ValiRx Plc , the clinical stage biotechnology company, provides the following update on its subsidiary joint venture – PharmiWeb.com

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London, UK., 14 January 2020: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, provides the following update on its subsidiary joint venture, ValiSeek, and its cancer therapeutic, VAL401.

ValiSeek and ValiRxs joint venture partner Tangent Reprofiling Limited (a member of the SEEK group) (Tangent) have entered into a letter of intent (the LOI) with Black Cat Bio Limited (Black Cat), a newly incorporated special purpose vehicle to raise up to 5 million towards commercialising VAL 401 in order to progress VAL401 through the next clinical trial. Black Cat has entered into, and will fund, a service agreement with Zenith Partners, a private investment, corporate advisory and business transformation enterprise, to source the funding.

ValiSeek currently has a worldwide exclusive licence granted from Tangent to progress VAL401 to commercialisation.

ValiSeek is a 55.5% subsidiary joint venture of ValiRx with the objective to develop VAL401 in the treatment of late-stage non-small cell lung cancer and potentially other indications. Further information on VAL401 is set out below

The LOI provides that, subject to Black Cat raising a minimum amount (details of which are commercially sensitive), ValiSeek will revoke its license for the VAL401 patent portfolio and Tangent would execute a new IP licence with Black Cat and Black Cat would be responsible for funding and executing future clinical development of VAL401.

It is proposed (subject to a successful fund raise) that ValiSeek would enter into an agreement with its shareholders to undertake a corporate reorganisation whereby existing shareholders in ValiSeek would become shareholders in Black Cat.

Therefore, following any reorganisation, ValiRx would hold a proportional shareholding directly in Black Cat and would benefit accordingly from future commercial upside.

Black Cat would utilise the co-financing agreements outlined in the Letters of Intent announced on 26 March 2019 in order to deliver the clinical trial in an effective and cost efficient manner.

About VAL401

VAL401 is the reformulation of a generic drug that has over 20 years of clinical use for treatment of a chronic non-oncology disease in an oral capsule. The re-formulation allows the drug to access previously unexploited anti-cancer activity. VAL401 has completed a clinical Phase II trial for the treatment of late-stage non- small cell lung cancer with data from the completed trial indicating a palliative effect and an improvement of quality of life in the patients treated.

Dr Satu Vainikka, CEO of ValiRx, commented: I am pleased to be able to announce that ValiSeek has come to an agreement with Black Cat to secure the future development of VAL401, to the advantage of all parties.

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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ValiRx Plc , the clinical stage biotechnology company, provides the following update on its subsidiary joint venture - PharmiWeb.com

Genetically Modified Organisms – European Commission

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Food and feed generally originates from plants and animals grown and bred by humans for several thousand years. Over time, those plants and animals with the most desirable characteristics were chosen for breeding the next generations of food and feed. This was, for example, the case for plants with an increased resistance to environmental pressures such as diseases or with an increased yield.

These desirable characteristics appeared through naturally occurring variations in the genetic make-up of those plants and animals. In recent times, it has become possible to modify the genetic make-up of living cells and organisms using techniques of modern biotechnology called gene technology. The genetic material is modified artificially to give it a new property (e.g. a plant's resistance to a disease, insect or drought, a plant's tolerance to a herbicide, improving a food's quality or nutritional value, increased yield).

Such organisms are called "genetically modified organisms" (GMOs). Food and feed which contain or consist of such GMOs, or are produced from GMOs, are called "genetically modified (GM) food or feed".

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Genetically Modified Organisms - European Commission

Biotechnology – fb.org

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Biotechnology has proven to be an important tool for better sustainability and food security. It helps farmers grow more food while improving the environment. For example, biotechnology reduces the use of costly inputs and improves weed management, allowing farmers to reduce tillage for better soil, water and air quality. Today, roughly 90 percent of corn, cotton and soybeans grown in the U.S. have been improved through biotechnology, and farmers are choosing biotech traits when growing other crops such as alfalfa, sugarbeets and canola.

Despite rapid adoption by farmers and a strong scientific consensus that biotechnology does not pose health and environmental risks, regulatory burdens are slowing research and innovation of new biotech traits and are starting to reduce U.S. farmers international competitive advantage. In addition, activist groups routinely threaten the availability of new traits by blocking science-based regulatory decisions, filing lawsuits and advocating for labeling mandates.

GM crops require less water and fewer chemical applications than conventional crops, and they are better able to survive drought, weeds, and insects.

U.S. agriculture will maintain its competitive advantage in world markets only if we continue to support innovations in technology and grasp opportunities for future biotech products.

To improve regulation of biotechnology, Farm Bureau supports:

Farm Bureau encourages efforts to educate farmers to be good stewards of biotech crops to preserve accessand marketability.

Farm Bureau believes agricultural products grown using approved biotechnology should not be subject to mandatory labeling. We supportexisting FDA labeling policies and opposestate policies on biotech labeling, identification, use and availability.

On July 29, 2016 the president signed S. 764, the National Bioengineered Food Disclosure Standard, into law. While not perfect, S. 764 was a compromise that Farm Bureau endorsed. The law creates a uniform standard for the disclosure of ingredients derived from bioengineering and allows food companies to provide that information through an on-package statement, symbol or electronic disclosure. It also created a strong federal preemption provision to protect interstate commerce and prevent state-by-state labeling laws and was effective on the date of enactment. USDA has two years to develop the disclosure standards and Farm Bureau will be an active participant in the rulemaking process.

Farm Bureau supports active involvement and leadership by the U.S. government in the development of international standards for biotechnology, including harmonization of regulatory standards, testing and LLP policies.

This resource can help set the record straight on GMOs, to correct misinformation and show why biotechnology is so important to agriculture.

Benefits of Biotech Toolkit (PDF)

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Biotechnology - fb.org