OPTISCAN IMAGING LIMITED ASX Announcement 29 April 2022
APPENDIX 4C
QUARTERLY ACTIVITIES & CASHFLOW REPORT
QUARTER ENDED 31 MARCH 2022
Melbourne, Australia, 29 April 2022: Optiscan Imaging Limited (ASX: OIL) (Optiscan or the Company), a leader in medical technology using confocal laser endomicroscopy, is pleased to release its Appendix 4C - Quarterly Cashflow report and business update for the quarter ended 31 March 2021 (Quarter). All financial results are in Australian dollars and are unaudited.
Highlights for the Quarter
• Commenced a key management hire campaign in the quarter, resulting in several new hires including a Marketing Manager, Commercial Manager and Finance Manager, with others in progress
• Buttressed manufacturing capability with two new Precision Technician hires over the quarter
• Progress in University of Melbourne's Dental School (MDS) clinical study to improve screening, diagnosis and treatment of oral cancer with data analysis well advanced
• Progress continues in preparing for the application for FDA approval for the InVivage™ device for use in oral cancer screening and surgery in the United States. Laser safety testing has been completed
• Updated ethics application submitted with Royal Melbourne Hospital for next stage Breast Cancer Surgical Margin Assessment Study
• Total Cash Flows of ($1.3m) for the Quarter with Cash Flows from Operating Activities of ($1.2m) for the Quarter ending 31 March 2022.
New Hire Campaign
The appointment of new key management staff including in marketing, sales, finance, and operations reflect the exciting new stage of growth that the company is embarking on. Once FDA approval is received, these key appointments along with the existing management team, will underpin the company's global preparedness to commercialise and market Optiscan's unique technology.
Oral Cancer Surgery and Screening Application - InVivage™
Oral Cancer Trial at Melbourne Dental School
The Melbourne Dental School (MDS) trial to improve screening, diagnosis, and treatment of oral cancer continued in the March 2022 quarter with all planned imaging for this part of the trial to be completed by end of March 2022. Images from this study have been supplied for inclusion in Optiscan's FDA submission. Image analysis and correlation to pathology will continue into the second quarter, with the final report from this study due by the end of September 2022.
Australian Centre for Oral Oncology Research & Education
Significant progress has been made in oral lesion imaging by Professor Farah and his team in Perth, with new cases imaged with multiple dyes and correlated with histopathology. Advanced correlation study analysis has been undertaken for potential development of alternative molecular markers to enhance imaging and improve diagnostic accuracy.
Phone (61 3) 9538 3333 Websitewww.Optiscan.com
Adelaide Dental School
Several cases of ex vivo oral cancer have been imaged while refinements of technical protocols with the Adelaide team are ongoing. This study will prove feasibility of using ex vivo imaging as an alternative workflow pathway, potentially leading to other advanced studies.
Preparations for seeking United States Food and Drug Administration (FDA) approval for the InVivage™ device in the United States
During the Quarter, Optiscan continued to progress preparing for its application for 510(k) clearance to market the InVivage™ clinical device for use in human oral cancer screening and surgery in the United States. One of the few last hurdles have been passed, with laser safety testing being completed during the Quarter.
Optiscan has been working closely with United States based independent contract testing laboratories for medical devices and pharmaceuticals to progress various cleaning and disinfection tests. The nature of these tests means they involve various stages and iterations towards validation to satisfy FDA requirements.
Breast Cancer Surgical Margin Assessment Study
Updated ethics application was submitted with Royal Melbourne Hospital in the Quarter and is currently under review. This amendment is to increase the number of patients in the study, and to add imaging during the tumor cut-up stage in the pathology laboratory. This will allow a direct comparison between the images obtained from the external surface of the resected lump with the tumor and tumor margins from within the lump, and provide a direct comparison between the images obtained live and the pathology histopathology slides. This assessment will prove the feasibility of our ex vivo approach and allow preparation for a larger in vivo study.
Corporate Update and Outlook
$120k revenue was derived from Carl Zeiss orders shipped in the Quarter (2 processors and 1 service probe). Orders for 5 new processors were received in the Quarter from Carl Zeiss (of value EUR 188k), with an anticipated similar number for each subsequent quarter this year.
Cash receipts from customers during the quarter totalled $63k, with the company receiving $153k cash inflow from grant income in the quarter. Research and development cash costs during the quarter amounted to $597k. The Company incurred $214k in cash outlay on manufacturing and operating costs.
All related party payments noted in Section 6 of the accompanying Appendix 4C during the Quarter relate to payment of executive and non-executive director's fees and salaries.
This announcement has been authorised for release by the Board of Optiscan.
For investor queries, please contact:
Prof Camile Farah
CEO and Managing Director E:cfarah@optiscan.com
About Optiscan
Optiscan is a global leader in the development of microscopic imaging and related technologies for surgery and medical research. Based in Victoria, Australia, Optiscan was established in 1994, and listed on the ASX in 1997 (ASX: OIL). Optiscan has developed and patented endomicroscopic technology which enables real-time, 3D, 'in vivo' imaging of human tissue at the cellular level for cancer screening, diagnoses and in surgery.
Disclaimer
All statements other than statements of historical fact included on this announcement including, without limitation, statements regarding future plans and objectives of Optiscan or any of the other parties referred to herein, are forward-looking statements. Forward-looking statements can be identified by words such as 'anticipate", "believe", "could", "estimate", "expect", "future", "intend", "may", "opportunity", "plan", "potential", "project", "seek", "will" and o ther similar words that involve risks and uncertainties. These statements are based on an assessment of present economic and operating conditions, and on assumptions regarding future events and actions that are expected to take place. Such forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties, assumptions and other important factors, many of which are beyond the control of the Company, its directors and management of Optiscan that could cause actual results to differ from the results expressed or anticipated in these statements.
Rule 4.7B
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Name of entity
OPTISCAN IMAGING LIMITED
ABN
81 077 771 987
Quarter ended ("current quarter")
31 MARCH 2022
Consolidated statement of cash flows | Current quarter $A'000 | Year to date (9 months) $A'000 |
| 63 (597) (175) (31) - (575) (74) - 5 - - 153 - | 754 (1,699) (928) (107) - (1,347) (311) - 16 - (77) 1,144 2 |
(1,231) | (2,553) |
2.
Cash flows from investing activities
2.1
Payments to acquire or for:
(a) | entities | - | - |
(b) | businesses | - | - |
(c) | property, plant and equipment | (39) | (43) |
(d) | investments | - | - |
(e) | intellectual property | - | - |
(f) | other non-current assets | - | - |
Page 1 |
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows | Current quarter $A'000 | Year to date (9 months) $A'000 |
| - - - - - - - - - | - - - - - - - - - |
(39) | (43) |
| - - - - - - - - (48) | - - 221 - - - - - (148) |
(48) | 73 |
4.
Net increase / (decrease) in cash and cash equivalents for the period
4.1
Cash and cash equivalents at beginning of period
4.2
Net cash from / (used in) operating activities (item 1.9 above)
4.3
Net cash from / (used in) investing activities (item 2.6 above)
7,237 (1,231)
8,442 (2,553)
(39)
(43)
Page 2
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Optiscan Imaging Limited published this content on 29 April 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 April 2022 03:31:02 UTC.
