclinical development plan for our lead asset (NXP002) to the next value inflexion point'.”

Financing • Preclinical • Idiopathic Pulmonary Fibrosis

Nuformix points to 2021 as the Inflection Point for its portfolio (Vox) - "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....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...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 company announced its plans to raise around £0.65m at a price of 2.8p a share back in October 2020...The proceeds will be used to maximise opportunities for the development pipeline, in particular for its lead asset, NXP002..."

Financing • Licensing / partnership • Preclinical • Idiopathic Pulmonary Fibrosis

Nuformix announces contract win and business update (Vox) - "...the Company has established a broader range of revenue sources and is currently in negotiations to out-licence all pan-Asian rights to the Company’s NXP002 programme....In spite of some delays, our negotiations with prospective partners in Asia for NXP002 are in good order and we are in an excellent position to conclude discussions as the present COVID-19 situation improves, which will be transformative for the Company. Progressing our NXP002...programmes remains our priority..."

Licensing / partnership • Idiopathic Pulmonary Fibrosis