Epistem is a biotechnology company applying its expertise in epithelial stem cells in the areas of oncology and gastrointestinal diseases as well as dermatological applications.

Epistem has become recognised as a specialist in epithelial tissue and stem cell analyses. Our heritage is based on our expert science and know-how in the field of epithelial tissue and adult epithelial stem cell biology.

Epistem does not conduct research into embryonic stem cells or stem cell transplantation.

Founded in 2000, the Company originally formed part of the Paterson Institute for Cancer Research, UK. The founders and management are international experts in epithelial tissue, tumours and stem cell control and lead a team of experienced scientific staff, with specialist skills in the field.

Located in purpose-built office and laboratory facilities adjacent to The University of Manchester, UK, Epistem maintains close links with drug development companies, clinicians and academics in the field, ensuring that the Company remains at the forefront of stem cell science and technology development.


http://www.epistem.co.uk/

Director/PDMR Shareholding

RNS


RNS Number : 5808U

Epistem Holdings plc

03 December 2013


Epistem Holdings Plc ("Epistem" or the "Company")

3rd December, 2013

Directors' shareholdings

Epistem (AIM: EHP), the biotechnology and personalised medicine company, announces that it has today been notified that the Company's Chairman, David Evans, today has acquired 18,200 ordinary shares in the Company at a price of 328.25p through his Self-Invested Personal Pension.

Following this transaction, David Evans has a beneficial holding of 98,845 ordinary shares in the Company, representing approximately 1% of the issued share capital of the Company.

As of Nov 30, 2013, the consensus forecast amongst 3 polled investment analysts covering EpiStem Holdings Plc advises investors to purchase equity in the company. This has been the consensus forecast since the sentiment of investment analysts improved on Oct 22, 2013. The previous consensus forecast advised investors to hold their position in EpiStem Holdings Plc

Re Agreement

RNS


RNS Number : 8074V

Epistem Holdings plc

18 December 2013










RNS Press Release

For release: 18th December 2013: 7.00 AM



Epistem announces evaluation of Genedrive® by US Department of Defence for pathogen detection



Epistem Holdings Plc (LSE: EHP), the biotechnology and personalised medicine company, announces today a cooperative agreement with the US Air Force alongside an agreement with Johns Hopkins University - Advanced Physics Laboratory, to undertake the combat (in field use) evaluation of Epistem's Genedrive® handheld molecular device for pathogen detection. The agreement will commence immediately and provides Epistem with $0.6m (£0.4m) during the initial 6 month phase to develop and evaluate Genedrive® for the identification of three known disease pathogens. Successful completion of the initial evaluation phase will secure ongoing investment for the development and potential roll out of the handheld pathogen detection unit for the US Department of Defence.



Preparations for the 2014 launch of the company's first Genedrive® disease test in Tuberculosis continue, with progress to resolve the earlier reported software and firmware issues now nearing completion. Whilst unit testing is ongoing, preparations are now being made for the commencement of final stage clinical trials in support of Indian regulatory approval. Plans to undertake clinical trials in 2014 with the Foundation for Innovative New Diagnostics (FIND) have also commenced as a forerunner to securing a World Health Organisation (WHO) recommendation in 2015.

Epistem Holdings stake held by Odey Asset Mgt rises above 15%

By John Harrington

February 03 2014, 4:12pm
Epistem Holdings stake held by Odey Asset Mgt rises above 15%

Odey Asset Management has lifted its stake in biotech firm Epistem (LON:EHP) above 15%.

Epistem announced that Odey now owns 1.512mln shares, up 848,000 from its stake at the end of January.

On the same day, Epistem revealed Invested Asset Management no longer has any shares in the company, having sold its stake of 702,000 shares.

Pre Close Trading Update

RNS


RNS Number : 9235M

Epistem Holdings plc

22 July 2014






Company Epistem Plc

TIDM EHP.L (AIM)

Headline Pre-Close Trading Update

Released 22nd July: 7.00am UK



Epistem Holdings Plc

("Epistem" or "the Company")

Pre-Close Trading Update

Epistem (AIM: EHP), the personalised medicine and biotechnology company, today announces a pre-close trading statement for the year ended 30th June 2014.

Income over the full year remained solid and broadly in line with market expectations, with EBITDA losses expected to be around £2.5m reflecting the growing expenditure in preparation for launch of the Company's first product Genedrive®. Net cash at 30th June 2014 was £4.2m.

