FIREBRICK PHARMA LIMITED 26 April 2022
ASX Announcement
March 2022 Quarterly Activity Report
Q3 FY22 HIGHLIGHTS
• Firebrick commences trading on the Australian Securities Exchange
• Two major Nasodine clinical trials planned for 2022
• Firebrick filing appeal against TGA initial decision for Nasodine
• Key US patent granted for Nasodine use in COVID-19
Firebrick Pharma Limited (ASX:FRE) (Company or Firebrick) is pleased to provide the business update for the quarter ending 31 March 2022, along with its Appendix 4C quarterly cashflow report.
REVIEW OF OPERATIONS
IPO
The Company filed its Prospectus with ASIC on 26 November 2021, offering 35 million shares at $0.20 per share, for a maximum raising of $7 million. The Company received subscriptions for the maximum raising and commenced trading on the Australian Securities Exchange on 28 January 2022, under the ASX code "FRE". Key projects for the Company that were highlighted in the Prospectus were two major clinicals trials.
Confirmatory Phase 3 Common Cold Trial
Plans for a second Phase 3 common cold trial were outlined in the Prospectus. This trial is designed to confirm the clinical efficacy of Nasodine® Nasal Spray ("Nasodine") as a treatment for the common cold in adults. The trial results are intended to be used in support of the regulatory approval of Nasodine in Europe and US, as well as Australia if required. Currently, the trial is planned to commence in May 2022.
Phase 2 COVID-19 Study
The Prospectus also highlighted plans for a multi-dose Phase 2 trial of Nasodine in the management of COVID-19. On 26 April 2022, the Company announced that the trial had started with the first patient having been recruited in South Africa. Depending on ongoing recruitment, the trial could be completed by August this year.
Appeal against TGA's initial decision
The Company's Prospectus stated (Section 2.4.3, p.21) that Firebrick was waiting for a formal letter from TGA confirming its initial decision and the reasons not to approve Nasodine in Australia based on the existing data. On 1 March 2022, the Company announced that it had received the letter and had decided to proceed with an appeal against TGA's initial decision not to approve Nasodine for sale in Australia, based on the existing clinical data. If successful, the appeal could lead to approval of Nasodine sometime in 2022. If unsuccessful, the Company will re-submit to TGA at the end of the year upon completion of the second Phase 3 trial.
Product development
Since listing, the Company has continued development work on a range of new products. These products include follow-on Nasodine products aimed at the common cold market, which would be launched after Nasodine Nasal Spray. The Company is also developing a range of products under a second brand, called Xilodine®, the first of which is expected to be launched in late 2023.
Patents
On 17 February 2022, the Company announced that the patent application covering the use of Nasodine in COVID-19 had been granted in the US. The US patent, dated 15 February 2022, is titled: "Prevention of infection by highly pathogenic viruses using topical application of povidone-iodine on mucous membranes." The patent has also been filed in Europe, Japan and other countries, as described in the Prospectus (section 5) and has been granted as an Innovation Patent in Australia.
Financial Overview
In the March quarter, net cash outflow from operating activities of $1.1m was higher than the December quarter mainly due to an increase in research and development costs of $559k and the exclusion of $422k received in the December quarter from government grants and tax incentives.
As at 31 March 2022, the Company had $8.8 million in cash reserves.
The Company provides the following disclosure required by ASX Listing Rule 4.7C.2 regarding a comparison of its actual expenditure since admission date against the "use of funds" statement in Section 8.3 of its Prospectus dated 26 November 2021 and lodged with ASX on 25 January 2022.
The table below provides the use of funds from the date of ASX admission on 28 January 2022 - 31
March 2022. The Appendix 4C covers the period 1 January 2022 - 31 March 2022
Use of Funds under Prospectus | Budgeted Expenditure $'000 | Actual Expenditure $0'000 |
Research & Development Sales & Marketing Manufacturing & Distribution General & Administration | 7,473 | 639 |
2,039 | 26 | |
48 | ||
3,274 | 466 | |
Total operating expenses | 12,834 | 1,131 |
Note: The above table represents budgeted expenditure for the period 1 Jan 2022 - 31 Dec 2023. Depending on Firebrick's progress and success in its programs, the Company may or may not require new capital in the future to complete the development and commercialisation of its intellectual property portfolio.
As per item 6 of the attached Appendix 4C cashflow report for the quarter, payments to related parties and their associates of $103k comprised of Executive Chairman and Executive Director/COO remuneration and Non-Executive Director Fees.
This announcement has been authorised for release by the Board of Firebrick Pharma Limited.
-ENDS
-
About Firebrick (FRE.ASX)
Firebrick is a pharmaceutical company founded in 2012 to develop and commercialise a nasal spray treatment for the common cold based around the potential of povidone-iodine as a broad-spectrum antiviral agent. The company's name comes from the colour of povidone-iodine (hex colour #b22222, called 'Firebrick'). The company owns numerous granted and pending patents, including a core patent that covers the use of intranasal povidone-iodine for the treatment and prevention of the common cold. This patent has already been granted in Australia, US, Europe and several other countries.
Media enquiries:
Heidi Cuthbert +61 411 272 366heidi.cuthbert@multiplier.com.au
Investor enquiries:
Investors@firebrickpharma.com
Rule 4.7B
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Name of entity
FIREBRICK PHARMA LIMITED
ABN
64 157 765 896
Quarter ended ("current quarter")
31 March 2022
Consolidated statement of cash flows | Current quarter $A'000 | Year to date (9 months) $A'000 |
| 1 (689) - (77) (16) (134) (223) - - (3) - - (4) | 4 (982) (283) (150) (38) (579) (610) - - (4) 422 (254) |
(1,145) | (2,474) |
2. 2.1
Cash flows from investing activities Payments to acquire or for:
ASX Listing Rules Appendix 4C (17/07/20)
(a) | entities | - | - |
(b) | businesses | - | - |
(c) | property, plant and equipment | (9) | (27) |
(d) | investments | - | - |
(e) | intellectual property | - | - |
(f) | other non-current assets | - | - |
Page 1 |
+ See chapter 19 of the ASX Listing Rules for defined terms.
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Firebrick Pharma Ltd. published this content on 26 April 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 April 2022 07:19:03 UTC.
