Pictor’s CEO, Dr Thomas Schlumpberger says: “The news of the Omicron variant has rocked the world. We are carefully investigating the implications for Pictor. It does stress that this pandemic is not going away anytime soon and knowing your immunity status through antibody testing will remain a priority. Pictor’s test which can detect both Spike Protein and Nucleocapsid Protein antibodies is going to be very much in demand as a consequence.
Positive samples from individuals who have been infected with the Omicron variant are being sourced by our team with urgency. The number of mutations in the Spike Protein may impact on the sensitivity of the PictArray SARS-CoV-2 assay for the Spike Protein antibody. The advantage of the PictArray assay is that it also detects Nucleocapsid protein antibodies unlike competing ELISA assays which are mostly based only on the Spike Protein antibody.
The COVID-19 pandemic remains the greatest health challenge the world has seen in the last century. Pictor has a role to play in fighting the pandemic with its multiplex platform that has allowed the development of the PictArray SARS-CoV-2 assay. The Board and Management of Pictor appreciate the support of shareholders as we meet the challenges of these uncertain times. Despite these challenges, I trust that this festive season will still allow you to have some respite as you enjoy the holiday season.
In the meantime, Pictor continues to make excellent progress in many aspects of its business – please see these details below.”
US CLINICAL TRIALS
During the next 10 days, clinical trials with the PictArray SARS-CoV-2 assay will take place at two sites: Boca Bio in Florida and Primex in Los Angeles.
One of our senior scientists, Dr Graham Bailey has arrived in the US to ensure staff at both sites are trained to the required standard for running the assay. Each site has a CL2 reader to be used in the trial. 200 negative samples and 100 positive samples will be tested to generate the data required for the EUA (Emergency Use Authorisation) submission.
Approval of the EUA is expected by February.
NEW ZEALAND CLINICAL TRIAL
Over 350 volunteers have been identified for the local PictArray SARS-CoV-2 trial. The trial is however being delayed by the bureaucracy associated with Ethics Approval. The team is however working assiduously to meet the detailed requirements for Ethics approval so that the trial can go ahead. This may delay the trial until the New Year.
GERMANY CLINICAL TRIAL
Earlier this year a plan was developed for a PictArray SARS-CoV-2 trial in Germany at the University Hospital Ulm, under the supervision of Professor Marion Schneider. The trial was delayed while the US has been the priority. To carry out this trial in this eminent institution under the supervision of such a thought leader Professor Schneider is a great opportunity for Pictor. A bank of samples has been created which will be used in a trial that will take place in the New Year.
INDIA CLINICAL TRIAL
India regulatory requirements dictate that both an Alpha and Beta clinical trials for PictArray SARS-CoV-2 take place in India before the product can be approved for marketing.
While the 96 well membrane free version of the product is being trialled and will be launched in US, NZ and Europe, in India, the product will be launched in the 16 well on-membrane format. This allows the much lower cost PictImager+ reader to be used in this market.
The goal is to have the product launched in India by April 2022.
A requirement of being granted an EUA, is to be able to have a manufacturing capacity equivalent to 500,000 tests per week within 3 months of the EUA being granted.
The two iONE1200s installed at Pictor and our contract manufacturer South Pacific Sera, have a capacity of half of that. Discussions with SPS on the feasibility of installing two more iONE1200s at SPS have been initiated.
The Series F funding round @ $1.25/share raised $3,748,921 of the targeted $7 million.
The shortfall of approximately $3.2 million will be raised at an increased share price of $1.50. The board considers this fully justified given the success of the Alpha Trial which confirmed that the PictArray SARS-SoV-2 test is highly accurate. This will be confirmed in the two US clinical trials that will take place in the next few days.
Shareholders wishing to take up their pro rata (or more) of this issue will have the option of paying for their share in instalments over a 6-month period from December 2021 through May 2022.