The Company expects to release its final results for the year ended 30th June 2014 on Tuesday 28th October 2014 and will hold an analysts' meeting on the day.

Successful Completion of Genedrive Trials

RNS


RNS Number : 4167V

Epistem Holdings plc

28 October 2014












RNS Press Release

For release: 28 October 2014: 7.01 AM



Successful completion of Genedrive® Indian clinical trials and regulatory submission

Epistem Holdings Plc (LSE: EHP), the personalised medicine and biotechnology company, announces today the successful completion of its Genedrive® Indian clinical evaluation study and the regulatory submission with the Drug Controller General of India (DCGI) of its first test for the diagnosis of Tuberculosis and Rifampicin antibiotic resistance (TB). Epistem is now awaiting approval from the Indian regulator for a license to import and sell its first major infectious disease assay for TB, which is anticipated early in 2015.



The clinical evaluation study was completed over a 4-month period ending September 2014 and involved the testing of 300 randomly referred and blinded pulmonary 'raw sputa' TB patient samples, with each Genedrive® test taking approximately 1 hour to complete. The test results demonstrated high levels of sensitivity (93%) and specificity (94%), versus the industry gold standard 'culture test' method for TB. The study also measured those patients showing resistance to the first line antibiotic Rifampicin, a growing concern due to irregular and incomplete treatment with differing regimens giving rise to the growth in Multi Drug Resistance-TB (MDR-TB) cases in India.



These levels of accuracy, speed to result and simplicity of operation compare favourably with other molecular and non-molecular TB test methods, such as culture which has lengthy turn around times to test result (culture testing typically takes up to 42 days to obtain a confirmed TB test result), microscopy which delivers less accurate results (lower sensitivity and specificity) and other competitive molecular tests which can require lengthy upfront extraction processes, extended timescales to test result and/or increased cost. Genedrive's advantage is its ability to deliver an industry leading speed to result, high levels of molecular accuracy and simplicity of use at low cost in remote/non laboratory-based settings, making it suitable for tackling disease in low-income countries and developing nations.



India is the highest TB burden country in the world with World Health Organisation (WHO) statistics for 2011 giving an estimated incidence figure of 2.2 million cases of TB for India out of a global incidence of 8.7 million cases *. Our Indian distributor partner Xcelris Lab is preparing for the launch of our TB test including first line antibiotic resistance (Rifampicin) detection.



Genedrive® (http://www.genedrive.com) has now commenced clinical evaluation studies in Nigeria, South Africa, Uganda and Brazil underpinned by funding from the Foundation for Innovative New Diagnostics (FIND), National Institute of Allergy and Infectious Disease (NIAID) and the Bill and Melinda Gates Foundation (BMGF). These studies will build on our Indian results to provide a dossier of support targeting a World Health Organisation (WHO) recommendation for our Genedrive® device and TB assay anticipated later in 2015.



Matthew Walls, CEO of Epistem commented: "The successful completion of the Genedrive®Indian study and submission for regulatory approval marks a vitally important milestone in the development of our flagship technology and moves us a significant step closer to commercial sales of our first TB product into India and the Indian sub-continent".

Final Results

RNS


RNS Number : 4182V

Epistem Holdings plc

28 October 2014










RNS Press Release

For release: 28th October 2014: 7.00 AM

Preliminary Results to 30 June 2014



Epistem Holdings Plc (LSE: EHP), the personalised medicine and biotechnology company, announces today its preliminary results for the year to the 30 June 2014. The Company has also announced today in a separate announcement the successful completion of the Genedrive® Indian Tuberculosis clinical evaluation study, and the filing of its Tuberculosis assay regulatory submission.



The 2013/14 financial year saw Epistem commence and successfully complete its Indian clinical evaluation study in advance of the planned launch of Genedrive® (www.genedrive.com), its revolutionary handheld molecular diagnostic device, whilst accelerating investment in its new product development programmes and delivering a solid set of financial results.



Financial and Operating Highlights

· Total sales of £5.8m (2013: £5.4m) driven by improving performance from the Personalised Medicine division and solid results from the Preclinical Research Services division.

· Successful completion of Genedrive® Indian clinical evaluation study and commencement of 'fast track' independently funded Tuberculosis clinical evaluation studies in Nigeria, South Africa, Uganda and Brazil.

· Development of 'Hepatitis C' collaboration with INSERM (Institut National de la Santé et de la Recherche Médicale) and Pasteur Institute for development of 'Hepatitis C' (HCV) test.

