RNS 14 October 202015 Dec 2020 09:08
Reminder :
The gross proceeds of the Placing will be used to:
· fund a Phase III clinical trial of SNG001 in c. 900 COVID-19 patients across c. 20 countries, with an anticipated start date in Q4 2020;
· fund SNG001 manufacturing and device scale up activities, with the aim of producing c. 100,000 treatment courses per month in 2021;
· generate further data to support SNG001 clinical development, manufacturing processes and regulatory activities;
· strengthen the balance sheet for potential partnering discussions with regards to the SNG001 opportunity, working capital
This Announcement contains (or may contain) certain forward-looking statements with respect to certain of the Company's current expectations and projections about future events. These statements, which sometimes use words such as "aim", "anticipate", "believe", "intend", "plan", "estimate", "expect" and words of similar meaning, reflect the directors' beliefs and expectations and involve a number of risks, uncertainties and assumptions which may occur in the future, are beyond the Company's control and could cause actual results and performance to differ materially from any expected future results or performance expressed or implied by the forward-looking statement.
Anticipated start Q4 enrol 900 patients over 20 countries = £30 Million This equates to £33,000 cost per clinical trial patient.
On 14 October 2020 the Company was informed by the National Institute for Health Research (NIHR) that the Phase III trial has been badged in the UK as Urgent Public Health and will be recognised as a National Priority study. Notwithstanding this, the commencement of the trial will still be subject to normal regulatory and ethical approvals.
The Company is continuing its strategy of progressing inhaled IFN-beta for the treatment of severe viral lung infections. SNG001 shows great promise as a treatment for COVID-19 patients, as shown by the announcement of positive results from the hospital-based trial, with the data further supplemented by the positive interim analysis of SNG001 in COPD patients in September 2020. The Company is now fully-focused on expediting the next steps with SNG001 as a treatment for COVID-19 patients, including discussions with regulatory agencies to set out a route to a potential approval, and separately working with its manufacturing partners to achieve meaningful supply scale-up.
This pandemic is not going away. Vaccines, therapeutics and great life saving health workers combined will all play their part AND ALL be needed. Regulators ARE supporting Synairgen. Results WILL be brilliant.
HOLD HOLD HOLD.
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