Nuformix Regulatory News (NFX)

Nuformix plc

("Nuformix" or the "Company")

Nuformix Expands Licensing Agreement with Newsummit Biopharma for cancer supportive care product

Receives First Milestone Payment for NXP001

Cambridge, UK, 27 November 2018: Nuformix, the pharmaceutical development company using cocrystal technology to unlock the therapeutic potential of approved small molecule drugs, announces it has expanded its licensing agreement with Newsummit Biopharma ("NSB"), its Chinese licensing partner for NXP001, which is in development for cancer supportive care.

Nuformix will be carrying out an additional pre-clinical study on NXP001 to further validate differentiated product opportunities. This will increase total milestone payments from NSB from £2.5 million to £3 million, following the addition of a second pre-clinical milestone of £500,000. NSB has now paid the Company the first milestone payment of £500,000, having achieved the first pre-clinical milestone for NXP001, as announced on 14 September 2018.

Data from the recent NXP001 studies carried out by Nuformix demonstrate additional commercial applications beyond its initial intended use as a generic alternative to the marketed reference product. Nuformix plans to carry out an additional pre-clinical study on NXP001 for differentiated product forms in early Q1 2019. Data from the additional milestone studies will support regulatory submissions in China to facilitate market approval of multiple NXP001-derived products.

The regulatory submission process is on-going in China with Nuformix supporting NSB, which has exclusive rights to NXP001 for marketing and distribution in China under its license agreement. Nuformix remains on track to commence its clinical studies for NXP001 in Q1 2019, with receipt of all milestone payments completed during Q2 2019.

Commenting on the news, Dr Dan Gooding, CEO of Nuformix, said: "The expanded licensing agreement demonstrates NSB's commitment to the commercialisation of NXP001 and its understanding of the commercial opportunity in China. This is a large, untapped and growing market, which in demographic terms has one third of global cancer patients. The milestone payment received validates Nuformix's business model and its commitment to reinvest initial revenues back into R&D, avoiding further fund-raising at this stage whilst maximising the potential value of its cocrystal platform."

The data also support Nuformix's business development activities for out-licensing the rest of world rights for NXP001. Nuformix confirms that, following these recent studies, it is in discussion with multiple parties regarding rest of world rights, which are expected to deliver further upfront and milestone payments for wider entry into the large and growing cancer supportive care market.

Global cancer rates are soaring and whereas treatments increasingly extend life, side effects can severely limit and delay treatment. Effective supportive care ensures a patient's treatment remains on track. NXP001 has the potential to enable wider patient access to an under-utilised product within the growing oncology supportive care market. Over the last decade, China has emerged as the second largest global market and is on course to become the largest single market, having previously been outside the top 10.

Market Abuse Regulation (MAR) Disclosure. Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 until the publication of this announcement via a Regulatory Information Service and accordingly, this inside information is now considered to be in the public domain.

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About Nuformix plc www.nuformix.com 

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

Nuformix has created an IP portfolio containing a range of granted patents covering cocrystal forms of five small molecule drugs. Nuformix is targeting high-value unmet needs with its lead programmes in oncology supportive care: NXP001 and fibrosis: NXP002.

Nuformix was established in Cambridge in 2009 and has invested in pharmaceutical cocrystal R&D, establishing world-class capability and know-how in cocrystal discovery and development, yielding multiple product opportunities. Nuformix plc shares are traded on the London Stock Exchange's Official List under the ticker: NFX.L.

About Newsummit Biopharma

Established in 2001, Newsummit Biopharma is committed to accelerating the translation of healthcare innovations into clinically relevant products and services, for the benefit of patients in China and the world.

Via its unique Collaborative Healthcare Organization (CHO) services model, Newsummit Biopharma leverages clinical, scientific, industrial, governmental and financial resources globally to create a unique, patient-centric healthcare product development ecosystem rooted in innovation. Newsummit Biopharma is a wholly owned subsidiary of Zhejiang Yatai Pharmaceuticals, a Chinese listed pharmaceutical company (SHE:002370) following its acquisition in 2017.