· Successful completion of ISO13485 medical device Quality Accreditation with scale up of units and assays underway in preparation for launch of Genedrive®.

· Ongoing patient stratification assessments in clinical trials for Genedrive® pharmacogenomic applications and collaborative discussions.

· Preclinical Research Services sales of £2.9m (2013: £2.9m) with strengthened offering in biodefence, leukemia imaging and rheumatoid arthritis.

· Following high levels of investment made in our Genedrive® technology, the Company reports an after tax loss of £1.7m (2013: £1.2m loss after tax).

· Cash reserves of £4.2m at June 2014, bolstered by recent Global Health Investment Fund investment, with Cash balance at 30 September 2014 of £7.9m.



Recent Developments

· Announcement today of market regulatory submission filed with the Indian regulator (Drug Controller General of India) for a license to import and sell Genedrive® for the molecular diagnosis of Tuberculosis; approval anticipated early in 2015.

· Announcement on 22 July 2014 of $8.0m (£4.7m) collaborative funding agreement with the Global Health Investment Fund I, LLC (GHIF) to support the roll-out of Genedrive® as part of the Global Access Programme.

· Joined Global Alliance TB Drug Susceptibility Test Consortium in collaboration with Bill and Melinda Gates Foundation, TB Alliance and PATH.

· Announcement today of Memorandum of Understanding (MOU) signed with Clinton Health Access Initiative (CHAI) to collaborate in bringing Genedrive® and TB diagnostic assay to markets in resource-limited countries.

Update re Indian regulatory approval
RNS
RNS Number : 9635J
Epistem Holdings plc
13 April 2015





RNS Press Release

For release: 13th April 2015: 7.00 AM


Indian Health regulator notification of import licence for Genedrive TB molecular diagnostic test

Epistem Holdings Plc (LSE: EHP), the personalised medicine and biotechnology company, announces today that in preparation for the launch of its first molecular diagnostic 'Point of Care' product for Tuberculosis, that its Indian partner Xcelris Labs has on 13th April 2015 via the website (http://www.cdsco.nic.in/forms/list.aspx?lid=2012&Id=3) been made aware that the Director General of Health Services, Ministry of Health and family Welfare, Government of India, will publish an approval letter in respect of the licence to import Epistem's Genedrive® Tuberculosis and antibiotic resistance molecular diagnostic kit.


A further update will be issued in due course on receipt of the formal approval letter.

UPDATE - Epistem partner receives licence to import Genedrive TB diagnostic

By Ian Lyall

April 23 2015, 8:14am
Xcelris Labs, Epistem’s distributor, will begin to place the device with key opinion leaders in the country.
Xcelris Labs, Epistem’s distributor, will begin to place the device with key opinion leaders in the country.


---ADDS BACKGROUND AND OPENING SHARE PRICE---

Epistem Holdings’ (LON:EHP) Indian partner has received a licence that will allow it to import the Genedrive molecular diagnostic test for tuberculosis.

Chief executive Matthew Walls said the green light from the Indian government provides “a powerful endorsement of our strategy of developing Genedrive for infectious diseases”. The licence runs for three years.

Xcelris Labs, Epistem’s distributor, will begin to place the device with key opinion leaders in the country.

It will also train and carefully monitor the operation of the first Genedrive field-based units to ensure the “rapid and accurate diagnosis of TB sufferers”.

CEO Walls said: “We are now focused on obtaining the support of Indian based key opinion leaders to support the use and adoption of our device and assays.

“We see great potential for our TB test and its technical and commercial advantages for roll out in low income and developing countries in addition to the emerging potential for our Genedrive platform in other disease areas.”

Genedrive is initially being targeted at TB market, but Epistem has been investigating its use in malaria, dengue fever, typhoid, HIV, HCV and a range of sexually transmitted diseases.

Epistem is expecting big things of its handheld diagnostic device, which can produce test results for a range of conditions within 30 minutes.

It is aiming to provide a 'gold standard' for the identification of TB and antibiotic resistance.

The World Health Organisation has publicly recommended that nations incorporate new rapid molecular tests for TB into their disease testing into their programmes.

After India, the plan is to roll out the Genedrive TB test worldwide.

The shares, up 33% in the past month, opened slightly higher at 318.7p each, valuing the business at just shy of £32mln.

proactiveinvestors/epistem-accelerating-global-push-of-unique-tb-diagnostic-device.